Inhaler device

Abstract

To provide an inhaler device provided with medicament carriers containing individual pockets or blisters of powdered medicament covered by a lidding sheet such as lidding foil.SOLUTION: An inhaler device (701) provides a common actuator (710) for controlling movement of indexing systems (712, 714) for advancing / indexing a dose, and provides opening systems (790, 791) for opening a dose such that progression of the opening systems (790, 791) is disproportional to progression of the indexing systems (712, 714) during movement of the common actuator (710).SELECTED DRAWING: Figure 66

Description

[Technical field]

[0001] The present invention relates to inhalation devices, and in particular to devices which are provided with a medicament carrier containing individual pockets or blisters of powdered medicament which are covered by a lid sheet such as a lid foil. [Background technology]

[0002] The delivery of medicine in aerosol form to the airways using an inhalation device is a known and effective method for treating diseases such as asthma and chronic obstructive pulmonary disease (COPD). The aerosol can be in the form of a liquid or a powder.

[0003] Dry powder devices often use the patient's inhalation airstream to aerosolize and deliver the dry powder drug. One advantage of this is that the user does not need to coordinate inhalation with a separate action, such as depressing a canister or pressing a button to release the propellant.

[0004] A variety of different types of dry powder inhalers are known.

[0005] The first group of devices holds the powdered drug in a reservoir and measures the dose prior to delivery. These devices often have poor dose metering accuracy and it can be difficult to protect the bulk powder from moisture.

[0006] Pre-metered dry powder devices are also known in which precise dose metering is performed as part of the manufacturing process and each dose is independently protected from moisture.

[0007] The individual doses used in pre-metered devices are typically held in either gelatin capsules or foil blisters. Capsule-based inhalation devices can be simple and low-cost, but typically require the patient to load the capsule into the inhaler before each use. Capsules are also not particularly effective at protecting the environment. This generally requires the use of a secondary foil-based package, which increases the number and complexity of steps in the use sequence.

[0008] Blister devices tend to be more environmentally friendly due to the use of aluminum foil in the construction of the blister device. Blister packs can also be more convenient for the user as they can contain several doses, ideally enough to last a month.

[0009] Most current asthma or COPD medications are used once or twice a day, so the inhaler should accommodate 30 or 60 doses. To allow these doses to be packaged in a conveniently sized device, the blisters can be configured in disk or strip form. Before an inhalation takes place, individual blisters must be opened, and as the patient inhales the powdered medication, it is entrained in the patient's inspiratory airstream and carried out of the device and into the patient's lungs. Before, during, or between each inhalation, the pack must be indexed by a blister and the previously emptied blister replaced with an unused blister.

[0010] Various means for opening and indexing the blisters are known from the prior art.

[0011] US Patent No. 5,399,633 discloses an inhalation device that uses a blister pack in the form of a disk. The doses are arranged in a circular pattern, with each disk housing eight blisters. A plunger is used to pierce each blister, allowing the medication within the blister to be inhaled. A separate indexing mechanism rotates the disk to move unused blisters into position.

[0012] Although mechanically simple, a challenge with this device is that in order to keep the device small and simple to operate, the number of doses is limited to eight. To configure a disk-based device to accommodate 30 or 60 doses and still be an acceptable size would require modifications to the pocket geometry, or significantly more complex devices with either multiple disks or dose cavities formed in (for example) concentric circular or spiral patterns.

[0013] This problem may be partially addressed by providing a similar device with the blisters in an elongated strip form. The elongated strip may be coiled within the inhalation device to minimize packaging space required. Separate indexing and piercing mechanisms may be provided, or a single actuating lever may be provided to first index the blister strip and then pierce the blisters to prepare them for inhalation.

[0014] A drawback of blister strip devices as described thus far is that the act of piercing a blister tends to involve the piercing element occupying and partially blocking the blister, and as a result pierceable blisters must typically be two or three times larger than the volume of the required dose to provide space for the piercer and allow the drug to move freely and be entrained in the airflow.

[0015] An alternative approach is to use a blister strip with a peelable lid, where the inhaler sequentially peels off the lid of each blister before each inhalation. The mechanism of such an inhaler is typically more complex, as it needs to manage both the used base sheet / foil and the used lid sheet or lid foil. However, since the blister is not perforated and the lid is completely removed, the blister only needs to be large enough to contain the powdered medicament. Thus, smaller blisters can be used for a given dose size.

[0016] US Patent No. 5,399,633 discloses a known peelable strip device. The device contains a coil of sealed blisters, a coil of used base sheet and a separate coil of used lid sheet. The base sheet and lid sheet are separated at an opening station where the lid is peeled away from the base as the strip is indexed. Thus, all three coils move simultaneously. The main strip drive is a drum incorporating recesses that engage the blisters of the base sheet, while the base and lid sheet coils are also driven to ensure that the used strip is coiled after use. The used base sheet / foil is loosely wound, while the used lid sheet is tightly wound to maintain the necessary tension for a reliable separation from the base sheet.

[0017] US Patent No. 5,399,633 discloses a variation of this device, incorporating two blister strips that are indexed and opened in the same manner. The two strips are arranged such that when opened, two unused blisters are placed on either side of a single airway manifold. Thus, the contents of both blisters can be inhaled simultaneously. A potential advantage of this approach is that two separate medications or combinations of medications can be contained in separate blisters, yet inhaled together.

[0018] One significant use error that can occur with peelable strip devices can arise from the fact that the opening of the blister occurs when the strip is indexed, rather than as a separate action as with most pierceable blister devices. Typically, the user input in such devices is directly coupled to a set of components that simultaneously index and peel the strip to present the open blister pocket to the airway where the user inhales. As a result, the blister can be opened when the actuation mechanism is only partially moved. This is particularly problematic in devices where the actuation mechanism is driven by the mouthpiece cover of the device, rather than a separate actuation lever. If a patient opens the cover to, for example, inspect or clean the mouthpiece, the blister can be partially or completely opened, thus exposing the contents of the blister to environmental moisture. The user may then return the mouthpiece cover to the unopened position, unaware of the potential degradation of the now exposed formulation. If the user subsequently opens the cover fully and inhales, there is a risk of inhaling an infected dose. Even if the user realizes that they have opened the blister early and does not use the associated dose, that dose will still be wasted.

[0019] This problem can be alleviated by providing the inhaler with a breath-actuated mechanism whereby the blister strip is indexed by actuation of a lever or mouthpiece cover, but the individual blisters are only opened upon inhalation by the user. For example, US Pat. No. 5,399,433 discloses a device having a strip comprising a base sheet and a lid sheet that are permanently sealed together, and a further tear sheet that is locally adhered to the lid sheet above each blister cavity and is capable of tearing a portion of the lid sheet away from the remainder of the blister. When the device is actuated, the blister strip is indexed, but the lid tear sheet is not under tension until an exhalation-actuated trigger releases a spring that drives the lid tear sheet winding mechanism. Although effective, the inclusion of a breath-actuated mechanism significantly complicates the inhalation device, and the construction of the tear strip is not standard in the manufacture of blister strips.

[0020] As discussed in U.S. Patent No. 5,933,963, one alternative approach is to provide a delayed activation mechanism, i.e., a mechanism that does not activate the indexing and opening mechanisms on initial movement of the mouthpiece cover. By delaying activation, the risk of false activation is reduced. However, there is still a risk of partial activation of the device if the cover is incompletely opened.

[0021] There is therefore a need for an improved inhalation device suitable for use with one or more medicament carriers, which has a simple means to enable a patient to move an actuation lever or cover without accidentally opening the blister and exposing the medicament.Ideally, the lever or cover should be reversibly movable over the majority of its travel, and the point at which the blister opens should be near the end of the actuation travel and clearly identifiable by the patient. [Prior art documents] [Patent documents]

[0022] [Patent Document 1] U.S. Pat. No. 4,627,432 [Patent Document 2] U.S. Patent No. 5,590,645 [Patent Document 3] U.S. Patent No. 8,511,304 [Patent Document 4] U.S. Patent No. 7,434,579 [Patent Document 5] U.S. Patent No. 8,746,242 Summary of the Invention [Problem to be solved by the invention]

[0023] It is an object of the present invention to provide an inhalation device which alleviates or overcomes some or all of the above mentioned problems whilst ideally being suitable for use with conventional pharmaceutical carriers such as standard blister strips. [Means for solving the problem]

[0024] According to a first aspect of the present invention there is provided an inhalation device as defined in claim 1. Further optional features are set out in the associated dependent claims.

[0025] A further aspect of the invention provides an inhalation device as defined in claim 31. Further optional features are set out in the associated dependent claims.

[0026] The present invention decouples or at least partially separates the indexing and peeling operations during use of the inhalation device, for example to allow indexing and peeling to be initiated at different times and / or to delay one or more particular points in one or more peeling operations (e.g., a point at which one or more doses may be damaged, such as the start of opening one or more dose pockets) to a more desired point in the operation of the device, without necessarily delaying one or more indexing operations as well.

[0027] User input to the device, such as the opening and closing of a cap or the actuation of a lever / button, can be used to first initiate the indexing of one or more pharmaceutical carriers and then the peeling of one or more lidding sheets / foils from one or more individual blisters to present the formulation to the airway.

[0028] Thus, the present invention allows the user to open the device at the desired "commitment" point without initiating the peeling of one or more lidding sheets / foils, or at least exposing the blister pocket of formulation, which means less chance of wasting a dose and less chance of inhaling a degraded formulation.

[0029] The defined point will generally be located at or near the end of the actuator's motion, for example at or near the end of the mouthpiece opening movement, but may be provided at any point after the indexing motion has begun, for example the peeling and opening of individual blisters of the pharmaceutical carrier may coincide with or overlap with part of the indexing motion.

[0030] Devices are known which use a series of geared components to deliver active pharmaceutical ingredients (API) from two separate blister strips.

[0031] A simple mechanical solution when designing this type of strip-based device is to directly couple the user input (usually either a lever / button or the cap of the device) to a set of components that simultaneously index and peel the blister strips. Individual doses or blisters within one or more blister strips are thereby peeled off and presented to a single / common airway for the user to inhale.

[0032] One common drawback of this system is that partially opening the cap (or partially depressing the lever / button) partially advances the dose, partially or completely opening the associated blister pocket. Release or return of the actuator can then return the blister to the "unpeeled" position, or leave the blister in the position it arrived at, without signaling to the user any degradation of the now exposed formulation.

[0033] This problem could be solved by charging a spring and releasing it at the end of the cap opening or lever action to simultaneously index and peel the strip. However, this would require a very strong spring, especially since the force required to index the strip would potentially change if the strip were to get stuck within the device. This would increase the input force required, negatively impacting the "feel" or feedback to the user while using the device.

[0034] Another known solution is to delay the initiation of the (indexing and peeling) motion until partway through the capping / actuation sequence, but this reduces the range of motion over which the user can input the required energy into the system (the user must input all of the required energy in a single part of the capping or lever movement), which creates similar issues as the incorporation of strong springs as discussed above.

[0035] In the system according to the invention, a relevant part of the peel operation, e.g. a part or stage of the operation exposing the dose ready for inhalation, may be delayed with respect to the start of the indexing operation. More generally, at least a part of the peel operation is delayed with respect to an equivalent part of the indexing operation. For example, the start of the peel may be delayed with respect to the start of indexing, and / or the point at which the peel operation has progressed 30% may be delayed with respect to the point at which the indexing operation has progressed 30%, etc. The point at which the dose is exposed may be delayed until the latest possible moment during the cap opening or operation of the alternative actuator.

[0036] In conventional systems, indexing and peeling can only be achieved simultaneously. The peeling and indexing actions are mechanically linked such that their progression is substantially balanced, and it is not possible to delay one relative to the other as described above. Pulling the two actions apart or decoupling them can result in disproportionate movement of the indexing and peeling components / systems from a single actuator. The benefit of delaying the peeling action can therefore be combined with a smoother user experience and improved feedback, since the indexing of the device can still occur throughout the entire actuator movement.

[0037] Considerable development work has been required to provide a solution to the problem of delaying at least a portion of the "peel" action that opens or exposes the inhalation dose, and disconnecting or separating it from the indexing of the inhalation device. The solutions can be broadly categorized into one of two main approaches: either adjusting the tension of the lid sheet below the level of tension required for peeling at the peel front - i.e., the absence or reduction to some extent of tension - or maintaining the position of the peel front relative to the drug carrier through the use of a moving "peel beak".

[0038] <Adjusting the lid sheet tension> This involves initially indexing the drug carrier under the position that the airway will occupy during inhalation, with the peel front (i.e. the position where the lidding sheet or foil is removed from the drug carrier) moving substantially with the next unopened blister in the drug carrier. For example, the peeled lidding sheet may be folded back over one or more unopened blisters in the drug carrier during the initial indexing. The lidding sheet take-up system may then be actuated or enabled to apply tension at a particular point during actuation of the actuator, causing the lidding sheet to peel under the airway and expose the opened blister to the airway.

[0039] In this embodiment, since there is nothing actively maintaining the position of the peel front (peel separation line), no tension should be applied on the lid sheet during the indexing operation, or the tension on the lid sheet should be released or "backed off" to ensure that peel does not occur until the desired moment.

[0040] <Moving detachment beak> This option involves the use of a specific component (per drug carrier) that essentially moves with the drug carrier, which keeps the peel front substantially stationary relative to the drug carrier during indexing. This moving / movable peel beak then moves relative to the drug carrier at the desired point, allowing the desired number of blisters / pockets to be peeled / opened. For example, the peel beak is released and tension in the lidding sheet pulls the peel beak back, thus allowing peeling to occur.

[0041] In some instances, the inclusion of a moving peeling pecker can create associated challenges that may need to be addressed. The space that the peeling pecker must pass through can result in a gap being present between the freshly peeled blister and the airway. This can be solved in a variety of ways, including, but not limited to, moving some or all of the airway, moving the drug carrier.

[0042] Movement of part or all of the airway - the airway can be moved into the gap between the airway and the drug carrier (previously occupied or passed by the stripping beak), this can be achieved in a number of ways including: Linking the stripping beak and the airway portion - the moving stripping beak component can include a portion of the (possibly straight) airway (e.g. an extra portion of the airway or the entire airway) that moves (e.g. rotates or translates) with the stripping beak, or can be attached to a portion of the airway and fill a gap previously occupied or traversed by the stripping beak. ··Separation of the moving airway - a portion of the airway (e.g. an excess portion of the airway or the entire airway) can move (e.g. rotate or translate, or other more complex movement) towards the drug carrier after / when the abrasion beak performs / enables abrasion, closing the gap previously occupied or passed by the abrasion beak.

[0043] Drug carrier movement - after / during rotation of the abrasion beak, the drug carrier can be moved (e.g. translated) towards the airway, e.g. by an indexing component or another component, to close the gap previously occupied or passed by the abrasion beak.

[0044] The movement of the ablation beak and the movement of the indexing component may be coupled by a single component or mechanism, or may be driven simultaneously.

[0045] Both the options of peeling below the inhalation position of the airway and using a moving peeling beak generally require that the lid sheet take-up system is capable of substantially moving the peeling front along with the drug carrier.

[0046] One way to achieve this is to position the lid sheet take-up system where the distance between the take-up system (during peeling) and the start and end positions of the peel front is substantially the same. For example, the take-up system can be located on (or close to) the perpendicular bisector of the movement of the peel front. Similarly, this effect can be achieved by positioning the lid sheet take-up system where the distance between the take-up system and the start position of the peel front (when peeling begins) is greater than the distance between the take-up system and the end position of the peel front (when peeling ends). For example, the take-up system can be located beyond (i.e. opposite to) the start position of the peel front, a line perpendicular to both the line struck through the start and end positions of the peel front and the line struck through the end position of the peel front, so that it only needs to operate in one direction (i.e. take up the lid sheet / foil).

[0047] An alternative approach is to configure the lid sheet winding system in such a way that it is possible to "release" some lid sheets, e.g. one index length of lid sheet (the length of lid sheet / foil associated with a single index step or dose). This requires extra winding of this released length of lid sheet, e.g. a length of lid sheet equal to two index lengths in total, when a peeling event occurs. Conventional winding systems are unidirectional and do not anticipate the need to release tension and / or run in the opposite direction. Providing this functionality can be achieved in various ways. Some examples are given below.

[0048] <Spring tension> In the case where a moving peel beak is provided, a spring element can be incorporated into the drive train of the winding system. The system can then automatically release some of the lid sheets from the indexing system under sufficient tension. This forced release generates extra spring potential energy which in turn provides the extra winding required during peeling. The spring bias can be provided in a variety of ways, including, for example: Spring-loaded winding drums or other winding systems (such as coil springs mounted on the winding drum or hub) Spring-loaded compound gears or other spring-loaded elements elsewhere in the driveline A lid sheet material capable of storing energy by elastic deformation, or Spring-induced tension in the lid sheet, e.g. One or more spring tensioners acting on the lid sheet A winding system that springs up from the stripping beak, e.g. a winding drum attached to a spring-loaded arm.

[0049] Spring induced tension in the lid sheet can be combined with active movement of the tension component to allow the system to reduce the maximum force experienced by one or more of the lid sheets / springs.

[0050] In known systems, the inclusion of a spring in the drive train of the winding system has been merely to compensate for the growth in diameter of the winding drum as used sheet is wound during use. The spring has not previously been considered as a means to cause the winding system to run in the opposite direction during indexing.

[0051] <Control tension> This approach involves actively controlling (e.g., reducing or releasing) a sufficient amount of tension in the lidding sheet so that the peel front substantially moves with the required amount of drug carrier to avoid substantial or undesirable peeling. There are several ways this can be accomplished, including moving the take-up system, reversing the take-up system, releasing the tensioner, and keeping the strip and peel front substantially stationary during indexing.

[0052] Movement of the take-up system - moving the take-up system (usually a take-up drum), for example translating the take-up system one indexing distance towards the peel front, allowing the release or movement of a sufficient amount of the lid sheet to cause the peel front to move the same distance.

[0053] · Reversing the winding system - releasing a clutch or similar mechanism, e.g. disengaging a ratchet set on the winding system, or actively reversing the winding system the required amount (e.g. mounting the winding drum on a ratchet wheel that turns at an appropriate angle to allow sufficient slack in the lid sheet, and then turning in the opposite direction during peeling).

[0054] Tensioner release - removing or moving the tension member out of the lid sheet tension path and releasing a distance of the sheet (e.g., one index distance) to allow the sheet to partially or completely straighten to an extent that allows the peel front to move substantially with the strip.

[0055] · Keeping the strip and peeling front substantially stationary during indexing - indexing is performed without moving the strip or the peeling front, e.g. indexing is performed by rotating the strip the required distance with an indexing wheel whilst moving the indexing wheel the same distance towards the take-up system, effectively keeping the strip and peeling front stationary.

[0056] Another advantage of separating indexing and stripping is that it allows some of the motion of the machine, such as indexing one or both wheels in a dual strip machine, to be performed during cap closure (or another similar reversing motion of the actuator). The required user input can then be spread over a larger range of motion, i.e., over one or more portions of the actuator motion, further reducing the force required and allowing for a smoother operation.

[0057] An inhalation device according to a first aspect comprises an actuation mechanism having an indexing system, an opening system and a common actuator for the indexing system and the opening system, the indexing system advances a drug carrier, the drug carrier having a base having a plurality of drug pockets or blisters and a peelable lid sheet such as a lid foil covering the blisters, the opening system peels the lid sheet from the drug carrier to open the blisters, the common actuator is movable between a first position and a second position via intermediate positions, and the progression of the opening system is disproportionate to the progression of the indexing system while the common actuator is moving.

[0058] In use, movement of the common actuator through a single defined range of motion causes the indexing system to move or advance sufficiently to advance the medicament carrier by a single dose, and the opening system to move or advance sufficiently to completely remove the lid-sheet from a corresponding length of the medicament carrier, but the movements of the opening system and the indexing system are not balanced - in other words, the speed ratio or rate of total movement / travel of the opening system and the indexing system is not constant during operation of the inhalation device.

[0059] Movement of the common actuator through a first range of motion allows the indexing system to operate, movement of the common actuator through a second range of motion allows the opening system to operate, and the indexing system can be decoupled (e.g., decoupled or separated) from the opening system such that the first range of motion is not the same as the second range of motion. Decoupling the opening system and the indexing system allows one to move largely independently of the other without the movements having to be balanced, as in the prior art.

[0060] A defined movement of a common actuator allows both the indexing system and the opening system to operate, and the speed of movement of the opening system relative to the speed of movement of the actuator can vary during the defined movement of the actuator.

[0061] Alternatively, a defined movement of the common actuator moves the opening system through a first phase of operation in which the indexing system operates to advance a dose of medicament and peeling occurs without exposing the medicament in the blister, and a second phase of operation in which said peeling exposes the medicament in the blister, thereby providing a dose of medicament ready for inhalation, said second phase of operation of the peeling system can be delayed until said operation of the indexing system is 30% complete. Some peeling of the lidding sheet may occur early in the operation of the device, but a significant portion of the operation when peeling the sheet over the edge of the blister pocket to actually expose the medicament is delayed until later in the operation.

[0062] The second, or critical, operational stage of the opening system may be delayed until said operation of the indexing system is 50% complete, or 60%, 70%, 80%, 90%, 95% or 100% complete.

[0063] A dose of drug may be defined as the dose delivered by an inhalation device according to a particular dosing regimen, which may include the contents of a single blister or a pair of blisters, or more, as appropriate.

[0064] The defined movement may be, for example, from a first position to a second position, or from the second position to the first position and back to the second position.

[0065] Any movement of the common actuator from said first position, for example away from the first position, can cause the indexing system to advance, and only movement of the common actuator beyond an intermediate position can cause the opening system to operate.

[0066] A reverse movement of the actuator from a position between the first position and the intermediate position back to the first position may reverse the advancement of the indexing system. This helps to avoid partial advancement and / or exposure of the dose during an incorrect or incomplete actuation of the inhalation device. The actuator may move to a point, e.g. a point to peel off or expose the dose, and then return to its initial position without partial advancement or exposure of the dose. Thus, the next "correct" or complete actuation of the inhalation device is not compromised by an incorrect or incomplete actuation. This is particularly relevant when indexing begins immediately upon actuator movement.

[0067] Additionally, movement of the actuator between the second position and the first position, ie, in a direction moving from the second position towards the first position, can cause the indexing system to advance.

[0068] The inhalation device may further comprise a central hub driven by a common actuator.

[0069] The inhaler may further comprise a gear linkage or cam system, such as a cam plate, to transfer drive from the central hub to the indexing system.

[0070] The actuation mechanism may further include a trigger component, the movement of which activates the opening system. The trigger component may be a linear movement component, such as a push rod or slider, that releases a spring biased component in the opening system.

[0071] Movement of the common actuator beyond the intermediate position may cause movement of the trigger component.

[0072] The actuation mechanism may further comprise a cam that controls the opening system.

[0073] The actuation mechanism may further comprise a lid sheet take-up component for receiving a used lid sheet peeled from the drug carrier, and a drive system between the common actuator and the lid sheet take-up component. The drive system may comprise a central hub.

[0074] The actuation mechanism may comprise a means for adjusting the tension exerted on the lid sheet during advancement of the indexing system. The system may be active (e.g. driven) or passive and may minimize tension in the lid sheet when the device is left idle or stored with the actuator in the first position.

[0075] A torsion spring may be provided between two rotating components provided on a common center of the driveline, for example between two stacked gears in a geared driveline, the two rotating components may be in a central logic hub, or in further drive elements in the driveline, or may form a spring-loaded idler.

[0076] During the advancement of the indexing system, a torsion spring is charged by the tension of the used lid sheet, which allows for a passive tension adjustment of the lid sheet.

[0077] Before or during the advancement of the indexing system, the drive system can actively move, e.g., rotate, the lid sheet winding component to adjust the tension in the lid sheet, e.g., to reduce the tension in the lid sheet or to create slack in the lid sheet.

[0078] During advancement of the indexing system, at least a portion of the peeled off lid sheet, e.g. the lid sheet that has become loose due to active tensioning, may be folded back onto the unopened portion of the pharmaceutical carrier.

[0079] The inhalation device may further comprise a peeling spigot component for regulating separation of the lid sheet from the medicament carrier. The peeling spigot component may resist peeling / separation of the lid sheet particularly at a location on the medicament carrier adjacent the peeling spigot during use.

[0080] The dissection beak component can move during or before advancement of the indexing system, for example, the dissection beak can move with the indexing system component during indexing.

[0081] The ablating beak component may follow a path that substantially coincides with the path of the drug carrier or a path that is offset from the path of the drug carrier.

[0082] The stripping beak component may be selectively engageable with a component of an indexing system, for example a moving indexing device such as an indexing wheel.

[0083] The stripping beak component may include a pawl or ratchet that selectively engages said component of the indexing system.

[0084] The indexing system may comprise means for indexing a first drug carrier and a second drug carrier, each of which comprises a base having a plurality of drug pockets or blisters and a peelable lidding sheet covering the blisters. Means for advancing three or more drug carriers may be provided.

[0085] The opening system may be configured to peel the lid sheet from each of the first and second drug carriers, such that movement of the common actuator from the first position operates the indexing system to advance the first drug carrier, and only movement of the common actuator beyond an intermediate position operates the opening system to peel the lid sheet from the blister of the second drug carrier.

[0086] The indexing system may comprise separate first and second indexing devices for indexing said first and second pharmaceutical carriers.

[0087] The indexing system may advance the first indexer and the second indexer disproportionately, i.e., the advancement of the first indexer is disproportionate to the advancement of the second indexer.

[0088] There is provided an inhalation device comprising an actuation mechanism having an indexing system comprising a first indexer and a second indexer for advancing a first medicament carrier and a common actuator for the first indexer and the second indexer, the common actuator being movable between a first position and a second position via intermediate positions, the progression of the first indexer being disproportionate to the progression of the second indexer, the progression may be during or after the movement of the common actuator, for example the progression may be driven by releasing a spring force after the movement of the actuator is completed.

[0089] The first indexer and the second indexer may in particular not advance simultaneously during movement of the common actuator, ie their movements may be mutually exclusive.

[0090] Movement of the common actuator through a first range of motion operates a first indexer, and movement of the common actuator through a second range of motion operates a second indexer, and the first indexer can be separated from the second indexer such that the first range of motion is not the same as the second range of motion.

[0091] When the common actuator moves from the second position to the first position, the indexing system can advance one of the first indexer and the second indexer.

[0092] At least one, and possibly both, of the first indexing device and the second indexing device may include an indexing wheel.

[0093] The indexing system may alternatively comprise a single indexer, which may comprise an indexing wheel.

[0094] The or each indexing wheel is rotatable and advances a medicament carrier in the form of a blister strip and may be provided with cavities for receiving individual blisters of the blister strip.

[0095] The opening system may be configured to simultaneously peel and open the blisters on each of the first and second pharmaceutical carriers.

[0096] The intermediate position of a common actuator may be closer to the second position of the common actuator than to the first position of the common actuator, for example the intermediate position may be within the last 45%, 35%, 25%, 20%, or 15% of a total movement between the first and second positions of a common actuator, or within the total range of movement.

[0097] The intermediate position of the common actuator may be proximate to the second position of the common actuator, for example within 0-10% of the movement of the common actuator and / or within 10° of the arc of movement of the actuator.

[0098] The actuation mechanism may include one or more gears having intermittent drive and / or locking surfaces, which allow for intermittent drive and / or locking of elements of the actuation system (e.g., lid sheet take-up components, individual indexers, moving peeling beak, etc.) during use.

[0099] The indexing system may comprise a locking means which selectively prevents movement of one or more components of the indexing system, for example one or more indexers / wheels.

[0100] The locking means may comprise one or more gears having a locking surface to provide a Geneva lock, and / or may comprise one or more pawls.

[0101] The common actuator may comprise a mouthpiece cover, and the first position may be a fully closed position of the mouthpiece cover, i.e. a position of the mouthpiece cover where the mouthpiece of the inhaler is fully covered, and the second position may be a fully open position of the mouthpiece cover, i.e. a position of the mouthpiece cover where the mouthpiece of the device is not fully covered.

[0102] Alternatively, the actuator may comprise a separate lever, button or other actuator and the first position and / or the second position may be defined stop positions for the actuator.

[0103] The inhalation device may further comprise a movable airway component, either as an integral movable airway or as part of a split airway comprising a static airway component and a movable airway component, the movable airway component providing a peeling beak component that controls separation of the lid sheet from the medicament carrier.

[0104] The movable airway component may follow a path that does not substantially coincide with the path of the drug carrier, or that is simply offset from the path of the drug carrier. For example, the movable airway component may follow a substantially straight path. The drug carrier may follow, for example, a curved or circular path.

[0105] The present invention can be used in devices containing one or more pharmaceutical carriers to deliver the formulation for inhalation by the user in a mechanically advantageous manner while minimizing the risk of accidental exposure of the formulation to the environment due to unintentional detachment.

[0106] Any of the essential or preferred features defined in relation to any one aspect of the invention may be applied to any further aspect, so far as practicable, and the invention may thus comprise various alternatives to those features defined above. [Brief description of the drawings]

[0107] [Figure 1] 1 is a perspective view of the inside of an inhalation device according to a first embodiment of the present invention. [Diagram 2] 1, but with some components removed. [Diagram 3] FIG. 2 is an exploded view of the device of FIG. 1. [Figure 4] 1 shows the first components from the central hub of the inhalation device. [Diagram 5] 2 shows the second component from the central hub of the inhalation device. [Figure 6] 2 shows the second component from the central hub of the inhalation device. [Figure 7] 1 shows the gear components that connect the central hub to the first drive train assembly of the inhaler device. [Figure 8] 1 shows a first driveline assembly. [Figure 9] 1 shows the gear components that connect the central hub to a second drive train assembly of the inhaler device. [Figure 10] 2 shows a second driveline assembly. [Figure 11] 13 shows the gear components that connect the central hub to the third drive train assembly of the inhaler device. [Figure 12] FIG. 13 is a front view of the third drive train assembly. [Figure 13] 3 shows components of a third driveline assembly. [Figure 14] 3 shows components of a third driveline assembly. [Figure 15] FIG. 13 is a rear view of the third drive train assembly. [Figure 16] FIG. 2 is a rear view of the overall mechanism of the inhaler of FIG. [Figure 17] The operation of the mechanism shown in FIG. 16 is shown. [Figure 18] The operation of the mechanism shown in FIG. 16 is shown. [Figure 19] The operation of the mechanism shown in FIG. 16 is shown. [Figure 20] The operation of the mechanism shown in FIG. 16 is shown. [Figure 21] The operation of the mechanism shown in FIG. 16 is shown. [Figure 22] The operation of the mechanism shown in FIG. 16 is shown. [Figure 23] FIG. 13 is a front view of the mechanism illustrating the paths of the blister strip, the lidding foil and the base foil. [Figure 23A] FIG. 24 is a detailed view of the area marked "A" in FIG. 23. [Figure 24] 1 illustrates an example of an alternative peeling mechanism. [Diagram 25] FIG. 25 is an exploded view of an inhaler according to a second embodiment of the invention incorporating the alternative peeling mechanism of FIG. 24. [Figure 26] FIG. 26 is a front view of the inhaler mechanism of FIG. 25. [Figure 27] FIG. 26 is a rear view of the inhaler mechanism of FIG. 25. [Figure 28] 26 shows a peel-off actuator component from the inhaler of FIG. 25. [Figure 29] 26 shows a peel-off actuator component from the inhaler of FIG. 25. [Diagram 30] 26 shows a ratchet component from the inhaler of FIG. 25. [Diagram 31] FIG. 11 is a rear exploded view of an inhaler according to a third embodiment of the present invention. [Diagram 32] FIG. 32 is a front perspective view of the inhaler mechanism of FIG. 31. [Diagram 33] FIG. 32 is a rear perspective view of the inhaler mechanism of FIG. 31. [Diagram 34] FIG. 34 is a rear detailed view of the mechanism of FIG. 33. [Diagram 35] FIG. 32 is a rear view of the mounting plate from the inhaler of FIG. 31. [Diagram 36] FIG. 10 is a front exploded view of an inhaler according to a fourth embodiment of the present invention. [Figure 37] FIG. 37 is a perspective view of components from the inhaler of FIG. 36. [Figure 38] FIG. 37 is a perspective view of components from the inhaler of FIG. 36. [Figure 39] FIG. 37 is a perspective view of components from the inhaler of FIG. 36. [Diagram 40] FIG. 37 is a perspective view of components from the inhaler of FIG. 36. [Diagram 41] FIG. 37 is a front view of the assembled mechanism of the inhaler of FIG. 36. [Diagram 42] 37 shows the operation of the inhaler of FIG. 36. [Diagram 43] 37 shows the operation of the inhaler of FIG. 36. [Diagram 44] 37 shows the operation of the inhaler of FIG. 36. [Diagram 45] 37 shows the operation of the inhaler of FIG. 36. [Figure 46] 37 shows the gearing at the rear of the inhaler of FIG. 36. [Figure 47] FIG. 10 is an exploded view of an inhaler according to a fifth embodiment of the present invention. [Figure 48] FIG. 48 is a cross-sectional view of a portion of the inhaler of FIG. 47 in a first configuration. [Figure 49] FIG. 48 is a rear view of the cam plate from the inhaler of FIG. 47. [Figure 50] FIG. 48 is a further cross-sectional view of the inhaler of FIG. 47 in the first configuration. [Figure 51] FIG. 48 is a front view of the inhaler of FIG. 47 in a second configuration. [Figure 52] 48 shows the path taken by a pair of blister strips through the inhaler of FIG. 47. [Diagram 53] 48 shows the gearing at the rear of the inhaler of FIG. 47. [Figure 54] 48 shows the operation of the inhaler of FIG. 47. [Figure 55] 48 shows the operation of the inhaler of FIG. 47. [Figure 56] 48 shows the operation of the inhaler of FIG. 47. [Figure 57] 48 shows the operation of the inhaler of FIG. 47. [Figure 58] 48 shows the operation of the inhaler of FIG. 47. [Figure 59]48 shows the operation of the inhaler of FIG. 47. [Figure 60] 48 shows the operation of the inhaler of FIG. 47. [Figure 61] FIG. 13 is an exploded view of an inhaler according to a sixth embodiment of the present invention. [Figure 62] FIG. 62 is a front view of the assembled inhaler of FIG. 61. [Figure 63] FIG. 63 is a rear view of the inhaler of FIG. 62. [Figure 64] FIG. 63 is a first cross-sectional rear view of the inhaler of FIG. 62. [Figure 65] FIG. 63 is a further rear view of the inhaler of FIG. [Figure 66] FIG. 13 is an exploded view of an inhaler according to a seventh embodiment of the present invention. [Figure 67] FIG. 67 is a perspective view of the input gear from the inhaler of FIG. [Figure 68] FIG. 68 is a top view of the drive gear from FIG. 67. [Figure 69] FIG. 67 is a front view of a portion of the inhaler mechanism of FIG. [Figure 70] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 71] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 72] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 73] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 74] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 75] 13 shows the movement of parts of the mechanism during opening of the mouthpiece cover. [Figure 76] 13 shows the movement of further parts of the mechanism during opening of the mouthpiece cover. [Figure 77] 13 shows the movement of further parts of the mechanism during opening of the mouthpiece cover. [Figure 78] 67 shows the drive mechanism of the inhaler of FIG. 66. [Figure 79] 67 shows a strip management mechanism for the inhaler of FIG. 66. [Figure 80] FIG. 13 is an exploded view of an inhaler according to an eighth embodiment of the present invention. [Figure 81] FIG. 81 is a perspective view of an indexing device from the inhaler of FIG. 80; [Figure 82] FIG. 81 is a perspective view of a first portion of a peel-off beak from the inhaler of FIG. 80. [Figure 83] FIG. 81 is a perspective view of a second portion of a peeled beak from the inhaler of FIG. 80. [Figure 84] 81 shows the operation of the locking mechanism of the inhaler of FIG. 80. [Figure 85] 81 shows the operation of the locking mechanism of the inhaler of FIG. 80. [Figure 86] FIG. 81 is a front view of the front plate from the inhaler of FIG. 80. [Figure 87] FIG. 81 is a perspective view of the input ratchet from the inhaler of FIG. 80. [Figure 88] 81 shows an opening of the mouthpiece of the inhaler of FIG. 80; [Figure 89] 81 shows an opening of the mouthpiece of the inhaler of FIG. 80; [Figure 90] FIG. 13 is a rear exploded view of an inhaler according to a ninth embodiment of the present invention. [Figure 91] FIG. 91 is a perspective view of a hub gear from the inhaler of FIG. 90. [Figure 92] FIG. 91 is a perspective view of the moving airway components from the inhaler of FIG. 90. [Figure 93] FIG. 91 is a perspective view of a mouthpiece cover from the inhaler of FIG. 90. [Figure 94] 13 shows the movement of the mouthpiece during opening of the mouthpiece cover. [Figure 95] 13 shows the movement of the mouthpiece while the mouthpiece cover is closing. [Figure 96] 91 shows the drive mechanism of the inhaler of FIG. 90. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0108] Possible embodiments of the invention are described in more detail below, by way of example only, with reference to the accompanying drawings, in which:

[0109] Figure 1 shows the interior of an inhalation device 2 according to a first embodiment of the invention. The inhalation device 2 is configured to use an elongated blister strip of medicament comprising a base sheet / foil defining individual blister pockets of medicament and a lid sheet in the form of a lid foil which can be peeled away from the base foil to open the pockets and expose the medicament to be inhaled.

[0110] The mid chassis 4 defines the internal chamber and pathway of the device which receives and guides the blister strip, while the rear chassis 6 provides mounting posts for the various rotating components 12, 14, 22, 24, 30 within the device. An airway manifold 8 is received in an opening at the top of the mid chassis 4, with configuration to allow interfacing with a mouthpiece, and a movable mouthpiece cover 10 (only the rear half of which is shown for clarity) is also provided.

[0111] The first and second indexing wheels 12, 14 respectively provide recesses 13, 15 which receive the blister pockets of the two separate blister strips as the first and second indexing wheels 12, 14 rotate and advance the blister pockets into position beneath the opening portion 16 of the air duct manifold 8. The unopened blister strips are stored coiled together within a storage chamber 18 defined by the intermediate chassis 4. From here, the first of the two blister strips is fed clockwise around the first indexing wheel 12 through a first passageway 20 within the intermediate chassis 4 before the base foil engages the first spool wheel 22. Similarly, the second blister strip is fed counterclockwise from the storage chamber 18 through a second passageway 26 around the second indexing wheel 14 before the base foil is attached to the second spool wheel 24.

[0112] In use, the lidding foil from each of the first and second blister strips is separated from the base foil at the first and second indexing wheels 12 and 14, respectively. The first and second spooling wheels 22 and 24 rotate together with the first and second indexing wheels 12 and 14 to wind the used base foil into a coil. The two lidding foils pass on either side of a tension balancer 28, which is attached to the intermediate chassis 4 at a pivot 29, before engaging a common winding drum 30. The rotation of the winding drum 30 creates tension in the lidding foil when blisters in the first and second blister strips need to be peeled open. As both lidding foils are wound on the same drum 30, slight imbalances in the tension of the first and second lidding foils may occur. However, the greater tension in the lid foils along either side of the tension balancer 28 acts to bias the tension balancer 28 towards the other foil about pivot 29. This effectively shortens the path followed by the high tension foil and lengthens the path followed by the low tension foil until the tensions in the two lid foils are balanced. In this way the tension in the lid foils can be maintained within an acceptable tension range.

[0113] 2 is a similar view of the inside of the inhaler device with the mid-chassis 4 and airway manifold 8 removed to expose the gearing between the various components of the inhaler device 2. In use, the mouthpiece cover 10 opens and closes as indicated by arrows 32 and 34, activating a mechanism that drives the indexing wheels 12, 14, spool wheels 22, 24 and take-up drum 30 in a predetermined sequence to index and strip the inhalation dose. This sequence is controlled by a central logic hub 36, which is mounted on a spindle 38 extending from the rear chassis 6 and is driven directly by the movement of the mouthpiece cover 10.

[0114] The central logic hub 36 is concentrically mounted with three drive gears 40, 42, 44 which surround and selectively engage the central logic hub 36. The winding drum drive gear 40 can be viewed as the gearing which engages the base of the winding drum 30, and the first index wheel drive gear 42 can be viewed as the gearing which engages the first index wheel 12 and the first spool wheel 22. Although not well visible in Figure 2, a second index wheel drive gear 44 is also provided which engages gearing on the second index wheel 14 and the second spool wheel 24.

[0115] Figure 3 is an exploded view of the inhaler device 2 of Figure 1, showing the components that make up the central logic hub 36. The two main components of the central logic hub 36 are an indexer drive ratchet wheel 46 that engages the first and second indexer wheel drive gears 42, 44, and a stripping drive ratchet wheel 48 that engages the take-up drum drive gear 40 and the take-up drum ratchet wheel 50, which together with the take-up drum 30 and the take-up drum drive gear 40 form a take-up drum drive train 60. Figure 3 also shows the components that make up the first and second indexer wheel drive trains 52, 54, as will be described in more detail below. A torsion spring 56 is disposed within the central logic hub 36 between the indexing drive ratchet wheel 46 and the peel drive ratchet wheel 48, and a slider 58 is provided to selectively resist rotation of one or the other of the indexing drive ratchet wheel 46 and the peel drive ratchet wheel 48.

[0116] The rear chassis 6 also includes a channel 62 for receiving the slider 58 and a generally crescent-shaped opening 64. An inner protrusion 66 and an outer protrusion 68 formed on the mouthpiece cover 10 extend through the opening 64. The opening 64 also receives a protrusion on the rear of the indexing drive ratchet wheel 46 and the peel drive ratchet wheel 48 so that these components can be driven by the rotational movement of the mouthpiece cover 10. More specifically, when the mouthpiece cover opens (moves clockwise from the position shown in FIG. 1), the inner protrusion 66 engages the indexing drive ratchet wheel 46 and drives it clockwise, while when the mouthpiece cover 10 closes, the outer protrusion 68 engages the peel drive ratchet wheel 48 and drives it counterclockwise.

[0117] The slider 58 allows one of the indexing drive ratchet wheel 46 and the peel drive ratchet wheel 48 to be "locked" while rotating the other with the rotation of the mouthpiece cover 10. This builds up a biasing force in the torsion spring 56 which can then be released by moving the slider 58 to release the previously locked components.

[0118] The rear chassis 6 also provides a first ratchet pawl 72 and a second ratchet pawl 74 for selectively locking the first indexing wheel 12 and the second indexing wheel 14, respectively.

[0119] FIG. 4 shows the rear of the indexing drive ratchet wheel 46 from the central logic hub 36. The wheel 46 comprises a generally circular plate 76 having a ring-shaped boss 78 extending from its rear surface. A recess 80 is provided in the rear surface of the plate 76 within the flange 78 to receive the arm of the torsion spring 56. Two circumferential ratchet pawls 82 and two axial ratchet pawls 84 are provided around the circumference of the plate 76. The circumferential ratchet pawls 82 and the axial ratchet pawls 84 are oriented to provide driving forces in opposite rotational directions. FIG. 4 also shows a protrusion 86 extending from the end of the boss 78 and a recess 88 formed in the outer periphery of the boss 78. The protrusion 86 engages the inner protrusion 66 of the mouthpiece cover, and the recess 88 receives the slider 58 to lock the indexing drive ratchet wheel 46 against rotation.

[0120] 5 and 6 show the peel drive ratchet wheel 48 in more detail. A rear view is provided in FIG. 5, showing a generally circular plate 90 having a large cutout 92 on one side and a generally crescent-shaped slot 94 and two small cutouts 96 on the other side. A protrusion 98 extends from the rear surface of the plate adjacent the edge of the slot 94 and engages with an outer protrusion 68 formed on the mouthpiece cover 10. FIG. 6 shows a front view of the peel drive ratchet wheel 48. Four radial ratchet pawls 100 are provided around the outer periphery of a ring-shaped boss 102 extending from the front of the plate 90. Two of the radial ratchet pawls 100 are located in the area of ​​the wheel 48 where the large cutouts 92 are provided, and the other two correspond to the location of the smaller cutouts 96, so that the plate 90 does not impede the movement of the ratchet pawls 100. The outer periphery of the plate 90 is provided with small toothed portions 104 along with a pair of notches 106 .

[0121] The inner diameter of the ring-shaped boss 102 is large enough to receive the boss 78 of the indexing drive ratchet wheel 46 when the central logic hub 36 is assembled. When assembled, the protrusion 86 extending from the end of the boss 78 on the indexing drive ratchet wheel 46 passes through the slot 94 and extends from the rear surface of the plate 90 of the peel drive ratchet wheel 48 as far as the protrusion 98 formed directly on the plate 90 of the peel drive ratchet wheel 48.

[0122] 7 shows the rear face of the first index wheel drive gear 42. The rear face of the drive gear 42 shows an internal cavity 110 having four radially extending notches 112 about an inner periphery 114 of the cavity 110. The diameter of the cavity 110 is sufficient to receive the generally circular plate 76 of the index drive ratchet wheel 46 shown in FIG. 4, with the circumferential ratchet pawls 82 being received in two of the four notches 112.

[0123] The assembly is shown in Figure 8 along with the rest of the first index wheel drive train 52. The engagement of the circumferential ratchet pawl 82 with the notch 112 transfers drive from the index drive ratchet wheel 46 to the first index wheel drive gear 42 only in a counterclockwise direction 116 (Figure 8 is a rear view of the assembly). During clockwise movement of the index drive ratchet wheel 46, which occurs during opening of the mouthpiece by the projection 86 engaging the inner protrusion 66 of the mouthpiece cover, the circumferential ratchet pawl 82 can flex out of the notch 112, which allows relative rotation between the index drive ratchet wheel 46 and the first index wheel drive gear 42. A boss 118 on the rear face of the first index wheel 12 provides a notch 122 that engages the first ratchet pawl 72 on the rear chassis 6 to resist rotation of the first index wheel 12 in the corresponding direction. Thus, the first indexing wheel drive train 52 drives the first indexing wheel 12 and the first spool wheel 22 only while the mouthpiece cover is closed.

[0124] 9 shows in more detail the ring-shaped second indexing wheel drive gear 44. The front face of the drive gear 44 is provided with four angled recesses or notches 124 which engage with the axial ratchet pawls 84 provided on the indexing drive ratchet wheel 46 when the boss 78 of the indexing drive ratchet wheel 46 is received within the ring. The inner diameter 120 of the indexing wheel drive gear 44 is the same as the inner diameter of the ring-shaped boss 102 of the peeling drive ratchet wheel 48 and receives the boss 78 of the indexing drive ratchet wheel 46.

[0125] 10 is a front view of the second index wheel drive train 54 incorporating the second index wheel drive gear 44 and index drive ratchet wheel 46 assembly described above. The axial ratchet pawl 84 is shown engaged with two of the notches 124, and a clockwise drive 126 from the index drive ratchet wheel 46 is transmitted to the second index wheel drive gear 44. As described above, the index drive ratchet wheel 46 is driven in a clockwise direction 126 by the projection 86 on the rear surface of the index drive ratchet wheel 46 engaging the inner protrusion 66 of the mouthpiece cover during opening of the mouthpiece cover. Therefore, both the second index wheel 14 and the second spool wheel 24 are driven when the mouthpiece 10 is opened. In contrast, counterclockwise rotation of the index drive ratchet wheel 46 causes the axial ratchet pawl 84 to deflect from the notch 124 which allows relative rotation between the index drive ratchet wheel 46 and the second index wheel drive gear 44 .

[0126] 11 shows in more detail the ring-shaped take-up drum drive gear 40. The drive gear 40 has an inner peripheral wall 132 with a number of notches 130 which function as ratchet teeth. The opening defined by the inner peripheral wall 132 has a diameter 136 which is sized to receive the boss 102 of the stripping drive ratchet wheel 48.

[0127] 12 is a front view of the winding drum drive system 60. The boss 102 of the peeling drive ratchet wheel 48 is inserted from behind the winding drum drive gear 40, and the radial ratchet pawl 100 of the peeling drive ratchet wheel 48 engages with the notch 130 to transmit the clockwise rotation 138 of the peeling drive ratchet wheel 48 to the winding drum drive gear 40. The winding drum drive gear 40 engages with gear teeth 140 provided around the base of the winding drum 30 to transmit the rotation to the winding drum 30. A pair of holding mechanisms 142 on one side of the winding drum 30 holds the free ends of the pair of lid foils, and in use, the counterclockwise rotation 144 of the winding drum 30 applies tension to the lid foils, winding them around the body of the winding drum 30.

[0128] A plate 90 of the stripping drive ratchet wheel 48 rests against the rear face of the winding drum drive gear 40 and the generally circular contour of the plate 90 can be seen between the gear teeth of the winding drum drive gear 40. A portion of the winding drum ratchet wheel 50 is also visible behind the winding drum 30 in the front view of FIG.

[0129] Figure 13 is a rear view of the take-up drum 30. The gear teeth 140 around the base of the take-up drum 30 are clearly visible along with a ring of ratchet teeth 146 provided on the rear face. In use, the ratchet teeth 146 engage a pair of ratchet pawls 148 provided on either side of the take-up drum ratchet wheel 50 and extending from the front face of the take-up drum ratchet wheel 50 shown in Figure 14. Gear teeth 150 are provided on the outer edge portion of the take-up drum ratchet wheel 50 adjacent the inwardly curved portion 152.

[0130] FIG. 15 is a rear view of the winding drum drive system 60. In this rear view, The ratchet pawl 148 and gear teeth 150 on the ratchet wheel 50 engage the take-up drum 30. and the toothed portion 104 on the stripping drive ratchet wheel 48. The gear teeth 150 are shown engaged with the toothed portion 104 while peeling away. The clockwise rotation 138 of the release drive ratchet wheel 48 rotates the take-up drum ratchet wheel 50 The resulting counterclockwise rotation 144 is transmitted to the ratchet pawl 148 and the ratchet It will be appreciated that the rotational speed of the winding drum 30 will be transmitted to the winding drum 30 via the tines 146. When the gear teeth 150 reach the end of the toothed portion 104, the winding drum ratchet wheel 50 has an inwardly curved portion 152 that receives the curved outer edge of the peel drive ratchet wheel 48; Provides a Geneva style lock to hold the take-up drum ratchet wheel 50 against further rotation As previously described, the ratchet pawl 148 can bend past the ratchet teeth 146 and peel off. The winding drum is driven by the drive ratchet wheel 48 and the winding drum drive gear 40. This allows further counterclockwise rotation 144 of the ram 30. However, the ratchet pawl 148 Engage ratchet teeth 146 while winding drum ratchet wheel 50 is stationary Any clockwise rotation of the take-up drum 30 can be resisted.

[0131] 16 is a rear view of the entire mechanism of the suction device 2, including the central logic hub 36, the take-up drum drive train 60, and the first and second indexer wheel drive trains 52, 54. The rear view also shows the boss 118 and notch 122 on the rear face of the first indexer wheel 12 as well as the notch 134 on the boss 128 on the rear face of the second indexer wheel 14. The notch 134 on the second indexer wheel 14 is configured to engage the second ratchet pawl 74 on the rear chassis 6, similar to how the notch 122 on the first indexer wheel 12 engages the first ratchet pawl 72, but resists rotation in the opposite direction.

[0132] The mouthpiece cover 10 is also shown in cross section and includes an inner protrusion 66 and an outer protrusion 68 formed thereon. The inner protrusion 66 is shown abutting a protrusion 86 of the indexing drive ratchet wheel 46 which extends through a generally crescent-shaped slot 94 in the peel drive ratchet wheel 48. The outer protrusion 68 is shown abutting a protrusion 98 on the peel drive ratchet wheel 48. The slider 58 is also shown with a tab 154 provided on an obscured front surface of the slider 58 shown in dashed lines. The tab 154 engages either a recess 88 (not shown) of the indexing drive ratchet wheel 46 or a similar recess 156 provided on the peel drive ratchet wheel 48 to selectively lock one or the other component against rotation.

[0133] As shown in Figure 16, the mouthpiece cover 10 is fully open and a dose has just been inhaled from the inhalation device 2. Operation of the device 2 from this position is explained in the following figures.

[0134] FIG. 17 shows the initial stage of the mouthpiece cover closing. The mouthpiece 10 has rotated approximately 45° in the direction of the arrow 32. The outer projection 68 engages the protrusion 98 on the peel drive ratchet wheel 48, directly driving the peel drive ratchet wheel 48 to rotate in the same direction 158 as the mouthpiece cover 10, which is counterclockwise when viewed from the front. None of the other components rotate from the position shown in FIG. 16. The ratchet pawl 100 allows the peel drive ratchet wheel 48 to rotate counterclockwise within the take-up drum drive gear 40. The curved outer edge of the peel drive ratchet wheel 48 travels past the inner curved portion 152 of the take-up drum ratchet wheel 50 until just after the point shown in FIG. 17, when the gear teeth 150 on the take-up drum ratchet wheel 50 approach engagement with the toothed portion 104 of the peel drive ratchet wheel 48. Tab 154 on slider 58 engages recess 88 on indexing drive ratchet wheel 46 preventing rotation of indexing drive ratchet wheel 46, thereby not indexing either of indexing wheels 12, 14. Relative rotation between peel drive ratchet wheel 48 and indexing drive ratchet wheel 46 causes torsion spring 56 to load.

[0135] 18 shows the next stage of operation. As the mouthpiece cover 10 continues to close 32, further counterclockwise rotation 158 of the peel drive ratchet wheel 48 occurs, causing the toothed portion 104 to engage gear teeth 150 on the take-up drum ratchet wheel 50. This causes the take-up drum ratchet wheel 50 and associated take-up drum 30 to rotate clockwise 160 (when viewed from the front), thereby reducing tension in both lid foils as the mouthpiece cover 10 closes. The tab 154 still prevents the index drive ratchet wheel 46 from rotating, but now closes to the edge of the recess 156 provided in the peel drive ratchet wheel 48. A radial protrusion 153 on the peel drive ratchet wheel 48 is also adjacent to the radially inner end of the slider 58.

[0136] 19 shows the mouthpiece cover 10 in a fully closed position. As the mouthpiece cover 10 continues to move 32, the winding drum 30 rotates further in a clockwise direction 160, further reducing the tension on the lid foil and slackening the lid foil between the winding drum 30 and the first 12 and second 14 indexing wheels.

[0137] The peel drive ratchet wheel 48 also rotates further and passes the fixed point, where the radial protrusion 153 and the inclined surface provided in the recess 88 of the indexing drive ratchet wheel 46 and the recess 156 provided in the peel drive ratchet wheel 48 guide / urge the slider 58 radially outward, so that the tab 154 moves from the recess 88 into the recess 156. The indexing drive ratchet wheel 46, which is now free, is driven by the torsion spring to "catch up" with the peel drive ratchet wheel 48 by rotating in the counterclockwise direction until the protrusion 86 of the indexing drive ratchet wheel 46 abuts against the inner protrusion 66 of the mouthpiece cover 10. 8, this counterclockwise rotation 116 of the indexing drive ratchet wheel 46 is transmitted through the first indexing wheel drive train 52 to advance or index the first indexing wheel 12 in a clockwise direction 162 by one recess 13 or one dose, which in turn drives the first spool wheel 22 to wind up the base foil. The pair of notches 106 of the peel drive ratchet wheel 48 are positioned to align with the ratchet pawls 72, 74 on the rear chassis 6, allowing the ratchet pawls 72, 74 to flex and prevent the first ratchet pawl 72 from impeding the rotation of the first indexing wheel.

[0138] The indexing action also applies tension to the first used lidding foil, but this only serves to take up the slack caused by the clockwise rotation 160 of the take-up drum 30. As a result, the lidding foil does not peel away from the blister strip, but instead folds back over the unopened blister strip in the space provided between the first indexing wheel 12 and the opening portion 16 of the air duct manifold 8. This is shown in more detail in Figure 23A.

[0139] FIG 20 shows the initial stages of opening of the mouthpiece cover 10. The opening movement 34 of the mouthpiece cover 10 causes the indexing drive ratchet wheel 46 to rotate in a clockwise direction 126 through engagement of the inner projection 66 of the mouthpiece cover 10 with the projection 86 of the indexing drive ratchet wheel 46. As described above in FIG 9 and FIG 10, this clockwise rotation 126 drives the second indexing wheel 14 and the second spool wheel 24, both of which rotate in a counterclockwise direction 164 to begin advancing / indexing the second blister strip. The peeling drive ratchet wheel 48 remains locked against rotation, the take-up drum 30 is not driven, and the notches 106 continue to allow movement of the ratchet pawls 72, 74 such that the second ratchet pawl 74 does not impede the counterclockwise rotation 164 of the second indexing wheel 14.

[0140] FIG. 21 illustrates further opening 34 of the mouthpiece cover and the resulting further clockwise rotation 126 of the indexing drive ratchet wheel 46 and the resulting counterclockwise rotation 164 of the second indexing wheel 14 and the second spool wheel 24. The second indexing wheel 14 has now advanced or indexed one recess 15 or one dose from the position shown in FIG. 19. As before, slack in the lidding foil during mouthpiece closure prevents the lidding foil from peeling from the second blister strip during indexing. The tab 154 is in close proximity to the recess 88 of the indexing drive ratchet wheel 46 in FIG. 21 and any further movement will urge the tab 154 from the recess 156 of the peel drive ratchet wheel 48 into the recess 88 of the indexing drive ratchet wheel 46.

[0141] 22, the mouthpiece cover has moved 34 through / over a further defined point to the mouthpiece cover's fully open position. A final clockwise rotation 126 of the indexing drive ratchet wheel 46 allows the tabs 154 to move radially inward from the recesses 156 in the peel drive ratchet wheel 48 into the recesses 88 in the indexing drive ratchet wheel 46. This frees the peel drive ratchet wheel 48 to rotate 138 clockwise under the drive of the torsion spring 56, which is transferred to both the take-up drum ratchet wheel 50 and the take-up drum 30.

[0142] The sudden rotation 144b of the winding drum simultaneously tensions both lidding foils, exposing the next inhalation dose in each blister strip. As described above in connection with Figures 12-15, the counterclockwise rotation 144b of the winding drum 30 is greater than the counterclockwise rotation 144a of the winding drum ratchet wheel 50. This allows the winding drum 30 to release the tension in the lidding foil when the mouthpiece closes after administration of a dose, while effectively peeling the lidding foil from the next dose when the mouthpiece opens. The sudden rotation of the peel drive ratchet wheel 48 also moves the notch 106 out of alignment with the ratchet pawls 72, 74 on the rear chassis 6, effectively locking the first indexing wheel 12 and the second indexing wheel 14 against rotation.

[0143] Once the user has inhaled the exposed dose, the inhaler reverts to the configuration shown and described in FIG.

[0144] Figure 23 is a schematic front view of a portion of the inhalation mechanism illustrating the path of the first blister strip 166 and the second blister strip 168 through the inhalation device 2. As explained in relation to Figure 19, the inhaler mouthpiece cover 10 is fully closed, so the winding drum 30 rotates clockwise 160 to actively release tension in the separated first lid foil 170 and second lid foil 172. However, the clockwise rotation 162 of the first indexing wheel 12 advances the base foil 174 of the first blister strip 166, dragging the first lid foil 170 around the first indexing wheel. As previously mentioned, the clockwise rotation 160 of the winding drum 30 creates slack in each lid foil 170, 172 equivalent to one indexing distance, so that there is little or no tension in the first lid foil 170 as the first indexing wheel 12 advances / indexes.

[0145] Since the second indexing wheel 14 is not rotating at this stage, the second lid foil 172 remains slack. In this way, any excess tension 176 that may develop in the first lid foil 170 due to the sudden movement of the first indexing wheel 12 can be accommodated by the movement 178 of the tension balancer 28 towards the second lid foil 172. The tension balancer 28 can thus act as an additional means of releasing or managing tension, keeping the tension in both lid foils 170, 172 to a minimum with the mouthpiece cover 10 closed, even if the first indexing wheel 12 has already advanced / indexed to this position.

[0146] FIG. 23A is an enlarged view of the portion marked "A" in FIG. 23. The first blister strip 166 is shown passing around the first indexing wheel 12, showing a first filled blister pocket 180 and a second filled blister pocket 182, as well as an empty blister pocket 184. The second filled blister pocket 182 has advanced to a position below the opening portion 16 of the air duct manifold 8. The first lidding foil 174 has been folded 186 over the second filled blister pocket 182 in the space between the first indexing wheel 12 and the air duct manifold 8. When tension 188 is applied to the lidding foils 170, 172 by the counterclockwise rotation 144b of the take-up drum 30, the first lidding foil 170 will be pulled around a static peel beak or end stop 190 provided on the intermediate chassis 4 and peeled from the second filled blister pocket 182.

[0147] From the above description it will be understood that the operation of the mechanism of the inhalation device 2 comprises several separate actions resulting from a single actuation of the mechanism (movement of the mouthpiece cover 10), and these actions encompass a number of defined points. Problems that may arise when some defined points are exceeded whilst others remain unreached include, for example: - Over-energization and under-energization of springs - Force desynchronization of the device Failure to detach blisters or properly present inhalation products Inaccurate dose measurement · Over tensioning of components resulting in failure.

[0148] Therefore, such actions are beneficially tied or coupled together and are no longer separable, but must be accompanied by sufficient synchronization to avoid these problems.

[0149] The inhalation device 2 described above uses a "catch-up" mechanism. When the mouthpiece cover 10 opens, it drives the indexing drive ratchet wheel 46, which rotates through an opening angle and then releases the slider 58. The slider 58 releases the peeling drive ratchet wheel 48 and rotates until peeling is complete. During the closing of the mouthpiece cover 10, the peeling drive ratchet wheel 48 is driven backwards until it resets the slider 58. This releases the indexing drive ratchet wheel 46 to rotate backwards until the first indexing wheel 12 indexes.

[0150] Ratchets / pawls connect the indexing drive ratchet wheel 46 to both the first indexing wheel 12 and the second indexing wheel 14, connect both indexing wheels 12, 14 to the rear chassis 6, and connect the take-up drum 30 to the take-up drum ratchet wheel 50. The suction device 2 aims to ensure that all of these ratchet reset points are "slave" to a defined point at which the slider 58 is released.

[0151] At a defined point when the mouthpiece opens, the slider 58 is forced down or radially inward by the peel drive ratchet wheel 48 onto the indexing drive ratchet wheel 46 by the ramps provided on the recesses 88, 156. This reduces the final rotation of the indexing drive ratchet wheel 46 when the slider 58 is released and the peel drive ratchet wheel 48 is allowed to rotate. This final rotation provides a ratchet reset window, specifically, a ratchet reset window associated with the movement of the second indexing wheel 14 and the movement of the indexing drive ratchet wheel 46 relative to the first indexing wheel drive gear 42. Since these occur at the end of the movement of the indexing drive ratchet wheel 46, they are coupled to the movement of the peel drive ratchet wheel 48 and cannot be operated separately.

[0152] On the return stroke, as the mouthpiece cover 10 closes, a definite point occurs when the peel drive ratchet wheel 48 rotates sufficiently to push the slider 58 back out of engagement with the index drive ratchet wheel 46, which, together with its associated ratchet pawl reset, causes the index drive ratchet wheel 46 to rotate and index to the first index wheel 12. This indexing is thus tied to the definite point and neither can be operated separately.

[0153] Various modifications to the described inhalation device may be made without departing from the scope of the general inventive concept. For example, the rotation of the first index wheel 12 and the second index wheel 14 can be changed. As described above, the first indexing wheel 12 is rotated by the first and second pawls 72 and 74, rather than by the first and second pawls 72 and 74. and a curved Geneva locking surface provided on the second indexing wheel 14, and a peeling drive ratchet wheel. Selectively preventing the wheel from rotating by interacting with a curved Geneva locking surface provided on the wheel 48. It is possible.

[0154] Peeling of the lid sheet / foil can also be achieved by alternative means. For example, the indexing wheel can be arranged to move linearly while rotating and indexing the strip, effectively rolling the indexing wheel along the strip by one blister pocket, and then translating the indexing wheel axis back to its original position with the indexing wheel rotation locked. This would allow the lid foil take-up system to peel the lid foil as the indexing wheel translates. Alternatively, a moving peel beak can be provided which rotates with either of both the first 12 and second 14 indexing wheels during indexing, and then released to allow peeling of the lid foil. Any of these arrangements essentially provide a moving peel front position, thereby avoiding the need to actively retract and release tension on the lid foil, and then re-apply tension to perform the peeling action. This potentially allows a less complex overall mechanism to be provided.

[0155] An example of a moving stripping beak arrangement is shown in Figure 24. Briefly, this view shows one side of the mechanism of the alternative inhaler device, showing the single indexing wheel 214. The mechanism shown also includes a central input hub gear 236, a take-up drum / hub 230 for the used lid sheet or foil, and a spool wheel 224 for receiving the used base / base foil.

[0156] A moving peel beak component 290 is provided about the indexing wheel 214. The moving peel beak component 290 defines a peel front and includes a ratchet pawl 292 that is shown engaging ratchet teeth 296 provided on or associated with the indexing wheel 214. A pin 294 is provided on the ratchet pawl 292 to enable a spring-loaded peel actuator (not shown) to disengage the ratchet pawl 292 from the ratchet teeth 296 when required.

[0157] Also shown is a storage hub 218 which stores the unused blister strip. The storage hub 218 comprises a front or inner gear 218A and a rear or outer gear 218B with a torsion spring disposed between them. The inner gear 218A is driven by rotation of the input hub gear 236 as shown, which transmits drive directly to the indexing wheel 214 and the spool wheel 224 to advance the blister strip. The winding drum / hub 230 in turn engages the outer gear 218B. As the moving peeling beak 290 rotates with the indexing wheel 214, tension generated in the lid foil rotates the winding drum / hub 230 relative to the winding direction, driving the outer gear 218B in the opposite direction to the inner gear 218A and charging the torsion spring within the storage hub 218.

[0158] When a dose is to be opened, a peel actuator (not shown) engages the pin 294, releasing the ratchet pawl 292 from the ratchet teeth 296. This frees the moving peel beak component 290 to rotate relative to the indexing wheel 214. The charged torsion spring then drives the rear / outer gear 218B to wind up the lid foil and peel and open the dose when the indexing wheel 214 is held stationary.

[0159] The moving stripping beak component 290 also includes an extra portion of the airway (not shown) to provide a passageway between the stripped doses / blisters on the indexing wheel 214 and the mouthpiece of the inhalation device.

[0160] The mechanism shown in Figure 24 is shown assembled to the rear plate 206 of the inhaler and constitutes the left side of the complete mechanism. The input hub gear 236 is surrounded by a rear ratchet ring 240 which is connected to the mouthpiece cover (not shown) through the rear plate 206 such that the mechanism is driven only in the direction of the arrow 234. This drive occurs when moving the mouthpiece from the closed position to the open position.

[0161] Figure 25 is an exploded view of a complete inhaler 202 incorporating a moving stripping nasal component 290. The back plate 206 has been omitted from the exploded view, but the remaining components discussed in Figure 24 are shown, along with a torsion spring 256 located between the front gear 218A and rear gear 218B of the storage hub 218. Also shown are the mouthpiece and airway manifold 208, mouthpiece cover 210, and linearly moving stripping actuator 258.

[0162] Also shown in Figure 25 are equivalent components making up the right side of the mechanism. The right side of the mechanism is driven by a front input hub gear 236' which is surrounded by a front ratchet ring 240'. The right side indexing wheel is labeled 212, the right side spool wheel is labeled 222, and other components are labeled equivalently to the left side components and differentiated by a prime symbol. The left and right halves of the mechanism are generally similar, with the exception of an additional gear 228 towards the rear of the assembly which forms part of the right side storage hub 218'.

[0163] Briefly, this second embodiment of an inhaler according to the invention comprises a moving mouthpiece cover connected to a central hub which comprises a pair of unidirectional ratchet wheels each associated with a separate gear system. This allows the action of closing the mouthpiece cover to advance a first indexing wheel whilst the action of opening the mouthpiece cover advances a second indexing wheel. The central hub also incorporates a cam track which controls the movement of a spring peeling actuator. When the mouthpiece cover opens beyond an intermediate position or fixed point, the peeling actuator is released to free the pair of peeling nasal components as described above and is reset when the mouthpiece is closed. The peeling actuator is constrained to linear motion.

[0164] After a dose is inhaled, the right side of the mechanism moves forward first, and henceforth the right side components will be referred to as the first indexing wheel 212, the first spool wheel 222, etc.

[0165] 26 is a front view of the assembled mechanism. As shown, the mouthpiece cover is closed after a dose is inhaled. The front ratchet ring 240' rotates the front input gear 236' in the direction of the arrow 232 as the mouthpiece closes, advancing the right side of the mechanism and rotating the first indexing wheel 212 one step / dose, rotating the first stripping beak component 290' to the position shown.

[0166] During closing of the mouthpiece cover 210, the input gear 236' directly drives the inner gear 218A' of the storage hub 218', which is transferred to the first indexing wheel 212 (via the additional gear 228 - see FIG. 27) and the first spool wheel 222 to advance the blister strip. The first winding drum / hub 230' is engaged with the outer gear 218B'. As the moving peeling beak 290' rotates with the indexing wheel 214, tension generated in the lid sheet / wheel rotates the winding drum / hub 230 against the winding direction, driving the outer gear 218B' in the opposite direction to the inner gear 218A' and energizing the torsion spring 256' in the first storage hub 218. Additionally, the peel actuator cam track 241 on the front ratchet ring 240' moves the peel actuator 258 vertically downward against the force of the biasing spring to the position shown so that the first peel beak 290' does not disengage from the first indexing wheel during rotation.

[0167] When the mouthpiece cover 210 is opened, the front ratchet ring 240' rotates in the direction of the arrow 234. This deflects the ratchet pawl 250' so that no drive is transmitted to the mechanism during mouthpiece opening.

[0168] FIG. 27 is a rear view of the assembled mechanism. The rear of the components shown in FIG. 25 is seen with the additional gear 228 engaged with the first index wheel 212. The additional gear 228 is directly connected to the inner wheel 218A′ of the first storage hub 218′, and as the additional gear 228 rotates when the mouthpiece cover closes, it directly drives the first index wheel 212 as shown in FIG. 26. As the rear ratchet ring 240 rotates in the direction 234 by the mouthpiece cover opening, it drives the second index wheel 214, the second spool wheel 224, etc. as shown in FIG. 25. The ratchet pawl 250 flexes, allowing the rear ratchet ring 240 to rotate in the direction of the arrow 234 without advancing the mechanism during mouthpiece closure. The additional gear 228 is not engaged with the rear input gear 236 and is therefore not driven by any movement of the rear ratchet ring 240.

[0169] It will thus be appreciated that the two unidirectional ratchet rings 240, 240' drive different halves of the mechanism when the mouthpiece is opened or closed. In particular, the first indexing wheel 212 is driven only during closing of the mouthpiece 210 and the second indexing wheel 214 is driven only during opening of the mouthpiece.

[0170] Figures 28 and 29 show the peel actuator 258 in isolation. The front view of Figure 28 shows a pin 260 at the lower end of the peel actuator 258 which engages a cam track 241 in the front ratchet ring 240'. Figure 29 shows a pair of prongs 262 on the rear of the peel actuator 258. In use, the prongs 262 simultaneously engage the pins 294 on the ratchet pawls 292 of both peeler beaks 290, 290' releasing the peeler beaks 290, 290' allowing the take-up drum / hub 230, 230' to rotate and pull the lidding foil from each of the two blister strips to expose an inhalation dose.

[0171] FIG. 30 shows the rear side of the front ratchet ring 240′ and provides details of the cam track 241 that guides the pin 260 of the peel actuator 258. The path of the pin 260 through the cam track is illustrated by an arrow. When a dose is released from the inhaler, the outer track 242 urges the pin 260 inwardly against the front ratchet ring 240′ during rotation 232 caused by closing the mouthpiece cover 210. This causes the peel actuator 258 to move downwards against the force of the spring until the mouthpiece cover 210 is fully closed. During opening 234 of the mouthpiece cover 210, the pin 260 is instead restrained by the inner track 244, which holds the peel actuator 258 in a retracted position. A resilient divider 246 is provided between the outer track 242 and the inner track 244 to provide the outer wall of the inner track 244. The divider 246 flexes as the pin 260 approaches the left end (as shown) of the cam track 241 during closing of the mouthpiece cover, allowing the pin 260 to move from the outer track 242 to the inner track 244. This is the position shown in the front view of Figure 26. The divider 246 then returns to the position shown in Figure 30, preventing the pin 260 from moving back into the outer track 242 during subsequent opening of the mouthpiece cover.

[0172] When the mouthpiece cover 210 is fully open, the pin 260 reaches the right end (as shown) of the cam track 241 and can then move into the straight section 248 of the cam track 241, which is disposed substantially vertically with the inhaler body in the fully open position. This results in a fixed point just after the second indexing wheel 214 has advanced one step / dose, at which point the peel-off actuator 258 is free to move vertically under the force of its spring, releasing the peel-off beak 290, 290′ to uncover the dose to be inhaled by the patient.

[0173] A further embodiment of the invention is illustrated in Figures 31-35. This embodiment includes a single dual height indexing wheel that accepts two blister strips, although it will be apparent that this mechanism could be provided for a single blister strip if desired. A one-way ratchet wheel drives the indexing system when the mouthpiece cover opens. A spring loaded floater having a structure similar to the storage hub 218 described in Figure 24, with a torsion spring, is provided in the drive train between the mouthpiece cover and the lid sheet winding component, and includes a moving peeling navel component similar to that described above. When the indexing wheel and peeling navel component rotate past a defined point corresponding to an intermediate position during mouthpiece cover opening, a cam track provided on the chassis of the inhaler engages a pin on the ratchet pawl of the moving peeling navel component, freeing the moving peeling navel component.

[0174] Figure 31 is an exploded view of this third embodiment, taken from the rear and therefore showing the rear side of the various components of the inhalation device 302 that are located within the outer housing.

[0175] The mechanism is formed from a number of geared components and is held in place by a mid-chassis 304 and a back plate 306 .

[0176] Two blister strips 366, 368 are also shown side-by-side, with individual pockets of medicament in each strip sitting side-by-side in recesses in an indexer 312 in the form of a dual-height indexing wheel located towards the top of the inhaler. A mobile stripping beak component 390 is also provided.

[0177] Also shown is a spool wheel 322 which advances and receives the used base sheet / foil of the blister strips 366, 368, and a take-up drum 330 which receives the used lid sheet / foil. The spring loaded idler 318 is formed from a front gear 318A and a rear gear 318B along with a first idler gear 352 and a second idler gear 354, with a torsion spring 356 disposed between the front gear 318A and the rear gear 318B.

[0178] A rear ratchet component 340 connects to the mouthpiece cover 310 and fits within a cavity in the rear of the central input hub gear 336 to drive the input hub gear 336 in only one direction.

[0179] 32 shows the assembly of the mechanism within the inhalation device 302. The input hub gear 336 is driven in a clockwise direction 334 when the mouthpiece cover 310 is opened, directly driving the indexing wheel 312 and the first and second idler gears 352, 354. The first idler gear 352 transmits drive to the spool wheel 322 and the second idler gear 354 transmits drive to the front gear 318A of the spring loaded idler.

[0180] 33 is a rear view of the inhalation mechanism. It can be seen that the moving stripping beak component 390 surrounds a portion of the indexing wheel 312 and occupies the space between the indexing wheel 312 and the mouthpiece and airway manifold 308. The rear gear 318B of the spring loaded floater 318 is shown engaging the take-up hub 330, and a torsion spring 356 can accommodate any required differential rotation of the take-up hub 330 and other components in the mechanism.

[0181] The engagement of rear ratchet component 340 with input hub gear 336 can be seen, and it will be understood that ratchet component 340 drives hub gear 336 when rotated in the direction of arrow 334 during opening of the mouthpiece cover, but can rotate relative to hub gear 336 when rotated in the opposite direction when mouthpiece cover 310 is closed.

[0182] It will also be appreciated that the clockwise rotation 334 (as viewed from the front of the inhaler) of the input hub gear 336 caused by the mouthpiece opening is transferred to a counterclockwise rotation 364 of the indexing wheel 312 as shown. A hook or pawl 392 can also be seen at the rear of the stripping beak component 390, with a pin 394 shown protruding from the remainder of the pawl 392.

[0183] Figure 34 is a rear plan view of the indexing wheel 312 and moving peeling beak component 390 from the mechanism shown in Figure 33. A pawl 392 on the peeling beak component 390 is shown engaging one of a series of radially inwardly extending ratchet teeth 316 on the rear side of the indexing wheel 312, causing the peeling beak 390 to rotate with the indexing wheel 312 in the direction of the arrow 364 during cap opening. As the indexing wheel 312 and peeling beak component 390 rotate together, the peel front of the blister strip 366, 368 moves with the indexing wheel. This creates tension in the lid sheet / foil, counter-rotating the take-up hub 330 and charging the torsion spring 356 in the spring loaded floater 318.

[0184] 35 shows the back plate 306 and the cam track 358 on the back plate 306 which acts as a peeling actuator. As the peeling beak 390 rotates with the indexing wheel 312 in the direction 364, the pin 394 of the pawl 392 passes through the cam track 358 as shown by arrows 344 and 348. The arc shown by arrow 344 corresponds to the rotation required to advance the indexing wheel 312 by less than one dose / step. As the mouthpiece cover 310 rotates further beyond this defined point, the second angled portion 348 of the cam track 358 guides the pin 394 to move the pawl 392 on the peeling beak component 390 radially inward as shown by arrow 378 in FIG. The indexing wheel 312 continues to rotate in a counterclockwise direction 364 as the pawl 392 retracts, causing the previously engaged ratchet tooth 316 on the indexing wheel 312 to move past the pawl 392. This frees the peeling beak component 390 to rotate clockwise relative to the indexing wheel 312, with the pin moving back through the cam track 358. The loaded torsion spring 356 in the spring loaded floater 318 then rotates the take-up hub 330 to take up the lidding foil and peel the dose as the peeling beak component 390 rotates.

[0185] As the front gear 318A and rear gear 318B rotate in opposite directions during the indexing operation, the torsion spring 356 is charged sufficiently to drive the take-up hub 330 two steps or doses' worth, ensuring that the take-up hub unwinds the "released" lid sheet (necessary to allow movement of the peeling beak component 390) and peels open the new dose.

[0186] A pawl 392 on the peeling beak component 390 automatically engages the next ratchet tooth 316 of the indexing wheel during this movement. The rear plate 306 also provides a pawl 372 that engages an axial ratchet tooth 320 on the rear of the indexing wheel 312 to prevent counter-rotation of the indexing wheel 312 while the dose is being peeled and to provide resistance to the ratchet component 340 when the mouthpiece closes in preparation for the next use.

[0187] 36 to 46 show another embodiment of the present invention. In this fourth embodiment, a Geneva lock is used. and an intermittent gear system is used to achieve the desired timing and mouthpiece cover. The opening of the bars rotates a pair of concentric timing gear wheels, which in turn rotates a pair of indexing wheels. The cam follower is loaded with a torsion spring to provide bistability and Rotation from the mouthpiece cover is transmitted to the timing gear wheel, which rotates the inhaler chassis. The mouthpiece cover advances along the cam track in the mouthpiece. The mouthpiece cover opens to an intermediate position or a fixed point. When this occurs, the cam track "flips" the follower, actuating the pushrod. The push rod moves linearly to drive a moving stripping beak component similar to that described above. This "reversal" releases the ratchet pawl located on the timing wheel. When the mouthpiece cover is closed, the cam follower is fully reset and the timing gear The one-way ratchet, on the other hand, indexes while the cam follower disengages. This prevents the wheels from rotating in the opposite direction. One of the pair of indexing wheels has an additional cam track. is provided to reset the push rod during mouthpiece opening. The drive from the bar is delivered through a spring-loaded storage hub, similar to spring-loaded storage hub 218 of FIG. The sheet is then transferred to the lid sheet take-up component.

[0188] 36 is an exploded view of the inhaler 402 with the outermost housing / body components omitted. The mid-chassis 404 is shown along with a front plate 405 and a rear plate 406. As indicated by the recesses 407 shown in the rear plate 406, various geared components are assembled between the rear plate 406 and the mid-chassis 404 to provide separate left and right drivetrains.

[0189] For clarity, only the components that make up the right hand drive train are labelled in Figure 36. Briefly, these comprise a spring loaded floater 418 which acts as a storage hub for the unused portion of the blister strip 466, a first floater gear 452 and spool wheel 422 which advance the blister strip to coil the used base sheet, and a take-up drum 430 which receives the used lid sheet / foil. The spring loaded floater 418 is formed from a front gear 418A and a rear gear 418B with a torsion spring 456 disposed between them, similar to the equivalent components 218, 318 of the second and third embodiments. Also shown are a front indexer output gear 412A and a rear indexer output gear 412B which form part of the first indexer 412.

[0190] A first indexing wheel 412C having pockets for receiving individual blisters of the blister strip 466, and a first indexing drive gear 412D make up the remainder of the first indexer 412 and are shown in the front exploded view. When assembled, the rear indexing output gear 412B is received within, but freely associated with, the front indexing output gear 412A. The front indexing output gear 412A is rigidly connected to the first indexing wheel 412C and the first indexing drive gear 412D is rigidly connected to a pin 413 extending from the first indexing wheel 412C.

[0191] A similar arrangement on the left side of the inhaler 402 allows for engagement of the second blister strip 368. As shown in FIG. 36, one difference is that the first The second indexing drive gear 414D is a simple toothed gear, whereas the first indexing drive The gear 412D is to provide a Geneva lock as described below. The second floating part 454 is , and is also associated with a second indexing drive gear 414D.

[0192] Disposed about the first indexing wheel 412C is a first moving peeling beak component 490. The peeling beak component 490 includes a ratchet pawl 492 that selectively engages a recess 416 in the front face of the first indexing wheel 412C. When assembled, the front face of the peeling beak component 490 is substantially flush with the front face of the front plate 405.

[0193] At the front of the front plate 405 is a central input hub gear 436. The central hub gear 436 is driven by a cam follower 480 which in turn is moved by an arm 440 which is connected to the mouthpiece cover 410. A curved cam track 461 is provided in the front plate 405 to control the movement of the cam follower 480 relative to the arm 440 and to resist the force of a stabilising spring 482 which is provided between the cam follower 480 and a further portion of the arm 440 as will be described below.

[0194] A further guide groove 459 in the front plate 405 receives a peel actuator 458 in the form of a push rod and constrains it to linear movement. The peel actuator 458 has a drive pin 460 at its lower end and a pair of tips 462 at its upper end. The tips 462 are positioned just above the front surface of the front plate 405 of the assembled inhaler 402 so that each tip 462 can engage a ratchet pawl 492 on the peel beak component 490 as the peel actuator 458 moves vertically. The peel actuator 458 also has a guide pin 463 which engages a generally circular cam track 441 provided on the rear surface of the hub gear 436.

[0195] 37 is a rear view of the central hub gear 436, which can be considered to have a front and rear half, each in the form of a generally circular plate. Four pairs of teeth 416 are spaced 90 degrees apart around the circumference of the front half, and four groups of three teeth 420 are spaced 90 degrees apart around the circumference of the rear half. Each half of the hub gear 436 thus provides four isolated gear portions 416, 420 separated by smooth radial portions 417, 421. The groups of gear teeth 416, 420 on the front and rear half are circumferentially offset from one another.

[0196] Also provided on the rear of the central hub gear 436 is a generally circular cam track 441. The cam track 441 forms a closed loop with each of its four quarters having a linear ramp portion 442, a constant radius portion 444, and a linear radially outwardly extending portion 448. Each radially outwardly extending portion 448 is located between offset groups 416, 420 of teeth on the front and rear half portions of the central hub gear 436.

[0197] 38 shows details of the cam follower 480. A pair of teeth 484 is provided to engage with the set of three teeth 420 on the rear half of the hub gear 436. There is also a pin 486 that engages the curved cam track 461, and a recess 485 that engages the peel actuator 458.

[0198] 39 and 40 respectively show the first indexing drive gear 412D and the second floating portion 45 4. The first indexing drive gear 412D has six isolation gear teeth 473, The teeth 473 engage with the pair of gear teeth 416 on the front half of the hub gear 436, forming a first They are separated by an inwardly curved portion 472 around the circumference of the index drive gear 412D. The radius of each curved portion 472 matches the radius of the smooth portion 417 of the hub gear 436. When the component teeth 416, 473 are engaged, the central hub gear 436 rotates. The first indexing drive gear 412D is advanced, but the curved portions 417, 472 When engaged, the first index drive gear 412D is held against rotation. Thus, drive gear 412D provides a Geneva lock with hub gear 436.

[0199] The second idler portion 454 comprises a front gear wheel and a rear gear wheel separated by a reduced diameter central portion and is shown from the rear in FIG. 40. The rear gear wheel has three pairs of gear teeth 475 that engage the set of three teeth 420 on the rear of the central hub and three inwardly curved portions 474 each having an equal radius to the curved portion 421 of the central hub gear 436. The front gear wheel is a standard gear 476 having teeth that engage the second index drive gear 414D. The second idler gear 454 thus provides the first index drive gear 414D with an intermittent drive and locking function similar to that provided by the first index drive gear 412D.

[0200] 41 is a front view of the assembled mechanism. As shown, the first indexing drive wheel 412D, i.e., the first indexer, is held against rotation by the central drive hub. The front gear 476 of the second idler gear 454 sits raised against the central hub gear 436 and engages the second indexing drive wheel 414D, while the rear gear wheel (not shown) engages the rear half of the central hub gear 436. A reduced diameter central portion of the second idler gear 454 spaces the front and rear gears such that no portion of the second idler gear 454 engages the front half of the central hub gear 436.

[0201] The peeling actuator 458 sits at the top of guide groove 459 with its tip 462 sandwiched between first and second indexing drive wheels 412D, 414D and first and second moving peeling beak components 490, 490'. Cam follower 480 and spring 482 are assembled with arm 440 such that when the mouthpiece cover is opened, arm 440 moves in clockwise direction 434, moving cam follower 480 along curved cam track 461. This movement is illustrated in the following figures which show hidden portions of the mechanism in dashed lines.

[0202] Figure 42 shows the mechanism with the mouthpiece cover slightly open from the position shown in Figure 41. The arm 440 rotates clockwise 434, which causes the central hub gear 436 to rotate due to engagement of tooth pair 484 on the cam follower 480 with the group of three teeth 420 on the rear half of the central hub gear 436. The path of the guide pin 463 of the peel actuator 458 along the angled portion 442 of the generally circular cam track 441 during this rotation is shown, causing the peel actuator 458 to move downwardly and clear the top of the guide groove 459. Gear teeth 473 of the first indexer drive wheel 412D engage tooth pair 416 on the hub gear 436 and further rotation drives the first indexer 412.

[0203] 43 shows the mechanism after further rotation. The guide pin 486 of the cam follower 480 moves through the inner portion 461A of the curved cam track 461 as shown, continuing to drive the hub gear 436. As a result of this rotation, the first indexing drive wheel 412D has advanced one step. The set of three teeth 420 on the front half of the hub gear 436 moves in and out of engagement with the pair of teeth 475 on the second floating part 454, rotating the second floating part 454 to drive the second indexing drive wheel 414D, and therefore the second indexer 414, one step. The first peeling beak component 490 and the second peeling beak component 490' rotate with their respective indexers 412, 414 as previously described to provide a moving peeling front in use.

[0204] The spacing of the groups of teeth 416, 420 on the central hub gear 436 ensures that the second indexing drive wheel 414D moves forward only after the first indexing drive wheel 412D moves forward one step. The peel actuator 458 is maintained in a retracted position during rotation by a guide pin 463 of the peel actuator 458 engaging a constant radius portion 444 of the generally circular cam track 441.

[0205] As shown in Figure 43, both the first indexing drive wheel 412D and the second indexing drive wheel 414D have moved one step forward from the position shown in Figure 42. Both are held against rotation by the inwardly curved portions 472, 474 of the first indexing drive wheel 412D and the second freewheeling portion 454, respectively, engaging the curved outer surface of the hub gear 436. The pin 463 of the peel actuator 458 abuts against the radially extending portion 448 of the generally circular guide track 441 to resist further rotation of the hub gear 436.

[0206] When the mouthpiece is fully opened, the arm 440 rotates further from the position shown in FIG. 43, thus causing relative movement between the cam follower 480 and the central hub gear 436. As shown in FIG. 44, the angled portion 461B of the curved guide track 461 urges the guide pin 486 of the cam follower 480 radially outward during this movement. This causes the cam follower 480 to flip from a first stable state to a second stable state in which the pair of teeth 484 disengages from the set of three teeth 420 on the rear half of the central hub gear 436, as shown in FIGS. 41-43. This flipping action allows the cam follower to move past the hub gear 436, and also causes the recess 485 to engage the drive pin 460 of the peel actuator 458, urging the drive pin 460 vertically to the top of the guide groove 459. This releases the ratchet pawl 492 of each stripping beak component 490, stripping both of the advanced doses of drug ready for inhalation. Thus, the position shown in Figure 43 can be considered a definite point beyond which the stripping action takes place.

[0207] Figure 45 shows the mechanism being reset as the mouthpiece cover 410 moves closed 432, during which the cam follower 480 is driven by the movement of the arm 440. The guide pin 486 of the cam follower 480 passes along the outer portion 461C of the curved guide track 461 to avoid any counter driving of the central hub gear 436. A stabilising spring 482 helps to maintain the cam follower 480 in the second disengaged state during this movement.

[0208] As shown in Figure 45, the pair of teeth 484 on the cam follower is adjacent to a different set of three teeth 420 on the rear half of the central hub gear 436. As the arm 440 moves further in fully closing the mouthpiece cover 410, the guide pin 486 of the cam follower 480 will move through the final straight portion 461D of the curved guide track 461. This serves to return the cam follower 480 to the first state, causing the pair of teeth 484 to engage with the set of three teeth 420 on the rear half of the central hub gear 436. The mechanism is thus returned to the position shown in Figure 41 and is ready for the next actuation.

[0209] FIG. 46 shows the rear gearing of the inhaler 402, i.e., a view from the rear of the device with the rear plate 406 removed. A first indexer 412 engages a first take-up drum 430 and a first spring loaded floater 418. A first floater gear 452 also engages a first spring loaded floater 418 and a first spool wheel 422 to complete a first drive train on one side of the inhaler 401. A second separate drive train incorporating a second indexer 414 is also provided. Arrows have been added to FIG. 46 to illustrate the movement of the drive trains. For clarity, a portion of the total movement / drive is shown for each of the first and second drive trains, with dashed arrows indicating engagement and movement of obscured components.

[0210] As previously mentioned, the first indexer drive gear 412D is driven by rotation of the central hub gear 436 during opening of the mouthpiece cover 410. This causes the indexer output gear 412A to rotate in a commanding manner which in turn drives the front gear 418A of the spring loaded idler 418 as shown. The front gear 418A of the spring gear idler 418 engages the first idler gear 452 which in turn engages the first spool wheel 422 to drive and coil the used basesheet. It will be appreciated that the second drive system operates in a similar manner for the second indexer 414 and second spool wheel 422'.

[0211] As the first indexer 412 and the second indexer 414 advance, a strain is applied to the used lid sheet by the moving stripping beak component 490, 490', which rotates the first take-up drum 430 and the second take-up drum 430'. As shown in the second drive train, the second take-up drum 430' engages the rear index output gear 414B of the second indexer, which acts as a floating transfer drive to the rear gear 418B' of the second spring loaded floater 418'. The counter rotation of the front gear 418A' and the rear gear 418B' causes energy to build up in the torsion spring 456 during indexing. This energy is released when the stripping actuator 458 releases the stripping beak components 490, 490', sufficient to rotate the second take-up drum 430' to strip the doses.

[0212] Figures 47-60 show a fifth embodiment of the invention in which both the indexing and peeling actions are controlled by a cam plate. Cam tracks provided on the cam plate engage pins on a pair of indexing wheels which in turn engage cam tracks on a pair of moving peeling beak components associated with the indexing wheels. A torsion spring is provided between the moving peeling beak components and the indexing wheels. The moving peeling beak is initially held against rotation while the indexing wheels are advanced by the cam plate during movement of the mouthpiece cover, and is only released when the mouthpiece cover opens beyond an intermediate position or fixed point. No ratchet components are used anywhere in the fifth embodiment.

[0213] 47 is an exploded view of the internal components of an inhaler 501 according to a fifth embodiment. As in the previous embodiment, a mid-chassis 504 and a front plate 505 are provided as part of the body of the inhaler 501, and a first indexing wheel 512 and a second indexing wheel 514 are provided as indexers for the first blister strip 566 and the second blister strip 568, respectively. Each of the first indexer 512 and the second indexer 514 comprises a fixed front gear 518A, 518A' and a rear gear 518B, 518B' rotatable relative to the front gears 518A, 518A'. A torsion spring 556 is connected between the rear gears 518B, 518B' and the remainder of the indexers 512, 514. As described in other embodiments, moving stripping beak components 590, 590' are provided surrounding each of the first indexer 512 and second indexer 514 to vary the position of the stripping front.

[0214] At the rear of the intermediate chassis 504, various geared components that make up the first and second geared drive trains are shown. Only the components that make up the first drive train are shown, namely, the first spool wheel 522, the first take-up drum 530, and the first and second idlers 552 and 554. The geared parts of each of the first and second indexers 512 and 514 extend beyond the rear of the intermediate chassis 504 to engage the first and second geared drive trains, respectively. The front faces of the first and second indexers 512 and 514 extend through cutouts in the front plate 505, and the front faces of the respective moving stripping beak components 590, 590' are located in front of the front plate 505 and exposed to the cam plate 536. A hub component 538 connects the cam plate 536 to a movable mouthpiece cover (not shown).

[0215] FIG. 48 is a cross-sectional view through a convoluted cam track 541 on the cam plate 536 illustrating the engagement of the cam plate 536 with the first indexer 512 and the second indexer 514. A first ring of six pins 553 is provided around the edge of the front face of the first indexer 512 and a second ring of six pins 563 is provided around the edge of the front face of the second indexer 514. The configuration shown in FIG. 48 shows the mouthpiece cover of the inhalation device 501 fully closed and the cam plate moving in a generally counterclockwise direction as indicated by the arrow 532. Three of each six-pin group 553, 563 engage the cam track 541, holding both the first indexer 512 and the second indexer 514 against rotation.

[0216] Figure 49 shows the path 543 taken by the pin 563 of the second indexer 514 through the cam track 541 during use of the inhalation device 501. The solid arrows show the path taken by the cam plate 536 as it moves from the position shown in Figure 48 during opening 534 of the mouthpiece cover. This serves to drive the second indexer 514 during opening of the mouthpiece cover. The dashed arrows show the path taken by the same pin 563 as the mouthpiece cover closes 532, holding the second indexer 514 against rotation. Each pair of arrows relates to a single opening and closing of the mouthpiece cover.

[0217] The rear face of the cam plate 536 also includes a drive pin 540 which engages one of six slots 542 provided on the front face of the first indexer 512 to drive rotation of the first indexer 512 during mouthpiece cover closure 532. A pair of peeling beak pins 562 are also provided to control the movement of the moving peeling beak component 590, 590' when the inhalation device 501 is in use.

[0218] Figure 50 is a further cross-sectional view of an apparatus similar to Figure 48 taken through a plane intersecting the six slots 542 of the first indexer 512. Also shown are the first and second peeling beak cam tracks 551, 561 in the first and second moving peeling beak components 590, 590', respectively. Cross sections of the drive pin 540 and the peeling beak pin 562 can also be seen.

[0219] The first and second moving peeling beak components 590, 590' are free to rotate relative to the first and second indexers and are not provided with engaging latches or ratchet pawls. Instead, their movement is regulated by the engagement of the peeling beak pin 562 with the first peeling beak cam track 551 or the second peeling beak cam track 561. Intermeshing gear teeth 596 on each of the moving peeling beak components 590, 590' ensure that their movements are coupled such that engagement of the peeling beak pin 562 with either the peeling beak cam track 551, 561 controls the movement of both peeling beak components 590, 590'.

[0220] 50, one peeling beak pin 562 is disengaged from the first peeling beak cam track 551, but the movement of both peeling beak components 590, 590' is still controlled by the engagement of the other peeling beak pin 562 with the second peeling beak cam track 561. In fact, in most positions of the cam plate 536, one or both of the peeling beak pins 562 are engaged with the peeling beak cam tracks 551, 561 in such a way as to drive the peeling beak components 590, 590' or hold the peeling beak components 590, 590' against rotation. The exception is when the moving peeling beak components 590, 590' are free to rotate as indicated by arrows 593 and 594 to allow peeling of the dose, and the peeling beak pins 562 are in the marked actuated position 592.

[0221] FIG. 51 shows the position of the cam plate 536 when the mouthpiece cover is in the fully open position. With the peeling beak pin 562 in the actuated position 592 shown in FIG. 50, the moving peeling beak components 590, 590' are free to rotate as described above. The intricate cam track 541 of the cam plate 536 is shown in dashed lines, as are the various configurations of the first indexer 512 and second indexer 514 which are obscured behind the cam plate 536. The drive pin 540 is positioned at one end of six slots 542 in the front face of the first indexer 512 such that movement of the cam plate 536 in the direction of the arrows 532 during closing of the mouthpiece cover will cause the drive pin 540 to move first into the slots 542 which will then advance the first indexer 512.

[0222] 52 shows the paths of two blister strips 566, 568 through the inhalation device. The first blister strip 566 runs around the first indexer 512 before the base used base sheet is taken up by the first spool wheel 522 and the used lid sheet is taken up by the first take-up drum 530, passing first around the peeling beak in the first movable peeling beak component 590. The second blister strip 568 follows a similar path around the second indexer 514, the second spool wheel 524, the second moving peeling beak component 590' and the take-up drum 530'.

[0223] FIG. 53 shows the gears at the rear of the inhaler. In the first drive system, the front gear 518A of the first indexer 512 drives the first spool wheel 522 through the first idler 552. As the front gear 518A rotates with the first indexer 512, the first spool wheel 522 is driven when the first indexer advances by the cam plate 536. The first winding drum 530 is driven by the rear gear 518B of the first indexer 512 through the second idler 554. The torsion spring 556 between the front gear 518A and the rear gear 518B responds to the change in tension of the lid sheet during operation and allows the movement of the peeling front to control the peeling operation, as described in the previous embodiment.

[0224] A second similar drive system is provided for the second indexer 514, although a second pair of idlers 554' is provided between the rear gear 518B' of the second indexer 514 and the second take-up drum 530'.

[0225] Figures 54-60 illustrate the movement of the various components. Figure 54 shows the inhaler 501 immediately after a dose has been released. The cam plate 536 is connected to the hub component 538 by a pin 537 that is offset from the axis of rotation of the hub component 538. The mouthpiece cover (not shown) is now fully open, with the first peeling beak component 590 and the second peeling beak component 590' in an outwardly rotated position. The remaining Figures 55-60 show the movement of the cam plate 536 as the central hub component 538 rotates during the opening 532 and closing 534 of the mouthpiece cover.

[0226] During the initial stage of mouthpiece cover closure, from Figure 54 to Figure 55, the peeling beak components 590, 590' begin to rotate inwardly and continue to do so as the first indexer 512 advances from Figure 55 to Figure 56. During the final portion of mouthpiece cover closure to the position shown in Figure 57, as the peeling beak pin 562 moves through the bottom of the cam track 561 in the second peeling beak 590', tension in the lidding sheet by the loaded torsion spring 556 urges the peeling beak components 590, 590' to rotate slightly outwardly in the direction of arrows 593, 594 in Figure 50.

[0227] Subsequent opening of the mouthpiece cover, as shown in Figures 58 and 59, advances the second indexer 514 as the hub component 538 rotates as shown at 534. In the position shown in Figure 59, both indexers 512, 514 and both moving peeling beak components 590, 590' are held in place by the cam plate 536. As shown in Figure 60, during the final opening movement, the intricate cam track 541 in the cam plate 536 continues to hold the indexers 512, 514 stationary while the peeling beak pins 562 move to the actuated position 592 shown in Figure 50, allowing outward rotation of the peeling beak components 590, 590'.

[0228] It will be appreciated that the peeling nabeak components 590, 590' move first after actuation of the inhalation device 501, so that the peeling front is always ahead of the next dose to be peeled from the inhalation device. Then, when the peeling nabeak pins 562 are in their actuated positions 592 in the cam tracks 551, 561 of the first and second peeling nabeak components 590, 590', no peeling action takes place until a set, determined point.

[0229] 61-65 show an embodiment of the invention where the indexing and stripping action is controlled by an intermittent ring gear with a cam track cut into it. This embodiment also provides a split airway, one half of which can reciprocate up and down (and also function as a moving stripping beak) while the other half remains stationary. A torsion spring is provided between the winding drum drive gear and the winding drum. Turning the intermittent ring gear (via a ratchet cap input wheel driving an input ratchet wheel) rotates the first indexing wheel, thereby indexing the first strip. At the same time, the moving half of the airway / moving stripping beak also translates to maintain the position of the strip with respect to the strip. This pulls the corresponding winding drum against the torsion spring to release the lid sheet and allow the stripping front to move. Continued rotation of the intermittent ring gear then rotates the second indexing wheel and second winding drum, stripping the second strip. The second winding drum is in communication with the first winding drum, which further charges the torsion spring of the second winding drum. The cam track then releases the moving airway / moving peel beak, which allows it to be pulled back by the tension of the first lid sheet resulting in the peeling of the first strip. When the cap is re-closed, the ratchet drive gear is reset. The position of the pin on the moving airway / moving peel beak prevents the intermittent ring gear, and therefore the input ratchet wheel, from rotating backwards.

[0230] Fig. 61 is an exploded view of an inhaler 601 according to the sixth embodiment. As part of the body of the inhaler 601, an intermediate chassis 604, a front plate 605, and a rear chassis 606 are provided. A first indexing wheel 612 and a second indexing wheel 614 are provided at the rear of the intermediate chassis 604 and extend through the intermediate chassis 604 as indexing devices for a first blister strip and a second blister strip (not shown). A first spool wheel 622 and a second spool wheel 624, a first winding drum 630 and a second winding drum 630', and a first floating part 652 and a second floating part 654 are also provided. A drive gear 618, 618' is provided for each of the first winding drum 630 and the second winding drum 630', and each drive gear 618, 618' is rotatable with respect to the respective winding drum 630, 630'. A torsion spring (not shown) is connected between each drive gear 618, 618' and the respective take-up drum 630, 630'.

[0231] A mouthpiece and airway manifold 608 is mounted in front of the mid-chassis 604 and comprises a split airway having a first half 690 which can move vertically back and forth during use whilst a second half 691 which remains stationary.

[0232] A ring gear / cam plate 636 is provided as a means for controlling / driving the movement of all components of the inhaler 601 and can therefore be thought of as a central logic hub. Inwardly extending gear teeth 616 on the ring gear drive the indexers 612, 614, spool wheels 622, 624 and take-up drums 630, 630'. A cam track 651 is also provided which engages a pin 662 in the airway first half 690 to control the vertical movement of the airway first half 690.

[0233] One-way ratchet component 640 connects to the mouthpiece cover (not shown) and fits into a cavity in the rear of central input hub gear 638 to drive the input hub gear 638 in only one direction. Hub gear 638 in turn engages the rear of ring gear / cam plate 636 such that movement of the mouthpiece cover is transferred to ring gear / cam plate 636.

[0234] 62 is a front view of the assembled components. First and second storage compartments 619, 620 are provided at the lower end of mid-chassis 604 to house first and second peelable blister strips (not shown) of medicament (not shown). Each blister strip is fed from storage compartments 619, 620 onto indexers 612, 614, after which the lid sheet passes through airway halves 690, 691 onto take-up drums 630, 630' and the base sheet is coiled around spool wheels 622, 624.

[0235] Vertical movement of the first half 690 of the airway is indicated by arrows 642 and 648. As will be explained more fully with reference to subsequent figures, the first indexer 612 and the second indexer 614 rotate sequentially in the directions shown during use. As the first indexer 612 advances, the first half 690 of the split airway moves upwards 642, causing the peel front to move in the same direction as the blister strip, retarding the peeling action. Subsequent downward movement 648 serves to peel the lid sheet from the base sheet and peel the dose of medication. The linear movement of the first half 690 of the split airway thus provides a moving peel beak component 690 to regulate the peeling action, as in other embodiments.

[0236] The rear view of Figure 63 shows the interaction of ratchet component 640, central input hub gear 638, and ring gear / cam plate 636. It is clear that rotational drive in the direction of the arrow 634, which would result from the mouthpiece cover being opened, would be transmitted to ring gear / cam plate 636, but drive in the opposite direction 632, which would result from the mouthpiece cover being closed, would not be transmitted.

[0237] FIG. 64 is a first cross-sectional view of the inhalation device from the rear. The first loose gear teeth 616 pass through the corresponding gear teeth 616 and engage the corresponding component, i.e., the first loose gear teeth 616. 652, a drive gear 618' of the second winding drum 630', and a second indexing device As shown in FIG. 64, the curved surfaces 672, 6 73, 674 engage the smooth portion 617 of the ring gear / cam plate 636 to form a Geneva lock The first free-floating portion 652 provides a first indexing The second free end 654 engages the second splitter 612 and the first spool wheel 622. The second winding drum drive gear 624 is engaged between the winding device and the second spool wheel 624. 18' engages with the first winding drum drive gear 618. A Geneva lock holds all these components against rotation as shown in FIG.

[0238] FIG. 65 is a further cross-sectional view again from the rear of the inhaler 601 , through the cam track 651 in the ring gear / cam plate 636 , and through the pin 662 of the first half 690 of the split air passage.

[0239] The operation of the inhaler will now be described with reference to both Figures 64 and 65.

[0240] As the ring gear / cam plate 636 rotates in the direction of the arrow 634, the inwardly extending teeth 616 first engage the first floating portion 652 to drive the first indexer 612 and the first spool wheel 622 to rotate during opening of the mouthpiece cover. The cam track 651 simultaneously guides the pin 662 to move as shown by the arrow 642, which moves the first half 690 of the split air passage vertically upwards during rotation. Thus, the first indexer 512 advances the dose, while the upward movement of the split air passage 690 adjusts the peel front position so that the dose is not peeled. This creates tension in the lid sheet of the first blister strip, which then stores energy in the torsion spring provided between them as the first winding drum 630 rotates relative to the drive gear 618 to release the required length of the lid strip.

[0241] As the first indexer 612 advances one step / dose, the curved surface 672 of the first floater 652 re-engages the smooth portion 617 of the ring gear / cam plate 636 to hold the first indexer stationary while rotation 634 of the ring gear / cam plate 636 continues. Further inwardly extending teeth 616 then engage first the second indexer 514 and then the drive gear 618' of the second take-up drum 630', advancing these components to index and peel the second blister strip while the mouthpiece cover continues to open. During the advancement of the second indexer 614, the split air passage 690 is maintained in a raised position as the pin 662 travels through the portion of the cam track 651 indicated by the arrow 644. The linkage between the drive gear 618' of the second winding drum 630' and the drive gear 618 of the first winding drum 630 further energizes the torsion spring of the first winding drum 630.

[0242] When both indexers move forward by one step / dose, the curved surfaces 672, 673, 674 re-engage the smooth portion 617 of the ring gear / cam plate 636, holding both indexers 612, 614 against rotation. The pin 662 is then in an actuated position or fixed point 692 in the cam track. At this point, the cam track 651 and actuated position 692 will have rotated to a position where movement of the pin 662 in the direction of the arrow 648 provides the previously shown downward movement of the split air duct 690. A torsion spring in the first take-up drum 630 pulls the first lid sheet and split air duct portion 690 downward, peeling the doses from the first blister strip. Thus, when the cap is fully opened, inhalation doses are exposed from both strips, but the second strip is peeled only after the opening operation is half completed and the first strip is peeled only after a defined fixed point near the end of the opening operation.

[0243] The ratchet component 640 then drives the mechanism even when the mouthpiece cover is closed. The engagement of pin 662 into cam track 651 and the Geneva lock described above does not work. This helps prevent other components from rotating in the opposite direction and ensures that the next operation is performed.

[0244] 66 to 79 illustrate a seventh embodiment of an inhaler 701 according to the present invention. For example, the aspirator 701 of FIG. 66 separates the indexing and stripping functions and functions similar to a Geneva mechanism. and controlling the indexing and peeling using a geared system configured to allow the first The indexing system and the second indexing system are allowed to advance independently.

[0245] As shown in the exploded view of Figure 66, as part of the body of the inhaler 701 there is provided a mid chassis 704, a front plate 705 and a rear chassis 706. The rear components of the mid chassis 704, including the moving air duct 708 and the moving stripping beak 790 and moving stripping beak 790', form the indexing and stripping control mechanism with the movement of the air duct 708 driven by the stripping beak mechanism and are therefore strictly linked to the stripping function of the inhalation device 701. The front components of the mid chassis 704 are responsible for managing the blister strip.

[0246] The mechanism of the inhaler 701 is driven by the movement of the mouthpiece cover 710, which is connected to a one-way ratchet component 740 located in a recess on the rear side of a hub gear 738. The hub gear 738 drives a first input gear 736, which in turn drives a second input gear 736'. The first input gear 736 and the second input gear 736' intermittently drive the first indexer 712 and the second indexer 714, respectively, and the first stripping beak component 790 and the second stripping beak component 790'. The first indexer 712 and the second indexer 714 each comprise an indexing gear 712A and an indexing gear 714A assembled around the respective stripping beak component 790, 790', and an indexing drum 712B and an indexing drum 714B. The inhaler 701 also includes a first slave beak component 791 and a second slave beak component 791' which interact with the first and second stripping beak components 790 and 790' as described below.

[0247] The remaining components are largely similar to those described in the previous embodiment: the used base foil is provided with a first 722 and a second 724 spooling wheel, and the used lid sheet / foil of the blister strip pair is provided with a first 730 and a second 730' winding drum connected via torsion springs 756, 756' to drive gears 718, 718', respectively.

[0248] Figure 67 shows the first input gear 736 in more detail. A boss 772 extends from the front of the input gear 736 and has a toothed portion 773 which extends the full height of the boss 772. One end of the toothed portion 773 is adjacent a cutout 774 which extends half way down from the free end of the boss 772. A ring of second gear teeth 716 is provided at the rear of the first input gear 736 opposite the boss 772 to engage the hub gear 738 in use. This can be seen in the top view of Figure 68 where the cutout 774 is again shown.

[0249] 69 shows a portion of the mechanism including first and second input gears 736, 736', movable air passage 708, and first and second stripping beak components 790, 790'. The second input gear 736' is similar in construction to the first input gear 736, except that there is no ring of second gear teeth 716 and therefore it is driven only by engagement with the first input gear 736. The second input gear 736' also has a slightly longer cutout 774' whose width is only half the height of the boss on the second input gear 736'.

[0250] Both the first peeling beak component 790 and the second peeling beak component 790' have toothed input portions 775, 775' that engage toothed portions 773, 773' of the first input gear 736 and the second input gear 736' adjacent the ends of the bosses 772, 772'. Also, the outer edge of each peeling beak component 790, 790' on either side of the toothed input portions 775, 775' is provided with a small recess 776, 776' and a drive pin 762, 762' that engages with a slot 751 in the rear of the air passage 708. The arrows indicate the direction of rotation of the components in use, and note that the first tooth 773A in the toothed portion on the first input gear 736 is cut to improve efficiency during initial engagement when the first input gear 736 first begins to drive the first stripping beak component 790. Although not labeled, the first tooth 773A' on the second input gear is similarly cut for the same reasons.

[0251] Figures 70-75 show the advancement of the mechanism shown in Figure 69 during use. When the mouthpiece cover 710 is opened, both the first input gear 736 and the second input gear 736' advance simultaneously in opposite directions as shown in Figure 70. This rotation causes the toothed portion 773 of the first input gear 736 to initially engage the toothed input portion 775 of the first peeling beak component 790, transmitting the rotational drive as shown in Figure 71. The first peeling beak component 790 rotates until the corresponding toothed portions 773, 775 are at their ends, at which point the recess 776 engages the outer surface of the boss 772 as shown. During this rotation, the drive pin 762 drives the air passage 708 downward as shown to maintain the position of the peeling front relative to the blister strip.

[0252] Once the first peeling beak component 790 has been advanced as described above, the mouthpiece cover is then The gear 710 continues to move, and then the toothed portion 773′ of the second input gear 736′ moves to the first input gear 736′. The second peeling beak component 790' engages the toothed input portion 775'. The component 790' is thus advanced by further opening movement while the recess 776 is pushed toward the boss 790'. 772, as shown in FIG. 73, provides a Geneva retaining surface that engages the outer surface of the first peeling beak structure. The component 790 is held against further rotation.

[0253] FIG. 74 shows that the second peeling beak component 790′ thus advances to the end of the corresponding toothed portion 773′, 775′. The second drive pin 762′ engages the slot 751 in the air passage 708, and both peeling beak components 790, 790′ are coupled through the movable mouthpiece 708. Upon further rotation from the position shown in FIG. 74, which may be considered the defining point of the mechanism, the cutouts 774, 774′ of the first and second input gears 736, 736′ move to a position above the first and second peeling beak components 790, 790′. The cutouts 774, 774′ then provide space for the periphery of each peeling beak component 790, 790′ to rotate past the bosses 772, 772′ of the respective input gears 736, 736′. As described below, as the mechanism advances, a spring bias is also generated through the blister strips, which drives the first peeling beak component 790 and the second peeling beak component 790' to rotate back to their initial positions. The air passage 708 also moves vertically upward, as shown in Figure 75. This release performs the peeling action to open the drug dose from each of the blister strip pair.

[0254] 74 also shows the peeling beaks 790A, 790A' of the first and second peeling beak components 790, 790' proximate the drive pins 762, 762'. The first and second slave beak components 791, 791' (not shown) have been driven by the peeling beaks 790A, 790A' during rotation and are now above the drive pins 762, 762'. This allows for a larger physical peeling beak to be provided without interfering with the drive pins 762, 762' or the rear of the mouthpiece 708 which provides the slots 751.

[0255] As described above in connection with FIGURE 66, the first index gear 712A and the first index hub 712B are assembled around the first peeling beak component 790, and the second index gear 712A and the index hub 714B are assembled around the first peeling beak component 790. Thus, the first index gear 712A and the second index gear 714A are located behind the first peeling beak component 790 and the second peeling beak component 790' in the assembly shown in FIGS.

[0256] Figures 76 and 77 correspond to the mechanism positions shown in Figures 74 and 75, respectively, and show the first index gear 712A and the second index gear 714A in dashed lines. Both index gears 712A, 714A have a similar form and will be described only once with reference to the first index gear 712A. Around the first index gear 712A, four toothed drive portions 777 are provided, each of which is similar to the toothed input portion 775 of the first peeling beak component 790. Between the toothed drive portions 777, locking recesses 778 are provided, similar to the recesses 776 of the first peeling beak component 790.

[0257] The first and second index gears 712A, 714A are initially advanced by the first and second input gears 736, 736' along with the first and second peeling beak components 790, 790' as described in connection with Figures 70-73. However, because the first and second index gears 712A, 714A are located behind the first and second peeling beak components 790, 790', their peripheral edges engage the lower portions of the respective bosses 772, 772' below the cutouts 774, 774'. The bosses 722, 722' thus remain engaged in the recesses 778, 778' of the first and second index gears 712A, 714A, holding them against rotation towards the open end of the mouthpiece. In other words, once the dose has been indexed, the first indexer 712 and the second indexer 714 are held stationary while the stripping operation is performed.

[0258] The mechanism as described provides for oscillating or reciprocating motion of the first and second stripping beak components 790, 790' and intermittent rotation of the first and second indexers 712, 714 from a common drive. Synchronization of component movement and movement of the moving air passage 708 can be ensured. The first and second indexers 712, 714 advance one-quarter turn at a time to accommodate the four provided dose pockets that receive the paired medication pockets of the blister strip.

[0259] Similar functionality can be achieved using a pin-geneva mechanism, with both halves of the overall mechanism being It has a single pin that drives a stack of two Geneva wheels, which drive the opposite ends of the beak. However, the present invention has a release area for one of the layers (the peeling beak layer) that allows the movement of the The use of gear drives such as those shown in Figure 1 results in less fluctuating force profiles and weaker This avoids the need for unsupported pins which may be vulnerable to snapping.

[0260] The mechanism indexes a first side, driving the air passage 708 down with the peel front, then indexes a second side which moves the peel front to the opening portion of the mouthpiece 708 before releasing both. As the peel beak components 790, 790' rotate back to their original positions, they are coupled via the air passage 708. This ensures simultaneous movement, driving the air passage 708 into position along with the revealed medication pockets of each blister strip.

[0261] The input drive to the mechanism is illustrated in the rear view of FIG. 78. The ratchet component 740 is shown received in a central recess of the hub gear 738 and is arranged to drive the hub gear 738 during rotation 734 that occurs when the mouthpiece cover (not shown) opens, but not during closing 732. The hub gear 738 is shown engaged with the second ring of gear teeth 716 on the first input gear 736, and the first indexing gear 712A is labeled with the first stripping beak component 790 largely hidden from the rear by the first indexing gear 712A. As previously explained, there is no need to transmit motion to the inhaler 701 mechanism during closing 732 of the mouthpiece cover 710 since the entire indexing and stripping action is completed during opening of the mouthpiece cover 710. The anti-return ratchet interacts with the gear system to ensure that the drive gearing is not driven backwards when the ratchet component 740 rotates within the hub gear 738 while the mouthpiece cover is closing.

[0262] Figure 79 shows the components of the inhaler 701 involved in strip management. The view in Figure 79 is a front view from the opposite side of the mid-chassis 704 of Figure 78. A first output gear 752 and a second output gear 754 are connected to the first indexer hub 712B and the second indexer hub 714B to transmit rotational drive from the first indexer 712 and the second indexer 714 to the first spool wheel 722 and the second spool wheel 724 and to the drive gears 718, 718' of the first take-up drum 730 and the second take-up drum 730'.

[0263] As in the other embodiments, the first 722 and second 724 spool wheels simply receive and wind the used base sheet / foil of the first and second blister strips, while the first 730 and second 730' wind drums receive the used lidding foil / sheet. The torsion springs 756, 756' provided between the drive gears 718, 718' and the wind drums 730, 730' act similarly to the previous embodiment to initially store spring energy while allowing movement of the lidding foil together with the indexers 712, 714 and beak components 790, 790' to subsequently drive the peeling action and compensate for the increasing diameter of the used lidding foil / sheet as the blister strips are used. The first 730 and second 730' take-up drums are counter-rotatingly geared to the corresponding indexers 712, 714, which further energizes the torsion springs 756, 756' during indexing, thereby providing sufficient tension for the lidding sheet / foil to retract past the peel front when the peel beak components 790, 790' are released, opening the next dose on the strip.

[0264] The inhaler 701 according to the seventh embodiment allows freedom of design in terms of layout, timing, alignment, force, torque, displacement etc. The moving air duct does not move on the same path as the blisters (or is offset from the blister strip) during use as its movement is linear rather than rotary. This means that during the peeling operation there is less chance of the lidding foil getting pinched between the moving air duct 708 and the first indexing wheel 712 and / or second indexing wheel 714 as they are only in close proximity to each other at the ends of their travel.

[0265] Unlike the sixth embodiment inhaler 601, there are no separate moving parts that would require a clearance gap between the two parts, there is only a single moving air passage 708. Therefore, a simpler piston type seal can be used between the air passage 708 and the mouthpiece of the inhaler 701.

[0266] An eighth embodiment of the present invention will now be described with reference to Figures 80-89. Again, the eighth embodiment inhaler 801 provides configurational freedom with respect to layout, timing, alignment, force, torque, displacement, etc., and functions using a mouthpiece cover to rotate a hub gear against a spring (tension or twist) via a ratchet drive to complete an indexing motion. Configurations on the chassis release the ratchet from the hub gear, and the spring returns the ratchet to the starting position. In this way, a unidirectional 120° movement of the mouthpiece cover is translated into a reciprocating motion of the mechanism input.

[0267] The exploded view of Figure 80 shows the components of the inhaler 801. Many of the components are similar to those described in the previous embodiment, including first and second spool wheels 822, 824, first and second indexers 812, 814, and first and second take-up hubs 830, 830' with their respective drive gears 818, 818'. First and second idler gears 852, 854 are provided to couple some of these components into a gear mechanism that manages the strip. Although not shown in Figure 80, torsion springs are provided between each of the first and second take-up hubs 830, 830' and their respective drive gears 818, 818' to provide a spring-loaded hub as previously described.

[0268] The mechanism of the inhaler 801 is driven through a mouthpiece cover 810, which is directly coupled to a ratchet component 840 in a hub gear 838. The hub gear 838 permanently engages and drives a first input gear 836 that extends through the front plate 805. The first input gear 836 engages and drives a second input gear 836'.

[0269] The first input gear 836 and the second input gear 836' drive a first peeling beak component 890 and a second peeling beak component 890'. The peeling beak components 890, 890' of the mechanism are formed in two parts, the first peeling beak component 890 comprises a front part 890A and a rear part 890B which are assembled from either side of the intermediate chassis 804. Similarly, the second peeling beak component 890' comprises a front part 890A' and a rear part 890B' which are assembled from either side of the intermediate chassis 804. A locking arm 866 having a protrusion 868 is also provided at the rear of the rear plate of the inhaler 801.

[0270] 81-83 are detailed views of the first indexer 812 and the front and rear pieces 890A, 890B of the first peeling beak 890. The first indexer 812, shown in FIG. 81, is provided at one end with a recess 897 to receive a ratchet tooth 896 provided on the face of the front piece 890A of the first peeling beak component, as shown in FIG. 82. The front piece 890A of the first peeling beak component also provides a drive slot 851 and a recess 899 to receive a tab 898 provided on the rear piece 890B of the peeling beak component, shown in FIG. 83, during assembly. The second indexer 814 and the front and rear pieces 890A', 890B' of the second peeling beak component 890' are of equivalent construction.

[0271] The advancement of the mechanism during opening of the mouthpiece is illustrated in the front views of Figures 84 and 85. The direction of rotation of the first input gear 836 and the second input gear 836' is shown.

[0272] FIG. 84 shows the initial stage of opening the mouthpiece cover, with the rear surface of the first input gear 836 8. A drive pin 862 provided on the first stripping beak component 890 is inserted into a drive slot 851 of the first stripping beak component 890. The first peeling beak component 890 is engaged with the first peeling beak component 890. Rotation is initially prevented by a Geneva-style lock between the boss 872 on the rear of the input gear 836. 85. The boss 872 is then rotated by a cutout 874 on one side thereof to the position shown in FIG. The ratchet teeth 896 of the first peeling beak component 890 allow the first The first indexer is driven with the first peeling beak by engaging the recess 897 of the indexer. 5 is pressed to advance the first blister strip. During the accelerated movement, the second stripping beak component 890' is mounted on the rear of the second input gear 836'. It is held stationary by engaging the outer surface of a boss 872' provided.

[0273] Once rotation of the first peeling beak component 890 is completed, it is again held in place by engaging the outer surface of boss 872, as shown in FIG. 85. Drive pin 862' on the rear face of second input gear 836' then engages drive slot 851' to drive second peeling beak component 890' to rotate in a similar manner via cutout 874' in boss 872' of the second input gear. The second indexer 814 is driven during this movement to advance the second blister strip, as described above for first indexer 812. The staggered positioning of drive pins 862, 862' and notches 874, 874' ensures that the two strips are indexed sequentially, rather than simultaneously.

[0274] FIG. 85 also shows a slot 855 on one side of the first input gear 836 which mounts one end of a tension spring (not shown). The other end of the tension spring is connected to an attachment point 857 on the front plate 805 shown in FIG. 86. The front plate 805 also includes a pair of cam slots 861 which receive protrusions 850 provided on the arms of the ratchet component 840 as shown in FIG. 87. One end 861A of each cam slot is angled to bias the protrusions 850 inwardly towards the rotating end 834 of the ratchet component 840 during cap opening. This allows the hub gear 838 to rotate past the ratchet component 840 and be reset to its original position, driven by tension springs and other spring forces in the system, such as from the spring loaded take-up drums 830, 830′. The first and second peeling beak components 890, 890' also rotate back to their initial positions during this reset operation, but the ratchet teeth 896 and recesses 897 ensure that this counter drive is not transmitted to the first and second indexers 812, 814. Thus, the peeling operation is achieved when a defined point (corresponding to the angled end 861A of the cam slot 861) is reached during mouthpiece opening. It will be appreciated that the ratchet component 840 does not transmit drive during rotation 832 when the mouthpiece cover 810 closes.

[0275] 88 and 89 illustrate the locking mechanism, which ensures that the first indexer 812 and the second indexer 814 remain in the forward position during the peeling operation. The locking mechanism is shown from the rear of the inhaler 801, with most of the rear plate 806 omitted for clarity. A locking arm 866 is connected to the mouthpiece cover 808 and rotates with the mouthpiece cover. When the mouthpiece cover rotates 834 to the open position, the locking arm also rotates. Towards the end of this opening movement, a protrusion 886 (see FIG. 80) on the locking arm 866 engages the latch component 819, driving it downwards into the locking recesses 820, 820′ provided at the rear end of the first indexer 812 and the second indexer 814, as shown in FIG. 89. The first indexer 812 and the second indexer 814 are released again when the mouthpiece cover closes.

[0276] 89 also shows the engagement of the first indexer 812 and drive gear 818 with the first indexer 830, and the engagement of the first indexer 812 and first spool wheel 822 via a first float 852. The second side of the mechanism is similarly arranged and driven via a second indexer 814. As with the other embodiments, the first spring loaded take-up drum 830 and the second spring loaded take-up drum 830' are driven in the opposite direction to their respective drive gears 818, 818' by the cover foil during indexing.

[0277] Figures 90 to 96 illustrate another inhaler 901 according to a ninth embodiment of the present invention. The 901 uses the mouthpiece cover to turn the hub gear through the ratchet component, This converts the reciprocating motion of the cover into a unidirectional drive for the input drive mechanism. This allows the two indexers, and thus the two blisters, to be fed through a geared Geneva-style mechanism. The strips are intermittently and continuously moved asymmetrically, and a geared Geneva-style mechanism is used to index the indexing wheels. The stripping beak is an integrated single linear air passage, and is divided into two parts. It is controlled using a desmodromic cam, the split desmodromic cam is the first strip This prevents peeling by synchronizing the movement of the cap with the lid foil of the second strip. cormorant.

[0278] 90 is a rear exploded view of the ninth embodiment of the inhaler 901 with some components omitted. A ratchet component 940 is provided to transmit drive from the mouthpiece cover (not shown) through the rear plate 906 of the inhaler body to the hub gear 936. Also provided at the rear of the rear plate 906 is a ring gear 938.

[0279] The first and second indexers 912, 914, spool wheels 922, 924, and idler gears 952, 954, along with the first and second take-up drums 930, 930' (and associated input gears 918, 918'), are located between the back plate 606 and the mid-chassis 904. As with the other embodiments, a torsion spring (not shown) is provided to form a spring loaded take-up drum 930, 930' to provide the benefits described above. The moving stripping beak component 990 is shown in front of the mid-chassis 904 and includes a drive pin 962 that extends through a slot in the mid-chassis to constrain the stripping beak component 990 to linear motion.

[0280] 91 is a front perspective view of the hub gear 936. The hub gear 936 includes a front drive gear 936A, a central cam plate 936B, and a rear intermittent drive gear 936C, which effectively provides a central logic hub for the inhaler 901, driving the various components of the inhaler 901 forward in a predetermined sequence. A ratchet component 940 is received within a recess in the rear of the hub gear 936, which drives the hub gear 936 in the direction of the arrow 934 during the opening movement of the mouthpiece cover. During this rotation, a cam track 951 on the edge of the cam plate 936B engages a drive pin 962 on the stripping beak component 990, driving the stripping beak component 990 vertically upward. The same drive pin 962 engages the bottom of the cam track 951, which resists the hub gear from rotating back when the stripping beak component is in the lowered position, during the closing of the mouthpiece cover.

[0281] Figure 92 shows a moving air conduit 908 which is associated with a moving stripping beak component 990 and which moves with the moving stripping beak component 990 during use of the inhaler 901. The air conduit 908 comprises a further drive pin 963 which extends in the opposite direction to the drive pin 962 of the stripping beak component 990 and which, in use, engages a further cam track 961 provided on the inner surface of the mouthpiece cover 910 shown in Figure 93. The further cam track 961 includes an enlarged area 961A in which the further drive pin 963 is received when the mouthpiece cover 910 is in the closed position.

[0282] Figures 94 and 95 further illustrate the movement of the stripping beak component 990 and air passage 908 during movement of the mouthpiece cover 910. Figure 94 shows a point during the opening movement 934 where the stripping beak component 990 (and the connected air passage 908) has been moved vertically upwards by the cam track 951 on the hub gear 936 as previously described. Further rotation 934 of the mouthpiece cover 910 during opening causes a further drive pin 963 in a further cam track 961 to move as shown. This drives the air passage 908 to move additionally upwards, such that the air passage 908 is held in a raised position when the mouthpiece cover 910 is fully open.

[0283] 95 shows the mouthpiece cover 910 in a fully open position and at a defined point of the inhalation device 901. From this position, the further drive pin 963 moves as shown during rotation 932 during closing of the mouthpiece cover 910. The air passage 908 and the stripping beak component 990 are initially free to move vertically downwards to perform the stripping action under the spring bias provided by the spring loaded take-up drums 930, 930' which are energized by the rotation of the hub gear 936 during opening. The stripping beak component 990 is then held in a low position, locking the hub gear against counter-rotation through the engagement of the cam track 551 of the hub gear with the drive pin 962 of the stripping beak component 990.

[0284] 96 is a rear view of the gearing of the inhaler 901. The ratchet component 940 is shown and the drive direction 934 during opening of the mouthpiece cover is shown.

[0285] The toothed portion 916 of the intermittent drive gear 936C drives the first indexer 912 (the first idler 912) and then the second indexer 914. It is clear that the first indexer 912 and the second indexer 914 move forward. When not in use, they are connected to the smooth portion 917 of the intermittent drive gear 936C and the first floating portion 95 2 or the second indexer 914. This is the same as the operation described for the sixth embodiment in FIG. 938 (see FIG. 90) from the first indexing device 912 and the second indexing device 914 , through gear teeth provided on the interior of ring gear 938, first spool wheel 922 and The ring gear 938 transmits drive to the second spool wheel 924 respectively. It is indexed to one minute and can therefore be used as a dose counter or, with further development, It can be used as a unit wheel in a more complex dose counter mechanism. The drive gears 918, 918' of the hub 930 and the second take-up hub 930' have front drive teeth. The wheel 936A and the second idler gear 954 are constantly driven. Apply the necessary tension to the lid wheel / sheet at the open end of the scabbard 910 and peel it off before the fixed point and spreads the work done by the user over the entire opening movement.

[0286] The aforementioned movement of the air duct 908 and peeling beak component 990 occurs during forward movement of the first indexer 912 to prevent peeling of the first blister strip before the second blister strip is in the indexed position, thereby causing the lidding foil / sheet of the second blister strip to overlap (it was unspooled from the second take-up drum 930' prior to this movement and placed back onto the base foil / sheet) and then recollected as it is indexed.

[0287] The configuration of cam tracks 951, 961 ensures that the air passage 908 moves in synchrony with the movement of the first blister strip and is held in a forward position until the second blister strip is indexed into position, after which a simultaneous peel action occurs at a defined point as shown in FIG.

[0288] The above embodiments generally provide an inhaler that allows for complex timing and sequencing with a reduced component count, and is resistant / resistant to user abuse without the need for an exhalation actuated mechanism. The use of ratchets in the mechanism is largely avoided, and simultaneous indexing of two medication strips (if used) is avoided, to minimize complex or confounding ratchet timing issues that may often prevent the device from recovering from deviations from the expected sequence of use. The use of definite points built into the mechanism helps address over-compliance issues.

[0289] It should be understood that while the various embodiments described above offer their own individual configurations and advantages, they all accomplish the same overall objective, namely, the asymmetric progression of the opening system and the indexing system during the movement of a common actuator of a single device.

Claims

1. 1. An inhalation device comprising an actuation mechanism having an indexing system, an opening system, and a common actuator for the indexing system and the opening system, said indexing system advancing a drug carrier; The drug carrier comprises a base having a plurality of drug pockets or blisters, and a peelable lid sheet covering the blisters; the opening system peels the lid sheet from the drug carrier to open the blister; the common actuator is movable between a first position and a second position via an intermediate position; An inhalation device, wherein the progression of the opening system is disproportionate to the progression of the indexing system while the common actuator is moving.

2. movement of the common actuator through a first range of motion operates the indexing system; movement of the common actuator through a second range of motion operates the opening system; 2. The inhalation device of claim 1, wherein the indexing system is separated from the opening system such that the first range of motion is not the same as the second range of motion.

3. a defined movement of the common actuator operates both the indexing system and the opening system; 2. The inhalation device of claim 1, wherein a speed of movement of the opening system relative to a speed of movement of the actuator varies during the defined movement of the actuator.

4. A defined movement of the common actuator activating the indexing system to advance a dose of the drug; moving said opening system through a first operational phase in which said peeling occurs without exposing medicament within the blister, and a second operational phase in which said peeling exposes medicament within the blister, thereby providing a dose of medicament ready for inhalation; 2. The inhalation device of claim 1, wherein the second stage of operation of the opening system is delayed until the operation of the indexing system is 30% complete.

5. 5. An inhalation device according to claim 3 or 4, wherein the defined movement comprises movement from the first position to the second position.

6. 5. An inhalation device according to claim 3 or 4, wherein the defined movement includes movement from the second position to the first position and movement back to the second position.

7. movement of the common actuator from the first position advances the indexing system; 3. An inhalation device according to claim 1 or 2, wherein only movement of the common actuator beyond the intermediate position activates the opening system.

8. 8. An inhalation device according to claim 7, wherein reversing movement of the actuator from a position between the first position and the intermediate position back to the first position reverses the advancement of the indexing system.

9. An inhalation device according to any preceding claim, wherein movement of the actuator between the second position and the first position causes the indexing system to advance.

10. An inhalation device according to any preceding claim, further comprising a central hub driven by the common actuator.

11. 11. An inhalation device as claimed in claim 10, further comprising a gear linkage to transfer drive from said central hub to said indexing system.

12. 11. An inhalation device according to claim 10, further comprising a cam system for transmitting drive from the central hub to the indexing system.

13. An inhalation device according to any one of claims 1 to 12, wherein the actuation mechanism further comprises a trigger component, movement of which activates the opening system.

14. 14. The inhalation device of claim 13, wherein movement of the common actuator beyond the intermediate position causes movement of the trigger component.

15. An inhalation device according to any one of claims 1 to 12, wherein the actuation mechanism further comprises a cam for controlling the opening system.

16. the actuation mechanism comprising: a lid sheet take-up component for receiving a used lid sheet peeled from a pharmaceutical carrier; An inhalation device according to any one of claims 1 to 15, further comprising a drive system between the common actuator and the lid sheet take-up component.

17. 17. An inhalation device according to claim 16, wherein the actuation mechanism comprises means for adjusting the tension exerted on the lid sheet during advancement of the indexing system.

18. 18. An inhalation device according to claim 16 or 17, wherein a torsion spring is provided between two rotating components mounted on a common centre of the drive train.

19. 19. An inhalation device according to claim 18, wherein the torsion spring is charged by tension in the used lid sheet during advancement of the indexing system.

20. An inhalation device according to any one of claims 16 to 18, wherein the drive train moves the lid sheet take-up component to adjust the tension in the lid sheet before or during advancement of the indexing system.

21. 21. An inhalation device according to claim 20, wherein during advancement of the indexing system, at least a portion of the peeled lidding sheet is folded back onto the unopened portion of the medicament carrier.

22. An inhalation device according to any preceding claim, further comprising a peel-away beak component for regulating separation of the lid sheet from the medicament carrier.

23. 23. An inhalation device according to claim 22, wherein the stripping beak component is movable during or before advancement of the indexing system.

24. 24. An inhalation device as claimed in claim 23, wherein the ablating beak component follows a path that substantially coincides with or is offset from the path of the drug carrier.

25. 25. An inhalation device according to claim 23 or 24, wherein the stripping beak component selectively engages a component of the indexing system.

26. 26. An inhalation device as claimed in claim 25, wherein the stripping beak component comprises a pawl or ratchet that selectively engages the component of the indexing system.

27. the indexing system comprising means for indexing a first pharmaceutical carrier and a second pharmaceutical carrier; An inhalation device according to any one of claims 1 to 26, wherein each of the first and second drug carriers comprises a base having a plurality of drug pockets or blisters and a peelable lid sheet covering the blisters.

28. the opening system is configured to peel the lid sheet from each of the first and second drug carriers; movement of the common actuator from the first position operates the indexing system to advance the first drug carrier; 28. An inhalation device according to claim 27, wherein only movement of the common actuator beyond the intermediate position activates the opening system to peel the lidding sheet from the second medicament carrier blisters.

29. 29. An inhalation device according to claim 27 or 28, wherein the indexing system comprises separate first and second indexers for indexing the first and second pharmaceutical carriers.

30. 30. An inhalation device according to claim 29, wherein the indexing system advances the first indexer and the second indexer such that advancement of the first indexer is disproportionate to advancement of the second indexer.

31. an indexing system including a first indexer and a second indexer for advancing a first drug carrier and a second drug carrier; a common actuator for the first and second indexing devices; an actuation mechanism having the common actuator is movable between a first position and a second position via an intermediate position; An inhalation device, wherein the advancement of the first indexer is disproportionate to the advancement of the second indexer.

32. An inhalation device according to any one of claims 29 to 31, wherein the first indexer and the second indexer do not advance simultaneously during movement of the common actuator.

33. movement of the common actuator through a first range of motion operates the first indexing device; movement of the common actuator through a second range of motion operates the second indexing device; An inhalation device according to any one of claims 29 to 32, wherein the first indexer is separated from the second indexer such that the first range of motion is not the same as the second range of motion.

34. An inhalation device according to any one of claims 29 to 33, wherein the indexing system advances one of the first indexer and the second indexer when the common actuator moves from the second position to the first position.

35. An inhalation device according to any one of claims 29 to 34, wherein at least one of the first indexing device and the second indexing device comprises an indexing wheel.

36. 29. An inhalation device according to claim 27 or 28, wherein the indexing system comprises a single indexer.

37. 37. An inhalation device according to claim 36, wherein the indexing device comprises an indexing wheel.

38. An inhalation device according to any one of claims 27 to 37, wherein the opening system is configured to simultaneously peel and open the blisters on each of the first and second medicament carriers.

39. An inhalation device according to any preceding claim, wherein the intermediate position of the common actuator is closer to the second position of the common actuator than to the first position of the common actuator.

40. 40. An inhalation device according to claim 39, wherein the intermediate position of the common actuator is adjacent to the second position of the common actuator.

41. An inhalation device according to any preceding claim, wherein the indexing system comprises one or more gears having intermittent drive and / or locking surfaces.

42. An inhalation device according to any preceding claim, wherein the indexing system comprises a locking means for selectively preventing movement of one or more components of the indexing system.

43. 43. An inhalation device according to claim 42, wherein the locking means comprises one or more gears having locking surfaces.

44. 44. An inhalation device according to claim 42 or 43, wherein the locking means comprises one or more pawls.

45. An inhalation device according to any preceding claim, wherein the common actuator comprises a mouthpiece cover.

46. 46. ​​An inhalation device according to claim 45, wherein the first position is a fully closed position of the mouthpiece cover.

47. 47. An inhalation device according to claim 45 or 46, wherein the second position is a fully open position of the mouthpiece cover.

48. An inhalation device according to any preceding claim, further comprising a movable airway component.

49. 49. An inhalation device according to claim 48, wherein the movable airway component comprises a unitary movable airway.

50. 49. The inhalation device of claim 48, wherein the inhalation device comprises a split airway comprising a stationary airway component and the moving airway component.

51. An inhalation device according to any one of claims 48 to 50, wherein the movable airway component provides a peeling beak component which controls separation of the lid sheet from the medicament carrier.

52. 52. An inhalation device according to any one of claims 48 to 51, wherein the moving airway component follows a path that does not substantially coincide with, or is simply offset from, the path of the medicinal carrier.

53. An inhalation device according to any one of claims 48 to 52, wherein the movable airway component follows a substantially straight path.

54. The opening system peels the lidding sheet from the drug carrier to completely open the blister. An inhalation device according to any one of claims 1 to 30, which is opened.

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