Patent Publication Number: US-2012037158-A1

Title: Passive inhaler with blister strip

Description:
The present invention relates to an inhaler according to the preamble of claim  1 . 
     The present invention relates to an inhaler for delivery of a powder-form inhalation formulation from a blister strip with a plurality of blister pockets (also called blisters) containing the inhalation formulation in doses. 
     GB 2 407 042 A discloses an inhaler with a rolled-up blister strip. The inhaler comprises a manually operated, pivotable actuator, which operates a conveyor for stepwise moving the blister strip. The actuator supports a piercer and an associated mouthpiece. By pivoting the actuator, the blister strip and be moved forward and blister pockets of the blister strip can be pierced one after the other. When a patient breathes in an air stream passes through the previously pierced blister pocket, with the result that the inhalation formulation in the blister pocket mixes with the air and is discharged to the patient. 
     The present invention relates to passive inhalers, i.e. inhalers where the patient or user breathes in to generate an air stream, which entrains the inhalation formulation and forms the desired aerosol. 
     The design of a piercing member for puncturing the blister pockets is important in order to achieve good discharge characteristics. Multiple piercing member designs are known. However, studies have shown that the present piercer designs do not result in optimized discharge characteristics and/or are difficult to produce and/or have a complicated design. 
     Object of the present invention is to provide an inhaler with optimized discharge characteristics and/or simple design. 
     The above object is achieved by an inhaler according to claim  1 . Advantageous embodiments are subject of the subclaims. 
     In the present invention, the piercing member comprises two piercing elements extending at least essentially in V-shape away from each other. The V-shape of the piercing elements result in that two main flaps of the lid or any other cover are formed when a receptacle is pierced. In particular, the flaps are bent by the piercing elements towards each other and/or away from opposite ends of the pierced receptacle. 
     According to one aspect of the present invention, the piercing member comprises only these two piercing elements for forming only two separate openings in the lid of a receptacle, such as a blister pocket, that is to be opened. In this case, the piercing elements are at least essentially flat, preferable plate-like. This allows optimized discharge characteristics and a simple design. 
     According to another aspect of the present invention, the piercing elements arranged at least essentially in V-shape are spaced from each other. In particular, a contact member is arranged between the piercing elements so that it can contact the lid in an area between separate openings formed by the piercing elements in the lid. This allows optimized discharge characteristics and a simple design. 
     Preferably, the contact member is interconnected with the piercing elements, in particular supports or holds the piercing elements, preferably exclusively. Preferably, the contact member is longitudinal and/or ridge- or bridge-like. 
     It is especially preferred to form the piercing member and/or piercing elements from sheet material, in particular by cutting the sheet material so that the piercing elements can be bent into the desired V-shape, wherein the piercing elements are interconnected by a common member, in particular the contact member. 
     In particular, the lid is only punctured by the piercing member. Preferably, the piercing member comprises only these two piercing members. 
     The different aspects and features of the present invention can be realized independently from each other and in any combination. 
    
    
     
       Further aspects, features, properties and advantages of the present invention are described in the claims and the subsequent description of a preferred embodiment, with reference to the drawing. There are shown in: 
         FIG. 1  a schematic sectional view of an inhaler without mouthpiece cover; 
         FIG. 2  a schematic sectional representation of the inhaler with closed mouthpiece cover; 
         FIG. 3  an enlarged sectional view of the inhaler in the region of a mouthpiece and a piercing member; and 
         FIG. 4  a perspective view of the piercing member with an insert seen from the piercing side. 
     
    
    
     In the Figures, same reference numbers are used for identical or similar parts, even if a repeated description is omitted. In particular identical or corresponding advantages and properties then also result or may be achieved. 
       FIG. 1  shows in a very schematic sectional representation an inhaler  1 . 
     The inhaler  1  serves to deliver a powdered inhalation formulation from a preferably band-shaped carrier, such as a blister strip  2 . The blister strip  2  is finite, not forming an endless or closed loop. It has a large number of blister pockets  3  respectively containing directly a dose of the loose inhalation formulation, in particular powder  10 . Thus, the formulation is pre-metered. 
     The inhaler  1  has a reservoir  4  for the still unused blister strip  2  with closed (sealed) receptacles, here blister pockets  3 . The blister strip  2  is preferably rolled up or wound up in the reservoir  4 . In the representation example the reservoir  4  is formed such that the blister strip  2  can be moved outwards or pulled out of the reservoir  4  as easily as possible. 
     In the representation example the blister strip  2  is directly received in the reservoir  4 . However, instead of this a cassette, a container, a drum or suchlike can also be fitted or inserted with the blister strip  2  into the inhaler  1  or the reservoir  4 . 
     The inhaler  1  has preferably a conveyor  5  for stepwise onward movement of the blister strip  2  in direction of arrow  5   a  by one blister pocket  3 , in order to feed the blister pockets  3  successively to an opening and/or removal position  6  where the respective blister pocket  3  is opened and can be emptied. 
     The blister pockets  3  can be opened respectively preferably by means of a piercing member  7 , which punctures or cuts open a lid of the respectively aligned blister pocket  3  in position  6 . The piercing member  7  is hollow and/or in fluid connection with an adjacent mouthpiece  8  of the inhaler  1 . 
     During or for inhalation a patient or user, not represented, places the mouthpiece  8  in his mouth and breathes in. The respectively opened blister pocket  3 , into which the piercing member  7  partly extends, is thereby emptied by sucking in. An air stream  9  of ambient air is sucked in and passed through the opened blister pocket  3  such that the loose powder  10  (forming the inhalation formulation and being schematically shown in  FIG. 1  only in the actually opened blister pocket  3  below mouthpiece  8 ) is dispensed with the sucked-in ambient air as an aerosol cloud  11  via the mouthpiece  8 . This situation is schematically represented in  FIG. 1 . 
     The inhaler  1  has a preferably manually actuatable, lever-like actuator  12  being pivotally mounted to a housing  12   a  of the inhaler  1 . The piercing member  7  and the mouthpiece  8  are attached to and supported by the actuator  12 . 
     The actuator  12  is operable (pivotable) to cause the piercing member  7  to puncture the lid of the respectively aligned blister pocket  3  in position  6  below the mouthpiece  8 . 
     When the actuator  12  swivels from the position shown in  FIG. 1  (here anti-clockwise) to the partially opened position shown in  FIG. 3 , the piercing member  7  is withdrawn from the last-pierced blister pocket  3 . 
     Then, the blister strip  2  is moved forward by one blister pocket  3 , so that the next blister pocket  3  is moved in position  6 . This will be explained in more detail later. 
     When the actuator  12  swivels back into the position shown in  FIG. 1 , i.e. is manually moved back, the next aligned blister pocket  3  of the blister strip  2  is punctured by the piercing member  7  and thereby opened. Then, the next inhalation can take place, i.e. the inhaler  1  is activated. 
     The inhaler  1  has preferably a receiving space or apparatus  13  to receive or store the used part of the blister strip  2 . The receiving space or apparatus  13  is formed such that the used part can be wound up.  FIG. 1  shows a situation with essentially filled reservoir  4  and still essentially empty receiving space  13 . 
     The conveyor  5  comprises preferably a conveying wheel  14 , which can engage between the blister pockets  3  and thus convey the blister strip  2  in form-locking or form-fit manner. This allows very secure or precise moving or indexing of the blister strip  2  as desired and/or necessary. 
     The conveyor  5  or its conveying wheel  14  is arranged preferably between the reservoir  4  and the receiving apparatus  13 , in particular between the removal position  6  and the receiving apparatus  13 , thus after the emptying of the blister pockets  3 . 
     The pivot axis of the actuator or lever  12  is coaxial with the rotation axis of the conveying wheel  14 . In particular, the actuator or lever  12  may be supported by an axle of the conveying wheel  14 . 
     The inhaler  1  comprises a mouthpiece cover  15 . The mouthpiece cover  15  is not shown in  FIG. 1 , which explains only the basic principle of the inhaler  1 , but in  FIG. 2 , which shows a more realistic, but still very schematic sectional view of the inhaler  1 .  FIG. 2  shows the inhaler  1  with closed mouthpiece cover  15 , wherein the blister strip  2  has been partly omitted for illustration purposes. 
     The mouthpiece cover  15  is pivotable around a cover axis  16 , which is indicated in  FIGS. 2 and 3  and extends perpendicular to the drawing plane in the present representation. 
     The pivot axis of the actuator  12  extends preferably coaxial to or with the cover axis  16 . The rotation axis of the conveying wheel  14  extends preferably coaxial to the cover axis  16  and to the pivot axis of the actuator  12 . 
     The conveyor  5  or its conveying wheel  14  is preferably driven by the mouthpiece cover  15 , namely by the pivotal movement of the mouthpiece cover  15 . In particular, the blister strip  2  is moved forward, when the mouthpiece cover  15  is opened. Preferably, only part of the opening movement of the mouthpiece cover  15  actuates or operates the conveyor  5  or its conveying wheel  14  to move the blister strip  2  forward. 
     When the mouthpiece cover  15  is opened starting with the completely closed position shown in  FIG. 2 , in a first phase of the opening movement, for example up to a first angle of about 10, 20 or 30 degrees, the blister strip  2  is not moved due to a respective freewheel (not shown) between the mouthpiece cover  15  and the conveying wheel  14 . 
     First of all, the actuator  12  has to be moved or opened in order to withdraw the piercing member  7  from the previously pierced and usually already emptied blister pocket  3 . This opening movement of the actuator  12  can be performed manually. However, the actuator  12  preferably opens automatically when opening the mouthpiece cover  15 . In particular, the mouthpiece cover  15  can be opened up to the first angle. When the mouthpiece cover  15  reaches this angle, e.g. about 20 degrees, the actuator  12  flips automatically open into its opened position, in particular due to a biasing or spring means (not shown) or the like. However, it also possible that the actuator  12  moves jointly with the mouthpiece cover  15  in the first phase of the opening movement (e.g. due to a ratchet mechanism, spring or the like) until the actuator  12  reaches its opened position or the first angle. 
     The opened position of the actuator  12  is preferably set such that the piercing member  7  is not exposed to the exterior and/or that the inhaler  1  is not completely opened in order to avoid or at least minimize any potential external influences. 
     In order to limit the open position of the actuator  12 , the opening or pivot range of the actuator  12  is smaller than the one of the mouthpiece cover  15  and/or is restricted to preferably at most 20 degrees, in particular to about 10 degrees or less. 
     However, it is also possible that the actuator  12  is not limited in its opening position, but can open or pivot as far as the mouthpiece cover  15 , in particular jointly with the mouthpiece cover  15 . 
     During the further opening (second phase) of the mouthpiece cover  15 , the conveyor  5  or its conveying wheel  14  is actuated to move or index the blister strip  2  by one blister pocket  3  onward to the next blister pocket  3  that shall be emptied. This blister movement happens preferably up to the complete opening of the mouthpiece cover  15 . 
     Only when the mouthpiece cover  15  is opened completely, i.e. reaches its end position, the movement of the blister strip  2  may be set or fixed by a respective mechanism (not shown) and/or decoupled from the mouthpiece cover movement to keep the next blister pocket  3  in position  6  for puncturing. However, if the mouthpiece cover  15  is not fully opened and closed again, then, the blister strip  2  is moved backward. This facilitates operation of the inhaler  1  and, in particular, prohibits that incomplete or unintended operation of the mouthpiece cover  15  results in an undesired movement of the blister strip  2  and eventually in an undesired opening of the next blister pocket  3 . 
     Preferably, a lock (not shown) is provided so that the opened actuator  12  can be closed again only if the mouthpiece cover  15  has been fully opened or pivoted back to the first angle or the last-pierced blister pocket  3  has been moved back into position  6 . Thus, the piercing member  7  cannot be pushed against an area of the blister strip  2  without or beside a blister pocket  3 . 
     When the mouthpiece cover  15  has been fully opened and the next blister pocket  3  has been moved in position  6 , the actuator  12  can be pivoted back, i.e. closed, in order to pierce the already aligned, still closed blister pocket  3 . Then, the inhaler  1  is ready for inhalation, i.e. activated as already described. 
     After inhalation, the inhaler  1  can be closed by pivoting back the mouthpiece cover  15  into its closed position. 
     In order to operate the conveyor  5  or its conveying wheel  14  by movement of the mouthpiece cover  15  as described above or in any other suitable manner, the mouthpiece cover  15  is coupled with the conveyor  5 , in particular the conveying wheel  14 , via the already mentioned freewheel, a suitable transmission, a slipping clutch and/or any other suitable coupling or the like. Preferably, the freewheel, transmission, coupling or the like is integrated into is or located adjacent to the conveying wheel  14  or a respective axle. 
     Preferably, the mouthpiece cover  15  covers axially an axle or the axis of the actuator and/or conveying wheel  14 . 
       FIG. 3  shows in an enlarged sectional view the piercing member  7  with the mouthpiece and an opened blister pocket  3  in the removal position  6 . It can be seen that the piercing member  7  or inhaler  1  preferably comprises an insert  17 , which is connected to the mouthpiece  8  and, in particular, extends into an outlet space or tube  18  of the mouthpiece  8 . 
     Preferably, the insert  17  is held form-fit within the mouthpiece  8  or its outlet tube  18 . However, other construction solutions are also possible. 
     The insert  17  is located adjacent to the piercing member  7 . In particular, the piercing member  7  forms or holds the insert  17  or vice versa. 
     The piercing member  7  is connected preferably with the actuator  12 , in particular via the insert  17  and/or the mouthpiece  8  as shown in  FIG. 3 . 
     The inhaler  1  or mouthpiece  8  comprises preferably at least one, here multiple air openings  19  through which the air stream  9  of ambient air can flow in. 
     The inhaler  1 , the piercing member  7 , the mouthpiece  8  and/or the insert  17  form a feeding path  20  for the air which has been flown through the opened blister pocket  3  and, in addition, preferably a bypass path  21  for air bypassing the blister pocket  3 . Both paths  20  and  21  end preferably within the mouthpiece  8  or its outlet tube  18  and/or at a mixing zone  22  where the respective streams through the paths  20  and  21  mix. 
     In particular, the air stream  9  entering through the air openings  19  is split up into a feeding air stream  23  flowing through the opened blister pocket  3  and then through the feeding path  20 , and into a bypass air stream  24  flowing through the bypass path  21 . 
       FIG. 3  shows schematically the aerosol generation when the air flows. The feeding air stream  23  flowing through the opened blister pocket  3  entrains the inhalation formulation (powder  10 ) and flows into the mouthpiece  8  or its outlet tube  18 , in particular to the mixing zone  22  where it mixes with the bypass air stream  24 . Thus, the aerosol cloud  19  is generated as schematically shown in  FIG. 3 . 
     In the present embodiment, the piercing member  7  comprises two piercing elements  25  and  26  as shown in  FIG. 3  and in the perspective view of the piercing member  7  according to  FIG. 4 . 
     The first piercing element  25  serves to form a first opening  28  (inlet opening) in the lid  27  of the blister pocket  3  as shown in  FIG. 3 . The second piercing element  26  forms a separate, second opening  29  (outlet opening) in the lid  27  as schematically shown in  FIG. 3 . Thus, the feeding air stream  23  can flow in through the first opening  28  and out through the second opening  29 . The second opening  29  is fluidically connected to the feeding path  20 , which is formed here preferably by a channel within the piercing member  7  and/or insert  17 . This channel opens to the mixing zone  22 . 
     In the present embodiment, the bypass path  21  leads through or is formed by a preferably annular bypass channel, preferably formed by the insert  17 , to the mixing zone  22 . In particular, the bypass channel surround concentrically or radially the channel of feeding path  20 . However, other constructional solutions are possible. 
     In particular, the piercing member  7  is unitary and/or essentially plate-like and/or comprises or forms the two piercing elements  25 ,  26  protruding and extending towards the blister pocket  3  to be opened. 
     Preferably, the piercing member  7  comprises only two piercing elements  25 ,  26  for puncturing the lid  27 , i.e. for opening a blister pocket  3  in position  6 , in particular for forming the two separate openings  28 ,  29  in the lid  27 . 
     Preferably, the piercing elements  25 ,  26  are at least essentially flat or plate-like. 
     According to the invention, the piercing elements  25 ,  26  run or extend at least essentially in V-shape away from each other. In particular, the piercing elements  25 ,  26  are inclined away from each other, so that the distance between then increases with increasing distance away from a plate forming the piercing member  7  or the lid  27  (when the piercing elements  25 ,  26  extend in to the blister pocket  3 ). 
     The piercing elements  25 ,  26  are inclined to a piercing plane  34  extending essentially in the direction of dispensing and/or essentially perpendicular to the lid  27  or any other cover of the receptacle/blister pocket  3 . 
     Preferably, the main extension planes of the piercing elements  25 ,  26  and the piercing plane  34  comprise a common line (cross line) where all the planes cross each other. With other words, one piercing element could be rotated geometrically into the other piercing element or vice versa around this cross line. However, other orientations of the piercing elements  25 ,  26  are also possible. 
     The angle of the piercing elements  25 ,  26  to the piercing plane  34  is about 30 to 60, preferably about 40 to 50 degrees, i.e. that the angle between the piercing elements  25 ,  26  is preferably about 80 to 100 degrees. 
     Preferably, the piercing elements  25 ,  26  are inclined to the surface or main plane of the lid  27  or blister strip  2 , to the longitudinal extension of the blister strip  2 , to the onward movement  5   a  of the blister strip  2 , and/or to the relative movement of the piercing member  7  to the blister pocket  3  during puncturing. In particular, the inclination is 30 to 60°, preferably about 40 to 50°, most preferably about 45°. 
     Preferably, the piercing elements  25 ,  26  are spaced from each other. 
     Preferably, a contact member  30  is arranged between the piercing elements  25 ,  26  so that the contact member  30  can contact the lid  27  in an unruptured area between the openings  28 ,  29  formed by the piercing elements  25 ,  26  in the lid  27 . 
     Preferably, the contact member  30  comprises a flat or ridge-like contact area for directly contacting the lid  27  in the area between the openings  28 ,  29 . 
     Preferably, the contact member  30  or its contact area extends at least over the entire width of the receptacle/blister pocket  3  or lid  27  to ensure a defined flow of the feeding air stream  23  through the first opening  28  into the blister pocket  3  and through the second opening  29  out of the blister pocket  3  and, in particular, to prevent any undesired leakage of feeding air between the lid  27  and the piercing member  7 , i.e. to prevent that (a relevant part of) the feeding air stream  23  can bypass the opened receptacle/blister pocket  3 . 
     Preferably, the piercing elements  25 ,  26  are interconnected or held or supported by a common member, in particular the contact member  30 . 
     Preferably, the piercing elements  25 ,  26  are respectively tapered to its respective free ends and/or respectively comprise or form a tip  31 . 
     Preferably, the piercing member  7  and/or piercing elements  25 ,  26  are made of sheet material, in particular metal sheet. 
     In the present embodiment, the piercing elements  25 ,  26  are bent into the respective inclined position. 
     Preferably, the piercing elements  25 ,  26  are only respectively connected to a flat, plate-like region of the piercing member  7  along an essentially linear edge. 
     Preferably, the piercing member  7  is made of metal and/or of sheet material. The piercing member  7  is preferably separately formed or made from the insert  17 . 
     Preferably, the piercing member  7  is held in a form-fit manner by the insert  17  or any other suitable component of the inhaler  1 . Preferably, the form-fit connection is achieved in that the piercing member  7  comprises at least one though hole  32  through which a protrusion  33  extends that is deformed at least at its free end to fix the piercing member  7 . The protrusion  33  protrudes from the insert  17  or any other suitable component of the inhaler  1 . The protrusion  33  is preferably made of plastic, so that the desired form-fit connection can be achieved in a simple manner, in particular by deforming, preferably due to pressure and/or heat. The through hole  32  is preferably located in a flat or plate-like region of the piercing member  7 . 
     In the present embodiment, the piercing member  7  is preferably held or connected at least two points, preferably by two protrusions  33  extending through two corresponding through holes  32 . 
     It has to be noted that  FIG. 3  shows only very schematically, in particular not in scale, a potential construction. Other constructional solutions are possible as a wall. 
     Preferably, the inhaler  1  is portable, works only mechanically and/or is hand-held. 
     Preferably, the terms “blister strip” and “blister pockets” have to be understood in a very broad sense to cover also other kinds of storage means with receptacles or even bulk storages for the formulation. 
     
       
         
           
               
             
               
                   
               
               
                 List of reference numbers 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                   
                  1 
                 inhaler 
               
               
                   
                  2 
                 blister strip 
               
               
                   
                  3 
                 blister pocket 
               
               
                   
                  4 
                 reservoir 
               
               
                   
                  5 
                 conveyor 
               
               
                   
                  5a 
                 onward movement 
               
               
                   
                  6 
                 opening and/or removal position 
               
               
                   
                  7 
                 piercing member 
               
               
                   
                  8 
                 mouthpiece 
               
               
                   
                  9 
                 air stream 
               
               
                   
                 10 
                 powder 
               
               
                   
                 11 
                 aerosol cloud 
               
               
                   
                 12 
                 actuator 
               
               
                   
                 12a 
                 housing 
               
               
                   
                 13 
                 receiving apparatus 
               
               
                   
                 14 
                 conveying wheel 
               
               
                   
                 15 
                 mouthpiece cover 
               
               
                   
                 16 
                 cover axis 
               
               
                   
                 17 
                 insert 
               
               
                   
                 18 
                 outlet tube 
               
               
                   
                 19 
                 air opening 
               
               
                   
                 20 
                 feeding path 
               
               
                   
                 21 
                 bypass path 
               
               
                   
                 22 
                 mixing zone 
               
               
                   
                 23 
                 feeding air stream 
               
               
                   
                 24 
                 bypass air stream 
               
               
                   
                 25 
                 first piercing element 
               
               
                   
                 26 
                 second piercing element 
               
               
                   
                 27 
                 lid 
               
               
                   
                 28 
                 first opening 
               
               
                   
                 29 
                 second opening 
               
               
                   
                 30 
                 contact member 
               
               
                   
                 31 
                 tip 
               
               
                   
                 32 
                 through hole 
               
               
                   
                 33 
                 protrusion 
               
               
                   
                 34 
                 piercing plane