Patent Publication Number: US-2020300837-A1

Title: Sensor clip for stacked sensor dispensing system, and systems, methods and devices for making and using the same

Description:
CROSS-REFERENCE TO REI .ATED APPLICATIONS 
     The application claims priority to U.S. Provisional Patent application Ser. No. 62/014,429, filed on Jun. 19, 2014, the contents of which are incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to systems, methods, and devices for determining an analyte concentration in a fluid sample. More particularly, aspects of the present disclosure relate to containers for storing and dispensing sensors for testing analytes. 
     BACKGROUND 
     The detection of a wide range of analytes present in fluid samples is of great importance in the diagnoses and maintenance of certain physiological abnormalities. Quantitative analysis of analytes in bodily fluids, for example, is necessary for the detection, management, and treatment of many degenerative medical conditions. For example, lactate, cholesterol, and bilirubin should be monitored in certain individuals. In addition, determining glucose in body fluids is important to diabetic individuals who must frequently check their blood glucose levels to regulate the carbohydrate intake in their diets. Failure to monitor glucose levels and take corrective action can have serious implications fora diabetic individual. When blood glucose levels drop too low—a condition known as hypoglycemia—a person can become nervous, shaky, and confused, and may become physically impaired and eventually pass out. A person can also become very ill if their blood glucose level becomes too high—a condition known as hyperglycemia—which, like hypoglycemia, is a potentially life-threatening condition. 
     Many conventional hand-held glucose testing devices (“meters”) utilize test strips that provide an indication of the presence and/or concentration of a particular substance within the body fluid being analyzed. These test strips are often thin strips of material, such as paper or plastic, which are coated or impregnated with a chemical reagent, A reagent is a substance or compound that is used to detect, measure, examine, or produce other substances by chemically reacting with a given substance present: in a test sample. When the test strip conies into contact with a body fluid, such as blood or interstitial fluid, the test strip “harvests” the body fluid, e.g., fluid is drawn into a capillary channel that transfers the fluid by capillary action to the reagent material. If a given substance is present in the body fluid, the reagent chemically reacts with that substance. The reaction of the reagent, upon contact with the body fluid, can be analyzed (e.g., electrochemically or optically) to determine the presence anal/or concentration of a particular substance, 
     Many test strip reagents are sensitive to the effects of ambient humidity and sunlight. One way to reduce or eliminate the effects of humidity and sunlight is to individually package each of the sensors with desiccant. Individually packaging each strip, however, increases manufacturing time and costs, and inflates packaging and shipping costs, all of which result in increased costs to the end user. To reduce costs and improve ergonomics, containers have been designed to store and dispense multiple test sensors, thereby eliminating the need to individually package each test strip. Examples of some containers for storing a stack of test sensors can be found in U.S. Pat. Nos. 7,677,409, 7,875,243, 8,097,210 and 8,153,080 and U.S. Patent Appl. Pub, No, US2013/0324822 A1, each of which is incorporated herein by reference in its entirety. Many of these containers enclose the sensor stack in a hermetically sealed, rigid outer housing. Some of the containers are provided with a mechanical dispensing mechanism to feed the test sensors, one at a time, for testing by the user. This configuration provides ease of use to normal users and is especially important for those users who may have some physical limitations. 
     Shown respectively in  FIGS. 1 and 2  are examples of a hand-held analyte testing device  10  (“meter”) and a package  30  of test strips  12  (“test strip pack”). The test strip pack  30  of  FIG. 2  is designed to be housed within the analyte testing device  10  of  FIG. 1 . The testing device  10  has a display device  20  for displaying information (e.g., analyte concentration readings) to the user. The analyte testing device  10  also includes a slider  18 , which cooperates with an “ejection” mechanism inside the testing device  10  for advancing test strips  12  from the package  30  for harvesting a sample of fluid. Prior to each test, an individual test strip  12  is pushed by the ejection mechanism through the package  30  such that a collection area  14  of the test strip  12  is extended from the testing device  10  through a slot  16  formed in the housing of the meter  10 . As seen in  FIG. 1 , the collection area  14  projects from the testing device  10 , while a contact area of the test strip  12  (visible in  FIG. 2 ), which is disposed at the opposite end of the strip  12 , remains inside of the testing device  10 , in electrochemical configurations, the contact area includes terminals that electrically couple test strip electrodes to testing instrumentation disposed within the testing device  10  This instrumentation is configured to measure the oxidation current produced at the electrodes by the reaction of glucose and the reagent. 
     A circular array of test strips  12  is shown in  FIG. 2  disposed inside of the test strip pack  30 . The test strip pack  30  comprises a disk-like circular container  32  with ten individual compartments  34 —referred to in the art as “blisters”—arranged radially on the circular container  32 . The circular container  32  is made from an aluminum foil/plastic laminate which is sealed with a burst foil cover  36  to isolate the sensors  12  from ambient humidity, sunlight, and from adjacent sensors. Each test strip  12  is kept dry by a desiccant located inside a desiccant compartment  37  disposed adjacent to the compartment  34 . Further details of the manufacture, configuration, and operation of the testing device  10  and test strip pack  30  are provided, for example, in U.S. Pat. Nos. 5,630,986, 5,575,403, 5,810,199 and 5,856,195.
         A drawback associated with the circular array of test strips  12  of  FIG. 2  is the large area that is required to house the test strip pack  30 . Size restrictions for band-held testing devices that internally house flat test strip packs constrain the size of the package, which restricts the number of test strips that can be provided in each package. Having a low number of strips in the disk results in a higher per strip cost for the package which is not desirable since in vitro diagnostic assays and, especially, glucose monitoring test strips are faced with continuing downward pressure on selling prices. Similarly, a drawback associated with conventional flip-top containers and screw-tight sensor bottles is the overall complexity of each container and the amount of material required to fabricate each container, in addition, the manual operations required for closing and opening test sensor bottles and for removing strips from the bottle is oftentimes not convenient, which discourages patient testing even though increased patient testing is associated with better glucose management. Customer convenience is another key factor in influencing compliance to a regular testing regimen. In addition, it is often necessary for a person with diabetes to test while “on the go” where manual manipulation of a bottle and strips can be very difficult. Finally, the large cylindrical foot print of a bottle necessitated by the need to retrieve strips by finger is not conducive to portability. What is needed then is a test sensor container configuration that can store a larger quantity of sensors in a small area, while maintaining customer convenience and offering low-cost manufacturing options for the sensor and packaging.       

     SUMMARY 
     Disclosed herein are low-cost test-sensor clips with intuitive and convenient strip handling. These test-sensor clip systems can provide a unique, low-cost means to offer 25-strip, 50-strip, 100-strip, or N-strip cartridge convenience in a low-cost disposable or reusable package. Because the test strips are held in a small, low-cost clip that can be injection molded, there is very little cost in the strip package. In addition, the sensor stack and clip can readily be foil wrapped in a reagent-grade foil package with a desiccant material. Because the clip and meter can automate sensor handling, the individual strips can be made smaller than their conventional counterparts, This, in turn, can significantly reduce the strip cost by reducing raw materials and increasing the throughput of manufacturing capital and overhead. For some configurations, the clip can have an auto-calibration label that would allow for better calibration, inclusion of anti-counterfeiting measures, geographic information, date of manufacture information, etc. Limiting the disposable part cost count and strip size offers real customer savings with a lower per-strip cost as compared to sensor bottles, blister packs, or other prior art container configurations. This allows for increased customer convenience while offering a low-cost manufacturing option for the sensors and packaging, an intuitive user experience, and a compact, reliable, and low-cost glucose meter. In addition, smaller sensors and reduced packaging are also more environmentally friendly. 
     The foregoing features and options of the low-cost test. sensor clip could also be applied to a durable flip-top bottle, which is separate from the testing meter. In this configuration, the flip-top bottle would provide cost, environmental, form factor, and convenience advantages while still allowing compatibility with existing meters. The flip-top bottle could be configured with an ejection mechanism to eject the strips, electrodes first, to eliminate strip handling by allowing the user to transfer the test strip directly from the bottle to a meter. This would be especially useful in point of care and/or hospital meters where there is concern about contamination from blood borne pathogens. 
     Some of the disclosed concepts are directed to a sensor clip assembly for storing and dispensing analyte testing sensors. The sensor clip assembly includes a plurality of test sensors arranged in a stack. Each of the test sensors is configured to assist in testing an analyte in a fluid sample. The sensor clip assembly also includes a skeletal frame with a top, a bottom, and a plurality of sides. The top, bottom and sides of the skeletal frame are interconnected to define an internal chamber within which is stored the stack of test sensors, At least one of the sides includes one or more elongated rails with structural gaps on opposing sides thereof. For some configurations, multiple sides or all of the sides of the skeletal frame comprise or consist essentially of one or more elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature. 
     Other disclosed concepts are directed to a sensor clip for retaining a stack of test strips. Each of the test strips is configured to assist in testing at least one analyte. The sensor clip includes a top, a bottom, and a plurality of sides that connect the top with the bottom to define therebetween an internal chamber within which is seated the stack of test strips. At least one of the sides comprises or consists essentially of one or more elongated rails with structural gaps on opposing sides thereof. In some embodiments, multiple sides or all of the sides of the sensor clip comprise or consist essentially of one or more elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature. 
     Aspects of the present disclosure are directed to an analyte testing system. This analyte testing system includes multiple test sensors arranged in a stack. Each test sensor is configured to receive a fluid sample and generate an indication of a characteristic of an analyte in the fluid sample. The analyte testing system also includes a hand-held meter with an outer housing defining an internal cartridge chamber with an opening, The meter may include an optional lid that is movably attached to the outer housing to cover the internal cartridge chamber opening when the lid is in a closed position. The meter also includes testing electronics stowed within the housing and configured to analyze the indication of the characteristic of the analyte generated by each of the test sensors. A sensor clip is removably disposed inside the internal cartridge chamber of the meter. The sensor clip includes a skeletal frame with a top, a bottom, and a plurality of sides. The top, bottom and sides of the skeletal frame are interconnected to define an internal sensor chamber within which is stowed the stack of test sensors. At least one of the sides includes one or more elongated rails with structural gaps on opposing sides thereof. Optionally, two or more or all of the skeletal frame sides comprises or consists essentially of elongated rails, each of which has structural gaps on opposing sides thereof and may be columnar in nature. 
     For any of the disclosed configurations, the bottom of the skeletal frame of the sensor clip may define an aperture configured to receive therethrough the stack of test sensors. The skeletal frame may further comprise a pair of opposing flexible tabs proximal the aperture. The tabs may be configured to flex such that the stack of test sensors can pass through the aperture in the bottom of the skeletal frame and into the internal chamber. The flexible tabs may be configured to retain the stack of test sensors inside the internal chamber. As another optional feature, one or more of the sides of the skeletal frame may comprise one. or more compliant alignment rails configured to align the stack of test sensors within the internal chamber. An optional desiccant pocket can be attached to the skeletal frame, the pocket storing therein a desiccant material. The desiccant material could also be co-molded to the skeletal frame or attached during assembly. The desiccant pocket/material could also double as a functional component of the assembly, for example as a rigid base plate on which the strip stack sits. 
     The above summary is not intended to represent each embodiment or every aspect of the present disclosure. Rather, this summary merely provides an exemplification of some of the novel features presented herein. The above features and advantages, and other features and advantages of the present disclosure, will be readily apparent from the following detailed description of exemplary embodiments and modes for carrying out the present invention when taken in connection with the accompanying drawings and the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective-view illustration of an example of a hand-held analyte testing device. 
         FIG. 2  is a partially exploded perspective-view illustration of an example of a test strip pack. 
       FIGS,  3 A-D are front, back, top and bottom view illustrations, respectively, of a representative stacked sensor clip assembly for multi-strip analyte testing devices and systems in accordance with aspects of the present disclosure. 
         FIGS. 4A and 48  are partially broken away side-view illustrations of an example of an analyte testing meter for use with the sensor clip assembly shown in  FIGS. 3A-D  is accordance with aspects of the present disclosure. 
         FIGS. 5A-5D  are diagrammatic illustrations showing a representative method for using of the sensor clip assembly of  FIGS. 3A-D  with the analyte testing meter of FIGS,  4 A and  41 . 3  in accordance with aspects of the present disclosure. 
         FIG. 6  is a schematic top-view illustration of another representative sensor clip for a stacked sensor dispensing system in accordance with aspects of the present disclosure, 
         FIG. 7  is schematic side-view illustration of an optional one-way strip port for an analyte testing meter in accordance with aspects of the present disclosure. 
         FIG. 8  is a perspective-view illustration of a representative test sensor clip with a flexible seal in accordance with aspects of the present disclosure. 
     
    
    
     While aspects of this disclosure are susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. 
     DETAILED DESCRIPTION 
     This invention is susceptible of embodiment in many different forms. There are shown in the drawings and will herein be described in detail representative embodiments of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspects of the invention to the embodiments illustrated. To that extent, elements and limitations that are disclosed, for example, in the Abstract, Summary, and Detailed Description sections, but not explicitly set forth in the claims, should not be incorporated into the claims, singly or collectively, by implication, inference or otherwise. For purposes of the present detailed description, unless specifically disclaimed: the singular includes the plural and vice versa; the words “and” and “or” shall be both conjunctive and disjunctive; the word “all” means “any and all”; the word “any” means “any and all”; and the words “including” and “comprising” mean “including without limitation.” Moreover, words of approximation, such as “about,” “almost,” “substantially,” “approximately,” and the like, can be used herein in the sense of “at, near, or nearly at,”, or “within 3-5% of,” or “within acceptable manufacturing tolerances,” or any logical combination thereof, for example. 
     Aspects of the present disclosure are directed to a simple, low-cost, compact, and light-weight clip that holds a stack of analyte testing strips (e.g., 50+ sensors/stack). in contrast to prior art sensor cartridges that are designed as fully-encapsulating enclosures, such as screw-tight bottles, blister packs, and moisture-proof cartridges, the sensor clip has a skeletal frame with sides comprising one or more elongated, columnar rails for retaining the stack of sensors. The stacked-sensor clip assembly can be packaged inside a reagent-grade foil wrapping with a desiccant material for storage and shipping of the sensor clip assembly. The low-cost, reagent-grade foil package protects the test strips by acting as both a vapor barrier and a guard against sunlight. The foil-wrapped sensor clip assembly can be commercialized as the final consumer product; additionally or alternatively, an external box could be used to provide the requisite protection for the sensors. There is no requirement that the sensor clip assembly be sealed in an additional outer casing that would otherwise increase the amount of material and the overall number of parts. It may also be desirable, for some applications, that the disposable sensor clip be fabricated without an ejection mechanism or a biasing member. After being removed from the foil package and/or box, the sensor clip assembly can be loaded as-is into a meter. 
     One or more or all of the disclosed configurations can offer no-strip-handling convenience with ultralow-cost sensor packaging, which results from a low disposable part count and a. small strip size. Other advantages can include automated, highly intuitive strip handling, as well as strip storage in a small rectangular package that has a lower volume and is a more convenient form factor compared to conventional sensor cartridges. Decreased environmental impact is also achieved through smaller test strips, a low -part-count clip, and a foil package that, singly and collectively, produce a smaller waste stream than conventional disposable sensor cartridges. Additional advantages and options may include (in any combination): a low-cost, simple and reliable strip-excision mechanism made with few moving parts; detailed calibration and other information provided on the clip for improved performance and robust anti-counterfeiting; reduced chance of having strip temperatures that are significantly different than meter temperatures because, once the clip is loaded, strips are exposed to a similar environment; and, a flip-top lid on the meter with a temperature sensor to detect temperature mismatches between the meter and the environment. 
     Referring now to the drawings, wherein like reference numerals refer to like features throughout the several views, there is shown in  FIGS. 3A-3D  a representative sensor clip assembly, designated generally as  100 , for storing and dispensing analyte testing sensors in accordance with aspects of the present disclosure. For purposes of explanation, the illustrated embodiments are generally described herein with regard to meters and sensors for analyzing the concentration of glucose in a blood sample. However, the aspects of the present invention are not intended to be limited to this specific application. The presently disclosed embodiments may be configured to determine one or more characteristics of other analytes in other types of samples. For example, the meters and test strips may measure lipid profiles (e.g., cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), etc.), microalbumin, hemoglobin A.I c, fructose, lactate, bilirubin, or other analytes. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, or body fluids, such as interstitial fluid (ISF) and urine, or other (non-body) fluid samples. 
       FIG. 3A  provides a side-view illustration of a cartridge or “sensor clip”  110  for use in a multi-strip analyte testing meter, such as the hand-held glucose meter  150  shown in  FIGS. 4A and 48 . Sensor clip  110  can be used to both store and dispense a plurality of biosensors or test strips (one of which is designated as  112  in  FIG. 3A ). such as the test strips  12  described above in connection with  FIGS. 1 and 2 . According to the embodiment illustrated in  FIGS. 3A-3D , the test strips  112  (also referred to herein as “test sensors”) are laid flat, arranged substantially one on top of the next in a stack  114 , and seated on top of an optional push plate  116 . Generally, in use, the test strips  112  are dispensed from the top  120  of the sensor clip  110 , one at a time, through a sensor slot  118  in a cap  138 . While the push plate  116  is illustrated in the figures as a part of the clip assembly  110 , alternative configurations are assembled without the push plate  116  (e.g, a push plate or similarly functioning structure is provided by the testing meter). As another option, the push plate  116  can be made of or encapsulate desiccant material. 
     Each of the test strips  112  is configured to assist in testing an analyte glucose) in a fluid sample (e.g., blood). As explained above with respect to the test strips  12  of FIGS,  1  and  2 , each of the test strips  112  of  FIGS. 3A-3C  is configured to receive a blood sample, and contemporaneously generate an indication of a characteristic of glucose in the blood. The test sensors may take on various forms, including electrochemical biosensors and/or optical biosensors. Electrochemical biosensors include a regent designed to chemically react with glucose in a blood sample to create an oxidation current at electrodes disposed within the electrochemical biosensor. The oxidation current that is generated by the biosensor is directly proportional to the user&#39;s blood glucose concentration. Non-limiting examples of electrochemical biosensors are described in U.S. Pat. Nos. 5,120,420, 5,660,791, 5,759364 and 5,798,031. Optical biosensors, in contrast, incorporate a reagent that is designed to produce a colorimetric reaction indicative of a user&#39;s blood glucose concentration level. The colorimetric reaction can then be read by a spectrometer incorporated into the testing device. Some non-limiting examples of optical biosensors are described, for example, in U.S. Pat. No. 5,194,393 and 8,202,488. 
     Each of the test strips  112  may contain biosensing or reagent material that reacts with, for example, blood glucose. The test strip  112  can be a multilayer test sensor that includes a base or substrate with a lid. For some multilayer test sensor configurations, the test strip  112  includes a spacer between the base and lid. The test sensor may harvest the fluid sample using a capillary channel. For an electrochemical test sensor configuration, the test strip  112  includes at least two electrodes (e.g., a counter electrode and a working (measuring) electrode) in the form of a metallic electrode pattern. A potential is applied across these electrodes and a current is measured at the working electrode. 
     The reagent converts the analyte of interest (e.g., glucose) in the fluid sample (e.g., blood) into a chemical species that is measurable. The reagent typically includes an enzyme and a mediator. For example, if the analyte —  of interest is glucose, the enzyme may be glucose dehydrogenase (GDH) or glucose oxidase. A mediator is an electron acceptor that assists in generating a current that corresponds to the analyte concentration. Non-limiting examples of mediators include ferricyanide (e.g., potassium ferricynaide), phenothizaines (e.g., 3-phenylimino-3H-phenothiazine), phenoxazines 3-phenyliminio-3H-phenoxazine). The reagent may include binders that hold the enzyme and mediator together, other inert ingredients, or combinations thereof. The reagent may include additional ingredients such as a buffer, polymer, surfactant or any combination thereof in some embodiments. 
     In the illustrated embodiment, the sensor clip  110  includes a top  120 , a bottom  122 , and a plurality of sides, namely first and second lateral sides  124 A and  124 B, respectively, and first and second longitudinal sides  126 A and  126 B, respectively. The top  120 , bottom  122 , and sides  124 A,  124 B,  126 A,  126 E of the sensor clip  110  are interconnected (e.g., injection molded as a single, unitary piece) to define an internal chamber  128  within which is retained and stored the stack  114  of test sensors  112 . Although alternative shapes are certainly envisioned as being within the scope of the present disclosure, the sensor clip  110  is portrayed with a polyhedral shape having six generally rectangular outer faces. The sensor clip  110  may optionally include greater or fewer than six faces, each of which may take on a different size and/or shape than that shown in the drawings. In this regard, the drawings presented herein are not to scale and arc provided purely for instructional purposes. Thus, the specific and relative dimensions shown in the drawings are not to be considered limiting. 
     By way of contrast to prior art sensor cartridges that are designed as fully-encapsulating enclosures, the sensor clip  110  of  FIGS. 3A-3D  comprises a skeletal frame with one or more “open” faces. As a non-limiting example, at least one side of the sensor clip&#39;s  110  skeletal frame comprises an elongated rail with structural gaps on opposing sides thereof. As used herein, a “structural gap” includes an opening, break, or space (i.e., an absence of structure) between adjacent solid structures. By way of illustration, and not limitation, the first lateral side  124 A of the skeletal frame comprises or consists essentially of two adjacent, substantially parallel, elongated rails  130 A and  130 B that arc spaced from one another by a centrally located structural gap  131 C that is disposed between and extends the entire length of the rails  130 A,  130 B, as seen in  FIG. 3A . Each of the elongated rails  130 A,  130 B is also spaced from one of the longitudinal sides  126 A,  126 B of the sensor clip&#39;s  110  skeletal frame by a respective intermediate structural gap  131 A and  131 B that extends the entire length of the rails  130 A,  130 B. Each rail  130 A,  130 B of  FIG. 3A  is columnar, extending between and connecting the top  120  and the bottom  122  of the skeletal frame. Alternatively, one or more of the rails  130 A,  130 B can be transversely oriented, extending between and connecting the longitudinal sides  126 A,  126 B of the skeletal frame, or can take on other orientations and configurations within the scope and spirit of this disclosure. 
     Optionally, the second lateral side  124 B of the clip&#39;s  110  skeletal frame comprises or consists essentially of two adjacent, substantially parallel, elongated rails  132 A and  132 B that are spaced from one another by a centrally located structural gap  133 C that is disposed between and extends the entire length of the rails  132 A,  132 B, as seen in  FIG. 3B . Each of the elongated rails  132 A,  132 B is also spaced from one of the longitudinal sides  126 B,  126 A of the sensor clip&#39;s  110  skeletal frame by a respective intermediate structural gap  133 A and  133 B that extends the entire length of the rails  132 A,  132 B. Each  132 A,  132 B rail is columnar, extending between and connecting the top  120  and the bottom  122  of the skeletal frame. Like the rails  130 A,  130 B of  FIG. 3A , one or more of the rails  132 A,  132 B of  FIG. 3B  can be transversely oriented or can take on other orientations and configurations. To that end, the number of rails on each side may vary from that which is shown in the drawings. It is also envisioned that one or both of the longitudinal sides  126 A,  126 B have open faces, e.g., comprising or consisting essentially of one or more elongated rails. 
     Referring to  FIG. 3D , the bottom of the sensor clip&#39;s  110  skeletal frame defines an aperture  134  which is shaped and sized to receive therethrough the stack  114  of test sensors  112 . The base  122  of the sensor clip  110  may be provided with retention means to secure or otherwise retain the, test sensor stack  114  inside the internal chamber  128 . The retention means may take on various thrifts, such as a base plate, spring clip(s), or support pin(s) that extend across and/or buttress the underside of the push plate  116 . As another option, one or more pairs of opposing flexible tabs  136 A,  136 B and  136 C may be attached to or integrally formed with the sensor clip&#39;s  110  skeletal frame proximate the base  122  such that the tabs project transversely into the aperture  134 , as seen in  FIG. 3D , to provide subjacent support to the sensor stack  114 . The tabs  136 A,  1368 ,  136 C are fabricated from a compliant material such that, when the test sensor stack  114  is pushed or otherwise passed through the aperture  134  in the bottom  122  of the sensor clip  110 , the tabs  136 A,  136 B,  136 C flex (e.g., upwardly in  FIGS. 3A and 3B ) wider the force of the moving sensors  112  to allow the stack  114  to pass into the internal chamber  128 . Once the entire stack  114  is situated inside the chamber  128 , the elastic tabs  136 A,  136 B,  136 C flex back to their original orientation such that the push plate  116  is seated on top of and supported by the tabs  136 A,  136 B,  136 C. 
     One or more or all of the tabs  136 A,  136 B,  136 C could be fabricated with chamfered or rounded edges to facilitate the insertion of the stack  114 . As another option, the tabs  136 A,  136 B,  136 C and/or rails  130 A,  130 B can be provided with structural interfaces for mating with a mechanical mechanism in the manufacturing equipment such that the equipment can pull and hold the tabs apart while the stack  114  is inserted into the clip  110 . In this regard, the structural gaps between the rails  130 A,  130 B can be used by the manufacturing equipment to hold the preformed stack of strips  114  for insertion into clip  110 . As another option, the tabs  136 A,  136 B,  136 C could be constructed as separate pieces that are attached to the bottoms of the elongated rails  130 A,  130 B after the stack  114  is inserted into the clip  110 . The tabs  136 A,  136 B,  136 C could be fastened by various means, including snap fit or friction fit. 
     Turning back to  FIG. 3C , the top  120  of the skeletal frame is covered by a cap  138  with an elongated slot  140  extending the length thereof. The slot  140  is configured to receive an ejection mechanism for advancing the test sensors  112  out of the internal chamber  128  of the sensor clip&#39;s  110  skeletal frame. A thumb-activated sensor ejection mechanism ( FIGS. 4A and 4B ), also known as a “picker” or “pusher tab” in the art, may be operatively coupled to the top  120  of the sensor clip  110  and configured to slide horizontally along the length of the cap  138 . A projection or “foot” protrudes from the bottom of the picker, through the slot  140 , and into the chamber  128  to engage at least the top-most test strip  112  which lies flush against the bottom of the cap  138 . The foot can be designed to engage and excise only a single test sensor at a given time or, in some configurations, can engage and excise multiple test sensors. The foot can reciprocally move from a standby position, e.g., towards the far left in  FIG. 3A , whereat the foot engages one end of a test sensor, to an ejection position, e.g., towards the far right in  FIG. 3A , whereat the foot pushes at least a portion of the test sensor through the sensor slot  118 . Some non-limiting examples of sensor ejection mechanisms that may be used with the sensor clip assembly  100  are described in U.S. Pat. Nos. 7,677,409 and 8,097,210, and International (PCT) Patent Application Publication No, WO 2013/180804. It is also envisioned that the clip  110  have provisions to accommodate various other sensor ejection means, such as an ejection wheel or lever. 
     To assist in protecting the reagents) of the test sensors  112 , desirable packaging material and/or desiccant material may be used. The sensor clip assembly  100  can be packaged in a material that prevents or inhibits air and moisture from entering into the interior  128  of the sensor clip  110 . One type of removable packaging that may be used to enclose the sensor clip assembly  100  is aluminum foil. It is contemplated that desiccant material, such as silica gel and other molecular sieve beads, may be added in the interior of the packaging to assist in maintaining an appropriate humidity level therein. The sensor clip assembly  100  may be provided with an optional desiccant pocket  144  for storing the desiccant material. The pocket  144  can be attached to one or more of the sides of the skeletal frame. Alternatively, a desiccant can be adhered directly to the clip, molded into the clip, or can even be formed into or as part of the pusher plate. 
     As another optional feature, the sensor clip assembly  100  can be provided with an auto-calibration tab  146  that is attached to one or more sides of the sensor clip&#39;s  110  skeletal frame. The auto-calibration tab  146  provides detailed calibration information for the sensor clip assembly  100 . This information may be read by a glucose meter to determine the brand, type, and/or specifications of the test strips in the clip. Optionally, the meter may make electrical contact with the auto-calibration tab  146  and read the coded calibration information specific to the sensor clip assembly  100 . Due to variations in biosensor manufacturing, this coding can allow the glucose meter to be automatically calibrated based on the test strips being used. ln addition to detailed calibration information, the auto-calibration tab  146  may contain anti-counterfeiting information, geographic information, date of manufacture information, etc. Additional information regarding auto-calibration information and related technologies can be found in U.S. Pat. Nos. 7,809,512, 8,124,014, and 8,206,564, each of which is incorporated herein by reference. 
       FIGS. 4A and 4B  illustrate an example of a hand-held glucose testing meter  150  for use with the sensor clip assembly  100  shown in  FIGS. 3A-D . The meter  150  includes an outer housing  152  with a display  154 , a test sensor port  156 , and one or more input devices, which may be in the nature of a. touchscreen  155  and/or a plurality of pushbuttons  158 . For at least some embodiments, the input devices allow a user to toggle between modes, adjust for various test strips, change the settings of the display, such as contrast and/or color, power the device on or off, check to see whether the device is functioning properly, check the battery level, access stored information, and/or enter personal information. 
     Shown schematically at  160  in HG.  4 A are one or more processors and one or more memory devices (which may be representative of “testing electronics”) that are located inside the meter  150  and operatively coupled to the display  154 , the input devices  155 ,  158 , and test sensor port  156 . The testing electronics  160  operatively connect with (e.g., electrically couple to) the test strips  112  to determine analyte concentration information from a fluid sample. The processor may comprise any combination of hardware, software, and/or firmware disposed in and/or disposed outside of the meter housing  152 . The memory is operatively coupled to the processor (or may be part of the processor), and is configured to store, among other things, the analyte concentration information, The memory may comprise, for example, volatile memory (e.g., a random-access memory (RAM)), non-volatile memory (e, g, are EEPROM), and combinations thereof. The meter  150  may include other known electronics, such as a communication interface for transmitting and receiving data either via wired or wireless links. 
     Blood glucose meter  150  includes an internal cartridge chamber  162  with an opening  164  through which the sensor clip assembly  100  is inserted into the outer housing  152  of the meter  150 . A flip-top lid  166  is movably attached to the outer housing  152  to cover the internal cartridge chamber opening  164  (and, thus, the sensor clip assembly  110 ) when the lid  166  is in a closed position. When pressed closed, the flip-top lid  166  can mate with a complementary gasket or other seal mechanism to make an “on meter seal” that provides a vapor-resistant barrier to prolong the use life of the clip of sensors  112 . It is desirable, for at least some embodiments, that the internal cartridge chamber  162  be vapor tight to protect the test strips  112 .  FIG. 4A  shows the meter  150  without a sensor clip assembly  100  loaded into the internal cartridge chamber  162 , while  FIG. 4B  shows a sensor clip assembly  100  removably disposed inside the chamber  162  of the meter  150 . A pair of spaced alignment tracks  170 A and  170 B within the outer housing  152  mate with and guide the sensor clip assembly  100  when loaded into the meter housing  152 , and also help to keep the assembly  100  properly aligned for repeated use. 
     A biasing member, such as a pusher spring  168 , which extends through the aperture  134  in the bottom  122  of the sensor clip  110 , presses against the push plate  116  and drives the sensor stack . 114  towards the top of the meter housing  152  (e.g., upwardly in  FIG. 48 ). In so doing, at least one test strip  112  lies flush against the underside surface of the cap  138  for excision through the sensor slot  118  and test sensor port  156  via operation of a thumb-activated sensor ejection mechanism  174 . Alternative mechanisms may be used to urge the push plate  116  and test strips  112  to the top of meter  150 . For example, a pawl-and-ratchet mechanism may be incorporated into the sensor clip  110  and/or meter housing  152  to provide upward. movement of sensors  112 . Another non-limiting example of a dispensing system that can be incorporated into the meter  150  is disclosed in U.S. Patent Application Pub. No. 2013/0324822 A1, which was tiled on Dec. 28, 2012. In the illustrated example, the ejection mechanism  174  is shown to be part of the meter  150 ; nevertheless, the sensor clip  110  may be manufactured with a built-in pusher tab or other ejection mechanism. An optional latch mechanism  172 , which is disposed on the top of the meter housing  152  adjacent the opening  164 , is configured to hold the sensor clip assembly  110  in place when it is inserted into the meter  150 . The latch mechanism  172  may take on various known forms, such as a spring-loaded clip. 
       FIGS. 5A-D  illustrate the sensor dip assembly  100  disposed within the blood glucose meter  150 .  FIG. 5A  shows the clip  110  loaded into the meter  150  with the flip-top lid  166  closed and the thumb-activated “pusher” ejection mechanism  174  in the standby position such that a test strip  112  has not been deployed from the sensor clip assembly  100  into the test sensor port  156 . In use, the user may open the blood glucose meter  150  by flipping the lid  166  over a hinge  167  ( FIG. 5C ) at the top of the meter  150  to reveal the ejection mechanism  174 , as seen in  FIG. 5B . The user may then slide the ejection mechanism  174  across the top of the meter  150  (to the right in the illustrations of FIGS,  5 A- 5 D) from the standby position (FIG.  5 B 1  to the election position ( FIG. 5C ) to thereby excise a test strip  112  from the sensor clip assembly  100 . When the ejection mechanism  174  reaches the ejection position, the test strip  112  is passed into and at least partially out of the test sensor port  156 , as best seen in  FIG. 5C . At this point, a blood sample (or other test sample) may be placed on the protruding test strip  112  to obtain a measurement of blood glucose (or other analyte) in the sample, which may be presented to the user on display  154 . In some optional configurations, the meter  150  is activated and the user is automatically prompted to take a measurement when the lid  166  is shut with a test strip  112  in the test sensor port  156 , as seen in  FIG. 5D . 
     Coupled with an optional contact switch  176  that detects the position of the lid  166 , the meter  150  may be provided with one or more thermal sensors (not shown) to sense temperature changes while the lid  166  is open to detect a mismatch between the ambient temperature and the meter&#39;s  150  internal temperature which can affect performance. If a mismatch is detected, the internal testing electronics  160  of the meter  150  can be configured to automatically trigger an algorithmic correction or, in extreme cases, not allow a test to be performed. In a similar regard, the meter  150  could be outfitted with sensors to monitor ambient and internal humidity to make sure that the reagent is properly protected. The contact switch  176  can also be used to generate a reminder to the user to close the lid  166 . 
       FIG. 6  is a schematic top-view illustration of another representative sensor clip  210  for a stacked sensor dispensing system. The sensor clip  210  can be similar in design, function and operation to the sensor clip  110  discussed above with respect to FIGS,  3 A- 3 D and, thus, can include any of the options, features and alternatives described above, For instance, the sensor clip  210  includes a skeletal frame with a top  220 , a bottom (not visible in the view provided), first and second lateral sides  224 A and  224 B, respectively, and first and second longitudinal sides  226 A and  226 B, respectively. A test sensor stack  114  is stowed within an internal chamber defined between the sides  224 A,  224 B,  226 A,  226 B of the sensor clip  210 . The second lateral side  224 B of the skeletal frame comprises or consists essentially of two adjacent, substantially parallel, elongated rails  232 A and  232 B, which may be identical in nature to the rails  132 A,  132 B in  FIG. 3B . Likewise, the first longitudinal side  226 A comprises an elongated rail  232 C with structural gaps on opposing sides thereof. 
     In the embodiment illustrated in  FIG. 6 , the first lateral side  224 A and the second longitudinal side  226 B of the sensor clip&#39;s  210  skeletal frame each comprises one or more compliant alignment rails  230 A and  230 B, respectively, which are configured to align the test sensor stack  114  within the clip  210 . For instance, the position of the sensor stack  114  is controlled by the fixed guide rails  232 A-C, while the compliant projections on the alignment rails  230 A and  230 B cooperatively urge the stack  114  toward a desired “home” position when the clip  210  is loaded with the stack  114  (e.g., during manufacturing fill). In addition, the fixed guide rails  232 A-C on the clip  210  can interact with the walls of a meter housing (e.g., housing  152  of  FIGS. 4A-4B ) to strengthen them and hold the stack  114  in alignment inside a meter (e.g,., glucose meter  150  of  FIGS. 4A-4B . 
       FIG. 7  is an enlarged side-view illustration of an optional test sensor port  256  that is attached to the housing  252  of another representative meter  250 . The meter  250  can be similar in design, function and operation to the meter  150  discussed above with respect to  FIGS. 4A and 4B  and, thus. can include any of the options, features and alternatives described above. The test sensor part  256  is provided with a spring-loaded stop  280  that can be pressed downwards to allow the test strip  112  to into and pass through the port  256 , but is biased upward to abut an obstruct the rear of the strip  112  and thereby prevent the test strip  112  from being inadvertently pushed backward (e,g, to the left in  FIG. 7 ) into the meter  250  during handling and blood drop acquisition. The test sensor port  256  can also be provided with one or more spring loaded electrical contacts  282  that are biased downwards to apply a compressive force on the test strip  112  to keep the strip  112  from slipping back up over the anti-reverse stop  280 . 
       FIG. 8  illustrates a representative test sensor clip  310  for use in a multi-strip analyte testing meter, such as the hand-held glucose meter  150  shown in  FIGS. 4A and 4B . Unless otherwise logically prohibited, the architecture shown in  FIG. 8  may include any of the features, options and alternatives described above with respect to the architecture shown in  FIGS. 3A-3D , and vice versa. For instance, sensor clip  310  can be used to both store and dispense a plurality of biosensors or test strips, such as the test strips  112  described above in connection with  FIG. 3A . Also similar to the sensor clip  110  of  FIGS. 3A-3D , the sensor clip  310  of  FIG. 8  comprises a skeletal frame with one or more “open” faces. By way of example, the first lateral side of the skeletal frame of  FIG. 8  comprises or consists essentially of two adjacent, substantially parallel, elongated rails  330 A and  330 B that are spaced from one another by a centrally located structural gap  331 C. Likewise, the second lateral side of the clip&#39;s  310  skeletal frame comprises or consists essentially of two adjacent, substantially parallel, elongated rails  332 A and  332 B that are spaced from one another by a centrally located structural gap  333 C. Likewise, the longitudinal sides of the clip  310  may each comprise a respective elongated rail  234 A and  234 B with structural gaps on opposing sides thereof. 
     In the embodiment illustrated in  FIG. 8 , a gasket or O-ring type seal member  380  is attached to or integrally formed with the top  320  of the clip  310 . The flexible seal member  380  extends continuously or substantially continuously around the outer edge of the top  320  of the clip  310 , e.g., at the base of a cap (e.g., cap  138  of  FIGS. 3A-3D ), to form a seal between durable surfaces on the clip and a meter or a storage container. For example, the flexible seal member  380  can be configured to compress against or otherwise mate with and thereby form a vapor-tight seal between a lid of a meter (e.g., flip-top lid  166  of  FIGS. 4A and 4B ) and the top  320  of the clip  310 . This seal could be a standalone seal or implemented with a separate durable seal for redundancy. 
     While many embodiments and modes for carrying out the present invention have been described in detail above, those familiar with the art to which this invention relates will recognize various alternative designs and embodiments for practicing the invention within the scope. of the appended claims.