Methods of making hollow microneedle arrays and articles and uses therefrom

• US 9,289,925 B2
• Filed: 03/22/2010
• Issued: 03/22/2016
• Est. Priority Date: 04/10/2009
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Ferguson, Dennis E., Rendon, Stanley
• Primary Examiner(s): Schiffman, Benjamin
• Application Number:
  US13/262,996
• Publication Number:
  US 20120041337A1
• Time in Patent Office: 2,192 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B29C 2043/025 forming a microstructure, i.e. fine patterning
• CPC Class Codes: B29C 2045/0094 injection moulding of small-sized articles, e.g. microarticles, ultra thin articles
• CPC Class Codes: B29C 33/0088 Multi-face stack moulds
• CPC Class Codes: B29C 33/301 Modular mould systems [MMS], i.e. moulds built up by stacking mould elements, e.g. plates, blocks, rods B29C33/0088 takes precedence
• CPC Class Codes: B29C 43/021 characterised by the shape of the surface
• CPC Class Codes: B29C 45/37 Mould cavity walls , i.e. the inner surface forming the mould cavity, e.g. linings
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles

Abstract

A method of making hollow microneedle arrays is described. Also described are the articles therefrom and the use of the articles in applications such as delivering fluid to and/or extracting body fluid from a subject.

Claims

1. A method of manufacturing a hollow microneedle array comprising:

(a) providing a first mold half comprising a stacked laminate mold, the stacked laminate mold comprising a plurality of plates and a plurality of cavities, wherein each of the plates comprises;

(i) opposed first and second major surfaces; and

(ii) a first mold surface connecting said first and second major surfaces; and

wherein the plurality of cavities is open at least to the first mold surface and includes a cavity surface wherein the cavity surface intersects each respective plate'"'"'s first major surface and each respective plate'"'"'s first mold surface;

(b) providing a second mold half comprising a second mold surface, wherein the second mold surface comprises a plurality of projections;

(c) contacting at least the first mold surface or the second mold surface with polymeric material; and

(d) inserting the plurality of projections into the plurality of cavities.

2. The method of claim 1, wherein the plurality of projections is inserted into the plurality of cavities before contacting at least the first mold surface or the second mold surface with polymeric material.

3. The method of claim 1, wherein at least the first mold surface or the second mold surface is contacted with polymeric material before inserting the plurality of projections into the plurality of cavities.

4. The method of claim 1, wherein the projection comprises a base end, which is connected through a neck to a tip end, wherein the maximum base end area is at least 3 times larger than the tip end.

5. The method of claim 4, further comprising positioning the tip end and at least a portion of the neck within the cavity.

6. The method of claim 1, further comprising registering the plurality of projections into the plurality of cavities.

7. The method of claim 4, further comprising contacting the tip end to at least one surface of the cavity.

8. The method of claim 1, wherein the cavity has a cavity aspect ratio (cavity length to cavity base width) of at least 1.5 to 1.

9. The method of claim 1, further comprising providing venting of the plurality of cavities by a submicrometer spacing between the plurality of plates.

10. The method of claim 9 wherein the submicrometer spacing is provided by the surface roughness of each respective plate'"'"'s first major surface and second major surface.

11. The method of claim 10, wherein the surface roughness is less than 30 RMS (root mean square) pinch (0.762 RMS μ

m).

12. The method of claim 1, wherein the cavity surface and the projection comprise different materials.

13. The method of claim 1, wherein the cavity surface comprises a first material and the projection comprises a second material, wherein the first material has a specific modulus that is at least 20 GPa higher than the specific modulus of the second material.