Skin test image analysis apparatuses and methods thereof

• US 10,244,981 B2
• Filed: 10/13/2011
• Issued: 04/02/2019
• Est. Priority Date: 03/30/2011
• Status: Active Grant

• Current Assignee: Sensivida Medical Technologies, Inc.
• Original Assignee: Sensivida Medical Technologies, Inc.
• Inventors: Mir, Jose, Spoonhower, John, Agostinelli, John A., Squilla, John
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US13/272,966
• Publication Number:
  US 20120253224A1
• Time in Patent Office: 2,728 Days
• Field of Search: 600556, 600300, 600426
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/442 Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment

Abstract

An apparatus and method for making an apparatus for skin testing includes a housing with an opening which defines a field of view of a skin testing region, an image sensing apparatus, an illumination apparatus, a binding apparatus, and an image processing controller. The image sensing apparatus is positioned with respect to the housing to capture images in the field of view provided by the opening. The illumination apparatus is positioned within the housing to direct light towards a portion of the field of view provided by the opening. The binding apparatus detachably secures the housing over the skin testing region and maintains a fixed distance between the image sensing apparatus and the skin testing region. The controller is configured to analyze test samples sites in each of the captured images from the image sensing apparatus and provide a skin test result for each of the test sample sites.

Claims

1. An apparatus for skin testing comprising:

a housing with an opening configured to define a field of view of a skin testing region during use;

a test cartridge configured to be removably inserted into the housing, the test cartridge comprising a plurality of microneedles, wherein each of the plurality of microneedles is spaced one millimeter to fifteen millimeters apart from at least one other microneedle in the plurality of microneedles to generate a corresponding plurality of allergy test sample sites spaced one millimeter to fifteen millimeters apart in the field of view of the skin testing region, wherein the housing has an actuator apparatus integrated within the housing to manage actuation of the test cartridge within the opening of the housing when the test cartridge is removably inserted into the housing;

an image sensing apparatus positioned with respect to the housing to capture one or more images in the field of view provided by the opening in the housing;

an illumination apparatus positioned with respect to the housing to direct light towards at least a portion of the field of view provided by the opening in the housing;

a binding apparatus having one or more straps configured to detachably secure the housing to a body area having a circumference with the opening over the skin testing region and a band extending from the one or more straps and around the housing and the image sensing apparatus configured to apply pressure around the circumference of the body area and to a skin surface proximate the skin testing region to constrain movement of the opening over the skin testing region and to maintain a substantially fixed optical distance and spatial registration between the image sensing apparatus and the skin testing region; and

an image processing controller configured to execute one or more programmed instructions comprising;

obtaining, from the image sensing apparatus, a baseline image of the skin testing region prior to an assessment image of the skin testing region including the two or more allergy test sample sites of the corresponding plurality of allergy test sample sites generated by the plurality of microneedles of the test cartridge;

generating a difference image between the baseline image and the assessment image; and

analyzing the two or more allergy test sample sites of the corresponding plurality of allergy test sample sites generated by the plurality of microneedles of the test cartridge based on the difference image to provide a skin test result for each of the two or more allergy test sample sites based on the analysis.

2. The apparatus as set forth in claim 1 wherein the opening in the housing has an opening which is no more than 600 mm².

3. The apparatus as set forth in claim 1 wherein the housing further comprises a passage having a shape configured to removably receive the test cartridge.

4. The apparatus as set forth in claim 1 wherein the actuator apparatus further comprises:

a plunger engageable to move the test cartridge towards the skin testing region;

a stop positioned in the housing to limit the movement of the test cartridge towards the skin testing region; and

a biasing device configured to bias the plunger away from the skin testing region.

5. The apparatus as set forth in claim 1 wherein the housing further comprises a skin attachment fixture with an array of apertures which is detachably positioned across the opening in the housing.

6. The apparatus as set forth in claim 5 wherein the array of apertures of the skin attachment fixture has an irregular pattern.

7. The apparatus as set forth in claim 5 wherein the skin attachment fixture further comprises one or more fiducials.

8. The apparatus as set forth in claim 1 wherein the image sensing apparatus comprises one of a CCD image sensor or a CMOS image sensor.

9. The apparatus as set forth in claim 1 wherein the image processing controller is configured to analyze the two or more allergy test samples sites spaced one millimeter to ten millimeters apart in the field of view in each of the one or more captured images.

10. The apparatus as set forth in claim 9 wherein the image processing controller is configured to analyze the two or more allergy test samples sites spaced one millimeter to five millimeters apart in the field of view in each of the one or more captured images.

11. The apparatus as set forth in claim 1 wherein the illumination apparatus further comprises a first light source positioned at an oblique angle with respect to the opening to direct light toward the opening at the oblique angle from normal.

12. The apparatus as set forth in claim 11 wherein the illumination apparatus further comprises a second light source positioned to direct light toward the opening at substantially centered about normal.

13. The apparatus as set forth in claim 12 wherein the illumination apparatus further comprises a third light source positioned to direct light toward the opening at an oblique angle from normal and offset from the first light source.

14. The apparatus as set forth in claim 1 wherein the illumination apparatus is configured to provide substantially collimated light.

15. The apparatus as set forth in claim 1 wherein the binding apparatus further comprises an attachment member coupled to the housing configured to enhance a grip between the housing and the body area.

16. The apparatus as set forth in claim 1, wherein generating the difference image removes one or more image features less than one millimeter in size, resulting from focus changes or geometrical distortions, from the baseline image and the assessment image.

17. A method for making an apparatus for skin testing, the method comprising:

providing a housing with an opening configured to define a field of view of a skin testing region during use;

providing a test cartridge configured to be removably inserted into the housing, the test cartridge comprising a plurality of microneedles, wherein each of the plurality of microneedles is spaced one millimeter to fifteen millimeters apart from at least one other microneedle in the plurality of microneedles to generate a corresponding plurality of allergy test sample sites spaced one millimeter to fifteen millimeters apart in the field of view of the skin testing region, wherein the housing has an actuator apparatus integrated within the housing to manage actuation of the test cartridge within the opening of the housing when the test cartridge is removably inserted into the housing;

positioning an image sensing apparatus with respect to the housing to capture one or more images in the field of view provided by the opening in the housing;

positioning an illumination apparatus with respect to the housing to direct light towards at least a portion of the field of view provided by the opening in the housing;

providing a binding apparatus having one or more straps configured to detachably secure the housing to a body area having a circumference with the opening over the skin testing region and a band extending from the one or more straps and around the housing and the image sensing apparatus configured to apply pressure around the circumference of the body area and to a skin surface proximate the skin testing region to constrain movement of the opening over the skin testing region and to maintain a substantially fixed optical distance and spatial registration between the image sensing apparatus and the skin testing region; and

providing an image processing controller configured to execute one or more programmed instructions comprising;

obtaining, from the image sensing apparatus, a baseline image of the skin testing region prior to an assessment image of the skin testing region including the two or more allergy test sample sites of the corresponding plurality of allergy test sample sites generated by the plurality of microneedles of the test cartridge;

generating a difference image between the baseline image and the assessment image; and

analyzing the two or more allergy test sample sites of the corresponding plurality of allergy test sample sites generated by the plurality of microneedles of the test cartridge based on the difference image to provide a skin test result for each of the two or more allergy test sample sites based on the analysis.

18. The method as set forth in claim 17 wherein the providing the housing further comprises providing the housing with the opening which is no more than 600 mm².

19. The method as set forth in claim 17 wherein the providing the housing further comprises providing a passage having a shape configured to removably receive the test cartridge.

20. The method as set forth in claim 17 wherein the providing the actuator apparatus further comprises:

providing a plunger engageable to move the test cartridge towards the skin testing region;

positioning a stop in the housing to limit the movement of the test cartridge towards the skin testing region; and

providing a biasing device configured to bias the plunger away from the skin testing region.

21. The method as set forth in claim 17 wherein the providing the housing further comprises providing a skin attachment fixture with an array of apertures which is detachably positioned across the opening in the housing.

22. The method as set forth in claim 21 wherein the providing the skin attachment fixture further comprises providing the skin attachment fixture with the array of apertures which have an irregular pattern.

23. The method as set forth in claim 21 wherein the providing the skin attachment fixture further comprises providing the skin attachment fixture with one or more fiducials.

24. The method as set forth in claim 17 wherein the positioning an image sensing apparatus further comprises providing the image sensing apparatus comprising one of a CCD image sensor or a CMOS image sensor.

25. The method as set forth in claim 17 wherein the providing the image processing controller further comprises providing the image processing controller configured to analyze the two or more allergy test samples sites spaced one millimeter to ten millimeters apart in the field of view in each of the one or more captured images.

26. The method as set forth in claim 25 wherein the providing the image processing controller further comprises providing the image processing controller configured to analyze the two or more allergy test samples sites spaced one millimeter to five millimeters apart in the field of view in each of the one or more captured images.

27. The method as set forth in claim 17 wherein the positioning the illumination apparatus further comprises positioning a first light source at an oblique angle with respect to the opening to direct light toward the opening at the oblique angle from normal.

28. The method as set forth in claim 27 wherein the positioning the illumination apparatus further comprises positioning a second light source to direct light toward the opening at an angle substantially centered about normal.

29. The method as set forth in claim 28 wherein the positioning the illumination apparatus further comprises positioning a third light source to direct light toward the opening at an oblique angle from normal and offset from the first light source.

30. The method as set forth in claim 17 wherein the positioning the illumination apparatus further comprises providing an illumination apparatus configured to provide substantially collimated light.

31. The method as set forth in claim 17 wherein the providing the binding apparatus further comprises providing an attachment member coupled to the housing configured to enhance a grip between the housing and the body area.

32. The method as set forth in claim 17, wherein generating the difference image removes one or more image features less than one millimeter in size, resulting from focus changes or geometrical distortions, from the baseline image and the assessment image.