Drilling microneedle device

• US 20050137525A1
• Filed: 06/04/2004
• Published: 06/23/2005
• Est. Priority Date: 06/04/2003
• Status: Abandoned Application

• Current Assignee: Valeritas, LLC
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Wang, Ping Ming, Prausnitz, Mark R.
• Application Number:
  US10/861,244
• Publication Number:
  US 20050137525A1
• Time in Patent Office: Days
• US Class Current: 604/93.10
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61M 2005/3289 with rotation of the needle, e.g. to ease penetration
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• 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
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Rotating microneedles and microneedle arrays are disclosed that “drill” holes into a biological barrier, such as skin. The holes can of controlled depth and diameter and suitable for microsurgery, administering drugs and withdrawal of body fluids.

Claims

1. A microneedle device comprising:

a microneedle tip for penetrating a biological barrier, said microneedle adapted to rotate about a longitudinal axis before, during, and/or after the penetration of the biological barrier.

2. The microneedle device of claim 1, comprising:

(1) a holder with a bottom surface for contacting said biological barrier, and an opening in said bottom surface allowing said microneedle to pass through;

(2) an insert rotatably disposed inside said holder, said insert having a through bore configured to receive said microneedle so positioned to pass through said opening.

3. The microneedle device of claim 2, wherein said bottom surface is convex.

4. The microneedle device of claim 2, wherein said bottom surface is concave.

5. The microneedle device of claim 4, wherein said concave-shaped bottom surface has a port connected to a suction device for applying a suction force and stretching said biological barrier.

6. The microneedle device of claim 2, wherein said bottom surface has a beveled-shape, a dome-shape, an inverse dome shape, a curve with the outside-shape of a barrel, a curve with the inside-shape of a barrel, or is connected to a suction cup.

7. The microneedle device of claim 2, wherein said biological barrier is skin.

8. The microneedle device of claim 2, wherein the outside surface of said insert engages the inside surface of said holder through spiral-shaped grooves or threads.

9. The microneedle device of claim 8, wherein said threads are on the outside surface of said insert.

10. The microneedle device of claim 2, wherein the maximum displacement distance of said insert relative to said holder along the longitudinal axis is limited by a limit stop protruding from the outside surface of said insert, at a pre-determined position from the top of said holder.

11. The microneedle device of claim 10, wherein the position of said limit stop is adjustable relative to the insert.

12. The microneedle device of claim 2, wherein the maximum displacement distance of said insert relative to said holder along the longitudinal axis is limited by a limit stop protruding from the inside surface of said holder, at a pre-determined position from the bottom of said insert.

13. The microneedle device of claim 12, wherein the position of said limit stop is adjustable relative to the holder.

14. The microneedle device of claim 2, wherein the outside surface of said insert engages the inside surface of said holder through spiral-shaped grooves or threads, and wherein the maximum displacement distance of said insert relative to said holder along the longitudinal axis is limited by a limited depth of said grooves or threads on the inside surface of said holder.

15. The microneedle device of claim 2, further comprising a sealing element for sealing the space of the microneedle tip against the ambient.

16. The microneedle device of claim 15, further comprising an O-ring between said sealing element and said insert, for sealing the microneedle against said insert.

17. The microneedle device of claim 2, wherein the movement of said insert along the longitudinal axis is effectuated by a mechanical coupling element attached to said insert.

18. The microneedle device of claim 17, wherein said mechanical coupling element comprises a wrench flat.

19. The microneedle device of claim 17, wherein said mechanical coupling element comprises a gear for coupling to another gear, a motor, or a micromotor.

20. The microneedle device of claim 17, wherein said mechanical coupling element comprises a handle.

21. The microneedle device of claim 2, having an expanding spring for pushing the top of said insert.

22. The microneedle device of claim 2, having a retracting spring inside said holder for pulling the bottom of said insert.

23. The microneedle device of claim 2, having a vacuum for generating a sub-atmospheric pressure inside the chamber bounded by the bottom of the insert, the inside wall of the holder, and the portion of the biological barrier contacting the opening, and wherein said vacuum or sub-atmospheric pressure is generated by a suction device connected to said chamber.

24. The microneedle device of claim 23, further comprising a spring inside said chamber, wherein the extension force generated by said spring facilitates retraction of said microneedle from said biological barrier after the vacuum is released.

25. The microneedle device of claim 2, wherein said microneedle is connected to a fluid reservoir storing fluids to be delivered across the biological barrier.

26. The microneedle device of claim 25, wherein said fluid reservoir generates a positive pressure to force the fluids into the microneedle.

27. The microneedle device of claim 26, wherein said positive pressure is generated after the penetration of said microneedle tip into the biological barrier.

28. The microneedle device of claim 2, wherein said microneedle is connected to a fluid reservoir for storing fluids extracted below the surface of the biological barrier.

29. The microneedle device of claim 28, wherein said fluid reservoir generates a negative pressure to extract fluids through the microneedle and from below the penetrated biological barrier.

30. The microneedle device of claim 29, wherein said negative pressure is generated after the penetration of said microneedle tip into the biological barrier.

31. The microneedle device of claim 2, wherein the microneedle tip is tapered.

32. The microneedle device of claim 2, wherein the microneedle tip is blunt.

33. The microneedle device of claim 2, wherein the microneedle tip is serrated.

34. The microneedle device of claim 2, wherein a spiral pattern is disposed on the outer surface of the microneedle tip.

35. The microneedle device of claim 2, wherein the microneedle tip is made of glass and covered with a plastic material.

36. The microneedle device of claim 2, wherein the microneedle tip is transparent/translucent.

37. The microneedle device of claim 2, further including a suction cup or mechanical stretching device to stretch the biological barrier to facilitate penetration by the microneedle tip.

38. The microneedle device of claim 2, wherein said insert comprises a plurality of through-bores, each configured to receive one additional microneedle, said microneedles are so arranged for rotating about a common longitudinal axis.

39. The microneedle device of claim 38, wherein the tips of said microneedles are so arranged to converge to the same area.

40. The microneedle device of claim 38, wherein each of said microneedles is independently connected to its own fluid reservoir.

41. The microneedle device of claim 40, wherein at least two of said fluid reservoirs contain different fluids.

42. The microneedle device of claim 2, wherein said insert comprises a plurality of through-bores, each configured to receive one additional microneedle, said microneedles are so arranged for rotating about their own longitudinal axis.

43. The microneedle device of claim 42, further comprising a drive to commonly drive at least two of said microneedles.

44. The microneedle device of claim 43, wherein the drive includes a common drive shaft with a gear wheel that engages with gear wheels disposed on the commonly driven microneedles.

45. The microneedle device of claim 2, wherein the microneedle is made of glass, silicon, or metal.

46. The microneedle device of claim 2, wherein the microneedle is made of a transparent or translucent material.

47. The microneedle device of claim 2, wherein the microneedle is coated with a plastic or polymer layer.

48. The microneedle device of claim 2, wherein the maximum penetration depth into the biological barrier is less than 1 mm or 500 μ

m.