JPWO2020106891A5 - - Google Patents
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- JPWO2020106891A5 JPWO2020106891A5 JP2021528452A JP2021528452A JPWO2020106891A5 JP WO2020106891 A5 JPWO2020106891 A5 JP WO2020106891A5 JP 2021528452 A JP2021528452 A JP 2021528452A JP 2021528452 A JP2021528452 A JP 2021528452A JP WO2020106891 A5 JPWO2020106891 A5 JP WO2020106891A5
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- sample collection
- collection container
- sealing cap
- sample
- connecting member
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- 239000000523 sample Substances 0.000 claims description 65
- 238000007789 sealing Methods 0.000 claims description 51
- 239000012472 biological sample Substances 0.000 claims description 29
- 239000012530 fluid Substances 0.000 claims description 25
- 230000000295 complement effect Effects 0.000 claims description 18
- 239000003153 chemical reaction reagent Substances 0.000 claims description 17
- 230000008878 coupling Effects 0.000 claims description 5
- 238000010168 coupling process Methods 0.000 claims description 5
- 238000005859 coupling reaction Methods 0.000 claims description 5
- 238000004891 communication Methods 0.000 claims description 4
- 238000000034 method Methods 0.000 claims 6
- 238000004321 preservation Methods 0.000 claims 1
- 230000000717 retained effect Effects 0.000 claims 1
- 238000000926 separation method Methods 0.000 claims 1
- 230000007246 mechanism Effects 0.000 description 9
- 238000011109 contamination Methods 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
Description
一つの態様では、接続部材及び、相補的な接続部材は、ねじ山を備える。相補的な接続部材のねじ山は、シーリングキャップの内側表面上に配置されてもよい。 In one aspect, the connecting member and the complementary connecting member include threads . A complementary connecting member thread may be arranged on the inner surface of the sealing cap.
一つの態様では、シーリングキャップを試料収集容器に連結させることは、試料収集容器の外側表面に配置された接続部材とシーリングキャップの内側表面に配置された相補的な接続部材とをねじ山を通して係合させることを含む。 In one embodiment, coupling the sealing cap to the sample collection container includes threaded engagement between a connecting member disposed on the outer surface of the sample collection container and a complementary connecting member disposed on the inner surface of the sealing cap. including matching.
以下により詳細に記載するように、バルブは、開いて試薬チャンバから試料収集チャンバ中へ試薬を放出させることが出来る。いくつかの実施形態で、選択的に移動可能なバルブの近位部分は、シーリングキャップと機械的に(例えば、摩擦フィットを介して)かみ合ってポストがシーリングキャップと調和して動くようになる。バルブヘッドは、それらの間に流体タイト接続を形成するポストの遠位部分に固定される。バルブヘッドは、試料収集容器の開口内にフィットするように形成及び成型され、そして、試料収集容器(又はそれらに連結した構造)の内側壁と係合するように形成及び成型されて配置されたカラーを備える。シーリングキャップを試料収集容器に連結させることで、バルブキャップは試料収集チャンバに入り、そして、それらの内側壁と係合する。シーリングキャップは、更に、試料収集容器(例えば、ねじ山を通した係合により)に固定されるので、ポストはシーリングキャップとかみ合って動き、そして、バルブキャップは動かないままである。このように、ポストはバルブヘッドに対して移動(例えば、回転)し、(例えば、物理的再構成を受けることにより)選択的に移動可能なバルブを開かせる。バルブキャップに対するポストの独立した動きは、例えば、バルブヘッドと試料収集チャンバとの間の力よりも小さいポストとバルブヘッドとの間(流体タイト接続を形成する)の力(例えば、摩擦力又は機械的にかみ合って克服するために必要とされる力)により可能になり得る。開いた配置に移動するとき、その前はポストにより形成され妨害されていた流体ベントは、バルブヘッドの本体中に形成されたアパーチャと少なくとも部分的に整合し、それにより、シーリングキャップの試薬チャンバから試料収集チャンバ中に試料保存溶液を連通するための溝を作成する。 As described in more detail below, the valve can be opened to release reagent from the reagent chamber into the sample collection chamber. In some embodiments, the selectively movable proximal portion of the valve mechanically engages the sealing cap (eg, via a friction fit) such that the post moves in unison with the sealing cap. The valve head is secured to the distal portion of the post forming a fluid tight connection therebetween. The valve head is shaped and shaped to fit within the opening of the sample collection container and is shaped and shaped and positioned to engage the interior wall of the sample collection container (or structure coupled thereto). Equipped with color. By connecting the sealing cap to the sample collection container, the valve cap enters the sample collection chamber and engages their inner wall. The sealing cap is further secured to the sample collection container (eg, by threaded engagement) so that the post moves in engagement with the sealing cap and the valve cap remains stationary. In this manner, the post moves (e.g., rotates) relative to the valve head to selectively open the movable valve (e.g., by undergoing physical reconfiguration). Independent movement of the post relative to the valve cap is caused by forces between the post and the valve head (forming a fluid-tight connection) (e.g., frictional forces or mechanical This can be made possible by the force required to engage and overcome the When moved to the open configuration, the fluid vent previously formed and obstructed by the post becomes at least partially aligned with the aperture formed in the body of the valve head, thereby removing the fluid from the reagent chamber of the sealing cap. Create a groove to communicate the sample storage solution into the sample collection chamber.
続けて、図1を参照しつつ、シーリングキャップ110及び、唾液漏斗(図示せず)は、接続機構を使用して試料収集容器102にそれぞれ独立して付けることが出来る。この接続機構は、例えば、ねじ山、スナップ又はプレスフィット接続、タング及びグラブ部材、差し込み接続若しくは、他のかみ合った又は機械的カップリング機構を備えることが出来る。例えば、漏斗は、相補的接続機構(例えば、相補的なねじ山、図示せず)を介して試料収集容器102に最初に付けることが出来る。使用者からの生体試料の受領を促進させた後、漏斗は、相補的な接続機構(例えば、漏斗を回して緩める、図示せず)を逆転させることにより除去することが出来、そして、シーリングキャップ110は、同様又は類似の相補的な接続機構を使用して試料収集容器102に固定することが出来る。例えば、図1に示すように、シーリングキャップ110は、相補的であり且つ試料収集容器102の外側表面上に配置された接続部材114(例えば、相補的なねじ山)とかみ合って働くシーリングキャップ110の内側円周壁上に配置された接続部材112(例えば、ねじ山)を備えることが出来る。 Continuing to refer to FIG. 1, the sealing cap 110 and saliva funnel (not shown) can each be independently attached to the sample collection container 102 using a connecting mechanism. The connection mechanism can include, for example, threads , snap or press-fit connections, tongue and grab members, bayonet connections, or other interlocking or mechanical coupling mechanisms. For example, the funnel can be initially attached to the sample collection container 102 via a complementary connection mechanism (eg, complementary threads , not shown). After facilitating receipt of the biological sample from the user, the funnel can be removed by reversing the complementary connection mechanism (e.g., unscrewing the funnel, not shown) and removing the sealing cap. 110 can be secured to sample collection container 102 using similar or similar complementary attachment mechanisms. For example, as shown in FIG. 1, the sealing cap 110 is complementary and operates in engagement with a connecting member 114 (e.g., complementary threads ) disposed on the outer surface of the sample collection container 102. A connecting member 112 (eg, a thread ) disposed on the inner circumferential wall of the connecting member 112 may be provided.
いくつかの実施形態で、漏斗と収集容器の間の接続機構は、溶液キャップと収集容器の間の接続機構とは異なる。例えば、漏斗は、収集容器上にプレスフィット又はスナップフィットされてもよく、一方、溶液キャップは、収集容器の外側部分上及び、溶液キャッの内側部分上に又はその逆に配置された相補的なねじ山の係合を通して回転して固定される。使用する付ける機構にかかわらず、試料保存流体は、試料収集チャンバ103中に導入されることが出来、そして、シーリングキャップ110が試料収集容器102に付けられた結果として、預けられた生体試料と混合される。先に提供されたように、これは、選択的に移動可能なバルブ104が開いたことによるものであり得、そして、試薬を開口バルブにより規定される流体ベント116を通って試料収集チャンバ103中に放出させる。 In some embodiments, the connection mechanism between the funnel and the collection container is different than the connection mechanism between the solution cap and the collection container. For example, the funnel may be press-fit or snap-fit onto the collection container, while the solution cap may be fitted with a complementary Rotationally fixed through engagement of threads . Regardless of the application mechanism used, sample storage fluid can be introduced into the sample collection chamber 103 and mixed with the deposited biological sample as a result of the sealing cap 110 being applied to the sample collection container 102. be done. As previously provided, this may be due to the selectively movable valve 104 opening and allowing reagents to flow into the sample collection chamber 103 through the fluid vent 116 defined by the open valve. to be released.
シーリングキャップ110は、試薬チャンバ111中に試薬の測定物を受容するように配置されており、そして、図1中の組立てられた試料収集システム100の断面図により示されるように、選択的に移動可能なバルブ104は、シーリングキャップ110と連結されている。ポスト106は、シーリングキャップ110中にスナップフィットで受容され得、その間に流体タイト接続を形成する。上記に示すように、ポストは、その中にシーリングキャップ110の内側側壁の突出部120が入り、ポスト106を安定化させる保持リング118を備える。いくつかの実施形態で、突出部120と保持リング118との間の相互作用により、シーリングキャップ110とポスト106との間の流体タイト接続を生じる。追加的に又は代替的に、ポストの上部カラー122は、シーリングキャップ110の本体中又は、試薬チャンバ111中に延び、そして、締まりばめを介して固定され、それにより、試薬チャンバ111とポスト106との間の流体タイト接続を生じさせる。保持リング118は、いくつかの実施形態で、ポスト106をキャップ110で固定し、そして、ねじ山を通した係合部材により固定された熱可塑性成分に一般的である変形を防止する。 Sealing cap 110 is positioned to receive a measurement of reagent in reagent chamber 111 and is selectively moved, as shown by the cross-sectional view of assembled sample collection system 100 in FIG. A possible valve 104 is connected with a sealing cap 110. Post 106 may be received in a sealing cap 110 with a snap fit to form a fluid tight connection therebetween. As shown above, the post includes a retaining ring 118 into which a protrusion 120 of the inner sidewall of the sealing cap 110 enters to stabilize the post 106. In some embodiments, the interaction between protrusion 120 and retaining ring 118 creates a fluid tight connection between sealing cap 110 and post 106. Additionally or alternatively, the post top collar 122 extends into the body of the sealing cap 110 or into the reagent chamber 111 and is secured via an interference fit, thereby connecting the reagent chamber 111 and the post 106. creating a fluid tight connection between the Retaining ring 118, in some embodiments, secures post 106 with cap 110 and prevents deformation that is common with thermoplastic components secured by threaded engagement members.
シーリングキャップ110と試料収集容器102との間の相補的なねじ山114,112は、相互に係合し、そして、シーリングキャップ110は、試料収集容器102の方向に進み、バルブヘッド108及び、ポスト106の連結された遠位部分は、試料収集チャンバ103の開口部に導入されるか又は、更に開口部中に延びる。バルブヘッド108のカラー126は、開口124を備えたバルブヘッドの遠位部分よりも大きい直径を有し、そして、この大きい直径のカラー126は、試料収集チャンバ103の開口部内にフィットするように形成又は成型されて、そこで、それらの側壁に係合する。バルブヘッド108とチャンバ側壁の係合に由来する反発力は、ポスト106とバルブヘッド108との間の力よりも大きい。トルク(又は他の力)が溶液キャップ110に適用されて、更に、溶液キャップ110を試料収集容器102に連結させ、ポスト106とバルブヘッド108との間の力は克服され、バルブヘッド108がそれぞれ動かない間、-シーリングキャップと直接結合している-ポスト106を、シーリングキャップに沿って回転させる。したがって、選択的に移動可能なバルブ104は、(図2中に示すように)閉じた配置から、ポスト106をバルブヘッド108内で回転させて、少なくとも部分的に流体ベント116を開口124と整合させる、(図1及び図3中に示すように)開いた配置に配置変換させる。 Complementary threads 114, 112 between sealing cap 110 and sample collection container 102 engage each other, and sealing cap 110 is advanced toward sample collection container 102 and threads 114, 112 between valve head 108 and post. The connected distal portion of 106 is introduced into or extends further into the opening of the sample collection chamber 103. Collar 126 of valve head 108 has a larger diameter than the distal portion of the valve head with opening 124 and this larger diameter collar 126 is shaped to fit within the opening of sample collection chamber 103. or molded therein to engage their side walls. The repulsive force resulting from the engagement of the valve head 108 with the chamber sidewall is greater than the force between the post 106 and the valve head 108. A torque (or other force) is applied to the solution cap 110 to further couple the solution cap 110 to the sample collection container 102 such that the force between the post 106 and the valve head 108 is overcome so that the valve heads 108 each While stationary, the post 106 - which is directly connected to the sealing cap - is rotated along the sealing cap. Accordingly, the selectively movable valve 104 rotates the post 106 within the valve head 108 from a closed configuration (as shown in FIG. 2) to at least partially align the fluid vent 116 with the opening 124. 1 and 3, and then repositioned to an open configuration (as shown in FIGS. 1 and 3).
使用者により獲得されたとき、上記に記載のキットは、組立てられ、そして、生体試料を保存するために使用することが出来る。具体的な実施で、生体試料は、生体試料収集容器102中に受容される。受容された生体試料は、生体試料チャンバ103中に直接入るか、又は、任意選択的に付属の漏斗の内側側壁にそって、重力の流れを介して導入されても良い。漏斗が使用されるとき、生体試料の受領をさせた後、生体試料収集容器102から漏斗は除かれる。シーリングキャップ110及び連結され閉じられたバルブは、バルブ104の遠位部分を生体試料チャンバ103により規定された開口部へ挿入し、そして、シーリングキャップ110を(例えば、キャップ110と容器102の間に相補的なねじ山112,114に沿ってシーリングキャップ110を回転させることにより)生体試料収集容器102上部の上に固定することにより、生体試料収集容器102と連結されて運ばれる。選択的に移動可能なバルブ104は、シーリングキャップ110が収集容器102上に固定され、バルブ104を閉じた配置から開いた配置へ転換させるとき、配置変換を受ける。シーリングキャップ110内に貯蔵された試薬は、試料収集チャンバ103と連通して、そして、いくつかの実施形態で、収集容器102は振られ又は、そうでなければ、かき回して、保存試薬の全部又は少なくとも一部が収集試料を覆い、そして混合されるようにさせる。試料は、シーリングキャップ110と容器102の間で形成された流体及び/又は空気タイトシールにより、化学的及び生物学的に外側の雰囲気から有益的に保存される。これは、試料汚染の機会を減少させ、そして、プロセシング施設への移動及び/又は保存中に証拠となる成分の完全性を維持することを助ける。 When obtained by a user, the kit described above can be assembled and used to store biological samples. In a particular implementation, a biological sample is received in biological sample collection container 102. The received biological sample may be introduced directly into the biological sample chamber 103 or via gravity flow, optionally along the inner sidewall of an attached funnel. When the funnel is used, it is removed from the biological sample collection container 102 after receiving the biological sample. The sealing cap 110 and the coupled closed valve may be inserted into the opening defined by the biological sample chamber 103 by inserting the distal portion of the valve 104 into the opening defined by the biological sample chamber 103 and inserting the sealing cap 110 (e.g., between the cap 110 and the container 102) into the opening defined by the biological sample chamber 103. The sealing cap 110 is secured onto the top of the biological sample collection container 102 (by rotating the sealing cap 110 along complementary threads 112, 114) and transported in conjunction with the biological sample collection container 102. Selectively movable valve 104 undergoes a positional transformation when sealing cap 110 is secured onto collection container 102, converting valve 104 from a closed configuration to an open configuration. Reagents stored within sealing cap 110 are in communication with sample collection chamber 103 and, in some embodiments, collection container 102 may be shaken or otherwise agitated to remove all or any of the stored reagents. Allow at least a portion to cover the collected sample and mix. The sample is advantageously preserved chemically and biologically from the outside atmosphere by the fluid and/or air tight seal formed between the sealing cap 110 and the container 102. This reduces the chance of sample contamination and helps maintain the integrity of the evidentiary components during transfer to a processing facility and/or storage.
Claims (15)
生体試料を受容する開口部を備えた試料収集容器(102)、
少なくとも部分的に試料収集容器の開口部と連結して配置された選択的に移動可能なバルブ(104)、並びに、
選択的に移動可能なバルブ(104)及び試料収集容器(102)と連結して配置されたシーリングキャップ(110)を備え、
前記選択的に移動可能なバルブ(104)は、
中空本体及び、その側面部分により規定された流体ベント(116)を有するポスト(106)、並びに、
ポスト(106)の遠位部分と連結し且つ、流体ベント(116)と選択的に整合可能な開口(124)を有するバルブヘッド(108)を備え、
前記シーリングキャップ(110)は、試料保存試薬を保存する試薬チャンバ(111)を備え、前記試薬チャンバ(111)はポスト(106)の中空本体と流体連通し、
シーリングキャップ(110)と試料収集容器(102)とを連結させることは、ポスト(106)とバルブヘッド(108)とを物理的再構成させて、流体ベント(116)が、試薬チャンバ(111)と試料収集容器(102)の間を流体連通させるように、バルブヘッド(108)により規定される開口(124)と整合するようになる、
生体試料を収集するシステム。 A system (100) for collecting a biological sample, the system comprising:
a sample collection container (102) with an opening for receiving a biological sample;
a selectively movable valve (104) disposed at least partially in communication with the opening of the sample collection container; and
a sealing cap (110) disposed in conjunction with a selectively movable valve (104) and a sample collection container (102) ;
The selectively movable valve (104) comprises:
a post (106) having a hollow body and a fluid vent (116) defined by a side portion thereof; and
a valve head (108) coupled to the distal portion of the post (106) and having an opening (124) selectively alignable with the fluid vent ( 116) ;
said sealing cap (110) comprises a reagent chamber (111) for storing sample preservation reagents , said reagent chamber (111) being in fluid communication with the hollow body of the post (106) ;
Coupling the sealing cap (110) and the sample collection container (102) physically reconfigures the post (106) and valve head (108) so that the fluid vent (116) is connected to the reagent chamber (111). aligned with an opening (124) defined by the valve head (108) to provide fluid communication between the sample collection container (102) and the sample collection container (102);
A system for collecting biological samples.
請求項1に記載の試料収集システムの試料収集容器で生体試料を受容する工程、および、
請求項1に記載の試料収集システムのシーリングキャップを試料収集容器に連結させて、シーリングキャップに連結された選択的に移動可能なバルブを開けさせ、それにより、シーリングキャップ内に保持された試料保存試薬を、試料収集チャンバ中に放出させる工程を備える、方法。 A method of collecting and preserving a biological sample, the method comprising:
receiving a biological sample in a sample collection container of the sample collection system of claim 1, and
The sealing cap of the sample collection system of claim 1 is coupled to the sample collection container to open a selectively movable valve coupled to the sealing cap, thereby causing sample storage retained within the sealing cap. A method comprising releasing a reagent into a sample collection chamber.
試料収集容器(102)、シーリングキャップ(110)及び、
任意選択的に、試料収集容器(102)と連結し且つ使用者から生体サンプルの受領を試料収集容器(102)の試料収集チャンバ(103)中に導くように配置された、漏斗を備え、
前記試料収集容器(102)は、
生体試料を試料収集チャンバ(103)中に受容するように配置されている開口を有する試料収集チャンバ(103)及び、試料収集容器の外側部分に配置された接続部材を備え、
前記シーリングキャップ(110)は、
試料保存試薬を保存する試薬チャンバ(111)及び、試料収集容器(103)の接続部材(112)と係合するよう配置された相補的な接続部材(114)並びに、シーリングキャップ(110)とつながれた選択的に移動可能なバルブ(104)を備え、
選択的に移動可能なバルブ(104)は、試料収集チャンバ(103)と連結するように配置され、
流体ベント(116)をその遠位部分で規定するポスト(106)及び、
ポスト(106)の遠位部分に連結され且つ開口(124)を規定するバルブヘッド(108)を備え、
選択的に移動可能なバルブ(104)は閉じた配置にあるとき、流体ベントはバルブヘッド(108)との流体タイト連結を形成し、
選択的に移動可能なバルブ(104)が開いた配置にあるとき、流体ベントは少なくとも部分的に開口(124)と整合している、キット。 A kit for collecting and storing biological samples, the kit comprising:
a sample collection container (102) , a sealing cap (110) , and
optionally comprising a funnel coupled to the sample collection container (102) and arranged to direct receipt of a biological sample from a user into a sample collection chamber ( 103) of the sample collection container (102);
The sample collection container (102) includes:
a sample collection chamber (103) having an opening arranged to receive a biological sample into the sample collection chamber (103) , and a connecting member arranged on an outer portion of the sample collection container;
The sealing cap (110) includes:
a reagent chamber (111) for storing sample storage reagents and a complementary connecting member (114) arranged to engage the connecting member (112) of the sample collection container (103) and a sealing cap (110) ; a selectively movable valve (104) ;
a selectively movable valve (104) arranged to communicate with the sample collection chamber (103) ;
a post ( 106 ) defining a fluid vent (116 ) at a distal portion thereof;
a valve head ( 108) coupled to a distal portion of the post (106) and defining an opening (124) ;
When the selectively movable valve (104) is in a closed configuration, the fluid vent forms a fluid tight connection with the valve head (108) ;
The kit, wherein the fluid vent is at least partially aligned with the opening (124 ) when the selectively movable valve (104) is in an open configuration.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862769740P | 2018-11-20 | 2018-11-20 | |
US62/769,740 | 2018-11-20 | ||
PCT/US2019/062484 WO2020106891A1 (en) | 2018-11-20 | 2019-11-20 | Sample collection system including sealing cap and valve |
US16/689,538 US11712692B2 (en) | 2018-11-20 | 2019-11-20 | Sample collection system including sealing cap and valve |
US16/689,538 | 2019-11-20 |
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-
2019
- 2019-11-20 AU AU2019384801A patent/AU2019384801A1/en active Pending
- 2019-11-20 WO PCT/US2019/062484 patent/WO2020106891A1/en unknown
- 2019-11-20 MX MX2021005918A patent/MX2021005918A/en unknown
- 2019-11-20 US US16/689,538 patent/US11712692B2/en active Active
- 2019-11-20 EA EA202191395A patent/EA202191395A1/en unknown
- 2019-11-20 CN CN201980089174.0A patent/CN113316646A/en active Pending
- 2019-11-20 CA CA3120708A patent/CA3120708A1/en active Pending
- 2019-11-20 EP EP19887385.3A patent/EP3884070A4/en active Pending
- 2019-11-20 KR KR1020217019069A patent/KR20210118065A/en unknown
- 2019-11-20 JP JP2021528452A patent/JP7413381B2/en active Active
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2022
- 2022-11-04 US US17/981,213 patent/US20230054207A1/en active Pending
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