Patent Application
20150169837
This application generally relates to the field of portable battery-powered blood glucose meters and more specifically to upgrading firmware in a blood glucose meter without using the meter's resident battery.
Hand held blood glucose measurement systems are used for testing an individual's blood in a variety of surroundings at any time of day. These systems typically comprise an analyte meter that is configured to receive a biosensor, usually in the form of a test strip. Because these systems are portable, and testing can be completed in a short amount of time, patients are able to use such devices in the normal course of their daily lives. Therefore, a person with diabetes may measure their blood glucose levels several times a day as a part of a self management process to ensure glycemic control of their blood glucose within a target range.
These types of blood glucose meters are typically powered using a small battery, such as a coin cell, and so are limited in the total power provided by the battery to the electronic sub-system that performs glucose measurements. This power limitation may result in unnecessary premature battery power depletion if the meter's battery is used for performing operations other than blood glucose measurements, such as by performing firmware upgrades.
In the electronic sub-system of the blood glucose meter, the firmware comprises program code stored in nonvolatile memory, such as in EEPROM or in flash memory that is accessible by the meter's microcontroller. This program code is typically the control program of the meter which controls operation of the meter's functions. Firmware upgrades require that new program code be sent to the meter, loaded into the nonvolatile memory, and installed as a replacement for the previous firmware version. This sequence of steps may be referred to as “reprogramming” or “upgrading” the meter. Users are motivated to install upgrades because the newer program code typically comprises improved performance over an existing version or the firmware may provide new or updated operational features.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention (wherein like numerals represent like elements).
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
As used herein, the terms “patient” or “user” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
The term “sample” means a volume of a liquid, solution or suspension, intended to be subjected to qualitative or quantitative determination of any of its properties, such as the presence or absence of a component, the concentration of a component, e.g., an analyte, etc. The embodiments of the present invention are applicable to human and animal samples of whole blood. Typical samples in the context of the present invention as described herein include blood, plasma, red blood cells, serum and suspension thereof.
The term “about” as used in connection with a numerical value throughout the description and claims denotes an interval of accuracy, familiar and acceptable to a person skilled in the art. The interval governing this term is preferably ±10%. Unless specified, the terms described above are not intended to narrow the scope of the invention as described herein and according to the claims.
The electronic components of the glucose measurement system 100 can be disposed on, for example, a printed circuit board situated within the housing 11 and forming the data management unit 150 of the herein described system.
Referring to
The analyte test strip 24 can be in the form of an electrochemical glucose test strip that includes one or more working electrodes. Test strip 24 can also include a plurality of electrical contact pads, where each electrode can be in electrical communication with at least one electrical contact pad. Strip port connector circuit 110 can be configured to electrically interface to the electrical contact pads and form electrical communication with the electrodes. Test strip 24 can include a reagent layer that is disposed over at least one electrode. The reagent layer can include an enzyme and a mediator. Exemplary enzymes suitable for use in the reagent layer include glucose oxidase, glucose dehydrogenase (with pyrroloquinoline quinone co-factor, “PQQ”), and glucose dehydrogenase (with flavin adenine dinucleotide co-factor, “FAD”). An exemplary mediator suitable for use in the reagent layer includes ferricyanide, which in this case is in the oxidized form. The reagent layer can be configured to physically transform glucose into an enzymatic by-product and in the process generate an amount of reduced mediator (e.g., ferrocyanide) that is proportional to the glucose concentration. The working electrode can then be used to measure a concentration of the reduced mediator in the form of a current magnitude. In turn, the strip port connector circuit 110 can convert the current magnitude into a glucose concentration. An exemplary analyte meter performing such current measurements is described in U.S. Patent Application Publication No. US 2009/0301899 A1 entitled “System and Method for Measuring an Analyte in a Sample”, which is incorporated by reference herein as if fully set forth in this application.
Still referring to
The memory module 121, i.e. on-board memory, includes, but is not limited to, volatile random access memory (“RAM”), a nonvolatile memory, e.g. program store 123, which may comprise read only memory (“ROM”), nonvolatile RAM (“NVRAM”), or flash memory. A USB circuit 101, comprising USB/data port 13, is electrically connected to the processing unit 120 over data/power interface 113, and data interface 114 which may also include a power line, as necessary. External memory devices may be connected to the USB/data port 13 including flash memory devices housed in thumb drives, portable hard disk drives, data cards, or any other form of electronic storage devices. The on-board memory 121 can include various embedded applications, i.e. firmware, executed by the processing unit 120 for operation of the analyte meter 10, as described herein. The on-board memory 121 can also be used to store a history of a user's blood glucose measurements including dates and times associated therewith. Using a wireless transmission capability of the analyte meter 10, or the data port 13, such measurement data can be transferred via wired or wireless transmission to connected computers or other processing devices.
A power supply module 118 is electrically connected to modules 107, 108, 109 of the DMU 150, and to the processing unit 120 over power supply interface 105 to supply electric power thereto. The power supply module 118 may comprise a standard battery, such as a coin cell, or rechargeable batteries that are recharged when the analyte meter 10 is connected to a source of AC power such as through a USB cable at data/power port 13. The power supply module 118 may also be electrically connected to processing unit 120 over a communication interface such that processing unit 120 can monitor a power level remaining in a battery of the power supply module 118.
In addition to connecting external storage for use by the analyte meter 10, the data port 13 can be used to accept a USB connector attached to a cable, thereby allowing the analyte meter 10 to be communicatively connected to an external device such as a personal computer, a data storage device, or any other USB compliant host device. Data/USB port 13 may be capable of receiving a USB connector inserted therein for transmission of data such as the firmware upgrade described herein. The firmware upgrade typically includes improvements and/or new operational features embodied in new program algorithms that are not included in the firmware that is currently resident in the meter 10.
Prior to downloading the firmware upgrade to the blood glucose meter 10, the firmware may be stored on a USB compliant device that is connectible to the blood glucose meter 10 via the data/USB port 13, such as a portable storage device or another processing system, such as a PC. The USB protocol provides that, in addition to data transmission, the USB cable/connector deliver about five volts (5 V) at a current level up to about 500 mA, which is sufficient to provide power to transfer data from a connected USB compliant device to the analyte meter 10 without requiring use of the analyte meter's power supply 118. When a connection is established as between an external device containing updated firmware for upgrading the firmware resident in the program store 123 of the meter 10, the USB provided voltage may be coupled via power interface 106, internal to the meter 10, for powering the flash memory 104, which typically resides in an integrated circuit chip. This power supply is provided to the flash memory 104 via the voltage regulator 103 over the voltage interface 111. The supplied USB power lines, typically provided over a two-wire conductor, enables the flash memory 104 to receive and store the firmware upgrade. In addition, the USB delivered power may be used to transfer the firmware upgrade from its temporary storage in the flash memory 104 to the program storage 123 of the processing unit 120 over the data interface 114 which may also include a power line, as necessary. A common chip-to-chip data transfer interface 124 may be implemented on-board the microcontroller 120, such as a SPI/I2C interface which provides for adequate data transfer speeds.
Electrical connections between the battery, e.g. coin cell, of the power supply 118 and the flash memory 104 are not required, such that the flash memory chip 104 is invisible to, and not accessible by, the microcontroller 120 unless a USB cable is plugged into data/USB port 13 to supply power thereto. This lack of an electrical connection saves several microamps of battery current when the test meter 10 is in a sleep mode, and several milliamps of battery current when the test meter 10 is in an active mode, i.e. performing or displaying a glucose measurement. During transfer of the upgraded firmware into the microcontroller program storage 123, the USB cable remains plugged into the data/USB port 13 and provides power to the components of the USB circuit 101. Thus, the flash memory 104 may be used only when it is powered by a connected USB device.
After the new firmware is transferred to the flash memory 104, whether encrypted or not, it may be checked for integrity, compatibility, version number, and/or decrypted before being finally installed in the microcontroller 120 program storage 123. During the data transfer, the USB cable remains inserted in the test meter's USB/data port 13 to provide power for the flash memory 104. The external power provided by the USB cable is sufficient to power the entire upgrade process. This can be guaranteed at all states of battery charge, and across the full operating temperature range of the test meter 10.
With reference to
As will be appreciated by one skilled in the art, aspects of the present invention may be embodied as a system, method, or computer program product. Accordingly, aspects of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.), or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “circuitry,” “module,” and/or “system.” Furthermore, aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon.
Any combination of one or more computer readable medium(s) may be utilized. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible, non-transitory medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
Program code and/or executable instructions embodied on a computer readable medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
Furthermore, the various methods described herein can be used to generate software codes using off-the-shelf software development tools. The methods, however, may be transformed into other software languages depending on the requirements and the availability of new software languages for coding the methods.
While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well.
