Abstract:
An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Description:
RELATED APPLICATIONS 
       [0001]    The present application claims priority to U.S. Provisional Patent Application No. 61/864,958 filed Aug. 12, 2013, and entitled “WASHABLE ANALYTE METERS, SEALED CONNECTORS, AND METHODS OF MANUFACTURING AND USING SAME” (Attorney Docket No. BHC124017US) which is hereby incorporated herein by reference in its entirety for all purposes. 
     
    
     FIELD 
       [0002]    The invention relates to analyte meters that may be used to detect an analyte concentration level in a bio-fluid sample, analyte sensor electrical connectors, and methods of using and manufacturing thereof. 
       BACKGROUND 
       [0003]    The monitoring of analyte concentration levels in a bio-fluid may be an important part of health diagnostics. For example, an electrochemical analyte sensor may be employed with an analyte meter for monitoring a patient&#39;s blood glucose level as part of diabetes treatment and care. Other types of analytes may be measured as well. An electrochemical analyte sensor may be employed, for instance, for detecting an analyte concentration level in a bio-fluid sample, such as from a single sample of blood or other interstitial fluid. The bio-fluid may be obtained from the patient using a lancet (e.g., by a pinprick or needle). Typically, after a bio-fluid sample has been obtained, the sample may then be transferred to an analyte sensor (e.g., typically an analyte sensor strip) for measurement of the bio-fluid sample&#39;s analyte concentration level (e.g., a glucose analyte level). 
         [0004]    As part of the process, electrodes formed on the analyte sensor are placed in electrical contact with an electrical connector of the analyte meter. Typically, the analyte sensor (e.g., sensor strip) is inserted into a sensor port of the sensor connector. However, portions of the sensor connector housing may be partially open to the inside of the analyte meter and the electrical connection takes place within the interior of the analyte meter. Once the connection is established, the bio-fluid is applied to a receiving end of the sensor strip and the analyte measurement is carried out. During this process, bio-fluids such as blood may contaminate portions of the outside of the meter, such as near the port. Further, the port and the internal electrical connections may become contaminated. 
         [0005]    Accordingly, there is a need to provide an analyte meter configured for bio-fluid analyte testing that may overcome certain issues due to contamination. 
       SUMMARY 
       [0006]    In a first aspect, an analyte meter is provided. The analyte meter includes an analyte sensor electrical connector having a sensor port configured to receive an analyte sensor in a port entryway, and at least one wash port coupled to the sensor port and separate from the port entryway, the at least one wash port configured to receive a cleaning fluid. 
         [0007]    In another aspect, another analyte meter is provided. The analyte meter includes a meter housing having a first part and a second part interfacing with each other to form an internal chamber, an electronic circuit within the internal chamber, and an analyte sensor electrical connector including a sealed electrical connection through the first part or the second part into the internal chamber, a sensor port configured to receive an analyte sensor in a port entryway, and at least one wash port coupled to the sensor port and separate from the port entryway, the at least one wash port configured to receive a cleaning fluid. 
         [0008]    In a method aspect, a method of cleaning an analyte meter is provided. The method includes providing an analyte meter having a sensor port configured to receive an analyte sensor, the sensor port having a port entryway and a wash port, and flowing a cleaning fluid through the wash port to clean the sensor port. 
         [0009]    In another method aspect, a method of manufacturing an analyte meter is provided. The method includes providing an analyte meter housing having an internal chamber, providing an analyte sensor electrical connector having at least two electrodes, providing an analyte meter battery connector, forming a sealed connection between the analyte sensor electrical connector and the internal chamber, and forming a sealed connection between the analyte meter battery connector and the internal chamber. 
         [0010]    In another aspect, another analyte meter is provided. The analyte meter includes a meter housing having a first part and a second part interfacing with and sealed to one another to form an internal chamber, an electronic circuit within the internal chamber, a sensor port configured to receive an analyte sensor in a port entryway, an analyte sensor electrical connector in the sensor port including a sealed electrical connection through the first part or the second part into the internal chamber, a screen display sealed to one of the first part and a second part, a keypad sealed to one of the first part and a second part, and a removable battery pack including a sealed electrical connection through the first part or the second part into the internal chamber. 
         [0011]    In another aspect, another analyte meter is provided. The analyte meter includes a display screen, a keypad, an analyte sensor port, and battery pack interfacing with an electronic circuit located in an internal chamber of a meter housing wherein the internal chamber is entirely sealed and liquid impermeable such that the analyte meter is washable and immersable. 
         [0012]    Still other aspects, features, and advantages of the invention may be readily apparent from the following detailed description wherein a number of example embodiments and implementations are described and illustrated, including the best mode contemplated for carrying out the invention. The invention may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The invention covers all modifications, equivalents, and alternatives falling within the scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The drawings, described below, are for illustrative purposes only and are not necessarily drawn to scale. The drawings are not intended to limit the scope of the invention in any way. 
           [0014]      FIG. 1A  illustrates a top plan view of a washable analyte meter including a washable sensor connector according to embodiments. 
           [0015]      FIG. 1B  illustrates a partial cross-sectioned side view of the analyte meter of  FIG. 1A  taken along section line “ 1 B- 1 B.” 
           [0016]      FIG. 1C  illustrates a partial perspective view of the washable analyte meter including the washable sensor connector according to embodiments. 
           [0017]      FIG. 1D  illustrates a front view of the washable sensor connector of  FIG. 1C , shown in isolation. 
           [0018]      FIGS. 1E-1H  illustrates various perspective views of certain components of the washable analyte meter including the washable sensor connector according to embodiments. 
           [0019]      FIG. 2  illustrates a flowchart of a method of using an analyte meter according to embodiments. 
           [0020]      FIG. 3  illustrates a flowchart of a method of manufacturing an analyte meter according to embodiments. 
           [0021]      FIGS. 4 and 5  illustrate perspective views of a washable analyte meter including a replaceable battery cartridge according to embodiments. 
           [0022]      FIGS. 6 and 7  illustrate perspective views of battery cartridge housings according to embodiments. 
           [0023]      FIGS. 8 and 9  illustrate cross-sectional and top plan views, respectively, of a replaceable battery cartridge according to embodiments. 
           [0024]      FIGS. 10 and 11  illustrate cross-sectional and top plan views, respectively, of another replaceable battery cartridge according to embodiments. 
           [0025]      FIG. 12  illustrates a perspective view of a battery cartridge connector and printed circuit board according to embodiments. 
           [0026]      FIG. 13  illustrates a perspective view of a battery cartridge housing according to embodiments. 
           [0027]      FIGS. 14 and 15  illustrate cross-sectional views of an assembly of a replaceable battery cartridge into the battery cartridge housing of  FIG. 13  according to embodiments. 
           [0028]      FIGS. 16 and 17  illustrate cross-sectional views of an assembly of another replaceable battery cartridge into the battery cartridge housing of  FIG. 13  according to embodiments. 
           [0029]      FIGS. 18-21  illustrate schematic circuit diagrams illustrating the electrical connections between a replaceable battery cartridge and an analyte meter according to embodiments. 
       
    
    
     DESCRIPTION 
       [0030]    Reference will now be made in detail to the example embodiments of this disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
         [0031]    Certain regulatory requirements regarding cleaning and disinfection efficacy in a clinical setting are becoming more stringent. Moreover, in cases of high levels of contamination, the analyte measurement itself taken by an analyte meter may be adversely affected because the electrical connection between the analyte (e.g., an analyte sensor strip) and one or more electrodes of the electrical connector may be contaminated or adversely affected in some way. 
         [0032]    In view of this concern, embodiments of the invention may provide an entirely hermetically sealed analyte meter that may be washable and, in some embodiments, may even be immersed in a liquid without damage. Accordingly, the sealed analyte meter may be washed in a washing fluid, such as a disinfecting liquid, or the like. In one or more embodiments, the one or more electrical connections of the analyte meter may be sealed. Some may be washable, such as, e.g., the analyte sensor port. Other electrical connections may be sealed and/or washable and/or removable such as a communication connector (e.g., a universal serial bus (USB) port) and/or a battery connection. In some embodiments, the analyte meter itself is entirely washable and all connections thereof may be sealed and washable, including the sensor port, enabling electrical connection with an analyte sensor. 
         [0033]    The analyte meter, in accordance with one or more embodiments, 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 Alc, 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. 
         [0034]    These and other embodiments of washable analyte meters, washable analyte sensor electrical connectors, and methods of using and manufacturing and using the analyte meter are described below with reference to  FIGS. 1A-21 . 
         [0035]      FIGS. 1A-1D  illustrates various views of a first example of an analyte meter  100  that is washable according to one or more embodiments. The analyte meter  100  may include a meter housing  102  that may be made of two parts, such as first part  104  and second part  106  that engage each other to form an internal chamber  108  ( FIG. 1B ). The internal chamber  108  may be configured to contain various internal components of the analyte meter  100 , such as a printed circuit board  110  (shown dotted in  FIG. 1A ), which may contain all or part of an internal electronic circuit. Internal chamber  108  may be entirely sealed and liquid impermeable such that the analyte meter  100  is washable and immersable. The first part  104  and second part  106  may be sealed to each other at their contact surfaces in order to form the internal chamber  108  as a sealed chamber that is sealed from the outside environment. Internal chamber  108  may be hermetically sealed. The first part  104  and second part  106  of the meter housing  102  may be formed of an insulating material such as plastic injection-molded pieces, for example. Sealing may be provided by ultrasonic welding of the first part  104  and second part  106 , or by providing a sealant (e.g., a curable sealant), o-ring, gasket, or the like between the first part  104  and the second part  106 . Other suitable sealing methods may be used. Connection of the first part  104  to the second part  106  may be made by screws, rivets, snap fit connectors molded on the first part  104  and second part  106 , or the like when using a sealant, o-ring, gasket, or the like. 
         [0036]    The printed circuit board  110  may reside within the confines of the internal chamber  108 . The printed circuit board  110  may include conventional electronic components such as a power supply, processor, memory, and the like that are conventional for carrying out analyte measurements and display thereof. The printed circuit board  110  may be retained in a defined position within the internal chamber  108  by projections and/or recesses formed in one or both of the first part  104  and second part  106 . Other suitable positioning features may be used. 
         [0037]    The meter housing  102  may have a first end  112  and a second end  113  opposite the first end  112 . The first end  112  may include an analyte sensor electrical connector  115  that is fully washable having a sensor port  116  configured to receive an analyte sensor  105  in a port entryway  119  thereof. The analyte sensor electrical connector  115  may also have a one or a plurality of wash ports  118  coupled to sensor port  116  that are separate from port entryway  119 . Wash ports  118  may be configured to receive a cleaning fluid there through. The analyte sensor electrical connector  115  may include a connector body  117  that may be received in a recessed pocket  114  of the first part  104  and/or the second part  106 . In some embodiments, the connector body  117  of the analyte sensor electrical connector  115  may include a first wall receiving two or more electrodes  121 , and a second wall opposite the first wall and including one or more wash ports  118 . Two or more electrical connectors  122  may be coupled to two or more electrodes  121  at the first wall. In some embodiments, the two or more electrical connectors  122  may be electrical connector pins. A sealing layer  123  may be provided in some embodiments between a surface of the analyte sensor electrical connector  115  and the first part  104  and/or second part  106 , such as in the recessed pocket  114 . 
         [0038]    In some embodiments, the wash ports  118  may cooperate with the port entryway  119  to form a fluid flow channel enabling flushing of the sensor port  116 . The wash ports  118  may be formed through a first wall of the analyte sensor electrical connector  115 . As shown best in  FIG. 1C , the wash ports  118  may be configured as elongated slots. The wash ports  118  may be one or more in number. 
         [0039]    The analyte meter  100  may further include a display screen  120  that may be sealed to the first part  104  and/or second part  106  such that fluids are prevented from entering the internal chamber  108  from between the display screen  120  and the first part  104  and/or second part  106 . Similar sealing methods as described above may be used. For example, a sealing material layer  124  may be provided around the periphery of the display screen  120 . 
         [0040]    The analyte meter  100  may still further include a keypad  125  that may be sealed to the first part  104  and/or second part  106  such that fluids are prevented from entering the internal chamber  108  from between the keypad  125  and the first part  104  and/or second part  106 . The seal between the keypad  125  and the first part  104  and/or second part  106  may be provided by employing a thin layer  126  covering over the keys of the keypad  125 . The thin layer  126  may be sealed to the first part  104  and/or second part  106  and may be adhered thereto. The thin layer may be a plastic sheet in some embodiments and may include indicia printed or otherwise marked thereon. Other means for sealing the keypad  125  or individual keys may be used. 
         [0041]    In some embodiments, the analyte meter  100  may include a battery connector  127  that is sealed to the first part  104  and/or second part  106  such that fluids are prevented from entering the internal chamber  108  from between the battery connector  127  and the first part  104  and/or second part  106 . The battery connector  127  allows the use of a removable battery pack  128 , as will be described herein. 
         [0042]    The analyte meter  100  may also include a universal serial bus (USB) port sealed to the first part  104  and/or second part  106  on a side, for example, such that fluids are prevented from entering the internal chamber  108  from between the USB port and the first part  104  and/or second part  106 . Sealed connection for the universal serial bus (USB) port may be the same as for the battery connector  127 . A connection seal  127 S, such as an elastomer seal, may be provided on the connector or on the first part  104  and/or second part  106  to seal the connection interface. 
         [0043]    As further shown in  FIGS. 1E-1H  and as otherwise described herein, the analyte meter  100  may eliminate any opening allowing liquid ingress into to the internal chamber  108 , and may be configured to drain and dry the analyte sensor electrical connector  115  upon washing or cleaning thereof with a cleaning fluid or other liquid. In some embodiments, the analyte sensor electrical connector  115  may be seated within the recessed pocket  114  in the first part  104  of the analyte meter  100 . In some embodiments, the electrical connectors may project through one or more apertures in the first part  104  and may be configured to be connected to (e.g., plugged into or otherwise contact) conducting receptacle features on the printed circuit board  110 . Other suitable electrical connectors may be used such as bendable leaf spring contacts that contact conducting pads on the printed circuit board  110 . In some embodiments, the electrical connectors may be insert-molded in the analyte sensor electrical connector  115  forming a seal between plastic (e.g., the first part  104 ) and metal. In some embodiments, a sealing layer  123  such as a gasket-type sealing arrangement or other sealing arrangement (sealing compound) may be used between the analyte sensor electrical connector  115  and the surface(s) of the first part  104  and/or second part  106 . In some embodiments, the surfaces within the analyte sensor electrical connector  115  may be sloped and/or ventilated as needed to facilitate fluid egress after washing. 
         [0044]      FIG. 2  is a flowchart illustrating a method  200  of cleaning an analyte meter in accordance with one or more embodiments. At process block  202 , method  200  may include providing an analyte meter (e.g., analyte meter  100 ) having a sensor port (e.g., sensor port  116 ) configured to receive an analyte sensor (e.g., analyte sensor  105 ), the sensor port having a port entryway (e.g., port entryway  119 ) and a wash port (e.g., wash port  118 ). At process block  204 , method  200  may include flowing a cleaning fluid through the wash port to clean the sensor port. The method  200  of cleaning may be accomplished without adversely affecting the analyte meter. 
         [0045]      FIG. 3  is a flowchart illustrating a method  300  of manufacturing an analyte meter in accordance with one or more embodiments. At process block  302 , method  300  may include providing an meter housing (e.g., meter housing  102 ) having an internal chamber (e.g., internal chamber  108 ). At process block  304 , method  300  may include providing an analyte sensor electrical connector (e.g., analyte sensor electrical connector  115 ). The analyte sensor electrical connector may include at least two electrodes (e.g., electrodes  121 ). Analyte sensor electrical connector  115  may be attachable to the meter housing  102 . At process block  306 , method  300  may include providing an analyte meter battery connector (e.g., battery connector  127 ). At process block  308 , method  300  may include forming a sealed connection between the analyte sensor electrical connector and the internal chamber. And at process block  310 , method  300  may include forming a sealed connection between the analyte meter battery connector and the internal chamber. Any suitable means for accomplishing the sealed connection may be used. 
         [0046]    The above process blocks of method  300  may be executed or performed in an order or sequence not limited to the order and sequence shown and described. For example, in some embodiments, process block  304  may be performed after or in parallel with process block  306 . Similarly, process block  308  may be performed after or in parallel with process block  310 . 
         [0047]      FIGS. 4-6  illustrate an embodiment of a removable or replaceable battery cartridge  428  of an analyte meter  400  that includes a sealed battery connector  429  that may protect against liquid ingress into the internal chamber  108 . The sealed battery connector  429  may be provided via the use of a sealed or potted interface in accordance with one or more embodiments. In some embodiments, the replaceable battery cartridge  428  may be configured to attach to an meter housing  402  via slideable insertion. 
         [0048]    As shown in  FIGS. 5 and 6 , some embodiments may include retention features, such as a pair of T-shaped retention rails  430  on opposite sides of a surface of an meter housing  402  ( FIG. 5 ) and a corresponding pair of retention slots  432  in the battery cartridge housing  428 H configured to receive the T-shaped rails. 
         [0049]      FIGS. 7-11  illustrate a battery cartridge housing  728 H ( FIG. 7 ) configured to receive battery cartridge inserts of different battery chemistries in accordance with one or more embodiments.  FIGS. 8 and 9  illustrate a battery insert assembly  832  including coin cell batteries and  FIGS. 10 and 11  illustrate a battery insert assembly  1032  including a prismatic battery cell, each configured to be inserted in battery cartridge housing  728 H. 
         [0050]      FIG. 12  illustrates a printed circuit board (PCB)  1200  that may be affixed to the inserts at locations  825  and  1025  (of  FIGS. 8 and 10 , respectively) in accordance with one or more embodiments. In some embodiments, potting compound may be used to encapsulate the electronics creating a fluid-tight seal (e.g., a water-tight seal). A gasket or potting compound may additionally be used in some embodiments to seal the prismatic battery. Battery electrical connector  1227  extending from the printed circuit board (PCB)  1200  may couple to and provide a sealed connection (e.g., with connection seal  127 S) with the meter housing of the analyte meter, for example. Optionally, sealed electrical connectors may be the same as for the analyte sensor electrical connector  115 . Thus, power may be readily provided to the analyte meter and the internal chamber  108  may remain entirely hermetically sealed. 
         [0051]    As shown in  FIGS. 13-17 , battery insert assemblies  832 ,  1032  may be slid into the battery cartridge housing  728 H first at an angle such that the interface battery connector slides through an access hole  1335  (see  FIG. 13 ) and then the battery insert assemblies  832 ,  1032  may be snapped down into the battery cartridge housing  728 H. In addition, in some embodiments, the battery insert assembly  832 ,  1032  may be secured in the battery cartridge housing  728 H with potting or an adhesive. In the case of the battery insert assembly  1032  this may also protect the prismatic battery and the battery compartment against liquid ingress. 
         [0052]    Embodiments of the battery cartridge housing  728 H may allow multiple battery chemistries to be used while maintaining an identical mechanical envelope for an analyte meter (or other suitable battery-powered device). In some embodiments, the electronics in the battery cartridge may be protected against liquid ingress such that the IP22 standard is met. The IP22 standard is part of the Ingress (or International) Protection Rating code published by the International Electrotechnical Commission (IEC). Embodiments of the replaceable battery cartridge may also allow an analyte meter (or other suitable battery-powered device) to meet the IP22 standard for liquid ingress. Embodiments of the replaceable battery cartridges may be user replaceable, thus reducing the cost of replacing a replaceable battery cartridge when the battery/batteries expire(s). In some embodiments, the coin cell batteries of the battery insert assembly  832  of the replaceable battery cartridge may be user replaceable. 
         [0053]      FIGS. 18-21  illustrate the electrical interface between a replaceable battery cartridge and an analyte meter (or other suitable battery-powered device).  FIGS. 18 and 19  illustrate less complex circuit topologies of electrical interfaces wherein power management circuitry common to all battery chemistries may be contained in an analyte meter (or other suitable battery-powered device), while the power management circuitry unique to a battery chemistry may be contained in the battery cartridge.  FIGS. 20 and 21  illustrate full cartridge electrical interface topologies wherein all power management circuitry may be contained in the battery cartridge. 
         [0054]    Accordingly, battery cartridges of different battery chemistries may be mechanically and electrically interchangeable, allowing an analyte meter (or other suitable battery-powered device) to be powered from different battery chemistries. 
         [0055]    The foregoing description discloses only example embodiments of analyte meters, sensor connectors, battery cartridges, and methods of manufacturing and using the analyte meters. Modifications of the above-disclosed analyte meters, sensor connectors, and methods, which fall within the scope of the invention, will be readily apparent to those of ordinary skill in the art. Accordingly, while the invention has been disclosed in connection with example embodiments thereof, it should be understood that other embodiments may fall within the scope of the invention, as defined by the following claims.