Intracutaneous edged microneedle apparatus

• US 6,652,478 B1
• Filed: 05/26/2000
• Issued: 11/25/2003
• Est. Priority Date: 06/09/1999
• Status: Expired due to Term

• Current Assignee: Corium, Inc.
• Original Assignee: The Procter & Gamble Company
• Inventors: Gartstein, Vladimir, Sherman, Faiz Feisal, Owens, Grover David, Arias, Francisco, Yuzhakov, Vadim Vladimirovich, Nebrigic, Dragan Danilo
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/580,780
• Time in Patent Office: 1,278 Days
• Field of Search: 604/19-22
• US Class Current: 604/22
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• 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 2037/0023 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
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 99/0085 using moulds and master templates, e.g. for hot-embossing

Abstract

A hollow microneedle with a substantially sharp edge is provided that includes at least one longitudinal blade at the top surface or tip of the microneedle to aid in penetration of the stratum corneum of skin. In a preferred embodiment, there are two such longitudinal blades that are constructed on opposite surfaces at approximately a 180° angle along the cylindrical side wall of the microneedle. Each edged blade has a cross-section that, when viewed from above the microneedle top, has an isosceles triangle profile. The blade'"'"'s edge can run the entire length of the microneedle from its very top surface to its bottom surface where it is mounted onto the substrate, or the edge can be discontinued partway down the length of the microneedle. A star-shaped solid microneedle also is provided having at least one blade with a relatively sharp edge to assist in penetrating the stratum corneum of skin. In a preferred embodiment, a three pointed star-shape is used, in which each blade has an isosceles triangular cross-section when viewed from the top of the microneedle. The base of each of the isosceles triangles meets at a center of the microneedle to form the star-shaped structure. At least one hole through the substrate is located near the side surfaces of the pairs of blades of the solid microneedle.

Claims

1. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a side wall extending between said first end and said second end, and of a length therebetween; and

said side wall having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle, wherein said longitudinal element exhibits a substantially cylindrical shape.

2. The microneedle structure as recited in claim 1, wherein said second end is in contact with a base element.

3. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a side wall extending between said first end and said second end, and of a length therebetween; and

said side wall having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle, wherein said second end is in contact with a base element and wherein said first end includes. an opening that does not extend through said base element.

4. The microneedle structure as recited in claim 3, wherein said opening is substantially filled with a leachable substance.

5. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a side wall extending between said first end and said second end, and of a length therebetween; and

said side wall having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle, wherein said first end includes an opening which runs from said first end throughout said length of the longitudinal element to said second end thereby forming a hollow microneedle.

6. The microneedle structure as recited in claim 5, wherein said longitudinal element exhibits a substantially cylindrical shape, and said side wall comprises a hollow tubular structure.

7. The microneedle structure as recited in claim 6, wherein said at least one substantially sharp edge comprises a pair of blade members that protrude from opposite areas of said tubular side wall, and each of said pair of blade members exhibits a substantially sharp edge that runs substantially parallel to a longitudinal axis of said longitudinal element.

8. The microneedle structure as recited in claim 7, wherein said blade members each comprise a substantially isosceles triangular cross-sectional profile, as viewed from said first end of the longitudinal element, in which a proximal tip of said triangular profile forms said at least one substantially sharp edge.

9. The microneedle structure as recited in claim 8, wherein said blade members each comprise a substantially smooth contoured surface, as viewed from said first end of the longitudinal element, until coming to a substantially sharp point at a proximal location of said blade member, in which said substantially sharp point forms said at least one substantially sharp edge.

10. The microneedle structure as recited in claim 9, wherein said at least one substantially sharp edge runs from said first end substantially to said second end.

11. The microneedle structure as recited in claim 10, wherein said at least one substantially sharp edge runs from said first end only part-way to said second end.

12. The microneedle structure as recited in claim 8, wherein said at least one substantially sharp edge runs from said first end substantially to said second end.

13. The microneedle structure as recited in claim 12, wherein said at least one substantially sharp edge runs from said first end only part-way to said second end.

14. The microneedle structure as recited in claim 5, wherein said first end comprises a substantially flat surface in a transverse direction perpendicular to said longitudinal element.

15. The microneedle structure as recited in claim 5, wherein said first end comprises a curved surface having at least one pointed member in a transverse direction perpendicular to said longitudinal element.

16. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a plurality of blade members extending from said first end toward said second end;

said longitudinal element having a length between said first and second ends; and

each of said blade members having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle.

17. The microneedle structure as recited in claim 16, wherein said blade members each comprise a substantially isosceles triangular cross-sectional profile, as viewed from said first end of the longitudinal element, in which a proximal tip of said triangular profile forms said at least one substantially sharp edge.

18. The microneedle structure as recited in claim 17, wherein said at least one substantially sharp edge runs from said first end substantially to said second end.

19. The microneedle structure as recited in claim 17, wherein said blade members each comprise a substantially smooth contoured surface, as viewed from said first end of the longitudinal element, until coming to a substantially sharp point at a proximal location of said blade member, in which said substantially sharp point forms said at least one substantially sharp edge.

20. The microneedle structure as recited in claim 16, further comprising at least one through-hole between a first side and a second side of said base element, said comprising at least one through-hole being located proximal to the second end of said longitudinal element.

21. The microneedle structure as recited in claim 20, wherein said at least one through-hole is located proximal to two of said plurality of blade members.

22. The microneedle structure as recited in claim 16, wherein said second end is in contact with a base element.

23. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a plurality of blade members extending from said first end toward said second end;

said longitudinal element having a length between said first and second ends; and

each of said blade members having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle, wherein said substantially sharp edge of the blade members runs substantially parallel to a longitudinal axis of said longitudinal element.

24. The microneedle structure as recited in claim 23, wherein said first end comprises a substantially flat surface in a transverse direction perpendicular to said longitudinal element.

25. A microneedle structure, comprising:

a longitudinal element having a first end and a second end, said longitudinal element having a plurality of blade members extending from said first end toward said second end;

said longitudinal element having a length between said first and second ends; and

each of said blade members having at least one substantially sharp edge running from said first end toward said second end, thereby forming an edged microneedle, wherein said blade members each comprise a substantially isosceles triangular cross-sectional profile, as viewed from said first end of the longitudinal element, in which a proximal tip of said triangular profile forms said at least one substantially sharp edge, and wherein said at least one substantially sharp edge runs from said first end only part-way to said second end.