Abstract:
An injector apparatus includes a housing ( 10   1   , 10   2 ) for a cartridge or syringe, a plunger ( 40 ) for cooperating in use with the cartridge or syringe to express successive doses, a dose setting arrangement ( 16, 20 ) to select a dose volume, and a drive mechanism ( 22, 24 ) releasable to advance the plunger in respective predetermined increments of magnitude to express the successive doses. The drive mechanism includes a drive spring ( 22 ) for imparting movement directly or indirectly to the plunger ( 40 ), and the dose setting arrangement includes a dose setting element ( 16 ) moveable in a dose setting routine to define a magnitude of an increment of movement of the plunger for a given dose. The drive mechanism further includes a clutch arrangement ( 56 ) operable during the dose setting routine to inhibit forward movement of the plunger and/or to isolate the dose setting element from the force of the drive spring.

Description:
This invention relates to injector apparatus and in particular, but not exclusively, to such apparatus used for injecting multiple doses of variable magnitude, for example of insulin. 
     BACKGROUND OF THE INVENTION 
     In our earlier Autopen® device, a rotatable dose setting knob attached to the rear end of the pen injector is connected to a hollow drive sleeve that carries an annular ratchet surface at its front end which engages a corresponding ratchet surface on a threaded drive collar. The threaded drive collar is threadedly engaged with the stem of a plunger so that rotary movement of the drive collar is converted into a linear advance of the plunger. A trigger can be moved to release the drive collar for rotary movement. During a dose setting routine, with the drive collar held against rotation by the trigger, a dose is dialled in by rotating the dose setting knob and the drive sleeve against a spring bias provided by a main drive spring. The dose setting movement is unidirectional only due to the ratchet action between the drive sleeve and the drive collar. Upon release of the trigger, the drive collar rotates by an angular amount equivalent to the angular amount initially dialled in, and the plunger is advanced by the corresponding amount to deliver the dose of the required number of units. 
     This device performs extremely well and enjoys considerable success but we have identified a number of improvement opportunities. In the above device, in setting a dose the user winds up the spring to provide the motive force that is needed for the next dose. This means that it can be awkward for those of limited dexterity to exert sufficient grip to rotate the dose setting knob against the bias of the drive spring. Also in this design, because the action of dose setting winds up the drive spring, a ratchet action is required so that when the user releases their grip on the dose setting knob, the knob stays in that position and does not immediately return to the zero position under the influence of the drive spring. To allow dose setting reversal in case of setting overshoot, a bi-directional ratchet mechanism is then needed, or otherwise a disconnection mechanism is required, either of which complicate the device. 
     SUMMARY OF THE INVENTION 
     We have therefore designed an injector apparatus in which a clutch arrangement is provided to isolate the dose setting element from the force of the drive spring during the dose setting routine. 
     Accordingly, in one aspect, this invention provides an injector apparatus for use with a cartridge or syringe to deliver a plurality of doses therefrom, the injector apparatus comprising:
         a housing for the cartridge or syringe;   a plunger for cooperating in use with the cartridge or syringe to express successive doses;   a dose setting arrangement to select a dose volume;   a drive mechanism releasable to advance said plunger in respective predetermined increments of magnitude to express said successive selected doses;   characterised in that said drive mechanism includes a drive spring for applying expulsion drive movement directly or indirectly to said plunger, and said dose setting arrangement comprises a dose setting element moveable in a dose setting routine to set a magnitude of an increment of movement of said plunger for a given dose, said drive mechanism further including a clutch arrangement operable during said dose setting routine to isolate said dose setting element from the force of said drive spring and optionally to inhibit directly or indirectly forward movement of the plunger.       

     In an arrangement where the dose setting element is isolated from the force of the drive spring during the dose setting routine, the dose setting element can be rotated easily, and also preferably can be moved in the reverse sense if the user moves the dose setting element past a required dose. Isolating the dose setting element means that the dose-setting movement of said dose setting element is not resisted by said spring. 
     It follows from the above that if the dose setting action does not energise the drive spring, the drive spring needs to be energised in some fashion. Conveniently, the drive spring is preloaded to an extent sufficient to deliver substantially the entire useable contents of the syringe or cartridge in a succession of doses. Where the dose setting element is isolated from the force of the drive spring during the dose setting routine, a more powerful spring may be used than would be appropriate for the conventional user-wound device. Instead of providing a fully preloaded drive spring, the drive spring could be partially preloaded or with no preload but with suitable separate means for energising the spring. It will also be appreciated that in such arrangements the drive mechanism will usually already be under load from the drive spring prior to dose setting, in contrast to prior art devices where the drive mechanism is under load only once the dose has been dialled in. 
     Preferably, the dose setting element is moveable angularly to set said increment of plunger movement. 
     The clutch arrangement preferably includes a clutch element moveable between disengaged and engaged positions. Thus the clutch element may be adapted to move axially with said dose setting element, whereby axial movement of said dose setting element from a first, rest, position to a second, dose setting position causes said clutch element to engage to inhibit movement of said plunger. It is also convenient for the dose setting element and the housing to include complementary abutments that engage to prevent relative rotation of said dose setting element relative to said housing when the dose setting element is in its rest position, but which disengage to allow dose setting rotation of the dose setting element when it is in its setting position. In this manner, the dose setting element may be moved axially from its rest position to its dose setting position, then turned to dial in a required dosage volume, and then returned axially to its rest position to lock it against rotation. 
     Preferably, upon moving the dose setting element from its rest position to its setting position, the clutch engages to inhibit movement of the drive plunger a predetermined distance before the abutments on the dose setting element and the housing disengage to release the dose setting element for dose setting movement. 
     In a preferred arrangement, when the dose setting element is in its rest position, it receives and reacts the thrust of the drive spring so that the dose setting element thereby inhibits movement of the drive plunger. In this manner, when the dose setting element is in its rest position the thrust of the drive spring is reacted by the dose setting element and thence to the housing, but when the dose setting element is in its setting position, the thrust of the drive spring is reacted by the clutch member having engaged with the housing. 
     Preferably, having set a dose, returning the dose setting element axially to its first position disengages the clutch element to release the drive mechanism to cause the plunger to advance by a predetermined increment corresponding to the predetermined set dose. 
     Preferably, said plunger is threadedly engaged with an associated drive or control element whereby advance of said plunger is accompanied by rotation of the plunger or the drive or control element, with the magnitude of the incremental advance being set by constraining said rotation. 
     Preferably a stop member is associated with the dose setting element and is adjustable by moving the dose setting element, thereby to define an angular increment for the relative rotation between the plunger and the drive or control element upon release of the drive mechanism. 
     The stop member could simply be an abutment surface provided on the dose setting element. This would allow the maximum useable extent of angular movement of the dose setting element to be just short of 360°. This would mean that the indicia needed to be fairly closely packed in some instances. Accordingly it is preferred for there to be an intermediate dial or shuttle member threadedly engaged with the dose setting element and constrained to rotate with the rotatable one of the plunger and the control member, with the extent of relative angular movement of the dial or shuttle member and the dose setting element being set by the relative position of the stop member associated with the dose setting element. The provision of a threaded dial or shuttle member means that it is now possible to set a dose of several turns. This has advantages both in terms of the available size for the indicia, and also allows greater flexibility over the choice of the pitch of the thread between the plunger and the control member. In a particularly preferred arrangement, the dosage indicia may be provided as a helical strip on one of said complementary dose setting elements, and read off via a marker or window on the other dose setting element. 
     The drive spring in the various arrangements described above may be either a torsion spring that imparts a rotary movement when released, or a compression spring that imparts a linear movement. 
     In many applications it may be desirable to provide a multiple dose injector device that is supplied preloaded so that it is not necessary to re-energise the drive between each dose, for example if the device is intended to be disposable. 
     Accordingly, in another aspect, this invention provides an injector apparatus for use with a cartridge or syringe to deliver a plurality of doses therefrom, the injector apparatus comprising:
         a housing for the cartridge or syringe;   a plunger for cooperating in use with the cartridge or syringe to express successive doses;   a dose setting arrangement to select a dose volume;   a drive mechanism releasable to advance said plunger in respective predetermined increments of magnitude to express said successive doses;       

     characterised in that said drive mechanism includes a rotary stored energy element with a preload sufficient to deliver at least a plurality of said successive doses. 
     In the above arrangement, the injector apparatus may for example be provided with a fully preloaded spring so that the user is not required to input the mechanical energy required to express the doses. This renders the device particularly suitable for those with limited dexterity or poor grip. 
     As noted above, conventional Autopen® and similar devices have an angular range of dose setting movement that is limited to 360°, and this places constraints on the marking indicia, the pitch of the drive thread, and the properties of the drive spring. We have therefore designed an arrangement in which the dose setting arrangement includes threadedly engaged first and second complementary dose setting elements which enables the dose setting movement to be several turns if required. 
     Accordingly, in another aspect of this invention, there is provided an injector apparatus for use with a cartridge or syringe to deliver a plurality of doses therefrom, the injector apparatus comprising:
         a housing for the cartridge or syringe;   a plunger for cooperating in use with the cartridge or syringe to express successive doses;   a dose setting arrangement to select a dose volume;   a drive mechanism releasable to advance said plunger in respective predetermined increments of magnitude to express said successive doses and in which advance of said plunger is controlled by a control member that moves angularly in response to advance of said plunger;       

     characterised in that said dose setting arrangement includes first and second complementary dose setting elements threadedly engaged for relative threaded movement away from a limit position, with said first dose setting element being moveable relative to said housing in a setting routine from a rest position to a variable angular position that sets the dose volume, and said second dose setting element being constrained to rotate with said control member, 
     whereby on release of said drive mechanism said control member and said second dose-setting element rotate until the second element returns to said first limit position with respect to the first element, thereby preventing further rotation of the control member. 
     According to another aspect, the invention provides an injector apparatus for use with a cartridge or syringe to deliver a plurality of doses therefrom, the injector apparatus comprising:
         a housing for the cartridge or syringe;   a plunger for cooperating with the cartridge or syringe to express successive doses;   a drive mechanism energised by a drive spring, and releasable to advance said plunger in predetermined increments as determined by adjustment of a dose setting element, and   a re-energising element for re-energising said spring independently of movement of said dose setting element.       

     Preferably said drive spring is a torsion spring and said re-energising element is a rotary element, for example a manually rotatable element. 
     According to another aspect, this invention provides an injection apparatus for use with a cartridge or syringe to deliver a plurality of doses therefrom, the injector apparatus comprising:
         a housing for the cartridge or syringe;   a plunger for cooperating in use with the cartridge or syringe to express successive doses;   a dose setting element movable to select a dose volume;   a drive mechanism releasable to advance said plunger in respective predetermined increments of magnitude to express said selected dose volumes, said drive mechanism including a drive spring for providing motive force directly or indirectly to said plunger to advance said plunger, and   the apparatus being configurable between a first position in which the motive force of the drive spring is transmitted via the dose setting element to the housing to be reacted thereby, and a second position in which a clutch element is moved into a position in which motive force of the drive spring is transmitted via the clutch element to the housing to be reacted thereby, so that dose setting movement of the dose setting element is not resisted by the drive spring.       

     Whilst the invention has been described above, it extends to any inventive combination of the features set out above or in the following description of claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may be performed in various ways, and an embodiment thereof will now be described by way of example only, reference being made to the accompanying drawings in which: 
         FIG. 1  is a side view of a first embodiment of pen injector in accordance with this invention: 
         FIG. 2  is a side section view of the pen injector of  FIG. 1 ; 
         FIG. 3  is an exploded view of the pen injector of  FIGS. 1 and 2 ; 
         FIG. 4  is an enlarged view of the main body of the pen injector of  FIGS. 1 to 3 , containing the drive mechanism, with one body half shown transparent; 
         FIG. 5  is a perspective section view of the dose setting knob showing the thread on the inside of the dose setting knob; 
         FIG. 6  is a perspective section view on the rear part of the drive mechanism showing the clutch and dose setting knob and dose dial; 
         FIG. 7  is an exploded view of a second embodiment of pen injector in accordance with the invention having a rewind facility; 
         FIG. 8  is a detailed view of the rewind knob, and 
         FIG. 9  is a side section view of a third embodiment of pen injector driven by a compression spring. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The embodiment of pen injector illustrated in  FIGS. 1 to 6  is designed to be a disposable automatic pen type injector capable of expelling a succession of doses of variable preset magnitude from a cartridge. The injector comprises a body made up of symmetric body halves  10   1  and  10   2  which may be snap-fitted or glued together. A cartridge or syringe  12  is received in a transparent forward cartridge housing  14  which is a snap-fit on the forward end of the body halves  10   1 ,  10   2 . On the rear end of the body is mounted a dose setting knob  16  having a window  18  through which a dose dial  20  is visible. As to be described below, the device contains a preloaded torsion spring which in this particular embodiment supplies the entire force required to express all the useable dosage volume in the cartridge. Doses are set by pulling the dose setting knob  16  rearwardly, rotating it until the required dosage unit is visible on the dose dial and then pushing the dose dial back in to release the drive mechanism to expel the required dose. 
     Referring now more particularly to  FIGS. 2, 3 and 4  the body  10   1 ,  10   2  defines an internal cylindrical space in which a torsion spring  22  is located in an energised state, with the forward end of the spring being anchored on an inner part  23  of the body. A hollow tubular drive shaft  24  is disposed concentrically within the spring having a radial flange  26  which is rotatably held within an annular recess  28  on the forward part of the body to allow rotation of the drive shaft but to prevent axial movement thereof. Towards its rear end, the diameter of the shaft increases at a shoulder  30  in which is provided an anchorage hole  32  for the rear end of the drive spring. When assembled and prior to first use, the torsion spring  22  is fully energised and acts on the drive shaft to rotate it in the dispensing direction. The enlarged portion  34  at the rear end of the drive shaft is provided with upstanding splines  36  adjacent the shoulder  30 , with four of the splines  38  at 90° extending the full length of the enlarged portion  34 . 
     At the front end the drive shaft has an internally threaded bore  39  into which is threaded the lead screw of a plunger  40 . The plunger has an enlarged head  42  which engages the bung  44  of the cartridge  12 . Immediately behind the enlarged head  42  the drive shaft has two diametrically opposed keyways  46  which cooperate with respective keys  48  on the front end of the body halves  10   1  and  10   2 , to allow axial movement of the plunger, but prevent rotation thereof, as the drive shaft  24  rotates to advance the plunger. 
     The dose dial  20  is slideably mounted on the enlarged portion  34  of the drive shaft  24  but prevented from rotation thereof by means of four, internal, equispaced, keyways  50  that engage the longer splines  38  on the enlarged portion. The forward end of the dose dial has an enlarged internal diameter so as to be clear of the shorter splines  36 . The external surface of the dose dial  20  carries a coarse helical thread  21  which threadedly engages a corresponding internal threaded portion  52  on the inner surface of the dose setting knob  16 . The threaded portion  52  on the inside of the dose setting knob  16  has a forward limit position set by termination of the thread (see blind end  54  in  FIG. 5 ). A rear limit position stop may optionally be provided, for example, on the inner part of a hinged cap portion  17  of the dose setting knob. 
     The dose setting knob  16  is connected at its forward end to a clutch collar  56  by means of a snap-fit which allows the clutch and the dose setting knob to rotate relative to each other but secures them against relative axial movement (see  FIG. 6 ). The clutch collar  56  is mounted for axial sliding movement in the body  10  but prevented from rotation with respect thereto by means of two lugs  58  in the body engaging opposed respective slots  60  in the cylindrical wall of the clutch collar  56 . At its rear end, the clutch collar  56  has an internal splined arrangement  57  designed to slide into splined engagement with the splines  36  on the enlarged portion  34  of the drive shaft so as to lock the drive shaft against movement under the influence of the spring by reacting the thrust into the body by via the lugs  58 . Referring now more particularly to  FIGS. 4 to 6 , the forward end of the dose setting knob  16  has a series of axially extending fingers  62  which are an axial sliding fit with a series of pockets  64  provided in the body. 
     The axial lengths of the fingers  62  and of the pockets  64  are carefully selected having regard to the axial spacing between the internal splines  57  on the clutch collar  56  and the external splines  36  on the drive shaft  24  such that, on pulling the dose setting knob  16  out axially, the splines  57  on the clutch collar  56  engage the splines  36  on the drive shaft  24  some distance before the fingers  62  of the dose setting knob  16  are withdrawn axially from the pockets  64  on the body. The reason for this is that, in the position shown in  FIG. 2 , as indicated above, the thrust of the drive spring is transmitted via the drive shaft splines  38  to the dose dial  20  and thence to the dose setting knob  16  (by virtue of the dose dial being at its forward limit position relative to the dose setting knob). It is therefore important to ensure that the clutch  56  has engaged the drive shaft  24  to react the load of the torsion spring  22  through the clutch  56  and the lugs  58  to the housing before the dose setting knob has withdrawn enough to rotate. 
     Once the dose setting knob has been withdrawn far enough to disengage the fingers  62  from the pockets  64 , it is in a setting position in which it may be rotated to set a dose against a light detent action provided by the fingers  62 , which provide a audible/tactile click to enable the user to count the number of units dialled in. It will be appreciated that during dose setting, the body  10 , drive shaft  24 , clutch  56  all remain stationary, both axially and rotationally. The dose dial is fixed against rotation due to its splined engagement with the large portion  34  of the drive shaft but is capable of moving axially. Thus in this condition, with the dose setting knob  16  axially in its setting position, rotation of the dose setting knob in the appropriate direction moves the dose dial  20  axially in a lead screw fashion. The dose dial numbers are visible through the window  18 . The threaded arrangement allows multiple turns of the dose setting knob. Also at this point there is no loading between the dose dial and the cap and so there is little resistance to rotary movement of the dose setting knob apart form that provided by the detent. 
     Once the required dose has been dialled in on the helical scale, the device is ready for firing. In this arrangement this is achieved by pushing the dose setting knob  16  back in. As the dose setting knob is pushed back in, the fingers  62  re-engage the pockets and thereafter the clutch  56  is shifted forwardly off the enlarged portion of the drive shaft to disengage it so that the drive shaft is now free to rotate. The drive shaft rotates by the angular amount dialled in. 
     In the above arrangement, as the setting of the dose is independent of the drive spring, the operating stroke length and force can be reduced to design a device in which a large dose is delivered with a small movement and force. This contrasts with existing devices in which the user has to apply a large user movement to set a dose and/or expel the set dose. 
     There is a potential issue in existing multi-dose devices in which after expulsion of a dose the plunger remains in contact with the bung. Due to the friction between the bung and the cartridge wall and its resilience, at the end of an injection the bung will be under residual compression. Vibrations transmitted to the bung either via the plunger or the wall of the cartridge can cause the bung to expand slightly and expel a drip which can affect dose accuracy. As a modification of the above embodiment the clutch arrangement can be designed so that, as it is pulled to disengage, it backs off the plunger  40  from the bung  44  a fraction, so that the bung  44  is unloaded. 
     This unloading effect may be achieved for example by putting a slight form on the splines  57  of the clutch collar  56  and on the splines  36  of the drive shaft  24  so that, as the dose setting knob is pulled out to engage the clutch collar  56  on the drive shaft, the drive shaft is rotated a few degrees against the spring bias to unload the bung. 
     Whilst in this embodiment the body is formed in two separate halves it may instead be formed in a clamshell type arrangement where the two halves are hinged by a live hinge. 
     In order to ease manufacture, the torsion spring in the illustrated embodiment may be formed with a wave or compression portion at its forward end to apply a light axial load to the cartridge in order to hold the cartridge firmly in a forward position. This allows variations in length due to production variances to be accommodated. Furthermore although the wire that is coiled to make the spring may be circular in section in some applications it is preferred for it to be non-circular, such as of square or rectangular section. 
     Referring now to  FIGS. 7 and 8 , a second embodiment provides an arrangement for rewinding the plunger  40  and simultaneously energising the drive spring  22  (see  FIGS. 3 and 4 ) of the first embodiment. In the second embodiment most of the components are similar to those of the first embodiment and will not be described again and will be given like reference numerals. Referring to  FIG. 7 , the forward part of the housing which defines the keys  48  that engage the keyways  46  on the lead screw of the plunger is formed as a separate rewind knob  70  which is uni-directionally rotatable about the longitudinal axis of the housing. The knob  70  is formed in two halves  70   1 ,  70   2  and defines a central aperture with the diametrically opposed keys  48 . The knob  70  has an outer circumferential groove  72  in the base of which are two diametrically opposed sprung ratchet teeth  74 , as seen in  FIG. 8 . The knob  70  is rotatably received in the forward end of the housing by means of an inwardly directed toothed annular rib  76  locating in the groove  72  and cooperating with the ratchet teeth  74  to allow rotation in one direction only. The rear end of the rewind knob  70  is provided with two slots  76  into one of which the front end of the torsion drive spring  22  (not shown) is anchored. Engagement of the keys  48  on the knob  70  with the keyways  46  on the lead screw of plunger  40  ensures that the plunger  40  rotates with the knob in one direction only but is capable of axial sliding movement. The knob and the plunger may therefore be rotated in the direction permitted by the ratchet to wind up the drive spring  22  and to retract the plunger back into the driveshaft  24  by virtue of the threaded engagement between the lead screw of the plunger  40  and the driveshaft. 
     The rewind knob will normally be accessible only when the cartridge housing (see first embodiment) has been removed from the body. 
     In the above arrangements, a torsion spring provides the motive force for expelling the useable contents of the cartridge. It would of course be possible to use other suitable drive configurations. For example, as shown in  FIG. 9 , the torsion spring could be replaced by a compression spring  80  which acts on the plunger  82  to apply a thrust in the longitudinal direction. In this case, instead of the drive shaft there is a drive control shaft  84  that is used to modulate forward movement of the plunger  82  under the influence of the compression spring  80 . 
     The rear end of the plunger  82  is formed with a threaded portion which threadedly engages an internal bore on the drive control shaft  84  so that as the plunger  82  is urged forwardly by the compression spring the drive control shaft rotates. The drive control shaft  84  is formed at its rear end with an enlarged portion  34  provided with upstanding splines  36  similar to those of the drive shaft  24  of the first embodiment, and fulfilling a similar function in conjunction with a clutch collar  56 , the dose setting knob  16  and the dose dial  20  of the first embodiment. The construction and operation of these elements will not be described in detail again. As previously, the drive control shaft  84  is alternately held and released by the clutch collar  56  and the dose setting knob  16 .