US6562014B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device and method for enhancing transdermal flux of agents being sampled
Assignee: Alza Corp
•
Filing: 2000-12-14
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Granted: 2003-05-13
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Expires: 2020-12-14
Abstract
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.
Inventors
- 👤 Wei-Qi Lin
- 👤 Michel J. N. Cormier
- 👤 Felix Theeuwes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 04:30
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/14532; A61B10/00; A61B10/0045; A61B5/15; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150053; A61B5/150061; A61B5/150099; A61B5/150206; A61B5/150221; A61B5/150236; A61B5/150244; A61B5/150977; A61B5/150984; A61B17/00; A61B17/20; A61B17/205; A61B2010/0009; A61B2010/008; A61M; A61M37/00; A61M2037/0007
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
133 words
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 μm to about 400 μm, 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.
Claim 2
Independent Claim
133 words
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 μm to about 400 μm, 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.
Claim 3
Dependent Claim
22 words
The apparatus of claim 1 , wherein the agent is selected from the group consisting of body electrolytes, illicit drugs and glucose.
Claim 4
Dependent Claim
12 words
The apparatus of claim 1 , the body fluid is interstitial fluid.
Claim 5
Dependent Claim
15 words
The apparatus of claim 3 , wherein the body fluid is substantially free of blood.
Claim 6
Dependent Claim
27 words
The apparatus of claim 1 , wherein the piercing member comprises a sheet having a multiplicity of openings therethrough and a multiplicity of microblades extending downward therefrom.
Claim 7
Dependent Claim
19 words
The apparatus of claim 5 , wherein the microblades are located along peripheries of the openings through the sheet.
Claim 8
Dependent Claim
42 words
The apparatus of claim 1 , wherein the piercing member comprises a plurality of spaced sheets, each of the sheets having a stratum corneum-contacting edge having a plurality of the microblades extending therefrom, the fluid flow pathways being voids between adjacent sheets.
Claim 9
Dependent Claim
21 words
The apparatus of claim 1 , wherein the piercing member has about 20 microblades/cm 2 to about 1000 microblades/cm 2 .
Claim 10
Dependent Claim
24 words
The apparatus of claim 1 , wherein the partial vacuum applying device applies a partial vacuum of about 0.3 atm to about 0.7 atm.
Claim 11
Dependent Claim
27 words
The apparatus of claim 1 , wherein the partial vacuum applying device applies the partial vacuum for a period of about 5 seconds to about 15 seconds.
Claim 12
Dependent Claim
22 words
The apparatus of claim 1 , wherein the partial vacuum applying device comprises a suction cup sealingly mounted on the piercing member.
Claim 13
Dependent Claim
30 words
The apparatus of claim 11 , wherein the suction cup is composed of a flexible material, the cup resiliently recovering its size and shape after applying a compressive force thereto.
Claim 14
Dependent Claim
15 words
The apparatus of claim 1 , wherein the suction cup includes a one-way air valve.
Claim 15
Dependent Claim
17 words
The apparatus of claim 1 , wherein the partial vacuum applying device comprises an animal venom extractor.
Claim 16
Dependent Claim
32 words
The apparatus of claim 14 , wherein the animal venom extractor comprises a syringe body having a stratum corneum engaging skirt and a piston and plunger having an air passageway extending therethrough.
Claim 17
Dependent Claim
46 words
The apparatus of claim 1 , wherein the partial vacuum applying device comprises a syringe body having an open stratum corneum-engaging end and a piston-plunger assembly having an air passageway extending therethrough, the syringe body also containing a spring-loaded plunger unit having the microblades mounted thereon.
Claim 18
Independent Claim
92 words
A method of sampling an agent, comprising: 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 μm to about 400 μm; 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.
Claim 19
Independent Claim
92 words
A method of sampling an agent, comprising: 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 μm to about 400 μm; 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.
Claim 20
Dependent Claim
27 words
The method of claim 17 , wherein the agent is selected from the group consisting of body analytes, electrolytes, blood gases, illicit drugs, licit drugs and glucose.
Claim 21
Dependent Claim
12 words
The method of claim 17 , the body fluid is interstitial fluid.
Claim 22
Dependent Claim
14 words
The method of claim 19 , wherein the fluid is substantially free of blood.
Claim 23
Dependent Claim
28 words
The method of claim 17 , wherein the piercing member comprises a sheet having a multiplicity of fluid flow pathways therethrough and a multiplicity of microblades extending therefrom.
Claim 24
Dependent Claim
27 words
The method of claim 21 , wherein the partial vacuum is applied through the fluid flow pathways to withdraw the body fluid through the fluid flow pathways.
Claim 25
Dependent Claim
11 words
The method of claim 17 , including collecting the body fluid.
Claim 26
Dependent Claim
18 words
The method of claim 17 , wherein the partial vacuum is about 0.3 atm to about 0.7 atm.
Claim 27
Dependent Claim
22 words
The method of claim 17 , wherein the partial vacuum is applied for a period of about 5 to about 15 seconds.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-05-12 | 2006-11-11 | 2007-05-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-05-12 | 2010-11-11 | 2011-05-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-05-12 | 2014-11-11 | 2015-05-13 | $7700.00 | Window Closed / Lapsed |