Protrudent analyte sensor

• US 20060293576A1
• Filed: 02/07/2006
• Published: 12/28/2006
• 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, Nanette M., Hoss, Udo
• Granted Patent: US 8,032,198 B2
• Time in Patent Office: Days
• 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. An apparatus for detecting an analyte in tissue of a subject comprising:

a sensor that 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;

wherein the conductive material is positioned on the support and the protrudent end of the conductive material protrudes beyond the distal end of the support.

2. The apparatus of claim 1, wherein the substrate comprises a polyimide film that is about 0.005 to about 0.007 inch in thickness.

3. The apparatus of claim 1, wherein the substrate comprises an insulative layer that covers the conductive material and does not cover the electrode at the protrudent end.

4. The apparatus of claim 1, further comprising an assembly means having a sensor end and an exterior face, wherein the sensor is affixed to the sensor end of the assembly means, and the assembly means is adapted for coupling with a venous flow device.

5. The apparatus of claim 4, further comprising a venous flow device coupled to the assembly means, the venous flow device having a lumen, wherein the sensor is suspended within the lumen of the venous flow device.

6. The apparatus of claim 5, wherein 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.

7. The apparatus of claim 1, wherein the support comprises an intravenous infusion catheter having a lumen.

8. The apparatus of claim 7, wherein the intravenous catheter has a single lumen.

9. The apparatus of claim 7, wherein the intravenous catheter has more than one lumen.

10. The apparatus of claim 7, wherein the conductive material is positioned on the external surface of the intravenous infusion catheter.

11. The apparatus of claim 7, wherein the conductive material is positioned on the lumen of the intravenous infusion catheter.

12. The apparatus of claim 4, wherein the venous flow device comprises an external blood loop.

13. The apparatus of claim 12, wherein the external blood loop further comprises a septum adapted to receive injections.

14. The apparatus of claim 1, wherein the sensor comprises an enzymatic, molecular recognition, optochemical or electrochemical sensor.

15. The apparatus of claim 1, wherein the sensor comprises a glucose sensor.

16. The apparatus of claim 1, wherein the substrate comprises a hydrophilic material.

17. The apparatus of claim 16, wherein the hydrophilic material comprises polyurethane, acrylate, polyester or cross-linked PEO.

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