Inhaler device for inhalable liquid

Abstract

The present invention relates to an inhaler device for inhalable liquids, in particular an inhaler device for administering an inhalable volatile liquid, such as a halogenated volatile liquid, to a patient. According to a specific embodiment, the inhaler device may comprise: a liquid container for hermetically storing the inhalable liquid; a wicking material for supporting the inhalable liquid; a piercing member configured to pierce the liquid container, wherein the liquid container may be arranged in a first position in which the piercing member is not engaged with the liquid container and the inhalable liquid is hermetically stored within the liquid container, and the liquid container may be moved from the first position to a second position such that the piercing member pierces the storage container to release the inhalable liquid onto the wicking material, whereby during inhalation, the inhalable liquid vapor from the wicking material is delivered to the patient.

Description

Technical Field

[0001] The present invention relates to an inhaler device for inhalable liquids, in particular an inhaler device for administering an inhalable volatile liquid, such as a halogenated volatile liquid, to a patient. Background Art

[0002] The storage and administration of inhalable liquids containing an active agent or being an active agent themselves for a patient generally pose challenges. Active agents, such as therapeutic agents or medicaments, are typically formulated for oral delivery in the form of tablets and capsules, nasal delivery in the form of sprays, and liquid formulations for intravenous delivery, depending on many factors.

[0003] In the case of advantageously administering an active agent to a patient's lungs, for example to treat or alleviate a respiratory disease, the active agent can be administered alone or in combination with nasal inhalation by oral inhalation. Suitable inhaler devices can include, for example, metered-dose inhalers and dry powder inhalers. These types of inhalation devices generally require a pressurizing device to deliver the active agent to the desired site of action in the lungs. In addition, a liquid containing an active agent or being an active agent itself typically needs to be converted into an inhalable respiratory form suitable for delivery at the time of administration.

[0004] Converting a liquid into an inhalable form, such as by atomization or aerosolization into respirable-sized droplets or heating to form a vapor, requires the delivery device to include a moving device, a mechanical device, a heating device, and / or an electrical device, which increases the complexity of design, manufacturing, and the cost to the end user, operability, and / or patient usability.

[0005] The use of volatile liquids as active agents or containing active agents is known. One such example is halogenated volatile liquids. Halogenated volatile liquids have been described as being useful for inducing and / or maintaining anesthesia (including amnesia, muscle paralysis, and / or sedation) and / or analgesia, and can thus be used as anesthetics and / or analgesics. The anesthetic properties of fluorinated compounds have been known since at least 1946 (Robbins, B. H. J Pharmacol Exp Tfter (1946) 86: 197 - 204). Subsequently, trifluoroethyl ether, halothane, and methoxyflurane were introduced into clinical use in the 1950s, and subsequently enflurane, isoflurane, sevoflurane, and desflurane, which are currently in clinical use in some countries, were developed (Terrell, R. C. Anesthesiology (2008) 108(3): 531 - 3).

[0006] Halogenated volatile liquids can be delivered to a patient under positive pressure via a delivery system including a vaporizer and a flow of breathable carrier gas when used for general anesthesia. Recently, halogenated volatile liquids have been formulated for local or regional anesthesia and delivery via non-inhalation routes. Examples include the following formulations:

[0007] Microdroplets for intradermal or intravenous injection (e.g., US 4725442; C / 143964);

[0008] Compositions suitable for formulation into solutions, suspensions, creams, pastes, oils, lotions, gels, foams, hydrogels, ointments, liposomes, emulsions, liquid crystal emulsions, and nanoemulsions for topical, intrathecal, epidural, percutaneous, local, oral, intra-articular, mucosal, buccal, rectal, vaginal, intramuscular, intravesical, and subcutaneous delivery (e.g., WO 2008 / 070490, WO 2009 / 094460, WO 2010 / 129686); and

[0009] Stable and injectable liquid formulations (WO 2013 / 016511).

[0010] For the safe storage and handling of volatile liquids, the main considerations typically include vapor pressure build-up, container robustness, and the integrity of the container seal. The chemical properties of the volatile liquid can also be important in cases where the active agent can penetrate, dissolve, or react with the container material during storage. Many storage containers for halogenated volatile liquids have been described, including:

[0011] Rigid polymer containers of various shapes and sizes for replacing glass vials, such as capped bottles, large tanks, and shipping containers (e.g., WO 1999 / 034762, WO 2012 / 116187);

[0012] Rigid polymer bottles and flexible containers with threaded nozzles equipped with gasketless valve assemblies for fluid connection to deliver liquid anesthetics to an anesthesia machine or vaporizer (e.g., WO 2010 / 135436, WO 2013 / 106608, WO2013 / 149263, WO 2015 / 034978);

[0013] Containers with overlying membranes for delivering stored liquid anesthetics to a vaporizer via a suture tube (WO 2009 / 117529);

[0014] And rigid polymer and aluminum containers optionally coated with materials to impart or enhance vapor barrier properties or container inertness (e.g., WO2002 / 022195, WO 2003 / 032890, WO 2010 / 129796).

[0015] Despite various advances in formulating volatile liquids, such as halogenated volatile liquids, in a non-inhalable form and in containers for storing them, there is still a need for volatile liquids in an inhalable form and for devices for storing such liquids and / or administering such liquids to a patient.

[0016] Attempts are currently being made to design new inhalers for inhalable drugs. For example, WO2008 / 040062 describes a variety of inhaler device concepts that rely on complex structures and moving parts for storing inhalable liquids and powdered solids and / or delivering inhalable liquids and powdered solids to the mouth or nose of a patient. The various devices described are adapted to hold one or two drug containers in the form of pressurized cans, ampoules, vials, and plungers. These devices are described as being actuated to deliver liquid drug from the drug container by sliding the outer wall of the device relative to the inner wall of the device. In many embodiments, the device includes a movable nozzle configured to open an air path. The device is also described as including one or more one-way valves to provide one-way air flow for one or both of inhaled air and exhaled air (a series of one-way valves for guiding inhaled and exhaled air flow has also been generally described in WO 2007 / 033400, which is incorporated by reference to the device previously described in WO 1997 / 003711).

[0017] When in use is required, the devices in WO 2008 / 040062 claim to be able to release the drug by perforating two corresponding frangible ends of the drug container with a stamping device, i.e., two punches, although various other devices are generally described, including: pressurizing devices (e.g., via a pressurized can); frangible devices (e.g., by breaking an ampoule with a firing pin or stamping a frangible membrane or the seal of a vial with a stamping device); crushable devices (e.g., by crushing a vial with a plunger); removal devices (e.g., by removing a screwed-off cap from a vial); and insertion devices (e.g., by inserting a drug from a plunger barrel).

[0018] However, inhalable liquids, such as halogenated volatile liquids, require an effective air chamber into which the vapor can evaporate and which allows effective air flow through the air / vapor chamber for delivery to the patient. Thus, it cannot be expected that the embodiments, such as those described in FIGS. 48A, 48B, 48C, 49A, 49B, 50A, 50B, 51A, 51B, 56A, 56B, 57, 58A, 58B, 58C, and 58D of WO2008 / 040062 for example, will function in practice because the evaporation device (i.e., the wick) is prevented by the walls of the liquid storage container itself from being effectively exposed to an effective air flow.

[0019] Inhaler devices for delivering inhalable liquids can generally be considered to be operated by either passive or active devices to deliver an active agent to a patient. Inhaler devices with active devices can include pressurizing devices, moving devices, mechanical devices, heating devices, and / or electrical devices to, for example, atomize, vaporize, and / or generally deliver the active agent. In contrast, inhaler devices with passive devices rely only on the vaporization or evaporation of the active agent under ambient conditions and the patient's respiration to deliver the active agent.

[0020] Analgizer TM The Inhaler device (Abbott Laboratories Corporation) is an example of a device operated by a passive device to deliver an inhalable liquid. According to the TESS database of the United States Patent and Trademark Office, Analgizer TM is a registered but now expired trademark for an inhaler for supervised self-administration of inhaled anesthesia and was first used in 1968. Analgizer TM is a very simple device that consists of an end-open tube of white cylindrical polyethylene with a nozzle and an absorbent core of polypropylene tightly wound into a "Swiss roll" shape, i.e., a cross-section in the shape of a "Swiss roll". Immediately before use, the inhaled anesthetic, methoxyflurane (15 mL), is poured into the end-open base of the inhaler and onto the tightly wound core. The patient can then self-administer the liquid anesthetic by inhaling through the nozzle.

[0021] Green Whistle TM The Inhaler device (Medical Developments International Limited) was subsequently developed during the 1990s and has since been used in Australia to deliver methoxyflurane (1.5 mL or 3 mL, in a screw-cap storage brown glass vial container) as an analgesic. Although the Green Whistle TM device is similar to the Analgizer TM in its simple design, the Green Whistle TMThe device also incorporates certain functional improvements, including a one-way valve located at the base end to prevent loss of drug vapor from the device during patient exhalation, and an activated carbon (‘AC’) chamber designed to fit externally into a dilution orifice in the nozzle to filter exhaled drug vapor. Additional design modifications to the base end include the introduction of the following features: a cap protrusion to assist in removing the cap from a glass vial used to store the drug dose to be delivered; a rounded top to facilitate the spread of the poured liquid onto the ‘S-shaped’ core (i.e., having an ‘S-shaped’ cross-section), or in an alternative embodiment, onto the rounded top; and an inlet mouth to allow attachment of a breathable gas line to direct gas through the device. Green Whistle TM The device is designed for single patient use.

[0022] Methoxyflurane ( Medical Developments International Limited) provides a non-narcotic, non-opioid analgesic alternative to commonly used analgesics such as morphine and fentanyl. Methoxyflurane also provides an alternative to analgesics administered to patients in the form of oral tablets or by intravenous injection, and can therefore be particularly useful when rapid pain relief is required in clinical, surgical (e.g., pre- and post-surgical) and / or emergency settings (e.g., emergency departments and triage management, and by first responders such as paramedics and search and rescue teams). However, Green Whistle TM The device is currently the only commercially available device for administering methoxyflurane. According to the device's instructions for use, the person administering the drug is required to hold the methoxyflurane vial upright to loosen the cap using the base of the inhaler, and then remove the cap by hand before tilting the inhaler to a 45-degree angle and pouring the contents of the vial into the base while rotating the device. Optionally, the AC chamber can be externally fitted to the device either pre- or post-use. Although the device is effective, the number of steps and separate components may present operational difficulties for the person administering the drug or the self-administering patient, for example, in high-stress and / or emergency settings.

[0023] Embodiments of the present invention seek to address one or more of the above disadvantages and / or at least provide a useful alternative to the public.

[0024] Any reference in this specification to any previously published or derived information or to any matter known is not and should not be taken as an acknowledgment or admission or any form of suggestion that the previously published or derived information or the matter known forms part of the common general knowledge in the technical field to which this specification pertains. Summary of the Invention

[0025] According to a first aspect of the present invention, there is provided an inhaler device for delivering an inhalable liquid to a patient, the inhaler device comprising:

[0026] A nozzle; an air inlet;

[0027] A liquid container for sealingly storing the inhalable liquid; a wicking material for supporting the inhalable liquid;

[0028] A piercing member configured to pierce the liquid container;

[0029] A first one-way valve configured to allow gas to flow into the nozzle during inhalation and prevent gas from flowing in the opposite direction during exhalation;

[0030] Wherein,

[0031] The nozzle, the first one-way valve, the wicking material and the air inlet are fluidly connected to provide an inhalation chamber; and

[0032] The inhaler device is configured such that:

[0033] The liquid container can be set in a first position in which the piercing member does not engage with the liquid container and the inhalable liquid remains sealed in the liquid container;

[0034] The liquid container can be displaced from the first position to a second position such that the piercing member pierces the storage container to release the inhalable liquid onto the wicking material, whereby during inhalation, air entering the air inlet flows through the inhalation chamber to deliver the inhalable liquid vapor from the wicking material to the patient via the nozzle.

[0035] In an embodiment according to the first aspect, the inhaler device further comprises: a return air chamber fluidly communicating with a second one-way valve such that during inhalation, the first one-way valve is open and the second one-way valve is closed, and during exhalation, the first one-way valve is closed and the second one-way valve is open to allow exhaled gas to flow from the nozzle through the return air chamber.

[0036] In an embodiment according to the first aspect, the return air chamber includes a filter material configured to filter volatile liquid vapor in the exhaled breath of the patient during exhalation.

[0037] In an embodiment according to the first aspect, the filter material includes activated carbon, optionally including activated carbon particles.

[0038] In an embodiment according to the first aspect, the liquid container contains a halogenated volatile liquid.

[0039] In an embodiment according to the first aspect, the halogenated volatile liquid is selected from the group consisting of: halothane (2-bromo-2-chloro-1,1,1-trifluoroethane), sevoflurane (fluoromethyl 2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether), desflurane (2-difluoromethyl-1,2,2,2-tetrafluoroethyl ether), isoflurane (1-chloro-2,2,2-trifluoroethyl difluoromethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyl difluoromethyl ether), and methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether).

[0040] In an embodiment according to the first aspect, the halogenated volatile liquid is methoxyflurane.

[0041] In an embodiment according to the first aspect, the piercing member includes at least one channel such that when the liquid container is in the second position, the inhalable liquid from the storage container can pass through the at least one channel and reach the wicking material.

[0042] In an embodiment according to the first aspect, the wicking material is spaced apart from the piercing member to allow air to enter the liquid container through the at least one channel, thereby preventing or reducing the restriction of air lock on the release of the inhalable liquid from the liquid container.

[0043] In an embodiment according to the first aspect, the inhaler device includes a spacer tab configured to space the wicking material apart from the piercing member.

[0044] In an embodiment according to the first aspect, when the liquid container is moved from the first position to the second position, the wicking material and / or the piercing member remain stationary within the inhaler device.

[0045] In an embodiment according to the first aspect, the liquid container includes only a single area configured to be pierced.

[0046] In an embodiment according to the first aspect, the inhaler device is configured to enable air to pass through or around the liquid container. Optionally, the inhaler device is configured to prevent air from passing through the liquid container.

[0047] In an embodiment according to the first aspect, the inhaler device includes a diluter orifice positioned to allow a portion of the inhaled air to bypass the wicking material before entering the nozzle.

[0048] In an embodiment according to the first aspect, the diluter orifice is positioned and configured to enable a patient to restrict or block the diluter orifice with a finger.

[0049] In an embodiment according to the first aspect, the nozzle includes a filter configured to reduce or prevent a patient from inhaling droplets.

[0050] In an embodiment according to the first aspect, the filter is formed of a polymeric non-woven material.

[0051] In an embodiment according to the first aspect, the inhaler device is configured to be able to replace the liquid container and / or the wicking material.

[0052] In an embodiment according to the first aspect, the wicking material is configured to enable inhaled air to pass through and along multiple surfaces of the wicking material, optionally, the wicking material is configured to enable inhaled air to pass through and along a first surface and a reverse surface of the wicking material.

[0053] Definition

[0054] In this specification and the appended claims, unless the context otherwise requires:

[0055] Terms such as "side", "end", "top", "bottom", "above", "below", etc. are only used to describe elements relative to each other and in no way imply a particular orientation of the device, indicate or imply a necessary or desired orientation of the device or specify how the invention described herein will be used, installed, displayed or positioned in use;

[0056] "Active agent" means therapeutic agents and non-therapeutic agents and compounds, formulations and compositions comprising therapeutic agents and non-therapeutic agents, and "active agent" has a corresponding meaning;

[0057] "Air" or "gas" may be used interchangeably;

[0058] "Alleviate", "alleviation" and their variants mean the remission, reduction, lowering, improvement or amelioration of the symptoms and / or underlying causes of a patient's disorder and / or disease;

[0059] "Comprise" and its variants such as "comprises" and "comprising" will be understood to imply the inclusion of the stated whole or step or group of wholes or steps, but not the exclusion of any other whole or step or group of wholes or steps;

[0060] "Delivery dose" means the dose of inhalable liquid or active agent administered to a patient;

[0061] "Filter", "filtering" and their variants mean the ability of a substance to absorb, adsorb, capture, trap, remove, purify or partially or completely remove inhalable volatile liquid vapors from the exhaled breath of a patient during exhalation;

[0062] "Halogenated volatile liquid" refers to the following volatile liquids: which (i) contain at least one halogen atom selected from the group consisting of chlorine (Cl) atom, bromine (Br) atom, fluorine (F) atom and iodine (I) atom; or (ii) contain an active agent which contains at least one halogen atom selected from the group consisting of chlorine (Cl) atom, bromine (Br) atom, fluorine (F) atom and iodine (I) atom. In some embodiments, halogenated hydrocarbons, especially fluorinated hydrocarbons, and halogenated ethers, especially fluorinated ethers, may be preferred. In some embodiments, halogenated ethers may be particularly preferred and include, but are not limited to, halothane (2-bromo-2-chloro-1,1,1-trifluoroethane), sevoflurane (fluoromethyl 2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether), desflurane (2-difluoromethyl-1,2,2,2-tetrafluoroethyl ether), isoflurane (1-chloro-2,2,2-trifluoroethyl difluoromethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyl difluoromethyl ether) and methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether);

[0063] "Inhalable liquid" refers to a liquid that contains an active agent or is itself an active agent and is easily inhaled or can be inhaled by or is suitable for being inhaled by a patient. In some embodiments, inhalable volatile liquids, especially halogenated volatile liquids, are preferred;

[0064] "Inhale", "inhalable" and their variants mean, for example but not limited to, the uptake by a patient of, for example, air, breathable gas, inhalable liquid and include both oral inhalation and nasal inhalation. In some embodiments, oral inhalation is particularly preferred;

[0065] "And / or" means "and" and "or" where the context permits both;

[0066] "Patient" refers to human patients and veterinary patients in the conceptual sense. In some embodiments, human patients may be particularly preferred. Thus, reference to a patient will be understood to mean a person or animal to whom an inhalable liquid is administered and, in the case of a human patient, will be understood to include administration by self-administration;

[0067] "Pharmaceutical agent" refers to a drug or a compound, preparation or composition containing the drug for treating the symptoms and / or underlying causes of a patient's disorder and / or disease. The term pharmaceutical agent may be used interchangeably with therapeutic agent or active agent;

[0068] "Respiratory", "respirational" and their variants refer to the act of a patient respiring, breathing, inhaling and exhaling, for example, but not limited to, air, breathable gas, inhalable liquid and active ingredients;

[0069] "Room temperature" refers to the ambient temperature, which can be, for example, between 10°C and 40°C, but more typically between 15°C and 30°C;

[0070] "Therapeutic agent" refers to an active agent, or a compound, preparation or composition containing an active agent (including biological compounds, preparations and compositions), which is capable of treating a patient or providing a therapeutic or medical benefit to a patient, or has or requires regulatory and / or marketing approval for use in the treatment of patients. Therapeutic agents include medicinal agents. Conversely, "non-therapeutic agent" is understood to mean an active agent that may not have or require regulatory approval and / or marketing approval for therapeutic use, such as smokeless tobacco products and electronic cigarettes, or an active agent that does not have an approved or established therapeutic use but may be used by a patient for non-therapeutic reasons, such as general health, well-being or physiological benefits, such as, for example, nutritional supplements;

[0071] "Treat", "treatment" and their variants mean to relieve, modulate, regulate or stop the symptoms and / or underlying causes of a patient's condition and / or disease. In some embodiments, treatment may include prophylactic or preventive treatment; and

[0072] "Volatile liquid" refers to a substance that exists primarily in liquid form but readily forms vapors, evaporates or vaporizes, such that they exist partially in vapor form under ambient conditions, such as at room temperature and standard atmospheric pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Figure 1A and Figure 1B show external views of an inhaler device having a fluid container in a first position and a second position, respectively, according to an embodiment of the present invention.

[0074] Figure 2A and Figure 2B show Figure 1A a cross-sectional view of the device along line A-A, wherein the fluid container is in the first position.

[0075] Figure 3 show Figure 1B a cross-sectional view of the device along line B-B, wherein the fluid container is in the second position.

[0076] Figure 4 show Figure 1A an exploded view of the inhaler device.

[0077] Figure 5 show Figure 1B a cross-section of the inhaler device in , wherein the fluid container is in the second position, which indicates the air flow within the device in use.

[0078] Figure 6 shows an Figure 1A isometric cross-sectional view of the end cap of an inhaler device.

[0079] Figure 7A and Figure 7B shows an Figure 1A isometric view of the end cap and the receiving portion of an inhaler device.

[0080] Figure 8 shows a holder for an inhaler device as shown in Figure 1A isometric cross-sectional view.

[0081] Figure 8A , Figure 8B and Figure 8C show different embodiments of an opener according to the present invention.

[0082] Figure 8D and Figure 8E show the receiving portion in the first position of an inhaler device according to Figure 1A and in the second position of an inhaler device according to Figure 1B .

[0083] Figure 8F shows another embodiment of an opener according to the present invention.

[0084] Figure 8G and Figure 8H show another embodiment of an opener according to the present invention.

[0085] Figure 9A and Figure 9B show different views of the wicking material of an inhaler device according to Figure 1A .

[0086] Figure 10 shows an Figure 1B isometric cross-sectional view of the body of an inhaler device.

[0087] Figure 11A , Figure 11B and Figure 11C show different embodiments of a barrel and a closing mechanism according to the present invention.

[0088] Figure 12 shows an Figure 1A isometric view of the valve arrangement of an inhaler device.

[0089] Figure 13 shows an Figure 8G and Figure 8H isometric cross-sectional view of an opener.

[0090] Figure 14 Another embodiment of the inhaler device is shown.

[0091] List of reference numerals

[0092] 10 - Inhaler device

[0093] 11 - Hand strap

[0094] 12 - Nozzle

[0095] 14 - Body

[0096] 16 - Receiving part

[0097] 18 - Liquid

[0098] 20 - Cylindrical part

[0099] 22 - Opener

[0100] 23 - Protrusion

[0101] 24 - Chamber

[0102] 26 - Fluid passage

[0103] 28 - Window part

[0104] 30 - Wick material

[0105] 31 - Void

[0106] 32 - Retainer

[0107] 34 - Valve assembly 34a - Valve support 34b - Valve plate

[0108] 36 - Receiver

[0109] 38 - Docking part

[0110] 40 - Air inlet

[0111] 42 - Perforation

[0112] 44 - Diluter hole

[0113] 50 - Exhalation chamber 52 - Adsorbent material 54 - Outlet end

[0114] 56 - End cap

[0115] 58 - Chamber body 60 - Filter assembly 64 - Filter

[0116] 70 - Slotted guide

[0117] 72 - Recessed part

[0118] 74 - Central raised part

[0119] 76 - Recessed portion

[0120] 80 - Spacer tab

[0121] 100 - Cannula

[0122] 101 - Piercing member

[0123] 102 - Hole

[0124] 104 - Cannula

[0125] 105 - Piercing member

[0126] 106 - Hole

[0127] 108 - Cannula

[0128] 110 - Hole

[0129] 120 - Vial

[0130] 122 - Closure

[0131] 130 - Vial

[0132] 132 - Threaded closure

[0133] 133 - Perforation

[0134] 134 - Membrane

[0135] 140 - Closure

[0136] 142 - Plug

[0137] 150 - Tab

[0138] 152 - Ridge

[0139] 158 - Piercing member

[0140] 160 - Hollow shaft

[0141] 162 - Flow member

[0142] 164 - Venting path

[0143] 166 - Channel

[0144] 180 - Diluter hole

[0145] 182 - Nozzle Detailed implementation mode

[0146] Broadly speaking, the present invention relates to a novel inhaler device for administering an inhalable liquid to a patient, where the inhalable liquid is, for example, a halogenated volatile liquid, particularly methoxyflurane used as an analgesic. Now, the present invention will be further illustrated with reference to the embodiments described below and in the accompanying drawings.

[0147] Embodiment

[0148] The embodiments of the present invention will now be described with reference to non - limiting examples.

[0149] According to a first embodiment, Figure 1A and Figure 1B An inhaler device 10 having a hand strap 11, a nozzle 12, a body 14, a receiving portion 16, and an end cap 56 is shown in a first position and a second position, respectively. In Figure 1A the first position shown in Figure 1B the receiving portion 16 projects from the body 14 of the inhaler device 10 and can be covered by the end cap 56. In

[0150] In Figure 2A and Figure 2B other details of the inhaler device 10 are shown, wherein the receiving portion 16 is shown in a first arrangement as partially receiving a cylindrical member 20 within the body 14 of the inhaler device 10. The cylindrical member 20 can hold a fluid, such as a liquid 18, such as a volatile liquid, such as methoxyflurane. An opener 22 connected to a chamber 24 through a fluid passage 26 is also within the body 14. The chamber 24 can include a wicking material 30.

[0151] In Figure 1A and Figure 2B the cylindrical member 20 is located within the receiving portion 16 such that air can flow around the cylindrical member 20 through the receiving portion 16 and into the chamber 24. An example of the air flow is as shown in Figure 5 In other embodiments (not shown), the receiving portion 16 and the cylindrical member 20 can be integral with each other, for example, molded from a single piece. In other embodiments (not shown), the air flowing into the chamber 24 can flow around the receiving portion 16, through the cylindrical member 20, or be completely separated between the receiving portion 16 and the cylindrical member 20.

[0152] As shown in Figure 4 the cylindrical member 20 can be loaded into the receiving portion 16 during the assembly or manufacture of the finished inhaler 10. The cylindrical member 20 can be a vial, such as a 5 - ml vial with a glass wall and having threads on the cap. The cap can have a pierceable portion, such as a butyl rubber segment with a low - permeability polymer coating, such as a PTFE coating, to help seal a volatile liquid such as methoxyflurane. Figure 2B The receiving portion 16 and the cylindrical member 20 in the first position are shown, wherein the opener 22 is not engaged with the cylindrical member 20. Figure 1B 、 Figure 3 and Figure 5Shows the receiving portion 16 and the barrel 20 in the second position, wherein the actuator 22 has engaged with the barrel 20 to release the liquid 18.

[0153] The embodiments shown and described herein are adapted to dispense liquids that can vaporize in sufficient amounts at room temperature to be medically effective and do not require storage pressure to assist in dispensing the liquid to the patient.

[0154] The receiving portion 16 may include a window portion 28 that allows visual inspection of the contents of the barrel 20. If the barrel 20 is transparent, such as a glass or plastic vial, the level of the remaining liquid in the barrel 20 will be visible to determine the level of the liquid in the barrel 20 before opening, and thus determine whether all of the liquid 18 has been dispensed from the barrel 20.

[0155] In Figure 4 the barrel 20 is fitted into the receiving portion 16 during assembly. The receiving portion 16 that holds the barrel 20 is loaded into the holder 32. The holder 32 incorporates a number of elements, including a receiver 36 for the wicking material 30 and a docking portion 38 for the receiving portion 16. The docking portion 38 allows the receiving portion 16 to move from the first position to the second position by engaging with the receiving portion 16, as described below.

[0156] The wicking material 30 can be provided in a variety of different configurations. In the embodiments shown in Figure 9A and Figure 9B the wicking material 30 is shown as a single piece in an S-shaped configuration such that the wicking material 30 generally follows the walls of the receiver 36 and spans the center of the receiver 36. Within the receiver 36, the wicking material 30 has voids 31 that allow air to pass freely through, and the air takes up the vapor from the liquid 18 that evaporates on the wicking material 30 and exits the receiver 36 from there. The receiver 36 is located in the chamber 38 within the body 10 during use, as shown in Figure 3 and Figure 5 shown.

[0157] According to this embodiment, the wicking material 30 is firmly held in the receiver 36 of the retainer 32 to ensure that the orientation and arrangement of the wicking material 30 are consistent and stable. The wicking material 30 can be made of a variety of materials, such as polypropylene felt or sintered polypropylene, to provide suitable wicking for a liquid such as methoxyflurane. When assembled, the inhaler device can be packaged and stored for some time before use and the wicking material may not have significant strength. In addition, the inhaler device 10 can be used in a variety of positions and is subject to rough handling before use. It is contemplated that the inhaler device 10 can be used in a variety of environments, including a moving ambulance, during military operations, or in a field situation outside a hospital environment. Therefore, a positioning device as described below can be employed to hold the wicking material in its preferred position.

[0158] Figure 10 Different views of the body 14 of the inhaler device 10 are shown. Specifically, the end of the body 14 is close to the nozzle 12. The tab 150 inside the body 14 helps to position the wicking material 30 at the end of the body 14 opposite the tab 80, and the tab 80 also helps to position the wicking material 30. Optionally, the ridge 152 can extend along all or part of the inside of the body 14 in the chamber 24 to prevent movement of the wicking material within the chamber 24, such as rotation.

[0159] According to a particular embodiment of the inhaler device 10, after the liquid 18 is dispensed onto the wicking material 30, the air flow through the wicking material 30 and any gaps or voids 31 is consistent to provide a reproducible air / vapor ratio. Unlike a pure liquid analgesic, the operation of an analgesic such as methoxyflurane depends on the ratio of the vapor of the active pharmaceutical ingredient to air. If too little vapor is inhaled, the therapeutic effect may be insufficient. The importance of the user being able to control or adjust the concentration or delivery of the active pharmaceutical ingredient is discussed below.

[0160] The receiving portion 16 is capable of moving from Figure 1A and Figure 2B the first position shown in Figure 1B and Figure 3 to the second position shown in Figure 3 and Figure 5 to release the liquid 18. When the receiving portion 16 moves, the barrel 20 is locked in place and moves, and the opener 22 moves to pierce or penetrate the pierceable portion of the barrel 20, as shown in Figure 11A , Figure 11B and Figure 11C shown and described below. If the inhaler device 10 is held substantially vertically or at an angle and the nozzle 12 is kept at the lowest point, the liquid 18 within the barrel 20 will then move from the barrel 20 through Figure 11BThe punctured perforation in the closure 132 shown in the figure passes through the fluid passage 26 and into the chamber 24, where the liquid 18 will be absorbed by the wicking material 30. According to the illustrated embodiment, the wicking material 30 has such a volume that not all of the space within it is filled with fluid, and some air remains as described above.

[0161] In Figure 11A 、 Figure 11B and Figure 11C different configurations of the tubular member are shown. Figure 11A A vial 120 with a closure 122 is shown in the figure. The closure 122 can be attached via heating or ultrasonic welding. The closure 122 can be a plastic material part that is selected to be easily welded to the vial 120, pierceable, and impermeable to the liquid 18.

[0162] Figure 11B The tubular member shown in the figure has a threaded closure 132, which is made of, for example, a hard plastic material. The top of the closure 132 can include a perforation 133, and a membrane 134 can be placed within the closure to fit between the closure 132 and the tubular member 20 when the closure is applied. The closure can be screwed onto the top of the tubular member 20, thereby holding the membrane 134 tightly against the tubular member 20 to prevent leakage during storage prior to use. The membrane 134 can be pierced by an intubation piercing member as shown by the opener 22 in Figure 2B and Figure 3 the figure.

[0163] Figure 11C Another embodiment is shown in the figure, where a tubular member, such as a vial 130 (only the top of the vial is shown), has a crimped closure 140 that has a plug 142 that fits below the closure 140 and can enter through a perforation 144. During assembly, the vial 130 is filled with liquid, and the closure 140 containing the plug 142 is fitted to the vial 130, where the edge of the closure 140 is crimped around the edge of the vial 130. The plug 142 is held tightly between the closure 140 and the vial 130 to provide a seal. The plug 142 is made of a pierceable material, such as butyl rubber, and can be combined with other impermeable membranes (not shown) if needed. In Figure 11A 、 Figure 11B and Figure 11C each case described and shown in the figure, a method of closing that is pierceable and retains liquid during storage is described.

[0164] In use, the patient can place their mouth on the nozzle 12 and inhale air, through as Figure 5The inhaler device shown in draws in air. The air enters through the air inlet 40, for example through perforations 42, then passes around the tubular member 20 and into the chamber 24, where the air interacts with the fluid 18 in the wicking material 30. The wicking material 30 supports the liquid 18 and provides a large surface area interface between the liquid 18 and the air, such that the air flowing through the wicking material 30 picks up vapor from the fluid 18. When the fluid 18 is a volatile fluid such as methoxyflurane, the vapor level can be high enough to produce a therapeutic response in a person inhaling air through the inhaler device 10. To allow the patient to vary the concentration of the air / vapor mixture, a diluter hole 44 is provided in the body 10, which supplies vapor-free air directly to the nozzle. The patient can, for example, completely or partially block the diluter hole 44 with their finger to adjust the vapor concentration in the air leaving the nozzle 12 and entering the patient's body. The uncovered diluter hole 44 dilutes the vapor in the air by allowing air that has not passed through the receptacle 36 to enter the inhaler device 10 before being inhaled by the patient.

[0165] In Figure 13 Another embodiment of the inhaler device 10 shown in , the diluter hole 180 is located at the end of the device adjacent to the nozzle 182. This embodiment allows for easier placement of a one-way valve (not shown), such as a reed valve, to prevent exhaled air from leaving the device, except through the chamber 50.

[0166] Exhaled air from the patient will contain some remaining vapor that has not been absorbed by the patient. The patient can exhale the air back into the nozzle, and then the valve assembly 34 (a new Figure 4 which will require a simple description of the parts) will direct the air containing the remaining vapor to the exhalation chamber 50 as shown in Figure 3 and Figure 5 The chamber 50 can contain an adsorbent material 52, such as activated carbon, to adsorb the remaining vapor in the exhaled air. The exhaled air leaves the inhaler device from the outlet end 54. Figure 4 A partial view of the chamber 50 is shown in , where the chamber body 58 is used to contain the adsorbent material 52, such as activated carbon granules, and to ensure that air does not leak into the body 10. The chamber 50 allows the adsorbent material to be kept separate from the other parts of the inhaler device 10 during assembly.

[0167] In some embodiments (not shown), the chamber 50 is not required and the patient can exhale normally without the aid of the device. The valve assembly 34 will still prevent air flow back through the chamber 24.

[0168] In Figure 6 One embodiment shown in , the end cap 56 is provided to be in the receiving portion 16 in the state as shown in Figure 1A Figure 1AWhen in the first position shown, it engages with the end of the receiving portion 16 and covers the end of the receiving portion 16. In one form, the end cap 56 engages with the receiving portion through, for example, an interference protrusion 57 to engage with the receiving portion 16 in a form - fit manner and prevent it from moving to the second position as shown in Figure 3 and Figure 5 until the end cap 56 is removed.

[0169] In use, the end cap 56 must be removed to expose the receiving portion 16. Then the patient can move the container to the second position, and during this process, the opener 22 engages with the closure (reference numerals and drawings) to pierce the closure and release the liquid 18, as described herein. This has significant advantages compared to prior - art methods with separate vials, for example when trying to open a liquid container and pour the liquid onto a wicking material in a moving vehicle, such as an ambulance.

[0170] Optionally, as shown in Figure 4 the filter assembly 60 is shown to include filter holders 62 on both sides of the filter 64. The filter assembly 60 is located on the nozzle side of the valve assembly 34. This prevents foreign objects from entering the inhaler device 10 and potentially interfering with the valve assembly 34. The filter assembly 60 also prevents materials that may be retained within the inhaler device 10 from being inhaled by the patient. The filter 64 can be a non - woven material or other suitable material. The filter assembly 60 can also prevent droplets of the liquid 18 from entering the patient's mouth or airway, rather than as a vapor mixed with air. Materials such as polypropylene can be used.

[0171] Figure 8 Multiple views of an embodiment of the retainer 32 are shown. The retainer 32 includes an opener 22, a receiver 36 for receiving the receiving portion 16 (not shown), a docking portion 38 for receiving the wicking material 30 (not shown), and a slotted guide 70. The slotted guide 70 has two recessed portions 72 that define the first and second positions of the receiving portion 16. As shown in Figure 8E the central raised portion 74 between the two recessed portions 76 provides positive resistance for the receiving portion to move to the second position without applying a minimum force. Additionally, once in the second position, the central raised portion prevents the receiving portion from sliding away from the opener and can prevent the liquid 18 from being completely discharged into the wicking material 30.

[0172] Figure 8Also shown in the holder 32 is a spacer tab 80 within the receiver 36. The spacer tab 80 ensures that an air gap exists between the wicking material 30 and the fluid passage 26. This helps to ensure that the liquid 18 diffuses around the wicking material 30, the barrel 20 is properly vented to prevent an air lock that would impede the discharge of fluid from the barrel, and air can flow freely through the wicking material and through the receiver 36. This provides better discharge of the barrel 20 and provides a more consistent air and vapor mixture from the initial opening of the receptacle 16 until most of the liquid has vaporized into the air stream through the inhaler device 10. The spacer tab 80 also ensures that the wicking material 30 is held firmly in place.

[0173] In Figure 2B and Figure 3 the opener 22 is shown as one embodiment of a piercing member, and in Figure 8A , Figure 8B and Figure 8C other embodiments are shown. In Figure 8 the opener 22 is shown as having a perforation 22A and a protrusion 23. The protrusion 23 is designed to pierce a pierceable member of the barrel, such as Figure 11A , Figure 11B and Figure 11C the pierceable members shown in.

[0174] In Figure 8A a cannula 100 is shown having a piercing member 101 and holes 102. Although two holes are shown away from the end of the piercing member 101, multiple holes 102 can be used.

[0175] In Figure 8B the piercing member 105 is offset from the centerline of the cannula 104 and the hole 106 exits from the side of the cannula 104.

[0176] In Figure 8C the cannula 108 has a single large hole 110. In the embodiment shown, the arrangement of the holes relative to the cannula is adapted to reduce the chance that a pierceable member will block the holes and prevent the discharge of liquid from the barrel. In some cases, it has been found that if the holes of the piercing member become blocked, the discharge of liquid from the barrel may be incomplete or blocked. The opener 22 has perforations to increase the size of the openings, and other embodiments place one or more holes in positions with a reduced risk of blockage. The choice of embodiment depends on the type of closure used on the barrel.

[0177] In Figure 8F another embodiment of the opener 66 is shown. The opener 66 has two piercing members 67 that surround a fluid passage 68 connected to the fluid passage 26 (not shown). A slot 69 is located between the piercing members 67. In use, when the barrel 20, such asFigure 11B When the cylindrical member 20 shown moves from the first position to the second position, the piercing member 67 pierces the membrane 134 such that the piercing member 67 moves into the cylindrical member 20, but the membrane 134 does not extend beyond the slot 69. The piercing member is designed to cut a circular section from the membrane 134. If the circular section becomes stuck between the piercing members 67 and otherwise blocks the fluid passage 68, the slot 69 allows fluid passage around the circular section.

[0178] In Figure 8G and Figure 8H a piercing member 158 is shown which has a hollow shaft 160 supported in a flow member 162. The hollow shaft can be made of metal and is in the form of a blunt needle with a venting path 164 and is adapted to pierce a stopper 142 of, for example, a vial 130. The flow member 162 can be made of a plastic material and has a number of flow channels 166 to allow liquid to flow from the vial 130 to the wicking material. Figure 13 A piercing member for piercing the stopper 142 is shown, where air can flow into the vial 130 to assist the release of liquid (in this case MeOF or methoxyflurane) through the flow channels 166. This is advantageous where the fluid is stored in an unpressurized vial and thus the fluid may not flow easily if there is no air passage.

[0179] Figure 12 An embodiment of a one-way valve 34 is shown which includes a support 34a and a flexible valve plate 34b. The flexible valve plate 34b has a lobe covering the air passage leading to the chamber 24 containing the wicking material 30 and another lobe covering the return air passage leading to the exhalation chamber 50. A difference in air pressure on each side of the lobe will cause deflection and allow air flow, thus creating a one-way valve for each of the chambers 24 and 50 respectively. The support 34a is located on the opposite side of the valve plate 34b to form a seal when inhaling air. This embodiment provides a simple but effective seal using two easily assembled parts.

[0180] The wicking material 30 can be made of any material suitable for absorbing an inhalable liquid and passively releasing it in the form of a vapor. Wick characteristics are generally understood to include the ability of the material to promote or enhance the rate of evaporation or vaporization of the liquid from the material surface by distributing the liquid throughout the material, whether via attraction, dispersion, pulling or other means, from the initial point of contact of the liquid and / or when the liquid evaporates from the exposed surface area of the material. The wicking material should have a large surface to volume ratio to help ensure good evaporation of the liquid into the surrounding air. In one embodiment, the wicking material is a wicking felt product or a porous polymer material. In a preferred embodiment, the wicking material is a polypropylene wicking felt. In another embodiment, sintered polypropylene material can be used.

[0181] The inhaler devices described in the various embodiments of the present disclosure have the advantage that the ratio of the active pharmaceutical ingredient can be varied by the patient / user in a number of ways. First, the user can control the concentration of the active pharmaceutical ingredient by covering Figure 14 the diluter holes 44 or 180 in to increase the concentration (reduce the additional air flow bypassing the wicking material 30) or by leaving the diluter holes fully or partially open to allow air to mix with the air and vapors flowing through the receiver 36 and the wicking material 30.

[0182] In addition, the user does not need to inhale air only from the inhaler device 10. The user can inhale one or more times through the inhaler device 10 to obtain relief and then breathe normally. The active pharmaceutical ingredient, such as methoxyflurane, will provide pain relief for many minutes after inhalation, so if the user is in pain, the inhaler device 10 is designed to be held and controlled by the user to control the user's own pain. This also allows the user to communicate during the process of using the analgesic, in which case a healthcare professional may be evaluating the user's injury or other information.

[0183] Those skilled in the art of the present disclosure will understand that modifications can be made without departing from the spirit and scope of the present disclosure. The embodiments or examples described herein are therefore to be considered illustrative and not restrictive.

Claims

1. An inhaler device for delivering an inhalable liquid to a patient, the inhaler device comprising: A nozzle; An air inlet; A liquid container for storing the inhalable liquid in a sealed manner; Wicking material for supporting the inhalable liquid; A piercing member configured to pierce the liquid container, the piercing member including at least one fluid channel arranged such that liquid can be discharged from the liquid container through the piercing member; And A first one-way valve configured to allow gas to flow into the nozzle during inhalation and prevent gas from flowing in the opposite direction during exhalation; Wherein, The nozzle, the first one-way valve, the wicking material and the air inlet are fluidly connected to provide an inhalation chamber; and The inhaler device is configured such that: The liquid container can be set in a first position in which the piercing member does not engage with the liquid container and the inhalable liquid remains stored in the liquid container in a sealed manner; The liquid container can be displaced from the first position to a second position such that the piercing member pierces the liquid container to release the inhalable liquid onto the wicking material through the piercing member, whereby during inhalation, air entering the air inlet flows through the inhalation chamber to deliver inhalable liquid vapor from the wicking material to the patient via the nozzle, and The wicking material is spaced apart from the piercing member to allow air to enter the liquid container through the at least one fluid channel, thereby preventing or reducing the restriction of the air lock on the release of the inhalable liquid from the liquid container.

2. The inhaler device according to claim 1, wherein the inhaler device further comprises: A return air chamber fluidly communicating with a second one-way valve such that during inhalation, the first one-way valve is open and the second one-way valve is closed, and during exhalation, the first one-way valve is closed and the second one-way valve is open to allow exhaled air to flow from the nozzle through the return air chamber.

3. The inhaler device according to claim 2, wherein, The return air chamber includes filter material configured to filter volatile liquid vapor in the exhaled breath of the patient during exhalation.

4. The inhaler device according to claim 3, wherein, The filter material includes activated carbon.

5. The inhaler device according to claim 4, wherein, The filter material includes activated carbon particles.

6. The inhaler device according to any one of claims 1 to 5, wherein, The liquid container contains a halogenated volatile liquid.

7. The inhaler device according to claim 6, wherein, The halogenated volatile liquid is selected from the group consisting of: halothane (2-bromo-2-chloro-1,1,1-trifluoroethane), sevoflurane (fluoromethyl 2,2,2-trifluoro-1-(trifluoromethyl)ethyl ether), desflurane (2-difluoromethyl-1,2,2,2-tetrafluoroethyl ether), isoflurane (1-chloro-2,2,2-trifluoroethyl difluoromethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyl difluoromethyl ether), and methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether).

8. The inhaler device according to claim 7, wherein, The halogenated volatile liquid is methoxyflurane.

9. The inhaler device according to any one of claims 1 to 5, wherein, The inhaler device includes a spacer tab configured to space apart the wicking material from the piercing member.

10. The inhaler device according to any one of claims 1 to 5, wherein, When the liquid container is moved from the first position to the second position, the wicking material and / or the piercing member remain stationary within the inhaler device.

11. The inhaler device according to any one of claims 1 to 5, wherein, The liquid container includes only a single area configured to be pierced.

12. The inhaler device according to any one of claims 1 to 5, wherein, The inhaler device is configured to enable air to pass through or around the liquid container.

13. The inhaler device according to any one of claims 1 to 5, wherein, The inhaler device is configured to prevent air from passing through the liquid container.

14. The inhaler device according to any one of claims 1 to 5, wherein, The inhaler device includes a diluter aperture positioned to enable a portion of the inhaled air to bypass the wicking material before entering the nozzle.

15. The inhaler device according to claim 14, wherein, The diluter aperture is positioned and configured to enable a patient to restrict or block the diluter aperture with a finger.

16. The inhaler device according to any one of claims 1 to 5, wherein, The nozzle includes a filter configured to reduce or prevent a patient from inhaling droplets.

17. The inhaler device according to claim 16, wherein, The filter is formed from a polymeric non-woven material.

18. The inhaler device according to any one of claims 1 to 5, wherein, The inhaler device is configured to be able to replace the liquid container and / or the wicking material.

19. The inhaler device according to any one of claims 1 to 5, wherein, The wicking material is configured to enable inhaled air to pass through and along multiple surfaces of the wicking material.

20. The inhaler device according to claim 19, wherein The wicking material is configured to enable inhaled air to pass through and along a first surface and a reverse surface of the wicking material.

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