SK8750Y1 - Device for supplying the mixture of gases during cardiopulmonary resuscitation of a patient - Google Patents

Abstract

A portable apparatus (10) for administering a gaseous mixture in cardiopulmonary resuscitation of patients comprises at least one cylinder (12) containing a mixture of oxygen, argon and possibly other gases, a valve (13) associated with the cylinder (12), which acts as a first pressure reducer of the gas mixture which exits directly from the cylinder (12), a control unit (14) comprising a programmable logic controller (PLC), in which programs and algorithms that control the operation of the apparatus (10) are stored, and a second pressure reducer (16) and a control system (16), both controlled by the PLC, for the flow of gas mixture from the first pressure reducer, delivered by the cylinder (12).The apparatus (10) is capable to deliver to the patient the gas mixture at reduced pressure by means of a mask (17) which can be accommodated in a compartment of the apparatus and wherein the apparatus (10) is configured to operate in such a way that the gas mixture is administered to the patient in three operating modes: a simple mode, an intermediate mode and an advanced mode.

Description

Technical field

The present technical solution relates to a device for administering a gaseous mixture as a part and in coexistence with cardiopulmonary resuscitation. Thus, the present invention relates to the field of medical devices that can typically be used in cardiopulmonary resuscitation to prevent cardiac and cerebral damage caused by ischemia and / or blockage, or to reduce blood flow to the brain after cardiac arrest.

Prior art

Cardiopulmonary resuscitation, also abbreviated as CPR (cardiopulmonary resuscitation), is an emergency procedure that combines and combines chest compressions with artificial lung ventilation to maintain intact brain and heart functions by performing manual or mechanical operations until measures are taken to restore recovery. and normal blood circulation in a person with cerebral ischemia, usually after cardiac arrest.

More specifically, cardiopulmonary resuscitation or CPR is recommended for those who do not respond to respiratory arrest and subsequent ischemia and do not breathe at all or have abnormal respiration.

As part of an emergency procedure provided by cardiopulmonary resuscitation, devices, also referred to as CPR ventilators, or simply ventilators, known and widely used, are capable of delivering a gaseous mixture, typically containing oxygen, to the lungs of an ischemic patient to oxygenate and preserve brain function while stimulated in combination with manual or mechanical chest compressions, cardiopulmonary resuscitation in the shortest possible time.

More specifically, the oxygen-containing gaseous mixture is administered to the patient's lungs via a special breathing mask attached to the face of the device operator or by intubation into the trachea.

The oxygen-containing gas mixture must be administered to the patient as soon as possible in the event of ischemia after cardiac arrest and consequent blocked blood flow to the brain.

It is also appropriate that, in view of the unexpected and emergency situations in which they are normally used, the equipment can also be operated by personnel without specific training.

On the other hand, cardiopulmonary resuscitation devices or CPR ventilators must offer characteristics that also allow trained people and more specifically medical staff to intervene selectively and with different approaches, more specifically depending on the circumstances and the patient's injury.

It is also clear that the immediate availability of a CPR ventilator at the time of a clinical event is of fundamental importance, as is the crucial use of the correct composition to be administered to a patient.

Cardiac arrest is a dramatic clinical event that can occur suddenly and often without any signals.

This clinical event is characterized by a sudden loss of consciousness caused by a lack of blood flow to the brain, which occurs when the heart stops pumping blood to the brain.

As various sources suggest, cardiac arrest is one of the leading causes of death in the Western world, with 350,000 to 700,000 people suffering from cardiac arrest each year in the United States, Canada and Europe.

Argon was first used in the 1930s by deep sea divers.

It was later found that argon has a narcotic effect under hyperbaric conditions, and that it has mild anesthetic properties under normobaric conditions.

Due to these effects, argon is mostly used as an inert gas with screening function in many industrial applications and medical devices.

In addition, the neuroprotective and cardioprotective effects of argon have been described in a number of documents. More specifically, the medical literature reports tests that show that argon, along with other rare gases with low anesthetic properties, such as helium and neon, has a cardioprotective effect when used as a pre-therapeutic agent in rabbits subjected to left anterior descending coronary artery occlusion during 30 minutes.

It has also been confirmed that the advantage of a mixture of argon and oxygen or argon and oxygen and other gases is greater if the gas gas is administered to the patient as soon as possible.

Prior art documents, although describing the use and administration of argon as a preventive pretreatment in the protection of the heart muscle, do not clearly describe the use and administration of argon for therapeutic purposes or as a therapeutic hectic.

More specifically, to date, as the applicant has been able to note, there is no device available on the market for use in cardiopulmonary resuscitation or CPR that is specially designed and constructed to administer a mixture consisting of argon and oxygen or argon, oxygen and other gases to prevent and avoided heart and brain damage in a patient suffering from ischemia after cardiac arrest and who is

With the K 8750 Υ1 simplicity, portability, efficiency as required by emergency situations in which cardiopunmonary resuscitation equipment is normally to be used.

CPR fan, which is the subject of this application meets those needs and, moreover, has reduced dimensions and knowledgeable ⁷ portability, it is able to be conveniently incorporated into medical first-aid equipment, more specifically positioned close to the defibrillator.

In addition, for the sake of completeness of information, it is emphasized that in the field of biological and health properties and effects of argon, the applicant has already presented a European patent application (EP 16183930.3) describing a special gas mixture containing mainly oxygen and argon and optionally other gases to be administered to a patient as part of and in coexistence with cardiopulmonary resuscitation CPR to prevent brain and heart damage induced in the same patient by ischemia and / or blocked or reduced blood flow to his brain after cardiac arrest.

The main goal of the present technical solution is to design and manufacture a new useful and practical device for cardiopulmonary resuscitation, which corrects the above-mentioned shortcomings of the prior art and more specifically, allows to advantageously use and administer a gaseous mixture containing oxygen and argon as part of and in coexistence with emergency cardiopulmonary resuscitation. combines chest compressions with artificial ventilation to prevent and avoid heart and brain damage in a patient with ischemia after cardiac arrest.

The essence of the technical solution

The subject of the technical solution is a device for the administration of a gaseous mixture (M, (OR + A)) as a part and in coexistence with the cardiopulmonary resuscitation (CPR) of a patient (P), which contains:

- a support frame for supporting the components of the device;

- at least one bottle containing a gas mixture (M) comprising oxygen and argon (OR + A) for administration to a patient (P) when resuscitated;

- a valve connected to the bottle normally switched to the closed position to prevent the release of the gas mixture from the bottle, the valve being able to function as the first gas mixture reducing valve when the valve is open and the gas mixture (M) leaves the bottle and is fed through the bottle;

- a control unit, more specifically formed from a programmable logic controller (PLC), in which programs and algorithms are stored for controlling and controlling the functions of the device;

- a second pressure reducing valve and a control system, both controlled by a control unit, of the flow of the gas mixture (M) fed by the bottle and coming from the first pressure reducing valve;

- a setting and command panel comprising a display or display to allow the operator to set up and control the device; and

- a battery to supply energy not necessarily operating the device, the device being connected to a mask or breathing mask, or a similar device by means of which a gaseous mixture (M, (OR + A)) supplied to a second pressure can be administered to a resuscitated patient (P) reducing valve and control system of contained devices.

In the device, the valve connected to the bottle is further able to be adjusted from the closed position, in which it is normally set to prevent the release of the gas mixture (M) from the bottle, exclusively to a certain open position, ie without the need for control by the device operator. (M) the bottle, the valve, when set in the open position, no longer being able to close again in the closed position, to prevent maneuvering errors by the operator during use of the device.

The device further comprises a compartment having sufficient space to hold and position both the respirator necessary to administer the gaseous mixture (M, OR + A)) contained in the bottle to the patient and the tube that connects the respirator to the second pressure reducing valve and control system. the flow of the gas mixture (M) administered to the patient (P) by the device.

In the device according to the present technical solution, the at least one bottle has a volume of 0.5 to 3 liters, preferably 2 liters and is dimensioned and designed to allow operation up to 45 MPa and containing up to 800 liters of gas mixture (M) by vacuum.

In the device, the adjustment and command panel further allows the operator of the device to adjust the flow of the gas mixture (M) contained in the bottle administered to the patient (P) based on the patient's height.

The device further comprises access, more specifically in bluetooth or USB mode, to connect the device to an external communication device, such as a tablet, to allow commands to be sent to the control unit and the respective PLC, to change the device parameter settings.

The battery of the device according to the present technical solution is dimensioned to allow the device to operate for at least 30-60 minutes and is able to be charged by connecting to a conventional battery charger, especially a charger already present in an ambulance, and to generate energy as soon as it is charged and the display contained in the setting. and the command panel is configured to be visible when the device is not in use and not

With K 8750 Υ1 in operation, for example because the battery has run out, a corresponding message, for example "NOT IN SERVICE" "out of service".

The device further comprises a connection for an additional bottle of composite material containing an oxygen-enriched gas mixture in which oxygen is present in a concentration higher than 21%.

In the apparatus, a valve is connected to the cylinder and acting as a first pressure reducing valve capable of reducing the pressure in the gas mixture (M) of the high pressure present in the cylinder to a reduced pressure at its outlet, to allow proper supply of the gas mixture (M, (OR + A)) to a second pressure reducing valve and a gas mixture flow control system (M, (OR + A)) and administering the gas mixture (M) at the desired pressure to the patient (P) during resuscitation.

The device also has the following features:

- weight under 5 kg;

- dimensions and construction to allow easy carrying of the device on the shoulders or in the hand;

- a battery to allow the device to operate for up to 120 minutes;

- connection to electrical systems to allow recharging of the battery or continuous operation of the device.

In the present device, the bottle containing the gaseous mixture (M, (OR + A)) administered to the patient (P) is made of carbon steel or aluminum alloy, or of a composite material with an inner lining of metal, aluminum or steel, or a polymeric composite material.

The device further comprises a device for connecting the device to the endotracheal tube.

The device further comprises a device for detecting and measuring carbon dioxide (CO2) in the patient's blood (P) to prevent hyperoxygenation.

The device according to the translated technical solution is able to deliver the gaseous mixture (M) contained in the bottle also in case of battery depletion by means of an additional autoresuscitation device capable of allowing manual ventilation of the resuscitated patient.

According to the present technical solution, the device is configured to operate in three operating modes depending on the features, qualifications and type of personnel designated to use the device for administering the gas mixture (M, (OR + A)) to the patient (P).

Accordingly, a control unit consisting of a programmable logic controller (PLC) can be configured for easy operation by untrained and non-specialized personnel with a predetermined specific control program to generate the correct flow of gas mixture (M) at appropriate pressure to prevent pneumatic injury to the patient; also in case of tracheal obstruction.

Furthermore, the device control unit consisting of a programmable logic controller can be configured to medium mode for operation by trained personnel with a predetermined specific control program to generate the correct flow of gas mixture (M) for administration to the patient using a professional type mask at appropriate pressure to prevent pneumatic injury. also in case of tracheal obstruction.

Finally, the device control unit consisting of a programmable logic controller (PLC) can be configured for advanced mode to be operated by medical personnel with programs controllable via bluetooth or USB, to adjust gas flow (M), pressure and oxygen concentration when an additional oxygen bottle is connected.

The object of the present technical solution is therefore, in connection with the above-mentioned object, also the realization of a new device capable of administering a mixture containing oxygen and argon in coexistence with an emergency cardiopulmonary resuscitation procedure, which has transferability to allow its immediate and easy use for gaseous administration. mixture to a patient in an ischemic state after cardiac arrest.

More specifically, it is intended to be a device that is portable so that it is immediately and easily usable when needed for administration to a patient by means of a breathing mask applied to his face, a special gas mixture containing oxygen and argon, or oxygen and argon and other gases.

Another object of this technical solution is also the implementation of a new device which can be used in the field of cardiopulmonary resuscitation intervention and which offers suitable characteristics appropriate to the type and qualification of the operator, who is then to use it in practice to administer a mixture of oxygen and argon to a patient suffering from ischemia. More specifically for untrained staff, trained staff and doctors.

These objects can be considered to be fully achieved by means of a gaseous mixture delivery device for cardiopulmonary resuscitation of a patient having the features set out in the main independent claim L

Preferably, the device according to the present invention is configured so that it can also be used by untrained persons to allow anyone to administer a gaseous mixture of oxygen and argon to a patient in the first minutes after a clinical event, i.e. immediately after the patient develops ischemia due to arrest. heart.

More specifically, as illustrated below, the device has been developed and designed to be suitable for use in a safe manner.

- people without training or specific training;

- trained people who come, for example, with an ambulance to the scene of a clinical event, such as volunteers working as medical staff; and

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- special staff, t. j. physicians.

As already emphasized, the location where the device according to the present technical solution is located and made available for use when needed is also of fundamental importance and should be as close as possible to the site of the clinical event.

For example, a preferred solution is to place the device close to the defibrillator, and it is assumed that this location is where there are usually many members of staff responsible for dealing with a patient who has suffered a cardiac arrest and must therefore be resuscitated.

Normally, the equipment must also be accessible in ambulances, hospitals, outpatient facilities and clinics and also designed to pass approvals for carriage on seagoing vessels or aircraft and in general emergency vehicles.

Overview of figures in the drawings

These and other objects, features and advantages of this technical solution will be elucidated and will become more apparent on the basis of the following description of one of its preferred embodiments, given exclusively as a non-limiting example with reference to the accompanying drawings, in which:

Figure 1 is a three-dimensional graphical view of a device according to this technical solution for administering a mixture of oxygen and argon and other gases to a resuscitated patient;

Figure 2 is a functional block diagram of the device of Figure 1 according to this technical solution for administering a gas mixture containing oxygen and argon to a patient during his cardiopulmonary resuscitation; and Figure 3 is a flow chart illustrating the use and operation of the device of Figures 1 and 2 for administering a gaseous mixture during cardiopulmonary resuscitation of a patient.

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Examples of embodiments

As expected, the subject of this technical solution is a new useful and advantageous device, which is provided for use in cardiopulmonary resuscitation, also called CPR, which is able to ventilate and deliver to the patient's lungs while resuscitating, a gaseous mixture and therefore also referred to as CPR fan.

According to the first basic feature of this technical solution, the gaseous mixture which is fed by means of this device, resp. The CPR of the ventilator to the patient during resuscitation specifically contains oxygen and argon or oxygen and argon plus other gases to prevent and avoid damage to the patient's heart and brain caused by ischemia and / or reperfusion after cardiac arrest.

More specifically, the invention is based on the finding that administration of argon via the respiratory system in coexistence with cardiopulmonary resuscitation technologies and procedures to a cardiac arrest person effectively protects both cardiac muscle cells and neuronal cells from damage caused by ischemia and / or reperfusion after cardiac arrest.

Therefore, according to the present invention, the administration of argon in coexistence and simultaneously with standard manual operations and maneuvers provided by cardiopulmonary resuscitation advantageously allows improved and more effective heart protection together with improved and more effective neuronal protection compared to administration of argon only after cardiopulmonary resuscitation.

Again according to another advantageous feature of the technical solution, the device, resp. The CPR ventilator has features of portability and ease of use to allow immediate and easy administration of a gaseous mixture containing argon to a patient in a clinical event or when the patient suffers from ischemia after cardiac arrest.

As is known, cardiopulmonary resuscitation typically involves manual or mechanical compression of the chest associated with ventilation or inhalation and administration of air from the patient's lungs, or involves only compression of the chest.

Preferably, the CPR ventilator according to this technical solution is equipped to be used also during these resuscitation operations, i.e. during the compression and stretching of the patient's chest, as schematically indicated by the double arrow CPR in Figure 2.

In a manner similar to that described in the prior art, the gaseous mixture can also be applied and administered passively by introducing, through a tubing, a stream of gas into the respiratory system of a resuscitated patient.

There are examples of this use when a gas stream is delivered via a nasal tube or mask directly above the laryngeal flap or into the endotracheal tube or also by means of flow ventilation or oscillating ventilation.

Briefly, in this context, the device according to the invention aims to provide forced ventilation of a protective gas mixture containing argon to a patient during cardiopulmonary resuscitation at the site of a clinical event until the patient arrives at the emergency department of the hospital.

As a result, the CPR ventilator can also be used to protect and reactivate the patient's cardiac circulation, both initially during cardiopulmonary resuscitation maneuvers and later and when the patient arrives at a hospital facility equipped with first aid and intensive care services.

As emphasized, the CPR ventilator is specifically configured to deliver a mixture of oxygen and argon or oxygen, argon and other inert gases to a patient suffering from ischemia, with the argon concentration in the case of a mixture consisting exclusively of argon and oxygen being preferably from 20 to 80% by volume.

In addition, as already specified, the gas mixture may also contain other gases, such as: helium, crypt. neon, xenon, nitrogen, hydrogen and in this case an argon concentration above 10% is preferred.

The CPR ventilator according to the technical solution is equipped with a battery so as to guarantee the ventilation time of the gaseous mixture to the resuscitated patient from 30 minutes to 2 hours, preferably from 30 minutes to 60 minutes.

If there are electrical sockets (for example in ambulances), the fan can be recharged or also used continuously via the mains supply.

More specifically, as described in detail, this ventilation was developed and implemented starting from a storage system in which the argon-containing gas mixture is stored to continue and pass through a pneumatic circuit to the patient interface, which interface may be a nasal or facial mask. or also a connector capable of connecting to a corresponding connector associated with the endotracheal tube.

The CPR ventilator is also equipped with a system to limit the pressure of the respiratory system to prevent overpressure damage to the patient's lungs; an indicator of pulmonary pressure and a series of analog and digital indicators that indicate the proper functioning of the CPR ventilator, further corresponding to the patient's regular breathing rate during cardiopulmonary resuscitation.

In addition, preferably, the CPR ventilator according to the technical solution is portable, battery-powered, can also be powered externally by connection to an electrical system, and a superfibrillation module can be connected.

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Again, as described below, the device according to the technical solution has been developed and designed to be used safely on the basis of three operating modes, more specifically:

- persons without training or specific instructions according to the operating mode of use referred to as "light mode";

- by trained persons who, for example, arrive by ambulance at the site of a clinical event where the patient has suffered a cardiac arrest, or by voluntary medical staff according to a working mode of use of the device referred to as "intermediate mode";

- medical personnel according to the operating mode of use referred to as "advanced mode".

In more detail, taking into account these possible different operating modes of the device, the patient's breathing sequence can be selected by a qualified physician, for example using a USB key, and is instead fully automatic if the device is used by non-medical personnel.

As assumed and shown in Figure 1, the CPR fan according to this technical solution has a light construction and is characterized by a reduced size so as to have portability features.

More specifically, the CPR fan is designed to have dimensions and weight suitable for its comfortable and easy transport on the operator's shoulders.

For example, referring to Figure 1, the indicative dimensions of a CPR ventilator without a bottle or additional oxygen-containing bottles provided for special use, as described, corresponding to the "advanced mode" reserved for physicians are:

- L1 = 400 ± 100 mm;

- L2 = 600 ± 150 mm;

- L3 = 250 ± 150 mm.

The indicative weight is indicatively less than 5 kg.

Naturally, the stated dimensions and weights are not binding, but may vary depending on the possible applications for which the CPR fan is intended.

Referring in detail to Figure 1 and the corresponding working block diagram in Figure 2, the device which is the subject of this technical solution is generally designated 10 and comprises:

- a tubular support frame 11, which carries the various components of the device 10;

- at least one bottle marked 12, containing a mixture of gas M comprising oxygen and argon (OR + A) administered to patient P, which saresuscitates;

a valve 13 connected to the bottle 12 normally placed in the closed position to prevent the gas mixture M from escaping from the bottle 12, this valve 13 being able to function as the first reducing valve of the gas mixture M as it exits the bottle and is fed directly through the bottle 12;

- a control unit 14, more specifically formed by a programmable logic controller (PLC), in which programs and algorithms are stored for controlling and controlling the operation of the device 10;

- a second pressure reducing valve and a control system, designated as a total of 16, of the flow of the gaseous mixture M supplied by the bottle 12 and coming from the first pressure reducing valve 13, the second pressure reducing valve and the control system 16 being both provided to be controlled by the control unit 14; and

- an adjustment and command panel 15 connected to the control unit 14 to allow the operator to adjust and control the flow of the gas mixture supplied by the device 10, said adjustment command panel 15 further comprising a display or display 15a capable of displaying signals and information concerning the operation of the device 10th

In addition, due to the use in the widest possible range of places, the device 10 according to the technical solution is provided to be powered by a battery marked 21 in figure 2, this battery 21 being dimensioned to guarantee the function of the device 10 and the flow of the gaseous mixture M in time from 30 to 60 minutes and is of the rechargeable type so as to be able to be connected to a conventional charger, for example a charger already placed in an ambulance.

When using the device 10, the display or display 15a located on the setting and command panel 15 is able to generate a visual signal "NOT IN SERVICE" if the battery 21 supplying the device 10 is discharged and therefore not able to supply any energy.

More specifically, this NOT IN SERVICE message is generated automatically and appears on the display 15a when the battery 21 is no longer energized, and when the battery 21 of the device 10 is sufficiently charged, the display 15a shows no indication, and therefore appears black or, in another version, the word 'ACTIVE' or another word with a similar meaning appears

In addition, as described below, the display 15a of the setting and command panel 15 has the function of visually indicating to the operator before starting the administration of the gaseous mixture to the patient to be resuscitated or already resuscitated that everything in the device 10 is functioning properly and is therefore ready for use.

The device 10 is additionally connected to a breathing mask 17, which may be located in a compartment 18 formed in the same device 10 to supply the resuscitated patient with a gaseous mixture M under reduced pressure supplied by a second pressure reducing valve and a control system 16.

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This compartment 18, formed on the device 10, has sufficient space to hold and position both the respirator 17 necessary to administer the gaseous mixture M supplied by the bottle 12 to the patient and the flexible tube designated 19 which connects the respirator 17 to the gaseous flow control system 16. mixture administered to the patient.

The bottle 12, containing a gaseous mixture containing oxygen and argon, is preferably made of a composite material so as to have a reduced weight in favor of the transportability and portability of the device 10.

In general, the bottle 12 can be made and coated with any type of material, provided that the material in contact with the gaseous mixture M contained in the bottle 12 is compatible with it.

The pressure of the gas mixture in the bottle 12 can reach up to 45 MPa and is preferably about 30 MPa.

The volume of the bottle 12 containing the gas mixture varies from 0.5 liters to 3 hectares of geometric volume and is preferably equal to 2 hectares so as to hold at a working pressure of 45 MPa to 800 hectares of the gas mixture.

The valve 13 connected to the bottle 12 may be made of a conventional commercial valve or may preferably be suitably designed and dimensioned to allow the flow of a predetermined speed and range and at a certain final pressure of the gas mixture M exiting the bottle 12 to operate as a pressure reducing valve.

Preferably, the pressure of the gas mixture M behind the valve 13, which is at the outlet of the bottle 12, is from 0.1 MPa to 1 MPa.

As already specified, the gaseous mixture contained in the bottle 12 has at least 20% oxygen.

Preferably, this gaseous mixture is enriched with oxygen in the case of an "advanced mode" of use and, for example, can reach a concentration of 50% oxygen or higher, the remainder being argon gas.

The same methods adopted to obtain a mixture enriched in various ways with oxygen can also be coupled to mixtures formed from other gases.

Gaseous mixtures administered to patients may contain only argon and oxygen or, as already specified, may be mixtures containing argon, oxygen, nitrogen, hydrogen, xenon, helium. krypton, neon in various concentrations, provided that the operations of the device 10 do not depend on the specific composition of the gaseous mixture that is administered to the resuscitated patient.

More specifically, as also described, if the device 10 were set to operate on a "light mode" or "medium mode", the concentration of oxygen administered to the patient could not vary and was equal to the concentration of slicon in the gas mixture contained in the bottle 12.

Instead, in the case of the "advanced mode" provided to physicians, the oxygen concentration may be appropriately changed by these medical personnel.

When using the device 10, the flow of the gas mixture M, which emerges from the bottle 12 even though it has already been depressurized by the valve 13 in the open position, enters the zone or part of the device 10 where the flow rate regulates this flow more precisely.

More specifically, this part of the device 10 includes a number of devices that allow accurate and efficient control of the flow of the gas mixture M as a function of the respiratory characteristics of the patient P during resuscitation.

Also located in this part of the device 10 is a control unit 14, which is a programmable logic controller (PLC) that controls the operation of the device 10 itself.

The rest of the device 10, left free and unoccupied by the bottle 12, the control unit 14 and the second pressure reducing valve and the gas flow control system M, is used to define and form a compartment 18 into which the breathing mask 17 and the flexible tube 19 can be placed. it connects them to the second pressure reducing valve and the control system 16.

The respirator 17, coupled and located in the device 10, usually conforms to the "basic model" to be easy to use by the operator and, more specifically, does not require application so that it adheres perfectly to the patient's face.

Therefore, by providing a breathing mask 17 of the normal type and standard, which is therefore easy to apply without the need for special skills, untrained persons are prevented, more specifically when the device 10 is designed to operate and be used according to "light weight". could cause pneumatic damage to the patient's internal organs.

Consequently, the differences in the features and characteristics of the device 10 according to the technical solution when it is intended to operate on the basis of "light mode" compared to when it is intended to operate on the basis of "medium mode" also relate to the type of mask that can be used by the operator of the same device 10. .

More specifically, the breathing mask provided when using the "medium mode" device 10 may be located in a corresponding special compartment created in the device 10 accompanied by an alert which is evident on the same device 10, such as "THIS MASK CAN BE USED BY MEDICAL PERSONNEL ONLY". (This mask may only be used by medical personnel) or a similar warning.

Instead, the breathing mask, usable in the "light mode", is already connected to the respective flexible hose, which connects it to the second pressure reducing valve and the control system of the device 10.

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Referring to the drawings and more particularly to the working block diagram of Figure 3, a description will now be given of the use and operation of the device 10 according to the invention for administering a gaseous oxygen-containing arargon mixture (OR + A) to a patient in cerebral ischemia during his cardiopulmonary resuscitation.

Advantageously, in order to facilitate the immediate use of the device 10 by the operator, the various operations to be performed for its proper functioning and its rapid use on a patient in cerebral ischemia are briefly described and symbolically shown on panel 20, part of the device 10 itself shown in the figure. first

In detail, the operations that the operator must perform when a patient suffers from cerebral ischemia, typically after cardiac arrest, and therefore, as indicated in Figure 3 under designations 31, 32 and 33, the operator reaches and uses the device 10 according to this technique are next:

- opening the valve 13 connected to the bottle 12 so as to allow the free discharge of the gaseous mixture M from the same bottle 12;

- switching the control knob 15b to the standby position, as shown in figure 1, contained on the setting command panel 15 of the device 10;

- controlling the signal on the display 15a of the setting and command panel 15, which indicates that everything in the device 10 is working properly;

- selecting, using the setting and command panel 15, the height of the resuscitated patient? and pressing the corresponding digit displayed on the same panel 15;

- putting the respirator 17 on the face of the resuscitated patientP and

- switching the control knob 15b from the standby position to the control position of the device 10.

As already mentioned, the correct availability, as described, of the operations performed is usually indicated by the device 10 itself and can also be guided by a recorded voice.

In general, these operations, designated 34 in Figure 3, are intended to adjust the correct device 10 until it is activated to administer the gaseous mixture M to a patient in a state of cerebral ischemia who must resuscitate as soon as possible.

It is specified that the valve 13 connected to the bottle 12 is preferably of a special type, non-adjustable so that starting from the initial closed position it can switch only to the open position, in which the valve 13 is fully open and when the operator 10 switches it to the open position. it can no longer return to the closed position.

Therefore, in this way, the malfunction of the valve 13 is prevented at agitated moments in which the step of activating and using the device 10 on the patient takes place.

The patient height selection P regulates and automatically determines the flow of this gaseous mixture M on the basis of algorithms and programs stored in the PLC control unit 14.

At this point, by the end of the preparation phase, the device 10, as shown in Figure 3 by 36, is activated to operate according to a specific mode of operation of the appropriate type and qualification of the appropriate operator to be administered to patient P in coexistence with his cardiopulmonary resuscitation. symbolized by the double arrow CPR in Figure 2, a gaseous mixture M containing oxygen and argon so as to prevent cerebral and neurological damage to patient P.

Therefore, if the device 10 is activated to operate according to the operating mode corresponding to the "light mode", it will operate to feed the gaseous mixture M based on the program 37-1 stored in the control unit 14 corresponding to this "light mode" 37, as shown in Figure 3.

Instead, if the device 10 is activated to operate according to the operating mode corresponding to the "medium mode", it will operate to supply the gaseous mixture M based on the program 38-1 stored in the control unit 14 corresponding to the "medium mode" 38, as indicated. in Figure 3.

Finally, if the device 10 is activated to operate according to the operating mode corresponding to the "advanced mode", it will operate to supply the gaseous mixture M based on the program 39-1 stored in the control unit 14 corresponding to this "advanced mode" 39, as shown in Figure 3.

As shown previously, the basic difference between the so-called "Light mode" of use and the so-called "Medium mode" of use corresponds to and is reflected in the difference in the type of mask that untrained personnel corresponding to the "light mode" or trained personnel corresponding instead of "moderate mode" should be used appropriately to administer a gaseous mixture M containing oxygen and argon to patient P.

In addition, there are other important differences that distinguish the so-called "Advanced mode" of use, provided and reserved for doctors, with respect to the other two modes of use "light mode", resp. "Intermediate mode" provided for untrained and middle-level trainees.

More specifically, doctors or other persons and professionals who are specifically trained or who are legally responsible for the use of the device 10 have additional equipment at their disposal, additional and different from the device 10, which may be connected to it if necessary. .

In detail, this further device or additional part of the device 10 is formed of:

- bottles containing oxygen or bottles containing a gaseous mixture enriched with oxygen; and

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- a special software key on which the program for controlling this additional device or additional part is stored with respect to the device 10.

This additional and distinct part is not provided to accompany the device 10, but is usually worn by physicians or, in any case, by trained persons who come to the site of a clinical event, for example with an ambulance, to assist in resuscitating the patient.

Similar to the bottle 12, which is already included and part of the device 10, this additional bottle, which contains an oxygen-enriched mixture, is also made of a composite material to obtain a minimum weight.

The working pressure in this additional bottle can reach up to 45 MPa, but preferably approximately 30 MPa.

In use, this additional bottle can be connected to the device 10 in a very simple manner and is equipped with an appropriate pressure reducing valve which is configured to operate in the same way as the valve 13 connected to the bottle 12, containing a gaseous mixture M with argon, inseparable and substantial. 10 so that this pressure reducing valve is provided to be arranged in only two positions "open", resp. "Closed" and when the saraz opens, it can no longer close.

Using the software key, the physician has access to a number of different functions controlled by the PLC control unit 14 of the device 10 and can use them to change, for example, oxygen concentration in mixture M administered to patient P, dosing and administration pressure of this mixture M, flow rate and relative delivery time.

Again, access to the PLC allows the physician to advantageously use the device 10 during the chest compression massage provided by cardiopulmonary resuscitation to exhale air from the lungs and during the subsequent regeneration phase to inhale air.

Again, a program or software that allows the physician to access the PLC resources of the control unit 14 can be downloaded to the tablet.

Therefore, when the tablet is connected in USB or bluetooth mode to the device 10, the commands for the PLC can be issued by the physician using the touch screen of the same tablet, on which the parameters of the device 10 can also be indicated.

Block diagram resp. The flow chart shown in Figure 3 thus shows:

Occurrence of cerebral ischemia in patient (P) after cardiac arrest.

Immediate application of the presumed cardiopulmonary resuscitation (CPR) procedure to resuscitate a patient (P) in a cerebral ischemic state.

Use of a device (10) according to the invention in connection with operations involving cardiopulmonary resuscitation (CPR) for administering a gaseous mixture (M) containing oxygen and argon (O + A) to a patient (P) in a cerebral ischemic state.

Performing various preliminary operations involving selecting the patient's height (P) to properly adjust the device (10) for administering a gaseous mixture (M) containing oxygen and argon (O + A) to the patient (P) in a cerebral ischemic condition that resuscitate itself.

Activation and function of the device (10) depending on the type of appropriate operator for administering a gas mixture (M) containing oxygen and argon (O + A) to the patient (P) in coexistence with his cardiopulmonary resuscitation (CPR) so as to prevent cerebral and neurological damage to the patient (P) in an ischemic state.

Fungal mode (light mode) for untrained persons.

Functioning mode (medium mode) for trained persons.

Functioning mode (advanced mode) for medical staff.

37- 1 Control program of the corresponding operating mode (light mode), which has been activated and on the basis of which sapodávazmes (M) oxygen and argon.

38- 1 Control program of the corresponding fusion mode (middle mode) that has been activated and on the basis of which sapodávazmes (M) oxygen and argon.

39- 1 Control program of the corresponding fusion mode (advanced mode) that has been activated and on the basis of which sapodávazmes (M) oxygen and argon.

Therefore, it is clear from the above description that this technical solution fully achieves the stated objectives and more specifically proposes a new and useful device for administering a gaseous mixture containing specific argon in connection with coexistence with cardiopulmonary resuscitation of a patient suffering from cardiac arrest to avoid and prevent heart damage. and brain in the same patient caused by ischemia and / or blocked or reduced blood flow to the brain due to this cardiac arrest.

In addition, and preferably, the device has features of portability so as to allow, if necessary, its easy and immediate use during cardiopulmonary resuscitation of a patient suffering from ischemia after cardiac arrest.

S K 8750 Υ1

OPTIONS

Naturally, without violating the principle and basic technical concepts of this technical solution, it is also clear that a gaseous mixture delivery device for cardiopulmonary resuscitation to avoid and prevent damage to the patient's heart and brain due to ischemia or blocked or reduced blood flow after cardiac arrest may subject to variants, changes and improvements with respect to what has been described and illustrated so far, without departing from the scope of this technical solution.

For example, based on the first variant, the device may integrate a CO 2 detector, which may be useful to prevent hyperoxygenation of the patient during the resuscitation phase.

As already mentioned, the gaseous mixture administered to the patient may contain other gases as well as oxygen and argon, and more specifically helium m

In this case, the gaseous mixture may be composed of oxygen in a percentage of at least 21%, argon, preferably in a percentage of more than 10%, and helium, with a balancing function to obtain a lighter mixture which is easier to inhale and therefore capable of facilitating respiration. certain patients.

It is clear that in this case the respective nature of the provision of helium in the composition of the gas mixture is determined by the low molecular weight of this gas, which means that the gas mixture administered to the patient is easily breathable.

Again, a CPR fan can be designed to be able to easily pass approval tests to be transported by aircraft or helicopter.

Finally, as already mentioned, the construction and configuration of the device can be such as to allow its transport as if it were a rucksack or in the hand as a bag.

Claims (17)

CLAIMS FOR PROTECTION Device (10) for administering a gas mixture (M, (OR + A)) as a component and in coexistence with the cardiopulmonary resuscitation (CPR) of a patient (P), characterized in that it comprises a support frame (11) for supporting components; at least one bottle (12) containing a gaseous mixture (M) comprising oxygen and argon (OR + A) for administration to a patient (P) during resuscitation; a valve (13) connected to the bottle (12) normally switched to a closed position to prevent the release of the gaseous mixture from the bottle (12), the valve (13) in the open position for the gaseous mixture (M) to exit the bottle and be fed through the bottle (12) is the first gas mixture reduction valve; a control unit (14), more specifically formed by a programmable logic controller (PLC), in which programs and algorithms for controlling and controlling functions are stored; a second pressure reducing valve and a control system (16), both controlled by a control unit (14), of the flow of the gaseous mixture (M) supplied by the bottle (12) and coming from the first pressure reducing valve (13); a setting and command panel (15) comprising a display or display (15a) for setting and operating by an operator; and a battery (21) for supplying energy not forced to be fused, being connected to a breathing mask (17) or device for delivering a gaseous mixture (M, (OR + A)) to a resuscitated patient (P) under reduced pressure supplied by a second pressure reducing valve and the regulatory system (16). Device (10) according to claim 1, characterized in that the valve (13) connected to the bottle (12) is intended to adjust from a closed position in which it is normally set to prevent the release of the gaseous mixture (M) from the bottle ( 12), exclusively to a certain open position, i.e. without the need for control by the operator, to allow free dosing of the gas mixture (M) by the bottle (12), and that the valve (13) set in the open position no longer has the possibility to close again to the closed position. , to prevent operator maneuvering errors. Device (10) according to claims 1 and 2, characterized in that it comprises a compartment (18) which has sufficient space to hold and position the respirator (17) necessary for the administration of the gaseous mixture (M, OR + A)). contained in the bottle (12) to the patient, as well as a tube (19) which connects the breathing mask (17) to the second pressure reducing valve and the flow control system (16) of the gas mixture (M) administered to the patient (P). Device (10) according to any one of the preceding claims, characterized in that the at least one bottle (12) has a volume of 0.5 to 3 liters, preferably 2 liters and is dimensioned and designed to allow operation up to 45 MPa and with a capacity of up to 800 grams of gas mixture (M) by vacuum. Device (10) according to any one of the preceding claims, characterized in that the adjustment and command panel (15) is intended to adjust the flow of the gaseous mixture (M) contained in the bottle (12) administered to the patient (P) based on the patient's height (P) by the operator. Device (10) according to any one of the preceding claims, characterized in that it further comprises access, more specifically in bluetooth or USB mode, to connect to an external communication device, for example a tablet, to allow commands to be sent to the control unit (14) and of the relevant PLC, to change the parameter settings. Device (10) according to any one of the preceding claims, characterized in that the battery (21) is dimensioned to allow fusing for at least 30-60 minutes and charged by connection to a conventional battery charger, in particular to a charger already present in an ambulance, and generates energy as soon as it is charged and that the display (15a) contained in the setting and command panel (15) is configured for visibility, when not in use and out of service, for example when the battery (21) is discharged, a corresponding message, for example "NOT IN SERVICE" - " out of service". Device (10) according to any one of the preceding claims, characterized in that it further comprises: a connection for an additional bottle of composite material comprising an oxygen-enriched gas mixture in which oxygen is present in a concentration of more than 21%. Device (10) according to any one of the preceding claims, characterized in that the valve (13) connected to the bottle (12) and acting as a first pressure reducing valve is designed to reduce the pressure in the gas mixture (M) from the high pressure present in the bottle. (12) to reduce the pressure at its outlet, to allow the correct supply of the gas mixture (M, (OR + A)) to the second pressure reducing valve and the gas mixture flow control system (16) (M, (OR + A)) and to supply the gas mixture (M) at the desired patient pressure (P) during resuscitation. Device (10) according to any one of the preceding claims, characterized in that it has the following features: weight below 5 kg; dimensions and construction to allow easy carrying on the shoulders or in the hand; a battery (21) to allow fusing for up to 120 minutes; connection to an electrical system to allow recharging of the battery (21) or continuous operation. Device (10) according to any one of the preceding claims, characterized in that the bottle (12) containing the gaseous mixture (M, (OR + A)) administered to the patient (P) is made of carbon steel or aluminum alloy, or of composite material with inner lining of metal, aluminum or steel, or of a polymeric composite material. S K 8750 Υ1 Device (10) according to any one of the preceding claims, characterized in that it further comprises a device for connecting to the endotracheal tube. Device (10) according to any one of the preceding claims, characterized in that it further comprises a device for detecting and measuring carbon dioxide (CO 2) in the blood of the patient (P) to prevent hyperoxygenation. Device (10) according to any one of the preceding claims, characterized in that it is intended for feeding the gaseous mixture (M) contained in the bottle (12), also in case the battery (21) is depleted, by means of an additional autoresuscitation device for manual ventilation of resuscitation. patient. Device (10) according to any one of the preceding claims 1 to 14, characterized in that the control unit (14) formed by a programmable logic controller (PLC) is configured to light mode (37) to be operated by untrained and non-specialized personnel with a predetermined control program. (37-1) for generating a flow of gaseous mixture (M) at a pressure preventing pneumatic injury to the patient and also in the case of clogged trachea. Device (10) according to any one of the preceding claims 1 to 14, characterized in that the control unit (14) formed by a programmable logic controller (PLC) is configured to a medium mode (38) for operation by trained personnel with a predetermined control program (38-1). ) to generate a flow of gaseous mixture (M) for administration to a patient by means of a mask of the professional type at a pressure preventing pneumatic damage to the patient and also in the case of clogged trachea. Device (10) according to any one of the preceding claims 1 to 14, characterized in that the control unit (14) formed by a programmable logic controller (PLC) is configured to an advanced mode (39) for operation by medical personnel with control programs (39-1) adjustable via bluetooth or USB, to adjust the gas mixture flow (M), pressure and oxygen concentration if an additional oxygen cylinder is connected.