Transpulmonary drug delivery device

Abstract

A transpulmonary drug delivery device (10) includes a spherical reservoir (12) defining inlet and outlet openings (14, 16) that penetrate its surface (18), and an elongated, arc-shaped, substantially flat back member (20) defining an inlet aperture (22) through it at one end and an outlet aperture (24) through it at the other end. The back member (20) is configured to engage complementaryly with the outer surface portion of the spherical reservoir (12) so that i) the inlet aperture (22), in coordination with the inlet opening (14), forms an inlet port (26) perpendicular to the surface (18) of the spherical reservoir (12), and ii) the outlet aperture (24), in coordination with the outlet opening (16), defines an outlet port (28) that is tangentially arranged on the surface (18) of the spherical reservoir (12). In this way, the inlet and outlet ports (26 and 28) are opposite each other on the spherical reservoir (12) and are not aligned in a line.

Description

Technical Field

[0001] Technical Field The present invention generally relates to the field of transpulmonary drug delivery, and more particularly to transpulmonary drug delivery devices.

Background Art

[0002] Background Art The following discussion of background art is intended only to facilitate an understanding of the present invention. This discussion is not an admission or concession that any of the materials referenced is or was part of the common general knowledge as of the priority date of the present application.

[0003] Transpulmonary drug delivery is a route of administration in which a patient uses an inhaled drug delivery device, such as an inhaler, to inhale a drug and medicine that acts on a target site within the airway or for absorption into the bloodstream via 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.

[0004] Appropriate education regarding inhaler use is important for ensuring that the inhaled drug is effectively delivered to the airway and produces its proper effect. The rate, efficiency, and effectiveness of transpulmonary drug delivery are affected by the properties of the drug particles, respiratory pattern, and the geometric structure of the respiratory apparatus. As a result, the rate, efficiency, and effectiveness of transpulmonary drug delivery are affected by the properties of the drug particles, respiratory pattern, and the geometric structure of the respiratory apparatus and typically rely on such transpulmonary drug administration on the technique of the inhaler and patient compliance with proper use of the inhaler, i.e., inadequate timing, synchronization, and depth, rate, and pattern of breathing.

[0005] To achieve effective transpulmonary drug delivery, inhaled particles should ideally not adhere to the upper respiratory tract, because they may be swallowed or exhaled without reaching the lungs, resulting in a loss of the intended pharmacological effect and / or causing undesirable systemic side effects. Incorrect inhaler techniques, such as insufficient synchronization, not exhaling before inhaling the drug aerosol, or not holding your breath for several seconds after inhalation, can cause drug adhesion within the respiratory tract rather than the lungs, leading to inefficient and inadequate treatment.

[0006] Different inhalers require specific techniques for proper use; for example, metered-dose inhalers (MDIs) require synchronization between inhalation and inhaler operation, dry powder inhalers (DPIs) require an appropriate inspiratory flow rate from the patient and may be hygroscopic, and nebulizers may give low drug delivery efficiency to the lungs because a substantial percentage of the drug is typically lost into the atmosphere during use, which can pose a risk to others around the patient.

[0007] To address some of these shortcomings, the field has focused on inhaler spacers designed specifically for use with MDIs, which are generally several methods of devices that provide a space between the patient's mouth and the MDI, typically in the form of a tube or chamber. Such spacers are intended to help patients inhale medications more effectively by introducing a storage space where the medication can be stored until it is ready for immediate inhalation. The volume of the spacer in which the medication is stored is important, and small-volume spacers (which constitute more than 80% of the solid (sold) of the spacer) only minimize the requirement for synchronizing with the patient's respiration to allow the patient to inhale properly and facilitate transpulmonary drug administration. Conventional spacer walls are typically made of rigid plastic, where droplets collide and are held, reducing the amount of medication that exits the spacer and enters the patient's mouth by up to 40%. This reduces the amount of medication that reaches the airways and produces its effect, substantially limiting the intended benefits of spacers, especially in children, people with severe respiratory distress, and people with cognitive impairment. The general bulkiness of spacers limits their appeal to patients.

[0008] Various spacers have been developed in the art. For example, U.S. Patent Application Publication 2016 / 0256641 to Lisberg describes a device comprising a collapsible bag to which a bidirectional mouthpiece is attached, and an adapter for receiving MDI. The mouthpiece includes a reed that functions as an audible signal and a screen to prevent inhalation of unwanted particles. U.S. Patent 4,790,305 to Zoltan et al. teaches a device comprising a mouthpiece for delivering a pharmaceutical composition to a patient's mouth, a rigid chamber for holding an aerosol before inhalation, the rigid chamber having an orifice that restricts the flow of air passing through it, and a collapsible chamber for the patient to inhale air without the drug before inhaling air containing the drug from the rigid chamber.

[0009] U.S. Patent No. 4,484,577 to Sackner discloses a device comprising an inflatable bag and a bidirectional channel for communicating a drug to a patient's respiratory passage, substantially impermeable to air. When the inflatable bag is deflated while the bidirectional channel for communicating with the respiratory passage is in place, the drug is delivered to the patient's respiratory passage, and a signal in the bidirectional channel indicates that the rate of drug passage exceeds a desired limit.

[0010] U.S. Patent No. 7418,962 to Rao describes an inhaler having a collapsible recirculation chamber or rebreather. The inhaler has an aerosol holding chamber having an inlet end for attaching a holder or nebulizer device for aerosol drugs therein and an outlet end for attaching to a mouthpiece or mask for dispensing drugs or substances to the user, and a recirculation chamber is lowered from the outlet end of the holding chamber or from a mask extending from the outlet chamber of the chamber.

[0011] U.S. Patent No. 5,791,340 to Schleufe et al. teaches a resuscitation device for artificial resuscitation, comprising a bag having a patient valve at one end and an inlet valve for drawing in fresh ambient air at the opposite end. A small flow-through opening is provided between the periphery and the bag interior, through which the bag can be supplied with the contents of a drug-administering aerosol for inhalation administration of pharmaceutically active air cells, enabling the use of the resuscitation device as an inhalation spacer.

[0012] U.S. Patent No. 7,360,537 to Snyder et al. discloses an aerosol drug delivery device comprising an antistatic holding chamber having an input end and an output end and defining an interior space. UK Patent No. 2,285,396 to Savoullas describes an inhaler comprising a suspended rebreathing bag, the inhaler comprising a mask and upper inputs for an inhalant and oxygen. The administered drug or oxygen is captured in the rebreathing bag and, during inhalation, passes through a one-way valve, resulting in nearly all delivery to the lungs. Due to the flexibility of the rebreathing bag, the bag deflates during inhalation, indicating the degree of inhalation.

[0013] In improving upon some known shortcomings in the field of transpulmonary drug delivery, the applicant has also developed multiple inhaler spacer technologies for use with different types of inhalers, as described in U.S. Patent Nos. 11,207,476; 11,426,543 and 11,458,264.

[0014] Considering the practical applications of conventional spacers, the applicant identified a drawback in the art of spacers: conventional spacer chambers generally include inlets and outlets positioned in specific directions relative to each other, and such relative positioning prevents proper dispersion of drug aerosols from the inhaler. For example, conventional spacers include opposing inlets and outlets, such as those of Schleufe; shared inlets and outlets, such as the single bidirectional channel of Sackner, Zoltan, and Savoullas; or inlets and outlets positioned laterally in a single plane, such as those of Lisberg.

[0015] In addition, conventional spacer chambers are also not optimized for efficient aerosolized drug delivery, and therefore conventional inlets, outlets, and / or spacer chambers generally exhibit obstacles to efficient aerosolized drug dispersion due to angular and abrupt surface transitions and abrupt surface ends, which obstruct the flow of drug dispersion within the chamber and provide surfaces against which the aerosolized drug adheres upon impact.

[0016] This invention was devised taking these disadvantages into consideration. [Overview of the Initiative] [Problems that the invention aims to solve]

[0017] Summary of the Invention Those skilled in the art will recognize that references herein to “sphere” and its derivatives such as “spherical” broadly refer to a spherical, spherical, or substantially spherical object that is substantially spherical, and may encompass spheres, ellipsoids (oblate and oblate), or any similar approximately spherical body whose inner surface in three-dimensional space does not have a significant interior angle containing such a body. [Means for solving the problem]

[0018] According to one aspect of the present invention, A spherical reservoir defining each inlet and outlet opening through the surface; An elongated, substantially flat, arc-shaped back member defining an inlet aperture through which one end passes and an outlet aperture through which the other end passes, wherein the arc-shaped back member is configured to engage complementarily with the outer surface portion of the spherical reservoir, thereby i. The inlet aperture, in coordination with the inlet opening, forms an inlet port perpendicular to the surface of the spherical reservoir; ii. The outlet aperture, in coordination with the outlet opening, defines an outlet port tangentially positioned on the surface of the spherical reservoir. back member, Transpulmonary drug delivery including is provided. The inlet and outlet ports are not facing each other or aligned on the spherical reservoir.

[0019] One skilled in the art will recognize that the specific configuration of the spherical reservoir and the back member of the device defining complementary inlet and outlet ports provides a reservoir for the dispersion of aerosolized drugs, as well as a fluid passageway that is not significantly hindered by structural obstacles and abrupt surface transitions and terminations, thereby facilitating efficient delivery of aerosolized drugs 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 that is perpendicular to the center point of the spherical reservoir.

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

[0022] In one embodiment, the outlet opening is offset from the inlet opening along the surface of the reservoir at an angle between 60° and 170°.

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

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

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

[0026] In one embodiment, the spherical reservoir is made of a flexible material such as a polymer, whereby the reservoir is crushable by pressure fluctuations therein to conform to breathing patterns and / or rebreathing.

[0027] In one embodiment, the spherical reservoir is made from an anti-static agent or coated with an anti-static agent to minimize adhesion of aerosolized drug particles.

[0028] In one embodiment, the spherical reservoir defines at least one engagement portion on its surface to facilitate complementary engagement by the back member.

[0029] In one embodiment, at least one engaging portion includes an engaging collar defined around a portion of an inlet and / or outlet opening, the engaging collar being configured for engagement with a back member.

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

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

[0032] In one embodiment, the back member is configured such that its arched structure substantially conforms to the arched structure of the outer surface portion of the spherical reservoir.

[0033] In one embodiment, the shape of the inlet aperture is configured to match the shape of the inlet opening.

[0034] In one embodiment, the shape of the outlet aperture is configured to match the shape of the outlet opening.

[0035] In one embodiment, the back member defines engagement mounts around a portion of the inlet and / or outlet aperture, and the engagement mounts are configured to accommodate the inlet and / or outlet adapters, respectively.

[0036] In one embodiment, the engagement mount is configured to accommodate inlet and / or outlet adapters on a spherical reservoir in a fluid-tight manner.

[0037] In one embodiment, the device includes inlet and / or outlet adapters.

[0038] In one embodiment, the inlet adapter includes an inhaler adapter configured to arrange an inhaler in fluid-seal communication with a spherical reservoir.

[0039] In one embodiment, the inhaler can be selected from a non-exclusive group consisting of a metered-dose inhaler (MDI), a dry powder inhaler (DPI), a soft mist inhaler, and a nebulizer.

[0040] In one embodiment, the inlet port includes an adjustable auxiliary inlet port through which a fluid, such as air, can enter the spherical reservoir.

[0041] In one embodiment, the inlet adapter includes an adjustable auxiliary inlet port.

[0042] In one embodiment, the inlet adapter defines an auxiliary fluid passage through which the fluid can pass, and this auxiliary fluid passage is selectively adjustable to control the volumetric flow rate of the fluid that can pass through the spherical reservoir.

[0043] In one embodiment, an inlet adapter defines a valve cradle around an inlet port, the valve cradle defines an auxiliary fluid passage, and an annular valve member is receptacleably rotatable within the valve cradle and defines a valve aperture, and selective rotation of the valve member within the valve cradle aligns or shifts the auxiliary fluid passage and valve aperture accordingly, thereby infinitely adjustable the volumetric flow rate of fluid that can pass through the spherical reservoir.

[0044] In one embodiment, the outlet adapter is configured to have fluid communication with a person's breathing passage and to position a spherical reservoir.

[0045] In one embodiment, the exit adapter can be selected from a non-exclusive group consisting of a mouthpiece and a mask facepiece.

[0046] In one embodiment, the outlet adapter includes a valve configured to receive fluid flow from a spherical reservoir into a person's breathing passage during use, and to divert fluid flow back from the person's breathing passage to the atmosphere.

[0047] In one embodiment, the valve includes an oblique flap member positioned to traverse the fluid passage of the outlet adapter, the angle of which facilitates the reception and diversion of the fluid flow. Those skilled in the art will recognize the broad definition of flap as "something flat and broad that is attached to only one side and loosely spans or covers the opening."

[0048] In one embodiment, the angle of the flap member with respect to the fluid passage of the outlet adapter is between 30° and 90°.

[0049] In one embodiment, the angle of the flap member with respect to the fluid passage of the outlet adapter is between 30° and 60°.

[0050] In one embodiment, the valve includes a support, such as a wire mesh, that crosses the fluid passage to support a flap member that crosses the fluid passage during the bypass of the fluid flow.

[0051] In one embodiment, the valve includes a trapdoor flap through which the return fluid flow from the person's breathing passage is diverted to the atmosphere.

[0052] In one embodiment, the inlet adapter and / or outlet adapter include a whistle configured to provide auditory feedback about inhalation and / or expiratory velocity when using the device.

[0053] In one embodiment, the inlet adapter includes a handle to facilitate holding the device during use.

[0054] A further aspect of the present invention provides a transpulmonary drug delivery device substantially as described and / or illustrated herein.

[0055] The explanation will be given with reference to the attached diagrams. [Brief explanation of the drawing]

[0056] [Figure 1] Figure 1 is a schematic perspective view of one embodiment of a transpulmonary drug delivery device according to an aspect of the present invention. [Figure 2a] Figure 2a shows a schematic representation of a substantially unimpeded aerosolized drug pathway using the transpulmonary drug delivery device shown in Figure 1. [Figure 2b] Figure 2b shows a schematic representation of a substantially unimpeded aerosolized drug pathway using the transpulmonary drug delivery device shown in Figure 1. [Figure 3] Figure 3 is a wireframe diagram of a schematic perspective view of one embodiment of the transpulmonary drug delivery device shown in Figure 1. [Figure 4] Figure 4 is a schematic, enlarged view of the transpulmonary drug delivery device shown in Figure 3. [Figure 5] Figure 5 is a wireframe diagram of a schematic perspective view of the spherical reservoir and back member of the transpulmonary drug delivery device shown in Figure 3. [Figure 6] Figure 6 is a wireframe diagram of a schematic, enlarged perspective view of the spherical reservoir, back member, inlet adapter, and outlet adapter of the transpulmonary drug delivery device shown in Figure 3. [Figure 7] Figure 7 is a schematic wireframe drawing of an example of an inlet adapter showing a nebulizer inhaler. [Figure 8] Figure 8 is a schematic, enlarged wireframe drawing of an outlet adapter, illustrating an example of a valve. [Figure 9] Figure 9 is a schematic perspective view depicting different examples of outlet adapters with valves. [Figure 10] Figure 10 is a schematic perspective view of different examples of outlet adapters with valves. [Figure 11] Figure 11 is a schematic perspective view of different examples of outlet adapters with valves. [Figure 12] Figure 12 is a schematic perspective view depicting different examples of outlet adapters with valves. [Figure 13] Figure 13 is a schematic, enlarged perspective view showing an example of components of a transpulmonary drug delivery device according to an embodiment of the present invention. [Figure 14] Figure 14 is a schematic perspective view of a further embodiment of a transpulmonary drug delivery device according to an aspect of the present invention. [Figure 15] Figure 15 is a schematic, enlarged view of the transpulmonary drug delivery device shown in Figure 14. [Figure 16] Figure 16 is a schematic top perspective view of the transpulmonary drug delivery device shown in Figure 14. [Figure 17] Figure 17 shows an enlarged perspective view depicting one embodiment of an adjustable auxiliary inlet port for a transpulmonary drug delivery device. [Modes for carrying out the invention]

[0057] Detailed description of the embodiment Further features of the present invention are described more fully in the following description of several non-limiting embodiments. This description is included solely for the purpose of illustrating the invention to those skilled in the art. It should not be understood as a limitation to the broader overview, disclosure, or description of the invention presented previously.

[0058] In drawings incorporated to illustrate one or more exemplary embodiments, similar reference numerals are used throughout to identify similar parts. In addition, features, mechanisms, and embodiments that are well known and understood in the art are not described in detail because such features, mechanisms, and embodiments are within the realm of trade understanding.

[0059] In addition, the attached figures do not represent technical or design drawings, but only provide a functional overview of the present invention. As a result, features and actual configuration details required for various embodiments may not be shown in each figure, and the requirements for such configurations are within the understanding of those skilled in the art.

[0060] In general, the present invention provides a transpulmonary drug delivery device 10 that typically functions as an inhaler spacer for the dispersion and delivery of an aerosolized drug between an inhaler 38 and a person's respiratory passage. The device 10 is designed to further facilitate and improve the ease and efficiency of aerosolized drug delivery to a person, particularly to assist in the proper collection and dispersion of drug aerosols from the inhaler 38. Importantly, such collection, dispersion, and delivery are suitable for the patient's variable breathing patterns and associated rebreathing, as needed.

[0061] In addition, as will be described in more detail below, the device 10 includes modularity for accommodating different types of inhalers 38, as well as different means of aerosolized drug evaporation, whether via a mouthpiece, facepiece, extension tube, or the like. Thus, in one embodiment, the inhaler 38 may include a metered-dose inhaler (MDI), a dry powder inhaler (DPI), a soft mist inhaler, a nebulizer, or the like. Similarly, the evaporation means may include a mouthpiece, mask facepiece, extension tube, or the like, typically via an evaporation adapter 36 as described below.

[0062] Refer to the attached figures herefore, there is an exemplary embodiment of such a transpulmonary drug delivery device 10. In one embodiment, the device 10 generally includes a spherical reservoir 10 and a back member 20, as shown. Those skilled in the art will recognize that the reference to “spherical” includes reference to a shape that is a sphere, an ellipsoid, or any similar approximately spherical body in three-dimensional space whose inner surface does not have a significant interior angle containing such a tangent body. For example, the spherical reservoir 10 may include an elongated ellipsoid, such as a football shape or similar.

[0063] The spherical reservoir 12 generally defines inlet and outlet openings 14 and 16 through its surface 18. In one embodiment, the inlet opening 14 of the spherical reservoir 12 includes a circular or elliptical opening perpendicular to the center point of the spherical reservoir 12. For example, the inlet opening includes a round or elliptical opening on the side of the spherical reservoir 12, as shown, and the opening is directed toward or oblique to the center point of the spherical reservoir 12.

[0064] In one embodiment, the outlet opening 16 of the spherical reservoir 12 includes a slot, which is, of course, possible and predictable. In various embodiments, the outlet opening 16 may be offset from the inlet opening 14 along the surface 18 of the reservoir at an angle between 60° and 170°. Typically, such a slot is offset from the inlet opening 14 at a substantially 90° angle along the surface 18 of the reservoir 12.

[0065] For example, as shown in Figure 4, the inlet opening is located on the side of the reservoir 12, and the outlet opening is defined by approximately a quarter turn around the spherical reservoir 12. In a typical embodiment, the inlet and outlet openings 14 and 16 are defined on the great circle or orthodrom of the spherical reservoir 12, but variations are possible and expected. The fact that the outlet opening 14 is a slot allows for the tangential arrangement of the outlet port 28. Such a configuration is important because it facilitates the inlet and outlet ports 26 and 28 not facing each other and not aligned in a line, but rather lying approximately coplanar on the spherical reservoir 12, as described below.

[0066] In one embodiment, the spherical reservoir 12 is manufactured from a flexible material such as a polymer, e.g., silicone, so that the reservoir 12 is collapsible by pressure fluctuations therein to match the breathing pattern and / or rebreathing of a person using the device 10. In one embodiment, the spherical reservoir 12 is manufactured from an antistatic agent or internally coated with an antistatic agent to minimize adhesion of aerosolized drug particles. For example, the inner surface of the reservoir 12 may be coated with an antistatic agent or subjected to an ultraviolet curing process to reduce electrostatic activity and promote hydrophobic properties in order to reduce liquid adhesion to the material and / or the like.

[0067] In one embodiment, the spherical reservoir 12 defines at least one engaging portion 30 on its surface 18 to facilitate complementary engagement with it by the back member 20. For example, in an exemplary embodiment, the at least one engaging portion 30 includes an engaging collar defined around portions of the inlet and outlet openings 14 and 16, as shown, the engaging collar being configured for engagement with the back member 20. Such engagements may include interference fits or the like.

[0068] For example, the back member 20 may be made from a substantially rigid polymer material, and the reservoir 12 may be made from a flexible silicone material. The back member 20 may define suitable locations, such as peripheral grooves, to receive the reservoir's engagement portion(s) 30 inside, typically as an interference fit that allows for the removal and replacement of the reservoir 12 as needed.

[0069] In one embodiment, the spherical reservoir 12 is configured to define a predetermined internal volume. In one embodiment, the predetermined internal volume includes a range between 30 ml and 2500 ml. Typically, such a predetermined internal volume is selectable according to the patient's treatment requirements, generally to match the respiratory pattern, rebreathing volume, lung volume, or similar. As a result, variations in this internal volume are possible and predictable.

[0070] The back member 20 generally includes an elongated, arc-shaped, and substantially flat member, as shown. The back member 20 defines an inlet aperture 22 through which one end passes, and an outlet aperture 24 through which the other end passes. The back member 20 is configured to engage complementaryly with the outer surface portion of the spherical reservoir 12, so that the inlet aperture 22, in coordination with the inlet opening 14, forms an inlet port 26 perpendicular to the surface 18 of the spherical reservoir 12. Similarly, the outlet aperture 24, in coordination with the outlet opening 16, defines an outlet port 28 that is tangentially positioned on the surface 18 of the spherical reservoir 12.

[0071] The back member 20 is typically configured such that its arched structure substantially conforms to the arched structure of the outer surface portion of the spherical reservoir 12, as shown. Such a configuration provides an interference fit between the reservoir 12 and the back member 20, where the back member 20 is located in contact with the reservoir 12. The back member 20 may include appropriate fluid seals at the inlet and outlet apertures 22 and 24 to facilitate a fluid-seal engagement with the spherical reservoir 12, or similar.

[0072] The back member 20 may be implemented in various functional configurations. For example, the embodiments in Figures 1 to 13 show the back member as an integrated component, while Figures 14 to 16 show embodiments in which the back member 20 is composed of two interlocking parts. Such variations facilitate different manufacturing methods and are included within the scope of this disclosure.

[0073] In one embodiment, the shape of the inlet aperture 22 is configured to conform to the shape of the inlet opening 14. Similarly, in one embodiment, the shape of the outlet aperture 24 is configured to conform to the shape of the outlet opening 16. Such conformity between the openings and apertures generally facilitates coordination between the reservoir 12 and the back member 20 to define the inlet and outlet ports 26 and 28.

[0074] Typically, the device 10 includes inlet and outlet adapters 34 and 36 to provide modularity for use with different inhalers 38 and discharge means, as previously mentioned. In one embodiment, the back member 20 defines engagement mounts 32 around portions of the inlet and / or outlet apertures 22 and 24, as shown, and the engagement mounts 32 are configured to mount the inlet and / or outlet adapters 34 and 36, respectively. Typically, the engagement mounts 32 are configured to mount the inlet and outlet adapters 34 and 36 on the spherical reservoir 12 in a fluid-sealed manner. Of course, in other embodiments, the inlet and / or outlet adapters 34 and 36 may be included in a unitary manner or as components of the back member 20.

[0075] In the described method, the resulting inlet and outlet ports 26 and 28 are not opposite each other, not aligned in a line, and are generally, but not necessarily, coplanar on the spherical reservoir 12. Ports 26 and 28 are opposite each other in the fluid flow through them, as shown in Figure 2a, and are generally oriented in opposite directions. In addition, ports 26 and 28 are not aligned in a line in that they are not directly opposite each other on the reservoir 12. Furthermore, ports 26 and 28 are typically coplanar on the reservoir, and they exist on a shared plane with respect to the reservoir 12, as defined by the back member 30, although this is optional.

[0076] Those skilled in the art will recognize that the specific configuration of the spherical reservoir 12 of the apparatus and the back member 30 defining the complementary inlet and outlet ports 26 and 28 provides the reservoir 12 for the dispersion of the aerosolized drug, as well as a flow path that is not significantly hindered by structural obstructions and abrupt surface transitions and terminals, thereby facilitating the efficient delivery of the aerosolized drug from the inlet port 26 to the outlet port 28.

[0077] For example, referring specifically to Figure 2, such a flow path is shown via dashed arrows. In Figure 2a, the inlet port 26 facilitates the direct entry of aerosolized drug from the inhaler 38 into the reservoir 12, generally directed towards the center point of the spherical reservoir 12, as shown by the specific configuration in which the inlet opening and inlet aperture work together to form the inlet port 26. In contrast, as clearly shown by the cross-sectional view in Figure 2b, the outlet port 28, located tangentially on the surface of the reservoir, ensures, through the coordination and specific configuration of the outlet opening 16 and outlet aperture 24, that the inlet and outlet ports 26 and 28 are not opposed to each other, not aligned in a line, and are typically, though not necessarily, on the same plane on the spherical reservoir 12.

[0078] Importantly, the nature of ports 26 and 28, which are opposite each other, not aligned in a line, and typically coplanar on the spherical reservoir 12, allows the aerosolized drug to enter and disperse into the reservoir until it is readily inhalable by a person, without affecting any sharp surface transitions or sharp surface ends. However, this presupposes that the "smooth" internal arrangement of the spherical reservoir and the relatively "smooth" and unobstructed outlet flow path provided by the tangentially positioned outlet port 28 further facilitate the unobstructed discharge of such dispersed aerosolized drug from the reservoir 12. The spherical nature of the reservoir 12, as shown in Figure 2a, promotes the dispersion of the aerosolized drug and the formation of vortices within the reservoir, and the paths of such vortices readily transition into the tangentially positioned outlet port 28. In this way, proper drug dispersion and efficient delivery of such dispersed aerosolized drug to a person are improved.

[0079] In one embodiment, the inlet adapter 34 is configured to fluid-seal communication with the spherical reservoir 12 to position the inhaler 38. As mentioned, such an inlet adapter 34 may take various forms to accommodate different types of inhalers 38, such as MDI, DPI, and nebulizers. Depending on the inhaler 38 used, support characteristics such as seals, support plates, and closing caps may be relevant. For example, in the embodiments of Figures 3 and 7, the inhaler 38 includes a nebulizer having a support plate / seal 54 and a closing cap 56. Variations relating thereto are possible and anticipated.

[0080] In one embodiment, the inlet port 26 includes an adjustable auxiliary inlet port 60 through which a fluid such as air can enter the spherical reservoir 12. Such an adjustable auxiliary inlet port 60 facilitates human suction when the spherical reservoir 12 is collapsed due to suction pressure or the like. The adjustable auxiliary inlet port 60 may also be selectively activatable, such as an aperture or the like that can be closed by a human finger until required.

[0081] In one embodiment, as illustrated in detail in Figure 17, the inlet adapter 34, which forms part of the entire inlet port 26, includes an adjustable auxiliary inlet port 60. In the exemplary embodiment, the inlet adapter 34 defines an internal auxiliary fluid passage 62, as shown, which is selectively adjustable to control the volumetric flow rate of fluid that can pass through the spherical reservoir 12 during use of the device 10.

[0082] In an exemplary embodiment, as shown, the inlet adapter 34 defines a valve cradle 70 around the inlet port 26, which defines an auxiliary fluid passage 62. An annular valve member 66 can be received complementaryly rotatably within the valve cradle 70, which further defines a valve aperture 64, as shown. In this way, selective rotation of the valve member 66 within the valve cradle 70 aligns or dealigns the auxiliary fluid passage 62 and the valve aperture 64 accordingly, typically via an external adjustment knob 68, thereby infinitely adjusting the volumetric flow rate of fluid that can pass through the spherical reservoir 12.

[0083] In such embodiments, the adjustable auxiliary inlet port 60 acts as an additional, but generally entirely occupied by the inhaler 38, i.e., fluid-sealed, separate fluid passage from the overall inlet port 26. This separate, adjustable auxiliary 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 completely collapsed and when the user suddenly refuses adequate air for breathing. The separate fluid passage 62 can further provide a passage for captured air to be drawn into the reservoir 12, so that the reservoir 12 slowly reinflates by its own elastic recoil, i.e., facilitating the inhalation of additional air, such as when the spherical reservoir collapses before the user completes inhalation, and as the reservoir reinflates by its own elastic recoil, it allows air to flow into the reservoir. Additionally, the separate fluid passage 62 can also provide a connection point for an oxygen tube or similar which may be attached for supplemental oxygen supply to the patient as needed during administration of transpulmonary drug delivery.

[0084] In one embodiment, the outlet adapter 36 is generally configured to fluidly communicate with the person's breathing passage and position the spherical reservoir 12. In one embodiment, the outlet adapter 36 may engage with a mouthpiece 58, a mask facepiece 58, or the like. This variation is also possible and anticipated.

[0085] In a typical embodiment, the outlet adapter 36 further includes a valve 40 configured to receive the fluid flow from the spherical reservoir 12 to the human breathing passage during use, i.e., to prevent the return fluid flow from the human breathing passage back into the reservoir, but instead to divert the return fluid flow from the human breathing passage to the atmosphere. As shown by various examples in Figures 8-12, one embodiment of the valve 40 typically includes an oblique flap member 42 positioned to traverse the fluid passage 44 of the outlet adapter 36.

[0086] Importantly, in one embodiment, the angle of the flap member 42 is typically such that it minimizes obstruction to either the fluid flow from the reservoir or, conversely, to the atmosphere, thus facilitating the acceptance and diversion of the fluid flow; i.e., an angled flap 42 provides a “smooth” obstruction to the desired fluid flow. Therefore, the angle of the flap member 42 with respect to the fluid passage 44 of the outlet adapter is generally between 30° and 60°. Similarly, the flap member 42 is typically selected and configured to be lightweight and easily bendable to provide little resistance to opening in order to reduce turbulence generation by disturbing the fluid flow through the valve, thereby maximizing efficient transpulmonary drug delivery. For example, a film-like fluid sealing flap member with very little mass, or similar.

[0087] In one embodiment, the valve 40 includes a wire mesh 46 positioned across the fluid passage 44 to support a flap member 42 that crosses the fluid passage 44 during the diversion of fluid flow. In one embodiment, the valve 40 also includes a trapdoor flap 50 through which the return fluid flow from the person's breathing passage is diverted to the atmosphere. The valve 40 typically includes an outlet passage, often a portion of the fluid passage 44, which is closed by the trapdoor flap 50 as the fluid passes through the flap member 42 into the person's breathing passage. As the fluid passes from the person's breathing passage into the passage 44, the flap member 42 is pushed against the wire mesh 46 to seal off entry into the reservoir, and the flap member 42 bends any such return fluid toward the trapdoor flap 50 through the outlet passage, where the return fluid is discharged into the atmosphere.

[0088] In one embodiment, the inlet adapter 34 and / or outlet adapter 36 include a whistle (not shown) configured to provide auditory feedback regarding inhalation and / or expiratory velocity when using the device 10. In one embodiment, the inlet adapter 34 includes a handle 48 for facilitating the holding of the device 10 while using it.

[0089] The applicant believes it is particularly advantageous that the present invention provides a device 10 having a specific structure that exhibits minimal obstacles to efficient aerosolized drug dispersion due to angular surface migration and abrupt surface ends, while promoting proper dispersion of drug aerosols from the inhaler. The specific arrangement of the inlet and outlet ports 26 and 28 also facilitates the efficiency of aerosolized drug delivery through the device 10.

[0090] The applicant also believes that the specific configuration of the adjustable auxiliary inlet port 60, the reservoir 12, and the valve 40, and their interaction, is advantageous in facilitating the efficient dispersion and delivery of aerosolized drugs without impeding unnecessary obstruction to the fluid flow. In addition, the collection and dispersion of drug aerosols from the inhaler via the device 10 is not adversely affected by variability in respiratory patterns among patients, while this variability in respiratory patterns can have a detrimental effect on the performance of conventional aerosolized drug delivery devices.

[0091] Any optional embodiments of the present invention may also be said to be extensive, either individually or collectively, in any combination of parts, elements, and features referenced or shown herein, and any particular integer referred herein has known equivalents to it in the art to which the present invention relates, and such known equivalents are deemed to be incorporated herein as if individually shown.

[0092] The use of the terms “a,” “an,” “said,” “the,” and / or similar referents in the context of describing various embodiments (particularly in the context of the claimed subject matter) shall be construed to encompass both singular and plural unless otherwise indicated herein or unless the context clearly contradicts this. The terms “contain,” “have,” “include,” and “contain” shall be construed as unrestrictive terms unless otherwise stated (i.e., “include, but not limited to”). As used herein, the term “and / or” encompasses any combination of one or more of the related enumerated items. No language herein shall be construed to indicate any unclaimed subject matter as essential to the practice of the claimed means. Spatially related terms such as “internal,” “external,” “below,” “downward,” “underside,” “up,” and “upper” may be used herein to facilitate descriptions of the relationship of one element or feature to another element or feature as shown in the figures.

[0093] Furthermore, it will be recognized that references to “one example” or “a certain example” of the present invention, or similar exemplary language in this specification (e.g., “etc.”), are not made in an exclusive sense. Thus, one example may illustrate a particular aspect of the invention, while other aspects are illustrated in different examples. Changes, modifications, and / or enhancements to one or more embodiments described herein may become apparent to those skilled in the art by reading this application. The inventors anticipate that those skilled in the art will take advantage of such changes as appropriate, and the inventors intend that the claimed subject matter will be practiced in ways other than those specifically described herein.

Claims

1. A spherical reservoir defining each inlet and outlet opening passing through its surface; An elongated, substantially flat, arc-shaped back member defining an inlet aperture through which one end passes and an outlet aperture through which the other end passes, wherein the arc-shaped back member is configured to engage complementaryly with the outer surface portion of the spherical reservoir, thereby i. The inlet aperture coordinates with the inlet opening to form an inlet port perpendicular to the surface of the spherical reservoir; ii. The outlet aperture coordinates with the outlet opening to define an outlet port that is tangentially positioned on the surface of the spherical reservoir. back member, A transpulmonary drug delivery device including, The inlet port and the outlet port are not opposite each other and arranged in a line on the spherical reservoir. Transpulmonary drug delivery device.

2. The apparatus according to claim 1, wherein the inlet opening of the spherical reservoir includes a circular or rounded opening perpendicular to the center point of the spherical reservoir.

3. The apparatus according to either claim 1 or 2, wherein the outlet opening of the spherical reservoir includes a slot.

4. The apparatus according to any one of claims 1 to 3, wherein the outlet opening is offset from the inlet opening along the surface of the reservoir at an angle between 60° and 170°.

5. The apparatus according to any one of claims 1 to 4, wherein the outlet opening is offset at a substantially 90° angle from the inlet opening along the surface of the reservoir.

6. The apparatus according to any one of claims 1 to 5, wherein the inlet and outlet ports are coplanar with respect to the spherical reservoir.

7. The apparatus according to any one of claims 1 to 6, wherein the inlet and outlet openings are defined on the great circle or orthodrom of the spherical reservoir.

8. The apparatus according to any one of claims 1 to 7, wherein the spherical reservoir is manufactured from a flexible material such as a polymer, and the reservoir is so compressible by pressure fluctuations therein to match the breathing pattern and / or rebreathing.

9. The apparatus according to any one of claims 1 to 8, wherein the spherical reservoir is manufactured from an antistatic agent or coated internally with an antistatic agent to minimize adhesion of aerosolized drug particles.

10. The apparatus according to any one of claims 1 to 9, wherein the spherical reservoir defines at least one engagement portion on its surface to facilitate complementary engagement by the back member.

11. The apparatus according to claim 10, wherein the at least one engaging portion includes an engaging collar defined around a portion of the inlet and / or outlet opening, the engaging collar being configured for engagement with the back member.

12. The apparatus according to any one of claims 1 to 11, wherein the spherical reservoir is configured to define a predetermined internal volume.

13. The apparatus according to claim 12, wherein the predetermined internal volume includes a range between 30 ml and 2500 ml.

14. The apparatus according to any one of claims 1 to 13, wherein the arched structure of the back member is configured to substantially conform to the arched structure of the outer surface portion of the spherical reservoir.

15. The apparatus according to any one of claims 1 to 14, wherein the shape of the inlet aperture is configured to match the shape of the inlet opening.

16. The apparatus according to any one of claims 1 to 15, wherein the shape of the outlet aperture is configured to match the shape of the outlet opening.

17. The apparatus according to any one of claims 1 to 16, wherein the back member defines engagement mounts around a portion of the inlet and / or outlet aperture, and the engagement mounts are configured to each mount an inlet and / or outlet adapter.

18. The apparatus according to claim 17, wherein the engaging mount is configured to mount the inlet and / or outlet adapters to the spherical reservoir in a fluid-tight manner.

19. The apparatus according to claim 17, comprising the aforementioned inlet and / or outlet adapters.

20. The apparatus according to any one of claims 17 to 19, wherein the inlet adapter includes an inhaler adapter configured to arrange an inhaler in fluid-seal communication with the spherical reservoir.

21. The apparatus according to any one of claims 1 to 20, wherein the inlet port is configured to receive an inhaler by fluid-seal communication with the spherical reservoir.

22. The apparatus according to either claim 20 or 21, wherein the inhaler can be selected from a non-exclusive group consisting of a metered-dose inhaler (MDI), a dry powder inhaler (DPI), a soft mist inhaler, and a nebulizer.

23. The apparatus according to any one of claims 1 to 22, wherein the inlet port includes an adjustable auxiliary inlet port through which a fluid, such as air, can enter the spherical reservoir.

24. The apparatus according to claim 23, wherein the inlet adapter includes the adjustable auxiliary inlet port.

25. The apparatus according to claim 24, wherein the inlet adapter defines an auxiliary fluid passage through which the auxiliary fluid passage can be selectively adjusted to control the volumetric flow rate of the fluid that can pass through the spherical reservoir.

26. The apparatus according to claim 25, wherein the inlet adapter defines a valve cradle around the inlet port, the valve cradle defines the auxiliary fluid passage, and an annular valve member is receptively rotatable within the valve cradle and defines a valve aperture, and selective rotation of the valve member within the valve cradle aligns or dealigns the auxiliary fluid passage and the valve aperture accordingly, thereby infinitely adjusting the volumetric flow rate of fluid that can pass into the spherical reservoir.

27. The apparatus according to any one of claims 17 to 2, wherein the outlet adapter is configured to fluidly communicate with a person's breathing passage and to position the spherical reservoir.

28. The apparatus according to claim 27, wherein the outlet adapter can be selected from a non-exclusive group consisting of a mouthpiece and a mask facepiece.

29. The apparatus according to any one of claims 17 to 28, wherein the outlet adapter includes a valve configured to receive fluid flow from the spherical reservoir into a person's breathing passage when in use, and to divert fluid flow back from the person's breathing passage to the atmosphere.

30. The apparatus according to claim 29, wherein the valve includes an oblique flap member positioned to traverse the fluid passage of the outlet adapter, and the angle of the flap member facilitates the reception and bypass of the fluid flow.

31. The apparatus according to claim 30, wherein the angle of the flap member with respect to the fluid passage of the outlet adapter is between 30° and 90°, and preferably between 30° and 60°.

32. The apparatus according to any one of claims 29 to 31, wherein the valve includes a support, such as a wire mesh, that crosses the fluid passage to support the flap member that crosses the fluid passage during the bypass of the fluid flow.

33. The apparatus according to any one of claims 29 to 32, wherein the valve includes a trapdoor flap through which the return fluid flow from the person's breathing passage is diverted to the atmosphere.

34. The apparatus according to any one of claims 17 to 33, wherein the inlet adapter and / or outlet adapter include a whistle configured to provide auditory feedback about inhalation and / or expiratory velocity when using the apparatus.

35. The apparatus according to any one of claims 17 to 34, wherein the inlet adapter includes a handle for facilitating the holding of the apparatus during use.

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