EP2541120A1 - Aluminium cylinder for NO/nitrogen gaseous mixture and use thereof in the treatment of pulmonary vasoconstrictions - Google Patents

Aluminium cylinder for NO/nitrogen gaseous mixture and use thereof in the treatment of pulmonary vasoconstrictions Download PDF

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Publication number
EP2541120A1
EP2541120A1 EP12171927A EP12171927A EP2541120A1 EP 2541120 A1 EP2541120 A1 EP 2541120A1 EP 12171927 A EP12171927 A EP 12171927A EP 12171927 A EP12171927 A EP 12171927A EP 2541120 A1 EP2541120 A1 EP 2541120A1
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EP
European Patent Office
Prior art keywords
mixture
main body
gas
container according
aluminum alloy
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Withdrawn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
EP12171927A
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German (de)
French (fr)
Inventor
Pierre de Villemeur
Laurent Lecourt
Bénédicte Levinson
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.)
Air Liquide SA
Air Liquide Sante International SA
LAir Liquide SA pour lEtude et lExploitation des Procedes Georges Claude
Air Liquide Sante France SA
Original Assignee
Air Liquide SA
Air Liquide Sante International SA
LAir Liquide SA pour lEtude et lExploitation des Procedes Georges Claude
Air Liquide Sante France SA
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Application filed by Air Liquide SA, Air Liquide Sante International SA, LAir Liquide SA pour lEtude et lExploitation des Procedes Georges Claude, Air Liquide Sante France SA filed Critical Air Liquide SA
Publication of EP2541120A1 publication Critical patent/EP2541120A1/en
Withdrawn legal-status Critical Current

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    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C1/00Pressure vessels, e.g. gas cylinder, gas tank, replaceable cartridge
    • F17C1/14Pressure vessels, e.g. gas cylinder, gas tank, replaceable cartridge constructed of aluminium; constructed of non-magnetic steel
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C13/00Details of vessels or of the filling or discharging of vessels
    • F17C13/002Details of vessels or of the filling or discharging of vessels for vessels under pressure
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2201/00Vessel construction, in particular geometry, arrangement or size
    • F17C2201/01Shape
    • F17C2201/0104Shape cylindrical
    • F17C2201/0109Shape cylindrical with exteriorly curved end-piece
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2201/00Vessel construction, in particular geometry, arrangement or size
    • F17C2201/01Shape
    • F17C2201/0104Shape cylindrical
    • F17C2201/0119Shape cylindrical with flat end-piece
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2201/00Vessel construction, in particular geometry, arrangement or size
    • F17C2201/03Orientation
    • F17C2201/032Orientation with substantially vertical main axis
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2201/00Vessel construction, in particular geometry, arrangement or size
    • F17C2201/05Size
    • F17C2201/058Size portable (<30 l)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2203/00Vessel construction, in particular walls or details thereof
    • F17C2203/06Materials for walls or layers thereof; Properties or structures of walls or their materials
    • F17C2203/0602Wall structures; Special features thereof
    • F17C2203/0612Wall structures
    • F17C2203/0614Single wall
    • F17C2203/0617Single wall with one layer
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2203/00Vessel construction, in particular walls or details thereof
    • F17C2203/06Materials for walls or layers thereof; Properties or structures of walls or their materials
    • F17C2203/0634Materials for walls or layers thereof
    • F17C2203/0636Metals
    • F17C2203/0646Aluminium
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2203/00Vessel construction, in particular walls or details thereof
    • F17C2203/06Materials for walls or layers thereof; Properties or structures of walls or their materials
    • F17C2203/0634Materials for walls or layers thereof
    • F17C2203/0636Metals
    • F17C2203/0648Alloys or compositions of metals
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2205/00Vessel construction, in particular mounting arrangements, attachments or identifications means
    • F17C2205/03Fluid connections, filters, valves, closure means or other attachments
    • F17C2205/0302Fittings, valves, filters, or components in connection with the gas storage device
    • F17C2205/0323Valves
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2205/00Vessel construction, in particular mounting arrangements, attachments or identifications means
    • F17C2205/03Fluid connections, filters, valves, closure means or other attachments
    • F17C2205/0302Fittings, valves, filters, or components in connection with the gas storage device
    • F17C2205/0338Pressure regulators
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2221/00Handled fluid, in particular type of fluid
    • F17C2221/01Pure fluids
    • F17C2221/014Nitrogen
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2221/00Handled fluid, in particular type of fluid
    • F17C2221/03Mixtures
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2223/00Handled fluid before transfer, i.e. state of fluid when stored in the vessel or before transfer from the vessel
    • F17C2223/01Handled fluid before transfer, i.e. state of fluid when stored in the vessel or before transfer from the vessel characterised by the phase
    • F17C2223/0107Single phase
    • F17C2223/0123Single phase gaseous, e.g. CNG, GNC
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2223/00Handled fluid before transfer, i.e. state of fluid when stored in the vessel or before transfer from the vessel
    • F17C2223/03Handled fluid before transfer, i.e. state of fluid when stored in the vessel or before transfer from the vessel characterised by the pressure level
    • F17C2223/036Very high pressure (>80 bar)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2260/00Purposes of gas storage and gas handling
    • F17C2260/01Improving mechanical properties or manufacturing
    • F17C2260/011Improving strength
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2260/00Purposes of gas storage and gas handling
    • F17C2260/01Improving mechanical properties or manufacturing
    • F17C2260/012Reducing weight
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2260/00Purposes of gas storage and gas handling
    • F17C2260/02Improving properties related to fluid or fluid transfer
    • F17C2260/024Improving metering
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2260/00Purposes of gas storage and gas handling
    • F17C2260/05Improving chemical properties
    • F17C2260/053Reducing corrosion
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17CVESSELS FOR CONTAINING OR STORING COMPRESSED, LIQUEFIED OR SOLIDIFIED GASES; FIXED-CAPACITY GAS-HOLDERS; FILLING VESSELS WITH, OR DISCHARGING FROM VESSELS, COMPRESSED, LIQUEFIED, OR SOLIDIFIED GASES
    • F17C2270/00Applications
    • F17C2270/02Applications for medical applications
    • F17C2270/025Breathing

Definitions

  • the invention relates to a NO / N 2 mixture conditioning vessel comprising a main body made of aluminum or an aluminum alloy, in particular a cylindrical gas cylinder, and its use in the treatment of pulmonary vasoconstrictions. in the adult or the child.
  • Gaseous NO / N 2 mixtures are commonly used to treat pulmonary vasoconstriction in adults or children, particularly in neonates with primary pulmonary hypertension or in patients undergoing cardiac surgery.
  • NO / N 2 mixtures are conventionally packaged in steel gas cylinders. Typically, these bottles contain 100 to 1000 ppm by volume of NO and nitrogen (N 2 ) for the rest. These bottles usually have a water capacity of 2 to 50 liters, which allows to introduce a total load of up to 15 m 3 of NO / N 2 mixture.
  • the packaging that is to say the bottling of these mixtures, is done in gas conditioning centers.
  • packaging containers must also not be overweight and especially withstand shocks and gas pressure of up to several hundred bar, typically 200 to 300 bar, and corrosion.
  • the object of the present invention is to solve these problems, that is to say to minimize said difference in capacity by obtaining a final load as close as possible to the load reference, that is to say a difference of order of +/- 1.5% or less, while offering a container packaging resistant to shocks and high pressures, as well as corrosion, but without presenting too much weight.
  • the solution of the invention is a NO / N 2 mixture conditioning container comprising a main body comprising an internal volume having a capacity of between 2 and 30 liters and containing a NO / N 2 mixture at a pressure greater than atmospheric pressure.
  • the main body being formed of an aluminum alloy, characterized in that the main body is formed of an aluminum alloy comprising predominantly aluminum, that is to say more than 50% by weight or even more than 60% by weight, preferably more than 75% by weight, and a mass proportion of Cr between 0.05 and 0.80%, Cu between 1 and 3%, Pb of not more than 100 ppm, Zn between 5 and 8%, and Mg between 1 and 3%.
  • the aluminum alloy must be chosen carefully so as not to cause excessive fragility of the bottles.
  • This fragility can be avoided or minimized by controlling in particular the composition of the chosen aluminum alloy, that is to say the content of the various elements of the alloy, in particular that in Mg, Cr, Cu and / or Zn, but also the lead content of the alloy and incidentally the grain size of the alloy.
  • the invention also relates to a method for conditioning a NO / N 2 mixture in a conditioning container according to the invention, comprising a main body comprising an internal volume into which the NO / N 2 mixture is introduced at a pressure greater than the atmospheric pressure.
  • the invention also relates to the use of a container according to the invention comprising a main body comprising an internal volume, said main body being formed of aluminum or an aluminum alloy, for conditioning a mixture gaseous NO / N 2 containing from 1 to 1000 ppm by volume of NO and nitrogen for the remainder.
  • the invention also relates to a gaseous mixture conditioning system NO / N 2 comprising a container according to the invention.
  • the invention also relates to a NO / N 2 mixture dispensing system that can be used for the treatment of pulmonary hypertension in adults, children or newborns, including a ventilator delivering a gas. containing oxygen, such as air or an oxygen / nitrogen mixture, comprising a patient circuit connecting said ventilator to a patient interface, for example a breathing mask or a cannula, characterized in that the patient circuit is supplied with gas by a container according to the invention, in particular a gas bottle.
  • the gas passes through a control device, such as the device Opti Kinox Air Liquide Health, arranged between the (or) container and the patient circuit.
  • the invention also relates to a NO / N 2 gas mixture for use in treating or preventing pulmonary vasoconstriction or pulmonary hypertension in an adult, child or newborn, wherein the NO / N mixture 2 is administered by inhalation, advantageously by means of a NO / N 2 mixture dispensing installation comprising a fan comprising a patient circuit connecting said ventilator to a patient interface, said patient circuit being supplied with NO / N 2 gas mixture delivered by a container according to the invention, in particular a gas bottle, whose main body is formed of an aluminum alloy comprising aluminum (for the most part) and a mass proportion of Cr between 0.05 and 0.80%; , Cu between 1 and 3%, Pb at most 100 ppm, Zn between 5 and 8%, and Mg between 1 and 3%.
  • the gaseous mixture NO / N 2 is used to treat a newborn with primary pulmonary hypertension or an adult, a child or a newborn to undergo, undergoing or having undergone cardiac surgery.
  • FIG. 1 attached an embodiment of a container according to the invention (sectional view), namely a bottle of gas mixture NO / nitrogen mixture which consists of a main body 1 of generally cylindrical shape comprising a constriction or neck 2 at which is the opening 5 of the gas passage and at its other end, a flat bottom 3 on which the bottle rests when it is placed on a support, such as the ground 6.
  • a bottle of gas mixture NO / nitrogen mixture which consists of a main body 1 of generally cylindrical shape comprising a constriction or neck 2 at which is the opening 5 of the gas passage and at its other end, a flat bottom 3 on which the bottle rests when it is placed on a support, such as the ground 6.
  • a NO / nitrogen mixture containing up to 1000 ppm by volume of NO and nitrogen for the remainder, for example 225, 450 or 800 ppm vol., Is packaged in the bottle at a pressure of more than 150 bar, by example of 180 bar.
  • a valve 4 or an integrated pressure reducer valve is mounted, for example screwed, at the neck 2 of the bottle so as to control the flow rate and / or the pressure of the gas leaving the container.
  • the body 1 of the bottle is formed of an aluminum alloy
  • alloy compositions A and B are given in the following Table.
  • the Figure 2 attached hereto illustrates an embodiment of a NO / N 2 mixture dispensing installation comprising a fan 10 comprising a patient circuit 11 connecting the fan 10 to a patient interface 14.
  • the patient circuit 11 is supplied with gas by a receptacle 1 according to the Figure 1 whose composition is for example that of the alloy A or B of the preceding table.
  • the ventilator 10 thus supplies with respiratory gas enriched in NO, a respiratory circuit or patient circuit 11 with two branches, that is to say with an inspiratory branch 12 and a branch expiratory 13.
  • the inspiratory branch 12 is designed to convey a breathing gas, for example air, oxygen-enriched air, oxygen or a nitrogen / O 2 mixture, from the ventilator 10 to the patient 15
  • the exhalation branch 13 is designed to convey the exhaled gas by the patient 15, thus rich in CO 2 , to the ventilator 10.
  • the administration of the gas is by means of a patient interface 14, for example a respiratory mask, a probe or a tracheal cannula or any other suitable gas delivery device.
  • the fan 1 is supplied with a gas containing oxygen, for example air (O 2 content of 21% by volume), air enriched with oxygen (O 2 content> 21% by volume). or pure oxygen (100% O 2 ).
  • a gas containing oxygen for example air (O 2 content of 21% by volume), air enriched with oxygen (O 2 content> 21% by volume). or pure oxygen (100% O 2 ).
  • the oxygen-containing gas comes from a gas source 17, such as one or more gas cylinders, a gas mixer in which is operated for example a mixture of air and oxygen, or one or more gas pipelines conveying one or more gases, for example a pipe carrying oxygen from an oxygen production unit, such as a modulated pressure unit (PSA), or an oxygen storage unit, such as a buffer or storage tank.
  • a gas source 17 such as one or more gas cylinders, a gas mixer in which is operated for example a mixture of air and oxygen, or one or more gas pipelines conveying one or more gases, for example a pipe carrying oxygen from an oxygen production unit, such as a modulated pressure unit (PSA), or an oxygen storage unit, such as a buffer or storage tank.
  • PSA modulated pressure unit
  • oxygen storage unit such as a buffer or storage tank.
  • the oxygen-rich gas is delivered by the ventilator 10 into the inspiratory branch 12 of the patient circuit 11.
  • a NO distribution device 16 is fluidly connected to said inspiratory branch 12 of the patient circuit 11 to deliver, via a feed line 18, a NO / N 2 mixture, for example formed of 400, 800 or 1000 ppmv. NO and nitrogen for the rest.
  • the NO distribution device 16 is itself fed with a NO / N 2 mixture, via a gas supply line 19, with a container 1 of NO / N 2 forming part of a storage and distribution system according to the invention.
  • the NO / N 2 container is an aluminum alloy gas cylinder (alloy A or B for example) containing 2, 5 or 11 liters (water equivalent), equipped with a built-in pressure regulating valve, preferably protected by a rollover protection hood.
  • the integrated regulator valve also called “RDI” allows to control the gas outlet of container 1 and its outlet pressure. Controllers control the release of the gas and also adjust the output pressure level.
  • Such an installation is suitable for treatment with inhaled NO administration, pulmonary vasoconstriction or pulmonary hypertension in a patient 15, who may be an adult, a child or a newborn.
  • the NO / N 2 gas mixture conveyed to the patient 15 by the patient circuit 11 and distributed by means of the interface 14, is particularly recommended for treating a newborn with primary pulmonary hypertension or an adult. a child or newborn who has to undergo, undergoing or having undergone cardiac surgery.

Abstract

The container has a main body (1) including an internal volume (7) having a capacity between 2 and 30 liters and containing a nitric oxide (NO)/nitrogen (N2) mixture at a pressure above atmospheric pressure. The main body is formed from an aluminum alloy having predominantly aluminum and a proportion by weight of chromuim (Cr) of between 0.05 and 0.80 percent, copper (Cu) of between 1 and 3 percent, lead (Pb) of at most 100 parts per million, zinc (Zn) of between 5 and 8 percent, and magnesium (Mg) of between 1 and 3 percent, where the aluminum content is between 85 and 93 percent by weight. Independent claims are also included for the following: (1) a process for packaging an NO/N2 mixture in a packaging container (2) an installation for dispensing NO/N2 mixtures (3) a method for treating or for preventing pulmonary vasoconstriction or pulmonary hypertension in adults, children or newborns.

Description

L'invention concerne un récipient de conditionnement de mélanges NO/N2 comprenant un corps principal formé d'aluminium ou d'un alliage d'aluminium, en particulier une bouteille de gaz de forme cylindrique, et son utilisation dans le traitement des vasoconstrictions pulmonaires chez l'adulte ou l'enfant.The invention relates to a NO / N 2 mixture conditioning vessel comprising a main body made of aluminum or an aluminum alloy, in particular a cylindrical gas cylinder, and its use in the treatment of pulmonary vasoconstrictions. in the adult or the child.

Les mélanges gazeux NO/N2 sont couramment utilisés pour traiter les vasoconstrictions pulmonaires chez l'adulte ou l'enfant, en particulier chez les nouveaux nés souffrant d'hypertension pulmonaire primitive ou chez les patients subissant une opération de chirurgie cardiaque.Gaseous NO / N 2 mixtures are commonly used to treat pulmonary vasoconstriction in adults or children, particularly in neonates with primary pulmonary hypertension or in patients undergoing cardiac surgery.

Ces mélanges NO/N2 sont classiquement conditionnés dans des bouteilles de gaz en acier. Typiquement, ces bouteilles contiennent de 100 à 1000 ppm en volume de NO et de l'azote (N2) pour le reste. Ces bouteilles ont habituellement une contenance en eau de 2 à 50 litres, ce qui permet d'y introduire une charge totale pouvant aller jusqu'à 15 m3 de mélange NO/N2.These NO / N 2 mixtures are conventionally packaged in steel gas cylinders. Typically, these bottles contain 100 to 1000 ppm by volume of NO and nitrogen (N 2 ) for the rest. These bottles usually have a water capacity of 2 to 50 liters, which allows to introduce a total load of up to 15 m 3 of NO / N 2 mixture.

Le conditionnement, c'est-à-dire la mise en bouteille de ces mélanges, se fait dans des centres de conditionnement de gaz.The packaging, that is to say the bottling of these mixtures, is done in gas conditioning centers.

Or, on a constaté en pratique une imprécision lors du conditionnement des mélanges gazeux NO/N2 dans ces bouteilles en acier. En effet, on a noté un écart entre le volume interne de chaque bouteille disponible pour le conditionnement du NO par rapport au volume théorique en eau de ces bouteilles ; cet écart est appelé ci-après « écart de contenance ».However, it has been found in practice imprecision during the conditioning of gas mixtures NO / N 2 in these steel bottles. Indeed, there was a difference between the internal volume of each bottle available for the conditioning of the NO with respect to the theoretical volume of water of these bottles; this difference is hereinafter referred to as the "capacity gap".

Cet écart de contenance n'a pas d'influence sur la teneur en NO finale mais se répercute sur la charge finale de la bouteille qui est alors soit supérieure, soit inférieure à la charge désirée, c'est-à-dire par rapport à la charge de consigne.This difference in capacity has no influence on the final NO content but has repercussions on the final charge of the bottle, which is then either greater or less than the desired load, that is to say with respect to the setpoint charge.

Toutefois, cet écart de contenance n'est pas négligeable puisque qu'il peut atteindre environ 5% de la charge totale en gaz de chaque bouteille.However, this difference in capacity is not negligible since it can reach about 5% of the total gas load of each bottle.

Par ailleurs, les récipients de conditionnement doivent en outre ne pas être de poids excessif et surtout résister à des chocs et à une pression gazeuse pouvant atteindre plusieurs centaines de bar, typiquement de 200 à 300 bar, ainsi qu'à la corrosion.In addition, the packaging containers must also not be overweight and especially withstand shocks and gas pressure of up to several hundred bar, typically 200 to 300 bar, and corrosion.

Le but de la présente invention est de résoudre ces problèmes, c'est-à-dire de minimiser ledit écart de contenance en obtenant une charge finale aussi proche que possible de la consigne de charge, c'est-à-dire un écart de l'ordre de +/- 1,5% ou inférieur, tout en proposant un récipient de conditionnement résistant aux chocs et aux hautes pressions, ainsi qu'à la corrosion, mais sans présenter un poids trop élevé.The object of the present invention is to solve these problems, that is to say to minimize said difference in capacity by obtaining a final load as close as possible to the load reference, that is to say a difference of order of +/- 1.5% or less, while offering a container packaging resistant to shocks and high pressures, as well as corrosion, but without presenting too much weight.

La solution de l'invention est un récipient de conditionnement de mélanges NO/N2 comprenant un corps principal comprenant un volume interne ayant une contenance comprise entre 2 et 30 litres et contenant un mélange NO/N2 à une pression supérieure à la pression atmosphérique, le corps principal étant formé d'un alliage d'aluminium, caractérisé en ce que le corps principal est formé d'un alliage d'aluminium comprenant majoritairement de l'aluminium, c'est-à-dire plus de 50% en masse, voire plus de 60% en masse, préférentiellement plus de 75% en masse, et une proportion massique de Cr entre 0,05 et 0,80%, de Cu entre 1 et 3%, de Pb d'au plus 100 ppm, de Zn entre 5 et 8%, et de Mg entre 1 et 3%.The solution of the invention is a NO / N 2 mixture conditioning container comprising a main body comprising an internal volume having a capacity of between 2 and 30 liters and containing a NO / N 2 mixture at a pressure greater than atmospheric pressure. , the main body being formed of an aluminum alloy, characterized in that the main body is formed of an aluminum alloy comprising predominantly aluminum, that is to say more than 50% by weight or even more than 60% by weight, preferably more than 75% by weight, and a mass proportion of Cr between 0.05 and 0.80%, Cu between 1 and 3%, Pb of not more than 100 ppm, Zn between 5 and 8%, and Mg between 1 and 3%.

Dans le cadre de la présente invention, il a été mis en évidence que l'écart de charge, c'est-à-dire l'imprécision de volume de charge, était en fait liée aux bouteilles utilisées pour conditionner les mélanges NO/N2. En effet, il a été remarqué que l'utilisation de bouteilles en acier ne permettait pas d'obtenir une précision de charge désirée mais qu'à l'inverse, l'utilisation de bouteilles en aluminium permettait d'obtenir la précision désirée.In the context of the present invention, it has been demonstrated that the load difference, that is to say the imprecision of the volume of charge, was in fact related to the bottles used to condition the NO / N mixtures. 2 . Indeed, it was noticed that the use of steel bottles did not allow to obtain a desired load accuracy but that, conversely, the use of aluminum bottles made it possible to obtain the desired precision.

Or, si le fait de réaliser les bouteilles en aluminium permet également d'apporter une relative légèreté, il a été constaté que l'alliage d'aluminium doit être choisi avec soin pour ne pas engendrer une fragilité trop importante des bouteilles. Cette fragilité peut être évitée ou minimisée en contrôlant notamment la composition de l'alliage d'aluminium choisie, c'est-à-dire la teneur en les différents éléments de l'alliage, en particulier celle en Mg, Cr, Cu et/ou Zn, mais aussi la teneur en plomb de l'alliage et accessoirement la taille des grains de l'alliage.However, if the fact of making the aluminum bottles also makes it possible to bring about a relative lightness, it has been found that the aluminum alloy must be chosen carefully so as not to cause excessive fragility of the bottles. This fragility can be avoided or minimized by controlling in particular the composition of the chosen aluminum alloy, that is to say the content of the various elements of the alloy, in particular that in Mg, Cr, Cu and / or Zn, but also the lead content of the alloy and incidentally the grain size of the alloy.

Selon le cas, le récipient de conditionnement de l'invention peut comprendre l'une ou plusieurs des caractéristiques techniques suivantes :

  • l'alliage d'aluminium comprend (% en masse) moins de 0,5% de Mn, moins de 0,3% de Fe, moins de 0,2% de Si et/ou moins de 0,2% de Ti.
  • l'alliage d'aluminium comprend (% en masse) au plus 50 ppm de Pb, de préférence au plus 30 ppm de Pb.
  • l'alliage d'aluminium comprend (% en masse) entre 0,1 et 0,50% de Cr, entre 1,5 et 2,8 % de Cu, entre 5,4 et 7,6% de Zn et/ou entre 1,2 et 2,8% de Mg.
  • la teneur en aluminium de l'alliage d'aluminium est comprise entre 85 et 93% en masse.
  • l'alliage d'aluminium comprend (% en masse) entre 0,12 et 0,30% de Cr, entre 1,6 et 2,7 % de Cu, et/ou entre 1,25 et 2,6% de Mg.
  • l'alliage d'aluminium comprend (% en masse) entre 0,15 et 0,25% de Cr, entre 1,7 et 2,6 % de Cu, et/ou entre 1,3 et 2,5% de Mg.
  • l'alliage d'aluminium comprend (% en masse) entre 5,5 et 7,5% de Zn.
  • l'alliage d'aluminium comprend (% en masse) moins de 0,3% de Mn, de préférence moins de 0,2% de Mn.
  • l'alliage d'aluminium comprend (% en masse) moins de 0,2% de Fe.
  • l'alliage d'aluminium comprend (% en masse) moins de 0,15% de Si
  • l'alliage d'aluminium comprend (% en masse) moins de 0,15% de Ti, de préférence moins de 0,10% de Ti.
  • l'alliage d'aluminium comprend (% en masse) moins de 0,02% de Bi, de préférence moins de 0,01% de Bi.
  • l'alliage d'aluminium comprend (% en masse) moins de 0,01% de Zr, de préférence moins de 0,05% de Zr.
  • la taille maximale du grain de l'alliage ne doit normalement pas dépasser 1 mm, voire 0,56 mm dans certains cas (bouteilles de 2 litres par exemple). L'exigence de taille du grain s'applique à tous les grains et non pas à la taille moyenne du grain.
  • il est une bouteille de gaz comprenant un corps principal de forme cylindrique.
  • il a une contenance (volume en eau) comprise entre 2 et 25 litres.
  • il a un diamètre compris entre 10 et 30 cm, et une hauteur comprise entre 50 et 120 cm environ.
  • le corps principal comprend un col avec un orifice de sortie au niveau duquel est fixé un dispositif de contrôle du passage de gaz et/ou de réduction de pression.
  • le corps comprend une paroi périphérique ayant une épaisseur entre 2 et 20 mm.
  • le mélange NO/N2 contient de 1 à 1000 ppm en volume de NO et de l'azote (N2) pour le reste.
Depending on the case, the conditioning container of the invention may comprise one or more of the following technical characteristics:
  • the aluminum alloy comprises (% by mass) less than 0.5% Mn, less than 0.3% Fe, less than 0.2% Si and / or less than 0.2% Ti.
  • the aluminum alloy comprises (% by weight) at most 50 ppm Pb, preferably at most 30 ppm Pb.
  • the aluminum alloy comprises (% by weight) between 0.1 and 0.50% of Cr, between 1.5 and 2.8% of Cu, between 5.4 and 7.6% of Zn and / or between 1.2 and 2.8% Mg.
  • the aluminum content of the aluminum alloy is between 85 and 93% by weight.
  • the aluminum alloy comprises (% by weight) between 0.12 and 0.30% Cr, between 1.6 and 2.7% Cu, and / or between 1.25 and 2.6% Mg .
  • the aluminum alloy comprises (% by mass) between 0.15 and 0.25% of Cr, between 1.7 and 2.6% of Cu, and / or between 1.3 and 2.5% of Mg .
  • the aluminum alloy comprises (% by weight) between 5.5 and 7.5% Zn.
  • the aluminum alloy comprises (% by weight) less than 0.3% Mn, preferably less than 0.2% Mn.
  • the aluminum alloy comprises (% by weight) less than 0.2% Fe.
  • the aluminum alloy comprises (% by weight) less than 0.15% Si
  • the aluminum alloy comprises (% by weight) less than 0.15% Ti, preferably less than 0.10% Ti.
  • the aluminum alloy comprises (% by weight) less than 0.02% Bi, preferably less than 0.01% Bi.
  • the aluminum alloy comprises (% by weight) less than 0.01% Zr, preferably less than 0.05% Zr.
  • the maximum grain size of the alloy should not normally exceed 1 mm, or even 0.56 mm in some cases (2 liter bottles for example). The grain size requirement applies to all grains and not to the average grain size.
  • it is a gas cylinder comprising a cylindrical main body.
  • it has a capacity (volume in water) of between 2 and 25 liters.
  • it has a diameter of between 10 and 30 cm, and a height of between 50 and 120 cm approximately.
  • the main body comprises a neck with an outlet orifice at which is fixed a device for controlling the passage of gas and / or pressure reduction.
  • the body comprises a peripheral wall having a thickness between 2 and 20 mm.
  • the NO / N 2 mixture contains 1 to 1000 ppm by volume of NO and nitrogen (N 2 ) for the remainder.

L'invention concerne aussi un procédé de conditionnement d'un mélange NO/N2 dans un récipient de conditionnement selon l'invention, comprenant un corps principal comprenant un volume interne dans lequel est introduit le mélange NO/N2 à une pression supérieure à la pression atmosphérique.The invention also relates to a method for conditioning a NO / N 2 mixture in a conditioning container according to the invention, comprising a main body comprising an internal volume into which the NO / N 2 mixture is introduced at a pressure greater than the atmospheric pressure.

Par ailleurs, l'invention porte également sur l'utilisation d'un récipient selon l'invention comprenant un corps principal comprenant un volume interne, ledit corps principal étant formé d'aluminium ou d'un alliage d'aluminium, pour conditionner un mélange gazeux NO/N2 contenant de 1 à 1000 ppm en volume de NO et d'azote pour le reste.Furthermore, the invention also relates to the use of a container according to the invention comprising a main body comprising an internal volume, said main body being formed of aluminum or an aluminum alloy, for conditioning a mixture gaseous NO / N 2 containing from 1 to 1000 ppm by volume of NO and nitrogen for the remainder.

En outre, l'invention concerne également un système de conditionnement de mélange gazeux NO/N2 comprenant un récipient selon l'invention.In addition, the invention also relates to a gaseous mixture conditioning system NO / N 2 comprising a container according to the invention.

Par ailleurs, l'invention concerne également une installation de distribution de mélanges NO/N2 utilisable dans le cadre d'un traitement de l'hypertension pulmonaire chez l'adulte, l'enfant ou le nouveau né, comprenant un ventilateur délivrant un gaz contenant de l'oxygène, tel de l'air ou un mélange oxygène/azote, comportant un circuit patient reliant ledit ventilateur à une interface patient, par exemple un masque respiratoire ou une canule, caractérisée en ce que le circuit patient est alimenté en gaz par un récipient selon l'invention, en particulier une bouteille de gaz. De préférence, le gaz transite par un dispositif de régulation, tel le dispositif Opti Kinox de Air Liquide Santé, agencé entre le (ou les) récipient et le circuit patient.Furthermore, the invention also relates to a NO / N 2 mixture dispensing system that can be used for the treatment of pulmonary hypertension in adults, children or newborns, including a ventilator delivering a gas. containing oxygen, such as air or an oxygen / nitrogen mixture, comprising a patient circuit connecting said ventilator to a patient interface, for example a breathing mask or a cannula, characterized in that the patient circuit is supplied with gas by a container according to the invention, in particular a gas bottle. Preferably, the gas passes through a control device, such as the device Opti Kinox Air Liquide Health, arranged between the (or) container and the patient circuit.

Enfin, l'invention porte aussi sur un mélange gazeux NO/N2 pour une utilisation pour traiter ou pour prévenir une vasoconstriction pulmonaire ou une hypertension pulmonaire chez l'adulte, l'enfant ou le nouveau né, dans lequel le mélange NO/N2 est administré par inhalation, avantageusement au moyen d'une installation de distribution de mélange NO/N2 comprenant un ventilateur comportant un circuit patient reliant ledit ventilateur à une interface patient, ledit circuit patient étant alimenté en mélange gazeux NO/N2 délivré par un récipient selon l'invention, en particulier une bouteille de gaz, dont le corps principal est formé d'un alliage d'aluminium comprenant de l'aluminium (majoritairement) et une proportion massique de Cr entre 0,05 et 0,80%, de Cu entre 1 et 3%, de Pb d'au plus 100 ppm, de Zn entre 5 et 8%, et de Mg entre 1 et 3%.Finally, the invention also relates to a NO / N 2 gas mixture for use in treating or preventing pulmonary vasoconstriction or pulmonary hypertension in an adult, child or newborn, wherein the NO / N mixture 2 is administered by inhalation, advantageously by means of a NO / N 2 mixture dispensing installation comprising a fan comprising a patient circuit connecting said ventilator to a patient interface, said patient circuit being supplied with NO / N 2 gas mixture delivered by a container according to the invention, in particular a gas bottle, whose main body is formed of an aluminum alloy comprising aluminum (for the most part) and a mass proportion of Cr between 0.05 and 0.80%; , Cu between 1 and 3%, Pb at most 100 ppm, Zn between 5 and 8%, and Mg between 1 and 3%.

Selon l'invention, le mélange gazeux NO/N2 est utilisé pour traiter un nouveau-né souffrant d'hypertension pulmonaire primitive ou un adulte, un enfant ou un nouveau-né devant subir, subissant ou ayant subi une opération de chirurgie cardiaque.According to the invention, the gaseous mixture NO / N 2 is used to treat a newborn with primary pulmonary hypertension or an adult, a child or a newborn to undergo, undergoing or having undergone cardiac surgery.

L'invention va maintenant être mieux comprise grâce à la description suivante faite en références aux Figures annexées parmi lesquelles :

  • la Figure 1 schématise un récipient de gaz selon l'invention (vue en coupe) ; et
  • la Figure 2 schématise une installation de distribution de mélanges NO/N2 comprenant une bouteille de NO/N2 selon la Figure 1.
The invention will now be better understood thanks to the following description given with reference to the appended figures in which:
  • the Figure 1 schematizes a gas container according to the invention (sectional view); and
  • the Figure 2 schematizes a NO / N 2 mixture distribution plant comprising a bottle of NO / N 2 according to the Figure 1 .

La Figure 1 ci-jointe monte un mode de réalisation d'un récipient selon l'invention (vue en coupe), à savoir une bouteille de conditionnement de mélanges gazeux NO/azote qui se compose d'un corps principal 1 de forme générale cylindrique comprenant un étranglement ou col 2 au niveau duquel se trouve l'ouverture 5 de passage du gaz et, à son autre extrémité, d'un fond 3 plat sur lequel repose la bouteille lorsqu'elle est posée sur un support, tel le sol 6.The Figure 1 attached an embodiment of a container according to the invention (sectional view), namely a bottle of gas mixture NO / nitrogen mixture which consists of a main body 1 of generally cylindrical shape comprising a constriction or neck 2 at which is the opening 5 of the gas passage and at its other end, a flat bottom 3 on which the bottle rests when it is placed on a support, such as the ground 6.

Cette bouteille comprend un volume interne 7 ayant une contenance typique :

  • soit de 5 litres (en eau), un diamètre de 14 cm, et une hauteur de 63 cm.
  • soit de 20 litres (en eau), un diamètre de 21 cm, et une hauteur de 108 cm.
This bottle comprises an internal volume 7 having a typical capacity:
  • or 5 liters (in water), a diameter of 14 cm, and a height of 63 cm.
  • 20 liters (in water), a diameter of 21 cm, and a height of 108 cm.

Il est toutefois également possible d'avoir une bouteille de contenance inférieure, par exemple de 2 litres seulement, ou de dimensions différentesIt is however also possible to have a bottle of lower capacity, for example of only 2 liters, or of different dimensions

Un mélange NO/azote contenant jusqu'à 1000 ppm en volume de NO et d'azote pour le reste, par exemple de 225, 450 ou 800 ppm vol., est conditionné dans la bouteille à une pression de plus de 150 bar, par exemple de 180 bar.A NO / nitrogen mixture containing up to 1000 ppm by volume of NO and nitrogen for the remainder, for example 225, 450 or 800 ppm vol., Is packaged in the bottle at a pressure of more than 150 bar, by example of 180 bar.

Un robinet 4 ou un robinet à détendeur intégré est monté, par exemple vissé, au niveau du col 2 de la bouteille de manière à contrôler le débit et/ou la pression du gaz sortant du récipient.A valve 4 or an integrated pressure reducer valve is mounted, for example screwed, at the neck 2 of the bottle so as to control the flow rate and / or the pressure of the gas leaving the container.

Conformément à l'invention, le corps 1 de la bouteille est formé d'un alliage d'aluminium dont des exemples de compositions d'alliages A et B sont donnés dans le Tableau suivant. Tableau Eléments Proportion en masse Alliage A Proportion en masse Alliage B Pb < 30 ppm < 100 ppm Fe < 0,2 % < 0,12 % Si < 0,15 % < 0,1 % Cu 1.8 - 2.6 % 1,7 - 2,3 % Mn < 0,2 % < 0,05 % Mg 1.3 à 2.1 % 1,5 - 2,5 % Cr 0,15 à 0,25 % 0,15 à 0,25 % Zn 6.1 - 7.5 % 5,5 - 6,5 % Ti < 0,05 % < 0,1 % Zr < 0,05% / Bi / < 0,01 % Impuretés 0,15 % maxi Al 86.7-90.7% 87,9 - 91,2% According to the invention, the body 1 of the bottle is formed of an aluminum alloy, examples of alloy compositions A and B are given in the following Table. <U> Table </ u> elements Mass ratio Alloy A Mass ratio Alloy B Pb <30 ppm <100 ppm Fe <0.2% <0.12% Yes <0.15% <0,1% Cu 1.8 - 2.6% 1.7 - 2.3% mn <0.2% <0.05% mg 1.3 to 2.1% 1.5 - 2.5% Cr 0.15 to 0.25% 0.15 to 0.25% Zn 6.1 - 7.5% 5.5 - 6.5% Ti <0.05% <0,1% Zr <0.05% / Bi / <0.01% impurities 0,15% maximum al 86.7-90.7% 87.9 - 91.2%

En utilisant une bouteille avec corps 1 en un alliage d'aluminium, tel que donné notamment le Tableau précédent, il est possible de minimiser l'écart de contenance susmentionné en obtenant une charge finale aussi proche que possible de la consigne de charge, c'est-à-dire un écart de l'ordre de +/- 1,5% ou inférieur, tout en ayant un récipient résistant aux chocs, aux hautes pressions et à la corrosion.By using a bottle with a body 1 made of an aluminum alloy, such as given in particular in the preceding table, it is possible to minimize the difference in the aforementioned capacity by obtaining a final charge as close as possible to the charging setpoint. that is to say a deviation of the order of +/- 1.5% or less, while having a container resistant to shocks, high pressures and corrosion.

La Figure 2 ci-annexée illustre un mode de réalisation d'une installation de distribution de mélanges NO/N2 comprenant un ventilateur 10 comportant un circuit patient 11 reliant le ventilateur 10 à une interface 14 patient. Le circuit patient 11 est alimenté en gaz par un récipient 1 selon la Figure 1 dont la composition est par exemple celle de l'alliage A ou B du tableau précédent.The Figure 2 attached hereto illustrates an embodiment of a NO / N 2 mixture dispensing installation comprising a fan 10 comprising a patient circuit 11 connecting the fan 10 to a patient interface 14. The patient circuit 11 is supplied with gas by a receptacle 1 according to the Figure 1 whose composition is for example that of the alloy A or B of the preceding table.

Le ventilateur 10 alimente donc en gaz respiratoire enrichi en NO, un circuit respiratoire ou circuit patient 11 à deux branches, c'est-à-dire avec une branche inspiratoire 12 et une branche expiratoire 13. La branche inspiratoire 12 est conçue pour acheminer un gaz respiratoire, par exemple de l'air, de l'air enrichi en oxygène, de l'oxygène ou un mélange azote/O2, du ventilateur 10 jusqu'au patient 15, alors que la branche expiratoire 13 est conçue pour acheminer le gaz expiré par le patient 15, donc riches en CO2, jusqu'au ventilateur 10.The ventilator 10 thus supplies with respiratory gas enriched in NO, a respiratory circuit or patient circuit 11 with two branches, that is to say with an inspiratory branch 12 and a branch expiratory 13. The inspiratory branch 12 is designed to convey a breathing gas, for example air, oxygen-enriched air, oxygen or a nitrogen / O 2 mixture, from the ventilator 10 to the patient 15 , while the exhalation branch 13 is designed to convey the exhaled gas by the patient 15, thus rich in CO 2 , to the ventilator 10.

Au niveau du patient 15, l'administration du gaz se fait au moyen d'une interface patient 14, par exemple un masque respiratoire, une sonde ou une canule trachéale ou tout autre dispositif d'administration de gaz adapté.At the level of the patient 15, the administration of the gas is by means of a patient interface 14, for example a respiratory mask, a probe or a tracheal cannula or any other suitable gas delivery device.

Le ventilateur 1 est alimenté avec un gaz contenant de l'oxygène, par exemple de l'air (teneur en O2 de 21 % en volume), de l'air enrichi en oxygène (teneur en O2 > 21 % en volume) ou de l'oxygène pur (100% O2).The fan 1 is supplied with a gas containing oxygen, for example air (O 2 content of 21% by volume), air enriched with oxygen (O 2 content> 21% by volume). or pure oxygen (100% O 2 ).

Le gaz contenant de l'oxygène est issu d'une source de gaz 17, telle une ou plusieurs bouteilles de gaz, un mélangeur de gaz au sein duquel est opéré par exemple un mélange d'air et d'oxygène, ou une ou plusieurs canalisations de gaz véhiculant un ou plusieurs gaz, par exemple une canalisation véhiculant de l'oxygène provenant d'une unité de production d'oxygène, telle une unité à pression modulée (PSA), ou d'une unité de stockage d'oxygène, telle un réservoir tampon ou de stockage.The oxygen-containing gas comes from a gas source 17, such as one or more gas cylinders, a gas mixer in which is operated for example a mixture of air and oxygen, or one or more gas pipelines conveying one or more gases, for example a pipe carrying oxygen from an oxygen production unit, such as a modulated pressure unit (PSA), or an oxygen storage unit, such as a buffer or storage tank.

Comme déjà dit, le gaz riche en oxygène est délivré par le ventilateur 10 dans la branche inspiratoire 12 du circuit patient 11.As already stated, the oxygen-rich gas is delivered by the ventilator 10 into the inspiratory branch 12 of the patient circuit 11.

Par ailleurs, un dispositif 16 de distribution de NO est relié fluidiquement à ladite branche inspiratoire 12 du circuit patient 11 pour y délivrer, via une ligne d'alimentation 18, un mélange NO/N2 par exemple formé de 400, 800 ou 1000 ppmv de NO et d'azote pour le reste.Furthermore, a NO distribution device 16 is fluidly connected to said inspiratory branch 12 of the patient circuit 11 to deliver, via a feed line 18, a NO / N 2 mixture, for example formed of 400, 800 or 1000 ppmv. NO and nitrogen for the rest.

Le dispositif 16 de distribution de NO est lui-même alimenté en mélange NO/N2, via une ligne d'amenée de gaz 19, par un récipient 1 de NO/N2 faisant partie d'un système de stockage et de distribution selon l'invention.The NO distribution device 16 is itself fed with a NO / N 2 mixture, via a gas supply line 19, with a container 1 of NO / N 2 forming part of a storage and distribution system according to the invention.

Le récipient de NO/N2 est une bouteille de gaz en alliage d'aluminium (alliage A ou B par exemple) de contenant de 2, 5 ou 11 litres (équivalent en eau), équipée d'un robinet à détendeur intégré, de préférence protégé par un capotage de protection contre les chocs. Le robinet à détendeur intégré, encore appelé « RDI » permet de contrôler la sortie du gaz du récipient 1 et sa pression de sortie. Des organes de commande permettent de contrôler la libération du gaz et par ailleurs de régler le niveau de pression de sortie.The NO / N 2 container is an aluminum alloy gas cylinder (alloy A or B for example) containing 2, 5 or 11 liters (water equivalent), equipped with a built-in pressure regulating valve, preferably protected by a rollover protection hood. The integrated regulator valve, also called "RDI" allows to control the gas outlet of container 1 and its outlet pressure. Controllers control the release of the gas and also adjust the output pressure level.

Une telle installation est adaptée au traitement avec administration de NO par inhalation, des vasoconstrictions pulmonaires ou de l'hypertension pulmonaire chez un patient 15, qui peut être un adulte, un enfant ou un nouveau né.Such an installation is suitable for treatment with inhaled NO administration, pulmonary vasoconstriction or pulmonary hypertension in a patient 15, who may be an adult, a child or a newborn.

Plus précisément, le mélange gazeux NO/N2 véhiculé jusqu'au patient 15 par le circuit patient 11 et distribué au moyen de l'interface 14, est particulièrement recommandé pour traiter un nouveau-né souffrant d'hypertension pulmonaire primitive ou un adulte, un enfant ou un nouveau-né devant subir, subissant ou ayant subi une opération de chirurgie cardiaque.More specifically, the NO / N 2 gas mixture conveyed to the patient 15 by the patient circuit 11 and distributed by means of the interface 14, is particularly recommended for treating a newborn with primary pulmonary hypertension or an adult. a child or newborn who has to undergo, undergoing or having undergone cardiac surgery.

Claims (12)

Récipient de conditionnement de mélanges NO/N2 comprenant un corps principal (1) comprenant un volume interne (7) ayant une contenance comprise entre 2 et 30 litres et contenant un mélange NO/N2 à une pression supérieure à la pression atmosphérique, le corps principal (1) étant formé d'un alliage d'aluminium, caractérisé en ce que le corps principal (1) est formé d'un alliage d'aluminium comprenant majoritairement de l'aluminium et une proportion massique de : - Cr entre 0,05 et 0,80%, - Cu entre 1 et 3%, - Pb d'au plus 100 ppm, - Zn entre 5 et 8%, et - Mg entre 1 et 3%. NO / N 2 mixing container comprising a main body (1) comprising an internal volume (7) having a capacity of between 2 and 30 liters and containing a NO / N 2 mixture at a pressure above atmospheric pressure, the main body (1) being formed of an aluminum alloy, characterized in that the main body (1) is formed of an aluminum alloy comprising predominantly aluminum and a mass proportion of: Cr between 0.05 and 0.80%, - Cu between 1 and 3%, - Pb not more than 100 ppm, Zn between 5 and 8%, and - Mg between 1 and 3%. Récipient selon la revendication précédente, caractérisé en ce que la teneur en aluminium de l'alliage d'aluminium est comprise entre 85 et 93% en masse.Container according to the preceding claim, characterized in that the aluminum content of the aluminum alloy is between 85 and 93% by weight. Récipient selon l'une des revendications précédentes, caractérisé en ce qu'il est une bouteille de gaz comprenant un corps principal (1) de forme cylindrique et ayant un fond plat et ayant un diamètre compris entre 10 et 30 cm, et une hauteur comprise entre 50 et 120 cm, de préférence le corps (1) comprend une paroi périphérique ayant une épaisseur (E) entre 2 et 20 mm.Container according to one of the preceding claims, characterized in that it is a gas cylinder comprising a main body (1) of cylindrical shape and having a flat bottom and having a diameter of between 10 and 30 cm, and a height included between 50 and 120 cm, preferably the body (1) comprises a peripheral wall having a thickness (E) between 2 and 20 mm. Récipient selon l'une des revendications précédentes, caractérisé en ce que le corps principal (1) comprend un col (2) avec un orifice (5) de sortie au niveau duquel est fixé un dispositif (4) de contrôle du passage de gaz et/ou de réduction de pression.Container according to one of the preceding claims, characterized in that the main body (1) comprises a neck (2) with an outlet orifice (5) at the level of which is fixed a device (4) for controlling the passage of gas and / or pressure reduction. Récipient selon l'une des revendications précédentes, caractérisé en ce que le mélange gazeux NO/N2 contient de 1 à 1000 ppm en volume de NO et de l'azote (N2) pour le reste.Container according to one of the preceding claims, characterized in that the gaseous mixture NO / N 2 contains from 1 to 1000 ppm by volume of NO and nitrogen (N 2 ) for the remainder. Procédé de conditionnement d'un mélange NO/N2 dans un récipient de conditionnement selon l'une des revendications précédentes, comprenant un corps principal (1) comprenant un volume interne (7) dans lequel est introduit le mélange NO/N2 à une pression supérieure à la pression atmosphérique.Process for conditioning a NO / N 2 mixture in a conditioning container according to one of the preceding claims, comprising a main body (1) comprising an internal volume (7) into which the NO / N 2 mixture is introduced at a temperature of pressure above atmospheric pressure. Utilisation d'un récipient selon l'une des revendications 1 à 5 comprenant un corps principal (1) comprenant un volume interne (7), ledit corps principal (1) étant formé d'aluminium ou d'un alliage d'aluminium, pour conditionner un mélange gazeux NO/N2 contenant de 1 à 1000 ppm en volume de NO et d'azote pour le reste.Use of a container according to one of claims 1 to 5, comprising a main body (1) comprising an internal volume (7), said main body (1) being made of aluminum or an aluminum alloy, for condition a gaseous mixture NO / N 2 containing from 1 to 1000 ppm by volume of NO and nitrogen for the remainder. Système de conditionnement de mélange NO/N2 comprenant un récipient selon l'une des revendications 1 à 5.Mixture conditioning system NO / N 2 comprising a container according to one of claims 1 to 5. Installation de distribution de mélanges NO/N2 comprenant un ventilateur comportant un circuit patient reliant ledit ventilateur à une interface patient, caractérisée en ce que ledit circuit patient est alimenté en gaz par un récipient selon l'une des revendications 1 à 5.NO / N 2 mixture dispensing installation comprising a fan comprising a patient circuit connecting said ventilator to a patient interface, characterized in that said patient circuit is supplied with gas by a receptacle according to one of claims 1 to 5. Mélange gazeux NO/N2 pour une utilisation pour traiter ou pour prévenir une vasoconstriction pulmonaire ou une hypertension pulmonaire chez l'adulte, l'enfant ou le nouveau né, dans lequel le mélange NO/N2 est administré par inhalation, ledit mélange gazeux NO/N2 étant délivré par un récipient selon l'une des revendications 1 à 5 au sein duquel est conditionné le mélange NO/N2.NO / N 2 gas mixture for use in treating or preventing pulmonary vasoconstriction or pulmonary hypertension in an adult, child or newborn, wherein the NO / N 2 mixture is administered by inhalation, said gas mixture NO / N 2 being delivered by a container according to one of claims 1 to 5 wherein the NO / N 2 mixture is conditioned. Mélange gazeux NO/N2 selon la revendication 10, caractérisé en ce que le mélange NO/N2 est administré par inhalation au moyen d'une installation de distribution de mélange NO/N2 comprenant un ventilateur comportant un circuit patient reliant ledit ventilateur à une interface patient, ledit circuit patient étant alimenté en mélange gazeux NO/N2 délivré par un récipient selon l'une des revendications 1 à 5.NO / N 2 gas mixture according to claim 10, characterized in that the NO / N 2 mixture is administered by inhalation by means of a NO / N 2 mixture dispensing installation comprising a fan comprising a patient circuit connecting said fan to a patient interface, said patient circuit being fed with NO / N 2 gas mixture delivered by a container according to one of claims 1 to 5. Mélange gazeux NO/N2 selon l'une des revendications 10 ou 11, caractérisé en ce que le mélange gazeux NO/N2 est utilisé pour traiter un nouveau-né souffrant d'hypertension pulmonaire persistante (PPHN) ou un adulte, un enfant ou un nouveau-né devant subir, subissant ou ayant subi une opération de chirurgie cardiaque.NO / N 2 gas mixture according to one of Claims 10 or 11, characterized in that the gaseous mixture NO / N 2 is used to treat a neonate suffering from hypertension persistent pulmonary disease (PPHN) or an adult, child, or newborn who is undergoing, undergoing, or having undergone cardiac surgery.
EP12171927A 2011-06-29 2012-06-14 Aluminium cylinder for NO/nitrogen gaseous mixture and use thereof in the treatment of pulmonary vasoconstrictions Withdrawn EP2541120A1 (en)

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