RU2848286C1 - Inhaler holder and inhaler system - Google Patents

Abstract

FIELD: tooling.

SUBSTANCE: inhaler holder comprising a casing forming a casing cavity and an outer surface, and a sleeve located inside the casing cavity. The sleeve is designed to accommodate an inhaler device, and the sleeve is designed to move inside the casing cavity between a first position and a second position. A piercing element is designed to pierce an inhaler device placed inside the sleeve when the sleeve is in the second position. The sleeve is electrically connected to the casing to form a static electricity discharge circuit when the casing is electrically grounded.

EFFECT: providing an electrically conductive path within the dry powder inhalation system to prevent or minimise electrostatic build-up within the dry powder flow path, thereby preventing dry powder from accumulating on the surfaces of the holder along the dry powder flow path.

15 cl, 6 dwg

Description

The present invention relates to a holder for an inhalation product, wherein said holder for an inhalation product includes a circuit for removing an electrostatic charge when held by a user.

Dry powder inhalers are not always fully capable of delivering dry powder particles to the lungs at inhalation rates or airflows within the range of inhalation rates or airflows experienced during normal smoking. Dry powder inhalers can be complex to operate or contain moving parts. Dry powder inhalers are often designed to deliver the entire dry powder dose or capsule contents in a single inhalation.

Inhalation devices can contain capsules containing dry powder. These capsules can be activated by puncturing the capsule wall. The user draws (inhales or puffs) from the mouthpiece. This action creates a flow of air through the dry powder inhaler. It is well known that drug delivery in dry powder inhalers and aerosol inhalers can be hampered by electrostatic attraction of the drug to surfaces along the airflow path.

As dry particles flow through a dry powder inhaler system, interactions between the particles and surfaces encountered during their passage through the dry powder inhaler system cause electrostatic buildup. This electrostatic buildup causes particles to be attracted to each other and to surfaces they encounter during their passage through the dry powder inhaler system. This can lead to adhesion of dry particles to surfaces encountered during their passage through the dry powder inhaler system. Adhesion or accumulation of dry powder on these surfaces impairs the operation of the dry powder inhaler. Adhesion or accumulation of dry powder on these surfaces increases the need for maintenance required for the effective operation of the dry powder inhaler.

CN 111526747 A (A24F 42/60, 11.08.2020) describes a dry powder inhaler for delivering pharmaceutically active particles, which includes a mouthpiece portion removably connected to a distal end portion.

It is desirable to provide an electrically conductive path within the dry powder inhalation system to prevent or minimize electrostatic buildup within the dry powder flow path. It is desirable to provide an inhalation device holder that prevents or minimizes the buildup of static electricity and the attraction of dry powder particles to the holder surfaces. It is desirable to effectively dissipate any static electricity from the inhalation device holder to prevent dry powder accumulation on the holder surfaces along the dry powder flow path.

According to one aspect of the present invention, a holder for an inhalation device is provided, comprising a housing defining a housing cavity and an outer surface, and a sleeve located within the housing cavity. The sleeve is configured to accommodate an inhalation device, and the sleeve is movable within the housing cavity between a first position and a second position. A piercing element is configured to pierce the inhalation device positioned within the sleeve when the sleeve is in the second position. The sleeve is electrically connected to the housing to form a static discharge circuit when the housing is electrically grounded.

Providing a static discharge path from the cartridge eliminates static buildup on the cartridge and prevents or reduces dry powder accumulation on cartridge surfaces, which provides significant benefits. Reducing static electricity prevents or reduces dry powder accumulation, keeping device surfaces clean and reducing maintenance requirements. Reducing powder accumulation in or on the device provides more powder for the user, increasing device efficiency. The use of antistatic materials for the cartridge and static-discharge circuit components ensures a simple and easy-to-assemble inhaler holder.

The present invention relates to a holder for an inhalation device, referred to as an "inhalation device holder." The inhalation device holder comprises a single, remote piercing element. The inhalation device holder is configured to accommodate a consumable inhalation device, activate a capsule within the inhalation device by piercing the capsule, and create a vortex-like inhalation airflow for inhalation into the inhalation device during consumption. The inhalation device holder and the inhalation device may form an inhalation system, to which the present invention also relates.

Portions of the inhalation device holder, particularly portions of the movable sleeve housing the inhalation device, may come into contact with dry powder particles that are entrained in the inhaled airflow. For example, the airflow element forms part of the sleeve, and the airflow element also extends through the lumen of the sleeve and into the inhalation device. The applicant discovered that this airflow element is susceptible to dry powder accumulation on its surfaces during consumption due to the electrostatic attraction of the dry particles interacting with the electrically insulating airflow element.

The antistatic design of these sleeve components and the additional electrical connection of these sleeve components to the conductive casing of the inhaler holder create a circuit for discharging electrostatic charges when the user grounds the casing by contact with it during inhaler use. In this case, static electricity is discharged from the surfaces of the inhaler holder that interact with entrained dry powder particles during use. Reducing static electricity prevents or reduces the accumulation of dry powder, keeping the device surface clean and reducing the need for maintenance.

The inhalation device holder described herein can be used in combination with an inhalation device containing a capsule. The inhalation device can be used to activate the inhalation device by puncturing the capsule, which ensures reliable activation of the capsule by perforating the capsule with the piercing element of the inhalation device holder. Particles can be released from the capsule by aspiration or by creating an air flow around the punctured capsule. In this way, the inhalation system delivers dry powder particles to the user. The inhalation device holder is separate from the inhalation device, but the user uses both the inhalation device and the inhalation device holder during the consumption of dry powder particles released within the inhalation device. Multiple such inhalation devices can be combined with the inhalation device holder to form a system or kit. A single inhalation device holder may be used on 10 or more, or 25 or more, or 50 or more, or 100 or more inhalation devices to activate (perforate or pierce) the capsule contained in each inhalation device and ensure reliable activation. The inhalation device may optionally provide a visual indication (marking) of inhalation device activation for each inhalation device.

The inhalation device has an airflow path. The airflow is directed into the inhalation device by the user's inhalation (or puff). The inhalation device holder creates a swirling inhaled airflow. This swirling inhaled airflow is directed into the inhalation device. The distal end, or the upstream end, of the inhalation device contains an open opening that forms the open central passage of the open tubular element, configured to receive the swirling inhaled airflow.

The swirling inhaled airflow then passes downstream into the capsule cavity and causes the capsule to rotate within the cavity. The activated capsule then releases a dose of particles into the swirling inhaled airflow downstream through the mouthpiece to the user. Thus, the swirling inhaled airflow is created upstream of the inhaler device, and the swirling inhaled airflow enters the distal end or the upstream end of the inhaler device.

The inhaler device comprises an elongated tubular main portion extending along the longitudinal axis of the inhaler from the mouthpiece end to the distal end. The mouthpiece end is the proximal end, or downstream end. The distal end is the upstream end. A cavity for the capsule is formed within the main portion, defined by a downstream filter element, and limited upstream by an open tubular element defining a central passage. Prior to insertion into the inhaler device holder, the distal end of the inhaler device may be closed. After insertion into the inhaler device holder, the distal end of the inhaler device may be open. The distal end of the inhaler device may interact with corresponding structures in the inhaler device holder such that, upon insertion of the inhaler device into the inhaler device holder, the distal end of the inhaler device may open. When inserted into the inhaler holder, the distal end of the inhaler device has a central passageway that forms an open air inlet extending from the distal end of the main body to the capsule cavity. The capsule is positioned within the capsule cavity, with the central passageway having a smaller diameter than the capsule itself. This prevents the capsule from passing through the central passageway and keeps it within the capsule cavity.

The inhalation device holder comprises a housing containing a housing cavity for accommodating the inhalation device and a sleeve configured to retain the inhalation device within the housing cavity. The housing cavity is defined by a single opening in the housing, which extends into the housing to its closed end along the longitudinal axis of the housing. Said single opening in the housing is configured to accommodate the inhalation device. The housing is made of an electrically conductive material. Preferably, the housing is formed of a metal, such as aluminum.

The sleeve is contained within the cavity of the casing and is movable along the longitudinal axis of the casing between a first position and a second position. The sleeve can be configured to slide along the longitudinal axis of the casing between the first position and the second position. In the first position, the sleeve is located adjacent to the single opening of the casing. In the second position, the sleeve is located further from the single opening of the casing at a distance laterally along the longitudinal axis.

The cartridge case extends from the open end to the closed end (or limited end) and forms a cylindrical lumen along the longitudinal axis of the case. The open end of the case is aligned with the single opening of the casing.

The closed end of the cartridge includes an airflow element and an opening that allows a piercing element to pass through the closed end and into the lumen of the cartridge. The airflow element includes one or more inhalation air inlets that provide airflow from the annular space around the cartridge to the cylindrical lumen within the cartridge. This airflow element is configured to create a vortex of inhaled air flowing into the cylindrical lumen of the cartridge and directly into the capsule cavity of the inhalation device. This vortex or rotational inhalation air flow can be transmitted to the inhalation device to rotate the capsule and release the dry powder contained within the capsule.

The air flow element comprises a tubular element having a central passage in fluid communication with the sleeve cavity. The air flow element has at least one air inlet allowing inhaled air to enter the central passage. The at least one air inlet extends in a direction tangential to the central passage to create a vortex or rotational inhaled air flow.

The air flow element comprises a tubular element having a central passage in fluid communication with the sleeve cavity. The air flow element has at least two air inlets allowing inhaled air to enter the central passage. The at least two air inlets extend in a direction tangential to the central passage to create a vortex or rotational inhaled air flow.

The air flow element comprises a tubular element having a central passage in fluid communication with the sleeve cavity. The air flow element has at least three air inlets allowing inhaled air to enter the central passage. The at least three air inlets extend in a direction tangential to the central passage to create a vortex or rotational inhaled air flow.

The inhalation device holder may further comprise a piercing element attached to the inner surface of the housing cavity and extending therefrom. 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. The piercing element contacts the capsule of the inhalation device and pierces it when the sleeve is moved from the first position to the second position. Moving the sleeve from the second position to the first position removes the piercing element from the capsule and opens an opening in the capsule, allowing dry particles contained in the capsule to be released from the capsule when the capsule is rotated by inhaled air. The piercing element is preferably electrically conductive. The piercing element is preferably formed of metal.

A piercing element may electrically connect the sleeve to the housing. The piercing element may contact the sleeve in the area of the airflow element. The airflow element may comprise an opening for receiving the piercing element and allowing it to pass through the airflow element.

The closed end of the cartridge case may further include a cartridge base element, which substantially defines the closed end of the cartridge case. The cartridge base element may be attached to and in contact with the airflow element. The base element may extend from the airflow element for a distance along the longitudinal axis of the cartridge case and toward the closed end of the housing cavity. The cartridge base element may have an opening that contains a piercing element and allows the piercing element to pass through the opening of the cartridge base element.

The piercing element may contact the cartridge case in the area of the cartridge case base. The cartridge case base may electrically connect the cartridge case or the airflow element to the housing. The piercing element may electrically connect the cartridge case to the housing through either the cartridge case base or the airflow element.

The inhalation device holder may further comprise a spring element configured to bias the sleeve away from the piercing element. The spring element may bias the sleeve from the second position to the first position. The spring element may be in a relaxed state in the first position. The spring element may be in a compressed state in the second position. Preferably, the piercing element is located within the spring element. The spring element is preferably electrically conductive. The spring element is preferably formed of metal.

The spring element may electrically connect the liner to the housing. The spring element may contact the airflow element and electrically connect the liner or the airflow element to the housing. The spring element may contact the base element of the liner and electrically connect the liner to the housing through either the base element of the liner or the airflow element.

The cartridge case may comprise an elongated slot extending along the longitudinal length of the cartridge case. The housing may further comprise a pin extending from the inner surface of the housing cavity. The pin may be configured to engage the elongated slot to maintain cartridge case alignment as it moves between the first and second positions.

An inner casing may be contained within the casing cavity. The inner casing may separate at least a portion of the cartridge case from the inner surface of the casing cavity. The inner casing may separate the attached end of the piercing element from the inner surface of the casing cavity. The inner casing may separate the spring element from the inner surface of the casing cavity.

The inner jacket may electrically connect the cartridge case to the jacket. The inner jacket may contact the spring element and electrically connect the cartridge case or the airflow element to the jacket. The inner jacket may contact the piercing element and electrically connect the cartridge case to the jacket through either the cartridge case base element or the airflow element.

The sleeve may have a resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square. The sleeve may be made of a plastic material having a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

The air flow element has a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square. The air flow element may be made of a plastic material having a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

The base element of the cartridge case has a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square. The base element of the cartridge case may be made of a plastic material having a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

The inner casing has a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square. The inner casing may be formed from a plastic material having a surface resistance of less than 1×10 ¹² ohms/square, or less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

The term "surface resistance" refers to a material's ability to dissipate electrostatic charges. Surface resistance is measured using ASTM D 257 ESD STM11.11 IEC 60093. Surface resistance is the resistance to current leakage across the surface of an insulating material. Two parallel electrodes, separated by a distance equal to their contact length, are brought into contact with the surface of the material to measure surface resistance. The potential gradient coefficient (V/m) and the current per unit electrode length (A/m) respectively represent resistance. The lengths in surface resistance and coefficient cancel out, and the result is usually measured in ohms, since the four ends of the electrodes form a square. However, some test results use ohms per square due to a more descriptive nature. Surface resistance determines the electrical resistance of a fixed length of the surface of an insulating material. This measure does not take into account physical dimensions such as thickness and diameter. Since it determines only the surface resistance, only one physical measurement is required. Accordingly, surface resistance is measured between electrodes along the surface of the insulating material.

Plastic materials typically have a surface resistance greater than 1× ¹⁰ ohm/square. These plastic materials typically allow the accumulation of electrostatic forces on their surfaces. This accumulation of electrostatic forces attracts dry powder particles and causes adhesion of these dry powder particles to the surface of these plastic surfaces.

Antistatic materials have a surface resistance of less than 1× ¹⁰¹² ohms/square, or less than 1× ¹⁰¹¹ ohms/square, or less than 1× ¹⁰¹⁰ ohms/square. Antistatic plastic materials are commercially available, for example, from RTF (Winona, Minnesota, USA) under the trade names RPT 399 X 155792 B NS Polycarbonate, RPT 2599 X 156311 NS Polycarbonate/ABS Alloy, RPT 1199 A X 155793 NS Polyethylene Terephthalate Glycol Modified PETG, or RPT 899 X 149765 B Acetal (POM).

Inhalable powders can contain various active agents. The active agent may comprise an alkaloid, such as nicotine, anatabine, or anabasine. Preferably, the active agent comprises a solid alkaloid salt, such as a nicotine salt.

The amount of active agent can be selected depending on the desired or intended use of the inhalable dry powder. For example, the amount of active agent can be from 0.5 wt.% to 10 wt.% of the total weight of the dry powder particles. The dry powder particles can contain 0.5 wt.% or more, 1 wt.% or more, 2 wt.% or more, or 3 wt.% or more of the active agent and 12 wt.% or less, 10 wt.% or less, 9 wt.% or less, 8 wt.% or less, or 7 wt.% or less of the active agent, or from 0.5 wt.% to 10 wt.%, from 1 wt.% to 8 wt.%, from 1.5 wt.% to 6 wt.%, or from 2 wt.% to 5 wt.% of the active agent.

The dry powder particles contain 0.5 wt.% or more, 1 wt.% or more, 2 wt.% or more, or 3 wt.% or more nicotine and 12 wt.% or less, 10 wt.% or less, 9 wt.% or less, 8 wt.% or less, or 7 wt.% or less nicotine, or from 0.5 wt.% to 10 wt.%, from 1 wt.% to 8 wt.%, from 1.5 wt.% to 6 wt.%, or from 2 wt.% to 5 wt.% nicotine.

The amount of active agent can also be selected on a per dose basis. The inhalable powder can be packaged in single dose form or in multi-dose form. For example, the inhalable powder can contain 0.5 mg or more, 1 mg or more, 2 mg or more, or 5 mg or more of the active agent per dose. The inhalable powder can contain 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 the active agent per dose. In some embodiments, the inhalable powder contains from 0.01 to 10 mg of anatabine, or nicotine, or anabasine per dose, from 0.05 to 5 mg of anatabine, or nicotine, or anabasine per dose, or from 0.1 to 1 mg of anatabine, or nicotine, or anabasine per dose.

In embodiments, the capsule contains from 1 to 20 doses. In embodiments, the capsule contains from 1 to 10 doses. In embodiments, the capsule contains from 10 to 20 doses. In embodiments, the capsule contains 1 dose. In embodiments, the capsule contains 2 doses. In embodiments, the capsule contains 3 doses. In embodiments, the capsule contains 4 doses. In embodiments, the capsule contains 5 doses. In embodiments, the capsule contains 6 doses. In embodiments, the capsule contains 7 doses. In embodiments, the capsule contains 8 doses. In embodiments, the capsule contains 9 doses. In embodiments, the capsule contains 10 doses. In embodiments, the capsule contains 11 doses. In embodiments, the capsule contains 12 doses. In embodiments, the capsule contains 13 doses. In embodiments, the capsule contains 14 doses. In embodiments, the capsule contains 15 doses. In embodiments, the capsule contains 16 doses. In some embodiments, the capsule contains 17 doses. In some embodiments, the capsule contains 18 doses. In some embodiments, the capsule contains 19 doses. In some embodiments, the capsule contains 20 doses.

The dry powder particles may have a particle size of 20 μm or less, 10 μm or less, 5 μm or less, 0.1 μm or more, 0.2 μm or more, 0.5 μm or more, or in the range of 0.5 μm to 10 μm, or 0.75 μm to 5 μm, or 1 μm to 5 μm, or 1 μm to 3 μm, or 1.5 μm to 2.5 μm. The desired particle size range can be achieved by spray drying, milling, sieving, or a combination thereof.

The dry powder particles can be further mixed with a second plurality of particles to form a powder system. Preferably, the second plurality of particles can have a different particle size or a larger particle size than the dry powder particles. For example, the second plurality of particles can have a particle size of approximately 20 μm or greater, or approximately 50 μm or greater, 200 μm or less, 150 μm or less, or in the range of 50 μm to 200 μm, or 50 μm to 150 μm. The second plurality of particles can have any suitable size distribution for delivery by inhalation selectively to the user's oral or buccal cavity. The larger size of the flavor particles in the second plurality can facilitate the delivery of the dry powder particles into the user's inhaled air stream.

The dry powder particles and the second plurality of particles may be combined in any suitable relative amount such that the second plurality of particles is perceived by the user upon consumption of the dry powder particles. Preferably, the dry powder particles and the second plurality of particles constitute at least about 90 wt.%, or at least about 95 wt.%, or at least about 99 wt.%, or 100 wt.% of the total weight of the powder system.

The dry powder particles can be mixed with a second plurality of flavor particles to form a powder system. Preferably, the second plurality of flavor particles has a different particle size or a larger particle size than the dry powder particles. For example, the flavor particles can have a particle size of approximately 20 μm or greater, or approximately 50 μm or greater, 200 μm or less, 150 μm or less, or in the range of 50 μm to 200 μm, or 50 μm to 150 μm. The second plurality of flavor particles can have any suitable size distribution for delivery upon inhalation selectively to the oral or buccal cavity of the user. The larger size of the second plurality of flavor particles can facilitate the delivery of the dry powder particles into the air stream inhaled by the user.

The dry powder particles and the second plurality of flavor particles may be combined in any suitable relative amount such that the second plurality of flavor particles is perceived by the user upon consumption of the dry powder particles. Preferably, the dry powder particles and the second plurality of flavor particles constitute at least about 90 wt.%, or at least about 95 wt.%, or at least about 99 wt.%, or 100 wt.% of the total weight of the powder system.

Dry powder particles or a powder system may be provided in a suitable dosage form. For example, dry powder particles or a powder system may be presented in the form of a capsule. The dosage form (e.g., a capsule) may be configured for use in a suitable inhaler. For example, the capsule may be used in an inhaler device having a capsule cavity. Directing airflow through the capsule cavity of the inhaler device may cause the capsule to rotate during inhalation and consumption. The capsule may contain dry powder particles or a powder system.

The term "particle size" is used herein to refer to the mass median aerodynamic diameter (MMAD) of a particle or set of particles, unless otherwise noted. Such values are based on the distribution of particle aerodynamic diameters, defined as the diameter of a sphere with a density of 1 g/ ^cm3 that has the same aerodynamic characteristics as the particle being characterized.

In particular, the mass median aerodynamic diameter (MMAD) is typically specified for a powder system. This is one of the metrics most widely accepted as a single numerical parameter of the aerodynamic particle size distribution. The MMAD is a statistically derived metric for a particle sample: as an example, an MMAD of 5 micrometers means that 50 percent of the total sample mass will be present in particles with an aerodynamic diameter of less than 5 micrometers, and the remaining 50 percent of the total sample mass will be present in particles with an aerodynamic diameter greater than 5 micrometers. In the context of the present invention, when describing a powder system, the term "particle size" preferably refers to the MMAD of the powder system.

The MMAD of a powder system is preferably measured using a cascade impactor. Cascade impactors are instruments widely used for sampling and separating airborne particles to determine aerodynamic size classification of aerosol particles. In practice, cascade impactors separate the incoming sample into discrete fractions based on particle inertia, which is a function of particle size, density, and velocity. A cascade impactor typically consists of a series of stages, each of which includes a plate with a specific nozzle arrangement and a collecting surface. Because both the nozzle size and the total nozzle area decrease with increasing number of stages, the velocity of the air saturated with the sample increases as it passes through the instrument. At each stage, particles with sufficient inertia break away from the prevailing airflow and strike the collection surface. Thus, at any given flow velocity, each stage is associated with a cutoff diameter, a parameter that determines the size of the particles being collected. As the number of stages increases, the velocity increases, and therefore the cutoff diameter of the stages decreases. Thus, the cutoff diameter associated with a given stage is a function of the airflow rate used for testing. To reflect efficiency, nebulizers are typically tested at 15 L/min, while dry powder inhalers can be tested at values up to 100 L/min.

Preferably, in the context of the present invention, the MMAD of a powder system is measured using a Next Generation Impactor (NGI) 170 (available from Copley Scientific AG). The NGI is a high-performance, high-precision cascade impactor with particle classification, comprising seven stages plus a microdiaphragm collector (MDC). The characteristics and operating principle of the NGI are described, for example, in Marple et al., Journal of Aerosol Medicine - Volume 16, Number 3 (2003). More preferably, measurements are performed at 20 ± 3 degrees Celsius and a relative humidity of 35 ± 5 percent.

The dry powder composition typically contains moisture in an amount less than or equal to about 15% by weight, preferably less than or equal to about 10% by weight, and even more preferably less than or equal to about 6% by weight of moisture. Most preferably, the dry powder composition contains moisture in an amount less than or equal to about 5% by weight, or even less than or equal to about 3% by weight of moisture, or even less than or equal to about 1% by weight of moisture.

All values given as percentages are assumed to be mass percentages based on total weight.

All scientific and technical terms used in this document have the meanings commonly used in the art unless otherwise specified. The definitions provided in this document are intended to facilitate understanding of certain terms frequently used in this document.

As used herein, the singular forms "a," "an," and "the" include embodiments with plural references unless the content clearly dictates otherwise.

In this document, the conjunction "or" is generally used to include "and/or," unless the context clearly indicates otherwise. The term "and/or" refers to one or all of the listed elements, or a combination of any two or more of the listed elements.

As used herein, the terms "have," "having," "include," "including," "contain," "containing," or similar terms are used in their broad sense and generally mean "including without limitation." It should be understood that the terms "consisting essentially of," "consisting of," and the like are included within the category of "comprising," and the like.

The words "preferred" and "preferably" refer to those embodiments of the present invention that are capable of providing certain advantages under certain circumstances. However, other embodiments may also be preferred under the same or different circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are not applicable, and is not intended to exclude other embodiments from the scope of the present invention, including the claims.

As used herein, the term "substantially" has the same meaning as "significantly" and may be understood as modifying the corresponding term by at least approximately 90%, at least approximately 95%, or at least approximately 98%. As used herein, the term "substantially not" has the same meaning as "insignificantly" and may be understood as having the inverse meaning of the term "substantially", that is, modifying the corresponding term by no more than 10%, no more than 5%, or no more than 2%.

The present 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.

Example 1. A holder for an inhalation device comprising a casing defining a casing cavity and an outer surface, and a sleeve located within the casing cavity. The sleeve is configured to accommodate the inhalation device, and the sleeve is movable within the casing cavity between a first position and a second position. A piercing element is configured to pierce the inhalation device located within the sleeve when the sleeve is in the second position. The sleeve is electrically connected to the casing to form a static discharge circuit when the casing is electrically grounded.

Example 2. A holder for an inhalation product according to example 1, further comprising a spring element in contact with a portion of the sleeve, wherein said spring element electrically connects the sleeve to the casing.

Example 3. An inhalation product holder according to any of the previous examples, wherein the piercing element electrically connects the sleeve to the housing.

Example 4. A holder for an inhalation product according to examples 2 or 3, in which the piercing element is located inside the spring element.

Example 5. An inhalation product holder according to any of the previous examples, wherein the piercing element is located inside the sleeve when the sleeve is in the second position.

Example 6. A holder for an inhalation product according to any of the previous examples, wherein the casing is made of metal.

Example 7. A holder for an inhalation product according to any of the previous examples, wherein the piercing element is made of metal.

Example 8. A holder for an inhalation product according to examples 2-7, in which the metal element is made of metal.

Example 9. An inhalation product holder according to any of the previous examples, wherein the sleeve is made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square (ASTM D 257 ESD STM11.11 IEC 60093).

Example 10. A holder for an inhalation product according to any of the previous examples, in which the sleeve comprises an air flow element having two or more air inlets configured to create a vortex air flow in the sleeve, and the air flow element is electrically connected to the casing.

Example 11. A holder for an inhalation product according to example 10, in which the air flow element is made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square or less than 1×10 ¹⁰ ohms/square.

Example 12. A holder for an inhalation article according to example 11, in which the sleeve extends from the open end to the closed end and forms a cylindrical lumen for receiving the inhalation article, and the open end of the sleeve is aligned with an opening in the casing for receiving the inhalation article.

Example 13. A holder for an inhalation article according to example 12, in which the closed end of the sleeve comprises a bottom member of the sleeve, substantially closing the sleeve at the closed end, and an air flow element is connected to the bottom member of the sleeve, and wherein the air flow element extends from the bottom member of the sleeve and into the cylindrical lumen of the sleeve, and wherein the air flow element is electrically connected to the casing through the bottom member of the sleeve and the spring element or the piercing element.

Example 14. A holder for an inhalation article according to example 12, in which the sleeve extends from the open end to the closed end and forms a cylindrical lumen for receiving the inhalation article, wherein the open end of the sleeve is aligned with an opening in the casing for receiving the inhalation article, the closed end of the sleeve comprises a bottom element of the sleeve, substantially closing the sleeve at the closed end, and an air flow element is connected to the bottom element of the sleeve and extends from the bottom element of the sleeve and into the cylindrical lumen of the sleeve, and the air flow element is electrically connected to the casing through the bottom element of the sleeve and a spring element or a piercing element.

Example 15. A holder for an inhalation product according to example 13 or 14, in which the bottom element of the sleeve is made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

Example 16. A holder for an inhalation product according to any of the previous examples, further comprising an inner casing made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square, and wherein the inner casing electrically connects the spring element to the casing.

Example 17. A holder for an inhalation product according to example 16, in which the inner casing electrically connects the piercing element to the casing.

Example 18. A holder for an inhalation product according to any of the previous examples, in which the housing is grounded to the user in contact with the outer surface of the housing.

Example 19. A holder for an inhalation article according to any of the previous examples, in which each of the elements of the electrostatic charge removal circuit has a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square.

Example 20. A holder for an inhalation article according to example 12, in which the opening in the casing receives the inhalation article and forms an air inlet in the casing and provides the flow of inhaled air through the air flow element into the cylindrical lumen of the sleeve.

Example 21. An inhalation system comprising a holder of an inhalation article according to any of the preceding examples, and an inhalation article comprising a capsule located in a capsule cavity of the inhalation article. The capsule contains pharmaceutically active particles containing nicotine and having a mass median aerodynamic diameter of approximately 5 micrometers or less, or in the range from approximately 0.5 micrometers to approximately 4 micrometers, or in the range from approximately 1 micrometer to approximately 3 micrometers.

Example 22. The system according to example 21, characterized in that the capsule further comprises a second plurality of particles of the flavoring substance having a mass median aerodynamic diameter of approximately 20 micrometers or more, or approximately 50 micrometers or more, or in the range of from approximately 50 to approximately 200 micrometers, or from approximately 50 to approximately 150 micrometers.

Below, the examples will be further described with reference to figures in which:

FIG. 1 is a schematic cross-sectional view of an illustrative inhaler system;

FIG. 2 is an exploded perspective view of an illustrative holder for an inhaler;

FIG. 3A is a schematic cross-sectional view of an illustrative inhaler system in which the inhaler article is positioned in the inhaler article holder and pierces the capsule in a second position;

FIG. 3B is a schematic cross-sectional view of the exemplary inhaler system of FIG. 3A, in which the piercing member is retracted from the capsule in a first position;

FIG. 4 is another schematic cross-sectional view of FIG. 3B illustrating the flow path of inhaled air through the inhalation system;

FIG. 5 is a schematic diagram of an illustrative holder for an inhalation product; and

FIG. 6 is another schematic diagram of an illustrative holder of an inhaler article.

The schematic drawings are not necessarily to scale and are presented for illustrative purposes only, not limiting. The drawings depict one or more aspects described in the present invention. However, it will be understood that other aspects not shown in the drawings are within the scope and spirit of the present invention.

FIG. 1 is a schematic cross-sectional view of an exemplary inhalation system 10. FIG. 2 is an exploded perspective view of an exemplary inhalation article holder 30. FIG. 3A is a schematic cross-sectional view of an exemplary inhalation system 10 wherein an inhalation article 20 is received in the inhalation article holder 30 and pierces the capsule 25 in a second compressed position. FIG. 3B is a schematic cross-sectional view of an exemplary inhalation system 10 according to FIG. 3A wherein the piercing element 50 is retracted from the capsule 25 in a first relaxed position. FIG. 4 is another cross-sectional view according to FIG. 3B, illustrating the flow path 150 of inhaled air (arrows) through the inhalation system 10.

The inhalation device holder 30 is configured to accommodate the inhalation device 20 being consumed and to create a vortex flow of inhaled air into and through the inhalation device 20 during consumption. The inhalation device holder 30 and the inhalation device 20 form an inhalation system 10. The inhalation device 20 remains in the inhalation device holder 30 during use by the consumer. The inhalation device holder 30 is configured to create a vortex flow of inhaled air entering the accommodated inhalation device 20.

An illustrative inhalation article 20 comprises a housing 22 extending from a mouthpiece end 21 to a distal end 23. A capsule cavity 24 is formed in the housing 22. A capsule 25 is contained in the capsule cavity 24. The described dry powder particles may be contained in the capsule 25. The capsule 25 may be punctured to form an opening through the capsule housing 25, and inhaled air may flow through the inhalation article 20 with the release of dry powder particles from the punctured capsule 25 and into the inhaled air stream and out of the mouthpiece end 21.

The holder 30 of the inhalation device includes a casing 32 defining a casing cavity formed by an inner surface 34 and an outer surface 35 of the casing. A sleeve 40 is located within the casing cavity. The sleeve 40 is configured to accommodate the inhalation device 20 therein, and the sleeve 40 is configured to move within the casing cavity between a first position and a second position along the longitudinal axis of the casing cavity.

The piercing element 50 is configured to pierce the capsule 25 inside the inhalation device 20 located inside the sleeve 40 when the sleeve 40 is in the second position as shown in FIG. 3A. The sleeve 40 is electrically connected to the casing 32 to form a circuit for removing static electricity charge when the casing 32 is electrically grounded, for example, when the user holds it with his hand during inhalation.

The piercing element 50 may be configured to extend into the sleeve 40 along the longitudinal axis of the casing 32. The holder 30 of the inhalation article may comprise a spring element 60 configured to bias the sleeve 40 and any inhalation article 20 placed therein away from the piercing element 50.

The sleeve 40 extends from the open end 42 to the closed end 44 (or limited end) and forms a sleeve cavity 45 or cylindrical clearance 45 along the longitudinal axis of the sleeve 40. The open end 42 of the sleeve aligns with a single opening 36 of the casing.

The closed end 44 of the sleeve includes an air flow element 46 and an opening that allows a piercing element to pass through the closed end 44 and into the cavity 45 of the sleeve. The air flow element 46 includes one or more inlets 47 for inhaled air that provide airflow communication from the annular space around the sleeve 40 into the cylindrical lumen 45 of the sleeve. The air flow element 46 is configured to direct a rotational or vortex flow of inhaled air into the cylindrical lumen 45 of the sleeve and directly into the cavity 24 for the capsule of the inhalation article. This vortex or rotational inhaled air flow can be transmitted to the inhalation article 20 for rotating the capsule 25 and releasing the dry powder contained in the capsule 25.

The air flow element 46 of the sleeve 40 comprises a tubular element having a central passage in fluid communication with the cavity 45 of the sleeve. The air flow element 46 has at least one air inlet 47 allowing inhaled air 150 to enter the central passage. The at least one air inlet 47 extends in a direction that is tangential to the central passage to create a vortex or rotational inhaled air flow.

The sleeve 40 comprises a tubular element that can extend into the cavity 45 of the sleeve by approximately 5 mm and has an outer diameter of approximately 5.5 mm and an inner diameter of approximately 4 mm. The open distal end 23 of the received inhaler article 20 can have an inner diameter of approximately 5.5 mm to ensure a friction fit with the tubular element of the air flow element 46.

The closed end 44 of the sleeve may further comprise a bottom element 48 of the sleeve, which substantially forms the closed end of the sleeve 40. The bottom element 48 of the sleeve may be attached to the air flow element 46 and contact it. The bottom element 48 of the sleeve may extend from the air flow element 46 for a certain distance along the longitudinal axis of the sleeve and to the closed end of the cavity of the casing. The bottom element 48 of the sleeve may have an opening that comprises a piercing element 50 and allows the piercing element 50 to pass through said opening of the bottom element 48 of the sleeve.

An inner casing 70 may be contained within the cavity of the casing. The inner casing 70 may separate at least a portion of the sleeve 40 from the inner surface of the cavity of the casing. The inner casing 70 may separate the attached end of the piercing element 50 from the inner surface of the cavity of the casing. The inner casing 70 may separate the spring element 60 from the inner surface of the cavity of the casing.

The annular cover 38 can fix the inner casing 70 and the sleeve 40 in the cavity of the casing. The annular cover 38 forms a single opening 36 of the casing for placing the inhalation article 20. The annular cover 38 can be attached to the casing 32 by a pin element 39.

FIG. 4 illustrates the flow path of inhaled air 150 through the inhalation system 10. The inhaled air flow 150 enters the holder 30 of the inhalation article along the outer surface of the received inhalation article 20 and the annular cover 38. After entering the cavity of the housing, the inhaled air 150 passes along the length of the sleeve 40 to the closed end 44 of the sleeve 40. The inhaled air 150 then enters the air inlet 47 of the air flow element 46 and forms a vortex or rotational flow of inhaled air 150 inside the lumen 45 of the sleeve. This vortex or rotational flow of inhaled air is then directly directed to the distal end 23 of the inhalation article 20 and into the cavity 24 of the capsule. The vortex flow of inhaled air rotates and shakes capsule 25, and dry powder particles are captured in the inhaled air flow. The inhaled air flow with particles then flows out of the inhaler device through mouthpiece end 21 and to user 100. Inhaled air flow 150 is shown in FIG. 4 by arrows.

FIG. 5 is a schematic diagram of an exemplary holder for an inhalation article. FIG. 6 is another schematic diagram of an exemplary holder for an inhalation article.

In FIG. 5, the circuit includes an air flow sleeve or element 46 electrically connected to a housing 32, and the housing 32 is grounded through a user 100 in contact with the housing 32. Electrostatic forces e" are conducted through the air flow sleeve or element 46 to the housing and then to ground, which effectively minimizes electrostatic forces e ^- on the surface of the air flow sleeve or element 46.

In FIG. 6, the circuit includes an air flow element 46 electrically connected to the housing 32, and the housing 32 is grounded through the user 100 in contact with the housing 32. Electrostatic forces e ^- are conducted through the air flow element 46 to the bottom member 48 of the sleeve, and then to the spring member 60 or the piercing member 50, then to the inner housing 70, then to the housing 32, and then to the ground, which effectively minimizes the electrostatic forces e" on the surface of the air flow element 46.

For the purposes of this specification and the appended claims, except where otherwise indicated, all numbers expressing quantities, amounts, percentages, etc., are to be understood as modified in all instances by the term "about." Furthermore, all ranges include the disclosed maximum and minimum points and any intermediate ranges therebetween, which may or may not be specifically listed herein. Accordingly, in this context, the number A is to be understood as A ±2% of A. In the same context, the number A may be considered to include numerical values that are within the normal standard error of measurement of the property that modifies the number A. The number A, in some instances, when used in the appended claims, may deviate by the percentages listed above, provided that the amount by which A deviates does not materially affect the essential and novel characteristic(s) of the claimed invention. In addition, all ranges include disclosed high and low points and any intermediate ranges therebetween that may or may not be specifically listed herein.

Claims (19)

1. A holder for an inhalation device, comprising: a casing that forms a casing cavity and an outer surface; a sleeve located within the cavity of the casing, wherein the sleeve is configured to accommodate an inhalation product therein, and wherein the sleeve is configured to move within said cavity of the casing between a first position and a second position; and a piercing element configured to pierce the inhalation device located inside the sleeve when the sleeve is in the second position; wherein the sleeve is electrically connected to the housing to form a static discharge circuit when the housing is electrically grounded. 2. The holder of the inhalation product according to claim 1, further comprising a spring element in contact with a portion of the sleeve, wherein said spring element electrically connects the sleeve to the casing. 3. A holder for an inhalation product according to paragraph 1 or 2, characterized in that the piercing element electrically connects the sleeve to the casing. 4. A holder for an inhalation product according to paragraph 2 or 3, characterized in that the piercing element is located inside the spring element. 5. A holder for an inhalation product according to any of the preceding paragraphs, characterized in that the casing is made of metal. 6. A holder for an inhalation product according to any of the preceding paragraphs, characterized in that the sleeve is made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square. 7. A holder for an inhalation product according to any of the preceding paragraphs, characterized in that the sleeve contains an air flow element configured to create a vortex air flow, and the air flow element is electrically connected to the casing. 8. The holder of the inhalation product according to claim 7, characterized in that the air flow element is made of a polymer having a surface resistance of less than 1×10 ¹¹ Ohm/square or less than 1×10 ¹⁰ Ohm/square. 9. The inhalation article holder of claim 8, wherein the sleeve extends from the open end to the closed end and forms a cylindrical lumen for receiving the inhalation article, wherein the open end of the sleeve is aligned with an opening in the housing for receiving the inhalation article, the closed end of the sleeve comprises a bottom member of the sleeve that substantially closes the sleeve at the closed end, and an air flow element is connected to the bottom member of the sleeve, and wherein the air flow element extends from the bottom member of the sleeve and into the cylindrical lumen of the sleeve, and the air flow element is electrically connected to the housing through the bottom member of the sleeve and the spring member or the piercing member. 10. The holder of the inhalation product according to paragraph 9, characterized in that the bottom element of the sleeve is made of a polymer having a surface resistance of less than 1×10 ¹¹ Ohm/square or less than 1×10 ¹⁰ Ohm/square. 11. The holder of the inhalation product according to any one of paragraphs. 2-10, further comprising an inner casing made of a polymer having a surface resistance of less than 1×10 ¹¹ ohms/square, or less than 1×10 ¹⁰ ohms/square, and wherein the inner casing electrically connects the spring element to the casing. 12. A holder for an inhalation product according to any of the preceding paragraphs, characterized in that the casing is grounded to the user in contact with the outer surface of the casing. 13. The holder of the inhalation product according to paragraph 11, characterized in that the inner casing electrically connects the piercing element to the casing. 14. An inhalation system comprising an inhalation article holder according to any of the preceding claims and an inhalation article comprising a capsule located within a capsule cavity of the inhalation article, wherein the capsule comprises pharmaceutically active particles containing nicotine, wherein the pharmaceutically active particles have a mass median aerodynamic diameter of from 1 to 3 μm. 15. An inhalation system according to claim 14, characterized in that the capsule additionally contains a second plurality of particles of a flavoring substance having a mass-median aerodynamic diameter of 50 to 150 μm.