Port connector

Abstract

The present disclosure relates to a port connector for sterilizing an exposed surface of a fluid port of an article to be sterilized to a sterilization apparatus. The port connector can include a housing that couples to the fluid port. The housing can define an inlet that fluidly couples to the fluid port, an outlet that fluidly couples to the sterilization apparatus, and a fluid passageway that fluidly couples the inlet and the outlet. The port connector can include a porous member supported by the housing. The porous member has a porous structure that defines a plurality of micropassages. The porous member is positioned relative to the housing to engage the fluid port when the port connector is connected to the fluid port.

Description

Cross - reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 193,377, filed May 26, 2021, which is hereby incorporated by reference in its entirety.

Technical Field

[0002] The present disclosure generally relates to port connectors, and more specifically, to port connectors for sterilizing the surface of fluid ports.

Background Art

[0003] Certain articles, such as medical devices (e.g., endoscopes), need to be sterilized between uses. These articles can include internal lumens that require sterilization. One way to sterilize these internal lumens is to move a sterilizing fluid or agent through the lumen. To move the sterilizing fluid through the lumen, a port connector is generally coupled to the fluid port of the article.

[0004] For example, International Publication No. WO 2018 / 090133 describes a sterilization system in which an endoscope is placed in a chamber having a port connector attached to a fluid port of the endoscope. The port connector fluidly couples the internal lumen of the endoscope to a pressure source (e.g., a negative pressure source). To sterilize the internal lumen of the endoscope, a sterilizing fluid (such as hydrogen peroxide vapor) is introduced into the chamber and then drawn through the internal lumen of the endoscope via the pressure source that is fluidly coupled to the endoscope by the port connector.

Summary of the Invention

[0005] In one aspect, a port connector for connecting to a fluid port of a device to be sterilized to a sterilization device is disclosed. The fluid port has a distal end that defines a fluid port outlet. The fluid port defines a lumen that extends proximally from the fluid port outlet. The port connector includes a housing configured to couple to the fluid port. The housing defines an inlet configured to be fluidly coupled to the lumen of the fluid port, an outlet configured to be fluidly coupled to the sterilization device, and a fluid passage extending between the inlet and the outlet to fluidly couple the inlet and the outlet. A porous member is supported by the housing. The porous member has a porous structure defining a plurality of microchannels. The porous member is disposed relative to the housing to engage the distal end of the fluid port when the port connector is connected to the fluid port.

[0006] In another aspect, a method of sterilizing a device having a fluid port includes connecting a port connector to the fluid port. The port connector defines an inlet, an outlet, and a fluid passage extending between the inlet and the outlet to fluidly connect the inlet and the outlet and being in fluid communication with the fluid port. The port connector has a porous member that engages an end of the fluid port. The method includes fluidly connecting a sterilization device to the outlet of the port connector and sterilizing the end of the fluid port by moving a sterilizing fluid through the porous member while the port connector is connected to the fluid port.

[0007] In another aspect, a port connector for connecting a fluid port of a device to be sterilized to a sterilization device includes a housing configured to couple to the fluid port. The housing defines an outlet configured to be fluidly coupled to the sterilization device. A seal is disposed to form a fluid tight seal with the fluid port. A piston is supported by the housing and is movable relative to the housing upon application of a pressure differential by the sterilization device.

[0008] In another aspect, a port connector for connecting to a fluid port of a device to be sterilized of a sterilization device includes a porous member having a porous structure defining a plurality of microchannels, and the fluid port defines a lumen. The porous member defines at least a part of a receiving chamber sized and formed to receive the fluid port. The inner surface is arranged to engage with the fluid port when the fluid port is disposed within the receiving chamber. A housing is coupled to the porous member. The housing defines an inlet configured to be fluidly coupled to the lumen of the fluid port, an outlet configured to be fluidly coupled to the sterilization device, and a fluid passage extending between the inlet and the outlet to fluidly couple the inlet and the outlet. The inlet is disposed in the at least a part of the receiving chamber defined by the inner surface of the porous member.

[0009] Other objects and features of the present disclosure will be in part apparent and in part pointed out hereinafter.

Brief Description of the Drawings

[0010]

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[0011] Corresponding reference numerals indicate corresponding parts throughout the drawings.

DETAILED DESCRIPTION OF THE INVENTION

[0012] The port connector disclosed herein can be used with the sterilization systems and methods described in International Publication No. WO 2018 / 090133. The port connectors described herein enable the sterilization of the fluid port itself even when the port connector is attached. The port connector allows the sterilizing fluid to contact the inner surface and / or outer surface of the fluid port that would otherwise be blocked or covered when using conventional port connectors, thus generally enabling the sterilization of the entire fluid port. More specifically, the outer or exposed surface is closest to the lumen of the fluid port because these surfaces are most likely to come into contact with the fluid flowing through the fluid port. The port connectors disclosed herein may be referred to as leak connectors because they may not form a fluid-tight seal with the fluid port and / or may form a fluid-tight seal with the fluid port only under certain conditions.

[0013] Referring to FIGS. 1-6, one embodiment of a port connector according to the present disclosure is generally indicated by reference numeral 100. The port connector 100 is shown attached to a fluid port 10 of an article (not shown) such as an endoscope. The illustrated fluid port 10 is a male fluid port having one or more circumferential barbs on the outside to facilitate connection and sealing of components and devices (such as tubes) to the fluid port, as is generally known in the art. As shown in FIGS. 2 and 3, the fluid port defines a fluid port outlet 16 at its end (e.g., distal end or free end) and a lumen 12 extending proximally from the fluid port outlet. The fluid port 10 has a distal end face 14 (broadly, an outer surface) at its end. The distal end face 14 faces distally and is adjacent to the fluid port outlet 16. Other configurations of the fluid port are within the scope of the present disclosure. The port connector 100 is used to connect a fluid port 10 of an article or device to be sterilized (by a sterilizing fluid) to a pressure source (e.g., a negative pressure source and / or a positive pressure source) of a sterilization system or apparatus (not shown) such as the sterilization system described in International Publication No. WO 2018 / 090133. In one embodiment, the pressure source is a negative pressure source that creates a pressure differential to draw a fluid (e.g., a sterilizing fluid) from the environment surrounding the article and the port connector 100 through the fluid port 10 and into the internal lumen of the article to sterilize the inner surface (e.g., the internal lumen) of the article. The negative pressure source can be any suitable pressure source such as a vacuum, a pump, or a chamber having a lower pressure than the environment surrounding the article.

[0014] The port connector 100 includes a housing 102. The housing 102 has a proximal end and a distal end. The proximal end defines an inlet 104 (FIG. 3) configured to be fluidly coupled to a fluid port (e.g., the inlet is arranged to be in fluid communication with the fluid port). In the illustrated embodiment, the proximal end includes an insertion portion 103 dimensioned and formed to be inserted through the fluid port outlet 16 into the lumen 12 of the fluid port 10 such that the inlet 104 is disposed within the lumen. The insertion portion 103 defines the inlet 104. Preferably, the insertion portion 103 does not engage the fluid port 10. The distal end (e.g., the distal port) defines an outlet 106 configured to be fluidly coupled to a negative pressure source (broadly, a sterilization device). In other words, the outlet 106 is arranged to be in fluid communication with the negative pressure source. In the illustrated embodiment, the distal end is configured to be coupled to a fluid conduit or tube to fluidly couple the outlet 106 to the negative pressure source. The distal end comprises a hooked tube port fixture. The housing 102 defines a fluid passage 108 (e.g., a lumen, a hole) that extends between the inlet 104 and the outlet 106 to fluidly couple the inlet 104 and the outlet 106 (e.g., effect fluid communication between the inlet 104 and the outlet 106).

[0015] The housing 102 is configured to be coupled to the fluid port 10. The housing 102 includes a coupler 110 configured to couple (e.g., attach) to the fluid port 10. In the illustrated embodiment, the coupler 110 includes first and second elastically flexible clips 112. The first and second clips 112 are configured to engage the fluid port 10 to couple (e.g., secure) the port connector 100 to the fluid port. Each clip 112 includes a retainer 114 configured to engage the fluid port 10 to secure the port connector 100 to the fluid port. The retainer 114 engages a hooked portion of the fluid port 10 to secure the coupler 110 to the fluid port. The clips 112 are disposed on opposite sides of the housing 102 and engage opposite sides of the fluid port 10. The housing 102 includes living hinges 116 that connect each clip 112 to the remainder of the housing (e.g., the central body). The living hinges 116 allow each clip 112 to elastically flex so that the coupler can be attached to and detached from the fluid port. The living hinges 116 bias the retainers 114 toward each other so that the port connector 100 is not inadvertently disconnected from the fluid port 10. Each clip 112 includes a finger tab 118 configured to be engaged by a user to flex the clip or pivot about the living hinge 116. Other configurations of the coupler are within the scope of the present disclosure. Additionally, the housing 102 can include one or more port guides 120 configured to engage the fluid port 10 to assist in centering the port connector 100 on the fluid port. In the illustrated embodiment, the housing 102 includes two port guides 120 disposed between the two clips 112 on opposite sides of the housing 102 so as to engage opposite sides of the fluid port 10. Opposing inner surfaces of the port guides 120 can engage the fluid port 10 to facilitate positioning of the port connector 100 on the fluid port. The housing 102 can be a single piece or a plurality of parts fixed to each other. The guides 120 and / or the clips 112 (broadly, the port connector 100) define a space sized and formed to receive an end portion of the fluid port 10.

[0016] Referring to FIGS. 3, 5, and 6, the port connector 100 includes a seal or gasket 122 (broadly, a fluid port interface member). The gasket 122 is supported (e.g., connected) by the housing 102. As shown in FIG. 3, the gasket 122 is supported by the housing 102 such that the gasket is partially spaced from the fluid port 10 when the housing is coupled to the fluid port. Specifically, the gasket 122 is disposed to face and be adjacent to the distal end face 14 of the fluid port 10 when the port connector 100 is attached to the fluid port. The guide 120 can also function as a stopper that engages the fluid port 10 to position the gasket 122 adjacent to the distal end face 14 (e.g., in a longitudinal or proximal direction). When the port connector 100 is attached to the fluid port 10, the port connector 100 (e.g., the gasket 122) does not form a fluid tight seal with the fluid port. Thereby, the sterile fluid in the environment surrounding the fluid port 10 of the article can contact and sterilize the surface (e.g., end face 14) of the fluid port that would otherwise be blocked or covered when the port connector 100 engages the fluid port to form a fluid tight seal.

[0017] When a negative pressure (i.e., a negative pressure difference) is applied to the lumen 12 of the fluid port via a negative pressure source, the port connector 100 forms a fluid-tight seal together with the fluid port 10. This allows a fluid (e.g., a sterilizing fluid) to be drawn through the fluid port 10 into the internal lumen of the article for sterilizing the article. The gasket 122 is configured to move towards the fluid port 10 and engage with the fluid port 10 when a negative pressure from a negative pressure source is applied to draw fluid through the fluid port, thereby forming a fluid-tight seal. As used herein, the term "fluid-tight seal" refers to a seal that provides a sufficient barrier to the flow of fluid as a result of a pressure difference such that fluid flows from other regions (e.g., the end of the internal lumen of the article opposite the fluid port), without requiring an absolute fluid-tight seal that prevents fluid from passing through. For example, the fluid-tight seal between the gasket 122 and the fluid port 10 must form a sufficient barrier to the flow of fluid between the gasket 122 and the fluid port 10 such that fluid is drawn into the port connector 100 through the fluid port and through the lumen(s) into the internal lumen(s) of the article. During operation, preferably, the gasket 122 forms an absolute fluid-tight seal together with the fluid port 10 such that fluid cannot pass between the gasket 122 and the fluid port 10, although such an absolute fluid-tight seal is not required for the operation of the port connector 100. As used herein, the phrase "negative pressure" means a pressure that is lower than the pressure of the environment surrounding the relative component to which the negative pressure, such as the port connector 100, is applied. For example, applying a negative pressure from a negative pressure source to the port connector 100 means imparting a pressure to the port connector that is lower than the pressure of the environment surrounding the port connector (e.g., the chamber of the sterilization system in which the port connector is located). In other words, the negative pressure creates a negative pressure difference between the environment surrounding the relative component and the negative pressure source, thereby causing fluid to flow from the environment towards the negative pressure source. The negative pressure can be a pressure above atmospheric pressure or a pressure below atmospheric pressure (a vacuum). In certain preferred embodiments, the negative pressure is lower than atmospheric pressure (a vacuum).

[0018] In the illustrated embodiment, gasket 122 includes flange 124. Flange 124 is bendable (e.g., elastically bendable). Flange 124 is ring-shaped. Flange 124 is configured to move toward fluid port 10 (as indicated by the arrow in FIG. 3) to engage fluid port 10 (e.g., end face 14) to form a fluid tight seal with the fluid port due to the application of a negative pressure. Flange 124 is disposed adjacent to end face 14 of fluid port 10 when port connector 100 is attached to the fluid port. For example, flange 124 may be spaced only a few millimeters from end face 14. As a result, when a negative pressure is applied by a negative pressure source, the negative pressure (e.g., a sufficient pressure difference occurring across flange 124) causes the flange to bend and engage the end face of fluid port 10, forming a fluid tight seal. In one embodiment, the pressure difference between the negative pressure source and the environment surrounding the article may be a ratio of about 1 / 100, although other differences are within the scope of the present disclosure. Flange 124 preferably extends radially outside a portion of housing 102 adjacent to the flange such that the radially outer portion (e.g., the distal face) of the flange is exposed to the environment to increase the effect of the pressure difference on the flange. Flange 124 can include a bending section 126 where most of the bending of the flange occurs. In the illustrated embodiment, the bending section is adjacent to the radially inner edge of flange 124 and has a thickness that is thinner than the thickness of the more radially outer portion of the flange. Thus, a weak point of flange 124 is formed around which the flange can be bent. Flange 124 is elastically deformable such that as the pressure difference approaches (or reaches) equilibrium, flange 124 returns to its non-deformed or non-bent state as shown in FIG. 3. For example, flange 124 may be designed to return to its non-bent state when the pressure difference is about half of the pressure difference initially applied by the negative pressure source. Thus, flange 124 can be configured to disengage from fluid port 10 and break the fluid tight seal over a specific pressure difference or range of pressure differences.

[0019] During operation, to sterilize an article having a fluid port 10, the port connector 100 is connected to the fluid port. As described above, the gasket 122 is spaced apart from the fluid port 100 when the port connector is first connected to the fluid port 10 (e.g., before a fluid tight seal is formed). A negative pressure source is fluidly connected to the port connector 100 (e.g., the outlet 106). The article with the fluid port 10 is placed within a chamber (e.g., a wash chamber). A fluid (e.g., a sterilizing fluid) is supplied or introduced into the chamber. The fluid can remain within the chamber for a period such as 5 - 10 minutes before the negative pressure is applied. During this time, the fluid can move naturally or be forced to move around the chamber and contact and sterilize the surfaces of the article and the fluid port, such as the surfaces that are blocked or covered when the port connector 10 engages the fluid port to form a fluid tight seal. Thereafter, the operator applies a negative pressure via the negative pressure source. As a result, a fluid tight seal is formed between the port connector 100 and the fluid port 10 (e.g., the end face 14) by moving the gasket 122 (e.g., the flange 124) towards and engaging it with the fluid port. As described above, the fluid tight seal is formed by bending the flange 124. Furthermore, the application of the negative pressure moves (e.g., draws) the fluid through the fluid port 10 and the port connector 100 and into the internal lumen of the article, thereby sterilizing the interior of the article. Thus, even if the port connector 100 is attached to the fluid port 10 during the sterilization process, generally, the entire fluid port is exposed to and sterilized by the sterilizing fluid at some point.

[0020] Referring to FIGS. 7 to 14, another embodiment of the port connector according to the present disclosure is generally indicated by reference numeral 200 as a whole. The port connector 200 in FIGS. 7 to 14 is generally similar to the port connector 100 in FIGS. 1 to 6. Therefore, for ease of understanding, when similar, analogous, or identical parts are used, the higher reference numeral "100" is used. Therefore, unless otherwise specified or indicated, the above description regarding the port connector 100 in FIGS. 1 to 6 also applies to the port connector 200 in FIGS. 7 to 14.

[0021] In this embodiment, the housing 202 includes a piston or plunger 230, a connector body 232, a sleeve or slide 234, and a cap 236. The cap 236 defines an outlet 206 and is configured to be coupled to a fluid conduit or tube to fluidly couple the outlet to a source of negative pressure. The plunger 230 defines an insertion portion 203 and an inlet 204. A gasket 222 is supported by the plunger 230. The connector body 232 defines a longitudinal bore 238 that extends through the connector body 232. The plunger 230 is movably (e.g., slidably) disposed within the longitudinal bore 238. The port connector 200 can include a seal 240, such as an O-ring, disposed between the plunger 230 and the connector body 232 to prevent fluid flow between the plunger and the connector body. In the illustrated embodiment, the seal 240 can also function as a stopper against which the plunger 230 engages to limit distal movement of the plunger relative to the connector body 232. The slide 234 is movably (e.g., slidably) supported (e.g., mounted) by the connector body 232. The slide 234 has a peripheral wall 242 that surrounds and moves relative to a cylindrical portion of the connector body 232. Accordingly, the peripheral wall 242 defines a cavity that is sized and formed to receive a distal end of the connector body 232. The port connector 200 can include one or more seals 244, such as O-rings, disposed between the slide 234 (e.g., the peripheral wall 242) and the connector body 232 (e.g., the cylindrical portion) to prevent fluid flow between the slide and the connector body. One or both of the slide 234 and the connector body 232 can define a groove that is sized and formed to receive a portion of the seal 240. In the illustrated embodiment, the connector body 232 defines the groove. The cap 236 is fixed to the slide 234 (e.g., the distal end of the slide). The slide 234 and the plunger 230 are operably coupled to each other such that movement of the slide results in movement of the plunger. In the illustrated embodiment, the plunger 230 is directly fixed to the slide 234.Slide 234 defines a plunger recess 258 (FIG. 13) sized and configured to receive the distal end of plunger 230.

[0022] Plunger 230, connector body 232, slide 234, and cap 236 define fluid passageway 208. That is, plunger 230, connector body 232, slide 234, and cap 236 each define a part of fluid passageway 208. Referring to FIG. 9, a part of fluid passageway 208 defined by plunger 230 includes one or more plunger openings 246 and a plunger passage (e.g., an elongate bore) 248. Plunger passage 248 extends between inlet 204 and plunger opening 246, fluidly coupling inlet 204 to the plunger opening. In the illustrated embodiment, plunger 230 defines two plunger openings 246 on both sides of the plunger. Fluid passageway 208 includes fluid chamber 250 defined by housing 202. One or more plunger openings 246 are in fluid communication with (e.g., directly in fluid communication with) fluid chamber 250. As will be described in more detail below, fluid chamber 250 is configured to substantially collapse or decrease in volume due to the application of a negative pressure (i.e., a pressure differential). Fluid chamber 250 is at least partially defined by connector body 232 and slide 234. Specifically, fluid chamber 250 is compartmentalized by the distal end of connector body 232, plunger 230, peripheral wall 242, and separation wall 252 of slide 234. A part of fluid passageway 208 defined by slide 234 includes at least one slide passage 254 (FIG. 13). Slide passage 254 fluidly couples fluid chamber 250 to outlet 206. In the illustrated embodiment, slide 234 includes four slide passages 254. Slide 234 and cap 236 define an outlet chamber 256 (FIG. 8) that is fluidly coupled to outlet 206. Slide passages 254 extend between outlet chamber 256 and fluid chamber 250 on both sides of separation wall 252, fluidly connecting them.

[0023] When a pressure difference (i.e., negative pressure) is applied, the plunger 230 moves along the longitudinal hole 238 toward or proximally to the fluid port 10 so as to move the gasket 222 toward the fluid port 10 (e.g., the end face 14) so that the gasket engages with the fluid port and forms a fluid tight seal together with the fluid port. Specifically, the slide 234 moves proximally relative to the connector body 232 due to the application of the negative pressure from the negative pressure source, and substantially reduces (e.g., collapses) the volume of the fluid chamber 250 (FIG. 10). As a result of the proximal movement of the slide 234, the plunger 230 moves proximally (from the initial position shown in FIG. 9) so as to move the gasket toward the fluid port so that the gasket 222 engages with the fluid port 10 (e.g., the end face 14) and forms a fluid tight seal together with the fluid port. FIG. 10 shows the gasket 222 in the sealing position that forms a fluid tight seal together with the fluid port 10 after the application of the negative pressure. Preferably, the gasket 22 forms an absolute fluid tight seal together with the fluid port 100. To facilitate the collapse of the fluid chamber 250, the combined cross-sectional area of the one or more slide passages 254 is larger than the combined cross-sectional area of the plunger openings 246. With this configuration, the plunger openings 246 create a restriction to the flow of fluid (compared to the slide passages 254), thereby facilitating the formation of a local negative pressure within the fluid chamber 250 sufficient to move the slide 234 proximally. Preferably, the plunger openings 246 are configured such that the plunger openings remain in fluid communication with the fluid chamber 250 when the plunger is moved proximally. In the illustrated embodiment, the distal end of the connector body 232 also includes a chamfer or inclined surface 260 at the distal end of the longitudinal hole 238 to keep the plunger openings 246 in fluid communication with the fluid chamber 250 when the plunger moves proximally (e.g., at the sealing position).

[0024] In the illustrated embodiment, the elasticity (e.g., flexibility) of gasket 222, the weight of slide 234 and cap 236, and the weight of the fluid conduit attached to cap 236 generally maintain slide and plunger 230 in the initial position (Figure 9) prior to the application of negative pressure when coupler 210 (e.g., clip 212, port guide 220) is attached to fluid port 10. In one embodiment, port connector 200 can include a spring (e.g., a coil spring) that can bias slide 234 and plunger 230 distally in the initial position.

[0025] Referring to Figure 14, plunger 230 is generally cylindrical. Plunger 230 defines a groove 262 in which gasket 222 is disposed. Groove 262 is defined distally by a radial or circumferential flange 264. Flange 264 supports gasket 222 when the gasket engages fluid port 10. Further, flange 264 is disposed to engage connector body 232, more specifically seal 240, in order to limit the distal movement of plunger 230 (e.g., position the plunger and slide 234 in the initial position).

[0026] Referring to FIG. 8A, a version of the port connector without seals 240, 244 is generally indicated by reference numeral 200'. The port connector 200' of FIG. 8A is similar to the port connector 200 of FIG. 8, and like, similar, or identical elements are given the same reference numeral with a trailing prime added. In this embodiment, the clearance between the outer surface of the connector body 232' and the inner surface of the slide 234' is very small, thereby forming an ultra-low leakage low-friction interface between the connector body and the slide that allows the slide to move relative to the connector body. Similarly, the clearance between the inner surface of the connector body 232' that defines the longitudinal hole 238' and the outer surface of the plunger 230' is also very small, again forming an ultra-low leakage low-friction interface between the connector body and the plunger that allows the plunger to move relative to the connector body. The low-leakage interfaces between these components are sufficient to provide a sufficiently large resistance to the flow of fluid between them, such that when a negative pressure is applied to the port connector 200', the slide 234' and the plunger 230' move to the sealing position in the proximal direction and draw fluid through the fluid port 10 as described herein in connection with the port connector 200 of FIG. 8. This occurs despite the fluid that can flow along these low-leakage interfaces. Thus, the port connector 200' of FIG. 8A generally functions and operates similarly to the port connector 200 of FIG. 8.

[0027] During operation, to sterilize an article having a fluid port 10, the port connector 200 is connected to the fluid port. As described above, the gasket 222 is spaced from the fluid port 10 when the port connector 200 is first connected to the fluid port (e.g., before a fluid tight seal is formed). A negative pressure source is fluidly connected to the port connector 200 (e.g., the outlet 206). The article with the fluid port 10 is placed within a chamber (e.g., a wash chamber). A fluid (e.g., a sterilizing fluid) is supplied or introduced into the chamber. The fluid can remain within the chamber for a period such as 5 - 10 minutes before applying the negative pressure. During this time, the fluid can move naturally or be forced to move around the chamber and contact and sterilize the surfaces of the article and the fluid port, such as the surfaces that are blocked or covered when the port connector 10 forms a fluid tight seal with the fluid port. Thereafter, the operator applies a negative pressure via the negative pressure source. As a result, a fluid tight seal is formed between the port connector 200 and the fluid port 10 (e.g., the end face 14) by moving the gasket 222 towards and engaging it with the fluid port when connected to the fluid port by each clip 212 (e.g., the retainer 214). As described above, moving the gasket 222 includes moving the plunger 230 and the slide 234. Specifically, applying the negative pressure creates a vacuum within the fluid chamber 250 that moves the slide 234 proximally relative to the connector body 232. Further, applying the negative pressure moves (e.g., draws) the fluid through the fluid port 10 and the port connector 200 into the internal lumen of the article, thereby sterilizing the interior of the article.

[0028] Referring to FIGS. 15 to 17, another embodiment of the port connector according to the present disclosure is generally indicated by reference numeral 300 as a whole. The port connector 300 of FIGS. 15 to 17 is generally similar to the port connector 100 of FIGS. 1 to 6. Therefore, for ease of understanding, when similar, analogous, or identical parts are used, a higher reference numeral "200" is used. Accordingly, unless otherwise specified or indicated, the above description regarding the port connector 100 of FIGS. 1 to 6 also applies to the port connector 300 of FIGS. 15 to 17.

[0029] The port connector 300 of the present embodiment includes a porous member 322 (broadly, a fluid port interface member). The porous member 322 is supported by the housing 302. In the illustrated embodiment, the porous member 322 is attached to the insertion portion 303. As shown in FIG. 17, the porous member 322 is disposed with respect to the housing 302 so as to engage with the fluid port 10 when the port connector 300 is connected to the fluid port. Specifically, the porous member 322 is disposed so as to engage with the distal end (specifically, the distal end face 14) of the fluid port 10. The porous member 322 has a porous structure that defines a plurality of randomly arranged interconnected interstitial spaces, and the interstitial spaces penetrate the porous member and / or form a plurality of microchannels 321 within the porous member. The porous member 322 is disposed so as to face and engage with the distal end face 14 of the fluid port 10 when the port connector 300 is attached to the fluid port. The porous member 322 is disposed with respect to the housing 302 such that at least a part of the microchannels fluidly couples the fluid port outlet 16 to the external environment of the port connector 300 when the port connector is connected to the fluid port 10. Therefore, when the port connector 300 is attached to the fluid port 10, the porous member 322 does not form an absolute fluid tight seal with the fluid port. Instead, fluid can move through the porous member 322 via the microchannels 321. However, as will be described in more detail below, the port connector 300 can still be considered to form a fluid tight seal (as defined herein) with the fluid port because the porous member 322 sufficiently impedes the flow of fluid through the fluid port 10 such that fluid flows from other regions (e.g., the end of the internal lumen of an article on the opposite side of the fluid port) as a result of a pressure difference.

[0030] The porous member is preferably made of a biocompatible, hydrophobic, and / or nonflammable material. In one embodiment, the porous member is formed from expanded polytetrafluoroethylene (ePTFE) such as FluroFlex® ePTFE, although other suitable materials are also within the scope of the present disclosure. In one embodiment, the porous member has a density of about 0.3 - 0.6 g / cm 3Within its comprehensive range, or more preferably, having a density within the range of about 0.4 to 0.5 g / cm 3 may be obtained.

[0031] In one embodiment, as shown, the microchannels 321 of the porous member 322 are arranged substantially randomly throughout the porous member. In one embodiment, a porous control material or coating 325 (FIG. 17A) is applied to the porous member 322. For example, the porous control material 325 may be applied to one or more surfaces (e.g., the outer surface) of the porous member 322. The porous control material 325 may be applied over the entire surface of the porous member 322 or only to a portion of the surface. The porous member 322 may be fitted or coated with the porous control material 325. By applying the porous control material 325 to one or more surfaces of the porous member 322, a flow path can be defined through the porous member without relying on the randomness of the microchannels 321. The porous control material 325 at least partially blocks at least a portion of the microchannels 321 of the porous member 322 to control how and where the sterilizing fluid flows through the porous member. The porous control material 325 may completely block the microchannels 321 or may only partially block the microchannels where the porous control material is aligned (e.g., a cover). Also, the porous control material 325 can increase the resistance to the flow of the sterilizing fluid through the porous member 322 to allow an appropriate amount of the sterilizing fluid to also be drawn through the article. Preferably, the resistance to the flow of the sterilizing fluid through the article and the porous member 322 is relatively similar to allow the sterilizing fluid to be drawn through both the porous member and the article when a pressure differential is applied by the sterilization device. By applying the porous control material 325 to the porous member 322, a fluid path (through the microchannels 321) through the porous member closest to or in contact with the fluid port 10 (e.g., the surface of the fluid port) can be more easily defined to more reliably ensure that the sterilizing fluid contacts the fluid port when the sterilizing fluid flows through the porous member. For example, in one embodiment, the porous control material 325 is spaced apart from the portion of the porous member in contact with the fluid port 10. The porous control material 325 may be non-porous or may have a porosity smaller than the porosity of the porous member 322. The porous control material 325 can be made of any suitable material such as polytetrafluoroethylene (PTFE).

[0032] Referring further to FIG. 17, the porous member 322 is disposed relative to the housing 302 such that when the port connector 300 is connected to the fluid port 10, the porous member covers a part (broadly, at least a part) of the fluid port outlet 16. The porous member 322 includes an engagement surface 323 that is disposed to engage the distal end (e.g., distal end face 14) of the fluid port 10. The engagement surface 323 generally faces proximally. In the illustrated embodiment, the engagement surface 323 has a generally annular shape so as to coincide with the generally annular end of the fluid port. The inner diameter ID (FIG. 17A) of the engagement surface 323 is smaller than the diameter D of the fluid port outlet 16. Similarly, the engagement surface 323 has an outer diameter OD (FIG. 17A) that is larger than the diameter D of the fluid port outlet 16. In one embodiment, the porous member 322 has a generally donut shape.

[0033] The porous member 322 allows the sterilizing fluid in the environment surrounding the fluid port 10 of the article to contact and sterilize the surface (e.g., end face 14) of the fluid port. When a negative pressure differential force is applied to the port connector 300 via a negative pressure source, the sterilizing fluid moves (e.g., is drawn) through the porous member 322 (specifically, through at least some of the plurality of microchannels 321). Some of these microchannels 321 lead to and / or along the portion (e.g., end face 14) of the fluid port 10 with which the porous member 322 is engaged. As a result, when the sterilizing fluid passes through the porous member 322, the sterilizing fluid contacts the fluid port 10 such as the end face 14, thereby sterilizing the portion of the fluid port with which the porous member engages.

[0034] In this embodiment, the housing 302 includes a plurality of port guides 320 configured to engage with the fluid port 10 to align the porous member 322 with the end of the fluid port. In the illustrated embodiment, the housing 302 includes six port guides 320, three of which are disposed on one side of the housing and three of which are disposed on the opposite side of the housing. Each port guide 320 includes a fin or flange having an inner edge that engages with the fluid port 10 to facilitate positioning of the port connector 300 on the fluid port 10. The inner edge of each port guide 320 is contoured or shaped to conform to the outer shape of the fluid port 10. Further, the port guide 320 also functions as a stopper for positioning the port connector 300 with respect to the fluid port 10 (e.g., positioning in the longitudinal or proximal direction).

[0035] During operation, to sterilize an article having a fluid port 10, a port connector 300 is connected to the fluid port. As described above, the porous member 322 engages the end of the fluid port 10 (e.g., the distal end face 14). The negative pressure source of the sterilization device is fluidly connected to the port connector 300 (e.g., the outlet 306). The article with the fluid port 10 is placed in a chamber (e.g., a washing chamber). A fluid (e.g., a sterilizing fluid) is supplied or introduced into the chamber. The fluid can remain in the chamber for a period such as 5 to 10 minutes before applying the negative pressure. During this time, the fluid can move naturally or be forced to move around the chamber and contact the surfaces of the article such as the exposed surface and the surface of the fluid port to sterilize the surface. Also, the fluid can move into and through the porous member 322. Then, the operator applies a differential pressure (e.g., a negative pressure differential) via the negative pressure source. As a result, the negative pressure differential moves (e.g., draws) the sterilizing fluid from the chamber through the porous member into the lumen 12 of the fluid port 12. As the sterilizing fluid moves through the microchannels 321 of the porous member 322, the sterilizing fluid contacts the distal end face 14 (and other surfaces engaged by the porous member), thereby sterilizing the distal end face of the fluid port 10. Further, the negative pressure differential moves (e.g., draws) the sterilizing fluid through the fluid port 10 and the port connector 100 into the internal lumen of the article, thereby sterilizing the interior of the article. The movement of the sterilizing fluid through the article and the porous member 322 generally occurs simultaneously. The sterilizing fluid drawn through the article and the porous member 322 is then drawn through the port connector 300 and moves towards the negative pressure source. Thus, even if the port connector 300 is attached to the fluid port 10 during the sterilization process, generally, the entire fluid port is exposed to and sterilized by the sterilizing fluid.

[0036] Referring to FIGS. 18-23, another embodiment of a port connector according to the present disclosure is generally indicated by reference numeral 600. The port connector 600 is shown attached to a fluid port 20 of an article (not shown) such as an endoscope. Other configurations of the fluid port are within the scope of the present disclosure. The port connector 600 is used to connect a fluid port 20 of an article or device to be sterilized (by a sterilizing fluid) to a pressure source (e.g., a negative pressure source and / or a positive pressure source) of a sterilization system or apparatus (not shown) such as the sterilization system described in International Publication No. WO 2018 / 090133. The pressure source creates a pressure differential to move a fluid (e.g., a sterilizing fluid) through the fluid port 20 and the port connector 600 from the environment surrounding the article into the internal lumen of the article to sterilize the inner surface (e.g., the internal lumen) of the article. The pressure source can be any suitable pressure source such as a vacuum, a pump, or a chamber having a pressure lower / higher than the environment surrounding the article.

[0037] The port connector 600 includes a housing 602. The housing 602 has a proximal end and a distal end. The proximal end defines an inlet 604 configured to be fluidly coupled to the fluid port. The inlet 604 is sized and formed to receive at least a portion (e.g., the distal portion) of the fluid port 20. In the illustrated embodiment, the inlet 604 is an elongated aperture. Preferably, the portion of the housing 602 that defines the inlet 604 does not engage the fluid port 20. The distal end (e.g., the distal port) defines an outlet 606 configured to be fluidly coupled to the pressure source. In the illustrated embodiment, the distal end is configured to be coupled to a fluid conduit or tube to fluidly couple the outlet 606 to the pressure source. The inlet 604 and the outlet 606 are fluidly coupled to each other. The housing 602 defines a fluid passageway 608 that extends between and fluidly couples the inlet 604 and the outlet 606. The housing 602 is configured to be coupled to the fluid port 20. In the illustrated embodiment, the housing 602 is composed of a plurality of components fixed to each other. The housing 602 can be made of any suitable material such as plastic (e.g., polypropylene).

[0038] The port connector 600 includes a seal or gasket 610 (broadly, a fluid port interface member). The seal 610 is supported (e.g., connected) by the housing 602. In particular, the seal 610 is disposed along the inlet 604. The seal 610 is configured to engage with the fluid port 20. As will be described in more detail below, the seal 610 is configured to move from a first location or position on the fluid port 20 to a second location or position on the fluid port. The seal 610 engages with the fluid port 20 to prevent the flow of fluid between the seal and the fluid port. Preferably, the seal 610 forms an absolute fluid tight seal with the fluid port 20. In the illustrated embodiment, the seal 610 is an O-ring. The housing 602 includes a groove 612 (e.g., a circumferential groove) in which the seal 610 is disposed. The seal 610 extends inwardly (e.g., radially inwardly) from the inner surface defining the inlet 610 to engage with the fluid port 20. The seal 610 can be made of any suitable material such as a thermoplastic elastomer (TPE) (e.g., styrene-ethylene-butylene-styrene (SEBS)).

[0039] The port connector 600 includes a piston or plunger 614. The plunger 614 is movably (e.g., slidably) disposed within the housing 602. The plunger 614 is disposed within the fluid passage 608. The plunger 614 includes a flange 618 and a shaft 616 extending proximally from the flange. The flange 618 has a generally conical shape. The flange 618 tapers outwardly (e.g., radially outwardly) as the flange extends distally from the shaft 616. The outer edge of the flange 618 (broadly, the plunger 614) includes one or more slots 620. The slots 620 are configured to allow the flow of fluid around the plunger 614. As will be described in more detail below, the slots 620 allow the flow of fluid from the inlet 604 to the outlet 606. The plunger 614 can be made of any suitable material such as plastic (e.g., polyethylene, polypropylene, polytetrafluoroethylene).

[0040] The plunger 614 is configured to move within the housing 602 from an initial position (Figs. 19 and 20) to a second position (Figs. 21 and 22). The plunger 614 moves proximally or toward the fluid port (and distally from the second position to the initial position) from the initial position to the second position. In the initial position, the plunger 614 (and the housing 602) is configured to allow fluid to flow between the inlet 604 and the outlet 606. As shown in Fig. 20, the housing 602 defines a plunger recess 622. When the plunger 614 is in the initial position, the outer edge of the flange 618 is aligned (e.g., laterally aligned) with the plunger recess 622. In some embodiments, the plunger recess 622 may be dimensioned and formed to receive the outer edge of the flange 618. The plunger recess 622 provides a clearance between the outer edge of the flange 618 and the inner surface of the housing 602 to allow fluid to flow around the plunger (e.g., the flange) toward the outlet 606 through the plunger recess 622 and the slot 620. In the illustrated embodiment, the flange 618 engages the distal inner surface 624 of the housing 602 when the plunger is in the initial position. The distal inner surface 624 functions as a stopper that limits the distal movement of the plunger 614 relative to the housing 602 and positions the plunger in the initial position. In the initial position, the plunger 614 is preferably spaced apart from the fluid port 20. In the second position, when the plunger moves proximally toward the second position, the outer edge of the flange 618 engages the inner surface of the housing 602. This engagement forms a seal between the plunger 614 and the housing 602 to prevent or block the flow of fluid between the plunger and the housing.

[0041] The fluid passage 608 includes a fluid chamber 626. The fluid chamber is defined by a plunger 614 (e.g., flange 618) and a housing 602. As will be described in more detail below, the fluid chamber 626 is configured to expand or increase in volume due to the application of a positive pressure (i.e., a positive pressure differential) from a pressure source (when the plunger 614 is in its initial position). Also, the fluid chamber 626 is configured to substantially collapse or decrease in volume due to the application of a negative pressure (i.e., a negative pressure differential) from a pressure source (when the plunger 614 is in a second position). As used herein, the phrase "positive pressure" means a pressure that is higher than the pressure of the environment surrounding a relative component, such as port connector 600, to which the positive pressure is applied. For example, applying a positive pressure from a pressure source to port connector 600 means applying a higher pressure to the port connector relative to the pressure of the environment surrounding the port connector (e.g., the chamber of a sterilization system in which the port connector is located). In other words, positive pressure creates a positive pressure differential between the environment surrounding the relative component and the pressure source, thereby causing fluid to flow from the pressure source towards the environment. Positive pressure can be a pressure above atmospheric pressure or a pressure below atmospheric pressure (a vacuum). In certain preferred embodiments, the positive pressure is above atmospheric pressure.

[0042] The plunger 614 is configured to press the fluid port upon application of a positive pressure from a pressure source, moving the housing 602 and the seal 610 distally relative to the fluid port 20, thereby moving the seal to a second location or position on the fluid port. Specifically, the plunger 614 moves proximally relative to the housing 602 due to the application of a pressure differential (i.e., positive pressure), expanding the fluid chamber 626 and pressing the fluid port 20. Thus, the plunger 614 engages the fluid port 20 when the plunger moves from an initial position to a second position. The plunger 614 generally forms a seal (e.g., a fluid tight seal) with the housing 602 as the plunger moves proximally from the initial position until the application of positive pressure from the pressure source, blocking the flow of fluid between the inlet 604 and the outlet 606. The plunger recess 622 and the slot 620 provide sufficient restraint to the fluid flow such that the flange 618 engages the inner surface of the housing when positive pressure moves the plunger proximally.

[0043] By moving the seal 610 on the fluid port 20 by moving the plunger 614, a portion of the fluid port at the first position (otherwise blocked or covered by the seal 610 when the port connector 600 was first coupled to the fluid port) is exposed to the fluid within the environment surrounding the fluid port of the article and contacts a portion of the surface at the first position to sterilize it. As will be described below, it will be understood that a portion of the surface at the second position was pre-sterilized by the fluid when the fluid was first drawn through the port connector 600. Also, the plunger 614 is configured to move distally towards the initial position after the plunger has pressed the fluid port 20, reducing (e.g., collapsing, shrinking) the volume of the fluid chamber 626 upon application of a negative pressure from the pressure source.

[0044] In the illustrated embodiment, the distal portion of the inlet 604 tapers (e.g., the inlet tapers radially inward as it extends proximally). The plunger 614 (e.g., the tip of the shaft 616) is sized and configured to move along the inlet 604. The taper of the inlet 604 serves to guide the plunger 614 into engagement with the fluid port 20. Further, preferably, the taper of the inlet 604 reduces the size of the inlet such that as the plunger moves proximally, the plunger eventually engages a portion of the housing 602 that defines the inlet, thereby stopping further movement. Thus, this portion of the housing 602 limits the proximal movement of the plunger 614 and acts as a stop for positioning the plunger in the second position.

[0045] During operation, to sterilize an article having a fluid port 20, the port connector 600 is connected to the fluid port. When connected, the seal 610 engages the fluid port 20 in a first position. A pressure source is fluidly connected to the port connector 600 (e.g., outlet 606). The article with the fluid port 20 is placed within a chamber (e.g., a washing chamber). A fluid (e.g., a sterilizing fluid) is supplied or introduced into the chamber. The fluid can remain within the chamber for a period such as 5 - 10 minutes before applying a negative pressure. During this time, the fluid can move naturally or be forced to move around the chamber and contact the surfaces of the article and the fluid port to sterilize the surfaces. Thereafter, the operator can apply a negative pressure via the pressure source. The application of the negative pressure moves (e.g., draws) the fluid into the internal lumen of the article through the fluid port 20 and the port connector 600, thereby sterilizing the interior of the article. The fluid flows around the plunger 614 through the inlet 604, the plunger recess 622, and the slot 620 and into the outlet 606. When the fluid flows into the inlet 604, the fluid flows across a second position on the fluid port 20. After a sufficient amount of fluid has been drawn through the article, the operator can apply a positive pressure via the pressure source. As a result of the application of the positive pressure, the seal 610 moves from the first position to the second position along the fluid port 20. As described above, the application of the positive pressure moves the plunger 614 relative to the housing 602 to move the seal 610. Specifically, the application of the positive pressure expands the fluid chamber 626 and presses the plunger into contact with the fluid port 20. When the plunger 614 contacts the fluid port 20, the continued application of the positive pressure continues to expand the fluid chamber 626 by moving the housing 602 (and thus the seal 610) distally relative to the plunger (this prevents further proximal movement due to engagement with the fluid port here). In one method of operation, the movement of the plunger 614 separates or disengages the port connector 600 (e.g., the seal 610) from the fluid port 20.Specifically, the plunger 614 not only moves the seal 610 to the second position, but also continues to move the seal until the seal is disengaged from the fluid port 20, such as by sliding the seal from the distal end of the fluid port. In another method of operation, after applying positive pressure, the operator can apply negative pressure again through the pressure source, thereby moving the plunger 614 distally back to the initial position. The reapplied negative pressure creates a vacuum in the fluid chamber 626 that moves the plunger 614 distally to the initial position relative to the housing 602. When in the initial position, fluid can flow freely around the plunger 614 again.

[0046] Referring to FIGS. 24-27, another embodiment of a port connector according to the present disclosure is generally indicated by reference numeral 400. As shown in FIGS. 25 and 26, the port connector 400 is attached to a fluid port 10' of an article (not shown), such as an endoscope, to be sterilized. The fluid port 10' shown in FIGS. 25 and 26 is substantially the same as the fluid port 10 described above, except that the fluid port 10' does not have any hook-like portions on its exterior. Instead, the fluid port 10' has a generally smooth cylindrical outer surface.

[0047] The port connector 400 includes a housing 402. The housing 402 has a proximal end and a distal end. The distal end (e.g., the distal port) defines an outlet 406 configured to be fluidly coupled to a negative pressure source (broadly, a sterilization device). In other words, the outlet 406 is arranged to be in fluid communication with the negative pressure source. In the illustrated embodiment, the distal end is configured to be coupled to a fluid conduit or tube to fluidly couple the outlet 406 to the negative pressure source. The distal end comprises a hooked tube port fixture. Also, the housing 406 defines an inlet 404 configured to be fluidly coupled to the fluid port 10’, specifically its lumen 12. In other words, the inlet 404 is arranged to be in fluid communication with the fluid port 10’, specifically its lumen 12. The housing 402 defines a fluid passage 408 (e.g., a lumen, a hole) that extends between and fluidly couples the inlet 404 and the outlet 406 (e.g., provides fluid communication between the inlet 404 and the outlet 406).

[0048] The port connector 400 of this embodiment includes a porous member 422 (broadly, a fluid port interface member). The porous member 422 is coupled to the housing 402. In the illustrated embodiment, the porous member 422 is mounted to the housing 402. The porous member 422 is flexible, deformable, and has a generally tubular shape. The housing 402 has a cylindrical wall 410. The porous member 422 has a proximal end and a distal end, both of which are coupled to the housing 402. The distal end of the porous member 422 is mounted to the cylindrical wall 410 (e.g., the cylindrical wall is disposed within the porous member). The cylindrical wall 410 defines a part of the fluid passage 408. The housing 402 also includes a mounting ring 412. The mounting ring 412 is disposed proximal to the cylindrical wall 410 and the inlet 404. The proximal end of the porous member 422 is mounted to the mounting ring 412. The connector 400 includes a retaining ring 414 (broadly, a retainer) that secures the porous member 422 (the proximal end of the porous member 422) to the mounting ring 412. In the illustrated embodiment, the porous member 422 folds back on itself to be fixed to the mounting ring 412. The proximal end of the porous member 422 bends around the mounting ring 412. The retaining ring 414 then clamps or secures the proximal end of the porous member 422 against the outside of the mounting ring 412. The housing 402 includes one or more supports 416 for supporting the mounting ring 412. The supports 416 extend between the mounting ring 412 and the body of the housing 422 to couple the mounting ring 412 to the body of the housing 422.

[0049] Connector 400 defines a receiving chamber 418. The receiving chamber 418 is dimensioned and configured to receive the fluid port 10'. The porous member 422 defines at least a portion of the receiving chamber 418. The inlet 404 of the housing 402 is in fluid communication with the receiving chamber 418. The inlet 404 is disposed in the portion of the receiving chamber 418 defined by the porous member 422. In the illustrated embodiment, the inlet 404 is disposed substantially adjacent to the distal end of the receiving chamber 418. The receiving chamber 418 includes a port or receiving inlet 420 (FIG. 24). The port inlet 420 is dimensioned and configured to receive the fluid port 10' to enable insertion of the fluid port into the receiving chamber 418. The port inlet 420 is disposed at the proximal end of the receiving chamber. In the illustrated embodiment, the port inlet 420 is defined by the porous member 422. The porous member 422 defines the proximal end of the port connector 400.

[0050] As shown in FIGS. 25 and 26, the porous member 422 is arranged to engage with the fluid port 10' when the port connector 400 is connected to the fluid port. Specifically, the porous member 422 (specifically, its interior or engagement surface) is arranged to engage with the fluid port 10' when the fluid port is disposed within the receiving chamber 418. The porous member 422 is arranged to engage with the cylindrical outer surface of the fluid port 10'. Preferably, the porous member 422 is configured to form an interference fit or a friction fit with the fluid port 10'. The porous member 422 has an inner diameter at the narrowest point of the receiving chamber 418 (when the porous member is stationary and not deflected by the fluid port 10'). The inner diameter is equal to or, more preferably, smaller than the outer diameter of the fluid port 10'. This ensures that the porous member 422 engages and deforms with the fluid port 10', and by elastic deformation, a force is applied to the fluid port to hold the port connector 400 thereon. In other words, the porous member is pressed against the fluid port. FIG. 26 shows the porous member 422 in its stationary and undeformed state, but it is understood that the fluid port 10' deforms the porous member by expanding the port inlet 420 and / or the receiving chamber 418 (e.g., a part of the receiving chamber) so that the fluid port can be received by the port connector 400.

[0051] The porous member 422 has a porous structure defining a plurality of interconnected interstitial spaces arranged randomly, and the interstitial spaces form a plurality of microchannels 421 through and / or within the porous member. The porous member 422 is disposed relative to the remainder of the port connector 400 such that at least a portion of the microchannels 421 fluidly couple the receiving chamber 418 to the external environment of the port connector 400. Thus, when the port connector 400 is attached to the fluid port 10’, the porous member 422 does not form an absolute fluid tight seal with the fluid port. Instead, fluid can move through the porous member 422 via the microchannels. However, as will be described in more detail below, the port connector 400 can still be considered to form a fluid tight seal (as defined herein) with the fluid port 10’ because the porous member 422 sufficiently impedes the flow of fluid through the fluid port 10’ such that fluid flows from other regions (e.g., to the end of the internal lumen of the article on the side opposite the fluid port) as a result of a pressure differential. The porous member 422 may be made of the same material as described above with respect to the porous member 322.

[0052] The porous member 422 allows the sterilizing fluid within the environment surrounding the fluid port 10’ of the article to contact and sterilize the surface of the fluid port (e.g., the end face 14, the cylindrical outer surface). When a negative pressure differential force is applied to the port connector 400 via a negative pressure source, the sterilizing fluid moves (e.g., is drawn) through the porous member 422 (specifically, through at least some of the plurality of microchannels 421). Some of these microchannels 421 lead to and / or along the portion of the fluid port 10’ with which the porous member 422 is engaged. As a result, as the sterilizing fluid moves through the porous member 422, the sterilizing fluid contacts the fluid port 10’, thereby sterilizing the portion of the fluid port engaged by the porous member.

[0053] In one embodiment, as shown, the microchannels 421 of the porous member 422 are arranged substantially randomly throughout the porous member. In one embodiment, a porous control material or coating 425 (FIG. 26) is applied to the porous member 422. For example, the porous control material 425 may be applied to one or more surfaces (e.g., the outer surface) of the porous member 422. The porous control material 425 may be applied over the entire surface of the porous member 422 or only to a portion of the surface. The porous member 422 may be mated or coated with the porous control material 425. By applying the porous control material 425 to one or more surfaces of the porous member 422, it is possible to define a flow path through the porous member without relying on the randomness of the microchannels 421. The porous control material 425 at least partially blocks at least a portion of the microchannels 421 of the porous member 422 to control how and where the sterilizing fluid flows through the porous member. The porous control material 425 may completely block the microchannels 421 or may only partially block the microchannels where the porous control material is aligned (e.g., a cover). Also, the porous control material 425 can increase the resistance to the flow of the sterilizing fluid through the porous member 422 to allow an appropriate amount of the sterilizing fluid to also be drawn through the article. Preferably, the resistance to the flow of the sterilizing fluid through the article and the porous member 422 is relatively similar to allow the sterilizing fluid to be drawn through both the porous member and the article when a pressure differential is applied by the sterilization device. By applying the porous control material 425 to the porous member 422, it is easier to define a fluid path that penetrates (via the microchannels 421) the porous member closest to or in contact with the fluid port 10' (e.g., the surface of the fluid port), making it more certain that the sterilizing fluid contacts the fluid port when flowing through the porous member. For example, in one embodiment, the porous control material 425 is disposed on the distal side of the proximal end of the porous member 422, thereby defining a fluid path that enters the proximal end of the porous member along the outer surface of the port 10' and enters the receiving chamber 418. The porous control material 425 may be non-porous or may have a porosity smaller than the porosity of the porous member 422.The porous control material 425 can be made of any suitable material such as polytetrafluoroethylene (PTFE).

[0054] Referring to FIGS. 26 and 27, the housing 402 includes a stopper 424. The stopper 424 is arranged to engage with the fluid port 10' and position the fluid port within the receiving chamber 418. The stopper 424 is arranged to engage with the distal end 14 of the fluid port 10'. The stopper 424 restricts the distal movement of the fluid port 10' relative to the port connector 400 in the insertion direction. The insertion direction is the direction in which the fluid port 10' moves relative to the port connector 400 when the port connector is connected to the fluid port, i.e., the direction in which the fluid connector is inserted into the port inlet 420. In the illustrated embodiment, the stopper 424 includes an edge arranged to engage with the fluid port 10. The edge is arranged at the proximal end of the cylindrical wall 410. Preferably, the stopper 424 is the only part of the housing 402 arranged to engage with the fluid port 10' to prevent the housing from otherwise obstructing the flow of the sterilizing fluid around the fluid port 10'. Preferably, the stopper 424 allows the sterilizing fluid to flow between the stopper and the fluid port 10' when the stopper is engaged with the fluid port and a pressure difference is applied. Thus, the narrow edge-like engagement of the stopper 424 disclosed herein does not form a seal with the fluid port 10', thereby allowing the sterilizing fluid to flow between the stopper and the fluid port. In one embodiment, the stopper 424 can define a recess or channel (not shown) to further facilitate the flow of the sterilizing fluid between the stopper and the fluid port 10'. In the illustrated embodiment, the stopper 424 defines an inlet 404.

[0055] The port connector 400 can include a port guide 426. The port guide 426 is configured to be substantially aligned with the lumen 12 of the fluid port 10' with the inlet 404. The port guide 426 is dimensioned and formed to be received within the lumen 12 of the fluid port 10'. In the illustrated embodiment, a portion of the port guide 426 is disposed within the fluid passage 408. The port guide 426 is attached to the inner wall of the housing 402 (broadly, the port guide is part of the housing). The inner wall defines one or more openings 428 (FIG. 27) that are part of the fluid passage 408 and through which the sterilizing fluid can flow as the sterilizing fluid flows from the inlet 404 to the outlet 406. The port guide 426 extends proximally from the inner wall of the housing 402. The port guide 426 extends through the inlet 404. In the illustrated embodiment, the port guide 426 has a generally frustoconical shape, although other shapes are within the scope of the present disclosure. The port guide 426 serves to properly position the fluid port 10' relative to the port connector 400 when the port connector is attached to the fluid port.

[0056] During operation, to sterilize an article having a fluid port 10’, the port connector 400 is connected to the fluid port by inserting the fluid port into the receiving chamber 418 through the port inlet 420. As described above, the porous member 422 engages the fluid port 10’. The negative pressure source of the sterilization device is fluidly connected to the port connector 400 (e.g., the outlet 406). The article with the fluid port 10’ is placed within a chamber (e.g., a washing chamber). A fluid (e.g., a sterilizing fluid) is supplied or introduced into the chamber. The fluid can remain within the chamber for a period such as 5 - 10 minutes before applying a negative pressure. During this time, the fluid can move naturally or be forced to move around the chamber and contact the surfaces of the article and the fluid port, such as the exposed surface, to sterilize the surface. Also, the fluid can move into and through the porous member 422. Thereafter, the operator applies a differential pressure (e.g., a negative pressure differential) via the negative pressure source. As a result, due to the negative pressure differential, the sterilizing fluid moves (e.g., is drawn) from the chamber through the porous member into the receiving chamber 418. When the sterilizing fluid moves through some of the microchannels 421 of the porous member 422, the sterilizing fluid contacts the cylindrical outer surface, thereby sterilizing the portion of the fluid port 10’ engaged by the port connector. After the sterilizing fluid enters the receiving chamber 418, the sterilizing fluid moves around the fluid port 10’ and sterilizes the remaining fluid ports housed in the receiving chamber before the sterilizing fluid enters the inlet 404 of the port connector 400. Aligning the inlet 404 with the porous member 422 (e.g., laterally aligning) is thought to result in a more substantial flow of the sterilizing fluid through the porous member. Further, the negative pressure differential moves (e.g., draws) the sterilizing fluid through the fluid port 10’ and the port connector 400 into the internal lumen of the article, thereby sterilizing the interior of the article. The movement of the sterilizing fluid through the article and the porous member 422 generally occurs simultaneously. The sterilizing fluid drawn through the article and the porous member 422 is then drawn through the port connector 400 and moves towards the negative pressure source.Accordingly, even if the port connector 400 is attached to the fluid port 10 during the sterilization process, generally, the entire fluid port is exposed to the sterilizing fluid and sterilized. Other descriptions of the present disclosure.

[0057] The following is a description of exemplary embodiments described in the present disclosure. Some of the following descriptions are not currently presented as patent claims, but these descriptions are considered to be patentable and may be presented as patent claims later. The following description or related methods corresponding to the apparatus or system are also considered to be patentable and may be presented as patent claims later. Similarly, related apparatuses or systems corresponding to the following description or methods are also considered to be patentable and may be presented as patent claims later. It is understood that the following description refers to one, two or more, or all of the above embodiments and may be supported thereby.

[0058] A1. A port connector for connecting to a fluid port of a device to be sterilized to a negative pressure source of a sterilization device, the housing being configured to couple to the fluid port, the housing having a proximal end defining an inlet configured to be fluidly coupled to the fluid port and a distal end defining an outlet configured to be fluidly coupled to the negative pressure source, and defining a fluid passage extending between the inlet and the outlet to fluidly couple the inlet and the outlet; and a gasket supported by the housing so as to be spaced from the fluid port when the housing is coupled to the fluid port, the gasket being configured to move toward the fluid port when a negative pressure from the negative pressure source is applied to draw fluid through the fluid port and engage the fluid port to form a fluid tight seal with the fluid port.

[0059] A2. The port connector of description A1, wherein the proximal end includes an insertion portion sized and formed to be inserted into the fluid port, the insertion portion defining the inlet.

[0060] Port connector according to any one of descriptions A1 - A2, wherein the gasket includes a bendable flange, and the bendable flange is configured to move towards the fluid port due to the application of negative pressure, engage with the fluid port, and form a fluid - tight seal together with the fluid port.

[0061] Port connector according to any one of descriptions A1 - A2, wherein the housing includes a plunger that supports the gasket, and the plunger is configured to move proximally when negative pressure is applied, moving the gasket towards the fluid port so that the gasket engages with the fluid port and forms a fluid - tight seal together with the fluid port.

[0062] Port connector according to any one of descriptions A1 - A4, wherein the fluid passage defined by the housing includes a fluid chamber, and the fluid chamber is configured to substantially collapse due to the application of negative pressure.

[0063] Port connector according to any one of descriptions A1 - A5, wherein the housing includes a connector body and a slide movably supported by the connector body, and the slide is operably coupled to the plunger such that movement of the slide causes movement of the plunger.

[0064] Port connector according to any one of descriptions A1 - A6, wherein the connector body and the slide at least partially define a fluid chamber, and the slide moves proximally relative to the connector body due to the application of negative pressure, substantially collapsing the fluid chamber and moving the plunger proximally, causing the gasket to move towards the fluid port so that the gasket engages with the fluid port and forms a fluid - tight seal together with the fluid port.

[0065] Port connector according to any one of descriptions A1 - A7, wherein the plunger defines an inlet, and the plunger further defines at least one plunger opening in fluid communication with the fluid chamber and a long hole fluidly coupling the inlet and the at least one plunger opening.

[0066] A9. The slide is any one of the port connectors of descriptions A1 - A8, defining at least one slide passage that fluidly couples the fluid chamber to the outlet.

[0067] A10. The housing is any one of the port connectors of descriptions A1 - A9, including a coupler configured to couple to a fluid port.

[0068] A11. The coupler includes a first elastically flexible clip and a second elastically flexible clip, and the first and second clips are configured to engage a fluid port to couple the port connector to the fluid port. The port connector is any one of the port connectors of descriptions A1 - A10.

[0069] A12. Each of the first and second clips includes a retainer configured to engage a fluid port to fix the port connector to the fluid port. The port connector is any one of the port connectors of descriptions A1 - A11.

[0070] B1. In a method of sterilizing a device having a fluid port, the steps of connecting a port connector to the fluid port, wherein the port connector has an inlet in fluid communication with the fluid port, an outlet, and a fluid passage extending between the inlet and the outlet to fluidly connect the inlet and the outlet; fluidly connecting a negative pressure source to the outlet of the port connector; forming a fluid - tight seal between the port connector and the fluid port by moving a gasket of the port connector towards the fluid port to engage the fluid port; and moving a sterilizing fluid through the fluid port and the port connector.

[0071] B2. The method of description B2 further includes the steps of placing the device in a cleaning chamber and supplying a sterilizing fluid to the cleaning chamber before moving the sterilizing fluid.

[0072] B3. The gasket includes a bendable flange, and the fluid sealing seal is formed by bending the bendable flange to move the bendable flange towards the fluid port and engage it with the fluid port, according to any one of the methods of descriptions B1 to B2.

[0073] B4. The port connector includes a plunger that supports the gasket, and the step of forming the fluid sealing seal includes the step of moving the plunger to move the gasket towards the fluid port and engage it with the fluid port, according to any one of the methods of descriptions B1 to B3.

[0074] B5. The port connector includes a connector body and a slide movably supported by the connector body. The slide is operably connected to the plunger such that movement of the slide results in movement of the plunger. The step of forming the fluid sealing seal includes moving the slide relative to the connector body to move the plunger, thereby moving the gasket towards the fluid port and engaging it with the fluid port, according to any one of the methods of descriptions B1 to B4.

[0075] B6. The connector body and the slide at least partially define a fluid chamber of the fluid passage. The step of forming the fluid sealing seal includes creating a vacuum within the fluid chamber to move the slide relative to the connector body and substantially collapse the fluid chamber as a result of the vacuum, according to any one of the methods of descriptions B1 to B5.

[0076] B7. The gasket is spaced from the fluid port prior to the step of forming the fluid sealing seal, according to any one of the methods of descriptions B1 to B6.

[0077] B8. The port connector includes a coupler for connecting the port connector to the fluid port, according to any one of the methods of descriptions B1 to B7.

[0078] The method according to any one of descriptions B1 to B8, wherein the step of forming the fluid seal includes applying a negative pressure to the port connector via a negative pressure source.

[0079] The method according to any one of descriptions B1 to B9, wherein the step of moving the sterilizing fluid includes drawing the sterilizing fluid through the fluid port and the port connector by applying a negative pressure from a negative pressure source.

[0080] C1. In a port connector for connecting to a fluid port of a device to be sterilized to a pressure source of a sterilizing device, a housing configured to be coupled to the fluid port, the housing having a proximal end defining an inlet configured to be fluidly coupled to the fluid port and a distal end defining an outlet configured to be fluidly coupled to a negative pressure source, the inlet being fluidly coupled to the outlet; a seal supported by the housing and configured to engage the fluid port in a first position; and a piston movably disposed within the housing and configured to press the fluid port when a positive pressure is applied from the pressure source to move the housing and the seal distally with respect to the fluid port and move the seal to a second position on the fluid port.

[0081] C2. The port connector according to description C1, wherein at least the piston and the housing define a fluid chamber, and the fluid chamber is configured to expand due to the application of a positive pressure.

[0082] C3. The port connector according to any one of descriptions C1 to C2, wherein the piston moves proximally with respect to the housing due to the application of a positive pressure to expand the fluid chamber and press the fluid port.

[0083] C4. The port connector according to any one of descriptions C1 to C3, wherein the piston is movable from an initial position, and in the initial position, the piston is configured to allow fluid to flow between the inlet and the outlet.

[0084] C5. The piston is configured to move proximally from an initial position to press a fluid port, and the piston forms a fluid seal with the housing substantially when the piston moves proximally upon application of a positive pressure to block the flow of fluid between the outlet and the inlet, any one of the port connectors of descriptions C1 - C4.

[0085] C6. The piston includes one or more slots configured to allow the flow of fluid around the piston, any one of the port connectors of descriptions C1 - C5.

[0086] C7. The piston is configured to move distally towards the initial position after the piston presses the fluid port to contract the fluid chamber upon application of a negative pressure from a pressure source, any one of the port connectors of descriptions C1 - C6.

[0087] D1. In a method of sterilizing a device having a fluid port, the steps of connecting a port connector to the fluid port such that a seal of the port connector engages the fluid port in a first position, fluid - connecting a pressure source to an outlet of the port connector, and moving a piston of the port connector relative to a housing of the port connector by application of pressure from the pressure source to move the seal to a second position on the fluid port.

[0088] D2. The method of description D1, wherein the step of moving the piston includes applying a positive pressure from the pressure source.

[0089] E1. In a port connector for connecting to a fluid port of a device to be sterilized with respect to a sterilization device, the fluid port defines a lumen, and the port connector is a porous member having a porous structure that defines a plurality of microchannels, the porous member defining at least a part of a receiving chamber that is sized and formed to receive the fluid port, and the inner surface of the porous member being arranged to engage the fluid port when the fluid port is disposed within the receiving chamber; a porous member; and a housing coupled to the porous member, the housing defining an inlet configured to be fluidly coupled to the lumen of the fluid port, an outlet configured to be fluidly coupled to the sterilization device, and a fluid passage extending between the inlet and the outlet to fluidly couple the inlet and the outlet, the inlet being disposed in the at least a part of the receiving chamber defined by the inner surface of the porous member. A port connector comprising a housing.

[0090] E2. The port connector according to description E1, wherein at least a part of the microchannels of the porous member fluidly couples the receiving chamber to the external environment of the port connector.

[0091] E3. The port connector according to any one of descriptions E1 to E2, wherein the porous member is configured to form an interference fit with the fluid port.

[0092] E4. The port connector according to any one of descriptions E1 to E3, wherein the porous member has an inner diameter at the narrowest point of the receiving chamber, and the inner diameter is less than or equal to the outer diameter of the fluid port.

[0093] E5. The port connector according to any one of descriptions E1 to E4, wherein the porous member has a substantially tubular shape.

[0094] E6. The port connector according to any one of descriptions E1 to E5, wherein the housing includes a stopper arranged to engage the fluid port and position the fluid port within the receiving chamber.

[0095] E7. The stopper restricts the movement of the fluid port relative to the connector in the insertion direction, where the insertion direction is the direction in which the fluid port moves relative to the port connector when the port connector is connected to the fluid port, for any one of the port connectors of descriptions E1 - E6.

[0096] E8. The stopper is arranged to engage with the distal end of the fluid port, for any one of the port connectors of descriptions E1 - E7.

[0097] E9. The stopper includes an edge, and the edge is arranged to engage with the fluid port, for any one of the port connectors of descriptions E1 - E8.

[0098] E10. The only part of the housing arranged to engage with the fluid port is the edge of the stopper, for any one of the port connectors of descriptions E1 - E9.

[0099] E11. Further includes a guide configured to substantially align the lumen of the fluid port with the inlet, for any one of the port connectors of descriptions E1 - E10.

[0100] E12. The guide is dimensioned and formed to be received within the lumen of the fluid port, for any one of the port connectors of descriptions E1 - E11.

[0101] E13. The guide extends through the inlet, for any one of the port connectors of descriptions E1 - E12.

[0102] E14. The guide is part of the housing and the guide extends proximally from the inner wall of the housing, for any one of the port connectors of descriptions E1 - E13.

[0103] E15. The porous member defines the proximal end of the port connector, for any one of the port connectors of descriptions E1 - E14.

[0104] E16. The porous member defines a receiving inlet at the proximal end of the receiving chamber, and the receiving inlet is sized and formed to receive the fluid port, and is any one of the port connectors of descriptions E1 to E15.

[0105] E17. The porous member has a proximal end and a distal end, and the proximal end and the distal end are coupled to the housing, and is any one of the port connectors of descriptions E1 to E16.

[0106] E18. The housing includes a cylindrical wall and a mounting ring, the distal end of the porous member is mounted on the cylindrical wall, and the proximal end of the porous member is mounted on the mounting ring, and is any one of the port connectors of descriptions E1 to E17.

[0107] E19. Further includes a retaining ring, and the retaining ring fixes the proximal end of the porous member to the mounting ring, and is any one of the port connectors of descriptions E1 to E18.

[0108] E20. The proximal end is bent around the mounting ring, and is any one of the port connectors of descriptions E1 to E19.

[0109] E21. The housing includes one or more supports for supporting the mounting ring, and is any one of the port connectors of descriptions E1 to E20.

[0110] E22. In combination with the fluid port, the fluid port has no hook-like portion on its outside, and is any one of the port connectors of descriptions E1 to E21.

[0111] E23. The fluid port has a substantially cylindrical outer surface, and the outer surface is smooth, and is any one of the port connectors of descriptions E1 to E22.

[0112] In a port connector for connecting a fluid port of a device to be sterilized to a sterilization device, a housing configured to be coupled to the fluid port and defining an outlet configured to be fluidly coupled to the sterilization device, a seal disposed to form a fluid tight seal with the fluid port, and a piston supported by the housing and movable relative to the housing when a pressure difference is applied by the sterilization device.

[0113] F2. The port connector of description F1, wherein the seal is supported by the piston and engages the fluid port and moves with the piston when a pressure difference is applied to form a fluid tight seal with the fluid port.

[0114] F3. The port connector according to any one of descriptions F1 to F2, wherein the seal is configured to engage the fluid port in a first position, and the piston is configured to press the fluid port when a pressure difference is applied to move the seal to a second position on the fluid port.

[0115] 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 elements, features, and / or teachings are described. Thus, it is clear and understood that the elements, features, and / or teachings described in one embodiment may be applied to one or more of the other embodiments disclosed herein.

[0116] When introducing elements of the present invention or its embodiments, the articles "a", "an", "the", and "said" are intended to mean that there are one or more elements. The terms "comprising", "including", and "having" are intended to be inclusive and mean that additional elements other than the recited elements may exist.

[0117] Changes and modifications of the disclosed embodiments are possible without departing from the scope of the invention as defined in the appended claims. For example, if specific dimensions are given, they are merely illustrative and it can be understood that other dimensions are possible. Since various changes can be made to the above structures, products, and methods without departing from the scope of the invention, all matters included in the above description and shown in the accompanying drawings are intended to be construed as illustrative rather than in a limiting sense.

Claims

1. In a port connector for connecting to a fluid port of a device to be sterilized with respect to a sterilization device, the fluid port has a distal end defining a fluid port outlet, the fluid port defines a lumen extending proximally from the fluid port outlet, and the port connector comprises a housing configured to be coupled to the fluid port, the housing defining an inlet configured to be fluidly coupled to the lumen of the fluid port, an outlet configured to be fluidly coupled to the sterilization device, and a fluid passage extending between the inlet and the outlet and fluidly coupling the inlet and the outlet, a porous member supported by the housing, the porous member having a porous structure defining a plurality of microchannels and being disposed with respect to the housing so as to engage the distal end of the fluid port when the port connector is connected to the fluid port, a port connector comprising the same.

2. The port connector according to claim 1, wherein the porous member is disposed with respect to the housing such that at least a part of the microchannels fluidly couple the fluid port outlet to the external environment of the port connector when the port connector is connected to the fluid port.

3. The port connector according to claim 1, wherein the porous member is disposed with respect to the housing such that the porous member covers a part of the fluid port outlet.

4. The port connector according to claim 1, wherein the porous member includes an annular surface disposed so as to engage the distal end of the fluid port.

5. The port connector according to claim 4, wherein the annular surface has an inner diameter smaller than the diameter of the fluid port outlet.

6. The port connector according to claim 5, wherein the annular surface has an outer diameter larger than the diameter of the fluid port outlet.

7. The port connector according to claim 1, wherein the housing includes an insertion portion sized and formed to be inserted into the fluid port outlet when the port connector is connected to the fluid port, and the insertion portion defines the inlet.

8. The port connector according to claim 7, wherein the porous member is supported by the insertion portion.

9. The port connector according to claim 1, wherein the housing includes a coupler configured to couple the port connector to the fluid port.

10. The coupler includes a first elastically bendable clip and a second elastically bendable clip, and the first and second clips are configured to engage with the fluid port to couple the port connector to the fluid port, the port connector according to claim 9.

11. The first and second clips each include a retainer configured to engage with the fluid port to fix the port connector to the fluid port, the port connector according to claim 10.

12. The first clip is movable with respect to a first living hinge, the second clip is movable with respect to a second living hinge, and the first and second living hinges are formed by the housing, the port connector according to claim 10.

13. The first and second clips each include a finger tab arranged to be engaged by a user to elastically bend the first and second clips, the port connector according to claim 10.

14. The housing is a one-piece component, the port connector according to claim 10.

15. The housing is a one-piece component, the port connector according to claim 1.

16. The porous member has a substantially donut shape, the port connector according to claim 1.

17. The porous member surrounds the insertion portion in the circumferential direction, the port connector according to claim 8.

18. The port connector according to claim 1, further comprising a porous control coating on the porous member configured to block a part of the microchannels of the porous member.

19. The porous control coating covers the outer surface of the porous member, the port connector according to claim 18.

20. The port connector according to claim 1, further comprising a port guide configured to engage with the fluid port to facilitate positioning of the porous member with respect to the distal end of the fluid port.

21. The port guide is configured to engage with the fluid port to limit insertion of the port connector into the fluid port, the port connector according to claim 20.

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