Fluid-dispensing vessel & components for the same

Abstract

A fluid dispensing vessel, comprising: a plunger, a cap, a barrel, an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member, a rod slidable along the barrel length and configured to communicate with the conduit to provide open and closed positions for said conduit, a handle attached to the rod, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from annular member mechanically breaking the seal and allowing fluid to flow through the conduit, characterised in that: the rod retracts into the plunger, and / or the cap defines an orifice and the rod slides along the barrel through the orifice, said rod comprises a stop larger than the orifice, such that the rod is retained by the interior of the cap and prevented from leaving the cap.

Description

[0001] FLUID-DISPENSING VESSEL & COMPONENTS FOR THE SAME

[0002] The present disclosure relates a fluid-dispensing vessel (such as a syringe, in particular a medical syringe) and components for the same, for example where said components are suitable to retrofit a commercially available vessel to provide a vessel according to the present present disclosure. Also provided is a method of making or assemblig the vessel, filing of the the vessel with fluid and / or solids, method of mixing the content of the vessel and a kit of parts comprising one or more components. Finally the present disclosure provides use of a vessel according to the present disclosure in treatment. The present arrangement can be used to premix the contents of the vessel before delivery (such as administration) or to deliver (e.g. administer) the contents sequentially.

[0003] BACKGROUND

[0004] Fluid-dispensing vessels, for example syringes, such as medical syringes, are commonly used devices for administering defined quantities of a fluid, such as a drug, in a controlled manner. Prefilled syringes are a particularly convenient way of storing a drug - an appropriate dose of the drug is ready for administration, without the inconvenience of drawing a drug into a syringe from a drug vial, or the associated risk of administering an incorrect amount of the drug.

[0005] There is a growing need for syringes which have two or more chambers for either sequentially delivering two or more liquids or mixing two liquids or a liquid and a solid before injection.

[0006] Whilst there are commercially available options they are difficult for end users, complicated and expensive to manufacture and the like. One such example is the Duplex technology (BBraun) which packages 50ml of diluent and 1g of powdered antibiotic drug in a flexible bag. A number of procedures are required to mix the diluent and powder within the bag before connecting to an infusion line.

[0007] US2,675,804 discloses a rod integral with a cap, such that when the cap 24 is pulled (removed) this withdraws the rod. This does NOT allow the contents of the syringe to be mixed whilst maintaining isolation from the external environment

[0008] W02024 / 042068 (‘068) discloses an elegant solution that is robust, simple, safe and easy to manufacture and therefore is cost efficient It meets a unmet need in the market and advantageously can be used in low resource settings. The presently disclosed device is an optimised version of ‘068 where the rod is retractable into the plunger and / or the rod in the cap comprise a stopper(i.e. a mechanical stop). The arrangements herein allow premixing of the contents of the syringe without exposing same to the atmosphere, which may not be sterile. The plunger arrangement has the benefit it can be employed with syringes which have a needle already attached. The latter is beneficial because the rod with a mechanical stop is captive within the cap and avoids the need to narrow the rod by including a waist disclosed in ‘068, which may introduce weakness into the structual integrity of the rod

[0009] SUMMARY OF INVENTION

[0010] The following paragraphs describe the present invention:

[0011] 1. A fluid dispensing vessel, such as a syringe including a manual syringe and / or a cartridge for an autoinjector, comprising: a plunger (for example comprising a body); a cap; a barrel; an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annular member; a rod slidable along the barrel length and configured to communicate with the conduit to provide open and closed positions for said conduit; a handle attached to the rod, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from the annular member mechanically breaking the seal and allowing fluid to flow through the conduit, characterised in that:

[0012] ■ the rod retracts into the plunger (for example into the plunger body); and / or (in particular or)

[0013] ■ the cap (e.g. an in situ cap) defines an orifice and the rod slides along the barrel through the orifice, said rod comprises a stop larger than the orifice (to act as a retainer against the interior of the cap, such as a mechanical stop) e.g. a flange, such that the rod is retained by the interior of the cap and prevented from leaving the cap.

[0014] 2. A rod and cap component for a fluid dispensing vessel, such as a syringe or cartridge, with a barrel and an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member comprising: a. a cap defining an orifice, and b. a rod comprising: a handle, and a stop larger than the orifice (to act as a retainer against the interior of the cap, such as a mechanical stop) eg. a flange, such that the rod is retained by the interior of the cap and prevented from leaving the cap, and said rod configured to slide through the orifice and communicate with the conduit to provide an open and closed positions for said conduit, for example, wherein the closed position is defined by the rod sealing the conduit (in the annual member defining the chambers), and the open position is defined by the rod sliding along the barrel away from annular member (defining the chambers) mechanically breaking the seal and allowing fluid to flow through the conduit (optionally a seal is provided between the rod and the cap, for example to maintain the contents of the syringe isolated from the external environment until the cap is removed).

[0015] 3. A plunger for a fluid dispensing vessel, such as a syringe or cartridge, with a barrel and an annular member configured to fit within the barrel, thereby defining a firstand second chamber in fluid communication via a conduit in the annular member said plunger comprising:

[0016] ■ a body, and

[0017] ■ characterised in that a retractable rod is receivable into the body and the rod together with the dispensing vessel defines an open and closed position for the conduit such that the rod is slidable along the barrel length of the vessel and configured to communicate with the conduit, wherein the closed position is defined by the rod sealing the conduit [of the annular member defining the chambers], and the open position is defined by the rod retracting into the plunger body and mechanically breaking the seal and allowing fluid to flow through the conduit (of the annular member defining the chambers).

[0018] 4. A vessel, component or plunger according to any preceding paragraph, wherein the conte nt(s) of the vessel is / are maintained isolated from the external environment during mixing, for example by an interference fit with the rod and forming a seal therewith during slidable engagement, for example forming a seal with the cap or plunger, such as where the seal is formed by an annular member.

[0019] 5. A vessel, component or plunger according to any preceding paragraph, wherein the cap remains in situ when the conduit is switched from a closed to open position.

[0020] 6. A vessel, component or plunger according to any preceding paragraph, which further comprises one or more further annular members (i.e. at least two annular members).

[0021] 7. A vessel, component or plunger according to paragraph 6, wherein a second annular member (i.e. a seal or annular ring) is located in the cap to form an interference fit with the retractable rod, for example to facilitate the rod sliding between the open and closed position and maintain the contents of the vessel isolated from the external environment until the cap is removed.

[0022] 8. A vessel, component or plunger according to paragraph 6 or 7, wherein a second (or further) annular member (also referred to herein as an annular ring) is located at the end of the plunger body to form an interference fit with the retractable rod (to seal fluid inside the vessel and / or facilitate the rod sliding between the open and closed position), for example wherein the rod is accommodated in the conduit of the second annular ring and forms an interference fit therewith.

[0023] 9. A vessel, component or plunger according to any preceding paragraph, wherein the plunger body comprises a flange (which can be pressed to depress the plunger into the barrel of the vessel).

[0024] 10. A vessel, component or plunger according to any preceding paragraph, wherein the plunger body comprises a sleeve which is slotted (for example comprises one or two (such as two) parallel slots to accommodate a handle, such as a washer with a diametric bar arranged to engage with said slots).

[0025] 11. A vessel, component or plunger according to paragraph 10, wherein the handle is a washer arranged to engage with the slots of the sleeve.

[0026] 12. A vessel, component or plunger according to paragraph 11, comprising a connector for attaching the rod to the handle.

[0027] 13. A vessel, component or plunger according to paragraph 12, wherein the connector comprises a first and a second flange, for example wherein the first flange has a smaller diameter than the second flange.

[0028] 14. A vessel, component or plunge according to any one of paragraphs 12 or 13, wherein the connector comprises a two-tiered structure.

[0029] 15. A vessel, component according to any preceding paragraph wherein the cap is a nozzle cap, for example a syringe nozzle cap. 16. A vessel, component or plunger according to any preceding paragraph wherein the conduit is concentric with the annular member, including 1, 2 or more annular members.

[0030] 17. A vessel, component or plunger according to any preceding paragraph, wherein the movement of the annular member(s) is restrained by fluid pressure, in particular the annular member defining the chambers.

[0031] 18. A vessel, component or plunger according to any preceding paragraph, wherein the upper surface of at least one (such as 1, 2 or more) annular member is tapered, conical or dished, in particular the annular member defining the chambers.

[0032] 19. A vessel, component or plunger according to any preceding paragraph, wherein the lower surface of at least one (such as one) annular member is tapered, conical or dished.

[0033] 20. A vessel, component or plunger according to any preceding paragraph wherein the rod(s) cylindrical.

[0034] 21. A vessel, component or plunger according to any preceding paragraph wherein the rod end which engages with the conduit is rounded, for example wherein the end is hemi-spherical.

[0035] 22. A vessel, component or plunger according to any preceding paragraph, wherein the cap has a locking means, for example a Luer Lock.

[0036] 23. A vessel, component or plunger according to any preceding paragraph, wherein the handle (to aid the gripping of rod to facilitate its movement by hand) for example is selected from: a frustoconical handle, a cylinder with a larger diameter than the dimensions of the rod, a three dimensional X, a ball, a cuboid, a cube, or a handle that is angled relative to the rod.

[0037] 24. A vessel, component or plunger according to any preceding paragraph, wherein the rod further comprises a lock (for example to prevent movement in transit), for example a Luer lock or other locking means.

[0038] 25. A vessel, component or plunger according to any preceding paragraph, wherein the handle prevents movement of the rod past a defined point in at least one direction, for example when the rod is withdrawn through the cap i.e. moving away from the plunger and / or alternatively when the rod is pushed into the cap towards the plunger.

[0039] 26. A vessel, component or plunger according to any preceding paragraph, wherein the annular member comprises one or more ribs, for example 1 or 2 , or 1, 2 or 3 ribs such as 2 or alternatively 3, such as the annular member defining the chambers, in particular all.

[0040] 27. A fluid-dispensing vessel according to any preceding paragraph, wherein the vessel is a syringe, such as a small syringe, for example having a volume of 0.2 to 5 ml such as 1 to 5 ml, or a large syringe, for example having a volume of 50 ml or more (such as 50 to 100ml).

[0041] 28. A fluid-dispensing vessel according to any preceding paragraph, wherein the barrel is a cartridge for an auto-injector.

[0042] 29. A fluid-dispensing vessel according to any preceding paragraph, wherein at least one chambers (for example the front and / or back chamber) contains a fluid (a liquid and / or a gas, eg or), such as a liquid.

[0043] 30. A fluid-dispensing vessel according to any preceding paragraph, wherein at least one chamber (for example the front and / or back chamber) contains a solid.

[0044] 31. A fluid-dispensing vessel according to paragraph 29 or 30, wherein a second chamber contains a fluid, such as a liquid. 32. A fluid-dispensing vessel according to any one ofparagraphs 29 to 31, wherein the first chamber contains a fluid (such as a liquid) and the second chamber contains a solid.

[0045] 33. A fluid-dispensing vessel according to any one of paragraphs 29 to 32, wherein both chambers contain a fluid.

[0046] 34. A kit of parts for use in a fluid dispensing vessel, said kit comprising

[0047] • a rod and cap component as defined herein, such as any one of paragraphs 2 to 26; and

[0048] • an annular member as defined hereinin, such as any one of paragraphs 1 to 26 (in particular an annular member which is a seal for the rod and cap and / or an annular member for defining the chambers).

[0049] 35. A kit of parts for use in a fluid dispensing vessel comprising:

[0050] • a plunger with a retractable rod as defined herein, such as any one paragraphs 3 to 26; and

[0051] • an annular member as defined herein, such as any one of paragraphs 1 to 26 (such as an annular member for sealing the plunger and / or annular member for defining the chambers in particular an annular member for location in the barrel).

[0052] 36. A kit of parts for use in a fluid dispensing vessel, said kit comprising:

[0053] • a cap configured with a hole to accommodate a rod, and

[0054] • a rod comprising a handle wherein mechanical force directly applied to the rod slidably engages with the cap to define an open and closed position the for a conduit in the annular member, characterised in that the cap remains in situ, providing an interference fit with the rod and forming a seal therewith during slidable engagement, and

[0055] • an annular member as defined in any one of paragraphs 1 to 26 (such as an annular member for sealing the rod and cap and / or annular member for defining the chambers, in particular an annular member for location in the barrel).

[0056] 37. A fluid dispensing device substantially as shown or described herein.

[0057] 38. A rod and cap arrangement substantially as shown or described herein.

[0058] 39. A plunger with a retractable rod substantially as shown or described herein.

[0059] 40. An annular member substantially as shown or described herein.

[0060] In one independent aspect there is provided a fluid dispensing vessel (referred to herein as a vessel), such as a syringe including a manual syringe and / or a cartridge for an autoinjector), comprising: a cap; a barrel; an annular member (such as moveable annular member) configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member; a rod slidable along the barrel length and configured to communicate with the conduit to provide open and closed positions for said conduit (eg where the conduit and the rod together function as a valve), and a seal between the cap and the rod to prevent exposure to the external environment during slideable engagement, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from annular member mechanically breaking the seal and allowing fluid to flow through the conduit (of the annular member defining the chambers]. Other features of the this disclosure are as as provided herein.

[0061] Advantageously adding a seal (such as an annular member) between the cap and rod arrangement makes the component relevant to most commercially available syringes with common needle attachment methods such as Luer Lock or Luer Slip nozzles. The more common Luer Lock is the preferred arrangement as the action of pulling up the rod by the handle may dislodge the cap from the syringe nozzle.

[0062] In one embodiment the interference fit does NOT comprise a seal and is just formed between the rod and the cap.

[0063] In one embodiment the interference fits comprises a seal (such as annular member) between the rod and the cap. This is advantageous in that it improves the isolation of the contents from external environment and may provide smoother movement, reduced production of particulates and contamination etc.

[0064] W02024 / 042068 defines a rod slidably engaged with the cap but does NOT disclose a seal between the components and simply uses the resistance of the two materials from which the rod and cap are made to create an interference fit In addition ‘068 does not disclose a stop on the rod (rod stopper).

[0065] In one embodiment disclosure from W02024 / 042068 is disclaimed.

[0066] In one embodiment there is only one rod in the cap and / or plunger. In one embodiment there is only one rod in the vessel, for example in the cap or plunger.

[0067] In one embodiment the rod is substantially cylindrical, such as cylindrical.

[0068] In one embodiment the rod has a dimension, such as a diameter, which is substantially the same along its length or the majority thereof (such as 80% or more, in particular 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100%). Thus, in one embodiment, the rod does not comprise a narrowed section(s) along its length, for example which functions in opening the conduit

[0069] In one embodiment, the rod which retracts into the plunger does not comprise a stop, for example does not comprise a stop that prevents the rod from leaving the annular member.

[0070] In one embodiment the rod lock is located with or in the handle.

[0071] In one embodiment, the handle comprises one or more grooves and / or ribs. In one embodiment, the cap comprises one or more grooves and / or ribs. Advantageously, the presence of grooves and / or ribs may make it easier to grip the handle and / or cap.

[0072] In one embodiment the plunger is tubular.

[0073] Also provided in an independent aspect is a fluid dispensing vessel, such as a syringe including a manual syringe and / or a cartridge for an autoinjector), comprising an autoinjector), comprising: a plunger (for example comprising a body); a cap; a barrel; an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member; a rod slidable along the barrel length and configured to communicate with the conduit to provide open and closed positions for said conduit, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from annular member mechanically breaking the seal and allowing fluid to flow through the conduit, characterised in that:

[0074] ■ the rod retracts into the plunger (for example into the plunger body], and / or (in particular or)

[0075] ■ the cap (e.g. an in situ cap) defines an orifice and the rod slides along the barrel through the orifice, said rod comprises a stop larger than the orifice (to act as a retainer against the interior of the cap) e.g. a flange, such that the rod is retained by the interior of the cap and prevented from leaving the cap.

[0076] In one embodiment in the plunger rod arrangement the withdrawal of the rod to open the conduit of the annular member defining the chambers does NOT involve moving said annular member with mechanical force, for example the annular is NOT moved towards the plunger by mechanical force. Having said that the annular member may be moved by fluid pressure.

[0077] As can be seen in the figures, the rod disconnects from the annular member defining the chambers during opening of the conduit, in the rod / cap embodiment and, or in the plunger / rod embodiment.

[0078] In one embodiment, the annular member defines a front chamber (for example proximal to a syringe nozzle) on one side of the annular member, and a back chamber (for example proximal to a syringe plunger) on the opposite side of the annular member.

[0079] In one embodiment a liquid is the front chamber.

[0080] In one embodiment a liquid is in the back chamber.

[0081] In one embodiment a liquid is in the front chamber and the back chamber.

[0082] In one embodiment a solid is in the front chamber.

[0083] In one embodiment a solid is in the back chamber.

[0084] In one embodiment a solid is in the front and back chamber (these can be reconstituted sequentially and administered sequentially or can be reconstituated concomitantly and premixed before administration, for liquid diluent (such as water for injection, saline, glucose or the like) can be drawn through a needle into the syringe) .

[0085] In one embodiment there is a solid in the front chamber and liquid in the back chamber.

[0086] In one embodiment there is a solid in the back chamber and a liquid in the front chamber.

[0087] The presently disclosed device, for which numerous working embodiments have been successfully tested, enables pre-mixing of two-liquids or a liquid diluent and a solid within a standard syringe. In comparison with complex prior art dual syringes, the device advantageously only requires low- cost parts.

[0088] Advantageously, the present components can be installed in a range of different types of vessels (in particular commercially available vessels), for example syringes, including medical syringes, oral syringes, dental syringes, laboratory syringes, syringes for applying chemical compounds such as grease, thermal paste and glues, etc.

[0089] The device can be retrofitted to an existing fluid-dispensing vessel, such a conventional syringe including a medical syringe, resulting in significant cost savings. An important advantage of the present invention is that the cap may remain in situ during mixing and the chambers remained sealed from the external environment. This ensures that the contents can be kept aseptic, if desired. Thus, in one embodiment the contents are kept aseptic during mixing. In one embodiment an interference fit is between the cap and the rod and / or between the retractable rod and the plunger body.

[0090] Where there is needle on the nozzle of the syringe there will generally be a cap (such as unmodified cap) to keep the contents of the vessel, such as a syringe aseptic.

[0091] In one embodiment at least one annular member is moveable, for example the annular member located in the barrel is moveable. Advantageously, the annular member can be positioned at any location within the fluid-dispensing vessel, for example any location within the barrel of a syringe. This allows the size of the chambers to be adjusted as required. In addition when the pressure is sufficient to overcome the resistance fit the annular member can move towards to the nozzle to facilitate emptying of the contents.

[0092] Further annular members can be used to create more chambers in the vessel (eg. the vessel has 2, 3, or 4 chambers). Alternatively, an further annular member can be used to seal-off a component, for example the plunger rod, wherein the conduit accomodates the retractable rod.

[0093] In one embodiment, there is only one or two annular members, such as one, in particular two.

[0094] In one embodiment, the annular member or members is constructed from a plastic or polymer, such as a thermoplastic or elastomeric material, in particular an elastomeric material, for example thermoplastic elastomer (TPE) including but not limited to Styrenic Block Copolymers (SBC), Polyolefin Blends (TPO), thermoplastic polyester copolymers (COPE) and Styrene-butadiene- styrene (SBS) rubber or a TPE blend (in particular a material suitable for for medical applications, such as specifically developed for same).

[0095] In one embodiment one or more (such as all) of the annular members are symmetrical (in particular the barrel annular member), in particular about an axis drawn through its depth (or height). This is advantageous in that it allows the fitting in any orientation and avoids errors.

[0096] In one embodiment, the annular member is not deformed when the conduit is opened, i.e. the shape of the annular member remains substantially the same before, during and after the opening of the conduit In one embodiment, the annular member is not deformed when a fluid pressure is applied to the conduit. Thus, in one embodiment, the annular member is made of a resilient material which is not deformable by fluid pressure.

[0097] In one embodiment the conduit is concentric with the annular member. This may be beneficial as the concentric hole acts as a self-centering mechanism to a cylindrical rod.

[0098] In one embodiment the conduit (for example the concentric hole) has one or both edges (or ends) tapered or curved to produce a funnel or conical shape, such as shown in Figures 1A to 1C.

[0099] In one embodiment, the conduit comprises one or more protrusions, for example bumps or vane-like protrusions, such as the protrusions found in an archimedes screw thread, for introducing a rotational vector to a fluid flowing throught the conduit

[0100] In one embodiment, the annular member comprises a raised upper surface. In one embodiment, the raised upper surface is selected from the group comprising a ridge, one or more protrusions, and a dished / dish-like upper surface. In one embodiment, the raised upper surface is a ridge, for example a ridge shaped like a pyramid. In one embodiment, the raised upper surface is one or more protrusions, such as a one or more bumps or rod-like protrusions.

[0101] In one embodiment, the raised upper surface is a dished / dish-like upper surface. Hence, in one embodiment, the annular member comprises a dished / dish-like upper surface.

[0102] In one embodiment, the annular member comprises one or more ribs, such as one, two or three ribs, for example on the exterior wall of the member. In one embodiment the annular member comprises two ribs. The ribs help to ensure that the annular member fits firmly within the fluiddispensing vessel, for example within the barrel of a syringe, the cap and / or the plunger, in particular the barrel of the syringe. The ribs can be a separate component added to the annular member, or the ribs can be molded as part of the annular member itself, i.e., the annular member and one or more ribs are unitary.

[0103] In one embodiment, the rod is made from a material selected from the group comprising copolymer (COC) or cyclic olefin copolymer [COP], polypropylene, polyethylene and polyamide. In another embodiment the rod is constructed from cyclic olefin poly (COP) or cyclic olefin copolymer (COC).

[0104] In one embodiment comprising a rod retractable into the plunger, there are at least two annular members, one in the barrel defining the chambers and one sealing the rod to the body of the plunger. These annular members are similar but have distinct functions.

[0105] In one embodiment, the upper or lower surface of the annular member (for example one or both annular members such as the barrel annular member) is a tapered, conical or dished / dish-like to aid mixing when the fluid passes back and forth through the annular member.

[0106] In one embodiment the upper and / or lower surface (such as both) of the annular member has a mouth that is exposed to the chamber it faces.

[0107] In trials conducted comparing the effacacy of the mixing of this type of geometry compared to a plain parallel sided hole demonstrated a reduction in time to mix a low viscosity (5-10cP) liquid with a high viscosity (1500cP) liquid.

[0108] In one embodiment, the plunger comprises a two-part design.

[0109] In one embodiment the diameter bar comprises a seat for housing a mounting.

[0110] In one embodiment the mounting holds the rod in position.

[0111] In one embodiment, the connector comprises one or more, such as two flanges. In one embodiment, the two flanges are of different sizes, for example wherein the first flange has a smaller diameter than the second flange. In one embodiment a flange, such as the larger flange engages with the end of the plunger sleeve. In one embodiment, a flange, such as the smaller flange engages with an annular member, such as the second annular member, to form a seal with the rod.

[0112] In embodiment the diameter bar of a washer engages with the slots of the plunger body to retract the washer, mounting and rod into the body.

[0113] In one embodiment, the component or plunger do not include a chamber for containing a fluid or solid. In other words, the chambers in the fluid-dispensing vessel are created by sub-dividing an interior volume in the fluid-dispensing vessel. Advantageously, this results in a simpler and cheaper to manufacture design compared to other prior art devices that typically comprise a chamber. Such prior art devices generally need to be filled with fluids and / or solids using specialised equipment which further adds to the complexity of implementing these devices.

[0114] In one embodiment the vessel (such as syringe) is NOT glass.

[0115] In one embodiment the vessel is NOT an ampoule, for example a glass ampoule.

[0116] In one embodiment the vessel (such as a syringe) is synthetic material.

[0117] In one embodiment the vessel according to the present disclosure is provided as a one unit (integral unit).

[0118] In one embodiment, the fluid-dispensing vessel (such as syringe) is selected from the group comprising a medical syringe, an oral syringe, a dental syringe and a laboratory syringe. In one embodiment, the fluid-dispensing vessel is a medical syringe.

[0119] In one embodiment, the syringe is a polymer or glass, in particular a polymer.

[0120] In one embodiment the syringe is disposable.

[0121] In oe embodiment the syringe is recyclable.

[0122] In one embodiment, the vessel, such as a syringe, has a volume of 100ml or less, for example 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 5, 4, 3, 2, 1 or less than 1ml, such a in the range 100 to 50 ml or 50 to 1ml, or 50 to 0.2ml.

[0123] In one embodiment, the syringe is a small syringe, for example a syringe 0.2 to 5 ml, such as 0.2, 0.5, 1, 2, 3, 4 or 5 ml.

[0124] In another embodiment, the syringe is a large syringe, for example 50 ml or more, such as 50, 60, 70, 80, 90 or 100 ml, in particular 60 ml. Such syringes are particularly suitable for infusion applications, such as intravenous infusion of drugs and fluids. For reconsituted liquid-solid drugs delivered via infusion, the volume of liquid diluent is typically larger and hence large syringes are more suited for this purpose.

[0125] In one embodiment, the fluid-dispensing vessel, such as a syringe.

[0126] In one embodiment, the syringe comprises a nozzle.

[0127] In one embodiment, the fluid-dispensing vessel, such as a syringe comprises a needle, such as a staked needle.

[0128] In one embodiment, the annular member is restrained by a negative fluid pressure, for example a negative fluid pressure generated in the front chamber when a syringe plunger is withdrawn from the barrel.

[0129] This can be achieved for example if the front chamber of a syringe contains a fluid and a syringe cap is attached to a syringe nozzle. When the syringe plunger is withdrawn (i.e. pulled), this generates a negative pressure in the front chamber, thus producing a hydraulic lock that restrains the movement of the annular member.

[0130] Negative fluid pressure can also be generated in the back chamber, for example when the back chamber of a syringe contains a fluid and a syringe cap is attached to a syringe nozzle. When the nozzle cap is pulled away from the nozzle, this generates a negative pressure in the back chamber, thereby also restraining the movement of the annular member.

[0131] In one embodiment a sealed chamber contains a gas, this gas being compressed when the syringe is plunged will provide a reactive pressure to return the plunger to its start position when released. In one embodiment, one or more of the components disclosed herein form a single part, i.e. are unitary. For example, the annular member and ribs may be one single part.

[0132] In one aspect, there is provided a method of mixing a fluid and a solid or two fluids in a fluid-dispensing vessel according to the present disclosure , such as a syringe, comprising opening the conduit, and repeatedly plunging and releasing (or retracting) a syringe plunger, in particular where the cap remains in situ (for example on the nozzle) and the contents of the vessel remain closed to the environment

[0133] In one embodiment the solid is a medicament or a drug.

[0134] In one embodiment the liquid is a pharmaceutical formulation, diluent and / or carrier.

[0135] This plunge and release action can be performed by hand or by a syringe driver.

[0136] A method of mixing (for example a fluid and a solid or two fluids) in a cartridge for an autoinjector is provided, wherein the auto-injector performs multiple plunge and release cycles such that a fluid repeatedly flows from one chamber to another chamber via the conduit hole in the annular member / central stopper.

[0137] A process is provided for assembling a component or despensing vessel according to the present disclosure, for example inserting an annular member according to the present disclosure; assembling a rod and cap arrangement; assembling a plunger and rod arrangement

[0138] Also provided is a method of filling a vessel according to the present disclosure with a content, e.g. at least one fluid, in particular wherein the fluid is a pharmaceutical formulation.

[0139] In one embodiment the assembly process involves applying the cap and rod arrangement to the vessel, for example the nozzle of a vessel.

[0140] In one embodiment the assembly process involves incorporating a plunger with a retractable rod according to the present disclosure into a vessel.

[0141] In one embodiment the there is provided a method of filling a fluid dispensing vessel, such as a syringe according to the present disclosure, comprising the step of filling a fluid (such as liquid or gas, in particular a liquid (more specifically an isotonic liquid) into a chamber of the vessel.

[0142] In one embodiment there is provided a method of filling a fluid dispensing vessel, such as as syringe, according to the present disclosure, comprising the step of filling a solid (such as a solid formulation of an active agent, such as a spray dried formulation) into a chamber of the vessel.

[0143] In one embodiment the filling process comprises the further step of filling a second chamber with a fluid, such as a liquid, for example a diluent and / or carrier.

[0144] In one aspect, there is provided a fluid dispensing vessel, for example a syringe, according to the present disclosure, comprising a medicament for administration to a patient such as a human, for use in treatment

[0145] In one aspect, there is provided an administration step according to the present disclosure wherein the contents of the vessel, such as syringe, are pre-mixed before administration.

[0146] In one aspect, there is provided an administration step according to the present disclosure wherein the one or more chambers of the vessel, such as a syringer are administered sequentially (i.e. without premixing). DETAILED DESCRIPTION

[0147] As used herein "fluid-dispensing vessel” refers to any vessel which is suitable for dispensing a fluid contained therein. In one embodiment, the fluid-dispensing vessel is a syringe, such as a medical syringe.

[0148] Syringe as employed herein includes a medical syringe, an oral syringe, a dental syringe, laboratory syringe and a cartridge for a syringe driver. Syringes (for example larger syringes, such as 50ml and above) can be used in syringe pumps or syringe drivers for automated delivery of a fluid. Syringes employed in syringe drivers are normally part of a cartridge.

[0149] Medical syringe as employed herein refers to a syringe suitable for holding and / or administering a fluid (such as a pharmaceutical formulation) to a patient

[0150] Patient as employed herien, refers to a human or an animal, in particular a human.

[0151] "Plunger” as used herein refers to a component employed to thrust into the barrel of the vessel and which can generally be retracted moving out of the barrel, wherein the movement agitates the contents of the vessel for mixing purposes and / or expels the contents out from an outlet, such as the nozzle. Usuallythe plunger is moved by mechanical force, sliding in and out of the barrel.

[0152] "Retracts into the plunger” as employed herein refers to where the rod moves towards the plunger and is accomodated or housed by an internal space defined by the plunger (including where rod simply passes through the plunger to a different location) thereby withdrawing the rod from the chamber / annual member, in particular to open the conduit Generally, as shown in the figures herein, the rod retracting breaks the physical contact with the annular member, i.e. the rod and the annular member disconnect. Plunger stopper as used herein is distinct from the rod stop. The latter is generally associated with the cap embodimentunless the context indicates otherwise. In contrast, the plunger stop separates the plunger from a chamber of the barrel and may be configured to accommodate the retractable rod. Generally the plunger stopper will be an annular member where the rod sits in the conduit and slides therethrough when it retracts. The plunger stopper / annular member acts to seal fluids, such as liquids in the chamber(s) and / or protect the contents of the chamber(s) from the external environment

[0153] Tubular as employed herein refers to comprising a section that is a tube.

[0154] The term "cap” as used herein refers to a covering used to seal an oudet (such as nozzle) of the fluid-dispensing vessel. The cap is dimensioned to correspond to the shape and nature of the outlet.

[0155] "In situ cap” as employed herein refers to a cap designed to remain in place when the rod slides to open the conduit, in particular to allow mixing of the contents without exposure to the external environment

[0156] The plunger and the cap are generally on opposing ends of the barrel.

[0157] The term "barrel” as employed herein is generally a cyclinder defining an interior volume for holding contents, with an open end to accommodate a plunger allowing it to slide in and out. At the opposing end the barrel comprises an outlet, for example a nozzle, to allow fluid to exit the vessel.

[0158] The term nozzle as used herein refers to a fluid outlet of the vessel, in particular a tapered fluid outlet.

[0159] Annular member / central stopper as employed herein refers to a ring-shaped object having a generally circular shape in particular a shallow cyclinder, defining a conduit in the form of hole passing through the object from one side to the opposing side generally along the axis of the smallest dimension. In one embodiment, the annular member is a ring. Central stopper may refer to the annular member located in the in barrel. Plunger stopper is an annular member employed in the plunger. Seal used in the context of the cap may also include an annular member.

[0160] The annular member may be constructed from any suitable material that would be familiar to the skilled person. Desirable properties of the material may include low cost of production, low weight, and / or compatibility with biological fluids, biologies, pharmaceutical compounds and the like.

[0161] Shaping the interior edges of the annular member may be beneficial by increasing turbulance and / or shear for mixing, particularly useful two fluids [eg liquids) with dissimilar viscosities. In one embodiment annular member (such as barrel annual member i.e. chamber forming annular member) is a double-sided conical shaped concentric hole, for example a doublesided curved conical shaped concentric hole.

[0162] Mouth as employed herein refers to an opening of the conduit widening in dimensions, for example as it approaches the surface of the annular member facing a given chamber. This may be provided on one or both sides of the annular member. Thus the conduit may start wide, narrow towards its centre and then widen out again as it approaches the other side.

[0163] An annular member may comprise one or more protrusions in the conduit for introducing a rotational vector to a fluid flowing throught the conduit. This has the advantage of further improving the mixing of a fluid and solid or two fluids.

[0164] Protrusions that may be suitable for achieving this effect include but are not limited to bumps or vane-like protrusions, such as the protrusions found in an archimedes screw thread.

[0165] Ribs on the annular member may improve the seal and / or grip of the annular member, for example in conjunction with the barrel wall.

[0166] Moveable annular member as employed herein refer to fact that the annular member is NOT fixed in one location i.e. is able to move within the barrel, for example where pressure is applied to the plunger (e.g the member moves towards cap or nozzle end) or may be inserted in different locations when assembling / retrofitting devices.

[0167] "Sealing annular member” or seal as used herein refers to an annular member, ring, gasket, seal or other functionally equivalent element, which is a component designed to form a barrier, closure, boundary, confine, for example a fluid-tight barrier (such as air-tight and / or liquid tight), in particular that is resilient in that it allowed movement of the rod therethrough without the integrity of the sealing function being compromised, for example in the context of the rod / cap and or plunger / rod. An example of a sealing annular member is shown in Figures 2C and 2D as part 5a. The sealing annular member is therefore distinct from the annular member / central stopper employed in the barrel of the syringe, whose function is to subdivide the barrel into two or more chambers. "Disconnects from the annular member defining the chambers” during opening of the conduit as employed herein refers to the fact the rod no longer touches and it NOT connected to the annular member.

[0168] "Chamber" as used herein refers a subdivision of the barrel formed by the annular member, allowing individual contents of the vessel to be separated. "Conduit” as used herein refers to a passageway (such as a tube or pipe) connecting a side, such as a distal end of the annular member with the opposite side, such as a proximal end of the annular member. The conduit allows a fluid to move from one side of the annular member to its opposing side, i.e. from one chamber to another chamber.

[0169] "Mechanical pressure to break a seal” in the context of the present disclosure will generally be achieved by pulling the plunger butt or pulling the rod to retract it from the chamber, for example into the body of the plunger or through the cap.

[0170] "Mechanical pressure” may also be achieved by pushing for the plunger (such as manually pressing the butt) to dispense the content of the vessel, such as a syringe.

[0171] "Rod” as used herein refers to a generally straight bar, which is typically cylindrical. However, the skilled person would be aware that the rod need not be completely straight and that non-cylindrical shapes can also be used, provided the rod is appropriately dimensioned such that it can fit and move within, in particular slide within the conduit of the annular member, and is able to form an adequate seal to close off access to the conduit

[0172] Generally the rod is NOT connected to the annular member defining the two chambers and simply abuts the conduit in the closed position. Thus when the rod retracts or withdraws thereby opening the conduit it disconnects (no longer touches) said annular member.

[0173] The rod may be made of any suitable material which will be known to the skilled person. For example the rod may be made from the same material as the syringe barrel, such as cyclic olefin copolymer (COC) or cyclic olefin copolymer (COP) or any medical grades of similar polymers used for other parts of a syringe. Other common materials can also be used for the rod such as polypropylene, polyethylene, polyamide (Nylon), cyclic olefin polymer (COP) or cyclic olefin copolymer (COC).

[0174] The term "handle” as employed herein refers to a feature that can be gripped to move an element, such as the rod, backwards and / or forwards (generally slidably). It may have a dimension that is larger than a corresponding dimension of the rod, for example it may protrude at an angle in the range 5 to 90 degrees to the length of the rod. Alternatively, or additionally it may be bigger than the width / diameter of the rod.

[0175] In one embodiment the handle is integrated with the rod, for example is simply a protrusion, including a longer length or another rod. In another embodiment the handle has a specific shape, for example as described elsewhere herein. For example, the handle may be of any axisymmetric shape, the geometry of which is ergonomic for gripping with fingers and which has a central axis common with that of the rod.

[0176] Open position or configuation as employed herein in the context of the conduit is where fluid can flow through the conduit The open position is actually a spectrum where the seal formed by rod with conduit is broken to where the conduit is full open. In the fully open position the rod may NOT yet be extended to its furthest position away from the conduit and the rod may be moved or retracted further to a final position / configuration.

[0177] Closed position or configuation as employed herein in the context of the conduit is where fluid can NOT flowthrough the conduit i.e. the rod from the cap and / or the plunger seals the conduit

[0178] There are also other seals within the dispensing vessel according to the present disclosure, namely a seal between the cap and the rod and / or a seal between the plunger body and the rod. The stop element of the rod is used to keep the rod and the cap in association, such that the rod is retained in proximity to the cap by the stop abutting the interior or underside of the cap and preventing the rod sliding completely away from the cap. The stop together with the rod keeps the contents of the vessel sealed from the environment, for example during mixing. The stop element is generally appended to the rod although it may be manufactured as a unitary item with the rod. The stop is generally a block, a unit, a ring and / or a protrusion, for example that has a profile outside the shape of the rod, for example is not part of the basic rod shape.

[0179] Stop element / stop member as employed herein does NOT include embodiments diclosed in W02024 / 042068, which prevent the rod passing through the cap, for example where the rod has a waist Thus stop element as employed herein is distinct from the rod, in that it has a different shape to the rod although it may be integral with the rod, for example molded. Hence, in one embodiment, the rod does not comprise a waist.

[0180] To access the contents of the vessel, the cap (for example together with the rod) is removed. Interference fit as employed herein refers to an arrangement (for example with the cap and rod and / or rod and plunger) where one part or element can move relative to another element but a liquid seal is generally maintained during the movement In optimised versions this may require a gasket(s) or seal(s) to be employed between the moving parts.

[0181] One or more locks may be employed on moving or removeable elements, for example the cap and / or rod. For example a lock may be employed to stop the plunger moving. This, for example prevents damage during transit.

[0182] Materials employed in the manufacture of devices and / or components according to the present disclosure must be fit for purpose.

[0183] Examples of solids include but are not limited to powders, granules and cakes, such as powders and cakes. In one embodiment the the solid comprises an active pharmaceutical agent These for example may be lyophilised drugs, powdered chemicals, crystals and the like.

[0184] Examples of fluids include but are not limited to buffers, such as biological buffers, and pharmaceutically acceptable diluents or carriers, which could be used to reconstitute lyophilised active agent, including isotonic forms thereof.

[0185] Mixing includes repeatedly pushing and releasing the syringe plunger, thereby creating turbulence and shear to aid in the mixing of the fluid and solid or fluids. This procedure is herein referred to as back-flushing. As the syringe has an air-tight seal in the front chamber, any air in the front chamber acts as a pneumatic spring and by plunging against this spring, this returns the plunger to its start position. The turbulence and shear created in the fluid as it is forced back and forth through the concentric hole of the annular member helps to accelerate the mixing process.

[0186] Advantageously the present mixing method works well in small vessels (such as syringes), which are difficult to agitate and generate mixing due to the small internal volume. The improved interior edges of the conduit (such as the tapered or curved conduit described above) may be particularly important in this group of devices.

[0187] Technical references such as patents and applications are incorporated herein by reference.

[0188] Any embodiments specifically and explicitly recited herein may form the basis of a disclaimer either alone or in combination with one or more further embodiments. In the context of this specification "comprising" is to be interpreted as "including". Embodiments of the invention comprising certain features / elements are also intended to extend to alternative embodiments "consisting" or "consisting essentially" of the relevant elements / features. Where technically appropriate, embodiments of the invention may be combined.

[0189] Subject headings herein are employed to divide the document into sections and are not intended to be used to construe the meaning of the disclosure provided herein.

[0190] The background section contains technical information relating to the invention and may be employed as basis for amendment

[0191] The present specification claims priority from GB2402462.2 filed 21 February 2024, and incorporated herein by reference. This document can be used as basis for correction.

[0192] Individual numerical values in the Examples and / or Figures may be isolates and used as basis for amendment of the claims without reference to the other parameters recited therein.

[0193] BRIEF DESCRIPTION OF DRAWINGS

[0194] Figure 1A shows an annular member 1 with a hole / conduit 2 and sealing ribs 3

[0195] Figure IB shows an annular member 1 with sealing ribs 3 and a curved conical concentric hole / conduit 2

[0196] Figure 1C shows an annular member 1 with sealing ribs 3 of the and a double-sided curved conical concentric hole / conduit 2

[0197] Figure ID shows a comparison between insertion of a cylindrical rod 4 with a semi-spherical end vs a rod without a semi-spherical end into the hole 2 of the annular member of Figure 1C

[0198] Figure 2A shows a cylindrical rod 4 slidably engaged with a syringe nozzle cap 5 and handle 6 attached to the cylindrical rod 4 and a stop 7 also attached to the cylindrical rod 4, the assembly is shown in the position where it would seal the annular member with a hole / conduit 2

[0199] Figure 2B shows a cylindrical rod 4 slidably engaged with a syringe nozzle cap 5 and handle 6 attached to the cylindrical rod 4 and a stop 7 also attached to the cylindrical rod 4, the assembly is shown in the position the annular member with hole / conduit 2 is open, and the stop 7 engages with the underside of the syringe cap 5

[0200] Figure 2C shows a sectional view of the cap assembly where cylindrical rod 4 slidably engaged with a sealing annular member 5a in the syringe nozzle cap 5 and handle 6 attached to the cylindrical rod 4 and a stop 7 as an integral part of the cylindrical rod 4, the assembly is shown in the position where it would seal the annular member with a hole / conduit 2

[0201] Figure 2D shows a sectional view of the cap assembly where cylindrical rod 4 slidably engaged with a sealing annular member 5a in the syringe nozzle cap 5 and handle 6 attached to the cylindrical rod 4 and a stop 7 as an integral part of the cylindrical rod 4, the assembly is shown in the position the annular member with hole / conduit 2 is open, and the stop 7 engages with the underside of the annular member 5a in the syringe cap 5 Figure 3A shows a cylindrical rod 4 slidably engaged with a tubular plunger rod 8 and plunger stopper 9 which has a hole) and handle 6a attached to the cylindrical rod 4 in the position where it would seal the annular member 1

[0202] Figure 3B shows a cylindrical rod 4 slidably engaged with a tubular plunger rod 8 and plunger stopper 9 which has a hole and handle 6a attached to the cylindrical rod 4 in the position where it would unseal the annular member 1, handle 6a in this arrangement acts also as a stop to maintain the seal between the cylindrical rod 4 and plunger stopper 9.

[0203] Figure 4A-D shows a fluid-dispensing vessel 10 employing the cylindrical rod 4 and syringe cap 5 of Figures 2A & 2B in conjunction with the annular member of Figure 1A, and wherein the vessel 10 is pre-filled with a liquid diluent 14 and solid 13 that are premixed before dispensation

[0204] Figure 5A-D shows a fluid-dispensing vessel 10 with a staked needle 16 wherein the cylindrical rod 4 is slidably engaged with the tubular plunger rod 8 and plunger stopper 9 which has a hole [figures 3A & 3B), in conjunction with the annular member of Figure 1A, and wherein the vessel is pre-filled with a liquid 18 in the front chamber and second liquid

[0205] 19 the rear chamber that are pre-mixed before dispensation

[0206] Figure 6A-D shows a fluid-dispensing vessel 10 with a staked needle 16 wherein the cylindrical rod

[0207] 4 is slidably engaged with the tubular plunger rod 8 and plunger stopper 9 which has a hole [figures 3A & 3B), in conjunction with the annular member of Figure 1A, and wherein the vessel is pre-filled with a solid 13 in the front chamber and a diluent 14 in the rear chamber that are pre-mixed before dispensation

[0208] Figure 7A-C shows a fluid-dispensing vessel 10 with a staked needle 16 wherein the cylindrical rod

[0209] 4 is connected to a syringe plunger 11, in conjunction with the annular member 1 of Figure 1A and wherein the vessel pre-filled with a liquid diluent 14 in the front chamber and solid 13 in the rear chamber that are pre-mixed before dispensation

[0210] Figure 8 shows the effect of the curved conical upper surface of the annular member 1 on the flow of the diluent 14 through the annular member hole / conduit 2

[0211] Figure 9 shows an exploded view of the arrangement for the tubular plunger rod 8 [comprised of two parts 8a & 8b), the handle 6a, the stopper plunger with a hole 9 and the cylindrical rod 4 which is fixed to the handle 6a

[0212] SUMMARY OF LIST OF PARTS

[0213] 1. Annular member 2. Conduit 3. Ribs

[0214] 4. Rod 5. Cap 5a Sealing annular member

[0215] 6 Cap Handle 7. Stop 8. Tubular Plunger Rod comprising:

[0216] 6a Plunger Rod Handle 8a Tubular Plunger Rod Body 8b Tubular Plunger Rod Top

[0217] 9. Plunger Stopper with hole 10. Syringe Barrel 11. Standard Plunger Rod

[0218] 12. Plunger Stopper 13. Solid Drug 14. Diluent

[0219] 15. Reconstituted Drug 16. Staked N 17. Rigid Needle Shield (RNS) [solid+liquid]

[0220] 18. Liquid 1 [Front Chamber] 19. Liquid 2 20. Mixed Liquidl + Liquid2 [Back Chamber] EXAMPLES

[0221] Example 1 - Liquid-solid pre-mix for cylindrical rod 4 slidably engaged with syringe cap

[0222] The syringe barrel 10 is pre-filled with a liquid diluent 14 [located in the back chamber proximal to the plunger stopper 12) and a solid drug [e.g. lyophilate or powdered drug) 13 located in the front chamber (proximal to the nozzle). The cylindrical rod 4 engaged with the annular member 1 prevents the liquid diluent 14 from mixing with the solid 13 during storage and / or delivery of the syringe. Syringe cap 5 ensures the contents remains aseptic.

[0223] Figure 4A shows the prefilled syringe. To mix the liquid diluent 14 and solid drug 13 the cylindrical rod 4 is pulled via handle 6 until stop 7 engages on the underside of the syringe cap 5 (see fig. 4B). In this position the conduit 2 is in a open position, which allows liquid diluent 14 to flow from the back chamber to the front chamber, whilst the syringe contents are sealed from the external environment by the interference fit between the syringe cap 5 and the cylindrical rod 4.

[0224] Now the liquid diluent 14 can be transferred into the front chamber to mix with the solid drug 13 by plunging the plunger rod 11. This also will compress the air in the front chamber as the seal is maintained and once the the applied plunging force is released the plunger rod 11 will return to its starting position.

[0225] Figure 4C illustrates that when a plunging force is (cyclically) applied the diluent 14 will go back and forth from the front chamber to the rear chamber (referred to as backflushcreating turbulence which dissolves (reconstitutes)the solid 13 efficiently. The speed of flushing can be controlled by the user. Once the solid drug 13 is completely in solution to form a homogenous mix of reconstituted drug 15, the syringe cap 5 and rod 4 can be removed together by unscrewing the syringe cap 5 (Luer Lock is the preferred cap type).

[0226] Figure 4D shows the syringe ready for a needle to be attached, the plunger stopper 12 engages with annular member 1 and the reconstituted drug is delivered by plunging the plunger rod 11 in the usual fashion for injecting liquid drugs.

[0227] Example 2 - Liquid-liquid pre-mix for cylindrical rod 4 slidable engaged with plunger rod

[0228] Many prefilled syringes have a permanently attached (staked) needle 16. The rod 4 needs to unseal the annular member 1 by being withdrawn in the opposite direction to the nozzle, i.e. slidably engaged with a tubular plunger rod 8.

[0229] Figure 5A shows this arrangement for a prefilled syringe containing a liquid in the back chamber 19 and a liquid in the front chamber 18 which are to be mixed before injection by withdrawing the rod 4 from the annular member 1 by pulling handle 6a downwards until it engages with the end of the tubular plunger rod 8 (Figure 5B).

[0230] In this position the plunger stopper 9 (which contains a hole) is still sealed by the rod 4 and the liquid in the back chamber 19 maybe transferred to the front chamber containing the liquid 18 by plunging the plunger 8 after removing the rigid needle shield (RNS) 17 (see figure 5C).

[0231] Figure 5D shows the syringe ready for injection (after any air is expelled), in the usual fashion for injecting liquid drugs.

[0232] Figure 9 shows a detailed exploded view of the parts which comprise the plunger rod 8 (components 8a and 8b), the rod 4, the plunger rod stopper with a hole 9 and the handle 6a.

[0233] Example 3 - Liquid-solid pre-mix for cylindrical rod 4 slidable engaged with plunger rod Figure 6A shows this arrangement for a prefilled syringe containing a liquid diluent 14 in the back chamber and a solid in the front chamber 13 which may be mixed before injection. To connect the two chambers the cylindrical rod 4 is withdrawn from the annular member 1 by pulling handle 6a downwards until it engages with the end of the plunger rod 8 (Figure 6B). The liquid diluent 14 may be transferred into the front chamber to mix with the solid 13 by plunging the plunger rod 8, compressing the aseptic air in the front chamber as the seal is maintained. Releasing the applied plunging force will return the rod plunger 8 to its starting position.

[0234] Figure 6C illustrates a plunging force applied cyclically moves the diluent 14 back and forth from the front chamber to the rear chamber to provide backflushing, creating turbulence in the liquid diluent 14 and causing the solid drug 13 to dissolve (reconstitute) efficiently. The speed of flushing can be controlled by the user.

[0235] Once the solid drug 13 is completely in solution to form a homogenous mix of reconstituted drug 15, the syringe RNS 17 can be removed. Figure 6D shows the syringe ready for injection (after any air is expelled) in the usual fashion for injecting liquid drugs.

[0236] Figure 9 shows a detailed exploded view of the "plunger” parts.

[0237] Example 4 - Liquid-solid pre-mix for cylindrical rod 4 connected to plunger

[0238] Figure 7A shows an embodiment wherein a shorter (cylindrical) rod 4 is connected to the plunger through the plunger stopper with a hole 9.

[0239] The syringe barrel 10 is pre-filled with liquid diluent 14 is in the front chamber and solid 13 in the small back chamber trapped between the annular member 1 and the plunger stopper with a hole 9. Rigid needle shield 17, which seals the front chamber, is kept on the syringe and the plunger is withdrawn (i.e. moving away from the nozzle). This creates a negative fluid pressure in the front chamber, which restrains the movement of the annular member 1. As the plunger is further withdrawn, shorter (cylindrical) rod 4 connected to plunger 11 via plunger stopper with a hole 9 is separated from conduit 2 thereby opening same. The RNS 17 is removed to release the hydraulic lock which allows liquid diluent 14 to flow into the back chamber via conduit 2 (see figure 7B), thereby allowing mixing of liquid diluent 14 and solid 13 producing reconstituted drug (solid+liquid) 15. The syringe 14 can optionally be shaken or back-flushed to aid in the mixing.

[0240] Reconstituted drug (solid+liquid) 15 is dispensed in the usual fashion for injecting liquid drugs (see Figure 7C).

[0241] Figure 8 shows the effect of a curved conical concentric conduit 2 in the annular member 1 which increases mixing efficiency by increasing the area of turbulence created. This was proved through testing. This curved conical concentric conduit 2 also aids the assembly process as the shape provides a natural self-centering effect.

Claims

CLAIMS1. A fluid dispensing vessel, such as a syringe including a manual syringe and / or a cartridge for an autoinjector), comprising: a plunger (for example comprising a body); a cap (such as a nozzle cap); a barrel; an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member; a rod (eg cylindrical rod) slidable along the barrel length and configured to communicate with the conduit to provide open and closed positions for said conduit; a handle attached to the rod, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from annular member mechanically breaking the seal and allowing fluid to flow through the conduit, characterised in that: the rod retracts into the plunger (for example into the plunger body), and / or (in particular or); the cap (e.g. an in situ cap) defines an orifice and the rod slides along the barrel through the orifice; said rod comprises a stop larger than the orifice (to act as a retainer against the interior of the cap) e.g. a flange, such that the rod is retained by the interior of the cap and prevented from leaving the cap.

2. A rod and cap component for a fluid dispensing vessel, such as a syringe, with a barrel and an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member comprising: a cap(for example an in situ cap) defining an orifice; a rod (eg a cylindrical rod) comprising:■ a handle■ a stop larger than the orifice (to act as a retainer against the interior of the cap) eg a flange, such that the rod is retained by the interior of the cap and prevented from leaving the cap, said rod configured to slide through the orifice and communicate with the conduit to provide an open and closed positions for said conduit for example, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod sliding along the barrel away from annular member mechanically breaking the seal and allowing fluid to flow through the conduit.

3. A plunger fora fluid dispensing vessel, such as a syringe, with a barrel and an annular member configured to fit within the barrel, thereby defining a first and second chamber in fluid communication via a conduit in the annual member said plunger comprising:■ a body, and■ characterised in that a retractable rod (eg cylindrical rod) is receivable into the body and the rod together with the dispensing vessel defines an open and closed position for the conduit, such that the rod is slidable along the barrel length of the vessel and configured to communicate with the conduit, wherein the closed position is defined by the rod sealing the conduit, and the open position is defined by the rod retracting into the plunger body and mechanically breaking the seal and allowing fluid to flow through the conduit.

4. A vessel, component or plunger according to any preceding claim wherein content(s) of the vessel is / are maintained isolated from the external environment during mixing, for example by an interference fit with the rod and forming a seal therewith during slidable engagement.

5. A vessel, component or plunger according to any preceding claim, wherein the cap remains in situ when the conduit is switched from a closed to open position.

6. A vessel, component or plunger according to any preceding claim, which further comprises one or more further annular members (i.e. at least two annular members, such as 2 or 3).

7. A vessel, component or plunger according to claim 6, wherein a second annular ring is located at the end of the plunger body to form an interference fit with the retractable rod (to seal fluid inside the vessel and / or facilitate the rod sliding between the open and closed position) for example wherein the rod is accommodated in the conduit of the second annular ring and forms an interference fit therewith.

8. A vessel, component or plunger according to any preceding claim wherein the plunger body comprises a flange (which can be pressed to depress the plunger into the barrel of the vessel)9. A vessel, component or plunger according to any preceding claim, wherein the plunger body comprises a sleeve which is slotted (for example comprises two parallel slots to accommodate a handle, such as a washer with a diametric bar arranged to engage with said slots).

10. A vessel, component or plunger according to claim 9, wherein the handle is a washer arranged to engage with the slots of the sleeve.

11. A vessel, component or plunger according to claim 10, comprising a connector for attaching the rod to the handle.

12. A vessel, component or plunger according to claim 11, wherein the connector comprises a first and a second flange, for example wherein the first flange has a smaller diameter than the second flange.

13. A vessel, component or plunge according to any one of claims 11 to 12, wherein the connector comprises a two-tiered structure.

14. A vessel, component or plunger according to any preceding claim, wherein the movement of the annular ring or rings is restrained by fluid pressure.

15. A vessel, component or plunger according to any preceding claim, wherein the upper surface of at least one (such as 1, 2 or more) annular member is tapered, conical or dished.

16. A vessel, component or plunger according to any preceding claim, wherein the lower surface of at least one (such as one) annular ring is tapered, conical or dished.

17. A vessel, component or plunger according to any preceding claim wherein the rod end which engages with the conduit is rounded, for example wherein the end is hemi-spherical.

18. A vessel, component or plunger according to any preceding claim, wherein the cap has a locking means, for example a Luer Lock.

19. A vessel, component or plunger according to any preceding claim, wherein the handle (to aid the gripping of rod to facilitate its movement by hand) for example a frustoconical handle, a cylinder with a larger diameter than the dimensions of the rod, a three dimensional X, a ball, a cuboid, a cube, or a handle that is angled relative to the rod.

20. A vessel, component or plunger according to any preceding claim, wherein the annular member comprises one or more ribs, for example 1, 2 or 3 , such as 2 or alternatively 3.

21. A fluid-dispensing vessel according to any preceding claim, wherein the vessel is a syringe, such as a small syringe, for example having a volume of 1 to 5 ml, or a large syringe, for example having a volume of 50 ml or more.

22. A fluid-dispensing vessel according to any preceding, wherein the barrel is a cartridge for an auto-injector.

23. A fluid-dispensing vessel according to any preceding claim, wherein at least one chambers (for example the front and / or back chamber) contains a fluid (a liquid or a gas), such as a liquid.

24. A fluid-dispensing vessel according to any preceding claim, wherein at least one chambers (for example the front and / or back chamber) contains a solid.

25. A fluid-dispensing vessel according to claim 24 or 25 wherein a second chamber contains a fluid such as a liquid, such as wherein the first chamber contains a fluid (such as a liquid) and the second chamber contains a solid; or both chambers contain a fluid.

26. A kit of parts for use in a fluid dispensing vessel, said kit comprising• a rod and cap component as defined in any one of claims 2 to 25; and• optionally an annular member as defined in any one of claims 1 to 25; or• a plunger with a retractable rod as defined in any one of claims 3 to 25; and• optionally an annular member as defined in any one of claims 1 to 25 (in particular an annular member for location in the barrel).

27. A fluid dispensing device substantially as shown or described herein.

28. A rod and cap arrangement substantially as show or described herein.

29. A plunger with a retractable rod substantially as shown or described herein.

30. An annular member substantially as shown or described herein.

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