Patent Document

This application is a continuation of U.S. patent application Ser. No. 12/465,942 filed May 14, 2009 now U.S. Pat. No. 8,236,254. The contents of which is incorporated herein by reference to it in its entirety. 
    
    
     BACKGROUND 
     Test strips for analytical purposes are generally supplied to users in test strip vials from which individual test strips are removed as needed. A variety of test strips are known in the art including, for example, those designed to measure the concentration of an analyte in a fluid sample. With currently available test strip vials, it may be difficult for a user to remove a single test strip without tilting and/or shaking the vial, especially when the test strip vial is filled with test strips. Furthermore, tilting and/or shaking of test strip vials may result in undesired test strip spills and potential contamination of test strips. The present disclosure addresses these and related issues in the art. 
     SUMMARY OF THE INVENTION 
     The present disclosure provides test strip carriers for insertion into test strip vials and methods of making the same. Also provided are test strip vials including test strip carriers, and systems including test strip vials, test strip carriers and analytical test strips. The test strip carriers of the present disclosure are capable of engaging with the caps of test strip vials and thereby facilitating the retrieval of one or more test strips from the test strip vials upon opening of the test strip vials. These and other objects, features and advantages of the present disclosure will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings. 
     In a first aspect, the present disclosure provides a test strip carrier for insertion into a test strip vial, wherein the test strip vial includes a cap hingedly coupled to the test strip vial. The test strip carrier includes a first end configured for insertion into the test strip vial and defining a test strip basket, the test strip basket including a base and a wall. The test strip carrier also includes a second end configured to engage the cap and a flexible connector connecting the first end to the second end, wherein the test strip carrier is configured such that when the first end is inserted into the test strip vial and the second end engages the cap, opening of the cap raises the test strip basket from a first position to a second position within the test strip vial. 
     In one embodiment of the test strip carrier according to the first aspect the wall is an annular wall. 
     In one embodiment, the second end of the test strip carrier is configured to snapedly engage the cap. 
     In one embodiment, the second end of the test strip carrier is at least substantially disk shaped. 
     The test strip carrier according to the first aspect can be formed from a single piece of flexible material. In one embodiment, the flexible material is a polymer. In one embodiment, the flexible material is a polymer, and the polymer is a plastic. 
     In one embodiment, the second end of the test strip carrier is attached via an adhesive to the cap. 
     In a second aspect, the present disclosure provides a system including a test strip vial, wherein the test strip vial comprises a cap hingedly coupled to the test strip vial. The system also includes a test strip carrier, wherein the test strip carrier includes a first end configured for insertion into the test strip vial and defining a test strip basket. The test strip basket includes a base and a wall. The test strip carrier also includes a second end configured to engage the cap and a flexible connector connecting the first end to the second end. The system also includes a plurality of test strips disposed in the test strip basket, wherein the test strip carrier is configured such that when the first end is inserted into the test strip vial and the second end engages the cap, opening of the cap raises the test strip basket from a first position to a second position within the test strip vial. 
     In one embodiment of the system according to the second aspect the wall is an annular wall. 
     In another embodiment, the second end of the test strip carrier is configured to snapedly engage the cap. 
     In another embodiment, the second end of the test strip carrier is at least substantially disk shaped. 
     In the system according to the second aspect, the test strip carrier can be formed from a single piece of flexible material. In one embodiment, the flexible material is a polymer. In one embodiment, the flexible material is a polymer, and the polymer is a plastic. 
     In a third aspect, the present disclosure provides a test strip vial including a cap hingedly coupled to the test strip vial. The test strip vial also includes a test strip carrier, wherein the test strip carrier includes a first end inserted into the test strip vial, wherein the first end defines a test strip basket. The test strip basket includes a base and a wall. The test strip carrier also includes a second end engaged with the cap and a flexible connector connecting the first end to the second end. Opening of the cap raises the test strip carrier from a first position to a second position within the test strip vial. 
     In one embodiment of the test strip vial according to the third aspect the wall is an annular wall. 
     In another embodiment, the second end of the test strip snapedly engages with the cap. 
     In another embodiment, the second end of the test strip carrier is at least substantially disk shaped. 
     In the test strip vial according to the third aspect, the test strip carrier can be formed from a single piece of flexible material. In one embodiment, the flexible material is a polymer. In one embodiment, the flexible material is a polymer, and the polymer is a plastic. 
     In one embodiment, the test strip vial includes a plurality of analytical test strips disposed in the test strip basket. 
     In one embodiment, the second end of the test strip carrier is attached via an adhesive to the cap of the test strip vial. 
     In a fourth aspect, the present disclosure provides a method of making a test strip carrier for insertion into a test strip vial having a cap hingedly coupled thereto. The method includes cutting a test strip carrier pattern from a sheet of flexible material and folding the test strip carrier pattern to form a test strip carrier, wherein the test strip carrier includes a first end configured for insertion into the test strip vial and defining a test strip basket. The test strip basket includes a base and a wall. The test strip carrier also includes a second end configured to engage the cap and a flexible connector connecting the first end to the second end. The test strip carrier is configured such that when the first end is inserted into the test strip vial and the second end engages the cap, opening of the cap raises the test strip carrier from a first position to a second position within the test strip vial. 
     In one embodiment of the method described in the fourth aspect the wall is an annular wall. 
     In one embodiment, where the wall is an annular wall, the test strip carrier pattern comprises a first engagement slit and a second engagement slit, and the annular wall is formed by engaging the first engagement slit with the second engagement slit. 
     In one embodiment, the second end of the test strip carrier is configured to snapedly engage the cap of the test strip vial. 
     In one embodiment, the second end of the test strip carrier is at least substantially disk shaped. 
     In one embodiment, the flexible material is a polymer. In one embodiment, the flexible material is a polymer, and the polymer is a plastic. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Referring now to the drawings, wherein like reference numerals and letters indicate corresponding structure throughout the several views: 
         FIG. 1  shows an embodiment of a test strip carrier according to the present disclosure; 
         FIG. 2  shows the test strip carrier of  FIG. 1  inserted into a test strip vial and engaged with a test strip vial cap; 
         FIG. 3  shows the test strip carrier of  FIG. 2  with analytical test strips disposed therein; and 
         FIG. 4  shows a cutout pattern which can be folded to form a test strip carrier according to the present disclosure. 
     
    
    
     Before the present invention is further described, it is to be understood that this invention is not limited to the particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. 
     Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. 
     As used herein and in the appended claims, the singular forms “a,” “and,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. 
     The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. 
     DETAILED DESCRIPTION 
     Test Strip Carriers 
     As indicated above, the present disclosure provides test strip carriers for insertion into test strip vials. With reference to  FIGS. 1 ,  2  and  3 , exemplary embodiments of the test strip carriers of the present disclosure are now described. A test strip carrier  100  includes a first end  101 . The first end  101  defines a test strip basket having a base  103  and a wall  104 . In the embodiment shown in  FIGS. 1 ,  2  and  3 , the wall  104  is an annular wall, although additional configurations are possible, e.g., a wall having one or more 90° angles. As used herein, the term “annular” refers to a shape which is at least substantially circular or elliptical. 
     With reference to  FIG. 1 , the test strip carrier  100  optionally includes one or more base tabs  106  which extend from the base of wall  104 , and which can be folded during assembly of the test strip carrier such that they engage the base  103  to form the test strip basket. The test strip carrier  100  optionally includes a first engagement slit  107  and a second engagement slit  108  (engagement slits  106  and  107  are visible in the cutout provided in  FIG. 4  and are shown in an engaged configuration in  FIG. 1 ). In one embodiment, during formation of the test strip carrier  100 , the wall  104  is formed by engaging first engagement slit  107  with second engagement slit  108  or vice versa. The dimensions of the wall  104  may vary. However, the distance from the base  103  to the top of the wall  104  should be less than the length of the test strips  120  held by the test strip basket to facilitate retrieval of the test strips from the test strip basket. 
     With reference to  FIGS. 2 and 3 , the first end  101  is configured for insertion into a test strip vial  109  which includes a cap  110  hingedly coupled to the test strip vial  109 , e.g., via a hinge or flange. When the test strip carrier  100  is inserted into the test strip vial  109 , the first end  101  slidably engages with the inner wall  111  of the test strip vial  109 . In other words, first end  101  engages the inner wall  111  via a sliding action. To allow for such slidable engagement, the dimensions of the first end  101  can be configured based on the dimensions of the test strip vial  109  into which the test strip carrier  100  will be inserted. In another embodiment, the test strip vial  109  is configured based on the dimensions of the test strip carrier  100  to be inserted therein. 
     In one embodiment, the first end  101 , is configured such that the outer dimensions of the first end  101 , e.g., the circumference of the base including the width of the wall, are sufficiently less than the circumference of the interior wall  111  of test strip vial  109  so as to allow the test strip carrier  100  to slide within the test strip vial  109  with the application of minimal force, e.g., the force applied by a user using one hand to open the test strip vial  109 . It may also be desirable to configure test strip carrier  100  such that it engages the inner wall  111  of the test strip vial  109  with sufficient tightness to prevent test strips  120  from sliding past the test strip carrier  100  to the space below the test strip carrier  100  in the test strip vial  109 . 
     In one embodiment, the base  103  optionally includes one or more apertures (not shown) extending through the base  103 . These apertures can provide for the exchange of gasses between the area beneath the base  103  and the area above the base  103 . Generally, these apertures are sized such that they are large enough to allow for the exchange of gasses between the area beneath the base  103  and the area above the base  103  but small enough to prevent the passage of test strips  120  through the apertures. 
     The test strip carrier  100  also includes a second end  102 , which is configured to engage the cap  110  of the test strip vial  109 . Engagement of the cap  110  with the second end  102  may be accomplished in a variety of ways. For example, via application of an adhesive material between the second end  102  and the interior surface  112  of cap  110 . 
     In one embodiment, the second end  102  is configured to detachably engage the cap  110  of the test strip vial  109 . In other words, in one embodiment, the test strip carrier is not a component of the cap  110 , but is instead a separate component which can detachably engage with the cap  110 . Such a configuration is of substantial benefit to the art because the test strip carrier  100  can be readily configured to work with a variety of preexisting test strip vials. In this manner, substantial costs associated with the design and production of new test strip vials and/or retooling of assembly lines can be avoided. 
     In one embodiment, the second end  102  is configured to snapedly engage, e.g., via a snap feature, the cap  110  of the test strip vial  109 . In other words, second end  102  and cap  110  can be configured for snap-fit engagement. For example, in one embodiment second end  102  is at least substantially disk shaped. Where second end  102  is at least substantially disk shaped, it may be sized to snap into annular gap  113  of cap  110 . 
     A flexible connector  105  connects the first end  101  to the second end  102 . The flexible connector may take a variety of shapes, provided that the flexible connector is capable of operating as described herein. As shown in  FIGS. 1-3 , in one embodiment the flexible connector  105  has an elongate rectangular shape. 
     Overall, the test carrier  100  is configured such that when it is inserted into test strip vial  109 , opening of the cap  110  raises the test strip basket from a first position to a second position within the test strip vial  109 . For example, with reference to  FIG. 3 , the pivoting motion of cap  110  about flange  115 , moves the cap  110  from a closed position to an open position. Because second end  102  is engaged with the cap  110 , the motion of the cap  110  exerts an upward force on the test strip basket via the flexible connector  105 . The distance between the first position and the interior surface  112  of cap  110 , when the cap  110  is in the closed position, is at least as long as the test strips  120  to be held by the test strip basket. The distance between the second position and the rim  114  of the test strip vial  109  is such that the ends of the test strips  120  will extend beyond the rim  114  of the test strip vial  109  when present. In other words, when a user opens cap  110  of test strip vial  109 , the test strip basket is raised within the test strip vial  109  thereby lifting the test strips  120  from a first position closer to the base of the test strip vial  109  to a second position towards the upper edge or rim  114  of test strip vial  109 . 
     Test Strip Vials for Use with the Disclosed Test Strip Carriers 
     The test strip carriers of the present disclosure can be configured for insertion into a variety of test strip vials known in the art. Vials suitable for use with the test strip carriers disclosed herein are described, for example, in U.S. Pat. Nos. 5,723,085, and 5,911,937, the disclosures of each of which are incorporated by reference herein. 
     In one embodiment, the test strip carriers of the present disclosure are configured for insertion into a test strip vial  109  as shown in  FIGS. 2 and 3 . In the embodiment shown in  FIGS. 2 and 3 , the test strip vial  109  is cylindrical in shape with an integrally formed bottom. The test strip vial  109  includes an interior wall  111 . A cap  110  is provided which is adapted to seal the vial closed with a substantially hermetic seal. The cap  110  can be integrally connected to the vial  109  with a small flange  115 . In one embodiment, the vial  109  and cap  110  are injection molded from a thermoplastic material. 
     The cap  110  includes a cap rim  116 . The cap rim  116  is intended to fit over the annular rim  114  of the outer wall  117  of the test strip vial  109  in a sealing manner. A ridge  118  may be formed on the inside of cap  110  to enhance the seal of the cap  110  to the vial  109 . An annular gap  113  extends from the ridge  118  to the outer edge of interior surface  112  of cap  110 . 
     The test strip vial  109  has an annular ridge  119  extending around the periphery of the test strip vial  109 . The annular ridge  119  and a smooth transition surface at the upper edge or rim  114  of the vial  109  form an annular region for interlocking with the cap  110 . 
     The inside of the cap  110 , including the ridge  118  and the annular gap  113 , combine to form an annular region for interlocking with the interlocking annular region on the vial  109 . The inner surface of cap  110  extending from cap rim  116  to ridge  118  is angled so as to guide the upper edge or rim  114  of the vial wall into the annular gap  113 . The annular rim  114  of the vial  109  is designed to fit within the annular gap  113 . 
     Analyte Test Strips for Use with the Disclosed Test Strip Carriers 
     The test strip carriers of the present disclosure can be configured to work with any of a wide variety of analyte test strips. In some embodiments, the test strip carriers of the present disclosure are configured to hold FreeStyle® test strips for use in blood glucose monitoring or Precision® brand test strips for use in monitoring glucose and ketones. FreeStyle® and Precision® brand analyte test strips are available from Abbott Diabetes Care Inc., Alameda, Calif. Exemplary analyte test strips are also described in U.S. Pat. Nos. 6,071,391; 6,120,676; 6,143,164; 6,299,757; 6,338,790; 6,377,894; 6,600,997; 6,773,671; 6,592,745; 5,628,890; 5,820,551; 6,736,957; 4,545,382; 4,711,245; 5,509,410; 6,540,891; 6,730,200; 6,764,581; 6,299,757; 6,338,790; 6,461,496; 6,503,381; 6,591,125; 6,616,819; 6,618,934; 6,676,816; 6,749,740; 6,893,545; 6,942,518; 6,175,752; and 6,514,718, the disclosures of each of which are incorporated by reference herein. 
     Test strips suitable for use with the test strip carriers described herein include optical and electrochemical test strips configured for use in testing for any of a wide variety of analytes, including, but not limited to, glucose, lactate, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. 
     Test strips suitable for use with the test strip carriers described herein also include test strips configured for use in testing for drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be determined and the like. 
     Materials for Construction 
     Test strip carriers according to the present disclosure may be formed and/or constructed from a variety of suitable materials, provided that the materials are sufficiently flexible to operate as described herein. In one embodiment, the test strip carrier is formed from single piece of flexible material, as shown in  FIG. 4 , which is folded to achieve the final configuration. In another embodiment, the test strip carrier is molded, e.g., injection molded, to achieve the final configuration. Suitable flexible materials include polymers, e.g., plastics. In one embodiment, the flexible material is a thermoplastic polymer, e.g., polycarbonate, polystyrene, polyethylene, polysulfone or polypropylene. 
     Desiccants 
     It may be desirable to keep the test strips stored in the test strip vials disclosed herein as moisture free as possible. As such, the test strip vials disclosed herein can include one or more desiccants, e.g., silica gel. The desiccant can be located in the test strip vial or included as a component of the test strip vial itself. The desiccant can also be located on and/or in the material used to form the test strip carrier. In one embodiment the desiccant is included in a moisture absorbing desiccant entrained polymer. This polymer can be used as a component of the test strip vial and/or the test strip carrier. It can also be used to coat one or more surfaces of the test strip vial and/or the test strip carrier. Processes and resulting structures for producing moisture absorbing desiccant entrained polymers are described, for example, in U.S. Pat. No. 5,911,937, the disclosure of which is incorporated by reference herein. 
     Method of Making 
     In one embodiment, the test strip carrier  100  is formed from a single piece of flexible material which is folded into the final configuration to be inserted into a test strip vial  109 . The single piece of flexible material can be cut from a sheet of flexible material, e.g., a flexible polymer. A variety of methods are known in the art for cutting a predetermined pattern from a sheet of flexible material. Such methods include, but are not limited to, die cutting and laser cutting. These methods can be readily adapted to large scale, high throughput applications as needed. 
     In one embodiment, the cutout pattern has the configuration shown in  FIG. 4 . The numeric identifiers in  FIG. 4  refer to the structures of the test strip carrier  100  that can be formed from the identified portions of the cutout pattern. The test strip carrier  100  shown in  FIGS. 1 ,  2  and  3  can be formed from the cutout shown in  FIG. 4  as follows. The portion of the flexible material forming base  103  is folded at position (A) at an approximately 90° angle relative to the portion of the flexible material which will form the wall  104 . The portion of the flexible material which will form the wall  104  is folded such that first engagement slit  107  engages second engagement slit  108  to form wall  104 . In another embodiment, the flexible material which will form the wall  104  is folded and engaged with itself via application of an adhesive. 
     Optional base tabs  106  can be folded at an approximately 90° angle relative to wall  104  such that they engage and/or provide support for base  103 . In one embodiment, a plurality of slits (not shown) is provided in base  103 . The base tabs  106  can be inserted into these slits in an interlocking manner to provide engagement of the base tabs  106  with the base  103 . In another embodiment, the base tabs  106  can engage with base  103  via application of an adhesive. The wall  104  together with base  103  and optional base tabs  108  form the test strip basket in which analytical test strips  120  can be disposed. 
     Second end  102  is folded at position (B) at one end of flexible connector  105  to form a disk shaped engagement element having a cutout which forms a portion of flexible connector  105  as shown in  FIGS. 1 ,  2  and  3 . The fold at position (B) allows the disk shaped engagement element to pivot about the fold axis while engaged with the cap  110  of test strip vial  109 . 
     As indicated above, the test strip carrier can also be molded, e.g., injection molded, to achieve the final configuration. 
     While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

Technology Category: 4