Drug delivery unit for an inhalation device

Abstract

A drug supply unit (23) for an inhalation device (50) includes a cartridge (1) containing a pharmaceutical solution (12) to be delivered. According to the present invention, the drug supply unit (23) includes a housing (22, 22', 22'', 22'''), the cartridge (1) is longitudinally displaceable within the housing, the housing has a septum needle (26) in an end region that, in the active position of the cartridge (1), pierces a septum (8) located at a distal end (6) of the cartridge (1) when the cartridge (1) is fully displaced longitudinally toward the end region, and the housing also has a releasable lock (34) that secures the cartridge (1) in a passive position within the housing such that the septum needle (26) is held spaced apart from the septum (8).

Description

[Technical Field]

[0001] The present invention relates to a medical inhalation device, in particular for nebulizing a drug to deliver its active ingredient to the respiratory system of a patient during treatment using a drug supply unit in which a formulation solution is provided in a cartridge, in particular a pre-filled cartridge. The invention further relates to a drug supply unit for such an inhalation device and to an nebulization system comprising such a drug supply unit. [Background technology]

[0002] Various drugs are intended to be delivered to a patient via the respiratory system by inhalation, which can be achieved in two different forms: on the one hand, in the form of so-called dry inhalation, and on the other hand, in the form of so-called moist or liquid inhalation.

[0003] In dry inhalation, the active ingredient is inhaled as a powder-air mixture, and the device used for such dry inhalation is typically called an inhaler. The advantage of such dry inhalation is that the dosage can always be precisely determined. However, the disadvantage of inhalers is that precise coordination between inhalation and expulsion is required for accurate administration. Therefore, inhalers are not very suitable for infants and small children. Dry inhalation is most often used to administer bronchodilators and anti-inflammatory agents. Emergency medications for asthma and other chronic lower respiratory diseases are also delivered in inhalers.

[0004] In contrast, for wet or liquid inhalation, so-called inhalation devices, also called nebulizers, are typically used. In this type of inhalation, an aerosol from the active substance is generated, and then the aerosol is provided to the patient for inhalation. The aerosol to be inhaled can be produced by various techniques. Depending on the technique, they are classified as ultrasonic nebulizers, compressed air nebulizers (or compressors), or membrane nebulizers. In such systems, the active substance is inhaled in the form of minute droplets. The size of the droplets can be precisely determined, thus optimally reaching either the upper, middle, or lower respiratory tract. Therefore, inhalation devices are suitable for a wide range of respiratory diseases.

[0005] The advantage of such a nebulizer is that it does not require any special breathing technique, since inhalation can also be performed through a mask.Therefore, the inhalation device is particularly suitable for small children and infants.The disadvantage of this method is that it takes a longer time to administer the same amount of active ingredient.

[0006] For the application of medical substances or drugs via a nebulizer, a liquid containing the active ingredient can be supplied to an integrated container of the nebulizer system, from which it is delivered to the actual nebulizer unit, typically an ultrasonic or membrane nebulizer. However, such systems cannot maintain a sterile environment, thereby limiting potential applications. Furthermore, handling of the components requires various steps and can be difficult for individuals, especially if the patient is expected to use the system themselves. To overcome these deficiencies, the drug can be delivered to the nebulizer in a prefilled cartridge. The use of such drug-containing cartridges in soft-mist inhaler systems is known, for example, from International Publication No. WO 2016 / 012102. However, such soft-mist inhalers are not strictly nebulizers, and are multi-dose devices with very small 15 ml cartridges, such that the cartridges can contain up to 180 doses.

[0007] Cartridges are commonly used to store pharmaceutical formulations. They are described in ISO 13926-1. A cartridge consists of a glass or plastic barrel, a pierceable septum held at one end by a crimped metal ferrule, and a stopper / piston at the other end. The needle is manually attached by the user before use, usually by threading a double-ended needle composed of the needle and septum needle onto a cartridge holder or other device, such as a pen, that holds the cartridge. This punctures or perforates the septum, creating a fluid pathway between the drug contents of the cartridge and the needle. Such configurations, in which the cartridge typically contains a single large dose to be delivered to the patient, are typically used in pen injectors such as insulin pens and cartridge-based dental syringes.

[0008] A configuration including a septum needle and a delivery nozzle instead of a syringe needle may also be used to deliver to a drug delivery device such as a nebulizer or inhalation device or other delivery device.

[0009] Cartridges are available in both ready-to-fill and much less expensive bulk formats, and they may be filled like a syringe by capping, filling, and stoppering, or they may be filled bubble-free by stoppering, filling, and capping. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2016 / 012102 [Non-patent literature]

[0011] [Non-Patent Document 1] ISO13926-1 Summary of the Invention [Problem to be solved by the invention]

[0012] The present invention relates to inhalation devices, and in particular to nebulizers particularly suitable for delivering medical drugs to patients, comprising a cartridge-based assembly designed to deliver the formulation to the nebulizer. It is an object of the present invention to provide a drug supply unit for such inhalation devices based on the use of pre-filled cartridges that is particularly user-friendly and easy and safe to use, even in the case of self-administration of the drug. [Means for solving the problem]

[0013] According to the present invention, this object is achieved by a drug supply unit for an inhalation device comprising a cartridge containing a pharmaceutical solution together with a housing, the cartridge being arranged in the housing so as to be longitudinally displaceable, the housing having a septum needle in an end region which, in the active position of the cartridge, pierces a septum arranged at the distal end of the cartridge when the cartridge is fully displaced in the longitudinal direction towards the end region, the housing also having a releasable lock which fixes the cartridge in a passive position within the housing so that the septum needle is held away from the septum.

[0014] The present invention is based on the determination that the intended use of a pre-filled cartridge to deliver a drug or active substance can be highly advantageous for the safe and user-friendly design of an inhalation device. Comparable to the use of a pre-filled syringe, such a pre-filled cartridge can be delivered to a user in a sealed state. Access to the drug or active substance in the cartridge can then be achieved by using a septum needle to pierce a septum at one end of the cartridge, which septum typically serves as a sealing element for such cartridges. For easy and reliable use, the engagement between the cartridge and the septum needle should be carefully and reliably designed, and for this purpose, the present invention provides a housing within which the cartridge can slide longitudinally. A septum needle is provided at one end region, and to access the interior of the cartridge, the cartridge can be moved within the housing toward the septum needle until the septum needle pierces the septum, thereby accessing the interior. This "opening" step of the sealed cartridge can be performed in a highly controlled and stable manner, and is therefore easy to perform even for inexperienced users.

[0015] During this procedure, unintended opening of the container or access to the interior of the container must be reliably prevented. To this end, the present invention provides a mechanism that keeps the cartridge out of range of the septum needle until opening is intentionally initiated by the user. To this end, the present invention provides a locking mechanism that keeps the cartridge in a first passive position sufficiently distant from the septum needle. The cartridge can be moved to an active position, in which the septum needle is allowed to pierce the septum after intentionally disengaging or releasing the lock by the user.

[0016] In a preferred embodiment, the drug supply lock comprises a locking pin which in a locked position protrudes into the interior of the housing, thereby mechanically preventing movement of the cartridge within the housing, and which is then preferably allowed to move radially outward from the interior of the housing in an unlocked mode in which the cartridge should be allowed to move within the housing.

[0017] In one aspect of the invention, the drug delivery system is part of an atomization system. In addition to the drug delivery unit, the atomization system in this aspect of the invention further comprises an atomizer body including an atomization chamber, and the septum needle is in fluid communication with a nozzle extending into the atomization chamber. Thus, when the cartridge in the housing is brought to the active position, the interior of the cartridge is fluidly connected to the atomization chamber via the septum needle and the nozzle, thereby allowing the formulation solution to flow from the cartridge into the atomization chamber. In one aspect of the invention, unlocking the lock is achieved by twisting or rotating the housing relative to the atomizer body about the longitudinal axis of the housing.

[0018] In yet another inventive aspect unique to the present invention, nebulizer systems are designed around the concept of single-use mouthpieces, making cleaning procedures obsolete. In existing systems, the aerosol generator is a vibrating membrane element containing thousands of tiny holes. These membranes deteriorate over time, resulting in inappropriate particle size, reduced output performance, and longer treatment times for patients. In such systems, it is paramount that users follow cleaning instructions after each treatment, which include weekly and sometimes even daily disinfection (e.g., boiling) routines. Furthermore, the mouthpiece, which comes into contact with the patient, must be cleaned and disinfected. Patients often do not follow the routines or read the instructions carefully enough. Longer treatment times, weakened treatment adherence, and hygiene risks are the consequences. This is a major problem with liquid nebulizer inhalation.

[0019] In one embodiment of the present invention, these problems are overcome by the single-use design of the nebulizer system. In this embodiment, the nebulizer system includes a separate "drug aerosol generator mouthpiece" unit that can be renewed for each treatment and can be specifically pre-packaged and sterilized. The single-use mouthpiece in one embodiment can be made of cardboard to conserve plastic (carbon oxide footprint). An inventive aspect of this embodiment is that all drug-contacting and patient-contacting components are "separated" (separated) from the operating base unit, which includes all electronics. This design allows for sustained performance, shorter treatment times, consistent hygienic cleanliness, and exceptional convenience, thus enabling improved adherence.

[0020] In another aspect of the present invention, an inhalation device equipped with a nebulization system of the type presented above is connected to a power supply and control unit by an electrical connection system, which includes a plurality of paired connector elements, each of which is personalized for the drug to be delivered. In other words, "paired connector elements" means that only paired elements of the various elements can be connected to each other due to their geometry, design, or electrical function. According to one aspect of the present invention, this pairing is based on the association of each element with a particular drug or dosage. In this way, a safety feature can be provided in that the elements can be coupled together, i.e., the nebulization system can be coupled to the power supply and control unit, only under conditions where both components refer to the same intended drug and / or dosage. Thus, if a patient uses a single-use nebulizer while reusing the power supply and control unit, only the components that provide the correct medication for the individual patient can be connected to the patient's multi-use power supply and control unit. Specifically, and in one inventive embodiment also unique to this invention, the "drug-aerosol generator mouthpiece" and drug cartridge "interact" with the operating base and electronics to ensure that the correct membrane vibration is used for that particular drug and drug dose.

[0021] Considering the high demands for reliability and precision in the context of drug delivery, the nebulizer according to a preferred embodiment comprises an atomizing element that utilizes a vibrating mesh to atomize the delivered liquid.

[0022] According to various aspects of the present invention, there is provided a method for manufacturing a semiconductor device comprising the following features: an atomizer comprising a mesh that atomizes the liquid supplied when vibrated; - an outer casing or housing or a syringe housing, - A cartridge having a glass or plastic barrel or a generally tubular barrel, a needle-pierceable septum or sealing element held by a crimped metal ferrule located at the distal end of the barrel, and a stopper / piston located at the other end of the barrel to contain a pharmaceutical or other compound between the septum or sealing element. an outer casing or housing or syringe housing that holds the - A plunger rod in communication with the cartridge stopper / piston, - a needle device consisting of a delivery nozzle at one end and a septum needle at the other end in fluid communication with each other; - the needle device is held firmly within the outer casing; - the outer casing or syringe is inserted into the nebulizer; - the filled cartridge is held in a first position within the outer casing; - the user can push the cartridge against and towards the septum needle to a second position in which the septum needle pierces the cartridge septum and the syringe is ready for use; may be provided, in particular in any suitable combination.

[0023] The cartridge may be held in the first position by an interference fit or friction between the cartridge barrel and the outer casing or housing.

[0024] The cartridge may be held in the first position by a deformable or movable stop on a shoulder or cap of the cartridge.

[0025] The cartridge may be further held in the first position by a lock on a shoulder or cap of the cartridge that is released by activating a switch or button, or by rotating the syringe relative to the sprayer, or by any other means.

[0026] The cartridge may be held in the first position by a combination of two or all three of the above holding methods.

[0027] To use the device, the user simply pushes the plunger rod with enough force to move the cartridge from a first position to a second position, overcoming any interference fit or friction and / or deformable or movable stops. This moves the cartridge to the second position toward the needle device, which pierces the septum and prepares the system for delivering medication to the inhaler. Further pushing of the plunger rod then delivers the formulation to the nebulizer.

[0028] The cartridge can be filled without bubbles or with air bubbles, this does not affect the use of the device.

[0029] The device may have a locking mechanism to hold the cartridge in place prior to use. If the device has a locking mechanism, the locking mechanism must be unlocked by a switch or button or other means so that the cartridge can be pushed to a second position by depressing the plunger rod.

[0030] The syringe or outer casing may be supplied separately from the sprayer or may be pre-assembled with the sprayer. If supplied separately, the cartridge may lock independently of the sprayer and unlock when the syringe is pushed into the sprayer and rotated relative to the sprayer. If supplied pre-assembled, the cartridge may unlock when the syringe is rotated relative to the sprayer.

[0031] The device may include a nozzle cap for covering the nozzle prior to use. The nozzle cap may be used to lock the cartridge in a first position prior to use. This locking feature may be part of the cap or the housing, in which case the lock is held in the locked position by the cap. The cap may have an opening that allows the nozzle to protrude therethrough. When the syringe is pushed into the sprayer, the cap may be pushed back to release the lock. The lock is finally released only when the syringe is rotated relative to the sprayer, allowing the cartridge to advance and pierce the septum, delivering the drug contents into the sprayer.

[0032] The entire assembly, including the cartridge, can be placed in a blister or other outer packaging and terminally sterilized. Depending on the type of drug and the packaging and device materials, drug-filled systems can be sterilized using moist heat (steam), dry heat, gamma or other radiation, ethylene oxide gas, vaporized hydrogen peroxide, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.

[0033] The cartridge barrel may be made of glass or plastic such as COC or COP according to Non-Patent Document 1.

[0034] The present invention is a significant improvement over existing state-of-the-art drug containers for nebulizers. The drug is stored in the cartridge in contact only with the barrel material, i.e., glass or plastic and elastomeric materials, similar to storage in a vial. Furthermore, the cartridge can have premium bake-on silicone for improved stopper migration and drug stability, and the entire system, including the filled cartridge, can be terminally sterilized.

[0035] Current nebulizers require the user to load a liquid into a reservoir. Therefore, the nebulizer must be placed on a stand, the blow-fill-seal or other primary container must be opened by the user, and the liquid must be transferred into the nebulization chamber. This procedure cannot be performed under sterile conditions and is therefore limited to use in delivering medicinal compositions or medicinal drugs. In comparison to such existing nebulizers, the present invention described above provides a pre-filled, ready-to-use nebulization unit that allows the user to safely transfer liquid under sterile conditions without compromising hygiene. This allows for improved dose reproducibility, ease of handling, time savings, and ultimately improved treatment adherence, which are key advantages of the present invention.

[0036] An embodiment of the invention will now be described in more detail with reference to the drawings. [Brief explanation of the drawings]

[0037] [Figure 1] Diagram of a conventional ISO 13926 cartridge with plunger rod in place. [Figure 2] FIG. 2 is a diagram of a nebulization system including the cartridge of FIG. 1. [Figure 3a] FIG. 3 is a diagram of user steps for operating the nebulization system according to FIG. 2. [Figure 3b] FIG. 3 is a diagram of user steps for operating the nebulization system according to FIG. 2. [Figure 4a] 3A-3C are diagrams of user steps in preparing for nebulization in the nebulization system of FIG. 2 by delivering a formulation to the nebulizer chamber. [Figure 4b] 3A-3C are diagrams of user steps in preparing for nebulization in the nebulization system of FIG. 2 by delivering a formulation to the nebulizer chamber. [Figure 5] FIG. 1 is a diagram of an inhalation device ready for use. [Figure 6] FIG. 10 is a view of another embodiment of a cartridge within a housing. [Figure 7] FIG. 7 is a diagram of an atomization system including the cartridge of FIG. 6. [Figure 8a] 8A-8C are diagrams of user steps in preparing for nebulization in the nebulization system of FIG. 7 by delivering a formulation to the nebulizer chamber. [Figure 8b] 8A-8C are diagrams of user steps in preparing for nebulization in the nebulization system of FIG. 7 by delivering a formulation to the nebulizer chamber. [Figure 9a] FIG. 10 is a diagram of an alternative embodiment of the atomization system. [Figure 9b] FIG. 10 is a diagram of an alternative embodiment of the atomization system. [Figure 10a] 10A-10C are views of an alternative embodiment of a cartridge within a housing including another form of locking mechanism. [Figure 10b] 10A-10C are views of an alternative embodiment of a cartridge in a housing including another form of locking mechanism. DETAILED DESCRIPTION OF THE INVENTION

[0038] In all the figures, identical parts are given the same reference numerals. The invention will be described below mainly with reference to the illustrated embodiment, but other embodiments are of course also envisaged and are encompassed by the invention.

[0039] The cartridge 1 according to Figure 1 has a plastic or glass barrel 2, which provides the actual container for the liquid medication or drug. The barrel 2 has an open or proximal end 4 and a closed or distal end 6, which is closed by a cap or septum 8. A movable stopper 10 inserted into the open end 4 and the septum 8 seal a pharmaceutical solution 12, particularly a liquid, within the barrel 2. A plunger rod 14, including a finger rest 16, is engaged with the stopper 10 so that the stopper 10 can be pushed forward and backward within the barrel 2 by the plunger rod 14.

[0040] Such a cartridge 1 is described in detail in the non-patent document 1 and may have a barrel 2 of glass or plastic.

[0041] A nebulizer system 20 according to the present invention is shown in Figure 2. In its basic concept, the nebulizer system 20 is designed to be particularly useful and convenient for atomizing and delivering a liquid pharmaceutical solution 12 contained in a cartridge 1 of the type shown in Figure 1. The cartridge 1 is mounted in a first position within a casing or housing 22. The assembly of the cartridge 1 and the housing 22 forms a drug supply unit 23. The housing 22 is mounted within a nebulizer body 24. A septum needle 26 secured to the housing 22 is provided in fluid communication with a delivery nozzle 28. The nozzle 28 within the nebulizer body 24 extends into a nebulizer chamber 30 in which the actual nebulization element 32 is provided. In the illustrated embodiment, the nebulization element 32 is an ultrasonic nebulizer. However, according to one aspect of the present invention, and in a preferred embodiment, the nebulization element 32 comprises a vibrating mesh.

[0042] In one unique and inventive embodiment shown, the ensemble of cartridge 1, plunger rod 14, housing 22, and septum needle 26 is comparable and equivalent in functionality and in design and layout to a pre-filled syringe into which the cartridge is loaded, with the primary difference being that in the illustrated embodiment, septum needle 26 is in fluid communication with nozzle 28 rather than in fluid communication with an injection needle.

[0043] In the state shown in FIG. 2 , the cartridge 1 is locked in a given first position within the housing 22 to prevent unintended, accidental movement. A lock 34 is provided to prevent unintended axial movement of the cartridge 1 to a second position within the housing 22 in a direction toward the septum needle 26 under the user's force on the plunger rod 14. The lock or locking pin 34 in the illustrated embodiment is designed as a locking wedge 36 including a beveled side that protrudes into the interior of the housing 22 in the state shown in FIG. 2 , and the distal end or beveled side 38 of the locking wedge 36 engages with the distal end 6 of the barrel 2. The locking pin 36 is prevented from moving outward in its longitudinal direction by the sprayer body 24.

[0044] The nebulizer body 24 is further provided with a mouthpiece 40 for delivering the aerosolized formulation to the user. The nebulizer body 24 is further provided with an electrical connector 42 that provides the necessary power and control signals / nebulization commands to the nebulization element 32. In this embodiment, the cartridge housing 22 and nebulizer body 24 are supplied assembled to the user. In one aspect of the invention, the complete (pre-assembled) assembly may be terminally sterilized after assembly and supplied to the user in a sterile blister.

[0045] 3a and 3b illustrate the first user step required to operate the inhalation device 20. To operate the nebulization system 20, the lock 34 must be disengaged to allow the user to move the cartridge 1 within the housing 22 toward the septum needle 26 so that the septum needle 26 can pierce the septum 8 of the cartridge 1. In accordance with one aspect of the present invention, in the illustrated embodiment, unlocking the lock 34 is achieved by twisting or rotating the housing 22 relative to the nebulizer body 24 about its length until the locking pin 36 rotationally overlaps with a corresponding recess 44 or cavity in the nebulizer body 24. The recess 44 is designed to allow the locking pin 26 to slide freely within the recess 44, such that the locking pin is free to move radially outward in this orientation, thereby not impeding forward movement of the cartridge 1 within the housing 22 in a direction toward the septum needle 26.

[0046] For illustrative purposes, Figure 3a shows the assembly in a first position as shown in Figure 2. Figure 3b shows the assembly after a user has rotated or twisted the cartridge housing 22 relative to the sprayer body 24, as indicated by arrow 46. (Accordingly, in Figure 3b and subsequent figures, the sprayer body 24 is shown in a rotated position relative to the cartridge housing 22.) Thus, by rotating the housing 22 relative to the sprayer body 24, the lock 34 is free to move outward, thereby releasing the cartridge 1 so that it can be pushed by the user toward the septum needle 26.

[0047] FIG. 4a shows the assembly after the user has depressed cartridge 1 toward sprayer chamber 30, as indicated by arrow 48. As shown in the step according to FIG. 3b, lock 34 has been unlocked by laterally pushing locking pin 36 into cavity 44 in sprayer body 24. As a result of pushing cartridge 1 downward, septum needle 26 pierces septum 8, thereby opening fluid communication between the interior of barrel 2 and sprayer chamber 30 via nozzle 28. Thus, in the state shown in FIG. 4a, formulation solution 12 is able to flow from barrel 2 into sprayer chamber 30. Further depression of plunger 14 delivers formulation contents 12 to sprayer chamber 30, where they are stored in a reservoir in preparation for atomization by sprayer element 32, as shown in FIG. 4b.

[0048] Generally, the drug supply unit 23 comprises a cartridge 1 containing a formulation solution 12 and a housing 22 within which the cartridge 1 is longitudinally displaceable. The housing 22 also has a septum needle 26 in an end region which, in the active position of the cartridge 1, pierces a septum 8 located at a distal end 6 of the cartridge 1 when the cartridge 1 is fully longitudinally displaced towards the end region. The supply unit 23 also has a releasable lock 34 which secures the cartridge 1 in a passive position within the housing 22 such that the septum needle 26 is held away from the septum 8 when the system is not yet ready to dispense the formulation solution.

[0049] The completed assembly or nebulization system 20 in the state shown in FIG. 4b can be converted into a fully functional inhalation device 50 by combining it with a corresponding power supply unit 52. This complete inhalation device 50 is shown in FIG. 5. More specifically, FIG. 5 shows the assembly attached to a power and control unit 52. The control unit or power supply unit 52 determines the correct power and nebulization time for each drug type and dose. Furthermore, the power and control unit 52 also provides an outer shell or casing for the assembled device, into which the nebulizer system 20 can be inserted only with the rod 14 pressed into the barrel 2, i.e., in the "primed" or activated state of the nebulizer system 20, with the formulation solution 12 being transferred into the nebulization chamber 30.

[0050] According to one inventive aspect unique to the present invention, the electrical connections between the electrical connector 42 and its counterpart in the power supply unit 52 are personalized, in the sense that their shape and geometry are distinct and dedicated to each individual or specific drug. In other words, the electrical connector 42 (and its matching counterpart in the power supply unit 52) ​​is specific to each drug and dosage type and plugs into the correct female connector 54 on the control unit 52. In accordance with this inventive concept, the assembly of the cartridge 1 and other components that collectively provide the nebulization system 20 may be provided to the user pre-assembled as a complete assembly, while the power supply unit 52 may be designed as a multi-use unit that can be reused several times by the user. The drug-specific personalized electrical connection system provides the user with an added safety feature to ensure that they are using the correct drug as intended; the drug-specific connection design ensures that only nebulization systems 20 containing the correct drug in the correct dosage are connected to the handpiece or power and control unit 52.

[0051] In another aspect of the present invention, as an added safety feature for the actual nebulization, plunger 14 must be fully depressed before nebulization system 20 can be plugged into place and fully connected to power and control unit 52. This ensures that the nebulizer is properly primed prior to connection to power source 52.

[0052] FIG. 6 illustrates another embodiment of the present invention. In this embodiment, the housing 22′ within which the cartridge 1 is provided is not initially positioned within the sprayer body 24 but is intended to be provided separately for later attachment to the sprayer body 24. For reference and comparison, FIG. 6a again illustrates the cartridge 1 and plunger 14. In the embodiment shown in FIG. 6b, the cartridge housing 22′ equipped with the septum needle 26 has a nozzle cap 60 covering the nozzle 28. The cap 60 has openings 62 and 64. The cap 60 is rotationally secured to the housing 22′ and is therefore prevented from rotating on the housing 22′. In this alternative inventive embodiment, the cartridge 1 is supplied to the user assembled only with the housing 22′, not the sprayer body 24. In this embodiment, in one aspect of the present invention, the locking pin 36 is prevented from moving laterally by the cap 60, and therefore the cartridge 1 is prevented from moving axially downward within the housing 22′ by the lock 34. This prevents the user from inadvertently activating the device. The assembly shown in Figure 6b may be placed in a blister and terminally sterilized. Overall, the assembly shown in Figure 6b may also be considered a drug supply unit 23' according to the present invention of the type that may be sold or provided to users as a separate, complete entity.

[0053] FIG. 7 illustrates the use of the cartridge 1 of FIG. 6 in a sprayer system 20′. In FIG. 7a, the cartridge 1 and housing 22′ assembly is inserted into the sprayer body 24. In FIG. 7b, the plunger 14 is squeezed by the user, causing the cartridge 1, along with the housing 22′, to move downward within the receiving socket 66 in the sprayer body 24. The housing 22′ thus moves axially relative to the cap 60, allowing the nozzle 28 to enter the sprayer chamber 30 while simultaneously aligning the release opening 68 in the cap 60 with the locking pin 36. In accordance with one aspect of the present invention, the assembly is now ready for final unlocking of the lock 34, which, as before, can be accomplished by twisting or rotating the housing 22′ about its length until the release opening 68, along with the locking pin 36, rotationally aligns with the corresponding recess 44 or cavity in the sprayer body 24. As in the previous embodiment, recess 44 is designed to allow locking pin 26 to slide freely within recess 44, so that the locking pin is free to move radially outward in this orientation, thereby not preventing cartridge 1 from being moved forward within housing 22' in a direction toward septum needle 26.

[0054] For illustrative purposes, Figure 8a shows housing 22' rotated relative to atomizer chamber 24 to align release opening 68 and locking pin 34 with cavity 44. In Figure 8b, plunger 14 has been squeezed by the user, as indicated by arrow 70, to force septum needle 26 to pierce septum 8 in preparation for delivering contents 12 into atomizer chamber 30 by further squeezing plunger 14, as indicated by arrow 72. In this embodiment, the positions of lock 34 and cavity 44 may be reversed. More than one lock 34 may be used.

[0055] In yet another embodiment shown in FIG. 9, the cap 60 may be replaced by a sleeve 74 that is slidably positioned on the outside of the housing 22'' and includes the relief opening 68. In this embodiment, no forward protection for the nozzle 28 is provided. In this case, the sleeve 74 may engage a shoulder 76 on the sprayer body 24. Alternatively, the sleeve 74 may be a short sleeve 74 as shown in FIGS. 9a and 9b.

[0056] In the embodiment shown in FIG. 9a, the sleeve 74 covers the locking pin 36 and therefore the lock 34. The sleeve 74 is prevented from rotating on the housing 22″. In this embodiment, the cartridge 1 is also supplied to the user assembled only with the housing 22″, and not with the sprayer body 24. In this embodiment, the locking pin 36 is prevented from moving laterally by the sleeve 74, and therefore the cartridge 1 is prevented by the lock 34 from moving axially downward within the housing 22″. This prevents the user from inadvertently activating the device. In FIG. 9b, the syringe-type assembly of the cartridge 1 and housing 22″ is shown assembled within the sprayer body 24. After the housing 22″ is pressed into the corresponding receiving socket 66 in the sprayer body 24, the sleeve 74 moves upward by engaging a shoulder 76 in the sprayer body 24, thereby releasing the locking pin 36 from its covering. In this position, the locking pin 36 is prevented from moving laterally by the surrounding sprayer body 24. From there, the housing 22'' can be rotated within the sprayer body 24 to align the locking pin 36 with the cavity 44, allowing the locking pin 36 to move freely laterally. Figure 9b shows the assembly prior to such final rotation to fully release the lock 34.

[0057] An alternative lock is shown in FIG. 10. Lock 34' is formed as part of housing 22'''. In FIG. 10a, lock 34' is prevented from bending outward by lock ring 80. In FIG. 10b, lock ring 80 is moved upward to release lock 34', allowing cartridge 1 to push outward against lock 34' and cartridge 1 to be pushed forward so that cartridge septum 8 is pierced by needle 26 in preparation for delivery of contents into atomizer chamber 30.

[0058] When the syringe-type assembly is rotated relative to the sprayer body 24, over-rotation is preferably prevented by a stop.

[0059] The septum needle 8 can be any hypodermic or other delivery needle. In a preferred embodiment, the gauge of the needle 26 is the smallest possible or has the largest diameter possible that will minimize resistance when the contents are injected into the aerosol. The gauge is preferably between 16G and 26G.

[0060] In all of the above embodiments, there may be more than one lock 34, 34'.

[0061] The cartridge 1 can be filled with or without air or bubbles. [Explanation of symbols]

[0062] 1 cartridge 2 barrels 4, 6 Ends 8 Bulkhead 10 Stopper 12. Pharmaceutical Solutions 14 Plunger Rod 16 Finger Placement 20, 20' Atomization System 22, 22' Housing 23, 23' Drug Supply Unit 24 Sprayer body 26 septum needle 28 nozzles 30 nebulizer chambers 32 Atomization element 34 Rock 36 Locking Wedge 38 distal end 40 mouthpiece 42 Electrical Connectors 44 Recess 46, 48 Arrows 50 Inhalation Devices 52 Power supply unit 54 Connector 60 Nozzle Cap 62, 64 Openings 66 sockets 68 Release opening 70, 72 Arrows 74 sleeve 76 Shoulder 80 Lock Ring

Claims

1. A drug supply unit (23, 23') for an inhalation device (50) comprising a cartridge (1) containing a pharmaceutical solution (12) together with a housing (22, 22', 22'', 22'''), wherein the cartridge (1) is arranged in the housing (22, 22', 22'', 22''') so as to be longitudinally displaceable, and the housing (22, 22', 22'', 22''') has a septum needle (26) in an end region thereof, the septum needle (26) being in contact with the cartridge (1) in the active position. a drug supply unit (23, 23') configured to pierce a septum (8) disposed at the distal end (6) of the cartridge (1) when the cartridge (1) is fully displaced in the longitudinal direction toward the end region, the housing (22, 22', 22'', 22''') having a releasable lock (34) that secures the cartridge (1) in a passive position within the housing (22, 22', 22'', 22''') such that the septum needle (26) is held spaced apart from the septum (8).

2. 2. The drug supply unit (23, 23') of claim 1, wherein the lock (34) comprises a locking pin (36) that protrudes into the interior of the housing (22, 22', 22'', 22''') in a locked position.

3. 3. The drug supply unit (23, 23') of claim 2, wherein the locking pin (36) in the unlocked mode is allowed to move radially outward from the interior of the housing (22, 22', 22'', 22''').

4. An atomization system (20, 20') comprising a drug supply unit (23, 23') as described in any one of claims 1 to 3, further comprising an atomizer body (24) including an atomization chamber (30), wherein the septum needle (26) is in fluid communication with a nozzle (28) extending into the atomization chamber (30).

5. 5. The atomization system (20, 20') of claim 4, wherein unlocking of the lock (34) is achieved by twisting or rotating the housing (22, 22', 22'', 22''') relative to the atomizer body (24) around the longitudinal direction of the housing (22, 22', 22'', 22''').

6. An inhalation device (50) comprising a nebulization system (20, 20') as described in claim 4 or 5, connected to a power supply and control unit (52) by an electrical connection system, the electrical connection system comprising a plurality of pairs of connector elements individualized for the drug to be delivered.

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