GB2584889A

GB2584889A - Ampoule closure

Info

Publication number: GB2584889A
Application number: GB1908815.2A
Authority: GB
Inventors: Vollen Martin; Andresen Marius; Geers Kevin
Original assignee: Rabmed As
Current assignee: Rabmed As
Priority date: 2019-06-19
Filing date: 2019-06-19
Publication date: 2020-12-23
Also published as: WO2020254666A1; GB201908815D0

Abstract

A closure 10 for an ampoule, the closure comprising: a cap portion 12 arranged to engage with a broken neck of an opened ampoule; a skirt portion 11 extending from the cap portion, the skirt portion being arranged to grip the sides of an ampoule; and a rigid support structure 20 removably attached to the cap portion, the rigid support structure comprising a support flange 21 and a handling projection 22 extending from the support flange. The removable rigid support structure provides rigidity to the closure during application of the closure to an ampoule and, in the case of closures with a rollable/foldable skirt portion (Figure 3), also provides rigidity to the closure during the assembly process by facilitating the rolling/folding of the skirt portion from the second position into the first position. The rigid support structure also helps to keep the cap portion aseptic during handling. A channel 13 comprising a Luer connector 24 may extend through the cap portion to form a fluid connection with the ampoule, and which may be sealed by a projection 29 on the support portion.

Description

Ampoule closure The invention relates to a closure device for an ampoule to facilitate and improve the use thereof. In particular, the invention relates to a sealing device for ampoules with a break off top and in some embodiments a content transfer device for extracting content from an ampoule.

An ampoule is a small sealed vial which is typically used to contain and preserve a sample. The sample is usually either a solid (e.g. a powder or granules) or liquid.

Ampoules are commonly made of glass, although plastic ampoules do also exist.

Modern ampoules are most commonly used to contain pharmaceuticals and chemicals that must be protected from air and contaminants and UV light for example. Glass ampoules are often used so as to avoid reaction of the sample with the container material during storage. They are usually hermetically sealed by melting the thin top with an open flame, and are typically opened by snapping off the neck (which may be deliberately formed as a point of weakness). If properly done, this last operation creates a clean break without any extra glass shards or slivers; however this is not guaranteed and small glass shards can fall into the ampoule leaving sharp edges and "shark teeth" that can present a cutting hazard to the user. Therefore the contents (e.g. liquid or solution) may be filtered for greater assurance. The space above the chemical may be filled with an inert gas before sealing. The walls of glass ampoules are usually sufficiently strong to be brought into a glovebox without any difficulty.

Glass ampoules are more expensive than vials or bottles and other simple containers, but there are many situations where their superior imperviousness to gases and liquids and all-glass interior surface are worth the extra cost. Examples of chemicals sold in ampoules are injectable pharmaceuticals (e.g. morphine and adrenaline), air-sensitive reagents like tetrakis(triphenylphosphine)palladium(0), hygroscopic materials like deuterated solvents and trifluoromethanesulfonic acid, and analytical standards.

There are several problems with these ampoules as follows: -2 -One of the major challenges for today's healthcare globally is the spreading of infections through patient care. 35-37% of Hepatitis A and B infection occurs as a result of cuts/needle stick during patient treatment situations. (Source WHO).

Research has revealed that there are many unrecorded incidences of needle stick injuries. Today's procedures and existing products do not provide effective solutions to this problem in a safe and user-friendly manner, and they generate large amounts of costly waste which is hazardous to the environment and an over-use of expensive pharmaceuticals.

Problems arise when a glass ampoule is broken and a sharp glass edge is exposed at the break point (usually the neck). This can be sharp and serrated and can easily cause lacerations with the associated risk of blood contamination. There is also a risk of injuries and blood contamination when using a needle to draw content out from within the ampoule due to the risk of needle stick when attempting to insert the needle into the small opening in the glass ampoule which is held with two or more fingers.

Once opened, the contents of the ampoule must be used immediately before the contents can become contaminated or spilled. However, as the quantity of substance will vary from use to use (e.g. with the size of patient or type/severity of treatment), ampoules often contain more substance than the required dose. Thus after the required dose has been withdrawn from the ampoule there is still a quantity of substance remaining within the ampoule. As the ampoule is not sealed there is a risk of spillage and wastage of vital drugs from an opened ampoule, as well as unnecessary exposure of the content (e.g. to air and/or UV light).

As mentioned above, there is a risk during breaking open the ampoule that small shards of glass may fall into the ampoule and its contents. If these are not adequately filtered out then there is a risk of these glass particles being accidentally drawn into a syringe and injected into a patient. A common filtering technique at present is to use a needle (or possibly a straw) to draw out the contents from the ampoule into a syringe, relying on the narrow diameter of the needle to prevent glass shards from being drawn up. However very small particles may still be able to pass through. In some countries and for some procedures it is recommended to -3 -use a filter for extraction, but in emergencies the use of a filter can often be bypassed for speed, just using the needle to provide the filtering function.

The current solutions are also not optimal for the handling of hazardous waste. For example there is risk of the contents spilling as described above. In particular the patient treatment will likely be carried out before any remaining ampoule and contents are disposed of. During this time there is a risk of the ampoule being knocked and broken or the content spilled. Additionally, in cases where injection is not via a catheter port (i.e. without a needle), the needle that is used to draw contents from the ampoule cannot be re-used for injection into the patient. Thus two needles are required for every use which is wasteful as well as increasing the risk of needle stick injuries through changing of the needle.

It will be appreciated that the users of ampoules include several different groups.

Ampoules are particularly important for paramedics, but are also used by other medical or medical-related professionals, such as those who work for vaccination programs, researchers, ER / HEMS / EMT personnel, anesthesiologists, pharmacists, veterinarians (for pets, farms and aquaculture). Ampoules are sold in billions annually for storage of medication in small volumes. Typical drugs that may be found in glass ampoules (purely by way of example) are morphine and adrenaline. Ampoules may be various shapes and sizes. Some typical ampoules for drugs range from about 1 ml to about 30 ml. Larger ampoules are also used for storage of other materials, e.g. Mercury. Such ampoules may have a volume of a litre or more. Also, while the majority of ampoules are circular in cross-section (broadly a circular cylinder), other shapes such as oval or rectangular cross-sections are also possible.

A lot of effort has been put into solutions that ensure a safe breaking of the neck of a glass ampoule, because this is a particularly risky operation. Therefore, there are a significant number of products that attempt to solve one or more of these problems. However each has its limitations and/or disadvantages.

A particularly advantageous solution is described in WO 2018/167321. This document describes an ampoule closure that can be pressed over the opened ampoule, sealing against the broken neck and gripping against the sides of the -4 -ampoule so as to prevent spillage. The closure may also have a content extraction channel that allows the contents of the ampoule to be withdrawn through the closure. The present invention is a development of the closure of WO 2018/167321 and the closure described herein may have any of the features that are described in detail in that document. The entire contents of WO 2018/167321 are incorporated herein by reference.

According to a first aspect of the invention there is provided a closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; a skirt portion extending from the cap portion, the skirt portion being arranged to grip the sides of an ampoule; and a rigid support structure removably attached to the cap portion, the rigid support structure comprising a support flange and a handling projection extending from the support flange.

The term closure is used here to mean something that closes off an opening (i.e. the opening that is formed in an ampoule when the neck is snapped and the top removed). It may include a cap or a sealing device or a protection device (for protecting against the sharp edge formed upon removal, and/or for protecting the contents from exposure or spillage). It may also provide a sealing function.

The skirt portion may be elastically deformable and may be 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.

Alternatively, a push-on or slide-on skirt portion may be used that may be either made from the same elastic material or may be made from a more rigid material.

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. -5 -

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.

While the skirt portion may be simply folded so as to form a single bend when in the first position, the skirt portion may be folded more times or may be rolled back on itself.

The cap portion is preferably wider than the broken neck's diameter so as to ensure that the broken rim is easily and fully sealed.

In the absence of an ampoule, the skirt portion is preferably arranged to extend downwards from the outer edge of the cap portion when it is in the second position and forms a cylinder with an internal diameter that is less than the diameter of the ampoule(s) that it is designed for. When the skirt is then rolled or folded into the first position, the lower surface of the cap portion preferably extends continuously into the inner surface of the skirt portion ('inner' here referring to the surface that will be the inner surface when the skirt is in the second position). This allows the contact surface for the rim to be wide and allows easy placement of the closure against the opened ampoule. The smooth surface then facilitates easy unrolling or unfolding of the skirt portion which can smoothly wrap into contact with the external surface of the ampoule. As the skirt portion is rolled or folded down into the second position, it constricts around the ampoule and holds the ampoule firmly through friction.

In earlier designs of the closure, the cap portion was formed with a significant quantity of material so as to provide a relatively stiff body against which the skirt portion could be rolled or folded and which could be used for handling and manipulating the closure, e.g. for deployment of the skirt portion. However, the skirt portion and cap portion were integrally formed (moulded as one piece) from silicone which is relatively costly. To reduce cost, it is desirable to reduce the amount of costly material in the cap portion, but simply reducing the quantity of material (i.e. by reducing the thickness of the cap portion) leaves the closure more difficult to handle when applying the closure to an ampoule (in particular when trying to handle -6 -it through an aseptic layer such as the packaging in which it is supplied) and, in the case of foldable/rollable skirts, more difficult to fold/roll the skirt portion from the second position into the first position.

This problem has been overcome by providing a removable rigid support structure which provides rigidity to the closure during application of the closure to an ampoule and, in the case of closures with a rollable/foldable skirt portion, also provides rigidity to the closure during the assembly process by facilitating the rolling/folding of the skirt portion from the second position into the first position. The support flange of the rigid support structure provides a surface parallel to the upper surface of the cap portion (and substantially perpendicular to the deployed skirt portion) and thus provides a rigid surface against which a rollable/foldable skirt portion can be rolled or folded. Additionally, the flange portion provides an intervening surface between the cap portion and the fingers of the person handling the closure. Thus the rigid support structure also helps to keep the cap portion aseptic during handling, including the application of the closure to an ampoule. In particular, the cap portion allows direct handling of the closure without risk of contamination of the fluid transfer parts of the device. Without the rigid support structure, the mounting of the closure to an ampoule needed to be done through another aseptic protective layer, e.g. the packaging in which the closure was provided. However, this rigid support structure is a much more convenient mechanism for handling the closure while avoiding contamination.

It will be appreciated that the rigid support structure is provided on a first or upper side of the cap portion ("upper" referring to the side that is uppermost if the closure is fitted to an ampoule which is stood on its base with its broken neck uppermost) while the skirt portion extends from a second or lower side of the cap portion. It is the second or lower side of the cap portion that is applied to the ampoule in use, while the first or upper side is handled by the user. Therefore the rigid support structure is the uppermost part of the closure and is the part that is handled in use.

As the rigid structure is a separate and removable part of the closure, it can be formed from a different, less costly material. Thus the rigid support structure allows a reduction in expensive material, while maintaining the required rigidity for assembly and use, with the closure still being easy to assemble and also improving -7 -the sterility of the uppermost surface of the cap portion. While in some examples the closure may simply be used as a cap to close off an ampoule (in which case the sterility of the upper surface of the cap portion is not so important), in more advantageous embodiments the closure is also used for content extraction from the ampoule and in such cases the sterility of the upper surface of the cap portion is important.

The handling projection extending away from the cap portion provides a handle for holding and manipulating the closure during assembly and during application. As the handle is narrower than the flange (smaller diameter) it is easily gripped by the fingers of a user, while the wider flange protects the cap portion from contact with the tips of the fingers (as well as providing rigidity as discussed above). Preventing such contact is important to maintain the aseptic state of the cap portion which is used for fluid transfer. Any contamination by fingers touching the fluid transfer parts would render the device unusable.

The diameter of the flange portion may be selected so as to provide the desired amount of rigidity to the cap portion as well as the desired amount of contact protection. In terms of the amount of contact protection, the longer the handling projection (i.e. the more it extends away from the cap portion), the smaller the flange portion needs to be. However, a smaller flange portion does not provide as much rigidity as a larger one.

The support structure is preferably arranged to allow gripping by fingers without contacting the cap portion. In some preferred embodiments the support flange has a diameter at least half the diameter of the cap portion. The support flange may have a diameter at least three quarters the diameter of the cap portion. The support flange may have a diameter greater than the diameter of the cap portion. When the support flange has a greater diameter than the cap portion, the whole upper surface of the cap portion is provided with rigidity and also completely separated from finger contact. However, this does require a larger rigid support structure component and thus more material.

Where the rigid support portion has a greater diameter than the cap portion, it may have a lip extending from a rim of the flange and at least partially surrounding the -8 -cap portion. In such embodiments the lip contacts the side of the cap portion and can provide extra grip to hold the rigid support portion against the cap portion. It will be appreciated that the lip could extend around the full circumference of the cap portion, or it may comprise one or more smaller lips each extending from the rim of the support flange.

The removable attachment of the rigid support portion to the cap portion may take a number of different forms, so long as it is readily removable during use. For example a threaded (i.e. screw) attachment is possible so that the rigid support portion can be removed with a twist when required. In other embodiments a temporary adhesive could be used to bond the rigid support portion to the upper surface of the cap (or to the sides of the cap in cases with a lip as discussed above), with a bonding strength selected to allow separation of the rigid support structure upon application of a small force. In certain preferred embodiments the rigid support structure is removably attached to the cap portion by a friction fit. With a friction fit, the rigid support structure is only held in place on the cap portion by friction against parts of the cap portion. In such embodiments when a separation force is applied that is greater than the frictional force, the rigid support structure will be removed from the cap portion.

In some embodiments the rigid support structure may have at least one recess formed on an internal surface thereof and the cap portion may have a corresponding projection formed on an external surface thereof such that when the projection is located in the recess the support projection is removably attached to the cap portion. Such a retaining mechanism holds the support projection in place against the cap portion until a removal force is applied that is sufficient to deform either the recess or projection enough to allow removal of the rigid support structure. It will be appreciated that the recess and projection may be the other way round, i.e. with the projection formed on an internal surface of the rigid support structure and a corresponding recess formed in an external surface of the cap portion. However, a recess is more easily formed in the internal surface of the more rigid component and hence this arrangement may be advantageous for manufacture. The recess and projection are preferably formed in surfaces that extend substantially perpendicularly away from an upper surface of the cap portion in use so that they provide resistance to separation in that perpendicular direction -9 - (the normal direction of removal of the support structure from the cap portion). This arrangement may provide a "locating" engagement of the two parts, or a "click" engagement of the two parts (because during assembly the rigid support structure will locate onto the cap portion with a tactile 'click').

It will be appreciated that several of these mechanisms may apply at the same time. For example a "click"-type engagement can also have an element of friction fit. Equally a threaded attachment can be accompanied by either or both of a friction fit and a "click"-type engagement.

Preferably the force required to remove the rigid support structure from the cap portion is less than the gripping force of the skirt portion against the ampoule. If this is not the case then the rigid support structure can still be removed by holding the skirt portion firmly against the ampoule sides, but it is advantageous that the rigid support structure will detach in preference to detaching the skirt portion so as not to affect the seal that the cap portion makes on the ampoule. This ensures a consistent application process and ensures sealing and thus sterility is maintained.

In some preferred embodiments the handling projection overhangs the support flange at an end of the handling projection that is distal from the support flange.

Thus the handling projection essentially has a waist or portion of narrower diameter between the flange and the distal end. This facilitates application of a removal force to separate the rigid support structure from the cap portion. As the handling projection may not be very big, a shape that facilitates application of a force is beneficial, especially as it may be handled by a user with wet gloves which may hinder removal if only a frictional force is possible.

As discussed above, the closure may act solely as a cap that closes off and seals an ampoule such that the contents are no longer accessible. This may be useful simply to prevent spillage of unused contents after use. However, in particularly advantageous forms, the closure is applied to the broken neck of the ampoule immediately after opening and before content extraction. Content extraction then takes place through the closure. To this end, the closure preferably has a content extraction channel that connects the lower surface of the cap portion (which is presented to the opened ampoule) to the upper surface of the cap portion. In use, the contents of the ampoule (e.g. a liquid) can be withdrawn through the channel. To facilitate this withdrawal, the upper surface of the cap portion may be provided with a connector element to which other fluid apparatus can be attached, e.g. a fluid conduit such as a syringe. In use, a syringe is the most common instrument for withdrawing the contents of an ampoule. While a needle may be used (e.g. inserted through the content extraction channel of the cap portion), this is wasteful of needles and increases the risk of needle-stick injuries. Therefore it is preferred to use other connectors such as luer type connectors (including luer-lock connectors and the like). This allows the contents of the ampoule to be extracted without using a needle. The connector element preferably provides a fluid tight connection so that no leakage occurs during withdrawal.

In some preferred embodiments, the cap portion comprises: a channel extending through the cap from a lower surface of the cap inside the skirt portion to an upper surface of the cap; and a connector element on the upper surface for attachment of a conduit; wherein the support structure forms a seal against the connector element to restrict airflow through the cap portion. One particular benefit of this arrangement is in closures with a rollable/foldable skirt portion. The seal formed by the support structure is useful during the assembly of such closures as the skirt portion is conveniently moulded in the deployed position and needs to be rolled or folded into the stored position during assembly. One particularly convenient way to achieve this is by providing a support rod on the inside of the skirt portion so that the skirt portion can be rolled up along the support rod. However, insertion of the support rod is not straightforward as the support rod is ideally slightly wider than the natural (unstretched) width of the skirt portion. One advantageous way to insert the support rod is for the support rod to have an air supply channel through its middle such that air can be blown through the support rod while the support rod is inserted, thus inflating the skirt portion over the support rod and facilitating insertion. For this to work, the air supplied through the support rod needs to exit predominantly back along the outside of the support rod, i.e. between the support rod and the skirt portion so that the skirt portion is supported on a cushion of air during the insertion of the rod. Where a content extraction channel is provided in the cap portion, air will escape through the channel and therefore during the support rod insertion process, air flow through this channel should be restricted to the extent that sufficient air flows back along the outside of the support rod. Some air flow through the channel could be permitted through the channel, but it is preferred that a fluid tight seal is provided so as to substantially prevent airflow through the channel. The rigid support structure can provide this seal and thus facilitates the assembly process in addition to its other functions.

As discussed above, the connector element may be a luer connector or luer-type connector. The connector element may be a male connector or a female connector. In some preferred embodiments the connector element is a female connector element and the support structure comprises a male projection that seals against the inside of the female connector element. This can form the air and fluid seal discussed above. Removal of the rigid support structure also thus opens up the channel for content extraction.

The connector element may be formed in a projection of the cap portion and the rigid support structure may be arranged to seal against the outside of the projection of the cap portion. Forming the connector element in a projection of the cap portion allows a reduction in the amount of material required for the cap portion, as the projection can be of smaller diameter than the rest of the cap portion. The rigid support structure may then form a seal around that projection such that it surrounds the projection. Advantageously, this sealing part of the rigid support structure can also form the handling projection. Thus in some embodiments the handling projection may be hollow and is arranged to seal against the outside of the projection of the cap portion.

As an alternative, or in addition, the rigid support structure may comprise a male projection that is inserted into and seals against the inside of the female connector element, sealing against the inside surface of the connector element.

In some embodiments the rigid support structure may comprise an aseptic area inside the handling projection, e.g. containing alcoholic content or similar aseptic material. This may be provided in an air-tight and closed chamber within the handling projection. This makes recapping the closure possible by reapplying the rigid support structure to the cap portion after extracting contents from the ampoule, thus allowing further usage of the ampoule contents at a later time, while maintaining the aseptic state of the closure and while using the same rigid support structure.

According to another aspect of the invention there is provided a method of forming a closure for an ampoule, comprising: forming a cap portion for engagement with a broken neck of an opened ampoule; forming a skirt portion extending from the cap portion for gripping the sides of the opened ampoule; removably attaching a rigid support structure to the cap portion, the rigid support structure comprising a support flange and a handling projection extending from the support flange; and rolling the skirt portion from an extended configuration into a retracted configuration while the cap portion is supported by the rigid support structure.

All of the preferred and optional features above also apply to this method. In particular, after removably attaching the rigid support structure and prior to folding the skirt portion, the method may comprise: inserting a support rod into the skirt portion, while blowing air through an internal conduit of the support rod. The cap portion may comprises: a channel extending through the cap from a lower surface of the cap inside the skirt portion to an upper surface of the cap; and a connector element on the upper surface for attachment of a conduit; and the rigid support structure may form a seal against the connector element that restricts air from the support rod from exiting through the channel. As discussed above, this air is redirected backwards between the support rod and the skirt portion, inflating the skirt portion and allowing insertion of the support rod.

The rolling may be performed by hand or it may be performed by a rolling machine. The rolling may be performed by one or more moving frictional surfaces 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. The moving frictional surface may be a wheel or a part wheel (e.g. a circular arc) that is rotated so as to roll up the skirt portion. The wheel may be translated axially towards the cap portion as the rolling takes place so as to maintain contact with the rolled skirt as it rolls towards the cap portion.

According to another aspect, the invention provides an opened ampoule having a rim around its opening and comprising a closure as described above, optionally including any of the optional features also described above.

The invention also provides a method of sealing an ampoule, comprising: holding a closure as described above by the rigid support structure; pressing the closure onto a broken neck of an ampoule; and deploying the skirt portion from the first position to the second position; and removing the rigid support structure from the cap portion.

The cap and skirt portion are left in place on the ampoule, whereby the ampoule is sealed and, in the case of a closure with a content extraction channel, ready for content extraction, e.g. by connection of a fluid transfer device such as a syringe to a connector element on the cap portion.

Preferred embodiments of the invention will now be described, by way of example only, and with reference to the accompanying drawings in which: Figs. 1 to 3 illustrate the general principles of closing an ampoule; Figs. 4 to 6 show different embodiments of a closure for an ampoule; Figs. 7 to 15 show a rolling and packing sequence for a closure for an ampoule; and Figs. 16 to 22 show a process of using a closure for an ampoule.

Figures 1 to 3 illustrate the general principles of closing an ampoule with a closure of the type discussed in this document.

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.

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.

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.

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.

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.

Fig. 3(a) shows a cross-section of a 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).

The content transfer channel 13 can also be clearly seen in Figs. 3(a) and 3(b). In this particular 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. It will also be appreciated that a single tube may be used, either with or without an additional filter.

Figs. 4 to 6 illustrate three different embodiments of a closure 10, each comprising a skirt portion 11, a cap portion 12 and a rigid support structure 20 (with specific examples referred to with a letter suffix, i.e. 20a, 20b, 20c). Each cap portion 12 has a slightly different shape and the rigid support structures 20 also have different shapes. Otherwise, these three embodiments function in substantially the same manner.

In each of Figs. 4, 5 and 6, the rigid support structure 20 has a support flange 21 and a handling projection 22. The handling projection 22 extends from the support flange 21 in a direction away from the cap portion 12. The support flange 21 provides rigidity to the cap portion 12, thereby allowing the cap portion 12 to be formed from a reduced amount of material. The cap portion 12 and skirt portion 11 are typically formed from an elastic material such a silicone which is relatively expensive. On the other hand, the rigid support structure 20 can be formed from a less expensive, more rigid material such as polypropylene. Overall the cost of the closure 10 is reduced while its rigidity is increased.

The rigidity of the rigid support structure 20 has two main benefits. Firstly, it prevents deformation of the cap portion 12 during the process of rolling up the skirt portion 11 into the groove 16. This process requires a certain amount of axial force (along the axis of the cylindrical skirt portion 11), i.e. towards the cap portion 12 and the groove 16. Without sufficient rigidity in the cap portion 12 (e.g. as provided by the rigid support structure 20), the cap portion 12 deforms under that force and hinders the rolling process. Thus the rigid support structure 20 holds the cap portion 12 rigidly against the rolling up force, thereby facilitating the rolling up process which takes the moulded form of the closure 10 (as shown in Figs. 4, 5 and 6) and assembles it into the stored position shown in Fig. 3(b). An example of this process will be described with reference to Figs. 7 to 15. The second function of the rigid support structure 20 is to provide handling of the closure 10 during the process of using the closure 10. An example of this process will be described with reference to Figs. 16 to 22.

In Fig. 4 the support flange 21 of the rigid support structure 20a is of wider diameter than the upper surface of the cap portion 12. The support flange 21 also has a lip 23 that extends down from the outer perimeter of the support flange 21, overlapping with the upper part of the cap portion 12 and surrounding it. The wide support flange 21 provides a complete barrier separating the user's fingers from the cap portion 12 and skirt portion 12 when the user picks the closure 10 up by the handling projection 22. This keeps the cap portion 12 and the skirt portion 11 sterile even during the process of removing the closure 10 from the packaging and applying it to an ampoule body 2. In addition, the fingers of the user are protected from the serrated neck 4 of the ampoule body 2.

Fig. 4 is a cross section taken through the closure 10 and shows some other features of the rigid support structure 20a and the cap portion 12. Firstly, the cap portion 12 has a connector element 24 projecting away from the upper surface of the cap portion 12 (and integrally formed therewith) for connection to a fluid transfer device such as a syringe. In use, the syringe tip is inserted into the middle of the connector element 24 whereby it makes fluid connection with the content extraction channel 13. On the outside surface of the connector element 24 is a projection 25 which locates within a recess 26 formed on an inner surface of the hollow handling projection 22. The engagement of the projection 25 with the recess 26 serves to retain the rigid support structure 20a on the cap portion 12 (together with some additional friction from between the rigid support structure 20a and the cap portion 12) until a sufficient force is applied to deform the projection 25, allowing removal of the rigid support structure 20a.

As can be seen in the cross-section, the distal end of the handling projection 22 (i.e. the end furthest from the cap portion 12) has an overhang 27 that overhangs the support flange 21, thereby forming a narrower waist 28 in the central part of the handling projection 22. This allows better grip of the handling projection 22 by the user's fingers and thus facilitates removal of the rigid support structure 20a after the closure 10 has been applied to the ampoule body 2.

Finally, the handling projection 22 has a male projection 29 that extends inside the handling projection 29 towards the cap portion 12 and which inserts into and seals against the inside of the female connector element 24. This contact between male projection 29 and female connector element 24 adds to the friction that holds the rigid support structure 20a onto the cap portion 12, but also serves to provide an air tight seal that prevents air from escaping through the content extraction channel 13 and the female connector element 24 during an assembly process (discussed further below).

Fig. 5 is similar to Fig. 4 in most respects. Fig. 5 differs from Fig. 4 in that the handling projection 22 is longer (extends further from the upper surface of the cap portion 12) and has a smaller diameter support flange 21. The support flange 21 does not extend across the full diameter of the cap portion 12, but rather only extends about three quarters of the diameter of the cap portion 12. It therefore also has no lip as described in relation to Fig. 4. However, the support flange 21 still provides adequate support to the cap portion 12, providing rigidity to allow rolling up of the skirt portion 11. With this arrangement, the cap portion 12 can be formed with small wings 40 that give stability to the closure 10 and may counteract rolling on a flat surface. The greater extent of the handling projection 22 makes it easier to grip by the user's fingers and also means that there is less chance of contact with the cap portion 12. In any case, the support flange 21 and handling projection 22 still protect the fluid transfer surfaces of the cap portion 12 and connector element 24 during handling. The overhang 27 is larger in Fig. 5, but functions the same as that of Fig. 4, simply providing a better gripping surface for pulling the support structure 20b off the cap portion 12.

Fig. 6 is similar to both of Figs. 4 and 5 in most respects. Fig. 6 differs from Figs. 4 and 5 in that the handling projection 22 has no overhang or waist shape and is therefore of simpler structure and easier to manufacture. Another difference is that the male projection 29 in Fig. 6 has perfectly parallel sides for greater frictional contact with the connector element 24 and thus greater resistance to removal. It will be seen that the male projections 29 of Figs. 4 and 5 have a tapered form which tapers as it approaches the cap portion 12, for easier insertion into the female connector part 24. It will also be seen that the female connector parts 24 of Figs. 5 and 6 do not feature the projection 25 and recess 26 of Fig. 4.

Figs. 7 to 15 show the assembly process of the closure 10 in which the skirt portion 11 is rolled up into the groove 16.

Fig. 7 shows the cap portion 12 and skirt portion 11 moulded as one piece of silicone in the form which it has when it has just been removed from the mould. The skirt portion 11 is in a first position in which it is extended (and this is also its deployed configuration when sealing against an ampoule). The groove 16 is for retaining the skirt portion 11 once it has been rolled up. The connector element 24 (also integrally moulded with the cap portion 12 and skirt portion 11 is for connection to a fluid transfer device such as a syringe (not shown in this figure). In Fig. 8, the rigid support structure 20 is provided for removable attachment to the cap portion 12. The rigid support structure is formed from polypropylene and is mounted over the top of the connector element 24 and the cap portion 12 (the rigid support structure 20 in this process is substantially in the form of the Fig. 4 example described above). As can be seen in this figure, the support flange 21 is wide enough to provide a barrier to provide finger contact with the cap portion 12 and in particular with the connector element 24. Any finger contact with the connector element 24 would be considered contamination leading to the device being unusable. Fig. 9 shows the rigid support structure 20 mounted to the cap portion 12.

In Fig. 10, a steel support rod 45 is inserted into the skirt portion 11 while blowing air through a central passage of the rod 45 (not shown in the figure) so as to inflate the skirt portion 11, allowing insertion of the rod 45. The air is prevented from escaping through the content extraction channel 13 and connector element 24 because the rigid support structure 20 seals that pathway. Therefore the air returns along the inside of the skirt portion 11, forming a cushion of air between the inside of the skirt portion 11 and the outside of the steel support rod 45, thus allowing easy insertion of the rod 45. In Fig. 11 the support rod 45 has been inserted inside the skirt portion 11 and the rolling process is illustrated by two arc shaped rollers 46 which are brought into contact with the skirt portion (initially the enlarged rim 15) and rotated so as to roll the skirt portion 11 up towards the groove 16. Although only two rollers 46 are shown in Fig. 11, any number may be used. In particular, four rollers may be used, at 90 degree intervals around the skirt portion 11. In Fig. 12, the support rod 45 is removed. Fig. 13 shows the closure 10 with fully rolled up skirt portion 11 now stored in the second position within the groove 16. Fig. 14 shows the closure 10 (including the rigid support structure 10 mounted to the cap portion 12) being placed into packaging and Fig. 15 shows the packaging being sealed, e.g. by high frequency welding.

Figs. 16 to 22 illustrate the process of using the closure 10. In Fig. 16 the closure (including the cap portion 12 with rolled up skirt portion 11 and the rigid support structure 20) is provided in a sterile packaging. The packaging is opened with the rigid support structure 20 (specifically the handling projection 22) pointing upwards. In Fig. 17 the user grips the handling projection 22 between fingers and removes it from the packaging. The support flange 21 protects the cap portion 12 and skirt portion 11 from contact with the fingers. In Fig. 18 the closure 10 is manipulated by the handling projection 22 of the rigid support structure 20 and positioned onto the broken neck 4 of an opened ampoule body 2. Fig. 19 shows the closure 10 in position but before deployment of the skirt portion 11 (i.e. with the skirt portion 11 still rolled up). The user then applies pressure on the rigid support structure 20 towards the ampoule body 2. This pressure causes the elastic body of the cap portion 12 to deform, dislodging the skirt portion 11 from the groove 16 and causing it to unroll onto the ampoule body 2. The skirt portion 11 is now in its unrolled or deployed position as shown in Fig. 20. The friction force between the skirt portion 11 and the ampoule body 2 is significantly greater than the retaining forces that hold the rigid support structure 20 onto the cap portion 12. Therefore the user now simply pulls on the handling projection 22, causing the rigid support structure 20 to separate from the cap portion 12, exposing the connector element 24 as shown in Fig. 21. In Fig.22, the user connects a fluid transfer device such as a syringe 30 to the connector element 24 with the ampoule 2 and closure 10 upside down so as to facilitate withdrawal of the ampoule contents through the content extraction channel 13 (now visible in this figure) and the connector element 24.

Finally, after use, the whole apparatus can simply be disposed of in the sharps bin.

Alternatively, if the ampoule has not been completely used, it may be retained for further use providing the closure 10 is designed with a valve to prevent unintentional leakage of fluid. The closure 10 remains in place on the ampoule body 2, keeping the broken neck 4 away from the user.

In some embodiments the rigid support structure 20 may have an aseptic area inside the handling projection 22, e.g. with alcoholic content or similar. This may be provided in an air-tight and closed chamber within the handling projection 22. This can be used for recapping the closure 10 by reapplying the rigid support structure 20 to the cap portion 12 after extracting contents from the ampoule, thus allowing further usage at a later time, while maintaining the aseptic state of the closure 10 and while using the same rigid support structure.

A particular benefit of the rigid support structure is that it is a single structure that is used throughout the processes of assembly and use and thus is a particularly convenient and cost effective arrangement.

Claims

-21 -Claims 1. A closure for an ampoule, the closure comprising: a cap portion arranged to engage with a broken neck of an opened ampoule; a skirt portion extending from the cap portion, the skirt portion being arranged to grip the sides of an ampoule; and a rigid support structure removably attached to the cap portion, the rigid support structure comprising a support flange and a handling projection extending from the support flange.
2. A closure as claimed in claim 1, wherein the support flange has a diameter at least half the diameter of the cap portion.
3. A closure as claimed in claim 2, wherein the support flange has a diameter at least three quarters the diameter of the cap portion.
4. A closure as claimed in claim 3, wherein the support flange has a diameter greater than the diameters of the cap portion.
5. A closure as claimed in claim 4, wherein the support flange has a lip extending from a rim of the flange and at least partially surrounding the cap portion.
6. A closure as claimed in any preceding claim, wherein the rigid support structure is removably attached to the cap portion by a friction fit.
7. A closure as claimed in any preceding claim, wherein the rigid support structure has at least one recess formed on an internal surface thereof and the cap portion has a corresponding projection formed on an external surface thereof such that when the projection is located in the recess the support projection is removably attached to the cap portion.
8. A closure as claimed in any preceding claim, wherein the force required to remove the rigid support structure from the cap portion is less than the gripping force of the skirt portion against the ampoule.
9. A closure as claimed in any preceding claim, wherein the handling projection overhangs the support flange at an end of the handling projection that is distal from the support flange.
10. A closure as claimed in any preceding claim, wherein the support structure is arranged to allow gripping by fingers without contacting the cap portion.
11. A closure as claimed in any preceding claim, wherein the cap portion comprises: a channel extending through the cap from a lower surface of the cap inside the skirt portion to an upper surface of the cap; and a connector element on the upper surface for attachment of a conduit; wherein the support structure forms a seal against the connector element to restrict airflow through the cap portion.
12. A closure as claimed in claim 11, wherein the connector element is a luer connector.
13. A closure as claimed in claim 11 or 12, wherein the connector element is a female connector element and wherein the support structure comprises a male projection that seals against the inside of the female connector element.
14. A closure as claimed in claim 11, 12 or 13, wherein the connector element is formed in a projection of the cap portion and wherein the support structure is arranged to seal against the outside of the projection of the cap portion.
15. A closure as claimed in claim 14, wherein the handling projection is hollow and is arranged to seal against the outside of the projection of the cap portion. 30
16. A method of forming a closure for an ampoule, comprising: forming a cap portion for engagement with a broken neck of an opened ampoule; forming a skirt portion extending from the cap portion for gripping the sides of the opened ampoule; removably attaching a rigid support structure to the cap portion, the rigid support structure comprising a support flange and a handling projection extending from the support flange; and rolling the skirt portion from an extended configuration into a retracted configuration while the cap portion is supported by the rigid support structure.
17. A method of forming a closure as claimed in claim 16, wherein after removably attaching the rigid support structure and prior to folding the skirt portion, the method comprises: inserting a support rod into the skirt portion, while blowing air through an internal conduit of the support rod.
18. A method as claimed in claim 17, wherein the cap portion comprises: a channel extending through the cap from a lower surface of the cap inside the skirt portion to an upper surface of the cap; and a connector element on the upper surface for attachment of a conduit; wherein the rigid support structure forms a seal against the connector element that restricts air from the support rod from exiting through the channel.
19. A method as claimed in claim 16, 17 or 18, wherein the rolling is performed by a rolling machine.
20. A method of sealing an ampoule, comprising: holding a closure as claimed in any of claims 1 to 14 by the rigid support structure; pressing the closure onto a broken neck of an ampoule; and deploying the skirt portion from the first position to the second position; and removing the rigid support structure from the cap portion.