Sterilization equipment and related containers

Abstract

A sterilization system and associated components and methods for sterilizing an article. The sterilization system includes a container for use with a sterilization apparatus for sterilizing an article. The container includes an external fluid connector port facing an environment surrounding the container that is fluidly connectable to a first fluid connector of the sterilization apparatus. An internal fluid opening face is fluidly coupled to the external fluid connector port and fluidly connects to the article. A valve is fluidly disposed between the external fluid connector port and the internal fluid opening. The valve is disposed to be engaged by the sterilization apparatus to move a valve member to an open position to allow fluid flow between the first fluid connector and the article when the sterilization container is used with the sterilization apparatus and when the article is fluidly connected to the internal fluid opening.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 317,684, filed March 8, 2022, which is incorporated by reference herein in its entirety. [Technical field]

[0002] The present disclosure relates generally to sterilization systems, and more specifically to sterilization apparatus and associated containers for sterilizing one or more articles. [Background technology]

[0003] Certain articles, such as medical instruments (e.g., endoscopes), need to be sterilized between uses. These articles may contain internal lumens that require sterilization. One way to sterilize these internal lumens is to move a sterilizing fluid through the lumen. For example, WO 2018 / 090133 describes a sterilization system that places an endoscope in a chamber that has a port connector attached to a fluid port of the endoscope. The port connector fluidly couples the internal lumen of the endoscope with a pressure source that creates a pressure differential. To sterilize the internal lumen of the endoscope, a sterilizing fluid (such as hydrogen peroxide vapor) is introduced into the chamber and drawn through the internal lumen of the endoscope via the pressure differential created by the pressure source. Summary of the Invention

[0004] In one aspect, a sterilization container for use with a sterilization apparatus for sterilizing an article has a body defining an interior configured to receive the article. An external fluid connector port faces an environment surrounding the body. The external fluid connector port is fluidly connectable to a first fluid connector of the sterilization apparatus. An internal fluid opening faces an interior of the body and is in fluid communication with the interior of the body. The internal fluid opening is configured to fluidly connect to the article. The internal fluid opening is fluidly coupled to the external fluid connector port. A valve is fluidly disposed between the external fluid connector port and the internal fluid opening. The valve includes a valve member movable between an open position in which the valve allows fluid flow between the external fluid connector port and the internal fluid opening and a closed position in which the valve blocks fluid flow between the external fluid connector port and the internal fluid opening. The valve is disposed to be engaged by the sterilization apparatus to move the valve member to the open position to allow fluid flow between the first fluid connector and the article when the sterilization container is used with the sterilization apparatus and when the article is fluidly connected to the internal fluid opening.

[0005] In another aspect, a sterilization apparatus for sterilizing articles within a sterile container has a sterilization chamber defining an interior sized and shaped to receive the sterile container. A container connector assembly is configured to fluidly connect the sterile container to the sterilization apparatus. The container connector assembly includes a fluid connector that is movable between a retracted position and an extended position. The fluid connector is configured to engage the sterile container as the fluid connector moves from the retracted position toward the extended position to fluidly connect the fluid connector to the sterile container.

[0006] In another aspect, a sterilization system for sterilizing an article includes a sterilization container configured to receive the article. A sterilization chamber defines an interior sized and shaped to receive the sterilization container. A fluid connector is configured to fluidly connect the sterilization container to a sterilization apparatus. At least one of the fluid connector or the sterilization container is configured to move toward the other of the fluid connector or the sterilization container to fluidly connect the fluid connector and the sterilization container to one another.

[0007] In another aspect, a sterilization container for use with a sterilization apparatus for sterilizing an article has a body defining an interior configured to receive the article. An external fluid connector port faces an environment surrounding the body. The external fluid connector port is fluidly connectable to a first fluid connector of the sterilization apparatus. An internal fluid opening faces an interior of the body and is in fluid communication with the interior of the body. The internal fluid opening is configured to fluidly connect to the article. The internal fluid opening is fluidly coupled to the external fluid connector port. A valve is fluidly disposed between the external fluid connector port and the internal fluid opening. The valve includes a valve member movable between an open position in which the valve allows fluid flow between the external fluid connector port and the internal fluid opening and a closed position in which the valve blocks fluid flow between the external fluid connector port and the internal fluid opening. A valve actuator is operably coupled to the valve member. The valve actuator is disposed to be engaged by the sterilization apparatus to move the valve member toward the open position to allow fluid flow between the first fluid connector and the article when the sterilization container is used with the sterilization apparatus and when the article is fluidly connected to the internal fluid opening.

[0008] Other objects and features will be in part apparent and in part pointed out hereinafter. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic diagram of a sterilization system including a sterilization apparatus according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a front perspective view of a sterilization container of the sterilization system. [Diagram 3] FIG. 2 is a rear perspective view of the sterilization container. [Figure 4] FIG. 2 is a perspective view of the sterilization container box. [Diagram 5] FIG. 2 is a rear perspective view of the septum of the sterilization container. [Figure 6] FIG. [Figure 7] FIG. 2 is a longitudinal cross-sectional view of a partition wall. [Figure 8]FIG. 1 is a perspective view of a sterilization chamber of a sterilization apparatus with a sterilization container therein. [Figure 9] FIG. 1 is a schematic cross-sectional view of a sterilization chamber with a sterilization container therein. [Figure 10] FIG. 2 is a schematic side view of a container connector assembly of a sterilization chamber. [Figure 11] FIG. 2 is a schematic top view of a receptacle connector assembly. [Figure 12] FIG. 2 is an enlarged schematic side view of the sterile container and the container connector assembly, the container connector assembly being shown in a retracted position. [Figure 13] Similar to FIG. 12, but the receptacle connector assembly is shown in an extended position. [Figure 14] FIG. 2 is a schematic longitudinal cross-sectional view of a sterile container with a container connector assembly shown in an extended position.

[0010] Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 1 and 2, one embodiment of a sterilization apparatus (e.g., sterilizer) according to the present disclosure is generally indicated by reference numeral 100, and one embodiment of a sterilization container according to the present disclosure is generally indicated by reference numeral 12. Collectively, the sterilization apparatus 100 and the sterilization container 12 form a sterilization system, generally indicated by reference numeral 10, for sterilizing one or more articles (not shown), such as an endoscope. The sterilization container 12 holds the articles and is placed within the sterilization apparatus 100, which sterilizes the articles using a sterilizing fluid (e.g., a sterilant) such as hydrogen peroxide vapor. It is understood that the use of other suitable sterilants is within the scope of the present disclosure. The sterilization apparatus 100 generally draws (broadly, moves) a sterilizing fluid onto the articles and through one or more internal lumens of the articles to sterilize the articles. Further details on how the sterilization apparatus 100 sterilizes the articles can be found in PCT Publication WO2018 / 090133.

[0012] 2-7, the sterilization container 12 is configured to hold one or more articles to be sterilized by the sterilization apparatus 100. The sterilization container 12 is used with the sterilization apparatus 100 to sterilize the articles. More specifically, the sterilization container 12 is configured to be positioned within and connected to the sterilization apparatus 100 to receive a sterilizing fluid provided within the sterilization apparatus into the interior 16 of the sterilization container to sterilize the articles held within the sterilization container. The sterilization container 12 includes a body 14 defining an interior 16 configured to receive one or more articles. The body 14 includes a base or box 18 and a lid 20. The lid 20 is attachable to the box 18 and forms a fluid-tight seal with the box to prevent fluids (e.g., gases, liquids, steam, etc.) from passing therebetween. Removal of the lid 20 from the box 18 allows an article to be placed within or removed from the interior 16. The box 18 has a base with opposing front and rear end walls extending upwardly from the base and opposing left and right side walls extending upwardly from the base. The sterilization container 12 may include one or more latches or fasteners (not shown) for securing the lid 20 to the box 18. The sterilization container 12 includes one or more sterilant-permeable membranes 22. These membranes 22 may generally be anywhere on the box 18 and / or the lid 20. In the illustrated embodiment, the membranes 22 are attached to the base of the box 18. Each membrane 22 is configured to allow sterilizing fluid in the environment surrounding the body 14 (e.g., the environment external to the sterilization container 12) to pass therethrough and enter the interior 16 of the body. The sterilizing fluid is drawn through the membranes 22 by a sterilization apparatus 100, as generally described in PCT Publication WO2018 / 090133, to sterilize items contained in the interior 16. The membrane 22 is preferably impermeable to contaminants (e.g., dust, debris, microorganisms, etc.) to prevent the release of contaminants into the interior 16 of the sterilization container 12. This helps to maintain the sterility of the interior 16 and the articles contained therein after the articles have been sterilized.

[0013] 3-6, the sterilization container 12 includes a septum 24 attached to the box 18. As will become apparent, the septum 24 is used to fluidly connect the interior 16 of the sterilization container 12, and particularly the items contained therein, with the sterilization apparatus 100 to allow the sterilization apparatus to draw sterilizing fluid into and out of the interior. The septum 24 extends through a rear wall of the box 18. The septum 24 includes a body 26 and a seal or gasket 28. The seal 28 is disposed between the body 26 and the rear wall of the box 18 to form a fluid-tight seal to prevent fluid from passing between the body and the box. The seal 28 generally extends around the periphery of the body 26.

[0014] 5-7, the bulkhead 24 includes a plurality of article lines 30. Each article line 30 is configured to fluidly couple to a corresponding article at one end and to the sterilization apparatus 100 at the other end for fluidly coupling the article to the sterilization apparatus 100. In this manner, the sterilization apparatus 100 can move sterilizing fluid through the articles via the associated article lines 30. Generally, each article line 30 is associated with one article, although other arrangements (e.g., two or more articles associated with one article line) are within the scope of the present disclosure. In the illustrated embodiment, the sterilization container 12 is configured to sterilize eight different articles, and thus the bulkhead 24 includes eight article lines 30, one for each article. More or fewer article lines 30 are within the scope of the present disclosure. Because the article lines 30 are generally identical, one article line will be described with the understanding that the description applies to all article lines.

[0015] 7, the article line 30 (broadly, the sterilization container 12) includes an external fluid connector port 32, an internal fluid connector port 34, a passageway 36 extending between the ports, and a valve 38 (broadly, a member that is selectively permeable to fluids) disposed within the passageway. Thus, the external and internal fluid connector ports 32, 34 are fluidly coupled together. The passageway 36 fluidly couples the external and internal fluid connector ports 32, 34. The external fluid connector port 32 is connectable (e.g., fluidly connectable) to a fluid connector 154 (FIG. 14) of the sterilization apparatus 100. The external fluid connector port 32 is generally disposed on the exterior of the body 14 and faces the environment surrounding the body (e.g., faces the exterior). In the illustrated embodiment, the external fluid connector port 32 includes an external fluid opening 40. The external fluid opening 40 is sized and shaped to receive the fluid connector 154. Specifically, the external fluid opening 40 allows the fluid connector 154 to extend through the external fluid opening into the passageway 36 to allow the fluid connector to engage with the valve 38, as described in more detail below. The internal fluid connector port 34 is connectable (e.g., fluidly connectable) to an item connector (not shown) associated with the item to fluidly connect the item (specifically, its one or more internal lumens) to the item connector. In general, the item connector can be any suitable connector for connecting the item to the item line 30. In some embodiments, the item line 30 can include an item connector. In other embodiments, the item connector can be omitted and the item can be directly connected to the internal fluid connector port 34. In the illustrated embodiment, the internal fluid connector port 34 includes a dovetail slot for connecting to the item connector. The internal fluid connector port 34 is generally disposed on the interior side of the body 14. The internal fluid connector port 34 faces the interior 16 of the body 14 and is in fluid communication with the interior of the body. In the illustrated embodiment, the internal fluid connector port 34 includes (e.g., defines) an internal fluid opening 42. The internal fluid opening 42 is configured to fluidly connect to an item. Specifically, the internal fluid opening 42 is fluidly connected to the item (e.g., its internal lumen) when the item connector connects the item to the internal fluid connector port 34.Other configurations of external and internal connector ports are within the scope of this disclosure.

[0016] The valve 38 is fluidly disposed between the external and internal fluid connector ports 32, 34 (e.g., external and internal fluid openings 40, 42) to selectively block or allow fluid flow (e.g., flow of a sterile fluid) therebetween. The valve 38 is generally disposed in the passageway 36 between the external and internal fluid connector ports 32, 34. The valve 38 includes a valve member 44 (FIG. 7). The valve member 44 is movable between a closed position (FIG. 7) and an open position (not shown). When the valve member 44 is in the closed position, the valve 38 is closed to block or prevent the flow of any fluid, such as a sterile fluid, between the external and internal fluid connector ports 32, 34. When the valve member 44 is in the open position, the valve 38 is open to allow the flow of any fluid, such as a sterile fluid, between the external and internal fluid connector ports 32, 34. The valve member 44 is biased toward the closed position, such as by a spring (not shown). Other selectively fluid permeable members other than valves that can allow sterilant to pass through and prevent the release of contaminants into the interior 16 of the sterilization container 12 are within the scope of this disclosure. For example, in one embodiment, the selectively fluid permeable member includes a membrane similar to membrane 22 described above that allows sterilant to travel through the article tubing but inhibits the release of contaminants.

[0017] In the illustrated embodiment, the valve member 44 is configured to be operatively connected to the sterilizer 100 such that the sterilizer can move the valve member toward the open position. In the illustrated embodiment, the valve 38 is arranged to be engaged by the sterilizer 100 to move the valve member 44 to the open position to allow fluid flow between the external and internal fluid connector ports 32, 34. In this manner, the sterilizer 100 places the valve member 44 in the open position when the sterilizer container 12 is used with the sterilizer to allow the sterilizer to move sterilizing fluid through the article piping 30 (e.g., the valve). In operation, when the sterilizer container 12 is used with (e.g., connected to) the sterilizer 100 and when an article is fluidly connected to the internal fluid connector port 34, placing the valve member 44 in the open position allows fluid flow between the sterilizer fluid connector 154 (connected to the external fluid connector port 32) and the article. This allows the sterilizer 100 to sterilize the article by moving sterilizing fluid through the article, via the article piping 30 of the sterilizer 12. In the illustrated embodiment, the valve 38 is positioned to be engaged by the fluid connector 154 of the sterilizer 100 to move the valve member to the open position. The valve actuator 46 is operably coupled to the valve member 44. Actuating the valve actuator moves the valve member 44 between the open and closed positions to open and close the valve. In the illustrated embodiment, the valve actuator 46 is part of the valve 38, but it is understood that the valve actuator may be separate from the valve. In one embodiment, the valve actuator 46 is a push member or plate disposed in the passageway 36 on the external port connector 32 side of the valve. In this embodiment, the valve actuator 46 is positioned to be engaged and pushed by the end of the fluid connector 154 of the sterilizer 100 to move the valve member 44 towards the open position when the fluid connector is connected to the external fluid connector port 32 (e.g., when the fluid connector is inserted into the passageway 36 through the external fluid opening 40).The fluid connector 154 of the sterilizer 100 continues to engage the valve 38 to hold the valve member 38 in an open position while the sterilization container 12 is connected to the sterilization device 100 (e.g., mated with the sterilization device 100) to allow sterilizing fluid to flow between the interior 16 and the sterilization device. Because the valve member 44 is biased toward a closed position, when the fluid connector 154 of the sterilization device 100 is removed from the external fluid connector port 32, the fluid connector releases the valve actuator 46 of the valve 38, thereby allowing the valve member 44 to move to the closed position. Thus, when the sterilization container 12 is disconnected from the sterilization device 100, the valve 38 automatically closes to seal the interior 16 and the articles contained therein from the external environment to maintain the sterility of the articles. Unless the sterilization container 12 is opened by removing the lid 20, the interior 16 and the articles sterilized therein remain sterile and generally free of external contaminants for extended periods of time, such as months or years. This allows the sterilization container 12 to be used to sterilize an article, after which the sterilization container can be stored, such as self, until such time as the article contained therein is needed by a user. When the article is needed, the user simply removes the lid 20 and removes the stationary sterilized article from the interior 16 of the sterilization container 12. In the illustrated embodiment, the valve actuator 46 is part of the valve. In other embodiments, the valve actuator may be separate from the valve and operably connected to the valve member, such as by a linkage, such that actuation of the valve actuator causes a corresponding actuation of the valve member. Additionally, the valve actuator may be located in other locations on the container 12 and / or engaged by other components of the sterilization apparatus 100 to open and close the valve 38. For example, the valve actuator may be located on a wall (e.g., the rear wall of the box 18). Additionally, other methods of actuating the valve actuator other than engagement with the sterilization apparatus are within the scope of this disclosure. For example, the valve actuator may be manually actuated.In another example, the valve actuator may be actuated by a prime mover, such as an electric motor, a linear actuator, a solenoid, or the like. In another example, the valve actuator may include a prime mover.

[0018] 5, the septum 24 (broadly, the sterilization container 12) includes several features to facilitate connection or mating of the septum (broadly, the sterilization container) with the sterilization apparatus 100. In the illustrated embodiment, the septum 24 includes two initial alignment guides 48 (broadly, at least one initial alignment guide) and two final alignment guides 50 (broadly, at least one final alignment guide). Each initial alignment guide 48 is configured to be engaged by the sterilization apparatus 100 (specifically, its initial alignment guide 140) to initially position the sterilization container 12 relative to the sterilization apparatus. In the illustrated embodiment, each initial alignment guide 48 includes a blind hole. The blind hole is positioned, sized, and shaped to receive a corresponding initial alignment guide 140 of the sterilization apparatus 100. The blind hole may be defined by one or more tapered surfaces to aid in moving the sterilization container 12 and the sterilization apparatus 100 relative to one another. Further, each final alignment guide 50 is configured to be engaged by the sterilization apparatus 100 (specifically, its final alignment guide 162) to align the external fluid connector port 32 and the corresponding fluid connector 154 of the sterilization apparatus 100 with respect to one another. In the illustrated embodiment, each final alignment guide 50 includes a blind hole. The blind hole of the final alignment guide 50 has a cross-sectional area that is much smaller than the blind hole of the initial alignment guide 48. The blind hole of the final alignment guide 50 is positioned, sized, and shaped to receive the corresponding final alignment guide 162 of the sterilization apparatus 100. In general, the initial alignment guide 48 provides an initial coarse alignment between the sterilization container 12 and the sterilization apparatus 100, while the final alignment guide 50 provides a final fine alignment between the external fluid connector port 32 and the fluid connector 154 of the sterilization apparatus 100, as described in more detail below.

[0019] 1 and 8-14, a sterilization apparatus 100 is used to sterilize one or more articles 100 inside a sterilization container 12. The sterilization apparatus 100 includes a sterilization chamber 102 and other components (not shown), such as tanks, pumps, piping, controls, etc., supported by a housing generally designated 104 (FIG. 1). For purposes of this disclosure, only the sterilization chamber 102 and its corresponding associated components are generally shown. Further details regarding the other components of the sterilization apparatus 100 not shown can be found in PCT Publication WO2018 / 090133. In the illustrated embodiment, the sterilization apparatus 100 includes only one sterilization chamber 102. However, it is understood that the sterilization apparatus 100 can include one or more (e.g., two, three, four, etc.) sterilization chambers 102.

[0020] The sterilization chamber 102 includes a housing 106 having a bottom wall 108, a top wall 110, opposing left and right side walls 112, 114, a rear wall 116, and a door 118 defining a front wall 120. The housing 106 defines an interior 122 sized and shaped to receive the sterilization container 12. The interior 122 has an open front face that the door 118 closes through which the sterilization container 12 can be inserted and removed from the interior. The sterilization chamber 102 can include one or more bottom guide rails above the bottom wall 108 along which the sterilization container 12 can slide. These guide rails can also space the bottom of the sterilization container 12 from the bottom wall 108 to allow sterilizing fluid to travel through the membrane 22 at the bottom of the sterilization container. The sterilization chamber 102 can include one or more (e.g., two) side or lateral guides or guide rails to laterally position the sterilization container 12 within the interior 122. In one embodiment, the lateral guides are positioned to engage sides of the sterilization container 12 to laterally position the container. The sterilization chamber 102 may also include a stopper 130 (e.g., a front stopper) to limit longitudinal (e.g., forward) movement of the sterilization container 12 within the interior 122 for reasons that will become apparent. In the illustrated embodiment, the stopper 130 is supported by the door 118. The stopper may include one or more resiliently compressible members (e.g., pins) positioned to engage the front of the sterilization container 12. Other configurations of the stopper are within the scope of this disclosure.

[0021] 9-14, the sterilization apparatus 100 includes a container connector assembly 134 associated with the sterilization chamber 102. The container connector assembly 134 is configured to fluidly connect the sterile container 12 to the sterilization apparatus 100. When the container connector assembly 134 is connected or mated to the sterile container 12 (specifically, to the bulkhead 24 thereof), the sterilization apparatus 100 can draw sterile fluid into the interior 16 of the sterile container 12 and pass one or more articles through it. The container connector assembly 134 is movable between a retracted position (FIG. 12) and an extended position (FIG. 13). In the retracted position, the container connector assembly 134 is decoupled (e.g., spaced apart) from the sterile container 12 and is not fluidly connected to the sterile container 12. In the extended position, the container connector assembly 134 is connected or mated to the sterile container 12 and is fluidly coupled to the sterile container 12. The container connector assembly 134 generally moves between a retracted position and an extended position along a longitudinal axis LA of the sterilization chamber 102. The longitudinal axis LA extends between the door 118 and the rear wall 116.

[0022] The container connector assembly 134 is movably (e.g., slidably) mounted on two slide rails or rods 136 (broadly, at least one slide rail) of the sterilization chamber 102. The slide rails 136 are elongated and generally cylindrical. The slide rails 136 are fixed to the rear wall 116 of the sterilization chamber 102 and extend forward toward the door 118. In one embodiment, the container connector assembly 134 includes two slides or sleeves (broadly, at least one slide) each mounted on one of the slide rails 136. Each slide can move or slide longitudinally along the length of the corresponding slide rail 136. Each slide is elongated and generally cylindrical. Each slide can define a longitudinal cavity having an open rear end that receives the slide rod 136 and allows the slide to move relative to the slide rod. The container connector assembly 134 includes two (broadly, at least one) initial alignment guides 140. In one embodiment, a front end portion of each slide forms (e.g., defines) an initial alignment guide 140. Each initial alignment guide 140 of the container connector assembly 134 is configured to engage with a sterile container to initially position the sterile container relative to the sterilization chamber 102 and the container connector assembly. Specifically, each initial alignment guide 140 of the container connector assembly 134 is configured to mate with (e.g., be inserted into) a corresponding one of the initial alignment guides 48 of the sterile container 12, as shown in FIG. 13. In one embodiment, each initial alignment guide 140 of the container connector assembly 134 includes a generally conical tip that is positioned to be inserted into a blind hole of a corresponding one of the initial alignment guides 48 of the sterile container 12. The conical tip may include a passage between the longitudinal cavity and an environment external to the tip to mitigate pressure build-up or loss within the longitudinal cavity as the slide moves along the slide rail 136.Additionally, each initial positioning guide 140 may include a peripheral flange rearward of the conical tip that is positioned to engage with the sterile container 12 (specifically, the bulkhead 24) to limit the distance the initial positioning guide can be inserted into the blind hole of the initial positioning guide 48 of the sterile container 12.

[0023] The receptacle connector assembly 134 includes a pusher 146 movably (e.g., slidably) mounted on two slides, and thus, by extension, on two slide rails 136. Thus, the pusher 146 can move relative to the slides, and the slides can move themselves relative to their respective slide rails 136. The pusher 146 includes a push member or plate 148 and two slide bearings (not shown) secured to the plate. Each slide bearing is mounted to one of the slides, thereby allowing the pusher 146 to move (e.g., slide) relative to the slides. The receptacle connector assembly 134 includes a fluid connector mount or plate 152. Attached to the fluid connector mount 152 are a plurality (broadly, at least one) of fluid connectors 154. In the illustrated embodiment, the receptacle connector assembly 134 includes eight fluid connectors 154, although more or fewer fluid connectors are within the scope of this disclosure. Preferably, the container connector assembly includes as many fluid connectors as the sterile container 12 includes external fluid connector ports 32. The fluid connectors 154 are disposed on the fluid connector mount 152 such that each is inserted into a corresponding external fluid connector port 32 of the sterile container 12, as described herein. Each fluid connector 154 is movable along the longitudinal axis LA between a retracted position and an extended position. In the illustrated embodiment, all of the fluid connectors 154 move together between the retracted position and the extended position. Each fluid connector 154 is configured to engage the sterile container 12 (e.g., mate with a corresponding external fluid connector port 32) when the fluid connector moves from the retracted position toward the extended position to fluidly connect the fluid connector to the sterile container. Each fluid connector 154 includes a front insertion portion configured to be inserted into one of the external fluid openings 40 of the corresponding external connector port 32 and a rear conduit connection portion configured to be connected to a flexible fluid conduit (not shown) of the sterilization apparatus 100.The insert portion of each fluid connector 154 may include a seal, such as an O-ring, that engages with the inner surface of the septum 24 that defines the passageway 36 to form a fluid-tight seal between the fluid connector and the sterile container 12.

[0024] The pusher 146 is configured to move the fluid connector 154 from a retracted position toward an extended position. In particular, the pusher 146 is operatively connected to the fluid connector mount 152 for moving the fluid connector mount and the fluid connector 154 from the retracted position toward the extended position.

[0025] The fluid connector mount 152 is movable relative to the pusher 146 and relative to the slide (not shown) (and thus, by extension, relative to the two slide rails 136). In the illustrated embodiment, the fluid connector mount 152 is free-floating. This allows the fluid connector mount 152 to move generally in any direction, facilitating alignment of the fluid connector 154 with the corresponding external fluid connector port 32 of the sterilization container 12. Specifically, the fluid connector mount 152 and the fluid connector 154 are free to move relative to the sterilization chamber 102 (e.g., slide rails 136) along or within (broadly, parallel to) an imaginary reference plane RP (FIG. 14) perpendicular to the longitudinal axis LA. This allows the fluid connector 154 to move freely vertically and / or laterally to align with the corresponding external fluid connector port 32 of the sterilization container 12. In the illustrated embodiment, the fluid connector mount 152 is supported by the pusher 146. The fluid connector mount 152 includes two oversized openings 156 sized and shaped to receive the forward portion of each slide bearing. The openings 156 have a diameter larger than the diameter of the forward portion of each slide bearing. Preferably, the diameter of the openings 156 is about 5 / 32 inches (about 4 mm) larger than the diameter of the forward portion of each slide bearing. The oversized openings 156 allow the fluid connector mount 152 and the fluid connector 154 to move along a reference plane RP for alignment with the external fluid connector port 32 of the sterile container 12. The forward portion of each slide bearing includes a flange or shoulder that engages a rear face or face of the fluid connector mount 152 to urge the fluid connector mount from a retracted position to an extended position along the longitudinal axis LA.

[0026] The receptacle connector assembly 134 may include two clips or stops (not shown), such as two C-clips, that hold the fluid connector mount 152 on a forward portion of the slide bearing of the pusher 146. Thus, the fluid connector mount 152 is generally restrained from moving longitudinally relative to the pusher 146, but is free to move vertically and laterally relative to the pusher 146. The receptacle connector assembly 134 also includes two clips or stops, such as two C-clips (not shown), adjacent the rear end of each slide to hold the pusher 146 on the slide.

[0027] The initial alignment guide 140 can move (e.g., move longitudinally) relative to the fluid connector 154. This relative movement aids in connecting the fluid connector 154 to the container 12, as described in more detail below. In one embodiment, the initial alignment guide 140 can be biased in a forward direction (e.g., toward an extended position). In one embodiment, the container connector assembly 134 includes two springs (not shown), such as coil springs, that bias the initial alignment guide 140 toward the extended position. In one embodiment, each spring surrounds one of the slides that define the initial alignment guide 140, with one end of the spring engaging a flange of the initial alignment guide 140 and the other end of the spring engaging the fluid connector mount 152 and / or clip.

[0028] The container connector assembly 134 includes two (broadly speaking, at least one) final alignment guides or pins 162. Each final alignment guide 162 of the container connector assembly 134 is configured to engage the sterile container 12 to align the fluid connector 154 and the external fluid connector port 32 with respect to one another. Specifically, each final alignment guide 162 of the container connector assembly 134 is configured to mate with (e.g., be inserted into) a corresponding one of the final alignment guides 50 of the sterile container 12. In the illustrated embodiment, each final alignment guide 162 includes a front end portion that is positioned to be inserted into a blind hole of a corresponding one of the final alignment guides 50 of the sterile container 12. The front end portion may include a conical tip.

[0029] In one embodiment, the sterilization apparatus 100 is configured to determine whether the container connector assembly 134 is mated with the sterile container 12. In the illustrated embodiment, each final alignment guide 162 may include a fluid passageway extending longitudinally therethrough and a rear conduit connection portion configured to be connected to a flexible fluid conduit (not shown) of the sterilization apparatus 100. A front end portion of each final alignment guide 162 may include a seal, such as an O-ring, that engages an inner surface of the final alignment guide 50 of the sterile container 12 that defines a blind hole to form a fluid-tight seal between the final alignment guide of the sterilization apparatus 100 and the sterile container 12. This allows the sterilization apparatus 100 to draw a vacuum through the final alignment guide 162 of the container connector assembly 134 via the fluid passageway. If the sterilization apparatus 100 is able to draw a vacuum through the final alignment guide 162, then the sterilization apparatus can confirm that the container connector assembly 134 is sufficiently mated with the sterile container 12. Sterilization apparatus 100 may include appropriate pumps (for drawing a vacuum), sensors (for detecting the vacuum), and tubing (not shown) fluidly connected to final alignment guide 162 of container connector assembly 134 for drawing and detecting vacuum. Other methods of determining whether the container connector assembly is mated with a sterilization container, e.g., sensors, buttons, etc., are within the scope of this disclosure.

[0030] The sterilization apparatus 100 includes a prime mover 164 operably coupled to the container connector assembly 134 to move the container connector assembly between a retracted position and an extended position. In particular, the prime mover 164 is operably coupled to the fluid connector 154 and configured to move the fluid connector between a retracted position and an extended position. In the illustrated embodiment, the prime mover 164 is a linear actuator, although other types of prime movers (e.g., electric motors) are within the scope of the present disclosure. A drive train interconnects the container connector assembly 134 and the prime mover. The drive train includes a drive shaft 166 connected at one end to the linear actuator and at the other end to the pusher 146 (e.g., push plate 148) (broadly, the drive train includes the pusher). The drive shaft 166 extends through a slide bearing (not shown) secured to the rear wall 116. The sterilization apparatus 100 includes a switch assembly 170 including first and second switches (not shown), such as limit switches. The first switch is positioned to be engaged by the drive train when the container connector assembly 134 is in the retracted position. Similarly, the second switch is positioned to be engaged by the drive train when the container connector assembly 134 is in the extended position. By activating one of the switches, the sterilizer 100 can know when the container connector assembly 134 is in either the retracted or extended position and will stop the prime mover 164 from continuing to operate, thereby positioning the container connector assembly 134 to be in either the retracted or extended position.

[0031] 12-14, the operation of the container connector assembly 134 as it moves between the retracted and extended positions will be described. FIG. 12 shows the container connector assembly 134 resting in the retracted position. Starting from the retracted position, the linear actuator 164 holds the pusher 146, and thus the fluid connector mount 152 and the fluid connector 154, in the longitudinal position shown in FIG. 12 (i.e., the retracted position). A spring can bias the initial alignment guide 140 forward toward the extended position. In one embodiment, a clip (broadly speaking, a stopper) attached to the rear end of each slide engages the rear of the pusher 146, thereby positioning the initial alignment guide 140 in the position shown in FIG. 12. When the container connector assembly 134 is in the retracted position, the sterilization chamber 102 is ready to receive a sterile container 12. The user opens the door 118 and inserts the sterile container 12 into the interior 122. Once the sterilization container 12 is inserted into the sterilization chamber 102, the guide rails may guide the sterilization container vertically and / or laterally to position the sterilization container in coarse alignment with the container connector assembly 134. The sterilization container 12 is moved rearwardly within the interior 122 until the sterilization container contacts the container connector assembly 134 and / or a rear stop 176 (FIG. 9) (broadly, at least one stop) at the rear of the interior. After the sterilization container 12 is positioned within the interior 122 of the sterilization chamber 102, the door 118 is closed. It will be appreciated that before the sterilization container 12 is placed within the sterilization chamber 102, one or more articles are placed into the sterilization container interior 16, each connected via an article connector to a respective interior fluid connector port 34.

[0032] After the door 118 is closed, the container connector assembly 134 moves toward the extended position. To move the container connector assembly 134 toward the extended position, the linear actuator 164 moves the pusher 146 forward. As the pusher 146 moves forward, it pushes or moves the fluid connector mount 152 forward as well. In one embodiment, the spring continues to bias the initial alignment guide 140 (e.g., slide) in a forward direction as well. Thus, as the pusher 146 moves forward, the initial alignment guide 140 also moves forward, and the spring continues to engage the clip with the pusher. The slide slides forward along the slide rail 136. At this point in the operation, the pusher 146, the fluid connector mount 152, the fluid connector 154, the initial alignment guide 140, the slide, and the final alignment guide 162 all move together in the forward direction. Eventually, the initial alignment guide 140 engages the sterile container 12. As the initial alignment guides 140 move forward, the initial alignment guides of the container connector assembly 134 mate with the initial alignment guides 48 of the sterile container 12. The tip of each initial alignment guide 140 of the container connector assembly 134 is inserted into a blind hole of the corresponding initial alignment guide 48 of the sterile container 12. During this process, the engagement between the initial alignment guides 140, 48 can move the sterile container 12 vertically and / or laterally to position the sterile container 12 relative to the container connector assembly 134. The initial alignment guides 140 of the container connector assembly 134 continue to be inserted into the corresponding initial alignment guides 48 until the flanges of the initial alignment guides 140 engage the sterile container 12.

[0033] With the flange of the initial alignment guide 140 engaged with the sterile container 12, the flange pushes the sterile container forward against the stop 130 on the door 118. The stop 130 limits or blocks continued forward movement of the sterile container 12. At this point, the initial alignment guide 140 has reached its forward-most position (i.e., is in an extended position) and is prevented from further forward movement by the sterile container 12 and the stop 130. The initial alignment guide 140 (and the slide) now does not move relative to the slide rail 136. However, the linear actuator 164 continues to move the pusher 146 in a forward direction. The linear actuator 164 applies a sufficient amount of force to overcome the bias of the spring so that the spring begins to compress. At this point in operation, the pusher 146, the fluid connector mount 152, the fluid connector 154, and the final alignment guide 162 still move together in a forward direction relative to the initial alignment guide 140 (e.g., along the slide). In one embodiment, as the pusher 146 continues to move forward, the slide bearing slides along the slide. Eventually, the final alignment guide 162 engages with the sterile container 12. As the final alignment guide 162 moves forward, the final alignment guide of the container connector assembly 134 mates with the final alignment guide 50 of the sterile container 12. Each final alignment guide 162 of the container connector assembly 134 is inserted into a blind hole of the corresponding final alignment guide 50 of the sterile container 12. During this process, the engagement between the final alignment guides 162, 50 can move the fluid connector mount 152 and the fluid connector 154 vertically and / or laterally along the reference plane RP (relative to the pusher 146 and the sterile container 12) to align the fluid connector with the external fluid connector port 32 of the sterile container 12. When the final alignment guide 162 of the container connector assembly 134 is inserted into the corresponding final alignment guide 50, the final alignment guide of the container connector assembly 134 forms a seal with the final alignment guide 50 of the sterilization container 12, thereby enabling a vacuum to be created as described above.

[0034] After the final alignment guides 162, 50 are engaged with one another, the linear actuator continues to move the pusher 146 forward, inserting the fluid connectors 154 into the corresponding external fluid connector ports 32 of the sterile container 12 (FIG. 14). The pusher 146 continues to move forward, pushing the fluid connectors 154 toward and engaging the valves 38 (broadly, the valve actuators 46) associated with each external fluid connector port 32. This engagement opens the valves 38, as described herein, thereby creating an open fluid passageway between the sterile container 12 (e.g., interior 16) and the sterilization apparatus 100 (e.g., fluid connector 154). After this engagement, the linear actuator 164 stops moving the pusher 146 forward. The container connector assembly 134 is now in the extended position (FIG. 13). The sterilization apparatus 100 can move (e.g., draw) sterilization fluid from the interior 122 of the sterilization chamber 102 into the sterilization container 12, through the articles, through the opening valve 38, and into the fluid connector 154 to sterilize the articles.

[0035] After the sterilization process is completed, the movement of the container connector assembly 134 is generally reversed to disconnect the container connector assembly from the sterile container. The linear actuator 164 moves the pusher 146 in a rearward direction. The pusher 146 moves the fluid connector mount 152, the fluid connector 154, and the final alignment guide 162 in a rearward direction as well. As the fluid connector mount 152 moves rearward, the fluid connector 154 disengages or disengages from the external fluid connector port 32. Similarly, the final alignment guide 162 of the container connector assembly 134 disengages or disengages from the final alignment guide 50 of the sterile container 12. The pusher 146, the fluid connector mount 152, the fluid connector 154, and the final alignment guide 162 can move rearward relative to the initial alignment guide 140 (e.g., along the slide) until the pusher 146 engages the clip at the rear end of the slide. Any springs expand as the pusher 146 moves rearward to maintain the initial alignment guide 150 (e.g., slide) in a generally stationary position until the clip is engaged by the pusher 146. As the pusher 146 continues to move rearward, it engages the clip at the rear end of the slide, thereby moving the initial alignment guide 140 and slide rearward along the slide rail 136. At this moment, the pusher 146, the fluid connector mount 152, the fluid connector 154, the final alignment guide 162, and the initial alignment guide (e.g., slide) all move rearward together. As the initial alignment guide 140 moves rearward, it disengages or disengages from the initial alignment guide 48 of the sterilization container 12. The pusher 146, fluid connector mount 152, fluid connector 154, final alignment guide 162, and initial alignment guide 140 continue to move rearward until they reach the retracted position, at which point the linear actuator 164 stops moving, thereby holding the container connector assembly 134 in the retracted position. The door 118 can now be opened by the user and the sterilization container 12 can be removed from the sterilization chamber 102 containing the sterilized articles.If the articles are to be used immediately, the lid 20 of the sterilization container 12 can be opened to remove the sterilized articles from the container. If the articles do not need to be used immediately, the sterilization container 12 can be stored until the articles are needed. As described herein, the sterilization container 12 continues to sterilize the articles while they are stored.

[0036] As will be apparent, in the sterilization system 10 described above, the fluid connector 154 generally moves relative to the sterile container 12 to fluidly couple the sterile container to the sterilization apparatus 100. In another embodiment, the sterile container may generally move relative to the fluid connector to fluidly couple the sterile container to the sterilization apparatus. In this embodiment, the sterile container and sterilization apparatus may be generally the same as described above, except that instead of or in addition to the movable container connector assembly 134, the sterilization apparatus may include a container mover that moves the sterile container toward the fluid connector to fluidly couple the fluid connector to the container. The container mover may move the sterile container between a first or non-engaged position in which the sterile container is not fluidly coupled to the fluid connector, and a second or engaged position in which the sterile container is fluidly coupled to the fluid connector. In one example, the container mover includes a pair of jaws that releasably engage opposite sides of the sterile container, and a prime mover (e.g., an electric motor, a linear actuator, etc.) that moves the jaws (and the sterile container gripped thereby) between the engaged and non-engaged positions. In another example, the container mover has a pusher operably coupled to the prime mover. The pusher is positioned to engage the sterile container and push the sterile container rearwardly toward the fluid connector (e.g., toward the engaged position). It is understood that a sterilization apparatus may include both (broadly, at least one of) the movable container connector assembly 134 and the container mover.

[0037] It is clear and understood that the elements, features, and / or teachings described in each embodiment disclosed herein are not limited to the particular embodiment in which the element, feature, and / or teaching is described, and thus, it is clear and understood that an element, feature, and / or teaching described in one embodiment may be applied to one or more of the other embodiments disclosed herein.

[0038] When introducing elements of the invention or embodiments thereof, the articles "a," "an," "the," and "said" are intended to mean that there are one or more of the elements. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements.

[0039] Modifications and variations of the disclosed embodiments are possible without departing from the scope of the invention as defined in the appended claims. For example, where specific dimensions are given, it will be understood that they are exemplary only and that other dimensions are possible. Since various changes can be made in the structures, products, and methods described above without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense.

Claims

1. 1. A sterilization container for use with a sterilization apparatus for sterilizing an article, said sterilization container comprising: a body defining an interior configured to receive the article; an external fluid connector port facing the environment surrounding the body, the external fluid connector port being fluidly connectable to a first fluid connector of the sterilization apparatus; an interior fluid opening facing the interior and in fluid communication with the interior of the body, the interior fluid opening configured to fluidly connect to the article and fluidly coupled to the external fluid connector port; a valve fluidly disposed between the external fluid connector port and the internal fluid opening, the valve including a valve member movable between an open position, in which the valve allows fluid flow between the external fluid connector port and the internal fluid opening, and a closed position, in which the valve blocks fluid flow between the external fluid connector port and the internal fluid opening, the valve being arranged to be engaged by the sterilization apparatus to move the valve member toward the open position to allow fluid flow between the first fluid connector and the article when the sterilization container is used with the sterilization apparatus and when the article is fluidly connected to the internal fluid opening. Sterile container.

2. the valve is arranged to be engaged by a first fluid connector of the sterilizer to move the valve member to the open position.

10. The sterilization container of claim 1.

3. the valve member is biased toward the closed position; 3. The sterilization container according to claim 1 or claim 2.

4. the external fluid connector port defines an external port opening sized and shaped to receive the first fluid connector; 3. The sterilization container according to claim 1 or claim 2.

5. further comprising an internal fluid connector port, the internal fluid connector port defining the internal fluid opening, the internal fluid connector port configured to be fluidly connected to an article fluid connector associated with the article to fluidly connect the article to the internal fluid opening.

3. The sterilization container according to claim 1 or claim 2.

6. the body including an initial positioning guide configured to be engaged by the sterilization apparatus to initially position the sterile container relative to the sterilization apparatus when the sterile container is to be used with the sterilization apparatus; 3. The sterilization container according to claim 1 or claim 2.

7. the body including a final alignment guide configured to be engaged by the sterilization apparatus to align the external fluid connector port and the first fluid connector relative to one another when the sterilization container is used with the sterilization apparatus.

7. The sterilization container according to claim 6.

8. The article is a first article, the external fluid connector port is a first external fluid connector port, the internal fluid opening is a first internal fluid opening, the valve is a first valve, and the sterilization container further comprises: a second external fluid connector port facing the environment surrounding the body, the second external fluid connector port being fluidly connectable to a second fluid connector of the sterilization apparatus; a second interior fluid opening facing the interior of the body and in fluid communication with the interior of the body, the second interior fluid opening configured to fluidly connect with a second item and in fluid communication with the second external fluid connector port; a second valve fluidly disposed between the second external fluid connector port and the second internal fluid opening, the second valve including a valve member movable between an open position allowing fluid flow between the second external fluid connector port and the second internal fluid opening and a closed position blocking fluid flow between the second external fluid connector port and the second internal fluid opening, the second valve being arranged to be engaged by the sterilization apparatus to move the valve member of the second valve toward the open position to allow fluid flow between the second fluid connector and the second item when the sterilization container is used with the sterilization apparatus and when the second item is fluidly connected to the second internal fluid opening.

3. The sterilization container according to claim 1 or claim 2.

9. further comprising a sterilant-permeable membrane configured to allow sterilant in an environment surrounding the body to pass through and enter the interior of the body; 3. The sterilization container according to claim 1 or claim 2.

10. The main body includes a box and a lid attachable to the box.

3. The sterilization container according to claim 1 or claim 2.

11. 1. A sterilization apparatus for sterilizing items inside a sterilization container, the sterilization apparatus comprising: a sterilization chamber defining an interior sized and shaped to receive the sterilization container; a container connector assembly configured to fluidly connect the sterile container to the sterilization apparatus, the container connector assembly including a fluid connector movable between a retracted position and an extended position, the fluid connector configured to engage the sterile container as the fluid connector moves from the retracted position toward the extended position to fluidly connect the fluid connector to the sterile container; Sterilization equipment.

12. a prime mover operably coupled to the fluid connector and configured to move the fluid connector between the retracted position and the extended position.

12. The sterilization device of claim 11.

13. the container connector assembly includes a pusher configured to move the fluid connector from the retracted position toward the extended position.

13. A sterilization apparatus according to claim 11 or claim 12.

14. the pusher is slidably mounted on at least one rail; 14. The sterilization device of claim 13.

15. the receptacle connector assembly includes a fluid connector mount, the fluid connector mounted to the fluid connector mount, and the pusher operably connected to the fluid connector mount for moving the fluid connector from the retracted position toward the extended position.

14. The sterilization device of claim 13.

16. the container connector assembly includes an initial positioning guide configured to engage the sterile container to initially position the sterile container relative to the sterilization chamber; 16. The sterilization device of claim 15.

17. the fluid connector mount including a final alignment guide configured to engage the sterile container to align the fluid connector with a fluid connector port of the sterile container relative to one another; 17. The sterilization device of claim 16.

18. the fluid connector moves along a longitudinal axis between the retracted position and the extended position, and the fluid connector is freely movable relative to the sterilization chamber along an imaginary plane perpendicular to the longitudinal axis.

13. A sterilization apparatus according to claim 11 or claim 12.

19. the sterilization chamber including a stopper positioned to engage the sterilization container and limit movement of the sterilization container as the fluid connector moves from the retracted position to the extended position.

13. A sterilization apparatus according to claim 11 or claim 12.

20. In combination with the sterilization container as claimed in claim 1.

13. A sterilization apparatus according to claim 11 or claim 12.

21. the sterile container is configured to maintain sterility of the article after sterilization by automatically sealing itself when the container connector assembly moves toward the retracted position and releases the sterile container.

21. The sterilization device of claim 20.

22. 1. A sterilization system for sterilizing an article, the sterilization system comprising: a sterilization container configured to receive the article; a sterilization chamber defining an interior sized and shaped to receive the sterilization container; a fluid connector configured to fluidly connect the sterilization container to a sterilization apparatus; and at least one of the fluid connector or the sterile container is configured to move toward the other of the fluid connector or the sterile container to fluidly connect the fluid connector and the sterile container to one another; Sterilization system.

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