Patent Publication Number: US-2022211949-A1

Title: An adaptor for a medicament delivery device and a related method

Description:
FIELD OF THE INVENTION 
     The present invention relates to medication management. In particular, it relates to an adaptor for a medicament delivery device such as a syringe, the adaptor configured to enable one or more set dosages of a medicament to be drawn into and/or expelled from the device. 
     BACKGROUND OF THE INVENTION 
     Critically unwell neonates are the most vulnerable population in terms of medication dose errors. Studies have shown that medication errors with the potential to cause significant harm are three times more likely in neonatal intensive care units than in adult wards. Due to the increased need for dose calculations, dilution and manipulation of medicines, a substantial proportion of preventable dose errors are reported to be 10 and 100 fold errors. In fact, a study conducted in 2000 showed that 8% of dosing errors in a paediatric hospital were 10-fold in magnitude and another study highlighted that 31% of prescriptions in a neonatal unit were for doses less than 10% of the contents of the vial and 4.8% are for doses less than 1% of the vial, demonstrating just how easy it is to give a fatal dose to a vulnerable neonate in this clinical environment. 
     Syringe dosing errors generally arise in two areas, being pharmacy dispensing of the dose and drawing of the dose into the syringe. 
     To date, technological innovations to reduce dose errors in neonates have focused on infusion rate, along with some simple physical stroke limiters for use with syringes. However there is no complete system that can reduce errors at the calculation, dispensing and administration stages of liquid dose administration. Even the most advanced (cloud-integrated) infusion pump systems used in some hospitals can be mistakenly overridden in the ward without controls or immediate traceability. 
     Reference to any prior art in the specification is not an acknowledgment or suggestion that this prior art forms part of the common general knowledge in any jurisdiction or that this prior art could reasonably be expected to be understood, regarded as relevant, and/or combined with other pieces of prior art by a skilled person in the art. 
     SUMMARY OF THE INVENTION 
     In one aspect, the present invention provides an adaptor for a medicament delivery device, the adaptor configured to enable a set dosage of a medicament to be drawn into and/or expelled from the device, the adaptor including: a body configured to be coupled to the device; an attachment portion movable with respect to the body and configured for attachment with a first part of the device; an engaging portion movable with the attachment portion; and a receiver configured to receive a movement constraint guide (MCG) and facilitate engagement between the engaging portion and the MCG; wherein the MCG includes one or more physical features defining at least an aspect of the set dosage; and wherein activation of said first part of the device to draw and/or expel the medicament is stopped when the set dosage is reached by engagement between the engaging portion and at least one of the one or more physical features of the MCG. 
     Advantageously, the present invention allows for a controlled dosage of fluid to be drawn in and/or expelled from the medicament delivery device, thereby substantially reducing the possibility of delivering a dosage of medicament that is not commensurate with the set dosage, particularly as it pertains to limiting the possibility of an overdose. This is achieved by using the one or more physical features of the MCG to limit the movement of the first part of the device. 
     The medicament delivery device is preferably a syringe for delivery of a fluid medicament, said first part of the device being a syringe plunger, activation of said first part of the device being movement of the syringe plunger. 
     In an alternative form, the medicament delivery device is a receptacle for delivery of medicament in solid (or part-solid) form, such as pills, capsules or tablets, said first part of the device comprising a mechanism to dispense the medicament elements in prescribed quantities, activation of said first part of the device being operation of said dispensing mechanism. 
     The MCG is preferably a planar element, such as a card of rectangular or other suitable form, the receiver having a complementary shaping to receive said element. The planar element may be flat or of curved form, such as arcuately curved in a part-cylindrical form. The MCG may be flexible if desired, allowing it to be positioned in the receiver through manipulation and flexion. 
     Alternatively, the MCG may take any other appropriate form, provided it is able to interact with the engaging portion to selectively limit the movement of the attachment portion and hence activation of the first part of the device. In a very simple form, for example, the MCG may be a block of a suitable material (such as a rectangular prism) which can be inserted into the receiver, the block of a particular dimension selected to limit movement of the engaging portion beyond a certain point. As will be understood, the MCG acts as a ‘key’, used to unlock the required medicament dosage from the device. The MCG may carry or be formed with a track providing said one or more physical features for guiding movement of a part of said engaging portion and thus movement of said first part of the device. In one form, the engaging portion and the attachment portion may be provided by a single unit, either an integral unit or an assembly of parts. 
     The set dosage may be a single dose or a prescribed dosing regime. In the latter case the MCG is configured to delimit more than one dose. 
     In one embodiment, the MCG may carry or be formed with a plurality of tracks. For example, the MCG may include a first track having said one or more physical features for guiding movement of a part of said engaging portion and thus movement of said first part of the device, and may also include a second track having one or more additional physical features configured to afford control of (and, optionally, and indication of) a number of doses of the medicament drawn and/or expelled. 
     In an embodiment, the engagement portion comprises an engaging element configured to be biased towards the MCG, and thereby allow the engaging element to engage the one or more physical features of the MCG when the MCG is suitably positioned in the receiver. The engaging element is preferably biased by a suitable fitted spring. 
     As the user is drawing and/or expelling the medicament from the medicament delivery device, the movement of the first part is stopped when engagement between the engaging portion and the one or more physical features of the MCG takes place. This indicates that the set dosage has been reached. 
     In another embodiment, the adaptor includes a second engaging portion movable in relation to the first engaging portion and configured to engage one or more additional physical features of the MCG. Engagement between the second engaging portion and the one or more additional physical features of the card may provide guidance to the number of dosages that can be administered (as well as, preferably, an indication of the number of dosages that have been administered). 
     Accordingly, in one form, engagement between the second engaging portion and the one or more additional physical features of the MCG may preclude further activation of said first part of the device to draw and/or expel the medicament when the set number of dosages to be administered has been reached. Preferably, the second engaging portion comprises a second engaging element configured to be biased towards the MCG, and thereby allow the second engaging element to engage the one or more additional physical features of the MCG when the MCG is suitably positioned in the receiver. The second engaging element is preferably biased by a biasing means, such as a spring. 
     In an embodiment, the engaging portion is adapted to be directly coupled to the attachment portion. This provides a simplified arrangement, whereby movement of the attachment portion, directly translates into movement of the engaging portion. 
     The one or more physical features (and, where applicable, the one or more additional physical features) may be protrusions or recesses on a surface of the MCG that provides abutment surfaces for the engaging portion. As discussed above, the one or more physical features may take the form of a track or tracks for guiding movement of said engaging portion, which may be a through-slot or a slot-like recess in the MCG. In an embodiment, the physical features include one or more frangible portions. When the engaging portion engages a frangible portion of the MCG, the frangible portion is ruptured. The MCG of this embodiment is therefore a consumable part that can be replaced by another MCG after is has been used. The rupturing of the frangible portions can provide an indication to a user that that the set dosage has been drawn and/or expelled from the medicament delivery device. 
     Alternatively, the MCG may be re-usable, i.e. not consumable after a single use. For example, a given MCG may be configured to provide a fixed set dosage when used. A user may use such a MCG whenever they intend to administer the fixed dosage. In another embodiment, the MCG may be adaptable to provide a desired dosage for a specific patient. 
     The one or more physical features (and, where applicable, the one or more additional physical features) of the MCG may define the set dosage in different forms. In one embodiment, the one or more physical features may be a defined pathway, wherein the path defines the amount of movement of the first part and thus the amount of medicament drawn into and/or expelled from the medicament delivery device. The pathway may alternatively or in addition define a plurality of set dosages. In one embodiment, the MCG may include multiple pathways, each pathway configured to engage a respective engaging portion and to define a set dosage. 
     In an embodiment, the MCG may be in the form of a punch card having one or more indications thereon for use in selecting the set dosage. The set dosage may be selected by marking or punching the punch card at or adjacent one or more of said indications. 
     In an embodiment, the first engaging portion is configured to move along a first track of the MCG and the second engaging portion is configured to move along a second track of the MCG. The first track may define a dosage volume of the set dosage and the second track may define a number of dosages of the set dosage. 
     In an embodiment, the adapter includes a retaining structure movably mounted to the body. Preferably, the retaining structure is mounted adjacent the second track. Preferably, the retaining structure is arranged to constrain the second engaging portion to incremental movement relative to the first engaging portion. In one form, the retaining structure is in the form of a sawtooth rack. 
     It is preferred that the MCG be specific for a given patient. For example, the MCG may include one or more smart features, such as an encoded element configured to provide patient specific information to an external device. The external device may be a computer, a smartphone, or the like. The patient specific information may include dosage information, identification information, etc. 
     In another aspect, the present invention provides a method for controlling medicament administration, including the steps of: recording prescription information regarding a medicament, a dosage and a patient to whom the medicament is to be administered; providing for production of a movement constraint guide (MCG), the MCG including: one or more physical features defining at least an aspect of the dosage; and one or more readable identification features including one or more pieces of the prescription information; recording administration information associated with the use of the MCG with a medicament delivery device; the administration information including: data produced by reading said one or more readable identification features from the MCG; and an indication of delivery of the dosage of the medicament to the patient by way of the medicament delivery device operating under constraints imposed by the interaction of the physical features of the MCG with the medicament delivery device. 
     In another aspect, the present invention provides a non-transitory computer-readable medium containing instructions which when executed on a processor performs the method of the previous aspect. 
     Thus, the present invention can provide an integrated dose management and hardware governing system, a generally mechanical recording function and optical recognition module for safely delivering medicaments. 
     As used herein, except where the context requires otherwise, the term “comprise” and variations of the term, such as “comprising”, “comprises” and “comprised”, are not intended to exclude further additives, components, integers or steps. 
     Further aspects of the present invention and further embodiments of the aspects described in the preceding paragraphs will become apparent from the following description, given by way of example and with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an upper isometric view of an adaptor in accordance with an embodiment of the present invention; 
         FIG. 2  is an upper plan view of the adaptor of  FIG. 1 ; 
         FIG. 3  is an upper isometric exploded view of a pin assembly in accordance with an embodiment of the present invention; 
         FIG. 4  is an front exploded view of the pin assembly of  FIG. 3 ; 
         FIG. 5  is an upper plan view of a smart card in accordance with an embodiment of the present invention; 
         FIG. 6  is a front view of an upper assembly of an adaptor in accordance with another embodiment of the present invention; 
         FIG. 7  is an upper isometric view of a base of an adaptor in accordance with another embodiment of the present invention; 
         FIG. 8  is an upper isometric view of a pin assembly in accordance with another embodiment of the present invention; 
         FIG. 9  is an upper isometric view of an inner longitudinal track component in accordance with another embodiment of the present invention; 
         FIG. 10  is an upper isometric view of a helical track component in accordance with another embodiment of the present invention; 
         FIG. 11  is an upper isometric view of an outer longitudinal track component in accordance with another embodiment of the present invention; 
         FIG. 12  is an isometric view of a card receiver insert part in accordance with another embodiment of the present invention; 
         FIG. 13  is an upper isometric view of an assembled adaptor in accordance with another embodiment of the present invention; 
         FIG. 14  is an isometric view of a smart card in accordance with another embodiment of the present invention; 
         FIGS. 15A-15H  illustrate plan views of an adaptor in accordance with a further embodiment of the invention in various operational states. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       FIGS. 1 and 2  show a first embodiment of an adaptor  10  configured for coupling to a syringe (not shown). The adaptor comprises a housing  12 , with a planar base  13  arranged along the longitudinal direction of the syringe, sidewalls  14 ,  15 ,  16 ,  17  extending perpendicularly therefrom, and a top cover (not shown). As described herein, the longitudinal direction of the syringe is parallel with the y-axis of housing  12  as shown. The x-axis is transverse to the longitudinal direction and parallel with the planar base  13 . The z-axis is perpendicular to the x and y-axis, i.e. sidewalls  14 ,  15 ,  16 ,  17  extend in the z-direction. 
     Extending perpendicularly outwardly from side wall  17  in the x-direction is flange coupling portion  18 , which is adapted to attach to or support the flange of the barrel of the syringe. The flange coupling portion  18  provides support for the housing  12  when the barrel and plunger are moved relative to one another whilst the adaptor  10  is coupled to the syringe, as described in further detail below. The end of the flange coupling portion  18  distant from housing  12  has a circular bore as shown, dimensioned for receiving the barrel of the syringe. 
     The adaptor  10  is connected to a plunger of the syringe by a substantially L-shaped linking member  22 , which at one end is received within housing  12  and at the other end is connectable to the plunger. Linking member  22  includes a first leg  23  extending longitudinally in the y-direction and a second, exterior leg  24  connected thereto and extending transversely in the x-direction away from housing  12 . First leg  23  passes through a complementary shaped aperture in sidewall  16  and connects within housing  12  to pin assembly  30 , as explained below. The end of second leg  24  away from housing  12  is provided with a plunger coupling portion  25  adapted to connect to or bear against the plunger of the syringe, plunger coupling portion  25  provided with a circular bore in line with the bore of flange coupling portion  18 . In this way, movement of the plunger in the y-direction (with the syringe barrel held by flange coupling portion  18 ) results in a corresponding movement of the linking member  22  in the y-direction. 
     The pin assembly  30  is illustrated in  FIGS. 3 and 4 . Pin assembly  30  is arranged in the x-direction and comprises three parts, a head part  32 , a body part  34  and a cap part  36 . Head part  32  is integrally formed from two generally tubular portions connected in a substantially T-shape, with a first tubular portion  31  forming the top bar of the T and a second tubular portion  33  forming the depending leg of the T. The first tubular portion  31  extends in the z-direction, having closed ends and a longitudinally-extending rectangular shaped through-hole  35  therethrough. Through-hole  35  is adapted to receive a sliding tracking bar  40 , as detailed below. Projecting into the housing  12  from the closed end of first tubular portion  31  is a pin  37 , configured to engage a track in a smart card  60  (see  FIG. 5 ). Second tubular portion  33  extends in the x-direction, having an open end at the end furthest from the first tubular portion  31 . A longitudinal rectangular shaped through-hole  38  is provided in second tubular portion  33 . 
     Body part  34  is generally tubular in form, similar to that of the second tubular portion  33  of part  32 , with an open end and a closed end. Body part  34  has an internal diameter complementary to the external diameter of portion  33  to receive the latter from its open end in a sliding manner, the two configured to house therebetween a suitably sized compression spring (not shown), as discussed below. In the assembled state of pin assembly  30 , a locking pin (not shown) extends through through-holes  38  and  39  to prevent separation of the parts. Hence, as will be understood, body parts  32  and  34  are connected in a telescoping arrangement in their longitudinal direction, the compression spring urging them apart and the locking pin precluding their separation. 
     Extending in the x-direction externally from the closed end of body part  34  is a shaped projection  41  configured to be received in a corresponding recess in the cap part  36 . When pin assembly  30  is appropriately positioned inside housing  12 , the projection  41  extends from the body part  34  and through a channel  43  in an internal divider wall  19 , which as shown (see  FIG. 1 ) extends from planar base  13  of housing  12  parallel to sidewalls  15  and  17  (ie. lying in the yz plane). Projection  41  is received by the cap part  36  on the other side of the divider wall  19 . On the side opposed to the recess, cap part  36  also includes a central shaped projection  42  to be received in a corresponding recess at the distal end of first leg  23  of linking member  22 . Therefore, by way of these connections, linking member  22  and pin assembly  30  can move with one another in the y-direction, while the head part  32  can move relative the rest of pin assembly  30  in the x-direction. 
     Movement of pin assembly  30  in the x-direction is facilitated by sliding tracking bar  40 . Bar  40  is an elongate member extending in the y-direction that passes through the through-hole  35  of tubular portion  31  of the pin assembly head part  32 . A further internal divider wall  46  extends from planar base  13  of housing  12  parallel and close to sidewall  14  (ie. lying in the xz plane). At its two ends, tracking bar  40  passes through long slots  44  and  45  in housing sidewall  16  and divider wall  46 , respectively, as shown in  FIG. 1 . Long slots  44  and  45  are therefore parallel and coincident when viewed in the y-direction. Bar  40  is retained at each end by external caps  47 , 48 , that bear against sidewall  16  and divider wall  46  respectively. Tracking bar  40  is therefore mounted to slide in the x-direction, thereby moving pin assembly head part  32  (including pin  37 ) in the x-direction. 
     The housing  12  includes a receiver  50  in the form of a rectangular plinth orientated in the xy plane, defined by standwalls as shown, sized to receive a smart card  60  (see  FIG. 5 ), so to facilitate engagement of the smart card  60  with the pin  37 . Receiver  50  includes a channel  52  through the plinth standwalls, which allows access of the pin  37  in the x-direction to the smart card  60  when positioned on the plinth. 
     Turning to the smart card  60  shown in  FIG. 5 , this includes a track that defines a set dosage to be drawn into and expelled from the syringe. Smart card  60  has rounded corners as shown, and length and width dimensions to suit receiver  50 . Directional references in relation to card  60  are made with reference to the same coordinate plane as used above with reference to housing  12 , i.e. with card  60  positioned in receiver  50 , lying in the xy plane with the long side of the card in the y-direction. 
     Card  60  is formed from different pieces of paper material laminated together. The different material provides the card  60  with different physical features, which influences the movement of the pin  37  when it engages the card  60 . For example, the card  60  includes both a combination of frangible portions, i.e. portions that rupture or tear when engaged by pin  37 , and non-frangible portions, i.e. parts which do not rupture or tear when engaged by pin  37 . The non-frangible portions thus constrain movement of the pin  37 . The non-frangible portions include an inverted T-shaped portion  63  and an inverted U-shaped portion  65  which are connected to one another by frangible portions  64 ,  66 ,  67  as shown in  FIG. 6 . A person skilled in the art will appreciate that the different physical features of the card can be realised in many other ways. For example, the physical features may be in the form of protrusions on the card  60  that constrain movement of the pin  37 . In another example, there may be no frangible portions, but instead the track may be covered by a foil, film or other marking that is visually and indelibly changed upon advancement of the pin along the track. For example, the track may be transparent, reflective, or revealing of a unique encoded background pattern. This can also provide the card  60  with an in-built security against forgery or digital methods to avoid traceability during use. The card may also have a visible smartphone scannable QR or bar code for ease of cross checking prior to use. The path on the card may also be scannable, embodying information relating to the dosage provided by the card  60 . The engagement between the pin  37  and the card  60  is further explained below. 
     The card  60  includes an entry way  62 , in the form of a slit, extending in the x-direction from the end of the card  60  that is nearest to the pin assembly  30 . Entry way  62  provides an entrance for pin  37  to engage with the card  60 . The pin  37  is configured to move along entry way  62  until it engages non-frangible portion  63 , which stops movement of the pin  37 . The pin  37  is then configured to move in the y-direction through frangible portion  64  until it engages non-frangible portion  65 . The pin  37  is then again configured to move in the x-direction through frangible portion  66  until it engages another part of non-frangible portion  65 , which stops further movement of the pin  37  in the x-direction. The pin  37  is then configured to move in the y-direction through frangible portion  67  until it engages another part of non-frangible portion  63 , which stops further movement of the pin in the y-direction. Finally, the pin  37  is then configured to move in the x-direction along exit way  69  which, like entry way  62 , is in the form of a slit extending in the x-direction from the end of the card  60  that is furthest from the pin assembly  30 , until it exits the card  60 , thereby bringing an end to the engagement between the pin  37  and the card  60 . 
     It will be readily appreciated by a person skilled in the art that for the card  60  to adequately function, the card  60  must be structurally stable whilst pin  37  is moving through the path defined by the card  60 . Thus, in some examples the card is made adequately thick relative to the depth of the frangible portions so as to avoid the card structurally failing during operation. In an alternative embodiment, the card  60  will not include frangible portions (as previously discussed), and thus the card must be able to suitably withstand any forces that act thereon in use (for example, by the pin  37 ). 
     A method of drawing and expelling liquid from the syringe will now be described. As the card  60  includes frangible portions  64 ,  66 ,  67 , the card  60  is therefore a consumable component, meaning a new card is required for each use. Firstly, adaptor  10  is suitably connected to the syringe, with the plunger coupling portion  25  connected to the plunger of the syringe and the flange coupling portion  18  connected to the flange of the syringe. The sliding tracking bar  40  is to be held in the position shown in  FIGS. 1 and 2 . In this position, the pin assembly  30  is in a retracted position as the compression spring is compressed. This is because the sliding tracking bar  40  forces the head portion  32  of the pin assembly  30  in the x-direction away from the receiver  50 . This leads to the compression spring housed within the second tubular portion  33  to be compressed and the second tubular portion  33  sliding further within body part  34 . The compression spring thus stores potential energy and is now biased to provide a force in the x-direction towards the receiver  50 . 
     In the next step, card  60  is received and secured within receiver  50 . The physical features of the card  60  define the set dosage that is to be drawn and the set dosage that is to be expelled from the syringe. Sliding tracking bar  40  is then released. This causes the release of some potential energy in the compression spring and movement of the pin  37  through channel  52  in the receiver  50 , and through entry way  62  of the card  60 . Pin  37  is brought to a halt when it engages non-frangible portion  63  of the card  60 . 
     The syringe is now ready to draw in the liquid that is to be administered to a patient. The user now proceeds to lift the plunger in the y-direction, thereby creating a pressure differential between the tip of the syringe and the inside of the barrel in order to draw liquid into the barrel. This movement of the syringe plunger leads to a corresponding movement in the y-direction of the linking member  22 . As the linking member  22  is connected to pin assembly  30  through the connection between the cap part  36  and the first leg  23 , the pin assembly  30  is also moved in the y-direction along the channel  43  of divider wall  19 . This movement leads to the pin  37  rupturing the frangible portion  64  of the card  60  as it progresses along the path provided by the card  60  until the pin  37  engages the non-frangible portion  65 . This engagement stops any further movement of the pin  37  and thus stops the user of the syringe moving the plunger any further upwards in the y-direction. Therefore, the dosage that can be drawn into the syringe barrel has been limited by the by the non-frangible portion  65  of the card  60 . 
     Once the pin  37  engages the non-frangible portion  65 , the pin  37  is presented with a frangible portion  66  in the x-direction towards receiver  50 . As frangible portion  66  does not constrain the movement of the pin  37 , and because of the biasing of the pin  37  in the x-direction towards the receiver  50 , the pin  37  will move through the path of frangible portion  66  as the spring releases further potential energy, thereby rupturing frangible portion  66 . In other words, once the pin  37  engages the non-frangible portion  65  (signifying the completion of the drawing in of liquid as defined by the set dosage provided by the card  60 ), the pin  37  is immediately urged in the x-direction towards the receiver  50  until the movement of the pin  37  is again halted by engaging another part of non-frangible portion  65 . 
     Now the user may expel the liquid in the syringe. The user pushes the plunger downwards in the y-direction. This movement of the syringe plunger leads to a corresponding downward movement in the y-direction of the linking member  22 . As the linking member  22  is connected to pin assembly  30 , the pin assembly  30  is also moved downward in the y-direction along channel  43 . This movement leads to the pin  37  rupturing the frangible portion  67  of the card  60  as it progresses along the path provided by the card  60  until the pin  37  engages another part of non-frangible portion  63 . This engagement stops any further movement of the pin  37  in the y-direction and thereby prevents any further expelling of liquid. Therefore, the set dosage as defined by the card  60  has been administered to the patient. 
     Once the pin  37  engages the non-frangible portion  63 , the pin  37  is presented with exit way  69  in the x-direction towards receiver  50 . As exit way  69  does not limit the movement of the pin  37 , and because of the biasing of the pin  37  in the x-direction towards the receiver  50 , the pin  37  will move through the exit way  69  as the spring releases its remaining potential energy. Thus, pin  37  will be moved until it completely exits the card  60 , thereby bringing to an end the engagement of the pin  37  with the card  60 . The ruptured frangible portions of card  60  provide an indicator to the user that the set dosage has been administered, and that a new card  60  would be needed in order to administer further dosages to the patient (or any future patient). 
     Reference is now made to  FIG. 6 , which depicts an alternative embodiment of an adaptor  100  configured to be coupled to a syringe. The mechanism of drawing and expelling liquid using the adaptor  100  differs from that of the adaptor  10  as will be described below. However the principle of operation of adaptor  10  is identical to that of adaptor  100 , the latter providing a more compact form of the device. 
     The adaptor  100  includes a base  113  (not shown in  FIG. 6 ) providing a support for the barrel of a syringe and an upper assembly  120  providing a mechanism to drive the plunger of the syringe relative to the barrel. 
     As illustrated in  FIG. 7 , base  113  is integrally formed from two concentric, generally tubular portions joined as shown to form a substantially T-shape in side view, the bar of the T-shape provided by a first tubular portion  111  of larger diameter than the second tubular portion  112  (the leg of the T-shape). Base  113  has a through bore  118  extending through its axial centreline sized to receive the barrel of the syringe and to provide support therefor when the syringe plunger is moved relative to the barrel. Base  113  also comprises four spaced shaped locating protrusions projecting from its upper surface  114  close to its outer periphery, to be received by complementary apertures  144  in a portion of the upper assembly  120  (see  FIG. 9 ). Upper surface  114  of base  113  further includes a recess  116  that surrounds through bore  118 , shaped and sized to provide a seat for the flange of the syringe barrel. The depending second tubular portion  112  of base  113  provides a grip portion for a user, avoiding need for the user to hold the syringe barrel. 
     The various components of upper assembly  120  will now be described with reference to  FIGS. 8-12 . A pin assembly  130  is configured to engage a card similar to card  60  (but of different dimensions) and to receive and engage the head of the syringe plunger to allow upward movement of the pin assembly  130  to pull up the syringe plunger and for the downward movement of the pin assembly  130  to push down the syringe plunger. More specifically, the pin assembly  130  includes a tubular portion  132  with a circumferential wall, a closed planar end and an opposed open end, the open end arranged to receive the flanged head of the syringe plunger. The open end of pin assembly  130  is configured to receive the head of the syringe plunger in a snap-fit arrangement. However, other connecting arrangements may also be employed as will be appreciated by a person skilled in the art. A shaft  134  is passed through a diametrical bore through tubular portion  132  such that its two ends protrude radially outwardly from diametrically opposed positions in tubular portion  132  close to the closed end, as shown in  FIG. 8 . In an alternative arrangement, not shown, the shaft  134  may be passed through a blind hole, whereby the shaft  134  protrudes radially outward from only one side of tubular portion  132 . In either embodiment, as discussed further below, the end or ends of shaft  134  realises a tracking function similar to pin  37  of the first embodiment described above. 
     The upper assembly  120  further includes an inner longitudinal track component  140  as shown in  FIG. 9 , which comprises a cylindrical tube portion  148  integrally connected to a concentric disk-shaped base portion  142 , the plane of the latter being perpendicular to the longitudinal direction of tube portion  148 . Base portion  142  includes apertures  144  sized and positioned to receive the protrusions  115  of the base  113  of device  100 , and a central bore (not shown), coincident with the inner diameter of tube portion  148 . When the inner longitudinal track component  140  is attached to base  113  the bore of base portion  142  is concentric with the through bore  118  of base  113 , allowing the syringe plunger to move upwardly or downwardly within tube portion  148 . 
     Tube portion  148  provides an inner linear pin track, the track provided by a pair of diametrically opposed slots  147  arranged in the axial direction running from the upper open end of the tube portion  148  to a point close to base portion  142 , the slots acting as a guide for the projecting ends of the shaft  134  when pin assembly  130  is engaged with inner longitudinal track component  140  and moved in the longitudinal direction. Tube portion  148  has an inner diameter to accommodate the outer diameter of tubular portion  132  of pin assembly  130  to allow the pin assembly  130  to move upwardly and downwardly along the inner longitudinal track component  140 , but to prevent any rotation between the two. 
     The upper assembly  120  further includes a helical track component  150  ( FIG. 10 ) that is configured to be placed over the inner longitudinal track component  140  and to act as an outer sleeve for rotation relative to the inner longitudinal track component  140 . Helical track component  150  comprises a tubular portion  152  with a base flange  154  as shown. Over a portion of the tubular portion  152  two helical slots  153  are provided, the slots starting from diametrically opposite positions close to base flange  154  and continuing for around 2/3 of the longitudinal extent of tubular portion  152 . This longitudinal extent corresponds to the length of slots  147  once the helical track component  150  is positioned over the inner longitudinal track component  140  such that helical track base flange  154  sits on inner longitudinal track base portion  142 . Like slots  147 , helical slots  153  are sized to accommodate the projecting ends of the shaft  134 . The upper end of the tubular portion  152  over which helical slot  153  does not extend provides a handle by which a user can rotate the helical track component  150  relative to inner longitudinal track component  140 . As will be understood, when the pin assembly  130  is in place, rotation of helical track component  150  (and engagement between the projecting ends of shaft  134  with helical slots  153 ) will cause it to move in the longitudinal direction relative to the tubular track provided by the inner longitudinal track component  140 . 
     The upper assembly  120  further includes an outer longitudinal track component  160  (see  FIG. 11 ), designed to be placed over the helical track component  150 , to act as an outermost sleeve around the inner longitudinal track component  140  and the helical track component. The outer longitudinal track  160  is seated on base portion  142  in the assembled adaptor  100 , thus providing a chassis structure for support of the other components. Outer longitudinal track component  160  also acts as a card receiver, as discussed in more detail below. 
     Outer longitudinal track component  160  has a double-walled tubular form with an outer wall  162  and a concentric inner wall  164 , providing an annular gap  163  therebetween. Gap  163  houses a spring means (not shown), the function of which will be described below. The outer and inner tubular walls  162 ,  164  are provided with diametrically opposed, angularly aligned longitudinal slots  166  as shown, running in the axial direction. The slot  166  of the inner tubular wall  164  is sized to accommodate the projecting ends of shaft  134  when the components are assembled together. The slot  166  of the outer tubular wall  162  can be provided with a clear outer window (not shown) that acts as a backing support for the ends of shaft  134  when it engages with the card, and allows observation by the user to check suitable engagement between the shaft  134  and the card. The material used for the window can be any suitable transparent or translucent material such as glass, plastic, etc. 
     As can be seen in  FIG. 11 , annular gap  163  extends only part of the angular extent of component  160 , terminating in a radial end wall. At the other end, annual gap continues in a tangential direction in a straight channel provided by a pair of planar walls  165 . A card receiver insert part  170  ( FIG. 12 ) is attached to the outer ends of walls  165 , providing an insert means for a card to be introduced into annular gap  163 . 
       FIG. 13  shows the upper assembly  120  positioned on base  113  (the syringe is not shown). To assemble the adaptor  100  with the syringe, the syringe barrel is passed through bore  118  in base  113  and barrel flange located in recess  116 . The upper assembly  120  is then assembled and placed over the syringe plunger, with the head of the syringe plunger received in the tubular portion  132  of pin assembly  130  and the apertures  144  of inner longitudinal track component base portion  132  located over protrusions  115  of base  113 . The card is then inserted through card receiver insert part  170  to be tangentially introduced into annular gap  163 , to interact with the projecting ends of shaft  134  as described further below. As noted above, the card used for this embodiment of the invention may be of different dimensions to card  60 , however it will take a generally similar form and the same reference numerals will be used when referring to parts of the card as used with reference to card  60 . When the card is introduced through insert part  170 , the card flexes to conform against the inner surface of the outer wall  162  and the outer surface of the inner wall  164 , with the card urged into the gap  163  until shaft  134  passes through entry way  62 , at which point portion  63  prevents further movement of the card relative to the shaft  134 . The card is now seated snugly in annular gap  163 . In this position, with the card engaged by shaft  134 , the card is prevented from moving axially, and the spring means is biased to cause rotation of the card out of annular gap  163 . The card can move circumferentially approximately 45-120°, corresponding to the arc of the length of the card. 
     Once the card has been inserted as described above, the syringe is ready to draw in the liquid medicament to be administered to a patient. The user begins by rotating the helical track component  150  clockwise, thereby rotating it relative to the inner and outer longitudinal track components  140 ,  160  and causing the projecting ends of shaft  134  to be urged axially upwardly, along slots  147  and  166  of the inner and outer longitudinal track components  140 ,  160  respectively. This movement of the projecting ends of shaft  134  is further constrained by engagement with portion  64  of the card and continues until the projecting ends of shaft  134  engage portion  65 . Thus, a set dosage of liquid has now been drawn into the syringe. The spring means then urges the card outwardly so that portion  66  moves against the shaft  134  until the shaft  134  engages another part of portion  65 . 
     To expel the liquid medicament, the helical track  150  is rotated anticlockwise relative to the inner and outer longitudinal track components  140 ,  160 , causing the projecting ends of shaft  134  to be urged axially downwardly and passing along portion  67  until meeting another part of portion  63 . Thus, a set dosage of liquid has now been expelled from the syringe. The spring finally continues to urge the card outwardly so that the card moves past shaft  134  through exit way  69 . The card can now be removed from adaptor  100 . 
     This embodiment can also employ a spring damping system for controlling draw and delivery rate. The spring damping system can assist in operation by smoothing the rotating action involved in drawing and expelling the medicament in order to mitigate against the formation of bubbles in the medicament or avoid leaks in the syringe plunger seal, particularly when dealing with thick liquid medicaments (which can otherwise cause dose inaccuracy). The spring means can be a torsion spring, and a damping element such as a pneumatic piston can be used, provided as a coupling between the syringe plunger and the pin assembly  130  and providing damping over (say) around 5-20 mm of travel. The piston can include an adjuster to control the rate of fluid flow into and out of the device, thereby controlling the rate of draw and expelling of the liquid medicament. 
     In the above described embodiment, where the card does not include frangible portions, the ends of shaft  134  can track along the card as a stylus in a fractional depth cut groove. In this case, the shaft  134  is permitted to exit the card by a tapering groove in the card that acts as a ramp, in combination with a trough feature on the inner surface of the outer wall  162  that removes the backing support provided for the shaft and card engagement. 
     In another embodiment, instead of using helical track component  150 , a card  180  as illustrated in  FIG. 14  can be used with adaptor  100 . Card  180  includes a track  188  (such as a grooved track) which has different physical features to the rest of the card  180  in a similar way to card  60  discussed above. Track  188  is provided with oblique grooves  182 ,  185 , rather than the axial and transverse grooves of card  60 , and groove portions  183 ,  187  provide mechanical stops, thus affording the required interaction between the projecting ends of shaft  134  and card  180 . The inclination of the grooves defines a dose rate, per unit of rotational movement, the axial length of the groove defining the dosage. 
     Track  188  of card  180  allows further dosages to be drawn and administered, the length of the track portions determining the amount of liquid to be drawn or administered at each step. In the present example, track  188  provides a common dosage and dosage rate at repeated intervals. However, in other examples, the track can provide for more than one dosage and/or more than one dosage rate. Card  180  also includes a barcode  189  (or other readable means) that can be used for scanning the card, as discussed in further detail below. 
     As will be understood, use of card  180  allows the card itself to directly govern the rate of advance of pin assembly  130  and allows more flexibility in customising dosage regimes for patients. However this embodiment requires track  188  to retain the ends of shaft  134 , which can present technical challenges when using a thin, flexible card. In the alternative, employing helical track component  150  can provide a more reliable and robust drive of the axial movement of pin assembly  130 , the movement governed by a card with an orthogonal groove arrangement. 
     It will be readily appreciated that other forms of a re-usable card may be provided. In one example, a card similar to card  60  can be provided but with no frangible portions. One or more cards of a similar nature may be provided, each card configured to provide a predetermined set dosage. 
     In one embodiment, a card, formed of a non-frangible material(s) is provided with a track in the form of a single linear slot or recess formed on the card. The pin may be placed at a first, terminal end of the slot or recess, with the pin then moved (in a similar manner as described in the embodiments above) along the slot or recess, until the pin engages a second, terminal end of the slot or recess. Thus, a set dosage may be drawn into the syringe, the dosage decided by the length of the slot or recess. Movement of the pin back along the slot or recess to the first, terminal end will thereby define expelling of the set dosage from the syringe. A kit can be provided with a plurality of different such cards, each with a slot or recess of a different length. The cards may be colour coded, the colour representing the length of the slot or recess and hence the corresponding set dosage. In this way, the user simply selects a card from the kit based on colour, so determining the dosage that will be administered. 
     Reference is now made to  FIGS. 15A-15H , which show adaptor  1000  both separate to and coupled to a syringe  2000 . It will be appreciated that adaptor  1000  functions in a similar manner to adaptor  10 . The adaptor comprises a housing  1012  similar to housing  12 . The x-y-z directions as defined above are similarly used with reference to the below description of this embodiment. 
     Extending perpendicularly outwardly from a side wall of housing  1012  in the x-direction is flange coupling portion  1018 , which is adapted to attach to or support the flange  2012  of the barrel  2010  of the syringe  2000 . Flange coupling portion  1018  provides support for housing  1012  when barrel  2010  and plunger  2014  are moved relative to one another whilst the adaptor  1000  is coupled to syringe  2000 . Adaptor  1000  is connected to a plunger  2014  of syringe  2000  by a rigid linking member  1020 , which at one end is received within housing  1012  and at the other end is connectable to the plunger. The end of linking member  1020  received within the housing is movable with a first pin assembly  1300  (as described below). 
     First pin assembly  1300  comprises two parts, an elongate arm  1332  and an oblique flap  1334  pivotally mounted thereto. Arm  1332  is substantially rectangular in shape as shown, having a pin  1337  extending therefrom (in the Z direction) within housing  1012 . Arm  1332  may form part of or be separately connected to the end of linking member  1020 . Linking member  1020  and first pin assembly  1300  are arranged to move with one another in the y-direction when plunger  2014  is moved relative to barrel  2010 . Movement of pin  1337  is prevented in the x-direction by an underlying longitudinal slot  1032 , such that movement of the pin  1337  is permitted only in the y-direction. Flap  1334  is pivotally mounted in a position as shown such as to engage a cam mechanism  1040 , as described below. 
     A second pin assembly  1500  is located within housing  1012 . The second pin assembly  1500  includes a body part (not shown) having a pin  1537  extending therefrom into housing  1012 . Movement of the pin  1537  is constrained to the y-direction by an underlying longitudinal slot  1034 . However, unlike pin  1337 , which moves in direct relation with movement of arm  1332  (and hence plunger  2014 ), pin  1537  is arranged for independent movement, dictated by a mechanism that allows it to move in one direction along slot  1034  and in an incremental fashion. 
     The mechanism to afford such limitation of movement includes a sawtooth rack  1050 , extending in the y-direction. Sawtooth rack  1050  is rotationally mounted to housing  1012  by a first rotating cam mechanism  1040 , mounted at a first end of rack  1050 , and a second mechanism  1042  rotationally mounted to a second end of rack  1050 . The teeth recesses  1052  of rack  1050  overlie slot  1034  when rack  1050  is in a home position (as shown in  FIG. 15A ). Pin  1537  is initially received within the first tooth recess  1052 , being the rightmost tooth recess in  FIG. 15A , and can then be moved incrementally to the recess of an adjacent tooth by way of operation of adaptor  1000 . 
     In this embodiment, first pin assembly  1300  and its movement is associated with a dosage volume to be administered (in a similar way to the embodiments described above), with second pin assembly  1500  associated with the number of dosages delivered. Thus adaptor  1000  is configured to facilitate both the administering of a set dosage volume and provide an indication of (and a limit to) the number of dosages of that set dosage volume that are to be administered. 
     Movement of pin  1537  will now be described. When plunger  2014  is moved relative to barrel  2010  in order to draw in a volume of medicament, arm  1332  is moved from right to left, thereby drawing pin  1337  along slot  1032 . This movement of arm  1332  will also result in the end of flap  1334 , particularly the inward facing end of flap  1334 , engaging with first cam mechanism  1040 , causing its rotation clockwise (as shown in  FIGS. 15C-15D ) and hence resulting in clockwise rotation of both mechanisms  1040  and  1042  resulting in a rotational action on rack  1050  relative to housing  1012 . This clockwise rotation of the rack, by way of action of the right-side edge of the tooth recess  1052 , pushes pin  1537  in the y-direction (ie. towards the left) along slot  1034 . This urging of the pin  1537  continues until the rack  1050  rotates sufficiently away from slot  1034  and therefore releases engagement with pin  1537 . This action leaves pin  1537  having moved a certain, limited distance along slot  1034  whilst pin  1337  (carried by first pin assembly  1300 ) proceeds its movement along slot  1032  until it reaches its end position, corresponding to the intended dosage volume. A suitably positioned leaf spring  1054  ( FIG. 15D ) acts on first cam mechanism  1040  biasing rack  1050  towards slot  1034  so that, once it has completed a full revolution, it will be biased back into the home position. Once in the home position, pin  1537  is engaged in the next successive tooth recess  1052  of rack  1050  (as shown in  FIG. 15E ). 
     As arm  1332  (carried by assembly  1300 ) moves back in the y-direction (ie. from left to right), by movement of plunger  2014  towards barrel  2010  to expel the medicament, pin  1337  moves along with arm  1332  along slot  1032  and flap  1334  rotates to slip past pin  1537 , thereby allowing arm  1332  (and pin  1337 ) to return to the initial position ( FIGS. 15E-15G ) ready to operate again in the same way for the next dosage. 
     Longitudinal movement of pins  1337  and  1537  in their respective slots are constrained by the introduction of a smart card  1600  into housing  1012 . Card  1600  is inserted into housing  1012  by sliding card  1600  through a suitable opening in housing  1012  (card enters from right to left in  FIG. 15B ). Once received in housing  1012 , card  1600  is engaged with the first and second pin assemblies so that pins  1337  and  1537  lie within the tracks of card  1600 . 
     Card  1600  includes two tracks. A first track  1612  is in the form of a single longitudinal slot formed on the card. As indicated by the markings adjacent first track  1612 , first track  1612  defines the predetermined, set dosage that can be withdrawn and expelled when card  1600  is operatively engaged with adaptor  1000 . Card  1600  also includes a second track  1614 , similarly in the form of a single longitudinal slot formed on the card. Second track  1614  is parallel with first track  1612 . When card  1600  is in place, the first and second tracks  1612 ,  1614  are aligned with slots  1032 ,  1034  respectively. The length of first track  1612  defines the predetermined, set dosage that can be withdrawn and expelled when the card  1600  is operatively engaged with adaptor  1000 , whilst the length of second track  1614  defines the number of dosages that can be withdrawn and expelled. As depicted in  FIG. 15B , card  1600  is configured to allow for a single 2 ml dosage, i.e. a 2 ml dose to be administered once. Similar to the embodiments described above, physical features of card  1600  (in this case the ends of first and second tracks  1612 ,  1614 ) act to limit movement of plunger  2014  relative to the barrel  2010  of syringe  2000 , due to pins  1337 ,  1537  engaging with the ends of the card tracks. 
     Thus, when pin  1337  encounters the end of first track  1612  (indicating a 2 ml dosage), pin  1337  is prevented from moving further along its slot and hence the plunger  2014  is prevented from further movement relative to barrel  2010 . Thus, only the set 2 ml dosage can be drawn into the syringe. With movement of pin  1337  (under action of the mechanism described above), pin  1537  is moved incrementally one sawtooth position along its track, to the abutment end of second track  1614 . Movement of arm  1332  back to its initial position will result in administration of the 2 ml dosage. 
     As card  1600  is intended to provide only a single dosage of the set dose volume, further attempts to draw and/or administer medicament are prevented by card  1600  as shown in  FIG. 15H . If an attempt is made to move plunger  2014  away from barrel  2010  in order to draw the medicament, pin  1537  can move no further as it has reached the end of the second track  1514 , hence preventing movement. Thus, the possibility of administering a second dosage is prevented. 
     The card is made so that the length of each track required can be punched out, by removing a portion of each track. The portion punched out (the shaded portions in  FIG. 15B ) indicating the prescribed dosage volume and the number of dosages to be administered. The card can then be inserted into adaptor  1000  for administration of the medication. The card also includes a suitable encoding element  1616 . The encoding element  1616  can be a readable QR code or barcode, or maybe an RFID tag or other remotely readable data store. 
     As will be understood, this embodiment provides the ability to guide or limit not only the dose but the number of repeats of that dose. The movement of the second pin  1537  along its track provides both an indicator to the user of the number of doses administered and a means of limiting that number of doses. 
     Method of Use 
     The steps below set out an example of a method of use of the invention for administering a liquid dose to a child, e.g. a simple analgesic such as ibuprofen or paracetamol. 
     1. Medication and dosage is prescribed by a medical practitioner.
 
2. The prescription is presented at a pharmacy and scanned. The scanned data is input to software which verifies the medication and dose and controls the dispensing of the medication in a vial or similar bearing a medication barcode. Along with the medicine, the software and suitable connected hardware prints a small individualised single-use plastic key card, encoded with data recording, inter alia, patient identity, medicine and dose, the data relating to the dispensing event being uploaded to a remote electronic medication system (EMS) for recordal. The encoding can be by way of a readable QR code or barcode, or maybe an RFID tag or other remotely readable data store.
 
3. At the ward, a nurse uses a scanner to read the key card, the child&#39;s wrist identifier and the medication barcode into suitable software, in order to verify the intended administration of the dose via the EMS.
 
4. The adaptor ( 10  or  100 ) is attached to the syringe, and the key card inserted. As discussed above, the card controls the volume of medication to be administered and the child is safely dosed. The EMS registers the key card as expired and it thus cannot be used again and is discarded.
 
5. The information regarding the administration is automatically uploaded to the EMS to record all the details relevant to the administration event, including the time of administration.
 
     The method can also include steps of photographing the smart card after use, which when uploaded to the EMS, provides further evidence that the dosage has been administered. 
     The invention therefore provides integration of smart cards, a governing device and software to accurately and safely deliver accurate doses and the correct number of doses, along with provision and storage of digital records relating to activities relating to the dosage. This approach therefore affords the prevention of error at the calculation and dispensing stages as well as at the administration stage. 
     It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention. 
     The embodiments described above are designed for use with liquid medicaments, e.g. oral medicines for administration to neonates (‘infant drops’) or injectable medication. However the invention can equally be applied to the dispensing and administration of solid form medicaments, such as pills, tablets or capsules. In such an application a mechanism of the sort described herein is used to control delivery of the required number of pills, tablets or capsules from a dispensing container.