Abstract
A closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; and a cylindrical skirt portion extending from the cap portion, the skirt portion being elastically deformable and being arranged to move from a first position in which it is at least partially folded back on itself to a second position in which it is unfolded and extends away from the cap portion. The closure can close off an opening such as that formed in an ampoule when the neck is snapped and the top removed. As the cap portion engages with the broken neck, it reduces the chances of users receiving lacerations from the sharp edges. The cap portion also seals the ampoule, preventing the contents from being spilled and/or wasted. The closure also provides a degree of impact protection, reinforcement and strengthening to the now weakened open end of the ampoule, e.g. in case the ampoule is dropped. The skirt portion not only provides a seal around the ampoule body by being in close contact therewith, but also holds the cap portion firmly against the broken rim of the open ampoule, thus holding the closure in place by means of the friction between the skirt portion and the outer surface of the ampoule body.
Claims
1. A closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; and a cylindrical skirt portion extending from the cap portion, the skirt portion being elastically deformable and being arranged to move from a first position in which it is at least partially folded back on itself to a second position in which it is unfolded and extends away from the cap portion.
2. A closure as claimed in claim 1, wherein in the first position the skirt portion is rolled back on itself.
3. A closure as claimed in claim 1 or 2, wherein the cap portion comprises a circumferential groove in which the skirt portion sits when in the first position.
4. A closure as claimed in claim 3, wherein the distal end of the skirt has an enlarged rim is seated in the groove when in the first position.
5. A closure as claimed in claim 3 or 4, wherein the surface of the cap portion inside the skirt portion is shaped such that when the cap portion is pressed against a broken neck of an opened ampoule, the force is transmitted through the cap portion to press the skirt portion out of the groove.
6. A closure as claimed in any preceding claim, wherein the surface of the cap portion inside the skirt portion comprises a projection, preferably having a cone shape.
7. A closure as claimed in any preceding claim, wherein the underside of the cap portion inside the skirt portion is formed from a deformable material.
8. A closure as claimed in any preceding claim, comprising a channel extending through the cap from a lower surface of the cap inside the skirt portion to an upper surface of the cap.
9. A closure as claimed in claim 8, wherein the channel comprises a one-way valve arranged to permit content extraction from inside the ampoule.
10. A closure as claimed in claim 8 or 9, wherein the channel connects to a connector element mounted on the upper surface of the cap portion.
11. A closure as claimed in claim 10, wherein the connector element is a syringe connector, preferably a luer slip connector or a luer lock connector.
12. A closure as claimed in any of claims 8 to 11, wherein the channel comprises a main channel and branches between the main channel and the side of the projection.
13. A closure as claimed in claim 12, wherein the branches comprise one or more through holes and/or one or more gullies.
14. A closure as claimed in any of claims 8 to 13, wherein a filter is provided in the channel.
15. A closure as claimed in any preceding claim, wherein the cap portion and skirt portion are integrally formed.
16. A closure as claimed in any preceding claim, wherein the cap portion and the skirt portion are formed from an elastomer, preferably silicone.
17. A closure as claimed in any preceding claim, wherein the skirt portion is transparent.
18. A closure as claimed in any preceding claim, wherein the cap portion comprises shaping on its exterior surface that inhibits rolling when the skirt is in the second position.
19. A closure as claimed in claim 18, wherein said shaping comprises one or more ribs.
20. A closure as claimed in claim 19, wherein the or each rib extends in a spiral.
21. A closure as claimed in any preceding claim, wherein the interior surface of the skirt is coated at least in part with a gripping material or an adhesive.
22. A closure as claimed in any preceding claim, wherein the interior surface of the skirt is provided with at least one circumferential rib.
23. A closure as claimed in claim 22, wherein the or each interior circumferential rib is asymmetric such that it resists removal of the closure more than it resists placement of the closure on an ampoule.
24. A closure as claimed in any preceding claim, further comprising a ring positioned circumferentially around the closure and around which the skirt portion is rolled or folded when in the first position.
25. A closure as claimed in claim 24, wherein the ring is formed integrally with the cap portion.
26. A closure as claimed in any of claims 1 to 23, further comprising a dispenser arranged to hold the skirt portion in the first position and being capable of releasing the skirt portion such that it can move to the second position.
27. A closure as claimed in claim 26, wherein the dispenser comprises a ring having a narrow diameter section sized to contact the cap portion and a wider diameter section sized to hold the skirt portion in the first position.
28. A closure as claimed in claim 27, wherein the dispenser comprises a split ring.
29. A closure as claimed in claim 26, wherein the dispenser comprises a gripper arranged to grip the skirt portion in the first position.
30. A closure as claimed in claim 29, wherein the gripper comprises a release mechanism arranged to release the skirt portion such that it can move from the first position to the second position.
31. A closure as claimed in any preceding claim, wherein the cap portion further comprises a gripping device arranged to be capable of gripping a break off a top of an ampoule to facilitate removal of the top from the rest of the ampoule.
32. A closure as claimed in claim 31, wherein the gripping device is a ring sized to receive an ampoule top.
33. A closure as claimed in any preceding claim, further comprising a lid arranged to cover the upper surface of the cap portion.
34. A closure as claimed in any preceding claim, further comprising a shield rib separating the skirt portion from an upper surface of the closure.
35. A closure as claimed in any preceding claim, wherein the skirt portion comprises one or more support projections positioned such that when the skirt portion is in its second position the support projections engage with the outer surface of the ampoule in the region of a shoulder of the ampoule.
36. A closure as claimed in claim 35, wherein when the skirt portion is in its first position the one or more support projections are located on an underside of the closure on a circle of larger diameter than the ampoule opening.
37. A closure as claimed in claim 35 or 36, wherein a plurality of support projections are provided around the skirt portion on a circle of larger diameter than the ampoule opening.
38. A closure as claimed in claim 37, wherein the support projections are tapered towards the centre of the closure.
39. A closure as claimed in any preceding claim, further comprising one or more air channels that, in use, connect the outside of the ampoule to the inside of the ampoule, said channels preferably comprising a filter.
40. A closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; and a skirt portion extending from the cap portion, the skirt portion being arranged to grip the sides of an ampoule; wherein the surface of the cap portion that is arranged to engage the broken neck comprises a convex shape projection arranged to project inside the open neck of the ampoule; and wherein the cap portion is formed from a deformable material so as to deform and seal against the broken neck.
41. A closure as claimed in claim 40, further comprising one or more air canals connecting a region inside the skirt portion to the outside of the closure.
42. A closure as claimed in claim 41, wherein the air canals connect the outside of the closure to a point inside the closure radially outward from the projection.
43. A closure as claimed in claim 40, 41 or 42, further comprising a rigid structure that is arranged to bias the skirt portion radially inwardly against the sides of the ampoule.
44. A closure as claimed in claim 43, wherein the rigid structure comprises at least one leg pivoted around a pivot structure such that it can be pivoted radially outwardly to release the skirt portion for mounting to or demounting from an ampoule.
45. A closure as claimed in claim 40, 41 or 42, wherein the skirt portion comprises a stiff, but flexible outer material or a sprung outer material with a softer, grippier inner material provided on the inside thereof.
46. A closure as claimed in claim 45, wherein the outer material is separated into a plurality of gripping fingers and the inner material is arranged to full encircle the ampoule.
47. A closure as claimed in any of claims 40 to 46, wherein the skirt portion comprises one or more internal ribs in the form of lamellae arranged to deflect substantially parallel with the ampoule body when pressed over the ampoule body.
48. A closure as claimed in any of claims 40 to 47, wherein the skirt portion further comprises a brim extending radially outwardly from the skirt portion.
49. A method of sealing an ampoule, comprising: pressing a closure as claimed in any of claims 1 to 39 onto a broken neck of an ampoule; and deploying the skirt portion from the first position to the second position.
50. A method of making a closure comprising: forming a closure with a cap portion and a cylindrical skirt portion extending from the cap portion, wherein the forming includes moulding over at least a first mould piece which defines the inner surface of the cylindrical skirt portion; and before removing the first mould piece, rolling up the cylindrical skirt portion onto the cap portion.
51. A method as claimed in claim 50, wherein the rolling is performed by a rolling machine.
52. A method as claimed in claim 51, wherein the rolling is performed by one or more moving frictional surfaces being brought into contact with the skirt portion so as to provide a force on the outer surface of the skirt portion towards the cap portion.
53. A method as claimed in claim 52, wherein the or each moving frictional surface is a wheel or part of a wheel.
54. A method as claimed in claim 53, wherein the wheel or part of a wheel is translated axially towards the cap portion during rolling.
55. An opened ampoule having a rim around its opening and comprising a closure as described in any of claims 1 to 48 fitted against the rim.
56. Packaging for an ampoule closure, the packaging comprising: a first blister arranged to enclose the ampoule closure; and a second blister arranged to receive an ampoule top.
57. Packaging as claimed in claim 56, wherein the second blister is larger than the ampoule top and formed from a sufficiently deformable material that the blister can be twisted so as to retain and seal the ampoule top within the blister.
58. Packaging as claimed in claim 56 or 57, wherein a removable sealing strip or cover is provided to seal the first blister until use.
59. Packaging as claimed in claim 58, wherein the removable sealing strip also seals the second blister until it is time for use.
60. A closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; and a skirt portion extending from the cap portion, the skirt portion being arranged to grip the sides of an ampoule; wherein the surface of the cap portion that is arranged to engage the broken neck is formed from a deformable material that is arranged to deform and seal against the broken neck.
61. A closure as claimed in claim 60, wherein the cap portion is arranged to form a seal against the broken rim of the neck of the ampoule around the full circumference of the rim so as to provide a separation between a sterile inside of an ampoule from a non-sterile outside.
62. A closure as claimed in claim 60 or 61, wherein the surface of the cap portion that is arranged to engage the broken neck is arranged to accommodate and seal against a broken neck having a surface that varies in height by at least 2 mm, preferably at least 3 mm, more preferably at least 5 mm.
Description
[0080] Preferred embodiments of the invention will now be described, by way of example only, and with reference to the accompanying drawings in which:
[0081] FIG. 1 illustrates an example process of a closure according to the invention being applied to an ampoule;
[0082] FIG. 2 shows a top view, front view and bottom view of a closure in its fully relaxed state;
[0083] FIG. 3 shows various views and cross-sections of a closure according to certain embodiments;
[0084] FIG. 4 illustrates protection from impact and rolling;
[0085] FIG. 5 illustrates another example process for using the closure, including unpacking, applying the closure to an ampoule and withdrawing content from the ampoule;
[0086] FIG. 6 illustrates in cross-section a deployment process of certain embodiments;
[0087] FIG. 7 illustrates in cross-section the protection from an ampoule with a broken neck;
[0088] FIG. 8 illustrates in cross-section the main important sterile surfaces of a closure;
[0089] FIG. 9 illustrates a cross-section of a filter in a closure;
[0090] FIG. 10 illustrates in cross-section the sealing of a closure against an ampoule;
[0091] FIG. 11 shows different fluid transfer connection options;
[0092] FIG. 12 shows a luer fluid transfer connection integrated into a closure;
[0093] FIGS. 13 and 14 illustrate examples of anti-roll mechanisms;
[0094] FIGS. 15 and 16 show examples of packaging for a closure;
[0095] FIG. 17 shows filtering options for a closure;
[0096] FIG. 18 shows alternative integrated fluid transfer connections for a closure;
[0097] FIG. 19 illustrates variations of a closure device, including different material thicknesses;
[0098] FIGS. 20 and 21 illustrate additional features of certain embodiments;
[0099] FIG. 22 shows an example of an integral ampoule breaking feature;
[0100] FIG. 23 shows additional protective or sealing elements of a closure;
[0101] FIG. 24 shows a trench seal in certain embodiments of a closure;
[0102] FIG. 25 shows a ring for use in deployment of a closure skirt;
[0103] FIG. 26 shows an integral ring or rim performing a similar function to the ring of FIG. 25;
[0104] FIGS. 27 and 28 show alternative arrangements for deployment of a skirt portion;
[0105] FIG. 29 shows an alternative gripping arrangement for a closure; and
[0106] FIGS. 30 to 33 show alternative methods and devices for applying a closure to an ampoule;
[0107] FIG. 34 shows a cross-section of another embodiment of a closure;
[0108] FIG. 35 shows a variant of a push-on type skirt;
[0109] FIG. 36 shows another variant of a push-on type skirt;
[0110] FIG. 37 shows another variant of a push-on type skirt with larger ribs;
[0111] FIG. 38 shows the closure of FIG. 37 on a smaller ampoule;
[0112] FIG. 39 shows another variant of a push-on type closure;
[0113] FIG. 40 shows a variant of the closure of FIG. 39;
[0114] FIG. 41 shows a variant of the closure of FIGS. 39 and 40;
[0115] FIG. 42 illustrates the sterile and non-sterile areas of a broken ampoule body;
[0116] FIG. 43 shows a roll-type closure used on different sized ampoules;
[0117] FIG. 44 shows an adapter ring providing a support projection for adapting to different sized ampoules;
[0118] FIG. 45 shows a one-way valve to prevent backflow of extracted content;
[0119] FIG. 46 shows a shield that protects a rolled-up skirt portion;
[0120] FIGS. 47 and 48 show ways of increasing content extraction from an ampoule;
[0121] FIG. 49 shows alternative arrangements for a closure lid;
[0122] FIG. 50 shows a stopper to define an insertion level of a syringe;
[0123] FIG. 51 shows air channels to compensate for pressure drop during extraction;
[0124] FIG. 52 shows different shapes of ampoule;
[0125] FIG. 53 illustrates a method and apparatus for rolling up a skirt portion;
[0126] FIG. 54 illustrates a variation of the apparatus and method of FIG. 53;
[0127] FIG. 55 illustrates an alternative method and apparatus for rolling up a skirt portion; and
[0128] FIG. 56 illustrates another method and apparatus for rolling up a skirt portion.
[0129] FIG. 1 shows an ampoule 1 which is typical of the type used to store pharmaceuticals such as morphine or adrenaline (purely by way of example). The ampoule 1 has a main body 2 which is typically cylindrical with a flat base so that it can stand on end and a top part 3 which is separated from the main body 2 by a neck 4. The neck 4 may be formed as a point of weakness (e.g. of thinner cross-section or with a weakness such as a scratch or groove) so that it will break in preference to other parts of the ampoule when a force is applied to the top part 3.
[0130] FIG. 1(a) shows the ampoule 1 in its sealed state, typically filled with some content such as a pharmaceutical or other chemical. FIG. 1(b) shows the ampoule after the top part 3 has been broken off from the main body 2, e.g. by applying a lateral force to the top part 3. This is typically performed by hand. This may be done simply by grasping the top part 3 and bottom part 2 and applying a lateral force or torque until the neck 4 breaks. Sometimes a tool may be used such as an empty syringe cylinder, or tissue/gauze may be used for protection. It can be seen here that the neck 4 is typically irregular, forming a serrated surface with potentially sharp projections that present a cutting hazard to the user.
[0131] After the top part 3 has been separated from the main body 2 and before content is extracted from the main body 2, a closure 10 is applied to the broken neck 4 of the main body 2 so as to cover the broken edge and protect the user. FIG. 1(b) shows the closure 10 in a folded or rolled-up state. This is the state in which it is typically supplied to the user and is ready for immediate deployment onto the ampoule body 2. FIG. 1(c) shows the closure 10 after it has been deployed onto the ampoule body 2. It can be seen that the closure 10 fully covers the broken and sharp neck part 4 and that a skirt portion 11 of the closure 10 is wrapped around the external surface of the ampoule main body 2, thereby gripping the body 2 and holding the closure 10 firmly in place.
[0132] FIG. 1(d) shows how the closure 10 can be applied to a smaller ampoule 1 providing that the skirt portion 11 remains slightly stretched, i.e. the rest position of the skirt portion 11 is smaller diameter than the ampoule body 2.
[0133] FIG. 2 shows a top view, front view and bottom view of a closure 10 in its fully relaxed state (in its deployed state, but not deployed on an ampoule). The closure 10 is divided into a cap portion 12 and a skirt portion 11. A content transfer channel 13 is formed through the cap portion 12 substantially along the central axis, allowing for extraction of content from within the ampoule main body 2 after the closure 10 has been affixed thereto.
[0134] FIG. 3 shows various views of a closure 10 according to certain embodiments. The closure 10 has ribs 14 formed on the external surface thereof, designed to prevent the closure 10 from rolling when placed on its side on a flat surface.
[0135] FIG. 3(a) shows a cross-section of the closure 10 in its fully relaxed state with the skirt portion 11 in the deployed position, but not engaged with an ampoule 1. As can be seen here, the bottom rim 15 of the skirt portion 11 has a slightly enlarged cross-section. This provides two functions. Firstly in the deployed state it provides additional gripping strength to help seal against the ampoule 1 and secondly in the stored state (shown in FIG. 3(b)) it helps to hold the skirt portion 11 in its rolled-up state. A groove 16 is provided in the cap portion 12 to at least partially accommodate the skirt portion 11 when the skirt portion 11 is rolled or folded back for storage. In this stored state the closure 10 is ready for fast and easy deployment from the stored state shown in FIG. 3(b) into the deployed state shown in FIG. 3(a) (or more specifically a similar state, but stretched around an ampoule 1).
[0136] The content transfer channel 13 can also be clearly seen in FIGS. 3(a) and 3(b). In this embodiment the content transfer channel 13 is formed from a plurality of small diameter parallel tubes so that it provides a filtering function as well as a content transfer function. It will be appreciated that this type of filter is predominantly suitable for liquid contents rather than solid or powdered or granulated contents.
[0137] FIGS. 3(c), (d) and (e) show respectively a top view, front view and bottom view of the closure 10 of this embodiment.
[0138] FIG. 4 illustrates how the closure 10 provides protection to the ampoule body 2 from impacts and how the ribs 14 provide protection against rolling. The closure 10 is typically formed from a soft and/or elastic material such as silicone that will absorb shocks upon impact, reducing the chances of ampoule breakage. FIG. 4(a) shows an ampoule body 2 falling with the closure 10 impacting against a surface 20. FIG. 4(b) shows the ampoule 1 and closure 10 at rest on the surface 20 with the ampoule body 2 raised off the surface and protected from impact. FIG. 4(c) shows an end view of the closure 10 resting on the surface 20 with the ribs 14 hindering rolling motion and thus increasing stability of the sealed ampoule.
[0139] FIG. 5 illustrates a process for applying the closure 10 to an ampoule 1 using a packaged closure device 10. As shown in FIG. 5(a) the closure device 10 is in its stored state with the skirt portion 11 rolled or folded up around part of the cap portion 12. The closure device 10 is sealed within a first sterile blister 25 being part of a packaging 24 and being sized and shaped to accommodate the closure 10. The other part of the packaging 24 is a second blister 26 which may also be sterile and which is sized and shaped to accommodate an ampoule top part 3. The second blister 26 may be generously sized so that it can accommodate a wide range of sizes and thus a large range of ampoules 1 from different manufacturers (the tops 3 being one of the more variable parts of ampoules). In other embodiments the second blister 26 may be provided with a protection device (e.g. tissue or gauze) or a tool for breaking the ampoule neck 4 while protecting the fingers. In FIG. 5(a) the second blister 26 has been opened and the ampoule top part 3 inserted into the second blister 26. As shown in FIG. 5(b) the second blister 26 is then twisted so as to seal and retain the broken top part 3 within the blister, thus preventing injury from the sharp broken neck of the top part 3 (in alternative embodiments the second blister 26 may be resealed in another fashion, e.g. by resealing with a sealing strip).
[0140] In FIG. 5(c) the first blister 25 is opened by peeling back a sealing strip or cover 27. A syringe 30 is then used to connect to an appropriately shaped content transfer connection 31 on the cap part of the closure 10 in FIG. 5(d). In FIG. 5 the content transfer connection 31 is a female luer type connection to which the male luer type connector 32 of the syringe 30 can be applied and locked. As shown in FIG. 5(e), the syringe 30 is used to transport the closure 10 from the packaging 24 to the ampoule main body 2, thus reducing non-sterile contact with the closure 10. In FIG. 5(f) the closure 10 is applied to the broken neck 4 of the ampoule main body 2 and in FIG. 5(g) the skirt portion 11 of the closure 10 is unfolded or unrolled from its stored state to its deployed state. In its deployed state, the cap portion seals against the broken neck 4 of the ampoule body 2 and the skirt portion 11 grips tightly against the outside surface of the ampoule body 2.
[0141] FIG. 5(h) shows the ampoule being inverted so that the content (in this example a fluid) is in contact with the content transfer channel 13 (fluid channel) ready to be drawn through the channel 13 and into syringe 30.
[0142] The sealed ampoule (ampoule body 2 plus closure 10 fitted thereon) and an attached syringe form a closed system. As the syringe draws content out of the ampoule body 2 through the channel 13, the pressure inside the ampoule is lowered. This suction effect pulls the skirt portion 11 and cap portion 12 tighter onto the ampoule body 2 and neck 4 respectively, thus improving the seal and maintaining a sterile environment. This is particularly beneficial where a rapid extraction of content may cause turbulence within the liquid content, requiring a more robust seal. By forming and maintaining a good seal around the ampoule body 2 during content extraction, the ampoule body 2 can be turned upside down for content extraction. Thus the contents (typically liquid) contact the bottom surface of the cap portion 12 and contact the extraction channel 13. This allows a greater quantity (substantially all if desired) of the contents to be extracted easily. Additionally, withdrawing the contents in this manner, any air drawn into the syringe is near the tip and can be expelled readily.
[0143] FIG. 6 illustrates in cross-section a deployment process of certain embodiments. FIG. 6(a) shows the closure 10 in its stored state in which the skirt portion 11 is rolled up around its enlarged rim 15 and stored in groove 14. This is a stable state from which the skirt portion will not move without some biasing force. Thus the closure 10 can remain in this state for an extended period of time until it is required for use. In preferred embodiments this may be for a year or more so as to match the shelf life of products with which the closure 10 may be used. The shelf life may of course by greater than this. The material of the closure 10 is selected so as to maintain its elasticity and deformability throughout this period of time.
[0144] FIG. 6(b) shows the closure 10 in the process of being applied to the ampoule main body 2. The closure 10 has been pressed against the broken neck 4 of the ampoule body 2. The cap portion 12 is shaped such that as the closure 10 is pressed against the neck 4, the force is transmitted through the elastic material of the cap portion 12, deforming the cap portion in the vicinity of groove 14 and pushing the skirt portion 11 out of the groove 14. This facilitates deployment of the skirt portion 11 by changing the shape of the outer surface of the cap portion 12 so that the skirt portion is either no longer in a stable stored state or is barely in such a state. From this state, the skirt portion 11 can easily by encouraged (e.g. pushed) into its deployed state, unfolding or unrolling down the outer side surface of the ampoule body 2 and sealing therewith. In some embodiments the force of pressing against the ampoule neck 4 may be sufficient to cause the skirt portion 11 to fully deploy into its deployed state without any further encouragement.
[0145] FIG. 6(c) shows the closure 10 after the skirt portion 11 has snapped into place in its deployed position with the inner surface of the skirt portion 11 in close gripping contact with the outer surface of the ampoule body 2. It can be seen that the skirt portion 11 is in a stretched state around the ampoule body 2 compared with the fully relaxed state shown in FIG. 3(a) and thus the skirt portion 11 grips firmly against the ampoule body 2.
[0146] FIG. 7(a) shows an ampoule body 2 with the serrated neck portion 4 after the cap part 3 has been broken off leaving a cutting hazard. FIG. 7(b) illustrates the protection that is provided by the closure 10 when installed on the ampoule body 2, covering the broken neck 4.
[0147] FIG. 8 shows the surfaces of the closure 10 that may come into contact with the contents of the ampoule 1 and which therefore need to be sterile surfaces for certain applications, in particular medical or other chemical applications. These surfaces are shown in thicker line compared with the rest of the drawing for illustrative purposes only. The lower surface of the cap portion 12 inside of the skirt will be inserted into the ampoule through the neck 4 and thus will contact the contents of the ampoule during the extraction process. Likewise, the content transfer channel 13 and the connection part for transfer of the content to another receptacle, e.g. a syringe, other reservoir or other content transfer conduit. FIGS. 8(a), (b) and (c) illustrate different shapes of the lower surface of the cap portion 12 inside the skirt portion 11. In FIG. 8(a) this surface projects down into the ampoule body 2 through the neck 4, whereas in FIG. 8(b) the lower surface of cap portion 12 is substantially flat and in FIG. 8(c) it is sloped away from the centre of cap portion towards the skirt portion 11, following the shape of a typical ampoule. FIGS. 8(b) and (c) will facilitate withdrawal of maximum content from the ampoule 2 as there is no place for the content to collect around the projection of FIG. 8(a) when the ampoule is turned upside down for content extraction.
[0148] FIG. 9 illustrates a filter 40 in a closure 10. In this example the filter 40 is a plurality of thin tubes as discussed above and thus forms the content transfer channel 13 extending through the cap portion 12 from the lower surface thereof (within the deployed skirt portion 11) and the upper surface thereof (for connection and transfer to other devices). As will be illustrated later, the filter 40 may take other forms. The process of breaking the ampoule top 3 from the main body 2 may result in small slivers of material (e.g. glass or plastic) detaching and falling into the interior of the ampoule body 2 along with the content of the ampoule. The filter 40 provides the benefit of preventing glass shards or fragments from being drawn out of the ampoule body 2 along with the other content. Moreover, the filter being an integral part of the closure 10 means that it is not likely to be bypassed for efficiency as it does not add an additional step to the content extraction process.
[0149] FIG. 10 illustrates the sealing of a closure against an ampoule. The closure 10 forms a seal with the ampoule body 2 in two ways. Firstly a seal is formed by pressing the bottom surface of the cap portion 12 against the broken neck 4 of the ampoule body 2. With the closure 10 being formed from a deformable material, the closure 10 can deform and seal against the irregular surface of the broken neck 4, thus moulding to that surface and sealing against it. As discussed above, the neck 4 may be sharp and may cut into the closure 10 which aids in forming a close seal between the two components. This seal is highlighted by the circle indicated by reference number 201. Secondly, the tight engagement of the skirt portion 11 with the external surface of the ampoule body 2 also forms a seal around the ampoule body 2. This is a liquid-tight seal formed by the constriction of the skirt portion 11 against the ampoule body 2 (as the ampoule body 2 is larger in diameter than the inner diameter of the skirt portion in its fully relaxed position). This seal is highlighted by the circle indicated by reference number 202.
[0150] As can be seen in FIG. 10, the lower surface of cap portion 12, inside skirt portion 11 has a projection formed thereon that extends into the ampoule 1 through the neck 4, i.e. it extends inside the opening formed in the ampoule 1 at the neck 4. This projection ensures that a concave shape is formed in the surface of the closure 10 that faces the ampoule neck 4. The projection extends inside the opening while the skirt portion 11 extends outside the opening. This shape ensures that the broken neck 4 comes into contact with the closure 10 and seals against it.
[0151] As shown in FIG. 10, content is extracted from the ampoule 1 by tipping it upside down so that the content comes into contact with the extraction channel 13. As content is drawn out from the ampoule 1, e.g. by a syringe, the pressure inside the ampoule is lowered. This lowering of the pressure relative to the pressure outside of the ampoule serves to create a suction effect pulling the closure 10 tighter against the ampoule body 2, thus improving its sealing properties.
[0152] FIG. 11 shows different fluid transfer connection options on a syringe 30. The three options shown in FIG. 11 are the male connector parts for Luer-Slip (left) 33, Luer Lock (middle) 34 and Luer Jack (right) 35. Each of these is capable of connecting to a female Luer type connector such as shown at 31 in FIG. 5 and also shown in FIG. 12(a). As an alternative to the female Luer type connector, the closure 10 may have a male connector such as those shown in FIG. 11. FIG. 12(b) shows a closure 10 with a male Luer type connector 203 provided on the upper surface of the cap portion 12 for engagement with a female Luer connector on other apparatus.
[0153] FIGS. 13 and 14 illustrate anti-roll mechanisms. FIG. 13 shows a circular cross-section closure 10 with ribs 14 as discussed above and also shows a substantially square cross-section closure 50 (with rounded corners) which also achieves the goal of preventing rolling of the closure 50. FIG. 14 shows some variations of the ribs 14. On the left, the ribs 14 have a rounded profile, in the middle the ribs 14 have a square profile and on the right is shown a closure 10 in which the ribs 14 on the skirt portion 11 have a spiral or helical shape. This spiral shape spreads the material of the ribs 14 in a circumferential direction so that when the skirt portion 11 is rolled or folded into its stored position, the ribs 14 are not rolled or folded fully back upon themselves. The ribs 14 (both spiral and non-spiral form) also have a positive effect on the rolling out of the skirt portion 11 onto the outer surface of the ampoule body 2. The ribs 14 provide regions of material that are thicker in cross-section than other regions of the skirt portion 11. These thicker portions affect the stiffness of the skirt portion 11. Once the rolling out of the skirt portion 11 is started, the ribs 14 help to continue that motion towards the fully deployed position on the ampoule body 2. It may be noted that the ribs 14 on the cap portion 12 need not have such a spiral form.
[0154] FIGS. 15 and 16 show examples of packaging for a closure similar that depicted in FIG. 5. FIG. 15(a) shows a packaging 24 with only a single blister 25 for housing the closure 10 in a sterile environment sealed by sealing strip 27. FIG. 15(b) shows the sealing strip 27 being removed by peeling it away from the blister 25. FIG. 15(c) show how the closure 10 can be installed onto the ampoule body 2 using the opened blister 25 to hold the closure 10 thereby minimising contact with the closure 10 and maintaining its sterility during installation.
[0155] FIG. 16 illustrates the process of FIG. 5 in more detail. FIG. 16 shows the use of a double blister package 24. In FIG. 16(a) the second blister 26 is opened by peeling back the sealing strip 27 (which is common to both blisters 25, 26). Two alternatives are shown in FIG. 16(a); on the left hand side the second blister 26 is empty, while on the right hand side the second blister 26 contains a tool 204 for breaking the ampoule neck 4 while protecting the fingers. The tool 204 takes the form of a tube designed to fit over the ampoule top part 3 and hold it securely after breaking. In FIG. 16(b), the second blister 26 is used to grasp and break the ampoule top part 3 away from the main body 2. The user is protected from the broken neck 4 by the second blister 26. Again, two versions are shown. In the left hand version the second blister 26 is empty, while in the right hand version the tool 204 is shown holding the ampoule top part 3 after breaking and thus providing additional protection. In FIG. 16(c) the second blister 26 is twisted so that the broken top 3 is held securely within the second blister 26. In FIG. 16(d) the first blister 25 is opened by peeling back the sealing strip 27. In FIG. 16(e) the first blister 25 is used to apply the closure 10 to the ampoule body 2 while maintaining the sterility of the closure 10. In FIG. 16(f) the skirt portion 11 of the closure 10 is moved from its stored position to its deployed position (e.g. by unfolding or unrolling) so that the skirt portion 11 grips the outer surface of the ampoule body 2. In FIG. 16(g) the packaging 24 with the broken top part 3 can be discarded safely without any cutting risk to the user.
[0156] FIG. 17 shows filtering options for a closure 10. FIG. 17(a) shows a filter 55 that is integrally moulded with the closure 10. This may be by bi-injection moulding or other moulding techniques. FIG. 17(b) shows a filter 56 formed from a plurality of small diameter parallel tubes which also form the content extraction channel 13. FIG. 17(c) shows a filter 57 formed from a network of small holes, i.e. a porous section. FIG. 17(d) shows a removable (and thus replaceable) filter 58 that can be inserted into a cavity 59 formed in the closure 10 adjacent to the content extraction channel 13. An advantage of a removable filter is that it can be omitted if not required for certain procedures, or different filters can be provided with different filter grades for different applications. Also, although the closure 10 is generally expected to be a one-use, disposable product, especially for sterile uses, this need not be the case and the invention is not so limited and thus the filter 58 can be replaced and the closure 10 reused. FIG. 17(e) shows the filter 58 installed in the cavity 59. FIG. 17(f) shows a luer type connection element 31 with an integral filter 60.
[0157] FIG. 18 shows alternative fluid transfer connections for a closure 10 as discussed above. FIGS. 18(a) and 18(b) show a female luer type connection 31. FIG. 18(b) has a raised lip around the upper surface of the cap portion 12 to provide a degree of protection to the luer connector.
[0158] FIG. 18(c) shows a threaded connection 61 designed to receive a correspondingly threaded connector to mate with the content extraction channel 13.
[0159] FIG. 19 illustrates variations of a closure device 10. FIG. 19(a) shows a rolled skirt portion 11 (or sleeve) in the rolled or stored position ready to be deployed onto an ampoule body 2. FIG. 19(b) shows the closure 10 of FIG. 19(a) in its deployed (unrolled) position, but without an ampoule 1 being present so that the fully relaxed state is shown. FIG. 19(c) shows an enlarged rim 15 at the bottom edge of the skirt portion 11 that helps to increase the gripping strength against the ampoule body 2 and also provides a convenient shape around which to roll the skirt portion 11 after manufacture and when configuring the closure 10 into its stored (rolled up) state. In FIG. 19(c), the skirt portion 11 also has a slight inward taper from the bottom of the cap portion 12 towards the enlarged rim 15 so that the gripping force against the ampoule body 2 is highest at the rim 15. FIG. 19(d) shows a much thinner skirt portion 11 that is easier to roll up and uses less material. In certain exemplary embodiments the skirt portion 11 may have a thickness of about 0.5 mm or about 1 mm.
[0160] FIGS. 20 and 21 illustrate additional features of certain embodiments. FIG. 20 shows adhesive surfaces 65 provided on the inner surface of the skirt portion 11 for contact and adhesion with the ampoule body 2. The adhesive provides sealing and also prevents movement of the closure 10 once it has been installed onto an ampoule body 2. The adhesive thus allows the skirt portion 11 to have a looser fit as the seal is no longer reliant entirely on frictional engagement between the skirt portion 11 and the ampoule body 2.
[0161] FIG. 21 shows ribs 66 or other projections formed on the inner surface of the skirt portion 11, preferably circumferential ribs, optionally with an asymmetrical profile that are arranged to increase the gripping of the skirt portion 11 against the ampoule body 2 so as to make it more difficult to remove the closure 10 after application. This helps to maintain the seal even in the face of rough handling during use, e.g. during use in an emergency vehicle such as an ambulance.
[0162] FIG. 22 shows an example of an integral ampoule breaking feature. This provides an alternative to the use of the second blister 26 described above. The closure 10 is provided with a ring 70 which may be integrally moulded with the cap portion 12 and is sized so as to allow insertion of at least part of an ampoule cap part 3. FIG. 22(a) shows an example of the ring 70 provided on the side wall of the cap portion 12. FIG. 22(b) shows the ring 70 being used to snap the top part 3 of an ampoule 1 from the main body 2. The use of the ring 70 allows the user to keep their fingers clear of the broken neck 4, thus reducing the chance of injury.
[0163] FIG. 22(c) shows an alternative arrangement in which the ring 70 is formed as part of the packaging 24 instead of being formed as part of the closure 10. FIG. 22(d) shows the ring 70 of FIG. 22(c) in use.
[0164] FIG. 23 shows additional protective or sealing elements of a closure 10. FIGS. 23(a) and (b) shows a lid 72 that can be fitted to the upper surface of the cap portion 12 so as to close off the content extraction channel 13 and protect it from contaminants. The lid 72 is simply removed when access is required. FIG. 23(c) shows a hinged lid 73 that works on a similar principle, but remains attached to the cap portion 12 when not in use to protect the channel 13. The hinged lid 73 may be integrally formed with the closure 10.
[0165] FIG. 24 shows a trench seal 75 in certain embodiments of a closure 10. The trench or groove 75 is formed circumferentially around the conic projection 76 that extends from the bottom surface of the cap portion 12 inside the skirt portion 11. The groove 75 is sized and shaped to receive the broken neck 4 of the ampoule body 2 after the cap part 3 has been removed. The groove 75 provides a deeper recess into which the broken neck 4 can be inserted thus improving the sealing against the broken neck 4. As the neck 4 can be inserted deep into the groove 75, sealing is provided across the whole broken surface of the neck, i.e. across the thickness of the ampoule wall, thus improving the sealing contact that is made with the inner wall of the ampoule body 2 by the projection 76. FIG. 24(a) shows a rectangular groove 75 (i.e. with rectangular cross-section) while FIG. 24(b) shows an angular groove 75 (which in this example has a substantially triangular cross-section being of greater extent at its radially outward end, tapering to a lower extent at its radial inward end.
[0166] FIG. 25 shows a ring for use in deployment of a closure skirt. The ring 80 of FIGS. 25(a)-(c) provides a feature around which to fold or roll the skirt portion 11 in the stored configuration. The ring 80 can also be used to provide some assistance in the unfolding or unrolling process by pushing the ring axially down towards the ampoule body 2, thus forcing the skirt portion 11 to be rolled down onto the outer surface of the ampoule body 2 and into sealing contact therewith. FIG. 25(a) shows the ring 80 and skirt 11 in their rest positions in the stored configuration. FIG. 25(b) shows the ring 80 being used to help push the skirt portion 11 down onto the ampoule body 2 and FIG. 25(c) shows the skirt portion 11 fully deployed into the deployed configuration. As was described earlier, the action of pressing the closure 10 against the neck 4 of the ampoule body 2 may transmit forces through the closure 10 that cause the skirt 11 and the ring 80 to be displaced and which may be enough to encourage the skirt 11 and the ring 80 to fully deploy onto the ampoule body 2.
[0167] FIG. 26(a)-(c) are similar to FIG. 25(a)-(c), but with a ring 81 in the form of a rim that is integrally formed with the cap portion 12 and thus provides a convenient surface around which to roll or fold the skirt portion 11, but which cannot be displaced axially down the closure 10 to provide additional assistance with deployment of the skirt portion 11.
[0168] FIGS. 27 and 28 show alternative arrangements for deployment of a skirt portion other than via rolling and/or folding. FIG. 27 shows a skirt portion 11 that is preformed in the deployed state ready to be slipped over the ampoule body 2. The skirt portion 11 is of narrower internal diameter than the outer diameter of the ampoule body 2 to which it is to be applied and thus will grip tightly against the ampoule body 2, providing the required seal. FIG. 27(a) shows the closure 10 before deployment on an ampoule body 2 and FIG. 27(b) shows the closure 10 deployed on an ampoule body 2.
[0169] FIG. 28 shows a skirt portion 11 that is folded into a concertina arrangement in the stored configuration shown in FIG. 28(a) and which is unfolded onto the ampoule body 2 as shown in FIG. 28(b).
[0170] FIG. 29 shows an alternative gripping arrangement for a closure 10 in which a rigid structure 85 is provided inside the closure 10 and which biases the skirt portion 11 against the ampoule body 2. The rigid structure 85 has a number of rigid arms 86 that are pivoted around a rigid ring or disc element 87 such that when upper parts 88 of the arms 86 (the parts above the ring 87 and formed in the cap portion 12) are pressed radially inwardly, the lower parts 89 of the arms 86 (the parts below the ring 87 and formed in the skirt portion 11) are biased outwardly so as to expand the skirt portion 11 allowing the skirt portion 11 to be mounted on or removed from the ampoule body 2. In this example the skirt portion 11 may be formed from a number of separate legs 90, each with its own rigid arm 86, although a full skirt portion 11 may still be used. FIGS. 29(c) and (d) show the closure 10 of FIGS. 29(a) and (b) mounted on two different sized ampoule bodies 2, illustrating how this arrangement can accommodate smaller ampoules by providing an additional radially inward biasing force in addition to any elasticity of the skirt portion 11.
[0171] FIG. 30 shows a dispenser 100 that can be used to hold the closure 10 in a storage configuration and which can also be used to deploy the closure 10 onto an ampoule body 2. The dispenser 100 has a shaped portion 101 around which the skirt portion 11 is wrapped, slightly folded back on itself. A release mechanism 102 is also provided that in the stored configuration holds the skirt portion 11 against the shaped portion 101 thereby retaining the skirt portion 11 in the stored configuration until it is needed for use. FIG. 30(a) shows the dispenser 100 and closure 10 in this stored configuration. FIG. 30(b) shows the release mechanism 102 being activated. The release mechanism 102 comprises a number of gripping arms 103 each pivoted about a pivot 104 such that when the upper part 105 is squeezed radially inwardly the lower part 106 is displaced radially outwardly, releasing the skirt portion 11. The skirt portion 11 then deploys automatically onto the outer surface of the ampoule body 2 as discussed above. FIG. 30(c) shows the closure 10 installed on an ampoule body 2 and the dispenser 100 being removed. The dispenser 100 can be discarded or reused.
[0172] FIG. 31 shows an alternative dispenser 100 of simpler construction. The dispenser 100 of this example is formed as a simple ring with a narrow section 110 sized to fit around the cap portion 12 and a wider (greater diameter) portion 111 sized to hold the skirt portion in a folded back (or rolled back) position for storage, ready for deployment. FIG. 31(a) shows the dispenser 100 in the stored arrangement. FIG. 31(b) shows the closure 10 being applied to the ampoule body 2 and the dispenser 100 in the process of being removed. The closure 10 is held on to the ampoule body 2 by pushing on the closure 10 on its upper surface through the hole in the dispenser 100 while the dispenser 100 is removed upwards (i.e. past the upper surface of the closure 10). FIG. 31(c) shows the dispenser 100 being fully removed as the skirt portion 11 of closure 10 snaps down into the deployed position in sealing contact with the ampoule body 2 and FIG. 31(d) shows the dispenser 100 being fully removed for discard or reuse.
[0173] FIGS. 32 and 33 show alternative dispensers 100 in the form of a split ring 120. As shown in FIG. 32(a), the dispenser 100 is similar to that described in relation to FIG. 31, having a narrow diameter section 110 sized to contact the closure 10 and a wider (greater diameter) portion 111 sized to hold the folded or rolled up skirt portion 11 for storage, ready for deployment. The narrow section 110 of split ring 120 has a smaller natural (relaxed) diameter than the cap portion 12 such that the split ring 120 must be pried apart a small amount to fit over the cap portion 12, thus leaving a small gap 125 in the ring 120. The ring 120 thus provides a biasing force radially inwardly against the cap portion 12, thus holding the skirt portion 11 securely in position as shown in FIG. 32(a). In FIG. 32(b), the dispenser ring 120 and closure 10 are in the process of being applied to the ampoule body 2. As shown in FIG. 32(c), the split ring 120 can be used to help deploy the skirt portion 11 by helping to roll it out over the ampoule body 2. The increased diameter caused by spreading the skirt 11 over the ampoule body 2 is accommodated by the widening of the gap 125 of split ring 120. In FIG. 32(d) the split ring can be removed and discarded or reused.
[0174] FIG. 33 shows the split ring 120 being used on a smaller ampoule body 2. In this case, the biasing force of the split ring 120 aids in holding the skirt portion 11 onto the smaller ampoule body 2. For smaller ampoules, the biasing force of the skirt portion 11 may not be sufficient on its own as the skirt will be close to its fully relaxed position. However, with the additional force provided by the split ring 120, a good seal can be maintained. In this example the split ring 120 is not removed after deployment. In other examples, even for small ampoules, where the biasing force of the skirt portion 11 is enough to make a good seal, the split ring 120 can be removed as for larger ampoules.
[0175] FIG. 34 shows a cross-section of another embodiment of a closure 10 with a number of additional features. The closure 10 has some wide ribs (or wings) 302 (also seen in FIGS. 51 and 52) on the cap portion 12 for providing the anti-roll function when the ampoule and closure are set down on their sides. The closure 10 also has a finger shield 304 for protecting the rolled up skirt portion 11 before deployment. The closure 10 also has an adapter ring 306 which facilitates deployment of the skirt portion 11 on different sized ampoules. These features will be further described below.
[0176] The closure 10 of FIG. 34 also has a number of the features which have already been described, including the enlarged rim 15 of the skirt portion 11, groove 14 for storing the rolled up skirt portion 11, the conic projection (or dome) 76 and Luer Lock connector 34. In FIG. 34 the Luer Lock connector 34 has a central hole (female luer part) to receive the central tip 360 (male luer part) of the Luer Lock type syringe and has a groove 362 surrounding that central tip 360 for receiving the threaded collar of the Luer Lock type syringe that surrounds the male tip, i.e. the threaded locking portion of a Luer Lock type syringe that engages with wings or threads on the female luer part to lock the two parts (male and female) together. A stopper 364 prevents over-insertion of the syringe tip. In FIG. 34 the groove 362 is formed integrally with the rest of the cap portion 12 and does not have any threads formed therein for engagement with the threads on the collar of a Luer Lock syringe. Instead, the groove 362 merely accommodates the structure (i.e. the collar and threads) of the Luer Lock syringe, allowing it to fit neatly onto the cap portion 12 when the male tip part is inserted into the female part. It will of course be appreciated that threads could be formed in the groove 362 for engagement with the Luer Lock syringe for a more robust, threaded connection.
[0177] FIG. 35 shows a variant of a push-on type skirt similar to FIG. 27, but with the skirt portion 11 formed from a flexible material that can expand at least radially so that it can provide a good grip against the outer surface of ampoules of different sizes. FIG. 35 shows that the skirt 11 in this embodiment tapers radially inwards away from the cap portion 12 such that the inner diameter at the end of the skirt portion 11 is smaller than the outer diameter of the ampoule body 2. FIG. 35(a) shows the closure 10 prior to application while FIG. 35(b) shows the closure 10 in place on the ampoule body 2 with the skirt portion 11 duly radially expanded to fit on the ampoule body 2. The closure 2 also has a brim 308 extending radially outwardly from the distal end of the skirt portion 11 to form a push-surface by which the closure 10 can be pressed over the ampoule body 2, e.g. using fingers.
[0178] FIG. 36 shows another variant of a push-on type skirt closure. This embodiment has a rigid outer housing 310 with a soft, deformable (e.g. elastic) material 312 provided on the inside thereof. The soft material 312 provides grip through friction against the outer surface of the ampoule body 2, thus holding the closure 10 against the broken neck after it has been pushed on. FIG. 36(a) shows the closure 10 just before pressing onto the ampoule body 2 while FIG. 36(b) shows the closure deployed onto the ampoule body 2. Flexible ribs 314 are formed on the inside of the skirt portion 11 extending towards the ampoule body 2 so as to provide grip and also allowing the closure 10 to accommodate a small variation in the size of the ampoule body 2.
[0179] FIG. 37 shows a variant of FIG. 36 with larger ribs 314 in the form of lamellae.
[0180] These lamellae 314 can accommodate a greater range of ampoule sizes. FIG. 37(a) shows the closure 10 before installation, FIG. 37(b) shows the closure 10 installed on a large ampoule body 2. FIG. 38 shows the same closure 10 installed on a smaller ampoule body 2. It can be seen that the lamellae have bent less against the smaller ampoule body 2, but are still deflected upwards, towards the broken neck by the process of applying the closure 10. This ensures that the frictional forces maintain a pull down of the closure 10 onto the neck of the ampoule body 2 to maintain sealing.
[0181] FIGS. 37 and 38 also show an additional feature of air canals 316 that connect the inside of the skirt portion 11 with the outside of the closure 10. These air canals 316 allow air to escape from inside the skirt portion 11 during the process of pressing the closure 10 onto the ampoule body 2 and thereby avoiding a build up of air pressure inside the skirt portion 11 which could otherwise bias the closure away from the neck of the ampoule body 2 (which could reduce the sealing effectiveness).
[0182] FIG. 39 shows a variant of a push-on type closure 10 which has a number of stiff gripping fingers 318 extending axially down the ampoule body 2, each finger 318 being capable of radial deflection (e.g. by bending or pivoting on the cap portion 12). As with the variant of FIG. 35, the inner diameter at the distal end (in its natural, non-stretched or deformed state) is smaller than the target ampoule outer diameter, but when pressed onto the ampoule body 2 the fingers separate radially outwardly to accommodate the outer diameter of the ampoule body 2.
[0183] FIG. 40 shows a first variation of FIG. 39 in which the inner soft material 312 inside the fingers 318 forms a complete cylindrical skirt for contact and sealing against the ampoule body 2 (i.e. the soft material 312 is not formed into separate fingers). The second variation shown in FIG. 41 has the soft material 312 formed into fingers, i.e. the soft material 312 is only formed on the inner surfaces of the fingers 318. This embodiment does not necessarily form a seal against the outer diameter of the ampoule body 2 at the point of gripping, but a seal is still formed against the broken neck.
[0184] FIG. 42 illustrates the areas of a broken ampoule body 2 (with the top part 3 removed) with a broken neck 4. The ampoule 1 is sterile inside, but may have been contaminated on its outer surface. Therefore it is important if the ampoule is to be reused (e.g. stored for later when it may be further emptied or fully emptied) to prevent any of the contents from coming into contact with any outer surface of the ampoule body 2 in case such contact draws contaminants back into the interior of the ampoule. In FIG. 42(a) the diagonal lines that cross the broken neck 4 show the divide between the sterile and non-sterile regions. The shaded area 320 illustrates that everything outside of those lines (they are lines in two dimensions, but are representative of a cone in three dimensions) is non-sterile, while everything between the lines is sterile. Another way to view this is that the ampoule body 2 has a certain thickness which is broken at the neck 4 and therefore the broken neck 4 has a certain thickness itself, separating the inner surface of the ampoule from the outer surface of the ampoule (it may be noted that this particular neck region is often thinner than the rest of the ampoule body 2 to facilitate breaking). The inner surface of the ampoule up to the inner edge of the broken neck is sterile, the surface of the broken neck itself is sterile (as it was previously part of the wall), while everything on the outer surface of the ampoule up to the outer edge of the broken neck is non-sterile. To from a sterile seal on the ampoule, sealing contact must be made around the full circumference of the broken neck against the sterile surfaces, i.e. internally of the outer edge of the broken neck. FIG. 42(b) shows a top down view of a broken ampoule with the outer surface (non-sterile) shown at 322, the inner surface (sterile) shown at 323. The outer edge of the broken neck is shown at 324 and the inner edge of the broken neck is shown at 325. The broken region between the inner edge 325 and the outer edge 324 is also sterile and can be used for forming a sterile seal.
[0185] FIG. 43 shows a roll-type closure 10 (i.e. with a flexible skirt portion 11 that can be rolled up prior to deployment and rolls down onto the outer surface of the ampoule body 2 during deployment). FIG. 43(a) shows the closure 10 applied to a small diameter ampoule body 2, while FIG. 43(b) shows the same closure 10 applied to a larger diameter ampoule body 2. It can be seen that the flexibility of the elastic skirt portion 11 can accommodate a wide range of ampoule sizes.
[0186] FIG. 44 shows an adapter ring 306 provided on the inner surface of the skirt portion 11. FIG. 44(a) shows the skirt portion 11 in the rolled-up (first) position such that the adapter ring 306 is essentially on the bottom surface of the cap portion 12. The adapter ring is a projection from the inner surface of the skirt portion 11 that helps to ensure that the skirt portion 11 can roll out quickly and easily over larger diameter ampoules as well as smaller diameter ampoules. FIG. 44(b) shows the closure 10 being installed onto a small diameter ampoule and FIG. 44(c) shows the same closure 10 being installed onto a larger diameter ampoule. It can be seen from FIG. 44(b) that when the closure 10 is deployed on a small ampoule, the adapter ring 306 does not interfere with the ampoule shoulder or body 2 and does not interfere with the normal unrolling motion of the skirt portion 11 which narrows slightly as it deploys until it contracts onto the outer surface of the ampoule body 2. By contrast, in FIG. 44(b), with the wider ampoule body 2, the adapter ring 306 comes into contact with the shoulder of the ampoule body 2 early on in the deployment of the skirt portion 11. The effect of this is to act as a support projection to hold the diameter of the skirt portion 11, preventing it from contracting early and onto the shoulder which can hinder further unrolling. In the absence of the adapter ring 306, the contracted skirt portion 11 would require further encouragement to re-expand over the shoulder before final unrolling proceeds unhindered. With the adapter ring 306, the skirt portion 11 does not contract above the shoulder and can unroll unhindered (and automatically, once it leaves the groove 14) onto the outer surface of the ampoule body 2, effecting the snap deployment. FIG. 44(d) shows some alternative cross-section profiles for the adapter ring 306, illustrating that it does not need to fill the space above the shoulder of the ampoule body 2 so long as it provides radial support to the skirt portion 11 (i.e. in the form of a plurality of support projections).
[0187] The adapter ring 306 need not be a full, solid ring and indeed is preferably a set of projections formed into a ring shape. It is only necessary to provide enough support to prevent the shoulder from hindering the snap deployment and therefore a single projection may be enough in some examples. However, some preferred embodiments of the adapter ring 306 are shown in FIG. 44(e) illustrating how the adapter ring 306 is preferably formed from a number of individual projections arranged around in a circle. The individual projections may vary greatly in number and in the spacing between them. As shown, the projections are preferably tapered towards the centre of the circle, e.g. as if they were formed by making radial cuts through a circular ring. The use of a smaller number of individual projections (as opposed to a solid adapter ring) reduces the tension that is introduced on the skirt portion 11 by the adapter ring 306, thus making it easier to roll up the skirt portion 11 and retain it in the groove 14. The tapering allows the projections to come together evenly when the skirt portion 11 rolls out and contracts onto a smaller ampoule.
[0188] FIG. 45 shows a one-way valve 336 that may be provided in the content transfer channel 13. The one-way valve 336 allows content to be extracted from the ampoule body 2, while preventing transfer in the opposite direction. FIG. 45(a) shows the valve 336 in place in the closure 10. The valve 336 may be integrally formed as part of the closure 10 or it may be formed as a separate part that can be inserted into a corresponding cavity formed in the cap portion 12. FIG. 45(b) shows a close-up of the valve 336 in an open condition with fluid flowing through and FIG. 45(c) shows the valve 336 in a closed condition with backflow prevented. The valve 336 is formed from two opposing flaps 338 angled in the direction in which flow is to be permitted (shown by the dashed arrow in FIG. 45(b)). The flow presses on the flaps 338 pushing between them and parting them. In FIG. 45(c) flow in the opposite direction presses the flaps 338 together causing them to seal against one another, preventing flow.
[0189] FIG. 46 shows a shield 304 that protects the rolled-up skirt portion 11 from being accidentally released by any force other than the intended force to press the closure 10 onto the ampoule body 2. The shield 304 may be formed as a ring around the cap portion 12 and is positioned just above the skirt portion 11 (i.e. closer to the top surface of the cap portion. FIG. 46(a) shows the skirt portion in the deployed (second) position, showing the skirt portion 11 in its natural, non-stretched position with a narrower internal diameter than the target ampoule. With the skirt portion 11 in this position, not on an ampoule body 2, it is quite difficult to roll the skirt portion 11 back up into the groove 14. Also, attempting to do so may compromise the sterility of the projection 76 that is for contact with the contents of the ampoule. This accidental deployment of the skirt portion 11 is inconvenient and may render the device unusable, particularly in medical applications where sterility and speed of use are important. As the closure is typically picked up and applied by gripping the cap portion 12 between the user's fingers, the shield 304 protects the rolled-up skirt 11 from the fingers and protects against accidental deployment of the skirt portion 11 before the closure 10 has been duly placed onto the target ampoule. FIG. 46(c) shows the closure 10 gripped between two fingers and with the shield 304 intervening between the fingers and the skirt portion 11. It may be noted in FIGS. 46(a) and (b) that the anti-roll ribs or wings 302 in this embodiment are relatively thin and flexible and while their full width is visible in the cross-section of FIG. 46(a), they can easily be bent or squeezed by the fingers in use (their shape can be seen better in FIG. 51(b)).
[0190] FIGS. 46(d) and (e) show variations of the shield 304 in which the shield 304 also provides an anti-roll function by being formed to be non-round. For example the shield 304 may be formed as a number of shield projections 340 with cut-outs between them so that when placed on a flat surface the closure 10 is hindered from rolling.
[0191] FIGS. 47 and 48 show ways of increasing the amount of content that can be extracted from the ampoule. The problem is best illustrated in FIG. 48(b) which shows an ampoule body 2 inverted for liquid extraction through the channel 13. However as the entrance to the channel 13 is at the tip of the conic projection 76, it is above the lowest level at which content can be situated, thus not all of the content can be extracted leading to a small amount of potential wastage. FIG. 47 shows a solution to this problem in the form of through holes 342 which may be bores through the side of the projection 76. These through holes 342 connect the channel 13 to points on the surface of the projection 76 that, when inverted, will be lower than the point at the tip of the projection 76 and thus allow more of the ampoule's contents to reach the channel 13. FIG. 47(a) shows the projection 76 engaging with a smaller ampoule with a narrower neck opening, while FIG. 47(b) shows the projection 76 engaging with a larger ampoule with a wider neck opening. It can be seen that the wider neck opening allows the projection 76 to be inserted further into the ampoule body 2 such that the through holes 342 are inserted further from the seal inside the neck. FIG. 48 shows an alternative to through holes 342 in the form of gullies or cuts or trenches 344 in the projection 76, i.e. slits that extend from the tip of the projection down the side of the projection 76 and thus provide elongated entrances to the channel 13. A plurality of such gullies 344 may be provided around the channel 13, e.g. three as shown in FIG. 48(a) at 120 degree intervals. The axial extent of the gullies is shown by the shaded section of the conic projection 76 in FIGS. 48(a) and (b).
[0192] FIG. 49 shows some alternative arrangements for providing a lid on the closure 10, similar to FIG. 23. FIG. 49(a) shows a lid 73 that is part of the moulding (i.e. it is formed integrally with the closure 10 and from the same material) and fits into the upper surface of the closure 10 by an interference fit in a recess 346 in the top of the closure 10. FIG. 49(b) shows a hinged lid 73. FIG. 49(c) shows a closure 10 with a syringe connector as a separate component 348 inserted into the closure 10. FIG. 49(d) shows a hinged lid 73 that is part of the closure 10 (e.g. integrally moulded) and can be press-fit (e.g. interference fitted) to the connector component 348.
[0193] The lids may be colour coded to indicate certain properties of the closure such as seal type, filter type, presence of valve, etc.
[0194] FIG. 50 shows a stopper or shoulder 350 that is provided in the cap portion 12 of the closure 10 to define the insertion level of a syringe 352 (shown in FIG. 50(b) in dotted line) or other connector or content extraction device. This may include a luer type connector inserted into the closure 10. The stopper 350 defines the end of a wider bore in which the connector can be inserted. Below the stopper 350 the bore is narrower just to provide the content extraction channel 13.
[0195] FIG. 51 shows air channels 354 that may be used in cases where the pressure drop within the ampoule body 2 may be inconvenient, e.g. too large to allow one-handed operation. The air channels 354 allow air to enter the inside of the ampoule to relieve the pressure difference. However, in order to maintain sterility of the inside of the ampoule, filters 356 are provided on each air channel 354 to prevent contaminants from entering the ampoule after sealing. As shown in FIG. 51(a), the air filter 356 could be provided just on the surface of the cap portion 12 as one or more filter elements 356 linked to the cone 76 by one or more inmoulded or postmoulding channels 354. FIG. 51(b) shows a variation in which the filter 356 is recessed into the upper surface of the cap portion 12 and is formed as a ring around the content extraction channel 13. Alternatively, the filter 356 could be attached to or recessed into a side of the cap portion. Recessing the filter 356 may help to protect it from damage or dirt from objects (e.g. fingers) contacting the outside of the cap portion.
[0196] FIG. 52 illustrates different shapes of ampoule, e.g. with a square or oval horizontal cross-section and how different shaped closures 10 may be used with corresponding cross-sections.
[0197] FIG. 53 illustrates a method of rolling up the skirt portion 11 after the closure 10 has initially been formed (e.g. moulded). The skirt portion 11 is moulded around a mould part 400 in the form of a long rod with a shaped end that forms the conic projection 76. The mould part 400 may be used to provide a surface against which a roller such as a wheel 410 can push and rotate to roll up the skirt portion 11 into the groove 14. Without the mould part 400 the wheel would not get enough purchase on the elastic skirt portion to grip it and roll it up. FIG. 53(a) shows the mould part 400 inside the skirt portion 11 immediately after moulding. FIG. 53(b) shows the wheels 410 in the process of rolling up the skirt portion 11. FIG. 53(c) shows an end view in an example in which four wheels 410 are provided, equally spaced around the skirt portion 11. FIG. 54 shows a variation in which instead of full wheels, only partial wheels 410 (semi-circles or half-moons) are used.
[0198] FIG. 55 shows an alternative method for rolling up the skirt portion 11 if the mould part 400 needs to be removed. To provide a surface against which the wheels or half-moons 410 of FIG. 53 or 54 can press, a mounting rod 420 is inserted into the skirt 11. To allow the rod to be pushed inside the skirt portion 11, air is channeled through a bore 430 in the middle of mounting rod 420 towards the closure 10 (as indicated by the dashed arrow). The content transfer channel 13 of the closure 10 is blocked by a lid or other stopper 440 so that the air from the mounting rod 420 is forced to escape between the sides of the rod 420 and the inside of the skirt portion 11, thus expanding the skirt portion 11 and allowing the mounting rod 420 to be inserted inside the skirt portion 11. The rolling up process may then proceed as described above in relation to FIGS. 53 and 54.
[0199] FIG. 56 shows an alternative method for rolling up without the need for wheels. The mould part 400 is divided into a first mould piece 401 and a second mould piece 402 forming two halves of the mould part 400 divided along the axis of the closure 10. As the two mould pieces 401, 402 are splayed apart as shown in FIG. 57(b) the skirt portion 11 is stretched more at its distal end, causing it to be biased towards the cap portion 12 in order to lose the stretch and causing it to roll up in the process. The two mould pieces 401 and 402 may be separated and splayed by driving a wedge 403 between them. As the wedge 403 is pressed further between the mould pieces 401, 402 it causes them to splay further apart and push the rolling skirt further towards the cap portion 12 and groove 14.
