ANALYTE SENSOR

• US 20080200791A1
• Filed: 03/25/2008
• Published: 08/21/2008
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Simpson, Peter C., Leach, Jacob S.
• Granted Patent: US 8,364,230 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 a circulatory system of a 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 and the second orifice is configured to couple with a fluid flow device; and

a plurality of sensors disposed within the lumen of the apparatus.

2. The device of claim 1, wherein the apparatus further comprises a plurality of sensor sites, wherein each sensor site is configured to receive a sensor.

3. The device of claim 2, wherein at least one of the sensor sites comprises a breakaway portion configured for insertion of a 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 plurality of sensors are 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 at least one of the sensors 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 at least two of the sensors are configured to generate signals associated with a concentration at least one analyte.

9. The device of claim 8, wherein the two sensors are configured to generate signals associated with a concentration of the analyte.

10. 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.

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

12. The device of claim 11, wherein the property is selected from the group consisting of pH, temperature, pressure, hematocrit, and oxygen tension.

13. The device of claim 1, wherein the sensors are disposed above a plane defined by the host'"'"'s skin.

14. The device of claim 1, wherein the sensors are integrally formed within the apparatus.

15. 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 at least one of the sensors is disposed within the in vivo portion.

16. The device of claim 1, wherein at least one of the sensors is deposited within the lumen.

17. The device of claim 1, wherein at least one of the sensors is screen-printed within the lumen.

18. The device of claim 1, wherein the apparatus is injection molded around at least one of the plurality of sensors.

19. The device of claim 1, wherein at least one of the sensors is received within the lumen.

20. A method for making a device for the detection of a plurality of analytes in a sample from a circulatory system of a host in vivo, the method comprising:

providing a plurality of sensors; and

forming an apparatus about the plurality of sensors, wherein the apparatus comprises a lumen, an external surface, and at least one orifice configured for coupling with a fluid flow device.

21. A method for making a device for the detection of a plurality of analytes in a sample from a circulatory system of a host in vivo, the method comprising:

providing an apparatus comprising a lumen, an external surface, and at least one orifice configured for coupling with a fluid flow device a plurality of sensors; and

forming a plurality of sensors situated at least one of within the apparatus and on the apparatus.

26. The method of claim 21, further comprising washing the sensors with an infusion fluid.

27. The method of claim 21, further comprising calibrating the signal of at least one of the sensors.

22. A method for detecting of a plurality of analytes in a sample from a circulatory system of a host in vivo, the method comprising:

applying an apparatus to a circulatory system of a host, the apparatus comprising a lumen and a plurality of sensors, wherein the at least two sensors are disposed above a plane defined by the skin of the host;

withdrawing a sample from the circulatory system of the host;

contacting the plurality of sensors with the sample; and

generating a signal from each of the sensors.

23. The method of claim 22, further comprising processing the signals from each of the sensors.

24. The method of claim 22, wherein the generating step comprises at least one of electrochemically generating, optically generating, radiochemically generating, physically generating, chemically generating, immunochemically generating, and/enzymatically generating a signal from each of the plurality of sensors.

25. The method of claim 22, further comprising reinfusing the withdrawn sample into the host.