Miles Inc.

Bayer Corporation

Bayer Healthcare LLC

Miles Laboratories, Inc.

Wogoman, Frank W.

Frank W Wogoman

Joseph L Moulton

Steven C Charlton

Anne Tregoning Miller

Matthew A Schumann

Dennis Slomski

Allen J Brenneman

Mirza A Khoja

Anne T Miller

Andrew J Dosmann

Christine D Nelson

Russell J Micinski

Joel M Blatt

Kin-Fai Yip

Jerry T Pugh

Eric W Miller

Robert J Heiland

Lowry J Messenger

George V Siddons

James R Morris

James J Silva

Robert Heiland

An optical waveguiding optical format enables consistent optical analysis of small sample volumes. The optical format is comprised of an illumination light guide, a read window upon which a sample is placed, a sample collection needle or capillary, and a detection guide. Light redirecting facets are provided within the format itself such that the format serves as a unitary component for accepting light, directing light through a sample, and emitting light for detection.

Optical format

An electrochemical sensor with a capillary channel is formed by placing a sacrificial insert and electrodes on a sensor base and applying plastic material. After the plastic material is cured, the sacrificial is removed leaving a capillary channel in the sensor. The inserts may be removed by a tool including a clamp for clamping and holding each insert stationary and a sliding block to which the sensor is secured.

Method of forming an electrochemical sensor

An optical reagent format with a precise capillary channel is made by molding a format on a carrier of a precise predetermined thickness. The carrier includes an insert at least a portion of which is molded in the format. Once the format is made, the insert is detached from the carrier and removed from the format leaving a precisely dimensioned capillary channel with an inlet and vent. A reagent may be applied in the capillary channel and the format used to measure the analyte in a fluid such as blood. An electrochemical sensor with a capillary channel is formed by placing a sacrificial insert and electrodes on a sensor base and applying plastic material. After the plastic material is cured, the sacrificial is removed leaving a capillary channel in the sensor. The inserts may be removed by a tool including a clamp for clamping and holding each insert stationary and a sliding block to which the sensor is secured.

Method of making a capillary channel

Sensors for the electro-chemical analysis of samples and methods for the manufacturing of sensors allow for more efficient manufacture and use of electro-chemical sensors. Flexible sheets, such as polycarbonate sheets, are used to easily manufacture sensor components, with sensor chemistry being applied to the sensor components at manufacture. Sensors may be manufactured with modular components, enabling easy production-line manufacture and construction of electro-chemical sensors with significant cost savings and increased efficiency over existing sensor styles and sensor manufacturing techniques.

Electrochemical test sensors

An electrochemical sensor with a capillary channel is formed by placing a sacrificial insert on a sensor base and applying casting material. After the casting material is cured, the sacrificial is removed leaving a capillary channel in the sensor. The insert may be removed by a tool including a clamp for clamping and holding the insert stationary and a sliding block to which the sensor is secured.

Electrochemical sensor

Cradle for analyte monitoring device

A sensor dispensing instrument is adapted to receive a generally circular sensor pack containing a plurality of blood glucose sensors. Each of the sensors are disposed in sensor cavities, each of which is in fluid communication with a corresponding desiccant cavity and has a support wall that assists in directing the sensor as its being ejected from the cavity. The sensor pack is loaded on an indexing disk in the instrument such that when a slide actuator on the instrument is moved toward a testing position, a feed mechanism engaged by the slide actuator moves a knife blade thereon toward one of the sensor cavities. The knife blade pierces a portion of a foil covering the sensor cavity and engages the sensor disposed in the cavity to thereby eject the sensor from the sensor cavity. The continued sliding of the slide actuator toward its testing position results in the sensor being completely ejected from the sensor cavity and disposed in a testing position with a testing end of the sensor projecting from the instrument. Once the blood analyzing test is completed, the slide actuator is moved in the opposite direction towards its standby position. As the slide actuator is moved away from its testing position, the indexing disk with the sensor pack thereon is rotated so that the next one of sensor cavities is positioned so that the sensor therein can be used for the next blood glucose test that is to be performed. The instrument includes circuitry to obtain test data from the sensor pack and to display testing data.

Dispensing instrument for fluid monitoring sensors

Dispensing instrument for fluid monitoring sensor

A sensor dispensing instrument (20) includes a sensor magazine (26) that contains a plurality of blood glucose sensors (38) disposed in sensor slots (30A-J). Each of the sensor slots (30A-J) is in fluid communication with a desiccant cavity (50A-J) in which desiccant material is disposed. The front and rear walls (34, 32) of the sensor magazine (26) are sealed with burst foils (40, 42) so as to seal the sensor slots (30A-J) and the desiccant cavities (36A-J). The sensor instrument (20) has an outer housing (22) with a laterally extending magazine opening (24) adapted to receive the sensor magazine (26). A pivot rod (28) is moved through the magazine (26) and is locked into an operating position. The magazine (26) is rotated on the pivot rod (28) until a detent arm (48) on the instrument housing (22) engages a detent groove (50A-J) on the magazine (26) to position the magazine (26) in a sensor feeding position. Once so positioned, a sensor push rod (54) is pushed forward resulting in the push rod (54) piercing the rear burst foil (42) and engaging a sensor (38) in one of the sensor slots (30A-J) to thereby push the sensor (38) out through the front burst foil (40) and into a testing position. While in this testing position, the sensor (38) can be placed in a blood sample that needs to be analyzed. Once the test is completed, the push rod (54) is advanced forward further to thereby eject the used sensor (38) from the sensor handling instrument (20). The push rod (54) then is retracted to a standby position and the sensor magazine (26) is rotated until the detent arm (48) engages another detent groove (50A-J) so that another sensor slot (30A-J) is in alignment with the push rod (54).

Means of handling multiple sensors in a glucose monitoring instrument

A high-precision liquid reagent delivery system is provided for convenient and efficient gravity flow delivery of substantially the entire volume of reagent contained within a sealed formed tray. The delivery system comprises a formed tray defining a curved cavity for holding a predetermined amount of liquid, and a substantially planar ledge surface defined around the cavity opening. The surfaces of the cavity are non-porous, uniform and smoothly converging to a point of liquid discharge at an intersection of the cavity and the ledge surface. The ledge surface further defines an apex extending longitudinally from the point of liquid discharge and defines a guide path for the delivery of liquid contained within the tray. The system also includes a flexible cover removably affixed to the ledge surface of the tray for forming a sealed chamber between the cavity and the affixed cover for containment of liquid. The cover extends beyond the apex of the ledge surface to define a tab portion which can be grasped and pulled from the ledge surface to remove the cover. Removal of the flexible cover in such a manner with the tray positioned in a upstanding manner with the point of liquid discharge directed downward provides gravity flow delivery of all liquid contained within the tray with a low coefficient of variation.

Reagent containment and delivery tray and method of use

Analytical reaction cassette and method for performing sequential analytical assay procedures to determine the amount of an analyte in a liquid test mixture. The reaction cassette can be in the form of a substantially square container having a substantially horizontal axis of rotation and incorporated with one or more analytical reagents such that they are contacted with a liquid test mixture in a desired ordered sequence to perform a particular assay procedure. Corners provided by the substantially square configuration of the reaction cassette disrupt the flow of liquids disposed in the reaction cassette upon contact therewith to thereby agitate and mix such liquids. A liquid disposed in the reaction cassette is capable of being manipulated and mixed therein by rotating the reaction cassette about the horizontal axis at sufficiently low velocities wherein the transport of such liquid is noncentrifugal and due substantially only to gravitational force. The reaction cassette is particularly useful for performing immunoturbidimetric assays, e.g., for the determination of glycated hemoglobin.

Reaction cassette for preforming sequential analytical assays by

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Granger, IN, United States of America

Frank W Wogoman