Method for detecting an analyte in blood

• US 8,600,470 B2
• Filed: 09/15/2011
• Issued: 12/03/2013
• Est. Priority Date: 09/08/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Van Antwerp, Nannette M., Hoss, Udo
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/233,338
• Publication Number:
  US 20120004524A1
• Time in Patent Office: 810 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/347
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Abstract

The methods and apparatus for detecting an analyte in blood are useful for detecting an analyte in tissue of a subject. The apparatus comprises a sensor, which comprises an elongated conductive material having a protrudent end, the protrudent end comprising an electrode that detects the presence of an analyte; a substrate affixed to the conductive material; and a support having an external surface, a proximal end, and a distal end. The conductive material is positioned on the support and the protrudent end of the conductive material protrudes beyond the distal end of the support. Optionally, the sensor is suspended within the lumen of a venous flow device. Typically, only a portion of the sensor is suspended within the lumen of the venous flow device, said portion comprising the protrudent end of the conductive material. Alternatively, the conductive material is positioned on the external surface of the intravenous infusion catheter.

Claims

1. A method of detecting an analyte in a tissue of a subject comprising contacting the tissue of the subject with an apparatus comprising:

an elongated conductive material having a protrudent end, the protrudent end comprising a sensor that detects the presence of an analyte, wherein the sensor comprises a plurality of layers including;

a base layer;

a plurality of electrodes disposed on the base layer;

an analyte sensing layer disposed upon the electrode;

an analyte modulating layer disposed on the analyte sensing layer; and

a support having a proximal end and a distal end;

wherein the conductive material is positioned on the support and the protrudent end of the conductive material comprising the sensor that detects the presence of an analyte;

(a) protrudes beyond the distal end of the support; and

(b) is positioned on the support in combination with a venous flow device and assembly means, wherein the sensor is affixed to a sensor end of the assembly means and the assembly means is adapted for coupling with the venous flow device.

2. The method of claim 1 wherein:

the plurality of electrodes disposed on the base layer include a working electrode, a counter electrode, and a reference electrode,

the analyte sensing layer comprises glucose oxidase; and

the analyte sensing layer is disposed upon the working electrode.

3. The method of claim 1 wherein the support further comprises an intravenous infusion catheter having a lumen and an external surface.

4. The method of claim 3 wherein the protrudent end of the conductive material comprising the sensor that detects the presence of an analyte is positioned on the external surface of the intravenous infusion catheter.

5. The method of claim 1, wherein the venous flow device comprises an external blood loop.

6. The method of claim 5, wherein the external blood loop further comprises a septum adapted to receive injections.

7. The method of claim 1, wherein the sensor comprises a hydrophilic coating, wherein the coating swells and forms a gel upon contact with a wet environment.

8. The method of claim 7, wherein the coating achieves a swell volume upon contact with a wet environment that is of at least two times the thickness of the coating in a dry environment.

9. The method of claim 2, further comprising:

a cover layer disposed on the analyte modulating layer and having an aperture, wherein the aperture is formed in the cover layer so as to expose the working electrode disposed at the distal end of the support to the tissue of the subject.

10. The method of claim 9, wherein the reference electrode is disposed on the support at a location relative to the aperture that is selected to avoid reference electrode exposure to the tissue of the subject.

11. The method of claim 1, wherein the sensor exhibits a flexibility that is sufficient to permit threading of the sensor through a venous flow device or a blood vessel.

12. The method of claim 1, further comprising an external coating disposed on the sensor, wherein the external coating comprises an anticoagulant, anti-inflammatory or antimicrobial agent.

13. A method of detecting an analyte in a tissue of a subject comprising:

(i) contacting a venous flow device with a tissue of the subject; and

(ii) coupling with the venous flow device an apparatus comprising;

an elongated conductive material having a protrudent end, the protrudent end comprising a sensor that detects the presence of an analyte, wherein the sensor comprises a plurality of layers including;

a base layer;

an electrode disposed on the base layer;

an analyte sensing layer; and

a support having a proximal end and a distal end;

wherein the conductive material is positioned on the support and the protrudent end of the conductive material comprising the sensor that detects the presence of an analyte;

(a) protrudes beyond the distal end of the support; and

(b) is positioned on the support in combination with the venous flow device and an assembly means, wherein the sensor is affixed to a sensor end of the assembly means and the assembly means is adapted for coupling with the venous flow device.

14. The method of claim 13 wherein the analyte is glucose, lactate or an amino acid.

15. The method of claim 13 wherein the tissue is circulating blood of the subject.

16. The method of claim 13 wherein the support further comprises an intravenous infusion catheter having a lumen and an external surface.

17. The method of claim 16 wherein the protrudent end of the conductive material comprising the sensor that detects the presence of an analyte is positioned on the external surface of the intravenous infusion catheter.

18. The method of claim 13, wherein the venous flow device comprises an external blood loop.

19. The method of claim 18, wherein the external blood loop further comprises a port adapted to receive an alignment means.

20. The method of claim 13, further comprising introducing an alignment means into the external blood loop from a side opposing the assembly means prior to coupling the apparatus with the venous flow device.