Patent Publication Number: US-2022219161-A1

Title: Analyte meters, test strip ejectors, and methods of using same

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority to, and the benefit of, Chinese Patent Application No. 202110028945.4, entitled “ANALYTE METERS, TEST STRIP EJECTORS, AND METHODS OF USING SAME” filed Jan. 11, 2021, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. 
     FIELD 
     The present disclosure relates to test strip ejectors of analyte meters used to eject a test strip after use, analyte meters, and methods using such test strip ejectors. 
     BACKGROUND 
     The monitoring of analyte concentration levels in a bio-fluid (e.g., blood) may be used as part of health diagnostics. For example, an analyte test strip (e.g., glucose test strip) may be employed with an analyte meter for monitoring a patient&#39;s blood glucose level as part of diabetes care and treatment. The analyte meter may receive the test strip in a test strip port of the analyte meter, and make contact with an electrical circuit of the analyte meter for detecting an analyte concentration level in a bio-fluid sample, such as from a single drop of blood. For example, a blood sample may be obtained from the patient using a lancet (e.g., by a pinprick). Typically, after the blood sample has been obtained, the sample may then be transferred to test strip for measurement of the blood&#39;s analyte concentration level (e.g., a glucose concentration level). 
     After the analyte (e.g., glucose) reading is complete, the test strip is removed from the test strip port of the analyte meter, to ready the analyte meter to receive another test strip for the next analyte measurement. 
     SUMMARY 
     In a first aspect, an analyte meter is provided. The analyte meter includes a housing body including a front side, a back side, a first side, a second side, an end, and a test strip port at the end configured to receive a test strip therein, and a test strip ejector configured to eject the test strip from the test strip port, the test strip ejector further comprising: a slide member slidable relative to the housing body, an engagement member coupled to the slide member and configured to be contacted by a user, the engagement member located on the back side of the housing body, and a push member coupled to the slide member and positioned to be engageable with the end of the test strip. 
     In yet another aspect, a test strip ejector of an analyte meter is provided. The test strip ejector includes a housing body, an engagement member configured to be contacted by a user&#39;s digit, the engagement member located on a back side of a housing body, a slide member coupled to the engagement member and slidable thereby, a test strip receiver configured to receive a test strip in a test strip port thereof, and a push member coupled to the slide member, the push member moveable in the test strip receiver and configured to contact an end of the test strip, wherein sliding motion of the engagement member along the back side, causes the test strip to be ejected from the test strip port. 
     In a method aspect, a method of ejecting a test strip from an analyte meter is provided. The method includes providing an housing body having a test strip ejector integrated therein, the test strip ejector comprising: an engagement member located on a back side of the housing body, a slide member coupled to the engagement member and configured to be slidable therewith, a test strip receiver configured to receive the test strip in a test strip thereof, and a push member coupled to the slide member, the push member moveable in the test strip receiver; and with a user&#39;s digit, causing a sliding motion of the engagement member along the back side to cause the push member to contact an end of the test strip and eject the test strip from the test strip port. 
     Other features and aspects of the present disclosure will become more fully apparent from the following detailed description, the accompanying drawings, and the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings, described below, are for illustrative purposes and are not necessarily drawn to scale. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not intended to limit the scope of the disclosure in any way. 
         FIG. 1A  is a bottom isometric view of an analyte meter including a test strip ejector enabling a test strip to be readily ejected from a test strip port according to embodiments of the disclosure. 
         FIG. 1B  is a bottom plan view of the analyte meter of  FIG. 1A  with the test strip ejector shown in a retracted starting position according to embodiments of the disclosure. 
         FIG. 1C  is a left side plan view of the analyte meter of  FIG. 1A  shown in a retracted starting position according to embodiments of the disclosure. 
         FIG. 1D  is a right side plan view of the analyte meter of  FIG. 1A  shown in a retracted starting position according to embodiments of the disclosure. 
         FIG. 1E  is a front side plan view of the analyte meter of  FIG. 1A  illustrating one embodiment of a display screen comprising a touch screen according to embodiments of the disclosure. 
         FIG. 1F  is cross-sectioned side view of an example of an assembly including a test strip ejector of an analyte meter provided according to embodiments of the disclosure. 
         FIG. 1G  is cross-sectioned side view of an example of a test strip receiver of an analyte meter provided according to embodiments of the disclosure. 
         FIG. 1H  is front plan view of an example of a test strip receiver of an analyte meter provided according to embodiments of the disclosure. 
         FIG. 2A  is a top plan view of an example test strip configured to be received in the test strip port of the analyte meter according to embodiments of the disclosure. 
         FIG. 2B  is an exploded perspective view of various components of an example test strip ejector of the analyte meter provided according to embodiments of the disclosure. 
         FIG. 3A  is back-side perspective view of an alternate analyte meter including another configuration of test strip ejector provided according to embodiments of the disclosure. 
         FIG. 3B  is front-side perspective view of the alternate analyte meter of  FIG. 3A  provided according to embodiments of the disclosure. 
         FIG. 3C  is end plan view of the alternate analyte meter of  FIGS. 3A and 3B  provided according to embodiments of the disclosure. 
         FIG. 4  is a flowchart illustrating a method of ejecting a test strip from an analyte meter according to embodiments of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Removal of the test strip from the test strip port can expose the user&#39;s digits (e.g., fingers and/or thumb) or others to blood remaining on the test strip after use, which may cross contaminate, is messy, and may enable transfer of blood to other items such as skin, clothing, furniture, etc. 
     In view of these concerns, embodiments of present disclosure provide an analyte meter that includes a strip ejector that is configured to allow a user to readily and effectively eject a used and contaminated test strip from the test strip port. Ejection of the test strip can be accomplished with one hand, which can have significant value in a clinical setting, for example. 
     In a first one-handed example, ejection of the test strip can be accomplished in a first way with a single digit (e.g., index finger), while holding the analyte meter between the thumb and one or more of the other fingers, and without having to touch the test strip. In other embodiments, a 2nd way to eject the test strip can be accomplished by using the thumb to push a first side or a second side of an engagement member of the test strip ejector apparatus. In a 3rd way, the index and/or middle finger is used to push the first side or second side of an engagement member. 
     The test strip ejector includes an engagement member that is positioned on a back side of the housing body of the analyte meter opposite from the front side containing the display screen. In particular, the engagement member is configured to be engaged by the user&#39;s digit (e.g., finger) while holding the analyte meter. Sliding the engagement member engages and sides a sliding member and causes a push member to contact an end of the test strip and upon further motion of the engagement member, eject the test strip from the test strip port. The push member is received inside and is moveable within a test strip receiver. The test strip receiver is configured to receive the test strip and includes electrical contacts (e.g., conductive leaf springs or the like) formed therein that are configured to electrically connect to electrical contacts formed on the test strip. 
     The analyte meter in accordance with embodiments of the present disclosure may be used to measure any number of analytes, such as glucose, fructose, lactate, keytone, microalbumin, bilirubin, total cholesterol, uric acid, lipids, triglyceride, high density lipoprotein (HDL), low density lipoprotein (LDL), hemoglobin A1c, and the like. These analytes may be detected in, for example, whole blood, blood serum, blood plasma, interstitial fluid, urine, etc. Other types of analytes may be measured provided a suitable reagent exists. 
     These and other embodiments of analyte meters, test strip ejectors, and methods of ejecting a test strip from an analyte meter are described below with reference to  FIGS. 1A-4 . 
       FIGS. 1A-1E and 2A-2B  illustrate various views of a first example of an analyte meter  100  including test strip ejector  114  according to embodiments of the disclosure. The test strip ejector  114  may be abbreviated herein as test strip ejector  114 . The analyte meter  100  may include a housing body  102 . The housing body  102  may be made up of multiple interconnected parts, such as first and second portions  102 A,  102 B and third portion  103  that engage each other to form an internal chamber  105  that is configured to contain various internal components of the analyte meter  100 . The portions  102 A,  102 B,  103  of the housing body  102  may be formed of an insulating material such as a plastic and may be injection molded plastic parts, for example. Connection of the various portions  102 A,  102 B,  103  may be by adhesive, ultrasonic welding, screws, rivets, interconnecting snap fit connectors molded on the parts, or the like. 
     The housing body  102  may have a front side  104 A, a back side  104 B opposite the front side  104 A, a first side  104 C, and a second side  104 D opposite the first side  102 C, and an end  106 . The end  106  can include, as shown, a test strip port  110  that can include a receptacle that is configured to receive the test strip  112  therein. The receptacle can include electrical contacts  121  that are configured to engage with contact pads  112 P located on the test strip  112 . 
     An example of a test strip  112  (sensor) is shown in  FIG. 2A , wherein the test strip  112  includes a strip body  112 B made up of multiple layers, a capillary passage  112 C (shown dotted) connecting to a reaction region  112 R containing one or more catalytic agents or reagents that are configured and compounded to react with a biological fluid F (e.g., blood) that is provided in contact with the reaction region  112 R through application of the fluid F to the end of the capillary passage  112 C during analyte measurement. The one or more catalytic agents or reagents can be an analyte-selective enzyme-salt combination that can convert an analyte (e.g., glucose) into a chemical species, which is electrochemically measureable in terms of an electrical current produced. The plurality of contact pads  112 P, which may include a working electrode, a counter electrode, and/or a reference electrode, are individually contacted by electrical contacts  121  in the test strip receiver  124  when the test strip  112  is received in the test strip port  110  of the receptacle. Embodiments of such strip sensors are disclosed in U.S. Pat. Nos. 4,721,677, 5,798,031, 6,531,040, 7,118,668, and 8,679,309, for example. 
     One group of catalytic agents useful for providing the reaction region  112 R may be the class of oxidase enzymes which includes, for example, glucose oxidase (which converts glucose), lactate oxidase (which converts lactate), and D-aspartate oxidase (which converts D-aspartate and D-glutamate). In embodiments in which glucose is the analyte of interest, glucose dehydrogenase (GDH) may optionally be used. Pyrolloquinoline quinine (PQQ) or flavin adenine dinucleotide (FAD) dependent may also be used. Catalytic enzymes other than oxidase enzymes may also be used. 
     The reaction region  112 R may include one or more layers (not explicitly shown) in which the catalytic agents (e.g., enzymes) and/or other reagents may be immobilized or deposited. The one or more layers may comprise various polymers, for example, including silicone-based or organic polymers such as polyvinylpyrrolidone, polyvinylalcohol, polyethylene oxide, cellulosic polymers such as hydroxyethylcellulose. 
     A vent  112 V in the form of a hole or perforation may be provided at the reaction region  112 R to improve capillary action and flow of the biological fluid F into the reaction region  112 R from the end  106  when applied thereat by the user. 
     As best shown in  FIGS. 1F-1H , within the confines of the internal chamber  105 , a portion or all of a printed circuit board  122  may reside. The printed circuit board  122  may include or be coupled to conventional electronic components such as processor and memory, power source, and power management, and the like. The printed circuit board  122  may be retained in a defined position within the internal chamber  105  by projections or recesses formed on, or in, the printed circuit board  122  and/or the body parts  102 A 1  and  102 A 2 . 
     In operation, upon insertion of a droplet of biological fluid F into the capillary passage  112 C such that the fluid F comes into contact with the reaction region  112 R, and upon application of a suitable voltage bias across the contact pads  112 P (e.g., about 300 mV), an electrical current may be generated that may be proportional to a concentration of the analyte present in the biological fluid F. This sensed electrical current may then be conducted by the electrical circuit including the contact pads  112 P, the electrical contacts  121 , and a conventional analyte measurement circuit (not shown). The calculation of the analyte measurement may be by any currently known method. The measured analyte concentration may then be displayed in any suitable readout form, such as in a display screen  125  of the analyte meter  100  (e.g., a blood glucose meter). 
     In more detail, analyte meter  100  can include a display screen  125  (e.g., a thin film transistor liquid crystal display (TFT LCD), in plane switching LCD(IPS-LCD), capacitive touch screen LCD, organic light emitting diode (OLED), active matrix OLED (AMOLED), and Super AMOLED, and the like) located on the front side  104 A (See  FIG. 1E ), and a user interface (e.g., including one or more push buttons, keys, a scroll wheel or ball, and/or a touch screen as shown in this embodiment, or any combination thereof). As shown in the embodiment of  FIG. 1E , a power button  126  may be provided on the front side  104 A below the display screen  125 . In some embodiments, the analyte meter  100  provides a sleek look by having the front side  104 A including only a display screen  125  and a power button  126 . The processor may be any suitable processor, such as a microprocessor device or collection of microprocessor devices that are capable of receiving the signals and executing any number of program routines, and may be a microcontroller, microprocessor, digital signal processor, or the like. Data received and/or processed by the processor may be stored in memory, which may store software routines that may be adapted to process raw analyte data and determine and display analyte measurement values. 
     In more detail, and as best shown in  FIG. 1F , which is a cross-sectioned side view of a portion  102 A of the analyte meter  100 . The test strip ejector  114  is configured and operable to eject the test strip  112  from the test strip port  110  under the action of the user. The test strip ejector  114  further comprises a slide member  116  that is slidable within the housing body  102 , formed as body part  102 A 1 . The test strip ejector  114  can further include one or more springs  117  in contact with portions of the slide member  116  and portions of the portion  102 A to spring bias the slide member  116  to a retracted starting position (as shown in  FIG. 1F ). Thus, after the test strip  112  is ejected from the test strip port  110 , the one or more springs  117  move the engagement member  118  back to the retracted position at the starting end of the stroke as shown in  FIG. 1F . 
     The test strip ejector  114  further includes an engagement member  118  coupled to the slide member  116  and that is configured to be contacted by a user&#39;s digit  119  (e.g., finger). The engagement member  118  is provided on the back side  104 B, such that the housing body  102  can be held between the thumb and middle or ring finger or both and the index finger can be used to slide the engagement member  118  and eject the test strip  112  from the test strip port  110 . 
     The engagement member  118  is coupled to the slide member  116  by fasteners  118 F that connect and secure to posts  118 P or other boss features formed on the engagement member  118 . Posts  118 P extend through slots  102 S formed in first part  102 A 1 . A limit stop  123  operates to limit the amount of sliding motion of the slide member  116  within pre-designed distance limits. Limit stop  123  can be made up of a first stop member  123 A and second stop member  123 B, such as post and slot shown. Post will only allow a pre-defined amount of sliding before the post contacts the end of the slot and limits further motion. 
     In the depicted embodiment, as best shown in  FIGS. 1A-1D , the engagement member  118  is configured to extend across the back side  104  of the housing body  102 , such as between the first side  104 C and the second side  104 D. As is shown in  FIGS. 1C and 1D , the engagement member  118  can further turn and extend at least part way alongside of the first side  104 C and the second side  104 D and towards the front side  104 A. Thus, the engagement member  1 As best shown in  FIGS. 1C-1D and 2B , the engagement member  118  may be received in a recessed area  102 R of the housing body  102 . 
     In some embodiments, the engagement member  118  may include one or more ribs  118 R, which are raised elongated elements that can have a dome-shaped profile. The one or more ribs  118 R can provide a tactile feel to the engagement member  118  that improves contact with the user&#39;s digit (e.g., finger). As shown, the one or more ribs  118 R may extend across the width of the engagement member  118 . Additionally, the engagement member ( 118 ) can comprise a contact radius (R) contactable with a digit  119  (e.g., finger) of the user. Contact radius (R) can comprise a radius of from 3 mm to 8 mm, for example, or even 4 mm to 5 mm in some embodiments, and may extend over an arc of from 0 degrees to about 90 degrees, for example. Contact radius (R) may extend across a width of the engagement member  118 , and may in some embodiments extend alongside of one or both of the first side  104 C and second side  104 D of the engagement member  118 . 
     The test strip ejector  114  further includes a push member  120  coupled to the slide member  116  and moveable therewith. The push member  120  can be coupled at an end of the slide member  116  nearest the end  106  and can include a portion  120 E positioned to be engageable with an end  112 E of the test strip  112  in order to eject the test strip  112  from the receptacle formed in the test strip receiver  124 . Push member  120  may be coupled to the slide member  116  by any suitable means, such as fasteners, snap fit features, adhesive, ultrasonic welding, and the like. Optionally, the push member  120  may be integrally formed with the slide member  116 . 
     As shown, the push member  120  can be received in, and is slidable within, a test strip receiver  124 . Test strip receiver  124  can be a molded plastic piece that has a plurality of electrical contacts  121 , such as conductive electrical contacts formed (e.g., molded or otherwise fastened) therein and can further include a slot  124 S formed therein. Test strip receiver  124  may be coupled to the printed circuit board  122 , such as by fasteners, molded snap-in features, or the like. Suitable electrical connections (not shown) may be made between the electrical contacts  121 A- 121 C and the processing circuitry  127 P. Processing circuitry  127 P is otherwise entirely conventional and is not further described herein. Push member  120  may reside in a slot  131  formed in the printed circuit board  127 . An end  127 E of the printed circuit board  127  opposite the slot  131  may couple to a power source  133  such as a battery contained inside of the second portion  102 B. Suitable conventional battery terminals and battery securing structure can be included in the second portion  102 B, and a portion of the second portion  102 B may be removable to allow access to the power source, such that it can be changed out, as needed. 
       FIGS. 3A-3B  illustrates an alternative embodiment of an analyte meter  300  according to another aspect of the disclosure. The structure of the analyte meter  300  is similar to the aforementioned embodiment of  FIGS. 1A-2E . In particular, the analyte meter  300  includes a test strip ejector  314  that is located on the back side  304 B of the analyte meter  300  opposite of the front side  304 A containing the display screen  325 . The internal mechanism of the test strip ejector  314  is the same as shown in  FIGS. 1F-1H and 2B  including a slide member  116 , push member  120 , test strip receiver  124 , and engagement member  318 . However, the engagement member  318  is smaller than the engagement member  118  and is recessed within and resides in a pocket  328  formed in the back side  304 B of the housing body  302 . In some embodiments, the analyte meter  300  provides a sleek look by having the front side  304 A include only a display screen  325  and a power button  326 . 
     As before, the engagement member  318  connects to the slide member  116  in the same manner and in  FIGS. 1F and 2B  except that the slots  102 S and posts  118 P may be spaced closer together. As in the previous embodiment, pushing on the engagement member  318  of test strip ejector  314  operates to eject the test strip  112  from the test strip port  310  after use without having to touch the contaminated test strip  112 . The springs  117  return the mechanism back to the starting position enabling the ejection of the next inserted test strip  112  after analyte measurement is completed. As can be seen in  FIGS. 3A and 3B , tactile traction features  330  can be provided on the first side  304 C and the second side  304 D of the analyte meter  300  to enhance the gripping on the analyte meter  300  by the user. 
     Tactile traction features  330  can comprise repeated indented areas  3301 , which may be provided in a substantially repeating pattern, or optionally in a random pattern. The repeated indented areas  3301  can be formed as indents in the housing body  302  that can be molded in, or optionally provided as molded insert strips that can be received and adhered into elongated side pockets  332  that can be formed in the housing body  302 . The material of the tactile traction features  330  can be the same as the rest of the housing body  302  in some embodiments, or optionally can be a soft elastomer material, such as a gel-like material. For example, the soft elastomer material may be any suitable molded or cast material that is different (e.g., softer) than the other molded portions of the housing body  302 . For example, the material may be a silicone, urethane, thermoplastic elastomer (TPE), or other “soft durometer” elastomer. “Soft durometer” as used herein means that the elastomer has a shore 00 durometer of less than 60, or even less than 30, for example. Likewise, tactile traction features  330 A may be provided on the engagement member  318 . For example, they may be provided as molded-in indents or possibly even raised features that enhance tactile feel of the engagement member  318 . 
     In some embodiments, as shown on  FIGS. 3A, 3B , and  3 C, one or more scanner buttons  334  can be included, which when depressed, initiate a scanner function of the analyte meter  300 . The scanner function may be used to scan information about the scanning clinician, the patient, the test strip (e.g., calibration constant), and/or control solution. The scanner function may be initiated, in either a one button or two button configuration, by depressing one or depressing both of the scanner buttons  334  with either a digit or digits (e.g., finger, thumb, or both). Depressing the one or more scanner buttons  334  can close a micro-switch, which in turn closes a circuit and initiates scanning by a scanner apparatus  335  located at the second end  336  opposite the end  306 . Scanning can be stopped by re-depressing one or both of the scanner buttons  334 . The scanner buttons  334  can be located on one or both of the first side  304 C and the second side  304 D of the housing body  302 . In some embodiments, the scanner buttons  334  are redundant, meaning either one can be depressed to initiate and stop the scanning function. The scanner function, which may be embodied as a barcode reader, may be located at any suitable location on the housing body  302 , such as at the second end  336 . Any conventional barcode reader construction may be used. The barcoded information may be embodied in a 1D or 2D barcode, such as a Code 39, Code 128, Interleaved 2 of 5, universal product code (UPC), international article number EAN, portable data file 417 (PDF417), data matrix, or quick response (QR) code. Additionally included at the second end  336  may be one or more charging ports  338 , which can be of any suitable construction to allow charging of a re-chargeable power source. 
     In another aspect, a test strip ejector  114 ,  314  is provided. Test strip ejector  114 ,  314  comprises an engagement member  118 ,  318 , slide member  116 , test strip receiver  124 ,  324 , and a push member  120 . Engagement member  118 ,  318 , is configured to be contacted by a user&#39;s digit  119 , the engagement member  118 ,  318  extending across a back side  104 B,  304 B of a housing body  102 ,  302 . The slide member  116  is coupled to the engagement member  118 ,  318  and is slidable thereby, namely sliding motion of the engagement member  118 ,  318  along the back side  104 B,  304 B towards the end  106 ,  306 . The test strip receiver  124 ,  324  is configured to receive a test strip  112  in a test strip port  110 ,  310  thereof. The push member  120  is coupled to the slide member  116 , and the push member  120  is moveable in the test strip receiver  124 ,  324  and configured to contact an end of the test strip  112 . Sliding motion of the engagement member  118  along the back side  104 B,  304 B causes the test strip  112  to be ejected from the test strip port  110 ,  310 . 
     In another aspect, methods of operating the analyte meter (e.g., analyte meter  100 ,  300 ) to a eject test strip  112  from a test strip port (e.g., test strip port  110 ,  310 ) are described herein. The method  400  of ejecting a test strip  112  from an analyte meter  100 ,  300 , comprises, in block  402 , providing an housing body  102 ,  302  having a test strip ejector  114 ,  314  integrated therein, the test strip ejector  114 ,  314  comprising: an engagement member  118 ,  318  located on a back side  104 B,  304 B of the housing body  102 ,  302 ; a slide member  116  coupled to the engagement member  118 ,  318  and slidable therewith; a test strip receiver  124 ,  324  configured to receive the test strip  112  in a test strip port  110 ,  310  thereof; and a push member  120  coupled to the slide member  116 , the push member  120  moveable in the test strip receiver  124 ,  324 . 
     The method  400  further includes, in block  404 , with a user&#39;s digit, causing a sliding motion of the engagement member  118 ,  318  along the back side  104 B,  304 B to cause the push member  120  to contact an end  112 E of the test strip  112  and eject the test strip  112  from the test strip port  110 ,  310 . 
     The foregoing description discloses only example embodiments of analyte meters, test strip ejectors, and methods of operating analyte meters. Modifications of the above-disclosed analyte meters, test strip ejectors, and methods which fall within the scope of the disclosure will be readily apparent to those of ordinary skill in the art. Accordingly, while the present disclosure has been disclosed in connection with example embodiments thereof, it should be understood that other embodiments may fall within the scope of claims and their equivalents.