Inhaler system with deviated puncture

Abstract

An inhaler system includes: a housing defining a housing cavity; a sleeve extending along a longitudinal axis of the sleeve and positioned within the housing cavity; a capsule contained within the sleeve, the capsule having a capsule longitudinal axis; and a piercing element having only a single axis extending from a fixed end to a tip along the piercing element longitudinal axis, the piercing element longitudinal axis being parallel to and offset relative to the capsule longitudinal axis. The piercing element forms only a single pore in the capsule.

Description

Technical Field

[0001] The present invention relates to an inhaler system comprising a single offset puncture element. Background Technology

[0002] Dry powder inhalers are not always perfectly suited to delivering dry powder particles to the lungs at inhalation or airflow rates within the range of those used in conventional smoking. Operating a dry powder inhaler can be complex or may involve moving parts. Dry powder inhalers typically aim to deliver the entire dry powder dose or capsule load in a single breath.

[0003] The inhaler contains capsules filled with dry powder. These capsules can be activated by piercing the capsule wall with a piercing element. The user then inhales (sucks or draws in) the powder through the edible mouthpiece. This action forces an airflow through the dry powder inhaler.

[0004] Activating the dry powder capsule requires puncturing the capsule to create pores. The dry powder particles can then exit the capsule through these pores by being carried along with the inhaled airflow to the user during inhalation and consumption. It has proven very difficult to form reliable open pores at the hemispherical end of the capsule. Once the puncturing element is withdrawn from the capsule, the pores tend to re-close. Furthermore, the puncturing element often strikes the hemispherical end of the capsule at different locations, resulting in pores of inconsistent shape. This leads to unpredictable and variable delivery of dry powder to the user. Summary of the Invention

[0005] There is a desire to provide an inhaler system that reliably punctures a capsule to form a uniform, single, stable pore. There is a desire to provide an inhaler system with a simple design that reliably punctures a capsule and delivers predictable and uniform dry powder to the user through a large volume of inhalation.

[0006] According to one aspect of the invention, an inhaler system is provided, comprising: a housing defining a housing cavity; a sleeve extending along a longitudinal axis of the sleeve and positioned within the housing cavity; a capsule contained within the sleeve, the capsule having a longitudinal axis of the capsule; and a piercing element comprising only a single axis extending from a fixed end to a tip along the longitudinal axis of the piercing element. The longitudinal axis of the piercing element is parallel to and offset relative to the longitudinal axis of the sleeve. The sleeve is movable within the housing cavity between a first position and a second position. When the sleeve moves from the first position to the second position, only a single pore is formed in the capsule.

[0007] According to one aspect of the invention, an inhaler system is provided, comprising: a housing defining a housing cavity; a sleeve extending along a longitudinal axis of the sleeve and positioned within the housing cavity; a capsule contained within the sleeve, the capsule having a capsule longitudinal axis; and a piercing element comprising only a single axis extending from a fixed end to a tip along the longitudinal axis of the piercing element. The longitudinal axis of the piercing element is parallel to and offset relative to the longitudinal axes of the sleeve and the capsule. The sleeve is movable within the housing cavity between a first position and a second position. When the sleeve moves from the first position to the second position, only a single pore is formed in the capsule.

[0008] An inhaler system that uses a single piercing element to pierce a capsule positions this single piercing element so that it coincides with the central longitudinal axis of the device or capsule cavity, causing the piercing element to impact the capsule at its central axis. This configuration is expected to provide a balanced piercing force on the capsule and avoid bending moments on the piercing element or capsule during capsule activation.

[0009] The applicant has discovered that positioning a single puncture element parallel to, but offset from, the longitudinal axis of the inhaler device, capsule cavity, or capsule improves the quality and reliability of the pores formed in the hemispherical end of the capsule by the offset puncture element. Specifically, when this single offset puncture element begins to cut from a surface closer to the puncture element (along the hemispherical surface of the capsule end cap) to a surface farther from the initial cut point, a hinge of capsule material is formed on the portion forming the periphery of the pore furthest from the initial cut point. This particular orientation of the puncture element's cutting plane produces stable open pores compared to any other orientation of the puncture element's cutting plane.

[0010] Advantageously, a single offset puncture element is provided to form a repeatable and reliable single open pore within the capsule. The single offset puncture element has a simple mechanical configuration. The single offset puncture element is relatively easy to assemble into an inhaler article retainer. The single offset puncture element enables predictably improved uniform dispensing during multiple inhalations.

[0011] This disclosure relates to a retainer for an inhaler article, referred to as an "inhaler article retainer." The inhaler article retainer includes a single offset piercing element. The inhaler article retainer is configured to receive an edible inhaler article, activate a capsule within the inhaler article by piercing it, and introduce a vortex inhalation airflow into the inhaler article during consumption. The inhaler article retainer and the inhaler article can form the inhaler system of this disclosure.

[0012] The inhaler product holder described herein can be combined with an inhaler product containing a capsule. The inhaler product can be used to activate it by piercing the capsule, thereby achieving reliable activation of the capsule by piercing the capsule with the piercing element of the inhaler product holder. Particles can be released from the capsule upon inhalation or the formation of an airflow around the pierced capsule. The inhaler system thus delivers dry powder particles to the user. The inhaler product holder is separate from the inhaler product, but the user can utilize both the inhaler product and the inhaler product holder while simultaneously consuming the dry powder particles released within the inhaler product. Multiple such inhaler products can be combined with the inhaler product holder to form a system or kit. A single inhaler product holder can be used on 10 or more, or 25 or more, or 50 or more, or 100 or more inhaler products to activate (pierce or puncture) the capsule contained within each inhaler product and provide reliable activation. Optionally, the inhaler product may provide a visual indication (marker) of activation for each inhaler product.

[0013] The inhaler article has an airflow path. Airflow is introduced into the inhaler article by inhalation (or inhalation) from the user. The inhaler article retainer generates a vortex inhalation airflow. This vortex inhalation airflow is introduced into the inhaler article. The distal or upstream end of the inhaler article includes an open orifice defining an open central passage of an open tubular element configured to receive the vortex inhalation airflow.

[0014] The vortex inhalation airflow then continues downstream into the capsule cavity, causing the capsule within to rotate. The activated capsule then releases a dose of particles into the vortex inhalation airflow, which travels downstream through the mouthpiece to the user. Thus, a vortex inhalation airflow is generated upstream of the inhaler article, and this vortex inhalation airflow reaches the distal or uppermost end of the inhaler article.

[0015] The inhaler article includes an elongated tubular body extending along the longitudinal axis of the inhaler from a mouthpiece end to a distal end. The mouthpiece end is the proximal or downstream end. The distal end is the upstream end. A capsule cavity is defined within the body, downstream by a filter element and upstream by an open tubular element defining a central passage. The distal end of the inhaler article can be closed before insertion into an inhaler article retainer. After insertion into the inhaler article retainer, the distal end of the inhaler article can be open. The distal end of the inhaler article can interact with complementary structures in the inhaler article retainer such that the distal end of the inhaler article can be opened after the inhaler article is introduced into the inhaler article retainer. When introduced into the inhaler article retainer, the distal end of the inhaler article has a central passage forming an open air inlet orifice extending from the distal end of the body to the capsule cavity. The capsule is disposed within the capsule cavity, and the central passage may have a diameter smaller than the capsule. Therefore, the capsule cannot pass through the central passage and remains within the capsule cavity.

[0016] The inhaler article retainer includes a housing comprising a housing cavity for receiving an inhaler article and a sleeve configured to retain the inhaler article within the housing cavity. The housing cavity is defined by a single housing opening extending into the housing along a longitudinal axis of the housing towards a closed end. The single housing opening is configured to receive the inhaler article.

[0017] The sleeve is contained within the housing cavity and is movable along the longitudinal axis of the housing between a first position and a second position. The sleeve is also slidable along the longitudinal axis of the housing between the first and second positions. In the first position, the sleeve is positioned close to a single housing opening. In the second position, the sleeve is positioned a certain lateral distance away from the single housing opening along the longitudinal axis.

[0018] The sleeve extends from the open end to the closed end (or confined end) and defines a cylindrical cavity along the longitudinal axis of the sleeve. The open end of the sleeve is aligned with a single housing opening.

[0019] The sleeve closure includes an airflow element and orifices to allow a piercing element to pass through the closure and extend into the sleeve lumen. The airflow element includes one or more inhalation air inlets providing airflow communication from the annular space surrounding the sleeve to the cylindrical lumen of the sleeve. This airflow element is configured to induce a rotating or vortex inhalation airflow into the cylindrical lumen of the sleeve and directly into the capsule cavity of the inhaler article. This vortex or rotating inhalation airflow can be delivered into the inhaler article to rotate the capsule and release the dry powder contained within.

[0020] The airflow element of the sleeve includes a tubular element having a central passage in fluid communication with the sleeve cavity. The airflow element has at least one air inlet allowing air to enter the central passage. The at least one air inlet extends in a direction tangential to the central passage to generate a vortex or rotating intake airflow.

[0021] The airflow element of the sleeve includes a tubular element having a central passage in fluid communication with the sleeve cavity. The airflow element has at least two air inlets that allow intake air to enter the central passage. The at least two air inlets extend in a direction tangential to the central passage to generate a vortex or rotating intake airflow.

[0022] The airflow element of the sleeve includes a tubular element having a central passage in fluid communication with the sleeve cavity. The airflow element has at least three air inlets that allow intake air to enter the central passage. The at least three air inlets extend in a direction tangential to the central passage to generate a vortex or rotating intake airflow.

[0023] The airflow element may include pores to receive the puncturing element and allow the puncturing element to pass through the airflow element.

[0024] Inhaled air may enter the inhaler article holder through an open orifice that receives the inhaler article, and travel along the length of the inhaler article to the airflow element at the closed end of the sleeve within the housing cavity. Alternatively, inhaled air may enter the inhaler article holder through an air inlet that passes through the surface of the housing.

[0025] The inhaler article retainer may further include a piercing element fixed to and extending from the inner surface of the housing. The piercing element comprises a single solid shaft extending from a fixed end to a tip along the longitudinal axis of the piercing element. The piercing element is configured to extend through the closed end of the sleeve and into the sleeve cavity along the longitudinal axis of the housing. Once the sleeve is moved from a first position to a second position, the piercing element contacts and pierces the capsule of the received inhaler article. Moving the sleeve from the second position to the first position removes the piercing element from the capsule and exposes a pore in the capsule that allows dry particles contained within the capsule to be released from the capsule when inhaled air rotates the capsule.

[0026] The piercing element of the inhaler system or inhaler article holder described herein is a single piercing element offset from the longitudinal axis of the inhaler article holder. The piercing element is a single piercing element offset from the movable sleeve of the inhaler article holder that receives the inhaler article. The piercing element is a single piercing element offset from the longitudinal axis or rotation axis of the capsule when the capsule spins during inhalation and consumption of dry particles released from the activated capsule. The inhaler system has fewer than two piercing elements. The inhaler system forms fewer than two pores in the capsule containing dry powder particles.

[0027] The piercing element of the inhaler system or inhaler article retainer described herein is a single piercing element that impacts and pierces the hemispherical end cap of the sac contained within the sac cavity of the inhaler device. The single piercing element impacts and pierces the hemispherical end cap of the sac that is offset from the central longitudinal axis of the sac, the central longitudinal axis of the sleeve, and the central longitudinal axis of the sac cavity. The single piercing element impacts and pierces the hemispherical end cap of the sac that is not located on the central longitudinal axis of the sac.

[0028] The puncture element shaft has a shaft diameter. The longitudinal axis of the puncture element is offset from the longitudinal axis of the sleeve or the longitudinal axis of the cyst by at least one puncture element diameter or at least one shaft diameter, or at least 1.5 puncture element diameters or at least 1.5 shaft diameters, or at least 2 puncture element diameters or at least 2 shaft diameters, or within the range of 1 to 2 puncture element diameters, or within the range of 1 to 2 shaft diameters.

[0029] The hemispherical end cap of the sac has a radius of 0% at the central longitudinal axis of the sac and a radius of 100% at the outer circumference of the hemispherical end cap. A single offset puncture element punctures the hemispherical end cap of the sac within a range of 25% to 90% of the sac radius from the longitudinal axis, or 33% to 80% of the sac radius from the longitudinal axis, or 50% to 75% of the sac radius from the longitudinal axis.

[0030] The hemispherical end cap of the sac may have an outer radius ranging from 2.6 mm to 3.2 mm or about 3 mm. The puncturing element punctures the sac at a radial distance of at least 1 mm from the longitudinal axis of the sac, or within a range of about 1 mm to about 2.5 mm from the longitudinal axis of the sac, or within a range of about 1.5 mm to about 2.2 mm from the longitudinal axis of the sac, or at a distance of about 2 mm from the longitudinal axis of the sac, at the curved end of the sac or at the hemispherical end cap.

[0031] The tip of the piercing element has only a single bevel or cutting plane. This single bevel or cutting plane is specifically offset and oriented relative to the piercing element to achieve reliable and repeatable piercing even if the sac is not oriented or aligned with the piercing element.

[0032] A single bevel or cutting plane of the piercing element may define a flat surface opposite to the longitudinal axis of the sleeve. A single bevel or cutting plane of the piercing element may define a flat surface opposite to the longitudinal axis of the capsule. A single bevel or cutting plane of the piercing element defines the flat surface that can face the inner diameter surface of the sleeve closest to the flat surface. A single bevel of the piercing element may face the capsule. A single bevel of the piercing element may face away from the capsule.

[0033] The piercing element forms a single pore within the capsule, defining only a single hinge of capsule material extending into the capsule cavity. This single hinge of capsule material can be located at a point around the single pore furthest from the capsule's longitudinal axis.

[0034] A piercing element forms a single pore within the capsule, defining only a single hinge extending into the capsule cavity of the capsule material. The hinge is formed when the beveled tip of the piercing element pierces the capsule. As the beveled tip of the piercing element enters the capsule, it cuts through the capsule to form the pore. It then continues to cut through the capsule as the beveled tip continues to enter. As the end of the bevel enters the capsule, a hinge is formed. When the piercing element is subsequently removed from the capsule, a hinged pore is formed within the capsule. Thus, a pore substantially related to the size of the piercing element is formed within the capsule, and the hinge is formed in the pore opposite the tip of the piercing element. If the single bevel of the piercing element faces the capsule, the hinge is formed at the inner edge of the pore, which is closer to the longitudinal axis of the capsule. If the single bevel of the piercing element faces away from the capsule, the hinge is formed at the outer edge of the pore, which is farther from the longitudinal axis of the capsule. When the beveled tip of the piercing element faces away from the longitudinal axis of the capsule, a single hinge of the capsule material is formed at the point of the single pore furthest from the longitudinal axis of the capsule.

[0035] The closed end of the sleeve may further include a sleeve bottom element that generally forms the closed end of the sleeve. The sleeve bottom element may be fixed and in contact with the airflow element. The sleeve bottom element may extend a distance away from the airflow element along the longitudinal axis of the sleeve and toward the closed end of the housing cavity. The sleeve bottom element may have an orifice containing a piercing element, allowing the piercing element to pass through the orifice of the sleeve bottom element.

[0036] The inhaler article retainer may further include a spring member configured to bias the sleeve away from the piercing element. The spring member can bias the sleeve away from the second position toward the first position. The spring member can be in a relaxed state in the first position of the sleeve. The spring member can be in a compressed state in the second position. Preferably, the piercing element is disposed within the spring member.

[0037] The sleeve may include an elongated slot extending along the longitudinal length of the sleeve. The housing may also include a pin extending from an inner surface of the housing cavity. The pin may be configured to mate with the elongated slot to maintain alignment of the sleeve as the sleeve moves between first and second positions.

[0038] The inner housing may be contained within the housing cavity. The inner housing may separate at least a portion of the sleeve from the inner surface of the housing cavity. The inner housing may separate the fixed end of the piercing element from the inner surface of the housing cavity. The inner housing may separate the spring component from the inner surface of the housing cavity.

[0039] Inhalable powders may contain various active agents. For example, the active agents may include alkaloids such as nicotine, neonicotinoids, or senna. Preferably, the active agents comprise solid salts of alkaloids, such as nicotine salts.

[0040] The amount of surfactant can be selected based on the desired or intended use of the inhalable dry powder. For example, the amount of surfactant can be between 0.5% by weight and 10% by weight of the total weight of the dry powder particles. The dry powder particles may include 0.5% by weight or more, 1% by weight or more, 2% by weight or more, or 3% by weight or more of surfactant, and may include 12% by weight or less, 10% by weight or less, 9% by weight or less, 8% by weight or less, or 7% by weight or less of surfactant, or may include 0.5% by weight to 10% by weight, 1% by weight to 8% by weight, 1.5% by weight to 6% by weight, or 2% by weight to 5% by weight of surfactant.

[0041] The dry powder particles may include 0.5% or more, 1% or more, 2% or more, or 3% or more of nicotine, and include 12% or less, 10% or less, 9% or less, 8% or less, or 7% or less of nicotine, or include 0.5% to 10% of nicotine, 1% to 8% of nicotine, 1.5% to 6% of nicotine, or 2% to 5% of nicotine.

[0042] The amount of active agent can also be selected on a per-dose basis. Inhalable powder can be packaged in single-dose or multi-dose form. For example, each dose of inhalable powder may include 0.5 mg or more, 1 mg or more, 2 mg or more, or 5 mg or more of active agent. Each dose of inhalable powder may include 500 mg or less, 200 mg or less, 100 mg or less, 50 mg or less, 20 mg or less, or 10 mg or less of active agent. In some embodiments, each dose of inhalable powder includes 0.01 to 10 mg of neonicotinoids or nicotine or chenopogonin, each dose includes 0.05 to 5 mg of neonicotinoids or nicotine or chenopogonin, or each dose includes 0.1 to 1 mg of neonicotinoids or nicotine or chenopogonin.

[0043] In one embodiment, the capsule contains 1 to 20 doses. In another embodiment, the capsule contains 1 to 10 doses. In yet another embodiment, the capsule contains 10 to 20 doses. In one embodiment, the capsule contains 1 dose. In another embodiment, the capsule contains 2 doses. In yet another embodiment, the capsule contains 3 doses. In yet another embodiment, the capsule contains 4 doses. In yet another embodiment, the capsule contains 5 doses. In yet another embodiment, the capsule contains 6 doses. In yet another embodiment, the capsule contains 7 doses. In yet another embodiment, the capsule contains 8 doses. In yet another embodiment, the capsule contains 9 doses. In yet another embodiment, the capsule contains 10 doses. In yet another embodiment, the capsule contains 11 doses. In yet another embodiment, the capsule contains 12 doses. In yet another embodiment, the capsule contains 13 doses. In yet another embodiment, the capsule contains 14 doses. In yet another embodiment, the capsule contains 15 doses. In yet another embodiment, the capsule contains 16 doses. In yet another embodiment, the capsule contains 17 doses. In yet another embodiment, the capsule contains 18 doses. In yet another embodiment, the capsule contains 19 doses. In yet another embodiment, the capsule contains 20 doses.

[0044] The dry powder particles may have a particle size ranging from 20 µm or smaller, 10 µm or smaller, or 5 µm or smaller, or 0.1 µm or larger, 0.2 µm or larger, or 0.5 µm or larger, or from 0.5 µm to 10 µm, or from 0.75 µm to 5 µm, or from 1 µm to 5 µm, or from 1 µm to 3 µm, or from 1.5 µm to 2.5 µm. The desired particle size range can be achieved by spray drying, grinding, sieving, or a combination thereof.

[0045] The dry powder particles can be further mixed with a second particle group to form a powder system. Preferably, the second particle group has a different particle size than or larger than the dry powder particles. For example, the second particle group can have a particle size in the range of about 20 µm or larger, or about 50 µm or larger, 200 µm or smaller, 150 µm or smaller, or in the range of 50 µm to 200 µm, or 50 µm to 150 µm. The second particle group can have any useful size distribution suitable for selective inhalation and delivery to the user's oral cavity or buccal cavity. A larger second flavoring particle group can help deliver the dry powder particles into the inhalation airflow toward the user.

[0046] The dry powder particles and the second particle group can be combined in any useful relative amount such that the second particle group is detectable by the user when consumed together with the dry powder particles. Preferably, the dry powder particles and the second particle group form at least about 90% by weight, at least about 95% by weight, at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0047] The dry powder particles can be mixed with a second flavoring particle group to form a powder system. Preferably, the second flavoring particle group has a different particle size than or larger than the dry powder particles. For example, the flavor particles can have a particle size in the range of about 20 µm or larger, or about 50 µm or larger, 200 µm or smaller, 150 µm or smaller, or in the range of 50 µm to 200 µm, or 50 µm to 150 µm. The second flavoring particle group can have any useful size distribution suitable for selective inhalation delivery to the user's oral cavity or buccal cavity. A larger second flavoring particle group can help deliver the dry powder particles into the inhalation airflow toward the user.

[0048] The dry powder particles and the second flavoring particle group can be combined in any useful relative amount such that the second flavoring particle group is detectable by the user when consumed together with the dry powder particles. Preferably, the dry powder particles and the second flavoring particle group form at least about 90% by weight, at least about 95% by weight, at least about 99% by weight, or 100% by weight of the total weight of the powder system.

[0049] Dry powder particles or powder systems can be provided in suitable dosage forms. For example, dry powder particles or powder systems can be provided in capsules. Dosage forms (e.g., capsules) can be configured for use in suitable inhalers. For example, capsules can be used in inhaler devices having a capsule cavity. Airflow management through the capsule cavity of the inhaler device allows the capsule contained therein to rotate during inhalation and consumption. Capsules may contain dry powder particles or powder systems.

[0050] Unless otherwise stated, the term "particle size" is used herein to refer to the mass median aerodynamic diameter (MMAD) of a particle or set of particles. Such values ​​are based on a mass median aerodynamic diameter (MMAD) of 1 gm / cm², defined as having the same aerodynamic behavior as the particle being characterized. 3 The distribution of the density of spheres and the diameter of aerodynamic particles.

[0051] Specifically, for powder systems, the mass median aerodynamic diameter (MMAD) is typically referenced, as it is the most widely used metric as a single numerical descriptor of aerodynamic particle size distribution. MMAD is a statistically derived graph of a particle sample: for example, an MMAD of 5 micrometers means that 50% of the total sample mass will be present in particles with an aerodynamic diameter of less than 5 micrometers, and the remaining 50% of the total sample mass will be present in particles with an aerodynamic diameter greater than 5 micrometers. In the context of this invention, when describing powder systems, the term "particle size" preferably refers to the MMAD of the powder system.

[0052] MMAD for powder systems is preferably measured using a cascade impactor. Cascade impactors are instruments widely used to sample and separate airborne particles to determine the aerodynamic size classification of aerosol particles. Essentially, a cascade impactor separates an incoming sample into discrete parts based on particle inertia, which varies with particle size, density, and velocity. A cascade impactor typically comprises a series of stages, each including a plate with a specific nozzle arrangement and collection surface. The velocity of the sample-carrying air increases as the number of stages increases, while the nozzle size and total nozzle area decrease with increasing stage number. At each stage, particles with sufficient inertia detach from the main airflow to impact the collection surface. Therefore, at any given flow rate, each stage is associated with a cutoff diameter, which numerically defines the size of the collected particles. As the number of stages increases, the velocity increases, and thus the stage cutoff diameter decreases. Therefore, the cutoff diameter associated with a given stage is a function of the airflow rate used for testing. To reflect in-service performance, aerosol inhalers are routinely tested at 15 L / min, and dry powder inhalers can be tested at flow rates up to 100 L / min.

[0053] Preferably, in the context of this invention, the MMAD of the powder system is measured using a Next-Generation Impactor (NGI) 170 (purchased from Copley Scientific AG). The NGI is a high-performance, precise cascade impactor for particle sorting with seven stages plus a micropore collector (MOC). The features and operating principles of the NGI are described, for example, in Marple et al., Journal of Aerosol Medicine - Vol. 16, No. 3 (2003). More preferably, the measurements are performed at 20 ± 3 degrees Celsius and 35 ± 5% relative humidity.

[0054] Dry powder formulations typically contain less than or equal to about 15% by weight of water, preferably less than or equal to about 10% by weight, and even more preferably less than or equal to about 6% by weight. Most preferably, the dry powder formulation contains less than or equal to about 5% by weight of water, or even less than or equal to about 3% by weight of water, or even less than or equal to about 1% by weight of water.

[0055] All values ​​reported as percentages are assumed to be weight percentages based on total weight.

[0056] All scientific and technical terms used in this article have their common meanings in the field, unless otherwise specified. The definitions provided are for ease of understanding of certain terms used frequently in this article.

[0057] As used herein, unless the content explicitly indicates otherwise, the singular forms “a” and “the” cover embodiments having plural referents.

[0058] As used herein, unless otherwise expressly indicated by the content, "or" is generally used in its meaning as including "and / or". The term "and / or" means one or all of the listed elements or any combination of two or more of the listed elements.

[0059] As used in this text, "having," "containing," "including," etc., are used in their open sense and generally mean "including (but not limited to)." It should be understood that phrases such as "basically composed of," "composed of," etc., fall under the category of "including."

[0060] The terms "preferred" and "ideally" refer to embodiments of the invention that provide certain benefits in certain environments. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are useless, and is not intended to exclude other embodiments from the scope of this disclosure, including the claims.

[0061] As used herein, the term “substantially” has the same meaning as “significantly” and can be understood as modifying the relevant term by at least about 90%, at least about 95%, or at least about 98%. As used herein, the term “generally not” has the same meaning as “significantly not” and can be understood as having the opposite meaning to “generally”, i.e., modifying the relevant term by no more than 10%, no more than 5%, or no more than 2%.

[0062] The invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

[0063] Example Ex1: An inhaler system comprising: a shell defining a shell cavity; a sleeve extending along a longitudinal axis of the sleeve and positioned within the shell cavity; a capsule contained within the sleeve and having a capsule longitudinal axis; and a piercing element comprising only a single axis extending from a fixed end to a tip along the longitudinal axis of the piercing element. The longitudinal axis of the piercing element is parallel to and offset relative to the longitudinal axis of the sleeve. The sleeve is movable within the shell cavity between a first position and a second position. When the sleeve moves from the first position to the second position, only a single pore is formed in the capsule.

[0064] Example Ex2: An inhaler system comprising: a shell defining a shell cavity; a sleeve extending along a longitudinal axis of the sleeve and positioned within the shell cavity; a capsule contained within the sleeve and having a capsule longitudinal axis; and a piercing element comprising only a single axis extending from a fixed end to a tip along the longitudinal axis of the piercing element. The longitudinal axis of the piercing element is parallel to and offset relative to the longitudinal axis of the capsule. The sleeve is movable within the shell cavity between a first position and a second position. When the sleeve moves from the first position to the second position, only a single pore is formed in the capsule.

[0065] Example Ex3: The inhaler system according to Ex1, wherein the longitudinal axis of the puncture element is offset relative to the longitudinal axis of the sleeve by at least one puncture element diameter, or at least 1.5 puncture element diameters, or at least 2 puncture element diameters, or within the range of 1 to 2 puncture element diameters.

[0066] Example Ex4: The inhaler system according to Ex2, wherein the longitudinal axis of the puncture element is offset relative to the longitudinal axis of the capsule by at least one puncture element diameter, or at least 1.5 puncture element diameters, or at least 2 puncture element diameters, or within the range of 1 to 2 puncture element diameters.

[0067] Example Ex5: An inhaler system according to any of the preceding examples, wherein the inhaler system has fewer than two puncture elements.

[0068] Example Ex6: An inhaler system according to any of the preceding examples, wherein the tip of the piercing element has only a single bevel or cutting plane.

[0069] Example Ex7: Inhaler system according to Ex6, wherein the single bevel or cutting plane of the piercing element defines a flat surface opposite to the longitudinal axis of the sleeve.

[0070] Example Ex8: Inhaler system according to Ex6, wherein the single bevel or cutting plane of the piercing element defines a flat surface opposite to the longitudinal axis of the capsule.

[0071] Example Ex9: The inhaler system according to Ex6, wherein the single bevel or cutting plane of the piercing element defines the flat surface toward the inner diameter surface of the sleeve that is closest to the flat surface.

[0072] Example Ex10: Inhaler system according to any of the foregoing examples, wherein the piercing element pierces the capsule at the curved end of the capsule within a range of 25% to 90% of the capsule radius from the capsule's longitudinal axis, or 33% to 80% of the capsule radius from the capsule's longitudinal axis, or 50% to 75% of the capsule radius from the capsule's longitudinal axis.

[0073] Example Ex11: An inhaler system according to any of the preceding examples, wherein the piercing element forms a single pore in the capsule, the single pore defining only a single hinge extending into the capsule cavity of the capsule material.

[0074] Example Ex12: The inhaler system according to Ex11, wherein a single hinge of the capsule material is located at the point furthest from the longitudinal axis of the capsule around a single pore.

[0075] Example Ex13: In an inhaler system according to any of the foregoing examples, the piercing element includes a single solid shaft extending along the longitudinal axis of the piercing element from the fixed end to the tip.

[0076] Example Ex14: An inhaler system according to any of the foregoing examples, wherein the capsule has a radius in the range of 2.6 mm to 3.2 mm, and the piercing element pierces the capsule at the curved end of the capsule at a radial distance in the range of at least 1 mm from the longitudinal axis of the capsule or about 1 mm to about 2 mm from the longitudinal axis of the capsule.

[0077] Example Ex15: An inhaler system according to any of the foregoing examples, wherein the sleeve extends from an open end to a closed end and defines a cylindrical lumen for receiving an inhaler article, the open end of the sleeve being aligned with an opening in the housing for receiving an inhaler article, and the closed end of the sleeve including an airflow element configured to form a vortex airflow during use to cause the capsule to spin about the longitudinal axis of the capsule.

[0078] Example Ex16: An inhaler system according to any of the preceding examples, wherein the capsule is contained within an inhaler article extending from a distal end to a mouthpiece end along a longitudinal axis of the inhaler article, and the sleeve is configured to receive the distal end of the inhaler article.

[0079] Example Ex17: The inhaler system according to Ex16, wherein the longitudinal axis of the inhaler article is offset relative to the longitudinal axis of the puncture element.

[0080] Example Ex18: An inhaler system according to any of the foregoing examples, wherein the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a median aerodynamic diameter of about 5 micrometers or less, or in the range of about 0.5 micrometers to about 4 micrometers, or in the range of about 1 micrometer to about 3 micrometers.

[0081] Example Ex19: The inhaler system according to Ex18, wherein the capsule further contains flavoring particles having a median aerodynamic diameter of about 20 micrometers or larger, or about 50 micrometers or larger, or in the range of about 50 to about 200 micrometers, or in the range of about 50 to about 150 micrometers. Attached Figure Description

[0082] The embodiments will now be described further with reference to the accompanying drawings, in which:

[0083] Figure 1 This is a schematic cross-sectional view of an illustrative inhaler system;

[0084] Figure 2 It is an exploded perspective view of the retainer of an illustrative inhaler product;

[0085] Figure 3A It is a schematic cross-sectional view of an illustrative inhaler system, wherein the inhaler article is received in an inhaler article holder and punctures the capsule in a second position;

[0086] Figure 3B yes Figure 3A A schematic cross-sectional view of an illustrative inhaler system, in which the piercing element is retracted from the capsule in a first position;

[0087] Figure 4 yes Figure 3B Another schematic cross-sectional view shows the airflow path through the inhaler system;

[0088] Figure 5 This is a front view of the sleeve of the retainer in an illustrative inhaler product;

[0089] Figure 6A It is a perspective view of an illustrative airflow element with a piercing element;

[0090] Figure 6B It is a perspective view showing the airflow element with six alternative piercing element offset positions around the center line of the airflow element;

[0091] Figure 7 This is a schematic cross-sectional view of the illustrative piercing element contacting the capsule end cap;

[0092] Figure 8 It is a schematic cross-sectional view of an illustrative capsule cavity with a capsule and a puncture element.

[0093] Figure 9A This is a front view of the illustrative capsule end cap after being pierced by the piercing element described in this article; and

[0094] Figure 9BThis is a front view of another illustrative capsule end cap after being punctured by the puncturing element described in this article.

[0095] The illustrations are not necessarily to scale and are presented for illustrative rather than limiting purposes. The accompanying drawings depict one or more aspects described in this disclosure. However, it should be understood that other aspects not depicted in the drawings fall within the scope and spirit of this disclosure. Detailed Implementation

[0096] Figure 1 This is a schematic cross-sectional view of the illustrative inhaler system 10. Figure 2 This is an exploded perspective view of the exemplary inhaler article retainer 30. Figure 3A This is a schematic cross-sectional view of an exemplary inhaler system 10, wherein the inhaler article 20 is received in the inhaler article retainer 30 and punctures the bladder 25 in a second or compressed position. Figure 3B yes Figure 3A A schematic cross-sectional view of an exemplary inhaler system 10, wherein the puncture element 50 is retracted from the sac 25 in a first or relaxed position. Figure 4 This shows the path (arrow) of the inhalation airflow 150 through the inhaler system 10. Figure 3B Another schematic cross-sectional view.

[0097] The inhaler product holder 30 is configured to receive a single edible inhaler product 20 and to induce a vortex of inhaled airflow that enters and passes through the inhaler product 20 during consumption. The inhaler product holder 30 and the inhaler product 20 form the inhaler system 10. During use by the user, the inhaler product 20 is held in the inhaler product holder 30. The inhaler product holder 30 is configured to induce a vortex of inhaled airflow into the received inhaler product 20.

[0098] The illustrative inhaler article 20 includes a body 22 extending distally from the mouthpiece end 21 to the distal end 23. A capsule cavity 24 is defined within the body 22. A capsule 25 is contained within the capsule cavity 24. The dry powder particles described above may be contained within the capsule 25. The capsule 25 may be punctured to form a pore through the body of the capsule 25, and inhaled air may flow through the inhaler article 20 to release the dry powder particles from the punctured capsule 25 and into the inhaled airflow, exiting from the mouthpiece end 21.

[0099] The inhaler article holder 30 includes a housing 32 defining a housing cavity defined by an inner surface 34 and an outer surface 35. A sleeve 40 is positioned within the housing cavity. The sleeve 40 is arranged to receive the inhaler article 20, and the sleeve 40 is movable within the housing cavity along the longitudinal axis of the housing cavity between a first position and a second position.

[0100] The piercing element 50 is arranged such that when the sleeve 40 is in the position of Figure 3AThe second position shown punctures the capsule 25 received within the inhaler article 20 inside the sleeve 40.

[0101] The piercing element 50 may be configured to extend into the sleeve 40 along the longitudinal axis of the housing 32. The inhaler article holder 30 may include a spring member 60 configured to bias the sleeve 40 and any received inhaler article 20 away from the piercing element 50.

[0102] The sleeve 40 extends from the open end 42 to the closed end 44 (or the restricted end) and defines a sleeve cavity 45 or a cylindrical cavity 45 along the longitudinal axis of the sleeve 40. The open end 42 of the sleeve is aligned with a single housing opening 36.

[0103] The sleeve closure end 44 includes an airflow element 46 and orifices to allow a piercing element to pass through the closure end 44 and extend into the sleeve lumen 45. The airflow element 46 includes one or more inhalation air inlets 47 providing airflow communication from the annular space surrounding the sleeve 40 to the sleeve cylindrical lumen 45. This airflow element 46 is configured to cause a rotating or vortex inhalation airflow into the sleeve cylindrical lumen 45 and directly into the inhaler article capsule cavity 24. This vortex or rotating inhalation airflow can be delivered into the inhaler article 20 to rotate the capsule 25 and release the dry powder contained within the capsule 25.

[0104] The airflow element 46 of the sleeve 40 includes a tubular element having a central passage in fluid communication with the sleeve cavity 45. The airflow element 46 has at least one air inlet 47 that allows intake air 150 to enter the central passage. The at least one air inlet 47 extends in a direction tangential to the central passage to generate a vortex or rotating intake airflow.

[0105] The sleeve 40 includes a tubular element that extends approximately 5 mm into the sleeve cavity 45 and has an outer diameter of approximately 5.5 mm and an inner diameter of approximately 4 mm. The received inhaler article 20 has an open distal end 23 that may have an inner diameter of approximately 5.5 mm to provide an interference fit with the tubular element of the airflow element 46.

[0106] The sleeve closing end 44 may further include a sleeve bottom element 48 that generally forms the closed end of the sleeve 40. The sleeve bottom element 48 may be fixed and in contact with the airflow element 46. The sleeve bottom element 48 may extend a distance away from the airflow element 46 along the longitudinal axis of the sleeve and toward the closed end of the housing cavity. The sleeve bottom element 48 may have a hole containing a piercing element 50 and allowing the piercing element 50 to pass through the hole of the sleeve bottom element 48.

[0107] The inner housing 70 may be contained within the housing cavity. The inner housing 70 may separate at least a portion of the sleeve 40 from the inner surface of the housing cavity. The inner housing 70 may separate the fixed end of the piercing element 50 from the inner surface of the housing cavity. The inner housing 70 may separate the spring component 60 from the inner surface of the housing cavity.

[0108] The annular cover 38 secures the inner housing 70 and the sleeve 40 into the housing cavity. The annular cover 38 defines a single housing opening 36 for receiving the inhaler article 20. The annular cover 38 can be secured to the housing 32 with a pin element 39.

[0109] Figure 4 The path of the inhalation airflow 150 through the inhaler system 10 is shown. The inhalation airflow 150 enters the inhaler article holder 30 along the outer surface of the received inhaler article 20 and the annular cover 38. Once inside the housing cavity, the inhalation air 150 travels along the length of the sleeve 40 toward the closed end 44 of the sleeve 40. The inhalation air 150 then enters the air inlet 47 of the airflow element 46 and forms a vortex or rotation of the inhalation air 150 within the sleeve cavity 45. This vortex or rotation of the inhalation air is then directly delivered to the distal end 23 of the inhaler article 20 and enters the capsule cavity 24. The vortex inhalation airflow rotates or agitates the capsule 25, and dry powder particles are entrained in the inhalation airflow. The entrained inhalation airflow then flows out of the inhaler article via the mouthpiece end 21 and toward the user 100. Figure 4 The arrow in the middle indicates the path of the intake airflow 150.

[0110] Figure 5 This is a front view of the sleeve 40 of the illustrative inhaler product retainer. Figure 6A It is a perspective view of an illustrative airflow element 46 having a piercing element 50. Figure 6B This is a perspective view showing the airflow element 46 at offset positions of six alternative piercing elements 50 around the center line of the airflow element 46.

[0111] A single cutting plane or bevel 54 is offset or spaced apart from the centerline of the airflow element 46, and is opposite to or away from the centerline. Figure 6B The diagram shows a solid line embodiment surrounding the centerline of the airflow element 46 and five dashed alternative piercing element 50 offset positions. Each alternative position shows a single cutting plane or bevel 54 offset or spaced relative to the centerline of the airflow element 46, and opposite or away from the centerline.

[0112] The central longitudinal axis L of sleeve 40 CLLocated at the intersection of the X and Y axes. The airflow element 46 defines the closed end of the sleeve 40. The inner housing 70 is fixed to the sleeve 40. The piercing element 50 extends through the airflow element 46 and relative to the central longitudinal axis L. CL Offset distance R O The central longitudinal axis L of the airflow element 46 CL With respect to the central longitudinal axis L of sleeve 40 CL Aligned and overlapping. The cutting end of the piercing element is defined by a single cutting plane or bevel 54 terminated at the tip 52.

[0113] Figure 7 This is a schematic cross-sectional view of the illustrative piercing element 50 contacting the capsule end cap 26. Figure 8 This is an illustrative schematic cross-sectional view of the capsule cavity 24 of an inhaler article 20 having a capsule 25 and a puncture element 50.

[0114] Figure 7 The orientation of the cutting plane or bevel 54 is shown. The cutting plane is aligned with the central longitudinal axis L of the sleeve 40. CL Relative. The central longitudinal axis L of capsule cavity 24 CL With respect to the central longitudinal axis L of sleeve 40 CL Alignment and overlap. Tip 52 first penetrates the capsule hemispherical end cap 26 to form a pore opening, and continues cutting through the capsule hemispherical end cap 26 until it pierces the entire circumference of the element shaft and enters the capsule 25. The portion of the circumference that forms the pore is closest to the central longitudinal axis L. CL The hinge of the capsule material forming part of the pores is closest to the central longitudinal axis L of the perimeter. CL The parts are relative.

[0115] Central longitudinal axis L CL It coincides with the longitudinal axis or rotation axis of capsule 25. Therefore, the central longitudinal axis L of sleeve 40 and capsule cavity 24 is... CL Coinciding with the longitudinal axis or rotation axis of capsule 25, such as Figure 7 and Figure 8 As explained. The longitudinal axis of the piercing element 50 is offset relative to the longitudinal axis or rotation axis of the capsule 25, such as... Figure 7 and Figure 8 As explained.

[0116] The piercing element 50 is parallel to the central longitudinal axis L CL And the offset distance R relative to the central longitudinal axis O The capsule hemispherical end cap 26 has a radius R at the circumference of the capsule 25. C The piercing element 50 can be positioned relative to the central longitudinal axis L. CL Closer to the circumference radius R CThe point of contact is the hemispherical end cap 26 of the capsule, as described above.

[0117] Figure 9A This is a front view of the end cap of the illustrative capsule 25 having a hole 29 after being punctured by the puncturing element described herein. Figure 9B This is a front view of another illustrative capsule 25 end cap having a pore 29 after being punctured by the puncturing element described herein.

[0118] For the purposes of this specification and the appended claims, unless otherwise stated elsewhere, all figures representing quantities, quantities, percentages, etc., shall be understood to be modified by the term "about" in all cases. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein. Thus, in this context, the numeral A is understood to be A ± 2%A. Within this context, the numeral A can be considered as including a value within the general standard error for the measurement of the attribute modified by the numeral A. In certain instances used in the appended claims, the numeral A may deviate from the percentages listed above, provided that the amount of deviation from A does not materially affect the essential and novel features of the claimed invention. Furthermore, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges that may be specifically listed or not listed herein.

Claims

1. An inhaler system comprising: The shell, which defines the shell cavity; A sleeve extending along a longitudinal axis and positioned within the housing cavity, wherein the sleeve is movable within the housing cavity between a first position and a second position; A capsule contained within the sleeve, the capsule having a longitudinal axis; as well as The piercing element comprises only a single axis extending from a fixed end to a tip along a longitudinal axis of the piercing element, the longitudinal axis of the piercing element being parallel to and offset relative to the longitudinal axis of the sleeve, and also offset relative to the longitudinal axis of the capsule. When the sleeve moves from the first position to the second position, only a single pore is formed in the capsule.

2. The inhaler system of claim 1, wherein the capsule is contained within an inhaler article extending from a distal end to a mouthpiece end along a longitudinal axis of the inhaler article, and the sleeve is configured to receive the distal end of the inhaler article.

3. The inhaler system according to claim 1 or 2, wherein the longitudinal axis of the puncture element is offset relative to the longitudinal axis of the sleeve or the longitudinal axis of the capsule by at least one diameter of the puncture element.

4. The inhaler system of claim 3, wherein the longitudinal axis of the puncture element is offset relative to the longitudinal axis of the sleeve or the longitudinal axis of the capsule by at least 1.5 puncture element diameters.

5. The inhaler system of claim 3, wherein the longitudinal axis of the puncture element is offset relative to the longitudinal axis of the sleeve or the longitudinal axis of the capsule by at least two puncture element diameters.

6. The inhaler system of claim 3, wherein the longitudinal axis of the puncture element is offset from the longitudinal axis of the sleeve or the longitudinal axis of the capsule by a range of 1 to 2 puncture element diameters.

7. The inhaler system according to claim 1 or 2, wherein the tip of the piercing element has only a single bevel or cutting plane.

8. The inhaler system of claim 7, wherein the single bevel or cut plane defines a flat surface facing away from the longitudinal axis of the sleeve.

9. The inhaler system of claim 7, wherein the single bevel or cut plane defines a flat surface facing away from the longitudinal axis of the capsule.

10. The inhaler system of claim 7, wherein the single bevel or cut plane defines a flat surface toward the inner surface of the sleeve closest to the single bevel or cut plane.

11. The inhaler system according to claim 1 or 2, wherein the piercing element pierces the capsule at the curved end of the capsule within a range of 25% to 90% of the capsule radius from the longitudinal axis of the capsule.

12. The inhaler system of claim 11, wherein the piercing element pierces the capsule at the curved end of the capsule within a range of 33% to 80% of the capsule radius from the longitudinal axis of the capsule.

13. The inhaler system of claim 11, wherein the piercing element pierces the capsule at the curved end of the capsule within a range of 50% to 75% of the capsule radius from the longitudinal axis of the capsule.

14. The inhaler system of claim 1 or 2, wherein the piercing element forms a single pore in the capsule, the single pore defining only a single hinge extending into the capsule cavity of the capsule material.

15. The inhaler system of claim 1 or 2, wherein the piercing element comprises a single solid shaft extending from the fixed end to the tip along the longitudinal axis of the piercing element.

16. The inhaler system of claim 1 or 2, wherein the capsule has a radius in the range of 2.6 mm to 3.2 mm, and the piercing element pierces the capsule at a curved end of the capsule at a radial distance of at least 1 mm from the longitudinal axis of the capsule.

17. The inhaler system of claim 16, wherein the piercing element pierces the capsule at the curved end of the capsule at a radial distance ranging from 1 mm to 2 mm from the longitudinal axis of the capsule.

18. The inhaler system of claim 1 or 2, wherein the sleeve extends from an open end to a closed end and defines a cylindrical lumen for receiving an inhaler article, the open end of the sleeve being aligned with an opening in the housing for receiving an inhaler article, and the closed end of the sleeve including an airflow element configured to form a vortex airflow during use to cause the capsule to spin about the longitudinal axis of the capsule.

19. The inhaler system of claim 2, wherein the longitudinal axis of the inhaler article is offset relative to the longitudinal axis of the puncture element.

20. The inhaler system of claim 1 or 2, wherein the capsule contains pharmaceutically active particles comprising nicotine, the pharmaceutically active particles having a median aerodynamic diameter of 5 micrometers or less.

21. The inhaler system of claim 20, wherein the pharmaceutically active particles have a median aerodynamic diameter in the range of 0.5 micrometers to 4 micrometers.

22. The inhaler system of claim 20, wherein the pharmaceutically active particles have a median aerodynamic diameter in the range of 1 micrometer to 3 micrometers.

23. The inhaler system of claim 20, wherein the capsule further comprises flavoring particles having a median aerodynamic diameter of 20 micrometers or greater.

24. The inhaler system of claim 23, wherein the flavoring particles have a median aerodynamic diameter of 50 micrometers or greater.

25. The inhaler system of claim 23, wherein the flavoring particles have a median aerodynamic diameter in the range of 50 to 200 micrometers.

26. The inhaler system of claim 23, wherein the flavoring particles have a median aerodynamic diameter in the range of 50 to 150 micrometers.

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