Blood contacting sensor

• US 20060052745A1
• Filed: 09/08/2004
• Published: 03/09/2006
• Est. Priority Date: 09/08/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Hoss, Udo, Enegren, Bradley J., Mastrototaro, John J., Zhang, Yanan, Van Antwerp, Nannette M., Wang, Jenn-Hann, Clark, Kent L.
• Granted Patent: US 7,468,033 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• 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; and

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.

2. The apparatus of claim 1, 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.

3. The apparatus of claim 1, wherein the assembly means further comprises a side port that is accessible from the exterior face of the assembly means and a passage that extends from the exterior face of the assembly means to the sensor end of the assembly means.

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

5. The apparatus of claim 4, wherein the intravenous catheter has a single lumen.

6. The apparatus of claim 4, wherein the intravenous catheter has more than one lumen.

7. The apparatus of claim 6, wherein an opening is provided between the lumens.

8. The apparatus of claim 2, wherein the venous flow device comprises an external blood loop.

9. The apparatus of claim 8, wherein the external blood loop further comprises a septum adapted to receive injections.

10. The apparatus of claim 8, wherein the external blood loop further comprises a cross connector adapted to receive injections from opposing sides of the external blood loop.

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

12. The apparatus of claim 11, wherein the alignment means comprises a needle having a lumen.

13. The apparatus of claim 12, wherein the needle is removable.

14. The apparatus of claim 1, wherein the assembly means comprises a luer lock connector.

15. The apparatus of claim 1, further comprising a medication delivery system, wherein the medication delivery system comprises means for infusing a medication into the venous flow device.

16. The apparatus of claim 15, further comprising a feedback loop, wherein an output from the sensor is communicated to the medication delivery system.

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

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

19. The apparatus of claim 1, wherein the sensor comprises a polyimide coated with a stiffening agent.

20. The apparatus of claim 1, wherein the sensor comprises polyimide film adhered to a glass substrate.

21. The apparatus of claim 1, wherein the sensor is coated with a hydrophilic material.

22. The apparatus of claim 21, wherein the hydrophilic material comprises polyurethane, acrylate, polyester or cross-linked PEO.

23. The apparatus of claim 1, wherein the sensor is coated with an anticoagulant.

24. The apparatus of claim 1, wherein the sensor is coated with an antimicrobial agent.

25. A method of introducing a sensor into the circulating blood of a subject comprising contacting a venous flow device with the circulating blood of the subject and introducing an apparatus of claim 1 into the venous flow device, wherein the sensor contacts the circulating blood of the subject as the blood flows through the venous flow device.

26. The method of claim 25, wherein the venous flow device comprises an external blood loop having a port adapted to receive the apparatus.

27. The method of claim 26, wherein the external blood loop further comprises a second port adapted to receive an alignment means, and wherein the method further comprises introducing an alignment means into the external blood loop from a side opposing the port adapted to receive the apparatus prior to introducing the apparatus.

28. The method of claim 26, wherein the method further comprises introducing an alignment means into the port prior to or simultaneously with introduction of the apparatus.

29. The method of claim 28, wherein the alignment means is removed following introduction of the apparatus.

30. The method of claim 25, wherein the venous flow device comprises an intravenous catheter.