VIAL SEAL

Abstract: A vial seal is provided for sealing a plural­ ity of reagent-containing vials (30) seated in a reagent pack. The vial seal comprises a pliable cover (12) having attached thereto a plurality of vial inserts (14) for seal­ ing a corresponding plurality of such vials (30). The pliable cover (12) contains a corresponding plurality of openings (24) which fit around the necks (32) of the vials (30) to allow the vial seal to remain with the vials (30) at all times. The pliable cover (12) contains a fastener which allows the vial seal to be held in a non-interfering position with respect to the vial openings when the inserts are disengaged from the vials (30).

Description: FIELD OF THE INVENTION This invention relates to seals for closing containers. More specifically, this invention relates to a seal for closing a group of reagent-containing vials arranged in a reagent pack for use with automated clinical analyzer apparatus. BACKGROUND OF THE INVENTION In the field of diagnostic testing of biological fluids for the presence of drugs, viral disease, bacterial infections, and the like, samples are collected, reacted with reagents, and the results of the reactions analyzed using well known techniques. The reagents used in such tests are typically purchased in and drawn from vials or other containers which are often arranged for convenience in pre-formed packs having a plurality of such vials containing the reagents required for a specific test. For economy and practicality, each vial typically contains an aliquot of reagent sufficient to test a number of samples. Such a reagent pack is described in U.S. Patent No. 4,849,177 (published 18.07.1989) entitled Reagent Pack and Carousel. A problem with such "multiple dose" reagent packs is that once opened, the reagents may become contaminated. For example, the properties of certain reagents may be affected by exposure to light or air, the passage of time, or exposure to other reagents or contaminants. The vials of such packs could be individually reclosed using individual screw-on or other closures typically provided with such vials. However, such individual closures can be misplaced or lost when separated from their vials. In addition, it is time consuming and inconvenient to individually open and reclose each vial of a pack with a separate closure, particularly in an automatic testing environment where test set-up time and the time between tests can have a critical impact on throughput. Thus, a need exists for a vial seal apparatus that provides expedient, economical and safe re-sealing of multiple dose reagent vials, once opened. A desirable feature of such an apparatus is to provide resealing of a group of vials arranged in a reagent pack. Another desirable feature is to provide an apparatus which minimizes contamination during handling and loss of the seal during the useful life of the reagents. It is advantageous to provide an apparatus that remains attached to, without interfering with, the vials of a reagent pack during use of the reagent pack in an automated clinical analyzer. SUMMARY OF THE INVENTION This invention, therefore, seeks to provide a vial seal which provides economical and expedient sealing of the vials contained in a reagent pack. The above-mentioned problems encountered in the use of the known vial closures are solved, and the aim of providing an economical and expedient sealing of vials contained in a reagent pack is achieved, by a vial seal as defined in claim 1. The vial seal of the invention is adapted to be removably attached to the vials throughout storage, as well as when the reagent pack is in use. In addition, the vial seal of the present invention, once attached, forms a single unit with its associated reagent pack. The vial seal of the present invention, therefore, comprises a number of vial inserts which are attached to a thin, pliable connecting cover in a linear arrangement corresponding to the openings of a number of reagent-containing vials in a reagent pack. The cover is capable of bending so that each insert can be individually inserted into or removed from the opening of its corresponding vial. The cover has a series of linearly-arranged openings which are adapted to fit over and around the necks of the reagent-containing vials so that the vial seal is removably attached to the necks of the reagent-containing vials. In the preferred embodiment the cover includes a first portion and a second portion. The first portion has first and second surfaces with the vial inserts formed on and projecting away from the first surface. The first surface is also flanged in a direction from an inner end to a free outer end. In addition, the vial seal of the present invention includes a post with a ball-shaped end and a corresponding aperture, both formed in the pliable cover. In the preferred embodiment the aperture is located in a midsection of the cover between the first and second portions. When the reagent pack is being used, the ball-shaped end is adapted to be fitted into the aperture to position the inserts away from the openings of the vials to prevent interference with the operation of a clinical analyzer or other instrument. The openings remain over and around the necks of the vials so that the vial seal remains with the reagent pack even during testing. BRIEF DESCRIPTION OF THE DRAWINGS The features which are believed to characterize the invention are set forth in the appended claims. The invention itself, together with further features and attendant advantages, will be best understood by reference to the following detailed description of a presently preferred embodiment thereof, taken in conjunction with the accompanying drawings, in which: FIG. 1 is a perspective view of the vial seal of the present invention attached to and in sealing contact with vials in a reagent pack. FIG. 2 is a perspective view of the present invention illustrating the vial inserts thereof and the openings thereof placed over and around the necks of the vials in the reagent pack. FIG. 3 is a perspective view of the vial seal of the present invention illustrating the ball-shaped end placed through the hole in the pliable cover to hold the inserts in a non-interfering position. DETAILED DESCRIPTION OF A PRESENTLY PREFERRED EMBODIMENT As seen in FIGS. 1, 2 and 3, a presently preferred embodiment of the present invention comprises a vial seal 10 having a pliable cover 12. One surface of the connecting cover 12 has formed thereon a series of closure means constituted by vial inserts 14. Each insert 14 has a cylindrical base 15 and a rib 16 located near the end of the insert 14. Each of the inserts 14 corresponds to an opening of a vial 30 which is mounted in a reagent pack 40. More specifically the cover 12 has a first portion 11 having first 13 and second 26 surfaces and a second portion 21. Vial inserts 14 are positioned on the first surface 13 of the first portion 11 which also has an inner end 17 and outer end 23. In the preferred embodiment, the first portion 11 is flanged from the inner end 17 toward the outer end 23. This "wing type" configuration of the first portion 11 provides a finger grip surface proximate the outer end 23. This finger grip area provides for opening and closing the cover 12 without touching the sealing portions 14 of cover 12, thereby minimizing cross-contamination of the reagents. Each of the inserts 14, like the connecting cover 12, is formed of a pliable plastic. When an insert 14 is inserted into the opening of a vial 30 formed by a neck 32, the insert 14 flexibly forms to and provides a secure fluid-tight press fit in the opening of the vial 30. Referring to Fig. 3, a tight press fit of insert 14 into vial 30 is enhanced by the enlarged portion or rib 16 of insert 14. The fluid-tight seal provided by the insert 14 prevents contaminants of the reagent by other reagents, samples, or the environment. In the preferred embodiment, the inserts 14 are arranged linearly along the first surface 13 of the first portion 11 to accommodate a linear arrangement of vials 30 when mounted in the reagent pack 40. Other geometries may also be used to accommodate various reagent pack configurations. The inserts 14 are formed along the first surface 13 of the pliable cover 12 at spacings corresponding to the spacings of the necks 32 of each of the vials 30. Ribs or joints 33 are preferably formed in the cover 12 intermediate each of the inserts 14 to further facilitate bending of the cover 12. In addition to the inserts 14, the pliable cover 12 also contains a series of openings 24, each corresponding to one of the vials 30 in the reagent pack 40. As best seen in Fig. 2, the openings 24 are aligned along the second portion 21. Each of the openings 24 preferably has a plurality of scores 22 extending radially therefrom and cut into the cover 12. The radiating scores 22 provide flexibility to allow the openings to be fitted over and around the necks of their respective vials, including any flanges or threaded portions formed thereon. The scores 22 also allow the openings 24, once in place, to grip the necks 32 of the vials 30 and remain firmly in place. The openings 24 on the second portion 21 of the vial seal 10 remain attached to the necks 32 of the vials 30 even when the inserts 14 on the first surface 13 of the first portion 11 are disengaged from the openings in the vials 30. Thus, the vial seal 10, once mounted on the vials 30 of a reagent pack 40, remains attached as a single unit with the reagent pack 40 until the vials 30 are emptied. While in the preferred embodiment the vial seal is intended to be disposable when vials 30 are empty, the vial seal 10 is removable and could be used with another reagent pack. The vial seal 10 also contains on the surface 26 opposite the inserts 14 means for securely positioning the inserts 14 proximate the vials 30 when the inserts 14 are disengaged from the vials. In its preferred embodiment the positioning means comprises a cooperating shaft and receiving aperture which the shaft securably engages. Most preferably, as shown in Fig. 3 the shaft is a post 18 with a generally ball-shaped end 19. The post 18 and ball-shaped end 19 correspond to the aperture 20 located between the last of the inserts 14 on the first portion 11 and the first of the openings 24 on the second portion 21, as seen in FIG. 2. The cover 12 can be "folded" as seen in FIG. 3, in such a way that the ball-shaped end 19 aligns with and fits through the aperture 20. When the end 19 is inserted into the aperture 20, the vial seal is maintained in a position wherein the inserts 14 are held in proximity to the vials 30 of the reagent pack 40, but are removed from the space above the necks 32 of the vials 30 so as not to interfere with access to the reagents contained therein by a clinical analyzer, for example. This feature allows the vial seal 10 to remain as a single unit with a set of reagent vials 30 in a reagent pack 40 at all times. The aperture 20 preferably contains radiating scores 22 similar to those associated with the openings 24. The scores 22 facilitate insertion of the ball-shaped end 19 of the post 18 through the aperture 20. Once the ball-shaped end 19 of the post 18 is inserted through the aperture 20, the radiating scores 22 help keep the ball-shaped end 19 in place. It should be noted that although a particular configuration of the vial seal 10 which is adapted for use with a particular reagent pack 40 has been described and illustrated, the vial seal 10 is advantageously used with reagent packs having different configurations as well. For example, although the reagent pack 40 as shown in the figures contains three vials 30, alternate embodiments such as the four vial configuration of the referenced application, as well as other configurations, are entirely conducive to the use of similar alternate embodiments of the present vial seal 10. In one alternate embodiment (not shown) the first surface 13 can include an additional cross-contamination protective means such as a projecting ring surrounding each insert 14 which fits around the neck 32 of each reagent containment vial 30 when the inserts 14 of cover 12 engage the vials 30. This additional protective ring serves as a shield to minimize cross-contamination. While the invention has been described in connection with the presently preferred embodiments thereof, it will be apparent to those skilled in the art that various changes and modifications to the structure, arrangement, portions, elements, materials and components used in the practice of the invention are possible without departing from the scope and spirit of the invention. The foregoing description is therefore to be taken as illustrative rather than limiting and the scope of the invention is defined solely by the following claims. Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the scope of each element identified by way of example by such reference signs.

Claims: A vial seal (10) comprising a plurality of vial closure means (14) for correspondingly sealing a plurality of vials (30), characterized in that said closure means (14) are attached to pliable cover means (12) and define together therewith a single unit, said closure means (14) being further connected to means (24) for attaching said cover means (12) to said plurality of vials (30). A vial seal (10) according to claim 1, characterized in that said pliable cover means (12) includes a first portion (11) and a second portion (21), said first portion (11) including said vial closure means (14) along one surface (13) thereof, said first portion (11) having an inner end (17) and a free outer end (23) and being flanged outwardly from said inner end (17) toward said outer end (23). A vial seal (10) according to claim 1 or 2, characterized in that said attaching means comprises a plurality of openings (24) formed in said pliable cover means (12) and adapted to fit over the upper ends or necks of a plurality of vials (30) to be sealed by said closure means (14) for attaching said cover means (12) thereto. A vial seal (10) according to claim 1, 2 or 3, characterized in that it further comprises means (18, 19, 20) for securably positioning the closure means (14) proximate to the vials (30) when said closure means (14) are disengaged from said vials (33). A vial seal (10) according to claim 1, 2 or 3 characterized in that said cover means (12) has first and second surfaces (13, 26) with said vial closure means (14) formed on a first portion (11) of said cover means (12) and said openings (24) positioned on a second portion (21) of said cover means (12). A vial seal (10) according to claims 4 and 5, characterized in that said closure means (14) project away from said first surface (13) and in that said means (18, 19, 20) for securably positioning said closure means (14) include at least one aperture (20) positioned between said first (11) and second (21) portions of said cover means (12). A vial seal (10) according to claims 5 and 6, characterized in that said aperture (20) is adapted to receive shaft means (18, 19) positioned along and extending outwardly from said second surface (26) of said second portion (21). A vial seal (10) according to claim 1, 2, 3, 5 or 6, characterized in that said closure means (14) of said pliable cover (12) comprises at least three closure means (14), and in that said cover means (12) has at least three of said openings (24). A vial seal (10) according to claim 1, 2, 3, 5, 6 or 8, characterized in that said pliable cover (12) contains rib means (33) formed therein between said closure means (14) for facilitating bending thereof. A vial seal (10) according to one or more of the preceding claims, characterized in that the first surface (13) includes shielding means adjacent each of said vial closure means (14). A vial seal (10) according to claim 1, 2, 3, 4, 5, 6, 8, 9 or 10, characterized in that the closure means (14) each have a circular base (15) attached to a cylindrical sidewall, said cylindrical sidewall preferably containing an outer rib (16) molded generally midway from said base (15) to the top of said cylindrical sidewall. A vial seal (10) according to claim 1 and 2, 3, 4, 5, 6, 8, 9, 10 or 11, characterized in that the closure means (14) are linearly arranged and connected by said pliable cover means (12), said pliable cover means (12) generally conforming to a reagent pack (40) containing vial openings into which said closure means (14) are to be inserted for sealing. A vial seal (10) according to one or more of the preceding claims characterized in that said pliable cover means (12) further comprises fastening means (18, 19, 20) positioned co-linearly with said closure means (14) for holding said closure means (14) in a position removed from vials (30). A vial seal (10) according to claim 13, characterized in that said fastening means includes a shaft (18) culminating in a ball-shaped end (19) and a corresponding hole (20) formed in said pliable cover (12) for receiving and retaining said ball-shaped end (19) to retain said pliable cover (12) in a folded position with said closure means (12) removed from said vials (30). A vial seal (10) according to claim 1, 2, 3, 5, 6, 8, 9, 12, 13 or 14, characterized in that the pliable cover means (12) contains a plurality of openings (24) formed therein corresponding in number to said closure means (14). A vial seal (10) according to claim 3, 5, 8, 12 or 15, characterized in that said openings (24) are adapted to fit over and around the necks (32) of vials (30) in a reagent pack (40) to retain the vial seal (10) with the vials (30) whether or not sealed by said closure means (14).

Inventors: JORDAN, WILLIE WALTER
Applicants: ABBOTT LABORATORIES
Application year: 1988
Main classification: B65D39
IPC codes: B65D71, G01N35, B65D77, B01L3, B65D39, B65D55