WO2007068094A1 - Container system for releasably storing a substance - Google Patents

Container system for releasably storing a substance Download PDF

Info

Publication number
WO2007068094A1
WO2007068094A1 PCT/CA2006/002009 CA2006002009W WO2007068094A1 WO 2007068094 A1 WO2007068094 A1 WO 2007068094A1 CA 2006002009 W CA2006002009 W CA 2006002009W WO 2007068094 A1 WO2007068094 A1 WO 2007068094A1
Authority
WO
WIPO (PCT)
Prior art keywords
container system
vial
lid
substance
piercing
Prior art date
Application number
PCT/CA2006/002009
Other languages
French (fr)
Inventor
Rod Muir
Derek Kirkland
Ian Curry
Roy Sunstrum
Paul Lem
H. Chaim Birnboim
Original Assignee
Dna Genotek Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38162510&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2007068094(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to PL06846923T priority Critical patent/PL1956969T3/en
Priority to US12/096,767 priority patent/US8221381B2/en
Priority to CN2006800526256A priority patent/CN101370425B/en
Priority to AT06846923T priority patent/ATE531311T1/en
Priority to JP2008543626A priority patent/JP5150507B2/en
Priority to CA 2632614 priority patent/CA2632614C/en
Priority to MX2008007253A priority patent/MX2008007253A/en
Priority to DK06846923T priority patent/DK1956969T3/en
Priority to AU2006324337A priority patent/AU2006324337C1/en
Priority to EP20060846923 priority patent/EP1956969B1/en
Priority to BRPI0619596A priority patent/BRPI0619596B8/en
Priority to ES06846923T priority patent/ES2375379T3/en
Application filed by Dna Genotek Inc. filed Critical Dna Genotek Inc.
Publication of WO2007068094A1 publication Critical patent/WO2007068094A1/en
Priority to IL19202708A priority patent/IL192027A/en
Priority to HK09104066A priority patent/HK1123960A1/en
Priority to US13/536,599 priority patent/US9207164B2/en
Priority to US14/831,690 priority patent/US20150353249A1/en
Priority to US16/209,279 priority patent/US20190210778A1/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
    • B65D51/2828—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil
    • B65D51/2835—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil ruptured by a sharp element, e.g. a cutter or a piercer
    • 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
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • 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
    • A61B10/0096—Casings for storing test samples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure
    • B01L2300/047—Additional chamber, reservoir
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • G01N2021/0325—Cells for testing reactions, e.g. containing reagents
    • G01N2021/0328—Arrangement of two or more cells having different functions for the measurement of reactions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1079—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices with means for piercing stoppers or septums
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/0318—Processes

Definitions

  • the field of the invention generally relates to a container system for releasably storing a substance.
  • a substance such as a liquid, solid, gas, mixtures thereof, or the like
  • a container prior to mixing the contents of the container with another material.
  • a compound, or compounds in a container for shipping and/or safe storage and handling, prior to combining the com ⁇ ound(s) with another material.
  • a toxic compound in a container, prior to combining such a toxic compound with a detoxifying material.
  • diagnostic and/or nucleic acid preserving compositions prior to combining such a substance with a biological sample.
  • containers for holding substances separately 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.
  • 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.
  • WO 2003/104251 describes a container for collecting a biological sample from a subject, and subsequently mixing the collected sample with a composition 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 contained in the other region is allowed.
  • a drawback of this container is that it includes multiple parts (e.g., lid, vial, disk, 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.
  • the present invention generally relates to a container system for releasably storing a substance.
  • a container system for releasably storing a substance comprising: a) a vial comprising a first open end for receiving a sample, a second end comprising a sample storage chamber and a piercing member; and b) a lid configured to removably engage said vial, said lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance within said reservoir, wherein, 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 sealed against leakage to the outside of the container system in the piercing position.
  • a container system for releasably storing a substance comprising: a) a vial comprising a chamber for retaining a sample b) a lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance 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 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 removable attachment of said Hd to said funnel, said system is movable to a piercing position in which the piercing member disrupts the pierceable membrane to allow fluid communication between said reservoir and said chamber, via said channel, wherein the chamber is sealed against leakage to the outside of the container system in the pier
  • a method of combining a substance with a biological sample comprising: (a) providing a container system as described herein; (b) providing the sample to the chamber in the vial; and (c) closing said container system by 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.
  • kits for releasably storing a substance comprising: a) a container system as described herein; and b) instructions for the use thereof.
  • Figure 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;
  • Figure 2 is a perspective view of the interior of the lid of the container system depicted in Figure 1;
  • Figure 3 is a perspective view of the interior of the vial of the container system depicted in Figure 1;
  • Figure 4 is a perspective view of a container system in accordance with one embodiment of the present invention.
  • Figure 5 is a top view of the container system depicted in Figure 4.
  • Figure 6 is a side view of the container system depicted in Figure 4.
  • Figure 7 is a side view of the container system depicted in Figure 4.
  • Figure 8 is a bottom view of the container system depicted in Figure 4.
  • Figure 9 is a cross-sectional view of the container system of Figure 4 taken along line A-A in Figure 5;
  • Figure 10 is a top perspective view of the container system depicted in Figure 4 showing the lid and vial separated
  • Figure 11 is a bottom perspective view of the container system depicted in Figure 4 showing the lid and vial separated
  • Figure 12 is a side perspective view a container system in accordance with one embodiment of the present invention.
  • Figure 13 is a top view of the container system depicted in Figure 12;
  • Figure 14 is a bottom view of the container system depicted in Figure 12;
  • Figure 15 is a side view of the container system depicted in Figure 12;
  • Figure 16 is a cross-sectional view of the container system of Figure 12 taken along line B-B in Figure 15;
  • Figure 17 is a side perspective view of the container system depicted in Figure 12;
  • Figure 18 is a top perspective view of the container system depicted in Figure 12, showing the lid and funnel separated;
  • Figure 19 is a bottom side perspective view of the container system depicted in Figure 12, showing the lid and funnel separated;
  • Figure 20 is a side view of the vial and cap of the container system depicted in Figure 9;
  • Figure 21 is a side view of the container system depicted in Figure 12, showing the lid, funnel, and vial separated;
  • Figure 22 is a side perspective view a container system in accordance with one embodiment of the present invention.
  • Figure 23 is a top perspective view of the vial portion of the container system depicted in Figure 22, showing the vial;
  • Figure 24 is a cross-sectional view of the lid of the container system depicted in Figure 22.
  • the numbers in bold face type serve to identify the component parts that are described and referred to in relation to the drawings depicting various embodiments of the present 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.
  • the present invention provides a container system for releasably storing a 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 cost, and makes accidental disruption of a sealed substance less likely. Additionally, in one example of the present invention, 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.
  • the container system additionally comprises a funnel mat is permanently or removably attached to the vial and that sealingly engages the lid.
  • the lid is 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.
  • the lid is suitable to store a substance to stabilize, preserve or facilitate the recovery of nucleic acid from a biological sample.
  • 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 Figures 1-11 and 22-24, container system 300 comprises lid 100 and vial l.
  • 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 preferences 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 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 acts as a physical barrier to releasably store a substance within reservoir 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 membrane 160 permits little or no diffusion of the substance 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 conditions.
  • pierceable membrane 160 is heat and cold resistant such that it remains intact and pierceable at temperatures ranging from about -8O 0 C to about +70 0 C.
  • 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. Desirably, pierceable membrane 160 is made from the same material 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 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 composition 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 of attachment include use of adhesive(s), heat-sealing treatment, fasteners, or any combination thereof, and the like.
  • heat-sealing is used to attach pierceable membrane 160 to sealing surface 106.
  • 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.
  • lid 100 comprises internal helical threads 108 on the inner surface of outer wall 110, which are adapted to engage external helical threads 18 on the outer surface of wall 12 on vial 1.
  • alternative means for releasable attachment of lid 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.
  • 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.
  • lid 100 is made from plastics such us polypropylene, medium-density polyethylene (MDPE), high-density polyethylene (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.
  • a transparent or translucent 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 of lid 100 can also include a labelling area for a user to identify the contents of the lid.
  • the outer surface of lid 100 may also include a region to affix or emboss a logo and/or other markings.
  • wall 104 has a generally cylindrical shape sized to fit within the interior of Hd 100.
  • lid 100 may be constructed from a single piece of material that includes wall 104, or wall 104 may be removably attached to lid 100. Desirably, lid 100 is formed from a single piece of material.
  • 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.
  • 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.
  • said second end is a second closed end.
  • said second end is a second open end.
  • the width of the first open end of vial 1 is approximately equivalent to the width of the second end.
  • first open end of vial 1 is generally wider than the second end vial 1.
  • the generally wider first open end facilitates sample collection by, for example, acting similar to a funnel.
  • container system In accordance with one embodiment, and as shown in Figure 22-24, container system
  • VM 1 and chamber 2 can be sized to accommodate a range of volumes of a sample.
  • 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.
  • chamber 2 accommodates about 1 ml to about 16 ml of a sample.
  • Vial 1 comprises at least one piercing member 6.
  • piercing member 6 extends from a base surface of chamber 2.
  • piercing member 6 extends approximately perpendicular from the base.
  • piercing member 6 is angled inwardly or outwardly toward the open end of vial 1.
  • piercing member 6 extends from an interior surface of said vial.
  • piercing member 6 extends from an interior surface of said vial and is angled inwardly or outwardly toward the open end of vial 1.
  • the piercing members are arranged in a generally semicircular fashion.
  • the piercing members are arranged in a generally semicircular fashion, as depicted in Figure 9, 10 and 23.
  • Piercing member 6 can be approximately trapezoidal in shape and includes first cutting edge 33 having pointed end 30 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.
  • side wall 34 also includes cutting edge 33, which extends from cutting edge 32.
  • Container system 300 further includes a means for sealing 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.
  • lid 100 and vial 1 are movable between an open position and a piercing position.
  • lid 100 is initially attached to vial 1 by threadingly engaging internal and external threads 108 and 18 with a twisting motion.
  • lid 100 and vial 1 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160 and end portion 30 of wall 12 engages sealing wall 120.
  • sealing wall 120 extends downwardly and outwardly from the interior of lid 100. This type of sealing mechanism is similar to a wipe seal that would be well known to the skilled worker.
  • chamber 2 is maintained out of fluid communication with reservoir 102 by pierceable membrane 160.
  • lid 100 and vial 1 are movable between a first position and a piercing position.
  • lid 100 is initially attached to vial 1 by threadingly engaging internal and external threads 108 and 18 with a twisting motion and thereby moved to the first position.
  • lid 100 and vial 1 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160.
  • end portion 30 of wall 12 sealingly engages sealing wall 120.
  • sealing wall 120 extends downwardly and outwardly from the interior of lid 100.
  • This type of sealing mechanism is similar to a wipe seal that would be well known to the skilled worker.
  • 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.
  • lid 100 and vial 1 From the open position, or the first position, to the piercing position, in which movement of lid 100 and vial 1 together results in disruption of pierceable membrane 160 by piercing member 6, and the release of the substance within reservoir 102 into chamber 2.
  • piercing member 6 In operation, in moving to the piercing position, pointed end 31 of piercing member 6 is brought into contact with pierceable membrane 160 and pierces pierceable membrane 160. Continued twisting moves cutting edge 32 through pierceable membrane 160, disrupting pierceable membrane 160, and thereby producing an opening in the sealing membran ⁇ to enable the substance to enter chamber 2. It will be clear that if more than one piercing member is present, less twisting of lid 100 and vial 1 is required to generate an opening. When three piercing members are present, a suitable opening is obtainable in about one quarter of a turn. Desirably, pierceable membrane 160 is not completely removed S from sealing surface 106. Thus, in the piercing position, piercing member 6 disrupts pierceable membrane 160 to allow fluid communication between reservoir 102 and chamber 2.
  • the distance between piercing member 6 and wall 104 will vary according to the needs and preferences of the user.
  • the distance between piercing member 6 and wall 104 0 can vary from being generally flush with one another, to being generally separated from one another.
  • piercing member 6 length, rigidity and the like, is selected such that it is sufficient to disrupt pierceable membrane 160 when lid 100 and vial 1 are in the piercing position, and not disrupt the pierceable membrane 160 5 when lid 100 and vial 1 are in the open or first position.
  • vial 1 is made from plastics such us polypropylene, medium-density polyethylene (MDPE), high-density polyethylene (HDPE), polyethylene and the like. Desirably, vial 1 is HDPE.
  • the container system comprises a lid, a funnel and a vial.
  • container system 600 comprises lid 100 and funnel
  • LID Lid 100 releasably stores a substance, as described above.
  • Funnel 400 includes a first open end for receiving a sample, a second open end for removable or fixed attachment to vial 500.
  • funnel 400 is integral with vial 500.
  • the interior of funnel 400 comprises interior channel 422 extending therethrough for maintaining the first open end and the second open end in fluid communication and for receiving a sample such as a liquid, solid, semi-solid, mixtures thereof and the like.
  • interior channel 422 is configured to receive a biological sample.
  • the biological sample is a sputum sample, such as saliva.
  • Interior channel 422 can be sized accommodate a range of volumes of sample.
  • lid 100 comprises internal helical threads 108 on the inner surface of outer wall 110, which are adapted to engage external helical threads 418 on the outer surface of wall 412 on funnel 400.
  • alternative means for releasable attachment of lid 100 to funnel 400 can be used in the container system of the present invention, provided that Hd 100 and funnel 400 are movable to the piercing position, as discussed in greater detail above.
  • Funnel 400 comprises at least one piercing member 6.
  • piercing member 6 extends from an interior surface
  • piercing member 6 is angled inwardly or outwardly toward pierceable membrane 160. Qther arrangements of piercing member 6 can be used, as would be readily appreciated by the skilled worker.
  • piercing member 6 there is one piercing member 6 within interior channel 422.
  • there is a plurality of piercing members for example, two piercing members, three piercing members or more than three piercing members.
  • the piercing members are arranged in a generally semicircular fashion, as shown in Figure 18.
  • piercing member 6 can be approximately trapezoidal in shape and includes first cutting edge 33 having pointed end 30 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.
  • side wall 34 also includes cutting edge 33, which extends from cutting edge 32.
  • Container system 600 further includes a means for sealing attachment of lid 1 to funnel 400. Such sealing means act to ensure that the contents of vial 1 remain sealed with chamber 2 when funnel 400 and vial 500 are attached to vial 1.
  • funnel 400 includes outwardly extending ribs 402 that can used by a user to twist funnel 400 and lid 100, and/or funnel 400 and vial 500.
  • funnel 400 The choice of the material of funnel 400 will be dependent upon a number of factors including manufacturing constraints, chemical suitability, and the like. Additionally, the construction material of funnel 400 may be same or different as that used to make lid 100 and collection vial 500.
  • the substance is a nucleic acid preservative for use with a saliva sample
  • funnel 400 is made from plastics such us polypropylene, high-density polyethylene (HDPE), polyethylene, medium-density polyethylene (MDPE), or any combination thereof, and the like. Desirably, vial 1 is HDPE.
  • lid 100 is polypropylene
  • vial 500 is polypropylene
  • funnel 400 is HDPE.
  • Vial 500 (or collection vial 500) is generally cylindrically shaped with an open end for removable or fixed attachment to the second end of funnel 400, and chamber 530 for receiving a sample.
  • Vial 500 can be a variety of shapes, as determined by the needs Or preferences of the user and/or application of use, and can be specifically manufactured for use in the container system of the present invention or can be a commercially available vial.
  • funnel 400 is integral with vial 500.
  • vial 500 is sized to fit within a standard test tube rack such as that typically used in biological sample processing.
  • vial 500 conforms with industry-standard dimensions for blood collection tubes (e.g., 13 mm x 75 mm).
  • vial 500 is suitable for use with robotic DNA purification systems (e.g., the Beckman BioMekTM EX).
  • vial 500 is commercially availably from Simport Plastics Limited (e.g., the T501 tubes).
  • the open end of vial 500 is also configured for securing attachment with a standard cap 520, as shown in Figure 21.
  • Cap 520 can be secured by a threaded screw, snap-fit, and the like.
  • Vial 500 optionally includes surface 502 that is suitable for labelling and/or for providing friction for gripping by a user.
  • Vial 500 may be removably attached to funnel 400 using a variety of locking mechanisms.
  • the locking mechanism is a helical threaded screw.
  • the locking mechanism is a snap-fit.
  • vial 500 is fixedly attached to, or integral with, funnel 400.
  • lid 100 and funnel 400 are movable between an open position and a piercing position, as discussed supra with lid 100 and vial 1.
  • lid 100 is initially attached to funnel 400 by threadingly engaging internal and external threads 108 and 18 with a twisting motion.
  • Hd 100 and funnel 400 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160, and end portion 30 of wall 12 engages sealing wall 120.
  • sealing wall 120 extends downwardly and outwardly from the inner surface of lid 100.
  • This type of sealing mechanism is similar to a wipe seal, that would be well known to the skilled worker.
  • interior channel 422 is maintained out of fluid communication with said reservoir 102 by pierceable membrane 6.
  • lid 100 and funnel 400 are movable between a first position and a piercing position, as discussed supra with lid 100 and vial 1.
  • Lid 100 is initially attached to funnel 400 by threadingly engaging internal and external threads 108 and 18 with a twisting motion.
  • lid 100 and funnel 400 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160.
  • end portion 30 of wall 12 sealingly engages sealing wall 120.
  • sealing wall 120 extends downwardly and outwardly from the inner surface of lid 100.
  • This type of sealing mechanism is similar to a wipe seal, that would be well know to the skilled worker.
  • interior channel 422 is sealed against leakage to the outside of the container system and maintained out of fluid communication with said reservoir 102 by pierceable membrane 6.
  • lid 100 and funnel 400 From either the open position or the first position, to the piercing position, in which moving lid 100 and vial 1 together results in disruption of pierceable membrane 160 by piercing member 6, and the release of the substance within reservoir 102 into chamber 2 and vial SOO.
  • pointed end 30 In operation, in moving to the piercing position, pointed end 30 is brought into contact with pierceable membrane 160 and subsequently pierces pierceable membrane 160. Continued twisting moves cutting edge 32 through pierceable membrane 160, thereby disrupting pierceable membrane 160 and producing an opening in pierceable membrane 160 to permit the substance to enter interior channel 422. If more than one piercing member is present, less twisting of lid 100 and vial 1 is required to generate an opening. When three piercing members are present, a suitable opening is obtainable in about one quarter of a turn. Thus, in the piercing position, piercing member 6 disrupts pierceable membrane 160 to allow fluid communication between reservoir 102 and interior channel 422.
  • the distance between piercing member 6 and wall 104 will vary according to the needs and preferences of the user.
  • the distance between piercing member 6 and wall 104 can vary from being generally flush with one another, to being generally separated from one another.
  • piercing member 6 length, rigidity and the like, is selected such that it sufficient to disrupt pierceable membrane 160 when lid 100 and vial 1 are in the piercing position, and not disrupt the pierceable membrane 160 when lid 100 and vial 1 are in the open or first position.
  • the container system of the present application is suitable for releasably storing a composition intended to stabilize, preserve, or facilitate the recovery of nucleic acid from a biological sample.
  • a biological sample can include bodily fluids and/or tissues.
  • vial 1 and/or funnel 400 are sized for collecting a biological sample from a subject.
  • biological samples include skin, hair, fecal matter, bodily fluids, tissue, cells and the like.
  • body fluid refers to a naturally occurring fluid from a human or an animal, such as saliva, sputum, serum, plasma, blood, pharyngeal, nasal/nasal pharyngeal and sinus secretions, urine, mucus, gastric juices, pancreatic juices, feces, semen, products of lactation or menstruation, tears, or lymph.
  • tissue refers to an aggregate of cells usually of a particular kind together with their intercellular substance that form one of the structural materials of a plant or an animal and that in animals include connective tissue, epithelium, muscle tissue, and nerve tissue, and the like.
  • nucleic acid refers to a chain of nucleotides, including deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), typically found in chromosomes, chromatin, mitochondria, ribosomes, cytoplasm, nucleus, microorganisms or viruses.
  • DNA deoxyribonucleic acid
  • RNA ribonucleic acid
  • RNA ribonucleic acid
  • RNA refers to a wide range of RNA species, including, but not limited to high molecular RNA, large and small ribosomal
  • RNAs messenger RNA
  • pre-messenger RNA small regulatory RNAs
  • RNA viruses single and double-stranded, positive stranded or negative stranded
  • the RNA may be from a variety of sources, including, but not limited to human, non-human, viral, bacterial, fungal, protozoan, parasitic, single-celled, multi-cellular, in vitro, in vivo, natural, and/or synthetic sources.
  • the bodily fluid is saliva.
  • saliva refers to the secretion, or combination of secretions, from any of the salivary glands, including the parotid, submaxillary, and sublingual glands, optionally mixed with the secretions from the numerous small labial, buccal, and palatal glands that line the mouth.
  • subject refers to an animal or human.
  • the subject is a mammal that can produce saliva for the purposes of nucleic acid stabilization and/or detection.
  • the subject is human.
  • a substance such as a composition intended to stabilize, preserve, or facilitate the recovery of nucleic acid from a biological sample is sealed within reservoir 102 with a pierceable membrane.
  • suitable compositions include those described in International PCT application WO 2003/104251; International PCT application PCT/CA2006/000380; United States Application Serial Nos. 60/828,563; or 60/866,985, all of the contents of which are. hereby incorporated by reference in their entirety.
  • the composition is OrageneTM DNA-preserving solution.
  • Other suitable compositions would be well known to the skilled worker.
  • a sample of saliva from a subject is placed within chamber 2 of vial 1.
  • vial 500 is attached to funnel 400, and a sample of saliva is placed within chamber 2 of funnel 400.
  • the subject is instructed to wait for a period of 30 - 60 minutes before last eating. If possible, the subject will brush his teeth (without using toothpaste). If possible, the subject will rinse his/her mouth with 50 ml of water. The subject will be requested to wait for 5-10 minutes to allow the mouth to clear of water. For subjects able to spit, they will be instructed to spit saliva into the special collection vial until the level of saliva reaches the 1 or 2 ml mark. Waiting after last eating and rinsing the mouth is desirable but not essential. Collection of saliva may take several minutes.
  • an implement e.g., swab, transfer pipette
  • a subject may be provided a liquid (e.g., mouthwash, water, saline) to gargle his/her mouth and throat or saline to flush his/her nasal cavity. Samples collected with said liquid would be delivered into the collection vial.
  • a substance, such as a composition to stabilize, preserve, and/or facilitate the recovery of nucleic acid and saliva is stored within reservoir 102 of lid 100.
  • Lid 100 is then attached to vial 1, moved to the piercing position, and the substance combines with the saliva in chamber 2.
  • lid 100 is attached to funnel 400, moved to the piercing position, and the substance combines with the saliva in interior 530.
  • the combination of the composition to stabilize, preserve, or facilitate the recovery of nucleic acid and saliva may then be used in standard nucleic acid testing reactions, for example for detection or quantitation.
  • the combination may be stored within container system 300 or 600 and subsequently used, for example, for detection of nucleic acid contained within the saliva.
  • funnel 400 is removed from vial S00, and cap 520 is attached to the open end of vial 500.
  • the combination may be stored within vial 500 and subsequently used, for example, for detection of nucleic acid contained within the saliva.
  • container system 300 and container system 600 are sized for shipping.
  • vial 1 and lid 100 of container system 300 are sized for shipping when securely attached.
  • lid 1, funnel 400 and collection vial 500 of container system 600 are sized for shipping when lid 1, funnel 400 and collection vial 500 are securely attached.
  • vial 1 and lid 100 of container system 300 are sized for shipping when vial 1 and lid 100 are separate.
  • lid 1, funnel 400 and collection vial 500 of container system 600 are sized for shipping when lid 1, funnel 400 and collection vial 500 are separate. It will be appreciated that a variety methods of shipping are contemplated. Non-limiting examples of shipping include shipping by hand, land, air, boat, animal, and the like, or combinations thereof.
  • container system 300 or container system 600 fit within a standard mail envelope.
  • container system 300 or container system 600 fit within an envelope sized to fit within a standard European mail slot.
  • the standard European mail slot has a width of about 3 cm.
  • container system 300 or container system 600 fit within an envelope sized to fit within a standard Canadian and/or United States of America mail slot.
  • Another aspect of the present invention provides a method of manufacture of a device for releasably storing a substance.
  • the method of manufacture comprises providing container system in accordance with the present invention.
  • Another aspect of the present invention provides a method of combining a substance with a biological sample.
  • This method comprises providing a container system in accordance with the present invention, wherein the container system includes the substance, and providing the biological sample.
  • Another aspect of the present invention provides a method of preserving nucleic acid in a biological sample.
  • This method comprises providing a container system in accordance with the present invention, wherein the container system includes a substance for preserving nucleic acid in a biological sample.
  • Another aspect of the present invention provides a method of archiving a biological sample for prolonged periods of time.
  • archiving is at room temperature.
  • This method comprises providing a container system in accordance with the present invention and providing a substance for archiving the biological sample.
  • prolonged storage is at room temperature for more than about one week, about two weeks, about three weeks, about one month, more than about one month, about one year.
  • kits for collection of a sample and mixing the sample with a substance includes a container system in accordance with the present invention and instructions for the use thereof, optionally with a substance stored within the lid of the container system.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Ceramic Engineering (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Closures For Containers (AREA)
  • Developing Agents For Electrophotography (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Packages (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Treatment Of Fiber Materials (AREA)
  • Lubricants (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

The present invention provides a container system for releasably 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.

Description

CONTAINER SYSTEM FOR RELEASABLY STORING A SUBSTANCE
RELATED APPLICATION
This application claims priority to United States Application Serial No. 60/748,977 filed on December 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
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 comρound(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 diagnostic and/or nucleic acid preserving compositions prior to combining such a substance with a biological sample.
Additionally, it may be desirable to keep a substance isolated 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 a container for collecting a biological sample from a subject, and subsequently mixing the collected sample with a composition 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 contained in the other region is allowed. A drawback of this container is that it includes multiple parts (e.g., lid, vial, disk, 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 the preceding information constitutes prior art against the present invention. SUMMARY OF THE INVENTION
The present invention generally relates to a container system 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 for receiving a sample, a second end comprising a sample storage chamber and a piercing member; and b) a lid configured to removably engage said vial, said lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance within said reservoir, wherein, 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 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 retaining a sample b) a lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance 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 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 removable attachment of said Hd to said funnel, said system is movable to a piercing position in which the piercing member disrupts the pierceable membrane to allow fluid communication between said reservoir and said chamber, via said channel, 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 system as described herein; (b) providing the sample to the chamber in the vial; and (c) closing said container system by 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 comprising: a) a container system as described herein; and b) instructions for the use thereof.
BRIEF DESCRIPTION OF THE FIGURES
Figure 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;
Figure 2 is a perspective view of the interior of the lid of the container system depicted in Figure 1;
Figure 3 is a perspective view of the interior of the vial of the container system depicted in Figure 1;
Figure 4 is a perspective view of a container system in accordance with one embodiment of the present invention;
Figure 5 is a top view of the container system depicted in Figure 4;
Figure 6 is a side view of the container system depicted in Figure 4;
Figure 7 is a side view of the container system depicted in Figure 4;
Figure 8 is a bottom view of the container system depicted in Figure 4;
Figure 9 is a cross-sectional view of the container system of Figure 4 taken along line A-A in Figure 5;
Figure 10 is a top perspective view of the container system depicted in Figure 4 showing the lid and vial separated; Figure 11 is a bottom perspective view of the container system depicted in Figure 4 showing the lid and vial separated;
Figure 12 is a side perspective view a container system in accordance with one embodiment of the present invention;
Figure 13 is a top view of the container system depicted in Figure 12;
Figure 14 is a bottom view of the container system depicted in Figure 12;
Figure 15 is a side view of the container system depicted in Figure 12;
Figure 16 is a cross-sectional view of the container system of Figure 12 taken along line B-B in Figure 15;
Figure 17 is a side perspective view of the container system depicted in Figure 12;
Figure 18 is a top perspective view of the container system depicted in Figure 12, showing the lid and funnel separated;
Figure 19 is a bottom side perspective view of the container system depicted in Figure 12, showing the lid and funnel separated;
Figure 20 is a side view of the vial and cap of the container system depicted in Figure 9;
Figure 21 is a side view of the container system depicted in Figure 12, showing the lid, funnel, and vial separated;
Figure 22 is a side perspective view a container system in accordance with one embodiment of the present invention;
Figure 23 is a top perspective view of the vial portion of the container system depicted in Figure 22, showing the vial; and
Figure 24 is a cross-sectional view of the lid of the container system depicted in Figure 22. The numbers in bold face type serve to identify the component parts that are described and referred to in relation to the drawings depicting various embodiments of the present 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
As will be discussed in more detail below, the present invention provides a container system for releasably storing a 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 cost, and makes accidental disruption of a sealed substance less likely. Additionally, in one example of the present invention, 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 funnel mat is permanently or removably attached to the vial and that sealingly engages the lid. The lid is 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 Figures 1-11 and 22-24, container system 300 comprises lid 100 and vial l.
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 preferences 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 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 Figure 19) acts as a physical barrier to releasably store a substance within reservoir 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 membrane 160 permits little or no diffusion of the substance 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 conditions. In a specific embodiment, pierceable membrane 160 is heat and cold resistant such that it remains intact and pierceable at temperatures ranging from about -8O0C to about +700C. 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. Desirably, pierceable membrane 160 is made from the same material 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 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 composition 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 of attachment include use of adhesive(s), heat-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 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 surface of outer wall 110, which are adapted to engage external helical threads 18 on the outer surface of wall 12 on vial 1. As would be appreciated by a skilled worker, alternative means for releasable attachment of lid 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 substance 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 polyethylene (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 compositions). A transparent or translucent 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 of lid 100 can also include a labelling area for a user to identify the contents of the lid. The outer surface of lid 100 may also include a region to affix or emboss a logo and/or other markings. In accordance with one embodiment of the present invention, wall 104 has a generally cylindrical shape sized to fit within the interior of Hd 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 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 invention, 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 generally wider first open end facilitates sample collection by, for example, acting similar to a funnel.
In accordance with one embodiment, and as shown in Figure 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. VM 1 and chamber 2 can be sized to accommodate a range of volumes of a 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 specific embodiment depicted in Figures 1-11 piercing member 6 extends from a base surface of chamber 2. In one example, piercing member 6 extends approximately perpendicular from the base. In another example, piercing member 6 is angled inwardly or outwardly toward the open end of vial 1. 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 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 generally semicircular fashion. In a specific example, in the case of three piercing members, the piercing members are arranged in a generally semicircular fashion, as depicted in Figure 9, 10 and 23.
Piercing member 6 can be approximately trapezoidal in shape and includes first cutting edge 33 having pointed end 30 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 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 of wall 12 engages sealing wall 120. For example, as depicted in Figure 9, sealing wall 120 extends downwardly and outwardly from the interior of lid 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 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 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 of wall 12 sealingly engages sealing wall 120. For example, as depicted in Figure 9, sealing wall 120 extends downwardly and outwardly from the interior of lid 100. This type of sealing mechanism is similar to a wipe seal that would 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 the present system for ensuring that chamber 2 is sealed against leakage to the outside of the container system. Such alternatives are considered to be within the scope of the present invention.
Continued twisting moves lid 100 and vial 1 from the open position, or the first position, to the piercing position, in which movement of lid 100 and vial 1 together results in disruption of pierceable membrane 160 by piercing member 6, and the release of the substance within reservoir 102 into chamber 2.
In operation, in moving to the piercing position, pointed end 31 of piercing member 6 is brought into contact with pierceable membrane 160 and pierces pierceable membrane 160. Continued twisting moves cutting edge 32 through pierceable membrane 160, disrupting pierceable membrane 160, and thereby producing an opening in the sealing membranβ to enable the substance to enter chamber 2. It will be clear that if more than one piercing member is present, less twisting of lid 100 and vial 1 is required to generate an opening. When three piercing members are present, a suitable opening is obtainable in about one quarter of a turn. Desirably, pierceable membrane 160 is not completely removed S from sealing surface 106. Thus, in the piercing position, piercing member 6 disrupts pierceable membrane 160 to allow fluid communication between reservoir 102 and chamber 2.
The distance between piercing member 6 and wall 104 will vary according to the needs and preferences of the user. The distance between piercing member 6 and wall 104 0 can vary from being generally flush with one another, to being generally separated from one another.
It will be clear to the skilled worker that length, rigidity and the like, of piercing member 6 is selected such that it is sufficient to disrupt pierceable membrane 160 when lid 100 and vial 1 are in the piercing position, and not disrupt the pierceable membrane 160 5 when lid 100 and vial 1 are in the open or first position.
The choice of the material of vial 1 will be dependent upon a number of factors including manufacturing constraints, chemical suitability, and the like. Additionally, the construction material of lid 1 may be same or different as that used to make reservoir 6. In the specific embodiment in which the substance is a nucleic acid preservative for use with a 0 saliva sample, vial 1 is made from plastics such us polypropylene, medium-density polyethylene (MDPE), high-density polyethylene (HDPE), polyethylene and the like. Desirably, vial 1 is HDPE.
In accordance with another aspect of the present invention, the container system comprises a lid, a funnel and a vial.
5 Referring to the Figures 12-21, container system 600 comprises lid 100 and funnel
400 and vial 500.
LID Lid 100 releasably stores a substance, as described above.
FUNNEL
Funnel 400 includes a first open end for receiving a sample, a second open end for removable or fixed attachment to vial 500. In one embodiment, funnel 400 is integral with vial 500. The interior of funnel 400 comprises interior channel 422 extending therethrough for maintaining the first open end and the second open end in fluid communication and for receiving a sample such as a liquid, solid, semi-solid, mixtures thereof and the like. Funnel
400 can be a variety of shapes, as determined by the needs or preferences of the user and/or application of use. Desirably, interior channel 422 is configured to receive a biological sample. For example, the biological sample is a sputum sample, such as saliva. Interior channel 422 can be sized accommodate a range of volumes of sample.
In the specific embodiments depicted in the Figures, lid 100 comprises internal helical threads 108 on the inner surface of outer wall 110, which are adapted to engage external helical threads 418 on the outer surface of wall 412 on funnel 400. As would be appreciated by a skilled worker, alternative means for releasable attachment of lid 100 to funnel 400 can be used in the container system of the present invention, provided that Hd 100 and funnel 400 are movable to the piercing position, as discussed in greater detail above.
Funnel 400 comprises at least one piercing member 6. In accordance with the embodiment depicted in Figures 12-21, piercing member 6 extends from an interior surface
(interior side wall 420) of funnel 400. In one example, piercing member 6 is angled inwardly or outwardly toward pierceable membrane 160. Qther arrangements of piercing member 6 can be used, as would be readily appreciated by the skilled worker.
In one example, there is one piercing member 6 within interior channel 422. In an alternative example there is a plurality of piercing members, for example, two piercing members, three piercing members or more than three piercing members. In the case of three piercing members, desirably the piercing members are arranged in a generally semicircular fashion, as shown in Figure 18. As above, piercing member 6 can be approximately trapezoidal in shape and includes first cutting edge 33 having pointed end 30 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 600 further includes a means for sealing attachment of lid 1 to funnel 400. Such sealing means act to ensure that the contents of vial 1 remain sealed with chamber 2 when funnel 400 and vial 500 are attached to vial 1.
Optionally, funnel 400 includes outwardly extending ribs 402 that can used by a user to twist funnel 400 and lid 100, and/or funnel 400 and vial 500.
The choice of the material of funnel 400 will be dependent upon a number of factors including manufacturing constraints, chemical suitability, and the like. Additionally, the construction material of funnel 400 may be same or different as that used to make lid 100 and collection vial 500. In the specific embodiment in which the substance is a nucleic acid preservative for use with a saliva sample, funnel 400 is made from plastics such us polypropylene, high-density polyethylene (HDPE), polyethylene, medium-density polyethylene (MDPE), or any combination thereof, and the like. Desirably, vial 1 is HDPE.
In a specific example, lid 100 is polypropylene, vial 500 is polypropylene and funnel 400 is HDPE.
VIAL
Vial 500 (or collection vial 500) is generally cylindrically shaped with an open end for removable or fixed attachment to the second end of funnel 400, and chamber 530 for receiving a sample. Vial 500 can be a variety of shapes, as determined by the needs Or preferences of the user and/or application of use, and can be specifically manufactured for use in the container system of the present invention or can be a commercially available vial. As noted above, and in one embodiment, funnel 400 is integral with vial 500. When the container system is used for laboratory purposes, desirably, vial 500 is sized to fit within a standard test tube rack such as that typically used in biological sample processing. In one example, vial 500 conforms with industry-standard dimensions for blood collection tubes (e.g., 13 mm x 75 mm). Desirably vial 500 is suitable for use with robotic DNA purification systems (e.g., the Beckman BioMek™ EX). Desirably, vial 500 is commercially availably from Simport Plastics Limited (e.g., the T501 tubes).
The open end of vial 500 is also configured for securing attachment with a standard cap 520, as shown in Figure 21. Cap 520 can be secured by a threaded screw, snap-fit, and the like.
Vial 500 optionally includes surface 502 that is suitable for labelling and/or for providing friction for gripping by a user.
Vial 500 may be removably attached to funnel 400 using a variety of locking mechanisms. In accordance with one embodiment of the present invention, the locking mechanism is a helical threaded screw. Alternatively, the locking mechanism is a snap-fit. Alternatively, vial 500 is fixedly attached to, or integral with, funnel 400.
In one example, lid 100 and funnel 400 are movable between an open position and a piercing position, as discussed supra with lid 100 and vial 1. In a specific example, lid 100 is initially attached to funnel 400 by threadingly engaging internal and external threads 108 and 18 with a twisting motion. Initially, Hd 100 and funnel 400 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160, and end portion 30 of wall 12 engages sealing wall 120. As depicted in Figures 9 and 16, sealing wall 120 extends downwardly and outwardly from the inner surface of lid 100. This type of sealing mechanism is similar to a wipe seal, that would be well known to the skilled worker. Thus, initially, interior channel 422 is maintained out of fluid communication with said reservoir 102 by pierceable membrane 6.
In an alternate example, lid 100 and funnel 400 are movable between a first position and a piercing position, as discussed supra with lid 100 and vial 1. Lid 100 is initially attached to funnel 400 by threadingly engaging internal and external threads 108 and 18 with a twisting motion. In moving lid 100 and funnel 400 to the first position, lid 100 and funnel 400 are threadingly connected, but piercing member 6 does not disrupt pierceable membrane 160. In the first position, end portion 30 of wall 12 sealingly engages sealing wall 120. As depicted in Figures 9 and 16, sealing wall 120 extends downwardly and outwardly from the inner surface of lid 100. This type of sealing mechanism is similar to a wipe seal, that would be well know to the skilled worker. Thus, in the first position, interior channel 422 is sealed against leakage to the outside of the container system and maintained out of fluid communication with said reservoir 102 by pierceable membrane 6.
Continued twisting moves lid 100 and funnel 400 from either the open position or the first position, to the piercing position, in which moving lid 100 and vial 1 together results in disruption of pierceable membrane 160 by piercing member 6, and the release of the substance within reservoir 102 into chamber 2 and vial SOO.
In operation, in moving to the piercing position, pointed end 30 is brought into contact with pierceable membrane 160 and subsequently pierces pierceable membrane 160. Continued twisting moves cutting edge 32 through pierceable membrane 160, thereby disrupting pierceable membrane 160 and producing an opening in pierceable membrane 160 to permit the substance to enter interior channel 422. If more than one piercing member is present, less twisting of lid 100 and vial 1 is required to generate an opening. When three piercing members are present, a suitable opening is obtainable in about one quarter of a turn. Thus, in the piercing position, piercing member 6 disrupts pierceable membrane 160 to allow fluid communication between reservoir 102 and interior channel 422.
The distance between piercing member 6 and wall 104 will vary according to the needs and preferences of the user. The distance between piercing member 6 and wall 104 can vary from being generally flush with one another, to being generally separated from one another.
It will be clear to the skilled worker that length, rigidity and the like, of piercing member 6 is selected such that it sufficient to disrupt pierceable membrane 160 when lid 100 and vial 1 are in the piercing position, and not disrupt the pierceable membrane 160 when lid 100 and vial 1 are in the open or first position.
METHODS According to one embodiment of the present invention, the container system of the present application is suitable for releasably storing a composition intended to stabilize, preserve, or facilitate the recovery of nucleic acid from a biological sample. A biological sample can include bodily fluids and/or tissues.
Desirably, vial 1 and/or funnel 400 are sized for collecting a biological sample from a subject. Non-limiting examples of biological samples include skin, hair, fecal matter, bodily fluids, tissue, cells and the like.
The term "bodily fluid", as used herein, refers to a naturally occurring fluid from a human or an animal, such as saliva, sputum, serum, plasma, blood, pharyngeal, nasal/nasal pharyngeal and sinus secretions, urine, mucus, gastric juices, pancreatic juices, feces, semen, products of lactation or menstruation, tears, or lymph.
The term "bodily tissue" or "tissue", as used herein, refers to an aggregate of cells usually of a particular kind together with their intercellular substance that form one of the structural materials of a plant or an animal and that in animals include connective tissue, epithelium, muscle tissue, and nerve tissue, and the like.
The term "nucleic acid", as used herein, refers to a chain of nucleotides, including deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), typically found in chromosomes, chromatin, mitochondria, ribosomes, cytoplasm, nucleus, microorganisms or viruses.
The term "ribonucleic acid" or "RNA", as used herein, refers to a wide range of RNA species, including, but not limited to high molecular RNA, large and small ribosomal
RNAs, messenger RNA, pre-messenger RNA, small regulatory RNAs, RNA viruses (single and double-stranded, positive stranded or negative stranded) and the like. The RNA may be from a variety of sources, including, but not limited to human, non-human, viral, bacterial, fungal, protozoan, parasitic, single-celled, multi-cellular, in vitro, in vivo, natural, and/or synthetic sources.
Optionally the bodily fluid is saliva. The term "saliva", as used herein, refers to the secretion, or combination of secretions, from any of the salivary glands, including the parotid, submaxillary, and sublingual glands, optionally mixed with the secretions from the numerous small labial, buccal, and palatal glands that line the mouth.
The term "subject", as used herein, refers to an animal or human. Desirably, the subject is a mammal that can produce saliva for the purposes of nucleic acid stabilization and/or detection. Most desirably, the subject is human.
In use, a substance, such as a composition intended to stabilize, preserve, or facilitate the recovery of nucleic acid from a biological sample is sealed within reservoir 102 with a pierceable membrane. Suitable compositions include those described in International PCT application WO 2003/104251; International PCT application PCT/CA2006/000380; United States Application Serial Nos. 60/828,563; or 60/866,985, all of the contents of which are. hereby incorporated by reference in their entirety. Desirably the composition is Oragene™ DNA-preserving solution. Other suitable compositions would be well known to the skilled worker.
In use, in one example, a sample of saliva from a subject is placed within chamber 2 of vial 1. Alternatively, vial 500 is attached to funnel 400, and a sample of saliva is placed within chamber 2 of funnel 400.
To collect saliva from a subject, in one example, the subject is instructed to wait for a period of 30 - 60 minutes before last eating. If possible, the subject will brush his teeth (without using toothpaste). If possible, the subject will rinse his/her mouth with 50 ml of water. The subject will be requested to wait for 5-10 minutes to allow the mouth to clear of water. For subjects able to spit, they will be instructed to spit saliva into the special collection vial until the level of saliva reaches the 1 or 2 ml mark. Waiting after last eating and rinsing the mouth is desirable but not essential. Collection of saliva may take several minutes. If the subject finds that he/she is unable to deliver sufficient saliva, he/she will be given a few grains of table sugar to chew, and told not to be concerned if some of the sugar is spit into the vial. For subjects unable to spit (e.g., infants, young children, individuals with limitations/disabilities), an implement (e.g., swab, transfer pipette) may be used for sample collection. Similarly, a subject may be provided a liquid (e.g., mouthwash, water, saline) to gargle his/her mouth and throat or saline to flush his/her nasal cavity. Samples collected with said liquid would be delivered into the collection vial.
A substance, such as a composition to stabilize, preserve, and/or facilitate the recovery of nucleic acid and saliva is stored within reservoir 102 of lid 100.
Lid 100 is then attached to vial 1, moved to the piercing position, and the substance combines with the saliva in chamber 2.
Alternatively, lid 100 is attached to funnel 400, moved to the piercing position, and the substance combines with the saliva in interior 530.
The combination of the composition to stabilize, preserve, or facilitate the recovery of nucleic acid and saliva may then be used in standard nucleic acid testing reactions, for example for detection or quantitation. Alternatively, the combination may be stored within container system 300 or 600 and subsequently used, for example, for detection of nucleic acid contained within the saliva. Alternatively, funnel 400 is removed from vial S00, and cap 520 is attached to the open end of vial 500. In this example, the combination may be stored within vial 500 and subsequently used, for example, for detection of nucleic acid contained within the saliva.
In one aspect of the present invention container system 300 and container system 600 are sized for shipping. In one example, vial 1 and lid 100 of container system 300 are sized for shipping when securely attached. In one example lid 1, funnel 400 and collection vial 500 of container system 600, are sized for shipping when lid 1, funnel 400 and collection vial 500 are securely attached. In another example, vial 1 and lid 100 of container system 300 are sized for shipping when vial 1 and lid 100 are separate. In another example, lid 1, funnel 400 and collection vial 500 of container system 600, are sized for shipping when lid 1, funnel 400 and collection vial 500 are separate. It will be appreciated that a variety methods of shipping are contemplated. Non-limiting examples of shipping include shipping by hand, land, air, boat, animal, and the like, or combinations thereof. Desirably, container system 300 or container system 600 fit within a standard mail envelope. In one example, container system 300 or container system 600 fit within an envelope sized to fit within a standard European mail slot. In a specific example, the standard European mail slot has a width of about 3 cm. Alternatively, container system 300 or container system 600 fit within an envelope sized to fit within a standard Canadian and/or United States of America mail slot.
Another aspect of the present invention provides a method of manufacture of a device for releasably storing a substance. The method of manufacture comprises providing container system in accordance with the present invention.
Another aspect of the present invention provides a method of combining a substance with a biological sample. This method comprises providing a container system in accordance with the present invention, wherein the container system includes the substance, and providing the biological sample.
Another aspect of the present invention provides a method of preserving nucleic acid in a biological sample. This method comprises providing a container system in accordance with the present invention, wherein the container system includes a substance for preserving nucleic acid in a biological sample.
Another aspect of the present invention provides a method of archiving a biological sample for prolonged periods of time. Desirably archiving is at room temperature. This method comprises providing a container system in accordance with the present invention and providing a substance for archiving the biological sample. In one example, prolonged storage is at room temperature for more than about one week, about two weeks, about three weeks, about one month, more than about one month, about one year.
KIT
Another aspect of the present invention provides a kit for collection of a sample and mixing the sample with a substance. The kit includes a container system in accordance with the present invention and instructions for the use thereof, optionally with a substance stored within the lid of the container system. AU publications, patents and patent applications mentioned in this Specification are indicative of the level of skill of those skilled in the art to which this invention pertains and are herein incorporated by reference to the same extent as if each individual publication, patent, or patent applications was specifically and individually indicated to be incorporated by reference.
The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

Claims

TEiE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A container system for releasably storing a substance, comprising:
a) a vial comprising a first open end for receiving a sample, a second end comprising a sample storage chamber and a piercing member; and
b) a lid configured to removably engage said vial, said lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance within said reservoir,
wherein, 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 sealed against leakage to the outside of the container system in the piercing position.
2. The container system according to claim 1 wherein said lid comprises a wall defining all or a portion of the perimeter of said reservoir, said wall having a sealing surface for sealingly attaching said pierceable membrane.
3. The container system accordingly to any one of claims 1 or 2, wherein said reservoir is configured to retain about 1 ml to about 4 ml of said substance.
4. The container system according to any one of claims 1 - 3, wherein said pierceable membrane is inert.
5. The container system according to any one of claims 1 - 4, wherein said pierceable membrane remains intact and pierceable at temperatures of from about -8O0C to about 7O0C.
6. The container system according to any one of claims 1 - 5, wherein said pierceable membrane is sealingly attached to said sealing surface by an adhesive, a heat-sealing treatment, a fastener, or any combinations thereof.
7. The container system according to claim 1, wherein the width of said first end is approximately equivalent to the width of said second end.
8. The container system according to claim 1, wherein said first end is generally wider than said second end.
9. The container system according to any one of claims 1 - 8, wherein said chamber is configured to receive about 1 ml to about 16 ml of said sample.
10. The container system according to claim 9, wherein said chamber is configured to receive about 1 ml to about 4 ml of said sample.
11. The container system according to any one of claims 1 - 10, wherein the said piercing member extends from a base surface of said chamber.
12. The container system according to claim 11, wherein said piercing member extends approximately perpendicularly from said base.
13. The container system according to claim 11, wherein said piercing member is angled inwardly or outwardly toward said first open end of said vial.
14. The container system according to any one of claims 1 - 13, wherein said piercing member comprises a side wall, a first cutting edge extending from a first pointed corner to a second corner that defines the intersection between said cutting edge and said side wall.
15. The container system according to claim 14, wherein said side wall further includes a second cutting edge.
16. The container system according to any one of claims 1 - 15, wherein said vial comprises a plurality of piercing members.
17. The container system according to claim 16, wherein said vial comprises three piercing members.
18. The container system according to claim 16, wherein said vial comprises two piercing members.
19. The container system according to any one of claims 1 - 18, wherein said system comprises sealing means for sealing said chamber against leakage to the outside of said container system following movement of said container system to said piercing position.
20. The container system according to claim 19, wherein said sealing means comprises a sealing wall about the interior circumference of said lid that sealingly engages a surface of said vial when the system is said piercing position.
21. The container system according to any one of claims 1 - 20, wherein said vial and said lid are sized for shipping in both an unattached state and an attached state.
22. A container system for releasably storing a substance, comprising:
a) a vial comprising a chamber for retaining a sample
b) a lid comprising a reservoir for holding the substance, and a pierceable membrane sealing the substance 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 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 removable attachment of said lid to said funnel, said system is movable to a piercing position in which the piercing member disrupts the pierceable membrane to allow fluid communication between said reservoir and said chamber, via said channel, wherein the chamber is sealed against leakage to the outside of the container system in the piercing position.
23. The container system according to claim 22 wherein said lid comprises a wall defining all or a portion of the perimeter of said reservoir and including a sealing surface for sealingly attaching said pierceable membrane
24. The container system accordingly to any one of claims 22 or 23, wherein said reservoir is configured to retain about 1 ml to about 4 ml of said substance.
25. The container system according to any one of claims 22 - 24, wherein said pierceable membrane is inert.
26. The container system according to any one of claims 22 - 25, wherein said pierceable membrane maintains intact and pierceable at temperatures of from about -8O0C to about 7O0C.
27. The container system according to any one of claims 22 - 26, wherein said pierceable membrane is sealingly attached to said sealing surface by an adhesive, a heat-sealing treatment, a fastener, or any combinations thereof.
28. The container system according to any one of claims 22 - 27, wherein said piercing member extends from an interior surface of said funnel.
29. The container system according to claim 28, wherein said piercing member is angled inwardly or outwardly toward said first open end of said funnel.
30. The container system according to any one of claims 22 - 29, wherein said piercing member comprises a side wall, a first cutting edge extending from a first pointed corner to a second corner that defines the intersection between said cutting edge and said side wall.
31. The container system according to claim 30, wherein said side wall includes a second cutting edge.
32. The container system according to any one of claims 22 - 31, wherein said funnel comprises a plurality of piercing members.
33. The container system according to claim 32, wherein said funnel comprises three piercing members.
34. The container system according to claim 33, wherein said funnel comprises two piercing members.
35. The container system according to any one of claims 11 - 34, wherein said system comprises sealing means for sealing said chamber against leakage to the outside of said container system.
36. The container system according to claim 35, wherein said sealing means comprises a sealing wall about the interior circumference of said lid that sealingly engages a surface of said funnel when the system is in the piercing position.
37. The Container system according to any one of claims 22 - 36, wherein said vial is releasably attached to said funnel and sized for attachment to a cap when released from said funnel.
38. The container system according to any one of claims 22 - 37, wherein said vial is configured for use in standard laboratory equipment.
39. The container system according to claim 38, wherein said vial has dimensions that conforms with industry-standard dimensions for a blood collection tube.
40. The container system according to claim 38 or 39, wherein said vial is a T501 tube.
41. The container system according to any one of claims 22 - 40, wherein said chamber is sized to hold about 1 ml to about 16 ml.
42. The container system according to any one of claims 1 - 41, wherein said substance is a composition for the stabilization and recovery of a nucleic acid from a biological sample.
43. The container system according to claim 42, wherein said nucleic acid is DNA or RNA.
44. A method of combining a substance with a biological sample, comprising:
(a) providing a container system according to any one of claims 1 -21;
(b) providing the sample to the chamber in the vial; and
(c) closing said container system by removably attaching said lid to said vial; and
(d) piercing said membrane to release said substance into said chamber by moving said lid and said vial to said piercing position.
45. A method of combining a substance with a biological sample, comprising:
(a) providing a container system according to any one of claims 22 - 41 ;
(b) providing the sample to the chamber in the vial through said funnel; and (c) closing said container system by removably attaching said lid to said first open end of said funnel; and
(d) piercing said membrane to release said substance into said chamber by moving said system to said piercing position.
46. The method according to claim 44 or 45, wherein the substance is a nucleic acid preserving substance.
47. The method according to any one of claim 44 - 46, wherein the sample is a biological sample.
48. The method according to any one of claim 44 - 47, for archiving the sample.
49. A kit for sample collection and storage, comprising:
a) a container system according to any one of claims 1 to 43; and
b) instructions for the use thereof.
50. A container system as substantially described herein.
PCT/CA2006/002009 2005-12-09 2006-12-11 Container system for releasably storing a substance WO2007068094A1 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
US12/096,767 US8221381B2 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
EP20060846923 EP1956969B1 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
AU2006324337A AU2006324337C1 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
AT06846923T ATE531311T1 (en) 2005-12-09 2006-12-11 CONTAINER SYSTEM FOR STORING AND EASILY DISPENSING A SUBSTANCE
JP2008543626A JP5150507B2 (en) 2005-12-09 2006-12-11 Container system for storing substances so that they can be released
CA 2632614 CA2632614C (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
MX2008007253A MX2008007253A (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance.
DK06846923T DK1956969T3 (en) 2005-12-09 2006-12-11 Container system for releasable storage of fabric
CN2006800526256A CN101370425B (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
PL06846923T PL1956969T3 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
ES06846923T ES2375379T3 (en) 2005-12-09 2006-12-11 CONTAINER SYSTEM TO STORE A SUBSTANCE SO THAT IT CAN BE RELEASED.
BRPI0619596A BRPI0619596B8 (en) 2005-12-09 2006-12-11 container system for releasable liquid storage, method for combining liquid with biological sample and kit for sample collection and storage.
IL19202708A IL192027A (en) 2005-12-09 2008-06-10 Container system and method for releasably storing a substance
HK09104066A HK1123960A1 (en) 2005-12-09 2009-05-04 Container system for releasably storing a substance
US13/536,599 US9207164B2 (en) 2005-12-09 2012-06-28 Container system for releasably storing a substance
US14/831,690 US20150353249A1 (en) 2005-12-09 2015-08-20 Container system for releasably storing a substance
US16/209,279 US20190210778A1 (en) 2005-12-09 2018-12-04 Container system for releasably storing a substance

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US74897705P 2005-12-09 2005-12-09
US60/748,977 2005-12-09

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/096,767 A-371-Of-International US8221381B2 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance
US13/536,599 Continuation US9207164B2 (en) 2005-12-09 2012-06-28 Container system for releasably storing a substance

Publications (1)

Publication Number Publication Date
WO2007068094A1 true WO2007068094A1 (en) 2007-06-21

Family

ID=38162510

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2006/002009 WO2007068094A1 (en) 2005-12-09 2006-12-11 Container system for releasably storing a substance

Country Status (16)

Country Link
US (4) US8221381B2 (en)
EP (1) EP1956969B1 (en)
JP (1) JP5150507B2 (en)
CN (1) CN101370425B (en)
AT (1) ATE531311T1 (en)
AU (1) AU2006324337C1 (en)
BR (1) BRPI0619596B8 (en)
CA (1) CA2632614C (en)
DK (1) DK1956969T3 (en)
ES (1) ES2375379T3 (en)
HK (1) HK1123960A1 (en)
IL (1) IL192027A (en)
MX (1) MX2008007253A (en)
PL (1) PL1956969T3 (en)
TW (1) TWI428119B (en)
WO (1) WO2007068094A1 (en)

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008147757A1 (en) * 2007-05-22 2008-12-04 3M Innovative Properties Company Devices and methods for dispensing reagents into samples
WO2010125404A1 (en) * 2009-05-01 2010-11-04 The University Of Bristol Apparatus for testing the quality of a fluid sample
KR20110047239A (en) * 2008-08-21 2011-05-06 디엔에이 제노텍 인코퍼레이티드 Sample receiving device
EP2422879A3 (en) * 2010-08-24 2012-03-28 Siemens Healthcare Diagnostics Products GmbH Closing device for a reagent container
CN103538785A (en) * 2012-07-17 2014-01-29 傅敏 Bottle cap assembly separating materials and water
WO2014165983A1 (en) * 2013-04-11 2014-10-16 Bottlecap Holdings Ltd. Dispenser having pierceable membrane
US9113850B2 (en) 2010-08-20 2015-08-25 Reflex Medical Corp. Saliva collection device
WO2015179976A1 (en) 2014-05-27 2015-12-03 Dna Genotek Inc. Composition and method for stabilizing and maintaining the viability of hardy microorganisms
US9207164B2 (en) 2005-12-09 2015-12-08 Dna Genotek Inc. Container system for releasably storing a substance
CN105874054A (en) * 2013-10-25 2016-08-17 贝克顿·迪金森公司 Blood culture bottles with mechanisms for controlled release of substances into culture media
EP3061401A3 (en) * 2011-06-14 2016-09-21 AX-Lab Innovation ApS Container assembly and associated method
ITUB20155037A1 (en) * 2015-11-06 2017-05-06 Traces S R L Container for the collection and storage of biopsy samples.
US9732376B2 (en) 2013-08-01 2017-08-15 Ancestry.Com Dna, Llc. Sample collection device
US10000795B2 (en) 2006-10-06 2018-06-19 Dna Genotek Inc. Stabilizing compositions and methods for extraction of ribonucleic acid
US11002646B2 (en) 2011-06-19 2021-05-11 DNA Genotek, Inc. Devices, solutions and methods for sample collection
US11360084B2 (en) 2018-02-14 2022-06-14 Salignostics Ltd Methods and apparatus for detecting analytes
US11572581B2 (en) 2002-06-07 2023-02-07 DNA Genotek, Inc. Compositions and methods for obtaining nucleic acids from sputum

Families Citing this family (69)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3351919A1 (en) 2003-01-24 2018-07-25 University of Utah Methods of predicting mortality risk by determining telomere length
US9821938B2 (en) 2006-12-20 2017-11-21 Craig R. Valentine Universal closure apparatus with delivery system
EP1995182A1 (en) * 2007-05-25 2008-11-26 F.Hoffmann-La Roche Ag A sealing cap for a fluid container and a blood collection device
JP5124651B2 (en) 2007-10-23 2013-01-23 ベクトン・ディキンソン・アンド・カンパニー Tissue containment and stabilization seal kit for molecular and histological diagnostics
EP2214561B1 (en) 2007-10-23 2020-04-29 Becton, Dickinson and Company Tissue container for molecular and histology diagnostics incorporating a breakable membrane
US8639387B2 (en) * 2007-11-02 2014-01-28 Vkr Holding A/S Method, system and device for controlling a device related to a building aperture
US8870832B2 (en) * 2007-11-08 2014-10-28 Elcam Medical A.C.A.L Ltd Vial adaptor and manufacturing method therefor
SE531873C2 (en) * 2007-11-12 2009-09-01 Lifeassays Ab Device for biochemical processing and analysis of sample liquid
US9689028B2 (en) 2008-12-22 2017-06-27 University Of Utah Foundation Monochrome multiplex quantitative PCR
US9279145B2 (en) 2010-12-30 2016-03-08 Ibis Biosciences, Inc. Buffers for the stable storage of nucleic acids
US20130092690A1 (en) * 2011-10-18 2013-04-18 Reflex Medical Corp. Seal cap with pre-filled agent for a specimen container
US20130164738A1 (en) * 2011-12-21 2013-06-27 Pathway Genomics Genetic Sample Collection Systems
US9138747B2 (en) 2012-03-26 2015-09-22 Alpha Tec Systems, Inc. Specimen collection apparatus
US9125456B2 (en) * 2012-03-26 2015-09-08 Chong Sun CHOW Object-containing button
US9339439B2 (en) * 2012-09-07 2016-05-17 P. J. Nudo Pharmaceutical container system
CA2912216A1 (en) 2013-05-22 2014-11-27 Telomere Diagnostics, Inc. Measures of short telomere abundance
US9332968B2 (en) 2013-05-24 2016-05-10 Reflex Medical Corp. Saliva container with optical volume indicator
KR101507234B1 (en) * 2013-07-17 2015-03-31 로레알 biomolecule extraction device and method thereof
WO2015031994A1 (en) * 2013-09-03 2015-03-12 Dna Genotek Inc. Method and composition for nucleic acid storage from blood fractions
GB2527516B (en) * 2014-06-23 2020-08-26 Nepesmo Ltd Improvements in and relating to sample collection
EP3034062B1 (en) * 2014-12-19 2017-03-22 Fresenius Kabi Deutschland GmbH Connector system comprising at least two outlet ports
CA2971169A1 (en) 2014-12-30 2016-07-07 Telomere Diagnostics, Inc. Multiplex quantitative pcr
USD743044S1 (en) * 2015-01-16 2015-11-10 Dna Genotek Inc. Tube restrictor for expressing fluid from a swab
JP7344631B2 (en) 2015-02-09 2023-09-14 アボゲン， インコーポレイティド Devices, solutions and methods for sample collection related applications, analysis and diagnostics
JP6481491B2 (en) * 2015-04-30 2019-03-13 凸版印刷株式会社 Saliva collection container set for DNA analysis
EP3127832A1 (en) 2015-08-05 2017-02-08 Antara AB A method of marking a product, and a device for marking a product
CN105154321A (en) * 2015-08-12 2015-12-16 杭州创新生物检控技术有限公司 Biological sample treatment tube
US10905113B2 (en) 2015-11-12 2021-02-02 Regents Of The University Of Minnesota Compositions and method for storing liquid biospecimens
JP2017194324A (en) * 2016-04-19 2017-10-26 株式会社ＤｅＮＡライフサイエンス Saliva preservation kit
US10525473B2 (en) * 2016-08-03 2020-01-07 Spectrum Solutions, L.L.C. Sample collection kit including twist and tear solution cap
US10456787B2 (en) * 2016-08-11 2019-10-29 Instrumentation Laboratory Company Reagent component dispensing caps for reagent containers used in automated clinical analyzers
AU2018234638B2 (en) 2017-03-15 2023-04-06 Ancestry.Com Dna, Llc Sample collection device and method
CN108688972A (en) * 2017-04-09 2018-10-23 福建奥正投资发展有限公司 A kind of outer packing container for piercing through release content, packaging compositions and its application
US10799422B2 (en) * 2017-05-30 2020-10-13 Spectrum Solutions L.L.C. Sample collection kit including removable stopper
CN107224301B (en) * 2017-07-25 2023-02-14 福建医科大学附属协和医院 Quantitative or limited marrow fluid anticoagulation tube
NZ764035A (en) 2017-10-06 2020-05-29 Ancestry Com Dna Llc Systems, devices, and methods for sample collection
US11426734B2 (en) 2017-11-22 2022-08-30 Ancestry.Com Dna, Llc Sample collection kit including cap having selectively movable sleeve
MX2020005246A (en) 2017-11-22 2020-11-09 Ancestry Com Dna Llc Sample collection kit including cap having selectively movable sleeve.
US10974248B2 (en) * 2018-03-14 2021-04-13 MTC Bio Inc. Adapter for laboratory cell strainer
US10399050B1 (en) * 2018-08-21 2019-09-03 Jooster IP AG Beverage blender system
KR200490307Y1 (en) * 2018-10-16 2019-10-24 주식회사 골든바이오텍 Filter for preventing tissue backflow and tissue preserving container including the same
US10899510B2 (en) * 2018-10-17 2021-01-26 Nicole Thomas Vial assembly with cap with disinfectant and related methods
CA3120708A1 (en) 2018-11-20 2020-05-28 Spectrum Solutions, Llc Sample collection system including sealing cap and valve
CN113474083A (en) * 2019-01-04 2021-10-01 仪器实验室公司 Container stopper for high puncture count applications
MX2021010260A (en) 2019-02-27 2021-09-21 Ancestry Com Dna Llc Graphical user interface displaying relatedness based on shared dna.
CN109959761B (en) * 2019-04-11 2024-06-14 石家庄禾柏生物技术股份有限公司 Device for releasing fluid
US11968975B2 (en) 2019-04-30 2024-04-30 Regents Of The University Of Minnesota Compositions and methods for storing liquid biospecimens
US11207240B2 (en) * 2019-05-22 2021-12-28 Jieryang Biotech, Inc. Drug mixing container
US11701094B2 (en) 2019-06-20 2023-07-18 Spectrum Solutions L.L.C. Sample collection system including valve and plug assemblies
US11701660B2 (en) 2019-07-27 2023-07-18 Clinical Reference Laboratory, Inc. Specimen sample collection device with buffer-containing cap
US12029397B2 (en) * 2019-09-23 2024-07-09 Spectrum Solutions L.L.C. Sample collection kit including cap having selectively openable diaphragm valve
WO2021093750A1 (en) * 2019-11-12 2021-05-20 Jacobson T&D Limited Sample processing device
CN110946624A (en) * 2019-12-17 2020-04-03 成都二十三魔方生物科技有限公司 Container system and method for releasably storing a substance
USD973484S1 (en) 2020-06-16 2022-12-27 Bacardi & Company Limited Beverage-containing pod for cocktail shaker
USD960623S1 (en) 2020-06-16 2022-08-16 Bacardi & Company Limited Cocktail shaker
USD960667S1 (en) 2020-06-16 2022-08-16 Bacardi & Company Limited Strainer for cocktail shaker
EP4206090A4 (en) 2020-08-28 2024-10-16 Kao Corp Specimen storage device
CA3130654A1 (en) 2020-09-15 2022-03-15 Norgen Biotek Corp. Sample collection apparatus and uses thereof
CN112057118B (en) * 2020-10-13 2024-10-11 江苏一米生物科技有限公司 Oral swab collector
EP4231922A1 (en) * 2020-10-22 2023-08-30 Merit Medical Systems, Inc. Saliva collection and transport devices, systems and methods
WO2022093782A1 (en) * 2020-10-27 2022-05-05 Detect, Inc. Apparatuses for performing rapid diagnostic tests
CN112793872B (en) * 2020-12-28 2022-12-06 嘉兴医脉赛科技有限公司 Rotary liquid storage box thorn membrane liquid transfer system
JP2024506655A (en) * 2021-02-13 2024-02-14 アプティテュード メディカル システムズ、インコーポレイテッド Systems and methods for analyzing samples
CN113373030A (en) * 2021-04-28 2021-09-10 任楚宇 Nucleic acid detection sample storage device with self-destruction function
WO2023196209A1 (en) * 2022-04-04 2023-10-12 Life Technologies Corporation Saliva collection devices and methods
WO2023250074A1 (en) * 2022-06-23 2023-12-28 Predicine, Inc. Devices and methods for sample collection
WO2024013313A1 (en) 2022-07-14 2024-01-18 Daklapack Europe B.V. Specimen collection device for home sampling and transport
NL2032490B1 (en) * 2022-07-14 2024-01-25 Daklapack Europe B V Specimen collection device for home sampling and transport.
CN116477197B (en) * 2023-04-03 2023-11-21 杭州萧山华谱医学检验实验室有限公司 High-stability detection kit for collecting and detecting blood plasma A beta-42

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4583971A (en) * 1984-02-10 1986-04-22 Travenol European Research And Development Centre (Teradec) Closed drug delivery system
US4741346A (en) * 1986-06-16 1988-05-03 Evergreen Industries, Inc. Speciman collector
EP0273015A2 (en) * 1986-12-24 1988-06-29 Vifor S.A. Container with a receiving device for a vial
US5567309A (en) * 1994-02-14 1996-10-22 Alcott Chromatography, Inc. Self-filtration cap
US5980834A (en) * 1996-07-25 1999-11-09 The United States Of America As Represented By The Secretary Of Commerce Sample storage devices
US6582415B1 (en) * 1998-09-15 2003-06-24 Thomas A. Fowles Sliding reconstitution device for a diluent container

Family Cites Families (96)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2279378A1 (en) 1974-07-22 1976-02-20 Chibret Laboratoires Flask for mixing powders and solvents esp for pharmaceutical compsns - has screw-cap with perforated tube which pierces seal between two containers
USD246600S (en) 1975-05-06 1977-12-06 Japan Medical Supply Co., Ltd. Test tube
USD246698S (en) 1976-05-28 1977-12-20 Morris Glenn H Reversible safety cap and screw cap for containers
US4340147A (en) 1980-11-03 1982-07-20 Mack-Wayne Plastics Company Cap with built in piercing device
JPS5896365A (en) 1981-12-03 1983-06-08 Nec Corp Linear graph detecting method
JPS604433U (en) * 1983-06-21 1985-01-12 株式会社吉野工業所 Two-component mixing container
USD285115S (en) 1983-12-05 1986-08-12 Terumo Medical Corporation Collector for capillary blood
USD310264S (en) 1987-03-04 1990-08-28 Nalge Company Cryogenic vial
CA1317860C (en) * 1987-04-01 1993-05-18 Daniel Louis Kacian Techniques for preparing specimens for bacterial assays
US4785931A (en) 1987-09-24 1988-11-22 Letica Corporation Molded plastic closure having integral stacking support ribs and rupturable mix compartments
WO1989006704A1 (en) 1988-01-11 1989-07-27 Microprobe Corporation Oligonucleotide probes for detection of periodontal pathogens
DE68902025T2 (en) 1988-09-01 1992-12-10 Capsulit Srl CLOSURE FOR BOTTLES AND THE LIKE THAT CONTAINS A CONTAINER WITH A PUSHABLE BOTTOM.
US5807527A (en) * 1991-05-29 1998-09-15 Flinders Technologies Pty. Ltd. Solid medium and method for DNA storage
US5496562A (en) * 1988-10-05 1996-03-05 Flinders Technologies Pty Ltd Solid medium and method for DNA storage
US5140043A (en) * 1989-04-17 1992-08-18 Duke University Stable ascorbic acid compositions
US5128247A (en) 1989-08-14 1992-07-07 Board Of Regents, The University Of Texas System Methods for isolation of nucleic acids from eukaryotic and prokaryotic sources
BE1005090A5 (en) 1991-06-25 1993-04-13 Saliva Diagnostic Systems Inc Device and sampling system fitness sample.
USD338956S (en) 1991-10-04 1993-08-31 Abbott Laboratories Protective overcap for a stick holder for medicament
JP3014548B2 (en) 1992-08-24 2000-02-28 沖電気工業株式会社 Video encoding device
US5843654A (en) 1992-12-07 1998-12-01 Third Wave Technologies, Inc. Rapid detection of mutations in the p53 gene
US5477863A (en) 1993-04-14 1995-12-26 Grant; Michael A. Collection kit with a sample collector
JP2599763Y2 (en) * 1993-04-20 1999-09-20 株式会社資生堂 Container for mixing two kinds of storage items
USD383214S (en) 1993-08-18 1997-09-02 Brennan V Jack Combined cap and vial
GB2288384B (en) 1994-04-07 1997-06-25 Johnson & Johnson Medical Two-component packages
US5814442A (en) 1994-06-10 1998-09-29 Georgetown University Internally controlled virion nucleic acid amplification reaction for quantitation of virion and virion nucleic acid
FR2722765B1 (en) 1994-07-25 1996-08-23 Oreal CONTAINER ALLOWING THE STORAGE OF AT LEAST TWO PRODUCTS, THE MIXTURE OF THESE PRODUCTS AND THE DISTRIBUTION OF THE MIXTURE THUS OBTAINED
USD383851S (en) 1994-12-30 1997-09-16 Evergreen Industries, Inc. Leak proof vial for microscope slides
US6423550B1 (en) 1995-03-30 2002-07-23 Ortho Pharmaceutical Corporation Home oral fluid sample collection device and package for mailing of such device
JPH11501732A (en) 1995-06-07 1999-02-09 ビエックス インコーポレイテッド Kits and methods for fluid collection
US6076570A (en) 1995-06-14 2000-06-20 Byrne; Paul Anthony Closure containing a fluid for mixture with a beverage
US5827675A (en) 1995-07-12 1998-10-27 Charm Sciences, Inc. Test apparatus, system and method for the detection of test samples
US5945515A (en) 1995-07-31 1999-08-31 Chomczynski; Piotr Product and process for isolating DNA, RNA and proteins
US6133036A (en) * 1995-12-12 2000-10-17 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Preservation of liquid biological samples
GB9525414D0 (en) * 1995-12-13 1996-02-14 Rocep Lusol Holdings A device for releasing a fluid into a liquid in a container
US6551791B1 (en) * 1995-12-21 2003-04-22 University Of Florida Rapid diagnostic method for distinguishing allergies and infections and nasal secretion collection unit
US5830154A (en) 1996-01-11 1998-11-03 Epitope, Inc. Device for collecting substances for testing
FI102642B1 (en) * 1996-06-19 1999-01-15 Orion Yhtymae Oyj Reaction vessel or similar stopper
WO1998003265A1 (en) 1996-07-18 1998-01-29 Kyoritsu Chemical-Check Lab., Corp. Cap-shape reagent container for analysis reagents
US5735320A (en) 1996-08-21 1998-04-07 The Sherwin-Williams Company Dispenser for a two-part composition
DE19635833C2 (en) 1996-09-04 1998-08-06 Henkel Kgaa Two-component container
US6720141B1 (en) 1999-11-01 2004-04-13 Interleukin Genetics, Inc. Diagnostics and therapeutics for restenosis
US5817630A (en) * 1997-03-18 1998-10-06 Austin Nutriceutical Corporation Glutathione antioxidant eye drops
AU6589698A (en) * 1997-03-28 1998-10-22 Epitope, Inc. Simultaneous collection of dna and non-nucleic analytes from oral fluids
CN1203863C (en) * 1997-04-07 2005-06-01 Iams公司 Process for improving glucose metabolism, satiety, and nutrient absorption in companion animals
ATE204549T1 (en) 1997-05-15 2001-09-15 R & D Injector Ag TWO-COMPONENT CONTAINER SYSTEM
USD401697S (en) 1997-05-21 1998-11-24 Abbott Laboratories Container
FR2765859B1 (en) 1997-07-08 1999-09-24 Oreal DEVICE FOR PACKAGING TWO COMPONENTS
US6786330B2 (en) * 1997-10-14 2004-09-07 Biogaia Ab Two-compartment container
US5968746A (en) * 1997-11-26 1999-10-19 Schneider; David R. Method and apparatus for preserving human saliva for testing
AU1719699A (en) 1997-12-10 1999-06-28 Sierra Diagnostics, Inc. Methods and reagents for preservation of dna in bodily fluids
DE19812657A1 (en) 1998-03-23 1998-12-24 Wella Ag Two-component container for the temporary storage of peroxide and hair dye
US6562300B2 (en) 1998-08-28 2003-05-13 Becton, Dickinson And Company Collection assembly
US6777210B1 (en) * 1998-09-24 2004-08-17 Ambion, Inc. Method and reagents for inactivating ribonucleases RNase A, RNase I and RNase T1
US6176836B1 (en) * 1998-09-25 2001-01-23 David Trudil Biological sample collection kit
US20010008614A1 (en) * 1998-11-16 2001-07-19 Jack L. Aronowitz Sample collection system and method of use thereof
US6039198A (en) 1998-11-24 2000-03-21 Owens-Illinois Closure Inc. Pierce and cut closure
WO2000050640A1 (en) * 1999-02-25 2000-08-31 Exact Laboratories, Inc. Methods for preserving dna integrity
US6716396B1 (en) 1999-05-14 2004-04-06 Gen-Probe Incorporated Penetrable cap
US6242188B1 (en) * 1999-07-30 2001-06-05 Applied Gene Technologies, Inc. Sample processing to release nucleic acids for direct detection
USD425618S (en) 1999-08-06 2000-05-23 Becton, Dickinson And Company Specimen collection device
EP1244811A1 (en) 1999-11-10 2002-10-02 Ligochem Inc. Method for isolating dna from a proteinaceous medium and kit for performing method
AU6066799A (en) * 1999-11-26 2001-05-31 Lily Hsu Container device for separately enclosing two different substances
US6832994B2 (en) * 2000-01-24 2004-12-21 Bracco Diagnostics Inc. Table top drug dispensing vial access adapter
DE10006662A1 (en) 2000-02-15 2001-08-23 Antigen Produktions Gmbh Sample vessel for stabilizing and isolating nucleic acid, contains a lytic solution that stabilizes nucleic acid and a solid phase that binds it, especially for sampling whole blood
AUPR038300A0 (en) * 2000-09-26 2000-10-19 Cryovac Australia Pty Ltd Reclosable container
US6602718B1 (en) * 2000-11-08 2003-08-05 Becton, Dickinson And Company Method and device for collecting and stabilizing a biological sample
EP1207208A3 (en) 2000-11-15 2003-12-10 Becton Dickinson and Company Method for preservation of cells and nucleic acid targets
WO2002044691A2 (en) 2000-11-28 2002-06-06 Mcmaster University Sputum fixative and methods and uses therefor
US6503716B1 (en) * 2000-11-28 2003-01-07 Pe Corporation (Ny) Compositions and methods for extracting a nucleic acid
US6634234B1 (en) 2001-02-10 2003-10-21 Vega Grieshaber Kg Adjustable measurement head and a level measurement device and method employing it
US6428962B1 (en) 2001-02-12 2002-08-06 Dna Analysis, Inc. Nucleic acid collection barrier method and apparatus
US20020197631A1 (en) 2001-04-26 2002-12-26 Lawrence Nathan P. Multichamber device and uses thereof for processing of biological samples
AUPR848001A0 (en) 2001-10-29 2001-11-15 Dixon, Brodie Container/bottle cap with a storage compartment
BR0206488A (en) * 2001-11-15 2008-08-05 Whatman Inc device, method and kit for storing and analyzing a portion containing nucleic acid in a biological sample
JP4467304B2 (en) 2001-12-06 2010-05-26 バイオコントロール システムズ，インコーポレイティド Sample collection and testing system
US7225689B2 (en) * 2002-01-14 2007-06-05 Rapid Medical Diagnostic Corporation Sample testing device with funnel collector
US7086545B2 (en) * 2002-01-16 2006-08-08 Ajava Pinata, L.L.C. Suspended containers
US7482116B2 (en) * 2002-06-07 2009-01-27 Dna Genotek Inc. Compositions and methods for obtaining nucleic acids from sputum
US20060094015A1 (en) 2002-10-04 2006-05-04 Whatman Inc. Methods and materials for using chemical compounds as a tool for nucleic acid storage on media of nucleic acid purification systems
AU2002951977A0 (en) * 2002-10-10 2002-10-24 Leo Engineering Pty Ltd Improvements to two-part vessels
CA101498S (en) 2002-12-06 2004-01-20 Dna Genotek Inc Saliva collection tube
US6935493B2 (en) * 2003-04-12 2005-08-30 Young Kook Cho Cap device for mixing different kinds of materials separately contained therein and in bottle
AU2004245051B2 (en) 2003-06-02 2010-10-07 Becton, Dickinson And Company Medicament microdevice delivery system with a cartridge
ATE553846T1 (en) 2003-11-19 2012-05-15 Michael O'donovan REAGENT CUVETTE
US20050191685A1 (en) * 2004-02-24 2005-09-01 Innogenetics N.V. Method for determining the risk of developing a neurological disease
CN101027223B (en) * 2004-09-29 2010-12-01 株式会社吉野工业所 vessel for Mixing two-part fluid or mixing easily flowable powder in the liquid
EP1859039A4 (en) 2005-03-16 2009-06-03 Dna Genotek Inc Compositions and method for storage of nucleic acid from bodily fluids
US20070196234A1 (en) * 2005-09-22 2007-08-23 Blane Huff Urine collection and drug testing cup
USD555802S1 (en) 2005-11-04 2007-11-20 Advanced Biotechnologies Limited Screw cap for screw capped tube
TWI428119B (en) 2005-12-09 2014-03-01 Dna Genotek Inc Container system for releasably storing a substance and method of combining a substance with a biological sample
CA118249S (en) 2005-12-09 2007-08-22 Dna Genotek Inc Vial
CA113861S (en) 2005-12-09 2007-08-22 Dna Genotek Inc Vial
JP2010505396A (en) 2006-10-06 2010-02-25 ディーエヌエー ジェノテック インク Stabilized composition and method for extracting ribonucleic acid
US7521213B2 (en) 2006-12-01 2009-04-21 Quest Diagnostics Investments Incorporated Sample processing for nucleic acid amplification
WO2010020043A1 (en) 2008-08-21 2010-02-25 Dna Genotek Inc. Sample receiving device
AU2010246874B2 (en) 2009-05-14 2014-10-02 Dna Genotek Inc. Closure, containing apparatus, and method of using same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4583971A (en) * 1984-02-10 1986-04-22 Travenol European Research And Development Centre (Teradec) Closed drug delivery system
US4741346A (en) * 1986-06-16 1988-05-03 Evergreen Industries, Inc. Speciman collector
EP0273015A2 (en) * 1986-12-24 1988-06-29 Vifor S.A. Container with a receiving device for a vial
US5567309A (en) * 1994-02-14 1996-10-22 Alcott Chromatography, Inc. Self-filtration cap
US5980834A (en) * 1996-07-25 1999-11-09 The United States Of America As Represented By The Secretary Of Commerce Sample storage devices
US6582415B1 (en) * 1998-09-15 2003-06-24 Thomas A. Fowles Sliding reconstitution device for a diluent container

Cited By (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11572581B2 (en) 2002-06-07 2023-02-07 DNA Genotek, Inc. Compositions and methods for obtaining nucleic acids from sputum
US9207164B2 (en) 2005-12-09 2015-12-08 Dna Genotek Inc. Container system for releasably storing a substance
US10767215B2 (en) 2006-10-06 2020-09-08 Dna Genotek Inc. Stabilizing compositions and methods for extraction of ribonucleic acid
US10000795B2 (en) 2006-10-06 2018-06-19 Dna Genotek Inc. Stabilizing compositions and methods for extraction of ribonucleic acid
WO2008147757A1 (en) * 2007-05-22 2008-12-04 3M Innovative Properties Company Devices and methods for dispensing reagents into samples
KR101629046B1 (en) 2008-08-21 2016-06-09 디엔에이 제노텍 인코퍼레이티드 Sample receiving device
US9079181B2 (en) 2008-08-21 2015-07-14 Dna Genotek Inc. Sample receiving device
KR20110047239A (en) * 2008-08-21 2011-05-06 디엔에이 제노텍 인코퍼레이티드 Sample receiving device
WO2010125404A1 (en) * 2009-05-01 2010-11-04 The University Of Bristol Apparatus for testing the quality of a fluid sample
US9113850B2 (en) 2010-08-20 2015-08-25 Reflex Medical Corp. Saliva collection device
US8714381B2 (en) 2010-08-24 2014-05-06 Siemens Healthcare Diagnostics Products Gmbh Closure device for a reagent container
EP2422879A3 (en) * 2010-08-24 2012-03-28 Siemens Healthcare Diagnostics Products GmbH Closing device for a reagent container
US10376247B2 (en) 2011-06-14 2019-08-13 Biopsafe ApS Container assembly and associated method
EP3653132A1 (en) * 2011-06-14 2020-05-20 Biopsafe ApS Container assembly and associated method
US9726585B2 (en) 2011-06-14 2017-08-08 Ax-Lab Innovation Aps Container assembly and associated method
EP3061401A3 (en) * 2011-06-14 2016-09-21 AX-Lab Innovation ApS Container assembly and associated method
US11592368B2 (en) 2011-06-19 2023-02-28 DNA Genotek, Inc. Method for collecting and preserving a biological sample
US11536632B2 (en) 2011-06-19 2022-12-27 DNA Genotek, Inc. Biological collection system
US11549870B2 (en) 2011-06-19 2023-01-10 DNA Genotek, Inc. Cell preserving solution
US11002646B2 (en) 2011-06-19 2021-05-11 DNA Genotek, Inc. Devices, solutions and methods for sample collection
CN103538785B (en) * 2012-07-17 2015-07-29 傅敏 The bottle cap component that a kind of material water is separated
CN103538785A (en) * 2012-07-17 2014-01-29 傅敏 Bottle cap assembly separating materials and water
WO2014165983A1 (en) * 2013-04-11 2014-10-16 Bottlecap Holdings Ltd. Dispenser having pierceable membrane
US10005599B2 (en) 2013-04-11 2018-06-26 Bottlecap Holdings Ltd. Dispenser having pierceable membrane
US9732376B2 (en) 2013-08-01 2017-08-15 Ancestry.Com Dna, Llc. Sample collection device
US10767146B2 (en) 2013-10-25 2020-09-08 Becton, Dickinson And Company Blood culture bottles with mechanisms for controlled release of substances into culture media
CN105874054A (en) * 2013-10-25 2016-08-17 贝克顿·迪金森公司 Blood culture bottles with mechanisms for controlled release of substances into culture media
US11840719B2 (en) 2013-10-25 2023-12-12 Becton, Dickinson And Company Blood culture bottles with mechanisms for controlled release of substances into culture media
WO2015179976A1 (en) 2014-05-27 2015-12-03 Dna Genotek Inc. Composition and method for stabilizing and maintaining the viability of hardy microorganisms
US11753616B2 (en) 2014-05-27 2023-09-12 DNA Genotek, Inc. Composition and method for stabilizing and maintaining the viability of hardy microorganisms
WO2017077467A1 (en) * 2015-11-06 2017-05-11 Traces S.R.L. Container for collection and preservation of biopsy samples
ITUB20155037A1 (en) * 2015-11-06 2017-05-06 Traces S R L Container for the collection and storage of biopsy samples.
US11360084B2 (en) 2018-02-14 2022-06-14 Salignostics Ltd Methods and apparatus for detecting analytes

Also Published As

Publication number Publication date
AU2006324337A1 (en) 2007-06-21
HK1123960A1 (en) 2009-07-03
IL192027A (en) 2014-02-27
IL192027A0 (en) 2008-12-29
BRPI0619596B8 (en) 2021-06-22
ATE531311T1 (en) 2011-11-15
EP1956969A4 (en) 2010-06-09
US20190210778A1 (en) 2019-07-11
TWI428119B (en) 2014-03-01
US20130025691A1 (en) 2013-01-31
BRPI0619596B1 (en) 2019-02-12
CA2632614A1 (en) 2007-06-21
CA2632614C (en) 2014-04-01
US20090216213A1 (en) 2009-08-27
AU2006324337C1 (en) 2013-03-21
CN101370425A (en) 2009-02-18
DK1956969T3 (en) 2012-01-30
ES2375379T3 (en) 2012-02-29
BRPI0619596A2 (en) 2011-10-04
US20150353249A1 (en) 2015-12-10
US8221381B2 (en) 2012-07-17
AU2006324337B2 (en) 2012-09-13
EP1956969B1 (en) 2011-11-02
TW200735843A (en) 2007-10-01
JP5150507B2 (en) 2013-02-20
JP2009518244A (en) 2009-05-07
EP1956969A1 (en) 2008-08-20
US9207164B2 (en) 2015-12-08
CN101370425B (en) 2011-08-24
PL1956969T3 (en) 2012-04-30
MX2008007253A (en) 2008-09-30

Similar Documents

Publication Publication Date Title
CA2632614C (en) Container system for releasably storing a substance
US20230051962A1 (en) Sample receiving device
EP2430420B1 (en) Closure, containing apparatus, and method of using same
EP3967242B1 (en) Sample collection apparatus and uses thereof
US20220409189A1 (en) Sample collection device with reagent

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2006846923

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: MX/a/2008/007253

Country of ref document: MX

Ref document number: 2632614

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2008543626

Country of ref document: JP

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2006324337

Country of ref document: AU

Ref document number: 5251/DELNP/2008

Country of ref document: IN

ENP Entry into the national phase

Ref document number: 2006324337

Country of ref document: AU

Date of ref document: 20061211

Kind code of ref document: A

WWP Wipo information: published in national office

Ref document number: 2006324337

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 200680052625.6

Country of ref document: CN

WWP Wipo information: published in national office

Ref document number: 2006846923

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 12096767

Country of ref document: US

DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
ENP Entry into the national phase

Ref document number: PI0619596

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20080609