Roche Diagnostics Operations, Inc.

Roche Diabetes Care, Inc.

Mercury Diagnostics, Inc.

Amira Medical

Disetronic Licensing Ag

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Charles C Raney

Steven Nelson Roe

Joel Sterling Douglas

Jeffrey N Roe

Edward P Perez

Hans List

John Cuevas Ramirez

Ryszard Radwanski

Christopher D Wiegel

Paul Patel

David A Hasker

John M Gleisner

Andrew M Drexler

Edison F Yee

Edward C Leung

Michael Keil

Daniel ManHung Wong

Volker Zimmer

Arturo Meuniot

Frank A Chan

Irio Giuseppe Calasso

John H Priest

Ian Michael Munson

Marco De Polo

Martin Kopp

Arne Lang-Ree

Chris Wiegel

John Ramierez

A Michael Jung

Rafael C Donnay

David S Fisher

John E Priest

Irio Guiseppe Calasso

Marco C De Polo

Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Devices and methods for expression of bodily fluids from an incision

A lancet enclosed in a sterility sheet forms a lancet packet to maintain the sterility of the lancet and prevent the lancet from unintentionally piercing the sterility sheet prior to lancet actuation. In one form, the lancet is immobilized by hot tack welding a portion of the sterility sheet to the lancet. Alternatively, portions of the sterility sheet are hot tack welded together through an opening in the lancet to limit movement of the lancet.

Flat lancet immobilization

A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. In the lancets' activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

Lancets for bodily fluid sampling supplied on a tape

Adjustment mechanisms are used in conjunction with integrated lancet test strips to adjust the position of the drive system, engagement system, or the drive coupling in a fixed stroke lancing system to thereby adjust the penetration depth of the lancet. In a variable drive stroke lancing system, the lancet penetration depth is adjusted by changing the stroke length of a drive system. The stroke length of a drive system is adjusted by rotating a cam or sliding a cam in a cam type drive system. In either the fixed or the variable drive stroke lancing system, the test strip and/or guidance foil of the integrated lancet test strip is immobilized while the lancet is actuated.

Lancet drive system depth control method and test strip location methods

A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. The lancets are non-circular in cross-section along their longitudinal lengths, and in their activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.

Integrated analytical test element

A test magazine with two film strips (), which are joined to one another in a sandwich-like manner, can be wound up, and between which holding cells () for test elements are kept free. The test magazine also comprises a multitude of test elements () each having a puncturing unit () for inserting into body tissue and a test unit () for being subjected to body fluid. To this end, the puncturing units () and test units () are placed in separate holding cells () whereby separating them from one another.

Test magazine and method for processing the same

A drug reservoir loading and unloading mechanism for drug delivery device using unidirectional rotated lead screw and method thereof are disclosed. The drug reservoir loading/unloading mechanism allows exchanging the drug reservoir quickly with very few steps and with more safety. The invention neither requires rewinding of the drive system either automatically or manually while replacing the drug reservoir nor requires an additional adapter to secure the drug reservoir.

Drug reservoir loading and unloading mechanism for a drug delivery device using a unidirectional rotated shaft

Systems and methods for the sampling of bodily fluid from an incision in the skin include test strips which are positioned adjacent to the skin and which include features to inhibit the passage of the bodily fluid between the skin and the underside of the test strip. One system utilizes a sealing member located on the bottom surface of the test strip and positioned to provide a fluid tight seal with the skin. A second system includes a recessed surface aligned with the inlet opening of the test strip to preclude contact of the bodily fluid directly with the bottom surface of the test strip. A third system involves the use of a hydrophobic surface on the underside of the test strip to inhibit wicking of the bodily fluid along the test strip. The present invention further encompasses the combination of the foregoing sampling systems with each other, and with incising, expressing and/or testing systems and methods, particularly in a single, integrated device.

Sampling devices and methods utilizing a horizontal capillary test strip

An expression device for a lancing device of the type that directs a skin-lancing medium against a skin site to make an incision for testing bodily fluids. The expression device has a pair of skin-engaging tabs curved and oriented to make the skin taut adjacent a lancet used with the device. This increases the incision width and enhances the quantity of blood removed for subsequent testing.

Split tip expression device

An integrated bodily fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a lancet for forming the incision in the skin. A housing is coupled to the lancet. The housing defines at least in part a capillary channel with an opening. The capillary channel is sized to draw the bodily fluid from the incision via capillary action. A test strip is positioned along the capillary channel for analyzing the fluid. In one form, a flexible sheet extends from the housing proximal the opening of the capillary channel for drawing the bodily fluid into the opening of the capillary channel. In another form, the lancet is slidably received inside the channel. During lancing, the lancet extends from the housing to form the incision. Fluid from the incision is drawn into the channel and is deposited on the test strip for analysis.

Integrated lancing test strip

Growing community of inventors

Camdenton, MO, United States of America

Charles C Raney