Abstract:
A medicament delivery device comprises a housing, a holder within the housing for receiving a medicament cartridge, a piston rod for driving a bung of the medicament cartridge, a drive mechanism including a motor for providing an output drive to the piston rod for delivering the medicament and control means for controlling operation of the device. The device is additionally provided with a bung sensor for sensing when the piston rod is in contact with the bung and the control means is operative for advancing the drive of the piston rod towards the bung.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 13/145,835, filed Dec. 6, 2011, which is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2010/051272 filed Feb. 3, 2010, which claims priority to EP Patent Application No. 09001576.9 filed on Feb. 5, 2009. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
     
    
     FIELD OF INVENTION 
       [0002]    This invention relates to medicament delivery devices for delivering medicine to the human or animal body and in particular to electronically controlled auto-injectors having a replaceable medicament cartridge. Such devices are commonly used by those with diabetes for the administration of insulin. 
       BACKGROUND 
       [0003]    Medicament delivery devices are routinely used by persons without formal medical training, i.e. patients where self-management of their condition is increasingly common. These circumstances set a number of requirements for medicament delivery devices of this kind The injector should be robust in construction, yet easy to use in terms of its operation by a user and the manipulation of the parts. In the case of those with diabetes, many users will be of impaired vision and may also be physically infirm. Devices that are too large or cumbersome may therefore prove difficult to use, particularly someone with reduced dexterity. 
         [0004]    U.S. Pat. No. 5,989,221 describes an electronically controlled injection device in which the readying of the device for administering and the subsequent drug delivery therefrom is controlled by an electronic control unit. Specifically, the control unit comprises a position or attitude sensor for transmitting a signal so that the readying of the device cannot take place unless the longitudinal axis of the injection cartridge is in a predetermined direction. This is in the context of removing air or mixing drug components. The control unit is also operative for driving a piston rod a predetermined distance for delivery of a drug dose. 
         [0005]    In such prior art devices, the user is still required to prime the device after installation of the medicament cartridge. Moreover, such devices may under dose particularly in cases where the medicament cartridge is not properly seated within the device after insertion by the user. 
       SUMMARY 
       [0006]    It is an aim of the present invention to provide a medication delivery device where replacement of the medicament cartridge is easier to carry out by the user. 
         [0007]    According to the present invention, there is provided a medicament delivery device for delivering a medicament to a patient, wherein the medicament delivery device comprises: a housing; a holder within the housing for receiving a medicament cartridge; a piston rod for driving a bung of the medicament cartridge; a drive mechanism including a motor for providing an output drive to the piston rod for delivering the medicament; and control means for controlling operation of the device; characterised in that:
       a bung sensor is provided for sensing when the piston rod is in contact with the bung;   wherein the control means is operative for advancing drive of the piston rod towards the bung.       
 
         [0010]    In a preferred embodiment, the control means is operative for advancing the drive of the piston rod until the bung sensor senses that the piston rod is in contact with the bung. A latch sensor may be provided for sensing the position of the holder as the holder moves from an open position to a closed position. In this case, the control means is operative for advancing the drive of the piston rod only when the latch sensor senses the holder is in the closed position. 
         [0011]    Furthermore, a cartridge sensor may be provided for sensing the presence of a medicament cartridge in the holder. In this embodiment, the control means is operative for advancing the drive of the piston rod when the cartridge sensor senses the presence of the medicament cartridge and the latch sensor senses that the holder is in a closed position. 
         [0012]    The control means is operative to stop further advancement of the piston rod: a) when the bung sensor senses that the piston rod is in contact with the bung; or b) when the cartridge has moved to a seated position within the housing after initial contact between the piston rod and the bung. In this case, the force needed to actuate the bung sensor is greater than the sliding friction between the cartridge and the holder. The holder may include a door of the medicament delivery device. The control means may be operative for advancing the piston rod drive when the cartridge sensor senses that the medicament cartridge is in a predetermined (i.e. ‘correct’ or ‘seated’) position relative to the holder to deliver a dose of medicament. 
         [0013]    In an alternative embodiment, the latch sensor and the bung sensor may each generate sensor signals that are combined so that the combined signal sent to the control means indicates that the cartridge is present and/or in the correct position when the piston rod contacts the cartridge bung. 
         [0014]    In another embodiment, the control means is operative to backwind the piston rod by a predetermined amount when the bung sensor senses that the piston rod is in contact with the bung. This is advantageous in the case where the bung sensor is in the form of a dome switch or other pressure switch (including solid state switches and pressure switches), thus leaving the dome switch in an open position. For dosing, the control means drives the piston rod by an amount that compensates for this backwind. 
         [0015]    Any one or all of the cartridge, latch and bung sensors may be switches that signal their respective sensing function to the control means. 
         [0016]    Embodiments of the present invention are advantageous in that the medicament delivery device automatically advances the piston rod towards the cartridge bung when a cartridge is present and the door/holder of the injector is closed. This simplifies the number of operations for the user, including avoiding a need for the user to dial an air-shot dose to position the piston rod against the bung. Battery life is saved by avoiding drive of the piston rod when no cartridge is present. As the cartridge is properly or fully seated within the holder, a further advantage is that the likelihood of under-dosing following insertion of a new or used cartridge is reduced. 
         [0017]    The term “medicament delivery device” according to instant invention shall mean a single-dose or multi-dose or pre-set dose or pre-defined, disposable or re-useable device designed to dispense a user selectable or pre-defined dose of a medicinal product, preferably multiple doses, e.g. insulin, growth hormones, low molecular weight heparins, and their analogues and/or derivatives etc. Said device may be of any shape, e.g. compact or pen-type. Dose delivery may be provided through a mechanical (optionally manual) or electrical drive mechanism or stored energy drive mechanism, such as a spring, etc. Dose selection may be provided through a manual mechanism or electronic mechanism. Additionally, said device may contain components designed to monitor physiological properties such as blood glucose levels, etc. Furthermore, the said device may comprise a needle or may be needle-free. In particular, the term “medicament delivery device” may refer to a needle-based device providing multiple doses having an electrical drive mechanism, which is designed for use by persons without formal medical training such as patients. Preferably, the drug delivery device is of the automated-type, i.e. an auto-injector. 
         [0018]    The term “housing” according to instant invention shall preferably mean any exterior housing (“main housing”, “body”, “shell”) or interior housing (“insert”, “inner body”) having a unidirectional axial coupling to prevent proximal movement of specific components. The housing may be designed to enable the safe, correct, and comfortable handling of the drug delivery device or any of its mechanism. Usually, it is designed to house, fix, protect, guide, and/or engage with any of the inner components of the drug delivery device (e.g., the drive mechanism, cartridge, plunger, piston rod) by limiting the exposure to contaminants, such as liquid, dust, dirt etc. In general, the housing may be unitary or a multipart component of tubular or non-tubular shape. Usually, the exterior housing serves to house a cartridge from which a number of doses of a medicinal product may by dispensed. 
         [0019]    The term “motor” according to the instant invention shall preferably mean any motorised means for driving the gearing system and ultimately the input drive means. In the instant invention a stepper motor is preferably utilised although any means for driving the gearing system or the drive means, including a mechanical or manual actuation means, may also be incorporated into the device. 
         [0020]    The “proximal end” of the device or a component of the device shall mean the end, which is furthest away from the dispensing end of the device. 
         [0021]    The “distal end” of the device or a component of the device shall mean the end, which is closest to the dispensing end of the device. 
         [0022]    Devices embodying the invention may be usefully deployed in re-useable medicament delivery devices that comprise replaceable medicament cartridges and may also be deployed within an auto-injector device. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0023]    The invention will now be further described by way of example with reference to the accompanying drawings, in which like reference numerals designate like elements: 
           [0024]      FIG. 1  is a front view of a medicament delivery device that may include an embodiment of the present invention; 
           [0025]      FIG. 2  is a front view of the medicament delivery device of  FIG. 1  with a medicament cartridge door shown in an open position for receiving a medicament cartridge; 
           [0026]      FIG. 3  is a perspective view of a cartridge sensor/switch; 
           [0027]      FIG. 4  is a sectional view taken along line A-A of  FIG. 3 ; 
           [0028]      FIG. 5  is a perspective view of a bung sensor/switch; and 
           [0029]      FIG. 6  is a transparent view of the medicament delivery device of  FIG. 2  to show the door or holder sensor/switch. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    In  FIG. 1 , a medicament delivery device  1  comprises a case  2  having a display  3  for displaying functional information relating to the operation of the medicament delivery device, including the set dose, number of doses remaining in the medicament cartridge. User interface buttons  4 ,  5  and  6  are provided to allow the user to operate the injector including priming, setting a dose, opening a medicament cartridge holder and door  7 , and activating the dispensing of the set dose. A threaded needle attachment  8  is provided to which a needle can be attached for dose delivery and subsequently removed and discarded. A cover (not shown) may be provided to fit over the lower portion of the case  2  to assist in protect the device from the ingress of particles and fluid.  FIG. 2  shows the medicament delivery device  1  with the cartridge holder and door  7  in an open position for receiving a replacement medicament cartridge  9 . 
         [0031]      FIG. 3  shows the cartridge holder and door  7  in more detail, with the cartridge  9  seated therein. The holder  7  is pivotally fixed to the case  2  by an attachment  11  so that the holder  7  can move between an open position (see  FIG. 2 ) and a closed position (see  FIG. 1 ). An arm  13  extends into the case  2  and has a stop  15  to limit the outward extent of the door/holder  7  in the direction of arrow B. The stop  15  may also engage a latch switch or sensor  16 , as shown in  FIG. 6 , which is provided for sensing when the holder  7  moves from an open or a closed position. An actuator/lever  17  is provided for sensing the presence of the cartridge  9  and closure of the holder  7  within the case  2 .  FIG. 4  is a sectional view taken along line A-A of  FIG. 3  and shows the cartridge  9  and the actuator/lever  17 . In this embodiment, the lever  17  forms part of a contact switch  19  that has a displaceable contact  21 . This displaceable contact  21  is moved to change the state of the switch  19  when the cartridge is received in the holder  7 . The lever  17 , contact switch  19  and displaceable contact  21  together form a cartridge sensor. 
         [0032]      FIG. 5  is a perspective view of a telescopic piston rod assembly  23  that comprises slidable components  25  and  27  which telescope within a housing  29 . The assembly  23  is provided with a dome switch  31  at the end thereof that contacts a bung  20  of the cartridge  9 . The dome switch  31  is connected to a flexible PCB element  33  that extends within the components  25  and  27 . The element  33  emerges from the other end thereof, through the housing  29  to terminate at a contact  35 . The contact  35  is coupled to a control means (not shown) that is operative for controlling the device, including the drive of the piston rod. 
         [0033]      FIG. 6  is a transparent view of the medicament delivery device of  FIG. 2  and shows the approximate location of the latch switch or sensor  16  and the stop  15  within the device. Although shown as a contact switch, it may be appreciated that the latch switch or sensor may alternatively be a mechanical latch or any other switch or sensor known in the art. 
         [0034]    The operation of the medicament delivery device  1  is as follows. The latch sensor  16  is provided for sensing when the holder  7  moves from an open or closed position and the bung sensor  31  is operative for sensing when the piston rod  25 ,  27  is in contact with the bung  20 . The control means is operative for advancing drive of the piston rod  25 ,  27  towards the bung  20  provided that the latch sensor  16  senses that the holder  7  has moved to a closed position. The control means is operative for advancing the drive of the piston rod  25 ,  27  until the bung sensor  31  senses that the piston rod is in contact with the bung  20 . 
         [0035]    A cartridge sensor  17 ,  19 ,  21  is provided for sensing the presence of a medicament cartridge  9  in the holder  7 . In this case, the control means is operative for advancing the drive of the piston rod  25 ,  27  when the cartridge sensor  17 ,  19 ,  21  senses the presence of the medicament cartridge and the latch sensor  16  senses that the holder  7  has moved from an open position to a closed position. 
         [0036]    It may also be beneficial for the cartridge sensor  17 ,  19 ,  21  to only be operative after the latch sensor  16  detects whether the holder  7  has been opened or closed. While the holder is not in a closed position, it is not necessary to monitor the cartridge sensor. This may increase battery life of the device. 
         [0037]    In this case, in order to load a medicament cartridge  9  into the device  1 , the holder  7  (without a cartridge) may be opened to the position shown in  FIG. 2 . The movement of the holder  7  from the closed position to the open position is detected by the latch sensor  16 . The signal from the latch sensor  16  prompts the control means to watch the cartridge sensor  17 ,  19 ,  21  to determine if a medicament cartridge  9  is present. In the present case, no cartridge is present, so no signal is detected. Therefore, the control means does not advance the drive of the piston rod  25 ,  27 . This also aids battery life. 
         [0038]    A medicament cartridge  9  may then be placed into the holder  7  and the holder closed. As the holder  7  closes, the latch switch  16  detects the movement of the holder, prompting the control means to watch the cartridge sensor  17 ,  19 ,  21 . As a medicament cartridge  9  is present within the holder  7  and the holder is closed, the displaceable contact  21  is in contact with the switch  19 , indicating the presence of a medicament cartridge. As both the latch sensor  16  and the cartridge sensor  17 ,  19 ,  21  have sensed that the holder  7  is closed and the medicament cartridge  9  is present, the control means is operative for advancing the drive of the piston rod  25 ,  27 . 
         [0039]    The control means is operative to stop further advancement of the piston rod  25 ,  27 : a) when the bung sensor  31  senses that the piston rod is in contact with the bung  20 ; or b) when the cartridge  9  has moved to a seated position within the holder (see  FIG. 3 ) after initial contact between the piston rod and the bung. In this case, the force needed to actuate the bung sensor  31  is greater than the sliding friction between the cartridge  9  and the holder  7 . The holder  7  may include a door of the medicament delivery device  1 . The control means may be operative for advancing the piston rod drive when the cartridge sensor  17 ,  19 ,  21  senses that the medicament cartridge  9  is in a predetermined (i.e. ‘correct’ or ‘seated’) position relative to the holder to deliver a dose of medicament. 
         [0040]    In an alternative embodiment, the latch sensor  16  and the bung sensor  31  may each generate sensor signals that are combined so that the combined signal sent to the control means indicates that the medicament cartridge  9  or holder  7  is present and/or in the correct position when the piston rod  25 ,  27  contacts the cartridge bung  20 . 
         [0041]    As the bung sensor  31  is in the form of a dome switch, the control means is operative to backwind the piston rod  25 ,  27  by a predetermined amount when the bung sensor  31  senses that the piston rod is in contact with the bung  20 .