US6837988B2
Expired / Lapsed
US
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Biological fluid sampling and analyte measurement devices and methods
Assignee: Cilag GmbH International
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Filing: 2001-06-12
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Granted: 2005-01-04
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Expires: 2021-06-12
Abstract
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.
Inventors
- 👤 Koon-Wah Leong
- 👤 Robert Shartle
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 10:20
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; A; A61; A61B; A61B5/00; A61B5/145; A61B5/1468; A61B5/1486; A61B5/14507; A61B5/1451; A61B5/14514; A61B5/14532
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
133 words
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.
Claim 2
Dependent Claim
133 words
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.
Claim 3
Dependent Claim
21 words
The device of claim 1 wherein the proximal portion is about 10 to 100 times more porous than the distal portion.
Claim 4
Dependent Claim
27 words
The device of claim 1 wherein the hydrophilic porous material transfers biological fluid by means of a capillary force exerted on the biological fluid in its presence.
Claim 5
Dependent Claim
21 words
The device of claim 1 wherein the porous material is selected from the group consisting of polymers, ceramics, glass and silica.
Claim 6
Dependent Claim
30 words
The device of claim 1 wherein the electrochemical cell comprises two spaced-apart electrodes defining a reaction chamber and a selected reagent for chemically reacting with an analyte targeted for measurement.
Claim 7
Dependent Claim
18 words
The device of claim 5 wherein the distance between the electrodes is from about 10 to 300 microns.
Claim 8
Dependent Claim
18 words
The device of claim 6 herein the distance between the electrodes is from about 10 to 150 microns.
Claim 9
Dependent Claim
23 words
The device according to claim 5 wherein the reagent is located on a surface of at least one electrode facing the reaction chamber.
Claim 10
Dependent Claim
10 words
The device of claim 5 wherein both electrodes are porous.
Claim 11
Dependent Claim
23 words
The device of claim 9 further comprising a housing having at least one vent hole for venting air from within the electrochemical cell.
Claim 12
Dependent Claim
17 words
The device of claim 1 wherein the biological fluid is interstitial fluid and the analyte is glucose.
Claim 13
Dependent Claim
10 words
The device of claim 1 further comprising a hydrophilic gel.
Claim 14
Dependent Claim
23 words
The device of claim 1 wherein the hydrophilic porous material comprises pores having diameters in the range from about 0.1 to 50 μm.
Claim 15
Dependent Claim
19 words
The device of claim 13 wherein the pore diameters are in the range from about 0.1 to 10 μm.
Claim 16
Dependent Claim
100 words
A system for sampling biological fluid from the skin of a patient and measuring a target analyte within the biological fluid, the system comprising: (a) at least one device according to claim 1 ; and (b) a control means in electrical communication with the at least one device, the control means comprising: (1) means for sending an electrical input signal to the device and for receiving an electrical output signal from the device, and (2) a software algorithm which automatically calculates and determines the concentration of the target analyte in the biological sample upon receipt of the electrical output signal.
Claim 17
Dependent Claim
46 words
The system of claim 15 further comprising a display means in electrical communication with the control means for displaying information in the form of electrical signals received from the control means related to the sampling of the biological fluid and the measuring of the target analyte.
Claim 18
Dependent Claim
19 words
The system of claim 16 wherein the device is mounted to the housing by means of a lock-and-release mechanism.
Claim 19
Dependent Claim
26 words
The system of claim 15 further comprising a housing wherein the control means is located within the housing and the device is mounted to the housing.
Claim 20
Dependent Claim
21 words
The system of claim 18 further comprising user input buttons on the housing for providing user input to the control unit.
Claim 21
Dependent Claim
20 words
The system of claim 18 further comprising a display means on the housing for displaying information from the control means.
Claim 22
Dependent Claim
12 words
The system of claim 18 wherein the housing has a hand-held configuration.
Claim 23
Dependent Claim
128 words
A method for sampling a biological fluid within the skin of a patient and for measuring the concentration of one or more target analytes contained therein, the method comprising the steps of: providing a biological fluid sampling and analyte measuring system according to claim 15 comprising a first sensor device operatively coupled to a control means; operatively applying the sensor device to the patient's skin wherein the system samples the patient's biological fluid and measures the concentration of the one or more target analytes therein; removing the sensor device from the patient's skin; removing the first sensor device from the control means; operatively coupling a second sensor device to the control means; and repeating the above steps until the desired number of samplings and measurements have been performed.
Claim 24
Dependent Claim
36 words
A kit for sampling a biological fluid from the skin of a patient and for measuring the concentration of a analyte within the sampled biological fluid, the kit comprising: a system according to claim 15 .
Claim 25
Dependent Claim
23 words
The kit of claim 23 wherein the biological fluid sampling and analyte concentration measurement device is disposable and the control unit is reusable.
Claim 26
Dependent Claim
39 words
A kit for sampling a biological fluid from the skin of a patient and for measuring the concentration of a analyte within the sampled biological fluid, the kit comprising: a plurality of disposable devices according to claim 1 .
Claim 27
Dependent Claim
24 words
The kit of claim 25 further comprising a support member wherein the plurality of micro-needles are arranged in an array on the support member.
Claim 28
Dependent Claim
126 words
A biological fluid sampling and analyte concentration measurement device, said device comprising: (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.
Claim 29
Dependent Claim
126 words
A biological fluid sampling and analyte concentration measurement device, said device comprising: (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.
Claim 30
Dependent Claim
19 words
The device of claim 27 further comprising a layer of insulating material over the second layer of conductive material.
Claim 31
Dependent Claim
14 words
The device of claim 27 wherein the array of micro-needles comprises an insulating material.
Claim 32
Dependent Claim
47 words
The device of claim 27 further comprising a layer of reagent material between the first and second layers of conductive material wherein an analyte targeted for measurement present in the in the space between the first and second layers of conductive material chemically reacts with the reagent.
Claim 33
Dependent Claim
27 words
The device of claim 30 wherein the layer of reagent material contacts either the first layer of conductive material, the second layer of conductive material or both.
Claim 34
Dependent Claim
14 words
The device of claim 27 wherein the second layer of conductive material is porous.
Claim 35
Dependent Claim
29 words
The device of claim 32 , further comprising an insulating layer over the second layer of porous conductive material, wherein the insulating layer has a venting hole there through.
Claim 36
Dependent Claim
14 words
The device of claim 27 wherein the biological fluid being sampled is interstitial fluid.
Claim 37
Dependent Claim
21 words
The device of claim 35 wherein the analyte is glucose and the reagent comprises a glucose oxidizing enzyme and a mediator.
Claim 38
Dependent Claim
20 words
The device of claim 35 wherein the enzyme is selected from a group consisting of glucose oxidase and glucose dehydrogenase.
Claim 39
Dependent Claim
11 words
The device of claim 36 , wherein the mediator is ferricyanide.
Claim 40
Dependent Claim
16 words
The device of claim 27 wherein the micro-needles of the array of micro-needles have varying lengths.
References Cited (Backward Citations)
US5304468A
Cited
US5563042A
Cited
US5231028A
Cited
US5529752A
Cited
US5161532A
Cited
US5821399A
Cited
US5820570A
Cited
US5582184A
Cited
US6080116A
Cited
US5746217A
Cited
US6162611A
Cited
WO1997000441A1
Cited
US5879367A
Cited
US5879310A
Cited
US5942102A
Cited
WO1997042888A1
Cited
WO1998000193A1
Cited
WO1998034541A1
Cited
US6059946A
Cited
WO1999013336A1
Cited
WO1999027852A1
Cited
US6083196A
Cited
US6091975A
Cited
WO1999064580A1
Cited
WO2000035530A1
Cited
WO2000045708A1
Cited
WO2000057177A1
Cited
WO2000074763A2
Cited
WO2000074765A1
Cited
US6379324B1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2008-01-04 | 2008-07-05 | 2009-01-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2012-01-04 | 2012-07-05 | 2013-01-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2016-01-04 | 2016-07-05 | 2017-01-04 | $7700.00 | Window Closed / Lapsed |