JP2025503133A - Cap with double valve aseptic seal - Google Patents

Abstract

A sterile closure system for attachment to a container includes upper and lower sections removably attached to one another. Each section includes a valve housing with a rotary valve attached to a bore extending through the valve housing. The upper section has an inlet port and an outlet port, each with a conduit that provides fluid communication through the port to the interior of the upper valve housing. The lower section is adapted to be attached to a container. The lower valve housing includes two conduits that allow fluid communication through the lower valve housing to the interior of the lower section. Rotation of the rotary valve blocks flow through the conduits in each housing. (Selected Figure)

Description

The present invention is directed to a bottle cap or closure system that includes a mechanically acting seal that, when closed, provides a sterile seal through the use of a mechanical (plug) seal.

In some fluid systems, such as some bioprocessing or blood processing systems, it may be desirable, or even necessary, to have couplers that allow sterile fluid lines, containers, or equipment to be aseptically connected and disconnected while maintaining sterility. For example, it may be desirable to aseptically connect and disconnect one or more fluid media bags or containers to a fluid line. To do so, sterile couplings are typically used to connect outlets on the fluid line or fluid media container, substantially preventing biological contamination of the fluid media container and fluid line. Similarly, it may be desirable to couple a fluid path from one part of the processing device to another fluid path from a secondary part of the processing device container while maintaining a sterile path for fluid flow.

Many types of sterile couplings exist that include two coupling parts that can be attached and detached from one another. However, most such couplings are quite complicated or can result in excess fluid being present between the two disconnected coupling parts, which can then be inadvertently exposed to the surrounding environment. To minimize any such fluid, it is usually necessary to add a clamping device upstream of the sterile coupling to block flow through the sterile coupling before separation.

There is a need for improved sterile coupling systems.

RELATED APPLICATIONS This application is related to and claims priority to U.S. Provisional Patent Application No. 63/317,161, filed March 7, 2022, entitled "Cap with Rotary Dual Plug Aseptic Seals," and U.S. Provisional Patent Application No. 63/232,259, filed August 12, 2021, entitled "Cap with Dual Plug Aseptic Seals," the disclosures of which are incorporated herein by reference in their entireties.

A sterile closure system for attachment to a container is disclosed. In one embodiment, the closure system includes an upper section and a lower section, with at least one of either the upper section or the lower section comprising a fitting for removably attaching the upper section to the lower section. The upper section has an upper valve housing including at least one inlet port and at least one outlet port. The inlet and outlet ports each comprise a conduit that allows fluid communication with the interior of the upper valve housing through the port. Each port is configured for fluid communication with at least one component with which it is desired to maintain a sterile connection.

The lower section includes an upper deck with an attachment mechanism disposed on a lower portion of the upper deck for engaging a top of the vessel. A lower valve housing is formed on an upper surface of the upper deck and extends upwardly from the upper surface of the upper deck. The lower valve housing includes two conduits that provide fluid communication through the lower valve housing to the interior of the lower section.

The upper rotary valve is mounted to the upper valve housing and configured to rotate relative to the upper valve housing. The upper rotary valve includes a cylindrical upper valve shaft that is rotatable within an upper bore that extends through the upper valve housing. Two upper shaft conduits extend through the upper valve shaft and are positioned such that when the upper rotary valve is in an open state, the upper valve shaft conduits are aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit to enable fluid communication between the upper section and the lower valve housing.

The upper rotary valve has a closed state in which the upper valve shaft rotates relative to the upper valve housing such that the upper shaft conduits are not aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit, and fluid communication between the upper section and the lower valve housing is prevented by the upper valve shaft.

The lower rotary valve is mounted to the lower valve housing and configured to rotate relative to the lower valve housing. The lower rotary valve includes a cylindrical lower valve shaft rotatable within a lower bore extending through the lower valve housing and includes two lower shaft conduits extending through the lower rotary valve shaft. The two lower shaft conduits are arranged such that when the lower rotary valve is in an open state, the lower shaft conduits are aligned with the lower valve housing conduits, allowing fluid communication between the upper and lower sections when the upper rotary valve is in an open state.

The lower rotary valve has a closed state in which the lower valve shaft rotates relative to the lower valve housing such that the lower shaft conduit is not aligned with the lower valve housing conduit, and fluid communication between the upper and lower sections is prevented by the lower valve shaft.

In one embodiment, the mounting component is a mounting bracket on the upper valve housing that extends downward from the base of the upper valve housing. The mounting bracket includes four walls that fit snugly around the exterior surface of the lower valve housing to enclose a portion of the lower valve housing within the walls.

The mounting bracket may have two openings on either side of the bracket that are press-fitted onto the ends of the lower valve shaft, which extends out of either side of the bore in the lower valve housing, thereby removably securing the upper section to the lower section.

The upper valve housing may include extensions extending downwardly from the lower ends of the inlet and outlet port conduits. Each extension engages with the upper end of a corresponding open one of the lower valve housing conduits. Each extension and opening preferably have a tapered interface that provides a press-fit connection with each other to facilitate a sterile connection between the upper and lower valve housings.

The inlet port, outlet port, and upper valve housing are preferably formed as a single piece.

The inlet and outlet ports may be equipped with hose barbs for connecting to tubing.

In some embodiments, at least one component is selected from a fluid media bag, a secondary container, or a processing device.

The lower section may include a skirt portion, and the attachment mechanism preferably includes threads formed on an inner surface of the skirt portion, the threads configured to releasably engage mating threads on the container.

The upper valve shaft preferably includes a tab formed on one end that can be grasped by a user to rotate the upper rotary valve relative to the upper valve housing between open and closed positions. The lower valve shaft preferably includes a tab formed on one end that can be grasped by a user to rotate the lower rotary valve relative to the lower valve housing between open and closed positions.

The upper valve housing may include a first stop and a second stop for interacting with the tab. The first stop is positioned to limit rotation of the tab on the upper valve shaft such that the upper rotary valve is preferably closed when the tab contacts the first stop. The second stop is positioned such that the lower rotary valve is preferably open when the tab on the lower valve shaft contacts the lower stop. The first stop, second stop, and tab may be positioned such that the lower rotary valve is not rotated to the closed state until the upper rotary valve has first rotated to the closed state.

In one embodiment, the lower rotary valve is connected to the upper valve housing.

In one embodiment, a sterile closure system for attachment to a container is provided. The closure system includes an upper section and a lower section, and at least one of either the upper section or the lower section includes a mounting bracket for removably attaching the upper section to the lower section.

The upper section includes an upper valve housing including at least one inlet port and at least one outlet port, each port having a conduit that allows fluid communication with the interior of the upper valve housing through the port. Each port is configured to be in fluid communication with at least one component with which it is desired to maintain a sterile connection.

The lower section includes an upper deck with an attachment mechanism disposed on a lower portion of the upper deck for engaging a top of the vessel. A lower valve housing is formed on an upper surface of the upper deck and extends upwardly from the upper surface of the upper deck. The lower valve housing includes two conduits that provide fluid communication through the lower valve housing to the interior of the lower section.

The upper rotary valve is mounted to the upper valve housing and configured to rotate relative to the upper valve housing. The upper rotary valve includes a cylindrical upper valve shaft that is rotatable within an upper bore that extends through the upper valve housing. Two upper shaft conduits extend through the upper valve shaft and are positioned such that when the upper rotary valve is in an open state, the upper valve shaft conduits are aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit to enable fluid communication between the upper section and the lower valve housing.

The upper rotary valve has a closed state in which the upper valve shaft rotates relative to the upper valve housing such that the upper shaft conduits are not aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit, and fluid communication between the upper section and the lower valve housing is prevented by the upper valve shaft.

The lower rotary valve is mounted to the lower valve housing and configured to rotate relative to the lower valve housing. The lower rotary valve includes a cylindrical lower valve shaft that is rotatable within a lower bore that extends through the lower valve housing. Two lower shaft conduits extend through the lower rotary valve shaft and are arranged such that when the lower rotary valve is in an open state, the lower shaft conduits are aligned with the lower valve housing conduits, allowing fluid communication between the upper and lower sections when the upper rotary valve is in an open state.

The lower rotary valve has a closed state in which the lower valve shaft rotates relative to the lower valve housing such that the lower shaft conduit is not aligned with the lower valve housing conduit, and fluid communication between the upper and lower sections is prevented by the lower valve shaft.

The mounting bracket removably connects the upper valve housing to the lower valve housing. The mounting bracket extends downward from the bottom of the upper valve housing or upward from the top of the lower valve housing.

The upper valve shaft has a tab formed on one end that can be grasped by a user to rotate the upper rotary valve relative to the upper valve housing between open and closed positions. The lower valve shaft has a tab formed on one end that can be grasped by a user to rotate the lower rotary valve relative to the lower valve housing between open and closed positions.

Preferably, the mounting bracket includes four walls that fit snugly against the exterior surface of the lower valve housing to enclose a portion of the lower valve housing within the walls. The mounting bracket includes two openings on either side of the bracket that are press-fitted onto the ends of the lower valve shaft that extend out of either side of the bore of the lower valve housing, thereby removably securing the upper section to the lower section.

The above and other features and advantages of the present invention will become apparent from the following detailed description of the preferred embodiment, as illustrated in the accompanying drawings. As will be understood, the present invention is capable of modifications in various respects, all without departing from the invention. The drawings and description are therefore to be regarded as illustrative in nature, and not as restrictive.

For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It is understood, however, that the invention is not limited to the precise arrangements and configurations specifically shown.

FIG. 2 is an isometric view of a cap with a dual valve sterile seal in an open state, in accordance with an embodiment of the present invention. FIG. 2 is a front view of the cap of FIG. 1 . FIG. 2 is a top view of the cap of FIG. 1 . FIG. 2 is a rear view of the cap of FIG. 1 . FIG. 2 is a side view of the cap of FIG. 1 . FIG. 2 is a bottom view of the cap of FIG. 1 . FIG. 1F is a cross-sectional view of the cap of FIG. 1 taken along line 1F-1F of FIG. B. 1G is a cross-sectional view of the cap of FIG. 1 taken along line 1G-1G of FIG. 1D. FIG. 2 is an isometric view of the cap embodiment of FIG. 1 in a closed state. FIG. 3 is a front view of the cap of FIG. 2 . FIG. 3 is a top view of the cap of FIG. 2 . FIG. 3 is a rear view of the cap of FIG. 2 . FIG. 3 is a side view of the cap of FIG. 2 . FIG. 3 is a bottom view of the cap of FIG. 2 . 2F is a cross-sectional view of the cap of FIG. 2 taken along line 2F-2F of FIG. 2D. FIG. 3 is a side view of the cap of FIG. 2 with the upper section separated from the lower section. FIG. 3B is a top view of the separate cap section of FIG. 3A. FIG. 3B is a rear view of the separate cap section of FIG. 3A. FIG. 3B is a front view of the separate cap section of FIG. 3A. 3E is a cross-sectional view of the separate cap section of FIG. 3A taken along line 3E-3E of FIG. 3D. FIG. 13 is an exploded view of another embodiment of a cap with a double sterile seal including a plug seal. 5 is a cross-sectional view of the cap of FIG. 4 in an open state with the container and cap generally positioned; 5 is a cross-sectional view of the cap of FIG. 4 in a closed state with the container and cap generally positioned. 1 shows the lower plug seal separated from the remainder of the body portion. 1 shows the upper plug seal separated from the remainder of the body portion. 13 shows an assembled view of a stopper or cap assembly having a sterile cutting arrangement according to another embodiment. FIG. 9 is an exploded view of the cap assembly of FIG. 8 . FIG. 9 is a cross-sectional view of the assembled view of FIG. 8 . FIG. 13 is a perspective view of a sterile cap assembly according to another embodiment. FIG. 10 is a cross-sectional view of the assembled view of FIG. FIG. 10 is an exploded view of the cap assembly of FIG. FIG. 9C is a cross-sectional view of the exploded view of FIG. 9B. 10 is a cross-sectional view of the cap assembly of FIG. 9 with the top and bottom rotated into a sealed position. FIG. 10 is a cross-sectional view of a modified version of the embodiment shown in FIG. 10A-E show various twisted positions of the cap assembly of FIG. 9 between the open and closed positions.

The present invention is directed to a cap or closure system for use on a bottle or other container requiring a sterile connection, the closure system including a mechanically acting seal that, when closed, provides a sterile seal, such as a rotating seal, a sliding seal, or a plug seal, through the use of moving parts.

With reference to Figures 1 and 1A-1G, an embodiment of a cap closure system with a sterile seal is shown. The closure system 100 includes an upper section 102 and a lower section 104. As described in more detail below, the upper section 102 is removably attached to the lower section 104, as described in more detail below.

The upper section 102 includes an upper valve housing 106, at least one inlet port 108, and at least one outlet port 110. The inlet port 108 and the outlet port 110 each include a conduit 108A, 110A that allows fluid communication with the interior of the upper valve housing 106 through the port. The inlet port 108, the outlet port 110, and the upper valve housing 106 are preferably formed as a unitary component, but they may be separate components attached to each other. In the illustrated embodiment, the inlet port 108 and the outlet port 110 are shown as hose barbs. However, it is contemplated that other connectors commonly used in bioprocessing (e.g., luer fittings, tri-clamps, etc.) can be integrated into the upper section 102. Each port 108, 110 is configured to connect, attach to, or be in fluid communication with at least one component for which it is desired to maintain sterility and/or reduce or minimize contamination from external or environmental sources. The component may be a bag or container of a fluid medium, such as a biofluid, chemical fluid, or medical fluid container, or a processing device, such as a bioreactor or a biofluid pump, or a tube that connects to any of the foregoing. For example, a tube may be connected at one end to one of the barb fittings and at the other end to the processing device.

The lower section 104 includes a skirt 112 and an attachment mechanism for engaging the top of the container. Preferably, the lower section includes a female thread 114 as an attachment mechanism that removably engages with a mating thread on the applicable container. However, it is contemplated that the lower section may be press-fit onto the neck of the container. The lower section 104 includes a lower valve housing 116 formed on and extending upwardly from an upper deck 118 above the lower section 104. The lower valve housing 116 connects to the upper valve housing 106, as described in more detail below. The lower valve housing 116 includes two conduits 120A, 120B that allow fluid communication through the lower valve housing 116 to the interior of the lower section 104.

The upper section 102 includes an upper rotary valve 130 that is mounted to the upper valve housing 106 and configured to rotate relative to the upper valve housing 106. The upper rotary valve 130 preferably includes a cylindrical valve shaft 131 that is rotatable within an upper bore 106A that extends through the upper valve housing 106. The upper valve shaft 131 preferably fits snugly into the bore 106A to provide a rotational seal. The upper rotary valve 130 includes two conduits 130A, 130B (FIG. 1F) that extend through the upper valve shaft 131 and are arranged such that when the upper rotary valve 130 is in an open state, the conduits 130A and 130B are aligned with the inlet and outlet port conduits 108A, 110A and the conduits 120A, 120B of the lower valve housing 116, thereby allowing fluid communication between the upper section 102 and the lower valve housing 116. The upper rotary valve 130 has a closed state in which the upper valve shaft 131 is rotated relative to the upper valve housing 106 such that the conduits 130A and 130B are not aligned with the inlet and outlet port conduits 108A, 110A and the conduits 120A, 120B of the lower valve housing 116. In the closed state, fluid communication between the upper section 102 and the lower valve housing 116A is prevented by the upper valve shaft 131. The closed state is shown in Figures 2, 2A-2F. A tab 132 is formed on one end of the upper valve shaft 131 that can be grasped by a user to rotate the upper rotary valve 130 relative to the upper valve housing 106 between the open and closed states.

The lower valve housing 116 includes a lower rotary valve 134 that is attached to the lower valve housing 116 and preferably connected to the upper valve housing as described in more detail below. The lower rotary valve is configured to rotate relative to the lower valve housing 106. The lower rotary valve 134 preferably includes a cylindrical valve shaft 135 that is rotatable within a lower bore 116A that extends through the lower valve housing 116. The lower valve shaft 135 preferably fits snugly into the bore 116A to provide a rotational seal. The lower rotary valve 134 includes two conduits 134A, 134B (FIGS. 1E and 3E) that extend through a rotary valve shaft 135 and are arranged such that when the lower rotary valve is in an open state, the conduits 134A and 134B are aligned with the conduits 120A, 120B of the lower valve housing 116, and when the upper rotary valve 103 is in an open state, the conduits 103A, 130B of the upper rotary valve 130 allow fluid communication between the upper section 102 and the lower section 104. The lower valve 134 has a closed state in which the lower valve shaft 135 rotates relative to the lower valve housing 116 such that the conduits 134A and 134B are not aligned with the conduits 120A, 120B of the lower valve housing 116. In the closed state, fluid communication between the upper section 102 and the lower section 104 is prevented by the lower valve shaft 135. The closed state of the lower rotary valve 134 is shown in Figures 2, 2A-2F. A tab 136 is formed on one end of the lower valve shaft 135 that can be grasped by a user to rotate the lower rotary valve 134 relative to the lower valve housing 116 between the open and closed states.

The upper valve housing 106 preferably includes a first stop 140 and a second stop 142. The stops 140, 142 are configured to interact with the tabs 132, 136. More specifically, the first stop 140 is positioned to limit the rotation of the tab 132 on the upper rotary valve 130. When the upper tab 132 contacts the first stop 140, the tab is preferably in a horizontal position and the upper rotary valve 130 is in a closed state. Similarly, the second stop 136 is positioned such that the lower tab 136 contacts the lower stop 142 when the lower rotary valve 134 is in an open state (the lower tab 136 is oriented vertically). Furthermore, the stops 140, 142 and tabs are positioned such that the lower rotary valve 134 cannot rotate to a closed state until the upper rotary valve 130 has first rotated to a closed state. This is designed to maintain a sterile environment for the contents of the container and anything connected to the port.

3A-3F, the plugging system 100 is shown with the upper section 102 separated from the lower section 104. More specifically, the upper valve housing 106 is shown separated from the lower valve housing 126, as described above. In the illustrated embodiment, the upper valve housing 106 includes a mounting bracket 150 that extends downwardly from a base 152 of the upper valve housing 106. The mounting bracket 150 preferably has four walls that fit snugly around the exterior surface of the lower valve housing 116 to enclose the lower valve housing within the walls. The mounting bracket 150 includes two openings 154 on either side of the bracket 150 that are press-fitted onto the ends of the lower valve shafts 135 that extend out of either side of the bore 116A of the lower valve housing 116, thereby removably securing the upper section 102 to the lower section 104. In the illustrated embodiment, the mounting bracket 150 is an integral extension of the upper valve housing 106.

The upper valve housing 106 preferably includes an extension 156 extending downwardly from the base 154 around the lower end of each of the conduits 108A, 110A. Each extension 156 engages an upper end of an opening 158 in a corresponding one of the conduits 120A, 120B in the lower valve housing 116. Each extension 156 and opening 158 preferably have a tapered interface that provides a press-fit connection with each other to facilitate a sterile connection between the upper valve housing 106 and the lower valve housing 116.

As shown, when the upper valve 130 and the lower valve 134 are in a closed state, the upper section 106 and the lower section 116 can be separated from each other while maintaining each section in a sterile sealed state. It will be apparent that the attachment of the upper section 106 to the lower section 116 can be reversed or other attachments can be included.

The present invention allows for aseptic sealing and separation of the supply container after use, thereby allowing the supply container to be stored, for example in a freezer, for later use.

4-7, a second embodiment of a cap closure system having a double sterile seal is shown. The closure system 210 includes an upper cap 212 and a lower cap 214. The upper cap 212 is configured to fit into and translate vertically relative to the lower cap 214, as described in more detail below.

The top cap 212 includes a top portion 216 and a body portion 218 attached to or integrally formed with the top portion and extending downwardly therefrom. The top portion 216 and body portion 218 in combination define an interior. The top portion 216 includes at least one inlet 220 and at least one outlet 222, each of which communicates with the interior. The inlet 220, outlet 222, and top portion are preferably incorporated into a replaceable cover cap 224, which is threaded or otherwise removably attached to the body portion 218. In the illustrated embodiment, the inlet 220 and outlet 222 are shown as hose barbs. However, it is contemplated that other connectors commonly used in bioprocessing (e.g., luer fittings, tri-clamps, etc.) can be integrated into the cap 224. The use of a removable cap 224 allows for the use of a wide range of connections with the same core components of the plugging system. The bottom of the body portion 218 includes two extensions 226 that extend downward to a first or lower plug seal 228.

The lower plug seal 228 is shown in more detail in FIG. 7, separated from the remainder of the body portion 218. The lower plug seal 228 includes a tapered seat 228S that preferably includes a groove 228G in which a rubber or elastomeric O-ring (not shown) seats.

The bottom cap 214 has an annular rim 230 configured to seat on the neck of the container during use. A sidewall 232 extends downwardly from the rim 230 and includes a generally cylindrical upper sidewall 232U and a tapered lower sidewall 232L. A bottom 234 of the lower sidewall 232L is open. The inner diameter of the upper sidewall 232U is sized to snugly but slidably receive the body portion 218 so that the body portion 218 can slide along the inner surface of the upper sidewall 232U. The taper of the lower sidewall 232L is configured such that its inner diameter and bottom 234 are slightly smaller than the diameter of the seat 228S of the first plug seal 228. Thus, when the top cap 212 is fully translated downwardly into the bottom cap 214, the seat 228S and O-ring of the first plug seal 228 seal the open bottom 234.

The second or upper plug seal 240 is attached to or seated within the lower cap 214 so that the second plug seal 240 is generally stationary as the upper cap 212 transitions between an open state (when the upper cap 212 is displaced upward relative to the lower cap 214) and a closed state (when the upper cap 212 is displaced downward relative to the lower cap 214). The second plug seal 240 is shown in more detail in FIG. 7. The second plug seal 240 preferably includes a plug head 240H that includes a groove 240G into which a rubber or elastomeric O-ring (not shown) is inserted. To secure or attach the second plug seal 240 to the lower cap 214, a support 242 is attached to and extends downwardly from the bottom of the plug head 240H. At least two legs 244 are angled radially outward and downward from the support 242 and have feet 246 positioned to contact the inner wall 232 that hold the second plug seal 240 in place within the bottom cap 214.

The interior of the body portion 218 of the top cap 212 includes a cavity 250 in which the second plug seal 240 is located when assembled. The cavity 250 includes a top hole 252 having a diameter slightly larger than that of the plug head 240H, such that when the plug head 240H is located inside the top hole 252, the plug head 240H seals the top hole to prevent or impede the passage of air or liquid. The cavity has a main chamber 254 having a diameter larger than that of the plug head 240H, such that when the plug head 240H is located inside the main chamber 254, the plug head 240H does not seal the top hole 252, thus allowing air and/or liquid to flow through the top hole 252, past the second plug seal 240, and through the open bottom 234.

The plugging system is designed to allow the container contents to remain isolated from the external (ambient) environment while allowing air and fluid exchange through the threaded cap connection, which is secured to tubing that connects to other components within the end user's bioprocessing system.

In use, the plugging system is in an open position when the top cap 212 is displaced vertically upward from the bottom cap 214. In this state, the second plug seal 240 is disposed in the main chamber 254 of the body portion 218, and the first plug seal is spaced upward from the open bottom 234. Thus, in this state, the plugging allows fluid and air to flow simultaneously through a shared passage in the top cap 212 and the bottom cap 214. This allows for simultaneous filling and evacuating of liquid, and avoids pressurizing the container. That is, when fluid is injected through the inlet 220, the fluid displaces air contained within the container, forcing the air to flow upward through the bottom cap 214 and the top cap 212 and out through the outlet 222.

To close the closure, the user presses the top cap 212 downward, causing it to slide downward into the bottom cap 214. The downward movement of the top cap 212 causes the first plug seal to move downward to close the open bottom 234. Because the second plug seal 240 is stationary, as the top cap 212 moves downward, the body portion 218 moves downward relative to the bottom cap 214 and the second plug seal 240, thereby moving the top hole 252 of the cavity 250 downward until it surrounds and seals against the plug head 240H of the second plug seal 240, thereby closing the top hole 252. The closed state of the closure system isolates the product in the bottle from fluid and air passages, the surrounding environment, and tubing connections.

Lateral Linear Action Sterile Cut Cap Referring now to Figures 8 and 8A, a second embodiment of a cap closure system 300 having a dual plug sterile seal is shown. Figure 8 shows an assembled view of a closure or cap assembly 300 having a sterile cut configuration. Figure 8A is an exploded view of the cap assembly of Figure 8. In this embodiment, the sterile seal is provided by a laterally translatable linear mechanical action sealing assembly 302. The cap 304 includes an outer annular cap ring or skirt 306 with threads 308 or other conventional mechanism on a surface (preferably the inner surface) of the ring for connection to the neck of a bottle (not shown).

The cap 304 includes an upper portion 310 and a lower portion 312 secured together by a spring clip 314. The upper portion 310 includes a top surface and has two ports 316 extending upwardly from the top surface, similar to the ports described above. The two ports 316 provide a flow path into the bottle. In a typical application in the bioprocessing industry, a tube is connected to one of the ports 316, and the other port 316 is used to evacuate air or other gases from the bottle. The entire assembly 300 is made of conventional materials that allow for sterilization by irradiation. In this embodiment of the sterile cap assembly, the user can separate the upper portion 310 of the cap 304 from the lower portion 312 by sliding a sliding seal, described below, to aseptically separate the tube and vent filter from the bottle while maintaining the closure and integrity of the container.

As shown in Figures 8A and 8B, the top 310 includes a slot 320 on each side. The top sliding seal 322 extends through the slot 320. The top sliding seal 322 and the slot 320 are configured such that the top sliding seal 322 slides laterally within the slot 320. The top sliding seal 322 includes a flat portion 322A in the center of the top sliding seal, and two holes 323 (shown in Figure 8B) are formed through the flat portion, which align with the port 316 and the hole 310A formed on the bottom wall 310CA of the top 310, which aligns with the port 316. The hole 310A on the top 310 is similar to the hole on the bottom, which will be described later. When the top sliding seal 322 is in the open position, the hole 323 of the top sliding seal 322 aligns with the port 316 and the hole 310A of the top, thereby allowing flow between the port 316 and the underside of the top. When the upper sliding seal 322 is slid to the closed position, the flat portion 322A of the upper sliding seal 322 blocks the port 316 and the upper hole 310A to prevent flow between the port 316 and the underside of the upper portion 310.

The lower portion 312 also includes slots 324 on both sides and a lower slide seal 326 extending through the slots 324. The lower slide seal 326 and the slots 324 are configured so that the lower slide seal 326 slides laterally within the slots 324. The lower slide seal includes a planar portion 326A having two holes 330 formed therethrough. The holes 330 are positioned to align with holes 312A formed in the top wall 312C of the lower portion 312 and aligned holes 312D in the bottom wall 312E. An elastomeric seal ring 336 is preferably inserted into an annular recess around the central hole 330 to provide a seal. Although the illustrated embodiment shows multiple holes 312A, 312B formed in the top wall 334, only the central hole 312A is required. The additional side holes 312B are provided to relieve compressive forces acting on the elastomeric seal ring 336 when the slide is in the closed position. Instead of through-hole 312B, a recess can be used to provide a buffer section.

As shown in FIG. 8B, the lower portion 312 preferably has a flange that engages with a rim on the cap ring 306, thereby securing the sealing assembly 302 to the cap ring 306.

The flow through the port can be controlled by moving the upper and lower sliding seals laterally. Once the port 316 is sealed, the operator can then remove the spring clamp 314 and separate the upper portion 310 from the lower portion 312 while maintaining a sterile seal.

Rotational Action Sterile Cutting Cap Referring to Figures 9, 9A, 9B, and 9C, another sterile cap assembly 400 is shown. In this embodiment, a cap 402 includes an upper rotating portion 404 and a lower rotating portion 406 designed to seal a port 408 from a bottle. Figure 8 is an assembled view of the cap assembly 400. Figure 9A is a cross-section of the assembled view of Figure 9. Figure 9B is an exploded view of the cap assembly 400. Figure 9C is a cross-section of the exploded view of Figure 9B. Figure 9D is a cross-section of the cap assembly 400 of Figure 9 with the top and bottom portions rotated into a sealed position.

As with the previous embodiment, the cap assembly 400 of this embodiment allows for aseptic disconnection of the connecting tube from the bottle while maintaining the sterility and integrity of the bottle's contents.

For simplicity, the components for attaching the cap assembly 400 to a bottle are not shown. As with the cap assembly 300 of FIG. 8, the lower portion 406 is attached to a cap ring (not shown), which is threadedly or conventionally connected to the neck of the bottle.

The top 404 includes an inner fixed portion 404A including two ports 408, and an outer rotatable portion 404B. A first set of channels 410 extend through the ports 408 to the underside of the inner fixed portion 404A. The outer rotatable portion 404B includes a second set of channels 412 that align with the first set of channels 410 when the top 404 is in the open position to allow flow between the first set of channels 410 and the second set of channels 412. An O-ring seal 414 is preferably disposed between the inner fixed portion 404A and the outer rotatable portion 404B.

To place the top 404 in the sealed position, the outer rotatable portion 404B is rotated 90 degrees relative to the inner fixed portion 404A. This rotates the second set of channels 412 out of alignment with the first set of channels 410. This prevents flow between the first set of channels 410 and the second set of channels 412.

The lower portion 406 is similar to the upper portion 404. Specifically, the lower portion 406 includes an inner fixed portion 406A and an outer rotatable portion 406B. A third set of channels 416 extends through the inner fixed portion 406A from the upper surface to the lower surface that is exposed to the interior of the bottle during use. The outer rotatable portion 406B includes a fourth set of channels 418 that aligns with the third set of channels 416 when the lower portion 406 is in the open position to allow flow between the third set of channels 416 and the fourth set of channels 418. An O-ring seal 420 is preferably disposed between the inner fixed portion 406A and the outer rotatable portion 406B of the lower portion.

To place the lower portion 406 in the sealed position, the outer rotatable portion 406B is rotated 90 degrees relative to the inner fixed portion 406A. This rotates the fourth set of channels 418 out of alignment with the third set of channels 416. This prevents flow between the third set of channels 416 and the fourth set of channels 418.

The O-ring seal 422 is preferably disposed between the underside of the upper outer rotatable portion 404B and the upper side of the lower outer rotatable portion 406B.

Fluid-resistant lightweight gaskets 424 are preferably disposed between the inner fixed and outer rotatable portions of the upper and lower portions 404 and 406. In one embodiment, the gaskets are a 1/32 inch thick paper fiber/Buna-N (nitrile) rubber blend, although other gaskets may be used.

Although not shown, it is contemplated that an external clamp may be included to connect the upper portion 404 to the lower portion 406 such that the outer rotatable portions of the upper portion 404 and lower portion 406 can rotate together.

Referring to FIG. 10, a cross-sectional view of a modified version of the embodiment shown in FIG. 9 is shown. In this configuration, additional O-ring seals 501, 502, 503, and 504 are incorporated between the various components and the gasket 424 is removed. Specifically, as shown, the inner stationary portion 404A of the upper portion 404 is preferably disk-shaped having an outer diameter and is disposed within a concave seat of the outer rotatable portion 404B. The O-ring seal 501 is preferably disposed between the outer diameter of the inner stationary portion 404A and the inner diameter of the seat of the outer rotatable portion 404B. Similarly, the inner stationary portion 406A of the lower portion 406 is preferably disk-shaped having an outer diameter and is disposed within a concave seat of the outer rotatable portion 406B. The O-ring seal 501 is preferably disposed between the outer diameter of the inner stationary portion 406A and the inner diameter of the seat of the outer rotatable portion 406B.

Another O-ring seal 502 is preferably disposed between the underside of the inner fixed portion 404A of the upper portion 404 and the upper surface of the seat of the outer rotatable portion 404B of the upper portion 404. Similarly, another O-ring seal 502 is preferably disposed between the upper surface of the inner fixed portion 406A of the lower portion 406 and the underside of the seat of the outer rotatable portion 406B of the lower portion.

A small O-ring seal 503 is disposed at the interface between each of the first set of channels 410 and the second set of channels 412, between the underside of the inner fixed portion 404A of the upper portion 404 and the upper surface of the base of the outer rotatable portion 404B of the upper portion 404.

Additional O-ring seals 503 are disposed at the interface between the second set of channels 412 and the fourth set of channels 418, between the underside of the outer rotatable portion 404B of the upper portion 404 and the upper side of the outer rotatable portion 406B of the lower portion 406.

Further O-ring seals 503 are disposed at the interfaces between the fourth set of channels 418 and the third set of channels 416, between the upper surface of the inner fixed portion 406A of the lower portion 406 and the lower surface of the base of the outer rotatable portion 406B of the lower portion 406.

The intermediate O-ring seal 504 is disposed between the underside of the outer rotatable portion 404B of the upper portion 404 and the upper side of the outer rotatable portion 406B of the lower portion 406.

Each of the upper and lower portions 404, 406 preferably has diametrically opposed tabs 506A, 506B extending radially outward from their respective outer rotatable portions 404B, 406B. A removable cap 505 slides over the tabs 506A, 506B, thereby temporarily securing the upper portion 404 to the lower portion 406 so that they can rotate together.

In use, when the cap assembly 400 is positioned as shown in FIGS. 10 and 11A, the channels are positioned to allow fluid flow and air evacuation. An outer O-ring seal between the inner fixed portion and the outer rotatable portion provides an interference fit seal between these components. O-ring seals 503 between the channels and O-ring seals 504 between the upper portion 404 and the lower portion 406 provide a fluid tight seal while allowing relative rotation of the fixed and rotatable component parts.

With the tabs 506A, 506B locked together with the cap 505, the outer rotatable portion 404B, 406B rotates clockwise relative to the fixed inner portion 404A, 406A. This causes the O-rings to provide a fluid tight seal and blocks fluid flow along the channel. The end cap 505 can then unlock and remove the upper portion 404 and lower portion 406. This allows the upper portion 404 to be aseptically separated from the lower portion 406 with a sterile barrier present between the seat of the outer rotatable portion 404B, 406B and the fixed inner portion 404A, 406A.

The present invention allows for aseptic sealing and separation of the supply container after use, thereby allowing the supply container to be stored, such as in a freezer, for later use.

For the purpose of promoting an understanding of the principles of the invention, reference will be made to preferred embodiments illustrated in the drawings, and specific language will be used to describe these embodiments. However, no limitation of the scope of the invention is intended by this specific language, and the invention should be construed to encompass all embodiments that would normally occur to one skilled in the art.

The specific embodiments shown and described herein are illustrative examples of the invention and are not intended to otherwise limit the scope of the invention in any way. Any and all examples provided herein, or the use of exemplary language (e.g., "etc."), are intended merely to better clarify the invention and do not impose limitations on the scope of the invention unless otherwise asserted. Many modifications and adaptations will be apparent to those of ordinary skill in the art without departing from the spirit and scope of the invention.

The use of the terms "a," "an," "the," and similar demonstratives in the context of describing the present invention (particularly in the context of the claims below) should be construed to include both the singular and the plural, unless otherwise specified herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" should be construed to be open-ended terms (i.e., meaning "including, but not limited to"), unless otherwise indicated. The term "connected" should be construed as partly or wholly contained within, attached to, joined together, even if there is something intervening.

The recitation of ranges of values herein is intended to serve merely as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated herein as if it were individually recited herein.

Unless otherwise defined or limited herein, terms such as "about" or "approximately" should be understood to define a variation of plus or minus 5% to 10% on the referenced numerical term.

All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to better illustrate embodiments of the invention and does not impose limitations on the scope of the invention unless otherwise asserted. The various embodiments and elements can be interchanged or combined in any suitable manner as desired.

The use of directions such as front, rear, top and bottom, upper and lower, etc., refers to the embodiment shown in the drawings and therefore should not be taken as limiting. Reversing or inverting the embodiment in the drawings would, of course, result in a consistent reversal or inversion of the terms.

No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. There is no intention to limit the invention to the particular form or forms disclosed, but on the contrary, it is intended to include all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention as defined in the appended claims. Therefore, it is intended that the present invention cover modifications and variations of the invention provided they come within the scope of the appended claims and their equivalents.

Claims (20)

1. A sterile closure system for attachment to a container, comprising:
an upper section and a lower section, at least one of the upper section or the lower section including a mounting component for removably mounting the upper section to the lower section;
the upper section includes an upper valve housing having at least one inlet port and at least one outlet port, each of the inlet port and the outlet port comprising a conduit that allows fluid communication with an interior of the upper valve housing through the port, each port configured to be in fluid communication with at least one component with which it is desired to maintain a sterile connection;
the lower section comprises an upper deck having an attachment mechanism disposed on a lower portion of the upper deck for engaging a top of the container, and a lower valve housing formed on an upper surface of the upper deck and extending upwardly therefrom, the lower valve housing comprising two conduits providing fluid communication through the lower valve housing to an interior of the lower section.
the upper section and the lower section;
an upper rotary valve mounted to the upper valve housing and configured to be rotatable relative to the upper valve housing, the upper rotary valve including a cylindrical upper valve shaft rotatable within an upper bore extending through the upper valve housing and two upper shaft conduits extending through the upper valve shaft, the two upper shaft conduits being arranged such that when the upper rotary valve is in an open state, the upper valve shaft conduits are aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit, thereby enabling fluid communication between the upper section and the lower valve housing;
the upper rotary valve has a closed state, in which the upper valve shaft is rotated relative to the upper valve housing such that the upper shaft conduit is not aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit, such that fluid communication between the upper section and the lower valve housing is prevented by the upper valve shaft.
The upper rotary valve;
a lower rotary valve mounted to the lower valve housing and configured to rotate relative to the lower valve housing, the lower rotary valve comprising a cylindrical lower valve shaft rotatable within a lower bore extending through the lower valve housing, the lower rotary valve comprising two lower shaft conduits extending through the lower rotary valve shaft, the two lower shaft conduits being arranged such that when the lower rotary valve is in an open state, the lower shaft conduits are aligned with the lower valve housing conduits, allowing fluid communication between the upper section and the lower section when the upper rotary valve is in an open state;
the lower rotary valve has a closed state, in which the lower valve shaft rotates relative to the lower valve housing such that the lower shaft conduit is not aligned with the lower valve housing conduit and fluid communication between the upper section and the lower section is prevented by the lower valve shaft.
the lower rotary valve. The aseptic stopper system of claim 1, wherein the mounting component is a mounting bracket on the upper valve housing, the mounting bracket extending downwardly from a base of the upper valve housing, the mounting bracket including four walls, the four walls fitting snugly around an exterior surface of the lower valve housing to enclose a portion of the lower valve housing within the walls. The aseptic plugging system of claim 2, wherein the mounting bracket includes two openings on either side of the bracket that are press-fit onto the ends of the lower valve shaft, and the lower valve shaft extends out of either side of the bore of the lower valve housing, thereby removably securing the upper section to the lower section. The aseptic plugging system of claim 1, wherein the upper valve housing includes extensions extending downwardly from the lower ends of the inlet port conduit and the outlet port conduit, each extension engaging an upper end of a corresponding open one of the lower valve housing conduits. The aseptic plugging system of claim 4, wherein each extension and opening has a tapered interface that provides a press-fit connection with one another to facilitate a sterile connection between the upper valve housing and the lower valve housing. The aseptic plugging system of claim 1, wherein the inlet port, the outlet port, and the upper valve housing are formed as a unitary component. The aseptic plugging system of claim 1, wherein the inlet and outlet ports are provided with hose barbs for connecting to tubing. The aseptic plugging system of claim 1, wherein the at least one component is selected from a fluid media bag, a secondary container, or a processing device. The aseptic closure system of claim 1, wherein the lower section further comprises a skirt portion, and the attachment mechanism is threads formed on an inner surface of the skirt portion, the threads configured to releasably engage mating threads on the container. The aseptic plugging system of claim 1, wherein the upper valve shaft has a tab formed on one end that can be grasped by a user to rotate the upper rotary valve relative to the upper valve housing between open and closed positions, and the lower valve shaft has a tab formed on one end that can be grasped by a user to rotate the lower rotary valve relative to the lower valve housing between open and closed positions. 11. The aseptic stopper system of claim 10, wherein the upper valve housing comprises a first stop and a second stop that interact with the tab, the first stop being arranged to limit the rotation of the tab on the upper valve shaft such that the upper rotary valve is in a closed state when the tab contacts the first stop, and the second stop being arranged to limit the rotation of the tab on the lower valve shaft such that the lower rotary valve is in an open state when the tab on the lower valve shaft contacts the lower stop. The aseptic stopper system of claim 11, wherein the first stop, the second stop, and the tab are positioned such that the lower rotary valve cannot be rotated to a closed state until the upper rotary valve is first rotated to a closed state. The aseptic plugging system of claim 1, wherein the lower rotary valve is connected to the upper valve housing. 1. A sterile closure system for attachment to a container, said sterile closure system comprising:
an upper section and a lower section, at least one of either the upper section or the lower section including a mounting bracket for removably mounting the upper section to the lower section;
the upper section includes an upper valve housing having at least one inlet port and at least one outlet port, each of the inlet port and the outlet port comprising a conduit that allows fluid communication with an interior of the upper valve housing through the port, each port configured to be in fluid communication with at least one component to which it is desired to maintain a sterile connection;
the lower section includes an upper deck having an attachment mechanism disposed on a lower portion of the upper deck for engaging a top of the container, and a lower valve housing formed on an upper surface of the upper deck and extending upwardly therefrom, the lower valve housing including two conduits providing fluid communication through the lower valve housing to an interior of the lower section.
the upper section and the lower section;
an upper rotary valve mounted to the upper valve housing and configured to rotate relative to the upper valve housing, the upper rotary valve comprising a cylindrical upper valve shaft rotatable within an upper bore extending through the upper valve housing and two upper shaft conduits extending through the upper valve shaft, the two upper shaft conduits being arranged such that when the upper rotary valve is in an open state, the upper valve shaft conduits are aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit to enable fluid communication between the upper section and the lower valve housing;
the upper rotary valve has a closed state, in which the upper valve shaft is rotated relative to the upper valve housing such that the upper shaft conduit is not aligned with the inlet port conduit, the outlet port conduit, and the lower valve housing conduit such that fluid communication between the upper section and the lower valve housing is prevented by the upper valve shaft.
The upper rotary valve;
a lower rotary valve mounted to the lower valve housing and configured to rotate relative to the lower valve housing, the lower rotary valve comprising a cylindrical lower valve shaft rotatable within a lower bore extending through the lower valve housing, the lower rotary valve comprising two lower shaft conduits extending through the lower rotary valve shaft, the two lower shaft conduits being arranged such that when the lower rotary valve is in an open state, the lower shaft conduits are aligned with the lower valve housing conduits, allowing fluid communication between the upper section and the lower section when the upper rotary valve is in an open state;
the lower rotary valve has a closed state, in which the lower valve shaft is rotated relative to the lower valve housing such that the lower shaft conduit is not aligned with the lower valve housing conduit, such that fluid communication between the upper section and the lower section is prevented by the lower valve shaft.
The lower rotary valve;
a mounting bracket removably connecting the upper valve housing to the lower valve housing, the mounting bracket extending downward from a lower portion of the upper valve housing or upward from an upper portion of the lower valve housing;
the upper valve shaft having a tab formed on one end that can be grasped by a user to rotate the upper rotary valve relative to the upper valve housing between an open position and a closed position;
the lower valve shaft including a tab formed on one end thereof that can be grasped by a user to rotate the lower rotary valve relative to the lower valve housing between an open position and a closed position.
The sterile plugging system. 15. The aseptic plugging system of claim 14, wherein the mounting bracket includes four walls that closely engage the exterior surface of the lower valve housing to enclose a portion of the lower valve housing within the walls, and the mounting bracket includes two openings on either side of the bracket that are press-fit onto the ends of the lower valve shaft, the lower valve shaft extending out of either side of the bore of the lower valve housing to removably secure the upper section to the lower section. The aseptic plugging system of claim 14, wherein the lower rotary valve is connected to the upper valve housing. 15. The aseptic stopper system of claim 14, wherein the upper valve housing comprises a first stop and a second stop for interacting with the tab, the first stop being arranged to limit the rotation of the tab on the upper valve shaft such that the upper rotary valve is in a closed state when the tab contacts the first stop, and the second stop being arranged to limit the rotation of the tab on the lower valve shaft such that the lower rotary valve is in an open state when the tab on the lower valve shaft contacts the lower stop. The aseptic stopper system of claim 14, wherein the first stop, the second stop, and the tab are positioned such that the lower rotary valve cannot be rotated to a closed state until the upper rotary valve is first rotated to a closed state. The aseptic plugging system of claim 14, wherein the inlet port, the outlet port, and the upper valve housing are formed as a unitary component. The aseptic closure system of claim 14, wherein the lower section further comprises a skirt portion, and the attachment mechanism is threads formed on an inner surface of the skirt portion, the threads configured to releasably engage mating threads on the container.