Method of manufacturing microneedle structures using photolithography

• US 7,763,203 B2
• Filed: 12/03/2003
• Issued: 07/27/2010
• Est. Priority Date: 03/14/2001
• Status: Active Grant

• Current Assignee: Corium Pharma Solutions, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Owens, Grover David, Arias, Francisco, Sherman, Faiz Feisal
• Primary Examiner(s): Vargot; Mathieu D.
• Application Number:
  US10/727,124
• Publication Number:
  US 20040146611A1
• Time in Patent Office: 2,428 Days
• Field of Search: 264/225, 264/219, 264/496, 264/319, 264/494, 264/313, 264/320, 205/70, 205/164, 216/11, 216/41
• US Class Current: 264/494
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• 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
• CPC Class Codes: B81C 2201/034 Moulding

Abstract

A method for manufacturing microneedle structures is disclosed using soft lithography and photolithography, in which micromold structures made of a photoresist material or PDMS are created. The micromold manufacturing occurs quite quickly, using inexpensive materials and processes. Once the molds are available, using moldable materials such as polymers, microneedle arrays can be molded or embossed in relatively fast procedures. In some cases a sacrificial layer is provided between the forming micromold and its substrate layer, for ease of separation. The microneedles themselves can be solid projections, hollow “microtubes,” or shallow “microcups.” Electrodes can be formed on the microneedle arrays, including individual electrodes per hollow microtube.

Claims

1. A method for fabricating microneedles, said method comprising:

(a) providing a substrate material;

(b) coating said substrate material with a first layer of a photoresist material;

(c) coating said first layer of photoresist material with a second layer of photoresist material;

(d) patterning said second layer of photoresist material with a plurality of microstructures by use of a photolithography procedure to form an overall patterned photoresist material comprising the first and second layers of photoresist material; and

(e) separating said overall patterned of photoresist material from said substrate material, thereby creating a microneedle structure comprised of said overall patterned photoresist material containing said plurality of microstructures.

2. The method as recited in claim 1, wherein said microneedle structure comprises one of:

(a) a plurality of solid protrusions, (b) a plurality of hollow protrusions forming through-holes, or (c) a plurality of hollow protrusions forming microcups that do not extend entirely through said overall patterned photoresist material.

3. The method as recited in claim 1, wherein said first layer of photoresist material is cured before said second layer of photoresist material is applied.

4. The method as recited in claim 1, further comprising:

applying a layer of acid-dissolvable material between said substrate and said first layer of photoresist material at the commencement of said method, and during said step of separating the overall patterned photoresist material from the substrate, dissolving said acid-dissolvable material as a sacrificial layer.

5. The method as recited in claim 4, wherein said substrate comprises one of a silicon or a metallic substance, and said acid-dissolvable material comprises one of PDMS or silicon oxide.

6. The method as recited in claim 4, further comprising:

creating break-away microneedles by briefly etching a portion of said plurality of microstructures proximal to a junction between a base structure and protrusions of the overall patterned photoresist material containing said plurality of microstructures, said base structure and said microstructure protrusions both being constructed of said photoresist material.

7. The method as recited in claim 1,

wherein the first of said photoresist layers being patterned with a first plurality of openings that are of a first size, the second of said photoresist layers being patterned with a second plurality of openings that are of a second size that is larger than said openings of said first size, said first and second plurality of openings being substantially in alignment with one another;

and after said separation of the substrate from the overall patterned photoresist material, said plurality of microstructures comprises a plurality of microneedles having sharp tips.

8. The method as recited in claim 1, wherein said microneedle structure comprises a plurality of individual microneedles that have an aspect ratio of at least 3:

1.