Minimally invasive allergy testing system

• US 7,942,827 B2
• Filed: 07/11/2006
• Issued: 05/17/2011
• Est. Priority Date: 07/11/2005
• Status: Active Grant

• Current Assignee: Infotonics Technology Center, Inc.
• Original Assignee: Infotonics Technology Center, Inc.
• Inventors: Zander, Dennis Roland, Mir, Jose
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/995,366
• Publication Number:
  US 20080269635A1
• Time in Patent Office: 1,771 Days
• Field of Search: 600/566
• US Class Current: 600/556
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/444 Evaluating skin marks, e.g. mole, nevi, tumour, scar
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

An allergy testing system includes encapsulated allergens, a microneedle array, and an activation system coupled to the microneedle array and the encapsulated allergens such that the encapsulated allergens are moved into contact with a subject as the microneedle array is moved from a resting position to a penetrating position. A method for determining a degree of reaction to one or more allergens by a patient in a minimally invasive manner is also disclosed. Penetration of one or more microneedles into a skin of the patient is caused. Each of the penetrations into the skin is exposed with an allergen from each of the one or more microneedles. One or more images are captured of each of the penetrations into the skin. Each of the captured images are analyzed to assess the degree of reaction to the specific allergen. Allergic reactivity data is output for at least one of the allergens.

Claims

1. An allergy testing system, comprising:

encapsulated allergens;

a microneedle array;

an activation system coupled to the microneedle array and the encapsulated allergens such that the encapsulated allergens are moved into contact with a subject as the microneedle array is moved from a resting position to a penetrating position;

at least one imaging system configured to capture a plurality of images of penetration sites by the microneedle array;

at least one image sensor;

an imaging optics system which focuses the images of penetration sites on the at least one image sensor;

a second image sensor;

a second imaging optics system which focuses the images of the penetration sites on the second image sensor, wherein the image sensors are used to determine a topographic profile of an allergic reaction; and

an analyzer coupled to the at least one imaging system and configured to analyze the plurality of images to determine a time rate of change of an allergy response to one or more of the allergens.

2. The allergy testing system of claim 1, wherein the microneedle array pierces the encapsulated allergens while moving to the penetrating position.

3. The allergy testing system of claim 1, wherein the encapsulated allergens are coupled between the activation system and the microneedle array, and the encapsulated allergens are released by a pressure exerted on the encapsulated allergens by the activation system as the microneedle array is moved to the penetrating position.

4. The allergy testing system of claim 1, wherein at least one microneedle in the microneedle array comprises a hollow needle.

5. The allergy testing system of claim 1, wherein at least one microneedle in the microneedle array comprises a grooved needle.

6. The allergy testing system of claim 1, wherein at least one microneedle in the microneedle array comprises a corrugated needle.

7. The allergy testing system of claim 1, wherein the microneedle array comprises at least one needle of a first penetration depth and at least one needle of a second penetration depth which is different from the first penetration depth.

8. The allergy testing system of claim 1, wherein the microneedle array comprises at least one needle with a cross-section that is selected from the group consisting of:

square, rectangular, triangular, and circular.

9. The allergy testing system of claim 1, wherein the microneedle array comprises at least one needle with a varying cross-section.

10. The allergy testing system of claim 1, wherein the microneedle array comprises silicon.

11. The allergy testing system of claim 1, wherein the microneedle array comprises glass.

12. The allergy testing system of claim 1, wherein the microneedle array comprises quartz.

13. The allergy testing system of claim 1, wherein the microneedle array comprises a substantially transparent material.

14. The allergy testing system of claim 1, further comprising a package that at least partially encloses the microneedle array and the encapsulated allergens, wherein the microneedle array is moveable within orifices in the package.

15. The allergy testing system of claim 14, further comprising at least one sheet covering the orifices to enclose at least one portion of the microneedle array.

16. The allergy testing system of claim 1, wherein the plurality of images of penetration sites captured by the imaging system comprise continuous images of the penetration sites.

17. The allergy testing system of claim 1, wherein the activation system comprises a mechanical system.

18. The allergy testing system of claim 1, wherein the activation system comprises an electromechanical system.

19. The allergy testing system of claim 1, wherein the activation system comprises a piezoelectric system.

20. The allergy testing system of claim 1, wherein the activation system comprises a micromechanical actuator.

21. The allergy testing system of claim 1, wherein the activation system is configured to be manually actuated.

28. The allergy testing system of claim 1, wherein the imaging system is further configured to capture the one or more images of penetration sites after the microneedle array is moved away from the penetrating position.

29. The allergy testing system of claim 1, wherein the imaging system is further configured to wait for a first period of time after moving to the penetrating position before the capturing of the one or more images.

30. The allergy testing system of claim 1, wherein the allergy testing system is further configured to output reactivity data comprising a topographic indicator of an allergic reaction.

22. An allergy testing system, comprising:

encapsulated allergens;

a microneedle array;

an activation system coupled to the microneedle array and the encapsulated allergens such that the encapsulated allergens are moved into contact with a subject as the microneedle array is moved from a resting position to a penetrating position;

at least one imaging system configured to capture a plurality of images of penetration sites by the microneedle array;

an analyzer coupled to the at least one imaging system and configured to analyze the plurality of images to determine a time rate of change of an allergy response to one or more of the allergens; and

an alignment guide configured to be captured in the plurality of images captured by the at least one imaging system of the penetration sites by the microneedle array;

wherein the analyzer is further configured to utilize the alignment guide in the captured plurality of images for an orientation of the plurality of images as part of the analysis of the plurality of images.

23. The allergy testing system of claim 22, wherein the alignment guide is a barcode near the allergy test area.

24. The allergy testing system of claim 22, wherein the alignment guide comprises a computer recognizable pattern of needle pricks in an image captured by the at least one imaging system of the allergy test area.

25. An allergy testing system, comprising:

encapsulated allergens;

a microneedle array;

an activation system coupled to the microneedle array and the encapsulated allergens such that the encapsulated allergens are moved into contact with a subject as the microneedle array is moved from a resting position to a penetrating position;

at least one imaging system configured to capture a plurality of images of penetration sites by the microneedle array;

an analyzer coupled to the at least one imaging system and configured to analyze the plurality of images to determine a time rate of change of an allergy response to one or more of the allergens;

an attachment band having a test frame, wherein the test frame defines an opening in the attachment band; and

a package, for interfacing with the test frame, the package comprising the microneedle array and the encapsulated allergens;

wherein the imaging system is configured to interface with the test frame.

26. The allergy testing system of claim 25, further comprising:

a first alignment coupling for removeably coupling the package to the test frame; and

a second alignment coupling for removeably coupling the imaging system to the test frame.

27. The allergy testing system of claim 26, wherein the package and the imaging system can be coupled to the test frame at the same time.

31. An allergy testing system, comprising:

a) encapsulated allergens;

b) a microneedle array;

c) an activation system coupled to the microneedle array and the encapsulated allergens such that the encapsulated allergens are moved into contact with a subject as the microneedle array is moved from the resting position to a penetrating position;

d) a package that at least partially encloses the microneedle array and the encapsulated allergens, wherein the microneedle array is moveable by the activation system within orifices in the package;

e) at least one sheet covering the orifices to enclose at least one portion of the microneedle array;

f) at least one imaging system that captures one or more images of penetration sites by the microneedle array, wherein the imaging system comprises;

1) at least one image sensor; and

2) an imaging optics system which focuses the images of penetration sites on the at least one image sensor;

g) an attachment band having a test frame, wherein the test frame defines an opening in the attachment band;

h) a first alignment coupling for removeably coupling the package to the test frame;

i) a second alignment coupling for removeably coupling the at least one imaging system to the test frame; and

j) an analyzer coupled to the imaging system.