TRANSCUTANEOUS ANALYTE SENSOR

• US 20100223013A1
• Filed: 05/14/2010
• Published: 09/02/2010
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Dobbles, J. Michael, Kamath, Apurv Ullas, Brauker, James
• Granted Patent: US 8,571,625 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 : invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 : comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 : using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 : invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 : Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 : for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/68335 : including release sheets or liners
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 5/72 : Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The 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.

Claims

1. A method for processing sensor data, comprising:

receiving sensor data from a continuous glucose sensor, wherein the sensor data is indicative of a glucose concentration in a host;

receiving reference data from a reference glucose monitor, wherein the reference data is indicative of a glucose concentration in the host;

determining a conversion function based on the sensor data and the reference data, wherein the conversion function comprises a sensitivity value; and

validating the conversion function based on predetermined calibration information, wherein the predetermined calibration information comprises a range of acceptable sensitivity values derived from in vivo testing of at least one other continuous glucose sensor or in vitro testing.

2. The method of claim 1, wherein the range of acceptable sensitivity values is derived from in vitro testing.

3. The method of claim 1, wherein the range of acceptable sensitivity values is derived from in vivo testing of at least one other continuous glucose sensor.

4. The method of claim 1, wherein the range of acceptable sensitivity values is derived from in vitro and in vivo testing of at least one other continuous glucose sensor.

5. The method of claim 1, further comprising converting the sensor data using the conversion function if the sensitivity value is within the range.

6. The method of claim 1, further comprising determining an error if the sensitivity value is outside of the range.

7. The method of claim 6, further comprising requesting additional reference data if an error is determined.

8. The method of claim 6, further comprising adjusting the conversion function if an error is determined.

9. The method of claim 8, wherein the conversion function further comprises a baseline value, and wherein adjusting the conversion function comprises adjusting the baseline value.

10. The method of claim 9, wherein adjusting the baseline value is based on predetermined baseline information.

11. The method of claim 1, wherein the conversion function further comprises a baseline value, and wherein the validating is further based on predetermined baseline information.

12. The method of claim 10, wherein the predetermined baseline information comprises a range of acceptable baseline values derived from in vivo testing of at least one other continuous glucose sensor.

13. A system for processing sensor data, comprising:

a continuous glucose sensor configured to provide sensor data indicative of a glucose concentration in a host; and

a processor module configured to determine a conversion function based on the sensor data and substantially time-corresponding reference data from a reference glucose monitor, wherein the conversion function comprises a sensitivity value, and wherein the processor module is configured to validate the conversion function based on predetermined calibration information, wherein the predetermined calibration information comprises a range of acceptable sensitivity values derived from in vivo testing of at least one other continuous glucose sensor or in vitro testing.

14. The system of claim 13, wherein the range of acceptable sensitivity values is derived from in vitro testing.

15. The system of claim 13, wherein the range of acceptable sensitivity values is derived from in vivo testing of at least one other continuous glucose sensor.

16. The system of claim 13, wherein the range of acceptable sensitivity values is derived from in vitro testing and in vivo testing of at least one other continuous glucose sensor.

17. The system of claim 13, wherein the processor module is further configured to convert the sensor data using the conversion function if the sensitivity value is within the range.

18. The system of claim 13, wherein the processor module is further configured to determine an error if the sensitivity value is outside of the range.

19. The system of claim 18, wherein the processor module is further configured to request additional reference data if an error is determined.

20. The system of claim 18, wherein the processor module is further configured to adjust the conversion function if an error is determined.

21. The system of claim 20, wherein the conversion function further comprises a baseline value, and wherein the processor module is configured to adjust the conversion function by adjusting the baseline value.

22. The system of claim 21, wherein the processor module is configured to adjust the baseline value based on predetermined baseline information.

23. The system of claim 13, wherein the conversion function further comprises a baseline value, and wherein the processor module is further configured to validate the conversion function based on predetermined baseline information.

24. The system of claim 23, wherein the predetermined baseline information comprises a range of acceptable baseline values derived from in vivo testing of at least one other continuous glucose sensor.

25. The system of claim 13, further comprising:

a transmitter unit operably coupled to the glucose sensor, the transmitter unit having a radio frequency transmitter configured to wirelessly transmit sensor data; and

a receiver unit comprising a radio frequency receiver and a display, the radio frequency receiver configured to receive the transmitted sensor data and the display configured to display information based on the transmitted sensor data.

26. The system of claim 25, wherein the processor module is incorporated in the transmitter unit, wherein the processor module is configured to convert the sensor data by applying the conversion function to the sensor data prior to the sensor data being transmitted by the radio frequency transmitter.

27. A system for processing sensor data, comprising:

a continuous glucose sensor configured to provide sensor data indicative of a glucose concentration in a host; and

a processor module configured to determine a conversion function based on the sensor data and substantially time-corresponding reference data from a reference glucose monitor, wherein the conversion function comprises a sensitivity value and a baseline value, and wherein the processor module is configured to validate the conversion function based on predetermined calibration information, wherein the predetermined calibration information comprises a range of acceptable sensitivity values and a range of acceptable baseline values.

28. The system of claim 27, wherein the predetermined calibration information is derived from in vivo testing of at least one other continuous glucose sensor or in vitro testing.