Patent Description:
The present disclosure relates to an aerosol generating apparatus and more particularly to an aerosol generating apparatus with replaceable vial assembly.

Nebulizer, also known as aerosolizer or atomizer, is used to deliver medication in fine particles/droplets to patients for inhalation. An aerosol generating module, which is a component of a nebulizer, receives liquid medicament to generate aerosol for treating a patient with respiratory conditions, such as Chronic Obstructive Pulmonary Disease (COPD). A typical aerosol generating module includes a perforated membrane and a vibratable element. One way for a vibratable element to generate vibration is through the incorporation of piezoelectric (PZT) materials. Vibration is provided to the liquid passing through the perforated membrane, thereby generating aerosol.

A reservoir or a liquid container such as a vial, with an internal chamber, stores the liquid medicament to be provided to the aerosol generating module. The vibratable element vibrates the perforated membrane, through which the liquid medicament permeates, to generate aerosol. Typically, the aerosol generating module is either permanently secured to the liquid container or integrally formed with the liquid container. The aerosol generating module may be permanently secured to the liquid container by adhesive or other known securing means. Accordingly, once the liquid medicament is depleted, the entire aerosol generating apparatus, including the aerosol generating module, is to be thrown away.

To achieve desired aerosolization, the liquid container may need to be cleaned prior to each use. The same applies to the perforated membrane. If the liquid container and/or the perforated membrane are not cleaned properly, the life of the nebulizer may be shortened. For example, residue may form and block either the perforated membrane or the opening of the liquid container. The foregoing may further lead to faster degradation of the vibratable element, thereby reduce the nebulization efficiency. Insufficient cleaning may also lead to contamination, which may jeopardize medical treatments. The abovementioned risks can be mitigated by using a new set of aerosol generating module and liquid container for every treatment. However, this will substantially increase the patient's financial burden.

Therefore, the present disclosure aims to design an aerosol generating apparatus with replaceable components, such as a vial and the assembly thereof. Certain components may be disposed after each treatment, while others can be preserved for repeated use.

Document <CIT> discloses a nebuliser device with a vibrating mesh, for administering medicaments, comprising a casing, a nozzle, a nebuliser and a chamber that houses a medicament.

The dependent claims define embodiments of the invention.

The present disclosure provides an aerosol generating apparatus including a vial, a cap assembly and a receptacle. The vial is capable of storing liquid medicament and includes a puncturable seal held in position by a retaining ring. The cap assembly includes an actuator with an interior bore extending therethrough, a perforated membrane coupled to the actuator, a fastener, and a first mating element. The fastener is adapted to detachably secure the cap assembly to the vial such that the perforated membrane aligns with the puncturable seal. The receptacle is configured to receive the cap assembly with the vial, and the receptacle includes a driving element and a second mating element capable of mating with the first mating element of the cap assembly. The driving element aligns and communicates with the perforated membrane when the receptacle engages the cap assembly. Operation of the actuator pierces the puncturable seal, which allows the liquid medicament to be displaced through the interior bore to the perforated membrane. The driving element will vibrate the liquid medicament at the perforated membrane to generate aerosol.

The present disclosure also provides a replaceable vial assembly for an aerosol generator. The vial assembly includes a vial and a cap assembly. The vial is capable of storing liquid medicament. The vial includes a puncturable seal held in position by a retaining ring. The cap assembly includes a cap body and an actuator. The cap body includes a perforated membrane. The actuator is received within the cap body and includes an interior bore extending therethrough. The actuator couples to the perforated membrane such that the interior bore is in communication with the perforated membrane. The cap body is adapted for detachably snap engagement over the retaining ring such that the perforated membrane aligns with the puncturable seal. Upon movement of the actuator, the vial's puncturable seal is pierced and the liquid medicament flows from the vial through the interior bore to the perforated membrane. The replaceable vial assembly is adapted to detachably engage with an aerosol generator.

The present disclosure also provides a method for operating an aerosolizer. The liquid medicament is stored in a vial that includes a puncturable seal. A cap assembly is detachably secured over the vial to form a vial assembly. As a result, a perforated membrane on the cap assembly is aligned with the puncturable seal of the vial. The cap assembly, securing over the vial, is subsequently actuated to pierce the puncturable seal. The vial assembly is detachably engaged with a receptacle in a way that the liquid medicament is displaced to the perforated membrane by gravity. A driving element of the receptacle is aligned with the perforated membrane in a way that the driving element communicates with the perforated membrane. The driving element is activated to nebulize the liquid medicament passing through the perforated membrane for aerosol generation.

One or more embodiments are illustrated by way of example, and not by limitation, in the figures of the accompanying drawings, wherein elements having the same reference numeral designations represent like elements throughout. The drawings are not to scale, unless otherwise disclosed.

The dimensions and the relative dimensions do not necessarily correspond to actual reductions to practice of the disclosure.

The making and using of the embodiments of the disclosure are discussed in detail below. It should be appreciated, however, that the embodiments provide many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the embodiments, and do not limit the scope of the disclosure.

Throughout the various views and illustrative embodiments, like reference numerals are used to designate like elements. Reference will now be made in detail to exemplary embodiments illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts. In the drawings, the shape and thickness may be exaggerated for clarity and convenience. This description will be directed in particular to elements forming part of, or cooperating more directly with, an apparatus in accordance with the present disclosure. It is to be understood that elements not specifically shown or described may take various forms. Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. It should be appreciated that the following figures are not drawn to scale; rather, these figures are merely intended for illustration.

In the drawings, like reference numbers are used to designate like or similar elements throughout the various views, and illustrative embodiments of the present disclosure are shown and described. The figures are not necessarily drawn to scale, and in some instances the drawings have been exaggerated and/or simplified in places for illustrative purposes. One of ordinary skill in the art will appreciate the many possible applications and variations of the present disclosure based on the following illustrative embodiments of the present disclosure.

It will be understood that when an element is referred to as being "on" another element, it can be directly on the other element or intervening elements may be present.

It will be understood that singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, relative terms, such as "bottom" and "top," may be used herein to describe one element's relationship to other elements as illustrated in the Figures.

It will be understood that elements described as "under" or "below" other elements would then be oriented "over" or "above" the other elements. The exemplary terms "under" or "below" can, therefore, encompass both an orientation of over and under.

It will be further understood that terms; such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

<FIG> illustrates an aerosol generating apparatus <NUM> based on some embodiments of the present disclosure. The aerosol generating apparatus <NUM> includes a vial assembly <NUM> and a receptacle <NUM>. The vial assembly <NUM> includes a vial <NUM> and a cap assembly <NUM>. The vial <NUM> contains liquid medicament. In one example, the vial <NUM> is designed for a single dosage. As will be discussed in subsequent disclosures and embodiments, the cap assembly <NUM> is detachably securable to the vial <NUM>. When the cap assembly <NUM> is secured to the vial <NUM>, the vial assembly <NUM> is formed. The vial assembly <NUM> is designed in a way that it can detachably engage the receptacle <NUM>, i.e., it is removable. When engaged with the receptacle <NUM>, the liquid medicament is directed to flow through the cap assembly <NUM> and release to the receptacle <NUM> for nebulization. The vial assembly <NUM> is removable and disposable, whereas the receptacle <NUM> is designed for repeated use. In this way, the cost of using the aerosol generating apparatus <NUM> is substantially reduced. The disposable nature of the vial assembly <NUM> also reduces the risk of contamination, because a new set of vial assembly <NUM> and the medication therein is used in every new treatment cycle. Users may always inhale fresh and precise amount of medication in each treatment. Moreover, when the vial assembly <NUM> is disengaged, a user may further clean and sterilize the rest of the aerosol generating apparatus <NUM>. The foregoing decreases the chances of clogging of the aerosol generating apparatus <NUM>, thus increasing its life and the aerosolization efficiency.

<FIG> illustrates a lateral view of the vial <NUM> according to some embodiments of the present disclosure. The vial <NUM> includes a puncturable seal <NUM> and a retaining ring <NUM>. The puncturable seal <NUM> can be a metal or inert plastic layer or an elastomer stopper or any conventional means that can securely close a vial. The puncturable seal <NUM> is held in sealing engagement to a neck <NUM> of the vial <NUM> by means of the retaining ring <NUM> provided with a central aperture which allows the insertion of an actuator to break the seal, i.e., either by pushing the stopper into the vial <NUM> or by puncturing the sealing layer. The retaining ring <NUM> may be made of metal such as anodized aluminum. The vial <NUM> also stores a liquid medicament <NUM>. The amount of the liquid medicament <NUM> can be adjusted, depending on the dosages desired, e.g. single or multiple. In another embodiment, the puncturable seal <NUM> is covered to the top surface of the retaining ring <NUM>. The puncturable seal <NUM> prevents the liquid medicament <NUM> from leaking out of the vial <NUM> and ensures that there is no fluid or air communication with the exterior environment.

<FIG> illustrate a top view and a perspective view of the cap assembly <NUM> of the aerosol generating apparatus <NUM> according to some embodiments of the present disclosure. The cap assembly <NUM> includes a circumferentially extending rib <NUM>, an actuator <NUM>, a perforated membrane <NUM>, a fastener <NUM> and a cap body <NUM>. The cap assembly <NUM> can detachably engage with a receptacle <NUM> via the rib <NUM>. In one example, the fastener <NUM> is equipped on the cap body <NUM>. The perforated membrane <NUM> is made of a macromolecular polymer of polyimide, polyethylene (PE), polypropylene (PP), polyether ether ketone (PEEK) and/or the combination thereof. In some embodiments, the perforated membrane <NUM> may be integrally formed with the cap body <NUM>; the two are made of the same material or same combination of materials. In some embodiments, the cap body <NUM> is made of metal. The perforated membrane <NUM> is affixed to the top surface of the cap body <NUM>. The actuator <NUM> includes an interior bore <NUM> extending therethrough, providing a passage through which the liquid medicament <NUM> can travel from the vial <NUM> to the perforated membrane <NUM>. Particularly, the actuator <NUM> is coupled to the perforated membrane <NUM> such that the interior bore <NUM> communicates with the perforated membrane <NUM>. The actuator <NUM> is also received within the cap body <NUM>. Specifically, the actuator <NUM>, along with the cap body <NUM>, is adapted to move along the X-Y direction (as shown in <FIG>) upon operation in order to break or move the puncturable seal <NUM>. When the cap assembly <NUM> is secured to the vial <NUM>, the fastener <NUM> secures the cap assembly <NUM> to the retaining ring <NUM> at the neck <NUM> of the vial <NUM>, in a detachable manner, and aligns the perforated membrane <NUM> with the puncturable seal <NUM>.

The fastener <NUM> may detachably secure the cap assembly <NUM> to the vial <NUM> using different coupling mechanisms. The coupling mechanisms include snap fit, interference fit, tongue-and-groove fit, post-and-bore fit, and press fit. In a preferred embodiment, the fastener <NUM> may be configured for detachably snap engagement of the cap assembly <NUM> over the retaining ring <NUM> at the neck <NUM> of the vial <NUM>. The engagement is adapted to align the perforated membrane <NUM> with the vial's seal <NUM>. It is to be noted that the present disclosure is not so limited, and a person having ordinary skill understands that any coupling mechanisms known in the art are within the scope of the present disclosure.

In certain embodiments, the actuator <NUM> includes one or multiple projection(s) <NUM> that extends from the interior bore <NUM>. Foolproof designs may be provided to the actuator <NUM> to prevent the puncturable seal <NUM> from blocking the flow of the liquid medicament <NUM> when the vial <NUM> is inverted. For example, projections <NUM> may be arranged to be circumferentially spaced such that liquid medicament <NUM> may flow into the interior bore <NUM> through the spaces between the projections <NUM>. In other embodiments, lengths of the projections <NUM> extending from the interior bore <NUM> may not be equal. Accordingly, the liquid medicament <NUM> may flow through the space formed by unequal lengths of the projections <NUM>. In certain embodiments, the projection <NUM> is a ring-shaped projection, a sidewall of which has at least one through hole. In this way, the liquid medicament may flow to the interior bore <NUM> through the through hole even if an opening formed on the ring-shaped projection is obstructed by the puncturable seal <NUM>.

In certain embodiments, the cap assembly <NUM> may also include an O-shaped ring <NUM> sandwiched between the actuator <NUM> and the retaining ring <NUM>. When the cap assembly <NUM> is secured to the vial <NUM>, the O-shaped ring <NUM> provides liquid or air tight seal by filling the tiny gap (not shown) between the actuator <NUM> and the retaining ring <NUM>. In this way, when the puncturable seal <NUM> is pierced and the vial <NUM> is inverted, the seal provided by the O-shaped ring <NUM> prevents any leakage of the liquid medicament <NUM>. In other words, the O-shaped ring <NUM> ensures that the liquid medicament <NUM> only exits the vial <NUM> through the interior bore <NUM> to the perforated membrane <NUM>.

<FIG> illustrate a process of securing the cap assembly <NUM> to the vial <NUM> based on some embodiments of the present disclosure. The vial assembly <NUM> is formed once the cap assembly <NUM> is secured to the vial <NUM>, and the liquid medicament <NUM> may communicate with the perforated membrane <NUM> for nebulization. <FIG> illustrates a first position of the actuator <NUM>. <FIG> illustrates a second position of the actuator <NUM>. <FIG> illustrates an exemplary state when the puncturable seal <NUM> is pierced.

In certain embodiments, the process of securing the cap assembly <NUM> to the vial <NUM> is split into two phases.

In the first phase as illustrated in <FIG>, the actuator <NUM> is at the first position when an aligning force F1 moves the cap assembly <NUM> towards the vial <NUM>, permitting the fastener <NUM> to secure the cap assembly <NUM> to the vial, i.e., by clamping to the neck <NUM> of the vial <NUM>. In another example, the fastener <NUM> may be configured to be abutments <NUM> and <NUM> that can detachably snap engage the vial <NUM>. In one example, the abutments <NUM> and <NUM> are circumferentially spaced and inwardly projecting. In this first phase, the puncturable seal <NUM> has not been pierced while the actuator <NUM> may or may not touch the puncturable seal <NUM>.

In the second phase as illustrated in <FIG>, the actuator <NUM> is moved to the second position by an actuating force F2. That is, upon actuation, the actuator <NUM> moves to the second position to puncture the puncturable seal <NUM>. In certain embodiments, the puncturable seal <NUM>, which may be an elastomer stopper, will be pushed into the vial <NUM> by the actuator <NUM> in the second phase. In certain embodiments, the actuating force F2 is larger than the aligning force F1 because puncturing the puncturable seal <NUM> requires a larger force than that of merely moving the cap assembly <NUM> towards the vial <NUM>. As further illustrated in <FIG>, the elastomer stopper drops into the vial <NUM> after being pushed in by the actuator <NUM>. In some other embodiments, the puncturable seal <NUM>, which may be a metal or plastic layer, is pierced by the actuator <NUM> in this second phase.

Under certain circumstances, a user of the aerosol generating apparatus <NUM> may prefer the vial <NUM> and the cap assembly <NUM> to be pre-assembled. In the first phase, the user may carry the vial <NUM> and the cap assembly <NUM> together while keeping the puncturable seal <NUM> intact. Such design prevents the hassle of carrying two separate components.

<FIG> illustrate how to assemble the aerosol generating apparatus <NUM>. Particularly, the vial assembly <NUM> is adapted to detachably engage the receptacle <NUM>, e.g. in a removably seatable manner, such that the vial assembly <NUM> is removable and can be replaced when needed. In <FIG>, the vial assembly <NUM> is inverted in order to engage the receptacle <NUM>. Particularly, the inverted vial assembly <NUM> ensures that the liquid medicament <NUM> may reach the perforated membrane <NUM> by gravity when the puncturable seal <NUM> is removed. A force F3 is applied to engage the vial assembly <NUM> with the receptacle <NUM>. Specifically, in one example, the rib <NUM> on the cap assembly <NUM> mates with a mating groove <NUM> on the receptacle <NUM> in a removably seatable manner. In some examples, the rib <NUM> may be a first mating element of any available form, and the mating groove <NUM> may be a second mating element of any available form, as long as the first and second mating element can properly engage each other. In some examples, the mating mechanism between the first mating element and the second mating element may be one of a snap fit, an interference fit, a tongue-and-groove fit, a post-and-bore-fit, and a press fit. In <FIG>, the vial assembly <NUM> is further rotated to slide the rib (not shown) further into the mating groove <NUM> via a rotational force F4. As a result, the vial assembly <NUM> is securely engaged to the receptacle <NUM>. Consequently, a driving element of the receptacle <NUM> (not shown) is aligned and in contact with the perforated membrane (not shown). Particularly, the driving element includes a piezoelectric element coupled to a substrate that may be made of metal. The substrate includes a projection in contact with the perforated membrane, and vibration energy generated by the piezoelectric element is transmitted to the perforated membrane via the projection for nebulization. In certain embodiments, the projection may deform, i.e., press against, the perforated membrane to an extent in order to achieve better nebulization effects. The liquid medicament <NUM> may flow out of the vial <NUM>, through the internal bore <NUM> of the actuator <NUM> (not shown) to the perforated membrane <NUM> (not shown), at which aerosolization occurs when the driving element vibrates the liquid medicament <NUM>.

In <FIG>, when the liquid medicament <NUM> is depleted and/or a user intends to replace the vial assembly <NUM>, the vial assembly <NUM> can be disengaged by rotating it in a direction opposite to that of engagement via a rotational force F5. In other words, the rib <NUM> slides away from a secured position to permit the vial assembly <NUM> to be disengaged. In <FIG>, the vial assembly <NUM> is removed from the receptacle <NUM> via a disengaging force F6. The vial assembly <NUM> may be disposed.

<FIG> illustrate the designs of the cap assembly <NUM> based on some embodiments of the present disclosure. The cap assembly <NUM> may further include a flexible arm <NUM> and a collar <NUM> coupled to the flexible arm <NUM>. The collar <NUM> engages the vial <NUM> at the neck <NUM>, as illustrated in <FIG>. The flexible arm <NUM> prevents the cap assembly <NUM> from being separated from the vial <NUM> when the cap assembly <NUM> is not engaged with the vial <NUM>. With the aid of the aforementioned components, the cap assembly <NUM> can be pre-coupled to the vial <NUM>. When the vial assembly <NUM> is to be used for nebulization, the flexible arm <NUM> may be bent to allow the cap assembly <NUM> to engage the vial <NUM>. As illustrated in <FIG>, the engagement of the cap assembly <NUM> with the vial <NUM> punctures the seal by pushing the puncturable seal (e.g. a stopper) <NUM> into the vial <NUM>.

<FIG> illustrates a design of the vial <NUM> based on some embodiments of the present disclosure. The vial <NUM> may include a first chamber <NUM> and a second chamber <NUM>. The first chamber <NUM> is closer to the opening of the vial <NUM> than the second chamber <NUM>. The first chamber <NUM> is separated from the second chamber <NUM> by a seal <NUM> that is liquid tight to or air tight. In certain embodiments, the seal <NUM> is a diaphragm. In one example, the first chamber <NUM> is used for storing the liquid medicament <NUM>, and the second chamber <NUM> is used for depositing a solid medicament <NUM>, e.g. in forms of powder. When the puncturable seal <NUM> is punctured by engagement of the cap assembly <NUM> to the vial <NUM>, the hydraulic pressure of the first chamber <NUM> is increased. In this way, the seal <NUM> is also punctured by the first chamber <NUM>'s increasing pressure. Accordingly, the two chambers <NUM> and <NUM> become communicative such that the liquid medicament <NUM> and the solid medicament <NUM> can be mixed. The solid medicament <NUM> can be better preserved with such design. In one example, the first chamber <NUM> may be a vacuum, and the liquid medicament is disposed in the second chamber <NUM>. Accordingly, even if the seal <NUM> is compromised and the first chamber <NUM> is exposed to exterior environment, the seal to the liquid medicament is still intact. In other words, the foregoing setting provides additional security, preventing the liquid medicament from becoming in contact with the environment before desired use.

Operation or movement of the actuator in the present disclosure is not to be limited to a specific manner. In one example, actuation may occur when a user pushes the cap assembly <NUM>, which includes the actuator <NUM> therein, against the vial <NUM> in order to allow the actuator to break or move the puncturable seal <NUM>. Another example of actuation may be in the form of screwing the cap assembly <NUM> on the vial <NUM> with continuous threads until the puncturable seal <NUM> is pierced.

Although the present disclosure and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the scope of the disclosure as defined by the appended claims. For example, many of the processes discussed above can be implemented in different methodologies and replaced by other processes, or a combination thereof.

Claim 1:
An aerosol generating apparatus (<NUM>), comprising:
a vial (<NUM>) for storing liquid medicament (<NUM>) comprising a penetrable seal (<NUM>);
a cap assembly (<NUM>) comprising an actuator (<NUM>) with an interior bore (<NUM>) extending therethrough, the interior bore (<NUM>) having a first end and a second end and open fluid communication between the first end and the second end, a perforated membrane (<NUM>) coupled to the cap assembly (<NUM>) and disposed at or near the first end of the interior bore (<NUM>) of the actuator (<NUM>), a fastener (<NUM>) and a first attachment element (<NUM>), wherein the fastener (<NUM>) is adapted to detachably secure the cap assembly (<NUM>) to the vial (<NUM>) in a first position such that the penetrable seal (<NUM>) aligns with the second end of the interior bore (<NUM>) of the actuator (<NUM>); and
a receptacle (<NUM>) for receiving the cap assembly (<NUM>) with the vial (<NUM>), the receptacle (<NUM>) including a driving element which is coupled to a substrate and a second attachment element (<NUM>) configured to attach with the first attachment element (<NUM>) of the cap assembly (<NUM>), wherein the perforated membrane (<NUM>) projects over and communicates with the driving element when the receptacle (<NUM>) engages the cap assembly (<NUM>), and the perforated membrane (<NUM>);
wherein the actuator (<NUM>) , when actuated from the first position to a second position, is configured to penetrate the penetrable seal (<NUM>) such that the liquid medicament (<NUM>) is displaced through the interior bore (<NUM>) from the second end to the perforated membrane (<NUM>) at or near the first end and the driving element is configured to vibrate the liquid medicament (<NUM>) at the perforated membrane (<NUM>) via the substrate to generate aerosol through the receptacle (<NUM>).