EP3503953A1 - Medical device for the closed-circuit administration of a gaseous mixture to a spontaneously breathing patient, and associated adjustment system - Google Patents

Medical device for the closed-circuit administration of a gaseous mixture to a spontaneously breathing patient, and associated adjustment system

Info

Publication number
EP3503953A1
EP3503953A1 EP16763926.9A EP16763926A EP3503953A1 EP 3503953 A1 EP3503953 A1 EP 3503953A1 EP 16763926 A EP16763926 A EP 16763926A EP 3503953 A1 EP3503953 A1 EP 3503953A1
Authority
EP
European Patent Office
Prior art keywords
gaseous mixture
recycling system
gas
patient
mixture
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Withdrawn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
EP16763926.9A
Other languages
German (de)
French (fr)
Inventor
Hélène DAVID
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.)
Monatomics Technology
Original Assignee
Monatomics Technology
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Monatomics Technology filed Critical Monatomics Technology
Publication of EP3503953A1 publication Critical patent/EP3503953A1/en
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0045Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • AHUMAN NECESSITIES
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    • A61M16/0057Pumps therefor
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    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022Control means therefor
    • A61M16/024Control means therefor including calculation means, e.g. using a processor
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    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0883Circuit type
    • A61M16/0891Closed circuit, e.g. for anaesthesia
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    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/201Controlled valves
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    • A61M16/20Valves specially adapted to medical respiratory devices
    • A61M16/208Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
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    • A61M16/209Relief valves
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    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
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    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/1005Preparation of respiratory gases or vapours with O2 features or with parameter measurement
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    • A61M2016/1025Measuring a parameter of the content of the delivered gas the O2 concentration
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Definitions

  • the field of the present invention is that of medical devices for the closed-loop administration of a gaseous mixture for therapeutic purposes to a patient breathing spontaneously.
  • the administration of a gaseous mixture to a patient by means of a breathing apparatus operating in a closed circuit requires the possibility of recycling the gaseous mixture, that is to say, on the one hand, to be able to purify the gas mixture and to secondly to be able to accurately adjust the composition of the gas mixture inspired by the patient to defined set values for each gas component of the gas mixture.
  • the administration of a gas mixture to a patient by means of a breathing apparatus operating in a closed circuit can be done either aided when the patient is anesthetized, or unassisted, said on demand, when the patient is not anesthetized and breathes spontaneously. In the latter case, the administration of the gas mixture to the patient follows the respiratory rhythm of the patient.
  • the gaseous mixture is dispensed to the patient when the patient inhales, then, after being exhaled by the patient, is recycled, i.e., purified and adjusted to the desired composition, before being again inspired by the patient. patient.
  • the present invention is in the context of the closed-loop administration of therapeutic gas mixtures composed of oxygen and one or more inert gases to a non-anesthetized patient breathing spontaneously, with the aim of protecting medical use. of this type of gas recycling equipment.
  • the medical device according to the invention makes it possible to administer in a controlled and safe manner a gaseous mixture composed of oxygen and inert gas (s) to a patient breathing spontaneously.
  • the invention relates to a system for recycling the gaseous mixture configured to be disposed on a closed circuit for administering said gaseous mixture.
  • a closed circuit for administering a gaseous mixture to a patient which comprises the system for recycling the gaseous mixture and a member for administering the gaseous mixture to the patient, and according to a third aspect of the invention a medical device for administering a gas mixture to be delivered to a spontaneously breathing patient comprising the closed administration circuit.
  • the system for recycling a gaseous mixture described in the present invention is a device intended to equip a closed circuit for administering a gaseous mixture to a patient. It has an inlet through which the gas mixture exhaled by the patient enters the device and an outlet through which the gaseous mixture recycled, that is to say purified and adjusted to the desired composition, is supplied to the patient , thus defining a flow direction of the gaseous mixture from the inlet to the outlet of the recycling system.
  • This recycling system comprises at least one treatment zone of the exhaled gas mixture containing a compound capable of retaining carbon dioxide.
  • the gaseous mixture recycle system comprises an adjustment zone of the gaseous mixture composition wherein the concentration of each gas comprising the gaseous mixture exhaled by the patient is adjusted to a value. deposit.
  • This zone for adjusting the composition of the gaseous mixture may in particular comprise at least one fan, which may be at adjustable speed, the dual function of which is on the one hand to optimize the homogenization of the gaseous mixture before it is distributed to the patient and, on the other hand, to relieve the inspiratory work of the patient; the fan may for example be controlled according to the inspiratory rhythm of the patient, in particular by being triggered at each inspirational session detected, and / or be controlled according to the inspiratory effort of the patient, in particular by increasing the speed of rotation of the patient. fan.
  • This zone for adjusting the composition of the gaseous mixture may further comprise intake orifices making it possible to inject into the recycling system the different gases constituting the gaseous mixture in order to adjust the composition of the gaseous mixture exhaled by the patient to defined setpoints for each gas constituting the gas mixture.
  • the injection of the various gases constituting the gaseous mixture can be controlled according to the concentration values of each gas constituting the gaseous mixture. These values can be determined by measurements made by gas sensors arranged either in situ in the closed circuit of administration, advantageously in the control system. gas recirculation, connected to gas analysis systems, either ex situ outside the closed administration circuit, in which case the sensors are supplied with gas by means of micropumps or microturbines and a tubing of suitable diameter connecting the closed circuit of administration, or preferably the gas recycling system, to the gas sensors.
  • the choice of the location of the sensors may in particular depend on the type of gas to be detected and the type of sensor that results.
  • the gas recycling system may comprise a filtration zone, housing a particle retention member, configured to retain in particular particles emanating from the compound capable of fixing carbon dioxide such as, for example, lime soda.
  • This filtration zone may in particular be located inside the recycling system after the gaseous mixture treatment zone and before the gaseous mixture adjustment zone mentioned above. Alternatively, it can be provided that the filtration zone is offset outside the recycling system and in particular at the outlet thereof, or directly before the administration member of the gas mixture to the patient.
  • the system for recycling the gaseous mixture may also comprise a heat exchange zone, in particular for cooling the gaseous mixture, housing for example a heat exchanger.
  • the system for recycling a gaseous mixture advantageously has a gaseous mixture treatment zone housing a compound capable of retaining carbon dioxide, an adjustment zone of the composition of the gas mixture, which may include gas inlet ports in the recycling system and, optionally, at least one adjustable speed fan.
  • the system for recycling a gaseous mixture also comprises at least one of the following characteristics, taken alone or in combination:
  • a heat exchange system in particular for cooling the gaseous mixture, housing, for example, a heat exchanger;
  • a filtration zone of the gaseous mixture housing a particle retention member
  • the treatment zone of the gaseous mixture is situated upstream of the filtration zone with respect to the direction of circulation of the gaseous mixture;
  • the gas mixture treatment zone is located upstream of the adjustment zone with respect to the flow direction of the gaseous mixture
  • the filtration zone of the gaseous mixture is situated upstream or downstream of the adjustment zone with respect to the direction of circulation of the gaseous mixture.
  • the present invention also relates to a closed circuit for administering a gaseous mixture to a patient, which comprises the gaseous mixture recycling system previously described, one or two flexible and deformable enclosures, generally called false-lungs, intended to facilitate the inspiratory and / or expiratory work of the patient, and an organ for administering the gas mixture to the patient.
  • the closed circuit for administering a gas mixture to a patient advantageously has at least one of the following characteristics, taken alone or in combination:
  • the closed circuit comprises at least one false-lung arranged upstream or downstream of the recycling system with respect to the direction of circulation of the gas mixture inside the closed circuit; or the closed circuit advantageously comprises two false-lungs arranged for one upstream and the other downstream of the recycling system with respect to the direction of flow of the gas mixture inside the closed circuit; if a false lung is placed downstream of the recycling system, it may be equipped with a pressure relief valve;
  • the closed circuit comprises a member for administering the gas mixture to a patient;
  • this administration member is for example a bucco-nasal mask, a face mask, or a hood wrapped around the patient's head;
  • the closed circuit is equipped with a vacuum pump, preferably placed as close as possible to the outlet of the administration member of the gas mixture;
  • the closed circuit houses at least two, preferably three, nonreturn valves.
  • the present invention according to a particular aspect particularly relates to a medical device for administering a gas mixture to be delivered to a patient breathing spontaneously.
  • This medical device may in particular comprise at least one of the following characteristics, namely:
  • At least two gas reservoirs a first reservoir containing pure oxygen, and a second reservoir containing one or more inert gases for the therapeutic purpose of combination or not with oxygen;
  • DMVP proportional solenoid valve
  • EVS single solenoid valve
  • one of the supply lines may be configured to supply the closed administration circuit with an inert gas for therapeutic purposes, or a mixture of inert gases for therapeutic purposes, this inert gas or these being alone or in combination with oxygen;
  • an electronic control unit in connection with various sensors, such as gas analysis sensors making it possible to continuously measure the partial pressure of carbon dioxide and of each of the gases constituting the gaseous mixture, sensors making it possible to measure continuously the pressure of the gas tanks, and a sensor for measuring the temperature of the gas administered to the patient;
  • the electronic control unit can be configured, for example, to automatically inject one or more gases into the recycling system by means of mass flowmeters - proportional valves and / or solenoid valves in order to adjust the composition of the gas mixture expired by the patient to the desired setpoints, and / or to calculate the volume of expanded gas available in the gas tanks, and / or to adjust the temperature of the gas mixture to a value to maintain the central temperature of the patient at a desired temperature.
  • the electronic control unit has high alarms and / or low to safely manage the partial pressures of carbon dioxide, oxygen and other gases constituting the gas mixture, the volume of gas expanded available in the gas tanks, the temperature of the gas administered to the patient, and the speed of the ventilator.
  • the figure in this document shows a block diagram of a medical device for the closed-loop administration of a gas mixture to a breathing patient spontaneously described in the present invention.
  • a medical device 1 of closed circuit administration of a gaseous mixture to a patient breathing spontaneously is adapted to be used in hospital, in a medical office, or in a similar place.
  • the medical device 1 for administering a gaseous mixture is used by a qualified practitioner to administer to a spontaneously breathing patient a gaseous mixture composed of oxygen and inert gases for therapeutic purposes.
  • the medical device 1 for administering a gaseous mixture, with recycling of the exhaled gas comprises a closed circuit 2 for administering a gaseous mixture, in particular with a member 3 for delivering the gaseous mixture to the patient, and a system recycling 4 of the gaseous mixture exhaled by the patient.
  • the medical device 1 for administering a gaseous mixture is furthermore equipped with two feed lines 101 and 102, respectively in relation to the gas reservoirs 201 and 202.
  • the first feed line 101 allows injection into the oxygen recycling system 4 from the tank 201 and the second feed line 102 allows the injection into the recycling system 4 of one or more inert gases, such as for example argon, xenon and helium, combined or not with oxygen, this mixture of inert gases and / or oxygen from the tank 202. Details of the feed lines will be given hereinafter.
  • the closed circuit 2 of the gaseous mixture comprises a delivery member 3 of the gaseous mixture, which is for example an oral-nasal mask, a face mask, or a hood wrapped around the patient's head.
  • the administration member 3 covers at least the patient's mouth and nose.
  • the closed circuit 2 of the gaseous mixture comprises a recycling system 4 of the gaseous mixture, through which the gaseous mixture passes from its inlet to its outlet.
  • the recycling system 4 of the gaseous mixture houses a compound 5 capable of capturing carbon dioxide, such as, for example, sodium lime or a similar product. This is arranged in the recycling system 4 of a treatment zone Z 1, arranged between the inlet of the recycling system 4 and the outlet thereof, inside which is disposed the compound 5 capable of capture the carbon dioxide.
  • the recycling system 4 can also house a particle retention member 6 configured to retain at least the particles from the compound 5 capable of fixing the carbon dioxide, such as for example soda lime. More specifically, soda lime is in the form of granules which may tend to crumble on contact with the exhaled air by the user.
  • a filtration zone 2.2 is provided, which consists, for example, of at least one filter through which the gas mixture is able to circulate. Thus, the patient is prevented from breathing particles from compound 5.
  • the recycling system 4 is equipped, in an adjustment zone of the composition of the gas mixture Z3, with at least one oxygen sensor for measuring the oxygen partial pressure and at least one oxygen dioxide sensor. carbon for measuring the partial pressure of carbon dioxide, placed inside or outside the recycling system 4 (in which case a tubing connects the sensors to said recycling system).
  • the recycling system 4 is equipped with at least two, advantageously three, oxygen sensors 9a, 9b and at least two, advantageously three, carbon dioxide sensors 10a, 10b.
  • the recycling system 4 may be equipped with sensor (s) 1 1, 12 for measuring the partial pressure of the inert gas constituting the gas mixture.
  • the above sensors are coupled to gas analyzers, which can be for example according to the nature of the gas to be analyzed, paramagnetic analyzers or catharometers, arranged outside the recycling system 4.
  • the sensors are directly arranged in the recycling system 4.
  • a connection may be made to the recycling system 4 or to a closed circuit line 2 to deport the sensors at most. close to the analyzers, and if necessary to integrate them into the housings of these analyzers, it being understood that the measurement principle and the exploitation of these data are not modified according to whether the data to be analyzed are collected outside the analyzer. device or in situ.
  • the recycling system 4 comprises, in the zone of adjustment of the composition of the gas mixture Z3, as many gas admission port (s) 301, 302 that the medical device for administering a gas mixture 1 comprises of supply lines 101, 102.
  • the recycling system 4 is the element of the medical device 1 for administering a gaseous mixture inside which the gases intended to be delivered to the user are admitted.
  • the recycling system 4 is also equipped according to the invention with at least one fan 7 placed in the zone for adjusting the composition of the gas mixture Z3, the role of which is to promote homogenization between the gases admitted to the the interior of the recycling system 4 via the inlet ports 301, 302 and the gaseous mixture exhaled by the patient, previously treated and filtered in zones Z1 and Z2 described above.
  • the fan 7 is also intended to promote a circulation of the gas mixture in a direction of circulation 8 of the gas mixture inside the closed circuit 2, thus reducing the inspiratory effort of the patient.
  • the medical device 1 for administering a gas mixture according to the invention applies to medical devices for delivering a therapeutic gas mixture to non-anesthetized patients breathing spontaneously. It is therefore advantageous to provide help with inspiration, especially for the weakest patients.
  • the ventilator 7 can operate at variable speeds to adapt to the patient's need for assistance.
  • the speed of the fan 7 can be either set manually by the practitioner or is advantageously automatically adjusted by the machine with one or more sensor (s) measuring the rhythm and / or inspiratory effort of the patient placed (s) for example on or in a false lung, on or in the administration member 3 of the gas mixture or in the recycling system 4 of the gas mixture.
  • the recycling system 4 of the gaseous mixture comprises successively three zones, among which the treatment zone Z1 inside which is disposed the compound capable of capturing the carbon dioxide 5, the filtration zone Z2 which accommodates the particle retention member 6, and the intake zone Zs which is provided with the sensors 9a, 9b, 10a, 10b, 11, 12, the intake orifices 301, 302, and the fan 7. More precisely in the illustrated example, these three zones ⁇ , Z2, and Z3 follow each other in the direction of circulation 8, from the entrance of the recycling system 4 to its exit.
  • the medical device 1 for administering a gaseous mixture according to the invention also comprises a cooling member 13 for the gaseous mixture.
  • Such a cooling member 13 is able to promote a transfer of calories from the gas mixture to a coolant, such as air, cold water, or the like.
  • a coolant such as air, cold water, or the like.
  • the gaseous mixture to be delivered can be cooled before inspiration by the patient, thus allowing, if necessary, maintaining the patient in a normothermic state or, if necessary, inducing a Controlled hypothermia of the patient in order, for example, to optimize the neuroprotective effects of certain inert gases.
  • the cooling member 13 of the gaseous mixture can be placed between the recycling system 4 and the administration member 3 of the gas mixture.
  • the cooling member 13 is integrated in the recycling system 4 which in this case has a heat exchange zone Z 4 , for example consisting of a chamber made of a material having conductive thermal properties exposed to a flow. cold.
  • the four zones Zi, Z2, Z3, and Z follow each other in this order of the input of the recycling system 4 at its exit in the direction of circulation 8. It may in particular be provided to dispose the organ 13 in the recycling system directly after the fan 7.
  • the recycling system 4 which is the subject of a first aspect of the invention, and especially as just described in a preferred embodiment, is advantageous in that it can be arranged in a medical application context on a closed circuit breathing apparatus, with gas recirculation, for administering a therapeutic gas mixture to a patient breathing spontaneously.
  • the recycling system 4 takes the form of a housing in which is housed at least one carbon dioxide capture compound to treat the mixture of gas exhaled by the patient in the closed circuit 2, and at least one adjustment zone of the composition of the gas mixture Z3 in which the concentration of each gas composing the gaseous mixture is adjusted to a set value, and in which there can be provided in particular a fan 7 whose function is to facilitate the homogenization of the newly injected gases in the housing with the gas exhaled by the patient and decrease the inspiratory work of the patient.
  • each of these components and if necessary, a particle filter, gas analysis sensors and a heat exchanger, facilitates the integration of each of these components on the closed circuit 2 for administering the gas mixture to the patient.
  • the closed circuit 2 for administering the gas mixture to the patient also comprises, in addition to the recycling system 4 of the gas mixture, at least one flexible and deformable enclosure, also called false lung, 14a, 14b. More particularly, the closed circuit 2 comprises a first false-lung 14a to facilitate the expiration of the patient and a second false lung 14b to facilitate the inspiration of the patient.
  • the first false-lung 14a is placed between the administration member 3 and the inlet of the recycling system 4 and the second false-lung is 14b is placed between the outlet of the recycling system 4 and the organ 3, in the direction of circulation 8.
  • the deformability of the false lungs 14a and 14b facilitates the circulation of the gas mixture by minimizing the inspiratory and expiratory work of the breathing patient through the administration member 3.
  • the second false -Poumon 14b can be equipped with an overpressure valve 15 which is provided to prevent its deterioration in case of overpressure during the injection of the gases in the recycling system 4.
  • the closed circuit 2 for administering the gas mixture comprises two nonreturn valves 16a, 16b.
  • a first nonreturn valve 16a is disposed between the delivery member 3 and the first false lung 14a, advantageously at the outlet of the delivery member 3, and a second non-return valve 16b is disposed between the second counter-lung 14b and the administration member 3, advantageously at the entrance of the administration member 3.
  • a third valve, not shown here, may be envisaged to be disposed between the first false-lung 14a and the recycling system 4, advantageously at the inlet of the recycling system 4.
  • the nonreturn valves 16a, 16b are intended to impose a circulation of the gaseous mixture in the direction of circulation 8.
  • the mixture of gas exhaled by the patient crosses the first nonreturn valve 16a which is housed inside a first exhalation pipe portion 17a, preferably closer to the body of the 3.
  • the gas mixture then continues to flow in the first exhalation pipe section 17a before entering the interior of the false lung 14a and then into a second exhalation pipe section 17b, before entering inside the recycling system 4, and more particularly inside the treatment zone Zi where the carbon dioxide present in the gas mixture exhaled by the patient is retained by the compound 5 so as to be regulated in below the toxicity thresholds.
  • the patient's exhaled gas mixture is also charged with water vapor, which tends to react with the soda lime by an exothermic reaction, so that the exhaled air tends to heat up inside the treatment zone.
  • the expired gas mixture then enters the filtration zone Z2 of the recycling system 4 inside which any Compound 5 particles are retained. Then the expired mixture enters the intake zone Zs of the recycling system 4 inside which it can be enriched with gas from the supply lines 101, 102 (ie oxygen and one or more inert gases combined or not with oxygen) so as to maintain the concentration of each gas constituting the gas mixture at predetermined set values.
  • gas from the supply lines 101, 102 ie oxygen and one or more inert gases combined or not with oxygen
  • the gas mixture can at this stage be homogenized by the implementation of the fan 7.
  • the gas mixture is cooled, if necessary, by a heat exchange zone Z 4 at a temperature suitable for treating the patient, in particular by swaying the heating of the gas mixture induced by the localized compound 5 in the treatment zone Z1 of the recycling system 4.
  • the gas mixture can be analyzed by means of gas sensors in order to regulate in particular the content of carbon dioxide and oxygen of the gaseous mixture to be administered to the patient, being understood that it may be interesting to place these sensors away from the gas inlet ports to obtain a better analysis of the composition of the mixture to be administered to the patient.
  • the gas mixture to be delivered to the patient penetrates inside a first inspecting pipe portion 18a which connects the recycling system 4 to the false lung 14b. Then the gaseous mixture passes through the false lung 14b and finally circulates inside a second part of the inspiration pipe 18b which connects the false lung 14b to the administration member 3.
  • the second part of the 18b inspiration pipe is provided with a non-return valve 16b, advantageously placed at the inlet of the administration member 3.
  • the gas mixture is then delivered to the user via the organ d administration 3 during an inspiration of the patient.
  • the gas mixture can be analyzed via sensors arranged outside the recycling system 4. Micro-turbines or micro-pumps will then be provided to suck and direct a part of the gas to the sensors via tubing of suitable diameter.
  • the first supply line 101 comprises a line 101a which connects an oxygen tank 201 to a first intake port 301 of the recycling system 4.
  • the tank 201 is equipped with a manual valve 401 which makes it possible to authorize or to prohibit the circulation of the oxygen of the reservoir 201 inside the feed line 101.
  • the reservoir 201 is also equipped with a pressure reducer 501 which makes it possible to lower the oxygen pressure from a high pressure inside the reservoir 201 to a low pressure inside the pipe 101 a.
  • the pipe 101a is equipped with a mass flowmeter coupled to a proportional valve 601, which will be called later by its acronym DMVP, whose function is to inject into the recycling system 4 of the oxygen reservoir 201 so as to maintain the oxygen concentration of the mixture to be delivered to the patient to a value equal to the set value defined for oxygen.
  • DMVP proportional valve 601
  • EVS simple solenoid valve
  • the first supply line 101 also includes a branch 101b, equipped with a manual valve 701, actuated in case of emergency by the practitioner, for example in case of malfunction of the DMVP and / or EVS mentioned above.
  • the second feed line 102 has an architecture similar to the architecture of the first feed line 101, it being noted, however, that no bypass equipped with a manual valve is provided on the feed line 102. Otherwise said second feed line 102 includes a conduit 102a which connects a reservoir 202 containing a gas mixture of oxygen and one or more inert gases to a second inlet 302 of the recycle system 4.
  • the tank 202 is equipped with a manual valve 402 which allows to allow or prohibit the flow of gas from the tank 202 inside the supply line 101.
  • the tank 202 is also equipped with a regulator 502 which allows lowering the gas pressure of a high pressure inside the tank 202 to a low pressure inside the pipe 102a.
  • the pipe 102a is equipped with a DMVP 602 whose function is to inject into the recycling system 4 the gas mixture of the tank 202 so as to maintain the concentration of the inert gas (s) composing the gas mixture. deliver to the patient at a value equal to their predefined setpoint value (s).
  • a DMVP is no limiting and that could be provided instead, or in addition to a bypass line also ending in the recycling system 4, to use other types of valves such as EVS.
  • the medical device 1 for administering a gas mixture could comprise a plurality of supply lines, each in connection with a gas tank, and opening into the recycling system 4.
  • the closed circuit 2 for administering a gaseous mixture to a patient is equipped with a vacuum pump 21 making it possible to purge said circuit of any gas by vacuum before use. More precisely, the closed circuit 2 is emptied with the vacuum pump 21, and the initial filling of the closed circuit 2 is carried out with the gas mixture to be administered to the patient via the control of the DMVPs and / or the EVSs. During this filling of the closed circuit 2 in gaseous mixture, the pressure relief valve 15, which can advantageously be placed on the recycling system 4 or the false lung 14b, makes it possible to avoid an overpressure inside the closed circuit of administration 2.
  • the medical device 1 for administering a gaseous mixture also comprises an electronic control unit 22 which is in connection with the oxygen sensors 9a, 9b and the inert gas sensors 1 1, 12.
  • the control unit 22 thus essentially manages the oxygen consumption of the gas mixture by the patient, but also possible inert gas leaks that may occur, and thus ensure the distribution of a suitable gas mixture to the patient.
  • appropriate gaseous mixture is meant a gaseous mixture in which the concentrations of the gases that make up the gaseous mixture are equal to, or close to, within acceptable limits set by the practitioner, to the predefined setpoint values for the mixture to be administered to the patient.
  • the electronic control unit 22 comprises, for example, memory means of a mapping of correspondence between the partial pressure and the concentration of each of the gases constituting the gas mixture. Based on all the information collected by the various sensors, the electronic control unit 22 is able to control the implementation of the DMVP 601 and 602, and / or the EVS, in order to deliver to the patient during the entire period of time. duration of treatment a suitable gas mixture, according to the prescription of a doctor.
  • the electronic control unit 22 is also in connection with a pressure sensor 23a for measuring the pressure inside the tank 201 and with a second pressure sensor 23b for measuring the pressure inside the tank 202.
  • the electronic control unit 22 comprises, for example memory means of a mapping of correspondence between the pressure in the tanks 201, 202 and the volumes of gas available in each of these tanks.
  • the electronic control unit 22 may, for example, emit an alarm when the amount of free gas available in a tank is less than a predetermined set point value, when the concentration of carbon dioxide is too high compared to a predetermined set point value. when the oxygen concentration is either too low or too high by a predetermined setpoint, or when the inert gas concentration (s) is also too low or too high relative to a predetermined set point value (s). Two types of alarms can be set up, in order to graduate the urgency of the alarm, too high a carbon dioxide content or too low oxygen content can be reported with more force than an inadequate content inert gases.
  • the electronic control unit 22 is for example also in connection with a temperature sensor 24 of the gas administered to the patient.
  • the electronic control unit 22 can then make it possible, in the case of a treatment combining administration of a gaseous mixture for therapeutic purposes and hypothermia, to regulate the temperature of the gaseous mixture so that the patient's temperature corresponds to a certain temperature. degree of hypothermia sought.
  • the electronic control unit 22 is preferably connected to a screen 25, such as a touch screen, to display the information delivered by the electronic control unit 22 and to control the implementation of the elements of the medical device 1. administration of a gas mixture.

Abstract

The invention relates to a medical device (1) for the closed-circuit administration of a gaseous mixture to be delivered to a spontaneously breathing patient, comprising a gas recycling system (4) disposed on a closed administration circuit (2). The recycling system (4) can comprise in particular an input for an exhaled gaseous mixture and an output for the gaseous mixture to be supplied to the patient, the orientation of which defines a direction of circulation (8) from the input to the output, as well as a zone (Z1) for treating the exhaled gaseous mixture housing a compound (5) capable of retaining carbon dioxide, as well as at least one zone (Z3) for adjusting the composition of the gaseous mixture, in which zone the concentration of each gas forming the gaseous mixture is adjusted to a setpoint value.

Description

DISPOSITIF MÉDICAL D'ADMINISTRATION EN CIRCUIT FERMÉ D'UN MÉLANGE GAZEUX À UN PATIENT RESPIRANT SPONTANÉMENT ET SYSTEME DE REGLAGE MEDICAL DEVICE FOR CLOSED CIRCUIT DELIVERY OF A GAS MIXTURE TO A SPONTANEOUS BREATHING PATIENT AND SETTING SYSTEM
ASSOCIE Le domaine de la présente invention est celui des dispositifs médicaux d'administration en circuit fermé d'un mélange gazeux à visée thérapeutique à un patient respirant spontanément. The field of the present invention is that of medical devices for the closed-loop administration of a gaseous mixture for therapeutic purposes to a patient breathing spontaneously.
L'administration d'un mélange gazeux à un patient au moyen d'un appareil de respiration fonctionnant en circuit fermé nécessite de pouvoir recycler le mélange gazeux, c'est-à-dire d'une part de pouvoir épurer le mélange gazeux et d'autre part de pouvoir ajuster de façon précise la composition du mélange gazeux inspiré par le patient à des valeurs de consigne définies pour chaque gaz composant le mélange gazeux. L'administration d'un mélange gazeux à un patient au moyen d'un appareil de respiration fonctionnant en circuit fermé peut se faire soit de façon assistée lorsque le patient est anesthésié, soit de façon non assistée, dite à la demande, lorsque le patient n'est pas anesthésié et respire spontanément. Dans ce dernier cas, l'administration du mélange gazeux au patient suit le rythme respiratoire du patient. Le mélange gazeux est distribué au patient lorsque celui-ci inspire, puis, après avoir été expiré par le patient, est recyclé, c'est-à-dire épuré et ajusté à la composition désirée, avant d'être à nouveau inspiré par le patient. La présente invention s'inscrit dans le contexte de l'administration en circuit fermé de mélanges gazeux à visée thérapeutique composés d'oxygène et d'un ou plusieurs gaz inertes à un patient non anesthésié respirant spontanément, en visant à protéger l'utilisation médicale de ce type d'appareils à recyclage de gaz. Le dispositif médical selon l'invention permet d'administrer de façon contrôlée et en sécurité un mélange gazeux composé d'oxygène et de gaz inerte(s) à un patient respirant spontanément. L'invention concerne, selon un premier aspect, un système de recyclage du mélange gazeux configuré pour être disposé sur un circuit fermé d'administration dudit mélange gazeux. Elle concerne, selon un second aspect de l'invention, un circuit fermé d'administration d'un mélange gazeux à un patient qui comprend le système de recyclage du mélange gazeux et un organe d'administration du mélange gazeux au patient, et selon un troisième aspect de l'invention un dispositif médical d'administration d'un mélange gazeux à délivrer à un patient respirant spontanément comprenant le circuit fermé d'administration. The administration of a gaseous mixture to a patient by means of a breathing apparatus operating in a closed circuit requires the possibility of recycling the gaseous mixture, that is to say, on the one hand, to be able to purify the gas mixture and to secondly to be able to accurately adjust the composition of the gas mixture inspired by the patient to defined set values for each gas component of the gas mixture. The administration of a gas mixture to a patient by means of a breathing apparatus operating in a closed circuit can be done either aided when the patient is anesthetized, or unassisted, said on demand, when the patient is not anesthetized and breathes spontaneously. In the latter case, the administration of the gas mixture to the patient follows the respiratory rhythm of the patient. The gaseous mixture is dispensed to the patient when the patient inhales, then, after being exhaled by the patient, is recycled, i.e., purified and adjusted to the desired composition, before being again inspired by the patient. patient. The present invention is in the context of the closed-loop administration of therapeutic gas mixtures composed of oxygen and one or more inert gases to a non-anesthetized patient breathing spontaneously, with the aim of protecting medical use. of this type of gas recycling equipment. The medical device according to the invention makes it possible to administer in a controlled and safe manner a gaseous mixture composed of oxygen and inert gas (s) to a patient breathing spontaneously. According to a first aspect, the invention relates to a system for recycling the gaseous mixture configured to be disposed on a closed circuit for administering said gaseous mixture. According to a second aspect of the invention, it relates to a closed circuit for administering a gaseous mixture to a patient which comprises the system for recycling the gaseous mixture and a member for administering the gaseous mixture to the patient, and according to a third aspect of the invention a medical device for administering a gas mixture to be delivered to a spontaneously breathing patient comprising the closed administration circuit.
Le système de recyclage d'un mélange gazeux décrit dans la présente invention est un dispositif destiné à équiper un circuit fermé d'administration d'un mélange gazeux à un patient. Il dispose d'une entrée par laquelle le mélange gazeux expiré par le patient pénètre dans le dispositif et d'une sortie par laquelle le mélange gazeux recyclé, c'est-à-dire épuré et ajusté à la composition désirée, est fourni au patient, définissant ainsi un sens de circulation du mélange gazeux de l'entrée vers la sortie du système de recyclage. Ce système de recyclage comprend au moins une zone de traitement du mélange gazeux expiré logeant un composé apte à retenir le dioxyde de carbone. The system for recycling a gaseous mixture described in the present invention is a device intended to equip a closed circuit for administering a gaseous mixture to a patient. It has an inlet through which the gas mixture exhaled by the patient enters the device and an outlet through which the gaseous mixture recycled, that is to say purified and adjusted to the desired composition, is supplied to the patient , thus defining a flow direction of the gaseous mixture from the inlet to the outlet of the recycling system. This recycling system comprises at least one treatment zone of the exhaled gas mixture containing a compound capable of retaining carbon dioxide.
Selon le premier aspect de la présente invention, le système de recyclage d'un mélange gazeux comprend une zone d'ajustement de la composition du mélange gazeux dans laquelle la concentration de chaque gaz composant le mélange gazeux expiré par le patient est ajustée à une valeur de consigne. According to the first aspect of the present invention, the gaseous mixture recycle system comprises an adjustment zone of the gaseous mixture composition wherein the concentration of each gas comprising the gaseous mixture exhaled by the patient is adjusted to a value. deposit.
Cette zone d'ajustement de la composition du mélange gazeux peut notamment comprendre au moins un ventilateur, qui peut être à vitesse réglable, dont la double fonction est d'une part d'optimiser l'homogénéisation du mélange gazeux avant qu'il ne soit distribué au patient et, d'autre part, de soulager le travail inspiratoire du patient ; le ventilateur peut par exemple être piloté en fonction du rythme inspiratoire du patient, notamment en étant déclenché à chaque séance d'inspiration détectée, et/ou être piloté en fonction de l'effort inspiratoire du patient, notamment en augmentant la vitesse de rotation du ventilateur. This zone for adjusting the composition of the gaseous mixture may in particular comprise at least one fan, which may be at adjustable speed, the dual function of which is on the one hand to optimize the homogenization of the gaseous mixture before it is distributed to the patient and, on the other hand, to relieve the inspiratory work of the patient; the fan may for example be controlled according to the inspiratory rhythm of the patient, in particular by being triggered at each inspirational session detected, and / or be controlled according to the inspiratory effort of the patient, in particular by increasing the speed of rotation of the patient. fan.
Cette zone d'ajustement de la composition du mélange gazeux peut en outre comprendre des orifices d'admission permettant d'injecter dans le système de recyclage les différents gaz constituant le mélange gazeux afin d'ajuster la composition du mélange gazeux expiré par le patient aux valeurs de consigne définies pour chaque gaz constituant le mélange gazeux. This zone for adjusting the composition of the gaseous mixture may further comprise intake orifices making it possible to inject into the recycling system the different gases constituting the gaseous mixture in order to adjust the composition of the gaseous mixture exhaled by the patient to defined setpoints for each gas constituting the gas mixture.
L'injection des différents gaz constituant le mélange gazeux peut être pilotée en fonction des valeurs de concentration de chaque gaz constituant le mélange gazeux. Ces valeurs peuvent être déterminées par des mesures faites par des capteurs de gaz disposés soit in situ dans le circuit fermé d'administration, avantageusement dans le système de recyclage des gaz, reliés à des systèmes d'analyse de gaz, soit ex situ à l'extérieur du circuit fermé d'administration, auquel cas les capteurs sont alimentés en gaz au moyen de micropompes ou microturbines et d'une tubulure de diamètre adapté reliant le circuit fermé d'administration, ou avantageusement le système de recyclage des gaz, aux capteurs de gaz. Le choix de la position d'implantation des capteurs pourra notamment dépendre du type de gaz à détecter et du type de capteur qui en résulte. The injection of the various gases constituting the gaseous mixture can be controlled according to the concentration values of each gas constituting the gaseous mixture. These values can be determined by measurements made by gas sensors arranged either in situ in the closed circuit of administration, advantageously in the control system. gas recirculation, connected to gas analysis systems, either ex situ outside the closed administration circuit, in which case the sensors are supplied with gas by means of micropumps or microturbines and a tubing of suitable diameter connecting the closed circuit of administration, or preferably the gas recycling system, to the gas sensors. The choice of the location of the sensors may in particular depend on the type of gas to be detected and the type of sensor that results.
Selon la présente invention, le système de recyclage des gaz peut comprendre une zone de filtration, logeant un organe de rétention de particules, configuré pour retenir notamment les particules émanant du composé apte à fixer le dioxyde de carbone tel que, par exemple, la chaux sodée. Cette zone de filtration peut notamment être située à l'intérieur du système de recyclage après la zone de traitement du mélange gazeux et avant la zone d'ajustement du mélange gazeux évoquée ci-dessus. En variante, on peut prévoir que la zone de filtration soit déportée à l'extérieur du système de recyclage et notamment à la sortie de celui-ci, ou directement avant l'organe d'administration du mélange gazeux au patient. According to the present invention, the gas recycling system may comprise a filtration zone, housing a particle retention member, configured to retain in particular particles emanating from the compound capable of fixing carbon dioxide such as, for example, lime soda. This filtration zone may in particular be located inside the recycling system after the gaseous mixture treatment zone and before the gaseous mixture adjustment zone mentioned above. Alternatively, it can be provided that the filtration zone is offset outside the recycling system and in particular at the outlet thereof, or directly before the administration member of the gas mixture to the patient.
Selon le premier aspect de la présente invention, le système de recyclage du mélange gazeux peut comprendre aussi une zone d'échange thermique, notamment pour le refroidissement du mélange gazeux, logeant par exemple un échangeur thermique. According to the first aspect of the present invention, the system for recycling the gaseous mixture may also comprise a heat exchange zone, in particular for cooling the gaseous mixture, housing for example a heat exchanger.
En d'autres termes, le système de recyclage d'un mélange gazeux selon le premier aspect de la présente invention présente avantageusement une zone de traitement du mélange gazeux logeant un composé apte à retenir le dioxyde de carbone, une zone d'ajustement de la composition du mélange de gaz, qui peut comprendre des orifices d'admission des gaz dans le système de recyclage et, éventuellement, au moins un ventilateur à vitesse réglable. Le système de recyclage d'un mélange gazeux comprend en outre au moins l'une des caractéristiques suivantes, prises seules ou en combinaison : In other words, the system for recycling a gaseous mixture according to the first aspect of the present invention advantageously has a gaseous mixture treatment zone housing a compound capable of retaining carbon dioxide, an adjustment zone of the composition of the gas mixture, which may include gas inlet ports in the recycling system and, optionally, at least one adjustable speed fan. The system for recycling a gaseous mixture also comprises at least one of the following characteristics, taken alone or in combination:
- un système d'échange thermique, notamment pour le refroidissement du mélange gazeux, logeant par exemple un échangeur thermique ;  a heat exchange system, in particular for cooling the gaseous mixture, housing, for example, a heat exchanger;
- une zone de filtration du mélange gazeux logeant un organe de rétention de particules ;  a filtration zone of the gaseous mixture housing a particle retention member;
- des capteurs d'analyse de gaz choisis pour permettre d'analyser les différents gaz composant le mélange de gaz. II peut notamment être prévu que : - la zone de traitement du mélange gazeux est située en amont de la zone de filtration par rapport au sens de circulation du mélange gazeux ; gas analysis sensors chosen to enable the various gases comprising the gas mixture to be analyzed. In particular, it may be provided that: the treatment zone of the gaseous mixture is situated upstream of the filtration zone with respect to the direction of circulation of the gaseous mixture;
- la zone de traitement du mélange gazeux est située en amont de la zone d'ajustement par rapport au sens de circulation du mélange gazeux ;  - The gas mixture treatment zone is located upstream of the adjustment zone with respect to the flow direction of the gaseous mixture;
- la zone de filtration du mélange gazeux est située en amont ou en aval de la zone d'ajustement par rapport au sens de circulation du mélange gazeux.  the filtration zone of the gaseous mixture is situated upstream or downstream of the adjustment zone with respect to the direction of circulation of the gaseous mixture.
La présente invention a aussi pour objet un circuit fermé d'administration d'un mélange gazeux à un patient, qui comprend le système de recyclage d'un mélange gazeux précédemment décrit, une ou deux enceintes souples et déformables, généralement appelées faux-poumons, destinées à faciliter le travail inspiratoire et/ou expiratoire du patient, et un organe d'administration du mélange gazeux au patient. The present invention also relates to a closed circuit for administering a gaseous mixture to a patient, which comprises the gaseous mixture recycling system previously described, one or two flexible and deformable enclosures, generally called false-lungs, intended to facilitate the inspiratory and / or expiratory work of the patient, and an organ for administering the gas mixture to the patient.
Le circuit fermé d'administration d'un mélange gazeux à un patient présente avantageusement au moins l'une des caractéristiques suivantes, prises seules ou en combinaison : The closed circuit for administering a gas mixture to a patient advantageously has at least one of the following characteristics, taken alone or in combination:
- le circuit fermé comprend au moins un faux-poumon disposé en amont ou en aval du système de recyclage par rapport au sens de circulation du mélange gazeux à l'intérieur du circuit fermé ; ou le circuit fermé comprend avantageusement deux faux-poumons disposés pour l'un en amont et pour l'autre en aval du système de recyclage par rapport au sens de circulation du mélange gazeux à l'intérieur du circuit fermé ; si un faux-poumon est placée en aval du système de recyclage, celui-ci peut être équipée d'une soupape de surpression ;  the closed circuit comprises at least one false-lung arranged upstream or downstream of the recycling system with respect to the direction of circulation of the gas mixture inside the closed circuit; or the closed circuit advantageously comprises two false-lungs arranged for one upstream and the other downstream of the recycling system with respect to the direction of flow of the gas mixture inside the closed circuit; if a false lung is placed downstream of the recycling system, it may be equipped with a pressure relief valve;
- le circuit fermé comprend un organe d'administration du mélange gazeux à un patient ; cet organe d'administration est par exemple un masque bucco-nasal, un masque facial, ou une cagoule enveloppant la tête du patient ;  the closed circuit comprises a member for administering the gas mixture to a patient; this administration member is for example a bucco-nasal mask, a face mask, or a hood wrapped around the patient's head;
- le circuit fermé est équipé d'une pompe à vide, préférentiellement placée au plus près de la sortie de l'organe d'administration du mélange gazeux ;  the closed circuit is equipped with a vacuum pump, preferably placed as close as possible to the outlet of the administration member of the gas mixture;
- le circuit fermé loge au moins deux, de préférence trois, clapets anti-retour. La présente invention selon un aspect particulier a notamment pour objet un dispositif médical d'administration d'un mélange gazeux à délivrer à un patient respirant spontanément. Ce dispositif médical peut notamment comprendre au moins l'une des caractéristiques suivantes, à savoir :  the closed circuit houses at least two, preferably three, nonreturn valves. The present invention according to a particular aspect particularly relates to a medical device for administering a gas mixture to be delivered to a patient breathing spontaneously. This medical device may in particular comprise at least one of the following characteristics, namely:
- au moins deux réservoirs de gaz, un premier réservoir contenant de l'oxygène pur, et un deuxième réservoir contenant un ou plusieurs gaz inertes à visée thérapeutique en combinaison ou pas avec de l'oxygène ; at least two gas reservoirs, a first reservoir containing pure oxygen, and a second reservoir containing one or more inert gases for the therapeutic purpose of combination or not with oxygen;
- au moins deux lignes d'alimentation, incluant chacune un débitmètre massique couplé à une électrovanne proportionnelle (DMVP) et/ou une électrovanne simple (EVS), reliant les réservoirs de gaz aux orifices d'admission des gaz dans le système de recyclage du mélange gazeux ;  - at least two supply lines, each including a mass flow meter coupled to a proportional solenoid valve (DMVP) and / or a single solenoid valve (EVS), connecting the gas tanks to the gas inlet ports in the recycling system of the gaseous mixture;
- l'une des lignes d'alimentation peut être configurée pour alimenter le circuit fermé d'administration en un gaz inerte à visée thérapeutique, ou un mélange de gaz inertes à visée thérapeutique, ce ou ces gaz inertes étant seuls ou combiné à de l'oxygène ;  one of the supply lines may be configured to supply the closed administration circuit with an inert gas for therapeutic purposes, or a mixture of inert gases for therapeutic purposes, this inert gas or these being alone or in combination with oxygen;
- une unité de contrôle électronique en relation avec différents capteurs, tels que les capteurs d'analyse de gaz permettant de mesurer en continu la pression partielle de dioxyde de carbone et de chacun des gaz constituant le mélange gazeux, des capteurs permettant de mesurer en continu la pression des réservoirs de gaz, et un capteur permettant de mesurer la température du gaz administré au patient ; avantageusement, l'unité de contrôle électronique peut être configurée, par exemple, pour injecter automatiquement un ou plusieurs gaz dans le système de recyclage au moyen de débitmètres massiques - vannes proportionnelles et/ou d'électrovannes afin d'ajuster la composition du mélange gazeux expiré par le patient aux valeurs de consigne désirées, et/ou pour calculer le volume de gaz détendu disponible dans les réservoirs de gaz, et/ou pour régler la température du mélange gazeux à une valeur permettant de maintenir la température centrale du patient à une valeur prédéterminée par un praticien qualifié, et/ou pour régler la vitesse du ventilateur à l'aide d'une information relative au rythme et/ou à l'effort inspiratoire du patient telle que mesurée automatiquement ou évaluée par un praticien qualifié ; avantageusement, l'unité de contrôle électronique dispose d'alarmes hautes et/ou basses permettant de gérer de façon sécuritaire les pressions partielles de dioxyde de carbone, d'oxygène et des autres gaz constituant le mélange gazeux, le volume de gaz détendu disponible dans les réservoirs de gaz, la température du gaz administré au patient, et la vitesse du ventilateur.  an electronic control unit in connection with various sensors, such as gas analysis sensors making it possible to continuously measure the partial pressure of carbon dioxide and of each of the gases constituting the gaseous mixture, sensors making it possible to measure continuously the pressure of the gas tanks, and a sensor for measuring the temperature of the gas administered to the patient; advantageously, the electronic control unit can be configured, for example, to automatically inject one or more gases into the recycling system by means of mass flowmeters - proportional valves and / or solenoid valves in order to adjust the composition of the gas mixture expired by the patient to the desired setpoints, and / or to calculate the volume of expanded gas available in the gas tanks, and / or to adjust the temperature of the gas mixture to a value to maintain the central temperature of the patient at a desired temperature. a predetermined value by a qualified practitioner, and / or to adjust the speed of the ventilator using information relating to the rhythm and / or inspiratory effort of the patient as automatically measured or evaluated by a qualified practitioner; advantageously, the electronic control unit has high alarms and / or low to safely manage the partial pressures of carbon dioxide, oxygen and other gases constituting the gas mixture, the volume of gas expanded available in the gas tanks, the temperature of the gas administered to the patient, and the speed of the ventilator.
D'autres caractéristiques, détails et avantages de l'invention ressortiront plus clairement à la lecture de la description donnée ci-après à titre d'exemple représentatif en relation avec la figure unique du présent document. Other features, details and advantages of the invention will emerge more clearly on reading the description given below as a representative example in relation to the single figure of this document.
La figure du présent document montre un schéma de principe d'un dispositif médical d'administration en circuit fermé d'un mélange gazeux à un patient respirant spontanément décrit dans la présente invention. Un tel dispositif médical 1 d'administration en circuit fermé d'un mélange gazeux à un patient respirant spontanément est adapté pour être utilisé en milieu hospitalier, dans un cabinet médical, ou dans un lieu analogue. Le dispositif médical 1 d'administration d'un mélange gazeux est mis en œuvre par un praticien qualifié en vue d'administrer à un patient respirant spontanément un mélange gazeux composé d'oxygène et de gaz inertes à visée thérapeutique. The figure in this document shows a block diagram of a medical device for the closed-loop administration of a gas mixture to a breathing patient spontaneously described in the present invention. Such a medical device 1 of closed circuit administration of a gaseous mixture to a patient breathing spontaneously is adapted to be used in hospital, in a medical office, or in a similar place. The medical device 1 for administering a gaseous mixture is used by a qualified practitioner to administer to a spontaneously breathing patient a gaseous mixture composed of oxygen and inert gases for therapeutic purposes.
Le dispositif médical 1 d'administration d'un mélange gazeux, à recyclage du gaz expiré, comprend un circuit fermé 2 d'administration d'un mélange gazeux, avec notamment un organe d'administration 3 du mélange gazeux au patient, et un système de recyclage 4 du mélange gazeux expiré par le patient. The medical device 1 for administering a gaseous mixture, with recycling of the exhaled gas, comprises a closed circuit 2 for administering a gaseous mixture, in particular with a member 3 for delivering the gaseous mixture to the patient, and a system recycling 4 of the gaseous mixture exhaled by the patient.
Le dispositif médical 1 d'administration d'un mélange gazeux est en outre équipé de deux lignes d'alimentation 101 et 102, respectivement en relation avec les réservoirs de gaz 201 et 202. La première ligne d'alimentation 101 permet l'injection dans le système de recyclage 4 d'oxygène en provenant du réservoir 201 et la deuxième ligne d'alimentation 102 permet l'injection dans le système de recyclage 4 d'un ou plusieurs gaz inertes, tels que par exemple l'argon, le xénon et l'hélium, combiné ou non à de l'oxygène, ce mélange de gaz inertes et/ou d'oxygène provenant du réservoir 202. On donnera ci-après des détails sur les lignes d'alimentation. Le circuit fermé 2 du mélange gazeux comprend un organe d'administration 3 du mélange gazeux, qui est par exemple un masque bucco-nasal, un masque facial, ou une cagoule enveloppant la tête du patient. L'organe d'administration 3 recouvre au moins la bouche et le nez du patient. Le circuit fermé 2 du mélange gazeux comprend un système de recyclage 4 du mélange gazeux, traversé par le mélange gazeux depuis son entrée jusqu'à sa sortie. The medical device 1 for administering a gaseous mixture is furthermore equipped with two feed lines 101 and 102, respectively in relation to the gas reservoirs 201 and 202. The first feed line 101 allows injection into the oxygen recycling system 4 from the tank 201 and the second feed line 102 allows the injection into the recycling system 4 of one or more inert gases, such as for example argon, xenon and helium, combined or not with oxygen, this mixture of inert gases and / or oxygen from the tank 202. Details of the feed lines will be given hereinafter. The closed circuit 2 of the gaseous mixture comprises a delivery member 3 of the gaseous mixture, which is for example an oral-nasal mask, a face mask, or a hood wrapped around the patient's head. The administration member 3 covers at least the patient's mouth and nose. The closed circuit 2 of the gaseous mixture comprises a recycling system 4 of the gaseous mixture, through which the gaseous mixture passes from its inlet to its outlet.
Le système de recyclage 4 du mélange gazeux loge un composé 5 apte à capter le dioxyde de carbone, tel que par exemple la chaux sodée ou un produit analogue. On dispose de la sorte dans le système de recyclage 4 d'une zone de traitement Zi , agencée entre l'entrée du système de recyclage 4 et la sortie de celui-ci, à l'intérieur de laquelle est disposé le composé 5 apte à capter le dioxyde de carbone. The recycling system 4 of the gaseous mixture houses a compound 5 capable of capturing carbon dioxide, such as, for example, sodium lime or a similar product. This is arranged in the recycling system 4 of a treatment zone Z 1, arranged between the inlet of the recycling system 4 and the outlet thereof, inside which is disposed the compound 5 capable of capture the carbon dioxide.
Le système de recyclage 4 peut également loger un organe de rétention de particules 6, configuré pour retenir au moins les particules provenant du composé 5 apte à fixer le dioxyde de carbone, tel que par exemple de la chaux sodée. Plus précisément, la chaux sodée se présente sous forme de granules qui peuvent avoir tendance à s'effriter au contact de l'air expiré par l'utilisateur. On dispose donc de la sorte dans le système de recyclage 4 d'une zone de filtration 2.2, qui est par exemple constituée d'au moins un filtre au travers duquel le mélange gazeux est à même de circuler. Ainsi, on évite au patient de respirer des particules provenant du composé 5. The recycling system 4 can also house a particle retention member 6 configured to retain at least the particles from the compound 5 capable of fixing the carbon dioxide, such as for example soda lime. More specifically, soda lime is in the form of granules which may tend to crumble on contact with the exhaled air by the user. Thus, in the recycling system 4, a filtration zone 2.2 is provided, which consists, for example, of at least one filter through which the gas mixture is able to circulate. Thus, the patient is prevented from breathing particles from compound 5.
Le système de recyclage 4 est équipé, dans une zone d'ajustement de la composition du mélange gazeux Z3, d'au moins un capteur d'oxygène permettant de mesurer la pression partielle d'oxygène et d'au moins un capteur de dioxyde de carbone permettant de mesurer la pression partielle de dioxyde de carbone, placés à l'intérieur ou à l'extérieur du système de recyclage 4 (auquel cas une tubulure relie les capteurs au dit système de recyclage). De préférence, par mesure de sécurité, le système de recyclage 4 est équipé d'au moins deux, avantageusement trois, capteurs d'oxygène 9a, 9b et d'au moins deux, avantageusement trois, capteurs de dioxyde de carbone 10a, 10b. Accessoirement, le système de recyclage 4 peut être équipé de capteur(s) 1 1 , 12 permettant de mesurer la pression partielle des gaz inertes constituant le mélange gazeux. Les capteurs ci-dessus sont couplés à des analyseurs de gaz, pouvant être par exemple selon la nature du gaz à analyser, des analyseurs paramagnétiques ou des catharomètres, disposés à l'extérieur du système de recyclage 4. The recycling system 4 is equipped, in an adjustment zone of the composition of the gas mixture Z3, with at least one oxygen sensor for measuring the oxygen partial pressure and at least one oxygen dioxide sensor. carbon for measuring the partial pressure of carbon dioxide, placed inside or outside the recycling system 4 (in which case a tubing connects the sensors to said recycling system). Preferably, for safety reasons, the recycling system 4 is equipped with at least two, advantageously three, oxygen sensors 9a, 9b and at least two, advantageously three, carbon dioxide sensors 10a, 10b. Incidentally, the recycling system 4 may be equipped with sensor (s) 1 1, 12 for measuring the partial pressure of the inert gas constituting the gas mixture. The above sensors are coupled to gas analyzers, which can be for example according to the nature of the gas to be analyzed, paramagnetic analyzers or catharometers, arranged outside the recycling system 4.
Dans l'exemple illustré, les capteurs sont directement disposés dans le système de recyclage 4. Dans une variante ici non illustrée, un raccordement pourra être réalisé sur le système de recyclage 4 ou sur une conduite du circuit fermé 2 pour déporter les capteurs au plus près des analyseurs, et le cas échéant pour les intégrer aux boîtiers de ces analyseurs, étant entendu que le principe de mesure et l'exploitation de ces données ne sont pas modifiés selon que l'on capte les données à analyser à l'extérieur du dispositif ou bien in situ. In the example shown, the sensors are directly arranged in the recycling system 4. In a variant not shown here, a connection may be made to the recycling system 4 or to a closed circuit line 2 to deport the sensors at most. close to the analyzers, and if necessary to integrate them into the housings of these analyzers, it being understood that the measurement principle and the exploitation of these data are not modified according to whether the data to be analyzed are collected outside the analyzer. device or in situ.
Le système de recyclage 4 comprend, dans la zone d'ajustement de la composition du mélange gazeux Z3, autant d'orifice(s) d'admission de gaz 301 , 302 que le dispositif médical d'administration d'un mélange gazeux 1 comprend de lignes d'alimentation 101 , 102. Autrement dit, le système de recyclage 4 est l'élément du dispositif médical 1 d'administration d'un mélange gazeux à l'intérieur duquel sont admis les gaz destinés à être délivrés à l'utilisateur. Le système de recyclage 4 est également équipé selon l'invention d'au moins un ventilateur 7, placé dans la zone d'ajustement de la composition du mélange gazeux Z3, dont le rôle est de favoriser l'homogénéisation entre les gaz admis à l'intérieur du système de recyclage 4 par l'intermédiaire des orifices d'admission 301 , 302 et le mélange gazeux expiré par le patient, traité et filtré préalablement dans les zones Z1 et Z2 décrites ci-dessus. The recycling system 4 comprises, in the zone of adjustment of the composition of the gas mixture Z3, as many gas admission port (s) 301, 302 that the medical device for administering a gas mixture 1 comprises of supply lines 101, 102. In other words, the recycling system 4 is the element of the medical device 1 for administering a gaseous mixture inside which the gases intended to be delivered to the user are admitted. . The recycling system 4 is also equipped according to the invention with at least one fan 7 placed in the zone for adjusting the composition of the gas mixture Z3, the role of which is to promote homogenization between the gases admitted to the the interior of the recycling system 4 via the inlet ports 301, 302 and the gaseous mixture exhaled by the patient, previously treated and filtered in zones Z1 and Z2 described above.
Le ventilateur 7 est également destiné à favoriser une circulation du mélange gazeux selon un sens de circulation 8 du mélange gazeux à l'intérieur du circuit fermé 2, permettant ainsi de diminuer l'effort inspiratoire du patient. En effet, on comprend que le dispositif médical 1 d'administration d'un mélange gazeux selon l'invention s'applique à des dispositifs médicaux permettant de délivrer un mélange de gaz à visée thérapeutique à des patients non anesthésiés respirant spontanément. Il est donc avantageux de prévoir une aide à l'inspiration, notamment pour les patients les plus faibles. Par ailleurs, le ventilateur 7 peut fonctionner à des vitesses variables pour s'adapter au besoin d'assistance du patient. La vitesse du ventilateur 7 peut être soit réglée manuellement par le praticien ou soit avantageusement réglée automatiquement par la machine grâce à un ou plusieurs capteur(s) mesurant le rythme et/ou l'effort inspiratoire du patient placé(s) par exemple sur ou dans un faux poumon, sur ou dans l'organe d'administration 3 du mélange gazeux ou dans le système de recyclage 4 du mélange gazeux. The fan 7 is also intended to promote a circulation of the gas mixture in a direction of circulation 8 of the gas mixture inside the closed circuit 2, thus reducing the inspiratory effort of the patient. Indeed, it is understood that the medical device 1 for administering a gas mixture according to the invention applies to medical devices for delivering a therapeutic gas mixture to non-anesthetized patients breathing spontaneously. It is therefore advantageous to provide help with inspiration, especially for the weakest patients. Moreover, the ventilator 7 can operate at variable speeds to adapt to the patient's need for assistance. The speed of the fan 7 can be either set manually by the practitioner or is advantageously automatically adjusted by the machine with one or more sensor (s) measuring the rhythm and / or inspiratory effort of the patient placed (s) for example on or in a false lung, on or in the administration member 3 of the gas mixture or in the recycling system 4 of the gas mixture.
Dans l'exemple illustré, le système de recyclage 4 du mélange gazeux comprend successivement trois zones, parmi lesquelles la zone de traitement Z1 à l'intérieur de laquelle est disposé le composé apte à capter le dioxyde de carbone 5, la zone de filtration Z2 qui loge l'organe de rétention de particules 6, et la zone d'admission Zs qui est pourvue des capteurs 9a, 9b, 10a, 10b, 1 1 , 12, des orifices d'admission 301 , 302, et du ventilateur 7. Plus précisément dans l'exemple illustré, ces trois zones Ζι, Z2, et Z3 se succèdent selon le sens de circulation 8, de l'entrée du système de recyclage 4 à sa sortie. Le dispositif médical 1 d'administration d'un mélange gazeux selon l'invention comprend également un organe de refroidissement 13 du mélange gazeux. Un tel organe de refroidissement 13 est apte à favoriser un transfert de calories depuis le mélange gazeux vers un fluide caloporteur, tel que de l'airfroid, de l'eau froide, ou analogue. Ainsi, le mélange gazeux à délivrer peut être refroidi avant inspiration par le patient, permettant ainsi si nécessaire de maintenir le patient dans un état normothermique ou au besoin d'induire une hypothermie contrôlée du patient dans le but, par exemple, d'optimiser les effets neuroprotecteurs de certains gaz inertes. In the example illustrated, the recycling system 4 of the gaseous mixture comprises successively three zones, among which the treatment zone Z1 inside which is disposed the compound capable of capturing the carbon dioxide 5, the filtration zone Z2 which accommodates the particle retention member 6, and the intake zone Zs which is provided with the sensors 9a, 9b, 10a, 10b, 11, 12, the intake orifices 301, 302, and the fan 7. More precisely in the illustrated example, these three zones Ζι, Z2, and Z3 follow each other in the direction of circulation 8, from the entrance of the recycling system 4 to its exit. The medical device 1 for administering a gaseous mixture according to the invention also comprises a cooling member 13 for the gaseous mixture. Such a cooling member 13 is able to promote a transfer of calories from the gas mixture to a coolant, such as air, cold water, or the like. Thus, the gaseous mixture to be delivered can be cooled before inspiration by the patient, thus allowing, if necessary, maintaining the patient in a normothermic state or, if necessary, inducing a Controlled hypothermia of the patient in order, for example, to optimize the neuroprotective effects of certain inert gases.
L'organe de refroidissement 13 du mélange gazeux peut être placé entre le système de recyclage 4 et l'organe d'administration 3 du mélange gazeux. Avantageusement, l'organe de refroidissement 13 est intégré dans le système de recyclage 4 qui présente dans ce cas une zone d'échange thermique Z4, par exemple constituée d'une chambre réalisée dans un matériau présentant des propriétés thermiques conductrices exposée à un flux froid. Dans l'exemple illustré, les quatre zones Zi, Z2, Z3, et Z se succèdent dans cet ordre de l'entrée du système de recyclage 4 à sa sortie dans le sens de circulation 8. On peut notamment prévoir de disposer l'organe de refroidissement 13 dans le système de recyclage directement à la suite du ventilateur 7. The cooling member 13 of the gaseous mixture can be placed between the recycling system 4 and the administration member 3 of the gas mixture. Advantageously, the cooling member 13 is integrated in the recycling system 4 which in this case has a heat exchange zone Z 4 , for example consisting of a chamber made of a material having conductive thermal properties exposed to a flow. cold. In the illustrated example, the four zones Zi, Z2, Z3, and Z follow each other in this order of the input of the recycling system 4 at its exit in the direction of circulation 8. It may in particular be provided to dispose the organ 13 in the recycling system directly after the fan 7.
Le système de recyclage 4, qui fait l'objet d'un premier aspect de l'invention, et notamment tel qu'il vient d'être décrit dans un exemple de réalisation préféré, est avantageux en ce qu'il peut être disposé dans un contexte d'application médicale sur un appareil de respiration à circuit fermé, à recyclage de gaz, destiné à administrer un mélange de gaz à visée thérapeutique à un patient respirant spontanément. Le système de recyclage 4 prend la forme d'un boîtier dans lequel est logé au moins un composé de captation du dioxyde de carbone pour traiter le mélange de gaz expiré par le patient dans le circuit fermé 2, et au moins une zone d'ajustement de la composition du mélange gazeux Z3 dans laquelle la concentration de chaque gaz composant le mélange gazeux est ajustée à une valeur de consigne, et dans laquelle on peut notamment prévoir un ventilateur 7 dont la fonction est de faciliter l'homogénéisation des gaz nouvellement injectés dans le boîtier avec le gaz expiré par le patient et de diminuer le travail inspiratoire du patient. The recycling system 4, which is the subject of a first aspect of the invention, and especially as just described in a preferred embodiment, is advantageous in that it can be arranged in a medical application context on a closed circuit breathing apparatus, with gas recirculation, for administering a therapeutic gas mixture to a patient breathing spontaneously. The recycling system 4 takes the form of a housing in which is housed at least one carbon dioxide capture compound to treat the mixture of gas exhaled by the patient in the closed circuit 2, and at least one adjustment zone of the composition of the gas mixture Z3 in which the concentration of each gas composing the gaseous mixture is adjusted to a set value, and in which there can be provided in particular a fan 7 whose function is to facilitate the homogenization of the newly injected gases in the housing with the gas exhaled by the patient and decrease the inspiratory work of the patient.
La présence dans un boîtier commun de chacun de ces composants, et le cas échéant, d'un filtre à particules, de capteurs d'analyse de gaz et d'un échangeur thermique, permet de faciliter l'intégration de chacun de ces composants sur le circuit fermé 2 d'administration du mélange gazeux au patient. The presence in a common housing of each of these components, and if necessary, a particle filter, gas analysis sensors and a heat exchanger, facilitates the integration of each of these components on the closed circuit 2 for administering the gas mixture to the patient.
Le circuit fermé 2 d'administration du mélange gazeux au patient comprend par ailleurs, outre le système de recyclage 4 du mélange gazeux, au moins une enceinte souple et déformable, également appelée faux-poumon, 14a, 14b. Plus particulièrement, le circuit fermé 2 comprend un premier faux-poumon 14a pour faciliter l'expiration du patient et un deuxième faux-poumon 14b pour faciliter l'inspiration du patient. De préférence, le premier faux-poumon 14a est placé entre l'organe d'administration 3 et l'entrée du système de recyclage 4 et le deuxième faux-poumon est 14b est placé entre la sortie du système de recyclage 4 et l'organe d'administration 3, dans le sens de circulation 8. La déformabilité des faux-poumons 14a et 14b facilite la circulation du mélange gazeux en minimisant le travail inspiratoire et expiratoire du patient respirant à travers l'organe d'administration 3. Le deuxième faux-poumon 14b peut être équipé d'une soupape surpression 15 qui est prévue pour éviter sa détérioration en cas de surpression lors de l'injection des gaz dans le système de recyclage 4. The closed circuit 2 for administering the gas mixture to the patient also comprises, in addition to the recycling system 4 of the gas mixture, at least one flexible and deformable enclosure, also called false lung, 14a, 14b. More particularly, the closed circuit 2 comprises a first false-lung 14a to facilitate the expiration of the patient and a second false lung 14b to facilitate the inspiration of the patient. Preferably, the first false-lung 14a is placed between the administration member 3 and the inlet of the recycling system 4 and the second false-lung is 14b is placed between the outlet of the recycling system 4 and the organ 3, in the direction of circulation 8. The deformability of the false lungs 14a and 14b facilitates the circulation of the gas mixture by minimizing the inspiratory and expiratory work of the breathing patient through the administration member 3. The second false -Poumon 14b can be equipped with an overpressure valve 15 which is provided to prevent its deterioration in case of overpressure during the injection of the gases in the recycling system 4.
Enfin le circuit fermé 2 d'administration du mélange gazeux comprend deux clapets anti-retour 16a, 16b. Un premier clapet anti-retour 16a est disposé entre l'organe d'administration 3 et le premier faux-poumon 14a, avantageusement à la sortie de l'organe d'administration 3, et un deuxième clapet anti-retour 16b est disposé entre le deuxième faux- poumon 14b et l'organe d'administration 3, avantageusement à l'entrée de l'organe d'administration 3. On pourra envisager un troisième clapet, ici non représenté, à disposer entre le premier faux-poumon 14a et le système de recyclage 4, avantageusement à l'entrée du système de recyclage 4. Les clapets anti-retour 16a, 16b, sont destinés à imposer une circulation du mélange gazeux selon le sens de circulation 8. Finally, the closed circuit 2 for administering the gas mixture comprises two nonreturn valves 16a, 16b. A first nonreturn valve 16a is disposed between the delivery member 3 and the first false lung 14a, advantageously at the outlet of the delivery member 3, and a second non-return valve 16b is disposed between the second counter-lung 14b and the administration member 3, advantageously at the entrance of the administration member 3. A third valve, not shown here, may be envisaged to be disposed between the first false-lung 14a and the recycling system 4, advantageously at the inlet of the recycling system 4. The nonreturn valves 16a, 16b are intended to impose a circulation of the gaseous mixture in the direction of circulation 8.
Il résulte de ces dispositions que le mélange de gaz expiré par le patient franchit le premier clapet anti-retour 16a qui est logé à l'intérieur d'une première partie de conduite d'expiration 17a, avantageusement au plus près de l'organe d'administration 3. Le mélange de gaz continue alors de circuler dans la première partie de conduite d'expiration 17a avant de pénétrer à l'intérieur du faux-poumon 14a puis dans une deuxième partie de conduite d'expiration 17b, avant de pénétrer à l'intérieur du système de recyclage 4, et plus particulièrement à l'intérieur de la zone de traitement Zi où le dioxyde de carbone présent dans le mélange de gaz expiré par le patient est retenu par le composé 5 de façon à être régulé en-deçà des seuils de toxicité. Le mélange de gaz expiré par le patient est également chargé en vapeur d'eau, laquelle tend à réagir avec la chaux sodée par une réaction exothermique, si bien que l'air expiré tend à se réchauffer à l'intérieur de la zone de traitement It follows from these provisions that the mixture of gas exhaled by the patient crosses the first nonreturn valve 16a which is housed inside a first exhalation pipe portion 17a, preferably closer to the body of the 3. The gas mixture then continues to flow in the first exhalation pipe section 17a before entering the interior of the false lung 14a and then into a second exhalation pipe section 17b, before entering inside the recycling system 4, and more particularly inside the treatment zone Zi where the carbon dioxide present in the gas mixture exhaled by the patient is retained by the compound 5 so as to be regulated in below the toxicity thresholds. The patient's exhaled gas mixture is also charged with water vapor, which tends to react with the soda lime by an exothermic reaction, so that the exhaled air tends to heat up inside the treatment zone.
Dans l'exemple illustré, le mélange de gaz expiré pénètre ensuite à l'intérieur de la zone de filtration Z2 du système de recyclage 4 à l'intérieur de laquelle d'éventuelles particules du composé 5 sont retenues. Puis le mélange expiré pénètre à l'intérieur de la zone d'admission Zs du système de recyclage 4 à l'intérieur de laquelle il peut être enrichi de gaz provenant des lignes d'alimentation 101 , 102 (à savoir de l'oxygène et un ou plusieurs gaz inertes combiné ou non à de l'oxygène) de façon à maintenir la concentration de chaque gaz constituant le mélange gazeux à des valeurs de consigne prédéterminées. Le mélange de gaz peut à ce stade être homogénéisé grâce à la mise en œuvre du ventilateur 7. In the example illustrated, the expired gas mixture then enters the filtration zone Z2 of the recycling system 4 inside which any Compound 5 particles are retained. Then the expired mixture enters the intake zone Zs of the recycling system 4 inside which it can be enriched with gas from the supply lines 101, 102 (ie oxygen and one or more inert gases combined or not with oxygen) so as to maintain the concentration of each gas constituting the gas mixture at predetermined set values. The gas mixture can at this stage be homogenized by the implementation of the fan 7.
Enfin, avant de sortir du système de recyclage 4, le mélange gazeux est refroidi au besoin par une zone d'échange thermique Z4 à une température appropriée au traitement du patient, notamment en balançant le réchauffement du mélange gazeux induit par le composé 5 localisé dans la zone de traitement Z1 du système de recyclage 4. Finally, before leaving the recycling system 4, the gas mixture is cooled, if necessary, by a heat exchange zone Z 4 at a temperature suitable for treating the patient, in particular by swaying the heating of the gas mixture induced by the localized compound 5 in the treatment zone Z1 of the recycling system 4.
Au cours de son déplacement à l'intérieur du système de recyclage 4, le mélange de gaz peut être analysé au moyen de capteurs de gaz afin de réguler notamment la teneur en dioxyde de carbone et en oxygène du mélange gazeux à administrer au patient, étant entendu qu'il peut être intéressant de placer ces capteurs à distance des orifices d'admission de gaz pour obtenir une meilleure analyse de la composition du mélange à administrer au patient. En sortie du système de recyclage 4, le mélange gazeux à délivrer au patient pénètre à l'intérieur d'une première partie de conduite d'inspiration 18a qui relie le système de recyclage 4 au faux-poumon 14b. Puis le mélange gazeux traverse le faux-poumon 14b et circule enfin à l'intérieur d'une deuxième partie de la conduite d'inspiration 18b qui relie le faux-poumon 14b à l'organe d'administration 3. La deuxième partie de la conduite d'inspiration 18b est pourvue d'un clapet anti-retour 16b, avantageusement placé à l'entrée de l'organe d'administration 3. Le mélange gazeux est alors délivré à l'utilisateur par l'intermédiaire de l'organe d'administration 3 lors d'une inspiration du patient. During its movement inside the recycling system 4, the gas mixture can be analyzed by means of gas sensors in order to regulate in particular the content of carbon dioxide and oxygen of the gaseous mixture to be administered to the patient, being understood that it may be interesting to place these sensors away from the gas inlet ports to obtain a better analysis of the composition of the mixture to be administered to the patient. At the outlet of the recycling system 4, the gas mixture to be delivered to the patient penetrates inside a first inspecting pipe portion 18a which connects the recycling system 4 to the false lung 14b. Then the gaseous mixture passes through the false lung 14b and finally circulates inside a second part of the inspiration pipe 18b which connects the false lung 14b to the administration member 3. The second part of the 18b inspiration pipe is provided with a non-return valve 16b, advantageously placed at the inlet of the administration member 3. The gas mixture is then delivered to the user via the organ d administration 3 during an inspiration of the patient.
Tel que cela a pu être décrit précédemment, le mélange de gaz peut être analysé par l'intermédiaire de capteurs agencés à l'extérieur du système de recyclage 4. On prévoira alors des micro-turbines ou des micro-pompes pour aspirer et diriger une partie du gaz vers les capteurs via des tubulures de diamètre adapté. As has been previously described, the gas mixture can be analyzed via sensors arranged outside the recycling system 4. Micro-turbines or micro-pumps will then be provided to suck and direct a part of the gas to the sensors via tubing of suitable diameter.
On va maintenant décrire les lignes d'alimentation en mélange gazeux du dispositif médical 1 d'administration d'un mélange gazeux, en se référant à l'exemple illustré, non limitatif de l'invention. The gas mixture supply lines of the medical device 1 for administering a gaseous mixture will now be described, with reference to the illustrated example, no limiting of the invention.
La première ligne d'alimentation 101 comprend une conduite 101 a qui relie un réservoir 201 d'oxygène à un premier orifice d'admission 301 du système de recyclage 4. Le réservoir 201 est équipé d'une vanne manuelle 401 qui permet d'autoriser ou d'interdire la circulation de l'oxygène du réservoir 201 à l'intérieur de la ligne d'alimentation 101 . Le réservoir 201 est aussi équipé d'un détendeur 501 qui permet d'abaisser la pression d'oxygène d'une haute pression à l'intérieur du réservoir 201 à une basse pression à l'intérieur de la conduite 101 a. En outre, la conduite 101 a est équipée d'un débitmètre massique couplé à une vanne proportionnelle 601 , que l'on appellera par la suite sous son acronyme DMVP, dont la fonction est d'injecter dans le système de recyclage 4 de l'oxygène du réservoir 201 de façon à maintenir la concentration d'oxygène du mélange à délivrer au patient à une valeur égale à la valeur de consigne définie pour l'oxygène. On comprend que le choix d'un DMVP est non limitatif et qu'on pourrait prévoir à la place, ou en complément sur une ligne de dérivation aboutissant également dans le système de recyclage 4, d'utiliser d'autres types de vannes telles qu'une électrovanne simple, que l'on appellera par la suite EVS. The first supply line 101 comprises a line 101a which connects an oxygen tank 201 to a first intake port 301 of the recycling system 4. The tank 201 is equipped with a manual valve 401 which makes it possible to authorize or to prohibit the circulation of the oxygen of the reservoir 201 inside the feed line 101. The reservoir 201 is also equipped with a pressure reducer 501 which makes it possible to lower the oxygen pressure from a high pressure inside the reservoir 201 to a low pressure inside the pipe 101 a. In addition, the pipe 101a is equipped with a mass flowmeter coupled to a proportional valve 601, which will be called later by its acronym DMVP, whose function is to inject into the recycling system 4 of the oxygen reservoir 201 so as to maintain the oxygen concentration of the mixture to be delivered to the patient to a value equal to the set value defined for oxygen. It will be understood that the choice of a DMVP is nonlimiting and that instead of or in addition to a bypass line terminating also in the recycling system 4, it would be possible to use other types of valves such as a simple solenoid valve, which will be called EVS afterwards.
La première ligne d'alimentation 101 comprend aussi une dérivation 101 b, équipée d'une vanne manuelle 701 , actionnable en cas d'urgence par le praticien, par exemple en cas de dysfonctionnement du DMVP et/ou de l'EVS susmentionnés. The first supply line 101 also includes a branch 101b, equipped with a manual valve 701, actuated in case of emergency by the practitioner, for example in case of malfunction of the DMVP and / or EVS mentioned above.
La deuxième ligne d'alimentation 102 présente une architecture similaire à l'architecture de la première ligne d'alimentation 101 , étant noté cependant qu'aucune dérivation équipée d'une vanne manuelle n'est prévue sur la ligne d'alimentation 102. Autrement dit, la deuxième ligne d'alimentation 102 comprend une conduite 102a qui relie un réservoir 202 contenant un mélange de gaz constitué d'oxygène et d'un ou plusieurs gaz inertes à un deuxième orifice d'admission 302 du système de recyclage 4. Le réservoir 202 est équipé d'une vanne manuelle 402 qui permet d'autoriser ou d'interdire la circulation du gaz du réservoir 202 à l'intérieur de la ligne d'alimentation 101. Le réservoir 202 est aussi équipé d'un détendeur 502 qui permet d'abaisser la pression de gaz d'une haute pression à l'intérieur du réservoir 202 à une basse pression à l'intérieur de la conduite 102a. En outre, la conduite 102a est équipée d'un DMVP 602 dont la fonction est d'injecter dans le système de recyclage 4 le mélange de gaz du réservoir 202 de façon à maintenir la concentration du ou des gaz inertes composant le mélange de gaz à délivrer au patient à une valeur égale à la(leur) valeur(s) de consigne prédéfinie(s). On comprend que le choix d'un DMVP est non limitatif et qu'on pourrait prévoir à la place, ou en complément sur une ligne de dérivation aboutissant également dans le système de recyclage 4, d'utiliser d'autres types de vannes telles qu'une EVS. On comprend de ce qui précède que le dispositif médical 1 d'administration d'un mélange gazeux pourrait comprendre une pluralité de lignes d'alimentation, chacune en relation avec un réservoir de gaz, et débouchant dans le système de recyclage 4. The second feed line 102 has an architecture similar to the architecture of the first feed line 101, it being noted, however, that no bypass equipped with a manual valve is provided on the feed line 102. Otherwise said second feed line 102 includes a conduit 102a which connects a reservoir 202 containing a gas mixture of oxygen and one or more inert gases to a second inlet 302 of the recycle system 4. The tank 202 is equipped with a manual valve 402 which allows to allow or prohibit the flow of gas from the tank 202 inside the supply line 101. The tank 202 is also equipped with a regulator 502 which allows lowering the gas pressure of a high pressure inside the tank 202 to a low pressure inside the pipe 102a. In addition, the pipe 102a is equipped with a DMVP 602 whose function is to inject into the recycling system 4 the gas mixture of the tank 202 so as to maintain the concentration of the inert gas (s) composing the gas mixture. deliver to the patient at a value equal to their predefined setpoint value (s). We understand that the choice of a DMVP is no limiting and that could be provided instead, or in addition to a bypass line also ending in the recycling system 4, to use other types of valves such as EVS. It will be understood from the foregoing that the medical device 1 for administering a gas mixture could comprise a plurality of supply lines, each in connection with a gas tank, and opening into the recycling system 4.
Selon une variante de réalisation, le circuit fermé 2 d'administration d'un mélange gazeux à un patient est équipé d'une pompe à vide 21 permettant de purger par le vide ledit circuit de tout gaz avant utilisation. Plus précisément, on vide le circuit fermé 2 avec la pompe à vide 21 , puis on effectue le remplissage initial du circuit fermé 2 avec le mélange de gaz à administrer au patient via le pilotage des DMVP et/ou des EVS. Lors de ce remplissage du circuit fermé 2 en mélange gazeux, la soupape de surpression 15, qui peut être placé avantageusement sur le système de recyclage 4 ou le faux-poumon 14b, permet d'éviter une surpression à l'intérieur du circuit fermé d'administration 2. According to an alternative embodiment, the closed circuit 2 for administering a gaseous mixture to a patient is equipped with a vacuum pump 21 making it possible to purge said circuit of any gas by vacuum before use. More precisely, the closed circuit 2 is emptied with the vacuum pump 21, and the initial filling of the closed circuit 2 is carried out with the gas mixture to be administered to the patient via the control of the DMVPs and / or the EVSs. During this filling of the closed circuit 2 in gaseous mixture, the pressure relief valve 15, which can advantageously be placed on the recycling system 4 or the false lung 14b, makes it possible to avoid an overpressure inside the closed circuit of administration 2.
Le dispositif médical 1 d'administration d'un mélange gazeux comprend également une unité de contrôle électronique 22 qui est en relation avec les capteurs d'oxygène 9a, 9b, et les capteurs de gaz inertes 1 1 , 12. L'unité de contrôle 22 permet ainsi essentiellement de gérer la consommation de l'oxygène du mélange gazeux par le patient, mais aussi les éventuelles fuites de gaz inertes qui pourraient survenir, et d'assurer ainsi la distribution d'un mélange gazeux approprié au patient. Par mélange gazeux « approprié », on entend un mélange gazeux dont les concentrations des gaz qui composent le mélange gazeux sont égales, ou proches dans des limites acceptables fixées par le praticien, aux valeurs de consigne prédéfinies pour le mélange à administrer au patient. Pour cela, l'unité de contrôle électronique 22 comprend par exemple des moyens de mémoire d'une cartographie de correspondance entre la pression partielle et la concentration de chacun des gaz constitutifs du mélange gazeux. À partir de l'ensemble des informations récoltées par les différents capteurs, l'unité de contrôle électronique 22 est à même de commander la mise en œuvre des DMVP 601 et 602, et/ou des EVS, afin de délivrer au patient pendant toute la durée du traitement un mélange gazeux approprié, conforme à la prescription d'un médecin. The medical device 1 for administering a gaseous mixture also comprises an electronic control unit 22 which is in connection with the oxygen sensors 9a, 9b and the inert gas sensors 1 1, 12. The control unit 22 thus essentially manages the oxygen consumption of the gas mixture by the patient, but also possible inert gas leaks that may occur, and thus ensure the distribution of a suitable gas mixture to the patient. By "appropriate" gaseous mixture is meant a gaseous mixture in which the concentrations of the gases that make up the gaseous mixture are equal to, or close to, within acceptable limits set by the practitioner, to the predefined setpoint values for the mixture to be administered to the patient. For this purpose, the electronic control unit 22 comprises, for example, memory means of a mapping of correspondence between the partial pressure and the concentration of each of the gases constituting the gas mixture. Based on all the information collected by the various sensors, the electronic control unit 22 is able to control the implementation of the DMVP 601 and 602, and / or the EVS, in order to deliver to the patient during the entire period of time. duration of treatment a suitable gas mixture, according to the prescription of a doctor.
L'unité de contrôle électronique 22 est également en relation avec un capteur de pression 23a permettant de mesurer la pression à l'intérieur du réservoir 201 et avec un deuxième capteur de pression 23b permettant de mesurer la pression à l'intérieur du réservoir 202. L'unité de contrôle électronique 22 comprend par exemple des moyens de mémoire d'une cartographie de correspondance entre la pression dans les réservoirs 201 , 202 et les volumes de gaz détendus disponibles dans chacun de ces réservoirs. The electronic control unit 22 is also in connection with a pressure sensor 23a for measuring the pressure inside the tank 201 and with a second pressure sensor 23b for measuring the pressure inside the tank 202. The electronic control unit 22 comprises, for example memory means of a mapping of correspondence between the pressure in the tanks 201, 202 and the volumes of gas available in each of these tanks.
L'unité de contrôle électronique 22 peut par exemple émettre une alarme lorsque la quantité de gaz détendue disponible dans un réservoir est inférieure à une valeur de consigne prédéterminée, lorsque la concentration de dioxyde de carbone est trop élevée par rapport à une valeur de consigne prédéterminée, lorsque la concentration d'oxygène est soit trop basse ou trop élevée par une valeur de consigne prédéterminée, ou lorsque la(les) concentration(s) de gaz inertes est(sont) également trop basse(s) ou trop élevée(s) par rapport à une(des) valeur(s) de consigne prédéterminée(s). Deux types d'alarme pourront être mis en place, afin de graduer l'urgence de l'alarme, une teneur trop forte en dioxyde de carbone ou une teneur trop faible en oxygène pouvant ainsi être signalée avec plus de force qu'une teneur inadéquate en gaz inertes. The electronic control unit 22 may, for example, emit an alarm when the amount of free gas available in a tank is less than a predetermined set point value, when the concentration of carbon dioxide is too high compared to a predetermined set point value. when the oxygen concentration is either too low or too high by a predetermined setpoint, or when the inert gas concentration (s) is also too low or too high relative to a predetermined set point value (s). Two types of alarms can be set up, in order to graduate the urgency of the alarm, too high a carbon dioxide content or too low oxygen content can be reported with more force than an inadequate content inert gases.
L'unité de contrôle électronique 22 est par exemple également en relation avec un capteur de température 24 du gaz administré au patient. L'unité de contrôle électronique 22 peut alors permettre, dans le cas d'un traitement combinant administration d'un mélange gazeux à visée thérapeutique et hypothermie, de régler la température du mélange gazeux de façon à ce que la température du patient corresponde à un degré d'hypothermie recherché. The electronic control unit 22 is for example also in connection with a temperature sensor 24 of the gas administered to the patient. The electronic control unit 22 can then make it possible, in the case of a treatment combining administration of a gaseous mixture for therapeutic purposes and hypothermia, to regulate the temperature of the gaseous mixture so that the patient's temperature corresponds to a certain temperature. degree of hypothermia sought.
L'unité de contrôle électronique 22 est de préférence reliée à un écran 25, tel qu'un écran tactile pour visualiser les informations délivrées par l'unité de contrôle électronique 22 et de commander la mise en œuvre des éléments du dispositif médical 1 d'administration d'un mélange gazeux. The electronic control unit 22 is preferably connected to a screen 25, such as a touch screen, to display the information delivered by the electronic control unit 22 and to control the implementation of the elements of the medical device 1. administration of a gas mixture.

Claims

REVENDICATIONS
1. Système de recyclage pour un dispositif médical d'administration d'un mélange gazeux (4), destiné à équiper un circuit fermé d'administration (2) d'un mélange gazeux à délivrer à un patient respirant spontanément, le système de recyclage (4) comprenant : 1. Recycling system for a medical device for administering a gaseous mixture (4) intended to equip a closed administration circuit (2) with a gas mixture to be delivered to a patient breathing spontaneously, the recycling system (4) comprising:
- une entrée d'un mélange gazeux expiré et une sortie pour le mélange gazeux à fournir dont l'orientation définit un sens de circulation (8) de l'entrée vers la sortie,  an inlet of an expired gaseous mixture and an outlet for the gaseous mixture to be supplied, the orientation of which defines a flow direction (8) from the inlet to the outlet,
- une zone de traitement (Zi) du mélange gazeux expiré logeant un composé (5) apte à retenir le dioxyde de carbone,  a treatment zone (Zi) of the exhaled gaseous mixture containing a compound (5) capable of retaining carbon dioxide,
caractérisé en ce qu'il comprend au moins une zone d'ajustement de la composition du mélange gazeux (Z3) dans laquelle la concentration de chaque gaz composant le mélange gazeux est ajustée à une valeur de consigne. characterized in that it comprises at least one adjustment zone of the composition of the gaseous mixture (Z3) in which the concentration of each gas composing the gaseous mixture is adjusted to a set value.
2. Système de recyclage (4) selon la revendication 1 , caractérisé en ce que la zone d'ajustement de la composition du mélange gazeux (Z3) comprend au moins un ventilateurRecycling system (4) according to claim 1, characterized in that the adjustment zone of the composition of the gas mixture (Z3) comprises at least one fan
(7). (7).
3. Système de recyclage (4) selon la revendication 2, caractérisé en ce que le au moins un ventilateur (7) est à vitesse variable. 3. Recycling system (4) according to claim 2, characterized in that the at least one fan (7) is variable speed.
4. Système de recyclage (4) selon la revendication 3, caractérisé en ce que le au moins un ventilateur (7) est piloté en fonction du rythme et/ou de l'effort inspiratoire du patient. 4. recycling system (4) according to claim 3, characterized in that the at least one fan (7) is controlled according to the rhythm and / or the inspiratory effort of the patient.
5. Système de recyclage (4) selon l'une des revendications précédentes, caractérisé en ce que la zone d'ajustement de la composition du mélange gazeux (Z3) comprend des orifices d'admission permettant d'injecter dans le système de recyclage (4) les différents gaz constituant le mélange gazeux afin d'ajuster la composition du mélange gazeux expiré par le patient aux valeurs de consigne définies pour chaque gaz constituant le mélange gazeux Recirculation system (4) according to one of the preceding claims, characterized in that the adjustment zone of the composition of the gas mixture (Z3) comprises inlet openings for injecting into the recycling system ( 4) the different gases constituting the gaseous mixture in order to adjust the composition of the gaseous mixture exhaled by the patient to the set values defined for each gas constituting the gaseous mixture
6. Système de recyclage (4) selon l'une des revendications précédentes, caractérisé en ce qu'il comprend une zone de filtration (Z2) logeant un organe de rétention (6) de particules du composé (5). 6. Recycling system (4) according to one of the preceding claims, characterized in that it comprises a filtration zone (Z2) housing a retention member (6) of particles of the compound (5).
7. Système de recyclage (4) selon l'une quelconque des revendications précédentes prise en combinaison de la revendication 4, dans lequel la zone de traitement (Z1) et la zone de filtration (Z2) sont situées en amont de zone d'ajustement de la composition du mélange gazeux (Z3) par rapport au sens de circulation (8). The recycling system (4) according to any one of the preceding claims taken in combination of claim 4, wherein the treatment zone (Z1) and the zone Filtration (Z2) are located upstream of the adjustment zone of the composition of the gas mixture (Z3) with respect to the direction of circulation (8).
8. Système de recyclage (4) selon la revendication précédente, caractérisé en ce qu'il comprend successivement, selon le sens de circulation (8), la zone de traitement (Z1), la zone de filtration (Z2), la zone d'ajustement de la composition du mélange gazeux (Z3) et une zone d'échange thermique (Z4). 8. recycling system (4) according to the preceding claim, characterized in that it comprises successively, in the direction of circulation (8), the treatment zone (Z1), the filtration zone (Z2), the zone d adjusting the composition of the gas mixture (Z3) and a heat exchange zone (Z 4 ).
9. Circuit fermé d'administration (2) d'un mélange gazeux à délivrer à un patient respirant spontanément, comprenant un système de recyclage (4) défini selon l'une quelconque des revendications précédentes. 9. Closed circuit of administration (2) of a gaseous mixture to be delivered to a spontaneously breathing patient, comprising a recycling system (4) defined according to any one of the preceding claims.
10. Circuit fermé d'administration (2) selon la revendication 9, dans lequel le circuit d'administration (2) comprend au moins une enceinte (14a, 14b) délimitée par une paroi souple et déformable. 10. closed administration circuit (2) according to claim 9, wherein the administration circuit (2) comprises at least one enclosure (14a, 14b) delimited by a flexible wall and deformable.
11. Circuit fermé d'administration (2) selon la revendication précédente, dans lequel la au moins une enceinte (14b) est disposée en aval du système de recyclage (4) selon le sens de circulation (8) du mélange gazeux à l'intérieur du circuit d'administration (2). 11. Closed circuit administration (2) according to the preceding claim, wherein the at least one enclosure (14b) is disposed downstream of the recycling system (4) in the direction of circulation (8) of the gas mixture to the inside the administration circuit (2).
12. Circuit fermé d'administration (2) selon la revendication 10, dans lequel le circuit d'administration (2) comprend deux enceintes (14a, 14b) disposées de part et d'autre du système de recyclage (4), une première enceinte (14a) étant disposée en amont du système de recyclage (4) selon un sens de circulation (8) du mélange gazeux à l'intérieur du circuit d'administration (2), et une deuxième enceinte (14b) étant disposée en aval du système de recyclage (4) selon le sens de circulation (8) du mélange gazeux à l'intérieur du circuit d'administration (2). 12. The closed management circuit (2) according to claim 10, wherein the administration circuit (2) comprises two enclosures (14a, 14b) disposed on either side of the recycling system (4), a first enclosure (14a) being disposed upstream of the recycling system (4) in a direction of circulation (8) of the gaseous mixture inside the administration circuit (2), and a second enclosure (14b) being arranged downstream of the recycling system (4) in the direction of circulation (8) of the gaseous mixture inside the administration circuit (2).
13. Circuit fermé d'administration (2) selon l'une des revendications 9 à 12, caractérisé en ce qu'il comprend une pompe à vide, préférentiellement placée au plus près de la sortie de l'organe d'administration du mélange gazeux. 13. Closed administration circuit (2) according to one of claims 9 to 12, characterized in that it comprises a vacuum pump, preferably placed closer to the outlet of the gaseous mixture delivery member. .
14. Dispositif médical d'administration (1 ) en circuit fermé d'un mélange gazeux à délivrer à un patient respirant spontanément, comprenant un système de recyclage de gaz disposé sur un circuit fermé d'administration. 14. A medical device for administering (1) in closed circuit a gaseous mixture to be delivered to a spontaneously breathing patient, comprising a gas recycling system disposed on a closed administration circuit.
15. Dispositif médical d'administration (1 ) d'un mélange gazeux à délivrer à un patient respirant spontanément, caractérisé en ce qu'il comprend un circuit fermé d'administration (2) selon l'une quelconque des revendications 9 à 13. 15. Medical device for administering (1) a gas mixture to be delivered to a patient breathing spontaneously, characterized in that it comprises a closed circuit of administration (2) according to any one of claims 9 to 13.
16. Dispositif médical d'administration (1 ) d'un mélange gazeux selon la revendication précédente, caractérisé en ce qu'il comporte au moins deux lignes d'alimentation (101 , 102) en gaz du système de recyclage (4). 16. Medical device for administering (1) a gaseous mixture according to the preceding claim, characterized in that it comprises at least two gas supply lines (101, 102) of the recycling system (4).
17. Dispositif médical d'administration (1 ) d'un mélange gazeux selon l'une quelconque des revendications 15 ou 16, caractérisé en ce que l'une des lignes d'alimentation est configurée pour alimenter le circuit fermé d'administration en un gaz inerte à visée thérapeutique, ou un mélange de gaz inertes à visée thérapeutique, ce ou ces gaz inertes étant seul(s) ou combiné(s) à de l'oxygène. 17. Medical device for administering (1) a gaseous mixture according to claim 15 or claim 16, characterized in that one of the supply lines is configured to supply the closed administration circuit with inert gas for therapeutic purposes, or a mixture of inert gases for therapeutic purposes, this or these inert gases being alone or combined with oxygen.
18. Dispositif médical d'administration (1 ) d'un mélange gazeux selon l'une quelconque des revendications 15 à 17, caractérisé en ce qu'il comprend une unité de contrôle électronique (23) configuré pour piloter une vitesse de fonctionnement du ventilateur (7) à l'aide d'une information relative à un rythme et/ou un effort inspiratoire du patient. 18. Medical device for administering (1) a gaseous mixture according to any one of claims 15 to 17, characterized in that it comprises an electronic control unit (23) configured to control a speed of operation of the fan. (7) using information relating to a rhythm and / or inspiratory effort of the patient.
EP16763926.9A 2016-08-25 2016-08-25 Medical device for the closed-circuit administration of a gaseous mixture to a spontaneously breathing patient, and associated adjustment system Withdrawn EP3503953A1 (en)

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