Apparatus for pulmonary dispensation of drugs

Description

1 / 34 APPARATUS FOR PULMONARY DRUG DISPENSING TECHNICAL FIELD

[001] This invention relates broadly to the field of pulmonary drug dispensing and, more specifically, to pulmonary drug dispensing apparatus. FUNDAMENTALS OF THE TECHNIQUE

[002] The following discussion of the prior art is intended only to facilitate understanding of the present invention. The discussion is not an acknowledgment or admission that any material referred to is or was part of the common general knowledge at the priority date of the application.

[003] Pulmonary drug delivery is a route of administration in which patients use an inhalation drug delivery device, such as an inhaler, to inhale their medications and drugs, acting on a target site in the airways, or even for absorption into the bloodstream through the pulmonary mucosa. This technique is most commonly used in the treatment of lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). Different types of inhalers include metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizers.

[004] Proper education on the use of inhalers is important to ensure that the inhaled medication is effectively delivered to the airways and produces its intended effects. The rate, efficiency, and effectiveness of dispensing Petition 870250094462, dated 10 / 16 / 2025, page 20 / 85 2 / 34 of pulmonary drug delivery is affected by the properties of the drug particles, respiratory patterns, and the geometry of the respiratory tract. As a result, the rate, efficiency, and effectiveness of pulmonary drug delivery are affected by the properties of the drug particles, respiratory patterns, and the geometry of the respiratory tract, making pulmonary drug delivery dependent on inhalation techniques and patient adherence to proper inhaler use, i.e., inadequate timing, coordination and depth, frequency, and respiratory pattern.

[005] To achieve successful pulmonary drug delivery, inhaled particles should ideally not be deposited in the upper respiratory tract, as they will be swallowed or expectorated without reaching the lungs, leading to loss of the intended pharmacological effect and / or causing undesirable systemic side effects. Incorrect inhalation techniques, such as inadequate coordination, failure to exhale before inhaling the drug aerosol, or failure to hold one's breath for a few seconds after inhalation, can lead to drug deposition in the respiratory tract instead of the lungs, resulting in inefficient and inadequate treatment.

[006] Different inhalers require specific techniques for their proper use. For example, metered-dose (MD) inhalers require coordination between inhalation and Petition 870250094462, dated 10 / 16 / 2025, page 21 / 85 3 / 34 Inhaler operation: Dry powder inhalers (DPIs) require adequate inspiratory flow from patients and can be sensitive to humidity, and nebulizers may have low efficiency in delivering the drug to the lungs, since a substantial percentage of the medication is normally lost to the atmosphere during use, which can pose risks to other people around the patient.

[007] In an attempt to address some of these shortcomings, the technique has turned to inhaler spacers designed for use only with an ID, which are generally some type of device that provides a space, usually in the form of a tube or chamber, between the patient's mouth and the ID. These spacers aim to help patients inhale their medication more effectively by introducing a storage space where the medication can be stored until the patient is ready to inhale. The volume of the spacer where the medication is stored is important, as small-volume spacers (which constitute more than 80% of spacers sold) only minimally reduce the need to synchronize the patient's breathing so that they can inhale properly and facilitate pulmonary dispensing of the drug.The walls of conventional spacers are typically made of rigid plastic, where droplets impact and are retained, reducing the amount of medication that exits the spacer into the patient's mouth. Petition 870250094462, dated 10 / 16 / 2025, page 22 / 85 4 / 34 patients experience up to 40% reduction in spacer volume. This reduces the amount of drug reaching the airways to produce its effect, substantially limiting the intended benefits of the spacer, particularly in children, people with severe shortness of breath, and people with cognitive impairment. The overall bulk of spacers limits their appeal among patients.

[008] A variety of spacers have been developed in the art. For example, US document 2016 / 0256641, by Lisberg, describes a device comprising a collapsible bag to which a bidirectional mouthpiece is attached and an adapter that receives an ID. The mouthpiece contains a reed that functions as an audible signal and a screen to prevent the inhalation of unwanted particles. US document 4,790,305, by Zoltan et al., describes an apparatus comprising a mouthpiece for delivering a pharmaceutical composition to a patient's mouth, a rigid chamber for containing the aerosol before inhalation, the rigid chamber having orifices to limit the airflow through it, and a collapsible chamber from which the patient inhales unmedicated air before inhaling the medicated air coming from the rigid chamber.

[009] Sackner's US patent 4,484,577 describes an apparatus that includes an expanded bag and a bidirectional channel for delivering a drug to a patient's airway and that is substantially impermeable to Petition 870250094462, dated 10 / 16 / 2025, p. 23 / 85 5 / 34 air passage. Retracting the expanded bag while the bidirectional channel for communication with the airway is in position releases the drug into the patient's airway, with a signal in the bidirectional channel indicating when the drug passage rate exceeds a desired limit.

[0010] US patent 7,418,962, by Rao, describes an inhaler comprising a collapsible recirculation chamber or a reinspirator. The inhaler has an aerosol retention chamber with an inlet end for attaching an aerosol medication holder or nebulizer device, and an outlet end for attaching a mouthpiece or mask in order to dispense the medication or substance to the user, with a recirculation chamber depending on the outlet end of the retention chamber or a mask extending from the outlet end of the chamber.

[0011] US patent 5,791,340, by Schleufe et al., describes a resuscitator for artificial resuscitation, comprising a bag that, at one end, is provided with a valve for the patient, and, at the opposite end, is provided with an inlet valve for the admission of fresh ambient air. Between the external environment and the interior of the bag, a small flow passage opening is provided, through which the bag can be filled with the contents of a metered-dose inhaler for administration, by inhalation, of Petition 870250094462, dated 10 / 16 / 2025, page 24 / 85 6 / 34 pharmacologically active air cells, allowing the resuscitator to be used as a spacer for inhalation.

[0012] US patent 7,360,537, by Snyder et al., describes an aerosol drug dispensing device, including an antistatic retention chamber having an inlet end and an outlet end, and defines an internal space. GB patent 2,285,396, by Savoullas, describes an inhaler comprising a suspended rebreathing bag, the inhaler having upper inlets for a mask, inhalant, and oxygen. The administered drug or oxygen is retained within the rebreathing bag, resulting in almost complete dispensing to the lungs, via one-way valves, during inhalation. Due to the flexibility of the rebreathing bag, it empties during inhalation, indicating the degree of air intake.

[0013] With the aim of mitigating some of the known shortcomings in the state of the art relating to pulmonary drug dispensing, the Applicant has also developed several inhaler spacer technologies, intended for use with different types of inhalers, as described in US patents no. US 11,207,476; US 11,426,543 and US 11,458,264.

[0014] In light of conventional practices relating to spacers, the Applicant identified an inadequacy in Petition 870250094462, dated 10 / 16 / 2025, p. 25 / 85 7 / 34 state of the art relating to such devices, wherein a chamber of conventional spacers generally comprises inlets and outlets arranged with specific orientations relative to each other, such orientations being relatively unfavorable to the adequate dispersion of a drug aerosol from an inhaler. For example, conventional spacers comprise opposite inlets and outlets, as in the case of Schleufe; or shared inlets and outlets, as in the single bidirectional channel of Sackner, Zoltan and Savoullas; or even inlets and outlets arranged laterally in the same plane, as in Lisberg devices.

[0015] Additionally, the chambers of conventional spacers are also not optimized for the efficient dispensing of aerosol drugs, since such inlets, outlets and / or chambers generally present obstacles to the efficient dispersion of the aerosol drug, due to the presence of angular and abrupt transitions on the surfaces, as well as abrupt surface ends, which interrupt the flow of drug dispersion within the chamber and provide surfaces for an aerosol drug to adhere to upon impact.

[0016] The present invention was conceived with such inadequacies in mind. SUMMARY OF THE INVENTION Petition 870250094462, dated 10 / 16 / 2025, p. 26 / 85 8 / 34

[0017] Those skilled in the art should understand that the reference in this descriptive report to a 'sphere' and its derivatives, such as 'spherical', refers comprehensively to a globe-like, globular, or substantially globe-shaped object that is more or less spherical, and may include a sphere, a spheroid (oblate or prolate), or any approximately spherical body similar in three-dimensional space, without significant internal angles in the regions where the internal surfaces of that body meet.

[0018] According to one aspect of the invention, an apparatus for pulmonary drug dispensing is provided, comprising: a spherical reservoir that defines respective inlet and outlet openings through one of its surfaces; an arched, elongated, and substantially flat column member defining an inlet orifice at one end and an outlet orifice at the other end, said arched column member being configured for complementary engagement on a portion of the outer surface of said spherical reservoir, such that: The inlet hole cooperates with the inlet hole to form a perpendicular entry port. Petition 870250094462, dated 10 / 16 / 2025, p. 27 / 85 9 / 34 on the surface of the spherical reservoir; and the outlet orifice cooperates with the outlet orifice to define an outlet port arranged tangentially to the surface of the spherical reservoir; wherein the inlet and outlet ports are opposite and not aligned on the spherical reservoir.

[0019] Those skilled in the art should understand that the specific configuration of the spherical reservoir of the device, together with the column member that defines complementary inlet and outlet ports, provides a reservoir intended for the dispersion of a drug in aerosol form, as well as a flow path uninterrupted by structural impediments and abrupt surface transitions and terminations, thus facilitating the efficient dispensing of the drug in aerosol form from the inlet port to the outlet port.

[0020] In one embodiment, the inlet opening of the spherical reservoir comprises a circular or rounded opening arranged perpendicularly to a central point of the spherical reservoir.

[0021] In one embodiment, the outlet opening of the spherical reservoir comprises a slit.

[0022] In one embodiment, the outlet opening is offset from the inlet opening along the surface of the reservoir, forming an angle between 60° and 170°. Petition 870250094462, dated 10 / 16 / 2025, p. 28 / 85 10 / 34

[0023] Typically, the slit is offset from the inlet opening at an angle substantially equal to 90°, along the surface of the reservoir.

[0024] In one embodiment, the inlet and outlet ports are coplanar on the surface of the spherical reservoir.

[0025] In one embodiment, the inlet and outlet openings are defined on a great circle or orthodrome of the spherical reservoir.

[0026] In one embodiment, the spherical reservoir is manufactured from a flexible material, such as a polymer, so that the reservoir is collapsible in response to pressure fluctuations within it, to accommodate a breathing pattern and / or reinspiration.

[0027] In one embodiment, the spherical reservoir is manufactured with, or internally coated with, an antistatic material in order to minimize the adhesion of aerosol drug particles.

[0028] In one embodiment, the spherical reservoir defines, on its surface, at least one engagement point to facilitate the complementary engagement of the column member.

[0029] In one embodiment, at least one engagement part comprises an engagement collar defined around a portion of the inlet and / or outlet opening, said engagement collar being configured for engagement with the member Petition 870250094462, dated 10 / 16 / 2025, page 29 / 85 11 / 34 of column.

[0030] In one embodiment, the spherical reservoir is configured to define a predetermined internal volume.

[0031] In one embodiment, the predetermined internal volume comprises a range between 30 ml and 2500 ml.

[0032] In one embodiment, the column member is configured so that its curvature conforms substantially to the curvature of the outer surface portion of the spherical reservoir.

[0033] In one embodiment, an inlet hole shape is configured to conform to an inlet opening shape.

[0034] In one embodiment, an outlet hole shape is configured to conform to an outlet opening shape.

[0035] In one embodiment, the column member defines a coupling assembly around a portion of the inlet and / or outlet holes, said coupling assembly configured to mount, respectively, an inlet and / or outlet adapter.

[0036] In one embodiment, the coupling assembly is configured to mount the inlet and / or outlet adapter in a watertight manner to the spherical reservoir.

[0037] In one embodiment, the device includes the input and / or output adapter. Petition 870250094462, dated 10 / 16 / 2025, p. 30 / 85 12 / 34

[0038] In one embodiment, the inlet adapter comprises an inhaler adapter configured to provide an inhaler in tight communication with the spherical reservoir.

[0039] In one embodiment, the inhaler is selectable from a non-exhaustive group consisting of: metered-dose inhaler (ID), dry powder inhaler (DPI), soft mist inhaler and nebulizer.

[0040] In one embodiment, the entrance port comprises an adjustable supplementary entrance port, through which a fluid, such as air, can enter the spherical reservoir.

[0041] In one embodiment, the input adapter comprises the adjustable supplementary input port.

[0042] In one embodiment, the inlet adapter defines an additional fluid passage, said additional passage being selectively adjustable to control a volumetric flow of fluid that can enter the spherical reservoir.

[0043] In one embodiment, the inlet adapter defines a valve housing around the inlet port, the valve housing defining the supplementary fluid passage, a complementarily rotatable annular valve member receiveable within said valve housing, and defining a valve orifice, in which selective rotation Petition 870250094462, dated 10 / 16 / 2025, p. 31 / 85 13 / 34 of the valve member inside the valve housing aligns or misaligns the supplementary fluid passage and the valve orifice, as the case may be, so that a volumetric flow of fluid entering the spherical reservoir is continuously adjustable.

[0044] In one embodiment, the outlet adapter is configured to place the spherical reservoir in fluidic communication with a person's airway.

[0045] In one embodiment, the output adapter is selectable from a non-exhaustive group consisting of a mouthpiece and a face mask.

[0046] In one embodiment, the outlet adapter comprises a valve configured to admit fluid flow from the spherical reservoir into a person's airway during use, and to divert return fluid flow from said airway to the atmosphere.

[0047] In one embodiment, the valve comprises an angled flange membrane arranged transversely along a fluid passage of said outlet adapter, wherein the angle of said flange membrane facilitates the admission or diversion of fluid flow. Those skilled in the art should understand that the broad definition of a flange comprises “something flat and wide that is affixed only on one side, and projects freely or covers an opening. Petition 870250094462, dated 10 / 16 / 2025, p. 32 / 85 14 / 34

[0048] In one embodiment, the angle of the flange membrane relative to the fluid passage of said outlet adapter is between 30° and 90°.

[0049] In one embodiment, the angle of the flange membrane relative to the fluid passage of said outlet adapter is between 30° and 60°.

[0050] In one embodiment, the valve comprises a support, such as a metal mesh, arranged transversely to said fluid passage, to support the flap membrane along the fluid passage during flow diversion.

[0051] In one embodiment, the valve comprises a trapdoor-type flap, through which the return fluid flow from said airway of a person is diverted to the atmosphere.

[0052] In one embodiment, the input adapter and / or the output adapter comprises a whistle configured to provide auditory feedback regarding the rate of inspiration and / or expiration during the use of the device.

[0053] In one embodiment, the input adapter includes a handle to facilitate handling of the device during its use.

[0054] According to a further aspect of the invention, an apparatus for pulmonary dispensing of drugs is provided, substantially as described and / or illustrated in Petition 870250094462, dated 10 / 16 / 2025, page 33 / 85 15 / 34 present document. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The description will be made with reference to the attached drawings in which: Figure 1 is a diagrammatic perspective representation of an embodiment of a pulmonary drug dispensing apparatus, according to an aspect of the present invention; Figures 2a and 2b show diagrammatic representations of substantially unobstructed routes of administration for aerosol drugs through the pulmonary drug dispensing apparatus of Figure 1; Figure 3 is a schematic perspective representation of one embodiment of the pulmonary drug dispensing device of Figure 1; Figure 4 is a schematic exploded view representation of the pulmonary drug dispensing apparatus of Figure 3; Figure 5 is a schematic perspective representation of the spherical reservoir and column member of the pulmonary drug dispensing device of Figure 3; Figure 6 is a schematic exploded perspective wireframe representation of the spherical reservoir, column member, inlet adapter, and outlet adapter of the pulmonary dispensing device. Petition 870250094462, dated 10 / 16 / 2025, page 34 / 85 16 / 34 drugs from Figure 3; Figure 7 is a schematic wireframe representation of examples of inlet adapters with a nebulizer inhaler shown; Figure 8 is a schematic exploded wireframe representation of the output adapter showing an example of a valve; Figures 9 to 12 are schematic perspective representations of different examples of the outlet adapter with a valve; Figure 13 is a schematic exploded perspective representation of examples of constituent parts of a pulmonary drug dispensing apparatus, according to aspects of the present invention; Figure 14 is a schematic perspective representation of an additional embodiment of a pulmonary drug dispensing apparatus, according to aspects of the present invention; Figure 15 is a schematic perspective representation of the pulmonary drug dispensing apparatus of Figure 14; Figure 16 is a schematic top perspective representation of the pulmonary drug dispensing apparatus of Figure 14; and Figure 17 shows a schematic representation in Petition 870250094462, dated 10 / 16 / 2025, page 35 / 85 17 / 34 perspective of a modality of the adjustable supplementary port for the pulmonary drug dispensing device. DETAILED DESCRIPTION OF MODALITIES

[0056] Other features of the present invention are described in more detail in the following description of various non-limiting embodiments thereof. This description is included solely for the purpose of exemplifying the present invention for the discerning recipient. It should not be construed as a restriction on the broad summary, disclosure or description of the invention as set forth above.

[0057] In the figures, incorporated to illustrate features of the example embodiment(s), similar reference numbers are used to identify similar parts. Furthermore, features, mechanisms and aspects well known and understood in the art will not be described in detail, since such features, mechanisms and aspects will be within the understanding of the skilled recipient.

[0058] Furthermore, the attached figures do not represent engineering or design drawings, but provide only a general functional overview of the invention. As a result, the practical construction features and details required for various embodiments may not be shown. Petition 870250094462, dated 10 / 16 / 2025, page 36 / 85 18 / 34 indicated in each figure, but such construction requirements will be within the understanding of the knowledgeable recipient.

[0059] In general terms, the present invention provides a pulmonary drug dispensing apparatus 10 that typically acts as an inhaler spacer for dispersing and dispensing aerosolized drugs between an inhaler 38 and a person's airway. The apparatus 10 is designed to be particularly conducive to the proper collection and dispersion of a drug aerosol from an inhaler 38, while further facilitating the ease and efficiency of dispensing aerosolized drugs to a person. Importantly, such collection, dispersion and dispensing are suitable for varying respiratory patterns and associated rebreathing of a patient as needed.

[0060] Furthermore, as described in more detail below, the device 10 includes modularity to accommodate different types of inhalers 38, as well as different means of delivering aerosol drugs, whether by means of a mouthpiece, a face mask, an extension tube or the like. Consequently, in one embodiment, the inhaler 38 may comprise a metered-dose inhaler (MDI), a dry powder inhaler (DPI), a soft mist inhaler, a nebulizer or the like. Similarly, the means of delivery, typically by means of the output adapter 36 described Petition 870250094462, dated 10 / 16 / 2025, page 37 / 85 19 / 34 below, may include a mouthpiece, a face mask, an extension tube or similar.

[0061] With reference now to the accompanying figures, there are exemplified embodiments of such a pulmonary drug dispensing apparatus 10. In one embodiment, the apparatus 10 largely comprises a spherical reservoir 10 and a column member 20, as shown. The skilled recipient shall understand that reference to “spherical” includes reference to forms that are more or less spherical, such as a sphere, a spheroid, or any similar approximately spherical body in three-dimensional space without significant internal angles where the internal surfaces comprising such a body abut. For example, the spherical reservoir 10 may comprise an oblong spheroid, such as an American football or the like.

[0062] The spherical reservoir 12 generally defines the respective inlet and outlet openings 14 and 16 through a surface 18 thereof. In one embodiment, the inlet opening 14 of the spherical reservoir 12 comprises a circular or oval opening perpendicular to a central point of the spherical reservoir 12. For example, the inlet opening comprises a round or oval opening on one side of the spherical reservoir 12, with said opening directed or angled relative to a central point of the spherical reservoir 12, as shown. Petition 870250094462, dated 10 / 16 / 2025, p. 38 / 85 20 / 34

[0063] In one embodiment, the outlet opening 16 of the spherical reservoir 12 comprises a slit, but, of course, variations are possible and expected. In several embodiments, the outlet opening 16 may be displaced from the inlet opening 14 along the surface 18 of the reservoir at an angle between 60° and 170°. Typically, such a slit is displaced at a substantially 90° angle from the inlet opening 14 along the surface 18 of the reservoir 12.

[0064] For example, as seen in Figure 4, the inlet opening is on one side of the reservoir 12, with the outlet opening set approximately a quarter revolution around the spherical reservoir 12. In a typical embodiment, the inlet and outlet openings 14 and 16 are set on a great circle or orthodrome of the spherical reservoir 12, but variations in the present document are possible and provided for. As the outlet opening 14 is a slit, it allows a tangential arrangement of the outlet gate 28. Such a configuration is important as it facilitates the inlet and outlet gates 26 and 28 being opposite, as well as misaligned, while they are generally coplanar in the spherical reservoir 12, as described below.

[0065] In one embodiment, the spherical reservoir 12 is manufactured from a flexible material, such as a polymer, for example, silicone, so that the reservoir 12 is bendable due to pressure fluctuations inside it to Petition 870250094462, dated 10 / 16 / 2025, page 39 / 85 21 / 34 accommodate the breathing pattern and / or rebreathing of a person using the device 10. In one embodiment, the spherical reservoir 12 is manufactured or internally coated with an antistatic material to minimize the adhesion of aerosol drug particles. For example, an inner surface of the reservoir 12 may be coated with an antistatic agent or subjected to an ultraviolet light curing process to reduce static electrical activity and promote hydrophobic properties to reduce the adhesion of liquids to the material, and / or the like.

[0066] In one embodiment, the spherical reservoir 12 defines at least one engagement part 30 on its surface 18 to facilitate complementary engagement to it by the column member 20. For example, in the embodiment given, the at least one engagement part 30 comprises an engagement collar defined around a portion of the inlet and outlet openings 14 and 16, as shown, with said engagement collar configured for engagement with the column member 20. Such engagement may include an interference fit or the like.

[0067] For example, column member 20 may be manufactured from a substantially rigid polymeric material, with the reservoir 12 manufactured from a flexible silicone material. The member of Petition 870250094462, dated 10 / 16 / 2025, page 40 / 85 22 / 34 column 20 can then define suitable receptacles, such as peripheral grooves etc., to receive the coupling part(s) 30 of the reservoir, typically as an interference fit to allow removal and replacement of the reservoir 12 as needed.

[0068] In one embodiment, the spherical reservoir 12 is configured to define a predetermined internal volume. In one embodiment, the predetermined internal volume comprises a range between 30 ml and 2500 ml. Typically, this predetermined internal volume is selectable according to a person's treatment needs, generally to accommodate respiratory pattern, rebreathing capacity, lung capacity, or similar. As a result, variations in this internal volume are possible and expected.

[0069] The column member 20 generally comprises an elongated, arched, and substantially flat member, as shown. The column member 20 defines an inlet hole 22 through it at one end, as well as an outlet hole 24 through it at the other end. The column member 20 is configured to fit complementarily around a portion of the outer surface of the spherical reservoir 12, such that the inlet hole 22 cooperates with the inlet opening 14 to form an inlet port 26 perpendicular to the surface 18 of the spherical reservoir. Petition 870250094462, dated 10 / 16 / 2025, page 41 / 85 23 / 34 12. Similarly, the outlet orifice 24 cooperates with the outlet opening 16 to define an outlet port 28, arranged tangentially on the surface 18 of the spherical reservoir 12.

[0070] The column member 20 is typically configured so that the curvature of said column member 20 substantially matches the curvature of the outer surface portion of the spherical reservoir 12, as shown. Such a configuration provides a perfect fit between the reservoir 12 and the column member 20, where the column member 20 rests against the reservoir 12. The column member 20 may include suitable fluid seals at the inlet and outlet ports 22 and 24 to facilitate fluid-tight engagement with the spherical reservoir 12, or similar.

[0071] Column member 20 can be realized in various functional configurations. For example, the embodiment in Figures 1 to 13 shows the column member as a unitary component, while Figures 14 to 16 show an embodiment where column member 20 is composed of two interconnected parts. Such variations can facilitate different manufacturing methods and are included within the scope of this description.

[0072] In one embodiment, an inlet hole shape 22 is configured to conform to a shape of Petition 870250094462, dated 10 / 16 / 2025, page 42 / 85 24 / 34 inlet opening 14. Similarly, in one embodiment, an outlet orifice shape 24 is configured to conform to an outlet opening shape 16. This conformity between openings and orifices generally facilitates cooperation between the reservoir 12 and the column member 20 to define the inlet and outlet ports 26 and 28.

[0073] Typically, the device 10 includes inlet and outlet adapters 34 and 36 to provide modularity for use with different inhalers 38, as well as outlet media, as mentioned above. In one embodiment, the column member 20 defines a coupling assembly 32 around a portion of the inlet and / or outlet ports 22 and 24, as shown, with the coupling assembly 32 configured to mount an inlet and / or outlet adapter 34 and 36, respectively. Typically, the coupling assembly 32 is configured to mount the inlet and outlet adapters 34 and 36 in a tight fit to the spherical reservoir 12. Obviously, in other embodiments, the inlet and / or outlet adapters 34 and 36 may also be included as part of the column member 20 in a unitary or similar manner.

[0074] As described, the resulting inlet and outlet ports 26 and 28 are opposite, misaligned, and generally, but not necessarily, coplanar in the spherical reservoir 12. Ports 26 and 28 are opposite in the fluid flow through them and generally directed in opposite directions. Petition 870250094462, dated 10 / 16 / 2025, page 43 / 85 25 / 34 as shown in Figure 2a. Furthermore, ports 26 and 28 are misaligned, as they do not align directly opposite each other in reservoir 12. Additionally, ports 26 and 28 are typically coplanar in the reservoir, as they are in a shared plane, as defined by column member 30, relative to reservoir 12, but this is optional.

[0075] The knowledgeable recipient must understand that the specific configuration of the spherical reservoir 12 and column member 30 of the apparatus, which define the complementary inlet and outlet ports 26 and 28, provides a reservoir 12 for dispersing a drug in aerosol form, as well as a largely uninterrupted flow path without structural impediments and abrupt surface transitions and terminations, thus facilitating the efficient administration of the drug in aerosol form from the inlet port 26 to the outlet port 28.

[0076] For example, with specific reference to Figures 2, such a flow path is indicated by dashed arrows.

[0077] In Figure 2a, the entry port 26 facilitates the direct entry of an aerosol drug from the inhaler 38 into the reservoir 12, generally directed to a central point of the spherical reservoir 12, as shown, due to the specific configuration of the entry opening and the entry orifice cooperating to form the entry port. Petition 870250094462, dated 10 / 16 / 2025, p. 44 / 85 26 / 34 26. In contrast, the outlet port 18, situated tangentially to the surface of the reservoir, as shown more clearly in the cutaway view of Figure 2b, due to the cooperation and specific configuration of the outlet opening 16 and the outlet hole 24, ensures that the inlet and outlet ports 26 and 28 are opposite, misaligned and typically, but not necessarily, coplanar in the spherical reservoir 12.

[0078] It is important to emphasize that such qualities of the opposite, misaligned, and typically coplanar ports 26 and 28 in the spherical reservoir 12 allow an aerosol drug to enter the reservoir and disperse until the person is ready to inhale, without impact against any angular and abrupt surface transitions and abrupt surface terminations, given the smooth internal arrangement of the spherical reservoir and the relatively smooth and unobstructed outflow path provided by the tangentially arranged outlet port 28, further facilitating the unimpeded exit of such dispersed aerosol drug from the reservoir 12. The spherical nature of the reservoir 12 facilitates the dispersion of the aerosol drug and the establishment of turbulent flow within the reservoir, as shown in Figure 2a, with such turbulent flow paths easily transitioned to the tangential outlet port 28. In this way, the dispersion Petition 870250094462, dated 10 / 16 / 2025, page 45 / 85 27 / 34 adequate drug administration is improved, as well as the efficient dispensing of the drug in aerosol form to a person.

[0079] In one embodiment, the inlet adapter 34 is configured to place the inhaler 38 in airtight communication with the spherical reservoir 12. As mentioned, such an inlet adapter 34 can assume various forms to accommodate different types of inhalers 38, such as ID, IPS, nebulizers, etc. Depending on the inhaler 38 used, support features such as seals, support plates, closing caps, etc. may be relevant. For example, in the embodiment of Figures 3 and 7, the inhaler 38 comprises a nebulizer with a support / seal plate 54 and a closing cap 56. Variations in this document are possible and expected.

[0080] In one embodiment, the entry port 26 comprises an adjustable supplementary entry port 60, through which fluid, such as air, can enter the spherical reservoir 12. This adjustable supplementary entry port 60 can facilitate inhalation by a person in circumstances where the spherical reservoir 12 has collapsed due to inhalation pressure, or similar. The adjustable supplementary entry port 60 can also be selectively activated, as an orifice that can be closed by the person's finger until needed, or similar. Petition 870250094462, dated 10 / 16 / 2025, p. 46 / 85 28 / 34

[0081] In one embodiment, an example of which is shown in more detail in Figure 17, the inlet adapter 34, which is part of the general inlet port 26, comprises the adjustable supplementary inlet port 60. In the embodiment given, the inlet adapter 34 defines a supplementary fluid passage 62 through it, as shown, with said supplementary fluid passage 62 selectively adjustable to control a volumetric flow of fluid that may enter the spherical reservoir 12 during the use of the apparatus 10.

[0082] In the embodiment exemplified, the inlet adapter 34 defines a valve housing 70 around the inlet port 26, with this valve housing 70 defining the supplementary fluid passage 62, as shown. An annular valve member 66 is additionally rotatable and receptive within said valve housing 70, with the valve member 66 additionally defining a valve orifice 64, as shown. In this manner, selective rotation of the valve member 66 within the valve housing 70, normally by means of the external adjustment knob 68, aligns or misaligns the supplementary fluid passage 62 and the valve orifice 64 accordingly, so that a volume flow of fluid available for entry into the spherical reservoir 12 is continuously adjustable.

[0083] In this mode, the entry point Petition 870250094462, dated 10 / 16 / 2025, p. 47 / 85 The 29 / 34 supplementary adjustable port 60 serves as an additional, but separate, channel from the general inlet port 26, which is usually entirely occupied by the inhaler 38, i.e., in a fluid-tight manner. This separate supplementary adjustable inlet port 60 is useful for providing a passage for any additional air to flow into the reservoir 12, such as when the reservoir 12 is fully closed and the user is not suddenly deprived of adequate air to breathe. The separate fluid passage 62 is additionally capable of providing a channel for the captured air to be drawn into the reservoir 12 as the reservoir 12 slowly re-expands with its own elastic recoil, i.e., it facilitates the inhalation of additional air, such as when the spherical reservoir closes before the user has completed inhalation, and to allow air to flow into the reservoir as it re-expands by its own elastic recoil.In addition, the separate fluid passage 62 can also provide a connection point for oxygen tubing or similar to be connected for supplying supplemental oxygen to a patient, if needed, during pulmonary drug delivery.

[0084] In one embodiment, the outlet adapter 36 is generally configured to place the spherical reservoir 12 in fluidic communication with a person's airway. In one embodiment, the outlet adapter 36 may Petition 870250094462, dated 10 / 16 / 2025, page 48 / 85 30 / 34 attach with a 58 nozzle, a 58 face mask, or similar. Again, variations are possible and expected.

[0085] In a typical embodiment, the outlet adapter 36 further comprises a valve 40 which is configured to admit fluid flow from the spherical reservoir 12 to a person's airway in use, that is, to prevent the return fluid flow from the person's airway from returning to the reservoir, but instead to divert the return fluid flow from said airway of a person to the atmosphere. As shown by the various examples in Figures 8 to 12, one embodiment of the valve 40 typically comprises an angled flap membrane 42 which is arranged transversely over a fluid path 44 of the outlet adapter 36.

[0086] It is important to note that, in one embodiment, an angle of said flange membrane 42 typically facilitates the admission or diversion of fluid flow, as it minimizes any impediment to fluid flow from the reservoir and, conversely, to the atmosphere; that is, the angled flange 42 presents a gentle impediment to the desired fluid flow. Consequently, the angle of the flange membrane 42 in relation to the fluid passage 44 of said outlet adapter is generally between 30° and 60°. Similarly, the flange membrane 42 is typically selected and configured to be lightweight and easily flexible in order to offer low resistance. Petition 870250094462, dated 10 / 16 / 2025, page 49 / 85 31 / 34 to the opening, in order to reduce the creation of turbulence by disturbing the fluid flow through the valve, thus maximizing efficient pulmonary drug delivery. For example, a fluid-tight, film-like flap membrane with very low mass, or similar.

[0087] In one embodiment, the valve 40 comprises a metal mesh 46 disposed across the fluid passage 44 to support the flap membrane 42 across the fluid passage 44 during diversion of fluid flow. In another embodiment, the valve 40 also comprises a trapdoor flap 50, through which the return fluid flow from a person's airway is diverted to the atmosphere. The valve 40 typically includes an outlet passage, often part of the fluid passage 44, which is closed by the trapdoor flap 50 when fluid passes through the flap membrane 42 into a person's airway. If fluid is passed from a person's airway into the passage 44, the flap membrane 42 is pushed against the metal mesh 46 to seal the entrance to the reservoir, and the flap membrane 42 directs the return fluid toward the trapdoor flap 50, through the outlet passage, where the return fluid is expelled to the atmosphere.

[0088] In one embodiment, the input adapter 34 and / or the output adapter 36 comprise a whistle (not shown) Petition 870250094462, dated 10 / 16 / 2025, page 50 / 85 32 / 34 which is configured to provide auditory feedback on the frequency of inspiration and / or expiration during use of the device 10. In one mode, the input adapter 34 includes a handle 48 to facilitate gripping the device 10 during use.

[0089] The applicant believes it is particularly advantageous that the present invention provides an apparatus 10 with specific configurations that facilitate the proper dispersion of a drug aerosol from an inhaler, while presenting minimal impediment to the efficient dispersion of the drug in aerosol form due to angular surface transitions and abrupt surface terminations. The specific arrangement of the inlet and outlet ports 26 and 28 also facilitates the efficiency of dispensing the drug in aerosol form through the apparatus 10.

[0090] The applicant also believes it is advantageous that the specific configurations and interactions between the adjustable supplementary port 60, the reservoir 12, and the valve 40 facilitate the efficient dispersion and dispensing of an aerosol drug without causing unnecessary impediment to fluid flow. Furthermore, the collection and dispersion of a drug aerosol from an inhaler through the device 10 are not negatively affected by variability in respiratory patterns among patients, whereas such variability in respiratory patterns may Petition 870250094462, dated 10 / 16 / 2025, page 51 / 85 33 / 34 have adverse effects on the performance of conventional aerosol drug dispensing devices.

[0091] It can also be said that optional embodiments of the present invention consist largely of the parts, elements and features mentioned or indicated herein, individually or collectively, in any or all combinations of two or more of the parts, elements or features, and where specific whole numbers are mentioned herein that have known equivalents in the art to which the invention relates, such known equivalents are considered incorporated herein as if they were individually established.

[0092] The use of the terms “a”, “an”, “referred to”, “the”, or similar referents in the context of the description of various embodiments (especially in the context of the claimed object) should be interpreted as encompassing both the singular and the plural, unless otherwise indicated herein or clearly contradicted by the context. The terms comprising, having, including, and containing should be interpreted as open terms (i.e., meaning including but not limited to), unless otherwise indicated. As used herein, the term and / or includes any and all combinations thereof. Petition 870250094462, dated 10 / 16 / 2025, p. 52 / 85 34 / 34 of one or more of the listed associated items. No language in the descriptive report should be interpreted as indicating any unclaimed matter as essential to the practice of the claimed matter. Spatially relative terms, such as “internal”, “external”, “below”, “below”, “inferior”, “above”, “superior” and the like, may be used herein for ease of description, to describe the relationship of an element or feature to another element(s) or feature(s), as illustrated in the figures.

[0093] It should also be noted that the reference to “an example” of the invention, or similar illustrative language (e.g., “such as”) in this document, is not used exclusively. Thus, one example may exemplify certain aspects of the invention, while other aspects are exemplified in a different example. Variations, modifications, and / or improvements of one or more embodiments described herein may become apparent to those with common technical knowledge after reading this application. The inventor(s) expect(s) that those skilled in the art will utilize such variations as appropriate, and the inventor(s) intend(s) that the claimed matter be applied in a manner different from that specifically described herein. Petition 870250094462, dated 10 / 16 / 2025, page 53 / 85

Claims

1 / 8 CLAIMS 1. Apparatus for pulmonary dispensing of drugs, characterized in that it comprises: a spherical reservoir that defines respective inlet and outlet openings through a surface thereof; and an arched, elongated and substantially flat support member that defines an inlet orifice at one end and an outlet orifice at the other end, said arched support member being configured for complementary engagement on a portion of the outer surface of said spherical reservoir, such that: i. the inlet orifice cooperates with the outlet orifice to form an inlet port perpendicular to the surface of the spherical reservoir; and ii. the outlet orifice cooperates with the outlet orifice to define an outlet port disposed tangentially to the surface of the spherical reservoir; wherein the inlet and outlet ports are opposite and not aligned on the spherical reservoir.

2. Apparatus, according to claim 1, characterized in that the inlet opening of the spherical reservoir comprises a circular or rounded opening disposed perpendicularly to a central point of the spherical reservoir.

3. Apparatus, according to one of claims 1 or 2, characterized in that the outlet opening of the spherical reservoir comprises a slit.

4. Apparatus, according to any one of claims 1 to 3, characterized in that the outlet opening is displaced from the inlet opening along the surface of the reservoir, forming an angle between 60° and 170° with respect to the central point of said reservoir.

5. Apparatus, according to any one of claims 1 to 4, characterized in that the outlet opening is displaced from the inlet opening at an angle substantially equal to 90°, along the surface of the reservoir relative to the central point of said reservoir.

6. Apparatus, according to any one of claims 1 to 5, characterized in that the inlet and outlet ports are coplanar with respect to the spherical reservoir.

7. Apparatus, according to any one of claims 1 to 6, characterized in that the inlet and outlet openings are defined on a great circle or orthodrome of the spherical reservoir.

8. Apparatus, according to any of the claims 1 to 7, characterized in that the spherical reservoir is manufactured from a flexible material, such as a polymer, so that the reservoir is collapsible due to pressure fluctuations inside it, to accommodate a breathing and / or reinspiration pattern.

9. Apparatus, according to any one of claims 1 to 8, characterized in that the spherical reservoir is manufactured with, or internally coated with, an antistatic material in order to minimize the adhesion of aerosol drug particles.

10. Apparatus, according to any one of claims 1 to 9, characterized in that the spherical reservoir defines, on its surface, at least one engagement point to facilitate the complementary engagement of the column member.

11. Apparatus, according to claim 10, characterized in that at least one engagement part comprises an engagement collar defined around a portion of the inlet and / or outlet opening, said engagement collar being configured for engagement with the column member.

12. Apparatus, according to any one of claims 1 to 11, characterized in that the spherical reservoir is configured to define a predetermined internal volume.

13. Apparatus, according to claim 12, characterized in that the predetermined internal volume comprises a range between 30 ml and 2500 ml.

14. Apparatus, according to any one of claims 1 to 13, characterized in that the column member is configured so that its curvature conforms substantially to the curvature of the outer surface portion of the spherical reservoir.

15. Apparatus, according to any one of claims 1 to 14, characterized in that an inlet hole shape is configured to conform to an inlet opening shape.

16. Apparatus, according to any one of claims 1 to 15, characterized in that an outlet orifice shape is configured to conform to an outlet opening shape.

17. Apparatus, according to any one of claims 1 to 16, characterized in that the column member defines a coupling assembly around a portion of the inlet and / or outlet holes, said coupling assembly configured to mount, respectively, an inlet and / or outlet adapter.

18. Apparatus, according to claim 17, Petition 870250094462, dated 10 / 16 / 2025, p. 65 / 85 5 / 8 characterized in that the coupling assembly is configured to mount the inlet and / or outlet adapter in a watertight manner to the spherical reservoir.

19. Device according to claim 17, characterized in that it includes the input and / or output adapter.

20. Apparatus, according to any one of claims 17 to 19, characterized in that the inlet adapter comprises an inhaler adapter configured to dispose of an inhaler in airtight communication with the spherical reservoir.

21. Apparatus, according to any one of claims 1 to 20, characterized in that the inlet port is configured to receive an inhaler in tight communication with the spherical reservoir.

22. Apparatus, according to one of claims 20 or 21, characterized in that the inhaler is selectable from a non-exhaustive group consisting of: a metered-dose inhaler (MDI), a dry powder inhaler (DPI), a soft mist inhaler and a nebulizer.

23. Apparatus, according to any one of claims 1 to 22, characterized in that the inlet port comprises an adjustable supplementary inlet port, through which a fluid, such as air, can enter the spherical reservoir. Petition 870250094462, dated 10 / 16 / 2025, p. 66 / 85 6 / 8 24. Device according to claim 23, characterized in that the input adapter comprises an adjustable supplementary input port.

25. Apparatus, according to claim 24, characterized in that the inlet adapter defines a supplementary fluid passage, said supplementary passage being selectively adjustable to control a volumetric flow of fluid that can enter the spherical reservoir.

26. Apparatus, according to claim 25, characterized in that the inlet adapter defines a valve housing around the inlet port, the valve housing defining the supplementary fluid passage, a complementarily rotatable annular valve member within said valve housing, and defining a valve orifice, wherein the selective rotation of the valve member within the valve housing aligns or misaligns the supplementary fluid passage and the valve orifice, as the case may be, whereby a volumetric flow of fluid capable of entering the spherical reservoir is continuously adjustable.

27. Apparatus, according to any one of claims 17 to 26, characterized in that the outlet adapter is configured to dispose of the spherical reservoir in fluidic communication with a person's airway. Petition 870250094462, dated 10 / 16 / 2025, page 67 / 85 7 / 8 28. Device according to claim 27, characterized in that the output adapter is selectable from a non-exhaustive group consisting of a mouthpiece and a face mask.

29. Apparatus, according to any one of claims 17 to 28, characterized in that the outlet adapter comprises a valve configured to admit the flow of fluid from the spherical reservoir into a person's airway during use, and to divert the return flow of fluid from said airway to the atmosphere.

30. Apparatus, according to claim 29, characterized in that the valve comprises an angled flange membrane arranged transversely along a fluid passage of said outlet adapter, wherein the angle of said flange membrane facilitates the admission or diversion of fluid flow.

31. Apparatus, according to claim 30, characterized in that the angle of the flap membrane relative to the fluid passage of said outlet adapter is between 30° and 90°, and preferably between 30° and 60°.

32. Apparatus, according to any one of claims 29 to 31, characterized in that the valve comprises a support arranged transversely to said fluid passage, to support the flap membrane along the fluid passage during flow diversion.

33. Apparatus, according to any one of claims 29 to 32, characterized in that the valve comprises a trapdoor-type flap, through which the return fluid flow from said respiratory tract of a person is diverted to the atmosphere.

34. Device according to any one of claims 17 to 33, characterized in that the input adapter and / or the output adapter comprises a whistle configured to provide auditory feedback as to the rate of inspiration and / or expiration during use of the device.

35. Device according to any one of claims 17 to 34, characterized in that the input adapter comprises a handle to facilitate handling of the device during its use. Petition 870250094462, dated 10 / 16 / 2025, pp. 69 / 85

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