METHOD OF MAKING MICRONEEDLE ARRAY AND DEVICE FOR APPLYING MICRONEEDLE ARRAY TO SKIN

• US 20100130940A1
• Filed: 01/27/2010
• Published: 05/27/2010
• Est. Priority Date: 01/10/2006
• Status: Active Grant

• Current Assignee: Vadim V. Yuzhakov
• Original Assignee: Vadim V. Yuzhakov
• Inventors: Yuzhakov, Vadim V.
• Granted Patent: US 8,414,548 B2
• Time in Patent Office: Days
• US Class Current: 604/173
• 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:

forming a substantially planar substrate having an array of spaced apertures therein; and

forming a plurality of microneedles projecting at an angle away from the plane in which the substrate lies, 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 at least one of the microneedles has at least one elongated 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.

2. The method of claim 1, wherein the step of forming the plurality of microneedles comprises 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.

3. 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.

4. The method of claim 3, 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.

5. The method of claim 3, 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.

6. The method of claim 3, wherein the channel (i) is open along at least part of the body portion and in fluid communication with at least one of the apertures in the planar substrate, and (ii) forms an opening extending through the substrate material.

7. An applicator device for applying a microneedle array to skin, comprising:

a housing having a substantially planar application side and an opposed top side;

a recess in the housing in which a drug delivery device that includes a microneedle array can be stored; and

a button on the top side of the housing, which button can be depressed to drive the drug delivery device out of the recess for insertion into skin with the microneedles oriented substantially perpendicular to the planar application side.

8. The applicator device of claim 7, wherein housing further comprises a roller disposed partially in a cavity on the planar application side of the housing.

9. The applicator device of claim 7, wherein the microneedle array comprises:

a substantially planar substrate having an array of spaced apertures therein;

a plurality of microneedles projecting at angle from the plane in which the planar substrate lies, 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 at least one of the microneedles 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; and

at least one drug storage element, which contains a drug formulation, positioned adjacent to the planar substrate.

10. The applicator device of claim 9, wherein the at least one of the microneedles has a substantially rectangular cross-sectional shape in a plane parallel to the substrate.

11. The applicator device of claim 10, wherein the at least one channel is open to two opposing surfaces of the microneedle.

12. The applicator device of claim 9, wherein the tip end portion of the at least one of the microneedles is tapered.

13. The applicator device of claim 12, wherein the at least one channel terminates in the body portion of the microneedle and does not extend into the tapered tip portion.

14. The applicator device of claim 9, wherein the substrate and the microneedles are formed of stainless steel or another biocompatible metal.

15. The applicator device of claim 9, wherein the body portion of the at least one microneedle is rectangular with a centrally located channel extending through the opposed longer sides of the body portion.

16. The applicator device of claim 9, wherein the apertures in the substrate are polygonal in shape, each aperture being defined by three or more interior side surfaces in the substrate.

17. The applicator device of claim 16, wherein the base portion of the at least one microneedle includes a curved portion that extends from at least one of the interior side surfaces of the substrate.

18. The applicator device of claim 9, wherein the drug storage element is attached to a first surface of the planar substrate, the first surface being opposed to a second surface of the planar substrate of the microneedle array, wherein the microneedles project from the second surface.

19. The applicator device of claim 9, further comprising a release mechanism for releasing the drug formulation from the drug storage element to permit the drug formulation to pass into and through the at least one channel of the at least one microneedle.

20. The applicator device of claim 9, wherein the drug formulation is a fluid and wherein the at least one elongated channel is dimensioned to provide a capillary effect to wick the fluid into the base portion of the microneedle from the substrate aperture, through the body portion of the microneedle, and toward the tip portion of the microneedle.