WO2015015394A1

WO2015015394A1 - Apparatus for aerosol therapy with adjustable positive airway pressure

Info

Publication number: WO2015015394A1
Application number: PCT/IB2014/063474
Authority: WO
Inventors: Luigi Abate; Riccardo Abate; Mauro Bertelli; Nicola Fraccaroli; Silvio DI PAOLO
Original assignee: Flaem Nuova S.P.A.
Priority date: 2013-08-02
Filing date: 2014-07-28
Publication date: 2015-02-05
Also published as: ITBS20130118A1; EP3027255A1

Abstract

The present invention relates to an apparatus (1) for aerosol therapy with adjustable positive airway pressure for the treatment and therapy of obstructive bronchopulmonary diseases, comprising a mixing chamber (2) having a tapered ending portion (11) and provided with a first and a second inlet (8; 9) and at least one outlet (10), the latter being arranged at the tapered ending portion, a nebulizing chamber (3), comprising an atomizing nozzle (4), which is outside the mixing chamber and which is fluidically connected therewith through the first inlet, a compressing device (5) connected to the nebulizing chamber to feed a flow of compressed air to the atomizing nozzle, a ventilation device/CPAP connected to the mixing chamber through the second inlet (9) to feed a flow of ventilation air therein, and an inhalation mask (7) connected to the mixing chamber (2) through the outlet (10).

Description

Title: "APPARATUS FOR AEROSOL THERAPY WITH ADJUSTABLE POSITIVE AIRWAY PRESSURE"

DESCRIPTION

Field of the Invention

The present invention, in its more general aspect, relates to an apparatus for aerosol therapy with adjustable positive airway pressure for the treatment of a subject (patient) with reduced inhalation power, i.e. a subject with a FEV1 (Forced Expiratory Volume in the 1st second) value lower than its own predictive value, for example due to cystic fibrosis, asthma, bronchiectasis and similar obstructive bronchopulmonary pathologies.

State of the Art

As it is known there are several pathologies impairing the pulmonary function and determining a decreased ventilation, specifically inhalation power in a subject suffering from one or more of these pathologies.

The inhalation power of a subject is generally indicated by the so called FEV1 or VEMS (Volume Espiratorio Massimo nel 1° secondo), parameter indicating the volume of air expired during the first second of a maximum forced expiration and indicating the patency degree of large airways.

Under a certain FEV1 value, for a given subject, the inhalation power is indeed decreased and it can be more or less severely reduced, based on the degree of bronchial obstruction and sometimes, further, its variability can also be poorly predictable.

Among pathologies determining a decreased inhalation power there are cystic fibrosis, chronic obstructive bronchitis, bronchiectasis and other obstructive bronchopulmonary pathologies which are often healed or however treated, inter alia, also by aerosol therapy.

Although advantageous for the therapy of the obstructive pulmonary pathologies, the classical therapy by aerosol is not free from drawbacks and, specifically, suffers a possible decreased ventilation power of a person subjected thereto, meaning that the therapy itself, in such cases, loses at least part of its efficiency due to the impaired pulmonary function of the treated person.

The pulmonary deposition of an aerosol, in fact, is always bound to the inhalation capacity of each subject. Persons with FEVl under 50% of the above said predictive value have a so-decreased pulmonary function to limit significantly the possibility for a nebulized medication to reach the lower airways.

Furthermore, it is always very hard to precisely establish the amount of nebulized medication which can really reach the bronchial tree.

In this regard, inter alia, vital capacity, age and FEVl of a person are discriminatory factors.

Furthermore, in certain pathologies implying the formation of mucus plugs, such as for example in chronic obstructive bronchopulmonary pathologies or in cystic fibrosis, mucus plugs can obstruct the airways to a large extent thereby perturbing the air flow of nebulized particles, thus decreasing the penetration thereof.

It has to be added that many studies have been done intended to optimize size and aerodynamics of particles composing an aerosol, so that today we speak of average aerodynamic diameter rather than particle diameter, since both particle size and shape and capability of remaining suspended in an air flow, determine the potentiality of a nebulized item.

Therefore, in the therapy of obstructive bronchopulmonary diseases and, particularly, in the treatment of a subject with decreased inhalation power, specifically of a subject with a FEVl value lower than its own predictive value, there is the need of increasing the effectiveness of the aerosol therapy or however of avoiding or limiting its efficiency from being more or less impaired by the degree of bronchial obstruction of the afore said person, and specifically there is the need of improving the pulmonary deposition of the nebulized item upon which the aerosol therapy is based.

Still as regard to the cystic fibrosis which, as known, is a rare genetic disease caused by an abnormal function of the CFTR {Cystic Fibrosis Transmembrane Regulator) protein regulating the intracellular ion exchange, specifically of chlorine, is has to be said that, among the most serious complications, it results in the dehydration of the liquid periciliary film which coats the airways and causes an impairment of the capability of expectorating the secretions with following bronchial obstruction, bacterial infections and inflammation of the respiratory tree.

Among therapies of increasing interest for the treatment and therapy of the cystic fibrosis, there is the one using highly hypertonic nebulized solutions (aerosols), i.e. 7% saline solutions.

A concentrated saline solution, such as the above mentioned hypertonic solutions, is able to draw water to the airways of a person subjected to such a treatment and, therefore, it is able to restore the periciliary aqueous film thus to at least partially restore the mucus ciliary function impaired by the disease.

The therapy with highly hypertonic nebulized solutions is however not free from drawbacks and undesirable effects among which a bothersome irritating pro-cough effect on the upper airways, a bronchial contraction effect which can cause the dosing termination and which however decreases the capability of carrying the aerosol in the deepest airways.

It has to be considered, furthermore, that the treatment with concentrated and nebulized saline solutions generally adjoins to other treatments carried out via inhalation, such as for example the antibiotic therapy or the therapy with mucolytics such as the DNase.

The variety of inhalation therapies, a patient suffering from chronic pulmonary disease has to be subjected to, dictates to have available inhalation systems which are effective regardless from the severity of the ventilation asset of the patient and thus provide with an effective inhalation therapy also the most impaired patients having FEV1 < 50-60% of the afore predictive value.

Still, in the therapy of the cystic fibrosis, there is the need of decreasing the annoyance a patient suffers during the treatment with a concentrated saline solution, due to the unpleasantness of the solution itself.

The known art compensated for some of the above described drawbacks limitedly to specific circumstances such as the hospital environment and the delivery of some active principles with determined chemical -physical features. US 2008/0000470, for example, describes an inhalation device for delivering a pulmonary surfactant nebulized in the therapeutic treatment of preterm infants comprising an aerosol generator, means for generating an air flow, a nebulizing chamber having a tapered area and means for intubating the patient connected to the tapered area of the nebulizing chamber.

Summary of the Invention

An object of the present invention is therefore to provide an apparatus for aerosol therapy for the therapy and the treatment of obstructive bronchopulmonary diseases and, particularly, of diseases featured by a FEV1 value lower than a predictive value for a given person subjected to the aerosol therapy (decreased inhalation power), having structural and functional characteristics such to overcome the above mentioned drawbacks and in particular such to improve the pulmonary deposition of the nebulized item upon which the aerosol therapy is based or, however, such to render the pulmonary deposition of the afore said nebulized item as independent from the FEV1 value as possible.

A further object of the present invention is to provide an apparatus for aerosol therapy for the treatment and the care of the cystic fibrosis, particularly but not exclusively through delivery of highly hypertonic solutions, which has structural and functional characteristics such to overcome the above mentioned drawbacks and, in particular, such to allow an improvement of the treatment effectiveness on one hand and a reduction of the unpleasantness of the same and the annoyance suffered by a patient subjected to the treatment on the other hand.

The afore said objects are satisfied by an apparatus for aerosol therapy for the treatment and care of obstructive bronchopulmonary diseases, specifically of diseases featured by a FEV1 value lower than a predictive value of a given person subjected to the aerosol therapy, particularly but not exclusively of cystic fibrosis, chronic obstructive bronchitis, bronchiectasis and asthma, apt to the delivery of a nebulized item, particularly but not exclusively of a highly hypertonic solution, i.e. a saline solution with salt concentration larger or equal to 7% by weight on the solution weight, wherein the afore said apparatus comprises a mixing chamber having a tapered ending portion and provided with a first and a second inlet openings and at least one outlet opening arranged at the afore said tapered ending portion, a nebulizing chamber comprising an atomizing nozzle, which is outside the afore said mixing chamber and fluidically connected therewith through the afore said first inlet, a compressing device connected to the afore said nebulizing chamber to feed a flow of compressed air to the atomizing nozzle, a ventilation device/CPAP connected to the afore said mixing chamber through the afore said second inlet for feeding a flow of ventilation air therein, and an inhalation mask connected to the afore said mixing chamber through the afore said outlet.

Preferably, the apparatus according to the invention comprises a tubular feeding element of the flow of ventilation air, having a tapered ending portion and connected to the afore said CPAP or ventilation device comprising, for example, a turbine and pressure sensors, and being associated with the afore said mixing chamber at the afore said second inlet, in particular associated with the same and free to slide therewith, at least for an extent of preset length wherein the afore said tapered ending portion, inside the mixing chamber, can have various distances from the afore said outlet.

Preferably, the apparatus according to the invention is a so called closed- circuit apparatus and comprises a first valve, preferably arranged in the mixing chamber and still preferably comprises a sealing gasket arranged peripherally on an outer edge of the afore said inhalation mask.

Preferably, the afore said first valve is a relief valve or a PEP valve {positive Expiratory Pressure) apt to be active and open during an expiratory step, i.e. a one-way valve provided with a relief opening having determined limited dimensions or provided/associated with an adjustable expiratory mechanical resistance, such to generate a pressure up to 20 cm H₂0.

Preferably the apparatus according to the invention is apt to operate in overpressure, due to the afore said ventilation device or CPAP, advantageously with a pressure comprised from 2 to 20 cm H₂0 and preferably from about 4 to about 8 cm H₂0. Preferably, the apparatus according to the invention comprises means for heating the afore said flow of ventilation air, more preferably heating means comprising a fitting duct, an electric power source and at least one electric resistance associated with said fitting duct and connected to the afore said electric power source, wherein the afore said fitting duct is interposed between the afore said ventilation device or CPAP and the afore said ventilation chamber or else possibly the afore said feeding element.

Preferably, the afore said mixing chamber comprises a cylindrical portion and a frusto-conical portion, consecutive one to another, the afore said outlet being preferably concentric to the afore said second inlet thus possibly concentric to the afore said tapered ending portion of the feeding element.

Preferably, the afore said nebulizing chamber is provided with an opening engaged by a second valve or valve for recovering air to be fed into the mixing chamber, i.e. a valve apt to be active and open during an inspiration step of a person subjected to the aerosol therapy treatment.

Substantially, in accordance with the invention, the present apparatus allows delivering a nebulized item to a subject, for example an aerosol comprising, or composed of, a specific medication for the disease to be treated, or a highly hypertonic solution, realized in the nebulizing chamber, advantageously after mixing with a positive-pressure flow of ventilation air, wherein the mixing speed between the nebulized item and the flow of ventilation air, and the particle size of the nebulized item in the same flow of ventilation air can be adjusted by means of the axial movement of the feeding element with respect to the mixing chamber.

The tapered ending portion of the feeding element having a section lower than a main portion of the same feeding element and arranged inside the mixing chamber, having in its turn a section larger than the section of the feeding element, and the position adjustable with respect to the outlet of the mixing chamber of the afore said tapered ending portion, as a matter of fact allow suctioning from the nebulizing chamber, by means of the afore said second valve, more or less nebulized item depending on the depression generated by Venturi effect in the mixing chamber.

During the inspiration step, therefore, a larger or smaller amount nebulized item is suctioned depending on the opening degree of the afore said second valve, whereas during the expiration step the flow of excess air of a patient subjected to treatment by the present apparatus is relieved outwards, through the afore said first valve.

In accordance with the invention, the particular combination of the present apparatus made of a compressing device and an atomizing nozzle to generate an aerosol of medications and, advantageously, also of essentially fat compounds, for example solutions with hyaluronic and/or linoleic acid, a ventilation device for example comprising a turbine and pressure sensors or CPAP to realize a flow of positive pressure ventilation air, a mixing chamber having a ending portion tapered at the outlet wherein the aerosol and the flow of ventilation air are mixed before the delivery to a patient, and the inhalation mask, allows increasing the effectiveness of the aerosol therapy, thereby allowing a pulmonary deposition of the nebulized item which is substantially not affected by a possible FEV1 limit, i.e. the reduced ventilation power of the treated subject.

Advantageously, in fact, the variability relating to the inspiration force of a patient subjected to aerosol therapy through the present apparatus is overcome since the person does not have to forcedly inhale the medication rather the latter has to forcedly penetrate directly into the airways.

Furthermore, the flow of ventilation air (positive air flow) facilitates the aerodynamics by reducing the interaction of the nebulized with the high airways, thus allowing a higher medication percent in the low airways.

Still in accordance with the invention, the present apparatus allows delivering a highly hypertonic solution, possibly and advantageously still comprising essentially fat compounds which, due to the increased pulmonary deposition in spite of the deposition in high airways of the nebulized item, reduces the annoyance suffered by a patient subjected to aerosol therapy, due to the unpleasantness, in particular bad palatability, of the hypertonic solution and to irritant effects at the throat and pharynx.

Furthermore, the present apparatus is conceived to be used at the patient home also, and is therefore easily portable, having little dimensions, weight and bulk, while allowing the use of the great majority of medications usually employed by inhalation.

Brief Description of the Figures

Further characteristics and advantages of the present invention will be more evident from a review of the following specification of a preferred, but not exclusive, embodiment, shown for illustration purposes only and without limitation, with the aid of the attached drawings, in which:

- figure 1 shows schematically an apparatus for aerosol therapy with adjustable positive airway pressure adjustable during its use on a patient, in accordance with an embodiment of the present invention;

- figure 2 illustrates in a longitudinal section a particular of the apparatus of figure 1;

- figure 3 illustrates an additional particular of the apparatus of figure 1;

- figure 4 illustrates an additional particular, partially in section, of the apparatus of figure 1.

Detailed Description of the Invention

Referring to figure 1, an apparatus for aerosol therapy with adjustable positive airway pressure in accordance with the present invention is wholly indicated by the numeral 1.

The apparatus 1, particularly suitable for the treatment and the therapy of obstructive bronchopulmonary diseases, essentially comprises a mixing chamber 2 provided with inlets and outlets, a nebulizing chamber 3 wherein an atomizing nozzle 4 is housed, which is arranged outside the mixing chamber 2 and both unidirectionally and fluidically connected therewith, a compressing device 5 connected to the nebulizing chamber 3 to feed a flow of compressed air to the atomizing nozzle 4, a ventilation device (for example a turbine type with pressure sensors) or CPAP 6 connected to the mixing chamber 2 to feed a flow of ventilation air therein, and an inhalation mask 7 connected to the mixing chamber 2.

In detail, also referring to figures 2 - 4 which show respective details of the apparatus of figure 1, the mixing chamber 2 is provided with a first inlet 8 and a second inlet 9 through which the afore said fluid communication with the nebulizing chamber 3 and, respectively, with the ventilation device or CPAP 6 is realized.

Furthermore, the mixing chamber 2 comprises an outlet 10 arranged opposite to the inlets 8 and 9 through which a fluid communication is realized with the inhalation mask 7.

In accordance with the invention, the mixing chamber 2 comprises a cylindrical portion and a frusto-conical portion, consecutive one to another, and comprises in detail a tapered ending portion 11 at which the outlet 10, which is advantageously concentric to the second inlet 9, is provided.

In accordance with the embodiment shown in the example of figures, the present apparatus also comprises a feeding element 12 of the flow of ventilation air, having a tubular shape and a tapered ending portion 13.

The feeding element 12 is connected at one side to the ventilation device or CPAP 6 and, on the other side, is associated with the mixing chamber 2 at the second inlet 9 and, in particular, is slidingly associated, i. e. axially free, with the mixing chamber 2 at least for an extent of preset length wherein the tapered ending portion 13 of the feeding element 12 is inside the mixing chamber 2 at various distances from the outlet 10.

The sliding of the feeding element 12 with respect to the mixing chamber 2 can be provided continuously or along predetermined discrete positions.

Still in accordance with the embodiment shown in the examples of figures, the apparatus 1 comprises means for heating the flow of ventilation air, on the whole indicated by the numeral 14, which advantageously comprise a fitting duct 15, an electric power source 16, and at least one electrical resistance associated with the fitting duct 15 and connected to the electric power source 16, not represented in the figures.

In detail, the fitting duct 15 is interposed between the ventilation device or CPAP 6 and the mixing chamber 2, particularly between the ventilation device or CPAP 6 and the feeding element 12.

Again, the apparatus 1 comprises a first valve 17 advantageously housed in the mixing chamber 2, which can be a pre-calibrated or variable relief valve or a PEP valve active during the expiratory step according to the needs, i.e. a one-way valve provided with a relief opening having preset limited dimensions or provided/associated with an adjustable expiratory mechanical resistance, such to generate a pressure up to 20 cm H₂0.

The first valve 17 is arranged on the same side of the inlets 8 and 9 and is active and open during an expiration step of a person subjected to treatment with the present apparatus, in particular for the relief of a flow of exceeding air or to generate the afore said PEP pressure up to 20 cm H₂0.

Again, it has to be mentioned that, in accordance with the invention, the present apparatus is of the so called closed-circuit type and in use provides a working over-pressure from 2 to 20 cm H₂0 and preferably from about 4 to about 8 cm H₂0, advantageously generated by the afore said ventilation device comprising a turbine and pressure sensors or CPAP, for example.

In particular, in order to realize the afore said closed-circuit, the present apparatus comprises a sealing gasket 18, arranged peripherally on an outer edge 19 of the inhalation mask 7.

Still in accordance with a further aspect of the invention, the apparatus 1 is provided with a second valve 20 which engages a suitable opening arranged in the upper portion of the nebulizing chamber 3.

In practice the second valve 20 is a usually closed valve for recovering air to be fed into the mixing chamber and can be active and open during an inspiration step of a person subjected to the treatment of aerosol therapy.

In this regard, it has to be mentioned that the nebulizing chamber 3 is advantageously constituted by a nebulizing ampule, for example of known type marketed by the same applicant.

Substantially, by virtue of the afore said second valve, during the use of the present apparatus, a higher or lower air requirement in the mixing chamber can be dealt with.

Furthermore, due to the afore said second valve, the present apparatus allows obtaining a nebulizing speed of about 0.5 ml/min. The advantages of the present invention, already evident during the above reported description, can be summarized by pointing out that an apparatus for aerosol therapy is provided which allows maximizing the pulmonary deposition of a nebulized delivered to a person treated through the present apparatus, by making the pulmonary deposition of the nebulized item substantially independent from the FEV1 value of the given subject, at least within a certain limit value thereof.

Maximizing the pulmonary deposition of the nebulized not only means increasing the treatment effectiveness, but also reducing the annoyance suffered by the patient in case of treatment by hypertonic solutions which are particularly unpleasant.

Still, the apparatus according to the invention advantageously allows a pre- mixing of the nebulized item with a flow of ventilation air thus making the inspiration step of the person subjected to aerosol therapy easier and, advantageously, by virtue of the atomizing nozzle of pneumatic type it allows nebulizing practically any substance useful for the treatment, comprising essentially fat substances, differently from ultrasound electrical apparatuses for aerosol therapy.

A further advantage is the possibility of adjusting the mixing between nebulized item and flow of ventilation air, therefore substantially the speed and the flow rate with which the nebulized item is delivered, due to the shape of the feeding element and in particular due to its tapered ending portion and the possibility of axially displacing the same with respect to the mixing chamber.

A further advantage is the portability of the present apparatus which makes it suitable to be used in domestic environment as well.

A person skilled in the art, in order to satisfy contingent and specific requirements, can make various changes to the present invention as it is in the illustrated and described embodiment, all of which however are contained in the scope of protection of the invention as defined by the following claims.

Claims

1. Apparatus (1) for aerosol therapy with adjustable positive airway pressure for the treatment and therapy of obstructive bronchopulmonary diseases, comprising a mixing chamber (2) having a tapered ending portion (11) and provided with a first and a second inlet (8; 9) and at least one outlet (10), the latter being arranged at said tapered ending portion (11), a nebulizing chamber (3) comprising an atomizing nozzle (4), which is outside said mixing chamber (2) and which is fluidically connected therewith through said first inlet (8), a compressing device (5) connected to said nebulizing chamber (3) to feed a flow of compressed air to the atomizing nozzle (4), a ventilation device/CPAP connected to said mixing chamber (2) through said second inlet (9) to feed a flow of ventilation air therein, and an inhalation mask (7) connected to said mixing chamber (2) through said outlet (10).

2. Apparatus according to claim 1, further comprising a tubular feeding element (12) of said flow of ventilation air, connected to said ventilation device/CPAP and having a tapered end portion (13) associated with said mixing chamber (2) at said second inlet (9).

3. Apparatus according to claim 2, wherein said tubular feeding element (12) is associated with said mixing chamber (2), freely to slide therewith, at least for an extent of preset length wherein said tapered ending portion (13) takes various distances from said outlet (10).

4. Apparatus according to any one of the preceding claims, further comprising a first valve (17) preferably arranged in said mixing chamber (2), wherein said first valve (17) is a relief valve or a PEP valve (Positive Expiratory Pressure) apt to be active and open during an expiratory step.

5. Apparatus according to any one of the preceding claims, further comprising a second valve (20) arranged in said nebulizing chamber (3), which is usually closed and apt to be active and open during an inspiratory step.

6. Apparatus according to any one of the preceding claims, further comprising heating means (14) of said flow of ventilation air.

7. Apparatus according to claim 6, wherein said heating means comprise a fitting duct (15), an electric power source (16), and at least one electric resistance associated with said fitting duct (15) and connected to said electric power source (16), wherein said fitting duct (15) is interposed between said ventilation device/CPAP (6) and said mixing chamber (2) or said feeding element (12).

8. Apparatus according to any one of the preceding claims, wherein said outlet (10) is concentric or substantially concentric to said second inlet (9).

9. Apparatus according to any one of the preceding claims apt to operate with an over-pressurized closed-circuit at a value comprised from about 4 to about 8 cm H₂0.

10. Apparatus according to any one of the preceding claims, further comprising a sealing gasket (18) peripherally arranged on an outer edge (19) of said inhalation mask (7).