Lifescan Corporation

Ernest J Kiser

Koon-Wah Leong

Edward G Rice

Michael F Tomasco

Deborah P Tuohy

Joel Sterling Douglas

Robert Justice Shartle

Lorin Philip Olson

Maria Teodorczyk

John M Dubowik

Devin McAllister

Vadim V Yuzhakov

Yeung Siu Yu

Scott Segelke

Remedios Dato

Karen R Drexler

Jennifer Hahamian

Victoria Page

Mark Maxson

Zbigniew Witko

A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Biological fluid constituent sampling and measurement devices

Methods and devices for electrochemically detecting a change in the viscosity of a fluid are provided. In the subject methods, a fluid sample (e.g., a whole blood sample) is introduced into an electrochemical test strip's electrochemical cell using a micro-needle integrated into one of oppositely spaced apart working and reference electrodes. An electric potential is applied to the electrochemical cell to first achieve a steady state cell current. A decrease in the steady state cell current is then detected and related to a change in viscosity of the sample. In many embodiments, the sample is blood and the change in viscosity is related to the onset of coagulation in the blood sample, and often the PT of the blood sample. An electrochemical test strip includes an electrochemical cell and an integrated micro-needle. The electrochemical cell includes oppositely spaced apart working and reference electrodes and a reagent mixture (e.g., a redox couple and a coagulation catalyzing agent). The micro-needle is integrated into one of the working and reference electrodes of the electrochemical cell.

Electrochemical test strip with an integrated micro-needle and associated methods

Methods of fabricating devices for collecting a sample of physiological and for measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. The fabrication methods provide various or forming the test strip and the skin-piercing element.

Methods of fabricating physiological sample collection devices

A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned co-axially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of 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 and/or systems.

Percutaneous biological fluid sampling and analyte measurement devices and methods

A test strip for determining the concentration of an analyte in a body fluid includes a membrane in fluid communication with a porous layer. The membrane and the porous layer are divided into compressed portions, which restrict the capillary flow of the body fluid, and uncompressed portions. The uncompressed portions are adapted to absorb and retain body fluids in excess of the amount required for operation of the test strip. The test strip may be constructed with an internal relief chamber to accommodate the uncompressed portions. A method of making the test strip by pressure and/or heat sealing individual components on a shaping die is also provided.

Method of making a test strip for determining analyte concentration over a broad range of sample volumes

Biological fluid constituent sampling and measurement devices and methods

A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned coaxially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of 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 and/or systems.

Test strip for measuring analyte concentration over a broad range of sample volume

A multilayer reagent test strip measures the concentration of analyte in a liquid sample that is applied to it. The sample is guided to a number of assay areas arrayed along the strip, where the analyte can react with a reagent to cause a color change. Each assay area also includes an inhibitor for the color-change reaction. The inhibitor concentration increases in successive assay areas; thus, the number of areas that change color is a measure of the analyte concentration. The test strip is particularly adapted for measuring glucose in a whole blood sample. In a preferred embodiment, the sample is guided to the assay areas along a path formed by crushing selected areas of a membrane, and the assay areas are uncrushed areas of the membrane.

Visually-readable reagent test strip

A chemical timer for a direct-reading reagent test strip changes color a predetermined time after a biological fluid is applied to the strip. The strip measures the concentration of an analyte in the fluid. The timer is a dry coating of an indicator, an enzyme-containing reagent that when hydrated can react with glucose to change the color of the indicator, an inhibitor to inhibit the change in color of the indicator, glucose, and optionally, an aldose that does not react with the enzyme in the reagent. Preferably, the reagent and glucose are present in excess in the coating, and the time it takes for the timer color to change can be controlled by the inhibitor concentration. The aldose provides timer stability, probably by interfering with glycosylation by the glucose in the dry state.

Chemical timer for a visual test strip

Visual test strip

A separation matrix impregnated with a separating agent separates red blood cells or hemoglobin from whole blood. Upon separation, an impregnated test reagent reacts with the separated substantially clear component fluid to form a colored product which enables a visual or meter test for glucose levels in whole blood.

Glucose test strip for whole blood

A separation matrix impregnated with a separating agent separates red blood cells or hemoglobin from whole blood. Upon separation, an impregnated test reagent reacts with the separated substantially clear component fluid to form a colored product which enables a visual or meter test for analyte levels in whole blood. Such a test is appropriate for, among other things measuring glucose, cholesterol, or alcohol levels in whole blood samples. A visual meter is disclosed which allows sample to be applied to one side of the strip, and reading takes place on the opposite side, after separation of red blood cells and reaction to test reagent. Also, a useful test strip format is disclosed.

Growing community of inventors

Los Altos, CA, United States of America

Ernest J Kiser