Method of making microneedle array and device for applying microneedle array to skin

• US 8,414,548 B2
• Filed: 01/27/2010
• Issued: 04/09/2013
• Est. Priority Date: 01/10/2006
• Status: Active Grant

• Current Assignee: Vadim V. Yuzhakov
• Original Assignee: Vadim V. Yuzhakov
• Inventors: Yuzhakov, Vadim V.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/694,314
• Publication Number:
  US 20100130940A1
• Time in Patent Office: 1,168 Days
• Field of Search: 604 20- 22, 604/46, 604/164.01, 604/164.09, 604/172, 604272-274, 604/890.1, 164/47, 164/113
• US Class Current: 604/272
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• 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

Abstract

Microneedle arrays and drug delivery devices are provided for transdermally delivering a drug formulation to a patient. The microneedle array device includes a substantially planar substrate having an array of apertures; and a plurality of microneedles projecting at angle from the planar substrate, the microneedles having a base portion integrally connected to the substrate, a tip end portion distal to the base portion, and body portion therebetween, wherein each microneedle has at least one channel extending substantially from the base portion through at least a part of the body portion, the channel being open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate. In a preferred embodiment, each microneedle has a substantially rectangular cross-sectional shape and the channel is open to two opposing surfaces of the microneedle.

Claims

1. A method for manufacturing a microneedle array comprising

providing a substantially planar substrate material;

forming a plurality of first apertures in the substrate material, wherein the interior surface of at least one of the first apertures defines a microneedle having a tip, a base, and a body portion therebetween;

forming a plurality of second apertures in the substrate material, each of the second apertures defining an elongated channel located in the body portion of the microneedle; and

bending the microneedle near its base such that the tip and body portion project out of the plane of the substrate material,

wherein the tip of the microneedle is tapered, the body portion is rectangular, and the channel extends through 50% to 99% of the length of the microneedle substantially from the planar substrate, through the base, and through at least a part of the body portion.

2. The method of claim 1, wherein the bending of the microneedle comprises direct or indirect application of a compressive force, heat, or a combination thereof, to the microneedle and/or substrate material.

3. The method of claim 1, wherein the substrate material and the microneedle comprise stainless steel or another biocompatible metal.

4. The method of claim 1, wherein the first apertures in the substrate material are polygonal in shape, each aperture being defined by three or more interior side surfaces in the substrate material.

5. The method of claim 1, wherein the microneedle has a length between 1 μ

m and 5000 μ

m.

6. The method of claim 1, wherein the microneedle has a length between 10 μ

m and 1000 μ

m.

7. The method of claim 1, wherein the microneedle has a width between 1 μ

m and 500 μ

m.

8. The method of claim 1, wherein the microneedle has a thickness between 1 μ

m and 200 μ

m.

9. The method of claim 1, wherein the steps of forming the first and second apertures comprise embossing, injection molding, casting, photochemical etching, electrochemical machining, electrical discharge machining, precision stamping, high-speed computer numerically controlled milling, Swiss screw machining, soft lithography, directional chemically assisted ion etching, or a combination thereof.