Patent Description:
In some embodiments, these devices comprise a base body provided with a nozzle suitable to be fluidly connected to a source of compressed air. The base body defines a chamber suitable to accommodate the substance to be nebulized. The substance can be introduced into the chamber by taking it from a container, such as a vial, or it can be contained in a disposable capsule suitable to be inserted and punctured inside the chamber.

A lid closes the chamber and is equipped with a mouth for dispensing the nebulized substance.

In order to nebulize the substance in a liquid state which is contained in the chamber, a nozzle cover, commonly called a 'pisper,' is fitted onto the nozzle, which forms with the nozzle at least one suction channel for the substance, which is sucked towards the constriction at the end of the nozzle cover, exploiting the Venturi effect produced by the pressurized air passing through the nozzle.

For aerosol therapy applications, the nozzle cover is usually equipped with a nebulizer element which extends in the form of a pin just above the end constriction and which, by mechanical impact, breaks up particles of the substance exiting said constriction, causing the substance to be nebulized. Examples of capsule are disclosed in the following prior art documents <CIT>, <CIT>, <CIT>, <CIT> and <CIT>. The document <CIT>, for example, discloses a single-use capsule for the generation of an aerosol. The capsule comprises: an external envelope having at least one inlet for a compressed gas and one outlet for the aerosol; a spray volume defined inside the external envelope and communicating with said inlet and with said outlet; a containment volume defined inside the envelope external and containing a liquid to be nebulized; an aerosol generator contained within the nebulization volume and designed to nebulize the liquid to be nebulized with the compressed gas to generate the aerosol; a first openable film applied to the outer casing to seal the entrance; and a second openable film applied to the outer casing to seal the outlet. A device for performing an inhalation therapy is also disclosed. The device comprises: the above capsule; a generator apparatus for generating a compressed gas; a connecting element adapted to connect an outlet of the generator apparatus to the inlet of the capsule; and an aerosol dispenser connected to the outlet of the capsule.

An object of this invention is to propose an assembly for nasal irrigation and aerosol therapy to make cleaning and sanitizing of the delivery device easier, faster, and safer.

Another object of the invention is to provide an assembly that allows for effective recovery of the nebulized substance that does not reach the delivery mouth, thereby ensuring the maximum performance of the device.

These objects are achieved with a capsule according to claim <NUM> and a dispensing assembly according to claim <NUM>.

The features and advantages of this invention will be more readily understandable from the following description of its preferred and non-limiting examples of embodiments, wherein:.

In the following description and in the attached drawings, the elements or parts of elements in common among various embodiments of the invention will be indicated with the same numerical references.

Further, the terms "upper" and "lower" are used in reference to the delivery device being at rest and positioned on a support plane.

With reference to the aforesaid <FIG>; <NUM> is used to globally refer to a delivery assembly of a nebulized substance, for example a substance for nasal irrigation or for aerosol therapy.

The assembly <NUM>; <NUM> comprises a capsule <NUM>; <NUM> containing the substance in a liquid state and a delivery device <NUM>; <NUM>, also known as an "ampoule," cooperating with the capsule <NUM>; <NUM> to nebulize the substance contained therein.

According to an aspect of the invention, when the capsule <NUM>; <NUM> is associated with the delivery device <NUM>; <NUM>, the capsule <NUM>; <NUM> in turn forms a part of the delivery device <NUM>; <NUM>. In other words, as will be described in more detail below, the capsule <NUM>; <NUM> is not inserted into a respective chamber formed in the dispensing device, as in some delivery devices according to the state of the art, but forms a structural element connecting two separate parts of the delivery device <NUM>; <NUM>.

With particular reference to <FIG> and <FIG>, the structure of the capsule <NUM>; <NUM> will thus first be described.

The capsule <NUM>; <NUM> comprises an inner capsule body <NUM>, e.g., cylindrical in shape, and an outer side wall <NUM> surrounding the inner capsule body <NUM>.

In an embodiment, the outer side wall <NUM> is arranged coaxially with the inner capsule body <NUM>.

The inner capsule body <NUM> forms at least one closed chamber <NUM> suitable to contain a respective substance to be nebulized. In some embodiments, multiple closed chambers <NUM> can be formed in the inner body <NUM>, for example in the form of hermetically separated sectors, each containing a respective substance.

The closed chamber <NUM> (or the set of closed chambers) is delimited at the bottom by a capsule bottom wall <NUM>.

At least one pierceable and/or tearable and/or peelable portion is obtained in the capsule bottom wall <NUM> to allow for the outflow of the substance from the capsule. The substance exiting the at least one enclosed chamber <NUM> will be collected in a substance catch basin of the delivery device, as will be further described below.

A capsule nozzle <NUM> ending with a substance outlet hole <NUM> at the top is formed in the inner capsule body <NUM>.

The capsule nozzle <NUM> is suitable to be fitted on a device nozzle <NUM> of the delivery device <NUM>; <NUM>, described further hereinafter, so as to define with the device nozzle <NUM> at least one substance suction channel <NUM> for suction of the substance towards the outlet hole <NUM> by means of a Venturi effect.

The closed chamber <NUM> is formed around the capsule nozzle <NUM>. The outer wall <NUM> delimits, with the inner capsule body <NUM>, a substance recovery channel <NUM>.

In an embodiment, the outer wall <NUM> is a cylindrical wall that delimits, with the inner capsule body <NUM>, an annular gap forming the substance recovery channel <NUM>.

For example, the outer wall <NUM> is connected to the inner capsule body <NUM> by means of septa or radial arms <NUM>.

The outer wall <NUM> forms a lower edge 104a suitable to connect to a lower portion of the delivery device <NUM>; <NUM>.

Further, the outer wall <NUM> forms an upper edge 104b suitable to connect with an upper portion of the delivery device <NUM>; <NUM>.

In an embodiment, the capsule body <NUM> and the capsule nozzle <NUM> are made in one piece in a single body, for example of a plastic material.

In other embodiments, the capsule nozzle <NUM> and the capsule <NUM> could be made separately and subsequently be connected to each other, such as by shape and/or force coupling or other attachment systems, such as screw, bayonet, etc..

Because the capsule <NUM>; <NUM> is configured to overlap and surround the device nozzle <NUM>, the capsule nozzle <NUM> penetrates the entire capsule body <NUM> and protrudes, with a conical top portion <NUM>' thereof, from a top wall <NUM> of the capsule body.

In an embodiment, the capsule body <NUM> thus has a substantially toroidal shape.

Obviously, the capsule body <NUM> could also have other shapes than the circular annular shape depicted in the drawings, for example it can be formed according to the shape of the body of the delivery device with which the capsule is associated.

As mentioned above, in some embodiments, the closed capsule chamber <NUM> can be divided into two or more compartments to contain respective different substances, for example different drugs, which can for example be mixed upon opening.

In the embodiment shown in <FIG>, the capsule <NUM> is configured to make the delivery device <NUM> suitable to perform a nasal irrigation. In this case, the substance exiting the outlet hole <NUM> is in the form of particles sized for this type of application.

In an embodiment illustrated in <FIG>, the capsule <NUM> is configured to make the delivery device <NUM> suitable for aerosol therapy applications. In this case, it is necessary to further reduce the particle size of the substance by means of special nebulization means <NUM>.

In particular, the capsule body <NUM> supports nebulization means <NUM> suitable to cause a nebulization of the substance exiting from the capsule nozzle <NUM> via the substance's impact with these nebulization means <NUM>.

In an embodiment, the nebulization means <NUM> comprise a transverse portion <NUM> extending orthogonally relative to a nozzle axis X parallel to the outlet direction of the substance from the capsule nozzle <NUM>, and a breaking pin <NUM> extending from the transverse portion <NUM>, coaxially to the nozzle axis, so as to break up the particles of the substance exiting the capsule nozzle <NUM>.

In an embodiment, the capsule body <NUM> further supports a cylindrical element <NUM> that extends coaxially around the nebulization means <NUM>. The height of this cylindrical element <NUM> determines, in conjunction with the delivery device, the size of the particulate matter that is conveyed to the delivery mouth of the delivery device.

In an embodiment, the cylindrical element <NUM> is integral with the nebulization means <NUM>.

In an embodiment, the nebulization means <NUM> are connected to the capsule body by at least two parallel support arms <NUM> extending from the top wall <NUM> of the capsule body <NUM>, parallel to the capsule nozzle <NUM>.

In an embodiment, the cylindrical element <NUM> is connected, by means of radial arms <NUM>', to a support ring <NUM>" that engages the top edge 104b of the outer side wall <NUM> with shape and/or force coupling.

In an embodiment, the pierceable and/or tearable and/or peelable portion <NUM> is made of a film or with a region having a thickness less than the thickness of the capsule bottom wall <NUM>.

Returning now to the assembly <NUM>; <NUM>, in a general embodiment, the delivery device <NUM>; <NUM> comprises a base body <NUM> provided with a device nozzle <NUM> suitable to be fluidly connected to a source of compressed air.

The device nozzle <NUM> ends in a compressed air delivery hole <NUM> and is configured to be inserted into the capsule nozzle <NUM>.

The base body <NUM> forms a concave wall <NUM> for collecting substance. From this concave wall <NUM> the device nozzle <NUM> extends.

The concave wall <NUM> is peripherally delimited by an upper capsule coupling edge <NUM> suitable to obtain a shape and/or force coupling with the lower edge 104a of the outer side wall <NUM>.

The concave wall <NUM> forms, with the upper capsule coupling edge <NUM>, a substance catch basin <NUM>.

Further, the concave wall <NUM> is provided with chamber opening means <NUM> suitable to obtain at least one opening in the pierceable and/or tearable and/or peelable portion by a related movement between the capsule <NUM> and the base body <NUM>.

The dispensing device <NUM> further comprises an upper dispensing body <NUM>; <NUM> having a side wall <NUM>; <NUM> forming a lower capsule connecting edge 32a; 302a suitable to obtain a shape and/or force coupling with the upper edge 104b of the outer side wall of the capsule.

Thus, the capsule <NUM>; <NUM> serves as a connecting element between the base body <NUM> and the upper delivery body <NUM>; <NUM>.

In an embodiment, the relative movement between the capsule <NUM>; <NUM> and the base body <NUM> is achieved by axial translation or roto-translation of the capsule <NUM> with respect to the base body <NUM>. For example, said relative movement coincides with or is a part of the movement that allows the capsule <NUM> to be connected to the base body <NUM>.

The capsule opening means <NUM> are suitable to obtain one or more passages in the capsule bottom wall <NUM> for the outflow of the substance contained in the closed chamber <NUM> into the substance catch basin <NUM>.

In order to make one or more passages in the capsule bottom wall, the opening means can pierce or tear or peel one or more portions of the capsule end wall.

In a variant embodiment, the opening means <NUM> can also cause the capsule bottom wall to separate or detach from the capsule body. Such separation or detachment can be due to a compression or a traction exerted on the capsule bottom wall.

In an embodiment, the capsule opening means <NUM> comprise one or more piercing tips.

In an embodiment, a passage <NUM>' suitable to drain the substance from the capsule into the catch basin <NUM> is formed in each piercing tip.

In a variant embodiment, the capsule opening means <NUM>, for example in the form of piercing tips, can be formed in a yielding bottom of the capsule obtained below the capsule bottom wall <NUM>.

Note that the concave bottom wall <NUM> and/or the capsule bottom wall <NUM> are shaped so as to form the substance catch basin <NUM> between the concave bottom wall <NUM> and the capsule bottom wall <NUM>, even when the capsule <NUM>; <NUM> is, for example, pressed flat against the concave bottom wall <NUM>.

The upper delivery body <NUM>; <NUM> is provided with a delivery mouth <NUM>; <NUM> of the nebulized substance suitable to convey the nebulized substance towards the outside of the capsule.

In an embodiment illustrated in <FIG>, the delivery device <NUM> is configured to perform a nasal irrigation. The upper delivery body <NUM> forms a bottom wall <NUM>, an inner siphon <NUM> which extends from the bottom wall <NUM> and which has an inlet mouth 36a arranged to receive the substance exiting from the capsule nozzle <NUM>.

The internal siphon <NUM> ends with an outlet mouth 36b, opposite the inlet mouth. In an assembly configuration of the assembly, the side wall <NUM>, the bottom wall <NUM> and inner siphon <NUM> delimit a mucus collection chamber <NUM> fluidly separated from the underlying capsule.

The bottom wall <NUM> and the inlet mouth 36a of the inner siphon <NUM> are spaced apart from the capsule <NUM> to allow a return of the nebulized substance from the inner siphon <NUM> to the concave substance collection wall <NUM> through the substance recovery channel <NUM>.

In other words, the nebulized substance that exits from the outlet hole <NUM> and does not reach the outlet mouth 36b can fall back into the catch basin formed by the concave wall <NUM> and then be recovered and again sucked up by the Venturi effect.

In an embodiment, a delivery cap <NUM> is mounted on the inner siphon <NUM> that ends in a delivery tip <NUM> suitable for insertion into a nostril of the user. The delivery cap <NUM> has a side wall <NUM> located around a portion of the top of the inner siphon <NUM>. Between this side wall <NUM> and the top portion, drainage channels <NUM> are obtained to drain the mucus into the mucus collection chamber <NUM>.

Accordingly, the liquid flowing down the nostril of the user can drain onto the outer wall of the cap <NUM> or, if it enters the delivery tip <NUM>, is diverted into the drainage channels <NUM> by the flow of compressed air directed towards the delivery tip <NUM>.

<FIG> and <FIG> show a delivery device <NUM> configured to perform aerosol therapy treatments. In this case, the capsule <NUM> is provided with the nebulization means <NUM>.

The delivery device <NUM> has the upper delivery body <NUM> equipped with a tubular portion <NUM> that is open above to the outside and below to the nebulization means <NUM> (when the upper delivery body <NUM> is connected to the capsule). This tubular portion <NUM> allows for an intake of air from the outside by the Venturi effect. The upper delivery body <NUM> forms a delivery mouth <NUM> in communication with a nebulization chamber <NUM> formed around the tubular portion <NUM>.

Also in this case, in an assembly configuration of the assembly, the nebulization chamber <NUM> is in fluid communication with the substance recovery channel <NUM> of the capsule <NUM>. Therefore, the nebulized substance that does not reach the delivery mouth <NUM> falls back into the catch basin formed by the concave wall <NUM> to be sucked in and nebulized again.

It is evident that the delivery assembly and the capsule described above enable the intended objects to be achieved.

In particular, the delivery device <NUM>; <NUM> has a simplified structure and is easier to clean and sanitize after use.

Due to the special structure of the capsule, which allows an effective recovery of the nebulized substance through the recovery channel <NUM>, all the substance contained therein is nebulized.

The assembly is assembled quickly and easily: the user only has to couple the capsule to the base body and the upper body to the capsule.

Claim 1:
A capsule (<NUM>, <NUM>) containing at least one liquid substance for aerosol therapy or for nasal irrigation, comprising an inner capsule body (<NUM>) and an outer side wall (<NUM>) surrounding the inner capsule body (<NUM>), wherein the inner capsule body forms at least one closed chamber (<NUM>) containing the at least one substance and delimited below by a capsule bottom wall (<NUM>) in which at least one pierceable and/or tearable and/or peelable portion is obtained to allow the outflow of the substance from the capsule, wherein in the inner capsule body there is a capsule nozzle (<NUM>) ending above with an outlet hole (<NUM>) of the substance from the capsule, the capsule nozzle (<NUM>) being suitable to be fitted onto a device nozzle (<NUM>) of a delivery device (<NUM>; <NUM>) so as to define with the device nozzle (<NUM>) at least one substance suction channel (<NUM>) for a suction of the substance towards the outlet hole (<NUM>) by Venturi effect, the closed chamber (<NUM>) being obtained around the capsule nozzle (<NUM>), wherein the outer wall (<NUM>) defines, with the inner capsule body (<NUM>), a substance recovery channel (<NUM>), and wherein the outer wall (<NUM>) forms a lower edge (104a) suitable to connect to a lower portion of the delivery device and an upper edge (104b) suitable to connect to an upper portion of the delivery device.