Patent Application
20160178559
This application generally relates to the field of blood analyte measurement systems and more specifically to portable analyte measurement devices that are configured to interact with numerous and/or disparate test strip designs.
Blood glucose measurement systems typically comprise an analyte measurement device (e.g., a portable test meter) that is configured to receive a biosensor, usually in the form of a test strip. Because many of these analyte determination systems are portable, and testing may be completed in a short amount of time, patients are able to use such devices in the normal course of their daily lives without significant interruption to their personal routines. As a result, 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. A failure to maintain target glycemic control may result in serious diabetes-related complications including cardiovascular disease, kidney disease, nerve damage and blindness.
There currently exist a number of available portable electrical analyte measurement devices that are designed to automatically activate upon insertion of a test strip into a port of the device, e.g., a test meter. Electrical contacts, or prongs, in a strip ort connector of the test meter establish connections with contact pads provided on the test strip. However, current analyte measurement devices are only capable of interacting with a test strip model with which they are initially designed to interact. When a new test strip model, including newly designed electrical contacts, is released or replaces a previous model, a new analyte measurement device, designed to interact with the new test strip model, must also be released. Designing and manufacturing this latter analyte measurement device model can be costly in time and resources for the manufacturers. Also, manufacturers and distributors are often left with unsold previous models that must be disposed of in some manner, resulting in a loss of profits. Furthermore, the release of new meter designs equipped to utilize the new test strip designs are costly and require consumers to purchase a new analyte measurement device to work with the new test strip model, even if the consumer's previous test meter was still functional.
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. Throughout the course of discussion, several terms are used in order to describe the salient features that are provided in the accompanying drawings. These terms, which can include, “upper”, “lower”, “top”, “bottom”, distal”, “proximal” and the like are not intended to overly restrict the scope of the herein described system and method, except where expressly indicated.
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 can include blood, plasma, red blood cells, serum and suspensions 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 electrical components of the analyte measurement system 100 can be disposed on, for example, a printed circuit board situated within the housing 11 and forming the DMU 140 of the herein described system 100.
The analytical test strip 24 can be in the form of an electrochemical glucose test strip, of which various embodiments are described below. The test strip 24 is defined by a nonporous substrate that can include one or more working electrodes. More specifically a typical analytical test strip 24 can also include a plurality of electrical contacts, where each electrode can be in electrical communication with at least one electrical contact. The strip port connector 104 can be configured to electrically interface to the electrical contacts, using a plurality of electrical contacts arranged on a PCB, and form electrical communication with the electrodes. A usual configuration of a strip port connector includes a set of prongs that are configured to engage the electrical contacts of an inserted test strip. As discussed herein and in contrast to previously known strip port connectors, the strip port connector 104 (shown only schematically in
In terms of additional background, the test strip 24 can include a reagent layer that is disposed over one or more electrodes within the test strip 24, such as a working 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 in the applied sample 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 of the sample. The working electrode can then be used to apply the preset voltage waveform to the sample and to measure a concentration of the reduced mediator in the form of an electric current. In turn, microcontroller 122 can convert the current magnitude into a glucose concentration for presentation on the display 14. An exemplary analyte measurement device 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” and in International Patent Application Publication No. WO 2012/091728 A1 entitled “Systems and Methods for High Accuracy Analyte Measurement”, which are incorporated by reference herein as if fully set forth in this application.
A display module 119, which may include a display processor and display buffer, is electrically connected to the processing unit 122 over the electrical interface 123 for receiving and displaying output data, and for displaying user interface input options under control of processing unit 122. The structure of the user interface, such as menu options, is stored in the user interface module 103 and is accessible by processing unit 122 for presenting menu options to a user of the blood glucose measurement system 100. An audio module 120 includes a speaker 121 for outputting audio data received or stored by the DMU 140. Audio outputs can include, for example, notifications, reminders, and alarms, or may include audio data to be replayed in conjunction with display data presented on the display 14. Such stored audio data can be accessed by processing unit 122 and executed as playback data at appropriate times. A volume of the audio output is controlled by the processing unit 122, and the volume setting can be stored in settings module 105, as determined by the processor or as adjusted by the user. User input module 102 receives inputs via user interface buttons 16 which are processed and transmitted to the processing unit 122 over the electrical interface 123. The processing unit 122 may have electrical access to a digital time-of-day clock connected to the printed circuit board for recording dates and times of blood glucose measurements, which may then be accessed, uploaded, or displayed at a later time as necessary.
The display 14 can alternatively include a backlight whose brightness may be controlled by the processing unit 122 via a light source control module 115. Similarly, the user interface buttons 16 may also be illuminated using LED light sources electrically connected to processing unit 122 for controlling a light output of the buttons. The light source module 115 is electrically connected to the display backlight and processing unit 122. Default brightness settings of all light sources, as well as settings adjusted by the user, are stored in a settings module 105, which is accessible and adjustable by the processing unit 122.
A memory module 101, that includes but is not limited to volatile random access memory (“RAM”) 112, a non-volatile memory 113, which may comprise read only memory (“ROM”) or flash memory, and a circuit 114 for connecting to an external portable memory device, for example, via a USB data port, is electrically connected to the processing unit 122 over a electrical interface 123. External memory devices may include flash memory devices housed in thumb drives, portable hard disk drives, data cards, or any other form of electrical storage devices. The on-board memory can include various embedded applications and stored algorithms in the form of programs executed by the processing unit 122 for operation of the analyte measurement device 10. On board memory can also be used to store a history of a user's blood glucose measurements including dates and times associated therewith. Using the wireless transmission capability of the analyte measurement device 10 or the data port 13, as described below, such measurement data can be transferred via wired or wireless transmission to connected computers or other processing devices.
A wireless module 106 may include transceiver circuits for wireless digital data transmission and reception via one or more internal digital antennas 107, and is electrically connected to the processing unit 122 over electrical interface 123. The wireless transceiver circuits may be in the form of integrated circuit chips, chipsets, programmable functions operable via processing unit 122, or a combination thereof. Each of the wireless transceiver circuits is compatible with a different wireless transmission standard. For example, a wireless transceiver circuit 108 may be compatible with the Wireless Local Area Network IEEE 802.11 standard known as WiFi. Transceiver circuit 108 may be configured to detect a WiFi access point in proximity to the analyte measurement device 10 and to transmit and receive data from such a detected WiFi access point. A wireless transceiver circuit 109 may be compatible with the Bluetooth protocol and is configured to detect and process data transmitted from a Bluetooth beacon in proximity to the analyte measurement device 10. A wireless transceiver circuit 110 may be compatible with the near field communication (“NFC”) standard and is configured to establish radio communication with, for example, another NFC compliant device in proximity to the analyte measurement device 10. A wireless transceiver circuit 111 may comprise a circuit for cellular communication with cellular networks and is configured to detect and link to available cellular communication towers.
As shown in
The PCB 208 includes a plurality of electrical contacts 210 that are mounted thereto. More specifically, the electrical contacts 210 can be spaced apart in an array disposed on the PCB 208. By way of example, the array can include a single linear one dimensional array of spaced contacts that are disposed in a direction which is orthogonal to the test strip insertion direction. One suitable form of connector is manufactured under the tradename of Zebra connectors manufactured by Fujipoly, among others although other connector designs having pluralities of spaced electrical contacts may also be utilized. For example and alternatively, the plurality of electrical contacts can be formed from a planar section of insulating material such as silicone having a series of holes disposed in rows and columns (i.e., a two dimensional plurality of openings), each hole being filled with an electrically conductive material.
Referring to
Various means can be utilized for moving the PCB 208 and array of electrical contacts 210 from the first position to the second position. For example and according to one version, a mechanical mechanism (not shown) employing a cam could be utilized having an actuable switch or other control on the housing of the meter. In another version, a light sensor (not shown) can detect the presence of the strip in the port 204 and automatically cause the PCB 208 to be moved toward the test strip 216 along the supports 206 using an electrically powered mechanism, such as a solenoid or motor (not shown). It will be readily apparent that other suitable techniques for enabling this movement can be contemplated. Since the test strip 216 is releasably attached to the test meter, the mechanism is enabled to move the PCB 208 along the supports 206 and electrical contacts 210 to the initial position of
In another version, the recess of the test strip connector can include a ramped shape (not shown) that causes a inserted test strip to bring the test strip 216 and the electrical contacts into direct engagement with the electrical contacts 210 of the strip port connector 200.
Though a one dimensional linear array of contacts 210 is shown in
Irrespective of the design of the formed array, the principle of operation is similar to that previously described according to
In order for the test meter to identify the specific test strip that has been inserted, a potential such as in the order of 10 mV to 5V, is applied to the electrical contacts 304 of the connector and current that is generated is measured across adjacent contacts to identify the presence of any short circuits in the array 302 of contacts 304. More specifically, an identified short in the array 302 indicates a physical connection between electrical contacts 304, 308 wherein a specific pattern, such as shown in
After a strip port connector has established a connection with the electrical contacts 508 of the test strip 500, the pattern of the test strip electrical contacts 508 can be programmed or stored into memory of the analyte measurement device (e.g., test meter). When a test strip with the same pattern is inserted in the analyte measurement device, the analyte measurement device can recognize the pattern and activate the appropriate strip port connector electrical contacts. The herein described strip port connector enables electrical contact to be established with a varied number of test strips having different or disparately located contact areas in which each inserted test strip can be identified prior to testing and in which the test meter can be suitably configured for performing the testing. For example and when a new test strip model is released, the pattern of the electrical contact areas of the test strip can be determined and stored or otherwise used by the analyte measurement device for testing of the inserted test strip and additional test strips from the same or different family (design).
In all of the above examples illustrated in
At block 604, the pattern of electrical contacts or contact areas of the inserted test strip is determined such as by physically moving the array of electrical contacts of the strip port connector into direct contact with the test strip. In an embodiment, the pattern of electrical contacts is determined by identifying applying an appropriate voltage across the PCB and determining by measuring current across the various contacts. The detection of the resulting pattern of contacts identifies the inserted test strip and therefore the appropriate testing protocol for analyte detection.
For purposes of testing, only some of the plurality of electrical contacts of the strip port connector are made active to interact with the corresponding test strip electrical contacts for purposes of analyte detection with regard to an applied sample using addressable switches or the like via control circuitry of the test meter.
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,” ‘subsystem” 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 electrical, 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.
