Shanbrom Technologies, LLC

Other

Edward Shanbrom, Inc.

Societe Anonyme Dite: L'oreal

American National Red Cross

Cryolife, Inc.

Luther Medical Products, Inc.

Schick Incorporated

Amersham Pharmacia Biotech, Inc.

Societe Anonyme Dite: Institut Merieux

Edward Shanbrom

Robert C Bishop

Jacques C Liautaud

Ronald B Luther

William N Drohan

Brenda S Morse

Shirley I Miekka

Jean F Pla

Robert Pollock

Timothy W Horton

Maryse Chanas

Blood collection, processing and transfer leads to the separation of discrete fractions by adding additional citrate (trisodium citrate) to bring the citrate concentration to 10%-15% w/v thereby leading to enhanced yield and purity of cryoprecipitate. The improved cryoprecipitate then yields concentrated clotting factors by an improved extraction process which uses polyvinyl pyrollidone to reduce the extraction of fibrinogen. Following extraction the remaining cryoprecipitate can advantageously be formed into a fibrin fabric used in surgeries and in the treatment of wounds.

Polyvinylpyrrolidone cryoprecipitate extraction of clotting factors

The blood collection, processing and transfer by separation of discrete components containing additional citrate (at least about trisodium citrate 9% w/v) in one or other of collection or processing bag provides for enhanced yield and purity of cryoprecipitate. Inhibiting the activation or denaturation of blood components including blood cells and plasma proteins and with the removal of the activated and denatured components thereby improving safety and efficacy of end products. The inventive process is particularly suited to an improved extraction process to yield concentrated clotting factors from single donors or limited pools without use of chromatography. Following extraction the remaining cryoprecipitate can advantageously be formed into a fibrin fabric used in surgeries and in the treatment of wounds.

Enhanced production of blood clotting factors and fibrin fabric

The blood collection, processing and transfer by separation of discrete components containing additional citrate (at least about trisodium citrate 2% w/v) in one or other of collection or processing bag provides for enhanced yield and purity of cryoprecipitate. Inhibiting the activation or denaturation of blood components including blood cells and plasma proteins and with the removal of the activated and denatured components thereby improving safety and efficacy of end products, which include fibrin glue, is achieved. In addition, the process allows 'cryo' precipitate to be prepared at temperatures above freezing and without freezing the plasma.

Enhanced production of blood components, blood cells and plasma without freezing

Simple carboxylic acids, in particular dicarboxylic acids such as citric acid shows an unexpected ability to enhance the antimicrobial power of a wide range of disinfectant and/or antibiotic agents. As little as 1% citrate greatly enhances the ability of antibiotics to kill or inhibit a wide range of bacterial species including antibiotic resistant strains. Citrate alone is effective in preventing bacterial growth in platelet concentrates and in red blood cell suspensions. Effective concentrations of citrate cause little if any damage to blood cells. Besides enhancing the power of antibiotics citrate also enhances the antimicrobial properties of disinfectant organic dyes such as crystal violet and methylene blue. In addition citrate enhances the antimicrobial properties of polyphenols of plant origin. Iodine-based disinfectants are also enhanced without enhancing protein denaturation.

Enhancers for microbiological disinfection

A mixed bed of iodine source/iodine capture resin provides high flow rates that are useful for treatment of water. The ratio of source/capture resin can be adjusted to meet the goals of the system. If insufficient iodine is being provided, the source resin amount can be increased relative to the capture resin. If excess iodine or iodide are found in the treated water, the capture resin amount can be increased relative to the source resin. The release of iodine from the source resin and its effectiveness can be significantly enhanced by using a mixed bed system in which one or both of the source and the capture ion exchange resins have had their exchange sites saturated with the anion of an organic acid such as citrate and/or isocitrate. This significantly increases the amount of iodine released into aqueous solution and enhances the disinfecting power of that iodine.

Enhanced iodine treatment of drinking water

A simple analytical method for determining antioxidant level in food product and body fluids such as urine is based on reduction of elemental iodine. The method adds an aqueous solution of iodine and an iodophor to the sample to be tested. Polyvinylpyrrolidone is a preferred iodophor. Antioxidant materials in the sample reduce the elemental iodine and the reaction is monitored by measuring either a decrease in iodine or an increase in iodide ion. A preferred method of practicing the invention is to measure the change in iodide ion with an ion selective electrode and an appropriate electronic meter. The method rapidly and inexpensively produces antioxidant measurements that are comparable to those produced by my more complex and cumbersome methods.

Method for quantifying antioxidant levels in food and medical specimens

The lees or &ldquo;dregs&rdquo; produced during wine making are rich sources of antioxidants. Unexpectedly, these materials show significant antibacterial properties as well as antioxidant properties. The lees of red wine which consist of tannins and plant pigments precipitated around crystals of potassium tartarate can advantageously be used directly as a tonic or demulcent. The material can also be used topically for disinfecting the skin, etc. In addition, it is possible to use organic polymers to bind the pigments and/or solubilize them from the tartaric salt to facilitate their use or to make a relatively pure pigment/tannin component.

Antimicrobial lees

A detergent such as nonionic, cationic or anionic detergents and preferably a &ldquo;sugar detergent&rdquo; such as octyl-glucopyranoside is rendered insoluble by being bound to an inert substrate. This detergent is effective at inactivating pathogens even when so bound. Under these conditions the concentration of detergent free in solution is vanishingly low: probably below one millimolar in concentration. Addition of insoluble detergent results in effective destruction of enveloped viruses in a variety of protein containing solutions such as blood, plasma, clotting factors or other proteins purified from human blood. Because the detergent is essentially entirely bound to the solid substrate, there is little or no difficulty in ensuring that the end product is detergent-free. Because the detergent is so bound, it causes essentially no damage to proteins, blood cells and other cellular material.

Disinfection by particle-bound and insolubilized detergents

Derivatives of simple carboxylic acids, particularly trisodium citrate and other citrate salts are effective agents for enhancing the production of blood clotting factors. Addition of citrate to plasma, especially at concentrations between 2 and 10% by weight, does not appreciably denature labile proteins. However, citrate is effective in inactivating or inhibiting a variety of pathogenic microorganisms. Further, the added citrate potentiates or enhances the killing of microorganisms by heat treatment. The added citrate causes a dramatic increase in the weight of cryoprecipitate that can be produced from plasma by the usual procedures. The majority of significant clotting factors are greatly concentrated in the resulting cryoprecipitate. Increasing the amount of citrate in blood bags so that the final concentration will be at least 2% by weight results in plasma that provides improved platelet concentrates because added citrate helps eliminate contaminating microorganisms.

Enhanced production of safe plasma preparations

A microbicidal organic polymer material for use in manufacturing of contact lenses, catheters, condoms, surgical sutures and gloves, medical examination devices and similar uses is provided by polymers to which is tightly adsorbed a disinfectant organic dye. Many polymers such as polyvinyl chloride and acrylic polymers show exceptional avidity for a number of microbicides, of acidic, basic, aromatic and/or hydrophobic character such as methylene blue and gentian violet. Consequently, devices constructed of these polymeric materials release no free dye to an aqueous solution. The material is generally a natural or synthetic polymer that releases no particles or fines into wounds or body orifices. Presence of adsorbed disinfectant organic dye allows the polymer to inhibit microbial growth in a number of different situations. Several common microbes are killed by being incubated in the present of an embodiment of the invention that contains a combination of methylene blue and gentian violet. Absorption of meglumine to the polymers in combination with the organic dyes enhances the anti-infective properties of the material.

Microbicide treated polymeric materials

A microbicidal organic polymer material for use in manufacturing of contact lenses, condoms, surgical sutures and gloves, medical examination devices and similar uses is provided by polymers to which is tightly adsorbed a disinfectant organic dye. Many polymers such as polyvinyl chloride and acrylic polymers show exceptional avidity for a number of microbicides, of acidic, basic, aromatic and/or hydrophobic character such as methylene blue and gentian violet. Consequently, devices constructed of these polymeric materials release no free dye to an aqueous solution. The material is generally a natural or synthetic polymer that releases no particles or fines into wounds or body orifices. Presence of adsorbed disinfectant organic dye allows the polymer to inhibit microbial growth in a number of different situations. Several common microbes are killed by being incubated in the present of an embodiment of the invention which contains a combination of methylene blue and gentian violet.

The present invention provides media for inactivating pathogens found within protein-containing biological fluids. The media of the present invention preserve the structural integrity and biological activity of labile proteins while simultaneously exhibiting potent disinfectant activity. The media of the present invention comprise iodinated chromatographic media, particularly ion exchange media. The invention further provides methods for disinfecting biological fluids.

Iodinated matrices for disinfecting biological fluids

An active coloring concentrate can be prepared from the juice of cranberries and blueberries by treating juice or homogenate with an appropriate binding matrix. Assorted ion exchange resins such as cholestyramine are effective binding matrices, but the currently preferred material is a food grade of cross-linked polyvinyl pyrollidone. The binding matrices are used to concentrate active materials from cranberry and a colored solid is produced. This substance shows anti-bacterial and anti-viral properties. It can be readily consumed as a therapeutic or nutraceutical, used as a coloring agent, or it can be used topically. Significant amounts of active concentrate can be produced from cranberry presscake which is normally a waste material.

Growing community of inventors

Santa Ana, CA, United States of America

Edward Shanbrom