Analyte sensor

• US 8,562,528 B2
• Filed: 11/07/2008
• Issued: 10/22/2013
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Leach, Jacob S., Simpson, Peter C., Yang, Richard C., Brister, Mark
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US12/267,548
• Publication Number:
  US 20090131769A1
• Time in Patent Office: 1,810 Days
• Field of Search: 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 5/14535 for measuring haematocrit
• 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
• 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 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. An integrated sensor system for measuring an analyte in a sample of a host and for fluid infusion into the host, comprising:

an analyte sensor configured and arranged for measuring an analyte concentration in a biological sample of a circulatory system of a host;

a tubing assembly comprising tubing that is configured to be in fluid communication with a vascular access device configured to be in fluid communication with the circulatory system of the host;

a flow control device configured to regulate exposure of the analyte sensor to the biological sample and to a reference solution according to a flow profile, wherein the flow control device comprises a valve, and wherein the valve is configured and arranged with a gravity flow position and a controlled flow position; and

a free-flow mitigation device comprising a spring clip occluder located on the tubing assembly

wherein the system is configured and arranged such that the free-flow mitigation device precludes flow responsive to at least one of power removal, loss of power to the system, and loss of power to the flow control device.

2. The system of claim 1, wherein the system is configured such that the analyte sensor is flushed by the reference solution when the valve is in the gravity flow position.

3. The system of claim 2, wherein the gravity flow position comprises a first flow rate of the solution, wherein the controlled flow position comprises a second flow rate of the solution, and wherein a ratio of the first flow rate to the second flow rate is at least about 10:

1.

4. The system of claim 3, wherein the gravity flow position has a flow rate of at least about 600 ml/hr.

5. The system of claim 3, wherein the controlled flow position has a flow rate of from about 0.5 ml/hr to about 4 ml/hour.

6. The system of claim 1, wherein the valve and the tubing assembly are configured and arranged such that the tubing is in a stretched state after installation of the tubing in the valve.

7. The system of claim 1, wherein the valve is configured and arranged to preclude tubing installation when the valve is in the controlled flow position.

8. The system of claim 1, wherein the valve and tubing assembly are configured and arranged to releasably interlock such that a portion of the valve mechanically interlocks with a portion of the tubing assembly.

9. The system of claim 1, wherein the vascular access device and the tubing assembly are configured and arranged to substantially preclude rotational movement between the vascular access device and the tubing assembly when engaged.

10. The system of claim 1, wherein the system is configured for electronic control of the free-flow mitigation device.

11. The system of claim 1, further comprising an electronic solenoid associated with the flow control device, wherein the electronic solenoid provides electronic control of the free-flow mitigation device.

12. The system of claim 1, wherein the system is configured and arranged such that the free-flow mitigation device is controlled at least in part by the flow profile.

13. The system of claim 1, further comprising an intravenous bag containing a reference solution, wherein the reference solution has a known analyte concentration.

14. The system of claim 1, wherein the analyte sensor is configured to measure at least one 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.