Source: http://www.google.com/patents/US8000901?dq=inassignee:integral+inassignee:peripherals
Timestamp: 2015-11-27 09:09:30
Document Index: 586509138

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

Patent US8000901 - Transcutaneous analyte sensor - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host....http://www.google.com/patents/US8000901?utm_source=gb-gplus-sharePatent US8000901 - Transcutaneous analyte sensorAdvanced Patent SearchPublication numberUS8000901 B2Publication typeGrantApplication numberUS 12/853,235Publication dateAug 16, 2011Filing dateAug 9, 2010Priority dateAug 1, 2003Fee statusPaidAlso published asUS7774145, US8311749, US8321149, US8915849, US20060222566, US20090192724, US20100305869, US20110231107, US20110257895Publication number12853235, 853235, US 8000901 B2, US 8000901B2, US-B2-8000901, US8000901 B2, US8000901B2InventorsJames H. Brauker, Apurv Ullas Kamath, Paul V. Goode, Mark C. BristerOriginal AssigneeDexcom, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (729), Non-Patent Citations (373), Referenced by (38), Classifications (25), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetTranscutaneous analyte sensor
US 8000901 B2Abstract
1. A device for monitoring a glucose concentration in a host, the device comprising:
a substantially continuous glucose sensor configured to produce sensor data indicative of a glucose concentration in a host; and
instructions configured to cause the processor to determine whether the rate of change is within a range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans; and
instructions configured to allow the processor module to calibrate the sensor data when the rate of change is within the range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans, but not allow the processor module to calibrate the sensor data when the rate of change is outside the range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans.
2. The device of claim 1, wherein the maximum normally sustainable rates of change of glucose in humans is within of a range of about +/−4 mg/dL/min.
3. The device of claim 1, wherein the instructions configured to allow the processor module to calibrate the sensor data comprise instructions configured to match the sensor data with a substantially time corresponding glucose concentration measurement obtained from the in vitro single point glucose monitor.
4. The device of claim 3, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a sensitivity of the substantially continuous glucose sensor determined from the calibration.
5. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a concordance of the sensor data and a substantially time corresponding glucose concentration measurement obtained from the in vitro single point glucose monitor.
6. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a clinical acceptability of a deviation of the sensor data from a substantially time corresponding reference glucose measurement obtained from the in vitro single point glucose monitor and a risk of the deviation based on a glucose value indicated by the sensor data and/or the reference glucose measurement.
7. The device of claim 1, wherein the computer readable memory further comprises instructions configured to use in vitro sensitivity information during the calibration.
8. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate an acceleration of the calibrated sensor data.
This application is a continuation of U.S. application Ser. No. 11/334,876 filed Jan. 18, 2006. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 10/633,367 filed Aug. 1, 2003; and is a continuation-in-part of U.S. application Ser. No. 11/007,920 filed Dec. 8, 2004, which claims priority under 35 U.S.C. �119(e) to U.S. Provisional Application No. 60/528,382 filed Dec. 9, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and is a continuation-in-part of U.S. application Ser. No. 10/991,966 filed Nov. 17, 2004, which claims priority under 35 U.S.C. �119(e) to U.S. Provisional Application No. 60/523,840 filed Nov. 19, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and is a continuation-in-part of U.S. application Ser. No. 11/077,715 filed Mar. 10, 2005, which claims priority under 35 U.S.C. �119(e) to the U.S. Provisional No. 60/587,787 filed on Jul. 13, 2004, U.S. Provisional Application No. 60/587,800 filed Jul. 13, 2004, U.S. Provisional No. 60/614,683 filed Sep. 30, 2004, and U.S. Provisional Application No. 60/614,764 filed Sep. 30, 2004. Each of the above-referenced applications is incorporated by reference herein in its entirety, and each is hereby made a part of this application.
In an embodiment of the first aspect, the computer system further comprises a conversion function module configured to create a conversion function based at least in part on at least one sensor data point, wherein the sensor data point is obtained when the rate of change of the data stream is below a threshold, and wherein the conversion function is configured to convert the sensor data point into a calibrated data point.
In an embodiment of the first aspect, the computer system further comprises a sensor data transformation module configured to convert at least one sensor data point into a calibrated data point, wherein the rate of change of the data stream at the time at which the sensor data point is obtained is below a threshold.
In an embodiment of the first aspect, the computer system further comprises a calibration module configured to form a calibration set based at least in part on at least one matched data pair, the matched data pair comprising a reference data point and a sensor data point, wherein the reference data point and the sensor data point are obtained at substantially corresponding times; and a calibration evaluation module configured to evaluate the matched pair, wherein the calibration evaluation module is configured to prevent the matched data pair from influencing the calibration set if the rate of change of the data stream at the time the sensor data point is obtained is above a threshold.
In an embodiment of the first aspect, the computer system further comprises a clinical module configured to compare a first reference data point to a second reference data point to determine whether the first reference data point is clinically acceptable, wherein the second reference data point is obtained prior to obtaining the first reference data point, and wherein the first reference data point is determined to be clinically acceptable if the difference between the first reference data point and the second reference data point is below a threshold.
In an embodiment of the first aspect, the computer system further comprises a clinical module configured to compare a first sensor data point to a second sensor data point to determine whether the first sensor data point is clinically acceptable, wherein the second sensor data point is obtained prior to obtaining the first sensor data point, and wherein the first sensor data point is determined to be clinically acceptable if the difference between the first sensor data point and the second sensor data point is below a threshold.
In an embodiment of the first aspect, the computer system further comprises a stability module configured to determine whether the sensor data is stable, wherein the sensor data is determined to be stable if the rate of change of the data stream is below a threshold at the time the sensor data is obtained. The analyte can comprise glucose, wherein the data stream comprises measurements indicative of in vivo glucose concentration, and wherein the threshold is at least about 2 mg/dL/min, or least about 4 mg/dL/min.
In an embodiment of the first aspect, the computer system further comprises a user interface, wherein the user interface is configured to request additional reference data when the rate of change of the data stream is above a threshold.
In a second aspect, a device for monitoring glucose concentration in a biological sample of a host is provided, the device comprising a substantially continuous glucose sensor that produces a data stream indicative of a glucose concentration in a host, the data stream comprising a plurality of time spaced sensor data points; an integrated receiver that receives the data stream from the substantially continuous glucose sensor, wherein the integrated receiver comprises a single point glucose monitor configured to receive a biological sample from the host and to measure the concentration of glucose in the sample, the measured glucose concentration comprising a reference data point; a microprocessor; and a computer readable memory comprising instructions configured to cause the microprocessor to process the data stream received from the continuous glucose sensor; instructions configured to cause the microprocessor to determine a rate of change of the data stream from the substantially continuous analyte sensor; and instructions configured to cause the microprocessor to calibrate the data stream using the glucose concentration measured by the single point glucose monitor.
In an embodiment of the second aspect, the reference input module is configured to reject a reference data point obtained when the rate of change of the data stream is above a threshold.
In an embodiment of the second aspect, the device further comprises a data matching module configured to match a reference data point to a sensor data point to form a matched data pair, wherein the reference data point and the sensor data point are obtained at substantially corresponding times, and wherein the rate of change of the data stream is below a threshold at the time the sensor data point is obtained.
In an embodiment of the second aspect, the device further comprises a calibration module configured to form calibration information based at least in part on at least one reference data point and at least one sensor data point, wherein the reference data point and the sensor data point are obtained at substantially corresponding times, and wherein the rate of change of the data stream is below a threshold at the time the sensor data point is obtained.
In an embodiment of the second aspect, the device further comprises a conversion function module configured to create a conversion function based at least in part on at least one sensor data point, wherein the sensor data point is obtained when the rate of change of the data stream is below a threshold, and wherein the conversion function is configured to convert the sensor data point into a calibrated data point.
In an embodiment of the second aspect, the device further comprises a sensor data transformation module configured to convert at least one sensor data point into a calibrated data point, wherein the rate of change of the data stream at the time at which the sensor data point is obtained is below a threshold.
In an embodiment of the second aspect, the device further comprises a calibration module configured to form a calibration set based at least in part on at least one matched data pair, the matched data pair comprising a reference data point and a sensor data point, wherein the reference data point and the sensor data point are obtained at substantially corresponding times; and a calibration evaluation module configured to evaluate the matched pair, wherein the calibration evaluation module is configured to prevent the matched data pair from influencing the calibration set if the rate of change of the data stream at the time the sensor data point is obtained is above a threshold.
In an embodiment of the second aspect, the device further comprises a clinical module configured to compare a first reference data point to a second reference data point to determine whether the first reference data point is clinically acceptable, wherein the second reference data point is obtained prior to obtaining the first reference data point, and wherein the first reference data point is determined to be clinically acceptable if the difference between the first reference data point and the second reference data point is below a threshold.
In an embodiment of the second aspect, the device further comprises a clinical module configured to compare a first sensor data point to a second sensor data point to determine whether the first sensor data point is clinically acceptable, wherein the second sensor data point is obtained prior to obtaining the first sensor data point, and wherein the first sensor data point is determined to be clinically acceptable if the difference between the first sensor data point and the second sensor data point is below a threshold.
In an embodiment of the second aspect, the device further comprises a stability module configured to determine whether the sensor data is stable, wherein the sensor data is determined to be stable if the rate of change of the data stream is below a threshold at the time the sensor data is obtained. The analyte can comprise glucose, wherein the data stream comprises measurements indicative of in vivo glucose concentration, and wherein the predetermined threshold is at least about 2 mg/dL/min, or is at least about 4 mg/dL/min.
In an embodiment of the second aspect, the device further comprises a user interface, wherein the user interface is configured to request additional reference data when the rate of change of the data stream is above a predetermined threshold.
FIGS. 9A to 9C are side views of an applicat