JP6968538B2 - 生体試料から生体分子を収集し、移動し、保管するための装置 - Google Patents
生体試料から生体分子を収集し、移動し、保管するための装置 Download PDFInfo
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Description
試料はバイアルまたは管内に収集され、その例は図1に管10として示されている。当技術分野に公知の一般的な試料収集管などの、あらゆる適切なバイアルを使用できるが、試料、特に糞便試料を収集するための管を有することが望ましいはずである。これは他の管には見出られないある特定の特性を有するものであり、以下に説明する。
図5a〜図5cに例証されたように、キャップ26は、容積式破壊器または受容体および管の開放端を補完する、あらゆる適切な被覆であることが可能である。しかし理想的には、示されたような例示的キャップが特に好都合である。キャップ26は円筒形であり、ポリエチレン、ポリプロピレン、または関連プラスチックなどの耐久材料から作成することができる。キャップ26は、上端28および容積式破壊器に連結する開放端32を備える。一部の実施形態では、容積式破壊器が使用されない場合にキャップを管に直接連結することができる。開放端と上端との間のキャップの円筒壁はあらゆる所望の厚さであることが可能であるが、キャップを容積式破壊器または管に取り付けるために、確実に使用者が適切に把持するように堅固であるべきである。キャップは概ね中空の円筒形であることが可能であるか、またはその中に中実部を有することができる。キャップの上端28は所望通りに開閉されてもよく、いかなる所望の印の付いたラベルを貼られてもよい。
容積式破壊器は、一定量の試料を受領するための取り外し可能な受容体である。容積式破壊器は管の開放端から取り外し可能であり、通常試料を管に導入する前に試料の一部を収集するために使用される。例えば容積式破壊器は、解析に適切な約200mg〜2gの試料、例えば400mgの糞便を受領することができるが、異なる量の試料を収容するためにより大きいまたはより小さい大きさの破壊器が所望されてもよい。容積式破壊器は通常概ね中空であり、容積式破壊器が管およびキャップの形状を補完するように、例えば円筒形形状または多角形(六角形など)形状である。
例1、試料を収集し保管するための本装置の使用
例示的使用では、管はボールベアリングおよび試料内の核酸を保存するための組成物を備える。容積式破壊器は、試料を受領するための管の開放端に取り付けられ(例えばネジで留められ)、確実に封止を形成するために指で締められる。糞便試料などの試料は容積式破壊器の試料受領端部内に置かれる。使用者は試料を探り針、棒、スプーン、スワブ、舌圧子、へら、またはあらゆる他の器具で塗布することができる。
Cole SR, Young GP, Esterman A, Cadd B, Morcom J (2003) A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. Journal of Medical Screening 10:117-122.
Couch RD, Navarro K, Sikaroodi M, Gillevet P, Forsyth CB, Mutlu E, Engen PA, Keshavarzian A (2013) The approach to sample acquisition and its impact on the derived human fecal microbiome and VOC metabolome. PloS One 8(11):e81163.
Culligan EP, Sleator RD, Marchesi JR, Hill C (2013).. Metagenomics and novel gene discovery: Promise and potential for novel therapeutics. Virulence 5(3):399-412.
DiGiulio DB, Romero R, Amogan HP, Kusanovic JP, Bik EM, Gotsch F, Kim CJ, Erez O, Edvin S, Relman DA (2008) Microbial prevalence, diversity and abundance in amniotic fluid during preterm labor: a molecular and culture-based investigation. PloS One 3(8):e3056.
Evans JM, Morris LS, Marchesi JR (2013) The gut microbiome: the role of a virtual organ in the endocrinology of the host. The Journal of Endocrinology 218(3):R37-47.
Heaton KW, Radvan J, Cripps H, Mountford RA, Braddon FEM, Huges AO (1992) Defecation frequency and timing, and stool form in the general population: a prospective study. Gut 33(6):818-24.
Korecka A, Arulampalam V (2012) The gut microbiome: scourge, sentinel or spectator? Journal of Oral Microbiology 4: 1-14.
Kostic AD, Howitt MR, Garrett WS (2013) Exploring host - microbiota interactions in animal models and humans. Genes and Development 27: 701-718.
Lewis SJ, Heaton KW (1997) Stool form scale as a useful guide to intestinal transit time. Scandinavian Journal of Gastroenterology 32: 920-924.
Osborne JM, Wilson C, Moore V, Gregory T, Flight I, Young GP (2012) Sample preference for colorectal cancer screening tests: Blood or stool? Open Journal of Preventive Medicine 2(3): 326-331.
Palmer C, Bik EM, DiGiulio DB, Relman DA, Brown PO (2007) Development of the human infant intestinal microbiota. PLoS Biology 5(7): e177.
Claims (16)
- バイアルと、
試料を受領するための受容体であって、前記バイアルと連通し、前記試料を受領するための第1の開放端、および前記バイアルと係合するための第2の端部を含む受容体と、
キャップと
を備え、
前記受容体は、前記キャップの補完的なネジ山と係合するためのネジ山を備え、前記受容体のネジ山と前記キャップの補完的なネジ山との係合が、前記キャップの前記受容体への取り付けおよび固定を可能せしめ、
前記受容体は前記試料を破壊するための破壊部材をさらに備え、
前記キャップは、前記試料が前記受容体内にあるときに前記試料と係合するためのプッシャーを備え、前記プッシャーは、前記キャップの内部と連結した第1の端部、および前記試料を係合するための第2の端部を備え、
前記受容体が前記試料を受領し、前記受容体のネジ山と前記キャップの補完的なネジ山とが係合すると、前記受容体に前記キャップが取り付けられて固定され、前記プッシャーの第2の端部が前記試料と係合して、前記試料を前記受容体の前記破壊部材を介して前記バイアルの中に放出させることで、前記試料が前記破壊部材によって破壊される、
試料受領装置。 - 前記受容体は容積式破壊器である、請求項1に記載の試料受領装置。
- 前記受容体は200mg〜2gの試料を収容できる、請求項1または2に記載の試料受領装置。
- 前記受容体は400mgの試料を収容できる、請求項3に記載の試料受領装置。
- 前記破壊部材は、それを通って試料を前記バイアルの中に通過させるための1つまたは複数の開口、および試料が前記破壊部材を通過する際に試料を破壊するための前記開口の中に入る破壊突起を備える、請求項1〜4のいずれか1項に記載の試料受領装置。
- 前記プッシャーは凹型であり、前記破壊部材は凸型である、請求項1に記載の試料受領装置。
- 前記第2の端部は縁部および下端面を備える、請求項6に記載の試料受領装置。
- 前記バイアルは混合手段をさらに備える、請求項1〜7のいずれか1項に記載の試料受領装置。
- 前記混合手段は1つまたは複数のボールである、請求項8に記載の試料受領装置。
- 前記1つまたは複数のボールはボールベアリングである、請求項9に記載の試料受領装置。
- 生体試料内の生体分子を保存する方法であって、a)試料を獲得することと、b)請求項1に記載の試料受領装置を獲得することと、c)前記バイアルに取り付けられた前記受容体から前記キャップを取り除くことと、d)前記試料を前記受容体内に置くことと、e)前記受容体の上に前記キャップを置くことと、f)前記受容体のネジ山と前記キャップの補完的なネジ山とを係合させて、前記受容体に前記キャップを取り付けて固定し、それによって前記プッシャーの第2の端部が前記試料と係合し、前記試料を前記受容体の前記破壊部材を介して前記バイアルの中に放出することと、g)前記試料内の前記生体分子を保存するために、前記放出された試料を前記バイアル内の組成物と混合することとを含む、方法。
- 前記混合するステップは、前記放出された試料を混合手段で均質化することをさらに含む、請求項11に記載の方法。
- 前記混合手段は1つまたは複数のボールベアリングである、請求項12に記載の方法。
- 試料から生体分子を保存するためのシステムであって、
請求項8〜10のいずれか1項に記載の試料受領装置と、
前記試料受領装置に備えられたバイアル内の、前記試料から放出された前記生体分子を保存するための組成物と
を備え、
前記試料受領装置に備えられた破壊部材は、試料をバイアルの中に排出するためにプッシャーが受容体内で試料と係合したときに、前記試料を破壊するように配置されており、
前記装置に備えられた混合手段は、前記受容体から前記バイアルの中に一旦排出された前記破壊された試料を均質化するように配置されている、システム。 - 前記破壊部材は、それを通って前記試料を前記バイアルの中に通過させるための1つまたは複数の開口、および前記試料が前記破壊部材を通過する際に前記試料を破壊するために開口の中に入る1つまたは複数の突起を備える、請求項14に記載のシステム。
- 請求項1〜10のいずれか1項に記載の試料受領装置、および生体試料から生体分子を保存するための使用説明書を備える、キット。
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PCT/CA2015/050434 WO2015172250A1 (en) | 2014-05-14 | 2015-05-13 | Device for collecting, transporting and storing biomolecules from a biological sample |
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IL (2) | IL248634B (ja) |
MX (1) | MX2016014871A (ja) |
PL (1) | PL3146307T3 (ja) |
PT (1) | PT3146307T (ja) |
RU (1) | RU2696484C2 (ja) |
SA (1) | SA516380270B1 (ja) |
SG (2) | SG11201609187YA (ja) |
WO (1) | WO2015172250A1 (ja) |
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- 2015-05-13 EP EP15792173.5A patent/EP3146307B1/en active Active
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RU2016146466A3 (ja) | 2018-12-27 |
SG10201810090QA (en) | 2018-12-28 |
AU2015258711B2 (en) | 2020-09-10 |
SG11201609187YA (en) | 2016-12-29 |
IL280814A (en) | 2021-04-29 |
MX2016014871A (es) | 2017-03-27 |
ES2919135T3 (es) | 2022-07-22 |
RU2016146466A (ru) | 2018-06-14 |
CA2948678A1 (en) | 2015-11-19 |
AU2020281110A1 (en) | 2021-01-07 |
DK3146307T3 (da) | 2022-07-04 |
US20170072393A1 (en) | 2017-03-16 |
IL248634A0 (en) | 2017-01-31 |
RU2696484C2 (ru) | 2019-08-02 |
CN106461518B (zh) | 2021-09-10 |
CN106461518A (zh) | 2017-02-22 |
PL3146307T3 (pl) | 2022-11-14 |
EP3146307A4 (en) | 2018-02-28 |
PT3146307T (pt) | 2022-06-27 |
AU2022283752A1 (en) | 2023-02-02 |
AU2015258711A1 (en) | 2016-11-24 |
EP3146307B1 (en) | 2022-03-23 |
KR20170012281A (ko) | 2017-02-02 |
EP3146307A1 (en) | 2017-03-29 |
BR112016026305B1 (pt) | 2021-05-11 |
JP2020190562A (ja) | 2020-11-26 |
KR102491359B1 (ko) | 2023-01-25 |
SA516380270B1 (ar) | 2021-03-18 |
WO2015172250A1 (en) | 2015-11-19 |
JP2017519975A (ja) | 2017-07-20 |
IL248634B (en) | 2021-02-28 |
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