Medicament (embodiment) and device for using same

Abstract

The invention aims to stop or slow down the progress of the acute stages of ischemic stroke, coronary failure and respiratory failure, and rescue injured and negative injured persons suffering from serious blood loss. The medicament according to the first embodiment comprises 40% to 50% by volume of helium, 25% to 35% by volume of argon, 0.2% to 5% by volume of xenon, 2% to 10% by volume of krypton, and no less than 21% by volume of oxygen, totaling 100% by volume, and the temperature of the gas mixture is 30-70 DEG C. A medicament according to a second embodiment comprises 21 to 60 vol% of oxygen, 0.2 to 35 vol% of xenon, 0.2 to 35 vol% of krypton, or 21 to 60 vol% of oxygen, xenon at a concentration ranging from 0.2 to 35 vol%, krypton at a concentration ranging from 0.2 to 35 vol%, and a remainder of argon in an amount of not less than 25 vol%, and the gas temperature is 15-70 DEG C. The claimed device is characterized by a mask 1 connected to a breathing bag 7 and a tank 12 containing an argon-xenon-krypton gas mixture, having a three-way valve for alternately supplying gas to the breathing bag 7, further equipped with a tank 9 containing a helium-oxygen-argon-xenon-krypton gas mixture, the invention relates to a heat exchanger for a gas mixture, having a mask (1) and having mounted thereon a valve with a pressure gauge connected to the mask to allow the gas mixture to be directly supplied into the mask (1), and having a chemical or electric heater (11) connected to a heat exchange line.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and in particular to medical and health care, emergency medical care, including emergency specialist medical care, military field treatment, and disaster medicine.

[0002] The drug is intended for use in alleviating and inhibiting the development of the acute phase of ischemic stroke, coronary and respiratory insufficiency, in rescuing injured persons and those with massive blood loss, with accompanying exogenous and endogenous hypothermia, mainly at home or in the wild, before the arrival of the rescue team, as well as during the stage of transport to and in medical institutions. Background Art

[0003] According to the related art, drugs and their use procedures are known to sustain the life of people suffering from severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure and hypothermia.

[0004] The procedure for providing medical care for the development of stroke and heart attack in the pre-medical stage is described in guidelines for the general population. These instructions propose the simplest measures that will not harm the patient, but in some cases these measures require the use of medical procedures and drugs (see, for example, https: / / medbe.ru / materials / ostrye-zabolevaniya / neotlozhnaya-pomoshch-pri-ostrykli-narusheniyakh-mozgovogo-krovoobrashcheniya / on the website www.MedBe.ru, and "8 main rules of first aid in case of stroke" on https: / / doktor-ok.com, etc.).

[0005] In this case, standard procedures for pre-medical care involve:

[0006] - Ensure the patency of the upper airway;

[0007] -Inhalation of oxygen through a nasal cannula;

[0008] -Relieve psychomotor agitation by intramuscular injection of 1-2 mL of 3% phenazepam solution;

[0009] -In case of elevated blood pressure: 2-4 mL of 2% papaverine solution and 2-4 mL of 1% dibazole solution intramuscularly;

[0010] - In case of arterial hypotension: 2-4 mL of cordiamine or 2-4 mL of 10% sulfocamphocaine solution.

[0011] The primary course of action at the time of injury includes a range of measures, including rapid prevention of blood loss through the use of bandages and tourniquets, and administration of anti-shock medications.

[0012] In general, this approach is designed to prevent brain and myocardial hypoxia, control hypovolemia, relieve painful shock, and ensure that vital functions are maintained until an ambulance arrives.

[0013] Obviously, it is difficult to implement the recommended set of measures in the absence of a specialist physician and under the conditions of pre-medical care in the country.

[0014] In the hospital setting, one of the main directions of specialized care in the acute phase of ischemic stroke and coronary insufficiency is also to provide anti-hypoxic and thrombolytic therapy, introduce antiplatelet drugs and neuroprotective agents. The most important task is to prevent the extension of penumbra ischemia and the expansion of the infarct area.

[0015] The pharmaceutical method includes administering drugs (anti-hypoxic drugs) with anti-hypoxia, neuroprotection and brain function improvement effects. Therefore, there is a method for protecting nerve cells in acute stroke by injecting the drug Noopept (Russian Federation (RF) patent No. 2330680, IPC A61K 38 / 05, A61K 31 / 401, A61K 9 / 08, A61K 9 / 19, A61J3 / 00, dated August 10, 2008). The use of Noopept can significantly reduce the area of ​​brain damage in experimental ischemia.

[0016] Another class of anti-hypoxemic drugs includes, for example, Hypoxene (sodium polydihydroxyphenylene thiosulfate), which is taken orally and regulates cell metabolism (RF Patent No. 2105000, C07C 381 / 02, C08G 61 / 10, A61K 31 / 05, published 02 / 20 / 1998; U.S. Patent No. 6117970, IPC A61RZ / 00; A61R43 / 00; C07C3 81 / 02; C08G61 / 10, dated September 12, 2000). Hypoxene restores the macroerg production process that is destroyed or interrupted by certain pathological processes. It is used to treat ischemic damage to the central nervous system, chronic fatigue syndrome, hypoxic poisoning and other chronic and acute hypoxic diseases.

[0017] The disadvantages of existing measures to prevent blood loss in the pre-medical stage are the need for involvement of medical staff, low effectiveness against deep or extensive lesions, inability to be used for preventive purposes, side effects, contraindications, and high cost of drugs.

[0018] Other agents with anti-hypoxic effects include the use of gas mixtures with high oxygen content.

[0019] Thus, an effective hyperbaric oxygen therapy method is known, which includes oxygen therapy under high pressure (for example, see Petrovsky BV, Efuni SN Fundamentals of hyperbaric oxygenation.-M.: Medicine, 1976.-344p.; Artru F., Charcornac R., Deleuze R. Hyperbaric oxygenation for severe head injuries: Preliminary results of a controlled study.-Eur Neurol., 1976,-V.14-p.310-318; Murthy T. Role of hyperoxia and hyperbaric oxygen insevere head injury: A review.-Indian Journal of Neurotrauma, 2006.-Vol 3.-№2-p.77-80). The therapeutic effect of hyperbaric oxygen therapy is based on a significant increase in oxygen tension in the body fluid medium (blood, lymph, tissue fluid), which allows rapid delivery of oxygen to tissues suffering from hypoxia and promotes the recovery of cellular respiration. However, the major disadvantage of using oxygen at high pressure is the potential for complications, primarily increased intracranial pressure.

[0020] Another effective way to prevent the acute development of ischemic stroke, heart attack, acute respiratory failure and hypovolemia is oxygen anti-hypoxia therapy using a ventilator (see "Features of oxygen transport in the acute period of ischemic stroke / KVLukashev et al. / / VANetovsky ResearchInstitute of General Resuscitation of the Russian Academy of MedicalSciences,electronic resource:cyberleninka.ru,2010").

[0021] A known method of oxygen therapy for the acute phase of stroke, heart attack, coronary heart disease and other diseases accompanied by hypoxia is implemented in the provision of pre-medical care (including self-rescue) using a portable oxygen cylinder, the breathing of which is intended to reduce the hypoxia phenomenon (see, for example, the electronic resource: medprep.info / oxygen; or the electronic resource: med.ru / the use of oxygentherapy for heart diseases, etc.).

[0022] A cylinder can provide several minutes of breathing with an oxygen-rich mixture, such as:

[0023] - Reserve air 0.28 liters, 20 MPa, air capacity under normal conditions (not specified)

[0024] -56 liters, diameter 5.71 cm, length 22.23 cm, weight 0.687 kg, refueling (approximately 6 minutes of use);

[0025] - Reserve air 0.42 liters, 20MPa, air capacity under normal conditions

[0026] -82 liters, diameter 5.71cm, length 34cm, weight 0.985kg, refueling (approximately 10 minutes application) and others.

[0027] A method of using "AirActive" oxygen cylinders in the form of inhalation is described to eliminate oxygen hunger (hypoxia), normalize the body's metabolism, increase mental and physical performance and endurance, as well as to prepare oxygen cocktails in everyday conditions. The oxygen tank "AirActive" contains a gas mixture of the composition Ag-25%, O2-75% (manufacturer OOO "TyumenAerosols").

[0028] A specific mixture of oxygen and argon is more effective in preventing organ hypoxia, but the argon content of the mixture is 25% by volume, with no other active ingredients such as xenon, and the supply of the gas mixture is small, which prevents the patient from breathing for the entire period of time, limiting the effectiveness of this method in relieving acute local ischemic attacks in providing pre-medical care, which in most cases is required for the arrival of an ambulance.

[0029] In cases where the patient or injured person is exacerbated by factors of cold climate exposure and endogenous factors associated with, for example, blood loss, the risk of developing terminal and irreversible conditions increases dramatically, requiring additional measures to maintain temperature homeostasis. However, the scope of these activities is severely limited in home and field conditions and is often limited to the use of additional equipment, which is often ineffective due to blood loss, forced immobility of the patient or injured person, and the entry of cold air into the body.

[0030] Therefore, in these cases, the only solution to the situation is to rush the casualty to an inpatient facility where the required amount of intensive care, including warming measures, can be administered.

[0031] However, in most cases, emergency transport to a medical facility is difficult. In these cases, the development of drugs and devices for stabilizing and maintaining the terminal state of the sick or injured and preventing compound hypothermia for a long time becomes particularly important.

[0032] In the case of hospitalization, resuscitative measures are taken to prevent or exit the terminal state, including fluid therapy aimed at eliminating hypovolemia.

[0033] Hemodynamic blood substitutes are also widely used to treat hypovolemia: dextran preparations (Rheopolyglucin, Polyglucin), gelatin solutions (Gelatinol), hydroxyethyl starch (Refortan, Stabizol, Infucol), saline solutions (Saline, Lactated Ringer's, Lactosol), sugar solutions (Glucose, Glucosteril). Among blood products, red blood cells, fresh frozen plasma, and albumin are more commonly used. In the absence of an increase in blood pressure, despite 1 hour of adequate fluid therapy, additional medications such as epinephrine, norepinephrine, dopamine and other vasoconstrictors were administered (after hemostasis) (see, for example: http: / / medbe.ru / materials / obshchie-voprosy-vpkh / pervaya-meditsinskaya-pomoshch-na-pole-boya-iv-ochage-massovykh-poter).

[0034] Therefore, in the treatment of hemorrhagic shock, drugs that improve blood rheology are used: heparin, Curantil, Trental and corticosteroids. After the patient is out of hemorrhagic shock and the direct threat to life is eliminated, the various links that disrupt the balance in the body (acid-base composition, hemostasis, etc.) are corrected.

[0035] However, there is only a limited set of emergency treatment measures and medicines available at home or in the wild.

[0036] At present, there are no effective drugs and methods to alleviate and inhibit the development of the acute phase of ischemic stroke, coronary artery and respiratory failure, rescue the injured and the injured with massive blood loss and concomitant exogenous and endogenous hypothermia under home or field conditions.

[0037] According to patent RU No. 2748126 dated May 19, 2021 "A method for the emergency relief of acute ischemic attacks with impaired cerebral or coronary circulation", it is known to use a gas mixture consisting of 1% to 10% by volume of xenon, 30% to 35% by volume of argon, 60% to 65% by volume of oxygen for the relief of acute ischemic attacks, wherein the patient is given an inhaled drug in the form of a gas mixture. The disadvantages of this drug include its unsuitability in cold conditions due to the possible condensation of xenon, which is related to its critical temperature of 289.74 K (16.59 ° C).

[0038] Drugs for massive blood loss are also known in the form of medical gaseous oxygen or mixtures of oxygen and nitrogen with an oxygen content above 60%. The use of these gas mixtures helps to increase blood oxygen saturation, but does not provide warmth and oxygen protection for the most important organs. In addition, in order to provide long-term treatment during the evacuation of casualties, large amounts of oxygen or oxygen-containing mixtures are required, which are not available in the field. The toxic effects of high oxygen content in the mixture are also negative.

[0039] A gas mixture called "heliox" is known which optimizes the temperature range of the human body. The heated heliox evenly warms the parenchyma of the chest organs and quickly relieves hypothermia in the body. These effects are associated with the high thermal conductivity and the highest diffusion capacity of helium (see LVShogenova, “The effects of using HELIOX as a working gas during inhalation of (32-agonists using a nebulizer in patients with exacerbation of asthma”. Federal State University “Research Institute of Pulmonology”-FMBA of Russia, Moscow, “Effective pharmacotherapy. Pulmonology andotorhinolaryngology”-No. 2.-2010). The mixture can also be used in the treatment of acute respiratory insufficiency in the treatment of patients with respiratory insufficiency (snoring syndrome) (use of hot helium-oxygen mixture (t-He / O2) / Clinical Recommendations of the Russian Federation for 2018-2020 (Russia) / https: / / medelement.com). However, when using the claimed technical means, this gas mixture affects the body only in the short term, and its composition is not sufficient to ensure the anti-hypoxic effect and long-term maintenance of the survivability of casualties with massive blood loss, as well as long-term prevention of the onset of acute respiratory failure.

[0040] Thus, from RF patent No. 2232013, IPC A61K 31 / 02, A61M 16 / 00, A61R 43 / 00, dated July 10, 2004, a "Method for exposing a gas mixture to a body" is known, which relates to exposing the body to a gas mixture containing oxygen and at least one diluent gas while treating. This action is performed by changing the conditions and mode of exposure by periodically replacing one gas mixture with another, and by changing at least one physical property of the injected mixture and / or its parameters, while oxygen is maintained within a range of 12% to 85% by volume. The invention contributes to the activation of reduction-oxidation and energetic processes in the body, increasing its specific adaptation to environmental changes.

[0041] However, disadvantages of using gas mixtures include insufficient effectiveness of drugs in sustaining life in patients with severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure and hypothermia during the first phase of emergency care in the field, at home and in the ambulance.

[0042] According to RF patent No. 2275211 (IPC A61M 16 / 00) dated April 27, 2006, there is known a method for rehabilitating a person suffering from exogenous hypothermia by warming and oxygenating the body by inhalation with a heated and humidified artificial breathing gas mixture, characterized in that the body is warmed and oxygenated by inhalation with an artificial breathing gas mixture containing: 49% to 51% by volume of oxygen, the remainder being helium, at a mixture temperature of 40-44°C.

[0043] A disadvantage of this gas mixture and its method of use is that this artificial respiration mixture lacks the additional anti-hypoxic effect (besides oxygen therapy) necessary to sustain the life of a patient suffering from ischemic attack, acute respiratory failure or severe blood loss.

[0044] The closest thing to the claimed invention in technical essence is a drug in the form of a gas mixture, proposed in the invention "A method for long-term maintenance of human viability in the field of wounds with severe blood loss and a device for its implementation" according to RF patent No. 2684748 (IPC A61M 16 / 12) of April 12, 2019, used as a prototype, which ensures long-term maintenance of vitality of the wounded while breathing a mixture. The gas mixture contains up to 1% by volume to 35% by volume of xenon, 30% by volume to 35% by volume of argon, at least 21% by volume of oxygen, and the rest is nitrogen.

[0045] Disadvantages of this gas mixture for the purposes of the present invention are the lack of a set temperature for the purposeful warming of the anti-hypothermic effect medication for patients, injured and wounded, and the absence of krypton in the gas mixture, which is used to achieve the analgesic effect of the proposed breathing gas mixture and ensure the use of medication at low temperatures.

[0046] In technical essence, the closest to the claimed device for supplying medicinal gases is the device described in the invention under RF patent No. 2684748 of April 12, 2019 (IPC A61M 16 / 12), which was used as a prototype and includes a front-mask, a breathing bag with an overpressure valve, a frame, a connecting tube, a replaceable regeneration cartridge, a mouthpiece located in the mask, a distribution bag with a switchable non-return valve and connecting lines, a gas cylinder with an argon-xenon mixture of up to 0.5 liters at a pressure of up to 30 MPa, or two separate gas cylinders of smaller capacity, with argon and xenon in the assembly and with a three-way valve for alternating gas supply, a mixture supply regulator, a connecting line for supplying the mixture to the distribution bag, and a mixture pressure sensor in the gas cylinder, a wristband portable computer with a heart rate (HR) and blood oxygen saturation sensor, oxygen and xenon concentration sensors in the breathing bag.

[0047] However, the device does not include a container and a gas path for storing and supplying the first heated breathing gas mixture, and has no sensor for monitoring the concentration of the argon-krypton-xenon mixture, and therefore, cannot ensure sufficient effectiveness of the present invention. Summary of the invention

[0048] The present invention aims to develop therapeutic agents for sustaining the life of patients suffering from severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure and hypothermia, for use in the initial preclinical stages of the development of the event, during the first emergency care phase in the field, at home, in the ambulance, in the hospital, during the preparation for surgery, during surgery, during intensive care and during recovery, and potentially in hypothermic conditions.

[0049] Technical tasks

[0050] The technical result of implementing the claimed invention is to reduce the mortality and disability rates of severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure and injuries and damage including hypothermia, and to reduce the possibility of using drugs under hypothermia in the first aid stage in the field, at home, in ambulances and in medical institutions.

[0051] Technical issues solved

[0052] According to Scheme 1, a drug for maintaining the life of a person suffering from severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure and hypothermia, the drug being a medical gas comprising oxygen, xenon and argon, and being different in that it contains helium in a concentration range of 40% to 50% by volume, argon in a concentration range of 25% to 35% by volume, xenon in a concentration range of 0.2% to 5% by volume, krypton in a concentration range of 2% to 10% by volume and at least 21% by volume of oxygen, with a total volume of up to 100%, and a temperature of the gas mixture of 30-70°C.

[0053] A drug for long-term maintenance of the survivability of casualties with severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure and hypothermia, wherein the drug is a medical gas comprising oxygen, xenon, argon and nitrogen, characterized in that it contains oxygen with a concentration ranging from 21% to 60% by volume, xenon with a concentration ranging from 0.2% to 35% by volume, krypton with a concentration ranging from 0.2% to 35% by volume, and argon with a remaining concentration of at least 25% by volume, and the gas temperature is 15-70°C.

[0054] Positive effects of the present invention

[0055] Use of the claimed drugs and devices will provide life-saving reserve time of up to six hours or more for evacuation from the incident scene to a medical facility from home and in field conditions.

[0056] In order to save patients suffering from severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure and hypothermia during the emergency phase in the field, at home and in the ambulance, the present invention claims a drug-therapeutic gas, which is a gas mixture with an increased content of inert gas and oxygen:

[0057] The claimed first breathing gas mixture has the following therapeutic effects:

[0058] - Rapid heating of the body, especially the vital organs (brain, heart, lungs, etc.), due to the receipt of a warm mixture with a high content of helium that helps accelerate heat transfer to the deeper tissues of the body;

[0059] - Provides a bronchodilator effect due to the action of helium and argon gases;

[0060] - Increased oxygen transport rate under hypovolemic conditions due to the special effect of helium on reducing blood viscosity and transcapillary gas transport;

[0061] - Due to the psychotropic and analgesic effects of xenon or krypton, the phenomenon of pain shock is reduced and the psychological and emotional state of the injured is improved;

[0062] - due to the special (protective) effect of argon, oxygen transfer to cells of vital organs is facilitated;

[0063] - Reduced oxygen and energy demand of cells, tissues and the body as a whole due to the hibernation behavior of xenon, synergistic effects of xenon or (and) krypton and argon on cellular energy systems.

[0064] The claimed second breathing gas mixture has the following therapeutic effects:

[0065] - Due to the psychotropic effect of mild anesthesia and higher concentrations of xenon, analgesic effect, analgesic effect of krypton, the phenomenon of pain shock is reduced and the psycho-emotional state of the wounded is improved;

[0066] - due to the special (protective) effect of argon, the transfer of oxygen to the cells of vital organs is promoted;

[0067] - Reduced oxygen and energy demand of cells, tissues and the entire body due to the hibernation behavior of xenon, synergistic effects of xenon, krypton and argon on cellular energy systems;

[0068] - Due to the anticoagulant properties of krypton at certain concentrations, it reduces the possibility of thrombosis and promotes the dissolution of blood clots;

[0069] -Maintaining the body's thermal balance due to the temperature of the mixture;

[0070] -The volumetric rate of oxygen transport into the capillary alveoli is increased due to the increased oxygen concentration in the breathing mixture, the accelerating effect of argon, krypton and xenon on transmembrane transport, and the bronchodilating effect of argon.

[0071] In order to achieve the properties of the claimed drug variant, which is a breathing gas mixture and is used for long-term maintenance of the survivability of injured patients suffering from local ischemic attacks and acute respiratory failure, injuries and severe blood loss, as well as exogenous and endogenous hypothermia at home and in the field, methods and devices for its use are described.

[0072] The medicine claimed in the present invention is used as follows:

[0073] - First, depending on the outside air temperature and the patient's condition, the patient or injured person is switched to a breathing mode with a gas mixture composed according to scheme 1, which contains helium in a concentration range of 40% to 50% by volume, argon in a concentration range of 25% to 35% by volume, xenon in a concentration range of 0.2% to 5% by volume, krypton in a concentration range of 2% to 10% by volume and at least 21% by volume of oxygen, with a total volume of up to 100%, and a temperature of the gas mixture of 30-70°C.

[0074] The mixture is used under the supervision of a physician for 5 to 30 minutes or longer to relieve hypothermia, enrich the blood and tissues of vital organs with oxygen, relieve painful shock, and relieve the onset of acute ischemia and respiratory failure. The conventional name for this gas mixture is "Hearoxxen-krypto."

[0075] Next, the patient is supplied with a second gas mixture according to Scheme 2, which contains oxygen in a concentration range of 21% to 60% by volume, xenon in a concentration range of 0.2% to 35% by volume, krypton in a concentration range of 0.2% to 35% by volume, and the remainder is argon in a concentration of at least 25% by volume, and the gas temperature is 15-70° C.,

[0076] The mixture is continuously supplied for 20 minutes to up to 6 hours or more to stabilize the patient's viability before the ambulance arrives or (and) is transported to a medical facility. The conventional name for this gas mixture is "Agohep-krypto".

[0077] The second mixture prevents hypothermia, enriches the blood and tissues of the most vital organs with oxygen, relieves painful shock, maintains viability for a long time in case of massive blood loss, and provides long-term relief from episodes of acute ischemia and respiratory failure.

[0078] In the absence of signs of endogenous hypothermia and acute respiratory failure, only the use of the second drug may be effective - the gas mixture "Agohep-krypto".

[0079] The mixture "Agohhep-krypto" used at home while waiting for the arrival of an ambulance specialist plays a particularly important role. The use of the drug "Agohhep-krypto" in a compressed gas cylinder for 20 to 40 minutes is most likely to save lives and reduce the consequences of ischemic attacks and hemorrhagic injuries while waiting for the arrival of an ambulance specialist.

[0080] Due to the exposure of the body to the claimed drug-respiratory gas mixture, the threshold for irreversible damage to cells and tissues of vital organs is "pushed back" and the survivability of the sick and injured is prolonged, providing the necessary time to transport him to a medical facility for qualified help or delivery of a blood substitute.

[0081] The patient himself, his assistant, or a professional medical practitioner can administer the drug ("Hearoxxen-krypto" and / or "Aroxxen-krypto") in the manner described.

[0082] For the use of medicines in conditions of densely populated areas, availability of communication facilities and ambulance services, a device for storing and supplying medicines should ensure a supply of medicines for 20 to 40 minutes while waiting for the arrival of an ambulance. Such a self-use device is a high-pressure gas cylinder with a gear valve, air tube, mask or mouthpiece. The device is easy to maintain, store and use, and does not require special medical training.

[0083] In order to use the drug in accident and disaster areas or in the wild far from habitats, a device is required that allows to produce and maintain a breathing gas mixture with a given component concentration and a given temperature for a long time in the wild. At the same time, it is important that the device is compact, easy to use and has a small mass. The continuous operation time of the device should be at least 3-4 hours or more when breathing in the resting state. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] Figure 1

[0085] [ Figure 1 ] Figure 1 The design of a device for making and using the medicament of the present invention is shown.

[0086] The device comprises a mask 1 with a secondary mask and a mouthpiece, a connection node 2 in the form of a connecting pipe with three outlets, a non-return valve 3 with a switchable module, an outward exhalation line 4, a connecting line 5, a regeneration cartridge 6 (e.g. RP-4P type with a starter block), a breathing bag 7 with an overpressure valve, a distribution bag 8 with a non-return valve (which may be an Ambu type non-return valve), a gas cylinder 9 with a small volume (e.g. 0.2 to 1 liter) with high pressure (e.g. up to 30 MPa), on which is mounted a valves and pressure gauges, filled with a helium-oxygen-argon-xenon-krypton gas mixture, heat exchange connecting lines 10 in the form of a heat exchanger, chemical or electrical heating pads 11 with batteries, and a small-capacity (e.g. 0.2 to 1 liter) and high-pressure (e.g. up to 30 MPa) gas cylinder 12 filled with an argon-xenon-krypton gas mixture, or several smaller-capacity individual gas cylinders filled with argon, xenon and krypton or a xenon+krypton mixture, each equipped with valves and pressure gauges. An assembly unit 13 with a three-way valve is connected to the gas cylinder 12 (or the gas cylinders in the assembly), which is used to supply the gas mixture to the breathing bag 7 through a regulator 14 and connecting lines 15.

[0087] The mask 1, the connection node 2, the check valve module 3, the connecting pipeline 5 and the heat exchange connecting pipeline 10, the breathing bag 7, and the distributor bag with a check valve 8 are equipped with a heat insulation device (not shown in the figure).

[0088] Furthermore, in order to monitor and control the condition of the patient or the injured, the device is equipped with a wrist portable computer 16 having sensors for the heart rate (HR), blood oxygen saturation and temperature of the injured, and a sensor 17 for the concentration of the mixture of oxygen and argon, xenon, krypton in the breathing bag 7. The device is placed in a packaging bag (not shown in the figure) and is equipped with a key, a stopper and other accessories.

[0089] The device works as follows.

[0090] After the device is assembled, it is necessary to start the chemical or electrical heating pad 11 in order to heat the heat exchange connecting line 10 and the breathing gas mixture therein to a temperature of 30-70°C, open the valve for supplying the breathing gas mixture from the cylinder 9, check its supply, set the operating mode of the switchable non-return valve module 3 to the line 4 after exhaling outwards; put the mask 1 on the patient or injured person and supply the first gas mixture for a given time (from 5 to 30 minutes or more) to relieve hypothermia. Before completing the gas supply, controlled by the bell and the pressure gauge reading on the cylinder 9, the regeneration cylinder 6 is started by using the start block, while the breathing bag 7 is filled with oxygen from the regeneration cylinder 6 through the connecting line 5.

[0091] Then, the valve of the gas cylinder 12 with argon, xenon and krypton is opened, in which case, through the assembly module 13, the regulator 14 and the connecting line 15, an argon-xenon-krypton mixture enters the breathing bag 7 and forms therein an oxygen-argon-xenon-krypton mixture with residual nitrogen, the composition of which is adjusted according to the readings of the oxygen concentration sensor 17 and the argon-xenon-krypton mixture and the reading of the pressure gauge on the gas cylinder 12. Then, the operating mode of the switchable module of the non-return valve 3 is set to the connecting line 5 to supply the regeneration cartridge with exhaled air, if necessary, the valve of the gas cylinder 9 is closed, the excess of the resulting oxygen-argon-xenon-krypton mixture and the remaining nitrogen are discharged through the overpressure valve of the breathing bag 7, and the remaining mixture enters it when inhaled through the regeneration cartridge 6 and the distribution bag 8 for breathing to the casualty, while, if necessary, using the distribution bag 8, forced breathing can be provided to the casualty. Furthermore, during exhalation, the mixture passes through the regeneration cylinder 6 into the breathing bag 7, is purified of carbon dioxide and water vapor and enriched with oxygen, and the chemical purification reaction is exothermic, which provides sufficient heat to heat the mixture in the breathing bag to a temperature of 15-70°C, and then, when inhaled, the oxygen-argon-krypton-xenon mixture passes through the regeneration cylinder 6 a second time, is purified, heated and enriched with oxygen again, thus completing the breathing cycle.

[0092] In the described breathing cycle, argon, krypton and xenon are not consumed due to their inertness and are not reduced from the breathing mixture involved in the breathing cycle, but are gradually reduced due to leaks in the mask 1, which can be controlled by a dedicated sensor 17, or by analyzing the condition of the casualty taking into account the computer readings 16, or based on the experience of the rescuer, and is adjusted by adding an argon-krypton-xenon mixture or argon and xenon (krypton) separately from the cylinder 12 to the breathing bag 7. In this case, the argon-xenon-krypton mixture is administered from the cylinder 12 through the assembly unit 13, the regulator 14 and the supply line 15 to the breathing bag 7 under the control of the pressure gauge and sensor 17 of the cylinder 12 for the required number of times to reach the predetermined ratio of oxygen and argon-krypton-xenon over the required time of up to 6-8 hours.

[0093] The ratio of the gases can also be changed by bleaching part of the gases through the mask 1.

[0094] In case of difficulty in spontaneous breathing, spontaneous breathing can be forced by means of the dispensing bag 8 by periodically pressing the dispensing bag 8 .

[0095] When the resources of the regeneration cylinder 6 are exhausted, it can be replaced with a new one. In addition, the gas cylinder 9 can also be replaced with a helium-oxygen-argon-xenon-krypton medical gas mixture, a gas cylinder 12 and a chemical heating pad or an electric heating pad battery 11, and the preparation procedure and the operation algorithm are repeated.

[0096] Figure 2

[0097] [ Figure 2 ] Figure 2 Another form of device is shown.

[0098] exist Figure 2 In another variant of the device shown, a flexible plastic transparent container 18 with a gas-tight zipper can be used instead of the regeneration cartridge 6 and the breathing bag 7, in which the patient or injured person is completely placed, and a device 19 with a regeneration substance and a chemical carbon dioxide absorbent and, if necessary, a mask 1 that can be worn on the injured person, a connection node 2, a distribution bag 8, gas cylinders 9 and 12 with a breathing gas mixture, a regulator 14 for supplying the gas mixture, connecting lines 5 and 15, a wrist portable computer 16 fixed to the arm of the injured person, which has sensors for the heart rate (HR), blood oxygen saturation and temperature of the injured person and a sensor 17 for the concentration of oxygen and xenon in an argon-krypton mixture. Gloves can be embedded in the container 18 to allow manipulation of the injured person and the device placed in the container (gloves are not shown in the figure). The container 18 must be completely insulated.

[0099] The gas mixture from the gas cylinder 9 is fed directly into the mask 1, the exhaled air enters the container 18, and the excess gas is then discharged via the overpressure valve 20. When the gas mixture is supplied from the gas cylinder 12, the second gas mixture is generated directly in the container. In this case, the switchable non-return valve module 3 is not required. After the injured person is placed in the container 18, the device 19 with the regeneration substance and the chemical CO2 absorbent located in the container 18 is immediately started.

[0100] Examples of using the claimed drugs and devices under real conditions.

[0101] In cases of ischemic episodes, injury or injury in "field" conditions, acute ischemia, massive blood loss, and hypothermic states, the following measures should be taken:

[0102] - Treat injured persons with antiseptics and hemostatic agents, if possible, and stop bleeding with bandages or tourniquets;

[0103] - If possible, analgesic solution by injection by means of an injection tube, in which antibiotic tablets are provided;

[0104] - Fighting suffocation;

[0105] - Compensate for blood loss by infusion of saline solution and other available means, if possible;

[0106] - Assemble the claimed device, activate the chemical or electrical heating pad, put on the mask for the sick or injured person, and supply the heated mixture of Hearoxxen-krypto gas according to Scheme 1 for the time required to recover from the hypothermic state and stabilize the pre-death state;

[0107] - before the end of the supply of the first breathing mixture, the regeneration cylinder is started and the components forming the second breathing mixture - argon, xenon and krypton - are added to the gas mixture obtained in the breathing bag in the required amounts to form an oxygen concentration of 21% to 60% by volume, a xenon concentration of 0.2% to 35% by volume, a krypton concentration of 0.2% to 35% by volume, and the rest is argon with a concentration of at least 25% by volume, and due to the heating of the gas in the regeneration cylinder, the gas temperature is 15-70°C, which ensures the transfer of the patient's body to an effective mode, providing oxygen to the most important organs, analgesia, mental stabilization, providing bronchodilator and thrombolytic effects, stabilization of the pre-death state;

[0108] The effect of applying the present invention is that the probability of death from local ischemic attacks, massive blood loss, acute respiratory failure and combined hypothermia is significantly reduced, because the possibility of sending the patient or the injured to the hospital in time after lowering the body temperature is increased, and the time for keeping the patient or the injured in a living state during the transfer from the field or home is significantly prolonged. DETAILED DESCRIPTION

[0109] Confirmation of the possibility of achieving the target effect in the implementation of the invention is the result of special studies conducted under the guidance and participation of the author, which were planned in a targeted manner and delivered to OOO "GEROPRO Institute", AO "ASM", Rostov State Medical University, St. Petersburg Institute of Nuclear Physics named after BP Konstantinov, research institute "Kurchatov Institute", Federal State Budgetary Agency of the Ministry of Health of the Russian Federation "Institute of Influenza named after AASmorodintsev, AO", Scientific Development and Production Center "House of Pharmacy" with the participation of volunteers and experimental animals.

[0110] The main findings of the research conducted are as follows:

[0111] Artificial gas mixtures (AGMs) of the claimed formulations, including heated artificial gas mixtures, supplied to experimental animals (rats, rabbits, pigs) for respiration, wherein acute episodes of cerebral and myocardial ischemia, acute massive blood loss combined with exogenous hypothermia are simulated, have greater clinical efficacy in prolonging life and the rate of recovery of the physiological functions of the experimental animals than air mixtures with the same (normal or elevated) oxygen content at normal or elevated temperatures.

[0112] The artificial gas mixture with the required composition and physical properties is free from acute and delayed toxicity and local irritation, as has been demonstrated in experiments on various types of experimental animals (rats, ferrets), including repeated use of test AGMs and with the participation of volunteers.

[0113] In order to sustain the life of injured patients suffering from acute cerebral and myocardial ischemia, acute respiratory failure, massive blood loss and hypothermia, the concentration ranges of the components of the mixture that provide a therapeutic effect were studied and determined, and the values ​​that provide the maximum effect or the optimum value of the concentration of the components were found, taking into account the errors in the measurement, production and administration of the mixture, such as:

[0114] Due to the complexity of the research and development work on argon based on the results of studies on experimental animals (State Scientific Center “Institute of Biomedical Problems of the Russian Academy of Sciences”), with the participation of volunteer testers (AO “ASM”), and according to foreign sources (Martens A., Ordies S., Vanaudenaerde VMet al. A porcine ex vivo lung perfusion model with maximal argon exposure to attenuate ischemia-reperfusion injury / / Med. Gas Res.–2017.-Vol.7.-P.28-36, etc.) the efficiency of a mixture of argon and oxygen for argon ranges from 30-70% (volume ratio);

[0115] - As a result of the complex work of the "Rostov State Medical University", taking into account the research and literature data, based on the results of studies on experimental animals and with the participation of voluntary testers, the effective concentration is estimated as a mixture of helium with oxygen, argon, xenon and krypton, with the concentration of argon at least 25% by volume, and the concentration of oxygen - 21% by volume, with an anti-hypothermic and anti-hypoxic effect. The helium content is at least 40% by volume, the temperature of the mixture should be 30-70 ° C, the initial temperature of the mixture should preferably be at the lower value of the range of variation, increase to the higher value within about 5 minutes, and then further maintain or gradually decrease to 30 ° C;

[0116] - the content of xenon and krypton in the mixture and their ratio are determined by the need to ensure the choice of achieving an analgesic effect (0.2% volume-10% volume) or an analgesic effect (30% volume-40% volume) (State Register of Medicines. Xenon (Xenonum). Official publication: in 2 volumes-M.: Medical Council, 2009.-Vol. 2, part 1-568p.; part 2-560p.);

[0117] - The need to use krypton is due to its properties (Kussmaul AR, “The biological effect of krypton on animals and humans under high pressure conditions”, dissertation for the degree of Candidate of Biological Sciences, “Institute of Bio-Medical Problems of the Russian Academy of Sciences”, Moscow, 2007.), as well as the following:

[0118] Krypton has a critical temperature of 209.35K, which allows it to be used in temperate winter fields and in arctic temperatures without risk of condensation (Xenon – 289.74K);

[0119] Krypton has similar effects to xenon and is 5-8 times cheaper.

[0120] - When setting the parameters of the mixture, the total relative error allowed is larger, up to 10%, due to the need to simplify the design and field operation, while at the same time, within the effective range found, the concentration of the ingredients within the required range will not significantly affect the effect of the drug used;

[0121] - Due to the wide effective concentration range of the mixture components and the smooth variation of their effects, it is possible to create a family of drugs and a family of devices for implementing the method within the declared concentration range or (and) within the general framework of the proposed devices, provide the physician with instructions for adjusting the composition of the provided mixture (qualitative and quantitative).

[0122] For example:

[0123] Devices for hot and warm climates can be lightweight, depending on the scheme [ Figure 1] implementation, with a reduced capacity of a cylinder of mixture 1, without insulation, using a xenon mixture entirely, if necessary, up to 35% by volume;

[0124] The device is suitable for areas with mild climates:

[0125] - In summer - light version, according to the scheme [ Figure 1 ] implementation, with a reduced capacity of a cylinder of mixture 1, without insulation, using a mixture of xenon and krypton throughout;

[0126] - In winter - according to the scheme [ Figure 2 ], with the increased capacity of the cylinders of Mix 1, thermally insulated, using either a mixture of xenon and krypton, or predominantly krypton;

[0127] The installation for the Arctic climate region is based on the scheme [ Figure 2 ] with the addition of a set of chemical heaters and the minimization of xenon in mixtures 1 and 2.

[0128] Example

[0129] After initial anesthesia, the pathological process (acute ischemia, massive blood loss combined with exogenous hypothermia) was modeled in two types of experimental animals (rats and rabbits). Acute myocardial ischemia was modeled in rats by ligation of the coronary arteries. Acute cerebral ischemia was modeled in rats by focal cerebral ischemia caused by occlusion of the middle cerebral artery (OMCA). Acute cerebral ischemia was modeled in rabbits by ligation of both carotid arteries and subsequent blood sampling from one carotid artery above the ligature at a volume of 40% of the circulating blood volume (approximately 4% of the rabbit's body weight). In rats, massive acute blood loss of up to 50% of the circulating blood volume was modeled by percutaneous puncture of the heart, and in rabbits, 40%-45% of the circulating blood volume was modeled by puncturing the femoral artery through a soft tissue incision. Exogenous hypothermia in both cases was modeled by pouring cold water on the operated animals, drying them with a towel, and then placing them in a cold room at -30°C for 10 minutes to prevent frostbite and freezing of the animals. Body temperature was monitored rectally.

[0130] After modeling, the animals were randomly divided into a control group or an experimental group.

[0131] Individuals in the control group were placed in a chamber with an air temperature of 20±2°C and oxygen contents of 23±2 vol%, 40±2 vol%, and 58±2 vol%.

[0132] 1 The individuals of the experimental group were first placed under a "hood" under which a heated mixture of "Hearoxxen-krypto" gas with a helium content of 45% by volume to 50% by volume was maintained for 5 minutes and 20 minutes, and further, the animals were moved to a chamber with an "Aroxxen-krypto" gas mixture with an initial temperature of 40±2°C to 60±2°C and an oxygen content of 23±2% by volume, 40±2% by volume and 58±2% by volume, an argon content of 33+2% by volume, a krypton content of 2±1% by volume, a xenon content of 2±1% by volume and the remainder being nitrogen.

[0133] The general condition, rectal temperature and mortality of the animals were observed and recorded. Remote monitoring of the animals (mortality assessment) continued for several days.

[0134] After local ischemia or acute massive blood loss was modeled under hypothermic background, the survival and recovery of vital functions of rats (21 in each experimental group) or rabbits (9 in each group) were observed and evaluated in paired experimental and control groups.

[0135] According to the experimental results of claim 1, it is obtained:

[0136] - In the ischemic experiment in rabbits, the survival rate during exposure to the claimed gas composition 2 for up to 4 hours was 100%, and in the control group it was 33%. After cessation of exposure to the claimed medicinal gas composition 2, the survival rate in the experimental group was 77.8%.

[0137] - In the experiment of modeling massive blood loss, the survival rate of experimental animals in the experimental group was significantly higher than that in the control group: rats - 18 out of 21 (87.5%), rabbits - 9 out of 9 (100%), rats - 5 out of 12 (58%), rabbits - 3 out of 8 (37.5%);

[0138] - The oxygen content in the gas mixture in the experimental groups did not significantly affect the survival of the experimental animals, unlike the control group, where 6 animals died at 23±2 volume %, 4 animals died at 40±2 volume %, and 3 animals died at 58±2 volume %.

[0139] 2 Individual rats from the experimental group were first placed under a "hood" under which a heated gas mixture with a helium content of 45-50% by volume was supplied for 5 minutes according to variant 1 of the present invention, and further, the animals were moved into a chamber with a gas mixture according to variant 2 of the present invention, the initial temperature of the gas mixture being 40±2° C. to 60±2° C., the oxygen content being 40±2% by volume, the krypton content being 10±2% by volume, the xenon content being 2±1% by volume, and the remainder being argon (approximately 43% by volume to 53% by volume).

[0140] The survival and vital function recovery of rats after acute massive blood loss under hypothermia were observed.

[0141] 3 Individual rats from the experimental group were first placed under a "hood" under which a heated gas mixture with a helium content of 45-50% by volume was supplied for 5 minutes according to variant 1 of the present invention, and further, the animals were moved into a chamber with a gas mixture according to variant 2 of the present invention, the initial temperature of the gas mixture being 40±2° C. to 60±2° C., the oxygen content being 40±2% by volume, the krypton content being 18±2% by volume, the xenon content being 2±1% by volume, and the remainder being argon (approximately 35% by volume to 45% by volume).

[0142] According to the experimental results of paragraphs 2 and 3, the following is obtained:

[0143] - The survival rates of the rats in the groups administered with the mixture containing 10±2% volume of krypton and 18±2% volume of krypton were the same.

[0144] - The functional recovery of the rats in the experimental group in the mixture with a krypton concentration of 18±2 volume % was slightly faster (about 1.2-1.3 times) than that of the rats in the experimental group in the mixture with a krypton concentration of 10±2 volume %.

[0145] 4 Individual rats of the experimental group were first placed under a "hood" under which a heated gas mixture with a helium content of 45-50% by volume was supplied for 10 minutes according to claim 1, and further, the animals were moved into a chamber with a gas mixture according to claim 2, the initial temperature of the gas mixture being 20±2° C. to 40±2° C., the oxygen content being 40±2% by volume, the krypton content being 2±1% by volume, the xenon content being 2±1% by volume, and the remainder being argon.

[0146] The survival and vital function recovery of rats after acute massive blood loss under hypothermia were observed.

[0147] 5 Individual rats of the experimental group were first placed under a "hood" under which a heated gas mixture with a helium content of 45-50% by volume was supplied for 20 minutes according to claim 1, and further, the animals were moved into a chamber with a gas mixture according to claim 2, the initial temperature of the gas mixture being 20±2° C. to 40±2° C., the oxygen content being 40±2% by volume, the krypton content being 2±1% by volume, the xenon content being 2±1% by volume, and the remainder being argon.

[0148] The survival and vital function recovery of rats after acute massive blood loss under hypothermia were observed.

[0149] According to the experimental results in Sections 4 and 5, we obtain:

[0150] The survival rate of rats in the group given 1 mixture for 10 minutes was better than that of rats in the group given 1 mixture for 20 minutes, which may indicate that the best effectiveness is achieved during the administration of the warming mixture and switching to the maintenance mixture 2.

[0151] Industrial Applicability

[0152] The analysis of the results of a large number of experimental studies involving animals and volunteers, including the given examples, allowed us to determine the optimal effective composition of variants of the gas "Hearoxxen-krypto" and "Aroxxen-krypto" for maintaining human life in conditions of severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure and hypothermia.

[0153] The general composition of the medicinal gases "Hearoxxen-krypto" and "Aroxxen-krypto" as well as examples of targeted variations of the claimed medicinal gas composition due to symptoms of the patient's condition and ambient temperature are shown in Table 1.

[0154] The pharmacokinetics and pharmacodynamics of the claimed medicinal gases, their range of action, make it possible to produce a variety of drugs with targeted action and applicability parameters within the claimed effective concentration range, or to use the claimed device to produce in the field the effective gas mixture required for the current condition of a specific patient in the claimed composition.

[0155] Table 1 - Formulation examples of variants of the claimed medicinal gas mixture for sustaining life in persons with severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure and hypothermia

[0156]

[0157]

[0158]

[0159]

Claims

1. A medicine for maintaining the life of a person suffering from severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure, and hypothermia, the medicine being a gas mixture comprising oxygen, xenon and argon, characterized in that: It contains helium in a concentration range of 40% to 50% by volume, argon in a concentration range of 25% to 35% by volume, xenon in a concentration range of 0.2% to 5% by volume, krypton in a concentration range of 2% to 10% by volume and at least 21% by volume of oxygen, with a total volume of up to 100%, and the temperature of the gas mixture is 30-70°C.

2. A medicine for maintaining the life of a person suffering from severe blood loss, acute cerebral ischemia and myocardial ischemia, acute respiratory failure, and hypothermia, the medicine being a gas mixture comprising oxygen, xenon, and argon, characterized in that: It contains oxygen in a concentration range of 21 volume % to 60 volume %, xenon in a concentration range of 0.2 volume % to 35 volume %, krypton in a concentration range of 0.2 volume % to 35 volume %, the remainder being argon in a concentration of at least 25 volume %, and the gas temperature is 15-70°C.

3. A device for maintaining the life of a person suffering from severe blood loss, acute cerebral and myocardial ischemia, acute respiratory failure, and hypothermia with the help of a drug according to any one of claims 1 to 2 (in the form of a breathing mixture of medicinal gases), characterized in that There is a face part - a mask 1 with a mouthpiece located therein, a connection node 2, a breathing bag 7 with an overpressure valve, a distribution bag 8 connected to a switchable non-return valve module and a regeneration cartridge 6 connected to a connecting line with the breathing bag 7, a gas cylinder 12 with an argon-xenon-krypton gas mixture or two smaller gas cylinders with argon, xenon and krypton in an assembly, and a three-way valve for alternately supplying gas to the breathing bag 7 via a gas mixture supply regulator 14, via a connecting line 15 for supplying the mixture to the breathing bag 7, a wrist portable computer 16 with a heart rate sensor and oxygen saturation blood, the breathing bag 7 The oxygen and xenon concentration sensor in the mask is designed for monitoring and controlling the condition of the injured, and is also characterized in that it is additionally equipped with a balloon 9, which has a medicinal product - helium-oxygen-argon-xenon-krypton gas mixture, on which a valve and a pressure gauge are installed, which is connected to the mask via a connecting line 10, and the gas mixture can be directly supplied to the mask 1, a chemical or electric heating pad 11 with a heat exchange connecting line, a switchable non-return valve module 3 installed between the outlet of the mask connection node and the regeneration cartridge 6, which is pneumatically connected to a distribution bag 8 and an exhalation line leading to the outside, an oxygen concentration sensor and an argon-krypton-xenon mixture.

4. The device according to claim 3, characterized in that The mask, the connection node, the switchable module of the non-return valve, the chemical heating pad with a heat exchange connecting line, the breathing bag, the connecting line through which the breathing gas mixture is supplied to it, and the metering bag with a non-return valve are provided with a thermal insulation layer.

5. The device according to claim 3, characterized in that In order to sustain human life for a long time, it further comprises a transparent plastic container with a gas-tight zipper and built-in gloves, for completely placing the injured person therein, a mask placed therein connected to a distribution bag, which can be placed on the injured person to stimulate breathing, and a device with a regenerative substance, as well as a distribution bag with a switchable non-return valve and a connecting pipeline, a gas cylinder containing a gas mixture or two separate gas cylinders of smaller capacity, argon and xenon are contained in the assembly and are provided with a three-way valve for alternating gas supply, a gas mixture supply regulator, a connecting pipeline for feeding the mixture into the distribution bag, and the device is also equipped with a gas cylinder with a helium-oxygen-argon-xenon-krypton gas mixture installed thereon, the gas cylinder is equipped with a valve and a pressure gauge connected to the mask via a heat exchange connecting pipeline, and the mixed gas can be directly supplied to the mask, a chemical heating pad with a heat exchange connecting pipeline and an overpressure valve is sealedly installed in the wall of the plastic container, and in the gas cylinder 12 with the argon-xenon-krypton gas mixture.

6. The device according to claim 5, characterized in that The clear plastic container is fully insulated.

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