Abstract:
A shaping tool as depicted in exemplary FIG.  3  comprising a rotatable base member having at least one profiled bending roller ( 13 ) which is mounted on a circular track and is rotatable about a rotation axis. The bending roller ( 13 ) arranged on a radially movable slide ( 11 ) is movable from a position defining a maximum working aperture for the tool, by means of a spring-loaded lever ( 9 ) which has an axial configuration, into a position defining a minimum working aperture for the tool.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    For administering inhalable pharmaceutical formulations of active substances, the patient uses hand-held, manually operated inhalers in which the pharmaceutical active substance formulation is contained in an inhaler cartridge. The inhaler cartridge consists of an external aluminium cartridge and a plastic container inserted therein, the plastic container being produced by co-extrusion and comprising a rigid outer container and a flexible inner pouch disposed inside it. In order to create a pressure equalisation opening between the inner pouch and the outer container, an opening is formed in the relatively rigid outer container by the so-called cut-crack-open process, for example. The plastic container is filled with the pharmaceutical active substance formulation and sealed, and inserted into the aluminium cartridge during the manufacturing process to form the inhaler cartridge. In a subsequent step, a deformed wall region is formed in the aluminium cartridge in the upper region of the inhaler cartridge thus assembled, this deformed region bearing on the outer surface of the plastic container inserted in the aluminium cartridge. To form the attachment region on the upper edge of the aluminium cartridge a drawing process is used in which a rotating drawing tool moves with its working aperture for the tool from above over the attachment region to be formed on the aluminium cartridge and thereby brings profiled drawing rollers arranged around the working aperture for the tool into contact with the outer surface of the aluminium cartridge, in order to shape the attachment region by axial movement. Then in another manufacturing step the aluminium cartridge is applied in gastight manner against the outside of the plastic container disposed therein, which is filled with a pharmaceutical active substance formulation. 
         [0002]    In the case of a shaping tool known in the art, comprising a rotatable base member with profiled bending rollers arranged on a circular track and rotatable about a rotation axis, the bending rollers are moved in a radial pivoting movement in one plane from a maximum working aperture for the tool into a minimum working aperture for the tool. This shaping tool has proved problematic in its reliability and susceptibility to breakdown. 
       SUMMARY OF THE INVENTION 
       [0003]    The problem that the invention sets out to solve is to provide a shaping tool of the kind mentioned hereinbefore which is reliable in operation. 
         [0004]    According to the invention the problem is solved by the fact that the bending roller arranged on a radially movable slide is movable from a position that defines a maximum working aperture for the tool, by means of a spring-loaded lever with an axial configuration, into a position that defines a minimum working aperture for the tool. 
         [0005]    Since the shaping tool rotates, the workpiece, i.e. the inhaler cartridge which is to be produced, filled with a liquid active substance formulation, can be fixed in place, thereby preventing foaming of the active substance formulation. The shaping tool is positioned relative to the workpiece, while the bending roller is located in the position defining the maximum working aperture for the tool. By an adjusting movement using the lever, the bending roller is moved into the position defining the minimum working aperture for the tool. The profiled bending roller is matched to the contour that is to be produced and as a result of the radial adjustment an encircling radius, for example, is produced in rotationally symmetrical manner on an upper edge of the obviously cylindrical workpiece, whereby after an initial adjustment or determination of the diameter of the minimum working aperture for the tool a reliable product which is accurate in its shape and dimensions is obtained. The resetting of the bending roller from the minimum working aperture for the tool to the maximum working aperture for the tool is carried out by means of a radially acting compression spring. 
         [0006]    According to a further feature, in the center, an axially acting depressor for the clamped workpiece is provided and a pressing member that is conical at least in parts is axially movable under spring loading relative to the depressor, while the pressing member cooperates with one end of the lever in order to move the bending roller into the minimum working aperture for the tool. When the rotating shaping tool moves axially downwards, first of all the depressor makes contact with the workpiece, which consists of an aluminium cartridge with a plastic container inserted therein. The depressor presses the plastic container into the aluminium cartridge and holds the workpiece. Thus the depressor performs the function of positioning the plastic container in the aluminium cartridge. At this height in which the depressor secures the workpiece in the axial direction, the bending roller is also positioned at the required height. During further downward motion the pressing member is moved downwards and the cone of the pressing member acts upon the lever in order to shift the bending roller in the radial direction into the position of the minimum working aperture for the tool where the workpiece has its end contour. In the event of incorrect axial positioning, the pressing member would act upon the lever too early or too late, resulting in a defective and in particular non-gastight end contour. 
         [0007]    In order to convert the axial movement of the pressing member into the radial direction of movement of the bending roller the lever is preferably provided, at its end facing the pressing member, with a roller that rolls on the pressing member and at its opposite end it is pivotably connected to the slide. 
         [0008]    So that the bending roller comes to engage with the workpiece in a rectilinear motion, a fixable eccentric bolt is expediently inserted in a bore in the slide, on the one hand, and in an oblong hole in the lever, on the other. The eccentric bolt is provided to allow fine-tuning of the minimum working aperture for the tool. By rotation of this bolt, the slide with the bending roller is moved in the direction of the workpiece or in the opposite direction while the pressing member stays in the same position. Once the contour to be produced with the bending roller has been shaped according to requirements, the eccentric bolt is secured for example by means of screws acting thereon. The eccentric bolt thus serves for radial adjustment of the bending roller. When the radial position of the bending roller is determined for example by varying the diameter of the roller associated with the lever which rolls over the pressing member, it is not essential to provide an eccentric bolt. 
         [0009]    In order to achieve a defined deflection of the respective direction of movement reliably and reproducibly, the lever is preferably pivotably mounted on a carrier member. The carrier member is fixedly positioned relative to the slide in the axial direction and the pressing member is movable relative to the carrier member. 
         [0010]    When the bending roller is in its radial end position in which it describes the minimum working aperture for the tool and the final dimensions of the workpiece have been achieved, a yielding movement is necessary in order to prevent further advancing of the bending roller with resultant destruction of the workpiece. According to a further feature, the lever has two arms articulated to one another between which a spring-loaded overload prevention device acts. In a radial position of the bending roller in which the final dimensions of the workpiece have been achieved, the overload prevention device ensures that the two arms of the lever pivot counter to the action of a spring, in order to prevent a further radial shift of the bending roller and consequent damage to the workpiece. However, with the spring-loaded overload prevention device it is also possible to generate the pressure needed to ensure the deformation and any tolerances in the workpiece can be equalised. The spring of the overload prevention device may be effective both with an undersized workpiece and with an oversized one and will always clamp the bending roller against the workpiece. 
         [0011]    According to one feature, at least one shaping roller for producing a crimp is rotatably mounted on an axis of the slide adjacent to the bending roller. Expediently, the slide is slidably mounted by means of a tongue and groove guide in a guide portion that is connected to the carrier member. 
         [0012]    For reproducibly adjusting the height of the shaping tool by simple means, a cam roller advantageously cooperates with a cam control for the axial movement of the shaping tool. The travel speeds and distances may be decided by means of the control cam of the cam control in known manner. 
         [0013]    Expediently, three radially adjustable slides each having one lever are arranged in a star shape with one another. The workpiece can be shaped relatively uniformly with the equidistantly distributed bending and shaping rollers and a high surface quality can be achieved at a high shaping speed while adhering to relatively narrow tolerances of form and dimensions. 
         [0014]    A retaining device fixes the workpiece, which consists of an aluminium cartridge and a plastic container, coaxially with respect to a longitudinal axis along which the shaping tool travels vertically. The retaining device may be part of a conveying and/or packaging apparatus, for example in the form of a rotary plate machine or a conveyor belt. 
         [0015]    The shaping tool described above is used for profiling a neck region of an inhaler cartridge which consists of an exterior aluminium cartridge and a plastic container placed therein which holds an active substance formulation. The plastic container can be produced by the co-extrusion method and may comprise a rigid outer container and a flexible inner pouch disposed therein. In the course of manufacture, the plastic container is filled with the pharmaceutical active substance formulation and sealed. 
         [0016]    The inhaler cartridge manufactured with the shaping tool is used as a storage container in a nebuliser for dispensing a specified amount of a fluid, particularly one that contains a medicament, as an aerosol through a nozzle from a pressurised store, wherein a mechanical pressure generator acts upon the measured out fluid in the pressurised store which is to be released in one go for nebulisation. A known nebuliser is marketed by Boehringer Ingelheim KG under the brand name “Respimat” in the form of an inhaler and is shown in WO 91/14468 A1 and in WO 97/12687 A1. 
         [0017]    It will be understood that the features mentioned above and to be explained hereinafter may be used not only in the particular combination specified but also in other combinations. The scope of the invention is defined only by the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    The invention is hereinafter explained in more detail by means of two embodiments by way of example, by reference to the attached drawings, wherein: 
           [0019]      FIG. 1  is a perspective representation of a shaping tool according to the invention. 
           [0020]      FIG. 2  is a view from below of the shaping tool according to  FIG. 1 . 
           [0021]      FIG. 3  is a schematic partial representation of the shaping tool according to  FIG. 1 . 
           [0022]      FIG. 4  is a partial representation of the shaping tool according to  FIG. 1  in section. 
           [0023]      FIG. 5  is another representation of the shaping tool according to  FIG. 4  in section. 
           [0024]      FIG. 6  is a representation of a nebuliser with an inhaler cartridge produced using the shaping tool according to  FIG. 1 , in section. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    The shaping tool comprises a rod  2  mounted in a hollow shaft  1  and connected to a rotary drive (not shown). An axial up and down movement of the shaping tool is controlled by means of a radially mounted cam roller  3  on the tool side, which cooperates with a cam control. In a housing  4  are various mounting, coupling and spring elements. 
         [0026]    Underneath the housing  4  is secured a pressing member  5  with a conical region  6  and underneath the pressing member  5  are a carrier member  7  and a guide portion  8 , while pivotably mounted in the carrier member  7  are three levers  9  which comprise, at one end, rollers  10  cooperating with the pressing member  5 , while the opposite ends from the rollers  10  act upon slides  11  mounted in the guide portion  8 . Each of the slides  11  has a bending roller  13  and a shaping roller  14  on a spindle  12 . 
         [0027]    By means of the pivotable levers  9 , the bending rollers  13  can be moved out of a position that defines a maximum working aperture for the tool into a position that defines a minimum working aperture for the tool. Specifically, in a downward movement of the rotating shaping tool as indicated by the arrow  16 , a depressor  15  first of all presses directly on a workpiece  17 , namely an inhaler cartridge  36 . As the downward movement continues, the levers  9  are pivoted in the direction of the arrow  18  as a result of the activity of the conical region  6  of the pressing member  5  and the pivoting movement of the lever  9  is converted into a radial advancing movement of the slide  11  in the direction of the arrow  19 , in order to move the bending roller  13  and the shaping roller  14  into their end position in which they describe the minimum working aperture for the tool. When the shaping tool is moved axially upwards, the levers  9  are pivoted by means of radially acting compression springs supported on an intermediate ring  20  so that the bending roller  13  and the shaping roller  14  are moved into a position in which they describe the maximum working aperture for the tool. 
         [0028]    In order to avoid damage to the workpiece  17 , which consists of an aluminium cartridge  21  with a plastic container  38  inserted therein, the lever  9  comprises, according to  FIGS. 1 ,  4  and  5 , two arms  22  articulated to one another, between which a spring-loaded overload prevention device  23  acts. The first arm  22  of the lever  9  comprises an oblong hole  24  through which projects an eccentric bolt  25  fixably connected to the slide  11 . Moreover, a blind bore  26  for a radially acting restoring spring is formed in this arm  22 . The first arm  22  and the second arm  22  of the lever  9  are connected via a common swivel joint  27  to a pin  28  engaging in the carrier member  7 . In the region underneath the roller  10  associated with the pressing member  5 , a spring  29  is arranged on a guide pin  30  such that the second arm  22  is pivotable relative to the first arm  22  of the lever  9  counter to the action of the spring  29 , in order to bias the bending roller  13  relative to the workpiece  17  and equalise the tolerances of the workpiece  17 . In particular the second arm  22  is pivotable relative to the first arm  22  of the lever  9  counter to the action of the spring  29  when the bending roller  13  and the shaping roller  14  have reached their end positions and the pressing member  5  is exerting further force on the lever  9 . 
         [0029]    With the bending rollers  13  a radius  33  is formed in the circumferential edge region of the workpiece  17 , the free edge of the aluminium cartridge  21  being shaped by the fact that it rests on the free end face of the plastic container. The shaping rollers  14  serve essentially to shape two encircling groove-like crimps  34  in a drawn neck region  35  of the workpiece  17 . 
         [0030]    The inhaler cartridge  36  is used in a nebuliser  37  which is used to nebulise a fluid  39 , particularly a highly potent medicament, and is in the form of a portable inhaler that operates without propellant gas. When the fluid  2 , preferably a liquid, is nebulised, an aerosol is formed which can be breathed in by a user (not shown). 
         [0031]    The nebuliser  37  comprises the inhaler cartridge  36  holding the fluid  39 , which can be inserted in the opened nebuliser  37  from below. In order to nebulise a predetermined adjustable amount of the fluid  39 , the nebuliser  37  comprises a pressure generator  41  surrounding a piston, with a holder  42  for the inhaler cartridge  36 , a drive spring  43  with a manually operated release button  44  for releasing the pressure, a conveying tube  40  with a non-return valve  45  inserted, a pressure chamber  46  and a nozzle  47 , with which a mouthpiece  48  is associated. 
         [0032]    As the drive spring  43  is axially tensioned by rotation of a lower housing part  49  with an inner part  50  releasably attached thereto, relative to an upper housing part  51  formed on the mouthpiece  48 , the holder  42  is moved downwards with the inhaler cartridge  36  and the conveying tube  40  and fluid  39  is sucked out of the inhaler cartridge  36  through the non-return valve  45  into the pressure chamber  46  associated with the piston of the pressure generator  41 . During the subsequent abrupt relaxation of the drive spring  43  by actuating the release button  44 , the fluid  39  in the pressure chamber  46  is pressurised by the drive spring  43  moving the conveying tube  40  upwards and is expelled through the nozzle  47 , whereupon nebulisation takes place. The nebulisation takes place for example in particles in the μm range, preferably in particles around 20 μm in size, which form a mist or jet of aerosol. A user is able to inhale the aerosol, while supply air can be sucked in through supply air openings  52  in the mouthpiece  48 . 
       LIST OF REFERENCE NUMERALS 
       [0033]      1 . hollow shaft 
         [0034]      2 . rod 
         [0035]      3 . cam roller 
         [0036]      4 . housing 
         [0037]      5 . pressing member 
         [0038]      6 . conical region 
         [0039]      7 . carrier member 
         [0040]      8 . guide portion 
         [0041]      9 . lever 
         [0042]      10 . roller 
         [0043]      11 . slide 
         [0044]      12 . spindle 
         [0045]      13 . bending roller 
         [0046]      14 . shaping roller 
         [0047]      15 . depressor 
         [0048]      16 . arrow 
         [0049]      17 . workpiece 
         [0050]      18 . arrow 
         [0051]      19 . arrow 
         [0052]      20 . intermediate ring 
         [0053]      21 . aluminium cartridge 
         [0054]      22 . arm of  9   
         [0055]      23 . overload prevention device 
         [0056]      24 . oblong hole 
         [0057]      25 . eccentric bolt 
         [0058]      26 . blind bore 
         [0059]      27 . swivel joint 
         [0060]      28 . pin 
         [0061]      29 . spring 
         [0062]      30 . guide pin 
         [0063]      33 . radius 
         [0064]      34 . crimp 
         [0065]      35 . neck region 
         [0066]      36 . inhaler cartridge 
         [0067]      37 . nebuliser 
         [0068]      38 . plastic container 
         [0069]      39 . fluid 
         [0070]      40 . conveying tube 
         [0071]      41 . pressure generator 
         [0072]      42 . holder 
         [0073]      43 . drive spring 
         [0074]      44 . release button 
         [0075]      45 . non-return valve 
         [0076]      46 . pressure chamber 
         [0077]      47 . nozzle 
         [0078]      48 . mouthpiece 
         [0079]      49 . lower housing part 
         [0080]      50 . inner part 
         [0081]      51 . upper housing part 
         [0082]      52 . supply air openings