Reconfigurable measurement system
11598763 · 2023-03-07
Assignee
Inventors
Cpc classification
A61B5/0024
HUMAN NECESSITIES
G16H10/60
PHYSICS
G16H40/40
PHYSICS
A61B5/6898
HUMAN NECESSITIES
A61B5/72
HUMAN NECESSITIES
International classification
G16H40/40
PHYSICS
G16H10/60
PHYSICS
Abstract
A system for measuring health data includes a measurement device. The measurement device includes at least one measurement interface to receive a first fluid sample, a processor to measure one or more first characteristics of the first fluid sample, and at least one memory device to store first data. The processor reads the first data and measures the one or more first characteristics of the first fluid sample according to the first data. The at least one memory device also stores second data. The processor reads the second data instead of the first data to reconfigure the measurement device and measures one or more second characteristics of a second fluid sample according to the second data. An external processing device may be communicatively coupled to the measurement device and may execute a healthcare application that communicates with the measurement device and may be employed to reconfigure the measurement device.
Claims
1. A system for measuring health data, comprising: a measurement device including: at least one measurement interface configured to receive a first fluid sample and a second fluid sample; at least one processor configured to measure a first characteristic of the first fluid sample received by the at least one measurement interface and a second characteristic of the second fluid sample received by the at least one measurement interface, the first characteristic relating to a blood glucose measurement, the second characteristic relating to an A.sub.1c measurement, a coagulation measurement, or a cholesterol measurement; at least one memory device configured to store firmware, first algorithm data, and second algorithm data, the first algorithm data including instructions for obtaining the first characteristic from the first fluid sample, the second algorithm data including instructions for obtaining the second characteristic from the second fluid sample, the first algorithm data and from the second algorithm data, wherein the firmware is configured to interface with various sensors on the measurement device as instructed by one of the first algorithm data or the second algorithm data for obtaining one of the first characteristic or the second characteristic; a wireless microcontroller configured to receive and send communications to an external computing device; the external computing device comprising an external device memory and at least one external device processor, the at least one external device processor executing an application providing a user interface to a user for remotely controlling operation of the measurement device, wherein responsive to receiving a first user selection from the external computing device to measure the first characteristic of the first fluid sample via the wireless microcontroller, the external computing device transmits the first algorithm data to the measurement device and the at least one processor executes the firmware with the first algorithm data to measure the first characteristic of the first fluid sample, and wherein responsive to receiving a second user selection from the external computing device to measure the second characteristic of the second fluid sample via the wireless microcontroller, the external computing device transmits the second algorithm data to the measurement device and the at least one processor executes the firmware with the second algorithm data instead of the first algorithm data to reconfigure the measurement device to measure the second characteristic of the second fluid sample.
2. The system of claim 1, wherein the measurement device further includes an analog front end coupled to the at least one measurement interface and the at least one processor, the first algorithm data including a first measurement sequence with instructions for obtaining a first raw measurement signal from the first fluid sample, and the second algorithm data including a second measurement sequence with instructions for obtaining a second raw measurement signal from the second fluid sample, the at least one measurement interface being configured to obtain the first raw measurement signal based on the first fluid sample according to the first measurement sequence, the analog front end being configured to receive the first raw measurement signal from the at least one measurement interface according to the first measurement sequence, and when the measurement device is reconfigured, the at least one measurement interface being configured to obtain the second raw measurement signal based on the second fluid sample according to the second measurement sequence, the analog front end being configured to receive the second raw measurement signal from the at least one measurement interface according to the second measurement sequence, the instructions for obtaining the first raw measurement signal from the first fluid sample being different than the instructions for obtaining the second raw measurement signal from the second fluid sample.
3. The system of claim 2, wherein the first algorithm data includes a first calculation sequence with instructions for converting the first raw measurement signal to a first measurement value, and the second algorithm data includes a second calculation sequence with instructions for converting the second raw measurement signal to a second measurement value, the at least one processor being configured to convert the first raw measurement signal to the first measurement value according to the first calculation sequence, and when the measurement device is reconfigured, the at least one processor being configured to convert the second raw measurement signal to the second measurement value according to the second calculation sequence, the instructions for converting the first raw measurement signal to the first measurement value being different than the instructions for converting the second raw measurement signal to the second measurement value.
4. The system of claim 1, wherein the at least one memory device is further configured to store at least one of software, program parameters, calibration data, or lookup tables.
5. The system of claim 1, further comprising an ftfl external processing device configured to be communicatively coupled to the measurement device and to execute a healthcare application that communicates with the measurement device.
6. The system of claim 5, wherein the ftfl external processing device and the measurement device are wirelessly coupled.
7. The system of claim 5, wherein the ftfl external processing device is a smart device.
8. The system of claim 5, wherein the healthcare application communicates the first algorithm data or the second algorithm data for storage on the at least one memory device of the measurement device.
9. The system of claim 8, wherein the ftfl external processing device is coupled to an external data source via a network, the external data source communicating the first algorithm data or the second algorithm data to the healthcare application for further communication to the measurement device.
10. The system of claim 4, wherein the measurement device communicates the first characteristic or the second characteristic to the application for display on a display of the external computing device.
11. The system of claim 2, further comprising an external processing device configured to be communicatively coupled to the measurement device and to execute a healthcare application that communicates with the measurement device, the measurement device sending the first raw measurement signal and the second raw measurement signal to the healthcare application, the external processing device storing a first calculation sequence and a second calculation sequence, the healthcare application converting the first raw measurement signal to a first measurement value according to the first calculation sequence and converting the second raw measurement signal to a second measurement value according to the second calculation sequence, and the healthcare application displaying the first measurement value and the second measurement value on a display of the external processing device.
12. The system of claim 3, further comprising an external processing device configured to be communicatively coupled to the measurement device and to execute a healthcare application that communicates with the measurement device, the measurement device sending the first measurement value and the second measurement value to the healthcare application, and the healthcare application displaying the first measurement value and the second measurement value on a display of the external processing device.
13. The system of claim 1, wherein the at least one measurement interface includes a plurality of measurement interfaces, and the measurement device is configured to receive a fluid sample via any one of the plurality of measurement interfaces.
14. The system of claim 13, wherein the first algorithm data configures the measurement device to receive the first fluid sample via one of the plurality of measurement interfaces and the second algorithm data configures the measurement device to receive the second fluid sample via another of the plurality of measurement interfaces.
15. The system of claim 13, wherein the plurality of measurement interfaces includes an electrochemical measurement interface and an optical measurement interface.
16. The system of claim 13, wherein one or more of the plurality of measurement interfaces is reconfigurable to receive fluid samples for at least one of the blood glucose measurement, the A1c measurement, the coagulation measurement, or the cholesterol measurement.
17. The system of claim 1, wherein the at least one measurement interface is a single measurement interface that receives both the first fluid sample and the second fluid sample.
18. The system of claim 1, wherein the first characteristic cannot be obtained using the second algorithm data and the second characteristic cannot be obtained using the first algorithm data.
19. A system for measuring health data, comprising: an external processing device including: at least one external processor; an external memory device storing a measurement sequence and a calculation sequence; and a reconfigurable measurement device communicatively coupled to the external processing device, the reconfigurable measurement device including: a measurement interface configured to obtain a fluid sample via a test sensor; a measurement memory device storing firmware and being configured to receive the measurement sequence from the external memory device of the external processing device in response to a user selection to measure a characteristic of the fluid sample, wherein the firmware is configured to interface with the test sensor as instructed by the measurement sequence from the external memory device of the external processing device; wherein the user selection is received at the external processing device; and at least one measurement processor configured to (i) read the measurement sequence from the measurement memory device of the reconfigurable measurement device, (ii) execute the firmware with the measurement sequence to obtain a raw measurement signal from the measurement interface based on the fluid sample received by the test sensor and (iii) cause the raw measurement signal to be transmitted to the external processing device, wherein the external memory device of the external processing device is configured to receive the raw measurement signal from the reconfigurable measurement device, and wherein the at least one external processor of the external processing device is configured to (i) read the calculation sequence from the external memory device of the external processing device, and (ii) execute the calculation sequence to convert the raw measurement signal to a measurement value of the characteristic of the fluid sample.
20. A system for measuring health data, comprising: an external processing device including: at least one processor; and a memory device storing instructions for: a first measurement sequence that includes instructions for: obtaining a first raw measurement signal, a first calculation sequence that includes instructions for converting the first raw measurement signal to a measurement value of a first characteristic, a second measurement sequence that includes instructions for obtaining a second raw measurement signal by a second test sensor via firmware, the instructions for obtaining the first raw measurement signal being different than the instructions for obtaining the second raw measurement signal, and a second calculation sequence that includes instructions for converting the second raw measurement signal to a measurement value of a second characteristic, the instructions for converting the first raw measurement signal to the measurement value of the first characteristic being different than the instructions for converting the second raw measurement signal to the measurement value of the second characteristic; and a reconfigurable measurement device configured to be communicatively coupled to the external processing device, the reconfigurable measurement device including: a measurement interface configured to receive (i) a first fluid sample via a first test sensor at a first time and (ii) a second fluid sample via the second test sensor at a second time after the first time; a measurement memory device storing the firmware; and a processor, wherein the firmware is configured to interface with the second test sensor as instructed by the second measurement sequence, wherein in response to a first user selection for a measurement value of the first characteristic received at the external processing device: the measurement memory device of the reconfigurable measurement device is configured to receive and store the first measurement sequence and the first calculation sequence from the memory device of the external processing device, and sample received by the measurement interface and convert the first raw measurement signal to the measurement value of the first characteristic of the first fluid sample received by the measurement interface, the first characteristic relating to a blood glucose measurement, and wherein in response to a second user selection for a measurement value of the second characteristic received at the external processing device: the measurement memory device of the reconfigurable measurement device is configured to receive and store the second measurement sequence and the second calculation sequence from the memory device of the external processing device, and the processor of the reconfigurable measurement device is configured to (i) read the second measurement sequence and the second calculation sequence from the measurement memory device of the reconfigurable measurement device, (ii) execute the firmware as instructed by the second measurement sequence and the second calculation sequence to obtain the second raw measurement signal from the second fluid sample received by the measurement interface and convert the second raw measurement signal to the measurement value of the second characteristic of the second fluid sample received by the measurement interface, the second characteristic relating to an A1c measurement, a coagulation measurement, or a cholesterol measurement.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(6) To address the limitations of using a hardcoded measurement device, embodiments of the present invention employ a measurement device that can be easily reconfigured to use a selected measurement sequence, calculation sequence, and/or other data that determines how the measurement device operates. In some cases, the measurement device may be reconfigured to use a measurement sequence or a calculation sequence that includes updated instructions, e.g., with bug fixes or enhancements. Advantageously, the measurement device can be reconfigured to conduct a plurality of chemistry measurements, i.e., to support multiple different algorithms as well as measurement of different types of health data (blood glucose, A.sub.1C, cholesterol, coagulation (PT/INR), etc.).
(7) Referring to
(8) The analog front end 102 is coupled to the at least one measurement interface 103, which includes hardware to receive a fluid sample directly or indirectly. In some embodiments, for example, the measurement device 100 measures the concentration of an analyte in the fluid sample. The fluid sample may include, for example, a whole blood sample, a blood serum sample, a blood plasma sample, other body fluids like ISF (interstitial fluid), saliva, and urine, as well as non-body fluids. Analytes that may be analyzed include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A.sub.1C, fructose, lactate, or bilirubin. In general, aspects of the present invention may be employed to measure one or more characteristics of a sample, such as analyte concentration, enzyme and electrolyte activity, antibody titer, etc.
(9) In some embodiments, the at least one measurement interface 103 includes a port that receives a test sensor (not shown) configured to receive the fluid sample directly. For example, a user may employ a lancing device to pierce a finger or other area of the body to produce a blood sample at the skin surface. The user may then collect this blood sample by placing the test sensor into contact with the sample. The test sensor contains a reagent which reacts with the sample to indicate the concentration of an analyte in the sample. In engagement with the test sensor, the at least one measurement interface 103 allows the reaction to be measured by the analog front end 102.
(10) In some cases, the test sensor may be an electrochemical test sensor. An electrochemical test sensor typically includes a plurality of electrodes and a fluid-receiving area that receives the fluid sample and includes appropriate reagent(s) (e.g., enzyme(s)) for converting an analyte of interest (e.g., glucose) in a fluid sample (e.g., blood) into a chemical species that produces an electrical current which is electrochemically measurable by the components of the electrode pattern. In such cases, the respective measurement interface 103 allows the analog front end 102 to be coupled to the electrodes of the test sensor, and the analog front end 102 receives a raw signal from the respective measurement interface 103.
(11) In other cases, the test sensor may be an optical test sensor. Optical test sensor systems may use techniques such as transmission spectroscopy, diffuse reflectance, or fluorescence spectroscopy for measuring the analyte concentration. For example, an indicator reagent system and an analyte in a sample of body fluid can be reacted to produce a chromatic reaction, as the reaction between the reagent and analyte causes the sample to change color. The degree of color change is indicative of the analyte concentration in the body fluid. The color change of the sample can be evaluated to measure the absorbance level of a transmitted light. In such cases, the respective measurement interface 103 allows a light to be transmitted to the test sensor and the analog front end 102 to receive a raw optical signal based on the light absorbed by, and reflected from, the fluid sample on the test sensor.
(12) In general, the analog front end 102 is employed to measure characteristic(s) of fluid samples received via the at least one measurement interface 103. It is understood that any number of measurement interfaces 103 (electrochemical, optical, etc.) may be coupled to the analog front end 102 to obtain any type of raw signal that can be translated into any type of measurement data.
(13) Also coupled to the analog front end 102, the main microcontroller 104 controls operative aspects of the measurement device 100 as described further below. For example, the main microcontroller 104 can manage the measurement sequence that determines how the actual electrochemical or optical measurement is performed and how the raw electrochemical or optical signal is obtained by the analog front end 102 from the respective measurement interface 103. In addition, the main microcontroller 104 can determine how the raw signal received by the analog front end 102 is converted with a calculation sequence into a final measurement value (e.g., blood glucose concentration expressed as milligrams per deciliter (mg/dL)) that can be communicated to the user, e.g., by a display. Although the analog front end 102 and the main microcontroller 104 are shown separately in
(14) The memory 105 (e.g., non-volatile memory) may include any number of storage devices, e.g., EEPROM, flash memory, etc. The memory 105 may store measurement data. In addition, the memory 105 may store data, e.g., firmware, software, algorithm data, program parameters, calibration data, lookup tables, etc., that are employed in the operation of other components of the measurement device 100.
(15) The measurement device 100 stores firmware on the memory 105, but according to aspects of the present invention, the firmware does not include a hardcoded algorithm. Instead, the firmware can be executed with any selected algorithm data modifiably stored on the memory 105. In other words, the algorithm can be changed dynamically by selecting different algorithm data stored on the memory 105. As such, the firmware essentially acts as an interpreter of algorithm data selected from the memory 105. Reconfiguring the operation of the measurement device 100 only requires modifying the algorithm data used with the firmware and does not require direct changes to the firmware.
(16) For example, the measurement device 100 can be reconfigured to use a different measurement sequence to obtain a raw signal via the at least one measurement interface 103 and/or a different calculation sequence to process the raw signal according to a different algorithm. Because the memory 105 can store any measurement sequence and/or calculation sequence, this solution enables using a single hardware device to support many different algorithms as well as different types of measurements (blood glucose, A.sub.1C, cholesterol, coagulation (PT/INR), etc.).
(17) For example,
(18) As further illustrated in
(19) The external processing device 200 also includes an antenna 207 that allows the external processing device 200 to communicate wirelessly with the measurement device 100. The measurement device 100 and the external processing device 200, for example, may communicate via Bluetooth® wireless technology. In other embodiments, however, communication may be established by other wireless technologies, including near field communication (NFC), radio frequency (RF), personal area network (PAN), Wi-Fi™ (IEEE 802.11), or the like. Alternatively or additionally, communication may be established by wired communication, e.g., universal serial bus (USB).
(20) The external processing device 200 includes a processor 204 that generally controls aspects of the external processing device 200. For example, the processor 204 provides the processing required to run software applications that reside on the external processing device 200. A memory 205 on the external processing device 200 stores the computer-readable instructions for such software applications. The memory 205 may include non-volatile memory, such as flash memory or the like, to store user software applications.
(21) According to aspects of the present invention, the memory 205 stores a healthcare application 12 that complements the operation of the measurement device 100. For example, if the external processing device 200 is a smart device, e.g., a smart telephone, the healthcare application 12 may be a mobile application that is downloaded onto the smart device by the user. In some embodiments, the healthcare application 12 may store and/or process measurements and/or other data communicated wirelessly from the measurement device 100. For example, the healthcare application 12 may statistically analyze the measurement data and provide advanced display of the statistical analysis on a display 208 of the external processing device 200. Indeed, the healthcare application 12 may provide features that are not available through the measurement device 100 alone, particularly because the external processing device 200 may have greater processing and display capabilities than the measurement device 100.
(22) In some embodiments, the healthcare application 12 is employed in a platform for delivering a variety of healthcare services relating to the use of the measurement device 100. For example, a company selling/distributing the measurement device 100 may provide its customers with the healthcare application 12 to provide features and services that enhance the measurement device 100. Because the measurement device 100 can be communicatively coupled to the external processing device 200, aspects of the present invention can employ applications on the external processing device 200 to expand the use of the measurement device 100. For example, the measurement device 100 can be coupled to the external processing device 200 so that the healthcare application 12 residing on the external processing device 200 can be used to reconfigure the measurement device 100 by providing new or updated data for the operation of the measurement device 100 (e.g., new or updated software, algorithm data, program parameters, calibration data, lookup tables, etc.).
(23) As shown in
(24) Through the network interface 210, the external processing device 200 may access any resource available through the external network 20. In particular, the external processing device 200 can access resources that relate to the operation of the measurement device 100. As shown in
(25) Because the external processing device 200 can be communicatively coupled to resources on an external network 20, the external processing device 200 can generally receive, from any external sources, data that can be used in association with the measurement device 100. Furthermore, because the external processing device 200 can be communicatively coupled to the measurement device 100, the measurement device 100 can in turn receive such data from the external sources. Taking this concept further, the external processing device 200 can be employed to reconfigure the measurement device 100 with data received from external sources, e.g., the healthcare platform server 30, on the external network 20.
(26) For example, the measurement device 100 can be coupled to the external processing device 200 so that the healthcare application 12 on the external processing device 200 can be used to receive new or updated algorithm data from an external source, e.g., the healthcare platform server 30, and to upload this new or updated algorithm data to the memory 105. The operation of the measurement device 100 is then reconfigured when the firmware is executed with the new or updated algorithm data. Allowing a user, e.g., PWD, to connect the measurement device 100 to the external processing device 200 (e.g., wirelessly) and to download data (e.g., algorithm data) requires significantly less manual intervention (e.g., by a manufacturer) to modify the operation of the measurement device 100 in a field upgrade.
(27) Employing the external healthcare application 12, the operation of the measurement device 100 can be reconfigured according to different approaches.
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(29) In the approach 400 of
(30) Because the external processing device 200 can be communicatively coupled to resources on an external network 20, the external processing device 200 can receive the measurement sequence and/or the calculation sequence from an external source, e.g., healthcare platform server 30. Furthermore, because the external processing device 200 can be communicatively coupled to the measurement device 100, the measurement device 100 can in turn receive the measurement sequence and/or the calculation sequence from the external source. According to aspects of the present invention, the measurement device 100 can be reconfigured to employ any measurement sequence and/or any calculation sequence received at any time from an external source, e.g., the healthcare platform server 30, on the external network 20. Thus, the measurement 100 is dynamically reconfigurable according to data received from an external source via the external processing device 200.
(31) In some embodiments, the memory 105 of the measurement device 100 and/or the memory 205 of the external processing device 200 may store the respective measurements sequence and/or the respective calculation sequences for measuring more than one type of health data. For example, as shown in
(32) Any number of the plurality of selectable measurement sequences and calculation sequences can be pre-stored on the memory 105 and/or the memory 205 for immediate availability and selection reconfigure the measurement device 100. These measurement sequences and calculation sequences can be selectively or automatically updated by accessing an external source, e.g., the healthcare platform server 30, via the network interface 210. Alternatively or additionally, any number of the selectable measurement sequences and calculation sequences can be made available on demand by accessing an external source, e.g., the healthcare platform server 30 at the time of reconfiguration.
(33) As described above, the at least one measurement interface 103 on the measurement device 100 may accommodate more than one sensing technology, e.g., electrochemical or optical sensing. Thus, referring to
(34) While the invention is susceptible to various modifications and alternative forms, specific embodiments and methods thereof have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular forms or methods disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention.