End of life locking mechanism for an inhaler

Abstract

A life-end locking mechanism for an inhaler is provided, the inhaler being of the type including a mechanical button (107) operable by a user to dispense a dose from the inhaler. The life-end locking mechanism includes: locking activation elements (106, 109) configured to be located within an outer housing (101a, 101b) of the inhaler, the locking activation elements (106, 109) configured such that operation of the inhaler causes the locking activation elements (106, 109) to move within the housing (101a, 101b); and a blocking element (110) configured to... Located within the housing (101a, 101b) of the inhaler, the blocking element (110) is configured such that the blocking element (110) can move from a first position or a first set of positions during normal operation of the inhaler to a second position that blocks the user from operating the button (107), wherein operation of the inhaler causes the locking activation element (106, 109) to move stepwise within the housing (101a, 101b) with each use of the inhaler until the locking activation element (106, 109) reaches a preset point and causes the blocking element (110) to move to the second position.

Description

Technical Field

[0001] This invention relates to a life-end locking mechanism for inhalers. Specifically, but not exclusively, this invention relates to a life-end locking mechanism for soft mist inhalers. The invention also relates to inhalers having a life-end locking mechanism. Background Technology

[0002] Inhalers, such as soft mist inhalers (SMIs), use a cartridge or container as the source of the medication they deliver. In this type of inhaler, the cartridge contains a volume of medication delivered to the user via discrete doses, which include a portion of the total volume within the cartridge. During use, the cartridge is located within an inhaler assembly that includes a micropump. Medication delivery from the cartridge is achieved using the micropump, which is typically manually operated / activated by the user. While reusable inhaler assemblies where the cartridge can be removed and replaced after its expiration date are known, it is more common for the inhaler and cartridge to be discarded after use and at the end of their lifespan. In use, the inhaler is operated to release a discrete dose of medication from the cartridge, where the micropump within the inhaler is used to deliver the medication dose from the cartridge.

[0003] Importantly, the inhaler delivers a precise and known dose of medication with each operation. However, the amount of medication in the cartridge decreases with each dose delivery. This can result in a situation where the level of medication remaining in the cartridge has decreased to an insufficient level to deliver the full dose in any single operation of the inhaler, but is still sufficient to make the inhaler appear (but not actually) to be successfully operated and deliver the full dose. Alternatively, or simultaneously, operating the micropump may result in the inhaler appearing (but not actually) to deliver the full dose successfully at the end of its cartridge life or nearing the end of its life. Alternatively, if continued use exceeds the labeled / design limits, the concentration of the delivered medication dose may be too high or too low.

[0004] Drug regulatory agencies typically require this type of inhaler to employ some form of dose indication, and many inhalers contain mechanisms such as a dose counter that provides a precise count of the remaining dose or a dose indicator that provides an indication of the percentage of the remaining dose. These counters are scaled or “counted” each time the inhaler is used, and are designed so that when the remaining dose count reaches zero, the user will know to replace the cartridge with a new, fully pressurized cartridge (either by replacing the cartridge or replacing the entire inhaler). Examples of this type of device are described and illustrated in US10,929,742, US11,544,520, US11,369,760, and WO2022 / 002993.

[0005] EP2617450 describes and illustrates a life-end mechanism in which a button remains pressed when the inhaler reaches the end of its life. US9,744,313 describes and illustrates an inhaler with a mechanism in which a drive spring 7 is held in a compressed state by a button or blocking element 8 until the button is activated. At the end of its life, the upper and lower housings are locked relative to each other and prevented from rotating relative to each other, thus preventing the inhaler from being pre-compressed for use. In this locked state, the button or blocking element 8 cannot be used to release the spring. AU2015 / 202524 describes a similar mechanism.

[0006] For many types of end-of-life mechanisms or counters, users may still be able to operate the inhaler, even after a zero-dose count has been reached. If a user attempts to use the inhaler after a zero-dose count has been reached, this can lead to problems such as those outlined above.

[0007] Therefore, there is still a need for an institution that can help overcome the above-mentioned shortcomings or at least provide the public with useful options. Summary of the Invention

[0008] The purpose of this invention is to provide a life-end locking mechanism for inhalers that overcomes the aforementioned disadvantages to some extent or at least provides a useful option for the public or industry.

[0009] Another object of the present invention is to provide an inhaler device with a life-end locking mechanism that overcomes the above-mentioned disadvantages to some extent or at least provides a useful option for the public or industry.

[0010] Therefore, in a first aspect, the present invention can generally be comprised of a life-end locking mechanism for an inhaler, the inhaler being of the type including a mechanical button operable by a user pressing the button from an outer position inward to dispense a dose from the inhaler, the life-end locking mechanism comprising: a blocking element configured to be positioned within the housing of the inhaler, the blocking element and the housing further configured such that the blocking element can be moved from a first position or a first set of positions within the housing to a second position in which normal operation of the inhaler occurs; a locking activation element configured to be located within the outer housing of the inhaler, the locking activation element configured such that each single operation of the inhaler causes the locking activation element to move stepwise within the housing until, after multiple single operations, the locking activation element reaches a preset point and moves the blocking element to the second position; the locking activation element and the blocking element are collectively configured to be positioned within the outer housing of the inhaler such that the button is blocked in the outer position by the blocking element in the second position.

[0011] In one implementation, the locking enable element includes a ring.

[0012] In one embodiment, the ring includes gear teeth.

[0013] In one embodiment, the ring includes an extension that extends outward from the ring.

[0014] In one embodiment, the life-end locking mechanism further includes a cam element configured to interact with the activation element and connect with a blocking element when the locking activation element reaches a preset point, so as to move the blocking element to a second position.

[0015] In one embodiment, the extension extends substantially axially outward from the ring.

[0016] In one embodiment, the extension extends outward from the ring in a substantially circumferential direction.

[0017] In one embodiment, the blocking element includes a pin having an elongated body and a key extending from the body.

[0018] In one embodiment, the blocking element includes a pin having an elongated body with gear teeth formed at one end of the body, the gear teeth being configured to interact with gear teeth of a ring in use to rotate the body as the ring rotates. The blocking element also includes a movable element positioned on the body in use, the body and the movable element being configured such that when the body rotates, the movable element moves along the body from one or more first positions to a second position.

[0019] In one embodiment, the blocking element includes a hook-shaped lower end, and the housing and the hook-shaped lower end are configured to engage with each other when the blocking element is in a first position or a first set of positions.

[0020] In one embodiment, the blocking element further includes a protrusion that extends outward from the body substantially toward the upper end of the body and is aligned in substantially the same direction as the hook-shaped lower end.

[0021] In one embodiment, the blocking mechanism further includes a spring configured to operate when the locking enable element reaches a preset point, thereby moving the blocking mechanism to a second position.

[0022] In a second aspect, the invention can generally be comprised of a life-end locking mechanism for an inhaler, the inhaler being of the type including a mechanical button operable by a user pressing the button from an outer position inward to dispense a dose from the inhaler. The life-end locking mechanism includes: a blocking element configured to be positioned within the housing of the inhaler, the blocking element and the housing further configured such that the blocking element can be moved from a first position or a first set of positions within the housing to a second position in which normal operation of the inhaler occurs; and a locking activation element configured to be located within the outer housing of the inhaler, the locking activation element configured such that each single operation of the inhaler causes the locking activation element to move stepwise within the housing until, after multiple single operations, the locking activation element reaches a preset point and moves the blocking element to the second position; the locking activation element and the blocking element are collectively configured to be positioned within the outer housing of the inhaler such that the button is blocked in the outer position by direct contact with the blocking element in the second position.

[0023] In one implementation, the locking enable element includes a ring.

[0024] In one embodiment, the ring includes gear teeth.

[0025] In one embodiment, the ring includes an extension that extends outward from the ring.

[0026] In one embodiment, the life-end locking mechanism further includes a cam element configured to interact with the activation element and connect with a blocking element when the locking activation element reaches a preset point, so as to move the blocking element to a second position.

[0027] In one embodiment, the extension extends substantially axially outward from the ring.

[0028] In one embodiment, the extension extends outward from the ring in a substantially circumferential direction.

[0029] In one embodiment, the blocking element includes a pin having an elongated body and a key extending from the body.

[0030] In one embodiment, the blocking element includes a pin having an elongated body with gear teeth formed at one end of the body, the gear teeth being configured to interact with gear teeth of a ring in use to rotate the body as the ring rotates. The blocking element also includes a movable element positioned on the body in use, the body and the movable element being configured such that when the body rotates, the movable element moves along the body from one or more first positions to a second position.

[0031] In one embodiment, the blocking element includes a hook-shaped lower end, and the housing and the hook-shaped lower end are configured to engage with each other when the blocking element is in a first position or a first set of positions.

[0032] In one embodiment, the blocking element further includes a protrusion that extends outward from the body substantially toward the upper end of the body and is aligned in substantially the same direction as the hook-shaped lower end.

[0033] In one embodiment, the blocking mechanism further includes a spring configured to operate when the locking enable element reaches a preset point, thereby moving the blocking mechanism to a second position.

[0034] Then, regarding the above description, it should be recognized that the optimal dimensional relationships of the components of the present invention (including variations in size, material, shape, form, function, and mode of operation, assembly, and use) will be apparent to those skilled in the art, and equivalent relationships shown in the drawings and described in the specification are intended to be covered by the present invention.

[0035] In general, the present invention may also consist individually or collectively of the components, elements and features mentioned or indicated in the specification of this application, and may consist of any or all combinations of any two or more components, elements or features. Furthermore, when a particular whole mentioned herein has a known equivalent in the field of the present invention, such known equivalent is considered to be incorporated herein as if set forth separately.

[0036] Therefore, the foregoing is considered merely an explanation of the principles of the invention. Furthermore, since many modifications and alterations will readily occur to those skilled in the art, it is not intended to limit the invention to the exact constructions and operations shown and described, and thus, all suitable modifications and equivalents falling within the scope of the invention may be employed. Attached Figure Description

[0037] Other aspects of the invention will become apparent from the following description, given by way of example only and with reference to the accompanying drawings, which illustrate embodiments of the apparatus by way of example, and in which: Figure 1 A cutaway side view of a known prior art inhaler from Boehringer-Ingelheim is shown. This inhaler is a typical soft mist inhaler of the known type. The figure shows internal details of the housing surrounding the cartridge, which has an upper part and a lower or base part. The housing forms a mouthpiece for the user and has a dose release button on the housing for triggering the dispensing of a dose of medication.

[0038] Figure 2A side view of another type of known prior art soft fog inhaler from Mercin is shown. The inhaler includes a housing with a base that surrounds the cartridge in use. An upper part of the housing forms a mouthpiece. A dose release button is provided on the housing. A cover is hinged to one side of the housing, and the cover is shown in the open position.

[0039] Figure 3 This image shows a perspective view of a known prior art inhaler taken from an oblique top, the inhaler being similar to... Figure 2 The inhaler shown is indicated by its cover being in the open position.

[0040] Figure 4 A perspective side view of an inhaler according to an embodiment of the present invention is shown, which is structurally similar to... Figure 2 and Figure 3 The inhaler shown is similar, having a life-end locking mechanism located in the housing on the same side as the cover hinge.

[0041] Figure 5 It shows Figure 4 A perspective side view of the inhaler, cut open in a vertical plane to show the internal details of the inhaler and in particular the life-ending mechanism, which includes a pin extending along the housing and shown in the normal use position toward the lower or base end of the inhaler.

[0042] Figure 6 It shows Figure 5 A three-dimensional view of the inhaler taken from an oblique angle.

[0043] Figure 7 It shows Figures 4 to 6 The inhaler is viewed from an oblique angle, cut across a horizontal plane directly above the lower end of the upper housing component, showing details of a portion of the life-end mechanism aligned for normal use.

[0044] Figure 8 From and Figure 7 The same angle shows Figures 4 to 7 A perspective view of the inhaler, cut across a horizontal plane directly below the upper end of the upper housing component, showing details of the upper portion of the button and life-end mechanism, aligned for normal use.

[0045] Figure 9 From and Figure 8 Similar angles show Figures 4 to 8 A three-dimensional diagram of an inhaler, which is larger than Figure 8 It was cut on a horizontal plane slightly higher than the horizontal plane.

[0046] Figure 10 It shows Figures 4 to 9 A three-dimensional top view of the inhaler taken from an oblique angle, which is larger than... Figure 9 The section is cut on a plane slightly higher than the cutting surface, in which the key block on the pin of the locking mechanism is aligned with the groove in the housing. When the key block is aligned with the groove, the pin moves upward to lock the mechanism.

[0047] Figure 11 It shows the relationship with Figure 10 Enlarged view of the life-ending mechanism and button, viewed from the same cutting plane and angle, pin and... Figure 10 They are in the same alignment position.

[0048] Figure 12 Showing Figures 4 to 11 A three-dimensional view of the inhaler taken from an oblique angle, which is larger than... Figure 9 The plane is slightly higher and than Figure 9 and Figure 10 The plane was cut on a horizontal plane slightly lower than the plane, and the pin and Figure 10 and Figure 11 They are in the same alignment position.

[0049] Figures 13a to 13d A perspective view of an embodiment of the pin of the life-end mechanism is shown.

[0050] Figure 14 A cross-sectional side view of an inhaler with a life-end locking mechanism according to a second embodiment of the invention is shown. The configuration and layout of the inhaler are similar to those of the inhaler of the first embodiment. The life-end locking mechanism in this embodiment includes a pin and a cam element that interacts with a protrusion on a dose counting ring. The pin is shown in a lower or normal use position.

[0051] Figure 15 An enlarged perspective sectional view of the life-end locking mechanism of the second embodiment is shown.

[0052] Figure 16 A perspective view of the cam element of a second embodiment of the locking mechanism, viewed from one end, is shown.

[0053] Figure 17 A perspective view of a counting ring according to a second embodiment is shown, the ring having a protrusion that interacts with a cam at the end of its lifespan.

[0054] Figure 18 A perspective top sectional view of the lower portion of the locking mechanism is shown, indicating that the cam is in the normal operating position.

[0055] Figure 19 From and Figure 18The same angle shows a three-dimensional top sectional view of the lower part of the locking mechanism, which shows the cam moving to the locked position under the push of the protrusion.

[0056] Figure 20 A perspective sectional view of the locking mechanism and the upper portion of the inhaler according to the second embodiment is shown. A groove is formed in the upper housing of the inhaler, and a key block on the pin forms part of the locking mechanism. The key block is shown to be aligned with the groove so as to move into the groove to lock the mechanism.

[0057] Figure 21 A cross-sectional side perspective view of an inhaler with a life-end locking mechanism according to a third embodiment of the present invention is shown. The configuration and layout of the inhaler are similar to those of the inhaler of the first embodiment. In this embodiment, the life-end locking mechanism includes a pin with a toothed gear at its lower end. In use, the teeth of the gear interlock with the teeth on the lower edge of a counting ring, such that rotation of the counting ring 306 drives rotation of the pin. Except for the top of the pin, the upper portion of the pin is threaded, and a nut is screwed onto the upper portion of the pin. When the life-end is reached, the nut moves upward and disengages from the threaded section to block the mechanism of the inhaler. The nut is shown as being located on the threaded section.

[0058] Figure 22 An enlarged sectional perspective view of a toothed gear interlocking with the teeth on the lower edge of the counting ring is shown.

[0059] Figure 23 It shows the relationship with Figure 21 A view of a similar third embodiment of the mechanism.

[0060] Figure 24 A cross-sectional view of the mechanism of the third embodiment, viewed from near the top of the mechanism, is shown, showing the nut in the upper position and locking the inhaler to prevent further use.

[0061] Figure 25 A cross-sectional side view of an inhaler with a life-end locking mechanism according to a fourth embodiment of the present invention is shown. The overall or general configuration and layout of the inhaler are similar to those of inhalers in other embodiments. The life-end locking mechanism in this embodiment includes a spring-loaded pin that is held in a lower position until the counting ring reaches the life-end position. The spring-loaded pin is released by the counting ring after the counting ring reaches the life-end position. After release, the pin moves upward to block the mechanism of the inhaler. The pin is shown in the lower position.

[0062] Figure 26 It shows Figure 25 A cross-sectional side view perspective of the inhaler.

[0063] Figure 27 It shows Figure 25 and Figure 26A magnified three-dimensional detailed cross-sectional side view of the pin mechanism of the inhaler.

[0064] Figure 28 It shows Figures 25 to 27 A top cross-sectional view of the top of the pin of the life-end mechanism, showing the position of the pin relative to the button of the inhaler.

[0065] Figure 29 It shows from Figure 28 A three-dimensional view observed from one side of a cross-section.

[0066] Figure 30 From and Figure 27 A similar angle shows an enlarged, detailed three-dimensional cross-sectional side view of the pin mechanism.

[0067] Figure 31 A three-dimensional cross-sectional side view is shown, which illustrates the details of the pin mechanism and the position of the pins within the inhaler relative to the counting ring.

[0068] Figure 32 A perspective view of an embodiment of a counting ring suitable for a locking mechanism is shown.

[0069] Figure 33 A three-dimensional cross-sectional view of the inhaler is shown, which illustrates the details of the counting ring and pin in contact at the end of their lifespan, such that the counting ring will move the pin to release it. Detailed Implementation

[0070] Overview

[0071] In all embodiments described below, the inhaler shares the following basic components: a housing 1, formed by an upper component 1a and a lower component 1b; a mouthpiece 2 (in the illustrated embodiment, integrally formed with the upper housing component 1b, but may be a separate item attached to the upper housing component); a cartridge 3; a spring 4; a spring cage 5; a counter ring 6; and a button 7. The inhaler also includes a micropump that operates during use to deliver a dose of medication from the cartridge to the mouthpiece.

[0072] The cartridge 3 is housed within the housing 1 and is fluidly connected to the mouthpiece 2 inside the housing, so that in use, when the inhaler is activated (i.e., by the user pressing button 7), the dose of medication can travel from the cartridge 3 to the mouthpiece for the user to inhale.

[0073] The inhaler operates by twisting the upper and lower parts 1a and 1b of the housing 1 relative to each other to "cock" the mechanism and pre-pressurize the micro-pump. This action causes the counting ring 6 to rotate stepwise and increment once. The user then presses button 7 to release a dose of medication via the mouthpiece.

[0074] After a set number of uses, the locking mechanism / life-end mechanism activates to prevent further use of the inhaler, as outlined below.

[0075] Based on the general numbering outlined above, similar numbering is used in all embodiments described below—for example, in the first embodiment, the upper and lower components are numbered 101a and 101b, the mouthpiece is numbered 102, the cartridge is numbered 103, the spring is numbered 104, etc. In the second embodiment, the upper and lower components are numbered 201a and 201b, the mouthpiece is numbered 202, the cartridge is numbered 203, the spring is numbered 204, etc.

[0076] When directional designations are used (such as "vertical" or "horizontal"), these designations have their normal meaning. However, when used in reference to the inhaler or any of its components, they should be understood to mean "the inhaler is upright on a flat, substantially horizontal surface" and the mouthpiece is pointing vertically upwards.

[0077] First Implementation Method

[0078] Figures 4 to 1 3 shows an inhaler with a life-end locking mechanism according to a first embodiment.

[0079] like Figure 4 As shown, the inhaler 100 has a housing 101 formed by an upper component 101a and a lower component or base component 101b. In this embodiment, the mouthpiece 102 is integrally formed with the upper housing component 101b and has an attachment hinge on one side for a cap (as shown in the image). Figure 2 (Similar to what is shown in the image).

[0080] The housing 101 surrounds the internal components of the inhaler, such as the cartridge (in Figures 5 to 1 (not shown in 3), springs and spring cages 104, 105, counting ring 106, and a micro pump. For example... Figure 5 As shown, spring 104 is a helical spring that extends within the housing between the upper and lower components. A spring cage 105 is substantially located within the upper component 101b and extends around the upper portion of spring 104. A counting ring 106 includes an annular element positioned within the upper housing component and extending around the spring cage, with the counting ring positioned towards the lower end of the upper housing component. In this embodiment, the counting ring 106 has a toothed upper edge. A worm gear 108 is positioned within and connected to the housing such that the worm gear 108 interacts with the teeth of the counting ring 106.

[0081] As described above, in use, the user "charges" or prepares the inhaler 100 for use by twisting the upper and lower portions 101a, 101b of the housing 101 relative to each other. This twisting motion occurs about a central axis that extends substantially centrally and vertically from the top to the bottom of the inhaler 100. A worm gear 108 is connected to the housing and positioned such that this relative rotational motion causes the worm gear to rotate, which in turn causes the counting ring 106 to rotate and index once (i.e., the ring 106 rotates an arc length about its central axis from an initial position to a second position to count "one dose"). This movement of the counting ring 106 occurs with each relative rotational movement, wherein the counting ring 106 moves in the same direction each time, causing the counting ring 106 to rotate in steps. The counting ring 106 can be numeral-marked and forms a window in the housing to allow the user to see how much dose has been used and / or how much dose remains.

[0082] This torsional action also pre-pressurizes the micro-pump for delivering the medication from the cartridge to the mouthpiece. After the inhaler is ready for use, the user then places their mouth on the mouthpiece 102 and presses button 107 to release a dose of medication into their mouth via the mouthpiece.

[0083] For reference Figure 7 As best shown, the counting ring 106 also includes an extension 109 extending downward from the underside of the counting ring 106 at a point on its circumference. As the ring rotates, the extension 109 moves about the inner circumference of the housing and eventually contacts and interacts with a pin 110, which is positioned in the upper housing component and extends along the side of the upper housing component outside the spring cage and the counting ring. The axis of the pin 110 is substantially perpendicular to and parallel to the overall longitudinal axis of the inhaler. The counting ring 106 and the extension 109 together form the locking activation element of the first embodiment.

[0084] Figure 13 shows a preferred embodiment of pin 110. Pin 110 includes an elongated body 110a having a wide hollow base section 110b that opens at its lower end and is adapted to accommodate spring 114 in use and position it on a vertical extension 115 within a housing. The upper end of pin 110 includes a key block 110c extending from one side of pin 110.

[0085] As shown in Figure 13, the interference extension or interference cam 112 extends radially outward from the base section 110b of the pin 110, and is aligned with the interior of the inhaler during use. During use, when the pin 110 is in place in the housing, the interference cam 112 is at the same vertical horizontal height as the extension 109 on the ring inside the inhaler.

[0086] like Figure 10 and Figure 11As shown, key block 110c is configured to engage through a groove 113 in the housing, the groove 113 being formed in the housing towards the top of the upper component 101a. In normal use, the base of pin 110 is positioned on the vertical extension 115 and pushed against the spring 114, causing the spring to compress. The initial position of the upper end of pin 110 (i.e., before using the inhaler) is not aligned with the groove 113, and key block 110c is pushed against the housing at the side of the groove 113, so that the pin remains in the lower position when the spring is compressed.

[0087] As the inhaler is used repeatedly, the counting ring 106 rotates in steps, and the extension 109 moves along with the rest of the counting ring. When only one or two doses remain to be delivered, the front or forward side of the extension 109 contacts the side of the interference cam 112. As the last dose is delivered, the extension 109 pushes against the interference cam 112, causing the pin 110 to rotate. This rotation aligns the key block 110c with the slot 113. When the key block 110c is aligned with the slot 113, the compression spring 114 returns, causing the pin to move upward (i.e., in the direction of the mouthpiece, substantially aligned with the main longitudinal axis of the inhaler) to the "locked" or "end-of-life" position, and the key block 110c... Figure 11 It is positioned in slot 113 as shown to prevent the counting ring from rotating further.

[0088] Since key block 110c is now in the slot, and since pin 110 is a solid, rigid object, pin 110 will remain in that position. (See reference...) Figure 10 and Figure 11 As best illustrated, button 107 can be pressed inward into the housing from its outward position during normal use to dispense a dose or release a medication from the inhaler, with the edge of the button extending beyond the top of pin 110. However, after pin 110 is moved upward to the "locked" or "end-of-life" position, the upper pin 110 blocks the button in its outward position and cannot push it into the housing, thus preventing further use of the inhaler. That is, the button is blocked in the outward position by the blocking element. Similarly, pin 110 no longer contacts the extension 109 on the ring—the lower end or base of the pin has moved upward so that it is now above the top of extension 109. This helps ensure that the user cannot continue to manipulate the inhaler mechanism to create a "false" reset.

[0089] As can be seen, pin 110 forms a blocking element, and this blocking element moves from a first position or a first set of positions (the normal use position, where the pin is pushed onto the spring in the downward starting position) to a second position, in which pin 110 in the upper position blocks the button to an outward position where the button cannot be pressed inward. This occurs when the upper end of pin 110 is not aligned with slot 113 and key block 110c pushes against the housing at the side of slot 113, causing the pin to align with slot 113 and move upward (pushed by spring 114).

[0090] Second Implementation Method

[0091] Figures 14 to 20 An inhaler with a life-end locking mechanism according to a second embodiment is shown.

[0092] The inhaler 200 of this embodiment has substantially the same components as the inhaler of the first embodiment and operates in a substantially similar manner to deliver medication to the user. The same or similar components are given similar designations in the manner outlined above.

[0093] The second embodiment's end-of-life locking mechanism operates in a similar manner to the first embodiment—pin 210 includes a key block 210c, which moves to align with slot 213 upon end of life. Spring 214 is held tensioned by pin 210 and unloads / rebounds when key block 210c aligns with slot 213, pushing key block 210c through slot 213. Pin 210 then moves linearly upward to block operation of button 207. That is, in normal use, button 207 can be pressed inward from the outer position into the housing to dispense a dose from the inhaler, but in the "locked" or "end-of-life" position, pin 210 in the upper position blocks button 207 in the outer position, and the button cannot be pushed into the housing, thus preventing further use of the inhaler. In other words, the button is blocked in the outer position by the blocking element.

[0094] However, in this embodiment, the life-end locking mechanism includes a pin 210 and a cam element 220. For example... Figure 14 and Figure 15 As shown, the body of pin 210 extends along the side of inhaler 200. Cam element 220 is positioned in the housing at the lower end of pin 210. The cam element is configured such that, in use, spring 214 remains compressed at the lower end of pin, thereby pressing upward against the lower end of pin. Cam element is hollow, wherein the lower end of spring is positioned in the top of cam element, and spring is positioned in the lower end.

[0095] In this embodiment, such as Figure 17As shown, the counting ring 206 has a protrusion 209 extending radially outward on the circumference of the ring 206. The counting ring 206 and the protrusion 209 together include a locking enable element for the second embodiment.

[0096] The cam element 220 has a protrusion 220a extending from the body of the cam element. In normal use, the cam element... Figure 18 Alignment is shown. With repeated use of the inhaler, the counting ring 206 rotates in steps, and the extension 209 moves with the counting ring. When only one or two doses remain to be delivered, the front or forward side of the extension 209 contacts the side of the protrusion 220a. As the last dose is delivered, the extension 209 pushes the protrusion 220a, causing it to move... Figure 18 The position shown. This causes a related rotation of pin 210. As... Figure 20 As shown, a groove 213 is formed in the upper housing. Rotation of pin 210 aligns key block 210c with groove 213, allowing spring 214 to return and push pin 210 upward toward the mouthpiece end of the inhaler. The upper end of the pin will then be in a position that blocks the operation of button 207—the button is locked in the outward position and cannot be pushed inward. For the first embodiment as described above, pin 210 no longer contacts the extension 209 on the ring—the lower end or base of the ring has moved upward so that it is now above the top of extension 209. This helps ensure that the user cannot continue to manipulate the inhaler mechanism to create a "false" reset.

[0097] As can be seen, in this embodiment, pin 210 forms a blocking element.

[0098] Third Implementation Method

[0099] Figures 21 to 24 An inhaler with a life-end locking mechanism according to a third embodiment is shown.

[0100] The inhaler 300 of this embodiment has substantially the same components as the inhalers of the first and second embodiments, and operates in a substantially similar manner to deliver medication to the user. Identical or similar components are given similar designations in the manner outlined above.

[0101] In this embodiment, pin 310 extends along the side of the inhaler, such as Figure 21As shown. In this embodiment, the lower end of the pin includes a toothed gear 321. In use, the teeth of the gear 321 interlock with the teeth on the lower edge of the counting ring 306, such that rotation of the counting ring 306 drives rotation of the pin 310. Except for the smooth, unthreaded top of the pin, the upper portion of the pin is threaded 323. In use, a nut 322 is screwed onto the upper portion of the pin, and this nut is positioned at or near the bottom of the threaded portion (i.e., at the end of the pin facing the base of the inhaler). A coil spring 314 is positioned on the pin 310 such that when the nut is screwed onto the pin, the spring 314 is compressed, with its upper end pressing against the lower side of the nut 322. The pin and nut are configured such that the length of the unthreaded section is slightly greater than the height of the nut. In this third embodiment, the counting ring 306 and the pin 310 form a locking activation element.

[0102] In use, the inhaler operates in a manner similar to that outlined above—that is, the user “charges” or prepares the inhaler for use by twisting the upper and lower components of the housing relative to each other. This causes the counting ring to rotate stepwise or index. As the counting ring 306 rotates stepwise, this causes the pin 310 to rotate. As the pin 310 rotates, the nut 322 moves upward along the pin driven by the thread 323. When the user “charges” or prepares the inhaler 300 for use for a final dose by twisting the upper and lower components of the housing relative to each other, the nut reaches the end of the threaded section and “jumps” upward from the end of the pin driven by a spring. It can be seen that in this embodiment, the nut 322 forms a blocking element.

[0103] In other words, during normal use, button 307 can be pressed inward from the outer position into the housing to dispense a dose from the inhaler. However, in the "locked" or "end of life" position, nut 322 has been spring-driven upward, thus nut 322 now blocks button 307 from the outer position, and the button cannot be pushed into the housing, thereby preventing further use of the inhaler. That is, the button is blocked in the outer position by the blocking element (nut 322).

[0104] Fourth Implementation Method

[0105] Figures 25 to 33 An inhaler with a life-end locking mechanism according to a fourth embodiment is shown.

[0106] Same as the aforementioned implementation method, and as follows Figure 25 and Figure 26 As shown, the inhaler 400 has a housing 401 formed by an upper part 401a and a lower part or base part 401b, wherein the mouthpiece 402 is integrally formed with the upper housing part 401b.

[0107] The housing 401 surrounds the internal components of the inhaler, which include a counting ring 406 (in... Figure 32 (Shown separately). Similar to the previous embodiment, the counting ring 406 includes an annular element with a toothed upper edge, which is located inside the upper housing member 401a during use. The counting ring is positioned toward the lower end of the upper housing member and extends around the interior of the upper housing member 401a. The toothed upper edge of the counting ring engages with the worm gear 408 during use.

[0108] In use, the user "charges" or prepares the inhaler 400 for use by twisting the upper and lower components 401a, 401b of the housing 401 relative to each other. This twisting motion occurs about a central axis that extends substantially centrally and vertically from the top to the bottom of the inhaler 400. A worm gear 408 is connected to the housing and positioned such that this relative rotational motion causes the worm gear to rotate, which in turn causes the counting ring 406 to rotate and index once (i.e., the ring 406 rotates an arc length about its central axis from an initial position to a second position to count "one dose"). This movement of the counting ring 406 occurs with each relative rotational movement, wherein the counting ring 406 moves in the same direction each time, causing the counting ring 406 to rotate in steps.

[0109] like Figure 32 As shown, the counting ring 406 also includes an extension or arm 409 extending upward from the counting ring 406 at a point on the circumference. As the ring rotates, the arm 409 moves about the inner circumference of the housing and eventually contacts and interacts with the post or pin 410, as described below. In this fourth embodiment, the counting ring 406 and the post 410 form a locking enable element.

[0110] The preferred embodiment of column 410 is in Figure 27 , Figure 30 and Figure 31 The figures are best shown in the diagram. As shown in these figures, the upper housing component 401a is configured to receive the pin 410 in a recess extending from one side of the upper housing component 401a, such that the pin 410 is substantially parallel to the axis of the inhaler about which the upper and lower housing components rotate. The pin can move within the recess between an upper position or an upper position and a lower position or a lower position.

[0111] The post 410 includes an elongated body 410a having a hook-shaped lower end 410b. An extension or protrusion 410c extends outward from the body 410a toward the upper end of the body and is aligned with the hook-shaped lower end in substantially the same direction. In the lower position or a first position, the top surface of the protrusion 410c is positioned against a portion of the housing to hold the post 410 in place.

[0112] A channel 425 is formed in the upper end of the post 410, extending substantially axially from the top of the post into the post. In use, the post 410 is positioned on a receiving extension 430, which forms part of the upper housing member 401a within a recess in the upper housing member 401a and extends downward from the top of the recess, such that the post 410 is held in place but can rotate on the receiving extension 430. When the post 410 is in the lower position (e.g.) Figure 27 and Figure 30 As shown in the diagram, the channel extends below the lower end of the receiving extension 430, such that there is space within the channel to allow the post 410 to move upward on the receiving extension.

[0113] The upper end of the post 410 is formed with a blocking extension 410d, which extends inward from the top of the post. When the post 410 is in the lower position, the button 407 can move above the top of the blocking extension 410d, as shown in the reference. Figure 28 and Figure 29 As best illustrated. When the column 410 is in the upper position, the blocking extension 410d is positioned directly behind the button 407, preventing the button from being pressed inward or pushed to activate the inhaler. That is, the button 407 can be pressed inward into the housing from the outer position during normal use to dispense a dose from the inhaler, but in the "locked" or "end-of-life" position, the blocking extension 410d on the column 410 is in the upper position and blocks the button 407 in the outer position. The button 407 cannot be pushed into the housing, thus preventing further use of the inhaler. In other words, the button is blocked in the outer position by the blocking element.

[0114] In addition, pin 410 no longer contacts extension 409 on the ring—the lower end or base of the pin has moved upward so that it is now positioned above the top of extension 409. This helps ensure that the user cannot continue to manipulate the inhaler mechanism to create a “false” reset.

[0115] The coil spring 414 is positioned around the central body portion of the post 410. As shown in the figure, the inner top side of the coil spring 414 is positioned against the lower side of the protrusion 410c. The outer top side of the coil spring is free.

[0116] The lower end of the coil spring 414 is positioned against a bracket 436 within the upper component 401a. The lower end of the post 410 extends through an opening 437 within the bracket, wherein the hook-shaped lower end 410b hooks onto the underside of the bracket 436. The opening 437 is large enough that the lower end of the post 410 and the body (including the hook-shaped end 410b) can be assembled through the opening.

[0117] With the hooked lower end 410b hooked onto the bracket, the post 410 is held in a lower position, wherein the coil spring 414 is compressed. The asymmetrical arrangement at the top of the post 410 (where the inner side of the spring 414 is held downward by the protrusion 410c and the outer side moves freely upward) applies a lever force to the post 410, which tends to push the post 410 to engage the hooked lower end 410b with the bracket 436—that is, to push the hooked end 410b inward.

[0118] As the counting ring 406 rotates incrementally during use, at the end of its lifespan, the arm 409 on the counting ring contacts the hooked lower end 410b, which also serves as an interference extension or cam. At the end of its lifespan (final dose), the arm 409 pushes the hooked lower end 410b out of engagement with the bracket 436. Since the lower end is no longer held by the bracket, the coil spring 414 rebounds to push the post 410 upward, and the blocking extension 410d moves upward with the rest of the post 410, such that the blocking extension 410d terminates behind the rear of the button 407 to prevent the button 407 from being pressed by the user. As can be seen, in this embodiment, the post 410 forms a blocking element.

Claims

1. An end-of-life lockout mechanism for an inhaler of the type comprising a mechanical button operable by a user to press the mechanical button inwardly from an outward position to dispense a dose from the inhaler, the end-of-life lockout mechanism comprising: a blocking element configured to be positioned within a housing of the inhaler, the blocking element and the housing further configured such that the blocking element is movable from a first position or a first set of positions within the housing in which operation of the inhaler normally occurs to a second position; a lock enable element configured to be located within an outer housing of the inhaler, the lock enable element configured such that each single operation of the inhaler causes the lock enable element to stepwise move within the housing until, after a number of single operations, the lock enable element reaches a preset point and causes the blocking element to move to the second position; characterized in that the lock enable element and the blocking element are collectively configured to be positioned within the outer housing of the inhaler such that the mechanical button is blocked in the outward position by the blocking element in the second position.

2. The end-of-life lock mechanism of claim 1, wherein, the lock enable element comprises a ring.

3. The end-of-life lock mechanism of claim 2, wherein, the ring comprises a gear tooth.

4. The end-of-life lock mechanism of claim 2 or claim 3, wherein, the ring comprises an extension extending outwardly from the ring.

5. The end-of-life lockout mechanism of claim 4, further comprising a cam element configured to interact with the lock enable element when the lock enable element reaches the preset point and to connect with the blocking element to cause the blocking element to move to the second position.

6. The end-of-life lock mechanism of claim 4 or claim 5, wherein, the extension extends substantially axially outwardly from the ring.

7. The end-of-life lock mechanism of claim 4 or claim 5, wherein, the extension extends substantially circumferentially outwardly from the ring.

8. The end-of-life lock mechanism of any one of claims 1 to 7, wherein, the blocking element comprises a pin having an elongate body and a key block extending from the body.

9. The end-of-life lock mechanism of claim 3, wherein, the blocking element comprises a pin having an elongate body, one end of the body forming a gear tooth configured to interact with a gear tooth of the ring in use to cause the body to rotate when the ring rotates, the blocking element further comprising a moving element positioned on the body in use, the body and the moving element collectively configured such that the moving element moves along the body from one or more of the first positions to the second position when the body rotates.

10. The end-of-life lock mechanism according to any one of claims 1 to 6, wherein, the blocking element comprises a hooked lower end, the housing and the hooked lower end configured to inter-engage when the blocking element is in the first position or the first set of positions.

11. The end-of-life lock mechanism of claim 10, wherein, the blocking element further comprises a protrusion extending substantially outwardly from the body towards an upper end of the body, the protrusion aligned in substantially the same direction as the hooked lower end.

12. The end-of-life lock mechanism of any one of claims 1 to 11, wherein, the blocking mechanism further comprises a spring configured to operate to cause the blocking mechanism to move to the second position when the lock enable element reaches the preset point.

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