Analyte sensor

• US 8,449,464 B2
• Filed: 11/07/2008
• Issued: 05/28/2013
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Estes, Michael J., Neale, Paul V., Boock, Robert, Leach, Jacob S., Yang, Richard C., Brister, Mark
• Primary Examiner(s): Mallari, Patricia
• APPLICATION: US 20090131777A1
• Time in patent office: 1663 Days
• Field of Search: 600/309, 600/347, 600/365
• US Class Current: 600/309
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor suction in pumping blood transfusion A61M1/02; infusion containers A61J1/05
• CPC Class Codes: A61M 5/16804 : Flow controllers
• 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: C12Q 1/001 : Enzyme electrodes
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• 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

Systems and methods of use for continuous analyte measurement of a host'"'"'s vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host'"'"'s circulatory system.

Claims

1. A system configured to measure at least one analyte in a host, the system comprising:

a fluid coupler having a first end and a second end, wherein the first end is configured to releasably mate with a connecting end of a catheter that is configured for insertion into a host, and wherein the second end is configured to releasably mate with a tubing assembly;

at least one analyte sensor, wherein at least a portion of the at least one analyte sensor is located in the fluid coupler, wherein the at least one analyte sensor is configured to be exposed to a biological sample, whereby a signal waveform is formed;

a processor operatively connected to the at least one analyte sensor and configured to process sensor data from the at least one analyte sensor, wherein the processor is configured to detect a fluidics malfunction based on a comparison of the signal waveform with an expected waveform.

2. The system of claim 1, wherein the at least one analyte sensor is exposed to the biological sample when a volume of about 300 μ

l or less of the biological sample is drawn back.

3. The system of claim 2, wherein the at least one analyte sensor is exposed to the biological sample when a volume of about 200 μ

l or less of the biological sample is drawn back.

4. The system of claim 1, further comprising the catheter that is configured for insertion into the host, wherein the catheter is 22 gauge or smaller.

5. The system of claim 1, wherein at least a portion of the at least one sensor is disposed in an orientation substantially parallel to a longitudinal axis of the fluid coupler.

6. The system of claim 1, wherein the fluid coupler is configured to provide identification information associated with a flow profile.

7. The system of claim 6, wherein the system is configured to program the flow profile in response to an automatic receipt of the identification information.

8. The system of claim 6, wherein the identification information is provided by a mechanical structure of the fluid coupler.

9. The system of claim 6, wherein the identification information is provided by electronics associated with the fluid coupler.

10. The system of claim 1, wherein the fluid coupler comprises at least a first lumen and a second lumen, and wherein the system is configured and arranged to infuse a fluid into the first lumen of the fluid coupler, and wherein the system is configured and arranged to draw back a biological sample into the second lumen of the fluid coupler.

11. The system of claim 1, wherein the at least one analyte sensor is configured to measure an analyte selected from the group consisting of albumin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, glucose, gamma-glutamyl transpeptidase, hematocrit, lactate, lactate dehydrogenase, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, uric acid, a metabolic marker and a drug.

12. The system of claim 11, wherein the at least one analyte sensor comprises at least three analyte sensors located within the fluid coupler, wherein the three sensors in combination are configured to measure at least three analytes selected from the group consisting of albumin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, glucose, gamma-glutamyl transpeptidase, hematocrit, lactate, lactate dehydrogenase, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, uric acid, a metabolic marker and a drug.

13. The system of claim 11, wherein the at least one analyte sensor comprises at least eight analyte sensors located within the fluid coupler, wherein the eight sensors in combination are configured to measure at least eight analytes selected from the group consisting of albumin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, glucose, gamma-glutamyl transpeptidase, hematocrit, lactate, lactate dehydrogenase, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, uric acid, a metabolic marker and a drug.

14. The system of claim 1, further comprising a flow control device configured to regulate exposure of the at least one sensor to a biological sample and to a solution according to a flow profile.

15. The system of claim 1, wherein the at least one analyte sensor extends from the fluid coupler to the catheter.

16. The system of claim 1, wherein the at least one analyte sensor comprises a first working electrode that comprises an enzyme configured to detect the analyte or an analyte-related compound and a second working electrode that is non-enzymatic.

17. The system of claim 1, wherein comparison of the signal waveform with the expected waveform is performed by quantifying overlap between signal waveform and the expected waveform.