Microneedle arrays and methods of manufacturing the same

• US 6,881,203 B2
• Filed: 09/05/2001
• Issued: 04/19/2005
• Est. Priority Date: 09/05/2001
• Status: Expired due to Fees

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Huntley, Douglas A., Fleming, Patrick R., Thomas, Cristina U., Keister, Jamieson C., Delmore, Michael D., Ferber, Richard H.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): DeSanto, Matthew F
• Application Number:
  US09/947,195
• Publication Number:
  US 20030045837A1
• Time in Patent Office: 1,322 Days
• Field of Search: 604/20, 604/22, 604272-274, 604/27, 604/173, 604/46, 264/400, 264/225, 163/1
• US Class Current: 604/272
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• 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

Abstract

Microneedle arrays, methods of manufacturing microneedles and methods of using microneedle arrays. The microneedles in the microneedle arrays may be in the form of tapered structures that include at least one channel formed in the outside surface of each microneedle. The microneedles may have bases that are elongated in one direction. The channels in microneedles with elongated bases may extend from one of the ends of the elongated bases towards the tips of the microneedles. The channels formed along the sides of the microneedles may optionally be terminated short of the tips of the microneedles. The microneedle arrays may also include conduit structures formed on the surface of the substrate on which the microneedle array is located. The channels in the microneedles may be in fluid communication with the conduit structures. One manner of using microneedle arrays of the present invention is in methods involving the penetration of skin to deliver medicaments or other substances and/or extract blood or tissue.

Claims

1. A microneedle array device comprising:

a plurality of microneedles projecting from a substrate surface, wherein each of the microneedles comprises a tapered shape comprising an outer surface, a base proximate the substrate surface, and a tip distal from the base, and further wherein the base is elongated along an elongation axis on the substrate surface such that the base comprises opposing ends along the elongation axis;

a channel formed in the outer surface of each microneedle of the plurality of microneedles, each channel extending from the base towards the tip of the microneedle, wherein the channel terminates short of the tip of the microneedle; and

a conduit structure formed on the substrate surface, the channel in each microneedle of the plurality of microneedles is in fluid communication with the conduit structure on the substrate surface.

2. A device according to claim 1, wherein the channel extends from one of the opposing ends of the elongated base towards the tip of the microneedle.

3. A device according to claim 1, wherein the channel extends from an intermediate location between the opposing ends of the elongated base towards the tip of the microneedle.

4. A device according to claim 1, wherein the base comprises an oval.

5. A device according to claim 1, wherein the channel comprises a channel depth, and further wherein the channel depth at the base of the microneedle is less than half of the dimension of the base as measured between the opposing ends.

6. A device according to claim 1, wherein the elongation axes of the plurality of microneedles are aligned with each other on the substrate surface.

7. A device according to claim 1, wherein the conduit structure comprises a series of barriers projecting from the substrate surface, with fluid pathways of the conduit structure being defined by the barriers.

8. A microneedle array device comprising:

a plurality of microneedles projecting from a substrate surface, wherein each of the microneedles comprises a tapered shape comprising an outer surface, a base proximate the substrate surface and a tip distal from the base;

a channel formed in the outer surface of each microneedle of the plurality of microneedles, each channel extending from the base of the microneedle towards the tip of the microneedle, wherein the channel terminates short of the tip of the microneedle; and

a conduit structure formed on the substrate surface, the channel in each microneedle of the plurality of microneedles is in fluid communication with the conduit structure on the substrate surface.

9. A device according to claim 8, wherein, for each microneedle of the plurality of microneedles, the base of the microneedle is elongated along an elongation axis on the substrate surface such that the base comprises opposing ends along the elongation axis, and wherein the channel extends from one of the opposing ends of the elongated base towards the tip of the microneedle.

10. A device according to claim 9, wherein the elongation axes of the plurality of microneedles are aligned with each other on the substrate surface.

11. A device according to claim 8, wherein, for each microneedle of the plurality of microneedles, the base of the microneedle is elongated along an elongation axis on the substrate surface such that the base comprises opposing ends along the elongation axis, and wherein the channel extends from an intermediate location between the opposing ends of the elongated base towards the tip of the microneedle.

12. A device according to claim 11, wherein the elongation axes of the plurality of microneedles are aligned with each other on the substrate surface.

13. A device according to claim 8, wherein the base comprises an oval.

14. A device according to claim 8, wherein the channel comprises a channel depth, and further wherein the channel depth at the base of the microneedle is less than half of a maximum dimension of the base on the substrate surface.

15. A device according to claim 8, wherein the conduit structure comprises a series of barriers projecting from the substrate surface, with fluid pathways of the conduit structure being defined by the barriers.

16. A microneedle array device comprising:

a plurality of microneedles projecting from a substrate surface on a substrate, wherein each of the microneedles comprises a tapered shape comprising an outer surface, a base proximate the substrate surface, and a tip distal from the base, and further wherein the base is elongated along an elongation axis on the substrate surface such that the base comprises opposing ends along the elongation axis;

a channel formed in the outer surface of each microneedle of the plurality of microneedles, each channel extending from the base towards the tip of the microneedle, wherein the channel does not extend through the substrate, and wherein the channel terminates short of the tip of the microneedle; and

a conduit structure formed on the substrate surface, the channel in each microneedle of the plurality of microneedles is in fluid communication with the conduit structure on the substrate surface.

17. A device according to claim 16, wherein the channel extends from one of the opposing ends of the elongated base towards the tip of the microneedle.

18. A device according to claim 16, wherein the channel extends from an intermediate location between the opposing ends of the elongated base towards the tip of the microneedle.

19. A device according to claim 16, wherein the base comprises an oval.

20. A device according to claim 16, wherein the channel comprises a channel depth, and further wherein the channel depth at the base of the microneedle is less than half of the dimension of the base as measured between the opposing ends.

21. A device according to claim 16, wherein the elongation axes of the plurality of microneedles are aligned with each other on the substrate surface.

22. A device according to claim 16, wherein the conduit structure comprises a series of barriers projecting from the substrate surface, with fluid pathways of the conduit structure being defined by the barriers.

23. A microneedle array device comprising:

a plurality of microneedles projecting from a substrate surface on a substrate, wherein each of the microneedles comprises a tapered shape comprising an outer surface, a base proximate the substrate surface and a tip distal from the base;

a channel formed in the outer surface of each microneedle of the plurality of microneedles, each channel extending from the base of the microneedle towards the tip of the microneedle, wherein the channel terminates short of the tip of the microneedle, and wherein the channel does not extend through the substrate; and

a conduit structure formed on the substrate surface, the channel in each microneedle of the plurality of microneedles is in fluid communication with the conduit structure on the substrate surface.

24. A device according to claim 23, wherein the base comprises an oval.

25. A device according to claim 23, wherein the channel comprises a channel depth, and further wherein the channel depth at the base of the microneedle is less than half of a maximum dimension of the base on the substrate surface.

26. A device according to claim 23, wherein the conduit structure comprises a series of barriers projecting from the substrate surface, with fluid pathways of the conduit structure being defined by the barriers.