Patent Application
20110127175
Embodiments of the present disclosure relate generally to containers for test strips, and especially to a test strip container with expandable insert, and methods of manufacturing and utilization thereof.
Apparatuses and methods for testing compositions of biological fluids, as well as test strips for use in such devices are well known. Typically, test strips are stored in a separate disposable vial, distinct from the test apparatus that analyzes the fluid sample. A test strip is first removed from the vial container, a sample of biological fluid is deposited onto the strip, and the strip is inserted into a test strip meter for analysis of the desired component. After the analysis is complete, the test strip is ejected from the meter, and disposed of.
A problem with test strips is that they are sensitive to environmental degradation due to air and water exposure. Prior art attempts to slow environmental degradation have proven only marginally effective. For example, in one conventional vial a lip seal is provided, in which the displacement of test strips can push them through the seal, and out of the container. In such an arrangement the vial remains sealed except when a strip is removed through the seal. This is ineffective to prevent environmental degradation due to the large amount of air and water ingress during strip removal.
Attempts have been made to protect the strips in a container by adding a desiccant to the chamber to absorb any moisture that enters the chamber during strip removal. However, these attempts have been ineffective because of the large amount of air ingress that occurs through repeated opening and closing of the container.
Test strips may also be packaged individually in tear-away packages, which ensures that the individual strips do not suffer environmental degradation. For instance, blister-type packaging methods may be used. In this configuration, the packages could include desiccant material to maintain the proper humidity in the package. In order for a person to use a single test strip, the package must be opened by tearing the seal. Opening of these packages can be difficult, especially for one with impaired circulation. Furthermore, carrying enough blister packs for a proper testing routine may be inconvenient, and cumbersome.
Test devices are known in which a plurality of test strips are provided on a cartridge disc, with each strip housed in a separate slot. A means is then provided to eject a test strip from its slot when required. U.S. Pat. No. 4,911,344 to Kahler discloses a strip dispenser box capable of dispensing a single test strip from a stack of test strips that does not require the user to insert a finger inside a vessel to retrieve a test strip. Rather, the '344 patent discloses a cap assembly with a strip feeder mechanism mounted to a housing having a magazine capable of holding a stack of test strips. The cap has a slot therein and a slide bar assembly slideably mounted in the slot for moving a test strip out of the dispenser, more particularly out of a gasket-sealed opening positioned on the cap assembly. However, the device disclosed in the '344 patent suffers from certain disadvantages. First and foremost, the strip dispenser of the '344 patent fails to maintain a completely moisture free environment. Specifically, at least two areas of the dispenser permit moisture to enter the housing and thus contact the test strips therein.
The first area which fails to provide a moisture free seal is the slot/slide bar assembly area. The slide bar is made of a cross shaped base member slideably positioned on the inner surface of the cap body and a finger grip which extends upward through the slot of the cap assembly. In operation, the finger grip is driven forward by the action of the thumb of the user and it carries a test strip out an opening of the cap assembly. As described in the patent, the preferred material of the dispenser is polyethylene plastic. In other words, both the cap assembly (the slot area) and the slide bar are made of polyethylene plastic. It will be apparent to one of skill in the art that such an assembly of two contacting polyethylene plastic surfaces cannot provide an adequate barrier to moisture.
The second area which fails to provide a moisture free seal is the opening through which a test strip is removed from the dispenser, even though a seal strip or gasket extends into the dispenser and covers the opening thereto. In other words, a gasket or the like is attached on a first side to the cap assembly and unattached on its other sides to allow a test strip to be pushed therethrough. It will similarly be apparent to one of skill in the art that such a seal cannot provide a barrier to moisture.
A problem with these test strip dispensers is the large size, and lack of portability which makes regular testing inconvenient. Furthermore, it is inconvenient for test strip users to carry around several distinct devices in order to perform routine testing.
Conventional storage vials are small, cylindrical containers that make it difficult to extract a single strip without spilling the entire contents of the vial. A user must invert the storage vial to extract a strip. Unfortunately, during inversion, multiple strips exit the vial, and a user must retrieve those strips from the ground. Additionally, the storage vial does not provide an adequate environmental barrier to prevent the degradation of the test strips.
There exists a need for a small portable container that provides test strips to users. The container must be easily used by the user. Furthermore, the container must provide improved environmental protection to the test strips stored therein.
It is against the above background that embodiments of the present disclosure provide a test strip container with an expandable insert, and methods of manufacturing and utilization thereof. The container includes a housing defining a cavity, a lid, and a compressible insert removably mounted in the cavity. The compressible insert is expandable to retain a plurality of test strips in the cavity and to protect the test strips from environmental degradation.
In one embodiment, a container for storing a plurality of test strips with each test strip having a reagent portion and a handling portion. The container comprises a housing defining a cavity, a lid hingedly connected to the housing to close the cavity, and a compressible insert removably mounted in the cavity. The compressible insert is expandable to retain the plurality of test strips.
In another embodiment, a container for storing a plurality of test strips, each test strip having a reagent portion and a handling portion, is disclosed. The container comprises a housing defining a cavity, a lid hingedly connected to the housing to close the cavity, and a compressible insert removably mounted in the cavity. The compressible insert is expandable to retain the plurality of test strips in the cavity. The compressible insert is folded to encompass a reagent portion of the plurality of test strips. The compressible insert further comprises a plurality of cooperating ridges. The compressible insert further comprises a coating.
In still another embodiment, a method for storing a plurality of test strips is disclosed. The method comprises providing a container for storing a plurality of test strips. Each test strip has a reagent portion and a handling portion. The container comprises a housing defining a cavity, a lid hingedly connected to the housing to close the cavity, and a compressible insert removably mounted in the cavity. The compressible insert is expandable to retain the plurality of test strips in the cavity. The method further includes providing a plurality of test strips in the cavity, and storing the plurality of test strips in the cavity. The compressible insert expands to releasably retain the plurality of test strips and protect the plurality of test strips from environmental degradation.
In yet another embodiment, a method of manufacturing a container for storing a plurality of test strips is disclosed. The method comprises providing a housing with a defined cavity and a lid hingedly connected to the housing for closing the cavity. A compressible insert is folded and inserted into the cavity. The compressible insert is expandable to retain the plurality of test strips in the cavity.
In still yet another embodiment, a method of protecting test strips from environmental degradation is disclosed which comprises utilizing a container according to an embodiment of the present disclosure.
These and other features and advantageous of these and other various embodiments according to the present disclosure will become more apparent in view the drawings, detailed description, and claims provided that follow hereafter.
The following detailed description of the embodiments of the present disclosure can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals, and in which:
Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements, as well as conventional parts removed, to help to improve understanding of the various embodiments of the present disclosure.
With reference to
The container 5 includes a housing 10 with a cavity 12 and a lid 14. The container 5 is suitable for dispensing any type of test strip 16, for example, electrochemical and colorimetric or photometric type test strips 16 as are known in the art, where such test strips 16 find use in the determination of a wide variety of different analyte concentrations, where representative analytes include, but are not limited to, glucose, cholesterol, lactate, alcohol, and the like. In many embodiments, the subject test strips 16 are used to determine the glucose concentration in a physiological sample, e.g., interstitial fluid, blood, blood fractions, constituents thereof, and the like. In further describing the embodiments of the present disclosure, a conventional test strip 16 is described with reference made to
The illustrated test strip 16 shown by
As shown, the reagent portion 20 is attached to the support element 18, in which the support element may be of a material (or material layers) that is sufficiently rigid to be inserted into the meter 34 without undue bending or kinking. In one embodiment, the support element 18 can be made of material(s) such as polyolefins, e.g., polyethylene or polypropylene, polystyrene or polyesters, and combinations thereof where in embodiments having a support element 18 formed from layers, such materials in support element 18 may be the same or different. Consequently, the length of the support element 18 typically dictates or corresponds to the length of the test strip 16.
Regardless of whether or not the length of the support elements 18 dictates or corresponds to the length of the test strip 16, the length of the test strip 16 generally ranges from about 3 mm to about 1000 mm, usually from about 10 mm to about 100 mm and more usually from about 20 mm to about 60 mm.
As described above, the support element 18 is usually configured to enable the test strip 16 to be inserted into a test strip meter 34 (
Examples of such test strips suitable for use with the present disclosure include those described in copending U.S. application Ser. Nos. 09/333,793; 09/497,304; 09/497,269; 09/736,788 and 09/746,116, the disclosures of which are herein incorporated by reference.
Referring again to
In one exemplary embodiment, the container 5 has a housing 10 and lid 14 comprising a rigid material that will retain its shape and form without cracking or breaking. The housing 10 and lid 14 may be manufactured from a variety of materials. In addition, where the housing 10 and lid 14 may be manufactured from the same or different materials. However, such materials will not interfere with the reagent portion 20 of the test strip 16 retained therein. Examples of such materials include, but are not limited to, plastics such as polytetrafluoroethylene, polypropylene, polyethylene, polystyrene, polycarbonate, and blends thereof. Materials may also include metals such as stainless steel, aluminum and alloys thereof, siliceous materials, and the like.
The housing 10 and lid 14 are alignable in a close configuration, such that the housing 10 and lid 14 form a substantially air and moisture tight seal when in a closed configuration. By substantially air and moisture tight seal is meant that the housing 10 and lid 14 are capable of preventing substantial air and moisture from entering the cavity 12 when the housing 10 and lid 14 are in a closed configuration.
With reference to
Referring to
Referring again to
Referring again to
As noted above, one or more, sometimes two or three or more of the above described attachment means may be used to create a seal between the lid 14 and the housing 10, where such a closure enables a substantially air and moisture tight seal.
The subject device may further include moisture absorbent reagents or components such as desiccant material, silica gel and the like, where such material is capable of absorbing moisture from the environment surrounding the stored test strips. Such absorbent reagents or components may be retained in one or more compartments positioned inside the housing 10 and/or lid 14.
With reference to
Reference now is made to
The compressible insert 22 is used to protect and retain the test strips 16 within the cavity 12 of the housing 10. In one embodiment, ridges 28 are perpendicularly disposed along the longitudinal axis X of the compressible insert 22. In one embodiment, the ridges 28 are spaced no more than about 10 mm apart from one another. In yet another embodiment, the ridges 28 are spaced no more than about 5 mm apart from one another. In another embodiment, the ridges 28 may be spaced any distance from one another so long as the test strips 16 are suitably retained when held thereby, as described below.
It is to be appreciated that the compressible insert 22 can be manually placed and removed to and from the cavity 12. Such a feature permits the easy loading of additional test strips as desired. When placed in the cavity, the compressible insert 22 is frictionally retained therein due to its expansion and conform to the cavity 12. The compressible insert 22 may be inserted into the cavity 12 before insertion of a plurality of test strips 16. The test strips 16 may be inserted in the front of the compressible insert 22 by manual insertion. Alternatively, in another embodiment, the test strips 16 may be placed within the cavity 12, and then the compressible insert 22 may be insert behind the test strips 16. Upon insertion the compressible insert 22 as mentioned will expand to releasably retain the test strips 16 in the front of the cavity 12. In other embodiments, the compressible insert 22 may be attached to the inside of the cavity 12 by adhesive, or mechanical mounting.
Another embodiment of the compressible insert 22 useable in the container 5 is illustrated in
Still another embodiment of the compressible insert 22 useable with the container 5 is shown in
In one embodiment, the compressible insert 22 is shaped to resemble the housing 10. In another embodiment, the compressible insert 22 may comprise the shape of substantially a cube, rectangular prism, elliptical shape. Alternatively, it may be shaped in an irregular fashion other than that which has been disclosed.
Referring to
Referring to
The size of the compressible insert 22 may also vary depending on a variety of factors such as the type and number of test strips 16 retained therein, or the size of the cavity 12 into which the insert is placed. In one embodiment, the compressible insert 22 has an about 40% larger volume than the cavity 12. In another embodiment, the compressible insert 22 has an about 25% larger volume than the cavity 12. The compressible insert 22 is compressible to fit within a smaller volume than originally provided. In one embodiment, the compressible insert 22 may be compressed to about 50% of its original volume. In another embodiment, the compressible insert 22 may be compressed to about 70% of its original volume. However, the compressible insert 22 may have a wide range of volumes in relation to the size of the cavity 12.
The dimensions of the compressible insert 22 may also vary depending on a variety of factors such as the type and number of test strips retained in the housing 10, or the size of the cavity 12 placed into. In one embodiment, the length of the compressible insert 22 is more then twice the length of the test strip 16, where the compressible insert 22 is folded to form a folded insert 24 (
With reference to
In one embodiment, storage chamber 26 of the folded insert 24 is configured to retain from about 1 to about 25 test strips at one time, usually about 1 to about 10, however the storage chamber 26 may be configured to retain more or fewer test strips as desired. In one embodiment, the storage chamber 26 may hold less than about ten test strips 16. In another embodiment, the storage chamber 26 holds more than about ten test strips 16, but not more than about twenty test strips 16. In another embodiment, the storage chamber 26 may hold from about ten to fifty test strips 16.
In another embodiment, the reagent portion 20 of the test strips 16 are enclosed in the storage chamber 26 of the folded insert 24 as depicted by
The compressible insert 22 has a coating to repel dirt, water, and lint from the compressible insert 22. The coating may comprise any material that repels dirt, water, and lint. In another embodiment, the coating may comprise a finish texture that repels dirt, water, and lint. In another embodiment, the coating is integral with the compressible insert 22.
Although the description above contains many specificities, these should not be construed as limiting the scope of the embodiment but as merely providing illustrations of some of the presently preferred embodiments. For example, the container may have other shapes, such as circular, oval, trapezoidal; the compressible insert may take other forms and materials; and the test strips may be oriented in a different fashion.
Thus the scope of the embodiment should be determined by the appended claims and their legal equivalents, rather than by the examples given.
