Closure member

A container or vial (1) for a fluid, the container (1) comprising a casing defining an interior for storage of the fluid and a closure member (2). The closure member (2) comprises a body and at least one resilient projection (7) to seal in a storage condition an outlet of the casing, wherein upon an increase in the pressure of the interior of the container (1) the at least one resilient projection (7) is deflected to accommodate outflow of fluid through the outlet. The pressure in the interior of the container (1) may be increased by displacing the closure member (2) into the container (1) or by displacing some other element such as a bung (61, 82) into the container (1). The container (1) and closure member (2) may be used in a dispenser (90) and the closure element may be used in a valve (110).

The present invention relates to a container, such as a vial, sealed by a closure member and to a dispenser, such as a nasal dispenser, including a container or vial and a closure member. The invention further relates to a closure member and to a valve.

It is known from EP 0827782 to provide a metered dose of medicament in a sealed vial to be dispensed from a dispenser. A piercing element provided on a piston pierces the sealing member in the vial. The sealing member is then displaced into the vial forcing medicament out of the vial through the pierced opening in the sealing member. The medicament then passes through a channel formed in the piston and is expelled from the dispenser. A similar arrangement is also known from U.S. Pat. No. 5,307,953.

However, there are a number of problems associated with these known containers. In particular, the piercing element may generate particulates when puncturing the seal. These particulates may be dispensed with the medicament, or they may become lodged inside the dispenser and reduce its effectiveness. Furthermore, the requirement that a sharp piercing element be provided increases the risk of an accident occurring, for example during disposal of the dispenser. Further problems may also be encountered with the prior art devices when attempting to seal the vials, which are typically made of glass, as variations in the tolerances can result in an incomplete seal being formed.

The present invention at least in preferred embodiments attempts to address at least some of the problems associated with prior art devices.

According to a first aspect, the present invention provides a container for a fluid, the container comprising a casing defining an interior for storage of the fluid and a closure member, the closure member comprising a body and at least one resilient projection to seal in a storage condition an outlet of the casing, wherein upon an increase in the pressure of the interior of the container the at least one resilient projection is deflected to accommodate outflow of fluid through the outlet.

The increase in pressure of the interior of the container causes the resilient projection to deflect to facilitate the outflow of fluid without piercing the closure member. Thus, a piercing element is not required.

Advantageously, the provision of at least one resilient projection on the closure member compensates for any tolerance variances in the internal dimensions of the container and, thus, ensures that a good seal is formed.

Preferably, the resilient projection acts in sealing engagement with the casing of the container. In an unbiased condition, the at least one resilient projection preferably extends substantially radially outwardly from the body of the closure member. Furthermore, the at least one resilient projection preferably has a larger transverse dimension than the interior of the casing.

The at least one resilient projection preferably extends circumferentially around the body of the closure member.

The at least one resilient projection may be provided in a channel in the body of the closure member and may be a valve.

Preferably, three resilient projections are provided.

The container preferably also comprises at least one sealing portion which remains in sealing engagement with the casing.

The closure member and the at least one sealing portion may be connected to each other or may be separate from each other.

The closure member and/or the at least one sealing portion may be displaceable relative to the casing wherein in use, displacement of the closure member and/or the at least one sealing portion increases the pressure in the interior of the casing.

The closure member may comprise a channel for directing the outflow of fluid from the container. The channel preferably has at least one inlet port which is brought into fluid communication with an interior of the container when the at least one projection is deflected. The provision of a channel enables the outflow of fluid to be more readily controlled and/or directed. The channel is preferably pre-formed in the closure member.

The channel preferably comprises an interconnected axial conduit and transverse conduit. An inlet port is preferably provided at each end of the transverse conduit.

If the closure member and the at least one sealing portion are connected to each other, the at least one sealing portion preferably extends circumferentially around the body of the closure member. Preferably three sealing portions are provided.

The closure member is preferably made of an elastomer blend or thermoplastic elastomer but may also be made from any other suitable material known to those skilled in the art such as high-density polyethylene (HDP) or low density polyethylene (LDP) and, preferably, the elastomer has a Poisson's ratio of less than or equal to 0.5.

Most preferably, the closure member has a closed cell foam structure as this structure readily facilitates the deformation of the closure member under a top load and thereby enables the closure member to be displaced into the container relatively easily.

The container is preferably a vial suitable for medicament.

According to a second aspect of the present invention there is provided a dispenser, for example, a nasal dispenser, comprising a container according to the first aspect of the present invention and the dispenser further comprising a plunger or piston for displacing the closure member and/or the at least one sealing portion relative to the container.

The plunger is preferably provided with a delivery channel through which the outflow of fluid from the container is delivered.

The plunger and the closure member and/or the at least one sealing portion may be integrally formed.

Alternatively, the plunger may be formed separately from the closure member and/or the at least one sealing portion and in this arrangement the two components, preferably, sealingly engage in use. A conical flange is preferably provided on the plunger, closure member and/or the at least one sealing portion to sealingly engage with a recess formed in the other of said plunger, closure member and/or the at least one sealing portion.

According to a third aspect, the present invention provides a closure member suitable for sealing an outlet of a container, dispenser or a valve body, the closure member comprising a body and at least one resilient projection for acting in sealing engagement with a container, dispenser or a valve body, wherein said at least one resilient projection is deformable under pressure.

The deformation of the resilient projection advantageously allows fluid to be dispensed from the container without piercing the closure member.

The at least one resilient projection preferably extends circumferentially around the body of the closure.

Preferably, three resilient projections are provided.

The closure member preferably also comprises a channel for guiding the outflow of fluid from the container. The channel preferably comprises an interconnected axial conduit and transverse conduit. Preferably an inlet port is provided at each end of the transverse conduit. The channel is preferably pre-formed in the closure member.

The closure member may comprise at least one sealing portion for maintaining, in use, a seal between the sides of the closure member and the container. In use, the at least one sealing portion may advantageously reduce the likelihood of contamination of the medicament. The at least one sealing portion may also guide the closure member as it is inserted into the container.

The closure member may be formed integrally with a plunger. Alternatively, the closure member may be provided with a recess for sealingly engaging a conical flange provided on a plunger.

The closure member described herein is preferably made of an elastomer material, but may also be made from any other suitable material known to those skilled in the art such as high-density polyethylene (HDP) or low density polyethylene (LDP), all of which may provide the required resilience whilst maintaining a seal with the container. The Poisson's ratio of the elastomer is preferably less than or equal to 0.5 and, preferably, has a closed cell foam structure to facilitate easy deformation. Suitable elastomers include EPDM, polychloroprene, hydrogenerated nitrile, butyl, halo-butyl, elastomer blends or an elastomer material that is FDA compliant, has low leachables and extractibles and is not swollen by the medicament fluid.

Alternatively, the closure member may include an elastomer blend, or a thermoplastic elastomer, such as dynamically cross-linked FPDM/PP, commonly known as Santoprene. Styrenic block copolymers such as block copolymers of styrene and butadiene or styrene, ethylene, butylene, copolymers are also suitable. Copolymers of polyester, polyether known as Hytrel or polyamide, polyether copolymers known as PEBAX can also be used.

The preferred closed cell foam structure can be created by the use of nitrogen releasing azodicarbonamode-blowing agents compounded in the material. The foam structure can also be created by using gas technology, such as injection of nitrogen in the moulding process.

According to a fourth aspect of the present invention there is provided a valve comprising a closure member according to the third aspect of the present invention, the closure member being provided in a hollow valve body with an internal surface for the at least one resilient projection of the closure member to sealingly engage when pressure is applied from one side of the hollow valve body. The at least one resilient projection is preferably arranged to deform under pressure applied from the other side of the hollow valve body to accomodate flow of fluid through the valve.

A vial1having a closure member2located therein in accordance with the present invention is shown inFIG. 1. The vial1comprises a casing defining an outlet3and an interior4. A metered dose of a liquid medicament5is filled in use in the interior4of the vial1. The vial1is constructed from glass in known manner or an impermeable polymer, and the closure member2is moulded from a resilient elastomer material having a closed cell foam structure.

The closure member2is circular in transverse cross-section and has an upper portion6and a lower portion8. As shown inFIG. 2, three resilient sealing projections7extend outwardly around the circumference of the lower portion8of the closure member2.

The upper portion6of the closure member2has three sealing portions9which extend outwardly around the circumference of the body of the closure member2. The sealing portions9each have a convex cross-section to engage sealingly the interior4of the casing of the vial1.

Prior to insertion into the vial1(i.e. in an unbiased condition), the resilient projections7extend substantially radially outwardly, and have a larger diameter than that of the interior4of the vial1. Upon insertion of the closure member2into vial1, the resilient projections7are deflected back on themselves. The rearward deflection and consequent biasing of the resilient projections7helps to maintain a good seal between the closure member2and the vial1and also to retain the closure member2in place.

A channel11is pre-formed in the closure member2in the shape of an inverted “T”. The channel11has two inlet ports13,15located between the resilient projections7and the sealing portions9which are joined by a first conduit. A second conduit connects to a mid-point of the first conduit and extends axially up to an outlet17formed in the upper end of the closure member2. The first and second conduits constitute channel11. A circular recess19is formed in the upper surface of the closure member2around the outlet17.

The assembly of the vial1will now be described. The metered dose of medicament5is introduced into the vial1and the closure member2is then inserted as a push-fit into the open end of the vial.

The insertion of the projections7into the vial creates a seal and the displacement of the closure member2further into the vial1results in an increase in pressure in the interior4of the vial1.

The increased pressure causes the resilient projections7to deflect creating a leak path to the atmosphere, via the channel11. Any excess fluid or air initially present in the vial1is expelled through this leak path. The expulsion of the fluid or air reduces the pressure inside the vial1and the projections7then return to their original positions sealingly engaging the sidewalls of the vial1.

The closure member2is inserted into the vial1until the sealing portions9are located therein, as shown inFIG. 1. The vial1is then ready for use.

The sealing portions9provide a primary seal for the vial1, and the resilient projections7provide a secondary seal capable of deflecting under pressure to facilitate the outflow of fluid. As the resilient projections7do not provide the only seal for the vial1they may be more flexible to facilitate deflection in response to a lower pressure in the interior4of the vial1. Advantageously, therefore, the force required to displace the closure member2relative to the vial1may be reduced. Furthermore, the configuration of the sealing portions9may be varied independently to create the desired seal for the vial1, without affecting the functionality of the resilient projections7.

In arrangements not having sealing portions9, the resilient projections7provide the only seal for the vial1. To ensure that an adequate seal is created the resilient projections7are typically less flexible so that they are biased more vigorously against the sidewalls of the vial1. Accordingly, a larger pressure in the interior4of the vial1is required to cause them to deflect. Thus, the force required to displace the closure member2relative to the vial1is greater.

The dispensing of the medicament5from the vial1will now be described. The closure member2is displaced downwardly into the vial1and, because the vial1is sealed by the projections7, there is again an increase in pressure in the interior4. The increased pressure causes the resilient projections7to deflect and create a pathway from the interior4of the vial1to the inlet ports13,15of the channel11.

Continued displacement of the closure member2causes the medicament5to be displaced from the vial1through the pathway formed by the deflection of the resilient projections7, through the inlet ports13,15and out through the outlet17of the channel11. As the closure member2is displaced downwardly, the sealing portions9maintain a seal between the closure member2and the vial1and thereby ensure that the medicament5is expelled only through the channel11. The closure member2is displaced into the vial1until the lower surface thereof abuts the base of the vial1.

As shown inFIG. 3, a plunger21is employed to displace the closure member2downwardly. The plunger21has a delivery channel23formed therethrough and an annular conical projection25formed at the distal end thereof. The annular conical projection25is arranged to engage sealingly the circular recess19provided in the upper end of the closure member2and to align the outlet17with the delivery channel23.

As shown inFIG. 4, the closure member2may comprise just the lower portion8as shown inFIGS. 1 to 3with at least one resilient sealing projection7extending outwardly around the circumference of the closure member body. The closure member2is shown inFIG. 4provided on a plunger40. In this example the plunger40is integrally formed with the closure member2. However the plunger40could be separate from the closure member2and could be arranged to engage sealingly the closure member2as for example in the example ofFIG. 3. The plunger40is surrounded by a concentric sleeve41such that an outlet channel42is provided therebetween. As in the examples ofFIGS. 1 to 3, the vial1is provided with a metered dose of fluid medicament. To dispense the medicament from the vial, the plunger40, closure member2and concentric sleeve41are displaced downwardly into the vial1. As in the devices ofFIGS. 1 to 3, as the vial1is sealed by the projections7there is an increase in pressure in the interior4of the vial1as the closure member2is displaced downwardly into the vial1. The increased pressure causes the resilient projections7to deflect upwardly and create a pathway from the interior4of the vial1to the outlet channel42. As the plunger40, closure member2and concentric sleeve41are all displaced downwardly into the vial1, ullage is reduced.

The example shown inFIG. 5is similar to the example shown inFIG. 4except that the concentric sleeve41is attached to the vial1so that when the plunger40and closure member2are displaced downwardly into the vial1, the concentric sleeve41remains fixed to the vial. Like the example shown inFIG. 4, medicament is expelled through the outlet channel42between the plunger40and concentric sleeve41.

The example shown inFIG. 6is similar to that ofFIG. 5except that the closure member2is provided on a fixed support member60and the vial1is sealed at its other end by a bung61provided on a plunger62. The bung61may be similar to the upper portion6described with reference toFIGS. 1 to 3and in this example comprises three sealing portions9which extend outwardly around the circumference of the bung61with each sealing portion9having a convex cross-section to engage sealingly with the interior of the vial1. As in the previous examples, the vial1is provided with a metered dose of fluid medicament. To dispense the medicament from the vial1, the bung61and plunger62are displaced upwardly into the vial1with the closure member2remaining fixed relative to the vial1. As the vial is sealed by the projections7of the closure member2and the bung61, there is an increase in pressure in the interior of the vial1as the bung61is displaced upwardly into vial1. The increase in pressure causes the resilient projections7to deflect upwardly and create a pathway from the interior of the vial to the outlet channel42.

Rather than the at least one resilient projection7being provided around the circumference of the closure member2, the at least one resilient projection may be provided in a channel70in the closure member2as shown inFIG. 7. In this example the closure member2is provided on a plunger71with an internal outlet channel72. The outside surface73of the closure member2seals against the inside surface of the vial1. The closure member2is provided with one or more internal resilient projections74which may act as a valve such as a duck-bill valve to seal the interior of the vial1. As in the previous examples, the vial1is provided with a metered dose of fluid medicament. To dispense the medicament from the vial1, the plunger71and closure member2are displaced downwardly into the vial1with the outside surface73of the closure member2maintaining a seal against the inside surface of the vial1which increases the pressure in the interior of the vial1. The increase in pressure causes the internal resilient projections74to deflect upwardly and create a pathway from the interior of the vial1to the outlet channel72.

The example shown inFIG. 8is similar to that ofFIG. 7except that the closure member2is provided on a fixed support member80with an internal outlet channel81and the vial is sealed at its other end by a bung82provided on a plunger83. The bung82may be similar to the bung61shown inFIG. 6. As in the previous examples, the vial1is provided with a metered dose of fluid medicament. To dispense the medicament from the vial1, the bung82and plunger83are displaced upwardly into the vial1with the closure member2remaining fixed relative to the vial1. The pressure increases in the interior of the vial1as the bung82is displaced upwardly into the vial1until the internal resilient projections74deflect upwardly and create a channel70from the interior of the vial1to the outlet channel81.

The examples ofFIGS. 7 and 8may be provided with a suitable elongate portion in their internal outlet channels72,81to aid mechanical break-up of the ejected fluid medicament.

The vial1in combination with the closure member2may be used, for example, in a dispenser such a nasal dispenser.FIG. 9shows an example of a dispenser90illustrating the present invention. The dispenser90includes or forms a container or vial91to be provided with a dose of fluid medicament. The vial91is sealed at its lower end by a bung92. The bung92in this example is similar to that shown inFIGS. 6 and 8and comprises three sealing portions93which extend outwardly around the circumference of the bung92with each sealing portion93having a convex cross-section to engage sealingly with the interior of the vial91. The bung92is provided on a plunger94forming part of a base95of the dispenser90. A closure member97is provided at the upper end of the vial91. The closure member97has three resilient projections98extending outwardly around the circumference of the closure member body to seal against the inside surface of the vial1.

The vial91is formed as part of an actuator96of the dispenser90. The actuator96has an outlet99through which medicament is dispensed after having been discharged from the vial91. The base95is provided with a sleeve100to be received in a recess101in the actuator96to guide the base95upon insertion into the actuator96.

The dispenser90may be actuated by a user displacing the base95upwardly with respect to the actuator96using finger supports102,103on the base95and actuator96respectively. Displacing the base95upwardly with respect to the actuator96forces the bung92upwardly into the vial91. As in the previous examples, as the vial91is sealed by the resilient projections98of the closure member97, there is an increase in pressure in the interior of the vial91as the bung92is displaced upwardly relative to the actuator96. The increased pressure causes the resilient projections98to deflect upwardly and create a pathway from the interior of the vial91to the outlet99.

The dispenser may be provided with a device for forming a spray for delivery of the medicament to the user.

After the dispenser90has been emptied of medicament, it is difficult to pull the base95and actuator96apart because the closure member97acts as a one-way valve preventing air from entering the vial91.

This dispenser does not require a piercing element to expel drug and so significantly reduces the risk of producing particulates and the risk of injury. The dispenser also has a very smooth operation due to the pre-compression not being produced by breaking snaps or the use of piercing elements and very low ullage.

FIGS. 10 to 13show examples of a number of valves embodying the invention. These valves provide an excellent seal to prevent fluid from the lower portion of the valve from passing through to the upper portion of the valve as illustrated, and yet require only a small pressure or force applied to the valve to enable fluid to be passed from the upper portion of the valve to the lower portion of the valve. The valves illustrated inFIGS. 10 to 13are check valves as may be used in the medical field for example for use in the insertion and removal of fluids into or out of animals or humans.

As shown inFIG. 10, the valve110comprises a hollow body111with an open end112at an upper end of the body111and an open end113at a lower end of the body111. A continuous bore114,115runs from open end112to open end113via aperture116. The upper portion of bore114is tapered with a Luer taper such that the inner diameter of bore114slightly decreases towards the aperture116.

A core117acting as a closure member is contained within the body111and comprises a generally cylindrical body member118, with a resilient sealing projection120in this example extending circumferentially outwardly from the core117, to engage a portion121of an inner surface of the bore. The core117is biased upwards in the example shown inFIG. 10by means of a spring122. The spring122biases the closure member120into sealing contact with a portion121of an inner surface of the bore.

When fluid is passed into the upper bore114, the increased pressure from this fluid deflects the resilient projection120downwardly and creates a pathway from the upper portion of the bore114to the lower portion of the bore115. The core117may also be pushed downwards against the biasing of spring122to accommodate a greater flow of fluid.

A cap123provided on the lower portion of the hollow body111is also displaced by the passage of fluid into the lower portion of the bore115to enable fluid to pass out of the valve.

FIGS. 11 to 13illustrate similar valves to that shown inFIG. 10except with the variations explained below.

InFIG. 11the core117and resilient projection120are made from foam overcoming the need for the spring122illustrated inFIG. 10.

InFIG. 12the core117, resilient projection120and cap123are provided as a single component reducing the overall number of components and thus reducing construction costs.

FIG. 13shows a further alternative arrangement of the valve110with the cap123provided as a separate component from the hollow body111.

The skilled person will appreciate that various modifications can be made to the invention described herein. For example, the plunger and closure member may be integrally formed to reduce the number of components required or may be provided as separate components. Furthermore, the channel11defined in the closure member of the example ofFIGS. 1 to 3may have only a single inlet or it may have more than two inlets.

Although the closure member is described with regard toFIGS. 1 to 3as a single component it will be appreciated that it may be formed from a plurality of components. For example, the upper portion6of the closure member may be a first component and the lower portion8may be a second component. At least a portion of the channel11may be defined between the resilient projections or components making up the closure member.

The at least one resilient projection may be provided around the circumference of the closure member's body, or, for example, in an internal channel to form a valve to seal the container. The valve could, for example, be provided in a channel in the lower portion8of the closure member shown inFIGS. 1 to 3.

Although many of the examples describe the closure member as having three resilient projections, any number of resilient projections will be suitable for performing the invention.

The resilience of the projections7,74,98,120may be chosen such that the medicament is subjected to a pre-compressive load before the projections7,74,98,120deflect sufficiently to allow the medicament to flow upwardly through the outlet channel. This is advantageous in that on deflection of the projections7,74,98,120the medicament is dispelled into the outlet channel with more energy leading to a quicker and more definite dispensation pattern. In addition, the added energy of the dispelled medicament allows for improved spray formation where the medicament is passed through a spray pattern block or similar.

The resilience of the projections7,74,98,120can be selected to any desired level to obtain release of medicament at any desired predetermined pressure. The resilience of the projections7,74,98,120may be varied by appropriate selection of materials from which the projections are made, the thickness of the projections and/or the profile of the projections for example.

The container and dispenser described above may be arranged to dispense a single dose or multi-doses as is well known to a person skilled in the art.

Although the above examples have been described in particular orientations, they can of course all be used in any desired orientation.