US20130175235A1

US20130175235A1 - Pharmaceutical product with closure assembly

Info

Publication number: US20130175235A1
Application number: US13/347,777
Authority: US
Inventors: Waleed M. Elsayyid; Roger H. Ramoth; Jean-Pol Warbecq; Craig T. Flanagan; Simon Freed; Margaret L. Benezra; David D. Chesley; Mark C. Perry; David D. Hsu; Steven C. Jepson; Donald A. Smith
Original assignee: Baxter Healthcare SA; Baxter International Inc
Current assignee: Baxter Healthcare SA; Baxter International Inc
Priority date: 2012-01-11
Filing date: 2012-01-11
Publication date: 2013-07-11
Also published as: WO2013106608A1

Abstract

A system includes a container and an adapter. The container may include a wall defining a receptacle and a neck, the neck forming an opening and a passage in fluid communication between the receptacle and the opening; a closure assembly having a portion disposed within the neck, and including an insert defining a valve seat, an actuator, a valve member attached to the actuator and sealingly engageable with the valve seat, and a biasing member disposed between the insert and the actuator. The biasing member urges the valve member into sealing engagement with the valve seat in an actuator advanced state, and the valve member disengages from the valve seat in an actuator retracted state, the actuator depending through the opening in the advanced state. The adapter may be removably attached to the container, and configured to move the actuator from advanced to retracted state upon attachment.

Description

BACKGROUND

The present disclosure relates generally to a pharmaceutical product and an anesthetic container, and, in particular, to a pharmaceutical product and an anesthetic container with a closure assembly to limit escape of anesthetic from the product or container.
Anesthetic vaporizers typically have an inlet port that is configured so that connections with the inlet port may be achieved using only those containers that have a similarly configured mating piece, conventionally referred to as an adapter, attached thereto or associated therewith. The adapter may have mating internal features, for example relative to the valve mechanism that regulates or controls the flow of anesthetic through the adapter between the container and the vaporizer. The adapter may also have mating external features. While it is possible to manufacture a container with a particular adapter attached at the factory, many times the container is shipped without a particular adapter attached in an “open bottle” container design. The “open bottle” design allows the user to attach that particular adapter that is configured to matingly connect with a uniquely designed fill port on the vaporizer to which the anesthetic is being added.
Current “open bottle” container designs feature a factory or manufacturer-affixed cap that is removed immediately prior to use, typically by unscrewing the cap from a threaded collar attached to or associated with the container. After the cap is removed, a specific adapter is attached to the collar, typically by forming a threaded engagement between an internal thread of the adapter and the external thread of the collar, to facilitate delivery of anesthetic from the container to a vaporizer. Once the anesthetic has been poured from the container into the vaporizer, the adapter is typically removed from the container so that the container may be disposed of and the adapter reused.
After the removal of the cap but before the fitting of the adapter to the bottle, a risk exists that the container may fall over or be tipped over, permitting a gross spillage of the liquid anesthetic to occur. It is also possible for the vapor to leak into the ambient environment from the open container, even without the container falling or being tipped. While spillage of large amounts of liquid anesthetic no longer may be an issue once the anesthetic has been poured from the container into the sump of the vaporizer, the container may still contain anesthetic vapors that could leak into the environment after the adapter is removed, but before the cap is replaced on the container. As a consequence, the “open bottle” container design is often perceived to be inferior to other containers having an adapter fitted on at the factory because of the opportunities for liquid anesthetic spillage and anesthetic vapor leakage.
As set forth in more detail below, the present disclosure sets forth an improved assembly embodying advantageous alternatives to the conventional devices and approaches discussed above.

SUMMARY

According to an aspect of the present disclosure, a system includes a container and an adapter. The container may include a wall defining a receptacle and a neck, the neck forming an opening and a passage in fluid communication between the receptacle and the opening. The container may also include a closure assembly having a portion disposed within the neck. The closure assembly includes an insert defining a valve seat, an actuator, a valve member attached to the actuator and sealingly engageable with the valve seat, and a biasing member disposed between the insert and the actuator. The biasing member urges the valve member into sealing engagement with the valve seat when the actuator is in an advanced state, and the valve member disengages from the valve seat with the actuator in a retracted state, the actuator depending through the opening in the advanced state. The adapter may be removably attached to the container, and configured to cooperate with a vaporizer inlet port and to cooperate with the actuator to move the actuator from the advanced state to the retracted state upon attachment of the adapter to the container.
Additional aspects of the disclosure are defined by the claims of this patent.

BRIEF DESCRIPTION OF THE FIGURES

It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. None of the drawings is necessarily to scale.

FIG. 1 is a partial cross-sectional view of a pharmaceutical product including a container with a closure assembly according to the present disclosure;

FIG. 2 is a partial cross-sectional view of a closure assembly according to a first variant;

FIG. 3 is a partial cross-sectional view of a closure assembly according to a second variant;

FIG. 4 is a partial cross-sectional view of the pharmaceutical product according to FIG. 1 in combination with a cap;

FIG. 5 is a partial cross-sectional view of the pharmaceutical product according to FIG. 1 in combination with an adapter; and

FIG. 6 is a particle cross-sectional view of a pharmaceutical product including an alternative container and closure assembly according to the present disclosure.

DETAILED DESCRIPTION

Although the following text sets forth a detailed description of different embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims defining the invention.
It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘______’ is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. §112, sixth paragraph.
FIG. 1 illustrates a pharmaceutical product including a container 100. According to certain embodiments, the container 100 may be filled for example with a halogenated inhalation anesthetic, such as sevoflurane (fluoromethyl 2,2,2-trifluoro-1-[trifluoromethyl]ethyl ether), desflurane (1,2,2,2-tetrafluoroethyl difluoromethyl ether), isoflurane (1-chloro-2,2,2-trifluoroethyl difluoroethyl ether), enflurane (2-chloro-1,1,2-trifluoroethyl-difluoromethyl ether), methoxyflurane (2,2-dichloro-1,1-difluoroethyl methyl ether) or halothane (2-bromo-2-chloro-1,1,1-trifluoroethane), to define the pharmaceutical product. In fact, according to particular embodiments, the container 100 may be filled with an anesthetic selected from the group consisting of sevoflurane, desflurane, isoflurane, enflurane, methoxyflurane and halothane. All of these halogenated anesthetics may be liquids under ambient conditions.
As illustrated, the container 100 may be in the form of a bottle, and may have a wall 102 defining a receptacle 104 in which the anesthetic is disposed. Furthermore, the wall 102 may define a neck 106 with a passage 108 in selective fluid communication with the receptacle 104. The passage 108 may have a smaller cross-section than the receptacle 104 in a plane perpendicular to the plane of the page as is illustrated, but this need not be the case according to all aspects of the present disclosure. The passage 108 may connect to an opening 110 formed by the neck 106. The wall 102 may define a flange 112 that depends radially outward from the opening 110.
According to an embodiment of the present disclosure, the wall 102 of the container 100 may be made of glass. According to other embodiments, the wall 102 of the container 100 may be made of metal, for example, aluminum or an aluminum alloy. According to still further embodiments, the wall 102 may be made of a polymer.
Further, according to certain embodiments, the wall 102 may include a layer of polymer or other material that defines all or part of an exterior surface 114 of the wall 102. Similarly, the wall 102 may include a layer of polymer or other material that defines all or part of an interior surface 116 of the wall 102. For example, the wall 102 may include a layer of inert material that defines, at least in part, the interior surface 116 of the wall 102 of the container 100. According to certain embodiments, the material is inert at least in the presence of the contents of the container 100. According to certain embodiments, the inert material may be a lacquer or an enamel, and according to particular embodiments an epoxyphenolic resin. Such a layer may limit impurities from entering the contents from the wall 102 of the container 100, the contents from wetting the wall 102 of the container 100, and/or surface reactions between the contents and the material of the wall 102 of the container, for example. According to other embodiments, the wall 102 may have an unlined interior surface 116 (e.g., an unlined aluminum interior surface) or a plated surface utilizing a metal such as nickel.
As illustrated in FIG. 1, the container 100 may also include a closure assembly 120. The closure assembly 120 may have a portion disposed within the neck 106. The closure assembly 120 may include an insert 122 defining a valve seat 124, an actuator 126 with an associated valve member 128, and a biasing member 130 disposed between the insert 122 and the actuator 126. The closure assembly 120 operates to limit the escape of anesthetic from the receptacle 104 through the passage 108 and out of the opening 110. In particular, the biasing member 130 (which may be a spring, for example) urges or biases the valve member 128 into sealing engagement with the valve seat 124 to occlude that portion of the passage 108 not already occluded by the closure assembly 120. Cooperation between the actuator 126 and an adapter configured to cooperate with a inlet port of an anesthetic vaporizer causes the valve member 128 to disengage from the valve seat 124 and permit anesthetic to flow through the passage 108 as explained in greater detail below.
Starting first at the insert 122, the insert 122 is disposed within the passage 108 of the neck 106 of the container 100. As illustrated in FIG. 1, the insert may only extend along a portion of the passage 108 formed in the neck 106 of the container 100. However, as illustrated in FIGS. 2 and 3, the insert 122′ or 122″ may extend along the entire length of the passage 108, between the receptacle 104 and the opening 110.
In particular, the insert 122 may be press-fit into the passage 108 such that the insert 122 and the interior surface 116 of the wall 102 of the container 100 form a sealed or sealing relationship therebetween. For example, a surface 132 of the insert 122 may face and abut the interior surface 116 of the wall 102 so as to form a seal therebetween. While the surfaces 116, 132 may be in direct contact over a substantial portion of their surface area, it is not necessary that the surfaces be in direct contact over their entire surface areas.
According to certain embodiments, the insert 122 may be made of low density polyethylene. The insert 122 thus formed may be plasma treated, for example, to enhance adhesion between the insert 122 and the container 100, in particular the wall 102 of the container 100. Additionally, the insert 122 so formed may comply with the rigid wall 102 of the container 100 in the neck 106, which may assist in centering and aligning the insert 122 in the neck 106, or more particularly, the passage 108.
Additionally, a material or structure may be disposed between the surfaces 116, 132. For example, an adhesive or sealant may be disposed between the surfaces 116, 132, as might an o-ring, which o-ring may be disposed at least in part within a groove formed in the wall 102 or the insert 122.
As illustrated, the insert 122 may occlude a portion of the passage 108. In fact, the insert 122 defines the valve seat 124 which may represent substantially that portion of the passage 108 that is not occluded by the insert 122. Because of the contact between the wall 102 and the insert 122, and in particular the surfaces 116, 132, the valve seat 124 may be the only portion of the passage 108 through which the anesthetic may flow when the closure assembly 120 is fitted into the passage 108.
The valve seat 124 may be defined at a proximal end of the insert 122, and, as illustrated, by a frustoconical surface that depends into the insert 122, such that the surface of the valve seat 124 appears as a pair of inclined surfaces in cross-section. However, the valve seat 124 is not limited to such a shape or configuration. For example, the surface may be curved in cross-section instead of angled or sloped. As a further alternative, the valve seat 124 may not depend into the insert at all, but may be defined on a external surface of the insert 122 rather than on a surface internal to the insert 122.
Cooperating with the insert 122 is a subassembly defined at least in part by the actuator 126 and the valve member 128. The actuator 126 cooperates with an adapter, for example, to cause the valve member 128 to disengage from the valve seat 124 to open at least one fluid flow path through the passage 108 (see FIG. 5). As illustrated, the actuator 126 (or at least a distal end of the actuator 126) depends through the opening 110, and thus is believed to be more compatible with existing adapters and adapter technology; however, it will be recognized that the adapter may also depend through the opening 110 and into the passage 108 to come into contact with an actuator that does not depend through the opening 110. The valve member 128 is attached to the actuator 126 and is configured, as illustrated, to move with the actuator 126 as the actuator 126 is moved along the passage 108 relative to the insert 122.
According to the embodiment illustrated in FIG. 1, the subassembly including the actuator 126 and the valve member 128 includes at least two annular or ring- like sections 140, 142 from which depends a central mounting hub 144 to which the valve member 128 is attached. The mounting hub 144 may depend from the annular sections 140, 142 in a first direction, which will be referred to as the proximal direction for ease of discussion into the insert 122. The hub 144 is substantially aligned or collinear with an axis 146 that runs along the center of the cross-sections of the annular sections 140, 142, although that is not a requirement according to all embodiments. In any event, the hub 144 is spaced from the stepped wall 148 that defines the sections 140, 142 (in particular, spaced from a surface of the portion of the wall 148 that defines section 142) to as to define one or more passages 150 therebetween through which anesthetic may flow when the valve member 128 is disengaged from the valve seat 124.
The mounting hub 144 may include one or more openings 152 to permit the flow of fluid through the hub 144. Moreover, the hub 144 may define a space in which is received a distal end 156 of the valve member 128. The valve member 128 may thus be attached to the remainder of the subassembly, and to a proximal end of the actuator 126 in particular.
As illustrated, a mechanical attachment mechanism may be provided according to certain embodiments, wherein a radially inwardly depending ring (whether continuous or discontinuous) 158 is received within a groove (again continuous or discontinuous) 160 to attach and secure the distal end 156 of the valve member 128 to the mounting hub 144. It will be recognized that the ring 158 and groove 160 may be reversed, such that a radially outwardly depending ring is formed on the distal end 156 of the valve member 128 and the groove 160 is formed in a wall 162 of the hub 144. Other attachment mechanisms may also be used.
As will be recognized with reference to FIG. 2, the mounting hub 144 as illustrated in FIG. 1 is only one such configuration. For example, the mounting hub 144′ illustrated in FIG. 2 may depend further distally into a space or region 164 defined by the sections 140′, 142′. Moreover, the hub 144′ lacks the openings 152 present in the embodiment illustrated in FIG. 1, but includes notches in the distalmost end 166 of the hub 144′. However, even in this embodiment, the mounting hub 144′ is spaced from the wall 148′ so as to define passages 150′ that permit fluid to flow through the passage 108′.
Returning to the embodiment of FIG. 1, a proximal end 170 of the valve member 128 defines a valve head 172 with a surface 174 that abuts or makes direct contact with the valve seat 124 when the valve member 128 is sealingly engaged with the valve seat 124 to control fluid flow through the closure assembly 120, and thus through the passage 108 of the container 100. The surface 174 may be configured, as illustrated in FIG. 1, in the form of a poppet valve. In fact, the valve seat 124 may be configured to have a sharp edge that cooperates with the surface 174 of the poppet valve head 172 to provide a more secure, fluid-tight (at least liquid-tight) seal between the valve seat 124 and the valve member 128.
It will also be recognized that the valve member 128 need not be limited to the configuration illustrated in FIGS. 1 and 2, wherein the valve member 128 is formed separately from the remainder of the subassembly formed with the actuator 126, and the valve head 172 is a single piece configured in the shape of a poppet valve. The valve member 128 may be formed as a single piece, for example with the mounting hub (or hub) 144. Further, the valve head 172 may be defined by more than one structure, and these separate structures may be made of different materials, such as a different polymers having different characteristics.
For example, FIG. 3 illustrates a further embodiment with a valve member 128″ that is formed as a single piece (i.e., integrally) with the hub 144″ and thus the actuator 126″. Moreover, the valve member 128″ includes a valve head 172″ that includes a groove 180 and a flexible sealing member 182 disposed within the groove 180. The flexible sealing member 182, which may be in form of an O-ring, may define the valve head surface 174″ that contacts the valve seat 124″ when the valve member 128″ sealingly engages the valve seat 124″. In the alternative, the flexible sealing member 182 may be in the form of a cap that is received over and around a portion of the valve head 172″, rather than being received within a structure, such as the groove 180, formed in the valve head 172″.
Returning to FIG. 1, it will be recognized that the subassembly including the actuator 126 and the valve member 128 is disposed through the insert 122. In particular, the section 142, hub 144 and distal end 156 of the valve member 128 are all received within a passage 190 formed within the insert 122. Cooperation of the valve seat 124 and the valve member 128 (in particular, the valve head 172) limits the motion of the subassembly in the distal direction along the axis 146. Moreover, cooperation of a shoulder 192 formed on an external surface 194 of the stepped wall 148 that defines sections 140, 142 with a shoulder 196 of the insert 122 may limit motion of the subassembly relative to the insert in the proximal direction along the axis 146.
As noted above, the biasing member 130 is disposed between the actuator 126 and the insert 122. In particular, the biasing member 130 (which may be in the form of a compression spring) may be disposed between a proximal end 200 of the section 142 of the subassembly including the actuator 126 and the valve member 128 (or, more generally, a distal end of the actuator 126) and an internal shoulder 202 formed on a radially inwardly directed rim 204 of the insert 122, with a distal end 206 of the biasing member 130 abutting the proximal end 200 and a proximal end 208 abutting the shoulder 202. The biasing member 130 causes the actuator 126 to be biased away from the insert 122. Because of the configuration of the actuator 126 and the valve member 128, the movement of the actuator 126 away from the insert 122 causes the valve member 128 to be biased into sealing engagement with the valve seat 124.
It will be recognized that the arrangement of the insert 122, actuator 126 and biasing member 130 is only one possible embodiment. For example, rather than including a biasing member 130 in the form of a compression spring, the biasing member 130 may be in the form of a tension spring. The biasing member 130 may still be attached at a first end to an insert that has a relatively fixed relationship to the container 100, while a second end is attached to the actuator 126 and by extension to the valve member 128 (or to the valve member 128, and thus by extension to the actuator 126). While rearrangement of the elements may be required to accommodate the use of a tension spring, the illustration of the compression spring should in no way exclude the use of a tension spring (or other biasing mechanism) in acting to bias the valve member 128 in to sealing engagement with the valve seat 124.
The biasing member 130 may be made of an inert material. In particular, the biasing member 130 may be inert in the presence of the contents of the container 100. For example, the biasing member 130 may be made of a nickel-based alloy, such as Inconel available from of Special Metals Corporation of New Hartford, N.Y. As one alternative, stainless steel may be used.
It will be noted relative to FIG. 1, that the container 100 also may include a collar 220 fitted about the neck 106 of the container 100. The collar 220 may be disposed between the flange 112 and a shoulder 222 of the container 100. The collar 220 may include a threaded region 224 that may cooperate with other structures, such as the cap and the adapter mentioned previously, and illustrated in FIGS. 4 and 5.
Turning first to FIG. 4, a cap 230 is illustrated in combination with the container 100. The cap 230 has an end wall 232 attached to a side wall 234, the end wall 232 and the side wall 234 formed as a single piece (i.e., integrally) as illustrated. The end wall 232 and the side wall 234 define a space 236 in which is received at least a part of the neck 106 of the container 100. The space 236 also accommodates the actuator 126 such that no surface of the actuator 126 is in contact with an inner surface of the cap 230, although in an alternative embodiment a plate (not shown) may be fixedly connected to the cap and extend within the space 236 to provide a seal between the cap and the flange 112 (FIG. 1). This plate may cooperate with the actuator 126 while the cap is attached to the container. A threaded region 238 of the side wall 234 of the cap 230 and the threaded region 224 of the collar 220 threadingly engage to attach the cap 230 to the container 100.
When the cap 230 is removed from the container 100 by unscrewing the cap 230 from the container 100 (e.g., as illustrated in FIG. 1), the closure assembly 120 limits the escape of anesthetic from the receptacle 104 of the container 100. According to certain embodiments, a fluid-tight (at least a liquid-tight) seal is formed between the valve member 128 and the valve seat 124 to prevent anesthetic from escaping from the container 100. The sealing engagement of the valve member 128 with the valve seat 124 will continue until the actuator is moved from the state illustrated in FIG. 1 to that illustrated, for example, in FIG. 5.
FIG. 5 illustrates the combination or system of the container 100 according to the present disclosure with an adapter 250, such as may be configured to cooperate with an inlet port of a anesthetic vaporizer at its distal end 252. The adapter 250 may include a wall 254 having an internal threaded region 256 that is threadingly engageable with the threaded region 224 of the collar 220 to removeably attach the adapter 250 to the container 100. At a distal end 258 of the threaded region 256 is a plate 260 which may cooperate with the inlet port of the vaporizer. The plate 260 also cooperates with the actuator 126 to cause the actuator 126 to move in the proximal direction from an advanced state illustrated in FIG. 1 to a retracted state illustrated in FIG. 5 upon attachment of the adapter 250 to the container 100, which in turn causes the movement of the associated valve member 128 and the disengagement of the valve member 128 from the valve seat 124. According to other embodiments, an internal shoulder of the adapter, for example, may cooperate with the actuator 126 instead of the plate 260.
As a consequence of the disengagement of the valve member 128 from the valve seat 124, fluid is permitted to flow through the passage 108. While the fluid is permitted to flow through the passage 108 because of the state of the closure assembly 120 illustrated in FIG. 5, the fluid may not be free to flow from the container 100 because the adapter 250 may include a separate valve assembly that limits or even prevents the flow of fluid from the container 100 until the adapter is disposed within the inlet port of the anesthetic vaporizer. However, because of the cooperation of the adapter 250 and the closure assembly 120, the fluid is free to flow from the container 100 into the adapter 250.
As will be noted by comparison between FIG. 1 and FIG. 5, the movement of the actuator 126 may not occur immediately with the engagement of the adapter 250 with the collar 220. The distance that the actuator 126 depends from the opening 110 is far less than the depth of the threaded region 256 of the adapter 250. Consequently, the threaded region 256 of the adapter 250 will engage the threaded region 224 of the collar 220 over a considerable distance before the actuator 126 cooperates with a feature of the adapter 250 (e.g., the plate 260) to cause the disengagement of the valve member 128 and the valve seat 124. It is believed that this may permit a sealing relationship to be formed between the threaded regions 224, 256 prior to the disengagement of the valve member 128 from the valve seat 124, which thereby permits anesthetic to flow from the container 100 and through the passage 108. This configuration places an additional limitation of the unintended escape of the anesthetic from the container 100.
FIG. 6 illustrates a further embodiment that illustrates additional features that may be combined with or used in substitution for those features described above without departing from the scope of the present application. Certain of these additional features will be described in detail below. The fact that a feature is illustrated in FIG. 6, but not described in detail below, should not be taken as a suggestion that the feature could not be combined with or substituted for those of the embodiments illustrated in FIGS. 1-5, however.
To begin, FIG. 6 illustrates the combination or system of a container 300 and a closure assembly 320. Both the container 300 and the closure assembly 320 include features not present in the embodiments illustrated in FIGS. 1-5. The features of the container 300 and/or the closure assembly 320 may be used in combination with or in substitution for the embodiments of FIGS. 1-5.
In regard to the container 300, the container 300 includes a wall 302 that defines a receptacle 304 in which the anesthetic is disposed. Similar to the container 100, the wall 302 may define a neck 306 with a passage 308 in selective fluid communication (via the closure assembly 320) with the receptacle 304. The passage may connected to an opening 310, and the wall 302 may have a flange 312 that depends radially outward from the opening 310, but with a rounded edge that may be deformed or bent around and about structures fitted to the neck 306 of the container 300.
The wall 302 has an exterior surface 314 and an interior surface 316. The wall 302 also includes a stop, step or shoulder 318 formed in the passage 308 of the container 300. As illustrated, the shoulder 318 is defined by a bend in the wall 302 of the container 300, such that the diameter of the passage 308 is greater above the shoulder 318 than below the shoulder 318 with the container 300 oriented as in FIG. 6. It will be recognized that the shoulder 318 may be defined instead by reducing the thickness of the wall 302 above the shoulder 318, such that the diameter of the passage 308 is greater above the shoulder 318 than below the shoulder 318.
In regard to the closure assembly 320, the closure assembly 320 includes an insert 322 with a valve seat 324, an actuator 326 with associated valve member 328, and a biasing member 330 disposed between the insert 322 (at a first end 332) and the actuator 326 (at a second end 334). In this regard, the closure assembly 320 is similar to the closure assemblies illustrated in FIGS. 1-5 and described above. In addition, the operation of the closure assembly 320 is similar to that described above relative to the opening and closing of the fluid flow path defined by the passage 308 between the receptacle 304 and the opening 310.
Unlike the embodiments of FIGS. 1-5, the insert 322 of FIG. 6 has an wall 340 with an exterior surface 342 and an interior surface 344. Of particular note, the insert 322 has a step, stop or shoulder 346 formed in the exterior surface 342 of the insert 322. As illustrated, the shoulder 346 is defined by a bend in the wall 340 of the insert, with a relatively constant thickness maintained between the exterior and interior surfaces 342, 344. However, the shoulder 346 could also be defined by a change in the thickness of the wall 340 instead.
The shoulders 318, 346 of the container 300 and the insert 322 define an interlocking feature that limits the advancement of the insert 322 into the receptacle 304 of the container 300. That is, the abutment of the shoulders 318, 346 may limit movement of the insert 322 relative to the container 300 along the passage 308 in the direction of the receptacle 304 along the passage 308. The interlocking feature thus may be of assistance in initially positioning the insert 322 within the neck 306 of the container 300. The interlocking feature may also act to limit the movement of the insert 322 in the direction of the receptacle 304 caused by the biasing force of the biasing member 330 applied to the insert 322 when the container 300 is combined with an adapter, as illustrated in FIG. 5.
In addition, it will be noted that the bend in the insert 322 causes the diameter of the space bounded by the interior surface 344 below the bend to more closely approximate an exterior diameter of the biasing member 330, at least at the end 332 of the biasing member 330 adjacent a shoulder 350 defined by a radially inwardly depending rim 352 of the insert 322. The reduced-diameter section or region of the interior surface 344 and the shoulder 350 define a well or sink 354 in which the end 332 of the biasing member 330 is disposed. The sink 354 may assist in centering and aligning the biasing member 330 within the insert 322, which may further assist in ensuring that the insert 322 and the valve seat 324 are aligned with the actuator 326 and associated valve member 328.
In fact, the actuator 326 also may include features that may assist in centering and aligning the actuator 326 relative to the biasing member 330, as well as features that may assist in centering the actuator 326 within the passage 308. For example, the actuator 326 may have a mounting hub 360 that connects the valve member 328 to the actuator 326. This hub 360 may define a general cylinder having an external diameter slightly smaller than the internal diameter of the biasing member 330 at its end 334, the end 334 of the biasing member 330 received about the mounting hub 360. Thus, the hub 360 (in particular its exterior surface 362) may assist in aligning the actuator 326 and the biasing member 330. In addition, the actuator 326 may have ribs or ridge on an exterior surface 370 of the actuator 326 that faces the interior surface 316 of the wall 302, which ribs may assist in aligning the actuator 326 within the neck 306 (in particular, in the passage 308) of the container 300.
The following enumerated paragraphs also describe exemplary embodiments according to the present disclosure:
1. A system comprising:
a container including:
a wall defining a receptacle and a neck, the neck forming an opening and a passage in fluid communication between the receptacle and the opening; and
a closure assembly having a portion disposed within the neck, the closure assembly comprising an insert defining a valve seat, an actuator, a valve member attached to the actuator and sealingly engageable with the valve seat, and a biasing member disposed between the insert and the actuator,
wherein the biasing member urges the valve member into sealing engagement with the valve seat when the actuator is in an advanced state, and the valve member disengages from the valve seat with the actuator in a retracted state, the actuator depending through the opening in the advanced state; and
an adapter removably attachable to the container, the adapter configured to cooperate with a vaporizer inlet port and to move the actuator from the advanced state to the retracted state upon attachment of the adapter to the container.
2. The system of enumerated paragraph 1, wherein:
the valve seat is defined at a proximal end of the insert,
the valve member is attached to a proximal end of the actuator;
a distal end of the actuator depends through the opening in the advanced state; and
the biasing member is disposed between the distal end of the actuator and the proximal end of the insert.
3. The system of enumerated paragraph 2, wherein the insert includes a radially inwardly directed rim, and the biasing member is disposed between the distal end of the actuator and the radially inwardly directed rim.
4. The system of enumerated paragraph 3, wherein the proximal end of the actuator depends into the insert, and a distal end of the valve member is attached to the proximal end of the actuator while a proximal end of the valve member sealingly engages the valve seat in the advanced state.
5. The system of any one of the preceding enumerated paragraphs, wherein the biasing member comprises a compression spring.
6. The system of any one of the preceding enumerated paragraphs, wherein the actuator has at least one annular wall and a central mounting hub to which the valve member is attached, the mounting hub spaced from an inner surface of the annular wall to define one or more passages therebetween.
7. The system of enumerated paragraph 6, wherein an end of the biasing member is received about the mounting hub to align the biasing member.
8. The system of any one of the preceding enumerated paragraphs, wherein the insert comprises a sink, and an end of the biasing member is disposed within the sink to align the biasing member.
9. The system of any one of the preceding enumerated paragraphs, wherein the valve member comprises a poppet valve head.
10. The system of any one of enumerated paragraphs 1 to 8, wherein the valve member comprises a valve head including a groove and a flexible sealing member received within the groove.
11. The system of any one of the preceding enumerated paragraphs, wherein the valve member is formed integrally with the actuator.
12. The system of any one of the preceding enumerated paragraphs, further comprising a halogenated inhalation anesthetic disposed within the receptacle, the halogenated inhalation anesthetic being selected from the group consisting of sevoflurane, desflurane, isoflurane, enflurane, methoxyflurane and halothane.
13. The system of any one of the preceding enumerated paragraphs, wherein the insert is press-fit into the neck passage.
14. The system of any one of the preceding enumerated paragraphs, wherein the container comprises a shoulder formed in the passage, and the insert comprises a shoulder formed in an exterior surface of the insert, the shoulders abutting to limit movement of the insert relative to the container along the passage.
15. The system of any one of the preceding enumerated paragraphs, wherein the container comprises a collar disposed about passage, the collar having a threaded region for threadingly engaging an adapter configured to cooperate with a vaporizer inlet port and to cooperate with the actuator to move the actuator between the advanced and retracted states.
It is believed that the pharmaceutical product and container according to the present disclosure may provide one or more advantages, one or more of which may be provided in a particular embodiment of the present disclosure. To begin, the container with closure assembly according to the present disclosure limits the possibility of spillage of the liquid-phase anesthetic if the container according to the present disclosure falls on the ground or tips over. Additionally, the closure assembly limits, if not eliminates, pollution from the anesthetic that may occur after unscrewing a factory affixed cap but before attaching an adapter to the container. This is achieved while allowing the user to then select a particular adapter for attaching to the container so that the anesthetic may be added to whatever vaporizer is in need of filling with that anesthetic. Frankly, the product and container according to the present disclosure also limits, or even prevents, spillage of the anesthetic and attendant pollution after unscrewing the adapter but before switching the bottle cap back again.
It should be understood other changes and modifications to the presently preferred embodiments described herein would also be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

What is claimed is:

1. A system comprising:

a container including:

a wall defining a receptacle and a neck, the neck forming an opening and a passage in fluid communication between the receptacle and the opening; and

a closure assembly having a portion disposed within the neck, the closure assembly comprising an insert defining a valve seat, an actuator, a valve member attached to the actuator and sealingly engageable with the valve seat, and a biasing member disposed between the insert and the actuator,

wherein the biasing member urges the valve member into sealing engagement with the valve seat when the actuator is in an advanced state, and the valve member disengages from the valve seat with the actuator in a retracted state, the actuator depending through the opening in the advanced state; and

an adapter removably attachable to the container, the adapter configured to cooperate with a vaporizer inlet port and to move the actuator from the advanced state to the retracted state upon attachment of the adapter to the container.

2. The system of claim 1, wherein:

the valve seat is defined at a proximal end of the insert,

the valve member is attached to a proximal end of the actuator;

a distal end of the actuator depends through the opening in the advanced state; and

the biasing member is disposed between the distal end of the actuator and the proximal end of the insert.

3. The system of claim 2, wherein the insert includes a radially inwardly directed rim, and the biasing member is disposed between the distal end of the actuator and the radially inwardly directed rim.

4. The system of claim 3, wherein the proximal end of the actuator depends into the insert, and a distal end of the valve member is attached to the proximal end of the actuator while a proximal end of the valve member sealingly engages the valve seat in the advanced state.

5. The system of claim 1, wherein the biasing member comprises a compression spring.

6. The system of claim 1, wherein the actuator has at least one annular wall and a central mounting hub to which the valve member is attached, the mounting hub spaced from an inner surface of the annular wall to define one or more passages therebetween.

7. The system of claim 6, wherein an end of the biasing member is received about the mounting hub to align the biasing member.

8. The system of claim 1, wherein the insert comprises a sink, and an end of the biasing member is disposed within the sink to align the biasing member.

9. The system of claim 1, wherein the valve member comprises a poppet valve head.

10. The system of claim 1, wherein the valve member comprises a valve head including a groove and a flexible sealing member received within the groove.

11. The system of claim 1, wherein the valve member is formed integrally with the actuator.

12. The system of claim 1, further comprising a halogenated inhalation anesthetic disposed within the receptacle, the halogenated inhalation anesthetic being selected from the group consisting of sevoflurane, desflurane, isoflurane, enflurane, methoxyflurane and halothane.

13. The system of claim 1, wherein the insert is press-fit into the neck passage.

14. The system of claim 1, wherein the container comprises a shoulder formed in the passage, and the insert comprises a shoulder formed in an exterior surface of the insert, the shoulders abutting to limit movement of the insert relative to the container along the passage.

15. The system of claim 1, wherein the container comprises a collar disposed about passage, the collar having a threaded region for threadingly engaging an adapter configured to cooperate with a vaporizer inlet port and to cooperate with the actuator to move the actuator between the advanced and retracted states.