Patent US6501976B1 successfully refreshed from Google Patents.
US6501976B1
Expired / Lapsed
US
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Percutaneous 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: 2002-12-31
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Expires: 2021-06-12
Abstract
Abstract Devices and methods for sampling a biological fluid and measuring a target constituent within the biological fluid are provided. Generally, the subject devices include a sampling device configured to pierce a skin surface to provide access to biological fluid and concentrically-spaced working and reference electrodes positioned within the elongated sampling device that define an electrochemical cell for measuring the concentration of analyte within the biological fluid. The subject devices and methods are particularly suited for use in the sampling and concentration measuring of glucose in interstitial fluids. Also provided are kits that include the subject devices for use in practicing the subject methods.
Inventors
- 👤 Borzu Sohrab
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 06:33
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/483; G01N33/487; A; A61; A61B; A61B5/00; A61B5/145; A61B5/1468; A61B5/1486; A61B5/14865; A61B5/14507; A61B5/1451; A61B5/14514; A61B5/15; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150358; A61B5/150977; A61B5/150984; A61B5/151; A61B5/15186; A61B5/157
Claims Analysis
Total Claims: 38
Claim 1
Independent Claim
55 words
A biological fluid sampling and analyte concentration measurement device, said device comprising: (a) an elongated sampling means configured to pierce a skin surface to provide access to the biological fluid; and (b) concentrically-spaced electrodes positioned within the elongated sampling means that define an electrochemical cell for measuring the concentration of analyte within the biological fluid.
Claim 2
Dependent Claim
55 words
A biological fluid sampling and analyte concentration measurement device, said device comprising: (a) an elongated sampling means configured to pierce a skin surface to provide access to the biological fluid; and (b) concentrically-spaced electrodes positioned within the elongated sampling means that define an electrochemical cell for measuring the concentration of analyte within the biological fluid.
Claim 3
Dependent Claim
14 words
The device of claim 1 further comprising an insulating material between the concentrically-spaced electrodes.
Claim 4
Dependent Claim
11 words
The device of claim 2 further comprising a redox reagent system.
Claim 5
Dependent Claim
31 words
The device of claim 2 wherein the insulating material comprises a plurality of pores configured to provide a capillary force sufficient to draw a sample of biological fluid into the pores.
Claim 6
Dependent Claim
19 words
The device of claim 1 further comprising a signal producing and receiving means in electrical communication with the electrodes.
Claim 7
Dependent Claim
28 words
The device of claim 1 wherein the sampling means comprises a lumen and an open distal end, wherein the open distal end provides a passageway into the lumen.
Claim 8
Dependent Claim
26 words
The device of claim 6 wherein the lumen is configured to provide a capillary force sufficient to draw a sample of biological fluid into the lumen.
Claim 9
Dependent Claim
17 words
The device of claim 1 wherein the biological fluid is interstitial fluid and the analyte is glucose.
Claim 10
Dependent Claim
19 words
A kit comprising at least one biological fluid sampling and analyte concentration measurement device according to claim 1 .
Claim 11
Independent Claim
56 words
A device for sampling biological fluid and measuring the concentration of a target constituent in the biological fluid, comprising: a first electrode; a second electrode concentrically positioned about and spaced apart from the first electrode; and a porous material positioned in the space between the electrodes, wherein the device has a configuration for piercing the skin.
Claim 12
Independent Claim
56 words
A device for sampling biological fluid and measuring the concentration of a target constituent in the biological fluid, comprising: a first electrode; a second electrode concentrically positioned about and spaced apart from the first electrode; and a porous material positioned in the space between the electrodes, wherein the device has a configuration for piercing the skin.
Claim 13
Dependent Claim
15 words
The device according to claim 10 having a penetration length no deeper than the dermis.
Claim 14
Dependent Claim
15 words
The device according to claim 11 having a penetration length no deeper than the epidermis.
Claim 15
Dependent Claim
17 words
The device according to claim 10 wherein the second electrode has a configuration for piercing the skin.
Claim 16
Dependent Claim
43 words
The device according to claim 13 wherein the second electrode has an open distal end and defines a space within the device, wherein the space has a configuration to provide a capillary force sufficient to draw biological fluid through the open distal end.
Claim 17
Dependent Claim
23 words
The device according to claim 10 further comprising a reagent in contact with the porous material or at least one of the electrodes.
Claim 18
Dependent Claim
25 words
The device according to claim 15 wherein the reagent is located on a surface of at least one of the electrodes facing the porous material.
Claim 19
Dependent Claim
82 words
A micro-needle for sampling a biological fluid and measuring a target constituent within the biological fluid, comprising: a core having a length; a first electrode coaxially conformed about the core length; a porous material coaxially conformed about the first electrode; a second electrode coaxially conformed about the porous material and having a length that extends beyond the core length and terminates at an open tip; and a reagent contained within the micro-needle wherein the reagent is selected based on the target constituent.
Claim 20
Dependent Claim
82 words
A micro-needle for sampling a biological fluid and measuring a target constituent within the biological fluid, comprising: a core having a length; a first electrode coaxially conformed about the core length; a porous material coaxially conformed about the first electrode; a second electrode coaxially conformed about the porous material and having a length that extends beyond the core length and terminates at an open tip; and a reagent contained within the micro-needle wherein the reagent is selected based on the target constituent.
Claim 21
Dependent Claim
19 words
The micro-needle according to claim 17 further comprises a plating formed circumferentially about the length of the second electrode.
Claim 22
Dependent Claim
38 words
A kit for sampling a biological fluid from the skin of a patient and for measuring the concentration of a constituent within the sampled biological fluid, the kit comprising: at least one micro-needle according to claim 17 .
Claim 23
Dependent Claim
30 words
The kit according to claim 19 further comprising a plurality of micro-needles and a support member wherein the plurality of micro-needles are arranged in an array on the support member.
Claim 24
Dependent Claim
12 words
The kit according to claim 20 wherein the micro-needles have varying lengths.
Claim 25
Dependent Claim
12 words
The kit according to claim 20 wherein the micro-needles comprise different reagents.
Claim 26
Independent Claim
177 words
A system for sampling biological fluid from the skin of a patient and measuring a target constituent within the biological fluid, the system comprising: (a) at least one micro-needle comprising sampling means, a reagent and an electrochemical cell housed within the micro-needle, (1) wherein the electrochemical cell comprises a reference electrode, a working electrode and an insulating material there between, wherein the reagent is in contact with at least one or more of the reference electrode, the working electrode or the insulating material, and (2) wherein the sampling means comprises a distal opening and at least one space within the micro-needle having a configuration capable of wicking biological fluid into the micro-needle; and (b) a control unit in electrical communication with the at least one micro-needle, comprising: (1) means for sending an electrical reference signal to the reference electrode and for receiving an electrical output signal from the working electrode, and (2) a software algorithm which automatically calculates and determines the concentration of the target constituent in the biological sample upon receipt of the electrical output signal.
Claim 27
Independent Claim
177 words
A system for sampling biological fluid from the skin of a patient and measuring a target constituent within the biological fluid, the system comprising: (a) at least one micro-needle comprising sampling means, a reagent and an electrochemical cell housed within the micro-needle, (1) wherein the electrochemical cell comprises a reference electrode, a working electrode and an insulating material there between, wherein the reagent is in contact with at least one or more of the reference electrode, the working electrode or the insulating material, and (2) wherein the sampling means comprises a distal opening and at least one space within the micro-needle having a configuration capable of wicking biological fluid into the micro-needle; and (b) a control unit in electrical communication with the at least one micro-needle, comprising: (1) means for sending an electrical reference signal to the reference electrode and for receiving an electrical output signal from the working electrode, and (2) a software algorithm which automatically calculates and determines the concentration of the target constituent in the biological sample upon receipt of the electrical output signal.
Claim 28
Dependent Claim
47 words
The system according to claim 23 further comprising a display unit in electrical communication with the control unit for displaying information in the form of electrical signals received from the control unit related to the sampling of the biological fluid and the measuring of the target constituent.
Claim 29
Dependent Claim
35 words
The system according to claim 23 further comprising a housing and a support means wherein the control unit is housed within the housing and the at least one micro-needle is mounted to the support means.
Claim 30
Independent Claim
141 words
A method for testing a biological fluid within the skin of a patient and for determining the concentration of a target constituent contained therein, the method comprising the steps of: providing at least one micro-needle comprising an open distal end and an electrochemical cell therein, the electrochemical cell comprising a reagent and a concentrically-layered electrode configuration; inserting the at least one micro-needle into the skin to a selected depth; wicking a sample of biological fluid present at the open distal end into the electrochemical cell; allowing the sample to react with the reagent wherein a substance is formed within the electrochemical cell as a result of the reaction; providing a first electrical signal to the substance; and receiving a second electrical signal generated by the substance, wherein the second electrical signal is representative of the concentration the constituent in the sample.
Claim 31
Independent Claim
141 words
A method for testing a biological fluid within the skin of a patient and for determining the concentration of a target constituent contained therein, the method comprising the steps of: providing at least one micro-needle comprising an open distal end and an electrochemical cell therein, the electrochemical cell comprising a reagent and a concentrically-layered electrode configuration; inserting the at least one micro-needle into the skin to a selected depth; wicking a sample of biological fluid present at the open distal end into the electrochemical cell; allowing the sample to react with the reagent wherein a substance is formed within the electrochemical cell as a result of the reaction; providing a first electrical signal to the substance; and receiving a second electrical signal generated by the substance, wherein the second electrical signal is representative of the concentration the constituent in the sample.
Claim 32
Dependent Claim
17 words
The method according to claim 26 wherein the selected depth is no greater than the viable epidermis.
Claim 33
Dependent Claim
17 words
The method according to claim 27 wherein the selected depth is no greater than the stratum corneum.
Claim 34
Dependent Claim
26 words
The method according to claim 26 wherein the step of wicking comprises exerting a capillary force on the biological fluid present at the open distal end.
Claim 35
Dependent Claim
34 words
The method according to claim 26 wherein the steps of providing a first electrical signal and receiving a second electrical signal is performed by a control unit in electrical communication with the electrochemical cell.
Claim 36
Dependent Claim
26 words
The method according to claim 26 further comprising the step of deriving the concentration of the constituent in the patient's blood from the second electrical signal.
Claim 37
Dependent Claim
26 words
The method according to claim 31 further comprising the step of displaying a numerical value representative of the concentration of the constituent in the patient's blood.
Claim 38
Dependent Claim
16 words
The method according to claim 31 wherein the step of deriving comprises using a software algorithm.
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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) | 2005-12-30 | 2006-07-01 | 2006-12-31 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-12-30 | 2010-07-01 | 2010-12-31 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-12-30 | 2014-07-01 | 2014-12-31 | $7700.00 | Window Closed / Lapsed |