Device and method for enhancing transdermal flux of agents being sampled
First Claim
1. An apparatus for piercing the stratum corneum and withdrawing a body fluid therethrough for sampling an agent in the fluid, comprising:
- a piercing member having a plurality of stratum corneum-piercing microblades, wherein the microblades having a length sufficient to pierce the stratum corneum to a depth in the range of about 25 μ
m to about 400 μ
m, the microblades being arranged on a stratum corneum-contacting portion of the apparatus, the piercing member having a plurality of fluid flow pathways therethrough, and a partial vacuum applying device connected to the piercing member for applying a partial vacuum in a range of about 0.1 atm to about 0.8 atm over a period of about 2 seconds to about 30 seconds through the fluid flow pathways to the pierced stratum corneum for withdrawing the body fluid.
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Abstract
A transdermal agent sampling device is provided. The sampling device is comprised of a microblade array and a device for applying a partial vacuum. The microblade array comprises a sheet having a plurality of microblades for piercing the skin to a very shallow depth (i.e., 25 μm to 400 μm) to create microslits in the outermost stratum corneum layer of the skin. The partial vacuum applying device applies a partial vacuum in the range of about 0.1 to about 0.8 atm, and preferably about 0.3 to about 0.7 atm, for sampling a body analyte such as glucose in interstitial fluid. The partial vacuum is applied for a period of about 2 to about 30 seconds, and preferably about 5 to about 15 seconds. The interstial fluid is analyzed for body analyte (e.g., glucose) content or concentration.
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Citations
25 Claims
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1. An apparatus for piercing the stratum corneum and withdrawing a body fluid therethrough for sampling an agent in the fluid, comprising:
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a piercing member having a plurality of stratum corneum-piercing microblades, wherein the microblades having a length sufficient to pierce the stratum corneum to a depth in the range of about 25 μ
m to about 400 μ
m, the microblades being arranged on a stratum corneum-contacting portion of the apparatus, the piercing member having a plurality of fluid flow pathways therethrough, anda partial vacuum applying device connected to the piercing member for applying a partial vacuum in a range of about 0.1 atm to about 0.8 atm over a period of about 2 seconds to about 30 seconds through the fluid flow pathways to the pierced stratum corneum for withdrawing the body fluid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of sampling an agent, comprising:
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a) piercing the stratum corneum with a piercing member having a plurality of microblades wherein the microblades having a length sufficient to pierce the stratum corneum to a depth in the range about 25 μ
m to about 400 μ
m;
b) applying a partial vacuum in the range of about 0.1 atm to about 0.8 atm to the pierced stratum corneum over a period of about 2 seconds to about 30 seconds to withdraw a body fluid containing the agent; and
c) analyzing for the agent. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25)
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Specification