EP0614368A1 - Sang de transfusion humain sans danger - Google Patents

Sang de transfusion humain sans danger

Info

Publication number
EP0614368A1
EP0614368A1 EP93911103A EP93911103A EP0614368A1 EP 0614368 A1 EP0614368 A1 EP 0614368A1 EP 93911103 A EP93911103 A EP 93911103A EP 93911103 A EP93911103 A EP 93911103A EP 0614368 A1 EP0614368 A1 EP 0614368A1
Authority
EP
European Patent Office
Prior art keywords
blood
iodine
serum
plasma
cell concentrate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP93911103A
Other languages
German (de)
English (en)
Other versions
EP0614368A4 (fr
Inventor
Edward Shanbrom
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP0614368A4 publication Critical patent/EP0614368A4/fr
Publication of EP0614368A1 publication Critical patent/EP0614368A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A01N59/12—Iodine, e.g. iodophors; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/18—Iodine; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3687—Chemical treatment
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • Iodine was officially recognized by the Pharmacopeia of the United States in 5 1930, also as tincture iodine (tincture of iodine) and linimentum iodi (liniment of iodine).
  • Clinicians and microbiologists described a great number of experimental data and clinical applications. Despite the successes that have been achieved with iodine, it was ascertained early that it also possesses properties imsuitable for practical application. 10 Although exact details about the killing of a living cell by the I 2 molecule
  • iodine reacts with basic N-H functions that are parts of some amino acids (e.g., lysine, histidine, arginine) and the bases of nucleotides (adenine, cytosine, and guanine) forming the corresponding N-iododerivatives.
  • basic N-H functions that are parts of some amino acids (e.g., lysine, histidine, arginine) and the bases of nucleotides (adenine, cytosine, and guanine) forming the corresponding N-iododerivatives.
  • amino acids e.g., lysine, histidine, arginine
  • nucleotides adenine, cytosine, and guanine
  • Iodine reacts with the phenolic group of the amino acid tyrosine, forming mono- or diiodo-derivatives.
  • Iodine - polymer complexes e.g., with poly(vinylpyrrolidone) (PVP), and 25 complexes of iodine with nonionic surfactants, eg, polyethylene glycol ⁇ nono(nonylphenyl) ether have been used with considerable success.
  • PVP poly(vinylpyrrolidone)
  • nonionic surfactants eg, polyethylene glycol ⁇ nono(nonylphenyl) ether
  • Iodine is capable, in certain circumstances, of killing all classes of pathogens encountered in nosocomial infections: gram-positive and gram-negative bacteria, mycobacteria, fungi, yeasts, viruses and protozoa. Most bacteria are killed within 15 to 30 seconds of contact. Iodine is generally considered to be an excellent, prompt, effective microbicide with a broad range of action that includes almost all of the important health-related microorganisms, such as enteric bacteria, enteric viruses, bacterial viruses, and protozoan cysts, if the sometimes severe limitations inherent in its use are overcome. Mycobacteria and the spores of bacilli and clostridia can also be killed by iodine.
  • iodine also exhibits a fungicidal and trichomonacidal activity. As to be expected, varying amounts of iodine are necessary to achieve complete disinfection of the different classes or organisms. Within the same class, however, the published data on the disinfecting effect of iodine correspond only to a small extent. In particular, the published killing time of spores and viruses are widely disparate.
  • iodine is consumed by proteinaceous substrates and its efficacy as a disinfectant is reduced at certain antiseptic applications. This is due to a reducing effect of the material to be disinfected which leads to the conversion of iodine into non-bactericidal iodide. Thus, not only the reservoir of available iodine is diminished but also the equilibrium of triiodide is influenced as well. Both of these effects cause a decrease in the proportion of free molecular iodine, the actual anti-microbial agent. In whole blood, a strong decrease of the concentration of free molecular iodine occurs, while, in the presence of plasma, it remains practically unchanged. Durmaz, et al, Mikrobiyol. Bid. 22 (3), 1988 (abstract); Gottardi W, Hyg. Med. 12 (4). 1987.
  • Iodine is used widely in human medicine is the disinfection of skin, (e.g., the preoperative preparations of the skin, the surgical disinfection of hands, the disinfection of the perineum prior to delivery, and the disinfection of the skin prior to infections and transfusions). Iodine preparations are also used for therapeutic purposes, e.g., the treatment of infected and burned skin but is a strong irritant.
  • Iodine has also been used for the disinfection of medical equipment, such as catgut, catheters, knife blades, ampules, plastic items, rubber goods, brushes, multiple-dose vials, and thermometers.
  • medical equipment such as catgut, catheters, knife blades, ampules, plastic items, rubber goods, brushes, multiple-dose vials, and thermometers.
  • the use of iodine as an aerial disinfectant has been advocated since 1926.
  • oxidizing iodine including “compounds incorporating molecules of oxidizing iodine” e.g. absorbed or grafted on a purified vegetable carbon, as blood- contacting reagents having bactericidal and bacteriostatic action are mentioned in passing in connection with an autotransfuser device in U.S. Patent 4,898,572,
  • I 2 is 2 to 3 times as cysticidal and 6 times as sporicidal as HOI, while HOI is at least 40 times as virucidal as L. This behavior is explained on the one hand by the higher diffusibility of molecular iodine through the cell walls of cysts and spores and on the other hand by the higher oxidizing power of HOI. Gottardi, W. Iodine and Iodine Compounds in DISINFECTION,
  • Polyvinylpyrrolidone (PVP, Povidone) is manufactured by BASF Aktiengesellschaft, Untemehemens Slow Feincheme, D-6700 Ludwigshaven,
  • Patent No. 3,488,312 Barabas, et. al, 1970 - water-insoluble graft polymer-iodine complexes; U.S. Patent No. 3,689,438, Field, et. al., 1972 - cross-linked polymer- iodine manufacture; U.S. Patent No. 3,907,720, Field, et. al., 1975 - cross-linked polymer-iodine manufacture; U.S. Patent No. 4,017,407, Cantor, et. al., 1977 - solid N-vinyl-2-pyrrolidone polymer carriers for iodine; U.S. Patent No.
  • PVP PVP-iodine
  • hydrogen triiodide forms a complex with PVP that is so stable that there is no appreciable vapor pressure. It is superior to tincture of iodine as a germicide.
  • poloxamers i.e., polyether alcohols
  • iodine i.e., Prepodyne, Septodyne
  • the iodophors are available in a variety of forms, such as a 10% applicator solution, 2% cleansing solution (scrub), aerosol spray, aerosol foam, vaginal gel (for trichonomal and candidal infections) ointment powder, mouthwash, perineal wash, and whirlpool concentrate (all 2%).
  • iodophors may be used in this invention in some of its various uses and applications and, to the extent that the iodophor is effective and does not injure the material undergoing treatment, are considered generally as equivalents or potential equivalents of povidone iodine.
  • povidone iodine In addition to the risk of transmitting infectious disease via blood or blood products, the growth of bacteria in blood and blood products at various stages of production and processing introduces pyrogens into the blood component or product which must be removed before the product can be used in therapy.
  • Introduction of molecular iodine, e.g. povidone- at an early stage in processing of blood products greatly reduces or eliminates the pyrogen-load of the ultimate product or fraction.
  • this invention is applicable to the treatment of donated blood and products produced from blood, for inactivating virus, bacteria, chlamydia, rickettsia, mycoplasma and other potentially pathogenic microorganisms.
  • Safe transfusion blood is manufactured by removing a substantial portion of blood plasma, and optionally coagulating to serum, from whole blood leaving a blood cell concentrate, passing the plasma, or, optionally, serum from such blood, into contact with a solid source of available oxidizing iodine for inactivating pathogenic microbes in the blood and for transferring an effective amount of iodine, from about 0.01% by weight to five percent by weight, into the plasma, or, optionally, serum from such blood, to inactivate pathogenic microbes in both the plasma, or, optionally, serum from such blood, and blood cell concentrate and reconstituting the whole blood by mixing the plasma, or, optionally, serum from such blood, containing available iodine with the blood cell concentrate, the available iodine in the plasma, or, optionally, serum from such blood, being from about 0.01% to about five percent by weight of the thus iodized plasma, or, optionally, iodized serum from such blood, and sufficient to inactivate substantially all pathogenic
  • a unit of transfusion quality blood is separated into plasma, or, optionally, serum from such blood, and blood cell concentrate.
  • Serum may, for example, be formed by coagulating plasma or by coagulating a separate unit of whole blood from the same donor.
  • Plasma removal may be accomphshed by compressing the blood through a filter to express a substantial amount of the plasma from the container leaving a blood cell concentrate, by centrifuging the blood lightly and decanting the plasma from such blood, or in any other way.
  • Serum may be formed from the plasma or from another unit of the same blood directly by coagulation and centrifugation, or in any other conventional way. Separating a substantial amount of the plasma, or, optionally, serum from blood to form the blood cell concentrate can be carried out using any convenient manipulation(s). It is not necessary that all of the plasma, or, optionally, serum from such blood, be separated; however, best results are achieved when substantially all of the plasma not interstitiaUy trapped between the cells of the cell concentrate is removed.
  • the plasma, or, optionally, serum from such blood is then contacted with a sohd source of iodine that holds the iodine loosely enough to permit some of the iodine to enter into the plasma, or, optionally, serum from such blood.
  • a sohd source of iodine that holds the iodine loosely enough to permit some of the iodine to enter into the plasma, or, optionally, serum from such blood.
  • One convenient way of carrying out the invention is to express plasma, or, optionally, serum from such blood, through a bed (filter) of polymer- iodine particles.
  • the separation of plasma from blood and iodinazation may be accomphshed by expressing the plasma from whole blood directly through a sohd iodine-containing filter.
  • sohd povidone-iodine or other polymer-iodine complex is a suitable form of such iodine.
  • the plasma, or, optionally, serum from such blood, and the blood cell concentrate are reconstituted to form whole blood or blood cells carried in serum. Residual iodine in the plasma, or, optionally, serum from such blood, is present in a sufficient amount, from 0.001 to five percent, typically from 0.1 to 1 percent, by weight, in the plasma, or, optionally, serum from such blood, to kill or inactivate all extracellular virus in the blood cell concentrate and substantially all or all intracellular virus by penetration into the cell.
  • the blood cell product will be reconstituted within less than about an hour and, preferrably in less than about a quarter of an hour, after the iodine has been added to the plasma, or, optionally, serum from such blood,.
  • iodine iodide (resulting from reduction of the iodine) All iodine is fairly rapidly reduced by blood constituents to iodide or bound to blood proteins, e.g. albumin, and, thus, non-toxic.
  • the blood is contacted with a solvent for iodine that has no effect or minimal effect on plasma and the hydrophilic components.
  • a solvent for iodine that has no effect or minimal effect on plasma and the hydrophilic components.
  • Normal alkane e.g. n-heptane
  • iodine that has been reduced to iodide will remain, largely, in the aqueous phase.
  • Other extraction solvents include analogous homolog of heptane and vegetable oils such as cotton seed oil, corn oil, etc. Any hydrophobic solvent for iodine that is essentially inert biologically and has sufficient density difference from water and respecting which water has a high enough interfacial tension to form a clean separation from the aqueous phase may be used as the solvent
  • Ji assurance of total conversion of iodine to iodide is desired, the addition of biologically compatible reducing substances, e.g. reducing sugars, ascorbic acid or ascorbate, sodium sulfite, etc. may be added.
  • the reconstituted blood may be passed into contact with a sohd iodine-adsorbing material, e.g. sohd povidone or starch. Any free iodine will, in such process, be adsorbed and removed from the reconstituted blood.
  • a sohd iodine-adsorbing material e.g. sohd povidone or starch. Any free iodine will, in such process, be adsorbed and removed from the reconstituted blood.
  • any combination of techniques may be used.
  • Pathogenic microbes that are inactivated in accordance with this invention include virus, bacteria, chlamydia, rickettsia, mycoplasma and other potentially pathogenic microorganisms.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pest Control & Pesticides (AREA)
  • Plant Pathology (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Environmental Sciences (AREA)
  • Organic Chemistry (AREA)
  • Agronomy & Crop Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Un procédé de préparation de sang de transfusion humain sans danger consiste à séparer le sang humain total en un concentré de cellules et en plasma, ou, facultativement, en sérum dudit sang, à faire passer le plasma, ou facultativement le sérum dudit sang, en contact avec un complexe de polymère solide-iode afin d'ajouter de l'iode au plasma, ou facultativement au sérum dudit plasma, et à reconstituer les cellules sanguines en suspension dans le sang total ou le sérum, à partir du plasma ainsi traité, ou facultativement du sérum dudit plasma, ainsi que le concentré cellulaire, puis à conserver la composition de sang reconstitué pendant une durée donnée afin de permettre l'inactivation de microbes pathogènes avant la transfusion du sang reconstitué à un patient. L'invention concerne également le produit de ce procédé.
EP93911103A 1992-05-04 1993-05-04 Sang de transfusion humain sans danger Withdrawn EP0614368A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US87918092A 1992-05-04 1992-05-04
US879180 1992-05-04
PCT/US1993/004280 WO1993021933A1 (fr) 1992-05-04 1993-05-04 Sang de transfusion humain sans danger

Publications (2)

Publication Number Publication Date
EP0614368A4 EP0614368A4 (fr) 1994-04-12
EP0614368A1 true EP0614368A1 (fr) 1994-09-14

Family

ID=25373587

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93911103A Withdrawn EP0614368A1 (fr) 1992-05-04 1993-05-04 Sang de transfusion humain sans danger

Country Status (3)

Country Link
EP (1) EP0614368A1 (fr)
JP (1) JPH06509118A (fr)
WO (1) WO1993021933A1 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5591350A (en) * 1994-04-15 1997-01-07 Pall Corporation Iodine disinfection method using a gaseous iodine treated porous medium
US6096216A (en) * 1994-06-09 2000-08-01 American National Red Cross Iodinated matrices for disinfecting biological fluids
AU1056397A (en) * 1996-11-20 1998-06-10 Edward Shanbrom Trace capture in biological fluids
US6106773A (en) * 1998-09-24 2000-08-22 American National Red Cross Pathogen inactivating compositions for disinfecting biological fluids
US7297716B2 (en) 2000-10-23 2007-11-20 Shanbrom Technologies, Llc Enhanced production of blood components, blood cells and plasma without freezing
US8389687B2 (en) 2000-10-23 2013-03-05 Shanbrom Technologies, Llc Polyvinylpyrrolidone cryoprecipitate extraction of clotting factors
US6881731B1 (en) * 2000-10-23 2005-04-19 Shanbrom Technologies, Llc Enhancers for microbiological disinfection
US7411006B2 (en) 2000-10-23 2008-08-12 Shanbrom Technologies, Llc Enhanced production of blood clotting factors and fibrin fabric
CA2438223A1 (fr) * 2001-02-07 2002-11-07 Shanbrom Technologies, Llc Acide carboxylique, par exemple acide citrique, utilise pour la desinfection ou l'amelioration de la production de produits sanguins, tels que le plasma, le cryoprecipite et/ou les plaquettes

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992004031A1 (fr) * 1990-09-04 1992-03-19 Edward Shanbrom Preservation de sang, de tissus et de fluides biologiques
WO1992004061A1 (fr) * 1990-09-04 1992-03-19 Edward Shanbrom Preservation antimicrobienne de plasma
WO1993004731A1 (fr) * 1991-09-03 1993-03-18 Edward Shanbrom Traitement a l'iode-iodure de cellules sanguines rouges
WO1993006911A1 (fr) * 1991-10-08 1993-04-15 Isp Investments Inc. Procede de traitement du sang

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5071648A (en) * 1989-04-06 1991-12-10 Merocel Corporation Polymeric broad-spectrum antimicrobial materials

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992004031A1 (fr) * 1990-09-04 1992-03-19 Edward Shanbrom Preservation de sang, de tissus et de fluides biologiques
WO1992004061A1 (fr) * 1990-09-04 1992-03-19 Edward Shanbrom Preservation antimicrobienne de plasma
WO1993004731A1 (fr) * 1991-09-03 1993-03-18 Edward Shanbrom Traitement a l'iode-iodure de cellules sanguines rouges
WO1993006911A1 (fr) * 1991-10-08 1993-04-15 Isp Investments Inc. Procede de traitement du sang

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9321933A1 *

Also Published As

Publication number Publication date
WO1993021933A1 (fr) 1993-11-11
EP0614368A4 (fr) 1994-04-12
JPH06509118A (ja) 1994-10-13

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