ANALYTE MONITORING DEVICE AND METHODS
Methods and devices for providing application specific integrated circuit architecture for a two electrode analyte sensor or a three electrode analyte sensor are provided. Systems and kits employing the same are also provided.
This application is a continuation of U.S. patent application Ser. No. 13/671,489, filed Nov. 7, 2012, which claims priority to, and the benefit of, U.S. Provisional Patent Application 61/556,824 filed Nov. 7, 2011, the contents of both of which are hereby incorporated by reference herein in their entirety and for all purposes.
BACKGROUNDThe detection and/or monitoring of glucose levels or other analytes, such as lactate, oxygen, A1C, or the like, in certain individuals is vitally important to their health. For example, the monitoring of glucose is particularly important to individuals with diabetes. Diabetics generally monitor glucose levels to determine if their glucose levels are being maintained within a clinically safe range, and may also use this information to determine if and/or when insulin is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their bodies.
Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and/or cost.
Devices have been developed for the automatic or continuous monitoring of analyte(s), such as glucose, in bodily fluid such as in the blood stream or in interstitial fluid (“ISF”), or other biological fluid. Some of these analyte measuring devices are configured so that at least a portion of the devices are positioned below a skin surface of a user, e.g., in a blood vessel or in the subcutaneous tissue of a user, so that the monitoring is accomplished in vivo.
With the continued development of analyte monitoring devices and systems, there is a need for such analyte monitoring devices, systems, and methods, as well as for processes for manufacturing analyte monitoring devices and systems that are cost effective, convenient, and with reduced pain, provide discreet monitoring to encourage frequent analyte monitoring to improve glycemic control.
SUMMARYIn view of the foregoing, devices, methods and systems for providing electronics for coupling to analyte sensors are provided including, for example, application specific integrated circuit (ASIC) configurations that provide electrical coupling with electrochemical sensors such as, for example, in vivo glucose sensors for continuous monitoring of analytes such as glucose.
These and other objects, features and advantages of the present disclosure will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings.
Before the present disclosure is described in detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure.
The figures shown herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity.
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In certain embodiments, input component 121 of display device 120 may include a microphone and display device 120 may include software configured to analyze audio input received from the microphone, such that functions and operation of the display device 120 may be controlled by voice commands. Display device 120 also includes data communication port 123 for wired data communication with external devices such as remote terminal (personal computer) 170, for example. Display device 120 may also include an integrated in vitro glucose meter, including in vitro test strip port 124 to receive an in vitro glucose test strip for performing in vitro blood glucose measurements.
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Further details and other display embodiments can be found in, e.g., U.S. patent application Ser. Nos. 12/871,901 and 12/807,278, the disclosures of each of which are incorporated herein by reference for all purposes.
After the positioning of on body electronics 110 on the skin surface and analyte sensor 101 in vivo to establish fluid contact with ISF (or other appropriate body fluid), on body electronics 110 in certain embodiments is configured to wirelessly communicate analyte related data (such as, for example, data corresponding to monitored analyte level and/or monitored temperature data, and/or stored historical analyte related data) when on body electronics 110 receives a command or request signal from display device 120. In certain embodiments, data from on body electronics 110 is retrieved using display device 120 or a reader device via a wireless link that operates using a near field reflective communication technique, such as is used in radio frequency identification (RFID) systems. Using such systems, in certain embodiments, analyte measurement from analyte sensor 101 can be obtained by positioning display device 120 within a short range of on body electronics 110, and optionally actuating a button such as input component 121 to initiate data transfer from on body electronics 110 to display device 120.
In certain embodiments, the RFID communication operates at a nominal operating frequency of 13.56 MHz, with minimum antenna input voltage for normal operation at about 2.5 Volts. Data rate for transmit and receive operations between on body electronics 110 and display device 120 may be about 20-30 kbits/second, or about 22-28 kbits/second, or about 26.48 kbits/second (data bits) in certain embodiments.
In certain embodiments, on body electronics 110 may be configured to at least periodically broadcast real time data associated with monitored analyte level which is received by display device 120 when display device 120 is within communication range of the data broadcast from on body electronics 110, i.e., on body electronics 110 does not need a command or request from display device 120 to send information.
In certain embodiments, the received data from on body electronics 110 may be stored (permanently or temporarily) in one or more memory of the display device 120. Referring still to
Data processing module 160 may include components to communicate using one or more wireless communication protocols such as, for example, but not limited to, infrared (IR) protocol, Bluetooth® protocol, Zigbee® protocol, and 802.11 wireless LAN protocol. Additional description of communication protocols including those based on Bluetooth® protocol and/or Zigbee® protocol can be found in U.S. Patent Publication No. 2006/0193375 incorporated herein by reference for all purposes.
In a further aspect, software algorithms for execution by data processing module 160 may be provided to a communication device such as a mobile telephone including, for example, WiFi or Internet enabled smart phones or personal digital assistants (PDAs) as a downloadable application for execution by the downloading communication device. Additional details describing field upgradability of software of portable electronic devices, and data processing are provided in U.S. patent application Ser. Nos. 12/698,124, 12/794,721, 12/699,653, and 12/699,844, and U.S. Provisional Application Nos. 61/359,265 and 61/325,155, the disclosures of each of which are incorporated by reference herein for all purposes.
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In the manner described, in accordance with certain embodiments of the present disclosure, analog front end circuitry configurations are provided to electrically couple to the electrodes of the analyte sensor, and to process the detected sensor signals for further processing. As described above, in certain embodiments, application specific integrated circuits are designed to incorporate the analog front end circuitry to interface with the analyte sensor and also, for subsequent processing of the signals obtained from the analyte sensor for filtering, storage, and/or communication to remote locations or devices such as display device 120 (
Certain embodiments of the present disclosure include an analyte monitoring device comprising an analyte sensor having a plurality of sensor electrodes, the analyte sensor having at least a portion in fluid contact with interstitial fluid under a skin layer, and sensor electronics coupled to the sensor electrodes of the analyte sensor and in signal communication with the analyte sensor, the sensor electronics including analog front end circuitry and programmed, or including programmable logic, to process signals generated by the analyte sensor and received by the analog front end circuitry, the signals generated by the analyte sensor corresponding to a monitored analyte level in the interstitial fluid, wherein the analog front end circuitry of the sensor electronics includes a single offset for calibration of the sensor electronics, and further wherein the analog front end circuitry of the sensor electronics are referenced to a reference potential.
In certain aspects, the analog front end circuitry may be provided with a fixed voltage between a working electrode and a reference electrode of the sensor to reference the analog front end circuitry of the sensor electronics to the reference potential.
In certain aspects, the fixed voltage may include the poise voltage associated with the analyte sensor.
In certain aspects, the fixed voltage may include 40 mV.
In certain aspects, the analyte sensor and the sensor electronics may be included within an integrated housing.
In certain aspects, the integrated housing may be configured to be worn on a skin surface of a patient.
In certain aspects, the analyte sensor may be configured to operate for a period of at least 7 days.
In certain aspects, the analyte sensor may be configured to operate for a period of at least 14 days.
In certain aspects, the sensor electronics may include a data communication component to communicate the processed signals to a remote device.
In certain aspects, the data communication component may include a radio frequency (RF) data communication component.
Certain embodiments include an antenna coupled to the data communication component.
In certain aspects, the antenna may include a loop antenna.
Certain embodiments include a guard trace surrounding the plurality of sensor electrodes of the analyte sensor.
Certain embodiments include an analog-to-digital converter, wherein the analog-to-digital converter is referenced to the same reference potential as the analog front end circuitry of the sensor electronics.
Certain embodiments of the present disclosure include a method comprising positioning at least a portion of an analyte sensor in fluid contact with interstitial fluid under a skin layer, the analyte sensor having a plurality of sensor electrodes, coupling sensor electronics to the sensor electrodes of the analyte sensor, wherein the sensor electronics are in signal communication with the analyte sensor, the sensor electronics including analog front end circuitry, and processing, using the sensor electronics, signals generated by the analyte sensor and received by the analog front end circuitry, the signals generated by the analyte sensor corresponding to a monitored analyte level in the interstitial fluid, wherein the analog front end circuitry of the sensor electronics includes a single offset for calibration of the sensor electronics, and further wherein the analog front end circuitry of the sensor electronics are referenced to a reference potential.
In certain aspects, the analog front end circuitry may be provided with a fixed voltage between a working electrode and a reference electrode of the sensor to reference the analog front end circuitry of the sensor electronics to the reference potential.
In certain aspects, the fixed voltage may include the poise voltage associated with the analyte sensor.
In certain aspects, the fixed voltage may include 40 mV.
In certain aspects, the analyte sensor and the sensor electronics may be included within an integrated housing.
In certain aspects, the integrated housing may be configured to be worn on a skin surface of a patient.
In certain aspects, the analyte sensor may be configured to operate for a period of at least 7 days.
In certain aspects, the analyte sensor may be configured to operate for a period of at least 14 days.
In certain aspects, the sensor electronics may include a data communication component to communicate the processed signals to a remote device.
In certain aspects, the data communication component may include a radio frequency (RF) data communication component.
Certain embodiments include coupling an antenna to the data communication component.
In certain aspects, the antenna may include a loop antenna.
Certain embodiments include surrounding the plurality of sensor electrodes of the analyte sensor with a guard trace.
Certain embodiments include operatively coupling an analog-to-digital converter to the analyte front end circuitry of the sensor electronics, wherein the analog-to-digital converter is referenced to the same reference potential as the analog front end circuitry.
Various other modifications and alterations in the structure and method of operation of the embodiments of the present disclosure will be apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. Although the present disclosure has been described in connection with certain embodiments, it should be understood that the present disclosure as claimed should not be unduly limited to such embodiments. It is intended that the following claims define the scope of the present disclosure and that structures and methods within the scope of these claims and their equivalents be covered thereby.
Claims
1-20. (canceled)
21. An analyte monitoring device, comprising:
- an analyte sensor having a plurality of sensor electrodes including a working electrode, a reference electrode and a counter electrode, the analyte sensor having at least a portion configured to be in contact with fluid under a skin surface, wherein the plurality of sensor electrodes generate at least one signal corresponding to an analyte level in the fluid;
- a first amplifier comprising a first input, a second input and an output, wherein the amplifier is configured such that the first input receives a signal from the working electrode, the second input receives a first reference voltage, and the output produces an output voltage;
- a second amplifier comprising a first input, a second input, and an output, wherein the amplifier is configured such that the first input receives a signal from the reference electrode, the second input receives a second reference voltage, and the output is electrically coupled with the counter electrode;
- at least two guard traces for at least two of the plurality of sensor electrodes; and
- an analog-to-digital converter configured to convert a signal representative of the output voltage to digital form.
22. The device of claim 21, further comprising a charge pump coupled with a power supply, wherein the charge pump is adapted to produce a charge pump voltage that is boosted from a power supply voltage.
23. The device of claim 22, wherein the analog-to-digital converter is powered by the charge pump voltage.
24. The device of claim 22, wherein the first and second amplifiers are biased with the charge pump voltage.
25. The device of claim 22, further comprising a reference generator adapted to generate the first and second reference voltages.
26. The device of claim 25, wherein the reference generator generates the first and second reference voltages from the charge pump voltage.
27. The device of claim 22, further comprising a voltage regulator adapted to receive the charge pump voltage and produce a regulator output voltage.
28. The device of claim 27, wherein the reference generator generates the first and second reference voltages from the regulator output voltage.
29. The device of claim 27, wherein the analog-to-digital converter is powered by the regulator output voltage.
30. The device of claim 27, wherein the first and second amplifiers are biased with the regulator output voltage.
31. The device of claim 21, further comprising a differential amplifier comprising a first input, a second input, and an output, wherein the differential amplifier is configured such that the first input receives a signal from the working electrode, the second input receives the output voltage, and the output is electrically coupled with the analog-to-digital converter.
32. The device of claim 31, further comprising a charge pump coupled with a power supply, wherein the charge pump is adapted to produce a charge pump voltage that is boosted from a power supply voltage, and wherein the differential amplifier is biased by the charge pump voltage.
33. The device of claim 32, wherein the analog-to-digital converter is powered by the power supply voltage.
34. The device of claim 21, further comprising a pre-amplifier adapted to receive the output voltage and provide the signal representative of the output voltage to the analog-to-digital converter.
35. The device of claim 21, wherein the first amplifier is a transimpedance amplifier.
36. The device of claim 21, wherein the second amplifier is a servo amplifier.
37. The device of claim 21, wherein the at least two guard traces comprise a first guard trace for a circuit connection of the working electrode and a second guard trace for a circuit connection of the reference electrode.
38. The device of claim 21, wherein the analyte level is a glucose level.
39. The device of claim 21, wherein a difference exists between the first reference voltage and the second reference voltage, and the difference is a poise voltage for the analyte sensor.
Type: Application
Filed: Apr 24, 2018
Publication Date: Mar 7, 2019
Inventors: Jean-Pierre Cole (Tracy, CA), Martin J. Fennell (Concord, CA)
Application Number: 15/961,448