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1. CA2394171 - DISPOSITIF DESTINE A AUGMENTER LE FLUX TRANSDERMIQUE DE SUBSTANCES ECHANTILLONNEES

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Claims:
1. An apparatus (10) for piercing the stratum corneum and withdrawing a body fluid therethrough for sampling an agent in the fluid, including a piercing member (2) having a plurality of stratum corneumpiercing microblades (4), wherein the microblades (4) have a length sufficient to pierce the stratum corneum to a depth in the range of about 25 to about 400 µm, the microblades (4) being arranged on a stratum corneum-contacting portion (48) of the apparatus, the piercing member (2) having a plurality of fluid flow pathways (8) therethrough, the apparatus (10) being characterized by: a partial vacuum applying device (11,12) connected to the piercing member (2) for applying a partial vacuum in a range of about 0.1 to about 0.8 atm over a period of about 2 to about 30 seconds through the fluid flow pathways (8) to the pierced stratum corneum for withdrawing the body fluid.
2. The apparatus of claim 1, wherein the agent is selected from the group consisting of body electrolytes, illicit drugs and glucose.
3. The apparatus of claim 1, the body fluid is interstitial fluid.
4. The apparatus of claim 3, wherein the body fluid is substantially free of blood.
5. The apparatus of claim 1, wherein the piercing member (2) comprises a sheet (6) having a multiplicity of openings (8) therethrough and a multiplicity of microblades (4) extending downward therefrom.
6. The apparatus of claim 5, wherein the microblades (4) are located along peripheries of the openings (8) through the sheet (6).
7. The apparatus of claim 1, wherein the piercing member (2') comprises a plurality of spaced sheets (106), each of the sheets (106) having a stratum corneum-contacting edge having a plurality of the microblades extending therefrom, the fluid flow pathways being voids (127) between adjacent sheets (106).
8. The apparatus of claim 1, wherein the piercing member (2) has about 20 to about 1000 microblades/cm2.
9. The apparatus of claim 1, wherein the partial vacuum applying device applies a partial vacuum of about 0.3 to about 0.7 atm.
10. The apparatus of claim 1, wherein the partial vacuum applying device applies the partial vacuum for a period of about 5 to about 15 seconds.
11. The apparatus of claim 1, wherein the partial vacuum applying device comprises a suction cup (12) sealingly mounted on the piercing member (2).
12. The apparatus of claim 11, wherein the suction cup (12) is composed of a flexible material, the cup resiliently recovering its size and shape after applying a compressive force thereto.
13. The apparatus of claim 1, wherein the suction cup includes a oneway air valve (11).
14. The apparatus of claim 1, wherein the partial vacuum applying device comprises an animal venom extractor (20).
15. The apparatus of claim 14, wherein the animal venom extractor (20) comprises a syringe body (22) having a stratum corneum engaging skirt
(40) and a piston (31) and a rod (34) having an air passageway (33) extending therethrough.
16. The apparatus of claim 1, wherein the partial vacuum applying device (120) comprises a syringe body (122) having an open stratum corneum-engaging end and a piston-rod assembly (124) having an air passageway (133) extending therethrough, the syringe body (122) also containing a spring-loaded plunger unit (123) having the piercing member (2) mounted thereon.
17. Use of the apparatus of claim 1 to withdraw a body fluid through the stratum corneum and to sample an agent in the fluid.
18. The use of claim 17, wherein the agent is selected from the group consisting of body analytes, electrolytes, blood gases, illicit drugs, licit drugs and glucose.
19. The use of claim 17, the body fluid is interstitial fluid.
20. The use of claim 19, wherein the fluid is substantially free of blood.
21. The use of claim 17, wherein the piercing member (2) comprises a sheet (6) having a multiplicity of fluid flow pathways (8) therethrough and a multiplicity of microblades (4) extending therefrom.
22. The use of claim 21, wherein the partial vacuum is applied through the fluid flow pathways (8) to withdraw the body fluid through the fluid flow pathways (8).
23. The use of claim 17, including collecting the body fluid.
24. The use of claim 17, wherein the partial vacuum is about 0.3 to about 0.7 atm.
25. The use of claim 17, wherein the partial vacuum is applied for a period of about 5 to about 15 seconds.