Classifications

• • 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
  • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
  • B01L3/50853—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates with covers or lids
• • A—HUMAN NECESSITIES
  • A47—FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
  • A47G—HOUSEHOLD OR TABLE EQUIPMENT
  • A47G19/00—Table service
• • 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
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L9/00—Supporting devices; Holding devices
  • B01L9/06—Test-tube stands; Test-tube holders
• • 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
  • B65D71/00—Bundles of articles held together by packaging elements for convenience of storage or transport, e.g. portable segregating carrier for plural receptacles such as beer cans or pop bottles; Bales of material
  • B65D71/50—Bundles of articles held together by packaging elements for convenience of storage or transport, e.g. portable segregating carrier for plural receptacles such as beer cans or pop bottles; Bales of material comprising a plurality of articles held together only partially by packaging elements formed otherwise than by folding a blank
• • 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
  • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
  • Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
  • Y02W30/00—Technologies for solid waste management
  • Y02W30/50—Reuse, recycling or recovery technologies
  • Y02W30/80—Packaging reuse or recycling, e.g. of multilayer packaging

Definitions

• the present invention relates generally to an apparatus for sealing a plurality of containers arranged in close proximity to one another. More particularly, the present invention relates to a reusable seal assembly for sealing a group of reagent-containing vials arranged in a unitary reagent pack for use with clinical analyzer apparatus.
• vials In many scientific fields including biology, chemistry, physics, medicine and pharmacology, various fluid materials are maintained in small, necked containers often referred to as vials. These vials frequently require closure means that will provide a safe, reliable seal while, at the same time, permit easy access to the fluids in the vials whenever required.
• a plurality of vials containing related fluids are maintained in close proximity to one another.
• samples are collected and reacted with reagents, and the results of the reactions are analyzed using well-known techniques.
• the reagents used in such tests are often purchased in and drawn from vials which are arranged in pre-formed packs having a plurality of vials containing all the reagents required for a particular test.
• samples of body fluids such as serum, plasma, urine and the like are assayed for the presence of analytes such as drugs, viruses or bacteria by reacting the samples according to a specific test protocol with specific reagents which are selected to identify a particular analyte.
• the protocol specifies the sequence in which the sample and reagents are to be introduced, the timing for the introduction of sample and reagents, the volumes of each to be used and other conditions to be controlled.
• the resulting reaction mix is typically- allowed to incubate for a predetermined time and is then read, optically or otherwise, to determine the presence and concentration of the specific analyte which the assay is designed to identify.
• procedures and apparatus for preparing and reading immunoassays are well-known and are not described in detail herein.
• the diagnostic testing of biological fluids is carried out in automated clinical analyzer apparatus which are capable of performing immunoassays on a plurality of samples simultaneously.
• a batch of sample containers is supported around the circumference of a rotatable carousel together with a corresponding number of reaction containers.
• the carousel is then mounted inside the analyzer, and in the analyzer, the carousel is caused to rotate stepwise to move each corresponding sample container and reaction container pair first to a position adjacent a preparation station, and then to a second position adjacent a reading station.
• Mechanical apparatus having pipette means and typically operating under program control is located in proximity to the preparation station together with' .a reagent pack which contains vials of the reagents required to perform a specific immunoassay on the batch of samples contained in the sample containers.
• the mechanical apparatus and pipette means operate to access and transfer volumes of samples from a sample container and reagents from the reagent vials into a reaction container according to the protocol established for the specific assay.
• the carousel rotates to position the next corresponding sample container and reaction container pair adjacent the preparation station and moves the previous pair toward the reading station.
• analyzers are capable of performing only one assay at a time on a batch of samples and, in order to perform a different assay, it is necessary to physically remove the reagent pack from the analyzer and replace it with a different reagent pack for the different assay.
• automated analyzers have been provided which can perform a plurality of different assays on a batch of samples.
• a plurality of different reagent packs can be mounted on a carousel to flexibly provide reagents for performing different assays on the same or different samples.
• reagent packs Such multi-dose reagent packs, multi-sample carousel analyzer apparatus, however, still require that the reagent packs be frequently handled so as to mount the packs on the carousel to perform the required series of tests and to remove them for storage or replacement with other reagent packs for different tests.
• a multi-dose reagent pack contains sufficient amounts of each reagent to test a large number of samples, e.g., up to one hundred or more; and thus it is common for such packs to be inserted into an analyzer for use and removed from an analyzer for storage many times during its useful life.
• an analyzer is designed to receive a single reagent pack or a plurality of packs.
• the properties of certain reagents may be affected by exposure to light or air or exposure to other reagents or contaminants.
• the vials of such packs could be individually reclosed using separate threaded closures as are typically provided with such vials; however, such individual closures can be easily misplaced or lost when separated from their respective vials.
• the present invention provides a reusable seal assembly for diagnostic test reagent packs and for other applications for sealing the openings of a plurality of containers which are positioned in close proximity to one another.
• the reusable seal comprises a pliable sealing component including a plurality of spaced protrusions for ' engaging the plurality of containers and for sealing the openings thereof, and a substantially rigid supporting component for supporting the pliable sealing component and for effecting the substantially simultaneous sealing of the openings of the plurality of containers by said plurality of protrusions when the seal assembly is mounted to the plurality of containers, and the substantially simultaneous withdrawal of the plurality of protrusions from the openings when the seal assembly is removed from the plurality of containers.
• the reusable seal assembly of the invention is positioned against the plurality of containers with the plurality of protrusions aligned with the openings of the containers. The user then presses the assembly against the containers to close and seal each of the openings.
• the substantially rigid supporting component provides sufficient rigidity to the assembly to cause each of the containers to be closed and sealed substantially simultaneously in a single pressing operation.
• the assembly is grasped at an edge thereof and pulled away from the containers.
• the rigidity of the supporting component causes each of the protrusions to be pulled away from the containers as a unit thus opening each of the plurality of containers substantially simultaneously.
• the rigid supporting component in effect, restricts the natural stretching tendency of the pliable sealing component thereby reducing the likelihood of liquid being flung from the containers or from the surface of the protrusions during removal of the seal assembly.
• the seal assembly of the invention is especially designed for use with containers having necked openings.
• the protrusions of the pliable' sealing component include button portions positioned to extend into the openings of the containers with an interference fit with the inner walls of the container necks to establish a radial seal therebetween.
• the protrusions preferably also include annular portions positioned to surround the outer walls of the necks.
• the pliable sealing component preferably comprises a thin, pliable, molded rubber web having a plurality of integral spaced protrusions extending downwardly from the lower surface thereof.
• the supporting component preferably comprises a thin plate of a molded, substantially rigid plastic and is affixed to the upper surface of the web.
• the support plate is preferably sufficiently thin to provide the assembly with a degree of flexibility to facilitate opening and closing of the containers.
• the reusable seal assembly of the present invention is particularly designed for use with multi-dose reagent packs for clinical analyzer apparatus, and typically includes three or more protrusions for sealing the openings of three or more reagent vials supported adjacent one another in the pack.
• the rigid support plate preferably also includes a downwardly extending flange defining a surface to which indicia may be applied for identification of a seal assembly to its respective reagent pack. This feature is especially important in analyzers which are capable of receiving a plurality of reagent packs at the same time to reduce the risk of remounting seal assemblies to the incorrect reagent packs after their removal from the analyzer.
• the seal assembly also includes a shipping component for enhancing the radial seal against the inner walls of the container necks.
• each button portion of the protrusions of the sealing component includes a tapered axial cavity extending downwardly thereinto from the top end thereof
• the shipping component comprises a rigid plate having a plurality of spaced, tapered pegs extending.downwardly therefrom which are positioned to extend into the cavities when the shipping component is incorporated into the assembly.
• the pegs push the button portions outwardly more firmly against the inner walls of the container necks to strengthen the radial seal therebetween.
• the shipping component is particularly designed for use during shipping of the reagent packs to the user when the reagent packs may be subjected to especially rough handling.
• the shipping component is generally not required once the reagent packs are delivered to the user as the subassembly consisting of the sealing component and the supporting component will normally provide an effective and reliable seal for normal handling in the laboratory.
• the seal assembly of the present invention will reliably prevent leakage or contamination of a plurality of reagent-containing vials both during shipping and during normal handling in the laboratory making the use of conventional threaded closures or the like unnecessary.
• the seal assembly can be used again and again throughout the useful life of the reagent pack. With the invention, also, the risk of cross-contamination or of mounting a seal assembly to the incorrect reagent pack is minimized so as to increase reliability of the assay.
• Fig. 1 is a partially exploded perspective view of a multi-vial reagent pack and a reusable seal assembly therefor according to a presently preferred embodiment of the invention
• Fig. 2 is a side view, partially in cross-section, of the reagent pack and seal assembly of Fig. 1;
• Fig. 3 is a cross-sectional side view of the seal assembly of Fig. 1 in assembled form and mounted to a reagent pack;
• Fig. 4 is a cross-sectional side view similar to Fig. 3 with the shipping component removed;
• Fig. 5 is an enlarged cross-sectional view illustrating details of the sealing component of the seal assembly of the invention.
• Figs. 1-4 illustrate a multi-vial reagent pack 10 and a reusable seal assembly 12 therefor according to a presently preferred embodiment of the invention.
• the reagent pack 10 which, in and of itself, does not form a part of the present invention, comprises a generally wedge-shaped package consisting of a molded plastic housing 14 having a plurality of wells or cavities 16 for receiving and supporting a plurality of reagent containing containers or vials 15.
• the vials 15 may be identical and may conveniently be formed of thin, flexible plastic by conventional molding techniques or be of glass or other suitable material as known in the industry.
• the vials are of generally cylindrical shape and have an upper neck portion 18 defining an opening 19 at the top thereof to provide access to the vials, and have a vertical dimension sufficient to elevate the neck portion and opening of the vials above the top surface 20 of the housing as illustrated in the Figs.
• the elevated neck portion provides for ease of access to the vials when the vials are mounted in the housing.
• the outer wall of the neck portions 18 of the vials is threaded to permit the vials to be closed by a conventional threaded cap.
• the reusable seal assembly of the present invention generally makes the use of threaded caps unnecessary.
• the vials may be formed integrally with the reagent pack housing if desired, it is generally preferred that the two components be manufactured separately because separate vials are easier to fill and avoids the risk of contaminating the reagent in one vial with reagent from an adjacent vial during the filling process.
• the reagent pack becomes a single integrated unit for use and handling.
• the individual vials or the reagent pack as a whole are intended to be disposable.
• a supplier of reagents provides reagents for specific assays to the user of a clinical analyzer apparatus in unitary reagent packs such as illustrated at 10.
• the user can purchase reagent packs for various drug tests and a single reagent pack will contain all the necessary reagents for a particular assay.
• a three vial reagent pack as illustrated in the Figs., is best suited for use in assays of the type which require a pretreat ent reagent, usually used to bind analytes of interest from certain proteins in a sample, an analyte complement for binding the unbound analyte, and a specifically tagged or labeled tracer reagent for indicating the presence of the analyte of interest.
• a pretreat ent reagent usually used to bind analytes of interest from certain proteins in a sample
• an analyte complement for binding the unbound analyte
• a specifically tagged or labeled tracer reagent for indicating the presence of the analyte of interest.
• a four vial reagent pack is preferred.
• the fourth vial is advantageously provided to contain a wash or buffer reagent that can be used to rinse a pipette heading means after it accesses such reagent.
• the seal assembly of the present invention is not intended to be limited to use with three vial reagent packs, but can be readily designed for use with other reagent packs or with any assembly of a plurality of vials or other containers that require sealing.
• a multi-dose reagent pack 10 such as illustrated in Figs. 1-4 is particularly adapted to be mounted on a carousel for use in an automated clinical analyzer apparatus along with several other reagent packs.
• eight or more different reagent packs can be mounted around the circumference of the carousel. This provides the operator of the analyzer with the ability to perform an entire battery of drug tests and other biological fluid tests which can be automatically carried out on the same or different samples.
• Many arrangements of combinations of samples, groupings of samples and groupings of reagent packs can be made within the apparatus depending on the particular tests that are to be performed. With such multitude of arrangements, the need for a reusable seal apparatus for closing and sealing reagent vials during periods of nonuse is a necessity.
• the reusable seal assembly 12 of the present invention is highly effective in achieving the above-described goals.
• the assembly comprises three components: a sealing component 21 of a pliable molded rubber or the like, a substantially rigid, molded plastic supporting component 22 and a molded, rigid plastic shipping component 23.
• the sealing component 21 comprises a thin, flat generally wedge-shaped web 13 of approximately the same dimensions as the top surface 20 of the reagent pack housing, having three integral protrusions 26 which extend downwardly from the lower surface 24 thereof.
• the outer tubular-shaped portion 28 is sized to fit around the outside surface of a neck 18 of a vial while the inner button portion 29 is adapted to extend into the opening 19 of the vial with an interference fit to establish a radial seal between the button and the inner wall 50 of the vial neck.
• the button portion 29 is preferably also formed to define a first, relatively wide upper portion 32 adjacent the top end thereof, and a second, narrower portion 33 of reduced diameter adjacent the bottom end thereof.
• the sealing component 21 also includes three portions 36 which extend upwardly from the upper surface 25 of the web in alignment with the button portions of the protrusions, and a central tapered cavity 37 extends into the button portions from the top of the upwardly extending portions to near the bottom of the button portions.
• the supporting component 22 comprises a generally wedge-shaped, thin, flat plate 40 also having generally the same dimensions as the top surface 20 of the reagent pack housing; and is provided with three circular openings or apertures 38 therein for receiving the upwardly extending portions 36 on the web 13. More particularly, as illustrated in Figs. 3-5, the upwardly extending portions 36 include annular flanges 39 which are adapted to be pushed up through the apertures 38 in the support plate 40 and, thereafter, to expand ' outwardly to attach and retain the web affixed to the support plate with the support plate positioned against the upper surface 25 of the web.
• the rigid plastic plate 40 also includes a downwardly extending flange 41 on the curved end thereof.
• Flange 41 defines a surface 42 upon which indicia can be placed to identify the reagent pack with which it is used or to provide other important information.
• a label or the like may be affixed to surface 42 and contain both human readable and machine readable indicia 43 , as shown in Fig. 1, for identifying a seal assembly to its particular reagent pack.
• Such information is especially important when the reagent pack is used in analyzers which are capable of receiving a plurality of reagent packs simultaneously to help reduce the risk of remounting a seal assembly to the incorrect reagent pack after it is removed from the analyzer.
• the reagent pack will normally have corresponding indicia 44 thereon for ease in matching a seal assembly with a reagent pack.
• the supporting component 22 functions to assist the user in mounting and removing the seal assembly on and from a reagent pack.
• the supporting component will provide sufficient rigidity to the assembly to cause each of the three vials to be sealed or opened substantially simultaneously.
• the supporting component in effect, restricts the natural stretching tendency of the pliable sealing component to prevent any significant deflection of the protrusions; and, particularly during the removal process, reduces the likelihood of the contents of one or more of the reagent vials being flung from the vials or from the surface of the protrusions.
• Shipping component 23 comprises a rigid, circular-shaped plate 47 having three spaced, tapered pegs 48 extending downwardly from the lower surface thereof.
• the shipping component is adapted to be mounted to the subassembly consisting of the sealing component 21 and the supporting component 22 such that the three pegs will extend into the tapered cavities 37 in the button portions 29 of the web as shown in Fig. 3.
• the pegs When fully inserted, the pegs will push the sidewalls of the buttons outwardly and more firmly against the inner walls 50 of the neck portions of the vials to enhance and strengthen the radial seal between the button portions and the inner walls.
• the shipping component is particularly designed for use when shipping a reagent pack to a user during which time the reagent pack is liable to receive particularly rough handling.
• the shipping component is normally not required after the reagent pack has been delivered to the user as the subassembly consisting of the sealing component 21 and the supporting component 22 will provide a fully effective seal of the vials in the laboratory.
• reagent packs are shipped to the user in a disposable container with one seal assembly mounted thereon.
• the seal assembly includes the shipping component incorporated into the assembly as shown in Fig. 3. With the shipping component in place, a strong, reliable seal of the vials is provided that can effectively withstand any rough treatment that the reagent pack may encounter during the shipping process. With the present invention, therefore, threaded caps or the like for the vials are unnecessary, even during shipping of the reagent pack.
• the user After delivery and prior to initial use of the reagent pack, the user will remove the shipping component and may dispose of it.
• the sealing component/supporting component subassembly can be retained in position on the reagent pack to provide a seal which is fully sufficient for normal handling within the laboratory.
• the subassembly When the reagent pack is to be used, the subassembly is grasped at an edge thereof and pulled away from the reagent pack, substantially simultaneously withdrawing the protrusions out of the openings of the vials and -.opening all three vials.
• the subassembly is preferably temporarily stored in a tray provided for that purpose while the reagent pack is in an analyzer or otherwise in use.
• the reagent pack is removed from the analyzer and the seal subassembly is repositioned on its appropriate reagent pack, utilizing the indicia provided on the seal and on the reagent pack for proper matching; and the subassembly is pressed downwardly to insert the three buttons 29 into the vials to close and seal the vials for storage until needed again. Because of the rigid supporting component, the buttons will also all be inserted into the openings of their respective vials substantially simultaneously to minimize possible spilling or spraying of the contents of the vials.
• the seal assembly of the present invention is designed to be used over and over during the life of the reagent pack with which it is used.
• a typical reagent pack may contain enough reagent for 100 tests or more, and the seal assembly can reliably be mounted on and removed from a reagent pack more than 100 times without loss of effectiveness.
• the seal assembly of the invention is also especially suitable for vials which include a chimney 51 therein as schematically illustrated in one vial in each of Figs. 2-4 which, as known to those skilled in the art, is sometimes used to reduce the rate of evaporation of the contents of an opened vial.
• the reduced diameter portion 33 at the lower end of the button portion provides an enlarged annular space for receipt of the chimney without interfering with the sealing ability of the button in any way as shown in Figs. 3 and 4.

Landscapes

• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Analytical Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Hematology (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)
• Packages (AREA)
• Sampling And Sample Adjustment (AREA)

Priority Applications (2)

Applications Claiming Priority (2)

Publications (1)

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Cited By (21)

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Citations (4)

• 1992
  • 1992-07-21 KR KR1019930704036A patent/KR940701227A/ko not_active Application Discontinuation
  • 1992-07-21 AU AU23827/92A patent/AU2382792A/en not_active Abandoned
  • 1992-07-21 WO PCT/US1992/006023 patent/WO1993001739A1/en active Application Filing
  • 1992-07-21 CA CA 2102315 patent/CA2102315A1/en not_active Abandoned
  • 1992-07-21 JP JP5502999A patent/JPH06509253A/ja active Pending

Patent Citations (4)

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