WO2000038758A1 - Utilisation d'une membrane selective dans un dispositif biomedical pour le traitement extra-corporel du sang et d'autres fluides organiques - Google Patents

Utilisation d'une membrane selective dans un dispositif biomedical pour le traitement extra-corporel du sang et d'autres fluides organiques Download PDF

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Publication number
WO2000038758A1
WO2000038758A1 PCT/IB1999/002041 IB9902041W WO0038758A1 WO 2000038758 A1 WO2000038758 A1 WO 2000038758A1 IB 9902041 W IB9902041 W IB 9902041W WO 0038758 A1 WO0038758 A1 WO 0038758A1
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WO
WIPO (PCT)
Prior art keywords
ozone
blood
use according
polyethylene
membrane
Prior art date
Application number
PCT/IB1999/002041
Other languages
English (en)
Inventor
Raffaella Scagliarini
Original Assignee
In.Te.C. S.R.L.
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 In.Te.C. S.R.L. filed Critical In.Te.C. S.R.L.
Publication of WO2000038758A1 publication Critical patent/WO2000038758A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/26—Polyalkenes
    • B01D71/261—Polyethylene
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/54—Polyureas; Polyurethanes
    • 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
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0216—Ozone

Definitions

  • the present invention relates to the use of a selective membrane in a biomedical device for the treatment of blood and biological fluids.
  • the present invention relates to a biomedical device for the extracorporeal ozonization of blood or biological fluids and to the use of particular membranes in blood treatments performed outside the body.
  • Ozone the active principle used in the present invention, is an unstable gas currently applied as a whitening, oxidizing, and water purifying agent thanks to its disinfectant activity.
  • autohemotherapy consists in the ex vivo exposure of human blood to a mixture of ozone and oxygen for a short period of time, thus inducing an oxidative stress. The treated blood is then reinfused to the patient.
  • the autohemotransfusion procedure has proved itself adequately safe, relatively low in cost and capable of justifying its use in various disorders.
  • One of the aims of the present invention consists in avoiding or substantially attenuating the drawbacks observed in the prior art related to the extracorporeal ozonization of blood or biological fluids.
  • a principal object of the invention is to provide new uses for selective membranes in the field of extracorporeal treatments for the ozonization of blood, plasma or other biological fluids.
  • Another object of the present invention is to provide a biomedical device for the ozonization of blood or biological liquids allowing to perform an extracorporeal treatment on the entire blood volume in a short time and with a wide safety margin for the patient.
  • Another object of the present invention is to provide a biomedical device for the ozonization of human blood limiting the risks of embolism that occur in the direct insufflation of the mixture of gases into the circulatory system or into body tissues.
  • Another object of the invention is to provide a biomedical device for the extracorporeal ozonization of human blood or body liquids which can be manufactured with low production costs.
  • a membrane of polymeric resin which is permeable to ozone by molecular diffusion and is substantially inert with respect to ozone in the extracorporeal ozonization of blood or of a biological liquid.
  • the membranes used in the scope of the present invention are membranes made of a polymeric resin which is resistant to the oxidative processes caused by contact with ozone and is selectively permeable to ozone or to a gas mixture containing ozone. The passage of the ozone gas occurs through the membranes by molecular diffusion according to the gas concentration gradient.
  • Particularly adapted polymeric resins are selected from the group that comprises resins of polyethylene, polyurethane, silicone, and combinations of layers of polyethylene/polyurethane/polyethylene resins.
  • the membranes used are hollow-fiber membranes or flat membranes.
  • Adapted hollow-fiber membranes are constituted by microporous capillaries having a thickness preferably between 40 and 60 ⁇ and an average pore diameter preferably between 0.05 and 0.3 ⁇ .
  • microporosity of the membranes prevents the gas from passing in the form of microbubbles (microembolisms), which would damage plasma proteins.
  • Adapted flat membranes are non-microporous membranes preferably made of silicone with a thickness which is advantageously between 5 and 100 ⁇ . Gas exchange through this type of membrane occurs by molecular diffusion and is proportional to the thickness of the membrane and to the gradient of concentration of the ventilated gas mixture.
  • a biomedical device for the extracorporeal ozonization of blood and biological liquids which comprises a hollow body in which there are two compartments for the passage of two fluids, these compartments being separated by a selective membrane, the device being characterized in that the selective membrane comprises at least one portion made of a polymeric resin which is permeable to ozone by molecular diffusion and is substantially inert with respect to ozone.
  • the Applicant has now found that it is possible to obviate the drawbacks of the prior art observed in the reinfusion of blood with mixtures of oxygen and ozone by supplying one of the compartments of the device of the above- described type with blood or other biological fluid and the other compartment with ozone or a gas mixture containing ozone, so as to provide the transfer of the ozone from the compartment at high concentration to the compartment at lower concentration by molecular diffusion through the selective membrane.
  • the device according to the invention is provided with membranes of the hollow-fiber or flat-fiber type as described above.
  • the ozone is preferably administered in a gaseous mixture with one or more physiologically tolerable gases, oxygen being the preferred one among these gases.
  • the mixture of ozone is supplied at a pressure which is preferably between 0.1 and 0.3 bar.
  • the therapeutic concentration of 0 3 in the gaseous mixture is advantageously between 5 and 40 ⁇ g/ml. It has been observed that the use of ozone at these levels of concentration facilitates the formation of ROS
  • ozone as a strong oxidizing agent, can regulate the production of antioxidant intracellular enzymes, inhibiting the constant cellular oxidative stress that usually causes degenerative and aging-related disorders.
  • Another aspect of the present invention relates to the use of a device of the type described above in a method for the extracorporeal ozonization of blood, plasma or biological fluids.
  • an extracorporeal stream of blood is pumped into one of the two compartments, while a gas mixture containing ozone is insufflated into the other compartment.
  • the two streams of fluid advantageously flow in countercurrent.
  • This operating method allows to process, in approximately one hour, a volume of blood which is equivalent to the entire blood volume of a patient, while obviating the risks of embolism that occur with methods that provide for the direct insufflation of the mixture of gas into the circulatory system.
  • a biomedical device 1 for the ozonization of blood or plasma which comprises a substantially cylindrical hollow body 2 inside which there is, in a substantially longitudinal position, a microporous membrane 3 of the hollow (capillary) fiber polyethylene type, which has an elongated shape and is fixed proximate to the ends 6 and 7 of the body 2 by poured polyurethane resin 15.
  • the microporous membrane 3 is constituted by a bundle of polymeric (polyethylene) microporous capillary fibers which allow the molecular diffusion of the ozone towards the blood that flows in the adjacent flow compartment 4.
  • the blood flow compartment 4 is delimited by the internal walls of the hollow body 2 and by the external surface of the capillary fibers 3.
  • the blood flow compartment 4 is supplied by a sterile cannula 12 which is connected, by means of a supply nozzle 8, to the inlet located at one end of the body of the device.
  • a second cannula 13 for reinfusing the treated blood to the patient is connected by means of a second nozzle 9 which is arranged at the opposite end of the body 2 of the device 1.
  • the body of the device 1 is further provided with an inlet 10 and with an outlet 11 which are arranged proximate to the two ends for the connection of the microporous hollow fibers 3 to the system for feeding the oxygen/ozone mixture.
  • This system is constituted by a feeder cannula 14 and by a discharge cannula 15 connected by means of nozzles to the body of the device 1.
  • the compartment 4 is provided with one or more collection chambers (not shown), which are preferably provided with paths for connection to the outside.
  • the blood for supplying the device is drawn intravenously from a patient requiring treatment and is transferred to an extracorporeal treatment system.
  • This system comprises a first sterile cannula for transferring the blood from the withdrawal needle to a feeder pump.
  • a second cannula leads from the pump and connects to the nozzle 10 for feeding the blood flow compartment 4 of the ozonization device 1.
  • a mixture of oxygen/ozone is insufflated into the microporous capillaries of the filtering membrane 3, so as to produce a stream of gas which flows inside the ozonization device in countercurrent with respect to the Mood stream .
  • the gas mixture for ozonization is administered by connecting, by means of a cannula 14, the delivery valve of a gas bottle (not shown) to the nozzle 10 arranged proximate to the inlet of the filtering membrane.
  • a second cannula 15, connected to the discharge nozzle 11 conveys the gas that leaves the device to a gas recovery system (not shown).
  • the illustrated extracorporeal treatment facilitates the formation of reactive oxygen species in the treated blood which act as natural activators for a large number of biological functions.

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  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Water Supply & Treatment (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne l'utilisation d'une membrane sélective (3) dans un dispositif biomédical (1) pour l'ozonisation extra-corporelle du sang et de fluides biologiques. Le dispositif utilisé pour ce traitement comprend un corps creux (2) contenant deux compartiments (compartiments à sang : 4) destinés au passage de deux fluides. Ces compartiments sont séparés par une membrane (3) constituée de résine polymère pour la diffusion moléculaire sélective d'ozone et/ou d'oxygène, laquelle membrane est sensiblement inerte par rapport à l'ozone.
PCT/IB1999/002041 1998-12-24 1999-12-22 Utilisation d'une membrane selective dans un dispositif biomedical pour le traitement extra-corporel du sang et d'autres fluides organiques WO2000038758A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI98A002831 1998-12-24
IT1998MI002831A IT1304503B1 (it) 1998-12-24 1998-12-24 Uso di una membrana selettiva in un dispositivo biomedicale per iltrattamento extracorporeo di sangue e di altri liquidi organici.

Publications (1)

Publication Number Publication Date
WO2000038758A1 true WO2000038758A1 (fr) 2000-07-06

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PCT/IB1999/002041 WO2000038758A1 (fr) 1998-12-24 1999-12-22 Utilisation d'une membrane selective dans un dispositif biomedical pour le traitement extra-corporel du sang et d'autres fluides organiques

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IT (1) IT1304503B1 (fr)
WO (1) WO2000038758A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7670797B2 (en) 2003-01-16 2010-03-02 The General Hospital Corporation Method of determining toxicity with three dimensional structures
US7759113B2 (en) 1999-04-30 2010-07-20 The General Hospital Corporation Fabrication of tissue lamina using microfabricated two-dimensional molds
US7776021B2 (en) 2000-04-28 2010-08-17 The Charles Stark Draper Laboratory Micromachined bilayer unit for filtration of small molecules
US7960166B2 (en) 2003-05-21 2011-06-14 The General Hospital Corporation Microfabricated compositions and processes for engineering tissues containing multiple cell types
US8097456B2 (en) 2003-08-18 2012-01-17 The Charles Stark Draper Laboratory Nanotopographic compositions and methods for cellular organization in tissue engineered structures
US8147562B2 (en) 2002-09-23 2012-04-03 The General Hospital Corporation Three dimensional construct for the design and fabrication of physiological fluidic networks
US8266791B2 (en) 2007-09-19 2012-09-18 The Charles Stark Draper Laboratory, Inc. Method of fabricating microfluidic structures for biomedical applications
ITMI20111439A1 (it) * 2011-07-29 2013-01-30 Paolo Benatti Apparato per l'ozonizzazione di fluidi biologici, particolarmente per sangue.
US8591597B2 (en) 2007-04-12 2013-11-26 The General Hospital Corporation Biomimetic vascular network and devices using the same
WO2016043649A1 (fr) * 2014-09-15 2016-03-24 Johan Sjöholm Appareil et procédé pour mettre en contact le sang avec de l'ozone
US9595206B2 (en) 2008-02-11 2017-03-14 The General Hospital System and method for in vitro blood vessel modeling
CN108485942A (zh) * 2018-03-13 2018-09-04 常州扬鹏科技有限公司 用于生物浸出反应器的微气泡生成装置
US10822461B2 (en) 2017-10-05 2020-11-03 Fresenius Medical Care Holdings, Inc. Polysulfone-urethane copolymer, membranes and products incorporating same, and methods for making and using same
WO2021094293A1 (fr) * 2019-11-11 2021-05-20 Fresenius Medical Care Deutschland Gmbh Système d'élimination de monoxyde de carbone dans le sang au moyen d'ozone
IT202000016723A1 (it) * 2020-07-09 2022-01-09 Eurosets Srl Circuito per la circolazione extracorporea del sangue

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2025256A (en) * 1978-06-15 1980-01-23 Mitsubishi Rayon Co A Gas Transfer Process Using a Hollow Fiber Membrane
EP0167162A2 (fr) * 1984-07-04 1986-01-08 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Oxygénateur à fibres creuses
AU637374B2 (en) * 1990-06-04 1993-05-27 Medizone International, Inc. Ozone decontamination of blood and blood products
DE4406106A1 (de) * 1994-02-25 1995-08-31 Ulrich Dr Med Werth Verfahren und Vorrichtung zum Eintrag von Ozon in Blut
JPH10277370A (ja) * 1997-04-10 1998-10-20 Nitto Denko Corp スパイラル型膜モジュール

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2025256A (en) * 1978-06-15 1980-01-23 Mitsubishi Rayon Co A Gas Transfer Process Using a Hollow Fiber Membrane
EP0167162A2 (fr) * 1984-07-04 1986-01-08 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Oxygénateur à fibres creuses
AU637374B2 (en) * 1990-06-04 1993-05-27 Medizone International, Inc. Ozone decontamination of blood and blood products
DE4406106A1 (de) * 1994-02-25 1995-08-31 Ulrich Dr Med Werth Verfahren und Vorrichtung zum Eintrag von Ozon in Blut
JPH10277370A (ja) * 1997-04-10 1998-10-20 Nitto Denko Corp スパイラル型膜モジュール

Non-Patent Citations (4)

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Title
DATABASE WPI Section Ch Derwent World Patents Index; Class D15, AN 1999-012762, XP002137899 *
KOLLA S ET AL: "TOTAL RESPIRATORY SUPPORT WITH TIDAL FLOW EXTRACORPOREAL CIRCULATION IN ADULT SHEEP", ASAIO JOURNAL,US,J.B.LIPPINCOTT CO.,HAGERSTOWN,MD, vol. 43, no. 5, 1 September 1997 (1997-09-01), pages 811 - 816, XP000728811, ISSN: 1058-2916 *
PATENT ABSTRACTS OF JAPAN vol. 1999, no. 01 29 January 1999 (1999-01-29) *
TATSUMI E ET AL: "DEVELOPMENT OF AN INTEGRATED ARTIFICIAL HEART-LUNG DEVICE FOR LONG-TERM CARDIOPULMONARY SUPPORT", ASAIO JOURNAL,US,J.B.LIPPINCOTT CO.,HAGERSTOWN,MD, vol. 42, no. 5, 1 September 1996 (1996-09-01), pages M827 - M832, XP000683650, ISSN: 1058-2916 *

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7759113B2 (en) 1999-04-30 2010-07-20 The General Hospital Corporation Fabrication of tissue lamina using microfabricated two-dimensional molds
US8642336B2 (en) 1999-04-30 2014-02-04 The General Hospital Corporation Fabrication of vascularized tissue using microfabricated two-dimensional molds
US7776021B2 (en) 2000-04-28 2010-08-17 The Charles Stark Draper Laboratory Micromachined bilayer unit for filtration of small molecules
US8491561B2 (en) 2002-03-25 2013-07-23 The Charles Stark Draper Laboratory Micromachined bilayer unit of engineered tissues
US8147562B2 (en) 2002-09-23 2012-04-03 The General Hospital Corporation Three dimensional construct for the design and fabrication of physiological fluidic networks
US7670797B2 (en) 2003-01-16 2010-03-02 The General Hospital Corporation Method of determining toxicity with three dimensional structures
US8173361B2 (en) 2003-01-16 2012-05-08 The General Hospital Corporation Method of determining metabolism of a test agent
US7960166B2 (en) 2003-05-21 2011-06-14 The General Hospital Corporation Microfabricated compositions and processes for engineering tissues containing multiple cell types
US8865466B2 (en) 2003-08-18 2014-10-21 The Charles Stark Draper Laboratory Nanotopographic compositions and methods for cellular organization in tissue engineered structures
US8097456B2 (en) 2003-08-18 2012-01-17 The Charles Stark Draper Laboratory Nanotopographic compositions and methods for cellular organization in tissue engineered structures
US8951302B2 (en) 2007-04-12 2015-02-10 The General Hospital Corporation Biomimetic vascular network and devices using the same
US8591597B2 (en) 2007-04-12 2013-11-26 The General Hospital Corporation Biomimetic vascular network and devices using the same
US10939989B2 (en) 2007-04-12 2021-03-09 The General Hospital Corporation Biomimetic vascular network and devices using the same
US10265698B2 (en) 2007-09-19 2019-04-23 The Charles Stark Draper Laboratory, Inc. Microfluidic structures for biomedical applications
US9181082B2 (en) 2007-09-19 2015-11-10 The Charles Stark Draper Laboratory, Inc. microfluidic structures for biomedical applications
US8266791B2 (en) 2007-09-19 2012-09-18 The Charles Stark Draper Laboratory, Inc. Method of fabricating microfluidic structures for biomedical applications
US9595206B2 (en) 2008-02-11 2017-03-14 The General Hospital System and method for in vitro blood vessel modeling
ITMI20111439A1 (it) * 2011-07-29 2013-01-30 Paolo Benatti Apparato per l'ozonizzazione di fluidi biologici, particolarmente per sangue.
WO2016043649A1 (fr) * 2014-09-15 2016-03-24 Johan Sjöholm Appareil et procédé pour mettre en contact le sang avec de l'ozone
US11426505B2 (en) 2014-09-15 2022-08-30 Sangair Ab Apparatus and method for contacting blood with ozone
US10822461B2 (en) 2017-10-05 2020-11-03 Fresenius Medical Care Holdings, Inc. Polysulfone-urethane copolymer, membranes and products incorporating same, and methods for making and using same
US11499016B2 (en) 2017-10-05 2022-11-15 Fresenius Medical Care Holdings, Inc. Polysulfone-urethane copolymer, membranes and products incorporating same, and methods for making and using same
CN108485942A (zh) * 2018-03-13 2018-09-04 常州扬鹏科技有限公司 用于生物浸出反应器的微气泡生成装置
WO2021094293A1 (fr) * 2019-11-11 2021-05-20 Fresenius Medical Care Deutschland Gmbh Système d'élimination de monoxyde de carbone dans le sang au moyen d'ozone
WO2022009078A1 (fr) * 2020-07-09 2022-01-13 Eurosets S.R.L. Circuit de circulation sanguine extracorporelle
IT202000016723A1 (it) * 2020-07-09 2022-01-09 Eurosets Srl Circuito per la circolazione extracorporea del sangue

Also Published As

Publication number Publication date
ITMI982831A1 (it) 2000-06-24
IT1304503B1 (it) 2001-03-19

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