Device with integrated allergy testing

• US 9,554,736 B2
• Filed: 11/29/2012
• Issued: 01/31/2017
• 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.
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/689,301
• Publication Number:
  US 20140187892A1
• Time in Patent Office: 1,524 Days
• US Class Current: 1/1
• 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, the device comprising:

a housing having an outer wall, a proximal end and a distal end;

a first chamber defined by the housing, the first chamber being configured to receive at least some blood withdrawn from a subject;

a second chamber defined by the housing, the second chamber being in fluid communication with the first chamber to receive at least some of the withdrawn blood from the first chamber;

a movable member within the outer wall between the proximal end and the distal end of the housing, the movable member being movable relative to the housing to cause a negative pressure in the second chamber to draw blood from the first chamber into the second chamber;

a test strip held within the second chamber;

a window within the outer wall of the housing and overlapping with the second chamber, the window enabling visual inspection of the test strip; and

a slider coupled to and over the outer wall of the housing, the slider being movable proximally or distally relative to the movable member to release the movable member allowing the movable member to move relative to the housing to cause the negative pressure in 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 substance is an antibody.

3. The device of claim 2, wherein the antibody is of the class IgG, IgA, IgM, or IgE.

4. 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.

5. The device of claim 4, 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.

6. The device of claim 1, wherein the movable member is a flexible dome, the flexible dome being configured to flex radially downward or radially outward relative to the housing, wherein the flexible dome flexes radially outwards to cause the negative pressure in the second chamber to draw blood from the first chamber into the second chamber, and wherein the flexible dome flexes radially downwards to increase pressure within the second chamber.

7. The device of claim 6, wherein the slider is configured to slide between a first position and a second position that is proximal of the first position.

8. The device of claim 7, wherein:

when the slider is in the first position, the slider depresses the flexible dome to flex the flexible dome radially downward.

9. The device of claim 7, wherein the flexible dome flexes radially outwards relative to the housing to cause the negative pressure in the second chamber when the slider is slid from the first position to the second position.

10. The device of claim 6, wherein the flexible dome is thinner at the peak of the flexible dome, and is thicker at the base of the flexible dome to bias the flexible dome radially outwards.

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 within the second chamber.

12. The device of claim 1, further comprising a needle defining an inner lumen that is in fluid communication with the first chamber, the needle being configured to withdraw the blood from the subject.

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

14. The device of claim 1, wherein the slider is configured to slide between a first position and a second position that is proximal of the first position.

15. The device of claim 14, wherein the slider visually indicates the proximal direction.

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

a housing having an outer wall, a proximal end and a distal end;

a chamber defined by the housing, the chamber being configured to receive at least some blood withdrawn from a subject;

a movable member within the outer wall between the proximal end and the distal end of the housing, the movable member being movable relative to the housing to cause a negative pressure in the chamber to draw blood into the chamber;

a test strip held within the chamber;

a window within the outer wall of the housing and overlapping with the chamber, the window enabling visual inspection of the test strip; and

a slider coupled to and over the outer wall of the housing, the slider being movable proximally or distally relative to the movable member to release the movable member and to allow the movable member to move relative to the housing to cause the negative pressure in 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.

17. The device of claim 16, wherein the slider is configured to slide between a first position and a second position that is proximal of the first position.

18. The device of claim 16, wherein the movable member is a flexible dome, the flexible dome being configured to flex radially downward or radially outward relative to the housing, wherein the flexible dome flexes radially outwards to cause the negative pressure in the chamber to draw blood into the chamber, and wherein the flexible dome flexes radially downwards to increase pressure within the chamber.

19. The device of claim 18, wherein the slider is configured to slide between a first position and a second position that is proximal of the first position.

20. The device of claim 19, wherein:

when the slider is in the first position, the slider depresses the flexible dome to flex the flexible dome radially downward.

21. The device of claim 19, wherein the slider visually indicates the proximal direction.

22. A method for allergy detection during catheterization, the method comprising:

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

sliding a slider over and relative to an outer wall of the housing and a movable member to allow the movable member to move relative to the housing without human interaction to cause a negative pressure within a second chamber within the housing of the device to draw at least some of the drawn blood from the first chamber into the second chamber, the movable member being within the outer wall of the housing, and the second chamber holding a test strip that reacts with the substance; and

visually inspecting the test strip through a window within the outer wall of the housing and overlapping with the second chamber 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.

23. The method of claim 22, 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 the movable member of the device, or capillary action of the test strip.