Process and apparatus for inspecting microneedle arrays

Patent metadata

Field	Value
Publication number	US-11460411-B2
Application number	US-201915734013-A
Country	US
Kind code	B2
Filing date	Jun 13, 2019
Priority date	Jun 18, 2018
Publication date	Oct 4, 2022
Grant date	Oct 4, 2022

Abstract

A process of making a microneedle array comprising providing a microneedle array having a plurality of microneedles of a desired shape, illuminating at least a portion of said microneedle array that comprises at least one microneedle, capturing an observed image of said at least one microneedle using an optical device, electronically processing said observed image and determining at least one shape parameter for said at least one microneedle, accepting said microneedle array if said at least one shape parameter is within an acceptable range, thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.

First claim

What is claimed is:

1. A process of making a microneedle array comprising:
providing a microneedle array having a plurality of microneedles of a desired shape;
illuminating at least a portion of said microneedle array that comprises at least one microneedle;
capturing an observed image of said at least one microneedle using an optical device, wherein the observed image is at least one shadow projected onto a surface of the microneedle array from the at least one microneedle;
electronically processing said observed image and determining at least one shape parameter for said at least one microneedle based upon the processed observed image;
accepting said microneedle array if said at least one shape parameter is within an acceptable range;
thereby providing a microneedle array that comprises a known shape of the plurality of microneedles.

2. The process of claim 1 , wherein said at least one microneedle is coated with a material.

3. The process of claim 2 , further comprising determining an amount of material on said at least one microneedle.

4. The process of claim 3 , wherein the step of determining an amount of material on said at least one microneedle further comprises;
defining a coated region from a shadow of an individual microneedle;
rotating a two-dimensional profile of the coated region around a microneedle tip's central axis to form a solid of revolution;
calculating an amount of a first material comprising the solid of revolution;
calculating an amount of a second material comprising an underlying microneedle structure for the coated region;
subtracting the amount of the second material from the first material;
thereby determining the amount of said material on said at least one microneedle.

5. The process of claim 1 , wherein the step of illuminating further comprises illuminating with a directed light source.

6. The process of claim 5 , wherein the light source projects light through the microneedle array at an acute angle of between about 10° and 75° to a surface of the microneedle array.

7. The process of claim 1 , wherein said shadows from said at least one microneedle do not project onto neighboring microneedles.

8. The process of claim 1 , wherein the optical device comprises a 2D array camera.

9. The process of claim 1 , wherein the optical device comprises a 1D linescan camera.

10. The process of claim 1 , wherein the optical device is positioned above the microneedle array and a linear line from the optical device through the microneedle array is normal to the array.

11. The process of claim 1 , wherein the step of electronically processing said observed image and determining shape parameter further comprises calculating the difference between a theoretical shape of an individual microneedle and an observed shape of the individual microneedle.

12. The process of claim 1 , wherein the observed image is an 8-bit to 16-bit grayscale image comprising said at least one microneedle with at least one microneedle shadow projected on a surface of the microneedle array.

13. The process of claim 12 , further comprising horizontally flat-fielding the observed image to account for variable background intensity.

14. The process of claim 12 , further comprising a binary threshold which segments the plurality of microneedle shadows from said surface on the microneedle array.

15. The process of claim 12 , further comprising a blob extraction algorithm to isolate an individual microneedle shadow.

16. The process of claim 1 , wherein the shape parameter is at least one of microneedle height, width, angle, spacing, base area, or combinations thereof.

17. A process of inspecting a microneedle array comprising:
illuminating at least a portion of a microneedle array that comprises at least one coated microneedle with a directed light source;
capturing an observed image of said at least one coated microneedle using an optical device, wherein the observed image is at least one shadow projected onto a surface of the microneedle array from the at least one coated microneedle;
electronically processing said observed image; and
determining an amount of a material coating on said at least one coated microneedle.

18. The process of claim 17 , wherein the light source projects light through the microneedle array at an acute angle of between about 10° and 75° to a surface of the microneedle array.

19. The process of claim 17 , wherein determining the amount of material on the at least one coated microneedle further comprises:
defining a coated region from a shadow of an individual microneedle;
rotating a two-dimensional profile of the coated region around a microneedle tip's central axis to form a solid of revolution;
calculating an amount of a first material comprising the solid of revolution;
calculating an amount of a second material comprising an underlying microneedle structure for the coated region;
subtracting the amount of the second material from the first material;
thereby determining the amount of the material on the at least one coated microneedle.

Assignees

• Kindeva Drug Delivery Lp

Inventors

• Adolf Jeffrey P
• Floeder Steven P
• Smith Jason P
• Dreger Steven R

Classifications

• H04N23/56

  provided with illuminating means · CPC title

• G01N2021/8427

  Coatings · CPC title

• G01B11/0616

  of coating · CPC title

• A61M2037/0053

  Methods for producing microneedles · CPC title

• G06T7/50

  Depth or shape recovery · CPC title