DEVICE WITH INTEGRATED ALLERGY TESTING

• US 20140187892A1
• Filed: 11/29/2012
• Published: 07/03/2014
• Est. Priority Date: 11/29/2011
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Teleflex Medical Incorporated (Teleflex Incorporated)
• Inventors: Gupta, Nisha, Rowe, David T., Denlinger, Rodney W.
• Granted Patent: US 9,554,736 B2
• Time in Patent Office: Days
• US Class Current: 600/367
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

The disclosure provides an allergy detection system for use during catheterization. The allergy detection system is incorporated into specialized syringes, connectors for use with standard syringes, or can be an independent test module designed for the sole purpose of allergy detection. The detection system features a test strip, such as an immunochromatographic test strip, and a structure to couple the system to a connector, syringe, or a housing, to form an independent test module. The detection system, by way of test strips, is used to detect potential allergic reactions.

Claims

1. A device for testing the presence of a substance in blood, comprising:

a housing defining an inner cavity, the inner cavity configured to receive blood withdrawn from a subject;

a first chamber within the housing, the first chamber configured to receive at least some of the withdrawn blood;

a second chamber in fluid communication with the first chamber, the second chamber configured to receive at least some of the withdrawn blood from the first chamber; and

a test strip held within the second chamber,

wherein a portion of the test strip that contacts the withdrawn blood including the substance in the withdrawn blood is visually distinguishable from a portion of the test strip that does not contact the withdrawn blood.

2. The device of claim 1, wherein the housing is a syringe barrel and wherein the first chamber is defined by the syringe barrel.

4. The device of claim 1, further comprising a syringe comprising a barrel, wherein a proximal end of the device is configured to be coupled to a distal end of the syringe barrel.

5. The device of claim 1, wherein the substance is an antibody.

6. The device of claim 5, wherein the antibody is of the class IgG, IgA, IgM, or IgE.

7. The device of claim 5, wherein the antibody binds to an antimicrobial agent.

8. The device of claim 1,

wherein a portion of the test strip that contacts the withdrawn blood including a first substance is visually distinguishable from a portion of the test strip that contacts the withdrawn blood including a second substance, the first substance being different from the second substance.

9. The device of claim 8, wherein the first substance is an antibody that specifically binds a pathogen and the second substance is an antibody that specifically binds an antimicrobial agent.

10. The device of claim 1, wherein the second chamber comprises a flexible dome, the flexible dome being configured to flex radially downward or radially outward, wherein the flexible dome flexes radially outwards to draw blood out of the first chamber and into the second chamber, and wherein the flexible dome flexes radially downwards to increase pressure within the second chamber.

11. The device of claim 1, further comprising an end-cap in contact with the test strip, wherein the end-cap is configured to stabilize the test strip.

12. The device of claim 1, wherein the second chamber comprises an opening for inserting the test strip.

13. The device of claim 12, further comprising an end-cap configured to seal the opening in the second chamber.

14. The device of claim 1, further comprising a needle defining an inner lumen that is in fluid communication with the inner cavity of the housing, the needle being configured to withdraw blood from a subject, wherein the needle is removably coupled to the housing.

16. The device of claim 1, wherein the test strip is an immunochromatographic test strip.

28. The device of claim 1, further comprising a window within an outer wall of the second chamber, the window allowing visual inspection of the test strip.

29. The device of claim 1, further comprising a wall configured to separate the first chamber from the second chamber.

30. The device of claim 29, further comprising an aperture in the wall configured to allow at least some of the withdrawn blood to pass from the first chamber to the second chamber.

31. The device of claim 4, wherein a distal end of the device is configured to be coupled to a needle.

32. The device of claim 1, wherein a distal end of the housing comprises a coupled that is configured to couple with a hub of a needle.

3. (canceled)

15. (canceled)

17. A device for testing the presence of an antibody in blood, the device comprising:

a housing defining an inner cavity, the inner cavity configured to receive blood withdrawn from a subject;

a chamber within the housing, the chamber configured to receive at least some of the withdrawn blood; and

a test strip held within the chamber,

wherein a portion of the test strip that contacts the withdrawn blood including the antibody is visually distinguishable from a portion of the test strip that does not contact the withdrawn blood.

18. A method for allergy detection during catheterization, comprising:

drawing blood from a subject into a first chamber within a housing of a device, the drawn blood including a substance;

allowing at least some of the drawn blood from the first chamber to enter a second chamber within the housing of the device, the second chamber holding a test strip that reacts with the substance; and

visually inspecting the test strip after the drawn blood in the second chamber has contacted the test strip held in the second chamber, wherein a portion of the test strip that reacts with the substance is visually distinguishable from a portion of the test strip that does not contact the drawn blood.

20. The method of claim 18, wherein drawing the blood from the subject into the first chamber comprises urging the blood into the first chamber by blood pressure of the subject, a vacuum produced by a syringe plunger of the device, a vacuum produced by a flexible dome of the device, or capillary action of the test strip.

19. (canceled)

21-22. -22. (canceled)

23. A system comprising a medical instrument configured to hold blood and a medical device, the medical device comprising:

a housing configured to couple to a needle, wherein the needle is configured to withdraw blood from a subject;

a first chamber in fluid communication with the needle and configured to receive at least some of the withdrawn blood;

a second chamber in fluid communication with the first chamber and configured to receive at least some of the withdrawn blood from the first chamber; and

a test strip held within the second chamber,

wherein a portion of the test strip that contacts the withdrawn blood including a substance in the withdrawn blood is visually distinguishable from a portion of the test strip that does not contact the withdrawn blood.

24. The system of claim 23, wherein the medical device is removably connected to the medical instrument.

25. The system of claim 24, wherein the medical device and the medical instrument are removably connected by a clip, a snap, a lock, or a tab.

26. The system of claim 23, wherein the medical device is permanently connected to the medical instrument, and wherein the medical device and the medical instrument are permanently connected by an adhesive or are integrally molded.

27. The system of claim 23, wherein the medical instrument comprises a syringe, a trocar, a catheter, an introducer, a sheath, a hub, a pump, or a valve.