Improvements in or relating to closed system transfer devices

Abstract

A closed system transfer device comprises a syringe that has a hollow, axially extending syringe body within which a plunger is slidably received to define a medicament chamber. The device also includes a syringe needle that is coupled with the syringe body to retain an interior conduit of the needle in fluid communication with the medicament chamber. Additionally, the device further includes a shield that is moveably coupled with the syringe, whereby the shield is operable selectively to expose and envelop the needle. The shield and syringe include mutually cooperable formations to constrain movement of the shield relative to the syringe from a transport position in which the shield envelops the needle and is immovable in both a proximal axial direction and a distal axial direction relative to the syringe.

Description

[0001] IMPROVEMENTS IN OR RELATING TO

[0002] CLOSED SYSTEM TRANSFER DEVICES

[0003] This invention relates to a closed system transfer device (CSTD) and to a method of using such a device.

[0004] Closed system transfer devices permit the compounding, transport, and administration of substances, principally medicaments, including potentially hazardous medicaments, while mechanically prohibiting both the transfer of environmental contaminants into the device and the escape of medicament or vapour concentrations thereof outside the device. Such devices specifically intended for medicament transfer are sometimes also known as closed system drug-transfer devices.

[0005] According to a first aspect of the invention there is provided a closed system transfer device comprising:

[0006] a syringe having a hollow, axially extending syringe body within which a plunger is slidably received to define a medicament chamber;

[0007] a syringe needle coupled with the syringe body to retain an interior conduit of the needle in fluid communication with the medicament chamber; and

[0008] a shield moveably coupled with the syringe, whereby the shield is operable selectively to expose and envelop the needle,

[0009] the shield and syringe including mutually cooperable formations to constrain movement of the shield relative to the syringe from a transport position in which the shield envelops the needle and is immovable in both a proximal axial direction and a distal axial direction relative to the syringe to one or other of:

[0010] a first needle depth position in which the needle is exposed to a first extent beyond which it cannot be further exposed; and

[0011] a second needle depth position in which the needle is exposed to a second extent, different to the first extent, beyond which it cannot be further exposed.

[0012] Having a shield and syringe with mutually cooperable formations that are configured to arrange the shield in a transport position relative to the syringe, a position in which the shield envelops the needle while being immovable in both proximal and distal axial directions relative to the syringe, is beneficial since it prevents exposure of the needle beyond the shield, and thus helps to eliminate the risk of needlestick injuries as well as inadvertent exposure to, and / or contamination of, a hazardous medicament held within the medicament chamber. As such, arranging the shield in its transport position ideally configures the closed system transfer device of the invention for being moved, in a safe and mechanically closed manner, e.g. from a medicament compounding area to a recipient administration area, such as a bedside or other healthcare setting.

[0013] Additionally, it then being possible to choose whether to move the shield from its transport position to one or other of a first needle depth position, in which the needle is exposed to a first extend, and a second needle depth position, in which the needle is exposed to a second extent, different to the first, allows a user of the device to easily select a desired needle exposure extent that corresponds to a given degree to which the user wishes to insert the needle, e.g. into a medicament recipient. The user is therefore less likely to make a mistake in selecting a desired needle insertion depth, i.e. a corresponding first or second needle depth position, than might otherwise be the case.

[0014] Moreover, having each of the first and second needle depth positions of the shield relative to the syringe define a corresponding first or second extent of needle exposure, beyond which the needle cannot be further exposed, ensures over-insertion of the needle cannot take place once movement towards a given first or second needle depth position has been chosen. Such features therefore advantageously avoid a user having to guess or gauge a correct needle insertion depth, i.e. a correct injection depth for a given medicament or injection procedure.

[0015] Preferably a first part of movement of the shield from the transport position to at least one of the first needle depth position and the second needle depth position takes place in a circumferential direction relative to the syringe.

[0016] Having the mutually cooperable formations configured to constrain movement of the shield relative to the syringe in the foregoing manner desirably allows a user to choose a particular first or second needle depth position, i.e. select a given extent to which it will, subsequently, be possible to expose the needle (and thus a given extent to which it will be possible to insert the needle into a recipient), before the needle becomes exposed to any degree.

[0017] It is therefore possible for a user to choose a given needle insertion depth, while the needle remains suitably encased or shrouded by the shield, and thus while there is no risk of needlestick injury and / or medicament contamination.

[0018] In a preferred embodiment of the invention the first part of movement of the shield from the transport position to the first needle depth position takes place in a first circumferential direction, and the first part of movement of the shield from the transport position to the second needle depth position takes place in a second circumferential direction, opposite the first circumferential direction.

[0019] Configuring the mutually cooperable formations to achieve the aforementioned constrained movement in opposite circumferential directions, advantageously provides a very clear distinction to a user in selecting movement, ultimately, to the first needle depth position or the second needle depth position, and thereby further reduces the likelihood of such a user making the incorrect choice of eventual needle injection depth.

[0020] Optionally a second part of movement, after the first part of movement, of the shield from the transport position to at least one of the first needle depth position and the second needle position takes place in the proximal axial direction.

[0021] Such subsequent movement of the shield in the proximal axial direction facilitates exposure of the needle, and thus desirably allows insertion of the needle to a predetermined depth, i.e. as determined by a corresponding one or other of the first and second needle depth positions, e.g. simply by abutting the shield against a recipient's body while the needle is inserted.

[0022] Meanwhile, such continuous abutment of the shield against the recipient's body helps to maintain mechanical closure of the device, and thus prevent needlestick injuries and / or contamination of the medicament within the syringe.

[0023] The second part of movement of the shield from the transport position to the first needle depth position may be limited in the proximal axial direction by a first depth stop, and the second part of movement of the shield from the transport position to the second needle depth position may be limited in the proximal axial direction by a second depth stop.

[0024] The inclusion of first and second depth stops desirably prevents further exposure of the needle, once the shield reaches a given first or second needle depth position, in a readily manufacturable manner.

[0025] Optionally the shield is urged towards at least one of the first depth stop or the second depth stop during the corresponding second part of movement of the shield from the transport position. Such urging of the shield towards one or both of the first and second depth stops, during the corresponding second part of movement of the shield from the transport position, desirably helps to ensure that the whole of the extent to which it then becomes possible to insert the needle into a recipient is utilised, and not just a part of the possible injection depth at either given first needle depth position or second needle depth position.

[0026] In turn, this provides a user with even better control over injection depth, e.g. compared with a continuously variable depth arrangement.

[0027] In another preferred embodiment of the invention the first depth stop is shorter than the second depth stop.

[0028] The inclusion of a shorter first depth stop renders the first needle depth position suitable for a shallower needle insertion, e.g. when a subcutaneous injection is desired, while rendering the second needle depth position suitable for a deeper needle insertion, such as when an intramuscular injection is desired.

[0029] Optionally the mutually cooperable formations of the shield and syringe are or include a male formation and a female formation.

[0030] Such an arrangement provides ready and reliable mutual cooperation in a form which is also readily manufacturable.

[0031] Preferably the male formation is or includes a pawl member and the female formation is or includes a plurality of slots within which the pawl member moves.

[0032] The inclusion of a pawl member provides a reliable follower element, while having a female formation in the form of a plurality of slots desirably allows for the provision of one or more pathways for the pawl to follow and thereby provide a user with different options for moving the shield away from the transport position.

[0033] In a further preferred embodiment of the invention the female formation includes a circumferentially extending slot from a first end of which extends a first axially extending slot, and from a second end of which extends a second axially extending slot.

[0034] Optionally one or more of:

[0035] a transport location lies along the circumferentially extending slot; the first axially extending slot terminates at the first depth stop to define a first needle depth location; and

[0036] the second axially extending slot terminates at the second depth stop to define a second needle depth location.

[0037] The foregoing arrangements desirably allow for mapping of the various transport, first needle depth, and second needle depth positions of the shield relative to the syringe, and thus the ability for a user to be guided through configuring the device in each of these positions, and indeed advantageously constrained to selecting from these positions.

[0038] The transport location may lie midway along the circumferential length of the circumferentially extending slot.

[0039] Arranging the transport location in such a manner beneficially avoids any bias of the shield to either of the first and second needle depth positions, and so helps a user to make the correct choice of which needle depth position, ultimately, to move to.

[0040] Optionally the circumferentially extending slot includes a positioning formation coincident with the transport location to selectively retain the shield in the transport position.

[0041] Such a positioning formation desirably provides tactile and / or audible feedback to a user when the shield is correctly positioned as desired in the transport position, as well as advantageously temporarily maintaining the shield in the said transport position until a user wishes to move it towards one or other of the first and second needle depth positions. This latter functionality, further beneficially helps to avoid inadvertent movement of the shield into either of the first and second needle depth positions, and thus similarly helps to avoid inadvertent exposure of the needle.

[0042] According to a second aspect of the invention there is provided a method of using a closed system transfer device according to any preceding claim comprising the step of moving the shield relative to the syringe from the transport position to one other of the first needle depth position or the second needle depth position.

[0043] The method of the invention shares the benefit of corresponding features of the device of the invention. It will be appreciated that the use of the terms "first" and "second", and the like, in this patent specification is merely intended to help distinguish between similar features and is not intended to indicate the relative importance of one feature over another feature, unless otherwise specified.

[0044] Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, and the claims and / or the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and all features of any embodiment can be combined in any way and / or combination, unless such features are incompatible. The applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to amend any originally filed claim to depend from and / or incorporate any feature of any other claim although not originally claimed in that manner.

[0045] There now follows a brief description of preferred embodiments of the invention, by way of non-limiting examples, with reference being made to the following figures in which:

[0046] Figure 1(a) shows an elevational view of a closed system transfer device (CSTD) according to a first embodiment of the invention;

[0047] Figure 1(b) shows a cross-sectional view through a CSTD according to a second embodiment of the invention;

[0048] Figure 2 shows an isometric view of a syringe forming a part of the CSTD shown in Figure 1(b);

[0049] Figure 3 shows a first elevational view of the syringe shown in Figure 2;

[0050] Figure 4 shows a second elevational view of the syringe shown in Figure 2; Figure 5 shows a cross-sectional view through the syringe shown in Figure 2; Figure 6(a) shows the CSTD of Figure 1(b) with a shield in a transport position; Figure 6(b) shows a cross-sectional view through the arrangement shown in Figure 6(a);

[0051] Figure 7(a) shows the arrangement of Figure 6(a) after a first part of movement of the shield from the transport position towards a first needle depth position;

[0052] Figure 7(b) shows a cross-sectional view through the arrangement of shown in Figure 7(a);

[0053] Figure 7(c) shows the Figure 7(a) arrangement after a second part of movement of the shield into the first needle depth position;

[0054] Figure 7(d) shows the Figure 7(c) arrangement after dispensing of a medicament; Figure 8(a) shows the arrangement of Figure 6(a) after a first part of movement of the shield from the transport position towards a second needle depth position;

[0055] Figure 8(b) shows a cross-sectional view through the arrangement of shown in Figure 8(a);

[0056] Figure 8(c) shows the Figure 8(a) arrangement after a second part of movement of the shield into the second needle depth position; and

[0057] Figure 8(d) shows the Figure 8(c) arrangement after dispensing of a medicament.

[0058] A closed system transfer device (CSTD) according to a first embodiment of the invention is designated generally by reference numeral 10, e.g. as shown in Figure 1(a), while a very similar CSTD according to a second embodiment of the invention is designated generally by reference numeral 10', e.g. as shown in Figure 1(b). The first and second closed system transfer devices 10; 10' are essentially identical to one another except they have differently shaped shields 32, as described below.

[0059] Meanwhile, each device 10; 10' includes a syringe 12 which has a hollow, axially extending, i.e. extending along a central longitudinal axis ALONG of the device 10; 10', syringe body 14. The syringe body 14 slidably receives a plunger 16 to define a medicament chamber 18.

[0060] More particularly, the plunger 16 includes a piston end 20, which together with the hollow syringe body 14 defines the medicament chamber 18, as well as an actuator end 22 that along with a flange 24 at an open, proximal end 26 of the syringe body 14 can be used by a user of the device 10; 10', e.g. a medical operative or other healthcare professional, to selectively insert the plunger 16 into the syringe body 14 or withdraw the plunger 16 within the syringe body 14 in a substantially conventional manner.

[0061] The size of the medicament chamber 18, and hence the amount of a medicament (not shown), i.e. a drug, medicine or other substance that has a physiological effect when introduced to a human body, stored therein, varies depending upon the degree of insertion of the plunger 16 within the syringe body 14.

[0062] The device 10; 10' also has a syringe needle 28 which is coupled with the syringe body 14, and preferably fixedly secured to the syringe body 14 as shown, in order to retain an interior conduit 30 of the needle 28 in fluid communication with the medicament chamber 18. In addition to the foregoing, as mentioned above the device 10; 10' further includes a shield 32 that is moveably coupled with the syringe 12, and which has a distal end 68 that is abuttable against, e.g. the skin of a medicament recipient.

[0063] Moveably coupling the shield 32 with the syringe 12 renders the shield 32 operable, selectively, to expose the needle 28 or, as shown in Figures 1(a) and 1(b), envelop, i.e. encase or shroud, the needle 28.

[0064] More particularly, the shield 32 and syringe 12 include mutually cooperable formations 34, 36 that constrain movement of the shield 32 relative to the syringe 12.

[0065] More particularly, the shield 32 includes a male formation 38, and more particularly still a pawl member 40, that preferably is resiliently biased (although not necessarily so), while the syringe body 14 includes a female formation 42 in the form of a plurality of slots within which the pawl member 40 moves, and into which the pawl member 40 preferably is biased.

[0066] Other embodiments of the invention (not shown) may include different mutually cooperable formations, and in such other embodiments the syringe body may instead include a male formation while the shield may instead include a female formation.

[0067] Returning to the embodiments shown, and as best illustrated in Figures 2 to 5, the female formation 42 of the syringe body 14 includes a circumferentially extending slot 44, that has a first end 46 from which extends a first axially extending slot 48, and a second end 50 from which extends a second axially extending slot 52.

[0068] The circumferentially extending slot 44 is arranged to constrain and position the pawl member 40 therein in such a manner that the shield 32 lies in a transport position relative to the syringe 12, e.g. as shown in Figure 6(a). In other words, a location of the pawl member 40 within the circumferentially extending slot 44 corresponds to a transport position of the shield 32 relative to the syringe 12, and thus the circumferentially extending slot 44 can be considered to define a transport location 54 corresponding to the location of the pawl member 40 when the device 10; 10' adopts the aforementioned safe, and shielded configuration.

[0069] When lying in such a transport position, the shield 32 envelops the needle 28 and is immovable in both a proximal axial direction Ap and a distal axial direction AD, e.g. as shown in Figures 6(a) and 6(b). The complete enveloping of the needle 28 by the shield 32, and the inability of the shield 32 to move in either a proximal axial direction AP or a distal axial direction AD, prevents exposure of the needle 28 beyond the shield 32, and thus helps to avoid both needlestick injuries and the ingress or egress of substances into / out of the device 10; 10'.

[0070] It follows that with the shield 32 lying in the transport position relative to the syringe 12, the device 10; 10' is ideally configured to be moved, i.e. "transported", e.g. from a medicament compounding area to a recipient administration area, such as a bedside or other healthcare setting.

[0071] More particularly, the aforementioned transport location 54 defined by the circumferentially extending slot 44 lies midway along the circumferential length CLENGTH of the circumferentially extending slot 44, although other locations are also possible.

[0072] Additionally, the circumferentially extending slot 44 includes a positioning formation 56, which in the embodiment shown takes the form of a detent portion 58 which lies between first and second sloped protrusions 70, 72, although other arrangements are also possible.

[0073] The positioning formation 56, i.e. detent portion 58, is coincident with the transport location 54, and cooperates with the pawl member 40 to selectively retain the pawl member 40 at the transport location 54, and hence selectively retain the shield 32 in the transport position relative to the syringe 12.

[0074] In this context, selectively retaining the pawl member 40 in the transport location 54, and the shield 32 too in its transport position, means that inadvertent movement of the pawl member 40 away from the transport location 54, and the shield 32 away from its transport position, is prevented, but a user can, when they wish, override the positioning formation 56, i.e. the detent portion 58, and move the pawl member 40 away from the transport location 54 by forcing the pawl member 40 over one or the other of the sloped protrusions 70, 72, and therefore also move the shield 32 also away from its transport position.

[0075] It follows that in this manner the positioning formation 56, i.e. detent portion 58, provides a user with tactile feedback of when the pawl member 40 is located correctly within the circumferentially extending slot 44, i.e. lies in the transport location 54, and thus when the shield 32 is in its transport position relative to the syringe 12. Other embodiments of the invention may additionally, or alternatively, have a positioning formation which is configured to provide a user with audible feedback on the correct positioning of the pawl member, and hence of the shield being in its transport position.

[0076] In any event, the positioning formation 56 is configured to avoid any bias in favour of movement of the shield 32 towards either of the first or second needle depth positions. In other words, from a user perspective, the positioning formation 56 is configured to ensure it is just as easy for a user to override when moving the shield 32 away from its transport position in either the clockwise or counterclockwise circumferential directions Ccw, Cccw.

[0077] In addition to the foregoing, the first axially extending slot 48 terminates at a first depth stop 60 which, as will be explained further in the context of use of the device 10; 10', is arranged to constrain and position the pawl member 40 in such a manner that the shield 32 lies in a first needle depth position relative to the syringe 12, e.g. as shown in Figure 7(c).

[0078] When the shield 32 lies in such a first needle depth position, the needle 28 is exposed to a first extent, beyond which it cannot be further exposed, and so in effect the shield 32 defines a first maximum depth to which the needle 28 can be inserted, e.g. into a recipient.

[0079] In this manner, when the shield 32 lies in the first needle depth position relative to the syringe 12, the pawl member 40 lies within the first axially extending slot 48 and in abutment with the first depth stop 60, such that the first axially extending slot 48 can be considered to define a first needle depth location 62 corresponding to the location of the pawl member 40 when the device 10; 10' has the shield 32 in the aforementioned first needle depth position.

[0080] Similarly, the second axially extending slot 52 terminates at a second depth stop 64 that, as will also be explained further in the context of use of the device 10; 10', is similarly arranged to constrain and position the pawl member 40 in such a manner that the shield 32 lies in a second needle depth position relative to the syringe 12, e.g. as shown in Figure 8(c).

[0081] When the shield 32 lies in such a second needle depth position, the needle 28 is exposed to a second extent, different to the first extent, but beyond which it also cannot be further exposed. Hence, in effect the shield's second needle depth position relative to the syringe 12 similarly defines a second maximum depth to which the needle 28 can be inserted, e.g. into a medicament recipient.

[0082] It therefore similarly follows that when the shield 32 lies in the second needle depth position relative to the syringe 12, the pawl member 40 lies within the second axially extending slot 52 and in abutment with the second depth stop 64, such that the second axially extending slot 52 can similarly be considered to define a second needle depth location 66 corresponding to the location of the pawl member 40 when the device 10; 10' has the shield 32 in the aforementioned second needle depth position.

[0083] The first depth stop 60 is shorter than the second depth stop 64, i.e. in other words, the first axially extending slot 48 is shorter than the second axially extending slot 52 and so, in the embodiment shown, the first depth to which the needle 28 can be inserted is shallower then the second depth to which it can be inserted.

[0084] Preferably the first, shallower, injection depth corresponds to the depth in a human recipient at which a subcutaneous injection typically is made, while the second, deeper, injection depth corresponds to the depth in a human recipient at which an intramuscular injection typically is made. Other, different length first and second depth stops, and hence different first and second needle depth positions of the shield relative to the syringe corresponding to other, different, first and second injection depths, are also possible, however.

[0085] In use the CSTD 10; 10' of the invention is operated as follows.

[0086] The device 10; 10' desirably has the shield 32 adopt its transport position relative to the syringe 12, e.g. as shown in Figures 6(a) and 6(b), i.e. has the pawl member 40 desirably lie at the transport location 54 within the circumferentially extending slot 44, and is temporarily held there by the positioning formation 56, i.e. by cooperation between the pawl member 40 and the detent portion 58.

[0087] The shield 32 may adopt the aforesaid transport position following compounding of the device 10; 10', such that the medicament chamber 18 within the syringe 12 is already primed with a medicament it is desired to dispense.

[0088] From the transport position, a user of the device 10; 10', e.g. a medical operative or other healthcare professional, has the choice of moving the shield 32 relative to the syringe 12 into either its first needle depth position, e.g. as shown in Figure 7(c), or its second needle depth position, e.g. as shown in Figure 8(c).

[0089] More particularly, in the event of the user wishing to carry out, e.g. a subcutaneous injection, at a first, shallower injection depth, they can elect for the shield 32 to be constrained to move from its transport position relative to the syringe 12 into its first needle depth position.

[0090] Desirably the first, shallower injection depth also corresponds with an optimal injection depth to pierce the sealing septum at an open end of a medicament container, such as a medicine vial, in order to permit the removal of as much medicament as possible form the container, e.g. during compounding of the device of the invention, and thus minimise the amount of unused, i.e. wasted, medicament left in the medicament chamber.

[0091] A first part of the movement of the shield 32 from its transport position to its first needle depth position takes place in a first circumferential direction, i.e. in a clockwise circumferential direction Ccw relative to the syringe 12, as the pawl member 40 moves from the transport location 54 within the circumferentially extending slot 44, over the first sloped protrusion 70, to the first end 46 of the circumferentially extending slot 44 and thereby into axial alignment with the first axially extending slot 48, as shown in Figures 7(a) and 7(b).

[0092] Such movement of the pawl member 40, and hence the shield 32 also, in the clockwise circumferential direction Ccw relative to the syringe 12 avoids any movement of the shield 32 in either the distal or proximal axial direction AD, Ap relative to the syringe 12, and so maintains enveloping of the needle 28 by the shield 32, e.g. as shown in Figure 7(a).

[0093] As a consequence, the user is able to make an initial decision to configure the device 10; 10' for an injection at the first, shallower injection depth without exposing the needle 28, and thus while avoiding the risk of a needlestick injury or contamination of, or unwanted exposure to, the medicament to be administered.

[0094] Thereafter, a second part of movement of the shield 32 into its first needle depth position takes place in the proximal axial direction Ap relative to the syringe 12, as the pawl member 40 now moves within the first axially extending slot 48 towards the first depth stop 60, i.e. towards the end of the first axially extending slot 48, and into abutment with the first depth stop 60.

[0095] Preferably the shield 32 is urged towards the first depth stop 60 during the second part of movement of the shield 32 from its transport position, i.e. preferably the pawl member 40 is urged into abutment with the first depth stop 60 during movement along the first axially extending slot 48.

[0096] Such urging of the shield 32 may be achieved by a first biasing arrangement (not shown) such as a first spring or a first gaseous actuator module that releases a gas from a gas storage volume to move the shield 32.

[0097] Meanwhile, such positioning of the pawl member 40, i.e. at the first needle depth location 62 defined by the first axially extending slot 48, corresponds, as mentioned, to the shield 32 adopting its first needle depth position relative to the syringe 12, as shown in Figure 7(c). With the shield 32 in this position the needle 28 is exposed to a first extent, e.g. by a first amount corresponding to a typical subcutaneous injection depth.

[0098] Meanwhile, abutment of the pawl member 40 against the first depth stop 60, i.e. against the end of the first axially extending slot 48, prevents any further movement of the pawl member 40, and hence the shield 32 also, in a proximal axial direction Ap relative to the syringe 12. Thus, exposure of the needle 28 to any greater extent is prevented.

[0099] The user advantageously may cause this second part of movement of the shield 32 into its first needle depth position by holding the distal end 68 of the shield 32 in contact with a recipient's body (not shown), e.g. a recipient's skin, and pushing the syringe 12, i.e. the syringe body 14, in a distal axial direction AD relative to the, essentially stationary, shield 32. This moves the pawl member 40 from the first end 46 of the circumferentially extending slot 44, along the first axially extending slot 48, and into the first needle depth location 62, i.e. into abutment with the first depth stop 60.

[0100] Additionally, in embodiments in which urging of the shield towards the first depth stop takes place during the second part of movement of the shield from its transport position, the user is further assisted in using contact with a recipient's body to cause movement of the shield into its first needle depth position. In either case, abutment of the pawl member 40 against the first depth stop 60, and the aforementioned prevention of any further movement of the shield 32 relative to the syringe 12 in a proximal axial direction AP, correspondingly limits the extent to which the user is able to push the syringe body 14 in the distal axial direction AD relative to the shield 32, and so in effect determines a maximum injection depth that, as described above, preferably corresponds to an injection depth at which subcutaneous injections typically occur.

[0101] Accordingly, having the CSTD 10; 10' of the invention constrain movement of the shield 32 relative to the syringe 12 from its transport position, e.g. as shown in Figure 6(a), to its first needle depth position, e.g. as shown in Figure 7(c), beyond which the shield 32 cannot be moved to expose the needle 28 further, provides a first "hard stop" injection depth that avoids the user having to guess or otherwise try and gauge a correct, desired first injection depth.

[0102] Once the needle 28 has been inserted to the desired first injection depth, the medicament (not shown) within the medicament chamber 18 can be dispensed by depressing the plunger 16 within the syringe body 14, e.g. as shown in Figure 7(d).

[0103] Following such administration of the medicament, the needle 28 can be withdrawn from the recipient by reversing the second part of movement of the shield 32, i.e. by moving the pawl member 40 away from the first needle depth location 62, that is to say, out of abutment with the first depth stop 60 and along the first axially extending slot 48 back to the first end 46 of the circumferentially extending slot 44, such that the shield 32 again envelops, and safely protects, the needle 28, e.g. in a similar manner to that shown in Figure 7(a).

[0104] Optionally the pawl member 40 may be urged to move in the reverse direction to the first end 46 of the circumferentially extending slot 44, e.g. by the first biasing arrangement as mentioned above, or a different biasing arrangement such as a second spring or a second gaseous actuator module that similarly releases a gas from a gas storage volume to cause such urging of the shield 32.

[0105] In any event, once the pawl member 40 lies at the first end 46 of the circumferentially extending slot 44, the user may additionally move the pawl member 40 back over the first sloped protrusion 70 and into the transport location 54 within the circumferentially extending slot 44, and thus additionally return the shield 32 to its transport position relative to the syringe 12, whereby the device 10; 10' is again safely configured for movement to another location.

[0106] Similarly, in the event of the user wishing to carry out, e.g. an intramuscular injection, at a second, deeper injection depth, they can elect for the shield 32 to be constrained to move from its transport position relative to the syringe 12 into its second needle depth position.

[0107] In some embodiments (not shown) the second, deeper injection depth may also correspond with a further optimal injection depth to pierce, e.g. a thicker sealing septum at an open end of a further medicament container, again to minimise the amount of unused, i.e. wasted, medicament left in the further medicament chamber after compounding of the device.

[0108] A first part of such movement of the shield 32 takes place in a second circumferential direction opposite the first circumferential direction, i.e. in a counterclockwise circumferential direction Cccw relative to the syringe 12, as the pawl member 40 instead moves from the transport location 54 within the circumferentially extending slot 44, over the second sloped protrusion 72, to the second end 50 of the circumferentially extending slot 44, e.g. as shown in Figures 8(a) and 8(b).

[0109] Such movement of the pawl member 40, and hence the shield 32 also, in the counterclockwise circumferential direction Cccw relative to the syringe 12 again avoids any movement of the shield 32 in either the distal or proximal axial direction AD, AP relative to the syringe 12, and so maintains enveloping of the needle 28 by the shield 32, as shown in Figure 8(a).

[0110] As a consequence, the user is similarly able to make an initial decision to configure the device 10; 10' for an injection at the second, deeper injection depth without exposing the needle 28, and thus again while avoiding the risk of a needlestick injury or contamination of, or unwanted exposure to, the medicament to be administered.

[0111] Thereafter, a second part of movement of the shield 32 into its second needle depth position again takes place in the proximal axial direction Ap relative to the syringe 12, as the pawl member 40 now moves within the second axially extending slot 52 towards the second depth stop 64, i.e. similarly towards the end of the second axially extending slot 52, and into abutment with the second depth stop 64. The shield 32 may again be similarly urged towards the second depth stop 64 during the second part of movement of the shield 32 from its transport position, i.e. the pawl member 40 may again be similarly urged into abutment with the second depth stop 64 during movement along the second axially extending slot 52.

[0112] Such urging of the shield 32 may again be achieved by the first biasing arrangement mentioned above, although a different biasing arrangement may also be used.

[0113] In any event, such positioning of the pawl member 40, i.e. now at the second needle depth location 66 defined by the second axially extending slot 52, similarly corresponds, as described, to the shield 32 adopting its second needle depth position, as shown in Figure 8(c). With the shield 32 in this position the needle 28 is exposed to a second extent, e.g. by a second amount corresponding to a typical intramuscular injection depth.

[0114] Meanwhile, abutment of the pawl member 40 against the second depth stop 64, i.e. against the end of the second axially extending slot 52, again prevents any further movement of the pawl member 40, and hence the shield 32 also, in a proximal axial direction Ap relative to the syringe 12, and thus similarly prevents the needle 28 from being exposed to any greater extent.

[0115] Again, the user may advantageously cause, with or without the assistance of the first biasing arrangement or another biasing arrangement, this second part of movement of the shield 32 into its second needle depth position by holding the distal end 68 of the shield 32 in contact with a recipient's body (not shown) and pushing the syringe 12, i.e. the syringe body 14, in a distal axial direction AD relative to the now stationary shield 32, so as to similarly move the pawl member 40 from the second end 50 of the circumferentially extending slot 44, along the second axially extending slot 52, and into the second needle depth location 66, i.e. into abutment with the second depth stop 64.

[0116] Moreover, in such circumstances, abutment of the pawl member 40 against the second depth stop 64, similarly in effect determines a maximum injection depth that, as described above, preferably corresponds to an injection depth at which intramuscular injections typically occur.

[0117] It follows that additionally having the CSTD 10; 10' of the invention constrain movement of the shield 32 relative to the syringe 12 from its transport position, as shown in Figure 6(a), to its second needle depth position, as shown in Figure 8(c), beyond which the shield 32 cannot be moved to expose the needle 28 further, provides a further, second "hard stop" injection depth that avoids the user having to guess or otherwise try and gauge a second correct, desired injection depth.

[0118] Moreover, again, once the needle 28 has been inserted to the desired second injection depth, the medicament (not shown) within the medicament chamber 18 can be dispensed by depressing the plunger 16 within the syringe body 14, e.g. as shown in Figure 8(d).

[0119] Following such administration of the medicament, the needle 28 can be similarly withdrawn from the recipient by reversing the second part of movement of the shield 32, i.e. by moving the pawl member 40 away from the second needle depth location 66, in other words by moving the pawl member 40 out of abutment with the second depth stop 64 and along the second axially extending slot 52 back to the second end 50 of the circumferentially extending slot 44, such that the shield 32 again envelops, and safely protects, the needle 28, e.g. in a similar manner to that shown in Figure 8(a).

[0120] Optionally the pawl member 40 may be urged to move in the reverse direction to the second end 50 of the circumferentially extending slot 44, e.g. by the first biasing arrangement, the second biasing arrangement or any other biasing arrangement.

[0121] Moreover, once the pawl member 40 lies at the second end 50 of the circumferentially extending slot 44, the user may similarly additionally move the pawl member 40 back over the second sloped protrusion 72 and into the transport location 54 within the circumferentially extending slot 44, and thus again additionally return the shield 32 to its transport position relative to the syringe 12, whereby the device 10; 10' is safely configured for movement to another location.

Claims

CLAIMS:

1. A closed system transfer device comprising:a syringe having a hollow, axially extending syringe body within which a plunger is slidably received to define a medicament chamber;a syringe needle coupled with the syringe body to retain an interior conduit of the needle in fluid communication with the medicament chamber; anda shield moveably coupled with the syringe, whereby the shield is operable selectively to expose and envelop the needle,the shield and syringe including mutually cooperable formations to constrain movement of the shield relative to the syringe from a transport position in which the shield envelops the needle and is immovable in both a proximal axial direction and a distal axial direction relative to the syringe to one or other of:a first needle depth position in which the needle is exposed to a first extent beyond which it cannot be further exposed; anda second needle depth position in which the needle is exposed to a second extent, different to the first extent, beyond which it cannot be further exposed.

2. A closed system transfer device according to Claim 1 wherein a first part of movement of the shield from the transport position to at least one of the first needle depth position and the second needle depth position takes place in a circumferential direction relative to the syringe.

3. A closed system transfer device according to Claim 2 wherein the first part of movement of the shield from the transport position to the first needle depth position takes place in a first circumferential direction, and the first part of movement of the shield from the transport position to the second needle depth position takes place in a second circumferential direction, opposite the first circumferential direction.

4. A closed system transfer device according to Claim 2 or Claim 3 wherein a second part of movement, after the first part of movement, of the shield from the transport position to at least one of the first needle depth position and the second needle position takes place in the proximal axial direction.

5. A closed system transfer device according to Claim 4 wherein the second part of movement of the shield from the transport position to the first needle depth position is limited in the proximal axial direction by a first depth stop, and the second part ofmovement of the shield from the transport position to the second needle depth position is limited in the proximal axial direction by a second depth stop.

6. A closed system transfer device according to Claim 5 wherein the shield is urged towards at least one of the first depth stop or the second depth stop during the corresponding second part of movement of the shield from the transport position.

7. A closed system transfer device according to Claim 5 or Claim 6 wherein the first depth stop is shorter than the second depth stop.

8. A closed system transfer device according to any preceding claim wherein the mutually cooperable formations of the shield and syringe are or include a male formation and a female formation.

9. A closed system transfer device according to Claim 8 wherein the male formation is or includes a pawl member and the female formation is or includes a plurality of slots within which the pawl member moves.

10. A closed system transfer device according to Claim 9 wherein the female formation includes a circumferentially extending slot from a first end of which extends a first axially extending slot, and from a second end of which extends a second axially extending slot.

11. A closed system transfer device according to Claim 10 wherein one or more of:a transport location lies along the circumferentially extending slot;the first axially extending slot terminates at the first depth stop to define a first needle depth location; andthe second axially extending slot terminates at the second depth stop to define a second needle depth location.

12. A closed system transfer device according to Claim 11 wherein the transport location lies midway along the circumferential length of the circumferentially extending slot.

13. A closed system transfer device according to Claim 11 or Claim 12 wherein the circumferentially extending slot includes a positioning formation coincident with the transport location to selectively retain the shield in the transport position.

14. A method of using a closed system transfer device according to any preceding claim comprising the step of moving the shield relative to the syringe from the transport position to one other of the first needle depth position or the second needle depth position.

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