Neomecs Incorporated

Light Pointe Medical, Inc.

Queststar Medical, Inc.

Hiroshi Nomura

Robert J Petersen

Arthur R Kydd

August R Hanson

Jong Hyung Ahn

Beginning with a sheet of optically transparent material, one may fabricate a great many shaped optical wafers, each in the form of a thin and essentially flat piece of optical material having a narrow cross-sectional width relative to length, and a sharply narrowed tip at one end. The fabrication process involves passing a sheet of optically transparent material through one or more operational steps wherein cutting, shearing, embossing, microperforating, or a combination thereof is performed. The fabrication process may further include a cladding operation, a tip texturing operation, and an analyte-reactive reagent deposition operation. The completed optical wafers are separated and each may be mounted into a user-operated device along with systems for educing a fluid sample to be expressed from a living organism, for bringing the tip of the optical wafer into contact with the fluid sample, and for illuminating and assaying the fluid sample.

Method of manufacturing an optical sensor element for analyte assay in a biological fluid

Optical sensor element for analyte assay in a biological fluid, and method of manufacture thereof

A nonhemolytic sensor for determination of analytes in erythrocyte-containing biological fluids is disclosed that comprises an optical material having a deposit on a surface thereof, where this deposit includes an analyte-reactive reagent and a particulate means for suppressing hemolysis of erythrocytes in an erythrocyte-containing biological fluid, such as whole blood. Thus, a porous array of negatively charged particles, e.g., polymeric beads having a plurality of carboxylate surface groups, are disposed on a sampling surface of an optical sensor, and suppress hemolysis of erythrocytes coming into contact with the sampling surface. In the case of an optical sensor, such particles can simultaneously enhance reflectance of a light beam transmitted through the optical material to the sampling surface site.

Nonhemolytic optical sensor with enhanced reflectance

A wicking material is disclosed that exhibits a horizontal wicking velocity of at least about 1.0 millimeter per second when contacted with a physiological fluid such as blood, lymph or cellular interstitial fluid. This high wicking rate is achieved by means of treatment of a fibrous wicking material candidate with a low temperature gas plasma, particularly a glow discharge gas plasma formed in a gaseous blend made up predominantly of a mixture of oxygen with a saturated alkane chosen from the group consisting of methane, ethane and propane. Diagnostic test strips made with the surface-modified wicking material, and containing an immobilized reagent means for analysis of an analyte in a physiological fluid, show improved performance in terms of increased accuracy, finer precision of analyses, reduced time of analysis, a smaller fluid sample size requirement, and improved compliance with manufacturing standards resulting in lower manufacturing costs blood sugar determinations.

Surface-modified wick for diagnostic test strip

Porous polymeric materials are hardened by a process of plasma-annealing, involving treatment of at least one surface with a gas plasma formed by glow discharge through a gas containing a saturated alkane or an acetylene. Plasma-annealed porous polymers with reduced adsorption toward proteins were obtained by exposure to a glow discharge through a gas mixture containing an alkane such as methane in combination with oxygen, air, or a hydrophilic unsaturated organic monomer. For example, porous polysulfone sheet and hollow fiber were plasma-annealed by treatment with a gas plasma containing methane and air or acrylic acid with simultaneous deposition of a hydrophilic polymerizate thereon.

Plasma-annealed porous polymers

The lumen surface of tubing is modified by exposure to a gas plasma in a vacuum apparatus. A method and apparatus are disclosed whereby plasma treatment of the lumen surface, such as by deposition of a plasma polymerizate, may be achieved inside a continuous length of tubing. A gas such as a monomer vapor is caused to enter the lumen of the tubing through openings sequentially arranged at a periodic interval along the length of the tubing, and is excited to a plasma state concurrently as the tubing passes through a tubular reaction conduit having an inner diameter in occlusive contact with the tubing's outer diameter. Essentially crack-free plasma polymerizate coatings with thicknesses greater than 1000 angstroms are selectively deposited on the lumen wall of the continuous tubing. Plasma-modified tubing is prepared having usefulness in medical devices such as catheters, vascular grafts and enteral feeding tubes.

Plasma modification of lumen surface of tubing

A minimally invasive sensing device, and method for its use, is disclosed which utilizes a light-conducting fiber having a localized textured site thereon, wherein a reagent is deposited. Interaction of the reagent with an analyte specific to the reagent produces a response, such as development of a colored product, which is detectable by means of a change in characteristics of a light beam transmittable through the fiber. By means of the textured site and its increased surface area, the sensitivity of the device is greatly enhanced, such that less than 5 microliters of a fluid is needed for an analysis. The sensor is particularly useful in blood glucose determinations, requiring smaller blood samples than flat strip devices.

Minimally invasive sensor

Improved porous materials useful in blotting analyses of proteinaceous and genomic matter are prepared by treating porous substrates with a gas plasma containing at least one monomer. Thus, a porous sheet-like substrate is modified by means of a deposit of a plasma polymerizate on at least one of its surfaces, whereby this modified surface exhibits reduced nonspecific binding of chemical probes in a blotting analysis. By means of a controlled deposition of the plasma polymer at a plasma composite parameter W/FM of less than 1.0.times.10.sup.9 Joules/kilogram, improved porous materials are obtained having increased signal-to-background ratios and enhanced sensitivities in genomic analyses. In a particularly preferred embodiment, a porous, positively charged nylon membrane is treated with a plasma containing an unsaturated carboxylic acid monomer, whereby the membrane surface is modified with an acidic polymeric deposit, this modification resulting in reduced nonspecific binding of oligonucleotide probes and increased sensitivity in chemiluminescent analyses of polynucleotide sequences.

Method of analysis of genomic biopolymer and porous materials for

Plasma polymerization of a fully alkylated disiloxane is greatly enhanced by the addition of oxygen to the plasma feed gases. Deposition rate of polysiloxane polymerizate upon substrates is increased, and the deposits are nontacky. Composite permselective membranes made by deposition of plasma-polymerized polysiloxanes in the presence of oxygen are useful for applications such as gas separations. Composite hollow fiber membranes of polysiloxane polymerizate on porous polypropylene exhibit oxygen/nitrogen permselectivities greater than 2.3 combined with increased oxygen permeability.

Growing community of inventors

Shorewood, MN, United States of America

Hiroshi Nomura