NL2034786B1

NL2034786B1 - Inhaler system and method for pulmonary delivering at least one agent to a user.

Info

Publication number: NL2034786B1
Application number: NL2034786A
Authority: NL
Inventors: Hans Bulstra Teake; Andrés Enriquez Flor Pablo
Original assignee: Belfry Medical Gmbh
Priority date: 2023-05-09
Filing date: 2023-05-09
Publication date: 2024-12-02
Also published as: WO2024231405A1

Abstract

An inhaler system for pulmonary delivering at least one agent to a user comprises a multi- dose container filled with multiple doses of a liquid or heat liquifiable substance containing at least one agent to be pulmonary delivered to a user. The system also comprises a carrier member configured to deposit thereon at least one separate individual dose of the substance and an inhaler device with a depositing station and a vaporization station.

Description

P36056NL00

INHALER SYSTEM AND METHOD FOR PULMONARY DELIVERING AT LEAST ONE

AGENT TO A USER.

The present invention relates to an inhaler system for pulmonary delivering at least one agent to a user, e.g. for treating a neurological and/or psychological disorder or symptom of the user.

Delivery of an agent by inhalation is, for example, discussed in EP 2 654 864 and in EP 3 160 553.

In EP 2 654 864 an inhaler device is disclosed, wherein a source material layer containing plant matter is carried by a material layer in contact with the source material layer. The material layer is configured for direct heating of the plant matter to create a vapor including the agent, which is delivered to the pulmonary tract of the user of the inhaler device.

In EP 3 180 553 an inhaler device is disclosed with a vaporization station that receives a so- called dose unit via a dose unit dispensing apparatus of the inhaler device. This apparatus removes the dose unit from a closed container wherein a plurality of dose units is present.

Each dose unit comprises an air-permeable pallet and an electrically resistive heating element in thermal contact with and extending across at least a portion of a surface of the pallet. The pallet comprises a solid carrier material and a bioactive agent is in and/or on the carrier material.

The documents EP 2 654 864 and EP 3 160 553 disclose many examples and details of the structure (including materials, dimensions, etc.) of the components of inhaler systems, of the substances that can be handled by inhaler systems, of the operation and use as well as of the potential beneficial effects of the use of inhaler systems, etc.

The present invention aims to provide an improved inhaler system, or at least an alternative inhaler system.

The present invention aims to provide an inhaler system that allows for an enhanced or optimized chain between the producer of the substance and the specific user. For example, the production of the dose units as in EP 3 160 553 is considered complex, e.g. in view of the shelf-life and/or of the properties of the substance over time.

The present invention also aims to provide a system that allows for enhanced involvement of a pharmacist or another health care professional in the chain between the producer of the substance, e.g. a cannabis extract, and the specific user.

According to a first aspect thereof, the present invention provides an inhaler system for pulmonary delivering at least one agent to a user, the system comprising: - a multi-dose container having a reservoir filled with multiple doses of a liquid or heat liquifiable substance containing at least one agent to be pulmonary delivered to a user, - a carrier member configured to deposit thereon at least one separate individual dose of the substance, - an inhaler device which comprises: - a housing, - a depositing station mounted to the housing, the depositing station comprising: - a receiver configured to exchangeable receive the multi-dose container, - a dispensing mechanism configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container and to deposit the individual dose in liquid form onto the carrier member, - a mouthpiece, - a vaporization station mounted to the housing, spaced from the depositing station, which vaporization station comprises a heater device configured to heat an individual dose of the substance deposited on a carrier member so as to create a vapor including said at least one agent, which vapor is to be delivered via the mouthpiece, - a transfer mechanism mounted to the housing and configured to transfer the carrier member with the individual dose from the depositing station to the vaporization station.

Contrary to the mentioned prior-art inhaler systems, in the first aspect of the invention the separate individual dose is deposited on the carrier member at the depositing station which is mounted to the housing of the inhaler device. This avoids combining the dose and the carrier member at an earlier stage, remote from the inhaler device, e.g. at a plant for production of the mentioned dose units. It also avoids or at least reduces any issues with the behavior of the substance over time once deposited on the carrier member.

In practical embodiments, the vaporization station and/or the depositing station are mounted within, or at least partially within, the housing of the inhaler device. In possible embodiments,

the vaporization station and/or the depositing station are mounted to extend partially outside the housing of the inhaler device.

In practical embodiments, the depositing of the individual dose in liquid form on the carrier member is effected by the depositing station upon an instruction from the user of the inhaler device, e.g. an instruction to start an inhalation session.

An inhalation session may, in practical embodiments, involve a single (deep) breath being taken by the user so that the vapor with the at least one agent passes via the mouthpiece to the pulmonary tract of the user.

Preferably, the carrier member with the deposited individual dose is transferred directly from the depositing station to the vaporization system where the creation of the vapor is performed. The vapor flows, e.g. via an airduct of the device, from the vaporization station to the mouthpiece and then arrives in the pulmonary tract of the user, e.g. as the user sucks in air via the mouthpiece which entrains the vapor.

In embodiments, the carrier member is only used once while applied to the inhaler device, e.g. the carrier member(s) being removed from the inhaler device after use and then being discarded or refurbished. In another embodiment, a carrier member remains associated with the inhaler device in order for the carrier member to be used several times, e.g. each time being loaded with the dose of substance at the depositing station and then being used to create the vapor at the vaporization station. Whether or not multiple times use of a carrier member in the inhaler device is possible, may depend on the substance, the structure of the carrier member, the occurrence of any residue on the carrier member after use, etc.

In embodiments, the inhaler device includes a counter configured to count the number of times a specific carrier member is used in the device, e.g. a maximum number being predetermined so as to discontinue use and/or an alarm being given when the maximum number is reached, e.g. upon providing a signal for the user to switch to a new carrier member or carrier members holder (e.g. in a casing).

The substance filled into the reservoir of the container can be in liquid form at room temperature or can be in a pasty, waxy, (partly) crystalized, or other more solid or solid form (e.g. with high viscosity) at room temperature so as to be liquified by application of heat to the substance.

It is envisaged, in embodiments, that liquefaction of the substance within the reservoir of the multi-dose container at the depositing station (rendering the substance more flowable in view of dispensing an individual dose) — when needed - is done in absence of any form of dilution of the substance at the deposition station, so — when needed - by application of heat to the substance at this depositing station only. This avoids any issue with providing a diluent at this disposition station, etc.

The initially liquid or thermally liquified substance is dispensed, e.g. micro-dispensed, in liquid form from the multi-dose container and deposited as a separate individual dose onto the carrier member. For example, dispensing and depositing of the liquid substance emerging from the container, e.g. from a nozzle of the container directly onto the carrier member, is done as a drop or droplet, e.g. a single drop or droplet forming an individual dose of the substance.

In embodiments, it is envisaged that the filling of the substance into the multi-dose container, possibly also the preparation of the substance, is done by a pharmacist. Preferably, this is done at the pharmacy where the user collects the system or the multi-dose container thereof, e.g. based on a prescription by a physician.

In an embodiment, the multi-dose container and the dispensing mechanism are configured to dispense the substance in the form of liquid drops or droplets. Preferably, one drop or droplet corresponds to an individual dose. For example, the one drop or droplet is deposited onto a discrete carrier member upon or just prior to commencement of an inhalation session. The carrier member with the one dose thereon is then transferred directly to the vaporization station by the transfer mechanism.

For example, a pendant drop or droplet is created at a nozzle of the multi-dose container, e.g. a needle of the container, which drop, or droplet is then deposited onto the carrier member.

For example, the size of the drop is determined by the controlled displacement of the plunger of the multi-dose container.

In embodiments, the spacing between the end of the nozzle, e.g. the tip of the needle of a syringe, and the carrier member is chosen (possibly controlled) so that the drop breaks free from the nozzle (e.g. under its weight) and then quasi immediately contacts the carrier member beneath the nozzle, e.g. contacts a porous portion thereof exhibiting a wicking effect so that the drop is spread over and into the porous portion, e.g. a metallic porous portion.

In embodiments, the dispensing mechanism is provided with a dose-setting device configured to allow for setting of the size of the individual dose that is deposited on the carrier member, e.g. the size of the drop. For example, the dose-setting device allows for a selection between predefined dosages, e.g. volumes of substance that make up a dose, e.g. the predefined dosages being based on a prescription for the specific user.

For example, the dose-setting device is configured to be set on the basis of a prescription for the specific user of the inhaler device. For example, the inhaler device is connectable to a remote database in which the prescription for a specific user is stored, e.g. in combination with a unique identification of the inhaler device, and/or the multi-dose container, and/or the carrier members holder (when present; e.g. embodied as a cartridge).

For example, the inhaler device has a memory wherein information related to past inhalation sessions are stored, e.g. date, time, dosage, identification of multi-dose container, identification of the cartridge, and/or other parameters, e.g. airflow, duration of the inhalation session, quality of the inhalation session {e.g. measured by an airflow sensor and possibly compared to tests done by the user of the inhaler device prior to the inhalation session(s)), etc.

For example, the discrete carrier member is made of metal, with the vaporization station being configured to heat the metallic carrier member, preferably by induction.

In an embodiment, the carrier member is configured to have a wicking effect for the substance in liquid form dispensed thereon.

For example, the carrier member has a porous portion, e.g. a porous metallic portion, which exhibits a capillary effect in combination with the dispensed dose of substance in liquid form.

This wicking effect may serve to keep the dose retained on the carrier member, e.g. in view of the transfer to the vaporization station, e.g. avoiding loss of the dose during this transfer.

The wicking effect also may serve to enhance the heating of the substance at the vaporization station, e.g. as the dose is effectively spread out as a thin film on the carrier member and/or as the heating of the dose can be effected very quick and homogenous.

-B-

In an embodiment, the depositing station further comprises a heating device configured to heat the substance in the multi-dose container prior to dispensing thereof. The heating may serve to liquify the substance from a (semi-)solid state and/or to lower the viscosity of the substance in view of the dispensing as an individual dose in liquid form onto the carrier member.

In an embodiment, the heating device of the depositing station is configured to heat all of the substance in the reservoir of the multi-dose container prior to dispensing of a separate individual dose. Heating of all of (the remaining) substance within the reservoir, e.g. at the start of an inhalation session, has the benefit of achieving a controlled and uniform temperature in a more effective/simple manner than, for example, an approach wherein just an individual dose is to be heated before the dispensing thereof. Also homogeneity of the substance may be enhanced.

In an embodiment, the heating device of the depositing station is configured to cease operation after dispensing of the individual dose of the substance in liquid form has been completed. So, for example, every time an inhaling session has ended, this heating of the substance in the multi-dose container is stopped, e.g. allowing the remaining substance in the reservoir thereof to cool down. The inhaler device may be provided with thermal insulation, e.g. an insulated chamber in which the multi-dose container is received, to reduce heat loss from the multi-dose container. Insulation of the space where the multi-dose chamber is received may also avoid undesirable thermal effects on other parts of the inhaler system.

In an embodiment, the depositing station comprises a stirring device configured to stir the substance in the reservoir of the multi-dose container prior to dispensing. For example, the stirring device is put in operation during operation of the heating device of the depositing station, so that heating and stirring are done to establish the correct consistency of the substance to be dispensed in liquid form. Stirring may, for example, involve shaking or vibrating the container.

In an embodiment, the multi-dose container is provided with one or more stirring members, and the stirring device of the depositing station is configured to cause stirring motion of the one or more stirring members. For example, one or more stirring members are arranged within the reservoir, e.g. one or more stirring members being rotary mounted in the reservoir.

In an embodiment, the stirring device is an electromagnetic stirring device, wherein the one or more stirring members of the multi-dose container are configured to be driven by an electromagnetic field established by the stirring device. For example, one or more metallic stirrer members, e.g. metallic balls, are presented in the reservoir with the field inducing their stirring motion.

In an embodiment, the dispensing mechanism is configured to pressurize the substance in the reservoir of the multi-dose container in order to dispense the individual dose of the substance, e.g. as a droplet. This, for example, allows to dispense with the provision of a pump to discharge the substance from the reservoir. For example, the container can be embodied with a collapsible, e.g. squeezable, reservoir, e.g. as a pouch.

In an embodiment, the multi-dose container comprises a barrel and a plunger delimiting the reservoir, and the plunger is movable relative to the barrel by the dispensing mechanism of the depositing station.

In a practical embodiment, the multi-dose container is a syringe.

For example, the reservoir is filled by pulling the plunger of the multi-dose container in one direction and dispensing of the dose is done by pushing the plunger in the other direction, in practice over a very small distance. Alternatively, filling is done with the plunger removed from the container.

For example, the dispensing mechanism is configured to engage on the plunger with the barrel being retained stationary in the housing of the inhaler device.

For example, the dispensing mechanism includes a stepper motor drive for the plunger.

For example, the barrel is made of plastic material and/or of glass.

In an embodiment, the multi-dose container comprises a dispensing nozzle configured to dispense the substance as a separate individual dose, e.g. as a drop or droplet.

For example, the nozzle is a hollow needle, e.g. a hollow metallic needle, e.g. as known for use with a syringe, e.g. with a Luer connector.

For example, the depositing station is configured to heat the dispensing nozzle, e.g. the metallic dispensing nozzle, for dispensing of the individual dase. This avoids undue obstruction of flow through the nozzle when dispensing the dose onto the carrier member and may enhance accuracy of the dose.

In an embodiment, the transfer mechanism is configured to advance the carrier member onto which the individual dose has been deposited directly to the vaporization station for the vaporization of the individual dose to be carried out. This entails that no other dose carrying carrier members remain present between the stations inside the inhaler device, e.g. within the cartridge, this may be beneficial in view of behavior of the substance in the dose over time.

The transfer of the carrier member may, for example, take place via a duct within the housing of the inhaler device extending between the stations, e.g. the duct being shielded from adverse air flows. The transfer could also take place primarily within a casing in which a carrier members holder is located, e.g. of a cartridge, holding multiple carrier members in a movable manner relative to the casing.

In an embodiment, the system comprises multiple carrier members, each configured for depositing thereon a single separate individual dose of the substance at the depositing station.

In embodiments, the carrier members are collected after use for disposal or refurbishment.

For example, the carrier member is introduced into a bin of the inhaler device after use.

In an embodiment, multiple carrier members are arranged on a carrier members holder that is located within a casing to form a cartridge that is releasably connectable to the inhaler device. Once the carrier members have been used, possibly multiple times, the cartridge including the carrier members holder and the carrier members is removed from the inhaler device for substitution by a new cartridge with carrier members holder and carrier members.

In embodiments, the carrier members holder is movable relative to the casing, e.g. rotatable about an axis, e.g. the carrier members being arranged in a circular array about the axis of revolution. For example, multiple tubular carrier members are arranged with a main axis thereof parallel to the axis of revolution of the carrier members holder.

For example, the carrier members are mainly or solely made of metal. This embodiment, e.g., allows for effective heating, e.g. between 150°C and 400°C, e.g. up to 300°C or more, in the vaporization station. Generally, the heater device of this station is controlled to provide a desired heating of the substance in the vaporization station, e.g. an upper limit avoiding combustion or other undesirable decomposition/degradation of the substance. The actual temperature of the metallic {portion of) the carrier member may be controlled by controlled operation of the heater device at the vaporization station. In embodiments, a sensor at the vaporization station is provided, e.g. a temperature sensor, e.g. an infrared temperature sensor. For example, the sensor provides a feedback signal for the control of the heater device and/or senses the temperature of the carrier member prior to the heating of the substance being started.

For example, the carrier member(s) is/are tubular, wherein — in use — the inhalation airflow passes through the tubular carrier member with the evaporating substance being provided at the inner surface of the tubular carrier member so as to be effectively entrained with the airflow.

In an embodiment, the multiple carrier members are discrete carrier members. In an embodiment, the carrier members are linked to form a chain of carrier members, e.g. with spacing between successive carrier members, e.g. a linear chain.

In an embodiment, the system comprises a carrier members holder accommodating multiple carrier members, e.g. multiple discrete carrier members.

For example, the transfer mechanism is configured to supply the carrier members one by one to the depositing station in order for each carrier member to be arranged at the depositing station for depositing the substance thereon.

In an embodiment, the system comprises multiple carrier members, each configured for depositing thereon a single separate individual dose, and the inhaler device comprises a carrier members collector device, e.g. a bin, configured to collect therein each of the carrier members after the vaporization has been effected at the vaporization station. For example, the transfer mechanism is configured to transfer the carrier from the vaporization station to the carrier members collector device.

In an embodiment, the carrier member is a carrier tape and the transfer mechanism is configured to advance the carrier tape from the depositing station to the vaporization station,

wherein the carrier tape is configured to deposit thereon multiple separate individual doses spaced from one ancther along the length of the carrier tape. For example, the system comprises a first reel from which the carrier tape is unwound and second reel onto which the carrier tape is spooled, e.g. the reels and carrier tape being embodied as a carrier tape cassette which is exchangeable receivable in the housing of the inhaler device.

In an embodiment, the carrier members holder, e.g. arranged movably within the casing of a cartridge, is part of the transfer mechanism. For example, the inhaler device comprises a carrier members holder drive which is configured to move the carrier members holder so as to allow positioning of each carrier member at the depositing station for depositing the dose thereon and to advance the carrier member with the dose thereon to the vaporization station.

In an embodiment, the carrier members holder is a rotary carrier members holder which is rotatable about an axis, e.g. a vertical axis, e.g. relative to the casing of the cartridge. For example, the holder has a disc body in which multiple carrier members are held. Herein the depositing station and the vaporization station are arranged at different angular positions relative to the rotary carrier members holder. For example, more than five carrier members, e.g. between five and twenty, are held by the carrier members holder in a circular array.

In an embodiment, the carrier members holder is arranged, preferably in a movable manner, within an associated casing to form a cartridge of the system. For example, the cartridge with the carriers members holder therein is releasably mountable to the housing of the inhaler device. The casing shields the carrier members, e.g. in view of one or more factors like moisture, UV-light, oxygen, etc., and may allow for easy handling, e.g. when the cartridge with the carrier members holder is releasably mounted to the inhaler device. For example, the casing has a first port to be located at the depositing station allowing for depositing of the dose of substance onto a carrier member held by the carrier members holder within the casing and the casing has a second port to be located at the vaporization station for interaction of the carrier member with the heater device of the vaporization station.

For example, the holder is movable about an axis of revolution relative to the casing with the carrier members in a circular array about this axis.

In an embodiment, instead of directly transferring a carrier member on which a dose has been deposited to the vaporization station it is envisaged that all or a selected number of the carrier members on a carrier members holder are provided with a dose thereon, e.g. a number of carrier members to be used on a day, so that the holder acts as a storage for a number, e.g. between two and six, of dose carrying carrier members. This approach may be beneficial, for example, in terms of the time needed to start-up of the inhaler device if the user wants to perform an inhalation session. For example, the inhaler device is configured to perform a depositing routing separate from an inhalation session, e.g. on command of the user or autonomous, e.g. during the night or outside of planned inhalation sessions.

In an embodiment, the drive of the carrier members holder is linked to a drive controller of the inhaler device, wherein the carrier members and their position in the carrier members holder are memorized as well as whether the carrier member has been loaded with a dose at the depositing station and/or used at the vaporization station, e.g. allowing for controlled motion of the holder.

In an embodiment, the carrier member comprises a metallic portion configured to deposit the individual dose thereon, and the heating device of the vaporization station and the carrier member are configured to heat the metallic portion and thereby the individual dose so as to create the vapor including said at least one agent. This may be, for example, done by the metallic portion being or including a resistive heater portion through which an electrical current is passed in the vaporization station. Yet, as explained herein, it is preferred that heating of the substance is done through inductive heating wherein the metallic portion is subjected to an electromagnetic field. The latter approach allows for fast, accurate, and uniform heating of the dose of substance on the carrier member. A general advantage of this approach is that no electrical contact with the carrier member is needed, and that there is no need for physical contact between the substance on the carrier member and the heater device, e.g. avoiding soiling of the device.

In an embodiment, a portion of the carrier member, e.g. the metallic portion, onto which the individual dose is to be deposited is porous, e.g. a mesh or perforated, so that the individual dose is partly embedded in said porous portion. Preferably, the porous metallic portion exhibits a capillary action, also called wicking action, when the individual dose is deposited thereon at the depositing station. The porosity is chosen to provide the desired wicking effect and the substance becomes in intimate contact with the porous structure of the carrier member.

For example, a portion of the carrier member is porous, and another portion of the carrier member is non-porous. Herein the non-porous portion may serve to keep the substance in the porous portion, but generally a wicking effect may prevent the substance from leaving the porous portion. Preferably, the one portion is a porous metallic portion and the other portion is a non-porous metallic portion. This latter design is beneficial in combination with an inductive heating at the vaporization station, e.g. as both the portions are heated. For example, the non-porous metallic portion effectively stores heat that may conductively flow to the metallic porous portion during the process of evaporation of the dose of substance absorbed by the porous portion of the carrier member. By appropriately dimension the porous and non-porous metallic portions of the carrier member, a desired thermal behavior may be obtained, e.g. in combination with inductive heating of both the porous and non- porous portions of the carrier member.

In an embodiment, the carrier member comprises a metallic susceptor portion, and the heating device of the vaporization station is configured to establish an electromagnetic field as so to heat the susceptor portion and thereby the individual dose of the substance so that the vapor including the at least one agent is created. For example, the susceptor portion is a porous metallic portion and the other portion is a non-porous non-metallic portion, and the vaporization station is configured to establish an electromagnetic field as so to heat the susceptor portion. In another embodiment, both a porous and a non-porous metallic portion of the carrier member act as susceptor portion.

In embodiments, the carrier member is tubular having inside, an outside, an inlet end, and an outlet end, wherein the carrier member and the depositing station are configured so that the separate individual dose of substance is deposited so as to be evaporated at the inside of the tubular carrier member. Herein the vaporization station is configured such that, in use, an airflow passes through the tubular carrier member to the mouthpiece, e.g. via an airduct of the device, e.g. the tubular carrier member forming a section of the airduct to the mouthpiece. For example, the airflow through the tubular carrier member is created solely by the user inhaling via the mouthpiece.

In a practical embodiment, the tubular carrier member has a porous inner portion, e.g. a tubular porous inner portion, e.g. a metallic inner portion, wherein the tubular carrier member has a non-porous outer portion, e.g. a tubular non-porous outer portion, e.g. a metallic outer portion.

In embodiments, the tubular carrier member is received within an inductive heating coil at the vaporization station, allowing for the metallic portion(s) of the carrier member to be subjected to an electromagnetic field and heated thereby to cause formation of the vapor, e.g. from the substance in/on the porous portion of the carrier member.

In embodiments, the carrier member is releasably held by the carrier members holder, e.g. by a frictional fit or some other releasable connection, wherein the inhaler device is configured to temporarily disengage the carrier member from the holder at the vaporization station in order to associate the carrier member with the heater device of said station and to re-engage the carrier member with the holder after use.

In embodiments, the inhaler device is configured such that placement of the mouthpiece causes the disengagement of the carrier member from the holder.

In embodiments, the multi-dose container is filled with at least ten individual doses of the substance, e.g. at least fifty individual doses.

In embodiments, the substance is a prescription medication and has been filled into the multi-dose container by a pharmacist for a specific user.

In embodiments, the multi-dose container has a unique container identifier and the inhaler device has a unique inhaler device identifier, and the system comprises an electronic database configured to store therein or storing therein the container device identifier and inhaler device identifier. The system is configured to link these identifiers upon providing the multi-dose container or the multi-dose container together with the inhaler device to the user, e.g. the system is configured to link the user to the combination of the multi-dose container and the inhaler device.

In embodiments wherein an exchangeable carrier members holder, e.g. with an associated casing as a cartridge, is provided holding multiple carrier members, a unique holder identifier can be provided as well. The system may then also link the holder or cartridge to the specific user and/or to the inhaler device that is used by the specific user. For example, the link is established by a pharmacist or another health care professional.

The present invention also relates to a method of delivering at least one agent to a pulmonary tract of a user, wherein use is made of a system as described herein. In an embodiment, the method comprises: - filling multiple doses of a substance into the multi-dose container, e.g. by a pharmacist, - arranging the multi-dose container in the inhaler device, - arranging the carrier member at the depositing station, - operating the depositing station so as to deposit a separate individual dose on the carrier member,

- operating the transfer mechanism to transfer the carrier member with the individual dose to the vaporization station, - operating the vaporization station so that the substance is heated, and a vapor is created including the agent, - delivering the vapor to the pulmonary tract of the user via the mouthpiece.

The present invention also relates to an inhaler device for pulmonary delivering at least one agent to a user which comprises: - a housing, - a depositing station mounted to the housing, the depositing station comprising: - a receiver configured to exchangeable receive a multi-dose container having a reservoir filled with a multiple doses of a liquid or heat liquifiable substance containing at least one agent to be pulmonary delivered to the user, - a dispensing mechanism configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container and to deposit the individual dose in liquid form onto a carrier member, - a mouthpiece, - a vaporization station mounted to the housing spaced from the depositing station, and comprising a heater device configured to heat an individual dose of the substance so as to create a vapor including said at least one agent, which vapor is to be delivered to the user via the mouthpiece, - a transfer mechanism mounted to the housing and configured to transfer the carrier member with the individual dose from the depositing station to the vaporization station.

A second aspect of the invention relates to an alternative inhaler system, wherein the activities of depositing the dose on the carrier member and of vaporization of the dose are not done with one inhaler device having both a depositing station and a vaporization station as in the system of claim 1.

The second aspect of the invention provides an inhaler system for pulmonary delivering at least one agent to a user, the system comprising: - a multi-dose container having a reservoir filled with multiple doses of a liquid or heat liquifiable substance containing at least one agent to be pulmonary delivered to a user,

- a carrier member configured to deposit thereon at least one separate individual dose of the substance, - a depositing device with a depositing station which comprises: - a receiver configured to exchangeable receive the multi-dose container, - a dispensing mechanism configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container and to deposit the individual dose in liquid form onto the carrier member, - an inhaler device, remote and separate from the depositing device, which comprises: - a housing, - a mouthpiece, - a vaporization station mounted to the housing and comprising a heater device configured to heat the individual dose of the substance deposited on the carrier member so as to create a vapor including said at least one agent, which vapor is to be delivered to the user via the mouthpiece, wherein the carrier member with the individual dose deposited thereon is transferable from the depositing device to the inhaler device.

In the second aspect of the invention, for example, the depositing device could be arranged at the pharmacy, e.g. where the multi-dose container is first filled with the substance, whereas the inhaler device is arranged at the home of the user.

In another embodiment, the depositing device is also placed at the home of the user, yet remote and separate from the inhaler device.

The second aspect, e.g. allows for a compact design of the inhaler device as it does not have the depositing station as in the first aspect of the invention according to claim 1.

It will be appreciated that the system according to the second aspect may have, and preferably has, one or more of the optional features discussed herein with reference to the first aspect of the invention. For example, one or more of the features listed in present subclaims 2, 3, 4, 5,6, 7, 8, 9, 10, 11, 13, and/or 14.

In embodiments of the second aspect of the invention, the system comprises a carrier members holder accommodating multiple carrier members, e.g. multiple discrete carrier members, the carrier members holder being configured to be arranged at the depositing device for depositing an individual dose on all or a selected number of the carrier members and for then being transferred to the inhaler device for vaporization of the dose deposited on the carrier member in an inhalation session.

For example, in the second aspect of the invention, each of the depositing device and the inhaler device is provided with a carrier members holder drive configured to move the carrier members holder so as to allow positioning of each carrier member at the depositing station and at the vaporization station respectively.

For example, in the second aspect of the invention, the carrier members holder is a rotary carrier members holder which is rotatable about an axis relative to the housing of the depositing device and of the inhaler device, e.g. a vertical axis.

For example, more than five carrier members, e.g. between five and twenty, are held by the carrier members holder in a circular array.

For example, in the second aspect of the invention, the carrier members holder is arranged within an associated casing to form a cartridge, the cartridge with the carriers members holder therein being releasably mountable to depositing device and to the inhaler device. For example, the casing has a first port to be located at the depositing station of the depositing device allowing for depositing of the dose of substance onto a carrier member held by the carrier members holder within the casing and the casing has a second port to be located at the vaporization station for interaction of the carrier member with the heater device of the vaporization station. For example, the carrier members holder is movable relative to the casing, e.g. by a drive of the depositing station and by a drive of the vaporization station. For example, the carrier members holder is rotatable about an axis of revolution relative to the casing, e.g. the carrier members being arranged in a circular array and/or the carrier members being tubular and having a main axis parallel to the axis of revolution.

For example, in the second aspect of the invention, one or more of the features listed in present subclaims 19, 20, 21, 22, 23, 24, 25, and/or 26 are present.

For example, in the second aspect of the invention, the carrier members holder, e.g. with an associated casing to form a cartridge, has a unique holder identifier. Preferably, also the inhaler device has a unique inhaler device identifier. Preferably, the system comprise an electronic database configured to store therein or storing therein the holder identifier and inhaler device identifier. The system is configured to link the identifiers upon providing the holder together with the inhaler device to the user, e.g. the system is configured to link the user to the combination of the holder and the inhaler device. For example, the link is established by a pharmacist or another health care professional.

The database may also store the prescription for the specific user, e.g. as prescribed by a medical professional, e.g. having remote access to the database. For example, the inhaler device is linked to the database, e.g. to monitor whether the use of the system by the specific user corresponds to the prescription.

The second aspect of the invention also relates to a method of delivering at least one agent to a pulmonary tract of a user, wherein use is made of a system of the second aspect of the invention as described herein. In an embodiment, the method comprises: - filling multiple doses of a substance into the multi-dose container, e.g. by a pharmacist, the substance being in liquid form or in heat liquifiable form, the substance including at least one agent to be pulmonary delivered to the user, - arranging the multi-dose container in the depositing device, - arranging the carrier member at the depositing station of the depositing device, - operating the depositing station so as to deposit a separate individual dose of the substance on the carrier member, - transferring the carrier member with the individual dose to the inhaler device, - arranging the carrier member at the vaporization station, - operating the vaporization station so that the individual dose of substance is heated, and a vapor is created including the at least one agent, - delivering the vapor to the pulmonary tract of the user via the mouthpiece.

The present invention also relates to a carrier member as described herein for use in an inhaler device for pulmonary delivering at least one agent to a user, e.g. according to claim 1 or according to the second aspect of the invention, or in another inhaler device having a housing, a mouthpiece, a vaporization station mounted to the housing comprising a heater device configured to heat the individual dose of the substance deposited on the carrier member so as to create a vapor including the at least one agent.

For example, the carrier member comprises a metallic portion configured to deposit the individual dose thereon, wherein the heating device of the vaporization station and the carrier member are configured to heat the metallic portion and thereby the individual dose so as to create the vapor including the at least one agent.

For example, a portion of the carrier member, e.g. the metallic portion, onto which the individual dose is to be deposited is porous, e.g. a mesh or perforated, so that the individual dose is partly embedded in the porous portion, e.g. by capillary action.

For example, a top portion of the carrier member is porous, and another lower portion of the carrier member is non-porous. For example, the porous portion is provided on a side of the carrier member that is configured to be exposed to and/or in communication with an airflow during an inhalation session. The non-porous portion is provided opposite from the porous side. The airflow is preferably created by the user taking a breath via the mouthpiece, possibly the user created airflow being controlled as discussed herein, e.g. by one or more valves.

Possibly, a fan is included in the inhaler device to create an airflow entraining the vapor, e.g. to be mixed with a user created inhalation airflow.

For example, the carrier member comprises a metallic susceptor portion and the heating device of the vaporization station is configured to establish an electromagnetic field as so to heat the susceptor portion and thereby the individual dose of the substance so that the vapor including the at least one agent is created. For example, a portion of the carrier member is a porous metallic portion and another portion is a non-porous metallic portion. The vaporization station is configured to establish an electromagnetic field as so to heat both metallic portions.

In embodiments, the carrier member is tubular having inside, an outside, an inlet end, and an outlet end, wherein the vaporization station is configured such that, in use, an airflow passes through the tubular carrier member. For example, the tubular carrier member connects to or is part of an air duct of the inhaler device leading to the mouthpiece. For example, the tubular carrier member has a porous inner portion, e.g. a tubular porous inner portion, wherein the tubular carrier member has a non-porous outer portion, e.g. a tubular non-porous outer portion.

The present invention also relates to a carrier members holder as described herein, the holder holding multiple carrier members for use in an inhaler device for pulmonary delivering at least one agent to a user, e.g. according to claim 1 or according to the second aspect of the invention, or in another inhaler device having a housing, a mouthpiece, and a vaporization station mounted to the housing and comprising a heater device configured to heat the individual dose of the substance deposited on the carrier member so as to create a vapor including the at least one agent.

For example, the carrier members holder is arranged within an associated casing to form a cartridge, e.g. the cartridge with the carriers members holder therein being releasably mountable to the housing of the inhaler device, e.g. the casing having a port to be located at the vaporization station for interaction of the carrier member with the heater device of the vaporization station. For example, the casing is also releasably mountable to a depositing device as in the second aspect of the invention.

In embodiments, the carrier members holder is movable relative to the casing, e.g. rotatable about an axis, e.g. the carrier members being arranged in a circular array about the axis of revolution. For example, tubular carrier members are arranged with a main axis thereof parallel to the axis of revolution of the carrier members holder.

The present invention also relates to a carrier member as described herein for use in an inhaler device, e.g. a tubular carrier member having an inner porous metallic portion and an outer non-porous metallic portion, e.g. to be heated by induction in an inhaler device, e.g. in a vaporization station thereof. For example, the inhaler device is according to the first or second aspect of the invention.

The present invention also relates to a carrier member as described herein in combination with an inhaler device, e.g. a tubular carrier member having an inner porous metallic portion and an outer non-porous metallic portion, e.g. to be heated by induction in the heater of an inhaler device. For example, the inhaler device is according to the first or second aspect of the invention.

The present invention also relates to a cartridge to be used in combination with a depositing station and a vaporization station as described herein. For example, one or both of the stations are embodied according to the first or second aspect of the invention.

The present invention also relates to methods for pulmonary delivering at least one agent to a user, wherein use is made of a carrier member, cartridge, and/or inhaler device, and/or depositing device as described herein.

The invention will now be described in more detail with reference to the drawings. In the drawings: -fig. 1 shows schematically the main components of an embodiment of an inhaler system according to the first aspect of the invention,

- fig. 2 shows schematically components of the system of figure 1 with the cartridge removed from the inhaler device, - fig. 3a shows schematically components of the system of figure 1 with the cartridge in an exploded view, -fig. 3b shows schematically an embodiment of the carrier member of the system of figure 1, - fig. 4 shows schematically the system of figure 1 as ready for use, - fig. 5 shows the system of figure 4 with the casing of the cartridge absent, - figs. 6, 7 show the operation of the depositing station of the system of figure 1, - fig. 8 shows the end of the depositing step and the transfer of the carrier member to the vaporization station of the inhaler device, - fig. 9 shows the operation of the vaporization station, - fig. 10 shows the system of figure 1 at the end of the inhalation session, - fig. 11 shows schematically the main components of an embodiment of an inhaler system according to the second aspect of the invention.

Figure 1 shows in a schematical view the main components of an exemplary embodiment of an inventive inhaler system according to the first aspect of the invention.

The system is configured for pulmonary delivering at least one agent to a user, e.g. for treating a neurological and/or psychological disorder or symptom of the user.

The system comprises: - a multi-dose container 10 having a reservoir filled with multiple doses of a liquid or heat liquifiable substance containing at least one agent to be pulmonary delivered to a user, - a cartridge 50 including multiple carrier members 60 which are each configured to deposit thereon at least one separate individual dose of the substance, - an inhaler device 100 which comprises: - a housing 110, represented in figure 2 by a dashed line for clarity, - a depositing station 120 mounted to the housing 110, the depositing station comprising: - a receiver 125 configured to exchangeable receive the multi-dose container 10 filled with the substance,

- a dispensing mechanism 130 configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container 10 and to deposit the individual dose in liquid form onto the carrier member 60, - a mouthpiece 150, - a vaporization station 140 mounted to the housing 110, spaced from the depositing station 120, and comprising a heater device 145 configured to heat an individual dose of the substance deposited on a carrier member 60 so as to create a vapor including said at least one agent, which vapor is to be delivered to the user via the mouthpiece 150, - a transfer mechanism 200 mounted to the housing and configured to transfer the carrier member 60 with the individual dose from the depositing station 120 to the vaporization station 140.

As can be best seen in figures 3 and 5, the exemplary system comprises a cartridge 50 having a movable carrier members holder 51 which is arranged within an associated casing 52, here in two halves, to form the cartridge 50. The holder 51 is configured to hold multiple carrier members 60, here in a releasable manner, here allowing for replacement back into the holder after being taken out temporarily at the vaporization station 140.

In this example, the carrier members holder 51 is rotatable about an axis of revolution 53 in the casing 52. The carrier members 60 are arranged in a circular array about the axis 53.

In this example, the carrier members 60 are tubular as will be explained in more detail below.

Other designs, e.g. as a plate-like carrier member, are also envisaged.

In this example, the tubular carrier members 60 each have a main axis that is parallel to the axis 53.

The cartridge 50 with the carriers members holder 51 therein is configured to be releasably mountable to the inhaler device 100.

As illustrated the casing 52 has a first port 54 to be located at the depositing station 120 allowing for depositing of the dose of substance onto a carrier member 60 held by the carrier members holder within the casing and the casing has a second port 55 to be located at the vaporization station 140 for interaction of the carrier member 60 with the heater device 145 of the vaporization station. For example, the ports 54, 55 are diametrically opposite one another.

In the depicted example, the carrier members holder 51 is part of the transfer mechanism 200. This transfer mechanism here also comprises a carrier members holder drive 201 which is mounted to the housing of the inhaler device 100 and which is configured to move the carrier members holder 51 so as to allow positioning of each carrier member 60 at the depositing station 120 and at the vaporization station 140. For example, the drive 201 includes an indexing drive for the holder allowing to position the carrier members 60 selectively at the port 54 and the port 55 of the casing.

In the illustrated example, the carrier members 60 are of tubular design, for example as shown in the figures 3a,b.

In the illustrated example, the multi-dose container 10 is embodied as a syringe, as is a preferred embodiment. As known in the art, the syringe 10 comprises a barrel 11 and a plunger 12 delimiting the reservoir filled with the substance. The plunger 12 is movable in the barrel 11 by the dispensing mechanism 130 of the depositing station 120. For example, the mechanism 130 includes a linear spindle drive, e.g. driven by a stepper motor, to linearly displace the plunger 12.

The syringe 10 has a dispensing nozzle 13 which is configured to dispense the substance as a separate individual dose, e.g. as a droplet. In a practical embodiment, the nozzle is embodied as a hollow needle 13, e.g. a hollow metallic needle, e.g. as is known in the field of syringes, e.g. having a Luer coupling to the barrel.

In an embodiment, the depositing station 140 is configured to heat the nozzle 13 for dispensing of the individual dose.

The syringe 10 or other embodiment of the multi-dose container 10 and the dispensing mechanism 130 are configured to dispense the substance in the form of liquid droplets, e.g. one drop or droplet corresponding to an individual dose.

Preferably, the dispensing mechanism 130 is provided with a dose-setting device configured to allow setting of the size of the individual dose that is deposited on the carrier member 60.

As is explained in more detail, preferably, the carrier member 60 is configured to have a wicking effect for the substance in liquid form dispensed thereon, e.g. in the form of a drop or droplet.

In an embodiment, the depositing station 120 further comprises a heating device configured to heat the substance in the multi-dose container 10 prior to dispensing thereof. In an embodiment, as preferred, the heating device of the depositing station is configured to heat all of the substance in the multi-dose container 10 prior to dispensing of a separate individual dose. For example, the station 120 is equipped with a contact heater device that engages on the container, e.g. the barrel of the syringe 10, e.g. with electrically heated elements of the heater, so as to heat the barrel and the substance in the reservoir.

For example, the heater device of the station 120 is configured to heat the substance to about 70°C, e.g. when the substance is a pure, undiluted, cannabis extract.

The effectiveness of the heating may be enhanced by no or minimal air gap between the container 10 and the heater device of the depositing station 120 when present. When the desired temperature has been reached, e.g. of 70°C, the plunger 12 is pressed down, e.g. by a stepper motor controlled dispensing mechanism 130. Possibly, meanwhile the substance is stirred, for instance with a screw as used in injection molding techniques or by using a magnetic stirring arrangement, e.g. in combination with metal balls added to the substance in the container 10 that keep stirring the substance.

The temperature may be controlled, e.g. to keep cannabis extract at 70°C to prevent crystallization, e.g. in view of the desired viscosity during the process of dispensing the drop.

For a diluted cannabis extract, contrary to a pure cannabis extract, heating and/or stirring at the depositing station 120 may be dispensed with as the substance may well be in flowable liquid form at room temperature.

In embodiments, the nozzle 13 is heated at the depositing station 120, e.g. by a nozzle heater, e.g. inductively when the nozzle is metallic, e.g. to obtain desired control of dispensing and/or formation of the drop or droplet.

In an embodiment, the heating device of the depositing station 120 is configured to cease operation after dispensing of the individual dose of the substance in liquid form on the carrier member 60 has been completed.

In an embodiment, the depositing station 120 comprises a stirring device configured to stir the substance in the container prior to dispensing. For example, the stirring device is in operation during operation of the heating device of the depositing station. In an embodiment, the multi-dose container is provided with one or more stirring members, and the stirring device of the depositing station is configured to cause stirring motion of the one or more stirring members.

As will be appreciated, in the depicted embodiment, the dispensing mechanism 130 is configured to pressurize the substance in the reservoir of the multi-dose container 10 in order to dispense the substance as a separate individual dose, e.g. as a drop or droplet.

For example, the multi-dose container 10 is filled with at least ten individual doses of the substance, e.g. at least fifty individual doses. For example, the container is filled with an amount sufficient for use by the user during a week.

In practical embodiments, the substance filled in the container 10, here syringe 10, is a prescription medication and has been filled into the multi-dose container 10 by a pharmacist for a specific user.

In embodiments, the multi-dose container 10 has a unique container identifier, and the inhaler device 100 has a unique inhaler device identifier.

In embodiments, the system comprise an electronic database configured to store therein the container device identifier and inhaler device identifier. The system is configured to link the identifiers upon providing the multi-dose container 10 or the multi-dose container 10 together with the inhaler device 100 to the user. For example, as preferred, the system is configured to link the specific user, e.g. based on a prescription, to the combination of the multi-dose container 10 and the inhaler device 100.

The carrier members 60 are of tubular design, for example as shown in the figures 3a,b.

As preferred, the tubular carrier members 60 have a tubular porous inner portion 61 and a non-porous tubular outer portion 62. As preferred, the outer portion surrounds the entire outside of the inner portion 81. Possibly, the porous inner portion 61 is shorter in length than the outer portion 62. In figure 3b, part of the outer portion 62 has been removed for clarity.

The depositing station 120 is configured to deposit the dose of substance on the porous inner portion 61, here via the needle 13 of the syringe 10.

D5.

The porous portion 61 is configured to exhibit a wicking effect for the substance in liquid form dispensed thereon, so that the dose is spread over and into the porous portion, preferably by capillary action. The dose does not enter into the outer portion.

Preferably, as in this example, the porous inner portion 61 is a metallic portion onto which the individual dose is to be deposited. For example, the portion 61 is embodied as a metallic mesh or perforated metal, so that the individual dose is partly embedded in the portion 61.

The tubular carrier member 60 is hollow and open at both ends thereof. In use of the inhaler system an airflow is created through the tubular carrier member 60, e.g. by the user inhaling.

In embodiments, one or more airflow control devices, e.g. one or more valves and/or one or more sensors (e.g. flowrate and/or pressure), are provided to monitor and/or control the airflow to the pulmonary tract of the user of the system, e.g. in view of flowrate, flow volume, and/or pressure. Such arrangements are known in the field of inhaler systems.

In embodiments, the user is instructed to first perform one or more inhalation session without the vapor being created allowing the one or more sensors to measure the actual airflow generated by the user. Based upon the measurement, one or more valves may be set or adjusted so that the user generates an airflow that is desired for proper delivery of the vapor to the user.

In embodiments, the inhaler device 100 has an airduct between an air inlet and an air outlet that is connectable or connected to the mouthpiece 150. During an inhalation session the user takes a deep breath and thereby causes an airflow, possibly regulated and/or monitored by one or more airflow control devices, in which the vapor is entrained. As will be explained in more detail below, in an embodiment, the carrier member is tubular and the inhalation airflow passes through the carrier member, so that the carrier member acts as a section of the airduct.

The hollow tubular carrier member 60, when positioned at the vaporization station 140, will be in communication with or form part of an air duct that extends to the mouthpiece, e.g. forming a section of this air duct. The porous portion 61 is thus provided on a side of the carrier member 60 that is configured to be exposed to and/or in communication with the air duct. The non-porous portion is provided opposite from the porous side of the carrier member.

In use, the substance is evaporated at the inside of the tubular carrier member 60. The vaporization station is configured such that the tubular carrier member 60 connects to the air duct so that, in use, the inhalation airflow passes through the tubular carrier member and entrains the vapor that is created by suitable heating of the dose of the substance.

The vaporization station is, in this example and as preferred, configured for inductive heating of the carrier member 60.

The metallic carrier member 80 forms a metallic susceptor portion that is be heated by induction.

The heating device 145 of the vaporization station 140 is configured to establish an electromagnetic field as so to heat the carrier member 60 and thereby the individual dose of the substance so that the vapor including the at least one agent is created.

In the depicted embodiment, both the porous metallic portion 61 and the non-porous metallic portion 62 are heated as they are in the electromagnetic field of the heating device 145.

For example, the carrier member 60 is heated to a temperature between 150°C and 400°C suitable for evaporating the substance or at least the agent therein that is to be delivered to the pulmonary tract of the user via the mouthpiece 150. Preferably, as known in the art, the heating of the substance is done without combusting, decompensation, formation of toxic gasses, etc.

The mouthpiece 150 is, possibly, a separate component that is readily releasable from the inhaler device 100, e.g. allowing for cleaning by the user after an inhalation session.

It is noted that, preferably, an inhalation session does not involve more than one (deep) breath taken by the user in order to convey the vapor into the pulmonary tract.

In the depicted embodiment, it is illustrated that the carrier member 80 that is to be heated at the vaporization station 140 is removed, here temporarily, from the carrier members holder 51, here from the cartridge 50 and brought into close proximity of the heater device 145, here the inductive heater device 145.

It is illustrated, as preferred, that the carrier member 60 is released from the holder 51 and then moved into a receiving space within the heater device 145, e.g. so that the carrier member 60 is surrounded by the heater device, e.g. by an inductive heater coil of the device 145. Preferably, the carrier member 60 is tubular with open ends, the heater device 145 being configured to allow an inhalation airflow to pass through the tubular carrier member 60 whilst located within the heater device 145, here whilst detached from the holder 51.

In this example, it is envisaged that in an embodiment the displacement of the carrier member 60 out of the cartridge 50 to the heater device 145 is done by action of engaging the mouthpiece 150 with the inhaler device. In this example, the user installs the mouthpiece 150 such that at the same time the mouthpiece 150 presses the carrier member 60 out of the holder 51 and to, here into, the heater device 145.

The inductive heater device 145 can be controlled by associated electronics to provide an accurate heating of the carrier member 60 and resulting creation of the vapor.

In figure 4 the system is ready for use. The multi-dose container, here syringe 10, and the cartridge 50 with multiple, still unloaded or virgin, carrier members 60 therein, are installed on the inhaler device 100.

The port of the casing is at the depositing station 120 and the other port is at the vaporization station 140.

The mouthpiece 150 is connected to the inhaler device 100, yet in a non-operative parking position.

One of the carrier members 60 is arranged underneath the nozzle 13, here needle of the syringe 10.

The rotatable carrier members holder 51 is connected to the drive 201 of the inhaler device 100 allowing for controlled rotation, e.g. indexed, of the holder 51 about the corresponding axis. Here the drive 201 has a rotatable shaft 202 that is connectable to the rotatable holder 51, e.g. fitting into a bore of the holder.

As shown in figure 5, where the casing 52 of the cartridge 50 has been removed for clarity, the carrier members 60 are tubular.

The mouthpiece 150 engages here in the parking position on a carrier member 60 located at the vaporization station 140. This carrier member 60 is still held by the holder 51.

In figure 6 it is illustrated that the nozzle 13 has been brought into close proximity of the carrier member, here the inner porous portion thereof, allowing for the subsequent deposition of the dose of substance on the carrier member, here as a drop dispensed from the nozzle 13 and absorbed by the porous portion by capillary effect.

The figure 7 illustrates that the drop is dispensed by controlled displacement of the plunger of the syringe 10 caused by the dispensing mechanism 130. Once the dispensing of the dose is completed, in this example, the needle 13, here the entire syringe 10 with needle, is moved upward, clearing the tip of the nozzle from the carrier member 80. This is illustrated in figure 8.

Upon completion of depositing the dose in liquid form on the carrier member 60, the drive 201 is operated to advance the loaded carrier member 60 to the vaporization station 140 of the inhaler device 100. For example, the loaded carrier member 80 is transferred immediately to the vaporization station for subsequent heating by heater device 145. So, effectively, no other loaded carrier members 60 are then present within the cartridge. The drive 201 may include a controller and related memory wherein the positions of the carrier members 60 in the holder 51 and their use is stored, e.g. so that each carrier member is only used a predetermined number of times, possibly just once.

Once the dose-loaded carrier member 60 is present at the port of the casing 51 aligned with the vaporization station 140, the user may press down the mouthpiece 150, e.g. based on a signal, so that the mouthpiece 150 is in its operational position and thereby (in this exemplary embodiment) the loaded carrier member 60 is released from the holder 51 and move to, here into, the heater device 145 outside of the cartridge 50. This is depicted in figure 9.

Once the carrier member 60 is arranged in or at the heater device 145, the heater device 145 is operated to heat the carrier member 60, e.g. inductive as described above.

Once heating and creating the vapor is sufficiently completed, the user is instructed to take a (deep) breath, e.g. by a signal presented by the inhaler device 100. This results in the vapor including the one or more agents therein to be delivered to the pulmonary tract of the user via the mouthpiece. As discussed, due to the airflow passing through the tubular carrier member 60 the vapor is effectively entrained with this inhalation airflow.

Upon completion of the inhalation session, a mechanism 250, here using a spring, is operated to cause the used carrier member 60 to be placed back into the holder 51.

As shown in figure 10, replacing the used carrier member in the holder 51 here causes the mouthpiece to be moved from the operational position back, here upward, to the parked position. The inhaler device can now be used for a next session.

With reference to figure 11 an example of an inhaler system according to the second aspect of the invention will now be discussed. Components corresponding to the components and details thereof discussed with reference to figures 1 — 10 have been denoted with the same reference numeral.

The second aspect of the invention relates to an alternative inhaler system, wherein the activities of depositing the dose on the carrier member 60 and of vaporization of the dose are not done with one inhaler device 100 having a housing 110 with both a depositing station 120 and a vaporization station 140 as in the system of the first aspect of the invention.

As schematically illustrated the system of figure 11 has a depositing device 300, here indicated with a dashed line, and an inhaler device 350, here indicated with a dashed line, which device 350 is remote and separate from the depositing device 330.

The depositing device 300 comprises: - the depositing station 120 comprising: - the receiver 125 configured to exchangeable receive the multi-dose container, - the dispensing mechanism 130 configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container 10 and to deposit the individual dose in liquid form onto the carrier member 60,

The inhaler device 350, remote and separate from the depositing device, comprises: - a housing 351, indicated with another dashed line - the mouthpiece 150, - the vaporization station 140 mounted to the housing 351 and comprising the heater device 145 configured to heat the individual dose of the substance deposited on the carrier member 60 so as to create a vapor including said at least one agent, which vapor is to be delivered to the user via the mouthpiece 150.

As shown, this second aspect of the invention entails that the loaded carrier member(s) is transferred from the depositing device 300 to the remote and separate inhaler device 350.

For example, the depositing device 300 is stationed at a pharmacy or other healthcare facility, and the inhaler device is at home of the user 350 and/or embodied as a portable inhaler device to be taken along by the user.

In another embodiment, the depositing device 300 is also placed at the home of the user, yet remote and separate from the inhaler device 350, e.g. the device 300 being stationary and the device 350 being portable.

The second aspect e.g. allows for a compact design of the inhaler device 350 as it does not have the depositing station 120 as in the first aspect of the invention.

It will be appreciated that the system according to the second aspect may have, and preferably has, one or more of the optional features discussed herein with reference to the first aspect of the invention, e.g. with reference to figures 1 - 10.

It is shown that the system preferably comprises the cartridge 50 with the carrier members holder 51 accommodating multiple carrier members 60, here multiple discrete carrier members.

The cartridge 50 is to be arranged at the depositing device 300 for depositing an individual dose on all of the carrier members 60 thereof, as is preferred, or on a selected number of the carrier members 80 in the cartridge 50. Then the cartridge 50 with the loaded carrier members 60 is removed from the device 300 and transferred, e.g. by the user, to the inhaler device 350. Now the inhaler device 350 can be readied for multiple inhalation sessions wherein vaporization of the dose deposited on the carrier member 60 in an inhalation session is carried out. lt is illustrated, each of the depositing device 300 and the inhaler device 350 is provided with a carrier members holder drive 201 which is configured to move the carrier members holder 51 so as to allow positioning of each carrier member 60 at the depositing station 120 and at the vaporization station 140 respectively. lt is illustrated, that, as an example, in the second aspect of the invention, the carrier members holder is a rotary carrier members holder which is rotatable about an axis relative to the housing of the depositing device 300 and of the inhaler device 350, e.g. a vertical axis.

For example, more than five carrier members 60, e.g. between five and twenty, are held by the carrier members holder 51 in a circular array.

For example, the carrier members holder 51 is rotatable about an axis of revolution relative tothe casing, e.g. the carrier members being arranged in a circular array and/or the carrier members being tubular and having a main axis parallel to the axis of revolution.

For example, in the second aspect of the invention, the cartridge 50 has a unique holder identifier. Preferably also the inhaler device 350 has a unique inhaler device identifier.

Preferably, the system comprise an electronic database configured to store therein the holder identifier and inhaler device identifier. The system is configured to link the identifiers upon providing the holder together with the inhaler device to the user, e.g. the system is configured to link the user to the combination of the holder and the inhaler device. For example, the link is established by a pharmacist or another health care professional.

The database may also store the prescription for the specific user, e.g. as prescribed by a medical professional. For example, the inhaler device is linked to the database, e.g. to monitor whether the use of the system by the specific user corresponds to the prescription.

Use of the system of figure 11 may comprise: - filling multiple doses of a substance into the multi-dose container 10, e.g. by a pharmacist, - arranging the multi-dose container 10 in the depositing device 300, - arranging the carrier member 80, here in the cartridge 50, at the depositing station 120, - operating the depositing station 120 so as to deposit a separate individual dose on the carrier member 60, - transferring the carrier member with the individual dose to the remote and separate inhaler device 350, here the entire cartridge 50 comprising multiple carrier members 60, - arranging the carrier member 60 at the vaporization station 140, - operating the vaporization station 140 so that the individual dose of substance is heated, and a vapor is created including the agent, - delivering the vapor to the pulmonary tract of the user via the mouthpiece 150.

The inventive systems may, for example, be used to deliver a vapor to the user based on a cannabis extract as substance that is deposited on the carrier member 60, e.g. on the porous portion 61 of tubular carrier member 60, e.g. metallic tubular carrier member 60.

In an embodiment, pure cannabis extract supplied by a manufacturer or diluted extract is handled by a pharmacist or other professional and filled into the multi-dose container 10. In practical embodiments, the extract is heated, e.g. up to 70°C, so that the extract is de- crystalized and/or the viscosity decreases allowing to fill the extract into the container in liquid form. Instead of heating, or combined with heating, a diluting material, e.g. alcohol, may be added to bring the cannabis extract in a more liquid form before it is filled into the multi-dose container, e.g. by the pharmacist.

In an embodiment, the container 10 is a syringe, e.g. with a reservoir between 0.5 ml and 2 ml

In an embodiment, the container 10 is heated during filling and/or stirring of the substance is done during filling. Stirring may enhance degassing of the substance in the reservoir and/or homogeneity of the substance.

Once filled into the container 10, the substance is allowed to cool. This may lead to crystallization of the cannabis extract.

In case the user collects the container 10 filled with substance, e.g. at a pharmacy, it is preferred that a unique identification of the container is linked to the user, e.g. based on a prescription, as well as to the inhaler device that is available for the user. Upon placing the container in the depositing station, the system may check whether the container 10 is indeed to be used in combination with the inhaler device.

The container 10 is preferably sealed so that no contamination can take place during storage and handling.

In embodiments, the container 10 and/or the depositing station 120 features a stirring function to stir to secure homogeneity of the substance.

In embodiments, the container 10 is configured to be heated repeatedly to 70°C at the depositing station 120.

In embodiments, the nozzle 13 is configured to be heated repeatedly to 70°C at the depositing station 120.

In embodiments, the container 10 is made of a material that is phobic to oily liquids to prevent creep of the substance.

For example, dimensions and design of container 10 and nozzle 13 are chosen to dispense consistently drops of liquid, e.g. heated liquid, e.g. cannabis extract at 70°C, or at room temperature.

For example the substance is a diluted extract + 10% allowing for dispensing at room temperature.

In an embodiment, the user sets the dose to be deposited on the carrier member 60 on the basis of a recipe prescribed by a physician.

In an embodiment, before active use of the system, an inhalation trial is performed by the user to determine the inhalation capacity of the user. The system may be configured to adjust — based on the measured inhalation capacity — the setting of the combination of temperature and lead time of the heater device at the vaporization station 140.

In use of the system, the effect of the agent on the user, e.g. as pain medicine, may be judged by the user/patient and by the physician. Possibly, the prescribed recipe can be adjusted by the physician. The user can then adjust the dose and/or regime according to the advice of the physician.

In an embodiment, the inhaler device 100, 350 is configured to indicate to the user by redundant signals, e.g. visual and auditive, to start the inhalation session once the vaporization has been completed sufficiently.

In an embodiment, inhaler device 100, 350 is configured to give feedback to user on the quality of the inhalation session as compared to the test inhalation of the user.

Claims

CONCLUSIONS

1. An inhaler system for pulmonary delivery of at least one agent to a user, the system comprising: - a multi-dose container having a reservoir filled with multiple doses of a liquid or heat-liquefiable substance containing at least one agent which is pulmonarily delivered to a user, - a carrier member configured to deliver thereon at least one discrete individual dose of the substance, - an inhaler device comprising: - a housing, - a delivery station mounted to the housing, the delivery station comprising: - a receiver configured to interchangeably receive the multi-dose container, - a delivery mechanism configured to deliver a discrete individual dose of the substance in liquid form from the multi-dose container and to deliver the individual dose in liquid form onto the carrier member, - a mouthpiece, - a vaporization station mounted to the housing, remote from the delivery station, the vaporization station comprising a heating device configured to heat an individual dose of the substance delivered onto a carrier member to create a vapor including said at least one agent, which vapor is delivered through the mouthpiece, - a transfer mechanism mounted on the housing and configured to transfer the carrier portion containing the individual dose from the delivery station to the vaporization station.

2. The system of claim 1, wherein the multi-dose container and the delivery mechanism are configured to deliver the substance in the form of liquid drops or droplets, for example one drop or droplet corresponding to an individual dose.

3. The system of claim 1 or 2, wherein the delivery mechanism comprises a dose setting device configured to meter the size of the individual dose delivered to the carrier member.

4. A system according to any one of claims 1 to 3, wherein the carrier member is configured to have a capillary effect for the dose of substance delivered thereto in liquid form.

5. The system of any one of claims 1 to 4, wherein the dispensing station further comprises a heating device configured to heat the substance in the reservoir of the multi-dose container prior to dispensing the individual dose thereof, for example wherein the heating device of the dispensing station is configured to heat all of the substance in the multi-dose container prior to dispensing a separate individual dose.

6. A system according to any one of claims 1 to 5, wherein the heating device of the dispensing station is configured to stop operating after dispensing of the individual dose of the substance in liquid form onto the carrier member is completed.

7. A system according to any one of claims 1 to 8, wherein the heating device comprises a stirring device configured to stir the substance in the reservoir of the multi-dose container prior to dispensing the individual dose, for example wherein the stirring device is in operation during operation of the heating device of the dispensing station.

8. The system of claim 7, wherein the multi-dose container is provided with one or more stirring means, and wherein the stirring device of the dispensing station is configured to cause a stirring motion of the one or more of the stirring means.

9. A system according to any one of claims 1 to 8, wherein the delivery mechanism is configured to pressurise the substance in the reservoir of the multi-dose container to deliver the substance as a separate individual dose, for example as a drop or a droplet.

10. A system according to any one of claims 1 to 9, wherein the multi-dose container comprises a cylinder and a plunger defining the reservoir, and wherein the plunger is movable relative to the cylinder by the dispensing mechanism of the dispensing station, for example wherein the multi-dose container is an injection.

A system according to any one of claims 1 to 10, wherein the multi-dose container comprises a dispensing nozzle configured to dispense the substance as a separate individual dose, e.g. as a drop or droplet, e.g. a hollow needle, e.g. a hollow metal needle, e.g. wherein the dispensing station is configured to heat the dispensing nozzle prior to dispensing an individual dose.

12. The system of any one of claims 1 to 11, wherein the transfer mechanism is configured to transfer the carrier portion on which the separate individual dose is dispensed directly to the vaporization station for vaporization of the individual dose performed at the vaporization station.

13. A system as claimed in any one of claims 1 to 12, wherein the system comprises a plurality of carrier members, each carrier member configured to deliver a single discrete individual dose thereto.

14. The system of claim 13, wherein the plurality of carrier members are discrete carrier members.

15. A system according to any one or more of claims 1 to 14, wherein the system comprises a carrier part holder accommodating a plurality of carrier parts, for example a plurality of discrete carrier parts.

16. The system of claim 15, wherein the carrier part holder is part of the transfer mechanism, the transfer mechanism comprising a carrier part holder drive configured to move the carrier part holder so that each carrier part can be positioned in a position at the dispensing station and in a different position at the vaporization station.

17. A system according to claim 18, wherein the carrier part holder is a rotating carrier part holder rotatable about an axis relative to the housing of the inhaler device, for example a vertical axis, wherein the dispensing station and the vaporization station are arranged at different angular positions relative to the rotating carrier part holder, for example wherein more than five carrier parts, for example between five and twenty, are held by the carrier part holder in a circular arrangement.

A system according to claim 16 or 17, wherein the carrier member holder is disposed within an associated housing to form a cartridge, for example the cartridge with the carrier member holder therein being releasably mountable to the housing of the inhaler device, for example the housing having a first outlet opening located at the delivery station enabling a dose of the substance to be delivered to a carrier member held by the carrier member holder within the housing and the housing having a second outlet opening located at the vaporisation station for interaction of the carrier member with the heating device at the vaporisation station.

19. The system of any one of claims 1 to 18, wherein the carrier member comprises a metal member configured to deliver an individual dose thereto, and wherein the heating device of the vaporization station and the carrier member are configured to heat the metal member and thereby the individual dose to create a vapor including said at least one agent.

20. A system according to any one of claims 1 to 19, wherein a portion of the carrier member, e.g. a metal member, onto which the individual dose is delivered is porous, e.g. a mesh or perforated, such that the individual dose is partially embedded in said member, e.g. by capillary action.

21. The system of claim 20, wherein a portion of the carrier member is porous and another portion of the carrier member is non-porous, for example wherein the porous portion is provided on a side of the carrier member configured to be exposed to and/or in communication with an inspiratory air stream, for example with an air channel through which an inspiratory air stream passes, and wherein the non-porous portion is provided opposite the porous side.

22. The system of claim 1-21, wherein the carrier portion comprises a metal susceptor portion, and wherein the heating device of the vaporization station is configured to create an electromagnetic field to heat the susceptor portion and thereby the individual dose of the substance to create the vapor including the at least one agent, for example wherein a portion of the carrier portion is a porous metal portion onto which the individual dose is delivered and another portion is a non-porous metal portion, and wherein the vaporization station is configured to create an electromagnetic field to heat both metal portions.

23. The system of any one of claims 1 to 22, wherein the carrier member is a tubular carrier member having an interior, exterior, an inlet end, and an outlet end, and wherein the carrier member and the delivery station are configured such that the discrete individual dose of the substance is delivered so that it is vaporized on the interior of the tubular carrier member, the vaporization station being configured such that, in use, an airflow passes through the tubular carrier member to the mouthpiece.

24. A system according to claims 21 and 23, wherein the tubular support member has a porous inner portion, for example a tubular porous inner portion, and wherein the tubular support member has a non-porous outer portion, for example a tubular non-porous outer portion.

25. A system according to any one of claims 1 to 24, wherein the multi-dose container is filled with at least ten individual doses of the substance in liquid form or in a heat-liquefiable form, for example at least fifty individual doses.

26. The system of any one of claims 1 to 25, wherein the substance is a prescription medication and is filled into the multi-dose container by a pharmacist for a specific user.

A system according to any one of claims 1 to 26, wherein the multi-dose container has a unique container identifier, and wherein the inhaler device has a unique inhaler device identifier, and wherein the system comprises an electronic database configured to store or has stored therein the container device identifier and inhaler device identifier, and wherein the system is configured to associate the identifiers when dispensing the multi-dose container or the multi-dose container together with the inhaler device to the user, for example wherein the system is configured to associate the user with the combination of the multi-dose container and the inhaler device.

28. A method for pulmonary delivery of at least one agent to an airway of a user, using a system according to any one of claims 1 to 27, the method comprising: - filling multiple doses of the substance in liquid or heat-liquefiable form into the multi-dose container, for example by a pharmacist, the substance containing at least one agent which is delivered pulmonarily to a user, - inserting the multi-dose container into the inhaler device,

- positioning the carrier portion at the dispensing station, - operating the dispensing station to dispense a separate individual dose onto the carrier portion, - operating the transfer mechanism to transfer the carrier portion containing the individual dose to the vaporization station, - operating the vaporization station to heat the substance and create a vapor including at least one agent, - delivering the vapor to the user's airway through the mouthpiece.

29. An inhaler device for pulmonary delivery of at least one agent to a user, the inhaler device comprising: - a housing, - a delivery station mounted to the housing, the delivery station comprising: - a receiver configured to interchangeably receive a multi-dose container having a reservoir filled with a plurality of doses of a liquid or heat-liquefiable substance containing at least one agent to be pulmonarily delivered to a user, - a delivery mechanism configured to dispense a separate individual dose of the substance in liquid form from the multi-dose container and to deliver the individual dose in liquid form onto the carrier member, - a mouthpiece, - a vaporization station mounted to the housing remote from the delivery station, the vaporization station comprising a heating device configured to heat an individual dose of the substance delivered onto a carrier member to create a vapor including said at least one agent, the vapor being delivered via the mouthpiece, - a transfer mechanism mounted to the housing and configured to transfer the carrier member containing the individual dose of the discharge station to the evaporation station.