Analyte sensor

• US 8,364,230 B2
• Filed: 03/25/2008
• Issued: 01/29/2013
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Simpson, Peter C., Brister, Mark, Leach, Jacob S.
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US12/055,227
• Publication Number:
  US 20080200791A1
• Time in Patent Office: 1,771 Days
• Field of Search: 600/347, 600/365
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 6/586 Detection of faults or malfunction of the device
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: 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. A device for the detection of at least one analyte in a circulatory system of a host in vivo, comprising:

an apparatus configured for fluid communication with the circulatory system of the host, wherein the apparatus comprises a lumen, an external surface, a first orifice and a second orifice, wherein at least one of the first orifice or the second orifice is configured to couple with a fluid flow device;

at least one analyte sensor disposed within the lumen of the apparatus, wherein the at least one analyte sensor comprises at least one working electrode; and

sensor electronics operably connected to the at least one sensor, wherein the sensor electronics comprise a module configured to detect a fluidics malfunction in the device by monitoring a pattern of signal increases or decreases generated on the at least working electrode.

2. The device of claim 1, wherein the at least one analyte sensor comprises a plurality of sensors, and wherein the apparatus further comprises a plurality of sensor sites, wherein each sensor site of the plurality of sensor sites is configured to receive a sensor of the plurality of sensors.

3. The device of claim 2, wherein at least one of the plurality of sensor sites comprises a breakaway portion configured for insertion of the sensor therethrough, whereby at least a portion of the sensor is disposed within the lumen.

4. The device of claim 3, wherein at least another portion of the sensor is disposed at the external surface.

5. The device of claim 1, wherein the apparatus is a vascular access device comprising an in vivo portion and an ex vivo portion, and wherein the at least one sensor is disposed within the ex vivo portion.

6. The device of claim 1, wherein the apparatus is configured to be disposed outside of the host'"'"'s body.

7. The device of claim 1, wherein the at least one analyte sensor is configured to generate a signal associated with a concentration of an analyte in a sample from the host'"'"'s circulatory system.

8. The device of claim 7, wherein the at least one analyte sensor comprises at least two sensors that are configured to generate signals associated with a concentration of at least one analyte.

9. The device of claim 7, wherein the analyte is selected from the group consisting of glucose, oxygen, lactate, glutamine, succinate, Cytochrome Oxidase, a medicament, and heparin.

10. The device of claim 1, wherein the at least one analyte sensor is configured to generate a signal associated with a property of a sample from the host'"'"'s circulatory system.

11. The device of claim 1, wherein the at least one analyte sensor is disposed above a plane defined by the host'"'"'s skin.

12. The device of claim 1, wherein the at least one sensor is integrally formed within the apparatus.

13. The device of claim 1, wherein the apparatus is a vascular access device comprising an in vivo portion and an ex vivo portion, and wherein the at least one sensor is disposed within the in vivo portion.

14. The device of claim 1, wherein the at least one analyte sensor is screen-printed within the lumen.

15. The device of claim 1, wherein the apparatus is injection molded around the at least one analyte sensor.

16. The device of claim 1, wherein the at least one analyte sensor comprises a first sensor and a second sensor.

17. The device of claim 16, wherein the first sensor comprises an enzymatic electrode and the second sensor comprises a non-enzymatic electrode.

18. The device of claim 1, wherein the apparatus is a fluid coupler, and wherein at least of one of the first orifice or the second orifice is configured to couple with a vascular access device.

19. The device of claim 18, wherein the fluid flow device comprises IV equipment.

20. The device of claim 1, wherein the signal pattern is compared to an expected waveform comprising an upper limit and a lower limit, and wherein the module is configured to detect the fluidic malfunction when the signal is above the upper limit or below the lower limit.

21. The device of claim 1, wherein the module is configured to evaluate the detected fluidics malfunction against a preprogrammed criterion.

22. The device of claim 1, wherein the module is configured to provide at least one of an alert, alarm, or an instruction responsive to detection of the fluidics malfunction.