Biological fluid sampling and analyte measurement devices and methods
First Claim
1. A biological fluid sampling and analyte concentration measurement device, said device comprising:
- (a) at least one skin-piercing member comprising a biological fluid access opening;
(b) an electrochemical cell for measuring the concentration of analyte within the biological fluid, wherein the cell comprises at least one porous electrode; and
(c) a hydrophilic porous material in fluid communication with the at least one piercing member and with the at least one porous electrode, wherein hydrophilic porous material transfers biological fluid present at the access opening of the at least one piercing member to the electrochemical cell, wherein the porous material comprises a distal portion associated with the at least one piercing member and a proximal portion adjacent to the at least one porous electrode, wherein the proximal portion is more porous than the distal portion.
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Abstract
A device for sampling a biological fluid and measuring a target analyte within the biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and access biological fluid, a sampling means and a measuring means. The sampling means comprises a fluid transfer medium, such as a hydrophilic porous material, by which sampled biological fluid is transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode and, typically, a reagent material, where the electrochemical cell is configured so as to make an electrochemical measurement of a target analyte in accessed biological fluid present therein. Methods of sampling biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices.
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Citations
38 Claims
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1. A biological fluid sampling and analyte concentration measurement device, said device comprising:
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(a) at least one skin-piercing member comprising a biological fluid access opening;
(b) an electrochemical cell for measuring the concentration of analyte within the biological fluid, wherein the cell comprises at least one porous electrode; and
(c) a hydrophilic porous material in fluid communication with the at least one piercing member and with the at least one porous electrode, wherein hydrophilic porous material transfers biological fluid present at the access opening of the at least one piercing member to the electrochemical cell, wherein the porous material comprises a distal portion associated with the at least one piercing member and a proximal portion adjacent to the at least one porous electrode, wherein the proximal portion is more porous than the distal portion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A biological fluid sampling and analyte concentration measurement device, said device comprising:
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(a) an array of micro-needles, each micro-needle having an access opening;
(b) a layer of porous material over the array;
(c) a first layer of conductive material over the layer of porous material, wherein the first layer of conductive material is porous and further wherein the access openings, the layer of porous material and the first layer of conductive material provide a fluid transfer pathway; and
(d) a second layer of conductive material, wherein the first layer of conductive material and the second layer of conductive material are spaced-apart, wherein biological fluid present at the access openings is caused to be transferred to the space between the first and second layers of conductive material. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 38)
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- 35. The device of claim 35 wherein the analyte is glucose and the reagent comprises a glucose oxidizing enzyme and a mediator.
Specification