Abstract:
A medicament dispenser, in particular a metered dose inhaler, which is able to count the number of time the dispenser is activated and then disable the device, which then prevents any additional medicament from being dispensed. Additional embodiments include a medicament dispenser which are adapted to display either the number of activations that have occurred or the number of activations remaining.

Description:
This application is a continuation of U.S. patent application Ser. No. 12/387,867, filed May 7, 2009 which claims priority under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 61/126,855, filed May 7, 2008, which are hereby incorporated by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention described herein relates to the field of drug delivery. More specifically, the present invention relates to an inhaler and a method for delivering doses of aerosolized medication for inhalation by a patient into the lungs which incorporates a dose counter component having a lockout feature and a method for counting the number of drug doses in an inhaler and inactivating the inhaler, so that no more drug can be delivered, when a predetermined number of doses have been delivered. 
     BACKGROUND OF THE INVENTION 
     Aerosols are increasingly being used for delivering medication for therapeutic treatment of the lungs as well as systemic delivery of therapeutic agents. For example, in the treatment of asthma, inhalers are commonly used for delivering bronchodilators such as β 2  agonists and anti-inflammatory agents such as corticosteroids. Two types of inhalers are in common use, pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs). Both types of inhalers have as their object the delivery of medication (which is typically in the form of a solid particulate or powder) into the airways of the lungs at the location of the condition being treated or for systemic delivery. 
     In a traditional pMDI device, the medication is provided in a pressurized aerosol canister, with the medication being suspended or dissolved in a liquid propellant such as a chlorofluorocarbon (CFC) or hydrofluoroalkane (HFA). The canister includes a metering valve having a hollow discharge stem which can be depressed inward against an internal spring. Once the discharge stem is fully depressed into the canister a metered volume of propellant-medication mixture is discharged through the stem. The discharge is in the form of an aerosol comprising fine droplets of propellant in which particles of the medication are suspended or dissolved. A typical pMDI for use with such a canister includes a housing having an actuator and a nozzle. The canister is inserted into the housing with the hollow discharge stem of the canister being received in a bore in the actuator. Depressing the closed end of the canister causes the stem to be pushed inward into the canister so that a metered volume of medication is discharged through the nozzle. The housing further defines a flowpath in fluid communication with the nozzle, with the flowpath having an outlet at a mouthpiece portion of the housing, such that the aerosolized medication may be inhaled after it exits the mouthpiece portion. The patient either inserts the mouthpiece into the mouth with the lips closed around the mouthpiece, or holds the mouthpiece at a slight distance away from an open mouth. The patient then depresses the canister to discharge the medication, and simultaneously inhales. 
     In the field of inhalers, it is known to use a dose counter for tracking and/or displaying the number of doses that have been dispensed or that remain to be dispensed from the inhaler. Such conventional counters are generally incremented each time a drug dose is expelled by the inhaler. 
     In addition, there exists a need to inactivate the inhaler in order to prevent a patient from delivering more than the required number of doses. For standard pills or tablets, only the actual number of doses prescribed by the physician are dispensed by the pharmacist. For an inhaler the problem is far more complicated. It isn&#39;t practical to limit the number of doses by limiting the amount of propellant/drug in the canister because then the last few actuations of the inhaler would only deliver a partial dose. Thus there is a need to be to able to inactivate the inhaler while there is still sufficient content in the canister to provide for the full amount of drug delivery for each of the actuations of the inhaler. 
     In addition it may be difficult from a manufacturing perspective to properly fill the canister with a de minimus amount of medicament. Thus from a quality control perspective, it is better to fill the canister with an amount that permits reproducible filling and then limit the number of doses by use of the counter/lockout mechanism of the present invention. 
     The disclosed invention was developed to correct the above-described problem. The disclosed invention of a dose counter/lockout mechanism is shown incorporated into an inhaler having a pMDI medication canister, a synchronized breath-actuated trigger, and a flow control chamber. However, the disclosed dose counter/lockout mechanism could be incorporated into a inhaler in which the canister actuation is done manually. 
     Furthermore, the disclosed inhaler includes a dose counter that increments only after an actual delivery of drug from the medication canister as occurs when the canister is depressed beyond a certain point. Upon reaching a predetermined number of actuations two things occur. One is that the dose counting wheel can no longer be incremented. Secondly, a spring assembly, which needs to be cocked (i.e. compressed) in order to depress and therefore discharge medicament from the canister, is disengaged from the rest of mechanism and therefore can&#39;t be compressed and therefore can&#39;t cause the medicament canister deliver a dose. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention described herein involves an actuation counter/lockout mechanism which disables a device after a predetermined number of mechanical actuations have occurred. Though described herein as being a component of a pressurized metered dose inhaler, the invention could be a component in any type of mechanical device which can cause a movable carriage to be translated. For example, the device might be used in conjunction with a device which delivers sugar pills to experimental lab animals and would be deactivated after the animal has triggered the device a predetermined number of times. The following descriptions, discussions and drawings will be directed to the invention being incorporated into a specific class of device—that of a pMDI. However, it will be understood by one skilled in the art that this is only one of many possible types of mechanical devices that could incorporate the invention. 
     The present invention also includes a method for counting and displaying the number of actuation cycles of a pMDI. Furthermore, the method may include a deactivation step which prevents the inhaler from being able to actuate the pMDI canister. 
     The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings. The detailed description and the drawings are merely illustrative of the invention rather than limiting the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and configurations shown. 
         FIGS. 1A-1D  depict in diagrammatic form the general operation of a prior art inhaler. 
         FIGS. 1E-1H  depict in diagrammatic form the dosage counter/lockout invention. 
         FIG. 2  is an external perspective view of one embodiment of the inhaler. 
         FIG. 3  is another external exploded perspective view of an embodiment of the inhaler. 
         FIG. 4  shows four perspective views of the Cradle of the present invention. 
         FIG. 5A  is a perspective view of a pMDI canister disposed within the Cradle of the present invention. 
         FIG. 5B  is an exploded perspective view of the pMDI canister and Cradle shown in  FIG. 5A ; 
         FIG. 6  is an exploded view of the Cradle and Manifold of the present invention. 
         FIG. 7  is an exploded perspective view of the Manifold showing several of the breath actuation components. 
         FIG. 8A  is an exploded perspective view of the Manifold and the Cocking Lever Retainer. 
         FIG. 8B  shows Cocking Lever Retainer positioned on the Manifold. 
         FIG. 9  is an exploded perspective view of the Cocking Lever Retainer and the Counter Wheel. 
         FIG. 10  is an alternative exploded perspective view of the Cocking Lever Retainer and the Counter Wheel. 
         FIG. 11  is an exploded view of the Spring Assembly. 
         FIG. 12  is a perspective view of internal Spring Assembly. 
         FIG. 13  is an alternate perspective view of Spring Assembly. 
         FIG. 14  is a perspective view of Spring Assembly disposed within the Cradle. 
         FIG. 15  is a perspective view of the Cocking Lever. 
         FIG. 16  is an alternate perspective view of Cocking Lever. 
         FIG. 17  is a perspective view of Cocking Lever, Cradle and Cocking Lever Retainer. 
         FIG. 18  is a cutaway view showing Cocking Lever in a partially elevated position. 
     
    
    
     I. DIAGRAMMATIC DEPICTION OF THE DOSAGE COUNTER-LOCKOUT 
     The diagrams shown in  FIGS. 1A-1H  are meant to provide a general functional explanation of how the dosage counter/lockout features works. Initially a description of the general operation of an inhaler without the dosage counter/lockout mechanism is shown in  FIGS. 1A-1D  and described below. The reference numbers below for  FIGS. 1A-1H , do not match the reference numbers used in  FIGS. 2-18 . 
       FIG. 1A : Cradle  53  holds the Canister  55  which has projecting from the canister, a hollow spring loaded Canister Stem  57 . Canister  55  is pressurized with a propellant containing a medicament, usually as a solution or a particulate suspension. When Canister Stem  57  is depressed and pushed against the spring pressure into the body of Canister  55 , a measured aliquot of the canister contents are expelled under pressure of the propellant out of the hollow Canister Stem  57  and into the inspired airflow caused by the patient breathing in through the Inhaler Body  50 . 
     Cradle  53  is rigidly attached to Spring Assembly  59 . Cradle  53  is slideably attached to Inhaler  50  but limited in its downward direction via Cradle Latch  52 . Cradle Latch  52  can be deactivated by various means which then allows Cradle  53  to slideably move along Inhaler Body  50 . Cradle Latch  52  can be designed to uncouple in response to air flow through the Inhaler  50  caused by a patient breathing in through the Inhaler Body  50 . Instead of being breath actuated, Cradle Latch  52  can alternatively be designed to be activated manually which means the patient must coordinate the inspiration of a breath with the manual activation of Cradle Latch  52 . 
       FIG. 1A  depicts what is considered to be the Reset or Resting configuration. Cam  63  is pushing against Reset Arm  67  which is holding Cradle  53  and Spring Assembly  61  in the fully upward position such that Cradle Latch  52  can be positioned in the engaged position. 
     In  FIG. 1B , Cam  63  has rotated such that it is now pushing on Spring Assembly  59 . And because Spring Assembly  59  is fixedly attached to Cradle  53 , Cradle  53  is biased slightly downward and is held in place by Cradle Latch  52 . Because the Moving Assembly (Spring Assembly  59 , Cradle  53 , and Canister  55 ) is held in position, the springs in Spring Assembly  59  are compressed as shown by the box representing Spring Assembly  59  being shown smaller in size. 
       FIG. 1C  shows the configuration after a patient has actuated Cradle Latch  52  either manually or by drawing in a breath which causes Cradle Latch  52  to uncouple and allows the Moving Assembly to be biased downwards by the expansion of the compressed springs. 
     Cradle  53  is configured to bias Canister  55  downwards which forces Canister Stem  57  to be biased against Stem Retainer  54 . As a result of being biased against Stem Retainer  54 , Canister Stem  57  is displaced into Canister  55 , which causes a measured aliquot of medicament to be discharged from the canister as discussed above. 
     After the dose of Medicament  69  has been discharged, Cam  63  is rotated back to the reset or rest position as shown in  FIG. 1D . The lobe on Cam  63  biases Reset Arm  67  upward, which in turn biases Moving Assembly back to its upward position. With the Moving Assembly located in its highest upward location, Cradle Latch  52  is then automatically reset. 
     Now the device is ready for the next actuation cycle. In practice, Cam  63  is attached to a Cocking Lever which also functions as mouthpiece cover which is positioned in the closed position in  FIG. 1A  and  FIG. 1D  (Reset Position) and rotated to the open position in  FIG. 1B  (cocked position) and FIG. C (discharged position). 
     When the patient picks up the inhaler, the cover is closed and all components are as shown in  FIG. 1A . The patient rotates the cover to the fully open position, which makes the inhaler available for use and which rotates Cam  63  and configures the device as shown in  FIG. 1B . With the cover open, the patient draws in a breath, actuates the breath actuated trigger which then allows the medicament to be dispensed into the air stream that is being drawn into the lungs by the patient. During medicament delivery the Inhaler is in the configuration shown in  FIG. 1C . 
     When the inhalation and medicament delivery are finished, the patient rotates the cover closed, which causes Cam  63  to be rotated back to its reset position which places the device in the configuration shown in  FIG. 1D , which is in fact the same as  FIG. 1A . When Cradle  53  is placed in the upper position, by the rotation of Cam  63 , pressure is removed from Canister  55 . The Canister Stem is then pushed back out by the action of the compressed spring(s) in Canister  55  which causes Canister  55  to move back to its reset position. 
     II. DOSAGE COUNTER—DIAGRAMMATIC DEPICTION OF FIRST COMPONENT OF THE INVENTION 
     The additional inventive components of the dosage counter lock out functions are now discussed, building upon the description given above. 
     As shown in  FIG. 1E , there are two additional components needed to effectuate the Dosage Counter feature. A Counter Actuation Arm  72  is attached to Cradle  53 . Each time that the Inhaler goes through the resetting function as described above for  FIG. 1D , the Counter Actuation Arm  72  pushes against one of a series of Notches  77  on the periphery of the Dosage Counter Wheel  75 . On the periphery of the Dosage Counter Wheel is imprinted a series of numbers (usually 1-4 or 1-8). Each time the inhaler goes through the steps of medicament delivery, Counter Actuation Arm causes the Dosages Counter Wheel to rotate a fixed amount which causes the next higher number on the Dosage Counter Wheel to be visible through a window in the housing of the inhaler. The Dosage Counter feature can be designed to either count up or count down as required. 
     Lock Out 
     There are two additional features needed to effectuate the lockout function. Notches  77 , which are described above, are located along only a portion of the periphery of Counter Wheel  75 . The Inhaler is designed to actuate only a predetermined number of times and the number of Notches  77  is same as this predetermined number of actuations. Once the Counter Wheel has advanced this predetermined number of times, there are no more Notches on the wheel that the Contact Arm  72  can contact. Thus Counter Arm  72  has nothing to push against. So even if the Cradle  53  moves back and forth between the positions shown in  FIG. 1A  and  FIG. 1C , because the Contact Arm  72  is not making contact with any Notches  77 , the Counter Wheel  75  doesn&#39;t rotate. 
     If no further components were added to the inhaler, the inhaler would still be able to deliver medicament, but the counter wheel would only record a predetermined number of actuations. 
     There are additional elements needed, which would work in conjunction with the Counter Arm and Counter Wheel, to disable the inhaler. With these additional elements, when the Counter Wheel has been incrementally rotated the predetermined number of times, the inhaler will be disabled and will not deliver medicament. The preferred method of disablement is to prevent the ability of the inhaler to compress the springs. It should be noted that there is no physical blocking or interference of any of the moving parts while in the disabled state and therefore there are no parts put under stress when the inhaler is disabled. 
     A Dropout Cam  79  is located along the periphery of Counter Wheel  75 . When Counter Wheel  75  has been incrementally rotated the proper number of times, it is positioned such that Dropout Cam  79  makes contact with Dropout Tab  81  which causes Spring Latch  83  to disengage as shown in  FIG. 1F . 
     Spring Latch  83 , when engaged, rigidly attaches Cradle  53  to Spring Assembly  59 . When Dropout Tab  81  is contacted by Dropout Cam  79 , it causes the two portions of Spring Latch  83  to separate. Thus Spring Assembly  59  is no longer rigidly attached to Cradle  53 . As a consequence, when Cam  63  rotates to the position as shown in  FIG. 1G , the springs in Spring Assembly  59  won&#39;t compress because the whole Spring Assembly moves in relation to Cradle  53 . Therefore there won&#39;t be any mechanical force available to bias Cradle  53  and Canister  55  and cause Canister Stem  57  to be depressed into Canister  53  and thus there will be no medicament delivery. 
     Even if Cradle latch  52  is activated, as shown in  FIG. 1G , there is no compressed spring force to drive the Canister. When the Cam  63  is rotated back to its original position, the Moving Assembly is returned to its initial position and Cradle Latch  52  is re-engaged. 
     Having gone through a diagrammatic depiction of the standard inhaler ( FIGS. 1A-1D ) and the improved inhaler having a dosage counter and lockout mechanism ( FIGS. 1E-1F ), a detailed description of the preferred embodiment will now be presented. 
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 2  shows Inhaler  100  in its closed resting state. Back Cover  105  and Front Cover  115  provide the basic housing structure for Inhaler  100 . Cocking Lever  110 , attaches to Inhaler  100  and pivots around Pivot Point  112 . A Dosage Counter Display Window  120  is formed within Front Cover  115 . The actual number of dose that have been delivered is indicated by numbers on a rotating surface that can be viewed through Dosage Counter Display Window  120 , as will be discussed in detail below. 
       FIG. 3  is an exploded view of Inhaler  100 . Front Cover  115  and Back Cover  105  enclose Manifold Assembly  125 . Mouth Piece  130  is inserted through an opening in the bottom of Front Cover  115  and makes a snap fit within an opening in the lower portion of Manifold Assembly  125 . Cocking Lever  110 , in its closed position, covers Mouth Piece  130 . In normal use, Cocking Lever  110  will be manually rotated approximately 135 degrees which fully uncovers Mouthpiece  130  and enabling Mouthpiece  130  to be inserted into the mouth of a patient. 
       FIG. 4  shows Cradle  140  from 4 different views in order that the various components of Cradle  140  can be properly viewed. Cradle  140  has a first pair of arms  151  that extends away from the body of Cradle  140 . In the embodiment shown in  FIG. 4 , Cradle  140  has a second pair of arms (Reset Arms  152 ) that extends away from the body of Cradle  140 . Each of Reset Arms  152  contains a Reset Lobe  290  (see  FIG. 17 ). A clear understanding of all of the functions of the Cradle  140  is critical to an understanding how all of the features of the invention work together. There are six separate functions that the Cradle  140  performs:
         1. Holds the Canister;   2. Slideably engages the Manifold  170 ;   3. Provides one part of the latch to the Manifold;   4. Provides one part of a latch to the Spring Assembly;   5. Actuates the Dose Counter Wheel; and   6. Provides support for the Spring Assembly.       

     These six functions are now discussed in detail. 
     1. Holds the Canister
         The Canister  167  is retained within Canister Enclosure  160 , which also pushes down on the Canister  167  when the Cradle  140  is pushed down, in order to activate Canister Stem  168  (See  FIGS. 5A and 5B ).       

     2. Slideably Engages the Manifold  170 ;
         Each of the first pair of arms  151  that extends away from the body of Cradle  140  contains a Slider Groove  145  (see  FIG. 4 ) which engages with a corresponding mating part (the Cradle Rails  180 ) on Manifold  170  (see  FIG. 6 ).       

     3. Provides One Part of the Latch to the Manifold Assembly;
         Cradle Latch A  155 , shown in  FIG. 4 , along with Trigger Shelf  190  (See  FIG. 7 ) forms Cradle Latch Assembly (not shown) which detachably fixes Cradle  140  to Manifold  170 . The second part of Cradle Latch Assembly is Trigger Shelf  190 , which is positioned within Trigger Pocket  187  as shown in  FIG. 5 . Panel  185  is shown detached from Manifold  170 . Panel  185  is normally positioned within Manifold  170  by positioning Attachment Bracket  188 A within Panel Pocket  188 B. Panel  185  through various gaskets and seals, not shown, can be biased at Flexible Location  186 , and displaced into Manifold  170  by utilizing a venturi effect caused by the inspiration of air by the patient. If Panel  185  is biased inwards by the intake of breath of a patient on the inhaler, then Trigger Shelf  190  becomes disengaged from Cradle Latch A  155 . This triggering action normally takes place after Spring Assembly has been compressed. The disengagement of the Cradle Latch Assembly then allows the Springs in the Spring Assembly to expand, forcing Cradle  140  downward which also forces Canister  167  downward causing a single dose of medicament to be discharged from Canister  167  through Canister Stem  168 .       

     4. Provides One Part of Spring Assembly
         Spring Assembly Latch A  157 , as shown in  FIG. 4  mates with a corresponding component on the Spring Assembly  240  which will be described below. The two components form Spring Assembly Latch  158 , which is a key component of the lockout feature of the present invention and will be discussed below.       

     5. Actuates the Dose Counter Wheel;
         Counter Actuation Rod  150  extends from Cradle  140  and contacts Counter Wheel  217 , shown in  FIG. 9 . Each time the Cradle  140  (See  FIG. 4 ) moves from its cocked position to its resting position, the Counter Actuation Arm  150  makes contact with notches on the periphery of Counter Wheel  217 , causing it to rotate a predefined amount.       

     6. Provides Support for the Spring Assembly
         Spring Assembly  240  (shown alone in an expanded view in  FIG. 11 , and in a front and back view in  FIGS. 12 and 13 ) is contained within Cradle  140  as shown in  FIG. 14 . As shown in  FIG. 14 , Spring Assembly Latch B  257  of Spring Assembly  240  is detachably engaged with Spring Assembly Latch A  157 , which is part of Cradle  140 . When Spring Assembly  240  is biased in the downward direction (as discussed below) the engaged Spring Assembly Latch  158  causes the downward force applied to the Spring Assembly to be transmitted to Cradle  140 .       

       FIG. 8A  shows Cocking Lever Retainer  200  detached from Manifold Assembly  125 . It is normally positioned on Manifold  170  as shown in  FIG. 8B . Locking Tangs  205  are inserted into Slots  195 . When Cocking Lever Retainer  200  is fully inserted into Manifold  170 , there are two Cocking Lever Apertures  197  formed which are used to retain Cocking Lever  110  as will be discussed below. 
       FIG. 9  shows Cocking Lever Retainer  200  and Counter Wheel  217 . Counter Wheel  217  fits over and is retained by Counter Wheel Axle  215 . Counter Wheel Axle  215  is made up of two arms which are compressed. Counter Wheel  217  is then positioned such that the compressed arms of Counter Wheel Axle  215  are inserted through Mounting Hole  213  formed in the middle of Counter Wheel  217 . Once Counter Wheel Axle  215  is fully inserted into and through Mounting Hole  213 , the two arms are allowed to expand, which rotatably locks Counter Wheel  217  on Counter Wheel Axle  215 . Counter Wheel  217  fits over Detent Arms  210  which are positioned to fit into Detent Teeth  230  as shown in  FIG. 8 . The interaction of Detent Arms  210  and Detent Teeth  230  permit Counter Wheel  217  to rotate in only one direction and in fixed increments determined by the spacing of Detent Teeth  230 . 
     Also shown in  FIG. 10  are Rotation Actuation Teeth  225 . These teeth are engaged by Counter Actuation Rod  150 , located on Cradle  140 , each time Cradle  140  is placed in its resting position. The spacing of Rotation Actuation Teeth  225  and Dose Numbers  218  are designed so that each movement of the Counter Actuation Rod  150  causes the next higher dosage number on Counter Wheel  217  to be visible in Dosage Counter Display Window  120 . 
     Various views of Spring Assembly  240  are shown in  FIGS. 11-13 . The three main elements of Spring Assembly  240  are the Pusher  245 , the Springs  250  and Spring Holder  255 . An exploded view of Spring Assembly  240  is shown in  FIG. 11 . 
       FIG. 12  shows one view of the fully assembled Spring Assembly  240 . One each of Springs  250  are placed over one each of Pusher Arms  247 . This assembly is placed within Spring Holder  255  such that Pusher Retaining Tabs  260  are inserted through openings in the bottom of Spring Holder  255 . Once place through these holes, Pusher Retaining Tabs  260  lock Pusher  247  within Spring Holder  255 . The diameter of Springs  250  are smaller than the holes in the bottom of Spring Holder  255 . Therefore, if Pusher  245  is biased downwards, Pusher Arms  247  are extended through the holes in the bottom of Spring Holder  255 . This causes Springs  250  to be compressed between the lower portion of Spring Holder  255  and the top of Pusher  245 . 
       FIG. 13  shows the opposite side of the view shown in  FIG. 12 . Dropout Tab  265 , which is located on the Dropout Arm  262 , is engaged by Dropout Cam  220  on Counter Wheel  217  ( FIG. 9 ). When Dropout Tab  265  is biased by contact with Dropout Cam  220  it moves in the direction indicated by Arrow A. This causes Spring Assembly Latch A  157  to disengage from Spring Assembly Latch B  257 . 
     When Spring Assembly Latch is engaged, any downward pressure on the Pusher  245  causes Springs  250  to compress and also transmits the downward pressure to Cradle  140 . And because the Cradle Latch (Cradle Latch A  155  and Trigger Shelf  190 ) is usually engaged, Cradle  140  is prevented from making any significant downward motion. Thus the downward pressure on Pusher  245  results in the Cradle  140  being biased tightly against the Cradle Latch and also results in the compression of Springs  250 . 
     However, when Spring Assembly Latch is disengaged, there can be no compression of Springs  250 , and the whole Spring Assembly  240  is moved downward within Cradle  140 , without imparting any downward force to Cradle  140 . When there is no compression of Springs  250 , there is no compression energy available to cause the downward motion of the Cradle  140  and the Canister  167  to overcome the forced needed to move the Canister Stem  168  into the Canister  167 . 
       FIG. 14  shows in detail the Spring Assembly  240  positioned within Cradle  140  and with Spring Assembly Latch components (Spring Assembly Latch A  157  and Spring Assembly Latch B  257 ) in is an engaged, but slightly separated position in order to better view these two components. Normally Spring Assembly Latch A  157  and Spring Assembly Latch B  257  are in direct contact, unless Dropout Cam  220  has engaged Dropout Tab  265  to cause the two components to disengage and to potentially slide past each other. 
       FIG. 15  shows Cocking Lever  110  with its Cams  270  and its Pivot Bearings  267  located at one end. Pivot Bearings  267  are pivotally retained within the Cocking Lever Apertures  197  formed by the Cocking Lever retainer and the Cocking Lever Support Brackets  192 . 
       FIG. 17  shows Cocking Lever  110  is its closed or resting position.  FIG. 17  also shows several of the components in the closed or resting positions. When Cocking Lever  110  is in the closed position, Cams  270  are oriented such that Reset Lobes  290  are located as shown in  FIG. 17 . In this position, Reset Lobes  290  are oriented upwards and directly in contact with Reset Cam Contact Surface  162 . In this position, Cradle  140  is biased in its uppermost position. 
     During normal operation, as Cocking Lever  110  is rotated away from Mouthpiece  130 , Cams  270  are rotated which brings Compression Lobes  280  into contact with Cam Contact Surface  246 , which causes Pusher  245  to compress Springs  250 . 
     When Cocking Lever  110  is rotated to its fully opened position (about 135 degrees), it brings the Stabilizing Surface  285  on Cam  270  in full contact with Cam Contact Surface  246 . Because Stabilizing Surface  285  is flat, when it is in full contact with Cam Contact Surface  246 , Cocking Lever  110  is stabilized it is fully open position which holds Springs  250  in a compressed state. 
     Typically, the next step is to trigger Cradle Latch Assembly, which disengages Cradle Latch A  155  from Trigger Shelf  190 . Cradle  140  is then biased by the expansion of Springs  250 . The force of the expansion of compressed Springs  250  is sufficient to overcome the force on Canister Stem which biases Canister Stem  168  into Canister  167  to cause delivery of a metered dose of medicament. 
     After the delivery, Cocking Lever  110  is rotated back to the closed position which causes Reset Lobe  290  to be rotated against Reset Arm Contact Surface  162  which returns Cradle  140  back to its normal position. When Cradle  140  is in its uppermost position, Cradle Latch Assembly reengages, causing Cradle  140  to be fixedly attached to Manifold  170 . 
       FIG. 18  shows a cutaway view of the Inhaler  100  with the Cocking Lever  110  in a partially elevated position. Cam  270  is shown oriented such that Compression Lobe  280  is in contact with Cam Contact Surface  246 . In this configuration Pusher  245  is biased in a downward direction which results in Springs  250  being partially compressed. 
       FIG. 18  also shows Spring Assembly Latch B  257  engaged with Spring Assembly Latch A  157 . If Cocking Lever  110  were to be raised further, Stabilizing Surface  285  would be rotated so that it comes in contact with Cam Contact Surface  246  and be held in a stabilized position. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the invention is not limited to the exemplary embodiment described above. All changes or modifications within the meaning and range of equivalents are intended to be embraced herein. 
     Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as mean “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, a group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group, but rather should also be read as “and/or” unless expressly stated otherwise. 
     The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. 
     As used in this application, the articles “a” and “an” refer to one or more than one (i.e., to at least one) of the grammatical objects of the article. By way of example, “an element” means one element or more than one element.