Device and method for enhancing transdermal flux of agents being delivered or sampled

1. A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising a sheet having a least one opening therethrough and a plurality of blades extending downward therefrom, an adhesive anchor applied to at least one surface of said sheet, wherein said adhesive anchor helps prevent said sheet from being dislodged from said body surface, and an agent delivery or sampling device connected to said sheet and positioned to deliver or sample an agent through said opening, said agent delivery or sampling device being selected from the group consisting of an electrotransport device, a passive diffusion device, an osmotic device, and a pressure driven device, and wherein a plurality of blades has a substantially identical and uniform configuration.

2. The device of claim 1 , wherein said agent comprises a polypeptide or protein.

3. The device of claim 1 , further comprising at least one additional anchoring means selected from the group consisting of a projection extending out from at least one blade of said plurality of blades, a barb, at least one opening extending through said plurality of blades, each one of the plurality of blades defines essentially a plane and wherein said additional anchoring means comprises a portion of said plurality of blades being oriented at an angle of about 90° with respect to a remaining portion of said plurality of blades, and wherein each one of said plurality of blades defines essentially a plane and wherein said additional anchoring means comprises a portion of said plurality of blades being oriented at an angle within a range of about 10° to about 89° with respect to a remaining portion of said plurality of blades.

4. The device of claim 3 , wherein said projection extends out from a plane defined by at least one blade.

5. The device of claim 1 , wherein said anchor is integral with an edge of said plurality of blades and in a plane defined by said plurality of blades.

6. The device of claim 1 , wherein a portion of said blades are located along a periphery of an opening through said sheet.

7. The device of claim 1 , wherein a portion of said blades are located along peripheries of a plurality of openings through said sheet.

8. The device of claim 1 , further comprising a plurality of second openings through said sheet.

9. The device of claim 1 , wherein said device has a blade density of about 600 to about 1000 blades/cm 2 .

10. The device of claim 1 , wherein said device has a blade density of at least about 800 blades/cm 2 .

11. The device of claim 1 , wherein at least a portion of said blades has a length sufficient to pierce the stratum corneum of said body surface to a depth of at least about 25 μm.

12. The device of claim 1 , wherein said blades are oriented approximately perpendicular to said sheet.

13. The device of claim 1 , wherein said blades are oriented at an angle in a range of about 10° to about 89° to said sheet.

14. The device of claim 1 , wherein said blades are oriented at an angle in a range of about 10° to about 60° to said sheet.

15. The device of claim 1 , wherein at least a portion of said blades have a thickness in a range of about 7 μm to about 100 μm.

16. The device of claim 1 , wherein at least a portion of said blades have a thickness in a range of about 25 μm to about 500 μm.

17. The device of claim 1 , wherein said blades are composed of a material selected from the group consisting of metals, metal alloys, glasses, ceramics and rigid polymers.

18. The device of claim 1 , wherein said sheet and said blades are substantially impermeable to passage of said agent.

19. The device of claim 1 , wherein said blades are thinner than said sheet.

20. The device of claim 1 wherein said sheet has openings per unit area in a range of at least about 10 openings/cm 2 to about 1000 openings/cm 2 .

21. The device of claim 20 having a blade density per unit area in a range of about 10 blades/cm 2 to about 1000 blades/cm 2 .

22. The device of claim 21 wherein said blade density per unit area is in a range of about 600 blades/cm 2 to about 1000 blades/cm 2 .

23. The device of claim 22 wherein said blade density per unit area is in a range of about 800 blades/cm 2 to about 1000 blades/cm 2 .

24. The device of claim 1 , having a percolation area in a range of about 0.005 to 0.05 cm 2 /cm 2 of body surface.