Inhaler with breath actuated dose counter

The present invention generally relates to pressurized metered dose inhalers and more particularly to a metered pressure metered dose inhaler having a breath activated delivery mechanism and dose counter.

2. Description of the Related Art [0002] Inhalers are commonly used to deliver a wide range of drugs to the bronchi, lungs, and user's bloodstream. Typical inhalers hold a container with a pressurized drug and an extrusion gas that can be activated, generally by squeezing, to deliver a dose of drug through the mouthpiece to the patient.

[0003] It is generally desirable that a dose of drug be dispensed at the same time as the patient inhales the air, so that most of the drug can enter the lungs instead of the mouth or esophagus.

Many inhalers have been developed that use breath-activated devices to automatically initiate drug release from the container as the patient inhales. Many of these devices, as in US Pat. No. 5,069,204 to Smith et al., Utilize latching mechanisms that require significant air pressure to release the drug. These high release pressures lead to difficulties during operation and release at the patient's respiratory cycle points that are not optimal. US Patent 5,119,806 discloses a dispenser with a holding device for preparing the release of a pressurized aerosol and a trigger catch for stopping the holding device in the rest position.

[0004] Document US2005 / 0028812 discloses an inhaler having an actuator comprising a triggering connecting member.

[0005] It is therefore an object of the present invention to provide a breath-activated inhaler that has a controllable force-sensitive release mechanism when inhaled by a user to provide synchronous air intake and drug delivery, optionally with a simple and reliable dose counter sensitive to release from the container with medicine.

BRIEF DESCRIPTION OF THE INVENTION [0006] An inhaler according to the appended claim 1 is provided. An apparatus for dispensing a first fluid provided from an external fluid source is provided, which includes a transducer adapted to receive the first fluid from a fluid source, wherein the first fluid is released into transducer when moving part of the fluid source along the first axis. The apparatus will generally have a loading member coupled to the fluid source to apply biasing force to the fluid source along the first axis.

[0007] The apparatus has a coupling coupling to the transducer and a fluid source, which connection has a folding joint that inhibits the movement of the fluid source in the first axis when the folding joint is oriented in the first position and allowing the fluid source to move in the first axis when the folding joint is oriented in second position. The apparatus further includes a movable element coupled to the connection, which

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The movable element is sensitive to the force exerted on the movable element upon inspiration, which in turn force on inspiration causes the movable element of the folding joint to move from the first position to the second position, thus allowing the fluid source to move in the first axis from the stowed position to the release position to release the first fluid into the transducer.

[0008] The movable element typically comprises a flap mounted pivotally to the transducer, the flap rotating in response to force upon inspiration. The flap is generally configured to rotate from a first orientation holding the folding joint in a first position to a second orientation allowing the folding joint to be moved to the second position by the force acting in the first axis. The device usually includes a flap spring coupled to the flap and a transducer to move the flap from the second orientation back to the first orientation after the inspiration disappears.

Preferably, the connection includes an upper connector and a lower connector, which upper connector and lower connector are pivotally attached to form a foldable connector, the first end of the lower connector being rotationally mounted in the transducer. The other end of the lower connector is coupled to the flap, and the mating surfaces of the lower connector and the flap are configured so that the lower connector contacts the flap to hold the foldable connector in the first position when the flap is in the first orientation. When the flap is in the second orientation, the bottom connector can move freely beyond the flap, which allows the folding joint to move to the second position. In a preferred embodiment, a reset spring is coupled to the lower connector to move the foldable connector from the second position back to the first position.

[0010] In another embodiment of the invention, the apparatus includes a dose counter coupled to the fluid source. Ideally, the dose counter is sensitive to the movement of the fluid source in the first axis to count each dose of fluid that is released from the fluid source.

[0011] In one embodiment, the dose counter further includes a first disk that has a plurality of teeth on its circumference, the plurality of teeth arranged to rotate the first disk in response to the fluid source moving along the first axis. Adjacent to the first disk is placed a second disk, which second disk has markings indicating the number of doses released from the fluid source. The first disk is preferably configured to engage the second disk so that the second disk rotates relative to the first disk in a scaled motion.

[0012] Further embodiments of the invention will be referred to in the following sections of the specification, the detailed description being intended to fully disclose preferred embodiments of the invention without limiting it.

BRIEF DESCRIPTION OF SEVERAL VIEWS IN THE DRAWINGS [0013] The invention will be better understood by reference to the following drawings provided for illustrative purposes only:

Fig. 1A is an explosion view of the upper part and dose counter

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Fig. 1B is an explosion view of the bottom of the device of Fig. 1A, together with the release mechanism.

Figs. 2A-C are perspective views of the outer casing of the embodiment of the inhaler of Figs. 1A-B in a fully assembled configuration.

Fig. 3A is a cross-sectional view showing in detail the release mechanism of the present invention in a stowed configuration.

Fig. 3B shows the device of Fig. 3A with the flap rotated due to the action of inspiration.

Fig. 3C shows the device of Fig. 3A with a folded elbow in a folded configuration and a drained fluid source.

Fig. 3D shows the device of Fig. 3A with the flap back in the retracted position and the folded elbow still in the folded configuration.

Fig. 3E shows the device of Fig. 3A with the release mechanism in a retracted configuration.

Fig. 4A is a perspective view of an embodiment of the flap.

Fig. 4B is a schematic cross-sectional view of the flap of Fig. 3A with the lower connector retained by the flap in a retracted configuration.

Figures 5A-B are schematic views of the flap and transducer.

Fig. 6A is a perspective view of an embodiment of the transducer.

Fig. 6B illustrates a schematic cross-sectional view of the transducer of Fig. 6A with the fluid source in a retracted configuration.

Fig. 7A is a cross-sectional view showing in detail the release mechanism in a retracted configuration and cut off by a dust cover to show the release mechanism.

Fig. 7B shows the device of Fig. 7A prior to breath activation, with the dust cover facing away from the mouthpiece and the release mechanism in a retracted configuration.

Fig. 7C shows the device of Fig. 7B with a release mechanism in a release configuration after breath activation.

Fig. 7D shows the device of Fig. 7B with a dust cover cam moving the release mechanism back to the retracted configuration.

Fig. 8A is a cross-sectional view of the device outer cover to show the dose counting mechanism of the embodiment according to the present invention in a retracted configuration.

Fig. 8B shows the device of Fig. 8A with the container sleeve partially shifted during release from the fluid source.

Fig. 8C shows the device of Fig. 8A with the container sleeve in a full release configuration.

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Fig. 8D shows the device of Fig. 8A with the container sleeve returning to the stowed position.

Fig. 10 shows an example of a dose counter disk.

Figures 11A-C show an embodiment of an indicator dial according to the present invention.

Figures 12A-E are schematic views of the dose counter dial and indicator dial in various count configurations.

Fig. 13 is a cross-sectional view of the membrane release mechanism.

Fig. 14 is a perspective view of an inhaler with a release mechanism over a fluid source. Fig. 15 is an explosion view of the device of Fig. 14.

Figs. 16A-D are schematic views of the device of Fig. 14 moved in its range of motion from the retracted position to the release position and back to the retracted position.

Fig. 17 shows the device of Fig. 14 with an electronic dose counter.

Fig. 18 shows the inhaler without part of the outer shell to show the release mechanism and mechanical dose counter with a vertically mounted indicator disc.

Figs. 19A-B show the mechanism for releasing the device of Fig. 18.

Figs. 20A-B show the dose counter of the device of Fig. 18.

Figs. 21A-F show an embodiment of the dose counter within one breath activation cycle.

Figures 22A and B are perspective views of the dose counter of Figures 21A-F.

Fig. 23 is a top view of the dose counter of Figs. 21A-F.

Figs. 24A-D show the movement of the breath activation mechanism using the trigger connector of the present invention.

DETAILED DESCRIPTION OF THE INVENTION [0014] Referring more specifically to the drawings, for illustrative purposes the present invention is implemented in an apparatus having a trigger connector shown in Figs. 24A to 24D. A valuable feature of the apparatus is that it can vary in configuration and part details without departing from the basic concepts disclosed here.

[0015] Figures 1A and 1B are an explosion view of the inhaler 20 with the breath activation assembly

100 and the dose counter assembly 130. The breath activation assembly 100 and the dose counter assembly 130 are located along the source of the medicament fluid 22 inside the front cover 42, back cover 44 and top cover 54, all of which preferably include plastic for medical purposes or other suitable materials known in the field. Fluid source 22 may include a container of a conventional pressurized metered dose inhaler (MDI) or other extrusion gas based drug available in the prior art. Fluid source 22 generally includes a container 108 holding the drug and extrusion gas mixture and a nozzle 110 that is in alignment with the release axis 86 of the container 108, as shown in Figure 6B. When container 108 is 4

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Extended relative to the nozzle 110 towards the release axis 86 (i.e., the nozzle 110 is pushed into the container 108), the drug is released from the nozzle 110 towards the release axis 86.

[0016] In Figs. 2A to 2C, the inhaler 20 is shown in an assembled configuration with a pivotally mounted dust cover 40 that is to cover the mouthpiece 58. The dust cover 40 can be turned away from the mouthpiece 58 to expose the opening 60, as shown in Fig. 2B. A manual release button 62 may also be attached to the rear cover 44, as shown in Figure 2C. The top cover 54 has an opening 56 to allow visual access to the indicator disc 52.

[0017] Referring also to Figures 1B and 3A to 3E, the breath activation assembly 100 includes a housing or transducer 32 that / which rotatably houses the lower connector 28 at the pivot axis 78. The lower connector 28 is connected at the folding connector 66 with top link 26. Reference may also be made to Figs. 5A-6B, in which the transducer is illustrated in more detail. The container holder 24 is shaped to receive the nozzle end of the container 108 so that the nozzle 110 extends up to the contact surface 112 of the transducer 32. The container holder 24 also has in the upper part of the upper connector 26 a pair of guides 122 which have slots 90 sized in terms of dimensions, to accommodate a pair of projections 92 as shown in Fig. 7A.

[0018] As shown in Figs. 3A to 4B, the flap 34 is pivotally mounted to the transducer 32 by means of a pin 98 that runs across the upper surface of the flap 34 and holes 114 in the side walls of the transducer 32. The bottom and side flaps of the flap 34 are selected are dimensionally compatible with the internal surface of the transducer 32 forming a gap 76. The flap 34 has an upper restraining surface 72 configured to hold the arm 74 of the lower connector 28 when the flap is in its nominal position shown in Fig. 4B.

[0019] As shown in Figs. 6A and 6B, the transducer 32 is configured to receive a fluid source nozzle 110 on the surface 112. The transducer also includes an inlet 106 that extends from the surface 112 to the first chamber 102. The inlet 106 is configured to to be in alignment with the nozzle 110 and the release axis 86 enabling the drug released from the fluid source 22 through the inlet 106 and further into the first chamber 102.

[0020] The transducer 32 is also configured to receive a plug 38 having a rugged surface 104. Fluid entering the chamber 102 through the inlet 106 is dispersed and redirected through the plug 38 and to the outlet 124, which ends at section 68 of the second chamber 64. Characteristics fluid dispersion for transducer 32 can be seen in more detail with reference to US Patents 4,972,830 and EP308524B.

[0021] The fluid source 22 is pressed to release along axis 86 by squeezing a loading element such as a pressure spring 48, between the upper lid 54 and the container sleeve 46, which is adapted to receive the other end of the container 108 opposite the nozzle 110. The compression spring 48 pre-loads the container 108 to slide it toward the surface 112 of the transducer 32 along the release axis 86.

[0022] In the retracted configuration shown in Fig. 3A, the fluid source container 108 is stopped before sliding along axis 86 by a folding connection including the top connector 26 and the bottom connector 28. The top connector 26 and the bottom connector 28 are pivotally coupled at the foldable connector 66 of type

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EP 1 962 933 B1. The upper end of the upper connector 26 has a pair of projections 92 that are held by a pair of slots 90 of the guides 122 in the container holder 24. The guides are generally aligned or at least parallel to the release axis 86 and allow the movement of the projections 92 (see Fig. 7A) the top link to slide up and down in the release axis 86 and allow the projection to rotate if necessary. One end of the bottom link 28 is attached to the transducer 32 at the pivot axis 78. As shown in Figure 3A, the projection 92 of the top link 26 and the pivot axis 78 of the bottom link are aligned substantially with the release axis 86, i.e. form a loading path, which is parallel or coaxial to the release axis 86. Because the folding joint 66 is eccentric, i.e. set away from the loading path formed by the projection 92 of the upper connector 26 and the axis of the joint 78, the downward force exerted in the retracted position by the pressure spring 48 on the container 108 predisposes the knee joint 66 to fold. The fold is held in the retracted position by applying the arm 74 of the lower connector 28 to the flap 34.

[0023] Fig. 3B illustrates the initiation of the breath activation mechanism 100 due to the patient's inspiration through mouthpiece opening 60. As shown in Figs. 3B-3C and 4A, an outward air flow 80 is created in the second chamber 64, which extends through a plurality of slots. 70 in the transducer. Air suction through slots 70 creates a small pressure difference 82 on the inner surface of the flap 34, whereby the flap rotates around the pin 98 and into the cavity of the transducer 32, as shown in Fig. 3A and 3B. The gap 76 between the flap 34 and the transducer 32 provides sufficient clearance to allow the flap to rotate into the recess of the transducer, and at the same time is small enough to allow a pressure difference with minimal suction through the mouthpiece. As the flap 34 rotates, the arm 74 of the lower fastener 28 is no longer held by the upper surface 72 of the flap and the arm 74 descends from the flap 34 through the cavity 88, and the lower fastener 28 has the ability to pivot around the pivot axis 78.

[0024] With the rotation of the lower connector 28 shown in Fig. 3C, the folding connector 66 moves past the center, allowing the container holder 24 and container 108 to move down along the axis 86, pushing a portion of the nozzle 110 into the container 108 to promote drug release from the container 108 The drug flows through the first chamber 102 and into the second chamber 64, where it is entrained with the air flowing through the slots 70, as described in more detail in US Patent 4,972,830. In the embodiment shown, the second chamber 64 has an internal cross-section shaped like a parabola. The entrained drug flows through the second chamber 64 and exits through mouthpiece opening 58 to be drawn in by the patient. In this way, the release of the measured dose of the drug is synchronized so that it is drawn in by the patient at the optimal time at the inspiration stage of the patient's respiratory cycle.

[0025] After the patient draws the dose, the flap returns to its nominal position shown in Fig. 3D due to the return force of the flap spring 36. The flap spring 36 is a metal rod or wire mounted between the retaining arms 96 of the transducer 32 and the collar 94 on the flap 34 Rotation of the flap results in spring deflection to generate a return force restoring the nominal position of the flap 94 after the forces disappear when inhaled.

[0026] The upper and lower connectors 26, 28, the container holder 24 and the container 108 remain in the folded release position shown in Fig. 3D due to the force exerted by the biasing spring 48. Return

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In order to cover the mouthpiece 58, the dust cover 40 (described in more detail with reference to Figs. 7A-7E below) manually forces the container handle 24 and container 108 to return to the hidden position under pressure of the pressure spring 48. Mounted on the lower connector 28 there is a torsion spring return 30, which is intended to engage the transducer 32 so that a torsional force is exerted on the folding connection forcing it to return to the locked configuration. In this way, the foldable joint 66 is prevented from folding when the dust cover 40 is re-opened.

[0027] Referring to Figs. 7A-7E, the operation of the dust cover 40 will now be described. In this embodiment, the dust cover 40 serves not only as a cover covering the mouthpiece entrance 60, but also serves to re-position the container in a retracted position after releasing the drug. Fig. 7A shows the inhaler 20 in a retracted configuration with a dust cover 40 covering the mouth 60 of mouthpiece 58. The dust cover 40 is pivotally connected to the transducer 32 so that it can be pivoted to allow access to the mouthpiece opening 60. Alternatively, the dust cover may be pivotally connected to the front or rear cover 42, 44. The dust cover 40 has two cams 120 that are configured to engage the bottom surface of the guides 122 of the container holder 24 throughout the entire range of movement along axis 86. When the dust cover 40 is rotated about the axis 118 (shown in Fig. 7B), the cams disengage from the guides 122. The container holder 24 and container 108 remain in the retracted position relative to the orientation of the folded connection off center.

[0028] Fig. 7C shows the breath activation assembly 100 in a collapsed configuration with the container handle 24 and the container 108 in the release position. To remain in this configuration, the breath activation assembly 100 is compressed by a compression force from the compression spring 48. When the dust cover is rotated back toward mouthpiece opening 60, as shown in FIG. 7D, the cams 120 engage the bottom surface of the guide 122, pushing the container handle 24 and container 108 up along the axis 86. When the dust cover 40 is in its final retracted position, covering the mouthpiece entrance 60, the container handle 24 is pushed through the cams 120 to the stowed position as shown in Fig. 7A. In this configuration, the breath activation assembly 100 has been returned to the locked position by means of the return spring 30 and the movement of the container 108 will be stopped by the cams of the dust cover regardless of the folding connection.

[0029] The inhaler 20 preferably includes a dose counter for automatically counting the doses remaining in the container after each drug release. The inhaler can be configured with a dose counter having many different configurations, including mechanical or electrical counters. Operation of the preferred embodiment using the mechanical dose counter assembly 130 will be described with reference to Figures 8A to 12E.

[0030] Fig. 8A shows the inhaler 20 with the dose counter assembly 130 configured above the container sleeve 46. The container sleeve 46 is sized to receive the non-dispensing end of the container 108. The container sleeve preferably has one or more tabs 132 having a projection 136 configured to mate with the teeth of the first disk 50 located just above the container sleeve 46. The embodiment shown in Figure 9 has two tabs 132 and projections 136. However, a valuable feature is that any number of tabs and protrusions can be realized.

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[0031] Returning to Fig. 8A, the first disk 50 is a gear rotatably mounted in a horizontal orientation to the top cover 54. The disk 50 has a plurality of lower teeth 140 and upper teeth 138 located on the outer diameter of the disk 50.

[0032] In a preferred embodiment, the indicator disc 52 is also pivotally mounted on the top cover 54 in a horizontal orientation between the first disc 50 and the top cover. Indicator disk 52 has an opening 154 to provide space for column 142 of first disk 50 that is positioned vertically to mount top cover 54. Indicator disk 52 has markings 150 to indicate the number of doses remaining in container 108 based on the position of indicator disk 52 . As shown in Figures 2A and 2B, the markings 150, which show in the opening 56 of the upper lid 54, indicate the number of doses remaining.

[0033] Figs. 8A-8D show the interaction between the container sleeve 46 and the first disk 50 when releasing fluid from the fluid source 22. When the container 108 is in the retracted position, the projection 136 is positioned on the periphery of the disk 50 between two of the upper teeth 138. As the container 108 and the container sleeve 46 slide down along the release axis due to the breath activation mechanism, the projection 136 contacts the upper slope of one of the lower teeth 140, as shown in Figure 8B. The projection 136 continues its movement along the axis 86 forcing the first disc 50 to rotate clockwise (viewed from above) until the container 108 reaches the release position, as shown in Fig. 8C. When the dust cover 40 is closed so that the container 108 returns to the retracted position, the projection 136 moves up until it contacts the lower slope of the upper tooth 138, as shown in Figure 8D. The projection 136 continues its upward movement, forcing the disc 50 to further turn clockwise until the container 108 reaches the retracted position, as shown in Fig. 8A. With the next dose, the cycle is repeated.

[0034] The lower disk 50 can be configured to change the number of doses required to rotate the lower disk 360 degrees by changing the number of teeth. In the above embodiment, a division into 40 teeth was used. However, this number can be changed depending on the number of doses contained in the container.

[0035] Figs. 12A-12C show the interaction between the indicating dial 52 and the lower dial 50. As shown in Figure 10 and indicated by the dashed line in Figures 12A-12C, the lower dial 50 has a drive pin 144 located on the upper surface of the lower dial. The indicator disk 52 has a plurality of semi-circular pickup pins 152 located on the bottom surface of the indicator disk. When the first disc rotates around the column mount 142, the drive pin 144 engages the first of the receiving pins 152 and causes the indicator disc 52 to rotate around the mount 156 and by a specified distance along the mark 150, which specific distance indicates the range of remaining doses (e.g. "Full 200 to 160") (see Fig. 12A). Within the rotation portion of the first disk, the drive pin 144 slides along the first of the pickup pins 152 (see Fig. 12B) and continues to complete one complete turn (40 doses) until it contacts the other of the receiving pins 152 (Figure 12C). The cycle is repeated until all the receiving pins 152 are used and after giving the specified number of doses in the window 56 the indicator "EMPTY" will appear.

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[0036] The meshing effect shown in Figs. 12A-C is intended to scale the movement of the indicator disk 52 relative to the first disk 50. To change the scale of the movement, one or more additional drive pins may be provided on the upper surface of the first disk 50. 144. For example, 180 degrees relative to the first, a second drive pin may be arranged so that the indicator dial moves twice as fast as the first container dial with a total of 100 doses.

[0037] Fig. 13 shows an alternative inhaler with an activated breath releasing mechanism 200 using the membrane 202 instead of the flap 34 shown in Figs. 1-7E. Diaphragm 202 is configured to be mounted to transducer 204 and dimensioned so that part of the diaphragm deflects in response to forces when the patient inhales. The release mechanism 200 further includes a latch 204 coupled to the membrane and bottom link 208 to maintain the foldable connection of bottom link 208 and top link 210.

[0038] In use, forces upon inspiration of the patient deflect a portion of the membrane communicating with the latch 204. Movement of the latch 204 allows the bottom connector 208 to pivot past the latch, thereby allowing the 208/210 connection to fold and release fluid from the fluid source 22.

[0039] Figures 14-17 show another alternative inhaler 300 with a loading lever 302 and an activated breath release mechanism 350 on a fluid source 22. By placing the release mechanism over the MDI inhaler reservoir, the mechanism can be used for any MDI inhaler actuator with minimal modifications of the form. The inhaler 300 has a bottom portion 304 housing a fluid source 22 and a transducer (not shown) for dispensing the drug. The middle body 308 cooperates with the bottom portion 304 and slidably covers the plunger 318 to selectively move the fluid source 22 down to release the drug.

[0040] The plunger 318 is restrained from movement relative to the central body 308 by a folding connection comprising a lower link 320 and an upper link 322. The plunger 308 is also configured to receive a compression spring 312 at its upper end. The compression spring 312 is shaped to receive a spring cap 310 that can be depressed to press the spring 312 against the plunger 318 in the release direction, downward, as shown in Fig. 16A. To push the spring attachment 310, the loading lever 302 is pivotally attached to the upper cover 306 so that the rotation of the loading lever 302 in vertical orientation pushes the spring attachment 310 downward to push the plunger and release fluid from the fluid source 22.

[0041] The movement of the folding connector 320 and connection 320/322 is limited by the flap 316. The flap 316 is pivotally mounted so that inspiratory forces cause it to rotate as shown in Fig. 16B, which allows the bottom link 320 to rotate downward in such way that consists of a 320/322 connection. The biasing force from spring 312 pushes the plunger down as shown in Fig. 16C. The loading lever 302 is then reset to the first position, allowing the fluid source 22 to be moved back to the stowed position shown in Fig. 16D.

[0042] Fig. 17 shows an inhaler 300 comprising an electronic dose counter 324. In this configuration, the flap 316 is coupled to a trigger 326 that presses the sensor in the dose counter 324 each time the flap is triggered to deliver a dose of drug. The 324 dose counter generally includes a printed circuit board (PCB) and other electronic components such as an LCD display to digitally display the number of doses. Alternatively 9 may be included in inhaler 300 instead

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The mechanical dose counter, largely in the same manner as in the inhaler disclosed in Figs. 9-12 or Figs. 21A-23.

[0043] Figures 18 to 20B show an embodiment of the present invention with an inhaler 400 having a mechanical dose counter 420 that has a vertically mounted disc 422. The inhaler 400 has a loading lever 402 that manually presses the fluid source 22 releasing fluid as it moves downwards.

[0044] As shown in Fig. 19A, the release of fluid from the fluid source 22 is inhibited by a folding fitting 416, which is formed by connecting the upper connector 406 and the lower connector 408. The lower connector is coupled to the horizontally oriented flap 410. Forces by inspiration through mouthpiece 404 causes air to flow through port 412 into the negative pressure chamber 414, so that negative pressure acts on flap 410 and forces flap 410 downward as shown in Fig. 19B. With the folding adapter 416 moved away from the locked position, the fluid source can move freely down and release the drug.

[0045] Figures 20A and 20B show an alternative embodiment using a dose counter 420 with a vertically oriented indicator disc 422. The container sleeve 426, adapted to receive the non-dispensing end of the container 22, has a plurality of projections 434. When the container slides down when fluid is released, moving the container sleeve 426 results in the projections 434 impacting the teeth 432 of the gear 424 ( gear, larger gear), which forces the gear 424 to rotate clockwise. Clockwise rotation of gear 424 engages the vertically oriented gear 430 (sprocket, chain sprocket, smaller gear) of the index disc 422, so that the index disc 422 rotates. The gear 430 may be configured to engage the gear 424 at predetermined intervals to change the rotation speed of the indicator disc 422 relative to the rotation speed of the gear 424.

[0046] Figures 21A-F show another preferred embodiment of the dose counter mechanism 450. The mechanism 450 includes a reservoir sleeve 46 that is pivotally limited but is able to slide axially with the reservoir of the MDI inhaler, as well as the rotatable top link 452. The upper link 452 is coupled to the gear column 468 so that the gear column 468 rotates incrementally as the upper link rotates. In fig. 21A mechanism 450 is in the ready state (before breath activation), with the tank sleeve 46 in the upper end position. The tank sleeve 46 has a plurality of teeth 456 that are shaped to fit the teeth and lock the teeth 454 of the upper link 452. In other words, both the teeth 456 and 454 have opposingly inclined surfaces, which prevents rotation of the upper link 452 relative to the tank sleeve 46 when coupling. When the reservoir 22 of the MDI inhaler (shown in Fig. 1B) is activated, the reservoir sleeve 46 and upper adapter 452 move downward.

[0047] On the upper link 452, a compressive load is generated from the counter spring 462, which is located between the indicator disc 464 and the upper link 452. The counter spring holds together the upper link 452 and the reservoir sleeve 46, ensuring engagement of teeth 456, 454. Used any other suitable elastic pressing means such as a compressible rubber element may also be left. The top link has multiple radial projections or on its circumference

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EP 1 962 933 B1 to the grooves 460, which are arranged and dimensioned so as to match the columnar teeth 458 of the bottom of the lid 466. The bottom of the lid 466 can be associated or integrated in the upper lid 470 (shown in Fig. 22) or an element shielding so that during movement of the reservoir and upper connector 452 the teeth 458 remain stationary. As the reservoir sleeve 46 and the upper connector slide down, the opposite sloping surfaces of the groove 460 and the bottom of the lid 466 engage so that the upper connector 452 separates from the reservoir sleeve 46, and the teeth 456, 454 can partially diverge and move relative to each other. The upper connector 452 thus gains the possibility of rotation relative to the tank sleeve 46. The opposingly inclined surfaces of the groove 460 and teeth 458 can now slide on each other, resulting in a rotation of the upper fastener by 4.5 °, as shown in Fig. 21B.

[0048] In Fig. 21C, the reservoir sleeve 46 continues to move downward without further rotation, while the inlets of the upper connector enter between the columnar teeth 458 of the bottom of the lid 466. When the reservoir sleeve 46 comes to the very bottom, as shown in Fig. 21D, it reflects starts and moves towards its original position in the ready state, while pushing the upper link 452. At this stage, the teeth of the upper link teeth 454 have passed beyond the teeth of the tank sleeve 456 of the barrel 46. Further rotation of the upper connector 452 is prevented from engaging the key 460 and teeth 458. As the barrel of the reservoir 46 moves further up, the key 460 moves away from the teeth 458 of the bottom of the lid 466, as shown in Fig. 21E. Then the teeth 456 of the reservoir sleeve 46 again fully engage with the teeth 454 of the upper connector 452, whereby the upper connector 452 rotates a further 4.5 ° clockwise as shown in Fig. 21F. This completes the full activation cycle of the MDI inhaler tank and the indexing mechanism is rotated by a total of 9 °. The upper link 452 of the indexing mechanism has shifted 1/40 full turn to activation.

[0049] In Fig. 22A, the dose counter mechanism 450 is mounted on the breath activation assembly 100 (see Fig. 1B). The upper lid 470 surrounds the reservoir sleeve 46 shown in Fig. 22B with the upper lid 470 removed for clarity. The upper lid has a window 472 in which the number of doses is shown, which is provided by the indicating disc 464. The indicating disc 464 has a scale 474 showing the number of doses remaining from 0 to 200 in increments of ten (e.g. designations 200, 190, 180, etc.).

[0050] Fig. 23 shows the upper part of the top cover 470 cut off and without a scale 474 to show the planetary gear mechanism 478. The indicator disc 464 is pivotally coupled to the gear column 468 via three intermediate gears 476. Three intermediate gears 476 of the gear mechanism planetary 478 are driven by rotation of the central toothed column 468. The teeth of the three intermediate gears 476 adapt to the inner toothed surface of the top cover 470 so that the indicator disc 464 rotates clockwise. When the central toothed column 468 rotates due to the movement of the indexing mechanism by 9 °, the planetary gear rotates the indicator disc by 1/10 of the scale. The scale is prepared for a resolution of 10 doses per indication, although this can be changed to reflect other increments. After 200 activations, the scale will move completely by 260 °, going from "200" to "0" or "Empty".

[0051] The planetary gear mechanism 478 scales the rotational movement of the upper link 452 and the gear column down so that the indicator disc can rotate at 200 activations less than

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EP 1 962 933 B1 one full turn. For a smaller number of doses (e.g. 60 or 120 dose reservoir), the indicator disc can be positioned simply so that the correct number is indicated through the window 472. Alternatively, to adapt to a different total number of doses, with a change in scale 474, a different number of teeth can be realized in the planetary gear mechanism 478.

[0052] Referring to Figs. 24A-D, an embodiment of the present invention is a breath activation mechanism 500 that includes a trigger connector 502 to increase the operating range of the previously described breath activation mechanism 100 shown in Figures 3A to 4E.

[0053] Fig. 24 shows the breath activation mechanism in the ready state (not activated, but loaded). Instead of working with the flap 34 directly, the lower connector 504 interacts with the flap 34 indirectly through the trigger connector 502. The upper connector 506 and the bottom connector 504 stop the fluid source 22 and the load F from the pressure spring through the locking knee joint 66. The knee joint 66 is eccentric relative to load F in the release axis 86 (i.e. the release axis 86 passes through the axis of the joint 78 and the projection 516 of the upper connector 506 as in Figs. 24A-D), whereby the downward force exerted by the biasing spring 48 on the container 108 in the ready position predisposes the knee joint 66 to fold.

[0054] The top link 506 and bottom link 504 are prevented from rotating or folding due to blocking the bottom link 504 from rotating through the latch or trigger edge 510 in the trigger link 502. The trigger link 502 is locked against rotation due to collision of the upper surfaces (contact surface) 512 Trigger connector 502 with the bounding surface or round cutout 514 in the flap 508.

[0055] Referring now to Fig. 24B, when the flap 508 rotates due to the force generated by the patient's inspiration (negative pressure), the upper edge 512 of the trigger connector exits from the notch 514, which allows the trigger connector 502 to rotate clockwise. Trigger edge 510 rotates accordingly to free contact surface of lower link 504.

[0056] With the now unrestricted bottom link 504, as in Fig. 24C, the knee joint 66 folds and moves to the left. Due to the connection of the upper edges of the upper fastener 506 with the container holder 24, the upper fastener can only slide in line with the load force path F, and the trigger fastener 502 rotates further clockwise, so the lower fastener 504 turns further counterclockwise.

[0057] Referring now to Fig. 24D, the mechanism further folds as the lower link 504 continues to turn counterclockwise on the connector 78, 26 slides down, allowing the MDI inhaler reservoir 22 to slide down and activate valve stem.

[0058] After activation, the reservoir slides up so that the knee joint moves back to the retracted orientation, with the lower connector rotating clockwise to the trigger connector 502. The trigger connector 502 is able to catch the bottom connector 504 trigger edge 510 to stop knee joint 66 for subsequent breath activation of flap 508.

VP / 3226 / AGR

[0059] By adding the trigger connector 502 to the previously described embodiments, the scope of cooperation of the bottom connector 504 with the flap 508 is extended, which improves the overlap of trigger edges and increases the production tolerances while maintaining the sensitivity of breath activation.

[0060] The addition of a trigger connector 502 extends, in particular, the extent of cooperation of the bottom connector 504 with the flap 508 in such a way that when the inhaler is in the ready state, it is less prone to accidental activation due to sudden movement or vibration of the inhaler causing unintentional rotation of the flap 508. Referring to Fig. 24A, it can be seen that the degree of overlap of the cutout surface 514 and the upper contact edge 512 is sufficient for the flap 508 to rotate a considerable distance without releasing the trigger connector 502, which allows the knee joint 66 to fold. Because the mating surfaces 514, 512 have a cylindrical shape with a concentric curvature, the contact area of ​​the flap 508 and the trigger connector 502 remains comparatively large until just before releasing the trigger connector 502. This also makes it difficult to accidentally activate the inhaler.

[0061] Additionally, after activation, the reservoir moves up and the lower connector 504 engages with the trigger connector 502. The end 520 of the lower connector 504 engages with the portion 522 of the trigger connector 502 and pushes the trigger connector 502 so as to rotate said connector 502 in the opposite direction clockwise (Fig. 24D). As the trigger switch 502 rotates, the tab 508 can be guided along a curve along the surface 524 of the trigger switch 502. Surface 524 is configured with respect to the axis of rotation of the trigger connector 502 in such a way as to engage with the flap 508 so that rotation of the trigger connector 502 is not prevented by engaging the tab 508 with it. The arrangement of the surface of the trigger connector 524 may be such that said surface is cylindrical, with the center of curvature consistent with the axis of rotation of the trigger switch 502. In this way, when the trigger switch 502 rotates counterclockwise (as seen in Fig. 24), the coupling between the flap 508 and the surface 524 of the trigger switch is such that the flap 508 does not rotate by itself. However, the surface 524 can be positioned so that when the trigger switch 502 is turned counterclockwise, the surface 524 allows the curve 508 to be guided back to the ready position. It should be understood that the surface 524 facilitates the return of the connection and the flap 508 to the standby position and ensures that the flap 508 does not prevent the connection from moving back to that position. In the arrangement shown in Fig. 24 surface 524 is on trigger 502 adjacent upper edge 512.

[0062] As the bottom connector 504 pushes the trigger connector 502 counterclockwise, the end 520 of the bottom connector 504 follows a curve into the groove 526 defined in part by the trigger edge 510.

[0063] Although the above description contains many details, they are not to be construed as limiting the scope of the invention, but only as illustrating some of the currently preferred embodiments of the invention. A valuable feature, therefore, is that the scope of the present invention fully encompasses other embodiments that may be apparent to those skilled in the art, and the scope of the present invention is not to be suitably limited by anything but the appended claims.

VP / 3226 / AGR

EP 1 962 933 B1