BLOOD CONTACTING SENSOR

• US 20090149728A1
• Filed: 11/04/2008
• Published: 06/11/2009
• Est. Priority Date: 09/08/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Clark, Kent L., Shah, Rajiv, Hoss, Udo, Enegren, Bradley J., Mastrototaro, John J., Zhang, Yanan, Van Antwerp, Nannette M., Wang, Jenn-Hann
• Granted Patent: US 8,352,011 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 invention provides methods and apparatus for detecting an analyte in blood. The apparatus is particularly suited for bringing a sensor into direct contact with blood in vivo. The apparatus comprises a sensor that detects the presence of an analyte and an assembly means. The assembly means has a sensor end, wherein the sensor end of the assembly means is affixed to the sensor, and the assembly means is adapted for coupling with a venous flow device. By coupling with a venous flow device, the assembly means brings the sensor into direct contact with blood flowing through the venous flow device. Examples of venous flow devices that bring the sensor into direct contact with the blood of a subject include, but are not limited to, intravenous catheters and external blood loops, such as are used in extra corporeal membrane oxygenation or hemodialysis.

Claims

1. An apparatus for detecting an analyte in blood comprising:

a sensor that detects the presence of an analyte, wherein the sensor comprises;

a base layer;

at least three electrodes disposed on the base layer including at least one working electrode;

an enzyme layer disposed upon the working electrode;

an analyte modulating layer disposed on the enzyme layer; and

an assembly having a sensor end and an exterior face, wherein the sensor is affixed to the sensor end of the assembly, and the assembly is adapted for coupling with a venous flow device.

2. The apparatus of claim 1, further comprising a venous flow device coupled to the assembly, the venous flow device having a lumen, wherein the sensor is suspended within the lumen of the venous flow device.

3. The apparatus of claim 2, wherein the venous flow device is an intravenous catheter.

4. The apparatus of claim 2, wherein sensor is suspended within the lumen so that a distal end of the sensor is positioned perpendicular to the flow of blood through the venous flow device.

5. The apparatus of claim 2, wherein the assembly further comprises a side port that is accessible from the exterior face of the assembly and a passage that extends from the exterior face of the assembly to the sensor end of the assembly.

6. The apparatus of claim 1, wherein the assembly comprises a luer lock connector adapted for coupling with a venous flow device.

7. The apparatus of claim 1, wherein the assembly further comprises a septum adapted to receive injections.

8. The apparatus of claim 1, wherein the assembly further comprises a cross connector adapted to receive injections from opposing sides of the assembly.

9. The apparatus of claim 1, wherein the assembly further comprises an alignment member adapted to guide insertion of the sensor into a venous flow device.

10. The apparatus of claim 9, wherein the alignment member comprises a needle having a lumen.

11. The apparatus of claim 10, wherein the needle is removable.

12. The apparatus of claim 1, further comprising an adhesion promoting layer disposed between the enzyme layer and the analyte modulating layer that functions to promote adhesion between the enzyme layer and the analyte modulating layer

13. The apparatus of claim 1, wherein the enzyme layer comprises glucose oxidase.

14. The apparatus of claim 13, wherein the enzyme layer is less than 1 micron in thickness.

15. The apparatus of claim 1, wherein the sensor is coated with a hydrophilic polymer comprising:

an antimicrobial agent or an anticoagulant; and

a polyurethane moiety, an acrylate moiety, a polyester moiety or a cross-linked PEO moiety.

16. A method of introducing a sensor into circulating blood of a subject and monitoring the concentration of an analyte, the method comprising:

contacting a venous flow device with the circulating blood of the subject and introducing an apparatus for detecting an analyte in blood into the venous flow device, the apparatus comprising;

a sensor that detects the presence of an analyte, wherein the sensor comprises;

a base layer;

at least three electrodes disposed on the base layer including at least one working electrode;

an enzyme layer disposed upon the working electrode;

an analyte modulating layer disposed on the enzyme layer; and

an assembly having a sensor end and an exterior face, wherein the sensor is affixed to the sensor end of the assembly.

17. The method of claim 16, wherein the venous flow device comprises an intravenous catheter.

18. The method of claim 16, further comprising monitoring the analyte concentration on a display that is telemetrically coupled to the sensor.

19. The method of claim 18 further comprising monitoring on the display:

a plurality of analyte concentrations; and

a meal or exercise activity that effects the treatment of diabetes.

20. The method of claim 16, wherein the analyte is glucose.