Inhalation device for liquids that can be inhaled

Abstract

The present invention relates to an inhalation device for administering inhalable liquids, particularly inhalable liquids such as halogenated volatile liquids, to a patient. According to certain embodiments, the inhalation device may include a liquid container for hermetically storing the inhalable liquid, a wicking material for supporting the inhalable liquid, and a piercing member configured to pierce the liquid container. The liquid container may be positioned in a first position in which the piercing member does not engage the liquid container, leaving the inhalable liquid sealed and stored in the liquid container. The liquid container may be displaced from the first position to a second position, whereby the piercing member pierces the storage container, releasing the inhalable liquid toward the wicking material. Thus, during inhalation, inhalable liquid vapor is delivered from the wicking material to the patient.

Description

Technical Field

[0001] The present invention relates to an inhalation device for administering to a patient an inhalable liquid, particularly an inhalable volatile liquid such as a halogenated volatile liquid.

Background Art

[0002] The storage and administration to a patient of an inhalable liquid containing an active agent, or an inhalable liquid that is itself an active agent, generally presents problems. Active agents such as therapeutic agents and pharmaceuticals are often formulated as oral administrations in the form of tablets and capsules, nasal administrations in the form of sprays, and liquid preparations for intravenous administration, depending on many factors.

[0003] For example, when it is advantageous to administer an active agent to a patient's lungs for the treatment or alleviation of a respiratory disease, the active agent can be administered alone by oral inhalation or in combination with nasal inhalation. Suitable inhalation devices can include, for example, metered-dose inhalers and dry powder inhalers. This type of inhalation device typically requires pressurizing means to supply the active agent to the desired site of action in the lungs. Furthermore, a liquid containing an active agent, or a liquid that is itself an active agent, usually needs to be converted into an inhalable respiratory form suitable for supply at the time of administration.

[0004] To convert a liquid into an inhalable form, such as by nebulization or aerosolization into respirable-sized droplets, or by heating to form a vapor, the supply device needs to include moving, mechanical, heating, and / or electrical means. For this reason, the design, manufacture, and costs for end-users, operability, and patient use are complicated.

[0005] It is known to use a volatile liquid as an active agent or a volatile liquid containing an active agent. One such example is a halogenated volatile liquid. Since halogenated volatile liquids have been described as useful for inducing and / or maintaining anesthesia (including amnesia, muscle paralysis, and / or sedation) and / or analgesia, they can be useful 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, fluoroxene, halothane, and methoxyflurane were used clinically in the 1950s, and thereafter, enflurane, isoflurane, sevoflurane, and desflurane were developed and are currently used clinically in several countries (Terrell, R. C. Anesthesiology (2008) 108(3): 531 - 3).

[0006] When used for general anesthesia, halogenated volatile liquids can be supplied to a patient under positive pressure via a supply system that includes a vaporizer and a flow of breathable carrier gas. More recently, halogenated volatile liquids have been formulated for use in local or topical anesthesia and are supplied via non - inhalation routes. Examples include formulations as micro - droplets for intradermal or intravenous injection (e.g., US4725442; C / 143964); compositions suitable for formulation as solutions, suspensions, creams, pastes, oils, lotions, gels, foams, hydrogels, ointments, liposomes, emulsions, liquid crystal emulsions, and nano - emulsions for topical, intrathecal, epidural, transdermal, topical, oral, intra - articular, mucosal, buccal, rectal, vaginal, intramuscular, intra - vesical, and subcutaneous administration (e.g., WO2008 / 070490, WO2009 / 094460, WO2010 / 129686); and stable injectable liquid formulations (WO2013 / 016511).

[0007] The main considerations regarding the safe storage and handling of volatile liquids generally relate to the rise in vapor pressure, the robustness of the container, and the integrity of the container seal. The chemical properties of the volatile liquid will also be important if the active agent can penetrate, solubilize, or react with the container material during storage. Many storage containers for halogenated volatile liquids are described, including the following. Hard polymer containers of various shapes and sizes in place of glass vials; for example, bottles with caps, large tanks, shipping containers (e.g., WO1999 / 034762, WO2012 / 116187); Hard polymer bottles fitted with valve assemblies without gaskets, and flexible containers having threaded outlets for fluid connection to supply liquid anesthetics to an anesthetic machine or vaporizer (e.g., WO2010 / 135436, WO2013 / 106608, WO2013 / 149263, WO2015 / 034978); Containers having capped membranes for supplying stored liquid anesthetics to a vaporizer via a grooved tube (WO2009 / 117529); Or hard polymer and aluminum containers coated with materials that impart or enhance the vapor barrier properties or inertness of the container (WO2002 / 022195, WO2003 / 032890, WO2010 / 129796).

[0008] Although the formulation of volatile liquids such as non-inhaled halogenated volatile liquids and the containers for storing them have advanced in various ways, there is still a need for inhaled volatile liquids and devices for storing and / or administering them to patients.

[0009] Attempts to design new inhalers for inhalable pharmaceuticals are generally still in progress. For example, WO2008 / 040062 describes various inhaler device concepts that rely on complex structures and moving parts to store and / or supply inhalable liquids and powder solids to the patient's mouth or nose. The various devices described above are adapted to hold one or two drug containers in the form of pressurized canisters, ampoules, vials, and plungers. The device is described as operating by sliding the outer wall of the device relative to the inner wall of the device to supply the liquid drug from the drug container. In many embodiments, the device includes a movable mouthpiece that deploys to open an air path. The device is also described as including one or more one-way valves for providing a one-way air flow to one or both of inspiration (inhaled air) and expiration (exhaled air) (a series of one-way valves that direct the inspiration and expiration flows are generally also described in WO2007 / 033400, which is incorporated by reference into the device previously described in WO1997 / 003711).

[0010] When needed in use, the device of WO2008 / 040062 is claimed to be able to release the drug by punch means, i.e., two punches that pierce two respective breakable ends of the drug container. However, generally various other means are described, including: pressurizing means (e.g., by a pressurized canister); breakable means (e.g., rupturing an ampoule with a striker, or punching a breakable membrane or seal of a vial with punch means); crushing means (e.g., crushing a vial with a plunger); removing means (e.g., removing a screwless cap from a vial); pushing means (e.g., pushing a drug into a plunger barrel).

[0011] However, inhalable liquids such as halogenated volatile liquids require an effective air chamber into which the above can evaporate and flow in, and enable an effective air flow to pass through the air / above chamber and be supplied to the patient. Therefore, 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 may not actually function as expected. This is because the wall of the liquid storage container itself cannot effectively expose the evaporation means (i.e., the wick / core) to the effective air flow.

[0012] Inhalation devices useful for administering inhalable liquids are generally considered to operate by either passive or active means to supply the active agent to the patient. Inhalation devices with active means include pressurization, movement, mechanical, heating and / or electrical means and can, for example, nebulize, vaporize, and / or generally supply the active agent. In contrast, inhalation devices with passive means rely only on ambient conditions and the vaporization or evaporation of the active agent in the patient's respiration to supply the active agent.

[0013] The Analgizer (trademark) inhalation device (Abbott Laboratories Corporation) is an example of a device that operates by passive means to supply an inhalable liquid. According to the USPTO TESS database, Analgizer (trademark) is a registered trademark (now expired) for an inhaler for self-administration with monitoring of inhaled anesthesia and was first used in 1968. The Analgizer (trademark) was a very simple device consisting of a white cylindrical open-ended polyethylene tube with a mouthpiece and an absorbent core made of polypropylene tightly wound in a "Swiss roll" pattern, i.e., in cross-section. The inhaled anesthetic methoxyflurane (15 ml) was injected into the base of the open end of the inhaler and the tightly wound core immediately before use. And the patient could self-administer the liquid anesthetic by inhaling through the mouthpiece.

[0014] Subsequently, the Green Whistle (trademark) inhalation device (Medical Developments International Limited) was developed in the 1990s and has since been used in Australia for the supply of methoxyflurane (1.5 mL or 3 mL, in a storage amber glass vial with a screw cap) as an analgesic. Although similar to the Analgizer (trademark) in terms of simplicity of design, the Green Whistle (trademark) has had certain functional improvements introduced. For example, a one-way valve is provided at the proximal end to prevent the loss of drug vapor from the device during the patient's exhalation, and an activated carbon ("AC") chamber is provided that is designed to be externally attached to the dilution hole of the mouthpiece to filter the exhaled drug vapor. As additional design changes to the proximal end, there is a cap lug to assist in removing the cap from the glass vial that stores the drug to be administered, a dome to facilitate spreading the injected liquid over an "S-shaped" wick (cross-sectional view), or instead of the dome, an inlet nipple to which a line for breathable gas can be attached to direct the gas passing through the device. The Green Whistle (trademark) device is designed for use by a single patient.

[0015] Methoxyflurane (Penthrox®, Medical Developments International Limited) provides a non-narcotic, i.e., non-opioid, analgesic as an alternative to common analgesics such as morphine and fentanyl. Further, since methoxyflurane serves as an alternative to analgesics administered orally or intravenously to patients, it can be particularly useful in situations where rapid analgesia is required at the clinical, surgical (e.g., pre- and post-operative), and / or emergency (e.g., emergency department, triage management, first responders such as emergency team members and search and rescue teams) sites. However, the Green Whistle™ device is currently the only device commercially available for administering methoxyflurane. According to the instructions for use of this device, the administrator needs to keep the methoxyflurane bottle upright, loosen the bottle cap using the base of the inhaler, remove the cap by hand, then tilt the inhaler at 45 degrees and pour the contents of the bottle into the base while rotating the device. Alternatively, the AC chamber may be externally attached to the device either before or later. Although this device is effective, due to the existence of many steps and separate parts, the administrator or self-administering person may have difficulty handling it in high-stress and / or emergency situations.

[0016] Embodiments of the present invention aim to address one or more of the above-mentioned drawbacks and / or at least provide useful alternatives to the public.

[0017] References in this specification to prior publications or information derived therefrom, or to known matters, are not to be taken as an acknowledgment or approval that prior publications or information derived therefrom, or known matters, form part of the common general knowledge in the field of endeavor relevant to this specification, nor as any form of suggestion that they should be so regarded.

Summary of the Invention

[0018] According to a first aspect of the present invention, there is provided an inhalation device for supplying an inhalable liquid to a patient, a mouthpiece, an air inlet, 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, a first one-way valve configured to allow gas to flow into the mouthpiece during inhalation and prevent gas from flowing in the reverse direction during exhalation, In an inhalation device comprising: the mouthpiece, the first one-way valve, the wicking material, and the air inlet are connected so that fluid can flow to provide an inhalation chamber, the inhalation device is configured such that the liquid container can be provided in a first position where the piercing member does not engage with the liquid container and the inhalable liquid remains hermetically stored in the liquid container, the inhalation device is configured such that, during inhalation, by displacing the liquid container from the first position to a second position by the piercing member piercing the storage container to release the inhalable liquid toward the wicking material, air flowing into the air inlet flows through the inhalation chamber, and inhalable liquid vapor can be provided from the wicking material to the patient via the mouthpiece. An inhalation device is provided.

[0019] In one embodiment according to the first aspect, the inhalation device further comprises a return air chamber in fluid communication with a second one-way valve, whereby, 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, so that exhaled air can flow from the mouthpiece through the return air chamber.

[0020] In one embodiment according to the first aspect, the return air chamber comprises a filtering material configured to filter volatile liquid vapor from the patient's exhalation during exhalation.

[0021] In one embodiment according to the first aspect, the filtering material includes activated carbon or activated carbon pellets.

[0022] In one embodiment according to the first aspect, the liquid container contains a halogenated volatile liquid.

[0023] In one 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).

[0024] In one embodiment according to the first aspect, the halogenated volatile liquid is methoxyflurane.

[0025] In one embodiment according to the first aspect, the perforated 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 at least one of the channels toward the wicking material.

[0026] In one embodiment according to the first aspect, the wicking material is spaced apart from the perforated member, enabling air to pass through at least one of the channels into the liquid container, thereby preventing or reducing the restriction of the release of the inhalable liquid from the liquid container by an air lock.

[0027] In one embodiment according to the first aspect, the inhalation device comprises a spacer tab configured to space the wicking material apart from the perforated member.

[0028] In one embodiment according to the first aspect, while the liquid container is being displaced from the first position to the second position, the wicking material and / or the perforated member remain stationary within the inhalation device.

[0029] In one embodiment according to the first aspect, the liquid container comprises only a single region configured to be perforated.

[0030] In one embodiment according to the first aspect, the inhalation device is configured such that air can pass near or around the liquid container, or the inhalation device is configured such that air does not pass through the liquid container.

[0031] In one embodiment according to the first aspect, the inhalation device comprises a dilution hole arranged such that a portion of the inhaled air can bypass the wicking material before passing through the mouthpiece.

[0032] In one embodiment according to the first aspect, the dilution hole is positioned and configured such that the patient can restrict or block the dilution hole with a finger.

[0033] In one embodiment according to the first aspect, the mouthpiece comprises a filter configured to reduce or prevent the patient from inhaling droplets.

[0034] In one embodiment according to the first aspect, the filter is formed from a polymeric non-woven material.

[0035] In one embodiment according to the first aspect, the inhalation device is configured to enable replacement of the liquid container and / or the wicking material.

[0036] In one embodiment according to the first aspect, the wicking material is configured such that inhaled air can pass through and along a plurality of surfaces of the wicking material, or the wicking material is configured such that inhaled air can pass through and along a first side and a back side of the wicking material.

[0037] Throughout this specification and the following claims, unless the context requires otherwise, the following definitions shall apply. According to a first aspect of the invention, terms such as "side", "end", "top", "bottom", "upper", "lower", etc. are used only to describe elements in relation to each other, and are not intended to describe a particular orientation of the device, indicate or imply a required or essential orientation of the device, or specify how the invention described herein is to be used, attached, displayed, or positioned in use. "(A plurality of) active agents" refers to therapeutic and non-therapeutic agents and compounds, formulations, and compositions containing them, and "(a single) active agent" has a corresponding meaning. "Air" or "gas" may be used interchangeably. "Relieve", "relieving" and their variants refer to reducing, decreasing, alleviating, improving or enhancing the patient's condition and / or the symptoms and / or underlying causes of the disease. "Comprise" and its variants are to be understood to mean including the stated integer or step, or group of integers or steps, or plurality of steps, but not to exclude any other integer or step, or group of integers or steps. "Delivery volume" refers to the dose of inhalable liquid or active agent to be administered to a patient. "Filtering" and its variants refer to the ability of a substance to absorb, adsorb, capture, trap, scavenge, clean, or partially or wholly remove inhalable volatile liquid vapors from a patient's exhalation during exhalation. "Halogenated volatile liquid" refers to (i) a volatile liquid containing at least one halogen atom selected from the group consisting of chlorine (Cl), bromine (Br), fluorine (F) and iodine (I) atoms, or (ii) a volatile liquid comprising an active agent containing at least one halogen atom selected from the group consisting of chlorine (Cl), bromine (Br), fluorine (F) and iodine (I) atoms. In a plurality of embodiments, halogenated, particularly fluorinated hydrocarbons, and halogenated, particularly fluorinated ethers may be suitable. In a plurality of embodiments, halogenated ethers may be particularly suitable. Halogenated ethers may 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-trifluoroethyldifluoromethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyldifluoromethyl ether) and methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether). "Inhalable liquid" refers to a liquid containing an active agent, or a liquid that is itself an active agent and is easily inhalable, or can be inhaled by a patient, or can be adapted to be inhaled. In a plurality of embodiments, inhalable volatile liquids, particularly halogenated volatile liquids, are suitable. "Inhalation", "inhalable" and their variants refer to ingestion by a patient that includes, but is not limited to, for example, air, breathable gas, inhalable liquid, etc., and includes both oral inhalation and nasal inhalation. In a plurality of embodiments, oral inhalation is particularly suitable. "And / or" means "and" and "or" when both are acceptable in the context. "Patient" refers to both human patients and veterinary patients. In a plurality of embodiments, human patients may be particularly suitable. Thus, references to a patient are to be understood to mean a human or animal to whom an inhalable liquid is administered. Also, in the case of human patients, it is to be understood that administration includes self-administration. "Pharmaceutical" refers to an agent for treating the symptoms and / or the underlying cause of a disease in a patient, or a compound, formulation, or composition containing an agent. The term "pharmaceutical" may be used interchangeably with "therapeutic agent" or "active agent". "Respiration", "respiratory", and variations thereof refer to the act of a patient breathing, inhaling, taking in, and exhaling, including, but not limited to, for example, air, breathable gas, inhalable liquid, and active ingredients. "Room temperature" refers to an ambient temperature that may be, for example, between 10°C and 40°C, but more typically between 15°C and 30°C. "Therapeutic agent" refers to an active agent, or a compound, formulation, or composition containing an active agent (including biological compounds, formulations, and compositions) that can treat a patient, provide a therapeutic or medical benefit to a patient, or has or requires regulatory and / or marketing approval for therapeutic use in a patient. Therapeutic agents include pharmaceuticals. In contrast, "non-therapeutic agent" refers to, for example, an active agent that does not have or require regulatory and / or marketing approval for therapeutic use, such as smokeless tobacco products and electronic cigarettes, or something that does not have an approved or specified therapeutic use but that a patient can use for non-therapeutic reasons, such as general health, well-being, or physiological benefits, such as dietary supplements. "Treat", "treatment", and variations thereof refer to the alleviation, modulation, adjustment, or cessation of a condition and / or the symptoms and / or the underlying cause of a disease in a patient. In a plurality of embodiments, treatment may include prophylactic treatment. "Volatile liquid" refers to a substance that exists primarily in liquid form but readily forms vapor and evaporates or vaporizes to exist, for example, in part in the form of vapor under ambient conditions of room temperature and normal atmospheric pressure.

Brief Description of the Drawings

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Mode for Carrying Out the Invention

[0039] 10 Inhalation device 11 Hand strap 12 Mouthpiece 14 Main body 16 Receptacle 18 Liquid 20 Cartridge 22 Opener 23 Protrusion 24 Chamber 26 Fluid path 28 Window 30 Wick material 31 Gap 32 Holder 34 Valve assembly 34a Valve support 34b Valve plate 36 Receiver 38 Dock 40 Air inlet 42 Aperture 44 Dilution hole 50 Expiratory chamber 52 Adsorbent 54 Outlet port 56 End cap 58 Chamber body 60 Filter assembly 64 Filter 70 Grooved guide 72 Recess 74 Central protrusion 76 Recess 80 Spacer tab 100 Cannula 101 Piercing member 102 Bore 104 Cannula 105 Piercing member 106 Bore 108 Cannula 110 Bore 120 Vial 122 Closure 130 Vial 132 Screw-in closure 133 Aperture 134 Membrane 140 Closure 142 Plug 150 Tab 152 Ridge 158 Piercing member 160 Hollow shaft 162 Flow member 164 Venting path 166 channels 180 dilution hole 182 mouthpiece

[0040] Broadly speaking, the present invention relates to a novel inhalation device for administering to a patient a liquid that can be inhaled, such as a halogenated volatile liquid, in particular methoxyflurane for use as an analgesic. The present invention will be further described with reference to the embodiments shown below and in the drawings.

[0041] Embodiments of the present invention will be described with reference to non-limiting examples.

[0042] According to the first embodiment, FIGS. 1A and 1B show an inhalation device 10 having a hand strap 11, a mouthpiece 12, a body 14, a receptacle 16, and an end cap 56. In FIGS. 1A and 1B, the receptacle 16 is in a first position and a second position, respectively. In the first position shown in FIG. 1A, the receptacle 16 protrudes from the body 14 of the inhalation device 10 and can be covered by the end cap 56. In FIG. 1B, the receptacle 16 has been moved to the second position, where, as will be described later, the receptacle 16 has moved into the body 14 of the inhalation device 10.

[0043] Further details of the inhalation device 10 are shown in FIGS. 2A and 2B. Here, the receptacle 16 is in a first configuration and partially houses a cartridge 20 within the body 14 of the inhalation device 10. The cartridge 20 can hold a fluid, such as a liquid 18 such as a volatile liquid like methoxyflurane. Within the body 14, there is an opener 22 connected to a chamber 24 by a fluid path 26. The chamber 24 can include a wicking material 30.

[0044] In FIGS. 1A and 2B, the cartridge 20 is disposed inside the receptacle 16. Thereby, air flows around the cartridge 20, passes through the receptacle 16 and into the chamber 24. An example of the air flow is as shown in FIG. 5. In other embodiments (not shown), the receptacle 16 and the cartridge 20 can be integrated with each other, for example, can be molded from a single piece. In other embodiments (not shown), the air flow into the chamber 24 can pass through the cartridge 20 around the receptacle 16, or can be completely separated from the receptacle 16 and the cartridge 20.

[0045] As shown in FIG. 4, the cartridge 20 can be loaded into the receptacle 16 during the assembly or manufacture of the completed inhaler 10. The cartridge 20 can be a vial, for example, a 5 ml vial with a glass wall and a screw-on cap. The cap can have a pierceable portion, for example, a butyl rubber section coated with a low permeability polymer coating such as PTFE coating to assist in sealing a volatile liquid such as methoxyflurane. FIG. 2 shows the receptacle 16 and the cartridge 20 in the first position. Here, the opener 22 is not engaged with the cartridge 20. FIGS. 1B, 3 and 5 show the receptacle 16 and the cartridge 20 in the second position. Here, the opener 22 is engaged with the cartridge 20 to release the liquid 18.

[0046] The embodiments illustrated and described herein are adapted to dispense a liquid that can vaporize at room temperature in an amount sufficient to be medically effective and do not require a storage pressure to assist in the dispensing of the liquid to the patient.

[0047] The receptacle 16 can include a window 28 that allows visual inspection of the contents of the cartridge 20. If the cartridge 20 is transparent, for example, a glass or plastic vial, the level of the liquid remaining in the cartridge 20 can be seen, so that the level of the liquid in the cartridge 20 can be determined before opening to determine whether all of the liquid 18 has been dispensed from the cartridge 20.

[0048] In FIG. 4, the cartridge 20 is inserted into the receptacle 16 during assembly. The receptacle 16 holding the cartridge 20 is loaded into the holder 32. The holder 32 incorporates a plurality of elements including a receiver 36 for the wicking material 30 and a dock 38 for the receptacle 16. By engaging with the receptacle 16, the dock 38 enables the receptacle 16 to move from the first position to the second position as will be described later.

[0049] According to various different configurations, the wicking material 30 can be provided. In the embodiment shown in FIG. 9, the wicking material 30 is illustrated as a single part in an S-shape. Thereby, the wicking material 30 is disposed generally along the wall of the receiver 36 and across the center of the receiver 36. Inside the receiver 36, the wicking material 30 has a gap 31 that permits free flow of air. The air takes in vapor from the liquid 18 that evaporates at the wicking material 30 and flows out of the receiver 36. As shown in FIGS. 3 and 5, the air is in the chamber 38 within the main body 10 during use.

[0050] According to this embodiment, the wicking material 30 is firmly held within the receiver 36 of the holder 32, ensuring that the orientation and placement of the wicking material 30 are consistently stable. The wicking material 30 can be composed of various materials such as polypropylene felt or sintered polypropylene so as to provide suitable wicking for liquids such as methoxyflurane. After assembly, the inhalation device can be packaged and stored until use, although the wicking material may not have great strength. Further, the inhalation device 10 can be used in a variety of locations and can be handled roughly before use. The inhalation device 10 is envisioned to be used in a variety of environments including in a moving ambulance, during military operations, or at the scene outside a hospital environment. Thus, a positioning device, as will be described later, can be employed to hold the wicking material in its preferred position.

[0051] FIG. 10 is various views of the body 14 of the inhalation device 10. Specifically, it is the end portion of the body 14 close to the mouthpiece 12. The tab 150 of the body 14 assists in positioning the wicking material 30 at the end of the body 14 opposite the tab 80. The tab 80 also assists in positioning the wicking material 30. Alternatively, the ridge 152 extends wholly or partially along the inside of the body 14 in the chamber 24 and may prevent movement, such as rotation, of the wicking material within the chamber 24.

[0052] According to a particular embodiment of the inhalation device 10, the airflow through the wicking material 30 and any gaps or spaces 31 after dispersion of the liquid 18 into the wicking material 30 is consistent so as to provide a reproducible air / vapor ratio. The operation of an analgesic such as methoxyflurane, which is different from a purely liquid analgesic, depends on the ratio of the vapor of the active pharmaceutical ingredient to the air. If too little vapor is inhaled, the therapeutic effect may not be fully obtained. The importance of the user being able to control or regulate the concentration or supply of the pharmaceutical active ingredient will be described later.

[0053] The receptacle 16 is movable from the first position shown in FIGS. 1A and 2 to the second position shown in FIGS. 1B and 3 to release the liquid 18. The cartridge 20 moves while being positioned as the receptacle 16 moves. Then, as shown in FIGS. 3 and 5, the opener 22 moves to pierce or penetrate the pierceable portion of the cartridge 20. Different embodiments of the cartridge and the pierceable portion are shown in FIGS. 11A, 11B and 11C and will be described below. When the inhalation device 10 is held substantially vertically or inclined with the mouthpiece 12 at the bottom, the liquid 18 in the cartridge 20 flows from the cartridge 20 through the fluid path 26 through the pierced aperture of the closure body 132 shown in FIG. 11B into the chamber 24. Here, the liquid 18 will be absorbed by the wicking material 30. According to the illustrated embodiment, the wicking material 30 has a volume such that not all of the internal space is filled with fluid and some air remains as described above.

[0054] Different configurations of the cartridge are shown in FIGS. 10A, 10B, and 10C. The vial shown in FIG. 11A has a closure body 122 that can be attached by heat or ultrasonic welding. The closure body 122 can be a component made of a plastic material selected such that welding to the vial 120 is easy, pierceable, and impermeable to the liquid 18.

[0055] The cartridge 20 shown in FIG. 11B has a screw-on closure body 132 made of, for example, a rigid plastic material. The top of the closure body 132 can include an aperture 133. Also, a membrane 134 can be disposed inside the closure body such that it fits between the closure body 132 and the cartridge 20 when the closure body is applied. The closure body 132 can be screwed onto the top of the cartridge 20 while holding the membrane 134 tightly against the cartridge 20 to prevent leakage during storage prior to use. The membrane 134 can be pierceable by a cannula-type piercing member shown as the opener 22 in FIGS. 2B and 3.

[0056] A further embodiment is shown in FIG. 11C. Here, a cartridge such as the vial 130 (only the top is shown) has a crimp-type closure body 140. The closure body 140 has a plug 142 fitted below the closure body 140 and having an aperture 144 through which access is possible. At the time of assembly, the vial 130 is filled with liquid and the closure body 140 containing the plug 142 is fitted into the vial 130. Here, the edge of the closure body 140 is crimped around the edge of the vial 130. The plug 142 is held tightly between the closure body 140 and the vial 130 to provide a seal. The plug 142 is made of a pierceable material such as butyl rubber and can include a further impermeable membrane (not shown) if necessary. In each of the examples described and illustrated in FIGS. 10A, 10B, and 10C, a closure body method is described that is pierceable and maintains the liquid during storage.

[0057] In use, the patient applies their mouth to the mouthpiece 12 and inhales air, which can be drawn in through the inhalation device as shown in Figure 5. The air enters the air inlet 40, for example, through the aperture 42 and flows into the chamber 24 around the cartridge 20. Here, the air interacts with the fluid 18 within the wicking material 30. The wicking material 30 supports the liquid 18 and provides a large interface area between the liquid 18 and the air. As a result, the air flowing through the wicking material 30 takes up vapor from the fluid 18. If the fluid 18 is a volatile fluid such as methoxyflurane, the vapor level can be made high enough to produce a therapeutic response in the person inhaling air through the inhalation device 10. A dilution hole 44 is provided in the body 10 so that the patient can change the concentration of the air / vapor mixture. The dilution hole 44 provides air that does not contain vapor directly to the mouthpiece. The patient can adjust the concentration of the vapor in the air that is present in the mouthpiece 12 and flows into the patient by, for example, completely or partially blocking the dilution hole 44 with a finger. When the dilution hole 44 is opened, air that has not passed through the receiver 36 can flow into the inhalation device 10 before being inhaled by the patient, thereby diluting the vapor in the air.

[0058] In another embodiment of the inhalation device 10 shown in Figure 13, the dilution hole 180 is located at the end of the device adjacent to the mouthpiece 182. In this embodiment, it is easier to arrange a one-way valve (not shown) such as a reed valve. The purpose is to prevent the exhaled air (expired air) from flowing out of the device except through the chamber 50.

[0059] The exhalation from the patient may contain a certain amount of vapor that was not absorbed by the patient. The patient can exhale the air and return it to the mouthpiece. At this time, as shown in FIGS. 3 and 5, the valve assembly 34 (the new FIG. 4 requires a simple description of the components) directs the air containing the remaining vapor into the exhalation chamber 50. The chamber 50 may include an adsorbent 52 such as activated carbon for adsorbing the vapor remaining in the exhalation. The exhalation exits the inhalation device through the outlet port 54. A partial view of the chamber 50 is shown in FIG. 4. The chamber body 58 houses the adsorbent 52 such as activated carbon pellets and is used to ensure that air does not leak out of the body 10. The chamber 50 allows the retained adsorbent to be separated from the other components of the inhalation device 10 during assembly.

[0060] In a plurality of embodiments (not shown), the chamber 50 is not required. And usually, the patient can exhale outside the device. Even in this case, the valve assembly 34 can prevent the air flow from returning through the chamber 24.

[0061] In one embodiment shown in FIG. 6, when the receptacle 16 is in the first position shown in FIG. 1, the end cap 56 is provided to engage and cover the end of the receptacle 16. In one shape, the end cap 56 engages with the receptacle, for example, by a buffer projection 57, and is positively engaged with the receptacle 16 so as not to move to the second position shown in FIGS. 3 and 5 until the end cap 56 is removed.

[0062] During use, it is necessary to remove the end cap 56 to expose the receptacle 16. And the patient can move the receptacle to the second position. In this process, the opener 22 engages with the closure body (number and photo) to pierce the closure body and release the liquid 18 as described above. This is very advantageous compared to the prior art method with a separate vial, for example, when trying to open the liquid container and pour the liquid onto the wicking material in a moving vehicle such as an ambulance.

[0063] Optionally, as shown in FIG. 4, a filter assembly 60 having filter holders 62 on both sides of a filter 64 is shown. The filter assembly 60 is disposed on the mouthpiece side of the valve assembly 34. This prevents foreign matter from entering the inhalation device 10 and interfering with the mouth assembly 34. Also, the filter assembly 60 prevents a patient from inhaling materials that may be retained within the inhalation device 10. The filter 64 can be a non-woven material or other suitable material. Also, droplets of the liquid 18 can be prevented from entering the patient's mouth or airway as non-vapor mixed with air. A material such as polypropylene can be used.

[0064] FIG. 8 shows a plurality of views of an embodiment of the holder 32. The holder 32 includes an opener 22, a receiver 36 for receiving a receptacle 16 (not shown), a dock 38 for receiving a wicking material 30 (not shown), and a grooved guide 70. The grooved guide 70 has two recesses 72 that define a first position and a second position of the receptacle 16. A central protrusion 74 between two recesses 76 shown in FIG. 8E provides positive resistance to movement of the receptacle to the second position without applying minimal force. Further, in the second position, the central protrusion prevents the receptacle from sliding away from the opener and, optionally, prevents complete drainage of the liquid to the wicking material 30.

[0065] Also, FIG. 8 shows a spacer tab 80 within the receiver 36 of the holder 32. The spacer tab 80 ensures that there is a gap between the wicking material 30 and the fluid path 26. This supports the following. That is, the liquid 18 spreads around the wicking material 30, the cartridge 20 is properly vented to prevent an air lock that would prevent the liquid from being discharged from the cartridge, and air is supported to flow freely through the receiver 36 over the wicking material 30. This provides better discharge of the cartridge 20 and more consistent mixing of air into vapor from the first opening of the receptacle 16 until most of the liquid vaporizes into the air stream passing through the inhalation device 10. Also, the spacer tab 80 ensures that the wicking material 30 is firmly held in place.

[0066] Figures 2B and 3 show an opener 22 as an embodiment of a piercing member. Further embodiments are shown in FIGS. 8A, 8B, and 8C. FIG. 8 shows an opener 22 having an aperture 22A and a protrusion 23. The protrusion 23 is designed to pierce a pierceable member of a cartridge as shown in FIGS. 10A, 10B, and 10C.

[0067] FIG. 8A shows a cannula 100 having a piercing member 101 and a bore 102. Two distal from the end of the piercing member 101 are shown, but a plurality of bores 102 may be used.

[0068] In FIG. 8B, the piercing member 105 is offset from the centerline of the cannula 104. The bore 106 exits from the side of the cannula 104.

[0069] In FIG. 8C, the cannula 108 has a single large bore 110. In the illustrated embodiment, the placement of the bore with respect to the cannula is adapted to reduce the risk that the piercing member blocks the bore and prevents liquid from being discharged from the cartridge. In some cases, it has been found that if the bore of the piercing member is blocked, the discharge of liquid from the cartridge may be insufficient or inhibited. The opener 22 has an aperture so as to increase the opening size. In other embodiments, the single or multiple bores are arranged in positions where the risk of blockage is reduced. The choice of embodiment depends on the type of closure used for the cartridge.

[0070] FIG. 8F shows a further embodiment of the opener 66. The opener 66 has two piercing members 67 surrounding a fluid channel 68 that connects to a fluid path 26 (not shown). A slot 69 is disposed between the piercing members 67. In use, when the cartridge 20 as shown in FIG. 11B is moved from a first position to a second position, the piercing members 67 enter into the cartridge 20, and in such a manner that the membrane 134 does not extend beyond the slot 69, the piercing members 67 pierce the membrane 134. The piercing members are designed to cut a round portion from the membrane 134. The slot 69 leaves room for the fluid path around the round section in case the round portion is pinched between the piercing members 67 or in some cases blocks the fluid channel 68.

[0071] In FIGS. 8G and 8H, a piercing member 158 having a hollow shaft 160 supported by a flow member 162 is shown. The hollow shaft can be made of metal and can be in the shape of a non-pointed needle having a vent passage 164 adapted to pierce, for example, the plug 142 of the vial 130. The flow member 162 can be composed of a plastic material and can have a plurality of flow channels 166 that allow liquid to flow from the vial 130 to the wicking material. FIG. 13 shows a piercing member for piercing the plug 142. Air flows into the vial 130 to assist in the release of the liquid (in this example, MeOF or methoxyflurane) through the flow channels 166. This is advantageous when the liquid is stored in a non-pressurized vial and the liquid cannot flow easily without an air channel.

[0072] FIG. 12 shows an embodiment of a one-way valve 34 consisting of a support 34a and a flexible valve plate 34b. The flexible valve plate 34b has a lobe covering an air passage to the chamber 24 that houses the wicking material 30 and another lobe covering a return air passage to the exhalation chamber 50. Flexure occurs due to the difference in air pressure on both sides of the lobe, allowing air to flow. Thereby, a one-way valve for each of the chambers 24, 50 is formed. The support 34a is disposed on the opposite side of the valve plate 34b to form a seal when air is inhaled. This embodiment provides a simple yet effective seal using two parts that can be easily assembled.

[0073] The wicking material 30 can be composed of any material suitable for absorbing an inhalable liquid and passively releasing it as vapor. The wicking property is generally understood to include the ability of a material to promote or enhance the rate of evaporation or vaporization of a liquid from the surface of the material by drawing, spreading, attracting, etc. the liquid and dispersing it throughout the material from its initial point of contact, and / or as the liquid evaporates from the exposed surface of the material. The wicking material should have a large surface area to volume ratio to assist in ensuring good evaporation of the liquid into the surrounding air. In one embodiment, the wicking material is a wicking felt or a porous polymer material. In a preferred embodiment, the wicking material is a wicking felt made of polypropylene. In another embodiment, a sintered polypropylene material can be used.

[0074] The inhalation devices described in various embodiments herein have the advantage that the ratio of the active pharmaceutical ingredient can be changed by the patient / user in many ways. First, the user can increase the concentration by covering the dilution holes 44 or 180 in FIG. 14 (reducing the additional air flow bypassing the wicking material 30), or by leaving the dilution holes fully or partially open to mix air into the vapor flowing through the receiver 36 and the wicking material 30, thereby controlling the concentration of the active pharmaceutical ingredient.

[0075] Also, the user does not need to only inhale air from the inhalation device 10. The user may obtain relief by inhaling through the inhalation device 10 one or more times and then breathing normally. Since pharmaceutical active ingredients such as methoxyflurane can provide an analgesic effect for a long time after inhalation, when the user is feeling pain, the inhalation device 10 is designed to be held and controlled by the user to manage the user's own pain. This allows for communication with the user during the process of the user taking an analgesic, such as in situations where medical staff are evaluating the user's injury or other information.

[0076] Those skilled in the art belonging to the technical field of the present invention will understand that modifications can be made without departing from the spirit and scope of the present invention. Therefore, the embodiments or examples described herein are considered to be illustrative and not restrictive.

Claims

1. An inhalation device for supplying an inhalable liquid to a patient, a mouthpiece, an air inlet, a liquid container for storing the inhalable liquid in a sealed manner, a wicking material for supporting the inhalable liquid, a piercing member configured to pierce the liquid container, the piercing member comprising at least one fluid channel arranged to allow liquid to be discharged from the liquid container through the piercing member, a first one-way valve configured to allow gas to flow into the mouthpiece during inhalation and to prevent gas from flowing in the reverse direction during exhalation, In an inhalation device comprising: the mouthpiece, the first one-way valve, the wicking material, and the air inlet are connected so that fluid can flow to provide an inhalation chamber, the inhalation device is configured such that the liquid container can be provided in a first position where the piercing member does not engage with the liquid container and the inhalable liquid remains sealed in the liquid container, the inhalation device is configured such that, during inhalation, by displacing the liquid container from the first position to a second position so that the piercing member pierces the storage container and the inhalable liquid is discharged through the piercing member towards the wicking material, air flowing into the air inlet flows through the inhalation chamber, and inhalable liquid vapor can be provided from the wicking material to the patient via the mouthpiece, the wicking material is spaced apart from the piercing member so that air can pass through at least one of the channels towards the liquid container, thereby preventing or reducing the restriction of the discharge of the inhalable liquid from the liquid container by an air lock, Inhalation device.

2. The inhalation device further comprises a return air chamber in fluid communication with a second one-way valve, whereby, 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, so that exhaled air can flow from the mouthpiece through the return air chamber. The inhalation device according to claim 1.

3. The return air chamber comprises a filtering material configured to filter volatile liquid vapor from the patient's exhalation during exhalation. The inhalation device according to claim 2.

4. The filtering material comprises activated carbon or activated carbon pellets. The inhalation device according to claim 3.

5. The liquid container contains a halogenated volatile liquid. The inhalation device according to any one of claims 1 to 4.

6. 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). The inhalation device according to claim 5.

7. The halogenated volatile liquid is methoxyflurane. The inhalation device according to claim 6.

8. The inhalation device comprises a spacer tab configured to space the wicking material apart from the perforated member. The inhalation device according to any one of claims 1 to 7.

9. While displacing the liquid container from the first position to the second position, the wicking material and / or the perforated member remain stationary within the inhalation device. The inhalation device according to any one of claims 1 to 8.

10. The liquid container comprises only a single region configured to be perforated. The inhalation device according to any one of claims 1 to 9.

11. The inhalation device is configured such that air can pass near or around the liquid container, or the inhalation device is configured such that air does not pass through the liquid container. The inhalation device according to any one of claims 1 to 10.

12. The inhalation device comprises a dilution hole arranged such that a portion of the inhaled air can bypass the wicking material before passing through the mouthpiece. The inhalation device according to any one of claims 1 to 11.

13. The dilution hole is positioned and configured such that the patient can restrict or block the dilution hole with a finger. The inhalation device according to claim 12.

14. The mouthpiece comprises a filter configured to reduce or prevent the patient from inhaling droplets. The inhalation device according to any one of claims 1 to 13.

15. The filter is formed from a polymeric non-woven material. The inhalation device according to claim 14.

16. The inhalation device is configured to allow replacement of the liquid container and / or the wicking material. The inhalation device according to any one of claims 1 to 15.

17. The wicking material is configured such that inhaled air can pass through and along a plurality of surfaces of the wicking material, or the wicking material is configured such that inhaled air can pass through and along a first side and a back side of the wicking material. The inhalation device according to any one of claims 1 to 16.

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