Disclosure of Invention
In order to solve the above-mentioned prior art problems, the present invention provides a dry powder medicament inhaler with a built-in buccal tablet dispersing unit.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
There is provided a dry powder medicament inhaler having a built-in mouthpiece dispersion unit, comprising an inhaler body having a mouthpiece in which a dispersion unit is provided, the dispersion unit comprising:
First and second resilient gratings defining the inlet and outlet of the dispersion unit, said first and second resilient gratings allowing the passage of an air stream and a medicament;
a plurality of elastic deagglomeration sheets disposed between the first elastic grille and the second elastic grille;
Wherein at least a portion of the elastic deagglomeration sheet has a triangular cross-section and the elastic deagglomeration sheet is arranged with its edges of triangular cross-section facing the inlet of the dispersing unit;
A vibration-inducing structure associated with an end anchor point of the elastic deagglomeration sheet;
wherein the vibration inducing structure is configured to generate vibration in response to a portion of the inhalation airflow and to transmit the vibration to the elastic deaggregation sheet through the anchor point to cause the elastic deaggregation sheet to vibrate during inhalation.
Preferably, the dispersing unit further comprises:
At least one purge channel;
Wherein the purge channel is configured to direct a portion of the suction airstream to flow tangentially across at least one windward side of the elastic deaggregation sheet.
Preferably, the purge channel has:
At least one slit-shaped outlet;
wherein the slit-shaped outlet is disposed adjacent to the windward side of the elastic deagglomeration sheet.
Preferably, the dispersing unit further comprises:
at least one airflow guiding cavity arranged at the anchor point of the elastic depolymerization sheet;
wherein the vibration inducing structure is associated with the airflow directing cavity and generates vibrations within the airflow directing cavity by receiving the portion of the inhaled air stream;
and, the air flow guiding chamber has at least one outlet constituting a slit-shaped outlet of the purge channel.
Preferably, the vibration-inducing structure comprises an extension of the elastic deagglomeration sheet itself beyond the anchor point, said extension being configured to flutter under a portion of the inhalation airflow.
Preferably, the extension portion has:
at least one tuning block;
Wherein the tuning block is positioned at the tail end of the extension part, and the mass of the tuning block is larger than the unit length mass of the elastic depolymerization sheet main body part.
Preferably, the end of the extension has a serrated edge and the region of the serrated edge has a thickness that is less than the thickness of its region proximate the anchor point.
Preferably, the first resilient grille defines a plurality of grille openings;
And at least a part of the grille opening is obliquely arranged relative to the central axis of the buccal device;
the first elastic grille is located upstream of the elastic deagglomeration sheet in the flow direction of the inhalation airflow.
Preferably, the inhaler body comprises:
A cartridge for containing a single dose of medicament;
Wherein the bin body is provided with a medicament outlet channel which is communicated with the buccal device;
And at least one main airflow cavity is provided on the peripheral side of the medicine outlet passage, and the main airflow cavity has a main airflow port communicating with the mouthpiece.
Preferably, the inhaler body comprises:
A medicament release mechanism integrated on the inhaler body and cooperating with the cartridge body;
the medicament release mechanism is for puncturing the single dose of medicament.
The invention provides a dry powder medicament inhaler with a built-in buccal device dispersing unit, which has the beneficial effects that:
The dispersing unit is arranged in the inner airflow channel of the buccal device. The dispersing unit is intended to partially convert the energy of the air flow generated by the inhalation of the patient into mechanical energy and hydrodynamic energy for overcoming the forces between the particles of the dry powder medicament, thereby effectively dispersing the dry powder medicament aggregates.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1-6, the following specific embodiments of the present invention are provided:
as shown in fig. 1 to 2, the present embodiment provides a dry powder medicament inhaler having a dispersing unit 3 with a built-in mouthpiece 2. The inhaler is used to deliver dry powder medicaments to the respiratory tract, particularly deep lung, of a patient for the treatment of respiratory diseases such as asthma or chronic obstructive pulmonary disease.
The inhaler comprises an inhaler body 1 and a mouthpiece 2. The inhaler body 1 constitutes the main part of the device, the overall shape of which may be of various shapes for easy handling and manipulation, such as a flat oval cylinder, a cylinder, or a special holding area with ergonomic curves. The body is preferably made of one or more rigid medical grade plastics by injection molding or the like to provide adequate structural strength and stability.
On the outer surface of the inhaler body 1, there is provided a structure in which an internal mechanism is linked or for display.
For example, a mounting location or opening comprising an operating button or slider for initiating dose preparation or release, or a transparent window for viewing the remaining dose. One end of the inhaler body 1 is formed as a mating interface, dedicated for connection with the mouthpiece 2.
The mouthpiece 2 is the part for the patient to directly contact and inhale the dry powder medicament therefrom. The mouthpiece 2 is generally tubular or flat duckbill for better fitting to the oral cavity. One end (connecting end) of the mouthpiece 2 has a connecting structure that mates with the mating interface of the inhaler body 1, which may be, for example, a snap-fit structure, a threaded structure, so that the mouthpiece 2 can be easily attached to the inhaler body 1 or detached from the inhaler body 1.
Of course, the mouthpiece 2 may be integrally formed with the body. The mouthpiece 2 is preferably made of a smooth, biocompatible medical grade plastic. The other end (the suction end) is formed with a contoured mouthpiece portion for convenient patient access to the inlet and ultimately to a dry powder medicament outlet which may be circular, oval or other shape suitable for dry powder medicament ejection.
Inside the mouthpiece 2, a central air flow channel is defined. The central air flow channel connects the air flow inlet from the inhaler body 1 (carrying the dry powder medicament) with the final dry powder medicament outlet. Furthermore, the exterior of the mouthpiece 2 may optionally be provided with a protective cover for covering the mouthpiece portion when not in use, keeping it clean and hygienic.
In the present embodiment, the center air flow passage of the mouthpiece 2 is provided with a dispersion unit 3. The dispersing unit 3 is intended to partially convert the energy of the air flow generated by the inhalation of the patient into mechanical energy and hydrodynamic energy for overcoming the forces between the particles of the dry powder agent, thereby effectively dispersing the dry powder agent aggregates.
As shown in fig. 2 to 5, in particular, the inlet and outlet of the dispersion unit 3 are clearly defined by a first elastic grille 301 and a second elastic grille 302. The first and second elastic grids 301 and 302 are preferably made of an elastomer having good biocompatibility and rebound resilience, and both themselves present a porous network structure, ensuring that the main air flow and the dry powder agent particles can pass through with low resistance, while constituting the upper and lower boundaries of the core deagglomeration area. And the elastic properties of both also allow some passive response to airflow pulsations.
Between the first elastic grille 301 and the second elastic grille 302 as shown in fig. 2 to 5 is a core space in which depolymerization occurs, in which a plurality of independent elastic depolymerization sheets 303 are arranged. The elastic depolymerized sheet 303 is also made of an elastic material and has flexibility and fatigue resistance.
In addition, on the basis of the above, the elastic disaggregation sheet 303 has a triangular cross section. When mounted, the resilient deaggregating sheet 303 is positioned such that one sharp edge of its triangular cross-section is directed towards the inlet of the dispersing unit 3, directly facing the incoming air flow carrying the dry powder medicament. The sharp edges are intended to create an initial, concentrated interaction with the incoming flow and the dry powder agent aggregates therein, including physical cutting, induced air flow separation, or creation of specific localized vortices. The two inclined sides forming the edge, the windward side 3031, guide the airflow and particles and provide the main interaction surface.
Specifically, when the dry powder agent (particularly, the agent aggregate having a large size therein) moves along with the main air flow and collides with the two inclined windward sides 3031 of the elastic disaggregation pieces 303, kinetic energy carried by the agent aggregate is transferred to the particles constituting the aggregate and the connection structure thereof at the moment of collision. When the impact energy is sufficient to overcome the binding forces (e.g., van der Waals forces, electrostatic forces) between the particles, structural failure or fragmentation of the aggregates can occur, breaking them down directly into smaller units or individual particles.
In addition, since the windward side 3031 is inclined, not a plane perpendicular to the incoming flow direction, such collision is more similar to an oblique collision. This can result in the particles of dry powder medicament or broken aggregate fragments changing their original trajectory after impact, being directed sideways or at a different angle to continue downstream rather than simply bouncing vertically. This deflection and scattering helps to spatially separate the otherwise concentrated agent aggregates primarily, increases the surface area upon which subsequent air flows act, and may reduce the probability of particles re-impinging and collecting within a short distance downstream.
In a specific embodiment, in order to drive these elastic deagglomeration sheets 303 to perform an effective deagglomeration operation, their two ends are firmly fixed to the cavity walls of the dispersion unit 3 or to the edges of the first elastic grille 301 and the second elastic grille 302 by anchor points 305 (to be understood as a fixed connection point). Also, at these end anchor points 305 or at locations closely associated therewith, vibration inducing structures 4 are provided.
In particular, the vibration inducing structure 4 is adapted to utilize the energy of a portion of the suction airstream directed thereto. When the patient inhales, a portion of the airflow drives the vibration-inducing structure 4, causing itself to generate a small mechanical vibration. Since the elastic depolymerization sheet 303 and the vibration inducing structure 4 are fixedly connected, vibration energy generated by the vibration inducing structure 4 can be efficiently and directly transferred to the elastic depolymerization sheet 303.
Thus, the elastic deagglomeration sheet 303, having a triangular cross section, will passively receive drive from the anchor point 305 throughout the inhalation and then experience sustained minute vibrations over its length. When the air flow carrying the dry powder agent aggregates passes through the first elastic grille 301 into the region constituted by the plurality of elastic deagglomerated sheets 303, repeated, multi-angle mechanical collisions with the slightly vibrating elastic sheets occur. Thus, the dry powder agent aggregates are effectively broken up and deagglomerated into fine particles suitable for pulmonary deposition, and then leave the dispersion unit 3 with the main air flow through the second elastic grille 302, eventually inhaled by the patient.
In a specific embodiment, after being fixedly connected to the cavity wall of the dispersion unit 3 or the first elastic grille 301 and the second elastic grille 302 by the end anchor points 305, the respective elastic depolymerization sheets 303 are not terminated in their structure, but integrally extended further outwards, forming a cantilevered extension 401. This extension 401 is composed of the same medical grade elastic material having specific elastic modulus and damping characteristics as the body of the elastic deagglomeration sheet 303.
To actuate the extensions 401, the inhaler body 1 is internally or the dispersion unit 3 is provided with an air flow guiding chamber 306, which air flow guiding chamber 306 captures a portion of the inhaled air flow and guides it to the area where these extensions 401 are located, causing the air flow to act on it at a preset angle and speed when the patient inhales.
When the air flow velocity acting on the extension 401 reaches its critical velocity of vibration, the extension 401 enters a aeroelastic vibration state due to the coupling action among the fluid force, the elastic force and the inertial force, and is represented as continuous and rapid reciprocating vibration.
Vibrations generated by this extension 401 are transmitted through the root and anchor 305 regions where they join the body of the elastic deagglomerated sheet 303. The structure of the connection region is configured to facilitate efficient transfer of vibrational energy, minimizing damping losses, such as a flexible neck or transition section having a lower stiffness. Thus, the vibration motion of the extension portion 401 can drive the main body portion of the elastic deagglomeration sheet 303 to vibrate accordingly, thereby generating a dispersing action on the dry powder agent aggregates passing through the dispersing unit 3.
Wherein the extension 401 is integrally or additionally provided with at least one tuning block 402 at its free end, i.e. the furthest end from the anchor point 305, cantilevered, for providing the extension 401 with a concentrated mass.
Specifically, the end region of the extension 401 may be thicker and wider than the root or middle thereof to form a geometrically concentrated mass region, or the end tuning block 402 may be made of another biocompatible material having a higher density than the elastic material used for the body of the extension 401 by two-shot molding, insert molding, or the like at the time of manufacture, or the effective mass of the tuning block 402 may be greater than the mass per unit length of the body portion of the elastic deagglomerated sheet 303, thereby ensuring that an effective inertial load is constituted.
Based thereon, the extension 401 is more easily excited by the lower velocity airflow, and is more easily dithered with aerodynamic coupling, thereby reducing the critical inspiratory flow rate at which the chatter occurs. This means that even if the patient's inspiratory effort is somewhat weaker, the vibrations are more easily and reliably excited.
In another embodiment, the extension 401 of the resilient deaggregating sheet 303 is not smooth or straight edges at its free end, but is configured with serrated edges. Such serrated edges may be embodied as a series of tiny serrations of a specific profile arranged along the distal edge, such as triangular, square or wavy teeth. The presence of these serrations alters the manner in which the airflow peels away from the surface of the extension 401 to promote its fluttering behaviour.
At the same time, this embodiment also defines that the extension 401 comprises a tip region of serrated edge having a thickness that is less than the thickness of the extension 401 near its root (i.e., near the location of the anchor point 305 region). That is, the serrated edge exhibits a thickness profile that tapers from the root to the tip. Thus, the reduced thickness results in a softer distal end of the extension 401, which is less resistant to bending deformation, making it more sensitive to airflow action, helping to reduce the critical airflow rate at which chatter occurs, and enabling vibration to be initiated even under weaker suction conditions.
In another embodiment, in order to cope with the problem that the dry powder agent may be deposited or adhered inside the dispersing unit 3 during use, thereby affecting the dose accuracy and the long-term use performance, the dispersing unit 3 further comprises at least one purge channel in this embodiment.
The purge channel is a specific gas flow path integrated in the cavity (e.g. sidewall) of the dispersion unit 3. Is in communication with an inhalation airflow source (e.g., the airflow directing chamber 306 described above) via an internal conduit. When the patient inhales, a portion of the inhalation flow is directed into the purge channel. Wherein the suction air stream is blown onto at least one windward side 3031 of the elastic deaggregation sheet 303 in a tangential flow manner substantially parallel to the surface of the elastic deaggregation sheet 303 (i.e., the two inclined sides facing the inlet of the dispersion unit 3 in a triangular cross section). This tangential purge flow creates a layer of continuously flowing weak air film or curtain near the windward side 3031 of the elastomeric deagglomeration sheet 303. For a small number of particles that have been or are about to adhere, this tangential airflow proximate to the surface may effectively strip or blow it away, re-enter the mainstream airflow or be carried out of the device.
In addition, as shown in fig. 5, in a specific embodiment, the outlet of the purge channel is preferably at least one slit-shaped outlet 3041. The slit-shaped outlet 3041 is capable of producing a flat, uniform air flow and is positioned next to the windward side 3031 of the elastic deaggregation flap 303, ensuring that the purge air flow effectively covers the target surface area.
In some embodiments, the function of the purge channel may be performed by the outlet of the airflow directing chamber 306. That is, the air flow for driving the vibration inducing structure 4 is discharged directly from the position of the slit-shaped outlet 3041 constituting the purge passage after leaving the air flow guiding chamber 306, thereby realizing the reuse of the air flow and the integration of functions.
In other embodiments, it is also contemplated to use a row of tiny, directionally aligned orifices in place of a single slit, with a combination of multiple tiny air jets covering the surface. The edges of the outlet may be chamfered or specially modified to reduce air flow separation and to allow the ejected air flow to flow more stably against the surface of the flexible sheet.
In summary, by adding the purge channel in the dispersing unit 3, the continuous tangential purge of the surface of the elastic deaggregation sheet 303 with a portion of the inhalation airflow can significantly reduce drug residues, and maintain the clean and efficient working state of the deaggregation element, thereby improving the accuracy, consistency and effectiveness of the delivered dose of the entire inhaler.
In one embodiment, the first resilient grille 301 at the inlet of the dispersing unit 3 is constructed of a resilient material and defines a plurality of grille openings through which the air flow and the dry powder medicament pass. And at least some, preferably most or all, of these grille openings do not extend perpendicular to the grille plane, but are disposed obliquely with respect to the central axis (i.e. the general suction airflow direction) of the mouthpiece 2 or the main airflow path. This tilting can be achieved in various ways, for example, the passage walls of the grating openings themselves are tilted, or the bars constituting the grating are tilted.
Still further, the grid may be divided into different regions, with openings in each region having a specific, uniform angle and direction of inclination, but with the angle/direction being different between regions.
Or all openings may be inclined in a direction toward the center or toward the periphery to create a converging or diverging airflow effect.
Or in a tangential arrangement in the direction of inclination of the openings to induce an overall swirling airflow (swirl) downstream.
The air jets from different angles and directions will thus interact, blend, shear, creating a stronger, more complex turbulent field at the entrance of the region where the elastomeric deagglomerating sheet 303 is located than a straight orifice grid, which aids in the initial dispersion of the dry powder agent before it comes into contact with the elastomeric sheet.
And by a specific oblique arrangement (e.g. creating a swirl) the overall airflow pattern into the core region can be shaped so that it can more effectively interact with the vibrating elastic deagglomerating plate 303, increasing deagglomeration efficiency or improving particle distribution within the cavity.
In this embodiment, to accommodate the use of a single dose of medicament 5 (e.g. a dry powder medicament pre-filled in a capsule), a cartridge 6 is provided inside the inhaler body 1. The cartridge body 6 is sized and shaped to receive and position a single dose of medicament unit, such as a standard inhalation capsule. The cartridge body 6 will typically be provided with corresponding means (e.g. a removable cover or drawer structure not shown) to facilitate loading or removal of the unit of single dose medicament 5 by a user.
As shown in fig. 1, 2 and 6, a medicament outlet channel 601 leads from the top of the cartridge body 6. The medicament outlet channel 601 is the only path for the medicament powder to leave the cartridge 6 and be directed towards the mouthpiece 2 after the medicament unit has been activated (e.g. the capsule has been pierced). The end of this medicament outlet channel 601 communicates with the connecting end of the mouthpiece 2.
Around the peripheral side (perimeter side) of the medicament outlet channel 601, at least one (typically symmetrically arranged two or ring-shaped) main airflow cavity 7 is also arranged within the inhaler body 1. The main airflow chamber 7 occupies a part of the inner space outside the medicine outlet channel 601 and communicates with a main air inlet provided outside the inhaler body 1. This means that when the patient inhales, the main inhalation airflow is flowing through the main airflow chamber 7, rather than directly through the cartridge 6 where the medicament is located.
Each main airflow chamber 7 also has a main airflow port 701 leading to the mouthpiece 2. The main air flow port 701 is also in communication with the connection end of the mouthpiece 2.
Preferably, the main air flow port 701 is arranged obliquely toward the medicine outlet channel 601.
The medicament outlet channel 601 and the primary airflow port 701 are separated within the inhaler body 1 so that the primary inhalation airflow can maintain a high flow rate and energy for efficient mixing, impingement and preliminary dispersion at the mouthpiece 2 inlet with the dry powder medicament stream sucked out of the medicament outlet channel 601, and then together enter the dispersing unit 3 downstream arranged in the mouthpiece 2 for further processing.
In order to effectively release a single dose of medicament 5 (in this embodiment typically a medicament capsule) contained within the cartridge body 6 in use, the inhaler body 1 further comprises a medicament release mechanism 8 functionally associated therewith and integrated thereon.
The medicament release mechanism 8 is used to pierce the outer shell (e.g. capsule wall) of the single dose medicament 5 so that upon subsequent inhalation, the dry powder medicament inside can flow out smoothly.
In one embodiment, the medicament release mechanism 8 comprises the following structure:
At least one (typically two or more, for example symmetrically disposed on either side of the capsule) sharp spike disposed at a side or end of the cartridge body 6. The lancet is mounted on a movable holder and is connected to a user operated button provided on the housing of the inhaler body 1 by means of a mechanical structure such as an internal link or cam.
After initial state or loading of a new single dose of medicament 5, the spike is in a retracted position away from the interior of the cartridge body 6. When the user needs to inhale the medicine and presses the operation button, the operation force drives the lancet to move toward the center of the cartridge body 6 through the internal transmission mechanism, and the tip thereof penetrates a specific area (provided with a hole for penetration) of the cartridge body 6 and pierces the housing of the single dose medicine 5 (capsule) placed therein. After puncturing, the push button is released or at the end of the button stroke, the spike automatically retracts (spring action) to avoid impeding the flow of dry powder medicament out and leaving an opening of sufficient size in the capsule wall.
By the action of the medicament release mechanism 8, the originally closed single dose medicament 5 is opened so that the dry powder medicament therein can be carried out of the cartridge 6 by the air flow via the medicament outlet channel 601 into the subsequent deaggregation and inhalation flow path when the patient inhales.
In describing embodiments of the present invention, it is to be understood that terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "center", "top", "bottom", "inner", "outer", and the like indicate an azimuth or positional relationship.
In describing embodiments of the present invention, it should be noted that, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and "assembled" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, or may be directly connected, or may be indirectly connected through an intermediate medium, or may be in communication with the interior of two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In the description of embodiments of the invention, a particular feature, structure, material, or characteristic may be combined in any suitable manner in one or more embodiments or examples.
In describing embodiments of the present invention, it will be understood that the terms "-" and "-" refer to ranges between two values, and that the ranges include endpoints. For example, "A-B" means a range greater than or equal to A and less than or equal to B. "A-B" means a range of greater than or equal to A and less than or equal to B.
In the description of the embodiments of the present invention, the term "and/or" is merely an association relation describing the association object, and means that three kinds of relations may exist, for example, a and/or B, and that three kinds of cases where a exists alone, while a and B exist alone, exist alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.