RU2771733C2 - Spraying device for medical mixture - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to spraying device (1) for a medical mixture. The device contains ampoule-container (2) for the mentioned medical mixture, containing upper component (2a) and lower component (2b) connected to each other. The device has outlet (11) for the mentioned sprayed medical mixture from mentioned ampoule-container (2). The device includes inlet window (19) for air intake to mentioned ampoule-container (2). The device contains sprayer (14) for the intake of gas under pressure in mentioned lower component (2b) of mentioned ampoule-container (2). Mentioned upper component (2a) is located above mentioned sprayer (14). The device has side selection window (24) on mentioned upper component (2a). The possibility of fencing an opening of mentioned side selection window (24) by fencing means (16) moved by controlling shaft (17). Mentioned fencing means (16) is made with the possibility of being moved by controlling shaft (17) through fencing switcher (15) connected and related to control handle (18) connected to mentioned controlling shaft (17). The connection between mentioned controlling shaft (17) and mentioned fencing switcher (15) is made by threaded connection.

EFFECT: providing a spraying device that provides the possibility of air intake from the outward in different volumes according to the required granulometry.

13 cl, 9 dwg

Description

FIELD OF TECHNOLOGY

The present invention relates to a portable nebulization device for medical fluids, and in particular to a versatile nebulization device optimized for treating all tracts of a patient's respiratory system.

The aforementioned spray device finds useful application in the field of medical technology, in particular in the field of technology for aerosol therapy.

BACKGROUND OF THE INVENTION

Respiratory administration of medicines by appropriate nebulizing devices is a therapeutic treatment commonly used for a variety of diseases, in particular for the treatment of the respiratory system.

In particular, nebulization allows the drug in liquid form to be separated into many very small particles, having a diameter of several micrometers, which can be easily inhaled by the patient.

It is also known that a specific nebulization is required to treat different pathways of the respiratory system.

Namely, in order for the sprayed particles to reach the upper respiratory tract, the tracheobronchial tract or the pulmonary alveoli differently, different particle sizes are required.

In fact, for the treatment of the upper respiratory tract, a coarser nebulization is recommended, while for the lower respiratory tract, a very fine nebulization is important.

The optimal granulometry for the treatment of specific airways is specified in the bibliography and in the specific standard EN UNI 13544-1, which specifies that:

- diameter greater than 5 microns provides deposition in the upper respiratory tract;

- a diameter between 2 µm and 6 µm ensures deposition in the tracheobronchial tract;

- a diameter between 0.5 µm and 3 µm ensures deposition at the level of the lung alveoli.

In order to obtain a granulometry suitable for the various needs above, the most suitable solution is to use specific components for each application.

In particular, in a known configuration of a spray device, a larger number of sprayers are provided from which pressurized gas is introduced (also referred to as "pisper").

According to the adopted sprayer, a more or less fine atomization of the medical liquid actually occurs.

This type of solution provides a distinct advantage in obtaining accurate spray sizes for all needs.

However, it is equally clear that this solution also has the disadvantage of being more difficult to use.

In fact, the patient should have a minimum of competence in selecting the correct nebulizer for their particular case. Obviously, this includes an inherent risk of incorrect sprayer selection.

Added to this disadvantage is the lack of practicality due to the need to replace and store a large number of components of the spray device, with the risk of loss in the absence of use.

For this reason, devices have also been provided that make it possible to change the geometric position of the same components in order to obtain different atomization.

For example, in European patent application EP 2952219A1 from 3A Health Care S.r.l. the displacement of the air intake channel in the spraying device is disclosed in order to vary its relative position relative to the sprayer from which the pressurized gas is introduced.

While this solution provides the advantage of different sprays based on the relative position between the above two components, it also has disadvantages from an operational point of view.

In fact, due to structural complexity, it does not allow proper disassembly of the components of the spray device and subsequent sufficient cleaning/disinfection/sterilization.

In fact, we state that since nebulization devices are used for patients suffering from lung infections, all suitable components should provide a certain level of sterilization in such a way as not to aggravate said infection.

Another well-known technical solution is disclosed in US patent application US 3658059 A, which relates to an inhaler containing a diaphragm to change the effective size of the passage, suitable for passing the suspension for inhalation. The diaphragm moves towards and away from the jet of the inhaler to increase or decrease the opening. Although advantageous in various respects, this solution cannot provide a simple disassembly of the components to facilitate their cleaning and sterilization.

Another known solution is described in European patent application EP 3 017 839 A1, which relates to a device for aerosol spray substances with a separating element configured to divide the spray chamber into at least two sectors, and with means for moving the separating element and adjusting flow leaving the device. This solution is also not effective in terms of simplicity and ease of use in adjusting the level of nebulization of the drug by the user.

The object of the present invention is to provide a nebulization device that allows different particle granulometry to be obtained according to the needs of a particular patient without changing components.

An additional challenge is to ensure that the spray device is completely disassembled to properly clean/disinfect/sterilize the received components.

Another object is to make the practical use of the nebulization device convenient, even for patients without special experience.

In addition, it is still another object to provide a spray device that is structurally simple, and thus eliminate design problems that should not be inherent in a product intended for mass production.

DISCLOSURE OF THE INVENTION

The idea of the solution underlying the present invention is to provide a spray device that allows air to be introduced from outside in various volumes according to the required granulometry.

The above technical problem is solved by means of a dispensing device for medical mixture of this type, which contains an ampoule-container for medical mixture, at least one sprayer for inlet of pressurized gas into said ampoule, at least one emitting orifice of said atomized medical mixture and at least one window for outside air intake. Above the sprayer is the upper part of the ampoule. At least one, preferably two, side selection windows are additionally made on the wall of the upper part of the ampoule, the openings of which are blocked by means of a blocking means. Said obstruction means is moved, enabling precise obstruction, by means of a control shaft connected thereto and by means of an obstruction switch connected and associated with a control handle connected to said control shaft; wherein the connection between said control shaft and said barrier switch is made by means of a threaded connection.

According to a preferred embodiment, the barrier means is contained in a skirt-shaped barrier switch to which the shaft is connected.

In addition, according to a preferred embodiment, the control shaft extends along the central axis of the channel.

According to another aspect of the invention, the obstruction means consists of at least two baffles that run parallel to the control shaft on the side selection windows.

According to another aspect of the invention, the spray device further comprises a control knob at the end of the control shaft to change position along the axis of the shaft itself through rotational translation.

According to a further aspect of the invention, the translational movement of said control handle, which moves the control shaft, is provided by means of a cam groove made on the inner wall of the ampoule in which the control handle moves.

Alternatively, according to another embodiment of the invention, a wide radius external thread is provided on the outer surface of the control shaft, the external thread engages with the corresponding internal thread of the threaded part of the barrier switch.

According to the second embodiment of the present invention, the barrier switch comprises two additional inlets for air inlet into said ampoule.

According to a further aspect of the invention, the nebulization device further comprises at least two valves at the base of said control knob for changing the air flow in the inspiratory and expiratory phases.

According to still another aspect of the present invention, the nebulization device is provided with a nozzle at the emitting outlet for connection with the airways of the patient.

In addition, according to an aspect of the invention, the ampoule is made of two parts connected to each other.

Additional features and advantages will become apparent from the following detailed description of a preferred, but not exclusive, embodiment of the present invention, with reference to the accompanying drawings, given as a non-limiting example.

BRIEF DESCRIPTION OF THE DRAWINGS

In the said drawings:

Fig. 1 is an exploded view of an embodiment of a spray device according to the invention;

Fig. 2a, 2b and 2c are sectional views of three operating positions of the spray device of FIG. one;

Fig. 3a, 3b, 3c and 3d are sectional views of the valve system and nozzle of the spray device of FIG. one;

Fig. 4 is an exploded view of a second embodiment of a spray device according to the invention;

Fig. 5a, 5b and 5c are sectional views of three operating positions of the spray device of FIG. 4;

Fig. 6a, 6b, 6c and 6d are sectional views of the valve system and nozzle of the spray device of FIG. one;

Fig. 7a and 7b show sectional views of a third embodiment of a spray device according to the invention;

Fig. 8a, 8b and 8c show an exploded view of a fourth embodiment of a spray device according to the invention;

Fig. 9a, 9b and 9c show an exploded view of a variation of the embodiment of FIG. 8a, 8b and 8c.

IMPLEMENTATION OF THE INVENTION

With reference to the drawings, and in particular to FIG. 1, reference number 1 globally and schematically indicates a spray device implemented in accordance with the present invention.

Said spray device 1 is illustrated in the drawings placed vertically according to the preferred operating configuration. Further in the present invention, the positions and orientations, relative and absolute, of the various elements of which the device is made, given by terms such as "top" and "bottom", "on" and "under", "horizontal" and "vertical" or in other equivalent terms, should be expressed with reference to said configuration without representing a limitation of the rights of the applicant.

The spray device 1 contains an ampoule 2, preferably divided into two components, an upper component 2a and a lower component 2b, respectively.

The top component 2a preferably has a circular cross-section shape with an upper part 3 having a larger diameter and a lower part 4 having a smaller diameter, which are connected to each other by means of a truncated conical part 5.

The lower component 2b is preferably also formed with a circular cross section. Said lower component 2b preferably has an ergonomic outer profile which makes it easier for the patient to grip during therapy. The lower component 2b additionally has an open end 6 in which the connection with the upper component 2a takes place.

Preferably, on the side surface 10 of the component 2b, an opening 11 is provided, from which a channel segment 12 extends, which is preferably inclined at a certain angle relative to the cross section of the lower component 2b.

Channel segment 12 is shaped such that it connects a connector to the patient's airway, such as, for example, a nozzle 13.

The use of other connecting devices with the patient's airways, such as known nasal masks or plugs, is not limited in any way.

At the end 7 opposite to the open end 6, a closing surface 8 is provided, which is cup-shaped and contains a nozzle channel 9.

Mounted on the nozzle channel 9 is a sprayer 14 (also known in the art as a "pisper").

Above said atomizer 14 is the lower part 4 of the upper component 2a.

Between said lower part 4 and sprayer 14 is placed a barrier switch 15, which preferably has the shape of a skirt and contains at least one, preferably two, barrier means 16. Said barrier means preferably consists of two partitions that run parallel in accordance with the longitudinal direction of the ampoule. 2. In addition, said obstruction means 16 is preferably arcuate.

In contrast to the prior art, the invention does not provide for the movement of the air inlet channel in the spray device to change its relative position relative to the sprayer from which the pressurized gas is admitted, but only the relative movement of the barrier means 16 relative to the sprayer 14.

The obstruction means 16, in accordance with the position along the axis, can control the flow emanating from the sprayer 14. The obstruction switch 15 is connected to the end 32 of the control shaft 17 controlling its movement.

The control shaft 17, preferably located along the longitudinal axis of the ampoule 2, slides in the longitudinal direction precisely moving the barrier switch 15.

At the opposite end 33 of the control shaft 17, and in connection with it, preferably there is a control knob 18.

The control handle 18 can be made in one piece with the control shaft 17.

The barrier switch 15 is connected and engaged with a control handle 18 connected to said control shaft 17; wherein the connection between said control shaft 17 and said barrier switch 15 is made by means of a threaded connection, such as a worm screw connection.

The control handle 18 has a circular cross section, with a gripping portion 29 along the diameter having an ergonomic shape to facilitate rotation of the control handle 18.

The handle 18 of the control on the sides of the gripping part 29 is crossed by at least one, preferably two inlet windows 19, through which the outside air is admitted into the ampoule 2.

On the control handle 18 there is a cam groove 21 on the outer surface 20.

The cam groove 21 engages with the corresponding engagement pins 22 located on the inner surface 23 of the upper part 3 of the upper component 2a.

In the lower part 4 of the upper component 2a, at least one, preferably two, side selection windows 24 are provided. Below said side selection windows 24 is a bottom sector 4 having a height H. The two windows 24 are preferably located on diametrically opposed parts.

Said side selection windows 24 may be completely, partially or not obstructed at all by the obstruction means 16, as can be seen in FIG. 2a, 2b and 2c, respectively.

Directly next to the control knob 18, in the input windows 19, a valve system 25 is made.

The valve system is more clearly visible in FIG. 3a, 3b and 3c.

The valve system 25 works in conjunction with the valve 26 located on the nozzle 13.

In particular, in FIG. 3b and 3c respectively show the closed and open states of the valve system 25.

The valve system 25 of the present embodiment includes two valves that open during the inspiratory phase. On the other hand, in this phase, the valve 26 located on the nozzle 13 closes. On the contrary, in the exhalation phase, the valves of the valve system 25 close and the valve 26 on the nozzle 13 opens.

Meanwhile, in FIG. 3d shows an enlarged cross section of the functional connection between the nozzle channel 9, the sprayer 14 and the barrier switch 15.

In FIG. 4 shows a second embodiment of the present invention.

Said embodiment is different from the embodiment shown in FIG. 1, by the presence of two additional input windows 27 on the barrier switch 15, near the connection with the control shaft 17.

Another difference of this embodiment with respect to the embodiment of FIG. 1 is represented by the fact that between the upper part 3 and the lower part 4 of the upper component 2a of the ampoule 2 there is no truncated-conical part 5. Instead of this truncated-conical part 5, an instantaneous reduction in the section between the upper part 3 and the lower part 4 in the cross section 28 is made.

The lower part 4 of the upper component 2a of the ampoule 2 is therefore longer than the first embodiment of the invention.

An additional difference of this embodiment with respect to the embodiment shown in FIG. 1 is represented by a valve system 25. In fact, instead of the two valves of the first embodiment, a unique baffle 30 is provided.

The different valve system of the second embodiment can be seen in detail in FIG. 6a, 6b and 6c.

The baffle 30 operates similarly to the valves of the first embodiment. In fact, its inward deformation allows airflow in the inspiratory phase when the corresponding valve 26 on the nozzle 13 is closed. Instead, in the exhalation phase, the deflector 30 returns to its straight shape, thereby plugging the inlet ports 19, while opening the valve 26 in the nozzle 13.

Meanwhile, in FIG. 6d is an enlarged section of the functional connection between the nozzle channel 9, the sprayer 14 and the barrier switch 15.

Because the valve system 25 is very complex and therefore expensive, there is a third embodiment shown in FIG. 7a, and 7b.

In the said drawings, it can be noted that the valve system is replaced by a virtual valve system 37. Said virtual valve system 37 is formed by a different structure of the inlet ports 19. In fact, instead of accommodating valves, such inlet ports 19 have a "wolf mouth" section, which is sufficient in order to ensure the correct delivery of the nebulized flow and meanwhile properly impede the release of the flow exhaled by the patient. Thus, said exhalation flow is freely ventilated through the side windows of the nozzle, which also does not have a valve.

There is also a fourth embodiment which is implemented as an alternative control mode via the barrier switch 15 .

According to the mentioned embodiment, the barrier switch 15 comprises an upwardly protruding threaded portion 34 which contains an internal thread 35 which is at least a single start thread.

Mentioned internal thread 35 is engaged by at least one external thread 36 with a wide radius, made on the outer surface 38 of the control shaft 17.

As a result, the aforementioned adjustment of the barrier switch 15 is carried out by rotational movement of the control shaft 17 in the threaded portion 34 of the barrier switch 15 itself.

Therefore, the engagement pins 22 sliding in the cam slot 21 of the control handle 18 are not provided.

Said solution makes it possible to reduce the height of both the control handle 18 and the upper part 2a, thereby making the ampoule 2 more compact.

There is no restriction on the use of a multiple threaded connection 36 as shown in FIG. 9a, 9b and 9c, instead of a wide radius male thread 36 with substantially the same performance.

In said drawings, further shows a sector 4' of the lower part, below the side windows 24 selection, having a height H1, which exceeds the dimension H present in the described embodiments. Said resizing provides the opportunity both to enhance such a sector and to provide a better choice of particle size, which may be more reduced in size.

In addition, in FIG. 9c also shows an enlarged sectional view of the projection 39 on the sector 4' of the lower part close to the upper part 3. Said projection 39 can be seen to accommodate locking wings 40 adapted to block the rotation of the control shaft 17 in the threaded portion 34 of the boom switch 15 after how the required position of the barrier is reached.

Next, the operation of the spray device 1 according to the invention will be described, considering the above-described embodiments by way of illustration.

In particular, reference is made to FIGS. 2a, 2b and 2c for the first embodiment and in FIG. 5a, 5b and 5c for the second embodiment.

Once the ampoule 2 of the nebulization device 1 is filled with medical fluid and assembled, the operation of the components also present in the prior art does not change as a result.

Thus, gas is admitted under pressure through the nozzle channel 9 and the sprayer 14.

At the same time, through the inlet windows 19, outside air is admitted into the ampoule 2.

In this way, a medical fluid is sprayed, which is inhaled by the patient through the nozzle 13 connected to the emitting channel 12.

According to the invention, by means of the control shaft 17, the barrier switch 15 and the side selection windows 24, the required granulometry can be obtained.

By rotating the control knob 18 and then sliding the engagement pins 22 inside the cam groove 21, the control knob and jointly control shaft 17 are rotated.

Thus, by virtue of this, the movement of the barrier switch 15 and the barrier means 16 is ensured.

As can be seen, in the present embodiments, three selection positions are provided, each corresponding to the correct airway granulometry for the treatment of a particular patient.

This does not preclude that more provisions may be made to indicate yet another route that therapy may be targeted without departing from the scope of the present invention as defined by the appended claims.

The three illustrated positions for selection correspond, in this case:

- position 1, as illustrated in FIG. 2a, 5a: full opening of the side selection windows 24 by means of the obstruction means 16 of the obstruction switch 15;

- position 2, as illustrated in FIG. 2b, 5b: partial opening of the side selection windows 24 by means of the barrier means 16 of the barrier switch 15;

- position 3, as illustrated in FIG. 2c, 5c: complete closing of the side selection windows 24 by means of the obstruction means 16 of the obstruction switch 15.

Thus, we get, respectively:

- large particles for the treatment of the upper respiratory tract;

- particles suitable for the treatment of the tracheobronchial tract;

- fine particles for the treatment of pulmonary alveoli. In particular, the experiments carried out by the Applicant show that the ampoule 2, according to the configuration, provides the possibility of obtaining a dimensional difference MMAD (mass median aerodynamic diameter) of the particles, which varies:

- approximately 30-50% between position 1 and position 2, and

- approximately 150-200% between position 1 and position 3.

Of course, the delivery rates are also markedly different, about the same change value mentioned for the particle sizes.

Using the second embodiment illustrated in FIG. 4 and described above, with the help of additional input windows 27 on the barrier switch 15, the cross-sectional area of the flow for the air entering the ampoule 2 is changed.

Of course, a larger or smaller size of the cross-sectional area of the flow, and therefore a greater or lesser consistency of the air flow, affects both the delivery rate and the size of the aerosol particles formed by the ampoule 2.

Moreover, in the second embodiment illustrated in FIG. 4, the installation of a frusto-conical part 5 instead of a sharp decrease in diameter between the upper part 3 and the lower part 4 of the upper component 2a can also affect the performance of the ampoule 2.

The advantage is that the described spray device allows the formation of a medical aerosol having different granulometry. Thus, the nebulization device 1 according to the invention allows universal optimization for all required therapies, whether they are directed to the upper respiratory tract, to the tracheobronchial tract, or more inwardly to the pulmonary alveoli.

An additional advantage is that this can be achieved simply by turning the control knob 18 by a predetermined amount, thereby obtaining the correct level of obstruction of the flow exiting the atomizer 14.

In addition, the advantage lies in the fact that the spray device 1 is completely collapsible. Therefore, the practicality of the phases of cleaning, disinfection and sterilization of the components of the spray device 1 is increased. In fact, with respect to the prior art, there are no built-in, hidden or hard-to-reach components as described above. Thus, the hygiene required for a medical device and necessary to prevent the spread of germs, bacteria and viruses is ensured.

Another advantage is that the collapsibility feature is essentially related to the replaceability feature. In fact, it is possible, in the event of a failure or damage to one of the components, to replace only the defective or damaged component.

Those skilled in the art should also understand the practicality of using the nebulization device 1 according to the invention by any patient, while avoiding mistakes that can lead to therapy failure.

Another advantage is that the parts of the atomizing device 1 are made of suitable materials both in terms of atomization and in terms of strength, easy accessibility, and finally, they are not excessively expensive.

Those skilled in the art will appreciate that the described embodiment may be subject to various changes and modifications according to specific and dependent needs, all of which are included within the scope of the invention as defined by the appended claims.

Claims (21)

1. Spray device (1) for a medical mixture of a type that contains: an ampoule-container (2) for said medical mixture containing an upper component (2a) and a lower component (2b) interconnected; at least one emitting hole (11) for said atomized medical mixture from said ampoule-container (2), and at least one inlet window (19) for air inlet into said ampoule-container (2); at least one sprayer (14) for inlet of pressurized gas in said lower component (2b) of said ampoule-container (2), wherein said top component (2a) is located above said sprayer (14), at least one side selection window (24) on said upper component (2a), wherein it is possible to block the opening of the said side selection window (24) by means of a blocking means (16) moved by means of a control shaft (17), characterized in that said barrier means (16) is movable by means of a control shaft (17) through a barrier switch (15) connected and associated with a control handle (18) connected to said control shaft (17); moreover, the connection between said control shaft (17) and said barrier switch (15) is made by means of a threaded connection. 2. A spray device according to claim 1, comprising two side selection windows (24) on said top component (2a). 3. A spray device according to claim 1 or 2, wherein said control shaft (17) is connected to one end (32) of a skirted switch (15) of the barrier containing said barrier means (16). 4. Spray device according to any one of paragraphs. 1-3, in which said control shaft (17) extends along the central axis of said upper component (2a). 5. Spray device according to any one of paragraphs. 1-4, in which said obstructing means (16) consists of at least two partitions that run parallel to the longitudinal passage of said ampoule-container (2) on said side selection windows (24). 6. Spray device according to any one of paragraphs. 1-5, in which said barrier switch (15) additionally contains two additional inlet windows (27) for air inlet into said ampoule-container (2). 7. Spray device according to any one of paragraphs. 1-6, in which said control handle (18) located at one end (33) of said control shaft opposite said barrier switch (15) is configured to change the vertical position of said control shaft (17) by means of rotational-translational movement. 8. Spray device according to any one of paragraphs. 1-7, in which on the outer surface (20) of the said control handle (18) there is a cam groove (21), which is configured to connect with the corresponding engaging pins (22) on the inner surface (23) of the said upper component (2a). 9. Spray device according to any one of paragraphs. 1-8, additionally containing at least one valve system (25) at the base of said control handle (18) for changing the air flow in the inhalation and exhalation phases. 10. Spray device according to any one of paragraphs. 1-8, characterized in that a virtual valve system (37) is provided, in which at least one inlet window (19) has the shape of a cleft palate to regulate the air flow entering and exiting the said ampoule-container (2) in the inhalation phases and exhale. 11. Spray device according to any one of paragraphs. 1-8, in which said barrier switch (15) comprises a threaded part (34) protruding upwards and containing an internal thread (35), such an internal thread (35) being made to engage with at least one single-start external thread (36) , made on the outer surface (38) of said control shaft (17), to obstruct the opening of said side selection windows (24). 12. Spray device according to any one of paragraphs. 1-10, additionally containing a channel segment (12) for connection with a nozzle (13) in at least one emitting hole (11). 13. Spray device according to claim 11, additionally containing rotation-stopping wings (40) for said control shaft (17) in said threaded part (34).

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