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EP3110489A1 - Device for the administration of an air/gas mixture for respiratory therapy - Google Patents

Device for the administration of an air/gas mixture for respiratory therapy

Info

Publication number
EP3110489A1
EP3110489A1 EP15710864.8A EP15710864A EP3110489A1 EP 3110489 A1 EP3110489 A1 EP 3110489A1 EP 15710864 A EP15710864 A EP 15710864A EP 3110489 A1 EP3110489 A1 EP 3110489A1
Authority
EP
European Patent Office
Prior art keywords
tubular body
section
gas
outlet nozzle
air
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Withdrawn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
EP15710864.8A
Other languages
German (de)
French (fr)
Inventor
Domenico Scardovi
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.)
Deas SRL
Original Assignee
Deas SRL
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 Deas SRL filed Critical Deas SRL
Publication of EP3110489A1 publication Critical patent/EP3110489A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
    • A61M16/125—Diluting primary gas with ambient air
    • A61M16/127—Diluting primary gas with ambient air by Venturi effect, i.e. entrainment mixers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/10—Mixing gases with gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/30—Injector mixers
    • B01F25/31—Injector mixers in conduits or tubes through which the main component flows
    • B01F25/312—Injector mixers in conduits or tubes through which the main component flows with Venturi elements; Details thereof
    • B01F25/3124—Injector mixers in conduits or tubes through which the main component flows with Venturi elements; Details thereof characterised by the place of introduction of the main flow
    • B01F25/31242—Injector mixers in conduits or tubes through which the main component flows with Venturi elements; Details thereof characterised by the place of introduction of the main flow the main flow being injected in the central area of the venturi, creating an aspiration in the circumferential part of the conduit
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/30—Injector mixers
    • B01F25/31—Injector mixers in conduits or tubes through which the main component flows
    • B01F25/312—Injector mixers in conduits or tubes through which the main component flows with Venturi elements; Details thereof
    • B01F25/3125—Injector mixers in conduits or tubes through which the main component flows with Venturi elements; Details thereof characteristics of the Venturi parts
    • B01F25/31252—Nozzles
    • B01F25/312521—Adjustable Venturi nozzle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/42—Reducing noise

Definitions

  • the present invention refers to a device for the administration of an air/ gas mixture for respiratory therapy.
  • the present invention refers to a device for the administration of oxygen-enriched air, especially in assisted breathing therapy of the CPAP (continuous positive air pressure) type.
  • CPAP continuous positive air pressure
  • Devices for the administration of air and oxygen are usually employed by connecting an inlet to an oxygen source and an outlet to devices, for instance hoods, masks, tracheal tubes, tracheostomy tubes or nasal cannulas, which interface with the patient's airways.
  • These devices are furthermore connected to a source of air, usually the surrounding ambient air, which is appropriately mixed with the oxygen and as a mixture administered to the patient.
  • a source of air usually the surrounding ambient air, which is appropriately mixed with the oxygen and as a mixture administered to the patient.
  • the concentration of the air/ oxygen mixture depends on the structure of a nozzle connected to the oxygen source and on the lateral apertures that are in fluid communication with the nozzle's outlet, by which ambient air is sucked in through the Venturi effect.
  • the result is a certain air/ oxygen mixture with a certain concentration.
  • GB2407043 discloses an adj ⁇ stable Venturi device for mixing gases for inhalation.
  • the device comprises a first gas inlet and a mixing chamber in fluid communication with a second gas inlet for introducing a second gas into the mixing chamber, first and second Venturi inlets for introducing a first gas into the mixing chamber, and a gas outlet by which a mixture of first and second gases can exit the mixing chamber.
  • Each of the first and second Venturi inlets comprises a fluid conduit that terminates at an exit orifice through which the first gas is introduced into the mixing chamber.
  • the Venturi device is switchable between a first state in which the first gas inlet is in fluid communication with the first Venturi inlet, and a second state in which the first gas inlet is in fluid communication with the second Venturi inlet.
  • CPAP therapy has to guarantee that positive pressure on the patient's airways is maintained for the whole of the respiratory cycle, also in case of deep inhalations by the patient, as even a momentary negative pressure could cause alveolar collapse, which would make the therapy less effective.
  • the device must be able to deliver elevated airflows that make it also possible to generate a particular pressure against which the patient can, in the absence of expiration valves, exhale (PEEP - positive end-expiratory pressure).
  • Venturi devices for respiratory therapy with a single amplification nozzle are known.
  • the technical problem at the basis of the present invention is therefore creating a device for the administration of a mixture of ambient air / oxygen that makes it possible to deliver flows up to 150 litres per minute with a limited consumption of oxygen, with reduced noise levels of the air jet and at the same time permitting a pressure to be generated up to 15 cm/H2O with a reduced overall airflow, within the context of a simple and rational constructive solution.
  • FIG. 1 shows a perspective view of a device in accordance with the invention, according to a first embodiment
  • FIG. 2 shows a front view of the device of figure 1 ;
  • FIG. 3 show a rear view, the opposite of the view of figure
  • FIG. 4 shows a cross section view of the device of figure 1 taken along the plane that passes through the line A-A in figure 3;
  • FIG. 5 shows a cross section view of the device of figure 1 taken along the plane that passes through the line B-B of figure 4;
  • FIG. 6 shows a perspective view of a detail of the device of figure 1 ;
  • FIG. 7 shows a top view of the detail of figure 6
  • FIG. 8 shows a side view of the device of figure 6
  • - Figure 9 shows a cross section view of the device of figure 6 taken along the plane that passes through the line C-C of figure 8;
  • FIG. 10 shows a perspective view of a device according to the invention, in accordance with a second embodiment
  • FIG. 1 1 shows an exploded view of the device of figure 10;
  • - Figure 12 shows a side view of the device of figure 10;
  • FIG. 13 shows a front view of the device of figure 10
  • the reference number 1 is used to indicate a device for the administration of an air/ gas flow for respiratory therapy according to the invention, in accordance with a first embodiment.
  • the entire device 1 is of the disposable kind and made entirely of a plastic material.
  • the device 1 comprises a hollow tubular body 2 that extends along a central axis X, a gas outlet nozzle body 3, a gas inlet nozzle 4 in fluid communication with the outlet nozzle body 3, at least one air intake aperture 5.
  • the hollow tubular body 2 can be directly connected to a device that interfaces with the patient's airways, e.g. hoods, masks, tracheal tubes, tracheostomy tubes or nasal cannulas.
  • a device that interfaces with the patient's airways e.g. hoods, masks, tracheal tubes, tracheostomy tubes or nasal cannulas.
  • tubular conduit 2 to the device that interfaces with the patient by means of a tube that is at some point intercepted by other devices known from prior art.
  • tubular body 2 is realized as a hollow cylindrical tubular conduit comprising a first section 2a with a first cylindrical inner wall, a second section 2c with a second cylindrical inner wall and a third section 2b with a conical inner wall.
  • the first cylindrical inner wall of the first section 2 a has a diameter D that is greater than the diameter d of the second cylindrical inner wall of the second section 2c.
  • the section 2 b with the conical inner wall is placed between the first section 2a and the second section 2c with cylindrical inner walls. Basically the third section converges in the direction of the flow.
  • the third section 2b will be referred to as the "conical section", meaning that it has a conical inner wall.
  • the outlet nozzle body 3 is placed inside the tubular body 2 at one of its extremities and it is distanced from the inner wall of the tubular body 2 in order to form an annular cavity 6. More particularly the outlet nozzle body 3 is placed alongside the first section 2a of the tubular body and partially alongside the conical section 2b.
  • outlet nozzle body 3 comprises a plurality of exit holes 31 from which the gas coming from the inlet nozzle 4 exits.
  • the placement of the outlet nozzle body 3 inside the tubular body 2 is such that the exiting gas is mixed with the air that enters the tubular body 2, as a result of the Venturi effect, through at least one aperture 5 through the annular cavity 6, before it reaches the interface device and thus the patient.
  • the inlet nozzle 4 has a tapered form to be able to be connected to an intake tube for the gas that is to be mixed with the air.
  • the inlet nozzle 4 is attached to a flange 7 and the latter is attached to an extremity of the tubular body 2.
  • the inlet nozzle 4 is connected to a source of pressurized oxygen.
  • aperture 5 there is at least one aperture 5 on the flange 7. In the illustrated example there are four apertures placed circumferentially with respect to the inlet nozzle 4 at the annular cavity 6.
  • the overall surface occupied by the apertures 5 is between 1 and 1.8 times the extent of the second section 2c (the one with the smaller cross section) of the tubular body 2.
  • the inlet nozzle 4 is placed centrally on the flange 7 so that it is coaxial with the axis X.
  • the outlet nozzle body 3 is attached onto the flange on an internal side of the tubular body 2.
  • the inlet nozzle 4 and the outlet nozzle body 3 are placed in axial alignment along the axis X.
  • the outlet nozzle body 3 has a cusp-shaped conformation that is hollow on the inside (figure 6) with a main central through hole 31 located at the apex 32 of the cusp and other secondary through holes 31 located circumferentially and axially at a distance from the central hole.
  • outlet nozzle body 3 is realized as a thimble with the main hole 31 at the centre on the point and the four secondary holes 32 placed inside longitudinal recesses 33 that are circumferentially equidistant to each other.
  • the four secondary holes 32 are located at a certain axial distance with respect to the main hole 31.
  • the four secondary holes 32 lie on a plane that is located at a certain distance from the main hole 31.
  • the conical section 2 b of the tubular body 2 which constitutes the passage from the larger diameter D of the first section 2a to the smaller diameter d of the second section 2c, is found at the main hole 31 of the outlet nozzle body 3.
  • the diameter of the tubular body 2 undergoes, with reference to its inner walls, a diminution precisely at the gas exit, usually oxygen, of the outlet nozzle body 3.
  • the diameter of the second section 2c of the tubular body 2 is preferably between 0.4 and 0.5 times the diameter of the first section 2a of the tubular body 2.
  • the diameter of the second section 2c of the tubular body 2 is at the most half of the diameter of the first section 2a of the tubular body 2.
  • a diameter of 27.6 mm becomes a diameter of 12 mm, this diminution occurs by means of a conical section having a length of 7.8 mm along the axis X, for a tubular body 2 that is 71.3 mm long.
  • the tubular body 2 has a tubular sleeve 22 placed around the second section 2c with the cylindrical inner wall of smaller diameter, which together with the tubular body forms a cavity 23, in such a manner that at the extremity where the air/ oxygen mixture exits, two different diameters are available, one that is smaller than the tubular body 2 - the one of the second section 2c - and one that is larger than the tubular sleeve 22.
  • the gas coming from the inlet nozzle 4 arrives inside the thimble 3 which functions as a collector from which the gas exits through the five holes 31, 32 before being led into the tubular body 2.
  • the breaking up of the oxygen flow in the plurality of holes of the thimble 3 considerably reduces noise levels and reinforces the effect of drawing in ambient air.
  • the device 1 of the present invention allows operation with exit flow rates in the order of 1 15 litres/ minute, with an oxygen delivery of 18 litres per minute at a pressure of 0.5 bar, all the while remaining at a noise level of around 68 dB, measured at a distance of 20 cm from the device, with a pressure (PEEP) of 5.0
  • the conformation of the outlet nozzle body 3 can be decided on the basis of the effect to be obtained.
  • a shutter valve 8 that is rotatably attached to the tubular body 2 and that can at least partially shut off the air intake into the annular cavity 6.
  • shutter valve 8 The application of the shutter valve 8 is illustrated in figures 10- 14 in which the second embodiment of the present invention is shown.
  • This device of the second embodiment is identical to the one described in relation to the first embodiment, with the exception of the presence of a shutter valve 8 and the different air intake aperture layout.
  • the air intake aperture 5 is placed laterally on the tubular body 2 at the annular cavity 6.
  • the shutter valve 8 is realized as a cap that is mounted over the flange 7 through a hole from which the inlet nozzle 4 sticks out.
  • Adjustment of the closure of the aperture 5 is done by rotating the cap 8 on the tubular body 2.
  • the cap presents two corresponding apertures 81 opposite each other that in a specific position line up with the apertures 5 on the tubular body 2.
  • the device for the administration of an air/ gas flow for respiratory therapy makes it possible to meet the needs and overcome the drawbacks discussed in the introductory part of this description with reference to the prior art.
  • the device for the administration of an air/gas flow for respiratory therapy is easy to manufacture, compact, versatile and easy to use.
  • the device for the administration of an air/ gas flow for respiratory therapy is a connector that in a single device combines the possibility of operating within a range of gas/ air concentrations that guarantees the delivery of an overall particularly high flow of the mixture also when operating at low pressures, so that noise levels are reduced and at the same time the secure fastening of the connections is ensured.

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  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

The present invention is concerned with a device for the administration of a flow of air/gas for respiratory therapy, comprising: - a hollow tubular body (2) that is intended to be connected to a patient interface device; - a gas outlet nozzle body (3) placed inside said tubular body and distanced from the inner wall of the tubular body in order to form an annular cavity (6); - a gas inlet nozzle (4) in fluid communication with the nozzle body and intended to be connected to a gas source; - at least one air intake aperture (5) intended to place the tubular body in communication with the outside environment, wherein the outlet nozzle body comprises a plurality of outlet holes (31, 32) from which the gas coming from the inlet nozzle exits, and wherein the gas exiting from the outlet holes is mixed with the air that enters the tubular body, as a result of the Venturi effect, from said at least one air intake aperture through said annular cavity, before it reaches the interface device.

Description

Title: "Device for the administration of an air/ gas mixture for respiratory therapy"
DESCRIPTION
Field of application
The present invention refers to a device for the administration of an air/ gas mixture for respiratory therapy.
More particularly the present invention refers to a device for the administration of oxygen-enriched air, especially in assisted breathing therapy of the CPAP (continuous positive air pressure) type.
Prior art
Devices for the administration of air and oxygen are usually employed by connecting an inlet to an oxygen source and an outlet to devices, for instance hoods, masks, tracheal tubes, tracheostomy tubes or nasal cannulas, which interface with the patient's airways.
These devices are furthermore connected to a source of air, usually the surrounding ambient air, which is appropriately mixed with the oxygen and as a mixture administered to the patient.
The concentration of the air/ oxygen mixture depends on the structure of a nozzle connected to the oxygen source and on the lateral apertures that are in fluid communication with the nozzle's outlet, by which ambient air is sucked in through the Venturi effect.
In other words, depending on the structure of the nozzle delivering the oxygen and the size of the apertures through which air is aspirated, with the oxygen flow delivered under pressure by the nozzle being equal, the result is a certain air/ oxygen mixture with a certain concentration.
GB2407043 discloses an adjμstable Venturi device for mixing gases for inhalation. The device comprises a first gas inlet and a mixing chamber in fluid communication with a second gas inlet for introducing a second gas into the mixing chamber, first and second Venturi inlets for introducing a first gas into the mixing chamber, and a gas outlet by which a mixture of first and second gases can exit the mixing chamber. Each of the first and second Venturi inlets comprises a fluid conduit that terminates at an exit orifice through which the first gas is introduced into the mixing chamber. The Venturi device is switchable between a first state in which the first gas inlet is in fluid communication with the first Venturi inlet, and a second state in which the first gas inlet is in fluid communication with the second Venturi inlet.
The administration of the mixture with a wide flow range of 1 -
180 litre per minute makes different therapeutic uses possible, including CPAP.
CPAP therapy has to guarantee that positive pressure on the patient's airways is maintained for the whole of the respiratory cycle, also in case of deep inhalations by the patient, as even a momentary negative pressure could cause alveolar collapse, which would make the therapy less effective.
To obtain that aim the device must be able to deliver elevated airflows that make it also possible to generate a particular pressure against which the patient can, in the absence of expiration valves, exhale (PEEP - positive end-expiratory pressure).
Venturi devices for respiratory therapy with a single amplification nozzle are known.
The constructive design of these devices, however, is inadequate for enabling a large effect of air entrainment, an appropriate exit pressure and an acceptable noise level when operated at high flow rates, as is the case in CPAP therapy.
The technical problem at the basis of the present invention is therefore creating a device for the administration of a mixture of ambient air / oxygen that makes it possible to deliver flows up to 150 litres per minute with a limited consumption of oxygen, with reduced noise levels of the air jet and at the same time permitting a pressure to be generated up to 15 cm/H2O with a reduced overall airflow, within the context of a simple and rational constructive solution.
Summary of the invention
This problem is resolved by a device for the administration of an air/ gas mixture for respiratory therapy in accordance with claim 1 of the present invention.
The dependent claims disclose preferred and particularly advantageous embodiments of the device in accordance with the invention.
Further characteristics and advantages will become clearer from the following detailed description of a preferred but not exclusive embodiment of the present invention, with reference to the enclosed figures, given by way of non-limiting examples. Brief description of the drawings
- Figure 1 shows a perspective view of a device in accordance with the invention, according to a first embodiment;
- Figure 2 shows a front view of the device of figure 1 ; - Figure 3 show a rear view, the opposite of the view of figure
2, of the device of figure 1;
- Figure 4 shows a cross section view of the device of figure 1 taken along the plane that passes through the line A-A in figure 3;
- Figure 5 shows a cross section view of the device of figure 1 taken along the plane that passes through the line B-B of figure 4;
- Figure 6 shows a perspective view of a detail of the device of figure 1 ;
- Figure 7 shows a top view of the detail of figure 6;
- Figure 8 shows a side view of the device of figure 6; - Figure 9 shows a cross section view of the device of figure 6 taken along the plane that passes through the line C-C of figure 8;
- Figure 10 shows a perspective view of a device according to the invention, in accordance with a second embodiment;
- Figure 1 1 shows an exploded view of the device of figure 10; - Figure 12 shows a side view of the device of figure 10;
- Figure 13 shows a front view of the device of figure 10;
- Figure 14 shows a cross section view of the device of figure
10.
Detailed description
With reference to figure 1 the reference number 1 is used to indicate a device for the administration of an air/ gas flow for respiratory therapy according to the invention, in accordance with a first embodiment.
Preferably the entire device 1 is of the disposable kind and made entirely of a plastic material.
The device 1 comprises a hollow tubular body 2 that extends along a central axis X, a gas outlet nozzle body 3, a gas inlet nozzle 4 in fluid communication with the outlet nozzle body 3, at least one air intake aperture 5.
The hollow tubular body 2 can be directly connected to a device that interfaces with the patient's airways, e.g. hoods, masks, tracheal tubes, tracheostomy tubes or nasal cannulas.
Alternatively it is possible to connect the tubular conduit 2 to the device that interfaces with the patient by means of a tube that is at some point intercepted by other devices known from prior art.
In the illustrated example the tubular body 2 is realized as a hollow cylindrical tubular conduit comprising a first section 2a with a first cylindrical inner wall, a second section 2c with a second cylindrical inner wall and a third section 2b with a conical inner wall.
The first cylindrical inner wall of the first section 2 a has a diameter D that is greater than the diameter d of the second cylindrical inner wall of the second section 2c.
The section 2 b with the conical inner wall is placed between the first section 2a and the second section 2c with cylindrical inner walls. Basically the third section converges in the direction of the flow.
For the sake of simplicity of explanation in the following description the third section 2b will be referred to as the "conical section", meaning that it has a conical inner wall.
The outlet nozzle body 3 is placed inside the tubular body 2 at one of its extremities and it is distanced from the inner wall of the tubular body 2 in order to form an annular cavity 6. More particularly the outlet nozzle body 3 is placed alongside the first section 2a of the tubular body and partially alongside the conical section 2b.
Furthermore the outlet nozzle body 3 comprises a plurality of exit holes 31 from which the gas coming from the inlet nozzle 4 exits.
The placement of the outlet nozzle body 3 inside the tubular body 2 is such that the exiting gas is mixed with the air that enters the tubular body 2, as a result of the Venturi effect, through at least one aperture 5 through the annular cavity 6, before it reaches the interface device and thus the patient.
Thanks to this particular configuration it is possible to obtain a more efficacious aspiration of outside air and a greater dynamic pressure of the exiting gas as a result of its increased velocity.
Preferably the inlet nozzle 4 has a tapered form to be able to be connected to an intake tube for the gas that is to be mixed with the air.
In the illustrated example the inlet nozzle 4 is attached to a flange 7 and the latter is attached to an extremity of the tubular body 2. Usually the inlet nozzle 4 is connected to a source of pressurized oxygen. In order to adjust the output of the tubular body 2 it is sufficient to directly modify the intake of gas from the inlet nozzle 4, for example by means of a flow meter.
There is at least one aperture 5 on the flange 7. In the illustrated example there are four apertures placed circumferentially with respect to the inlet nozzle 4 at the annular cavity 6.
These apertures 5, in addition to allowing the intake of external ambient air that is sucked into the annular cavity 6 as a result of the Venturi effect, also allow air exhaled by the patient during exhalation to exit without any need for a mechanical PEEP valve.
The overall surface occupied by the apertures 5 is between 1 and 1.8 times the extent of the second section 2c (the one with the smaller cross section) of the tubular body 2.
The inlet nozzle 4 is placed centrally on the flange 7 so that it is coaxial with the axis X.
The outlet nozzle body 3 is attached onto the flange on an internal side of the tubular body 2.
The inlet nozzle 4 and the outlet nozzle body 3 are placed in axial alignment along the axis X.
In accordance with a preferred embodiment of the present invention the outlet nozzle body 3 has a cusp-shaped conformation that is hollow on the inside (figure 6) with a main central through hole 31 located at the apex 32 of the cusp and other secondary through holes 31 located circumferentially and axially at a distance from the central hole.
In the example the outlet nozzle body 3 is realized as a thimble with the main hole 31 at the centre on the point and the four secondary holes 32 placed inside longitudinal recesses 33 that are circumferentially equidistant to each other.
The four secondary holes 32 are located at a certain axial distance with respect to the main hole 31.
In practice the four secondary holes 32 lie on a plane that is located at a certain distance from the main hole 31.
The conical section 2 b of the tubular body 2, which constitutes the passage from the larger diameter D of the first section 2a to the smaller diameter d of the second section 2c, is found at the main hole 31 of the outlet nozzle body 3. In practice, the diameter of the tubular body 2 undergoes, with reference to its inner walls, a diminution precisely at the gas exit, usually oxygen, of the outlet nozzle body 3.
The diameter of the second section 2c of the tubular body 2 is preferably between 0.4 and 0.5 times the diameter of the first section 2a of the tubular body 2.
In practice the diameter of the second section 2c of the tubular body 2 is at the most half of the diameter of the first section 2a of the tubular body 2.
By way of example, a diameter of 27.6 mm becomes a diameter of 12 mm, this diminution occurs by means of a conical section having a length of 7.8 mm along the axis X, for a tubular body 2 that is 71.3 mm long.
In order to improve the flexibility of the device of the present invention, the tubular body 2 has a tubular sleeve 22 placed around the second section 2c with the cylindrical inner wall of smaller diameter, which together with the tubular body forms a cavity 23, in such a manner that at the extremity where the air/ oxygen mixture exits, two different diameters are available, one that is smaller than the tubular body 2 - the one of the second section 2c - and one that is larger than the tubular sleeve 22.
This makes it possible on the one hand to avoid having to make a thick plastic wall that would be subject to deformation during injection moulding and on the other hand it makes it possible to connect the device 1 to two different connectors of different diameters.
From an operational point of view the gas coming from the inlet nozzle 4 arrives inside the thimble 3 which functions as a collector from which the gas exits through the five holes 31, 32 before being led into the tubular body 2.
The breaking up of the oxygen flow in the plurality of holes of the thimble 3 considerably reduces noise levels and reinforces the effect of drawing in ambient air.
In fact it has been shown that with a single hole measuring 0.95 mm2 a noise level of 82 dBA can be determined, whereas the presence of five holes of 0.5 mm2 (with a total surface area for these five holes that is equal to 0.95) a noise level of 70.7 dBA is reached, measured under equal circumstances. By way of example the device 1 of the present invention allows operation with exit flow rates in the order of 1 15 litres/ minute, with an oxygen delivery of 18 litres per minute at a pressure of 0.5 bar, all the while remaining at a noise level of around 68 dB, measured at a distance of 20 cm from the device, with a pressure (PEEP) of 5.0
With exit flow rates in the order of 180 litres/ minute, with 24 litres per minute of oxygen delivered at 1 bar, a noise level can be measured, at a distance of 20 cm from the device, that is around 74,3 dB and with a PEEP pressure of 1 1.8 cm/H20.
Because of the particular cusp- shaped configuration of the outlet nozzle body 3 it is possible to increase the gas/ air flow delivered to the patient.
The conformation of the outlet nozzle body 3 can be decided on the basis of the effect to be obtained.
Around the outlet nozzle body 3 air is sucked into the cavity 6 through the apertures 5 located on the flange 7.
Should different concentrations of oxygen be needed it is possible to apply a shutter valve 8 that is rotatably attached to the tubular body 2 and that can at least partially shut off the air intake into the annular cavity 6.
The application of the shutter valve 8 is illustrated in figures 10- 14 in which the second embodiment of the present invention is shown.
This device of the second embodiment is identical to the one described in relation to the first embodiment, with the exception of the presence of a shutter valve 8 and the different air intake aperture layout.
The reference numbers are therefore the same and what has already been stated previously with reference to the first embodiment of the device 1 will not be repeated.
In this second embodiment the air intake aperture 5 is placed laterally on the tubular body 2 at the annular cavity 6.
In the example there are two apertures 5 opposite each other. The shutter valve 8 is realized as a cap that is mounted over the flange 7 through a hole from which the inlet nozzle 4 sticks out.
Adjustment of the closure of the aperture 5 is done by rotating the cap 8 on the tubular body 2.
\ At the base of the cap 8 there is an arched slot 9 into which a pin 10 that is attached to the flange 7 is inserted (Fig. 13).
In this manner the cap 8 is constrained to rotating between the two extremities of the slot 9, this position being reached when the pin 10 comes to rest against the extremity of the slot 9.
By rotating the cap 8, the access of outside air through the apertures 5 is either opened or shut off.
To allow the air to pass through the apertures 5, the cap presents two corresponding apertures 81 opposite each other that in a specific position line up with the apertures 5 on the tubular body 2.
As can be appreciated from this description the device for the administration of an air/ gas flow for respiratory therapy according to the present invention makes it possible to meet the needs and overcome the drawbacks discussed in the introductory part of this description with reference to the prior art.
In fact the device for the administration of an air/gas flow for respiratory therapy according to the present invention is easy to manufacture, compact, versatile and easy to use.
In practice the device for the administration of an air/ gas flow for respiratory therapy according to the present invention is a connector that in a single device combines the possibility of operating within a range of gas/ air concentrations that guarantees the delivery of an overall particularly high flow of the mixture also when operating at low pressures, so that noise levels are reduced and at the same time the secure fastening of the connections is ensured.
Obviously, in order to meet contingent and specific needs a person skilled in the art can apply numerous modifications and variations to the device for the administration of an air/ gas flow for respiratory therapy as described above, all of which however fall within the scope of protection of the invention as defined by the following claims.

Claims

1. Device for the administration of an air/ gas flow for respiratory therapy comprising
- a hollow tubular body (2) that extends along a central axis (X) and that is intended to be connected to a patient interface device for the administration of the flow;
- a gas outlet nozzle body (3);
- a gas inlet nozzle (4) in fluid communication with the gas outlet nozzle body (3) and intended to be connected to a gas source;
- at least one air intake aperture (5) intended to place the tubular body (2) in communication with the outside environment,
wherein the outlet nozzle body (3) is placed inside said tubular body (2) at one of its extremities and distanced from the inner wall of the tubular (2) in order to form an annular cavity (6), and wherein the outlet nozzle body (3) comprises a plurality of outlet holes (31,32) from which the gas coming from the inlet nozzle (4) exits, said outlet nozzle body (3) being placed inside the tubular body (2),
characterized in that the hollow tubular body (2) comprises a first section (2a) with a first cylindrical inner wall, a second section (2c) with a second cylindrical inner wall, the first cylindrical inner wall having a diameter (D) that is greater than the diameter (d) of the second cylindrical inner wall, and a third section (2b) with a conical inner wall, said third section (2b) being placed between said first section (2a) and said second section (2 c), said outlet nozzle body (3) extending only along said first section (2a) and partially along said third section (2b), so that the gas exiting from the holes (31, 32) is mixed with the air that enters the tubular body (2) as a result of the Venturi effect from said at least one aperture (5) through said annular cavity (6), before reaching the interface device.
2. Device according to claim 1 , wherein said at least one aperture (5) is placed perpendicularly to said central axis (X) facing the annular cavity (6).
3. Device according to claim 1 or 2, wherein the inlet nozzle (4) is attached to a flange (7), the flange (7) being attached to an extremity of the tubular body (2).
4. Device according to claim 3, wherein said at least one aperture (5) is located on said flange (7).
5. Device according to claim 3 or 4, wherein said outlet nozzle body (3) is attached to the flange (7) on an interior side of the tubular body (2) .
6. Device according to any of the previous claims, wherein said outlet nozzle body (3) presents a hollow cusp-shaped conformation having a main central through hole (31) located at the apex of said cusp and other through holes (32) located circumferentially and axially distanced with respect to the central hole (31).
7. Device according to claim 6, wherein said one main central hole (31) is located in said third section with the conical inner wall (2 b) of the tubular body (2).
8. Device according to claim 6 or 7, wherein said other through holes (32) located circumferentially and axially distanced with respect to the central hole (31) are located in said first section (2a).
9. Device according to any of the previous claims, comprising a plurality of apertures (5) located circumferentially with respect to the inlet nozzle (4) and to the outlet nozzle body (3).
10. Device according to any of the previous claims, wherein the inlet nozzle (4) and the outlet nozzle body (3) are arranged coaxially.
1 1. Device according to any of the previous claims, comprising a cap (8) that is rotatably mounted onto the tubular body and that is able to shut the air intake aperture (5).
12. Device according to any of the previous claims, wherein the tubular body (2) has a tubular sleeve (22) placed around the second section (2c) to form together with the tubular body (2) a cavity (23), in such a manner that at the extremity where the air/ gas mixture exits, two different diameters are available.
EP15710864.8A 2014-02-26 2015-02-17 Device for the administration of an air/gas mixture for respiratory therapy Withdrawn EP3110489A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO20140092 2014-02-26
PCT/IB2015/000184 WO2015128716A1 (en) 2014-02-26 2015-02-17 Device for the administration of an air/gas mixture for respiratory therapy

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EP3110489A1 true EP3110489A1 (en) 2017-01-04

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CN113456960A (en) * 2021-07-22 2021-10-01 南京晨伟医疗设备有限公司 Miniature first aid breathing machine
GB202216125D0 (en) * 2022-10-31 2022-12-14 Univ Oxford Innovation Ltd Medical ventilator

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US821354A (en) * 1905-08-25 1906-05-22 Theophil H Gebauer Inhaling apparatus.
US4036253A (en) * 1975-11-12 1977-07-19 Peace Medical Gas dilution device
US4595002A (en) * 1983-10-20 1986-06-17 Baxter Travenol Laboratories, Inc. Nebulizer
AU614731B2 (en) * 1986-12-09 1991-09-12 Maersk Indoplas Pty Limited Oxygen dilution apparatus
US6718979B1 (en) * 2000-06-05 2004-04-13 Dhd Healthcare Corporation Oxygen mask assembly
GB0305117D0 (en) 2003-03-06 2003-04-09 Intersurgical Ltd An adjustable venturi device
ATE461721T1 (en) * 2005-09-01 2010-04-15 Deas S R L VENTILATION SUPPORT DEVICE
JP4654266B2 (en) * 2008-05-14 2011-03-16 株式会社群馬コイケ Nebulizer
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