Fluid delivery systems and methods and assemblies for making connections

[0002] This disclosure is a division of application Ser. No. 08/415,071, filed Mar. 31, 1995 which is a continuation-in-part application of PCT Application No. PCT/US93/09450 filed Oct. 1, 1993 which is a continuation-in-part of U.S. application Ser. No. 07/956,854 filed Oct. 2, 1992 now U.S. Pat. No. 5,393,101.

[0003] The present invention relates to fluid delivery systems and methods and assemblies for making connections. More particularly, the invention relates to fluid delivery systems and methods and assemblies for making connections which maintain the sterility of a fluid, for example, a biological fluid, which passes through the connector assembly.

[0004] Connector assemblies have been developed to handle fluids, e.g., biological fluids, while preserving their condition. More particularly, connectors have been developed to preserve the condition of a fluid, or maintain a fluid free of contaminants. Freedom from contaminants refers to a relative amount of contaminants and is variously defined according to a specific industry, fluid and/or intended use. For example, a biological fluid which is substantially free of contaminants is considered free of viable micro-organisms, and is typically referred to as “sterile”. Connector assemblies for use with biological fluids, for example, have been fashioned to preserve sterility of the fluid.

[0005] Attempts have been made to develop connector assemblies which isolate a fluid from the ambient environment of the connector, and from contaminants entrained in the ambient. Such connectors typically define a fluid conduit which is isolated from the ambient. Some conventional connector assemblies include mating male and female connectors having opposing, exposed surfaces. One surface may comprise the surface of a membrane, for example, while the other surface may comprise the surface of a rubber septum forming a blind end of an elastic, collapsible tube. These surfaces may be wiped with an antiseptic, then resiliently urged in contact when the connectors are coupled. Other conventional connector assemblies provide a removable protective cover on each opposing surface to be contacted. These covers must be removed prior to actually coupling the connectors.

[0006] Many problems are associated with these conventional connector assemblies. For example, wiping the surfaces with an antiseptic or removing the covers of these conventional connector assemblies may not sufficiently protect the fluid flowing through these assemblies. The surfaces are wiped and the covers are removed usually by hand. Although the attendant may use surgical gloves, a gloved finger may trail the antiseptic wipe along the protected surface, depositing on the surface contaminants that were on the glove. To unfasten and remove a cover, the gloved hand must manipulate the removable cover in intimate proximity to the protected surface under the cover, again risking incidental contact and the transmission of contaminants between the glove and the protected surface.

[0007] In addition, once the surfaces are wiped with an antiseptic or the protective covers are removed from the protected surfaces, the surfaces are exposed to the contaminant-laden ambient environment. For example, as the connectors are brought together, dust, micro-organisms, and other airborne contaminants may contact the protected surfaces, even if the connectors are quickly mated. Thus, while these conventional connector assemblies have been developed to form a sterile connection, none adequately protect the fluid flowing through the connector assembly.

[0008] In accordance with one aspect, the present invention is directed to a fluid delivery system comprising a connector assembly and a container for holding fluids. The connector assembly includes a first fitting defining a first aperture and a second fitting which is couplable to the first fitting and which defines a second aperture. The first fitting includes at least one removable contamination containment layer sealing the first aperture.

[0009] In addition, the first fitting includes a stem member having a head axially moveable from a first position wherein the head of the stem member is sealed within the first aperture of the second fitting. The container includes a wall, and the second fitting is directly associated with the wall of the container.

[0010] In accordance with another aspect, the present invention is directed to a fluid delivery system comprising a connector assembly and a container for holding fluids. The connector assembly includes a first fitting defining a first aperture and a second fitting which is couplable to the first fitting and which defines a second aperture. The first fitting includes at least one removable contamination containment layer sealing the first aperture. In addition, the first fitting includes a stem member having a head axially moveable from a first position wherein the head of the stem member is sealed within the first aperture of the second fitting. The second fitting comprises a flange having an aperture and tongues extending from the flange, wherein the tongues are adapted to couple the first and second fittings. The container includes a wall, and the second fitting is directly associated with the wall of the container.

[0011] The novel features and characteristics of this invention are set forth with particularity in the appended claims. However, the invention may best be understood with reference to the drawings, described below, and the accompanying detailed description of preferred embodiments.

[0012] FIG. 1 is an elevation view, in partial section, of disassembled components of a connector assembly in one embodiment according to the invention.

[0013] FIG. 2 is plan view of a female connector in the embodiment of FIG. 1.

[0014] FIG. 3 is plan view of a male connector in the embodiment of FIG. 1.

[0015] FIG. 4 is an elevation in cross section of a resilient mount in the embodiment of FIG. 1.

[0016] FIG. 5ais a schematic of one embodiment of a membrane assembly according to the invention.

[0017] FIG. 5bis a schematic of another embodiment of a membrane assembly according to the invention.

[0018] FIG. 6 is an elevation view in partial section of the components of FIG. 1 in partial assembly.

[0019] FIG. 7 is an elevation view in partial section, of the components of FIG. 1 in final assembly.

[0020] FIG. 8 is an elevation view in partial section of a male connector in another embodiment of a connector assembly according to the invention.

[0021] FIG. 9 is an elevation view in partial section of the male connector of FIG. 8, in final assembly.

[0022] FIG. 10 is an elevation view in section of another embodiment of a female connector in a connector assembly according to the invention.

[0023] FIG. 11 is an elevation view in partial section of the components of an alternative embodiment of the invention in partial assembly.

[0024] FIG. 12 is an elevation view in partial section of the components of an alternative embodiment of the invention in final assembly.

[0025] FIG. 13 is a plan view of a portion of the male connector in the embodiment of FIG. 11.

[0026] FIG. 14 is an elevation view, in partial section, of disassembled components of a connector assembly—fluid delivery system combination according to the invention.

[0027] FIG. 15 is an elevation view, in partial section, of disassembled components of a connector assembly—fluid delivery system combination in an alternate embodiment according to the invention.

[0028] FIG. 16 is an elevation view, in partial section, of disassembled components of a connector assembly—fluid delivery system combination in an alternate embodiment according to the invention.

[0029] FIG. 17 is an elevation view, in partial section, of disassembled components of a connector assembly-fluid delivery system combination in which the second fitting extends into the container.

[0030] FIG. 18 is an elevation view, in partial section, of disassembled components of a connector assembly-fluid delivery system combination in which the second fitting is directly associated with the wall of a syringe or of a rigid container.

[0031] A connector assembly according to the present invention includes mating connectors or fittings which can be coupled to connect different fluid conduit sections, defining a fluid flow path, e.g., a liquid flow path. The connector assembly isolates the fluid flow path from the ambient environment and from contaminants present in the ambient environment and is preferably sterile. Consequently, a connector assembly according to the present invention is suitable for use in an open system, a closed system, or a closed sterile system.

[0032] In a preferred embodiment illustrated in FIGS. 1-3, the connector assembly comprises two connectors, preferably a female connector 100 and a male connector 200. Each connector may be attached to any suitable fluid conduit section, for example, an inlet or outlet of a housing such as a blood filter. In the illustrated embodiment, the fluid conduits comprise sections of tubing 10, 20. Each connector may comprise any structure suitable to conduct fluid communication, preferable liquid communication, e.g. a housing of any form capable of containing fluid. The exemplary female connector 100, typically of unitary construction, generally comprises a fitting 130 and a membrane assembly 170. The exemplary male connector 200, typically of unitary construction, generally comprises a stem 210, a fitting 230 and a membrane assembly 270.

[0033] In the disassembled view of FIG. 1, the connectors are disposed generally opposing each other. For directional orientation in the following discussion, each connector has a proximate end, nearest the opposing connector, and a distal end, furthest from the opposing connector. Also, since the exemplary connectors 100, 200 in FIG. 1 comprise generally elongated bodies, the term axial denotes disposition along their axes.

[0034] The female and male connectors may comprise a detect mechanism adapted to interlock the female connector in predetermined relation with the male connector. Thus, the female fitting 130 may include a bracket 148. The bracket 148 may be variously configured. The bracket 148 may comprise a socket or cup having any suitable plan form, e.g. rectangular or circular. In the illustrated embodiment, the bracket 148 comprises a U-shaped bracket or clevis. The representative bracket 148 is defined by a flange 150 and side walls 156. The flange 150 may assume a radially extending annular plan form, for example, as best seen in FIG. 2.

[0035] The side walls 156 depend away from the flange 150 and toward the opposing male connector 200. One or more tongues 158 may depend from the walls 156. The tongues 158 can be formed integrally with the walls 156, for example, by continuing middle sections of the walls 156. The tongues 158 can thus register in grooves 248 formed in a flange 246 of the male connector 200, best seen in FIG. 6. Accordingly, tongues 158 can be adapted to couple the female and male connectors 100, 200 in a tongue-in-groove engagement, as seen in the elevation view of FIG. 6 (in partial assembly). Tapers 162 can be formed at the proximate ends of the tongues 158 to guide the insertion of the tongues 158 into the grooves 248. Catches 160 can be formed which pass through the grooves 248, abutting a distal surface of the flange 246 and antagonistically locking the female and male connectors 100, 200, as will be detailed below.

[0036] A socket 164, adapted to receive the male connector 200, is defined by the space enclosed by the flange 150 and side walls 156. The proximate surface of the flange 150 (i.e. the flange surface closest the opposing male connector) provides a socket seat 152. The seat 152 serves as an abutment to the male connector 200 when the latter is positively engaged with the female connector 100.

[0037] The female fitting 130 may define an internal chamber or aperture 141 which may have any suitable configuration. The illustrated chamber 141 may comprise a bore 142 relieved at its proximate end into a counterbore 144. The flange seat 152 surrounds the counterbore 144. The illustrative female fitting 130 may be connected integrally with the section of tubing 10. The internal chamber 141 may be connected in fluid communication with the tubing 10.

[0038] In an important aspect of the invention, the female connector is adapted to contain or provide fluid communication and preferably defines an isolated portion of the fluid path, e.g., containing or conducting isolated fluid communication. Accordingly, the chamber 141 is enclosed by a membrane assembly 170. The assembly of the female and male connectors 100, 200 may be surrounded by an atmosphere or ambient environment having contaminants. In one key function, the membrane assembly 170 isolates the chamber 141, and fluid therein, from the surrounding ambient environment and from contaminants present in the ambient environment. Regardless of when or how the connector 100 is sterilized, the seal provided by the membrane assembly 170 is preferably secure enough to maintain the sterility within the chamber 141 of female connector 100. In the illustrated embodiment, the female connector 100 is formed such that the fitting 130, the flange 150, the membrane assembly 170 comprise integral portions of the female connector 100.

[0039] The membrane assembly is preferably secured to the seat 152 of the female connector 100. Alternatively, the membrane assembly may be positioned in any other suitable location, such as within the internal chamber and sealed to the walls of the bore or the counterbore. The membrane assembly 170 can be secured to the seat 152 or the walls of the chamber 141 by a variety of means. Preferably, the membrane assembly 170 can be secured by ultrasonic welding. Alternatively, the membrane assembly 170 may be secured by a heat seal or bonded by an adhesive or a solvent, preferably along the periphery.

[0040] FIGS. 1, 6, and 7 show elevation views of the male connector 200 in different stages of assembly with the female connector 100. FIGS. 1, 6, and 7 comprise views in partial section, as the stem 210 is shown in plain (i.e. non-sectioned) elevation. The male connector 200 generally includes a stem 210 housed in a fitting 230. The male connector 200 may also include a resilient mount 249 having a membrane assembly 270 secured thereto.

[0041] The male connector 200 is preferably adapted to contain and conduct fluid communication and preferably defines an isolated portion of the fluid flow path, e.g., containing or conducting isolated fluid communication. Accordingly, the stem 210 is preferably housed within a sealed chamber or aperture 231 defined within the fitting 230. In the illustrative embodiment, the stem 210 is hollow, defining a lumen (not shown) therein. The proximate end of the stem 210 may have a head 220 formed thereon. The head 220 may comprise a piercing element since it may have a sharpened tip. The head 220 may have an aperture providing fluid access between the lumen and the exterior of the stem 210. The stem 210 may also be connected to a fluid conduit section, e.g., the tubing section 20. If the stem 210 and tubing 20 are fabricated as separate components, the tubing 20 may be joined to the base 223 using solvent, bonding or ultrasonic welding for example. Alternatively, the stem 210 and tubing 20 (or other fluid conduit structure) may be molded as an integral part. The stem 210 may also be formed with a ratchet structure, for example beveled annular ribs 216 formed on the external surface of the stem 210. These ribs 216 are shown in plain, non-sectioned elevation in the partially cross sectioned FIGS. 1, 6 and 7. The ribs 216 may circumfuse the external surface of the stem 210. The ribs 216 may be beveled such that they project from the surface of the stem 210, extending distally toward the base 223 of the stem 210 and forming an acute angle with the external surface of the stem 210.

[0042] Although the male connector may be variously configured, the illustrated male connector 200 comprises an arrangement of telescoping elements adapted to house at least a portion of the stem 210 within the internal chamber 231 in isolation from contaminants. Thus, by way of illustration, the fitting 230 may have a generally cylindrical sleeve 232 extending from the flange 246. The sleeve 232 defines a bore 234 forming a portion of the internal chamber 231. The stem 210 may register intimately with the sleeve 232. In the illustrated embodiment, a head portion 220 of the stem 210 is housed within the sleeve 232.

[0043] The illustrative male fitting 230 may further be constructed with a second outside sleeve 238 concentrically disposed about the first sleeve 232. The concentric sleeves 232, 238 may be connected by any appropriate means. In the representative embodiment, the fitting 230 is formed such that the sleeves 232, 238 and the flange 246 comprise integral portions of the fitting 230. Preferably, the outside sleeve 238 isolates both the stem 210 and the interior bore 234 of the inside sleeve 232 from exposure to the ambient environment. Thus, the axial length of the inside sleeve 232 may be shorter than the axial length of the outside sleeve 238. The remainder of the body of the stem 210 may be housed within an interior bore 239 defined within the outside sleeve 238.

[0044] The stem 210 may include a telescoping seal assembly adapted to mate in telescoping engagement with one or both of the sleeves 232, 238 to isolate and preferably seal the internal chamber 231. Generally, the telescoping seal assembly may be adapted to engage either sleeve, internally or externally. In the exemplary embodiment, the seal assembly 225 may mate in telescoping engagement at least with the interior bore 239 defined in the outside sleeve 238. The telescoping assembly may include elastomeric or deformable elements which intimately engage the walls of the interior bore 239. As shown in the representative embodiment of FIGS. 1, 6, and 7, the illustrative telescoping assembly 225 may include a plunger 226 and an O-ring 227 which fits within a groove in the plunger 226. Preferably the plunger 226 and/or the O-ring 227 tightly engage the inside wall of the outside sleeve 238. This engagement advantageously isolates the interiors of both the inside and outside sleeves 232, 238 from the ambient.

[0045] The telescoping seal assembly may also mate with the inside sleeve 232 to seal the internal chamber 231. For this purpose, the distal end of the sleeve 232 may be formed with a rim 233. The rim 233 may assume a tapered form as shown. The telescoping seal assembly 225 may additionally include a shoulder 224 formed on a base 223 of the stem 210. The shoulder 224 may have a tapered form adapted to mate with that of the rim 233, providing another seal for the chamber 231.

[0046] Although the illustrated embodiment comprises an arrangement of telescoping elements, the male connector may include other arrangements for advancing the stem. For example, a screw mechanism with a ratchet may be mounted between the outer sleeve and stem. The stem could then be advanced by rotating the screw mechanism.

[0047] As exemplified in the plan view of the male connector 200 in FIG. 3, the flange 246 may be generally annular, circumfusing and extending radially from the sleeve 232. The flange 246 may be formed with the grooves 248. As mentioned above, the engagement of one or more tongues 158 of the female connector 100 in the grooves 248 of the male connector 200 is part of one possible structure for coupling the connectors 100, 200. This coupling is shown in an initial stage of engagement in FIG. 6.

[0048] In an important aspect of the invention, the female and male connectors may form a resilient coupling mechanism for engaging these connectors in biased opposition. Though this resilient coupling mechanism may be fashioned in a variety of ways, in the exemplary embodiment, this coupling mechanism may include the resilient mount 249. A representative construction for the resilient mount 249 is detailed in the sectioned elevation view of FIG. 4. The mount 249 serves as a seat which has at least one of the membrane assemblies secured thereon and which is at least axially resilient (e.g. at least resilient along an axis of the sleeve 232) . The resilient mount 249 may be disposed generally between the female and the male connectors 100, 200, providing antagonism between the coupled connectors. The resilient mount 249 could be connected to the female connector 100. However, in the illustrated embodiment the resilient mount 249 is connected to the male connector 200.

[0049] As best shown in FIG. 4, the mount 249 may include a resilient neck 252 connecting a hub 250 to the flange 246. The exemplary hub 250 defines a sealable seat surrounding an opening into the chamber 231. Thus, the hub 250 may have a wall 256 defining a well 262. The wall 256 may have an annular plan form, for example, as best shown in FIG. 3. The well 262 communicates with the bore 234 in the sleeve 232. Together, the illustrative bore 234 and well 262 form the internal chamber 231. The wall 256 may further have a rim 258. This rim 258 forms the sealable seat circumfusing the well 262 which accesses the chamber 231. The membrane assembly 270 is preferably secured to the rim 258, enclosing the internal chamber 231.

[0050] As detailed particularly in FIG. 4, the neck 252 may be formed with a joint having a recess or groove, shown generally at 260. The grooved joint 260 connects the neck 252 to the hub 250, on the distal side of the hub. When the connectors 100, 200 are engaged, the grooved joint 260 yields, and the neck 252 is compressed at least axially. Thus, the axial resilience of the mount 249 urges the connectors into biased opposition, maintaining the membrane assemblies 170, 270 in positive contact. As one alternative to the grooved joint 260, the hub may be formed with a thin flange joining the neck.

[0051] The resilient mount 249 may be formed as an integral part of the male fitting 230. Thus, the sleeve 232, flange 246, neck 252 and/or hub 250 may be molded integrally for example. In this embodiment, the male fitting 230, like the female fitting 130, is molded as a single part from any suitable polymeric material, for example olefinic compositions such as polypropylene, polyethylene, butadiene; acrylics; polycarbonates; or elastomers.

[0052] In the illustrated embodiment, the male connector 200 is formed such that the fitting 230, the resilient mount 249, and membrane assembly 270 comprise integral portions of the male connector 200.

[0053] Preferably, the female and male connectors 100, 200 are interlocked in predetermined relation and are resiliently coupled in antagonistic biased opposition. The coupling structure on each connector may be proportioned relative to the other to produce an antagonistic coupling. As noted above, FIG. 6 shows the tongue-in-groove coupling of the representative female and male fittings 130, 230 in partial assembly. The catches 160 abut the distal surface of the flange 246, interlocking the connectors 100, 200 in predetermined relation to each other. The dimensions of the fittings 130, 230 are preferably proportioned such that when the catches 160 embrace the distal surface of the flange 246, the resilient mount 249, including the hub 250 and neck 252, compresses axially, forces the membrane assemblies 170, 270 into positive contact, and provides biased opposition between the membrane assemblies 170, 270. To protect the resilient mount 249, shoulders 154a-154d,seen particularly in FIGS. 1 and 2, may be formed preferably on the flange 148 of the female connector 100. These shoulders may serve as stops limiting the compression of the mount 249 by ensuring a minimum spacing between the connectors. Alternatively, the mount 249 may be constructed such that it can tolerate compression that is limited by contact between the flanges 148, 246 and the hub 250.

[0054] Prior to coupling the connectors 100, 200, the proximate, opposing surfaces of the membrane assemblies 170, 270, are exposed to the ambient environment. Upon coupling, these opposing surfaces are forced into positive contact with each other due to the biased opposition imposed by the resilient mount 249. In a principal feature of the invention, this positive contact is maintained as long as the connectors 100, 200 are coupled. Through this positive contact, the contacting surfaces of the membrane assemblies 170, 270 cover each other, isolating them from the ambient.

[0055] The membrane assemblies of the connectors may be variously configured and may be identical or not. FIGS. 5aand 5bare schematics showing different embodiments for the membrane assemblies. In a principal aspect of the invention, each membrane assembly includes at least two layers or surfaces. The first comprises a removable contamination containment surface. Initially, this surface comprises the proximate surface of each respective membrane assembly, i.e., the surface nearest and facing the opposing connector. The second surface of each membrane assembly comprises a protected sealing surface. This surface is protected and preferably isolated from the ambient environment and from contaminants present in the ambient environment. At least initially, prior to the stage of inserting the stem into the female connector, the sealing surface seals the chamber defined within each respective fitting. In FIGS. 5aand 5b, in the membrane assembly 170 of the female connector 100, the sealing surface and the contamination containment surface are denoted by 174 and 182, respectively. In the membrane assembly 270 of the male connector 200, the sealing surface and the contamination containment surface are denoted 274 and 282, respectively.

[0056] The layers or surfaces of the membrane assemblies may be variously configured. In the exemplary embodiment of FIG. 5a,the contamination containment surface comprises a surface of a cover layer which may be completely removed from the membrane assembly. This exposes a separate underlying sealing layer, having the sealing surface as one of its surfaces. In the embodiment of FIG. 5b, the contamination containment surface comprises a portion of a surface of a cover layer which is folded in a serpentine configuration. This cover layer may be unfolded, exposing a protected cover layer portion, or may be removed completely, exposing a separate sealing layer.

[0057] FIG. 5ashows one preferred embodiment of the membrane assemblies 170a, 270a. Each membrane assembly 170a, 270a, in the illustrative embodiment, comprises two separate layers. The membrane assembly 170ahas a cover layer 178aserving as a removable protective sheath covering a separate sealing layer 172a. The sealing surface 174acomprises the surface of the sealing layer 172afacing the female flange 148. The contamination containment surface 182acomprises the surface of the cover layer 178afacing the male connector 200.

[0058] More particularly, the sealing layer 172amay enclose the chamber 141 defined within the female fitting 130, preferably sealing it. Thus, the sealing surface 174amay be secured to the seat 152, preferably permanently, using any of the techniques discussed above, e.g. ultrasonic welding. In this embodiment the sealing layer 172ais laid flat over the opening to the chamber 141 and because the sealing layer 172ahas no folds, it has only two surfaces, the sealing surface 174aand an intermediate surface 176a. Also preferably, the sealing layer 172amay comprise a material which precludes the passage of bacteria therethrough. This material my be porous, preferably having a pore rating of about 0.2 μm or less. Alternatively, the sealing layer 172amay comprise a material which is impervious to both liquid and gas. Accordingly, in one key function the membrane assembly 170aisolates a portion of the fluid path from the ambient environment and from contaminants in the ambient environment since the sealing layer 172aseals the chamber 141.

[0059] In the illustrated embodiment, the cover layer 178ais disposed over the sealing layer 172ain a single fold configuration. The exemplary cover layer 178ahas a pull tab 179a(shown also in FIG. 2), an intermediate surface 180aand the contamination containment surface 182a. When the cover layer 178ais attached to the sealing layer 172a, the intermediate surface 176aof the sealing layer 172aand the intermediate surface 180aof the cover layer 178aare interfaced in intimate contact. The cover layer 178ais preferably removably attached to the sealing layer 172ain any suitable manner. The sealing layer 172aand the cover layer 178acan be attached together by heat sealing the perimeter of the intermediate surfaces 176a, 180a, for example. Alternatively, the intermediate surface 180a, but not the contamination containment surface 182a, of the cover layer 178ahas a tackiness or an adhesive which releasably holds the cover layer 178ato the sealing layer 172abut which entirely remains with the cover layer 178awhen the cover layer 178ais removed from the sealing layer 172a. The contamination containment surface 182aof the cover layer 178aand the intermediate surface 176aof the sealing layer 172athus remain free of adhesive, preventing ambient contaminants from being attracted to and held by either surface. Further, because the intermediate surface 176aof the sealing layer 172aremains free of adhesive, there is no risk that the adhesive will leach into fluid flowing through the connector assembly.

[0060] Prior to coupling the female and male connectors 100, 200, the contamination containment surface 182ais exposed to the ambient environment. Preferably, the cover layer 178aalso comprises a material, such as glassine paper, which precludes the passage of bacteria therethrough. Accordingly, while the cover layer 178ais attached to the sealing layer 172a, it isolates the sealing layer from the ambient environment. In another key function of the membrane assembly 170a, the cover layer 178aprotects the sealing layer 172a, isolating it from contact with other surfaces, or surface area portions, or the ambient environment. More particularly, the cover layer 178amay be advantageously folded as shown so that the intermediate surface 180aintimately interfaces with the sealing layer 172aand protects the sealing layer 172afrom even the exposed contamination containment surface 182a.

[0061] The membrane assembly 270aof the male connector 200 has a construction analogous to that of the membrane assembly 170a. The membrane assembly 270ahas a sealing layer 272aand a cover layer 278a. The sealing surface 274acomprises the surface of the sealing layer 272afacing the male flange 246. The contamination containment surface 282acomprises the surface of the cover layer 278afacing the female connector 100.

[0062] The sealing layer 272aseals the well 262, and thus the chamber 231 defined within the male fitting 230. Accordingly, the sealing surface 274ais secured to the rim 258 of the axially resilient hub 250. The sealing surface 274amay be secured, preferably permanently, using any of the techniques outlined above, e.g. ultrasonic welding. The sealing layer 272amay be laid flat over the well 262. Because the sealing layer 272ahas no folds in this embodiment, it has two surfaces, the sealing surface 274aand an intermediate surface 276a. The sealing layer 272amay be impervious to gas or liquid or may comprise a porous, hydrophobic material which precludes the passage of bacteria therethrough. The sealing layer 272athus isolates the chamber 231 from the ambient and from contaminants entrained in the ambient.

[0063] As in the female connector, the cover layer 278amay similarly be removably attached to the sealing layer 272a. This cover layer 278amay also be disposed over the sealing layer 272ain a single fold configuration. The exemplary cover layer 278ahas a pull tab 279a(shown also in FIG. 2), an intermediate surface 280aand the contamination containment surface 282a. When the cover layer 278ais attached to the sealing layer 272a, the intermediate surface 276aof the sealing layer 272aand the intermediate surface 280aof the cover layer 278aare interfaced in intimate contact. Accordingly, while the cover layer 278ais attached to the sealing layer 272a, it isolates the sealing layer from the ambient and from contact with other surfaces exposed to the ambient.

[0064] In each of the previous embodiments of the membrane assemblies 170, 270, the cover layer 178, 278 intimately contacts the sealing layer 172, 272. However, the membrane assembly may alternatively be configured with the sealing layer spaced from the cover layer. For example, the cover layer may be removably attached to the flange of the connector, enclosing the chamber, while the sealing layer is spaced from the cover layer and positioned within the chamber sealed to the walls of the bore.

[0065] The antagonistic coupling of the connectors created by the tongue-in-groove engagement and the axially resilient mount 249 urges the respective contamination containment surfaces 182a, 282a, into biased opposition. This resilience ensures positive contact between the contamination containment surfaces 182a, 282aas long as the connectors 100, 200 are coupled.

[0066] Preferably, the fittings 130, 230, and thus the surfaces within the fittings defining the chambers 141, 231, may be sterilized either before or upon assembly with each other. Each of the sealing surfaces 174a, 274aseals its respective chamber 141, 231, isolating the chamber from the ambient and contaminants entrained therein.

[0067] According to a principle aspect of the invention, each of the contamination containment surfaces 182a, 282acan be removed while maintaining these surfaces in positive contact. Once the connectors 100, 200 are coupled, they form a housing and the pull tabs 179a, 279aof the cover layers 178a, 278apreferably abut each other and extend in the same direction to the exterior of the housing. For example, in the embodiment illustrated in FIG. 6, the pull tabs 179a, 279aextend out of the channel of the U-shaped bracket 148 (i.e., into or out of the plane of the drawing page), beyond the assembly of the two connectors 100, 200. The pull tabs 179a, 279acan be pulled by hand, pinching the tabs together with two fingers. The tabs 179a, 279aare most preferably pulled simultaneously, while maintaining the contamination containment surfaces 182a, 282ain biased contact. When the tabs are pulled together, the biased opposition of the resilient coupling maintains the positive contact between the contamination containment surfaces 182a, 282a. Each contamination containment surface 182a, 282amay trap and isolate any contaminants on the other. Even as the cover layers 178a, 278aare removed, the resilient mount 249 urges the contamination containment surfaces 182a, 282ainto positive contact with each other. Also, a bacteriostatic or bacteriocidal compound or layer could be disposed on either or both contamination containment surfaces 182a, 282a. As the cover layers 178a, 278aare removed, each contamination containment surface 182a, 282ais pulled away from the respective sealing layer 172a, 272aby virtue of the advantageous fold configuration. Thus, in another key feature the membrane assemblies 170a, 270aisolate both the fluid path and surfaces intersecting the fluid path, e.g., the intermediate surfaces 176a276aat the sealing layers 172a, 277a, from the ambient and surfaces exposed to the ambient, e.g., contamination containment surfaces 182a, 282a.

[0068] In addition to being axially resilient, the resilient mount 249 is preferably flexible enough to tilt laterally or rock as the cover layers 178a, 278aare removed. Thus, as the cover layers 178a, 278aare removed, the hub 250 instantly urges the protected intermediate surfaces 176a, 276aof the sealing layers 172a, 272ainto positive contact, virtually preventing contamination of these surfaces.

[0069] Each contamination containment surface 182a, 282aisolates the other, trapping therebetween any contaminants incident on the surfaces from the exposure of these surfaces to the ambient. The membrane assemblies 170a, 270aisolate both internal chambers 141, 231, and the fluid path portion defined within the stem 210, from the ambient. Further, the membrane assemblies 170a, 270aisolate both internal chambers 141, 231, and the fluid path portion defined within the stem 210, from surfaces exposed to the ambient, e.g., from the contamination containment surfaces 182a, 282a. When the two connectors 100, 200 are coupled and the cover layers 178a, 278aare removed, only surfaces which were previously isolated define or intersect the fluid flow path.

[0070] In the embodiment of FIG. 5b, each membrane assembly 170b, 270bcomprises at least one sheet arranged in a serpentine fold configuration. Each fold defines a portion of the sheet forming a new layer. Thus, the membrane assembly 170bcan comprise a single sheet having one portion forming the sealing layer 172b. Another portion of the sheet after the first fold in the serpentine configuration forms a first cover layer 178b. Yet another portion of the sheet after the second fold in the serpentine configuration forms a second cover layer 181b.

[0071] More particularly, the sheet portion forming the sealing layer 172bhas two surfaces, a sealing surface 174band an intermediate surface 176b. Analogous to the embodiment of FIG. 5a, the sealing surface 174bmay be secured to the seat 152 of the female fitting 130, preferably permanently. Preferably, the sealing layer 172bcomprises a material which precludes the passage of bacteria. Thus the membrane assembly 170bisolates a portion of the fluid path from the ambient and contaminants present in the ambient since the sealing layer 172bseals the chamber 141.

[0072] The first cover layer 178bmay be removably attached to the sealing layer 172bas previously discussed with respect to the embodiment shown in FIG. 5a. The first cover layer 178bhas an intermediate surface 180b. When the membrane assembly 170bis folded, the intermediate surface 176bof the sealing layer 172band the intermediate surface 180aof the first cover layer 178bare interfaced in intimate contact.

[0073] The second cover layer 181bmay be disposed over the first cover layer 178b. The second cover layer 181bhas a pull tab 179band a contamination containment surface 182b. The contamination containment surface 182bcomprises the surface of the membrane assembly 170bmost proximate to the opposing male connector 200. Prior to coupling the female and male connectors 100, 200, the contamination containment surface 182bis exposed to the ambient. Preferably, the membrane assembly 170bcomprises a homogeneous membrane sheet. Thus, both cover layers 178b, 181balso preclude the passage of bacteria therethrough. Accordingly, while the cover layers 178b, 181bare protectively disposed over the sealing layer 172b, they isolate the sealing layer from the ambient contaminants and from surfaces exposed to the ambient.

[0074] In the embodiment of FIG. 5b, the membrane assembly 270bof the male connector 200 can be constructed in a fashion analogous to the membrane assembly 170bof the female connector 100. Reference numerals for components of the membrane assembly 270bare analogous to the numerals for the membrane assembly 170b, except that the 200 series is used.

[0075] In use, the hollow stem 210 forms an isolated portion of the fluid communication path. On the proximate side of the internal chamber 231 of the male connector 200, the membrane assembly 270 preferably seals the hollow stem 210 therein. On the distal side of the chamber 231, the telescoping seal assembly 225 preferably seals the stem 210 therein. As exemplified in FIG. 7, in final assembly the stem 210 is adapted to bridge the chambers 141, 231. Accordingly, the stem 210 is free to move axially within the bore 234, toward the proximate end of the male fitting 230.

[0076] To establish fluid communication between the internal chambers 141, 231, the connectors 100, 200 are first positively interlocked. The connectors 100, 200 may be interlocked by the tongue-in-groove coupling described above, for example. The resilient mount 249 is then compressed and urges the cover layers of the membrane assemblies 170, 270 into positive contact against each other. The cover layers 178, 278 can then be removed by pulling the tabs 179, 279. The biased opposition provided by the resilient mount 249 simultaneously urges the protected sealing layers of the membrane assemblies 170, 270 into positive contact against each other.

[0077] The stem 210 then can be advanced within the male fitting 230, typically by hand or by use of a tool. The stem 210 may advance within the sleeves 232, 238 until the rim 233 formed on the distal end of the inside sleeve 232 abuts the shoulder 224 formed on the stem 210. The mating tapered surfaces of the rim 233 and the shoulder 224 provide yet another seal isolating from the ambient the internal chamber 231 as well as the stem portion or head 220 therein. This abutment also serves as a stop, ultimately limiting the axial travel of the stem 210. The advance of the stem 210 is sufficient to allow the stem 210 to pierce at least the sealing layer 172, 272 of each membrane assembly 170, 270, respectively. The head 220, which comprises a piercing element, may thus have a pointed form for example, adapted for this penetration. By inserting the stem 210 into the female fitting 130, fluid communication is established between the female and male connectors 100, 200. Thus, the tubes 10, 20 are joined in fluid communication, and a single fluid path is formed through the connector assembly.

[0078] Preferably, once the stem 210 is inserted into the female fitting 130, an axial restraint resists retraction of the stem 210. Such a restraint preferably prevents altogether the retraction of the stem 210. This restraint is implemented in the illustrated embodiment by a ratchet or locking structure. The inside sleeve 232, including the tapered form of the rim 233 cooperates with the angle of the beveled ribs 216 to allow axial advance of stem 210 toward the female connector 100 with sufficient resistance to prevent accidental or incidental movement of the stem 210. The distal end of the inside sleeve 232 may further be formed with a lip or catch 236 depending radially inward within the bore 234. Upon attempting retraction of the stem 216, the beveled ribs 216 may engage the catch 236. This engagement prevents axial retraction of the stem 210, locking the stem within the female fitting 130. The ratchet structure may additionally include engagement of the beveled ribs 216 by an internal shoulder 235 (shown in FIG. 4) formed in the bore 234 of the sleeve 232, for example.

[0079] The axial restraint may also be implemented or augmented by the frictional telescoping engagement of mating parts. This includes the telescoping engagement of the plunger 226 and/or O-ring 227 within the bore 239. Also, both the head 220 of the stem 210 and the bore 142 defined within the female fitting 130 may comprise mating tapered forms. Accordingly, the head 220 may be lodged in frictional telescoping engagement within the internal chamber 141 of the female connector 100, sealing the stem 210 within the female connector 100 and resisting disengagement.

[0080] In another representative embodiment shown in FIGS. 8 and 9, components corresponding to the previous embodiment are denoted with the same reference numerals. The illustrated seal assembly 225 may further include a frangible flange 228, in addition to the plunger 226. The outside sleeve 238 may have a seat assembly 240 formed at the distal end thereof. The frangible flange 228 may be fixed to the seat assembly 240 by any appropriate means, e.g. by bonding or welding, and may thus seal the interior bore 239 defined within the outside sleeve 238. The seat assembly 240 may include a rim 242 which abuts the frangible flange 228 when the latter is fixed to the seat assembly. Preferably, the frangible flange 228 comprises an element which may be severed or broken. More particularly, the frangible flange 228 may comprise a thin wall for example. Further, the frangible flange 228 may have a cleavage or crease formed on either side of the flange. The position of this crease would coincide with the area where the rim 242 abuts the frangible flange 228. Also, the rim 242 may advantageously form a sharp edge.

[0081] The assembly of connectors 100, 200 of the embodiment of FIGS. 8 and 9 may operate similarly to the earlier embodiment. After the connectors 100, 200 are coupled and the removable cover layers are removed from the membrane assemblies 170, 270, the stem 210 can be advanced. The stem 210 may be forcibly advanced by hand or tool such that the flange 228 is severed or broken against the rim 242. As the stem 210 is advanced, the plunger 226 moves along the wall of the bore 239. The plunger 226 may again be advantageously formed from a compressible material, for example an elastomeric material. Contact between the plunger 226 and the wall of the bore 239 provides a secure seal from the ambient for both bores 239, 234 and the internal chamber 231. Also, part of the frangible flange 228 remaining with the plunger 226 preferably comprises a material which may yield, compressing radially or folding at its periphery, for example. Thus, the remaining portion of the severed flange 228 may initially enter and advance within the bore 239 while constantly maintaining sealed contact with the tapering wall defining the bore 239.

[0082] In summary, in this embodiment of the connector assembly, at least four mechanisms advantageously cooperate to isolate from the ambient the distal end of the internal chamber 231. Originally, prior to advancing the stem 210, the frangible flange 228 may be fixed to the seat assembly 240, sealing the bore 239. Once the stem 210 is advanced, the periphery of the remaining portion of the frangible flange 228 intimately contacts the wall defining the bore 239. Similarly, the plunger 226 also intimately contacts the tapering wall of the bore 239. Finally, the abutting tapered surfaces of the rim 233 of the inside sleeve 232 and shoulder 224 of the stem 210 mate to seal the bore 234.

[0083] In an alternate embodiment, illustrated in FIGS. 11-12, the connector assembly comprises a female connector 100 and a male connector 200 as described above for FIGS. 1-4. In this embodiment of the invention, male connector 200 includes a stem 310 preferably housed within a sealed chamber or aperture 231 defined within a fitting 230. Male connector 200 includes an inside sleeve 232, the distal end of which may be formed with at least one lip or catch 236, as noted above. In the illustrated embodiment, the sleeve 232 has three catches 236 equally spaced from one another.

[0084] The stem 310 may also be formed with a first ratchet structure 311 and a second ratchet structure 312. For example, each ratchet structure 311 and 312 may include beveled annular ribs formed on the external surface of the stem 310. These ribs are shown in plain, non-sectioned elevation in the partially cross sectioned FIGS. 11 and 12. The ribs may circumfuse the external surface of the stem 310. The ribs may be beveled such that they project from the surface of the stem 310, extending distally toward the base 223 of the stem 310 and forming an acute angle with the external surface of the stem 310. Tapers can be formed at the proximate end of the catches to guide the contact of the catches with the first and second ratchet structures.

[0085] In a preferred embodiment, stem 310 also includes a relatively smooth external surface 313 between first ratchet structure 311 and second ratchet structure 312, i.e., a surface which minimizes resistance to the movement of the stem 310 into the female connector 100 until fully engaged.

[0086] In use, the hollow stem 310 forms an isolated portion of the fluid communication path, as described above. The inside sleeve 232, including the tapered form of the rim 233 cooperates with the angled surface of the beveled ribs to allow axial advance of stem 310 toward the female connector 100 with sufficient resistance to prevent accidental or incidental movement of the stem 310. The stem 310 can be advanced within the male fitting (CONNECTOR) 200 by applying sufficient force to overcome the engagement of the catch 236 with the beveled rib(s) of first ratchet structure 311. In a preferred embodiment of the invention, the force required to move the rib(s) of the first ratchet structure 311 past the catch 236 is greater than the force required to move the rib(s) of the second ratchet structure 312 past the catch 236. For example, the bevel on the rib(s) of the first ratchet structure may be greater than the bevel on the rib(s) of the second ratchet structure.

[0087] Once the stem 310 is inserted into the female fitting 130, an axial restraint resists retraction of the stem 310. Such a restraint preferably prevents altogether the retraction of the stem 310. This restraint is implemented in the illustrated embodiment by the second ratchet structure 312 which engages with catch 236. Upon attempting retraction of the stem 310, the engagement of the beveled ribs with the catch 236 prevents axial retraction of the stem 310, locking the stem within the female fitting 130.

[0088] As with all illustrated embodiments herein, a number of variations in the illustrated constructions are envisioned. For example, another embodiment for the female connector 100 is illustrated in FIG. 10, where analogous components have the same reference numerals. In this embodiment, the counter bore 144 is closed at a blind end by a pierceable septum 147 and the septum 147 may comprise an integral part of the flange 150. Thus, the chamber 141 defined within the tubing 10 is sealed by both the membrane assembly 170 and the septum 147. The septum 147 may provide additional security in sealing the chamber 142 from ambient contaminants and from surfaces previously exposed to the ambient. The septum 147 may also resist the pressure of the fluid in the tubing section better than the membrane assembly 170. When the female and male connectors 100, 200 are coupled, the stem 210 can be axially advanced through the sleeve 232 to pierce three elements: the membrane assembly 270 of the male connector 200 and the membrane assembly 170 and the septum 147 of the female connector. In one possible mechanism for axial restraint of the stem, a throat may be formed where the septum is pierced, whereby the stem registers in an intimate friction fit within the throat.

[0089] Other variations are also envisioned. For example, where the female connector and fluid conduit comprise separate components, they could be connected by a variety of other means, e.g. mating threaded fittings. Alternatively, the bracket may be attached to a sleeve, either formed integrally with the bracket or otherwise connected thereto. This sleeve may be connected to a section of tubing through telescopic engagement, i.e. a coaxial friction fit wherein one member is inserted within the other, with friction between the two members retaining the coupling. In another variant construction for the female connector, the two bores and the tubing can be variously configured. In the exemplary embodiment of FIGS. 1-3 these components are generally cylindrical. Alternatively, they may be formed with cross sections of various geometries, for example rectangular or elliptical.

[0090] A number of variations are envisioned in the construction of the male connector. The hub and/or sleeve may assume cross sections of any suitable form, for example rhomboid or trapezoidal. Also, the sleeve, flange and/or hub, for example, can be molded or machined as separate parts, each with mating threads. The sleeve can also be constructed as separate, hollow telescoping sections housing a helical spring, for example. This may serve as a substitute for the illustrated construction of the resilient mount. The telescoping sections of the sleeve can be dimensioned to allow easy axial reciprocation of one half within the other. The spring would provide the resilience necessary to couple the connectors in biased opposition, maintaining positive contact between membrane assemblies. If the spring is helical, it can be sized such that the stem can be loosely housed, allowing for axial displacement within the helix. In another alternative to the illustrated construction of the resilient mount, the male fitting can alternatively be formed or machined as an integral piece from a post of elastomeric material. This post would be bored to make it a hollow sleeve, and may be constructed without a separate hub piece. Alternatively, a separate elastomeric hub can be mounted on a sleeve piece.

[0091] The axial resilience in the coupling can alternatively be provided by using a deformable or resilient material for one or both sealing layers of the membrane assemblies. The resilience and thickness in the sealing layer should provide the compliance and clearance necessary to urge the contamination containment surfaces into positive contact. Hence, the sealing layers may be made thick relative to the cover layers. The removable cover layers may be made thin relative to the sealing layers to make removal easy while assuring positive contact of interfacing intermediate surfaces.

[0092] The illustrated structure for coupling the female and male connectors can also be modified. The exemplary tongue-in-groove coupling can be replaced with any coupling, preferably an interlocking structure which locks or becomes non-separable after coupling. A rabbeted coupling, for example, can be implemented by forming one connector with a groove or recess cut out of an edge or face of its body. The other connector can be formed with a boss or rib having a shape that mates with that recess. In another alternative coupling, the female and male connectors can comprise any suitable form of mating threaded fittings.

[0093] Several alternative constructions for the axial restraint of the stem are possible. An axial restraint can be implemented by several embodiments of a friction fit, for example. The counter bore within the female fitting may be proportioned to accommodate any flaps formed when the membrane assemblies are pierced. As the stem passes, the flaps can be pressed radially against the inside wall of the counter bore. A tight friction fit may be formed with the flaps of the pierced membrane caught between the stem and the wall of the counter bore. Withdrawal of the stem from the female fitting may be prevented in part by friction. Forward edges of the membrane flaps may also engage the annular beveled ribs, preventing withdrawal of the stem.

[0094] In another alternative for the axial restraint, the stem and the male fitting may be formed as telescoping parts, coaxially engaging in a friction fit. These components may have tapered or conic sections, for example. Additionally or alternatively, these components may be formed with a rabbeted structure, e.g., a rib or lug may be formed on one component to engage in a mating recess formed in the other.

[0095] In the illustrated assembly of female and male connectors it may be desirable to ensure that accidental or incidental insertion of the stem through the membrane assemblies is prevented. Accordingly, the connector assembly can additionally be equipped with a mechanism initially preventing insertion of the stem. In one embodiment, this mechanism may be implemented by forming the proximate end of the stem with a relatively dull nipple rather than a head with a sharp tip. Additionally, the sealing and cover layers within a given membrane assembly could comprise different materials, e.g., materials which strongly resist being pierced by the stem. The nipple may also have a form which can penetrate one of the sealing or cover layers, but not the other. In another embodiment, this mechanism may comprise a cam structure. The connector housing the stem, e.g. the male fitting 230 in the illustrated embodiments, may have a slot formed in the sleeve and the stem may be formed with a lug which serves as a cam. The cam can prevent axial advance of the stem when it abuts the rim of the sleeve, but upon twisting the stem to align the cam with the slot in the sleeve the stem 210 is freed from the locking action of the cam. The stem may then be inserted into the female connector, piercing the membrane assemblies.

[0096] The connector assembly may be utilized in conjunction with various fluid delivery systems such as intravenous (IV) devices, which include flexible and/or rigid fluid containers. The connector assembly - fluid delivery system combination may be utilized to supply, for example, parenteral and biological fluids. As used herein, a parenteral fluid is a physiologically acceptable fluid, which is preferably sterile. Examples of parenteral fluids include saline solution, i.e., isotonic (about 0.9%) sterile saline solution, and an electrolyte solution, including for example, dextrose 5% in water (D5W). Biological fluids, as used herein, are fluids originating from a living organism, for example, blood and blood components.

[0097] An exemplary embodiment of a connector assembly—fluid delivery system combination is illustrated in FIG. 14, where analogous components have the same reference numbers as the connector assembly of FIG. 1. In FIG. 14, the female connector 100 of the connector assembly is connected to a container 600 via tubing 10. The tubing 10, as described previously, may be connected to the female connector 100 in any suitable manner, e.g., by utilizing solvents, bonding agents, hose clamps, ultrasonic welding, threaded connectors, or friction fitting. Alternatively, the tubing 10 may be molded to the female connector 100 as an integral part thereof. The tubing 10 may be connected to the flexible container 600 through a fitment which allows fluid communication between the tubing 10 and the container 600. The fitment may include a valve such as a transfer leg closure which controls fluid flow to or from the container 600. The female connector 100, the tube 10, and the container 600 may be constructed as a single, integral unit.

[0098] The tubing 20 connected to the male connector 200 of the connector assembly may be connected to other components comprising the fluid delivery system (not illustrated). For example, the tubing 20 may be connected to a series of connector assembly—fluid delivery system combinations, to a syringe, or to a filtration system. In addition, although not illustrated the male connector 200 of the connector assembly may be connected to the container 600, i.e., the roles of the male and female connectors 200, 100 may be reversed. In such an embodiment, the male connector 200, the tube 20, and the container 600 may be constructed as a single, integral unit.

[0099] The container 600 as well as the tubing 10, 20 which may be utilized in accordance with the connector assembly of the present invention may be constructed of any material compatible with parenteral and biological fluids. The composition of the container 600 and the tubing 10, 20 may vary with the nature of the particular fluid utilized. A wide variety of suitable containers and tubes are already known in the art. Exemplary containers include, but are not limited to syringes, flexible bags, and rigid containers. The container 600 may be formed from various materials such as metallic materials, glass, and plastics, including polyvinyl chloride (PVC). The container 600 preferably comprises plasticized PVC for flexibility and strength. Typical tubes comprise flexible plastics, such as plasticized PVC, for ease of use. It is intended that the invention should not be limited by the type or composition of the container and/or tubing being employed.

[0100] The connector assembly illustrated in FIG. 14 is similar to the connector assembly illustrated in FIG. 1. Specifically, the male connector 200 comprises the stem 210 having a head 220 which may include a piercing member 220a, the fitting 230, and the resilient mount 249. The female connector 100 comprises the fitting 130 including a bore 142 for receiving the piercing member. The connector assembly illustrated in FIG. 14, however, preferably comprises modified female and male membrane assemblies 400 and 500 as opposed to the membrane assemblies 170, 270 illustrated in FIGS. 5aand 5b. In the membrane assemblies 170, 270 previously described, each membrane assembly may include at least two layers, the first layer defining a removable contamination containment surface and the second layer defining a sealing surface. In the exemplary embodiment of FIG. 14, only the female and male contamination containment layers 400 and 500 are sealed to the connectors 100, 200. Preferably, the female and male contamination containment layers 400 and 500 have the double fold configuration and each comprise pull tabs 402, 502, intermediate surfaces 404, 504, contamination containment surfaces 406, 506, and cover layers 408, 508.

[0101] The female and male contamination containment layers 400 and 500 may comprise impermeable materials, such as glassine paper or impermeable polymeric films, or permeable materials, including papers such as Tyvek™ paper or porous polymeric films, which preclude the passage of bacterial contaminants. Permeable or porous materials offer the advantage, if desired, of allowing sterilizing gases, including ethylene oxide gas, to penetrate therethrough and spread to the interior of the female and male connectors 100, 200, thereby sterilizing them without having to remove the female and male contamination containment layers 400 and 500. Either permeable or impermeable materials are suitable for gamma or steam sterilization. Additionally, a bacteriostatic or bacteriocidal compound or layer (not illustrated) may be disposed on either or both contamination containment surfaces 406, 506.

[0102] The female and male contamination containment layers 400 and 500 function in a similar manner as the membrane assemblies 170 and 270 illustrated in detail in FIGS. 5aand 5b. Basically, once the female connector 100 and the male connector 200 are connected as previously described, the female and male contamination containment layers 400 and 500 are removed by pulling the tabs 402, 502 and the stem 210 is inserted into the bore 142. Because the female and male contamination containment layers 400 and 500 are removed, no piercing member is necessary on the head 220 of the stem 210, as illustrated in FIG. 1, to puncture the sealing surfaces 172aand 272a. However, the head 220 of the stem 210 preferably comprises a shape which frictionally engages the walls of the bore 142 in the female connector 100. Alternatively, the membrane assemblies 170 and 270 described in detail with respect to FIGS. 5aand 5bmay be utilized in the embodiment of FIG. 14. In this case, a piercing member 220awould again be preferable. In addition, if sealing layers are utilized, the gas can penetrate the porous material and sterilize the sealing surfaces without having to remove the contamination containment surfaces.

[0103] An exemplary alternate embodiment of a connector assembly—fluid delivery system combination is illustrated in FIG. 15, where analogous components have the same reference numbers as the components in FIG. 14. Once again, the male connector 200 comprises the stem 210 having a head 220, the fitting 230, the resilient mount 249, and the male contamination containment layer 500. The female connector 100 comprises the fitting 130, including a bore 142, and the female contamination containment layer 400. In this embodiment, however, the female connector 100 may be connected directly to the container 600. For example, as illustrated, the female connector 100 may be fitted with a transfer leg closure 602. In contrast to the female connector 100 illustrated in FIG. 1, wherein the tube 10 is connected to the fitting 130, the fitting 130 may be mounted directly to the fitment 602 of the container 600. Preferably, the female connector 100 and the container 600 may be constructed as a single integral unit.

[0104] As described above, the tubing connected to the male connector 200 of the connector assembly may be connected to other components in the fluid delivery system. For example, the tubing 20 may be connected to a series of connector assembly-fluid delivery system combinations, to a syringe, or to a filtration system. In addition, although not illustrated, the male connector 200 of the connector assembly may be connected to the container 600.

[0105] In the embodiment illustrated in FIG. 15, the female and male contamination containment layers 400 and 500 are utilized in a similar manner as described with reference to FIG. 14. Basically, once the female connector 100 and the male connector 200 are connected as previously described, the female and male contamination containment layers 400 and 500 are removed by pulling the tabs 402, 502 and the stem 210 is inserted into the bore 142. Because the female and male contamination containment layers 400 and 500 are removed, piercing member is necessary on the head 220 of the stem 210, as illustrated in FIG. 1, to puncture the sealing surfaces 172aand 272a. Alternatively, the membrane assemblies 170 and 270 described in detail with respect to FIGS. 5aand 5bmay be utilized in the embodiment of FIG. 15. In this case, a piercing member would again be necessary.

[0106] Once the female and male connectors 100, 200 are interlocked, the female and male contamination containment layers 400, 500 removed, or the contamination containment surfaces of the membrane assemblies 170, 270 removed and the sealing surfaces punctured by the piercing member, the transfer leg closure is opened to initiate the fluid flow.

[0107] FIG. 16 illustrates an exemplary embodiment of a connector assembly—fluid delivery system combination wherein a modified female connector 100 of the connector assembly is mounted directly to the wall of a container 600. Once again, analogous components have the same reference numbers as used in FIGS. 14 and 15. Again the container may be of any suitable type. For example, the container may be a flexible bag, a rigid container, or a syringe. FIG. 18 illustrates a fluid delivery system in which the second fitting is directly associated with the wall of a rigid container 800 or of a syringe 900. In this embodiment, the female connector 100 is different from the previously described female connectors 100. Essentially, in this embodiment, only the bracket 148 of the female connector 100 is utilized. As in the previously described embodiments, the U-shaped bracket is defined by a flange 150 and one or more tongues 158. The flange 150 may have a generally disc-shaped configuration with an aperture 148ain the center. The tongues 158 extend away from the flange 150 in a direction away from the container 600. The tongues 158 can thus register in grooves 248 (illustrated in FIG. 3), formed in the flange 246 of the male connector 200. Accordingly, tongues 158 can be adapted to couple the female and male connectors 100, 200 in a tongue-in-groove engagement as in the previously described and illustrated embodiments. Alternative arrangements for the connection of the female and male connectors 100, 200 are also possible, and may include, for example, threaded connectors. In an alternate embodiment, the fitting 130 of the female connector 100 may extend into the container 700, as shown in FIG. 17. The male connector 200 as with previously described embodiments comprises the same basic components, i.e., the stem 210 with a head 220, the fitting 230, the resilient mount 249 and the male contamination containment layer 500.

[0108] The female connector 100 may be connected to the wall of the container 600 by a variety of means. In the exemplary embodiment illustrated in FIG. 16, the female connector 100 is connected to a major surface of the container 600. The area of the wall where the female connector 100 is connected may be reinforced so that the female connector 100 will not tear away a portion of the wall. The reinforcement may be in the form of a grommet or any other suitable reinforcement means. The female connector 100 may be bonded or welded to the container 600 or may be formed integrally therewith.

[0109] In the embodiment illustrated in FIG. 16, the female and male contamination containment layers 400 and 500 are utilized in the same manner as described with reference to FIG. 14. Alternatively, or additionally, the membrane assemblies 170 and 270 described in detail with respect to FIGS. 5aand 5bmay be utilized in place of the female and male contamination containment layers 400 and 500. Basically, once the female connector 100 and the male connector 200 are interlocked as previously described, i.e., for example, via the tongue-in-groove arrangement, the female and male contamination containment layers 400 and 500 are removed by pulling the tabs 402, 502. The stem 210 is then moved from the male connector 200, through the aperture 148ain the female connector 100, and through the wall of the container 600, the piercing member piercing the wall of the container 600, thereby forming a fluid path therethrough. The aperture 148amay be sized to seal against the head 220 of the stem 210 which is preferably tapered to provide an increasingly snug fit and seal at the walls of the bracket 148 defining the aperture 148a. Alternatively, the female connector 100 may comprise a sealing member such as an O-ring to provide a fluid tight seal between the head 220 and the aperture 148a.

[0110] Although shown and described is what are believed to be the most practical and preferred embodiments, it is apparent that departures from specific methods and designs described and shown will suggest themselves to those skilled in the art and may be used without departing from the spirit and scope of the invention. The present invention is not restricted to the particular constructions described and illustrated, but should be constructed to cohere with all modifications that may fall within the scope of the appended claims.