I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US0082213 81 B2
`
`c12) United States Patent
`Muir et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,221,381 B2
`Jul. 17, 2012
`
`(54) CONTAINER SYSTEM FOR RELEASABLY
`STORING A SUBSTANCE
`
`(56)
`
`References Cited
`
`(75)
`
`Inventors: Rod Muir, South Mountain (CA); Derek
`Kirkland, Chelsea (CA); Ian Curry,
`Kanata (CA); Roy Sunstrum, Richmond
`(CA); Paul Lem, Ottawa (CA); H.
`Chaim Birnboim, Ottawa (CA)
`
`(73) Assignee: DNA Genotek Inc., Ontario (CA)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 669 days.
`
`(21) Appl. No.:
`
`12/096,767
`
`CA
`
`(22) PCT Filed:
`
`Dec. 11, 2006
`
`(86) PCT No.:
`
`PCT /CA2006/002009
`
`§ 371 (c)(l),
`(2), ( 4) Date: Nov. 24, 2008
`
`(87) PCT Pub. No.: W02007/068094
`PCT Pub. Date: Jun. 21, 2007
`
`(65)
`
`Prior Publication Data
`
`US 2009/0216213 Al
`
`Aug. 27, 2009
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/748,977, filed on Dec.
`9, 2005.
`
`(51)
`
`Int. Cl.
`A61B 19100
`(2006.01)
`A61F 5132
`(2006.01)
`(52) U.S. Cl. ....................................................... 604/415
`( 58) Field of Classification Search . ... ... ... ... .. ... 604/ 411,
`604/412, 414-416
`See application file for complete search history.
`
`U.S. PATENT DOCUMENTS
`4/1986 Bocquet et al.
`4,583,971 A
`5/1988 Wong et al.
`4,741,346 A
`8/1992 Darr et al.
`5,140,043 A
`5,364,763 A
`1111994 Kacian
`5,496,562 A
`3/1996 Burgoyne
`10/ 1996 Classon et al.
`5,567,309 A
`9/1998 Burgoyne
`5,807,527 A
`10/1998 Hofmann et al.
`5,817,630 A
`11/ 1999 Bruno
`5,980,834 A
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`2072331
`12/1992
`(Continued)
`
`OTHER PUBLICATIONS
`
`http://www.simport.com/products/tubes-caps-and-vials/tubes/t501.
`html, Copyright 2009-2011. *
`
`(Continued)
`
`Primary Examiner - Melanie Hand
`(74) Attorney, Agent, or Firm - Clark & Elbing LLP;
`Kristina Bieker-Brady
`
`(57)
`
`ABSTRACT
`
`The present invention provides a container system for releas(cid:173)
`ably storing a substance. The container system includes a vial
`having a sample storage chamber and a piercing member for
`piercing a membrane in the lid, which membrane seals a
`substance within a reservoir in the lid until the membrane is
`pierced by the piercing member. The container system
`optionally includes a funnel. There is also provided a method
`and kit for use of such a container system.
`
`50 Claims, 15 Drawing Sheets
`
`2
`
`18
`
`ANCESTRY EX. 1001
`
`1
`
`

`
`US 8,221,381 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`6,138,821 A
`10/2000 Hsu
`6,176,836 Bl
`1/2001 Trudi! et al.
`6,242,188 Bl
`6/2001 Dattagupta et al.
`6,291,178 Bl
`9/2001 Schneider
`6,309,827 Bl * 10/2001 Goldstein et al. ............ 435/6.11
`1/2003 Lai et al.
`6,503,716 Bl
`6,551,777 Bl
`4/2003 Shuber et al.
`6,582,415 Bl*
`6/2003 Fowles et al.
`9/2003 Augello et al.
`6,617,170 B2
`6,716,392 Bl
`412004 Putcha et al.
`6,832,994 B2 * 12/2004 Niedospial et al.
`6,869,769 B2
`3/2005 Burgoyne
`1/2009 Birnboim
`7,482,116 B2
`2001/0008614 Al
`7/2001 Aronowitz
`2002/0026046 Al
`212002 Pasloske et al.
`2002/0081575 Al
`612002 Small et al.
`2002/0197275 Al* 12/2002 Sunvold et al . .......... 424/195.18
`2004/0038269 Al
`212004 Birnboim
`
`604/413
`
`604/411
`
`CA
`EP
`EP
`EP
`EP
`EP
`JP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`FOREIGN PATENT DOCUMENTS
`2236240
`10/1999
`0273015
`6/1988
`273015 A2 *
`6/1988
`0586024
`3/1994
`0734684
`10/1996
`1207208
`512002
`H6-78282
`1111994
`WO 89/06704
`7 /1989
`WO 91/02740
`3/1991
`WO 97/05248
`2/1997
`WO 97/48492
`12/1997
`WO 98/44158
`10/1998
`WO 99/29904
`6/1999
`WO 01/34844
`5/2001
`WO 01/60517
`8/2001
`WO 02/44691
`612002
`WO 03/104251
`12/2003
`
`OTHER PUBLICATIONS
`
`English translation of specification for EP 273015 A2, http://world(cid:173)
`wide.espacenet.com. *
`English translation of claims for EP 273015 A2, http:! /worldwide.
`espacenet.com. *
`Birnboim, "Effect of Lipophilic Chelators on Oxyradical-Induced
`DNA Strand Breaks in Human Granulocytes: Paradoxical Effect of
`1,10-Phenanthroline," Archives of Biochemistry and Biophysics
`294(1):17-21 (1992).
`Birnboim, "Extraction of High Molecular Weight RNA and DNA
`from Cultured Mammalian Cells," Methods in Enzymology 216: 154-
`160 (1993).
`Birnboim and Doly, "A Rapid Alkaline Extraction Procedure for
`Screening Recombinant Plasmid DNA," Nucleic Acids Research
`7(6):1513-1524 (1979).
`Birnboim and Jevcak, "Fluorometric Method for Rapid Detection of
`DNA Strand Breaks in Human White Blood Cells Produced by Low
`Doses of Radiation," Cancer Research 41:1889-1892 (1981).
`Clarke and Martell, "Stabilities of the Alkaline Earth and Divalent
`Transition Metal Complexes of the Tetraazamacrocyclic Tetraacetic
`Acid Ligands," lnorganica Chimica Acta 190:27-36 ( 1991 ).
`French et al., "Ultra-Rapid DNA Analysis Using HyBeacon™
`Probes and Direct PR Amplification from Saliva," Molecular and
`Cellular Probes 16:319-326 (2002).
`
`Garcia-Closas et al., "Collection of Genomic DNA From Adults in
`Epidemiological Studies by Buccal Cytobrush and Mouthwash,"
`Cancer Epidemiology, Biomarkers & Prevention 10:687-696(2001 ).
`Heath et al. "Use ofBuccal Cells Collected in Mouthwash as a Source
`of DNA for Clinical Testing," Archives of Pathology and Laboratory
`Medicine 125:127-133 (2001).
`Hiraide et al., "Speciation of Iron in River Water," Analytical Sci(cid:173)
`ences 4:605-609 (1988).
`Loens et al., "Detection ofMycoplasma Pneumoniae in Spiked Clini(cid:173)
`cal Samples by Nucleic Acid Sequence-Based Amplification," Jour(cid:173)
`nal of Clinical Microbiology 40(4): 1339-1345 (2002).
`Lum and Marchand, "A Simple Mouthwash Method for Obtaining
`Genomic DNA in Molecular Epidemiological Studies," Cancer Epi(cid:173)
`demiology, Biomarkers & Prevention 7:719-724 (1998).
`Nilsson et al., "Real-Time Monitoring of DNA Manipulations Using
`Biosensor Technology," Analytical Biochemistry 224:400-408
`(1995).
`Pershadsingh and McDonald, "A High Affinity Calcium-Stimulated
`Magnesium-Dependent Adenosine Triphosphatase in Rat Adipocyte
`Plasma Membranes," Journal of Biological Chemistry 255(9):4087-
`4093 ( 1980).
`Roberts et al., "UV Laser Machined Polymer Substrates for the
`Development of Microdiagnostic Systems," Analytical Chemistry
`69:2035-2042 (1997).
`Rymaszewski et al., "Estimation of Cellular DNA Content in Cell
`Lysates Suitable for RNA Isolation," Analytical Biochemistry
`188:91-96 (1990).
`Seutin et al., "Preservation of Avian Blood and Tissue Samples for
`DNA Analyses," Canadian Journal of Zoology 69: 82-90 ( 1991 ).
`Terasaki et al., "Saliva as DNA Source for HLA Typing," Human
`Immunology 59:597-598 (1998).
`van Schie and Wilson, "Saliva: A Convenient Source of DNA for
`Analysis of Bi-Allelic Polymorphisms of Fey Receptor IIA (CD32)
`and Fey Receptor IIIB (CD16)," Journal Immunological Methods
`208:91-101 (1997).
`Videira and Werner, "Assembly Kinetics and Identification of Pre(cid:173)
`cursor Proteins of Complex I from Neurospora Crassa," European
`Journal of Biochemistry 181:493-502 (1989).
`International Preliminary Report on Patentability for PCT /CA2006/
`002009 dated Apr. 23, 2008.
`Transmittal of the International Search Report and Written Opinion
`of the International Searching Authority for PCT/CA2006/002009
`dated Mar. 30, 2007.
`Transmittal of the International Search Report and the Written Opin(cid:173)
`ion of the International Searching Authority for PCT/CA06/000380
`dated Jul. 6, 2006.
`Communication from European Patent Office regarding EP
`03729743 dated Oct. 1, 2007.
`Transmittal of the International Search Report for PCT/CA03/00869
`dated Mar. 30, 2004.
`Written Opinion for PCT/CA03/00869 dated Jul. 20, 2004.
`Applicant's Letter in Response to the Written Opinion for PCT/
`CA03/00869 dated Jun. 3, 2004.
`Rule 71(3) EPC Communication for European Patent Application
`No. 06846923.8 dated Mar. 8, 2011.
`Office Action for Mexican Patent Application No. MX/a/2008/
`007253 dated Mar. 30, 2011 (English translation provided).
`Australian Office Action (AU 2006324337) dated Aug. 18, 2011.
`Notice of Reasons for Rejection for Japanese Patent Application No.
`2008-543626, dated Jan. 17, 2012. (English Language Translation
`Provided).
`* cited by examiner
`
`2
`
`

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`U.S. Patent
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`Jul. 17, 2012
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`Sheet 1of15
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`US 8,221,381 B2
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`c C\l--(cid:173)
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`'t"-
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`• C> -LL
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`3
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`U.S. Patent
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`US 8,221,381 B2
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`(!) -u.
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`4
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`

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`U.S. Patent
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`Sheet 3of15
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`US 8,221,381 B2
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`5
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`U.S. Patent
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`Jul. 17, 2012
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`Sheet 4of15
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`US 8,221,381 B2
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`)300
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`~-1
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`I
`I ,
`
`FIG. 4
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`100
`
`1
`
`FIG. 5
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`6
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`

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`U.S. Patent
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`Jul. 17, 2012
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`Sheet 5of15
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`US 8,221,381 B2
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`100
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`J300
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`1
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`100 J300
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`1
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`1
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`FIG. 6
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`FIG. 7
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`FIG. 8
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`7
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`U.S. Patent
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`A
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`104
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`108
`110
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`6
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`6
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`6
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`FIG. 9
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`8
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`U.S. Patent
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`Sheet 7of15
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`100
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`34
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`30
`~-32
`--34
`\ - - -33
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`FIG. 10
`
`FIG. 11
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`9
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`Jul. 17, 2012
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`Sheet 8 of 15
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`100
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`402
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`500
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`FIG. 13
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`506
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`FIG. 12
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`FIG. 14
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`10
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`U.S. Patent
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`Jul. 17, 2012
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`Sheet 9of15
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`500
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`30
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`32
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`500
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`sL
`FIG. 15
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`418
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`FIG. 17
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`400
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`422
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`530
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`I sL
`FIG. 16
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`11
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`Sheet 10 of 15
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`100
`106
`160
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`100
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`6
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`FIG. 18
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`500
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`-
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`FIG. 19
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`12
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`U.S. \latent
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`Sheet 11 of 15
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`502
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`FIG. 20
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`13
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`402
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`FIG. 21
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`14
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`FIG. 22
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`15
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`FIG. 23
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`16
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`102
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`1
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`6
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`FIG. 24
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`17
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`

`
`1
`CONTAINER SYSTEM FOR RELEASABLY
`STORING A SUBSTANCE
`
`RELATED APPLICATION
`
`This application is the U.S. National Stage oflnternational
`Application No. PCT/CA2006/002009, filed Dec. 11, 2006,
`which, in tum, claims the benefit ofU.S. Application Ser. No.
`60/748,977 filed on Dec. 9, 2005, the contents of which are
`hereby incorporated by reference in its entirety.
`
`FIELD OF THE INVENTION
`
`The field of the invention generally relates to a container
`system for releasably storing a substance.
`
`BACKGROUND
`
`US 8,221,381 B2
`
`2
`rod, rod holder), which increases the cost of manufacture of
`the container. Additionally, because the disk is held in place
`by friction fit, there must be a high degree of precision for the
`manufacture of the components of the container.
`There remains a need for an improved container system for
`releasably and reliably storing a substance.
`This background information is provided for the purpose
`of making known information believed by the applicant to be
`of possible relevance to the present invention. No admission
`is necessarily intended, nor should be construed, that any of
`10 the preceding information constitutes prior art against the
`present invention.
`
`SUMMARY OF THE INVENTION
`
`It is often desirable to store a substance, such as a liquid,
`solid, gas, mixtures thereof, or the like, in a container prior to
`mixing the contents of the container with another material.
`For example, it may be desirable to package and store a
`compound, or compounds, in a container for shipping and/or
`safe storage and handling, prior to combining the compound
`( s) with another material. It may be desirable to package and
`store a toxic compound in a container, prior to combining
`such a toxic compound with a detoxifying material. As well,
`it is often desirable to keep a concentrated active ingredient
`separate from a diluent until immediately prior to use.
`Moreover, it may be desirable to store and/or ship diagnos(cid:173)
`tic and/or nucleic acid preserving compositions prior to com(cid:173)
`bining such a substance with a biological sample.
`Additionally, it may be desirable to keep a substance iso(cid:173)
`lated from a donor until the donor's biological sample has
`been collected. This will help to prevent the donor from
`accidentally ingesting or spilling the substance.
`It may also be desirable to inactivate pathogens/infectious
`particles in a biological sample by combining it with a stored
`substance prior to storage and/or shipping and/or handling of
`the sample.
`It may also be desirable to store and/or ship diagnostic
`and/or nucleic acid preserving compositions after combining
`such a substance with a biological sample.
`There are a variety of containers for holding substances
`separately in such a manner that a user may open a closure to
`combine the substances. Typically these containers are
`double compartment systems in which substances are stored
`separately and substances are combined by removal of the
`container closures by a user.
`International PCT application WO 2003/104251 describes 50
`a container for collecting a biological sample from a subject,
`and subsequently mixing the collected sample with a compo(cid:173)
`sition intended to stabilize, preserve, or facilitate the recovery
`of components of the sample. This container has a first region
`for collecting a biological sample, a second region containing
`a composition for preserving a nucleic acid, and a barrier
`between the first region and the second region, which when in
`a closed position, maintains the sample and composition
`separate. The exemplified barrier of WO 2003/104251 is a
`pivoting partition. Attachment of a lid to the container forces
`the barrier to pivot from its original closed position spanning
`the container and thereby separating the first region and the
`second region, to an open position in which both regions are
`exposed to each other and contact between the composition
`contained in one region space and the biological sample con- 65
`tained in the other region is allowed. A drawback of this
`container is that it includes multiple parts (e.g., lid, vial, disk,
`
`15
`
`The present invention generally relates to a container sys(cid:173)
`tem for releasably storing a substance.
`In accordance with one aspect of the present invention,
`there is provided a container system for releasably storing a
`substance, comprising: a) a vial comprising a first open end
`20 for receiving a sample, a second end comprising a sample
`storage chamber and a piercing member; and b) a lid config(cid:173)
`ured to removably engage said vial, said lid comprising a
`reservoir for holding the substance, and a pierceable mem(cid:173)
`brane sealing the substance within said reservoir, wherein,
`25 when said system is closed by removable engagement of said
`vial with said lid, said vial and said lid are movable to a
`piercing position in which the piercing member disrupts the
`pierceable membrane to allow fluid communication between
`said reservoir and said chamber, wherein the chamber is
`30 sealed against leakage to the outside of the container system
`in the piercing position.
`In accordance with another aspect of the present invention,
`there is provided a container system for releasably storing a
`substance, comprising: a) a vial comprising a chamber for
`35 retaining a sample b) a lid comprising a reservoir for holding
`the substance, and a pierceable membrane sealing the sub(cid:173)
`stance within said reservoir; and c) a funnel comprising a first
`open end for receiving said sample, a piercing member and a
`channel extending from said first open end to a second open
`40 end and being in fluid communication with said chamber, said
`funnel being removably attachable to said lid at said first open
`end and releasably or permanently attached to said vial at said
`second end, wherein, when said system is closed by remov(cid:173)
`able attachment of said lid to said funnel, said system is
`45 movable to a piercing position in which the piercing member
`disrupts the pierceable membrane to allow fluid communica(cid:173)
`tion between said reservoir and said chamber, via said chan(cid:173)
`nel, wherein the chamber is sealed against leakage to the
`outside of the container system in the piercing position.
`In accordance with another aspect of the present invention,
`there is provided a method of combining a substance with a
`biological sample, comprising: (a) providing a container sys(cid:173)
`tem as described herein; (b) providing the sample to the
`chamber in the vial; and ( c) closing said container system by
`55 removable attachment of the lid to the vial or funnel; and (d)
`piercing the membrane to release said substance into said
`chamber by moving the system to said piercing position.
`In accordance with another aspect of the present invention
`there is provided a kit for releasably storing a substance
`60 comprising: a) a container system as described herein; and b)
`instructions for the use thereof.
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`FIG. 1 is a cross-sectional view of a container system in
`accordance with one embodiment of the present invention,
`showing the lid and vial attached;
`
`18
`
`

`
`US 8,221,381 B2
`
`3
`FIG. 2 is a perspective view of the interior of the lid of the
`container system depicted in FIG. 1;
`FIG. 3 is a perspective view of the interior of the vial of the
`container system depicted in FIG. 1;
`FIG. 4 is a perspective view of a container system in accor(cid:173)
`dance with one embodiment of the present invention;
`FIG. 5 is a top view of the container system depicted in
`FIG. 4;
`FIG. 6 is a side view of the container system depicted in
`FIG. 4;
`FIG. 7 is a side view of the container system depicted in
`FIG. 4;
`FIG. 8 is a bottom view of the container system depicted in
`FIG. 4;
`FIG. 9 is a cross-sectional view of the container system of 15
`FIG. 4 taken along line A-A in FIG. 5;
`FIG. 10 is a top perspective view of the container system
`depicted in FIG. 4 showing the lid and vial separated;
`FIG. 11 is a bottom perspective view of the container
`system depicted in FIG. 4 showing the lid and vial separated; 20
`FIG. 12 is a side perspective view a container system in
`accordance with one embodiment of the present invention;
`FIG. 13 is a top view of the container system depicted in
`FIG. 12;
`FIG. 14 is a bottom view of the container system depicted 25
`in FIG.12;
`FIG. 15 is a side view of the container system depicted in
`FIG. 12;
`FIG.16 is a cross-sectional view of the container system of
`FIG. 12 taken along line B-B in FIG. 15;
`FIG. 17 is a side perspective view of the container system
`depicted in FIG. 12;
`FIG. 18 is a top perspective view of the container system
`depicted in FIG. 12, showing the lid and funnel separated;
`FIG. 19 is a bottom side perspective view of the container 35
`system depicted in FIG. 12, showing the lid and funnel sepa(cid:173)
`rated;
`FIG. 20 is a side view of the vial and cap of the container
`system depicted in FIG. 9;
`FIG. 21 is a side view of the container system depicted in
`FIG. 12, showing the lid, funnel, and vial separated;
`FIG. 22 is a side perspective view a container system in
`accordance with one embodiment of the present invention;
`FIG. 23 is a top perspective view of the vial portion of the
`container system depicted in FIG. 22, showing the vial; and 45
`FIG. 24 is a cross-sectional view of the lid of the container
`system depicted in FIG. 22.
`The numbers in bold face type serve to identify the com(cid:173)
`ponent parts that are described and referred to in relation to
`the drawings depicting various embodiments of the present 50
`invention. It should be noted that in describing various
`embodiments of the present invention, the same reference
`numerals have been used to identify the same or similar
`elements. Moreover, for the sake of simplicity, parts have
`been omitted from some figures of the drawings.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`4
`cost, and makes accidental disruption of a sealed substance
`less likely. Additionally, in one example of the present inven(cid:173)
`tion, the container system includes a removable vial which is
`suitable for subsequent processing of samples and/or for use
`in robotic systems.
`The container system of the present invention comprises a
`vial and a lid. Optionally, the container system additionally
`comprises a furmel that is permanently or removably attached
`to the vial and that sealingly engages the lid. The lid is
`10 configured to store a substance, and subsequently release the
`substance from the lid when the lid is sealingly attached to the
`vial, or the funnel. In use, the substance stored within the lid
`is released into the vial when the lid is attached to the vial or
`the funnel, if present.
`In accordance with a specific embodiment of the present
`invention, the lid is suitable to store a substance to stabilize,
`preserve or facilitate the recovery of nucleic acid from a
`biological sample. In accordance with a related embodiment,
`the vial, or the combination of the funnel and vial is suitable
`for the collection of a biological sample from a subject.
`Referring to the FIGS. 1-11 and 22-24, container system
`300 comprises lid 100 and vial 1.
`Lid
`Lid 100 releasably stores a substance. Lid 100 is generally
`cylindrically shaped with at least one open end. Lid 100 can
`be a variety of shapes, as determined by the needs or prefer(cid:173)
`ences of the user and/or the intended application of use. The
`interior of lid 100 includes wall 104 that is positioned within
`lid 100 and defines reservoir 102 for holding a substance such
`30 as a liquid, solid, semi-solid, gas, mixtures thereof and the
`like. Wall 104 defines all or a portion of the perimeter of
`reservoir 102. Wall 104 includes sealing surface 106 which is
`for sealingly attaching pierceable membrane 160
`Pierceable membrane 160 (depicted in FIG. 19) acts as a
`physical barrier to releasably store a substance within reser(cid:173)
`voir 102, when attached to sealing surface 106. Pierceable
`membrane 160 is made from material that is inert to the
`substance to be stored within the reservoir. Pierceable mem-
`brane 160 permits little or no diffusion of the substance
`40 through pierceable membrane 160 over time. Pierceable
`membrane 160 is made from a material that is suitable for the
`intended processing, storage and/or transportation condi(cid:173)
`tions. In a specific embodiment, pierceable membrane 160 is
`heat and cold resistant such that it remains intact and pierce(cid:173)
`able at temperatures ranging from about -80° C. to about
`+ 70° C. In a specific embodiment, pierceable membrane 160
`can be attached tightly enough to sealing surface 106 such
`that pierceable membrane 160 will not be disrupted by
`vacuum pressures. Pierceable membrane 160 can be made
`from a variety of materials including polypropylene. Desir(cid:173)
`ably, pierceable membrane 160 is made from the same mate-
`rial as wall 104. The thickness of pierceable membrane 160
`can vary according to application of use, and preference of the
`user. Desirably, pierceable membrane 160 has a thickness of
`55 about two thousandths of an inch. However, the specific
`thickness of the membrane will be determined by factors such
`as, nature of the substance, nature of the sample, overall
`dimensions of the container system and chemical composi(cid:173)
`tion of the membrane.
`A variety of methods of attaching pierceable membrane
`160 to sealing surface 106 can be used, and is dependent on
`the material used to make lid 100, the substance stored within
`reservoir 102, and/or the characteristics of membrane 160.
`Such methods ofattachment include use of adhesive( s ), heat-
`65 sealing treatment, fasteners, or any combination thereof, and
`the like. Desirably, heat-sealing is used to attach pierceable
`membrane 160 to sealing surface 106. As will be clear to the
`
`As will be discussed in more detail below, the present
`invention provides a container system for releasably storing a 60
`substance.
`The container system of the present invention has fewer
`parts and, thus, is less expensive and/or easier to manufacture,
`than previous containers. Additionally, the manufacturing
`tolerances can be less precise for the container system of the
`present invention, as compared to previous containers having
`separable compartments. Again, this reduces manufacturing
`
`19
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`US 8,221,381 B2
`
`5
`skilled worker, the type of pierceable membrane, the physical
`and/or chemical properties of the pierceable membrane will
`be dependent upon, in part, the composition to be stored.
`Desirably pierceable membrane 160 is inert with respect to
`the intended use, stored substance and sample of the container
`system.
`In the specific embodiments depicted in the Figures, lid
`100 comprises internal helical threads 108 on the inner sur(cid:173)
`face of outer wall 110, which are adapted to engage external
`helical threads 18 on the outer surface ofwall 12 on vial 1. As 10
`would be appreciated by a skilled worker, alternative means
`for releasable attachment oflid 100 to vial 1 can be used in the
`container system of the present invention, provided that lid
`100 and vial 1 are movable to a piercing position, as discussed
`in greater detail below.
`Lid 100 and reservoir 102 can be sized to accommodate a
`range of volumes of a substance. In the specific embodiment
`in which the substance is a nucleic acid preservative for use
`with a saliva sample, reservoir 102 accommodates about 1 ml
`to about 4 ml of a substance. The choice of material used to
`manufacture lid 100 is dependent upon a number of factors
`including manufacturing constraints, chemical suitability,
`and the like. In the specific embodiment in which the sub(cid:173)
`stance is a nucleic acid preservative for use with a saliva
`sample, lid 100 is made from plastics such us polypropylene,
`medium-density polyethylene (MDPE), high-density poly(cid:173)
`ethylene (HDPE), polyethylene and the like. Desirably, lid
`100 is polypropylene. The materials of lid 100 may be
`opaque, transparent or translucent, depending on the desired
`application. For example, an opaque material can be used to
`store a light sensitive composition(s). A transparent or trans(cid:173)
`lucent material is desirable if a visual (e.g., colour) indicator
`is present in the stored substance. Lid 100 and reservoir 102
`can be manufactured to include gradations to demarcate the
`quantity of the substance stored within reservoir 102. The
`outer surface oflid 100 can also include a labelling area for a
`user to identify the contents of the lid. The outer surface oflid
`100 may also include a region to affix or emboss a logo and/or
`other markings.
`In accordance with one embodiment of the present inven(cid:173)
`tion, wall 104 has a generally cylindrical shape sized to fit
`within the interioroflid 100. It will be clear that the shape and
`size of well 104 is dependent upon the intended use of the
`container system. Lid 100 may be constructed from a single
`piece of material that includes wall 104, or wall 104 may be 45
`removably attached to lid 100. Desirably, lid 100 is formed
`from a single piece of material.
`Vial
`In accordance with one embodiment of the present inven(cid:173)
`tion, vial 1 is generally cylindrically shaped with at least one
`open end. Vial 1 can be a variety of shapes, as determined by
`the needs or preferences of the user and/or application of use.
`The interior of vial 1 comprises chamber 2 for receiving a
`sample such as a liquid, solid, semi-solid, mixtures thereof
`and the like. Desirably, chamber 2 is configured to receive a
`biological sample, for example a sputum sample, such as
`saliva.
`Vial 1 comprises a first open end for receiving said sample,
`and a second end comprising chamber 2. In one example, said
`second end is a second closed end. In another example, said
`second end is a second open end.
`In one example, the width of the first open end of vial 1 is
`approximately equivalent to the width of the second end.
`In another example, the first open end of vial 1 is generally
`wider than the second end vial 1. In this example, the gener(cid:173)
`ally wider first open end facilitates sample collection by, for
`example, acting similar to a funnel.
`
`6
`In accordance with one embodiment, and as shown in FIG.
`22-24, container system 300 comprises a funnel fixedly
`attached to, or integral with, vial 1. In the case in which the
`funnel is fixedly attached to, or integral with vial 1, it can also
`be characterised as a vial having a wide mouth opening for
`receiving a sample. The wide mouth or funnel characteristics
`can make it easier for a subject to provide a sample.
`Vial 1 and chamber 2 can be sized to accommodate a range
`of volumes ofa sample. In the specific embodiment in which
`the substance is a nucleic acid preservative for use with a
`saliva sample, chamber 2 accommodates about 1 ml to about
`4 ml of a sample. In another specific embodiment, chamber 2
`accommodates about 1 ml to about 16 ml of a sample.
`Vial 1 comprises at least one piercing member 6. In the
`15 specific embodiment depicted in FIGS. 1-11 piercing mem(cid:173)
`ber 6 extends from a base surface of chamber 2. In one
`example, piercing member 6 extends approximately perpen(cid:173)
`dicular from the base. In another example, piercing member 6
`is angled inwardly or outwardly toward the open end of vial 1.
`20 Alternatively, piercing member 6 extends from an interior
`surface of said vial. In one example, piercing member 6
`extends from an interior surface of said vial and is angled
`inwardly or outwardly toward the open end of vial 1.
`In one example, there is one piercing member 6 within
`25 chamber 2. In an alternative example, there is a plurality of
`piercing members 6, for example, two piercing members,
`three piercing members or more than three piercing members.
`In one example the piercing members are arranged in a gen(cid:173)
`erally semicircular fashion. In a specific example, in the case
`30 of three piercing members, the piercing members are
`arranged in a generally semicircular fashion, as depicted in
`FIGS. 9, 10 and 23.
`Piercing member 6 can be approximately trapezoidal in
`shape and includes first cutting edge 33 having pointed end 30
`35 at one corner of the trapezoid and a second end at a second
`corner of the trapezoid where cutting edge 32 intersects side
`wall 34. Optionally, side wall 34 also includes cutting edge
`33, which extends from cutting edge 32.
`Container system 300 further includes a means for sealing
`40 attachment of lid 1 to vial 100. Such sealing means act to
`ensure that the contents of vial 1 remain sealed with chamber
`2 when lid 100 is attached to vial 1.
`In one example, lid 100 and vial 1 are movable between an
`open position and a piercing position. In a specific example,
`lid 100 is initially attached to vial 1 by threadingly engaging
`internal and external threads 108 and 18 with a twisting
`motion. Initially, lid 100 and vial 1 are threadingly connected,
`but piercing member 6 does not disrupt pierceable membrane
`160 and end portion 30 ofwall 12 engages sealing wall 120.
`50 For example, as depicted in FIG. 9, sealing wall 120 extends
`downwardly and outwardly from the interior oflid 100. This
`type of sealing mechanism is similar to a wipe seal that would
`be well known to the skilled worker. Thus, initially, chamber
`2 is maintained out of fluid communication with reservoir 102
`55 by pierceable membrane 160.
`In an alternate example, lid 100 and vial 1 are movable
`between a first position and a piercing position. In a specific
`example, lid 100 is initially attached to vial 1 by threadingly
`engaging internal and external threads 108 and 18 with a
`60 twisting motion and thereby moved to the first position. In
`moving lid 100 and vial 1 to the first position, lid 100 and vial
`1 are threadingly connected, but piercing member 6 does not
`disrupt pierceable membrane 160. In the first position, end
`portion 30 ofwall 12 sealingly engages sealing wall 120. For
`65 example, as depicted in FIG. 9, sealing wall 120 extends
`downwardly and outwardly from the interior oflid 100. This
`type of sealing mechanism is similar to a wipe seal that would
`
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`US 8,221,381 B2
`
`7
`be well known to the skilled worker. Thus, in the first position,
`chamber 2 is sealed against leakage to the outside of the
`container system by sealing engagement of wall 12 with
`sealing wall 120 and maintained out of fluid communication
`with reservoir 102 by pierceable membrane 160.
`A worker skilled in the art will recognize that there are
`known alternative sealing structures that can be incorporated
`into t