Article with hollow microneedles and method of making

• US 10,105,524 B2
• Filed: 12/13/2013
• Issued: 10/23/2018
• Est. Priority Date: 12/27/2012
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Meyer, Kenneth A. P., Markowicz, Przemyslaw P., Rendon, Stanley, Smithson, Robert L. W., Simmers, Ryan Patrick
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US14/653,494
• Publication Number:
  US 20150306363A1
• Time in Patent Office: 1,775 Days
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B29C 69/001 a shaping technique combined with cutting, e.g. in parts or slices combined with rearranging and joining the cut parts for reinforced material B29C70/545; B29C49/4278, B29C51/268 take precedence
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes

Abstract

The present application provides articles (10) having a polymeric substrate (12) with a plurality of solid and/or hollow microneedles (20) extending therefrom. Each solid microneedle is formed by a molding process and the microneedle has body with first (30) and second cavities (40) extending therein. The hollow microneedles are formed by removing a portion of the polymeric material disposed between the first cavity and the second cavity. A method for determining the location of a microneedle in an article comprising solid microneedles is also provided. The method comprises directing electromagnetic radiation toward an article comprising a plurality of microneedles and imaging the article.

Claims

1. An article, comprising:

a substrate having first side and second side opposite the first side;

wherein the first side comprises a first major surface that defines a base from which at least one microneedle extends;

wherein the at least one microneedle comprises a body, a tip and a first cavity extending into the body;

wherein the first cavity comprises an opening on the first side and a first terminus located within the body of the microneedle;

wherein the second side comprises a second major surface comprising a second cavity that extends into the body of the at least one microneedle;

wherein the second cavity comprises a second opening on the second side, and a second terminus located within the body of the microneedle;

wherein the first terminus is spaced apart from the second terminus;

and a thinned region disposed between the first cavity and the second cavity in the body of the microneedle;

wherein a straight line passing through the substrate can enter the substrate at a first point in the second cavity and exit the substrate at a second point in the first cavity.

2. The article of claim 1, wherein the first point is proximate the second terminus and the second point is proximate the first terminus.

3. The article of claim 1, wherein a shortest distance between the first cavity terminus and the second cavity terminus is about 1 micron to about 500 microns.

4. The article of claim 1, wherein:

the first cavity defines a first channel segment;

the second cavity defines a third channel segment; and

further comprising a third channel segment extending through at least a portion of the thinned region between the first terminus and the second terminus

wherein the first channel segment has a first interior surface topology, the second channel segment has a second interior surface topology, and the third channel segment has a third interior surface topology;

wherein the third interior surface topology is optically distinguishable from the first interior surface topology.

5. The article of claim 4, wherein the first channel segment extends from the first terminus to a first transition locus in the body of the at least one microneedle.

6. The article of claim 4, wherein the second channel segment extends from the second terminus to a second transition locus in the body of the at least one microneedle.

7. The article of claim 4, wherein the third interior surface topology is optically distinguishable from the first interior surface topology and the second interior surface topology.

8. The article of claim 4, wherein a maximum diameter of the third channel segment at a location distal to the second transition locus is smaller than a minimum diameter of the second channel segment at a location distal the second transition locus.

9. The article of claim 4, wherein the aspect ratio of the each microneedle in the plurality of microneedles is about 2:

1to about 5;

1, inclusive.

10. A method, comprising:

molding a material to form the article of claim 1,

affixing the substrate;

registering a location of at least one microneedle; and

forming a hollow channel through one of the plurality of microneedles, wherein forming a hollow channel comprises forming a channel through the thinned region between the first cavity and the second cavity.

11. The method of claim 10, wherein the first cavity comprises a first opening and a first terminus opposite the first opening, wherein the second cavity comprises a second opening and a second terminus opposite the second opening, wherein the straight line passing through the substrate can enter the substrate at a first point at the first terminus and exit the substrate at a second point at the second terminus.

12. The method of claim 10, wherein the plurality of microneedles comprises an array of microneedles, wherein the array comprises perimeter microneedles, wherein registering a location of at least one microneedle comprises registering the location of the perimeter microneedles.

13. The method of claim 10, wherein forming a hollow channel comprises using an ablation process, a melting process, or a mechanical drilling process, wherein the ablation process comprises a laser ablation process, wherein the method further comprises using a mask element or beam-splitting element to target the ablation process.

14. The method of claim 10, further comprising the step of imaging at least one microneedle of the plurality of microneedles.

15. The method of claim 14, wherein imaging at least one microneedle comprises directing electromagnetic radiation toward the first major surface and using an imaging device to capture an image of the second major surface or directing electromagnetic radiation toward the second major surface and using an imaging device to capture an image of the first major surface.

16. The method of claim 10, wherein forming a hollow channel through one of the plurality of microneedles further comprises simultaneously forming a hollow channel in two or more of the microneedles in the plurality of microneedles.

17. A method, comprising:

molding a material to form an article of claim 1, and

directing electromagnetic radiation toward the first major surface and using an imaging device to capture an image of the second major surface or directing electromagnetic radiation toward the second major surface and using an imaging device to capture an image of the first major surface; and

using the image to process two or more microneedles of the plurality of microneedles.

18. The method of claim 17, wherein each of the plurality of microneedles comprises a body, wherein molding a material to form a substrate comprises molding the material such that each cavity of the plurality of second cavities extends into the body of one of the plurality of microneedles.

19. The method of claim 17, wherein processing two or more microneedles comprises creating through-hole between the first and second cavities of a plurality of microneedles.

20. The method of claim 17, wherein processing two or more microneedles comprises applying a composition to a plurality of microneedles.