Allergy testing device and method of testing for allergies

• US 8,469,900 B2
• Filed: 11/30/2011
• Issued: 06/25/2013
• Est. Priority Date: 11/30/2011
• Status: Active Grant

• Current Assignee: Lincoln Diagnostics, Inc.
• Original Assignee: Lincoln Diagnostics, Inc.
• Inventors: Hein, Gary L. Jr., Hein, Douglas S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/308,111
• Publication Number:
  US 20130138013A1
• Time in Patent Office: 573 Days
• Field of Search: 600/556
• US Class Current: 600/556
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

An allergy testing system comprises a skin test device having a grip portion for holding the device. One or more legs extend from the grip, and each leg is oriented to interact with a well containing a potential allergen. Each leg has a test head, and each test head has a plurality of elongated spike members. The elongated spike members have a sharp end configured to receive the potential allergen from a well and to puncture a patient'"'"'s skin. In addition, each test head has at least one touch activator. The touch activator is longer than the plurality of elongated spike members, such that during an allergy test, the touch activator comes into contact with the skin prior to the elongated spike members, causing the touch activators to activate nerve tissue that blocks transmission of pain, resulting in a reduction of pain and/or discomfort during testing.

Claims

1. An allergy testing system comprising:

a skin test device comprising;

an elongated grip portion for holding the device;

a plurality of legs extending from the grip, the plurality of legs spaced and oriented to interact with a plurality of wells containing test solutions;

wherein each of the plurality of legs has a test head, each test head comprising a plurality of elongated spikes each having a sharp end configured to receive the test solution from a well and to puncture skin to deliver the test solution, each test head further comprising at least one touch activator, wherein the touch activator is longer than the plurality of elongated spikes, such that during an allergy test, the touch activator is configured to come into contact with the skin prior to the elongated spikes, to cause the touch activators to activate nerve tissue that suppresses transmission of pain, resulting in a reduction of pain during testing; and

a plurality of wells each well having a reservoir for receiving test solutions and wherein each reservoir is sized and oriented to receive a separate test head of the skin test device.

2. The allergy testing system of claim 1, wherein at least one of the touch activators on the plurality of test heads has a convex end portion.

3. The allergy testing system of claim 1, wherein the touch activator on each of the plurality of test heads is a cylindrical shaped post.

4. The allergy testing system of claim 1, wherein the elongated spikes are pyramid shaped.

5. The allergy testing system of claim 4 wherein bases of the elongated spikes are square shaped.

6. The allergy testing system of claim 1, wherein the elongated spikes surround the touch activator.

7. The allergy testing system of claim 1, wherein the touch activator has a convex outer portion and a concave inner portion.

8. The allergy testing system of claim 1, wherein the plurality of test heads each comprise two touch activators, each touch activator being arranged radially outward from a center of the test head and the elongated spikes being located radially inward on a portion of the test head between each touch activator.

9. The allergy testing system of claim 1, wherein the plurality of test heads each comprise one touch activator, the touch activator being arranged radially outward on the test head from a test head center and the elongated spikes being located radially outward from the test head center in the opposite direction from the touch activator.

10. The allergy testing system of claim 1, wherein a touch activator has a convex surface that follows the circumference of the test heads.

11. The allergy testing system of claim 1, wherein each touch activator is in the range of 0.005 in. to 0.010 in. longer than the longest of the elongated spikes.

12. The allergy testing system of claim 1, wherein each touch activator is 0.010 in. longer than the longest of the elongated spikes.

13. The allergy testing system of claim 1, wherein the elongated spikes are placed circumferentially around the touch activator on each test head.

14. The allergy testing system of claim 1, wherein each reservoir is sized and oriented to receive both the elongated spikes and the touch activator of each of the test heads of the skin test device and wherein each of the test heads are configured to receive test solution from a corresponding well.

15. The allergy testing system of claim 1, wherein the skin test device further comprises a T-shaped extension configured to ensure that each test head of the skin test device are placed into the wells in a proper orientation.

16. A skin test device comprising:

a grip portion for holding the skin test device;

at least one leg extending from the grip portion, each leg oriented to interact with a well containing a test solution; and

wherein each leg has a test head, each test head comprising a plurality of elongated spikes and at least one touch activator, wherein the plurality of elongated spikes each have a sharp end configured to receive the test solution from a well and to puncture skin for delivering the test solution, wherein the touch activator is longer than the plurality of elongated spikes, such that during an allergy test, the touch activator is configured to come into contact with the skin prior to the elongated spikes, to cause the touch activator to activate nerve tissue that suppresses pain, resulting in a reduction of pain during testing.

17. The skin test device of claim 16 wherein the touch activator on each test head has a convex end portion.

18. The skin test device of claim 16 wherein the touch activator on each test head is a cylindrical shaped post.

19. The skin test device of claim 16 wherein the elongated spikes are pyramid shaped.

20. The skin test device of claim 19 wherein bases of the elongated spikes are square shaped.

21. The skin test device of claim 16 wherein the elongated spikes surround the touch activator.

22. The skin test device of claim 16 wherein the at least one touch activator has a convex outer portion and a concave inner portion.

23. The skin test device of claim 16 wherein each test head comprises two touch activators, each touch activator being arranged radially outward from a center of the test head and the elongated spikes being located radially inward on a portion of the test head between each touch activator.

24. The skin test device of claim 16 wherein each test head comprises one touch activator, the touch activator being arranged radially outward on the test head from a test head center, and the elongated spikes being located radially outward from the test head center in the opposite direction from the touch activator.

25. The skin test device of claim 16 wherein the touch activator has a convex surface that follows the circumference of the test head.

26. The skin test device of claim 16 wherein each touch activator is in the range of 0.005 in. to 0.010 in. longer than the longest of the elongated spikes.

27. The skin test device of claim 16 wherein each touch activator is 0.010 in. longer than the longest of the elongated spikes.

28. The skin test device of claim 16, wherein the elongated spikes are placed circumferentially around the touch activator on each test head.

29. The skin test device of claim 16, wherein both the elongated spikes and the touch activator of each of the test heads of the skin test device are together configured to be placed into a reservoir and wherein each of the test heads are configured to receive test solution from a corresponding well.

30. The skin test device of claim 16 further comprising a T-shaped extension configured to ensure that each test head of the skin test device are placed into the wells in a proper orientation.

31. A skin test device comprising:

a grip portion for holding the skin test device;

at least one leg extending from the grip portion, the leg being oriented to interact with a well containing a test solution; and

wherein the leg has a test head, the test head comprising at least one elongated spike having a sharp end configured to receive the test solution from a well and to puncture skin for delivering the test solution, the test head further comprising at least one touch activator, wherein the touch activator is longer than the elongated spike, such that during an allergy test, the touch activator is configured to come into contact with the skin prior to the elongated spike, to cause the touch activator to activate nerve tissue that suppresses pain, resulting in a reduction of pain during testing.

32. The skin test device of claim 31, wherein the touch activator on the test head has a convex end portion.

33. The skin test device of claim 31, wherein the touch activator on the test head is a cylindrical shaped post.

34. The skin test device of claim 31, wherein the elongated spike is pyramid shaped.

35. The skin test device of claim 34 wherein bases of the elongated spikes are square shaped.

36. The skin test device of claim 31, wherein the test head comprises a plurality of elongated spikes and wherein the elongated spikes surround the touch activator.

37. The skin test device of claim 31, wherein the elongated spikes are placed circumferentially around the touch activator on each test head.

38. The skin test device of claim 31, wherein both the elongated spikes and the touch activator of each of the test heads of the skin test device are together configured to be placed into a reservoir and wherein each of the test heads are configured to receive test solution from a corresponding well.

39. The skin test device of claim 31 further comprising a T-shaped extension configured to ensure that each test head of the skin test device are placed into the wells in a proper orientation.

40. A method for administering an allergy test with an allergy test device having a test head comprising a plurality of elongated spikes and the test head comprising at least one touch activator longer than the plurality of elongated spikes comprising:

placing the allergy testing device into at least one well containing a test solution to load the test solution onto the test head; and

administering the test solution to skin of a patient by pressing the allergy testing device against the skin such that the touch activator of the test head comes into contact with the skin prior to the elongated spikes of the test head puncturing the skin of the patient and delivering the test solution, wherein the touch activator activates nerve tissue that suppresses pain, resulting in a reduction of pain during testing.

41. The method of claim 40 wherein the allergy test device comprises a plurality of legs and test heads, wherein each of the test heads comprise a plurality of elongated spikes and at least one touch activator and the method further comprises placing each of the plurality of test heads into a respective well containing a test solution.

42. The method of claim 41 further comprising pressing the plurality of test heads against the skin of a patient such that each of the test head touch activators come into contact with the skin before the elongated spikes of each test head resulting in a reduction of pain at each skin contact site of each test head.

43. The method of claim 41, wherein the plurality of elongated spikes and the at least one touch activator of each of the test heads contacts the test solution and the test solution adheres to each test head.