US20190125785A1 - Hypothermal inhalation gas composition - Google Patents

Hypothermal inhalation gas composition Download PDF

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US20190125785A1
US20190125785A1 US16/091,135 US201616091135A US2019125785A1 US 20190125785 A1 US20190125785 A1 US 20190125785A1 US 201616091135 A US201616091135 A US 201616091135A US 2019125785 A1 US2019125785 A1 US 2019125785A1
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helium
oxygen
xenon
mixture
gas
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Hélène DAVID
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Monatomics Technology
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit
    • A61F2007/006—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit of gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F2007/126—Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels

Definitions

  • the present invention relates to an inhalation gas composition and more particularly to a selection of appropriate proportions of the gases of the composition.
  • ischemia followed by a reperfusion and for example in the case of CVA (acronym for “cerebrovascular accident”), neonatal encephalopathy, or therapeutic ischemia such as ischemia due to an organ transplantation or to the placement of a clamp during a surgical intervention, in particular in cardiac surgery, it is conventional to set up a controlled hypothermia for the purpose of protecting the brain by reducing the cell metabolism.
  • hypothermal conditions are still very often the only therapy proposed in the context of neurological (ischemic or non-ischemic) and psychiatric pathologies (“Drug Treatment in Psychiatry,” Trevor Silverstone and Paul Turner Eds., 1995 (p. 291)).
  • Xenon is an anesthetic agent which has had a marketing authorization in Europe since 2007. It is probably as a glutaminergic receptor antagonist of the N-methyl-D-aspartate (NMDA) type and due to its anti-proteolytic effect that xenon has organoprotective and in particular neuroprotective properties (“Xenon: elemental anaesthesia in clinical practice,” Robert D. Sanders, Daqing Ma and Mervyn Maze, British Medical Bulletin (2005) 71 (1): 115-135).
  • NMDA N-methyl-D-aspartate
  • argon a type A GABAergic receptor agonist (“Gamma-aminobutyric acid neuropharmacological investigations on narcosis produced by nitrogen, argon, or nitrous oxide,” Abraini J H, Kriem B, Balon N, Rostain J C, Risso J J, Anesthesia and Analgesia 2003; 96:746-9) and mu type opioidergic receptor antagonist (“Argon blocks the expression of locomotor sensitization to amphetamine through antagonism at the vesicular monoamine transporter-2 and mu-opioid receptor in the nucleus accumbens,” David H N, Dhilly M, Degoulet M, Poisnel G, Meckler C, Vallée N, Blatteau J É, Risso J J, Lemaire M, Debruyne D, Abraini J H, Translational Psychiatry 2015; 5:e594), has organoprotective and in particular neuroprotective properties
  • xenon and argon have the disadvantage of having hyperthermal properties for certain inhalation temperatures, these inert gases having a higher molecular weight than that of nitrogen and a lower thermal conductivity than that of nitrogen, which gives them a hyperthermal character when they are used in inhalation gas compositions.
  • these inert gases having a higher molecular weight than that of nitrogen and a lower thermal conductivity than that of nitrogen, which gives them a hyperthermal character when they are used in inhalation gas compositions.
  • the use of a gas with hyperthermal properties will tend to put the subjects who inhale it in a state of hyperthermia, which is detrimental in the context of the therapies of most neurological or psychiatric diseases.
  • independent cooling means such as bags of water or cold gel are applied directly on the body or the area to be cooled.
  • the independent cooling means can also consist of the use of a hydraulic pad with adjustable temperature or of selective cooling carried out with the aid of a refrigerated water circuit.
  • cooling means by direct application on the skin do not make it possible to achieve an optimal cooling of the subject, that is to say a homogeneous cooling, it being understood that a temperature gradient forms between the skin in contact with the cooling means and the internal organs.
  • the subject matter of the invention is thus an inhalation gas composition including oxygen and a mixture of inert gases.
  • the mixture of inert gases includes a first compound selected from xenon and argon having hyperthermal properties, and a second compound having hypothermal properties, said mixture of inert gases comprising proportions of the first compound and of the second compound such that said mixture of inert gases is hypothermal under predetermined temperature conditions.
  • “Inhalation” gas composition is understood to mean a gas composition including at least 21% oxygen, so that it can be inhaled by a subject, it being understood that with less than 21% oxygen in the inhalation mixture, the subject is in a state of hypoxia.
  • a gas or a mixture of inert gases having hypothermal properties is defined as being a gas or a mixture having a lower molecular weight than that of nitrogen and a higher thermal conductivity than that of nitrogen, which thus gives it the possibility of putting the subject inhaling said gas or mixture in a state of hypothermia.
  • the gas composition inhaled at a certain temperature makes it possible to maintain the body temperature of the subjects inhaling it within a so-called hypothermal temperature range below 36° C. and more precisely from 32° C. to 35° C.
  • hypothermia of the body that is to say to maintain a body temperature in a hypothermal range, that is to say a range of temperatures below the range of normal variability of the body, roughly between 36.1° C. and 37.8° C. (Simmers, Louise. Diversified Health Occupations, 2nd ed. Canada: Delmar, 1988: 150-151), it being possible to round off this range to 36-38° C. or 37 ⁇ 1° C.
  • the therapeutic hypothermal range extends to below 36° C. and more specifically between 32° C. and 35° C.
  • the invention makes it possible to provide a gas composition which does not generate or does not risk generating an increase in the body temperature of subjects inhaling the composition outside of a range of so-called hypothermal values extending below 36° C. and more specifically from 32° C. to 35° C.
  • this gas composition makes it possible to avoid the temperature gradient between the skin and the internal organs that occurs with the use of mechanical cooling means.
  • the inhalation gas composition makes it possible to achieve an optimal cooling of the subject, that is to say homogeneous cooling.
  • the second compound having hypothermal properties also has organoprotective properties.
  • Organoprotective properties are understood to mean the protection of internal organs such as, for example, the brain, blood vessels and nerves.
  • the inhalation gas composition according to the invention makes it possible to protect the internal organs when it is inhaled by a subject.
  • the second compound can advantageously be helium.
  • helium has both hypothermal and organoprotective properties (“Heliox and oxygen reduce infarct volume in a rat model of focal ischemia,” Pan Y, Zhang H, Van Deripe D R, Cruz-Flores S, Pannerton W M (2007), Experimental Neurology 205:587-90; “The effect of helium-oxygen mixtures on body temperature,” Tapper D, Arensman R, Johnson C, Folkman J (1974), Journal of Pediatric Surgery 9:597-603; “Post-ischemic helium provides neuroprotection in rats subjected to middle cerebral artery occlusion-induced ischemia by producing hypothermia,” David N H, Haelewyn B, Chazalviel L, Lecocq M, Degoulet M, Risso J J, Abraini J H (2009), Journal of Cerebral Blood Flow & Metabolism 29:1159-1165; “Modulation by the Noble Gas Helium of
  • the inhalation gas composition includes 50% to 79% of the mixture of inert gases; these proportions make it possible to ensure that the composition can be inhaled and to avoid hypoxia of the subject inhaling the composition.
  • said composition includes at least 13% helium.
  • said composition includes at most 50% xenon. Limiting the xenon content to less than 50% makes it possible to avoid an anesthetic effect on the subject inhaling the composition, while at the same time limiting the costs of obtaining the composition.
  • said composition includes 21% to 25% oxygen, 43% to 48% helium, and 30% to 35% xenon.
  • the composition can include 45% to 47% helium and 31% to 33% of xenon, or for an oxygen level of 25%, it can include 43% to 45% helium and 30% to 32% xenon, in order to ensure a body temperature between 32° C. and 35° C. in humans.
  • said composition in order to ensure a body temperature of 34° C., said composition can include roughly 22% oxygen, 43% helium, and 35% xenon. Roughly is understood to mean that a margin of error or uncertainty of 1% is acceptable.
  • composition includes at least 11% helium.
  • said composition includes at most 67% argon.
  • said composition includes 21% to 25% oxygen, 22% to 76% helium, and 2% to 56% argon.
  • the composition when inhaled at a temperature of 22° C., it can include 22% oxygen, 37% to 68% helium, and 10% to 41% argon, or said composition includes 25% oxygen, 36% to 65% helium, and 10% to 39% argon, in order to ensure a body temperature between 33° C. and 35° C. in humans.
  • FIG. 1 is a graphic representation of the rat body temperature as a function of the temperature of the inhaled gas which is helium (curve C 1 ) or xenon (curve C 2 );
  • FIG. 2 is a graphic representation of the rat body temperature as a function of the temperature of the inhaled gas which is helium (curve C 1 ) or argon (curve C 3 );
  • appended table 1 represents the physical properties of the compounds of the present invention
  • appended table 2 represents the proportions of xenon and of helium as a function of the proportion of oxygen, of the temperature of inhalation of the composition and of its effect on the body temperature measured in rats;
  • appended table 3 represents the proportions of argon and of helium as a function of the proportion of oxygen, of the temperature of inhalation of the composition and of its effect on the body temperature measured in rats.
  • the air consists mainly of 21% oxygen, 78% nitrogen, and 1% rare gas. It is roughly equivalent to say that the reference air consists of 21% oxygen and 79% nitrogen, this oxygen content being the minimum value that a gas mixture has to contain to avoid hypoxia in a subject inhaling such a gas mixture.
  • the gas composition according to the invention comprises oxygen and a mixture of inert gases, the proportion of nitrogen in the air being replaced by the mixture of inert gases.
  • This mixture of inert gases consists of a first compound having hyperthermal properties and of a second compound having hypothermal properties.
  • the proportions of each compound of the mixture of inert gases are such that they enable the inhaled gas composition to maintain the body temperature of a subject within a so-called hypothermal temperature range from 32° C. to 35° C.
  • the composition contains at least 21% oxygen, in order to avoid any hypoxia during its inhalation.
  • the composition contains at most 50% oxygen, and preferably between 21% and 30%, and even between 21% and 25%.
  • the composition thus contains at least 50% of a mixture of inert gases, and preferably 70% to 79%.
  • the mixture of inert gases includes a first compound selected from inert gases having hyperthermal properties and a second compound selected from inert gases having hypothermal properties.
  • the inert gases have the advantage of not being metabolized after they have been inhaled.
  • the first compound selected from the inert gases with hyperthermal properties is xenon or argon.
  • xenon and argon have a higher molecular weight than nitrogen and a lower thermal conductivity than nitrogen, which gives them a hyperthermal character when either of the two replaces nitrogen in a gas mixture.
  • xenon and argon have organoprotective properties, that is to say that these compounds enable the protection of organs, blood vessels and nerves. These compounds are capable of protecting the brain in particular.
  • the gas composition includes xenon as first compound, that is to say as compound having the hyperthermal properties.
  • Xenon is then mixed with a gas having hypothermal properties in proportions such that the mixture has hypothermal properties.
  • a gas having hypothermal properties namely helium
  • an inert gas which is particular in that it has hypothermal properties namely helium
  • helium has a lower molecular weight than nitrogen and a higher thermal conductivity than nitrogen, which gives it a hypothermal character when it replaces nitrogen in a gas mixture.
  • helium also has organoprotective properties.
  • the graph of FIG. 1 which represents the experimental body temperature data Tc collected on rats as a function of the inhalation temperature Ti of a helium-oxygen mixture (curve C 1 ) or of a xenon-oxygen mixture (curve C 2 ), makes it possible to determine the proportions of the gas composition to be complied with in order to obtain a hypothermal gas mixture, depending on the inhalation temperature.
  • curves C 1 and C 2 correspond to regression lines obtained based on said experimental data Pi, several examples of which have been plotted in FIG. 1 .
  • the experimental data were obtained as follows: The rats were placed for 3 hours in a closed enclosure supplied with a continuous flow of a gas mixture containing 22% oxygen (O 2 ) and 78% helium, xenon or argon (He, Xe or Ar). This gas mixture was administered at different temperatures. The flow of the gas mixture was 10 mL/min and made it possible to maintain the carbon dioxide (CO 2 ) concentration below 0.03% and the humidity at around 60% to 70%.
  • the administration of a gas mixture at different temperatures in rats in a closed enclosure is thus comparable to the administration in humans of such a gas mixture at an inhalation temperature Ti which is roughly equal to the ambient temperature of the room in which the gas treatment is administered.
  • the inhalation temperature Ti can be between 16° C. and 27° C., for example.
  • the distance H 22 -X 22 corresponds to the difference between a body temperature of a rat inhaling an oxygen-helium mixture and a body temperature of a rat inhaling an oxygen-xenon mixture, at the same inhalation temperature of 22° C.
  • the distance X 22 -T 34 corresponds to the difference between a body temperature of rat inhaling an oxygen-xenon mixture at an inhalation temperature of 22° C. and a target body temperature of 34° C.
  • the distances X 22 -T 32 , X 22 -T 33 and X 22 -T 35 correspond to the difference between the body temperature of the rat inhaling the oxygen-xenon mixture and the target body temperatures of 32° C. to 35° C.
  • a first step consists of a calculation of the body temperatures: for an inhalation temperature roughly equal to 22° C., when a 22% O 2 -78% He mixture is inhaled, one gets a body temperature of 32.32° C. using the function representative of curve Cl, and when a 22% O 2 -78% Xe mixture is inhaled, one gets a body temperature of 38.60° C. using the function representative of curve C 2 .
  • a difference, for the inhalation temperature of 22° C., between the body temperatures obtained by the calculations in the first step, which will subsequently be used as reference value for the calculations of the content of each of the compounds of the mixture a first difference D 1 is thus calculated between the body temperature obtained with a 22% O 2 -78% Xe mixture and the body temperature obtained with a 22% O 2 -78% He mixture, and, in the case described with an inhalation temperature equal to 22° C., a value of 6.28 is obtained here.
  • a third step consists of a calculation of the content of one of the gases to be provided in order to ensure a body temperature of 34° C. for an inhalation temperature of 22° C.
  • one arbitrarily chooses to determine the helium content it being understood that one could choose to first determine the xenon content.
  • a second difference D 2 is calculated between the body temperature obtained with a 22% O 2 -78% Xe mixture and the body temperature desired for this inhalation temperature of 22° C., giving a value of 4.6 in this case.
  • This ratio between the values calculated in the second and third steps is used in a cross product calculation in order to determine the helium content, relative to the 78% of inert gases in addition to oxygen, of the gas composition to be prepared in order to obtain a body temperature of 34° C.:
  • a content equal to 57% (4.6 ⁇ 78/6.28)% is obtained here.
  • the composition includes 8 to 33% xenon and 45 to 70% helium. More precisely, if one wishes to achieve a body temperature of 34° C., the composition includes 22% oxygen, 56% to 58% helium, and 20% to 22% xenon.
  • the composition includes at least 9% helium and at most 65% xenon. More particularly, when the oxygen content is between 21 and 30%, the composition includes at least 13% helium and at most 65% xenon.
  • the aim is a gas composition enabling, on the one hand, the presence of the target thermal properties, that is to say the thermal properties obtained with the aid of a hypothermal mixture of inert gases, it being possible to read in the tables the appropriate proportions for obtaining such a composition, and, according to the present invention, the aim is a composition enabling, on the other hand, a use on subjects without risk of undesired anesthetic effect, that is to say by limiting the addition of xenon to a maximum of 50%.
  • the composition includes 21 to 30% oxygen, 26 to 77% helium, and 2 to 50% xenon.
  • the composition includes 22% oxygen, 45% to 47% helium, and 31% to 33% xenon.
  • the graph of FIG. 2 represents the experimental data Pi of the body temperature obtained in rats as a function of the temperature of inhalation of helium (curve C 1 ) or of argon (curve C 3 ), based on which the proportions of the different gases in a helium-argon-oxygen mixture were calculated (table 3).
  • the reference points A 18 and H 18 used in this case were taken at an inhalation temperature Ti of 18° C., and the distances with the target body temperatures T 32 , T 33 , T 34 and T 35 are thus representative of the proportions of the mixture of inert gases for this inhalation temperature of 18° C.
  • curve C 3 has a smaller slope than curve C 2 .
  • the proportions of the inert gases in the inhalation gas composition according to the invention vary as a function of the quality of the first compound used in this composition, which is selected from argon or xenon.
  • the composition includes at most 67% argon and at least 8% helium. More particularly, when the oxygen content is between 21 and 30%, the composition includes at most 67% argon and at least 11% helium. In addition, for inhalation temperatures Ti between 19° C. and 23° C., the composition includes 21 to 30% oxygen, 20 to 76% helium, and 2 to 56% argon. And again for inhalation temperatures Ti of between 19° C. and 23° C., the composition includes 21 to 25% oxygen, 22% to 76% helium, and 2% to 56% argon.
  • the inhalation of such a composition can be carried out by means of a human-machine interface such as a respiratory ventilator, a face mask, respiratory goggles or any other type of interface.
  • a human-machine interface such as a respiratory ventilator, a face mask, respiratory goggles or any other type of interface.
  • the packaging of such a composition is preferably carried out in a single container with the three compounds, namely xenon or argon, helium, and oxygen, in pre-established proportions under a pressure between 10 and 300 bar.
  • the container has a volume of 0.1 L to 50 L.
  • This packaging in a single bottle is referred to as “ready-to-use.”
  • the oxygen proportion in this type of packaging is always at least 22%.

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RU2524765C1 (ru) * 2012-12-29 2014-08-10 Сергей Александрович Наумов Способ лечения стресса и устройство для его осуществления

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WO2010035074A1 (fr) 2008-09-25 2010-04-01 Nnoxe Pharmaceutiques Inc Utilisation d'oxyde de diazote, d'argon, de xénon, d'hélium ou de néon pour fabriquer une composition pharmaceutique destinée à traiter des lésions ischémiques chez des patients ne pouvant pas être traités par des agents thrombolytiques
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FR3004350A1 (fr) 2013-04-12 2014-10-17 Air Liquide Delivrance de gaz medical a un receveur de materiel biologique

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US20100278942A1 (en) * 2007-04-30 2010-11-04 Nnoxe Pharmaceutiques Inc Pharmaceutical composition comprising at least one thrombolytic agent (a) and at least one gas (b) selected from the group consisting of nitrous oxide, argon, xenon, helium, neon
RU2524765C1 (ru) * 2012-12-29 2014-08-10 Сергей Александрович Наумов Способ лечения стресса и устройство для его осуществления

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CN109069412A (zh) 2018-12-21
CA3020039A1 (fr) 2017-10-12
US20200254010A1 (en) 2020-08-13
JP6840834B2 (ja) 2021-03-10
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CN109069412B (zh) 2022-07-05
EP3439630A1 (fr) 2019-02-13

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