Percutaneous 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) 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.
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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.
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Citations
33 Claims
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1. A biological fluid sampling and analyte concentration measurement device, said device comprising:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A device for sampling biological fluid and measuring the concentration of a target constituent in the biological fluid, comprising:
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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. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A micro-needle for sampling a biological fluid and measuring a target constituent within the biological fluid, comprising:
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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. - View Dependent Claims (18, 19, 20, 21, 22)
at least one micro-needle according to claim 17.
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20. 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.
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21. The kit according to claim 20 wherein the micro-needles have varying lengths.
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22. The kit according to claim 20 wherein the micro-needles comprise different reagents.
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23. A system for sampling biological fluid from the skin of a patient and measuring a target constituent within the biological fluid, the system comprising:
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(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. - View Dependent Claims (24, 25)
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26. 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:
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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. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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Specification