Microneedle devices and production thereof

• US 9,302,903 B2
• Filed: 12/14/2001
• Issued: 04/05/2016
• Est. Priority Date: 12/14/2000
• Status: Expired due to Fees

• Current Assignee: Valeritas, LLC
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Park, Jung-Hwan, Prausnitz, Mark R.
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US10/023,259
• Publication Number:
  US 20020082543A1
• Time in Patent Office: 5,226 Days
• Field of Search: 604/20, 604/21, 604/46, 604/181, 604/171, 604/173, 604/183, 604/184, 604/191, 604/239, 604/258, 604/272, 604/500, 604/506, 604/507, 604/273, 604/264, 128/898, 424/449, 424/483, 427/2.1, 427/2.13
• US Class Current: 1/1
• 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 5/150984 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: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 1/00111 Tips, pillars, i.e. raised structures microneedles A61M37/0015

Abstract

Microneedle devices and methods of manufacture are provided for transport of molecules or energy across or into biological barriers, such as skin. The device can comprise one or more microneedles formed of a first material and a second material, wherein the second material is dispersed throughout the first material or forms a portion of the microneedle. The first material preferably is a polymer. The second material can be pore forming agents, structural components, biosensor, or molecules for release, such as drug. The device also can comprise a substrate and a plurality of microneedles extending from the substrate, wherein the microneedles have a beveled or tapered tip portion, a longitudinally extending exterior channel, or both. Methods of making these devices include providing a mold having a plurality of microdepressions which define the surface of a microneedle; filling the microdepressions with a first molding material; and molding the material, thereby forming microneedles.

Claims

1. A device for transport of molecules or energy across or into a biological barrier, comprising:

a plurality of microneedles, wherein each microneedle formed of a first molding material, wherein the first molding material comprises a mixture of a) a polymer first material and b) a second material comprising rigid particles dispersed therein, wherein the first molding material is micromolded into the plurality of microneedles.

2. The device of claim 1, wherein the polymer is a biodegradable polymer.

3. The device of claim 2, wherein the polymer is selected from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid)s, poly(valeric acid)s, polyhydroxyalkanoates, degradable polyurethanes, copolymers thereof, and blends thereof.

4. The device of claim 1, wherein the polymer is a non-biodegradable polymer.

5. The device of claim 1, where in the second material comprises a metal.

6. The device of claim 1, wherein the first molding material further comprises a drug.

7. The device of claim 2, wherein the molding material comprises a drug.

8. The device of claim 7, wherein the drug is a vaccine.

9. The device of claim 2, wherein the biodegradable polymer is a soluble polymer.

10. The device of claim 1, wherein the molding material comprises a salt or other leachable particle.

11. The device of claim 1, further comprising a substrate from which the plurality of microneedles extend.

12. The device of claim 1, wherein the microneedles have lengths between about 10 and 1000 microns.

13. The device of claim 12, wherein the microneedles have widths between about 10 and 500 microns.

14. The device of claim 1, wherein the second material undergoes a temperature sensitive phase change at human body temperature.

15. The device of claim 14, where in the second material is a hydrate.

16. The device of claim 1, wherein the first material and second material are disposed in a layered relationship with respect to each other.

17. The device of claim 16, wherein the first material and second material are disposed in an alternating horizontal layer configuration with respect to each other.

18. The device of claim 1 wherein the polymer first material is a porous material and the second material is filled into the voids or pores of the first material.

19. The device of claim 1 wherein the second material is a rapidly degradable polymer particle.

20. A device for transport of molecules or energy across or into a biological barrier, comprising;

a plurality of microneedles, each microneedle formed of a polymer first material and a second material, wherein the second material comprises rigid particles that are dispersed throughout at least a portion of the polymer and wherein the first material and second material are disposed in a layered relationship with respect to each other, and wherein the first material and second material are disposed in an alternating horizontal layer configuration with respect to each other.

21. The device of claim 20, further comprising a substrate from which the plurality of microneedles extend.

22. The device of claim 20, wherein the polymer is a biodegradable polymer.

23. The device of claim 22, wherein the molding material comprises a drug.

24. The device of claim 22, wherein the biodegradable polymer is a soluble polymer.

25. The device of claim 20, wherein the molding material further comprises a drug.

26. The device of claim 20, wherein the second material comprises a vaccine.

27. A device for transport of molecules or energy across or into a biological barrier comprising;

a plurality of microneedles, each microneedle formed of a first molding material, wherein the first molding material comprises a mixture of a) a polymer first material and b) a second material, comprising rigid particles dispersed therein; and

a substrate from which the plurality of microneedles extend.

28. The device of claim 27, wherein the polymer first material is a biodegradable polymer.

29. The device of claim 28, wherein the molding material comprises a drug.

30. The device of claim 28, wherein the biodegradable polymer is a soluble polymer.

31. The device of claim 27, wherein the molding material further comprises a drug.

32. The device of claim 27, wherein the second material undergoes a temperature sensitive phase change at human body temperature.

33. The device of claim 32, wherein the second material is a hydrate.

34. The device of claim 27, wherein the first material and second material are disposed in a layered relationship with respect to each other.

35. The device of claim 34, wherein the first material and second material are disposed in an alternating horizontal layer configuration with respect to each other.

36. The device of claim 27, wherein the second material comprises a vaccine.