Methods of fabricating microneedle arrays using sacrificial molds

• US 6,511,463 B1
• Filed: 11/18/1999
• Issued: 01/28/2003
• Est. Priority Date: 11/18/1999
• Status: Expired due to Fees

• Current Assignee: Memscap Incorporated
• Original Assignee: Viavi Solutions, Inc. (Lumentum Holdings Inc.)
• Inventors: Markus, Karen W., Wynands, Henry A., Wood, Robert L.
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/442,827
• Time in Patent Office: 1,167 Days
• Field of Search: 604/272, 604/35, 604/43, 604/46, 604/501, 604/506, 604/181, 604/183, 604/186, 604/191, 604/239, 604/261, 298/900.1, 298/901, 298/84, 29/173, 29/171, 164/272, 164/421, 164/439, 264/219, 264/239, 264/323, 216/75, 216/100, 216/102
• US Class Current: 604/272
• 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 5/150984 Microneedles or microblades
• 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: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 99/0085 using moulds and master templates, e.g. for hot-embossing
• CPC Class Codes: Y10T 29/302 Clad or other composite foil or thin metal making
• CPC Class Codes: Y10T 29/49222 forming array of contacts or terminals

Abstract

Microneedle arrays are fabricated by providing a sacrificial mold including a substrate and an array of posts, preferably solid posts, projecting therefrom. A first material is coated on the sacrificial mold including on the substrate and on the array of posts. The sacrificial mold is removed to provide an array of hollow tubes projecting from a base. The inner and outer surfaces of the array of hollow tubes are coated with a second material to create the array of microneedles projecting from the base. The sacrificial mold may be fabricated by fabricating a master mold, including an array of channels that extend into the master mold from a face thereof. A third material is molded into the channels and on the face of the master mold, to create the sacrificial mold. The sacrificial mold then is separated from the master mold. Alternatively, wire bonding may be used to wire bond an array of wires to a substrate to create the sacrificial mold. The first material preferably is coated on the sacrificial mold by plating. Prior to plating, a plating base preferably is formed on the sacrificial mold including on the substrate and on the array of posts. The inner and outer surfaces of the array of hollow tubes preferably are coated with the second material by overplating the second material on the inner and outer surfaces of the array of hollow tubes.

Claims

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

providing a soluble mold including a substrate and an array of posts projecting therefrom;

forming a plating base on the soluble mold including on the substrate and on the array of posts;

forming a plated first material on the plating base except for across the tips of the array of posts;

at least partially dissolving the soluble mold to provide an array of hollow tubes projecting from a base; and

overplating the outer surfaces of the array of hollow tubes with a second material to create the array of microneedles projecting from the base.

2. A method according to claim 1 wherein the step of providing a soluble mold comprises the steps of:

fabricating a master mold including an array of channels that extend into the master mold from a face thereof;

molding a soluble material into the channels and on the face of the master mold to create the soluble mold; and

separating the soluble mold from the master mold.

3. A method according to claim 1 further comprising the step of:

sharpening the tips of the array of hollow tubes.

4. A method according to claim 3 wherein the step of sharpening comprises the step of etching the tips of the array of hollow tubes.

5. A method according to claim 1 wherein the at least partially dissolving step comprises the step of at least partially dissolving the soluble mold and the plating base to provide an array of hollow tubes projecting from a base.

6. A method according to claim 1 wherein the step of forming a plated first material is preceded by the step of masking the tips of the array of posts to prevent plating of the tips.

7. A method according to claim 1 wherein the step of forming a plating base is preceded by the step of masking the tips of the soluble mold to prevent formation of the plating base on the tips.

8. A method according to claim 6 wherein the step of masking the tips comprises the step of masking the tips of the array of posts at an oblique angle thereto to prevent plating of an obliquely extending portion of the tips.

9. A method according to claim 7 wherein the step of masking the tips comprises the step of masking the tips of the soluble mold at an oblique angle thereto to prevent formation of the plating base on an obliquely extending portion of the tips.

10. A method according to claim 7 wherein the plating base comprises at least one of copper and gold, wherein the first material comprises at least one of nickel and chromium and wherein the second material comprises at least one of gold, rhodium, platinum and ruthenium.

11. A method according to claim 1 wherein the following step is performed between the steps of at least partially dissolving and overplating:

removing the tips of the hollow tubes to reduce the height of the hollow tubes.

12. A method according to claim 1 wherein the step of overplating comprises the step of:

overplating the inner and outer surfaces of the array of hollow tubes with the second material to create the array of microneedles projecting from the base.

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

providing a sacrificial mold including a substrate and an array of wires projecting therefrom;

forming a plated first material on the sacrificial mold including on the substrate and on the array of wires except for across the tips of the wires;

removing the sacrificial mold to provide an array of hollow tubes projecting from a base; and

overplating the outer surfaces of the array of hollow tubes with a second material to create the array of microneedles projecting from the base.

14. A method according to claim 13 wherein the step of providing a sacrificial mold comprises the step of wire bonding an array of wires to a substrate to create the sacrificial mold.

15. A method according to claim 14 wherein the steps of wire bonding, plating, removing and overplating are performed in a continuous process and wherein the step of overplating is followed by the step of singulating individual arrays of microneedles.

16. A method according to claim 14 wherein the step of wire bonding comprises the steps of:

wire bonding both ends of a plurality of wires to the substrate to create a plurality of loops of wires on the substrate; and

cutting the loops of wires to create the sacrificial mold.

17. A method according to claim 13 further comprising the step of:

sharpening the tips of the array of hollow tubes.

18. A method according to claim 17 wherein the step of sharpening comprises the step of etching the tips of the array of hollow tubes.

19. A method according to claim 13 wherein the step of forming a plated first material is preceded by the step of masking the tips of the array of wires to prevent plating of the tips.

20. A method according to claim 19 wherein the step of masking the tips comprises the step of masking the tips of the array of wires at an oblique angle to prevent plating of an obliquely extending portion of the tips.

21. A method according to claim 13 wherein the wires comprise at least one of copper and gold, wherein the first material comprises at least one of nickel and chromium and wherein the second material comprises at least one of gold, rhodium, platinum and ruthenium.

22. A method according to claim 13, wherein the following step is performed between the steps of removing and overplating:

removing the tips of the hollow tubes to reduce the height of the hollow tubes.

23. A method according to claim 13 wherein the step of overplating comprises the step of:

overplating the inner and outer surface of the array of hollow tubes with the second material to create the array of microneedles projecting from the base.