WO2021250449A1

WO2021250449A1 - Portable breathing support equipment

Info

Publication number: WO2021250449A1
Application number: PCT/IB2020/055515
Authority: WO
Inventors: Alberto MEDINA VILLANUEVA; Daniel ÁLVAREZ DÍAZ; David Cereijo Martín; Iván GONZÁLEZ ESTEBAN; Pelayo PÉREZ FERNÁNDEZ; Virginia García Antolín; Marcos Castaño Fernández; Cebrián GARCÍA GONZÁLEZ; Fernando Jesús GARCÍA DÍAZ; Ignacio GÓMEZ DOSIL; David GONZÁLEZ FERNÁNDEZ; Paula QUEIPO RODRÍGUEZ; Ana María GARCÍA LORENZO; Ignacio DE ÁVILA PELÁEZ; Sául PADRÓS MOMPÓ; César MASEDA SOUTO; Roberto SUÁREZ SÁNCHEZ; José LÓPEZ FRESNO; Virgilio GARCÍA ORGEIRA; Paula RODRÍGUEZ ALONSO
Original assignee: Fundación Idonial; Arcelormittal
Priority date: 2020-06-12
Filing date: 2020-06-12
Publication date: 2021-12-16

Abstract

The invention relates to a portable breathing support equipment comprising: - a gas flow generation system (2) with a gas inlet and a gas outlet connector, - at least one interface (4) for adaptation to the face or head of a patient covering their nose and/or mouth, each with an inlet connector and an outlet connector, and - an expiratory resistance system connected to the outlet connector of the interface (4), characterised in that it further comprises a main distribution conduit (10) connected to the gas outlet connector of the gas flow generation system (2), said main conduit (10) having at least two gas flow outlet connections (11) along the main conduit (10), at least one of the two outlet connections (11) having an end of a secondary conduit (3) connected thereto, and the opposite end of the secondary conduit (3) connected to the inlet connector of the interface (4).

Description

PORTABLE BREATHING SUPPORT EQUIPMENT

OBJECT OF THE INVENTION

The present invention, portable breathing support equipment, relates to equipment for administering continuous positive airway pressure, or CPAP, in patients with spontaneous breathing. The equipment is essentially distinguished by being portable and by comprising a gas flow generation system connectable through corresponding ducts to a plurality of interfaces, or devices for adaptation to the face or head of a patient covering their nose and/or mouth, adaptable to each patient to enable providing breathing support to multiple patients simultaneously. This system can be connected to various expiratory resistance systems, and particularly to an expiratory resistance system object of the invention which comprises a liquid column connected to the outlet tube of the interfaces as a positive pressure control system and which, at the same time, can be used for retaining and purifying aerosols generated during patient expiration, preferably if disinfecting liquid is used.

The field of application of the present invention is comprised within the sector of the industry dedicated to the manufacturing of artificial breathing apparatus and devices.

BACKGROUND OF THE INVENTION

The term non-invasive ventilation (NIV) refers to breathing support techniques which do not require tracheostomy or intubation operations. Although systems with negative pressure are available, the most widely used technique is NIV with positive pressure, with systems working with one or more pressure levels being available. Ventilation with a CPAP (Continuous Positive Airway Pressure) system seeks to generate a level of positive pressure in the airway by means of a continuous flow, with the breathing of the patient being spontaneous. The continuous pressure of the CPAP enables the lung recruitment to be maintained, i.e., it enables the airways to be kept open by reducing the collapse of alveoli, increasing functional residual capacity, and protecting the patient from lung damage (atelectotrauma). This system has been proven to be effective in patients with sleep apnea, bronchiolitis, lung edemas, acute or chronic respiratory failure, pneumonias, etc.

The CPAP systems fundamentally consist of a source of airflow, tubulures or tubular conduits, an interface, and an expiratory resistance system for maintaining the level of positive expiratory pressure at the end of expiration or a PEEP (Positive End-Expiratory Pressure) system.

The interfaces or devices for adaptation to the face or head of a patient covering their nose and/or mouth are elements which enable the connection between the ventilation system and the patient, with there being various types: oronasal masks, nasal masks, full face masks, helmet-type systems, binasal pad systems, etc. The interface must adapt to the physiognomy of the patient in order to minimise the possibility of air leakage. In any case, regardless of the selected interface, uncontrolled air leakage may occur, with the system having to be defined taking into account this possible leakage to achieve the desired pressure.

The expiratory resistance systems are usually those referred to as positive pressure valves or PEEP valves.

The existence of home-use CPAP systems for chronic respiratory failures which require intermittent mechanical ventilation, as well as for sleep respiratory disorders, is known. Home systems for the treatment of sleep apneas are based on a turbine which generates a constant flow that is transmitted to the patient. The interface commonly used in home ventilation is the nasal mask. The home CPAP systems do not usually have oxygen mixers and the supplied gas flow is only enough for a single patient.

The existence of CPAP systems for hospital use is also known. Most of the CPAP systems for hospital use are simple systems which take air from the ducts of the hospital building, being provided with flowmeters for regulating the gas supply; these systems usually incorporate internal oxygen mixers for the treatment of specific pathologies which require an increase in the inspired oxygen fraction. In any case, they are systems designed for the treatment of a single patient through each hospital gas outlet. The most common interfaces are mask- type interfaces.

These types of systems for hospital use are used in the attempt to recruit alveoli in pneumonia situations or other causes which generate a loss in the functional residual capacity and an increase in the pulmonary shunt. In light of epidemics such as the COVID-19 epidemic, the availability of said systems for a large number of patients may be necessary. The “Clinical guide for the management of critical care patients during the coronavirus pandemic” published by the National Health Service (NHS) indicates that NIV or CPAP devices can be used for treatment for limited periods of time and they are used by normally employing interfaces such as oronasal masks, full face masks, or helmets. In this situation, many hospitals have been overwhelmed by the lack of sufficient equipment for the demand generated, with there being a need for using CPAP systems that are alternatively manufactured and enable several patients to be treated simultaneously under suitable safety conditions. It has also become necessary to make the systems available under conditions involving a low cost and easy manufacturing based on abundantly-available and readily-accessible elements.

The objective of the present invention is therefore to provide breathing support equipment by means of continuous positive airway pressure, which enables more than one patient to be treated at the same time and with a controlled cost, avoiding the use of components that are hard to acquire or have limited production.

As a reference to the current state of the art, various documents disclosing helmet-type interfaces for use as assisted breathing elements, such as those described in ES2343789T3, ES2389918T3, ES2290215T3, EP1790369A1 , or EP2548600A1 , are known. For the use thereof in CPAP systems, these devices usually require a positive pressure valve or PEEP valve. Given that this element can be affected by supply problems, the present invention has CPAP equipment which, in addition to the aforementioned advantages, can prevent the use of conventional PEEP valves, making use of a simple system for maintaining the positive pressure inside the interface used. Additionally, given that the systems are for treatment in a hospital setting, air is fed by means of the hospital gas supplies, which involves the need of a connection outlet for each patient to be treated.

DESCRIPTION OF THE INVENTION

The portable breathing support equipment for providing breathing support, by means of continuous positive airway pressure, to one or more patients simultaneously object of the present invention is intended for equipment such as the one of claim 1. Specifically, the invention relates to breathing support equipment with: a gas flow generation system with a gas inlet and a gas outlet connector; at least one interface or device for adaptation to the face or head of a patient covering their nose and/or mouth, each with an inlet connector and an outlet connector, and an expiratory resistance system connected to the outlet connector of the interface, further having a main distribution conduit connected to the gas outlet connector of the gas flow generation system, said main conduit having at least two gas flow outlet connections along the main conduit, at least one of the two outlet connections having an end of a secondary conduit connected thereto, and the opposite end of the secondary conduit connected to the inlet connector of the interface.

This equipment is applicable for achieving breathing support by supplying a continuous positive airway pressure (CPAP). The equipment has the particularity of being portable, as well as the particularity of being able to provide ventilation to multiple patients simultaneously and in a manner adapted to the needs of each patient.

To do so, the equipment is configured from a gas, preferably air, flow generation system connected through a main distribution conduit and a set of ducts to one or more interfaces adaptable to the head of each patient.

The gas flow generation system comprises at least one turbine-type gas driving device, preferably a fan or a blower, or any device which can provide flow at low pressures, and a gas flow control system, being independent from the hospital gas outlets. The gas flow control system includes operation parameter measurement systems and an alarm system. A possible control system is based on a redundant system for measuring the outlet pressure of the fan and on the generation of alarms for stopping the operation of the fan in the event that the pressure of both pressure meters differs by a specific amount. However, alternative gas flow control systems based on measuring other variables or on generating another type of alarm signals are possible. The gas flow generation system has an electrical energy source.

The equipment also comprises an expiratory resistance system which may consist of a conventional PEEP valve or any other system which enables a positive pressure to be maintained at the end of the expiration of the patient. In particular, the expiratory resistance system may comprise a column with a liquid, preferably water or a similar liquid, in a first bottle, connected to an outlet tube of the interfaces, one per interface. This liquid column in said first bottle, while maintaining the positive pressure in the interface, prevents the aerosols from the expiration of the patient from entering the atmosphere, also acting as a filter. Said first bottle may alternatively comprise a disinfecting agent, for example, bleach, or a mixture of a disinfecting agent and the preceding liquid, preferably water.

Alternatively, the equipment may have in the expiration circuit, located at the outlet of the interface, a second empty bottle, after the first bottle and connected thereto, which has the function of retaining possible residues which are contained in the expirated air and can therefore be emitted into the atmosphere.

The liquid column formed by the first bottle offers resistance to the circulating air in order to maintain the necessary positive pressure in the system, particularly inside the interface, which also enables the aerosols generated by the patient during expiration to be trapped. By varying the liquid column of the first bottle, resistance to the airflow is successfully modified, and therefore, the pressure thereof is regulated at a certain value. This system enables the pressure value for each patient to be regulated to a specific operating pressure supplied by the only gas flow generating system. In this manner, despite there being only one generating system which feeds several patients, the positive pressure applied to each patient can be modified by regulating the bottle system of the outlet. The pressure of each patient can preferably be regulated by means of two complementary or alternative systems, specifically by regulating the height of the water column of the first bottle acting as resistance, or by means of opening and/or closing a valve located between the central tube and the ducts reaching each interface.

Additionally, if needed, the equipment can have an anti-viral and/or anti bacterial filter located at the end of the line. This filter is recommendable in situations in which it is necessary to maintain conditions of extreme disinfection in the outlet gases, for example, for the use thereof as a breathing support system for COVID-19 patients. However, it may not be necessary for other pathologies.

Optionally, the equipment incorporates a flowmeter which enables the measurement of the operating flow and pressure at the outlet of the entire system.

Any of the interfaces known in the state of the art such as, for example, helmets, full face masks, oronasal masks, etc., can be used as an interface. Preferably, the interface is a helmet or a mask.

More preferably, the interface is a helmet manufactured with a transparent and flexible plastic material, sealed by means of any manufacturing process which enables a tight seal to be obtained, and having a dimension sufficient to go around the entire head of the patient, with the section thereof being cylindrical to adapt to each patient regardless of their sex and age. Preferably, the plastic material is polyurethane and the sealing method is high frequency welding. Preferably, the measurements are 300 mm in diameter and 350 mm in height, although these measurements may vary depending on the patient, and it has two connections, a first connection for the gas inlet and a second connection for the gas outlet. To fasten the helmet to the patient, the helmet comprises a harness provided with fastening elements, preferably Velcro fastening elements, in order to improve the fastening thereof, as well as side tensioning elements, preferably adjustable by means of clasps.

The gas flow generation system is connected with the interface or interfaces by means of a system of ducts comprising a main distribution conduit connected at one end to a gas outlet connector of the gas flow generation system and said main conduit having at least two gas flow outlet connections along same, preferably 20 connections, and at least one of the two outlet connections having an end of a secondary conduit connected thereto and the opposite end of said secondary conduit connected to the inlet connector of an interface. The outlet connections of the main conduit or the ends for connection to the interfaces of the secondary conduits have means which allow blocking same if connection of an interface is not desired.

A regulating valve which can act as a blocking system and as a system for regulating the gas flow circulating through said secondary conduit can be interposed between the outlet of the main distribution conduit and the secondary conduit connecting with an interface inlet connector.

This system enables the positive pressure supplied to each patient to be regulated in a personalised manner and independent of the positive pressure that is being supplied to other patients simultaneously from the equipment, this system being a regulation system that is alternative or complementary to positive pressure regulation by means of the height of the water column of the expiratory resistance system indicated above.

Optionally, the equipment incorporates an anti-viral/anti-bacterial filter interposed at a point between the outlet of the main distribution conduit and the interface inlet connector. This anti-viral/antimicrobial filter enables the hygienic conditions of the gas administered to a specific patient through a specific interface to be increased, if necessary.

Optionally, the equipment incorporates an oxygen outlet interposed at a point between the outlet of the main distribution conduit and the interface inlet connector. This oxygen outlet allows enables the composition of the gas administered to a specific patient through a specific interface to be modified, if necessary.

Optionally, the equipment incorporates a humidifier system interposed between a point of the outlet of the main distribution conduit and the interface inlet connector. This humidifier system enables the humidity of the gas administered to a specific patient through a specific interface to be modified, if necessary.

Optionally, the equipment incorporates a heater system interposed between a point of the outlet of the main distribution conduit and the interface inlet connector. This heater system enables the temperature of the gas administered to a specific patient through a specific interface to be modified, if necessary.

Based on the foregoing, the equipment may incorporate at least any element for gas treatment from those elements mentioned above or it may even incorporate other elements.

Therefore, the present invention allows for:

- Providing breathing support by means of continuous positive airway pressure to multiple patients simultaneously, where ventilation can preferably be supplied to up to 20 patients in comparison with the conventional CPAP systems for the treatment of sleep disorders which are for individual use, have small dimensions, and work by connection thereof to mask-type interfaces.

- Carrying out personalised treatment for each of the patients who may be connected to the same breathing support equipment: selection of a customised interface based on patient’s requirements, individual regulation of the positive pressure applied, possibility of providing additional oxygen, regulation of gas humidity, regulation of gas temperature, possibility of selecting the expiratory resistance system.

- Moving the equipment from one place to another as it is completely portable, which enables breathing support to be supplied by means of continuous positive airway pressure to one or more patients anywhere without requiring external gas supply, in comparison with the CPAP systems for hospital use which are fixed because they take air from the installations of the building itself.

- Avoiding the use of conventional PEEP valves incorporated by the systems for hospital use given that these valves may be hard to acquire at times of great demand, replacing same with the mentioned water columns.

- Purifying expirated aerosols by using the expiratory pathway pressure control liquid column preferably in combination with water or water with a diluted disinfectant product.

DESCRIPTION OF THE DRAWINGS

To complete the description of the present invention and to facilitate the understanding thereof, a set of illustrative, non-limiting drawings is included as part of the description.

Figure 1 shows a perspective view of a schematic depiction of the portable breathing support equipment for providing breathing support by means of continuous positive airway pressure object of the invention, wherein the main parts and elements it comprises, as well as the arrangement thereof, specifically the fan and various interfaces in the form of a helmet connected thereto through a system of ducts, can be seen.

Figure 2 shows an elevational view of another schematic depiction of the equipment of the invention, in this case including only one of the interfaces in the form of a helmet connected to the liquid column which acts as expiratory resistance system, wherein the incoming and outgoing gas circuit it comprises can seen.

Figure 3 shows an elevational view of a schematic depiction of the expiratory resistance system formed by the bottle of liquid water column and the empty bottle for the collection of residues.

Figures 4 and 5 show corresponding perspective, side, and bottom views, respectively, of an example of one of the helmet-type interfaces which the equipment of the invention may comprise, wherein the configuration and essential parts thereof can be seen.

PREFERRED EMBODIMENT OF THE INVENTION

An example of portable breathing support equipment according to the present invention is described below. In that sense, the portable breathing support equipment for providing breathing support, by means of continuous positive airway pressure, to one or more patients simultaneously, as seen in figures 1 and 2, shows equipment (1) comprising a gas flow generation system (2) connectable through a set of ducts(3) to a plurality of interfaces (4), in respective gas inlet connectors (5), each being adaptable to the head of a different patient, up to a maximum of twenty, supplying gas flow to all of them simultaneously, likewise, at least one bottle (6) of liquid, the weight and volume of said liquid being known, for example 1 litre of pure water, which, when connected to an expiration tube (7) coming from the outlet connection (8) of the interfaces (4), also having a known diameter, constitutes a “water column” which acts as a positive pressure control system in said interfaces (4).

Preferably, the interfaces (4) are helmet- or mask-type interfaces. More preferably, the interfaces (4) are mask-type interfaces.

The pressure of the equipment (1 ) can be regulated to a certain value since the volume of liquid contained in the bottle (6) of liquid and the diameter of the expiration tube (7) through which air is introduced from the interfaces (4) may vary.

The liquid contained by said bottle (6) of liquid or water column can be water or an aqueous solution of a disinfecting agent, for example, bleach, such that it is used at the same time for purifying aerosols generated by the patients.

Preferably, the equipment further comprises an empty bottle (16) connected to the bottle (6) of liquid in the circuit of the expiration tube (7) of the equipment (1) with the function of retaining possible residues contained in the expirated air. An example of said option can be observed in Figure 3.

Optionally, the equipment (1) further comprises a flowmeter (9) connected in the gas supply duct to each interface for taking the measurement of the operating flow/pressure.

Figure 2 shows the equipment (1) with only one helmet (4) and the direction in which the air flows from the gas flow generation system (2), i.e., a turbine which can be a fan or a blower, to said helmet (4) through the duct (3) is depicted by means of arrows, said turbine (2) can be seen to have flow control means (17) and an alarm indicator (18).

In this preferred embodiment, the turbine (2) is connected to the different helmets (4), as seen in figure 1, by interposing a main distribution conduit (10), preferably rigid, which is connected to the air outlet of the fan or blower (2) and wherein a series of perforations (11) has been made along same suitable for the connection of the respective secondary conduits (3) which are in turn connected to the gas inlet connection (5) of the respective helmets (4), said perforations (11 ) being provided with means for blocking same and thereby closing the passage of air if a secondary conduit (3) is not connected therein, allowing varying the number of helmets (4) that are connected to the fan (2) depending as needed, preferably up to 20.

Considering figures 3 and 4, it can be seen how the interfaces (4) are preferably helmet-type interfaces, and each helmet is formed by a hollow cylindrical body (12) made of a transparent and flexible plastic material, preferably polyurethane, sealed by means of a manufacturing method which ensures a tight seal, preferably by means of high frequency welding, said body going around the entire head of the patient fitted to their neck through a lower opening (13) and having two connections, i.e., a gas inlet connection (5) to which the ducts (3) coming from the fan (2) are connected and another outlet connection (8) wherein the expiration tube (7) connecting with the positive pressure control system formed by the bottle (6) of liquid or water column is connected.

Preferably, the helmet-type interface (4) further has a harness (14) provided with Velcro fastening elements for fastening to the torso of the body of the patient and adjustable side tensioning elements (15).

In a preferred embodiment, the portable breathing support equipment for providing breathing support by means of positive pressure enables the treatment of up to 20 patients simultaneously. To do so, the gas flow generation system (2) comprises, as a gas flow generation system (2), a blower which supplies a flow of 100 m³/h with a water column of 17.5 cm and a static pressure of 20 cm of water. The system also comprises, attached to the gas flow control system (2), a programmable logic controller, a display, gas flow parameter measuring systems, and a beacon system for visual alarm warning, all of these being electrically powered.

The main distribution conduit (10) is manufactured from sanitary PVC and has an inner diameter of 125 mm, being configured in segments of 1500 mm. Each of these segments includes five outlets for supplying gas to an interface (4) through a secondary conduit (3), with four segments therefore being necessary in order to provide 20 outlets simultaneously. In each of these outlets a regulating valve is preferably incorporated which enables the outlets to which no interface is connected to be closed, and if an interface is connected, it enables the positive pressure of the gas of the patient who is using said interface to be regulated.

Claims

1. Portable breathing support equipment comprising:

- a gas flow generation system (2) with a gas inlet and a gas outlet connector, - at least one interface (4) for adaptation to the face or head of a patient covering their nose and/or mouth, each with an inlet connector (5) and an outlet connector (8), and

- an expiratory resistance system connected to the outlet connector (8) of the interface (4), characterised in that it further comprises a main distribution conduit (10) connected to the gas outlet connector of the gas flow generation system (2), said main conduit (10) having at least two gas flow outlet connections (11) along the main conduit (10), at least one of the two outlet connections (11) having an end of a secondary conduit (3) connected thereto, and the opposite end of the secondary conduit (3) connected to the inlet connector of the interface (4).

2. The equipment according to claim 1 , characterised in that the expiratory resistance system comprises a first bottle (6) with a liquid therein, connected to the outlet connector (8) of the interface (4) by means of an expiration tube (7), acting as a system for controlling individual positive pressure in each interface (4) and as a system for purifying the expirated aerosols.

3. The equipment according to claim 2, characterised in that it comprises a second empty bottle (16) connected to the first bottle (6) of liquid for retaining possible residues.

4. The equipment according to any of claims 2 or 3, characterised in that the first bottle (6) comprises water.

5. The equipment according to any of claims 2 to 4, characterised in that the first bottle (6) of liquid comprises a disinfecting agent.

6. The equipment according to claim 5, characterised in that the disinfecting agent is bleach.

7. The equipment according to any of claims 2 to 6, characterised in that it comprises a low resistance anti-viral and/or anti-bacterial filter after the expiratory resistance system and before the outlet of the expirated gases into the atmosphere.

8. The equipment according to claim 1 , characterised in that said outlet connections (11 ) comprise means for blocking same when no secondary conduit (3) is connected thereto.

9. The equipment according to any of the preceding claims, characterised in that at least one gas flow regulating valve is interposed between the outlet connection (11) and the secondary conduit (3).

10. The equipment according to any of the preceding claims, characterised in that at least one element for gas treatment is interposed between the outlet connection (11) and the inlet connector (5) of the interface (4).

11. The equipment according to claim 10, characterised in that said element for gas treatment can be at least one low resistance anti-viral filter, and/or a low resistance anti-bacterial filter, and/or an oxygen supply system, and/or a gas humidification system, and/or a gas heating system, and/or a flowmeter, among others.

12. The equipment according to any of the preceding claims, characterised in that the main conduit (10) comprises up to 20 gas flow outlet connections (11).

13. The equipment according to any of the preceding claims, characterised in that the interface (4) is a helmet- or mask-type interface.

14. The equipment according to claim 13, characterised in that the helmet- type interface (4) comprises a hollow cylindrical body (12) made of a transparent and flexible plastic material, going around the entire head of the patient fitted to their neck through a lower opening (13).

15. The equipment according to claim 14, characterised in that the plastic material is polyurethane.

16. The equipment according to any of claims 14 or 15, characterised in that the interface (4) comprises a harness (14) provided with fastening elements for fastening to the torso of the body of the patient and adjustable side tensioning elements (15).

17. The equipment according to any of the preceding claims, characterised in that the gas flow generation system (2) comprises at least one turbine, a gas flow control system, and an electrical energy source.

18. The equipment according to claim 16, characterised in that the turbine is a fan and/or a blower.

19. The equipment according to any of the preceding claims, characterised in that the gas is air.