Patent Description:
The invention relates to analyte meters that may be used to detect an analyte concentration level in a bio-fluid sample and methods of cleaning analyte meters.

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'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's analyte concentration level (e.g., a glucose analyte level).

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.

Accordingly, there is a need to provide an analyte meter configured for bio-fluid analyte testing that may overcome certain issues due to contamination. It is referred to documents <CIT>, <CIT>, and <CIT> that disclose different analyte meters and analyte sensor electrical connectors and <CIT> that discloses a washable meter.

The problem is solved by an analyte meter according to claim <NUM> and a method of cleaning the analyte meter of claim <NUM>. Preferred embodiments are described in the dependent claims.

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 and alternatives falling within the scope of the invention.

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.

Reference will now be made in detail to the example embodiments of this disclosure, which are illustrated in the accompanying drawings.

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.

In view of this concern, embodiments of the invention may provide an entirely hermetically sealed analyte meter that is 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 are 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.

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 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 washable analyte meters and methods of cleaning the analyte meter are described below with reference to <FIG>.

<FIG> illustrates various views of a first example of an analyte meter <NUM> that is washable according to one or more embodiments. The analyte meter <NUM> includes a meter housing <NUM> that is made of two parts, namely first part <NUM> and second part <NUM> that engage each other to form an internal chamber <NUM> (<FIG>). The internal chamber <NUM> may be configured to contain various internal components of the analyte meter <NUM>, such as a printed circuit board <NUM> (shown dotted in <FIG>), which may contain all or part of an internal electronic circuit. Internal chamber <NUM> may be entirely sealed and liquid impermeable such that the analyte meter <NUM> is washable and immersable. The first part <NUM> and second part <NUM> may be sealed to each other at their contact surfaces in order to form the internal chamber <NUM> as a sealed chamber that is sealed from the outside environment. Internal chamber <NUM> may be hermetically sealed. The first part <NUM> and second part <NUM> of the meter housing <NUM> 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 <NUM> and second part <NUM>, or by providing a sealant (e.g., a curable sealant), o-ring, gasket, or the like between the first part <NUM> and the second part <NUM>. Other suitable sealing methods may be used. Connection of the first part <NUM> to the second part <NUM> may be made by screws, rivets, snap fit connectors molded on the first part <NUM> and second part <NUM>, or the like when using a sealant, o-ring, gasket, or the like.

The printed circuit board <NUM> may reside within the confines of the internal chamber <NUM>. The printed circuit board <NUM> 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 <NUM> may be retained in a defined position within the internal chamber <NUM> by projections and/or recesses formed in one or both of the first part <NUM> and second part <NUM>. Other suitable positioning features may be used.

The meter housing <NUM> may have a first end <NUM> and a second end <NUM> opposite the first end <NUM>. The first end <NUM> includes an analyte sensor electrical connector <NUM> that is fully washable having a sensor port <NUM> configured to receive an analyte sensor <NUM> in a port entryway <NUM> thereof. The analyte sensor electrical connector <NUM> also has a one or a plurality of wash ports <NUM> coupled to sensor port <NUM> that are separate from port entryway <NUM>. Wash ports <NUM> are configured to receive a cleaning fluid there through. The analyte sensor electrical connector <NUM> includes a connector body <NUM> that is received in a recessed pocket <NUM> of the first part <NUM> and/or the second part <NUM>. The connector body <NUM> of the analyte sensor electrical connector <NUM> includes a first wall receiving two or more electrodes <NUM>, and a second wall opposite the first wall and including one or more wash ports <NUM>. Two or more electrical connectors <NUM> may be coupled to two or more electrodes <NUM> at the first wall. In some embodiments, the two or more electrical connectors <NUM> may be electrical connector pins. A sealing layer <NUM> may be provided in some embodiments between a surface of the analyte sensor electrical connector <NUM> and the first part <NUM> and/or second part <NUM>, such as in the recessed pocket <NUM>.

The wash ports <NUM> cooperate with the port entryway <NUM> to form a fluid flow channel enabling flushing of the sensor port <NUM>. The wash ports <NUM> may be formed through a second wall of the analyte sensor electrical connector <NUM>. As shown best in <FIG>, the wash ports <NUM> may be configured as elongated slots. The wash ports <NUM> may be one or more in number.

The analyte meter <NUM> may further include a display screen <NUM> that may be sealed to the first part <NUM> and/or second part <NUM> such that fluids are prevented from entering the internal chamber <NUM> from between the display screen <NUM> and the first part <NUM> and/or second part <NUM>. Similar sealing methods as described above may be used. For example, a sealing material layer <NUM> may be provided around the periphery of the display screen <NUM>.

The analyte meter <NUM> may still further include a keypad <NUM> that may be sealed to the first part <NUM> and/or second part <NUM> such that fluids are prevented from entering the internal chamber <NUM> from between the keypad <NUM> and the first part <NUM> and/or second part <NUM>. The seal between the keypad <NUM> and the first part <NUM> and/or second part <NUM> may be provided by employing a thin layer <NUM> covering over the keys of the keypad <NUM>. The thin layer <NUM> may be sealed to the first part <NUM> and/or second part <NUM> 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 <NUM> or individual keys may be used.

In some embodiments, the analyte meter <NUM> may include a battery connector <NUM> that is sealed to the first part <NUM> and/or second part <NUM> such that fluids are prevented from entering the internal chamber <NUM> from between the battery connector <NUM> and the first part <NUM> and/or second part <NUM>. The battery connector <NUM> allows the use of a removable battery pack <NUM>, as will be described herein.

The analyte meter <NUM> may also include a universal serial bus (USB) port sealed to the first part <NUM> and/or second part <NUM> on a side, for example, such that fluids are prevented from entering the internal chamber <NUM> from between the USB port and the first part <NUM> and/or second part <NUM>. Sealed connection for the universal serial bus (USB) port may be the same as for the battery connector <NUM>. A connection seal <NUM>, such as an elastomer seal, may be provided on the connector or on the first part <NUM> and/or second part <NUM> to seal the connection interface.

As further shown in <FIG> and as otherwise described herein, the analyte meter <NUM> may eliminate any opening allowing liquid ingress into to the internal chamber <NUM>, and may be configured to drain and dry the analyte sensor electrical connector <NUM> upon washing or cleaning thereof with a cleaning fluid or other liquid. According to the invention, the analyte sensor electrical connector <NUM> is seated within the recessed pocket <NUM> in the first part <NUM> of the analyte meter <NUM>. In some embodiments, the electrical connectors may project through one or more apertures in the first part <NUM> and may be configured to be connected to (e.g., plugged into or otherwise contact) conducting receptacle features on the printed circuit board <NUM>. Other suitable electrical connectors may be used such as bendable leaf spring contacts that contact conducting pads on the printed circuit board <NUM>. In some embodiments, the electrical connectors may be insert-molded in the analyte sensor electrical connector <NUM> forming a seal between plastic (e.g., the first part <NUM>) and metal. In some embodiments, a sealing layer <NUM> such as a gasket-type sealing arrangement or other sealing arrangement (sealing compound) may be used between the analyte sensor electrical connector <NUM> and the surface(s) of the first part <NUM> and/or second part <NUM>. In some embodiments, the surfaces within the analyte sensor electrical connector <NUM> may be sloped and/or ventilated as needed to facilitate fluid egress after washing.

<FIG> is a flowchart illustrating a method <NUM> of cleaning an analyte meter in accordance with one or more embodiments. At process block <NUM>, method <NUM> includes providing an analyte meter (e.g., analyte meter <NUM>) having a sensor port (e.g., sensor port <NUM>) configured to receive an analyte sensor (e.g., analyte sensor <NUM>), the sensor port having a port entryway (e.g., port entryway <NUM>) and a wash port (e.g., wash port <NUM>). At process block <NUM>, method <NUM> includes flowing a cleaning fluid through the wash port to clean the sensor port. The method <NUM> of cleaning may be accomplished without adversely affecting the analyte meter.

<FIG> is a flowchart illustrating a method <NUM> of manufacturing an analyte meter, the method not covered by the appended claims. At process block <NUM>, method <NUM> may include providing an meter housing (e.g., meter housing <NUM>) having an internal chamber (e.g., internal chamber <NUM>). At process block <NUM>, method <NUM> may include providing an analyte sensor electrical connector (e.g., analyte sensor electrical connector <NUM>). The analyte sensor electrical connector may include at least two electrodes (e.g., electrodes <NUM>). Analyte sensor electrical connector <NUM> may be attachable to the meter housing <NUM>. At process block <NUM>, method <NUM> may include providing an analyte meter battery connector (e.g., battery connector <NUM>). At process block <NUM>, method <NUM> may include forming a sealed connection between the analyte sensor electrical connector and the internal chamber. And at process block <NUM>, method <NUM> 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.

The above process blocks of method <NUM> 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 <NUM> may be performed after or in parallel with process block <NUM>. Similarly, process block <NUM> may be performed after or in parallel with process block <NUM>.

<FIG> illustrate an embodiment of a removable or replaceable battery cartridge <NUM> of an analyte meter <NUM> not covered by the appended claims that includes a sealed battery connector <NUM> that may protect against liquid ingress into the internal chamber <NUM>. The sealed battery connector <NUM> 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 <NUM> may be configured to attach to an meter housing <NUM> via slideable insertion.

As shown in <FIG> and <FIG>, some embodiments not covered by the appended claims may include retention features, such as a pair of T-shaped retention rails <NUM> on opposite sides of a surface of an meter housing <NUM> (<FIG>) and a corresponding pair of retention slots <NUM> in the battery cartridge housing <NUM> configured to receive the T-shaped rails.

<FIG> illustrate a battery cartridge housing <NUM> (<FIG>) configured to receive battery cartridge inserts of different battery chemistries in accordance with one or more embodiments not covered by the appended claims. <FIG> illustrate a battery insert assembly <NUM> including coin cell batteries and <FIG> illustrate a battery insert assembly <NUM> including a prismatic battery cell, each configured to be inserted in battery cartridge housing <NUM>.

<FIG> not covered by the appended claims illustrates a printed circuit board (PCB) <NUM> that may be affixed to the inserts at locations <NUM> and <NUM> (of <FIG>, respectively) in accordance with one or more embodiments not covered by the appended claims. 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 <NUM> extending from the printed circuit board (PCB) <NUM> may couple to and provide a sealed connection (e.g., with connection seal <NUM>) 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 <NUM>. Thus, power may be readily provided to the analyte meter and the internal chamber <NUM> may remain entirely hermetically sealed.

As shown in <FIG> not covered by the appended claims, battery insert assemblies <NUM>, <NUM> may be slid into the battery cartridge housing <NUM> first at an angle such that the interface battery connector slides through an access hole <NUM> (see <FIG>) and then the battery insert assemblies <NUM>, <NUM> may be snapped down into the battery cartridge housing <NUM>. In addition, in some embodiments, the battery insert assembly <NUM>, <NUM> may be secured in the battery cartridge housing <NUM> with potting or an adhesive. In the case of the battery insert assembly <NUM> this may also protect the prismatic battery and the battery compartment against liquid ingress.

Embodiments of the battery cartridge housing <NUM> 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 <NUM> of the replaceable battery cartridge may be user replaceable.

<FIG> not covered by the appended claims illustrate the electrical interface between a replaceable battery cartridge and an analyte meter (or other suitable battery-powered device). <FIG> 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. <FIG> illustrate full cartridge electrical interface topologies wherein all power management circuitry may be contained in the battery cartridge.

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.

Claim 1:
An analyte meter (<NUM>), comprising:
a meter housing (<NUM>) having a first part (<NUM>) and a second part (<NUM>) interfacing each other to form an internal chamber (<NUM>); and
an analyte sensor electrical connector (<NUM>) having
a sensor port (<NUM>) configured to receive an analyte sensor in a port entryway (<NUM>), and
at least one wash port (<NUM>) coupled to the sensor port (<NUM>) and separate from the port entryway (<NUM>), the at least one wash port configured to receive a cleaning fluid;
characterized in that
the meter (<NUM>) comprises a recessed pocket (<NUM>) in the first part (<NUM>) or the second part (<NUM>) of the housing (<NUM>), and
the analyte sensor electrical connector (<NUM>) comprises a connector body (<NUM>) seated in the recessed pocket (<NUM>) of the analyte meter (<NUM>); wherein the connector body (<NUM>) comprises a first wall, a second wall, the sensor port (<NUM>), the at least one wash port (<NUM>) and at least two electrodes (<NUM>); wherein the at least two electrodes are located at a first wall of the analyte sensor electrical connector;
wherein the at least one wash port is disposed in the second wall opposite the first wall and directly over the at least two electrodes (<NUM>) to receive the cleaning fluid there through and onto the at least two electrodes (<NUM>) and out the port entryway (<NUM>) while the connector body (<NUM>) is seated in the recessed pocket (<NUM>) of the analyte meter (<NUM>).