AMPOULE

Abstract

An ampoule comprises a self-contained body that defines a storage chamber, and that includes a port with a valve reconfigurable to allow recovery of fluid from the chamber via the port. The chamber is in part defined by structure that is operable or replaceable by a plunger element moveable in the chamber to dispense fluid via the port.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims priority from Australian Application No. 2013900918, filed Mar. 15, 2013, incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention relates to a novel ampoule that has particularly useful application in the storage and supply of small volumes of liquid reagents, for example less than 10 ml or in many applications less than 5 ml. The invention is particularly useful for liquid volumes in the range 0.1 to 1.0 ml.

BACKGROUND

Ampoules are widely used to contain and supply fluids, typically liquids, requiring protection from air or contaminants. They are usually glass and are hermetically sealed after filling by heating the glass to melt and thereby close the opening. In chemical analysis processes, ampoules are commonly employed to supply liquids such as reagents and standards.

At the point of use, the normal approach to extracting the contents of the ampoule is to break open the ampoule. The breaking process typically involves a skilled operator undertaking a sequence of events to remove the top of the glass container without a) damaging himself or herself and, b) damaging or contaminating the liquid contained inside. The liquid is then removed from the container by a skilled operator using a manually operated syringe for immediate use. Because the top of the ampoule has been broken away, there is usually no readily available reliable method of resealing the container so quite often a portion of the contents must be aliquoted into a series of tubes to be stored under the appropriate conditions or discarded.

It is an object of the invention to provide an improved ampoule that at least in part addresses one or more of these challenges associated with conventional glass ampoules.

Reference to any prior art in the specification is not, and should not be taken as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge in Australia or any other jurisdiction or that this prior art could reasonably be expected to be ascertained, understood and regarded as relevant by a person skilled in the art.

SUMMARY OF THE INVENTION

In broad terms, the invention provides an ampoule that has one or both of a valved port and an arrangement for engaging the ampoule with a precision driving mechanism that facilitates the dispensing of the contents.

In a first aspect, the invention provides an ampoule comprising a self-contained body that defines a storage chamber, e.g. for storage of a known amount of fluid, and that includes a port with a valve reconfigurable to allow recovery of fluid from the chamber via the port, wherein said chamber is in part defined by structure that is operable or replaceable by a plunger element moveable in the chamber to dispense fluid via the port.

In one or more embodiments, the valve is reconfigurable by being selectively and reversibly operable to open the port. In this case, there may be a latch device on the valve that must be disengaged to allow operation of the valve.

Preferably, the latch device is a removable element that physically blocks operation of the valve and requires substantial finger force for its removal from its valve blocking position, preferably removal by complete separation from the ampoule body and/or the valve.

In one or more embodiments, the valve is reconfigurable by comprising a web with a break line about a hinge portion at which the web hinges back behind a needle employed to separate the web at the break line.

Advantageously, the ampoule further includes a formation for engaging the body to a precision drive tool having a driving mechanism that is thereafter operable to move the plunger element to dispense fluid via the port.

Advantageously, in either aspect of the invention, the port includes a hollow needle. The needle may be relatively slidable between a first position in which the interior of the needle is sealingly closed from the chamber and a second position in which the interior of the needle is in communication with the ampoule chamber. The ampoule body may include an integral segment or a sealingly mounted insert that defines a passage in which the needle is sealingly slidable between the aforementioned first and second positions. The needle may include one or more lateral holes which provide the aforesaid communication between the ampoule chamber and the needle interior in the second position of the needle.

Conveniently, the needle is provided with a hub element at least partly external to said segment or insert by which the needle may be manipulated. The latch device when in situ may be conveniently disposed between the hub element and an external surface of the ampoule body segment or insert.

Preferably, the valve is configured to allow the needle to be flushed clean when in its first position, not in communication with the ampoule chamber. For this purpose, the ampoule body segment or insert may have a lateral port for admitting flushing fluid and one or more second lateral holes by which the interior of the hollow needle communicates with the flushing fluid port in the first position of the needle.

In an advantageous configuration, the ampoule body includes a generally tubular barrel, advantageously of glass or other inert material, with a uniform cylindrical interior wall which bounds said chamber and along which the plunger element is sealingly slidable. The valved port is then conveniently provided in an insert sealingly engaged with an end of the barrel or integrally in an end of the barrel. In a preferred embodiment, the needle extends and is slidable co-axially with the barrel.

In a second aspect, the invention provides an ampoule comprising a self-contained body that defines a hermetically sealable chamber for storage of a known amount of a fluid, and that includes a port with a valve selectively operable to open the port to allow recovery of fluid from the chamber via the port, wherein the ampoule further includes a plunger element relatively moveable in the chamber to dispense fluid via the port, and a latch device on the valve that must be disengaged to allow operation of the valve.

In a third aspect of the invention, there is provided an ampoule comprising a self-contained body that defines a chamber for storage of a known amount of fluid, and that includes a port to allow recovery of fluid from the chamber via the port, wherein the ampoule further includes a plunger element relatively moveable in the chamber to dispense fluid via the port, and a formation on the body for engaging the body to a precision drive tool having a driving mechanism that is thereafter operable to move the plunger element to dispense fluid via the port.

In a further aspect of the invention, there is provided a dispensing system comprising a precision drive tool with a driving mechanism and an engagement head, and an ampoule according to the invention engageable with the tool so that the driving mechanism is thereafter operable to move the plunger element of the ampoule to dispense fluid from the ampoule.

In each aspect, the ampoule may be a filled ampoule in which the chamber contains a volume of fluid and the port is sealingly closed. Alternatively or additionally, the chamber may contain a known amount of a solid, which can be dissolved in a known amount of fluid.

As used herein, except where the context requires otherwise, the term “comprise” and variations of the term, such as “comprising”, “comprises” and “comprised”, are not intended to exclude further additives, components, integers or steps.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be further described, by way of example only, with reference to the accompanying drawings in which:

FIG. 1 is an isometric view of an ampoule according to a first embodiment of the invention:

FIG. 2 is an axial cross-sectional view of the ampoule illustrated in FIG. 1, showing the ampoule valve condition prior to removal of the latching clip;

FIG. 3 is a front end view of the ampoule;

FIGS. 4 to 6 are matching enlargements of part of FIG. 2 respectively depicting the ampoule valve condition prior to removal of the latching clip, after removal of the latching clip in the flushing condition of the valve, and with the valve open for accessing the contents of the ampoule;

FIG. 7 is a three dimensional exploded view depicting the engagement of the ampoule with a hand-held precision drive tool;

FIG. 8 is an isometric view of an ampoule according to a second embodiment of the invention;

FIG. 9 is a front end view of the ampoule depicted in FIG. 8;

FIG. 10 is an axial cross-sectional view of the ampoule illustrated in FIG. 8, showing the ampoule prior to reconfiguration of the valve to allow release of liquid via the valved port;

FIG. 11 is a fragmentary enlargement of the valved port in FIG. 10, more clearly showing the separable hingeable seal web;

FIG. 12 is a cross-section on the line 12-12 in FIG. 11;

FIGS. 13, 14 and 15 correspond to FIGS. 10 to 12 but show conditions after the seal web is separated and hinged back;

FIG. 16 is an axial cross-section of an ampoule according to a third embodiment of the invention; and

FIG. 17 illustrates a sequence of actions by which liquid is recovered from the ampoule depicted in FIG. 16.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The ampoule 10 illustrated in FIGS. 1 and 7 includes a self-contained body 12 that defines a hermetically sealed chamber 14 for storage of a known amount of a fluid, typically a liquid. Body 12 is in three parts: a generally tubular transparent glass barrel 16 with an internal cylindrical wall 17 of uniform diameter, a forward insert 18 that sealingly closes one end of barrel 16, and a plunger element 20 that is sealingly slidable within barrel 16 and occupies a rear-most position as illustrated when the ampoule is full, completing the closure of chamber 14. The exact position of plunger element 20 is determined by the volume of liquid in the chamber.

For many typical applications, chamber 14 has a volume in the range 0.1 to 10 ml, for example 0.1 to 5 ml. In general, the invention is especially useful for chamber volumes in the range 0.1 to 1.0 ml, but is not confined in its application to any particular volume.

Insert 18 includes an axially disposed port 22 with a valve 25 that is selectively reconfigurable to open the port to allow recovery of fluid from chamber 14 via port 22. As will be explained further subsequently, plunger element 20 is moveable in chamber 14 to dispense fluid via the port. Plunger element 20 may typically be PTFE.

Valve 25 has a latch device 30 that physically blocks operation of the valve and must be disengaged to allow such operation.

At the rear end of barrel 16 there is an external formation 15, including an annular groove or channel 15a, for engaging the ampoule body to an engagement head of a precision drive tool with a driving mechanism that is thereafter operable to move the plunger element 20 to dispense fluid from chamber 14. In this case, formation 15 is formed integrally on the barrel but in other arrangements (for example, the embodiment of FIGS. 8 to 15, described below) it may be provided on a separate element attached to the main body of the barrel but still part of the barrel.

Insert 18, which is typically machined PTFE or moulded polypropylene, is generally cylindrical and of T-shaped configuration, having a domed head 40 with an outer peripheral surface 42 that matches the outer surface of barrel 16, and a co-axial spigot 44 that extends into and firmly engages internal surface 17 of barrel 16. An orthogonal annular shoulder 46 between the two parts of the insert engages the end of the barrel: this interface, the main peripheral interface for spigot 44 and an undercut groove 48 adjacent shoulder 46 are filled with a suitable adhesive to ensure a hermetic seal.

The port 22 includes a hollow needle 50, typically of stainless steel or other suitable material, with an over-moulded PET or PTFE hub 52 forming part of valve 25. The needle 50 and hub 52 are respectively received into an axial bore 54 of the insert and an external counterbore 55. Bore 54 is also shallow counterbored 56 at its inner end where it opens into chamber 14.

Needle 50 is open at its outer end 53 and closed at is inner end 51. A pair of spaced lateral holes 60,62 communicate the interior bore 49 of the needle with its outer surface. Hole 60 is displaced slightly back from inner end 51 whole hole 62 is displaced further back but forwardly of the inner end of hub 52.

Hub 52 has an integral peripheral annular rib 58 displaced from its inner end which registers with either of two matching axially spaced grooves 59a,59b on the wall of counterbore cavity 55 to define two axially spaced positions of the valve. Between the two grooves 59a,59b counterbore cavity 55 is open to the external surface of the insert by way of a port 70 for admitting flushing fluid to cavity 55 for the purpose, as will be explained, of flushing out and cleaning the needle 50.

The valve 25 is latched or locked in an outer position, in which rib 58 engages groove 59b, by latch device 30, which in this embodiment comprises a retaining clip snap-fastened between the end face of ampoule body insert 18 and an annular shoulder 53 on hub 52. In this position, lateral hole 60 in needle 50 is sealed closed by being midway along bore 54 while lateral hole 62 is open to cavity 55.

This is the state in which the ampoule is delivered to the end user. When he or she wishes to access the contents of the ampoule, the end user employs finger force (preferably a substantial finger force is required) to snap off clip 30 and so separate it from the ampoule, whereby further finger manipulation is employed to push hub 52 inwardly to the other position of the valve in which rib 58 engages groove 59a (and in which the end of hub 52 is adjacent the inner end wall of cavity 55. (FIG. 6). Lateral hole 60 of needle 50 is now exposed to shallow counter-bore 56 and thereby to the contents of chamber 14, while the other lateral hole 62 is sealed off within bore 54.

The next step is to move plunger element 20 to dispense fluid from chamber 14 through the needle 50. This is conveniently achieved by engaging ampoule body 16 via its rear formation 15 with a suitable precision drive tool. Such a tool is the hand-held eVol® tool available from SGE Analytical Science Pty Ltd of Ringwood, Victoria, Australia. A hand-held precision drive tool 100 is illustrated in FIG. 7, as is an adaptor 102 for disengagably coupling ampoule 10 at formation 15 with the engagement head 103 of the tool. The driving mechanism of the precision drive tool becomes operatively engaged with plunger element 20 via a coupling pin 105 having a reduced diameter tip 106 that is firmly accommodated by a seat 21 on element 20. Once engagement is complete, the tool is operated to push plunger element 20 along the interior wall 17 of barrel 16 and so to dispense liquid from the chamber 54 via shallow counterbore cavity 56, lateral hole 60 and needle bore 54.

In a case where the whole contents of the ampoule is not required or not otherwise to be dispensed, the ampoule can be resealed closed by drawing valve hub 52 out to move the valve to its outer position in which rib 58 engages groove 59b. Chamber 14 is again isolated, but the interior bore 54 of the needle 50 can be rinsed and cleaned to guard against contamination of subsequent dispensed volumes by admitting flushing fluid to the needle bore via port 70, cavity 55 and lateral needle hole 62.

The ampoule is again locked or latched closed and sealed by reapplying snap-on latch clip 30. The tool is disengaged from barrel 16 and plunger element 20 which remains at the position to which it has been driven. In a subsequent dispending operation, the tool will typically be capable of identifying that position (by measuring the travel of the driving mechanism before it encounters resistance) and thereby identifying the residual available volume of liquid. Once the ampoule is empty, or no longer contains a useful volume of liquid, it will typically be discarded.

When initially made, an ampoule 10 will typically have plunger element 20 at the inner end of the barrel abutting insert 18. The ampoule may be filled, for example, by opening the valve while the needle is attached to a suitable filling machine that delivers a precisely measured quantity of fluid along the needle to chamber 14, pushing back plunger element 18 as it does so. The valve is closed and latch clip 30 snapped into position: the ampoule is then ready to transport its contents to the end-user. Other suitable filling protocols may of course be employed.

In variations of the above described embodiment, there may be no valve. In a still simpler construction, the insert or segment 18 may be omitted and the needle may be supported in an axial passage in the end of the barrel. In these cases, the filled ampoule may be supplied with a removable end-cap, cover, stopper or other closure closing over and sealing the outer end of the needle whereby the port is sealingly closed.

An ampoule 110 according to a second embodiment of the invention is illustrated in FIGS. 8 to 15. Again, a self contained body 112 defines a hermetically sealed chamber 114 for storage of a fluid, typically a liquid. Body 112 is in three parts: a generally tubular transparent glass barrel 116 with an internal cylindrical wall 117 of uniform diameter, a forward insert 118 that sealingly closes one end of barrel 116, and a plunger element 120 that is sealingly slidable within barrel 116 and occupies a rearmost position when the ampoule is full, completing the closure of chamber 114. The exact position of plunger element 120 is determined by the volume of liquid in the chamber: in the position illustrated in FIGS. 8 and 9, the ampoule is almost empty.

Insert 118 includes an axially disposed port 122 with a valve 125 that is reconfigurable to open the port to allow recovery of fluid from chamber 114 via port 122. As with the first embodiment, plunger element 120 is movable in chamber 114 to dispense fluid via the port. In this case, however, plunger element 120 is fitted with an O-ring 120a that provides the sliding sealing contact with barrel wall 117: a suitable O-ring material is a perfluoro elastomer (FFKM). The embodiment of FIG. 1 may of course also include this O-ring.

At the rear end of barrel 116 there is an external formation 115, including an annular groove or channel 115a, for engaging the ampoule body to a precision drive tool with a driving mechanism that is thereafter operable to move the plunger element 120 to dispense fluid from chamber 114. In this case, formation 115 is provided on a separate tubular element 107 attached and adhered to the main body of the barrel but still part of the barrel.

Insert 118, which is typically machined PTFE or moulded polypropylene, is generally cylindrical and of T shaped configuration, having a domed head 140 with an outer peripheral surface 142 that matches the outer surface of barrel 116, and a co-axial spigot 144 that extends into and firmly engages internal surface 117 of barrel 116. An orthogonal annular shoulder 146 between the two parts of the insert engages the end of the barrel: this interface, the main peripheral interface for spigot 144 and an undercut groove 148 adjacent shoulder 146 are filled with a suitable adhesive to ensure a hermetic seal.

The most substantive difference between the second embodiment and the earlier described embodiment illustrated in FIGS. 1 to 7 is in the form of the valved port 122 and the manner in which it is reconfigured to allow access to the liquid. In this case, the inner end face 119 of insert 118 is concave and frusto-pyramidal to match a complementary pyramidal inner end face 121 of plunger element 120. Axially centrally of end face 119 is a cylindrical recess 156 (FIG. 12), the floor of which has an integral shaped seal web 180 separating recess 156 from axial bore 154 behind the web 180. Bore 154 extends axially with respect to barrel 116 to open centrally of the outer face of insert 118. Bore 154 widens twice at successive sloped shoulders to define three segments: segment 154a terminating at web 180, an intermediate segment 154b and an outer segment 154c that flares in a bell shape to emerge at the front surface of insert 118.

A suitably adapted hollow needle 150 (FIG. 14), typically of stainless steel or other suitable material, with an over-moulded PET or PTFE hub 152, is dimensioned for receipt at its inner flat end into bore segment 154a with a radial interference 150a of 0.04 mm (FIG. 14).

When intact, web 180 (FIGS. 10 to 12) is of generally circular form with a break line 181, of 0.1 mm width, about most of its periphery except for a hinge 185 of 3.3 mm width at a defined peripheral portion of the web. The web has forward and rearward thickening 186 within the break line. The arrangement is such that, if the flat end of needle 150 is pushed along bore 154 into contact with web 180 (FIGS. 13 to 15) and pushed further, web 180 will be separated or severed from the adjacent body of insert 118 about most of its periphery at break line 181 except at hinge 185 and then be hinged back against an adjacent overhanging land 187, as depicted in FIG. 14. The innermost position of the needle will be defined by contact of hub 152 with the outer face of insert 118: at this point the open flat end 153 of the needle is still within recess 156 but past the hinged back web 180. The hollow bore 151 of needle 150 is now exposed to the contents of chamber 114.

As with the first embodiment, the next step is to move plunger element 120 to dispense fluid from chamber 114 through needle 50, for example, by engaging ampoule body 116 via its rear formation 115 with a suitable precision drive tool in the manner earlier described.

The hinging back of separated seal web 180 ensures that it does not block or partially occlude the open end of needle 150 and is not left floating within the ampoule. This embodiment has advantages over the first described embodiment in the simpler valving structure but in this case the ampoule cannot be resealed closed. Once the fluid has been recovered from the ampoule, in whole or in part, the ampoule 110 will typically be discarded.

A further embodiment 210 of the invention is illustrated in FIGS. 16 and 17. Here the valved port structure is similar to that of the second embodiment but the barrel 216 together with the structure 240 enclosing bore 254 and hingeable seal web 280 are formed in a suitable polymer material as an integral body 211. Suitable such polymer materials include, e.g. polypropylene, polyethylene or similar materials with good moulding and chemical compatibility properties. Furthermore, the ampoule is not initially provided with a plunger element but in this case the defined volume of liquid and the chamber 214 are closed by a seal element in the form of a foil 295 adhered to the end of the barrel. Foil 295 is protected with an end cap 290 that threadingly engages a complementary integral thread formation 293 on the end of the barrel. In this case, the precision drive tool for dispensing the contents of the ampoule will need to have an adaptor head suitable for threadingly engaging the thread formation 293 on barrel 216.

FIG. 17 illustrates a sequence of actions by which liquid is recovered from an ampoule 210 of the form depicted in FIG. 16. The ampoule is shipped with its liquid contents 209 sealed in by web 280 and foil 295. The first step is to unscrew the cap 290 and lift off the sealing foil 295. The structure comprising foil 295 and cap 290 is replaced by a plunger element 220 slidingly introduced into the barrel (FIGS. 17d and e) to reseal the liquid within chamber 214. (In an alternative arrangement, the plunger element 220 may have been provided already in place in the shipped, filled ampoule). The ampoule body can now be inverted and a needle 250 introduced into bore 254 to break web 280 (FIG. 17g). The ampoule is primed by adjusting plunger element 220 to occupy the full volume (FIG. 17h) before the ampoule is again inverted and engaged with a suitable tool to move the plunger element in chamber 214 and so dispense the contents via a needle 250.

In particular applications, the utility of embodiments of the invention arises because the analyte is present at a known concentration and once opened and the plunger tip installed the ampoule can be used as a precision syringe dispensing a known volume of a known concentration. In other applications, the chamber of the ampoule may contain a known amount of a solid, which for example can be dissolved in an known amount of fluid. The solid might have been freeze dried from a known amount.

Claims

1. An ampoule comprising a self-contained body that defines a storage chamber, and that includes a port with a valve reconfigurable to allow recovery of fluid from the chamber via the port, wherein said chamber is in part defined by structure that is operable or replaceable by a plunger element moveable in the chamber to dispense fluid via the port.

2. An ampoule according to claim 1 wherein said valve is reconfigurable by being selectively and reversibly operable to open the port.

3. An ampoule according to claim 2 further including a latch device on the valve that must be disengaged to allow operation of the valve.

4. An ampoule according to claim 3 wherein the latch device is a removable element that physically blocks operation of the valve and requires substantial finger force for its removal from its valve blocking position.

5. An ampoule according to claim 4 wherein said removal requires removal by complete separation from the ampoule body and/or the valve.

6. An ampoule according to claim 1 wherein said valve is reconfigurable by comprising a web with a break line about a hinge portion at which the web hinges back behind a needle employed to separate the web at the break line.

7. An ampoule according to claim 6 further including a hollow needle that is relatively slidable between a first position in which the interior of the needle is sealingly closed from the chamber and a second position in which the interior of the needle has separated the web at the break line and is in communication with the chamber.

8. An ampoule according to claim 6 wherein said structure comprises a plunger element mounted within said chamber and sealingly moveable in the chamber to dispense fluid via the port.

9. An ampoule according to claim 6 wherein said structure includes an end cap and seal element removeably engaged with an end of the body, being replaceable with said plunger element.

10. An ampoule according to claim 2 further including a hollow needle that is relatively slidable between a first position in which the interior of the needle is sealingly closed from the chamber and a second position in which the interior of the needle is in communication with the chamber.

11. An ampoule according to claim 10 wherein the needle includes one or more lateral holes that provide the aforesaid communication between the chamber and the needle interior in the second position of the needle.

12. An ampoule according to claim 10 wherein the valve is configured to allow the needle to be flushed clean when in its first position, not in communication with the chamber.

13. An ampoule according to claim 2 wherein said structure comprises a plunger element mounted within said chamber and sealingly moveable in the chamber to dispense fluid via the port.

14. An ampoule according to claim 2 wherein said structure includes an end cap and seal element removeably engaged with an end of the body, being replaceable with said plunger element.

15. An ampoule comprising a self-contained body that defines a hermetically sealable chamber for storage of a known amount of a fluid, and that includes a port with a valve selectively operable to open the port to allow recovery of fluid from the chamber via the port, wherein the ampoule further includes a plunger element relatively moveable in the chamber to dispense fluid via the port, and a latch device on the valve that must be disengaged to allow operation of the valve.

16. An ampoule comprising a self-contained body that defines a chamber for storage of a known amount of fluid, and that includes a port to allow recovery of fluid from the chamber via the port, wherein the ampoule further includes a plunger element relatively moveable in the chamber to dispense fluid via the port, and a formation on the body for engaging the body to a precision drive tool having a driving mechanism that is thereafter operable to move the plunger element to dispense fluid via the port.

17. A dispensing system comprising a precision drive tool with a driving mechanism and an engagement head, and an ampoule according to claim 1 engageable with the tool so that the driving mechanism is thereafter operable to move the plunger element of the ampoule to dispense fluid from the ampoule.

18. A dispensing system according to claim 17, wherein the ampoule is a filled ampoule in which the chamber contains a volume of fluid and the port is sealingly closed.

19. A dispensing system according to claim 17, in which said chamber contains a known amount of a solid, which can be dissolved in a known amount of fluid.

20. An ampoule according to claim 1, wherein the ampoule is a filled ampoule in which the chamber contains a volume of fluid and the port is sealingly closed.

21. An ampoule according to claim 1, in which said chamber contains a known amount of a solid, which can be dissolved in a known amount of fluid.