Roche Diagnostics Operations, Inc.

Amira Medical

Transvivo, Inc.

Mercury Diagnostics, Inc.

Palco Labs, Inc.

Henry M Grage

Joel Sterling Douglas

Jeffrey N Roe

Ryszard Radwanski

Michael S Sanchez

Reynolds G Gorsuch

Brent G Duchon

Harold W Peters

Harold H Handley, Jr

Jacob C Kearns

Michael J Sanchez

Paul D Levin

Pat S Lee

A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Methods and apparatus for expressing body fluid from an incision

A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (), drive mechanism (), kneading or vibration mechanism (), optional suction system (), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component () for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Blood and interstitial fluid sampling device

A plasmapheresis and/or ultrafiltration membrane comprises elongated hollow fibers each fiber having an interior lumen extending along the fiber length, the fiber wall having a plurality of zones between the inner and outer wall surfaces, each of the zones having a mass density different than the mass density of an adjacent zone. The fiber wall is characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface. The fiber is further characterized by having an average elongation breaking force strength of at least about 0.2 lbs. and an average elongation of at least about 45%.

Specialized hollow fiber membranes for plasmapheresis and ultrafiltration

An apparatus for automatically and periodically measuring a patient's blood glucose level wherein the patient has a catheter in a blood vessel and is receiving infusion fluid through the catheter. A testing unit is provided which has a main infusion channel and, in a preferred embodiment, the testing unit includes a side channel. The side channel has a restrictive cross-sectional area compared with the main infusion channel. A glucose test chamber is formed in the side channel. First and second valves are placed adjacent the test chamber in the side channel to isolate a blood sample for testing. The isolation of the sample provides more accurate blood glucose measurements than those provided by systems of the prior art. A second embodiment of the invention has an isolatable test chamber placed in the main infusion line and no side channel is utilized.

Method and apparatus for testing blood glucose in a reversible infusion line

An in-vivo plasmapheresis and/or in-vivo ultrafiltration membrane comprises elongated hollow fibers each fiber having an interior lumen extending along the fiber length, the fiber wall having a plurality of zones between the inner and outer wall surfaces, each of the zones having a mass density different than the mass density of an adjacent zone. The fiber wall is characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface. The fiber is further characterized by having an average elongation breaking force strength of at least about 0.2 lbs. and an average elongation of at least about 45%.

Specialized hollow fiber membranes for in-vivo plasmapheresis and ultrafiltration

An in-vivo plasmapheresis and/or in-vivo ultrafiltration membrane comprises a plurality of elongated hollow fibers each fiber having an interior lumen extending along the fiber length, the fiber wall having a plurality of zones between the inner and outer wall surfaces, each of the zones having a mass density different than the mass density of an adjacent zone. The fiber wall is characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface.

A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle ( ), drive mechanism ( ), kneading or vibration mechanism ( ), optional suction system ( ), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component ( ) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle, drive mechanism, kneading or vibration mechanism, optional suction system, and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

A disposable lancing element is adapted for use in a lancing device for making an incision through a user's skin. The lancing element includes a body which defines a longitudinal axis, and has a skin-lancing member projecting from a front end thereof. A capillary tube is mounted in the body in laterally spaced relationship to the skin-lancing member and is slidable longitudinally relative to the body so as to be extended forwardly past the skin-lancing member. The body includes a plurality of circumferentially spaced, radially outwardly projecting bosses formed thereon for guiding the disposable element installation in a carrier element. The skin-lancing member may comprise a plurality of needles or barbs arranged in parallel side-by-side relationship. In lieu of a skin-lancing member, the disposable element may possess a longitudinal through-hole for conducting a skin-piercing laser light beam or pressurized fluid. A capillary tube may have an outwardly flared lower (inlet) end. A capillary tube may possess a sensor for sensing a level of fluid rising therein.

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Alpharetta, GA, United States of America

Henry M Grage