Microneedle array module and method of fabricating the same

• US 7,262,068 B2
• Filed: 07/06/2004
• Issued: 08/28/2007
• Est. Priority Date: 08/21/2000
• Status: Expired due to Term

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Fleischman, Aaron J., Roy, Shuvo
• Primary Examiner(s): Parker; Kenneth
• Assistant Examiner(s): NGUYEN, JOSEPH H
• Application Number:
  US10/885,402
• Publication Number:
  US 20040243063A1
• Time in Patent Office: 1,148 Days
• Field of Search: 438/48, 216/49, 216/2, 216/11, 216/41, 216/51, 216/56, 216/66, 216/79, 216/99
• US Class Current: 438/48
• 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 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 1/00111 Tips, pillars, i.e. raised structures microneedles A61M37/0015

Abstract

A microneedle array module is disclosed comprising a multiplicity of microneedles affixed to and protruding outwardly from a front surface of a substrate to form the array, each microneedle of the array having a hollow section which extends through its center to an opening in the tip thereof. A method of fabricating the microneedle array module is also disclosed comprising the steps of: providing etch resistant mask layers to one and another opposite surfaces of a substrate to predetermined thicknesses; patterning the etch resistant mask layer of the one surface for outer dimensions of the microneedles of the array; patterning the etch resistant mask layer of the other surface for inner dimensions of the microneedles of the array; etching unmasked portions of the substrate from one and the other surfaces to first and second predetermined depths, respectively; and removing the mask layers from the one and the other surfaces. One embodiment of the method includes the steps of: providing an etch resistant mask layer to the other surface of the substrate to a predetermined thickness; patterning the etch resistant mask layer of the other surface to define a reservoir region in the substrate; and etching away the unmasked reservoir region of the substrate to form a reservoir well in the other surface of the substrate. A layer of material may be provided to the other surface to enclose the reservoir well and a passageway is provided through the layer to the well region.

Claims

1. A method of fabricating a microneedle array module comprising the steps of:

providing etch resistant mask layers to a first surface of a substrate to predetermined thicknesses;

patterning the etch resistant mask layer of the first surface for outer dimensions of the microneedles of said array;

etching unmasked portions of said substrate from the first surface to a first predetermined depth;

anisotropically etching underneath masked portions of the substrate from a second surface of the substrate to a second predetermined depth; and

removing the mask layers from the the first surface.

2. The method of claim 1 wherein the step of providing includes oxidizing the surfaces of the substrate to predetermined thicknesses.

3. The method of claim 2 wherein the step of oxidizing includes the step of thermally oxidizing the surfaces.

4. The method of claim 2 wherein the step of oxidizing includes chemically depositing an oxide on the surfaces.

5. The method of claim 1 wherein the step of providing includes the step of providing a mask layer of silicon nitride to the surfaces of the substrate.

6. The method of claim 1 wherein the step of providing includes the step of providing a mask layer of photoresist to the surfaces of the substrate.

7. The method of claim 1 wherein the unmasked portions of the substrate are etched anisotropically.

8. The method of claim 7 wherein the unmasked portions of the substrate are anisotropically etched using a deep reactive ion beam etching (RIE) process.

9. The method of claim 8 wherein the deep RIE process uses a SF₆ based ion beam.

10. The method of claim 1 wherein each step of patterning includes the steps of patterning the etch resistant mask layer using a photolithography process.

11. The method of claim 1 wherein the mask layers are removed away using a buffered hydrofluoric acid.

12. The method of claim 1 wherein the mask layers are removed away using a reactive ion etching (RIE) process.

13. The method of claim 12 wherein the mask layers are removed away using a fluorocarbon-based RIE.

14. The method of claim 1 wherein the second predetermined etching depths are greater than the first predetermined etching depths.

15. The method of claim 14 wherein the second etching depths leaving only thin layers of substrate at the one surface relative to the thickness of the substrate;

and wherein the thin layers of unetched substrate portions are etched from the one surface to provide openings for microneedle tips of the array.

16. The method of claim 14 wherein the second etching depths creating openings in the one surface for the microneedle tips of the array.

17. The method of claim 1 including the steps of:

providing an etch resistant mask layer to the other surface of the substrate to a predetermined thickness;

patterning the etch resistant mask layer of the other surface to define a reservoir region in the substrate; and

etching away the unmasked reservoir region of the substrate to form a reservoir well in the other surface of the substrate.

18. The method of claim 17 including the steps of:

providing a layer of material to the other surface to enclose the reservoir well; and

providing a passageway through said layer to the well region.

19. The method of claim 18 including the reservoir well is enclosed by a bonding a layer of material to the other surface.

20. The method of claim 19 wherein the material of the layer bonded to the other surface is selected from the group consisting of a form of SiO₂, silicon, ceramic, and plastic.