HK1198693B

HK1198693B - Medical connectors with fluid-resistant mating interfaces

Info

Publication number: HK1198693B
Application number: HK14112297.9A
Authority: HK
Inventors: T．F．范格罗
Original assignee: Icu医学有限公司
Priority date: 2011-09-09
Filing date: 2012-09-07
Publication date: 2018-09-21

Description

Medical connector with flow-resistant mating interface

RELATED APPLICATIONS

The present application claims the benefits of U.S. provisional application No. 61/533,138, entitled "medical connector with enhanced fluid containment" filed on 9/2011, U.S. provisional application No. 61/557,793, entitled "medical connector with flow-blocking mating interface", filed on 11/9/2011, U.S. provisional application No. 61/579,582, entitled "medical connector with flow-blocking mating interface", filed on 3/6/2012, U.S. provisional application No. 61/607,429, entitled "medical connector with flow-blocking mating interface", filed on 8/23/2012, and U.S. provisional application No. 61/692,516, entitled "medical connector with flow-blocking mating interface". Each of the above-mentioned patent applications is incorporated herein by reference in its entirety and forms a part of this specification in its entirety for all purposes.

Background

Technical Field

The present invention relates generally to medical connectors through which fluid flows, and more particularly, to medical connectors having enhanced fluid containment capabilities.

Description of the related Art

Systems of connectors, valves and tubing are routinely used in hospitals and other medical facilities to facilitate the transfer of fluids to and from patients. It is often a challenge to maintain the sterility of such systems and avoid leakage or appearance residue of fluids (e.g., liquids and/or vapors) as the components are joined and separated.

In certain medical applications, such as certain chemotherapy treatments, the fluid in the tubing and connector may be harmful if released, especially after repeated exposure to the fluid, even in relatively small amounts. To maintain a barrier against leakage of many types of fluids and to impede the ingress or egress of microorganisms or debris, connectors have been equipped with caps such as diaphragms, soft seals, or other barriers at their mating ends. When the first connector is engaged with the second connector, the cap of one or both of the connectors is temporarily opened, punctured or moved to allow fluid to flow between the two connectors. These connectors may allow for undesirable fluid release, such as by transmission or vaporization of residual fluid on the mating end of the connector after separation. These connectors have other drawbacks and deficiencies.

SUMMARY

In certain embodiments, medical connectors are disclosed having enhanced fluid containment capabilities and isolating fluid from the connector mating end and/or reducing or eliminating fluid residue on the connector mating end and having flow-resistant mating interfaces and dry-state separation, and/or improved connection systems or mechanisms for connecting the connectors together. In certain embodiments, the dry disconnect medical connector is free of fluid residue or leakage on the outer surface of the connector when disconnected. In certain embodiments, upon dry disconnection, the medical connector is free of noticeable fluid residue or leakage on the connector exterior surface upon disconnection, and thus any minor fluid residue or leakage does not exhibit significant functional defects or obvious health risks to the patient or health care provider. It is contemplated that any of the features, components, or steps of the various embodiments described herein and/or incorporated by reference can be combined with each other and/or substituted to form additional embodiments. Such combinations and/or substitutions are contemplated and are within the scope of the present invention.

In certain embodiments, a fluid-transferring connection system includes a first connector. The first connector may have a first central axis, a first end, a second end, and a protrusion. In some embodiments, the first connector includes a valve member at least partially positioned within the interior space of the boss and configured to transition between an open position and a closed position. The valve member may have a first end and a second end. In some embodiments, the valve member may include a valve flow passage extending within the valve member between the first and second ends of the valve member. The valve member may include at least one port proximate the first end of the valve member. In some embodiments, the valve member may have a first mating surface at a first end of the valve member. The valve member first end may be configured to prevent fluid flow from the valve flow passage through the valve member first end when the valve member is in the closed position. In certain embodiments, the first connector includes a biasing member configured to bias the valve member toward the closed position. The connection system may include a second connector configured to transition between an open configuration and a closed configuration.

In certain embodiments, the second connector includes a second housing having a second central axis, a first end configured to receive the male portion of the first housing, and a second end. The second connector may include a fluid conduit at least partially disposed within the interior space of the second housing and having a first end, a second end, a conduit passage extending within the fluid conduit between the first and second ends of the fluid conduit, at least one port proximate the first end of the fluid conduit and extending through the fluid conduit into the conduit passage, and a second mating surface configured to detachably mate with the first mating surface of the valve member. In certain embodiments, the second connector includes a seal at least partially located in the interior space of the second housing and having a first end, a second end, a bias between the first and second ends of the seal, and an aperture at the first end of the seal sized and shaped to correspond to the size and shape of the first end of the fluid line. The seal may be configured to prevent fluid from flowing out of the conduit channel through the at least one port of the fluid conduit when the second connector is in the closed configuration. The first connector and the second connector may be configured to connect to each other to transition the valve member to the open position and the second connector to the open configuration when the first connector is connected to the second connector. In some embodiments, the first mating surface and the second mating surface are configured to engage each other in a manner that prevents fluid from infiltrating between the first mating surface and the second mating surface when fluid flows through the first and second connectors.

In some embodiments as described above, the biasing member is a spring or a hose. The fluid lines may be constructed of a rigid or semi-rigid material. In certain embodiments, the male luer tip of the first connector is a male luer tip according to ANSI and/or the first end of the second connector is a female luer tip according to ANSI. The fluid line may be configured such that at least a portion of the fluid line is configured to enter the male portion of the first connector when the first connector is connected to the second connector. In certain embodiments, at least one of the first mating surface and the second mating surface is comprised of a flexible material. The first connector may include a ferrule portion having at least one mating feature configured to engage with an engagement feature of the second connector.

In some embodiments, the inner cross-sectional area of the sleeve portion is greater than the outer cross-sectional area of the second connector portion proximate the first end of the second connector. The at least one mating feature may be a hooked tab, the hook being configured to engage with an engagement feature of the second connector. In certain embodiments, the tab may include a release structure configured to urge the at least one mating structure out of engagement with the second connector. In certain embodiments, the release structure is a dome protrusion and/or at least one ridge protruding from the at least one tab. The engagement formation may be an annular groove on the outer surface of the second connector. In some embodiments, the tab includes a longitudinal rib. The second connector may include an abutment structure configured to limit passage of the ferrule portion past the first end of the second connector. The abutment structure may have an outer cross-sectional area greater than an inner cross-sectional area of the collar portion, the abutment structure including one or more flanges on an outer surface of the second connector. In certain embodiments, at least a portion of the fluid line is configured to enter the male portion of the first connector when the first connector is connected to the second connector. The convex portion may be configured such that at least a portion of the convex portion of the first connector enters the inner space of the second housing when the first connector is connected with the second connector. The various features, components and characteristics described above may be combined with or substituted for one another in order to arrive at variants of the described invention.

A method of transferring fluid from a fluid source to a fluid receptacle may include connecting the fluid source to a first connector. The first connector may include a first housing having a first central axis, a first end, a second end, and a projection, the second end configured for sealable engagement with a fluid source. In some embodiments, the first connector includes a valve member at least partially disposed within the interior space of the male portion and configured to transition between an open position and a closed position, the valve member including a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, and a first mating surface at the first end of the valve member. The valve member first end may be configured to prevent fluid flow from the valve flow passage through the valve member first end when the valve member is in the closed position. In certain embodiments, the first connector includes a biasing member configured to bias the valve member toward the closed position. A method of transferring fluid from a fluid source to a fluid receptacle may include connecting the fluid receptacle to a second connector configured to transition between an open configuration and a closed configuration. The second connector may include a second housing having a second central axis, a first end configured to receive the male portion of the first housing, and a second end configured to connect with the fluid receptacle.

In certain embodiments, the second connector includes a fluid conduit at least partially located in the interior space of the second housing and having a first end, a second end, a conduit passage extending within the fluid conduit between the first and second ends of the fluid conduit, at least one port proximate the first end of the fluid conduit and extending through the fluid conduit into the conduit passage, and a second mating surface structured to detachably engage the first mating surface of the valve member. In certain embodiments, the second connector includes a seal located at least partially in the interior space of the second housing and having a first end, a second end, a bias between the first and second ends of the seal, and an aperture at the first end of the seal sized and shaped to correspond to the size and shape of the first end of the fluid conduit, the seal configured to prevent fluid from exiting the conduit channel through at least one port of the fluid conduit when the second connector is in the closed configuration. The fluid transfer method may include connecting a first connector to a second connector, wherein the valve member transitions from the closed position to the open position and the second connector transitions to the open configuration when the first connector and the second connector are connected to each other. In certain embodiments, the method includes transmitting fluid from the fluid source through the first connector and the second connector to the fluid receptacle and separating the first connector from the second connector, wherein the first mating face and the second mating face remain free of fluid after being separated from each other.

The fluid transfer method may include connecting a male luer connector of a fluid source to the second end of the first connector. In certain embodiments, connecting the fluid receptacle to the second end of the second connector further comprises connecting a female luer fitting of the fluid receptacle to the second end of the second connector. The method may also include connecting the mating structure of the first connector with the engagement structure of the second connector. In certain embodiments, the method includes inserting at least a portion of a fluid line into the boss when the first connector is connected to the second connector. According to certain variations, the method may include inserting at least a portion of the protrusion into the first end of the second connector when the first connector is connected to the second connector. The various steps, features, components and characteristics described above may be combined with or substituted for one another in order to arrive at variations of the described invention and method.

A method of manufacturing a connection system for fluid transfer may include providing a first connector having a first housing with a first central axis, a first end, a second end, and a male portion. A valve member may be at least partially disposed within the interior space of the boss and may be configured to transition between an open position and a closed position. In some embodiments, the valve member includes a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, and a first mating surface at the first end of the valve member. The valve member first end may be configured to prevent fluid flow from the valve flow passage through the valve member first end when the valve member is in the closed position. In certain embodiments, the first connector includes a biasing member configured to bias the valve member toward the closed position. The method of manufacturing may include providing a second connector configured to transition between an open configuration and a closed configuration and including a second housing having a second central axis, a first end configured to receive the boss of the first housing, and a second end. In certain embodiments, the second connector includes a fluid line at least partially disposed within the interior space of the second housing and having a first end, a second end, a line channel extending within the fluid line between the first and second ends of the fluid line, at least one port proximate the first end of the fluid line and extending through the fluid line into the line channel, and a second mating surface configured to detachably mate with the first mating surface of the valve member. The seal may be at least partially located in the interior space of the second housing and may have a first end, a second end, an offset between the first and second ends of the seal, and an aperture at the first end of the seal sized and shaped to correspond to the size and shape of the first end of the fluid conduit, the seal being configured to inhibit fluid from flowing out of the conduit passageway through the at least one port of the fluid conduit when the second connector is in the closed configuration. The method of manufacturing may include connecting a first end of a first connector to a first end of a second connector to transition the second connector to an open configuration and transition the valve member to an open position when the first connector is connected to the second connector. In some embodiments, the first mating surface and the second mating surface are configured to engage one another in a manner that prevents fluid from infiltrating between the mating surfaces as fluid flows through the first and second connectors.

A closeable male connector configured to connect with a female connector may include a housing having a first central axis, a first end, a second end, and a male portion. In some embodiments, the male connector includes a valve member at least partially disposed within the interior space of the male portion and configured to transition between an open position and a closed position, the valve member including a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, and a first mating surface at the first end of the valve member, the first end of the valve member configured to block fluid flow from the valve flow passage through the first end of the valve member when the valve member is in the closed position. According to certain variations, the male connector includes a biasing member configured to bias the valve member toward the closed position. The first mating surface may be sized and shaped to detachably mate with a second mating surface on the female connector to transition the valve member to the open position when the male connector is connected with the second connector. In some embodiments, the first mating surface is configured to engage the second mating surface in a manner that prevents fluid from infiltrating between the first mating surface and the second mating surface when fluid flows through the male connector and the female connector.

A closeable female connector configured to connect with a male connector may be configured to transition between an open configuration and a closed configuration and may include a housing having a second central axis, a first end configured to receive a male portion of a first housing, and a second end. In some embodiments, the female connector includes a fluid conduit at least partially disposed within the interior space of the housing and having a first end, a second end, a conduit channel extending within the fluid conduit between the first and second ends of the fluid conduit, at least one port proximate the first end of the fluid conduit and extending through the fluid conduit into the conduit channel, and a mating face. The female connector may include a seal at least partially located in the interior space of the housing and having a first end, a second end, an offset between the first and second ends of the seal, and an aperture at the first end of the seal sized and shaped to correspond to the size and shape of the first end of the fluid conduit, the seal configured to inhibit fluid from flowing out of the conduit channel through the at least one port of the fluid conduit when the female connector is in the closed configuration. The female mating face may be configured to detachably engage with the male mating face of the male connector and may be configured to engage with the male mating face in a manner that prevents fluid from penetrating between the female mating face and the male mating face when fluid flows through the male connector and the female connector.

A fluid-transferring connection system having an open stage and a closed stage may include a first connector. The first connector may include a first housing having a first central axis, the first housing including a first end with a boss and a second end. A valve member may be disposed at least partially within the interior space of the boss, the valve member including a closed end, a first flow passage extending through the valve member, at least one port proximate the closed end of the valve member and extending through the valve member into the first flow passage, and a first mating surface at the closed end. In some embodiments, the first connector includes a biasing member functionally associated with the valve member. The connection system may include a second connector including a second housing having a second central axis, the second housing including a first end configured to receive the boss and a second end. In certain embodiments, the second connector includes a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including a closed end, a second flow passage extending through the fluid conduit, at least one port proximate the closed end of the fluid conduit and extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end and configured to mate with the first mating surface. The second connector may include a seal disposed within the second housing, the seal including a first end, a second end, and a bias therebetween, the first end including an aperture that opens during an open phase and a closed phase, and the first end having a size and shape generally corresponding to a size and shape of the closed end of the fluid line, the seal configured to prevent fluid flow through the at least one port of the fluid line. In certain embodiments, the first mating surface and the second mating surface are configured to engage one another in a manner that prevents fluid from infiltrating between the mating surfaces as fluid flows through the connectors.

According to certain variations, a medical fluid transfer connection system may have an open stage and a closed stage and may include a first connector. In certain embodiments, the first connector includes a first housing having a first central axis, the first housing including a first end having a protrusion and a second end, the protrusion having an inner cross-sectional area. The first connector may include a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end having a cross-sectional area, a first flow passage extending through the valve member, at least one port proximate the closed end of the valve member and extending through the valve member into the first flow passage, and a first mating surface at the closed end. In some embodiments, the first connector includes a biasing member functionally associated with the valve member. The connection system may include a second connector including a second housing having a second central axis, the second housing including a first end configured to receive the boss and a second end. The second connector may include a fluid conduit disposed at least partially in the interior space of the second housing, the fluid conduit including an open end, a closed end, a second flow passage extending between the open end and the closed end, at least one port proximate the closed end of the fluid conduit extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end configured to mate with the first mating surface. According to some embodiments, the second connector includes a seal disposed within the second housing, the seal including a first end, a second end, a bias between the first end and the second end, and an aperture at the first end of the seal having a cross-sectional area in the open phase that is greater than or equal to an inner cross-sectional area of the protrusion. The first mating face and the second mating face may be configured to engage each other in a manner that prevents fluid from infiltrating between the mating faces as fluid flows through the connectors.

A medical fluid transfer connection system may have an open stage and a closed stage and may include a first connector having a first housing with a first central axis, the first housing having a first end with a male portion and a second end. In certain embodiments, the first connector includes a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end having a cross-sectional area, a first flow passage extending between the valve member and the second end of the first housing, at least one port proximate the closed end of the valve member extending through the valve member into the first flow passage, and a first mating surface at the closed end. The first connector may include a biasing member functionally associated with the valve member. In some embodiments, the connection system includes a second connector having a second housing including a second central axis, the second housing including a first end configured to receive the boss and a second end. In some embodiments, the second connector includes a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including an open end, a closed end, a second flow passage extending between the open end and the closed end, at least one port proximate the closed end of the fluid conduit extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end configured to mate with the first mating surface. A seal may be disposed within the second housing, the seal including a first end, a second end, a bias between the first and second ends, and an orifice at the first end of the seal having a cross-sectional area at the opening stage that is greater than or equal to a cross-sectional area of the valve member. In certain embodiments, the first mating surface and the second mating surface are configured to engage one another in a manner that prevents fluid from infiltrating between the mating surfaces as fluid flows through the connectors.

According to certain variations, a medical system for medical fluid transfer may include a first connector having a first housing including a first central axis, the first housing including a first end having a male portion and a second end. In certain embodiments, the first connector includes a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end, a first flow passage extending through the valve member, at least one port proximate the closed end of the valve member and extending through the valve member into the first flow passage, and a first mating surface at the closed end. The first connector may include a biasing member functionally associated with the valve member. In certain embodiments, the medical system includes a second connector having a second housing including a second central axis, the second housing including a first end configured to receive the boss and a second end. The second connector may include a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including a closed end, a second flow passage extending through the fluid conduit, at least one port near the closed end of the fluid conduit extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end configured to mate with the first mating surface. In certain embodiments, the second connector has a seal disposed within the second housing and configured to prevent fluid flow through the at least one port of the fluid line, the seal including a bias. According to some arrangements, the first mating surface and the second mating surface are configured to engage one another in a manner that prevents fluid from infiltrating between the mating surfaces as fluid flows through the connectors.

Brief description of the drawings

Certain embodiments of the invention will now be described in detail with reference to the following drawings. These drawings are provided for illustrative purposes only, and the present invention is not limited to the technical solutions shown in the drawings.

Fig. 1 is a perspective view of an embodiment of a male connector adjacent to an embodiment of a female connector.

Fig. 2A shows a side view of a male connector embodiment connected to a tube designed to receive fluid from a gravity fed IV hanging bag.

Fig. 2B shows a side view of the male connector of fig. 1A in an open configuration.

Fig. 2C shows a side view of the connector embodiment of fig. 1A connected to a female connector connected to a tube inserted into a patient.

Fig. 3 is a perspective view of the male connector embodiment in a closed position.

Fig. 4 is a side view of the embodiment of the male connector shown in fig. 3, again in a closed position, showing certain internal features of the male connector in phantom.

Fig. 5 is an exploded perspective view of the component parts of the male connector embodiment shown in fig. 3.

Fig. 6 is a posterior view of a back view of the female end of the male connector embodiment shown in fig. 3.

Fig. 7 is a cross-sectional view of the male connector embodiment shown in fig. 3, taken along line 7-7 of fig. 6.

Fig. 8 is an enlarged cross-sectional view of the male connector embodiment shown in fig. 3, taken along line 8-8 of fig. 7.

Fig. 9 is a cross-sectional view of the male connector embodiment shown in fig. 3, taken along line 9-9 of fig. 6.

Fig. 10 is an enlarged cross-sectional view of the male connector embodiment shown in fig. 3, taken along line 10-10 of fig. 9.

Fig. 11 is a perspective view of an embodiment of a valve member of the male connector shown in fig. 3.

Fig. 12 is a perspective view of an embodiment of the spring of the male connector shown in fig. 3.

Fig. 13 is a perspective view of an embodiment of a seal of the male connector shown in fig. 3.

Fig. 14 is a perspective view of an embodiment of a luer tip seal of the male connector shown in fig. 3.

Fig. 15 is a perspective view of an embodiment of a first cap of the male connector shown in fig. 3.

Fig. 16 is a side view of the first cap shown in fig. 15.

Fig. 17 is a perspective view of a second cap embodiment of the male connector shown in fig. 3.

Fig. 18 is a front view of the second cap shown in fig. 17.

FIG. 19 is a cross-sectional side view of the second cap shown in FIG. 17, taken along line 19-19 of FIG. 18.

Fig. 20A is a side view of an engagement member in threaded engagement with the male connector embodiment shown in fig. 3.

Fig. 20B is a side view of the engagement member substantially fully threadedly engaged with the male connector embodiment shown in fig. 3.

Fig. 20C is a side view of an engagement member substantially fully threadedly engaged with another embodiment of a male connector.

Fig. 21 is a perspective view of a female connector embodiment in a closed position.

Fig. 22 is a side view of the female connector embodiment of fig. 21 in a closed position.

Figure 23 is an exploded perspective view of the component parts of the female connector embodiment shown in figure 21.

Fig. 24 is a front view of the embodiment of the female connector shown in fig. 21.

Fig. 25 is a cross-sectional view of the female connector embodiment of fig. 21 taken along line 25-25 of fig. 24.

Fig. 26 is a perspective view of an embodiment of a housing of the female connector shown in fig. 21.

Figure 27 is a perspective view of an embodiment of a fluid line of the female connector shown in figure 21.

Fig. 28 is a perspective view of a compressible seal embodiment of the female connector shown in fig. 21.

Fig. 29 is a side view of an embodiment of a male connector adjacent to the embodiment of the female connector shown in fig. 1.

Fig. 30 shows a cross-sectional view of the connector system of fig. 29 taken at line 30-30 of fig. 29.

Fig. 30A shows a cross-sectional view of the connector system of fig. 29.

Fig. 31 is a side view of an embodiment of a male connector engaged with the embodiment of the female connector shown in fig. 1.

Fig. 32 illustrates a cross-sectional view of the connector system of fig. 31 taken at line 32-32 of fig. 31.

Fig. 33 is a perspective view of another embodiment of a male connector embodiment adjacent to another embodiment of a female connector.

Fig. 34 is the male connector embodiment of fig. 33 in a closed position.

Fig. 35 is a side view of the male connector embodiment of fig. 34 in a further closed position.

Fig. 36 is an exploded perspective view of the component parts of the male connector embodiment shown in fig. 34.

Fig. 37 is a cross-sectional side view of the embodiment of the male connector shown in fig. 35.

Fig. 38 is a perspective view of a male housing embodiment of the male connector shown in fig. 34.

Fig. 39 is a perspective view of an embodiment of a valve member of the male connector shown in fig. 34.

Fig. 40 is a perspective view of an embodiment of a luer tip seal of the male connector shown in fig. 34.

Fig. 41 is a perspective view of the female connector embodiment shown in fig. 33 in a closed position.

Fig. 42 is a side view of the female connector embodiment of fig. 41 in a closed position.

Figure 43 is an exploded perspective view of various components of the embodiment of the female connector shown in figure 41.

Fig. 44 is a cross-sectional side view of the embodiment of the female connector shown in fig. 42.

Fig. 45 is a perspective view of an embodiment of a housing of the female connector shown in fig. 41.

FIG. 46 is a perspective view of an embodiment of a fluid line of the female connector shown in FIG. 41.

Fig. 47 is a perspective view of an embodiment of a first cap of the female connector shown in fig. 41.

FIG. 48 is a perspective view of an embodiment of a compressible seal of the female connector shown in FIG. 41.

Fig. 49 is a side view of the embodiment of the male connector shown in fig. 33 adjacent to the embodiment of the female connector shown in fig. 41.

Fig. 50 shows a cross-sectional side view of the connector system of fig. 49.

Fig. 50A shows a cross-sectional side view of the connector system of fig. 49.

Fig. 51 is a side view of the embodiment of the male connector shown in fig. 33 engaged to the embodiment of the female connector shown in fig. 41.

Fig. 52 shows a cross-sectional side view of the connector system of fig. 51.

Fig. 53 is a perspective view of another male connector embodiment adjacent to another female connector embodiment.

Fig. 54 is a perspective view of the male connector embodiment of fig. 53 in a closed position.

Fig. 55 is a side view of the male connector embodiment of fig. 54 in a closed position.

Fig. 56 is an exploded perspective view of the component parts of the male connector embodiment shown in fig. 54.

Fig. 57 is a cross-sectional side view of the embodiment of the male connector shown in fig. 55.

Fig. 58 is a perspective view of an embodiment of a male housing of the male connector shown in fig. 54.

Fig. 58A is a perspective view of an embodiment of a male housing.

Fig. 59 is a perspective view of an embodiment of a valve member of the male connector shown in fig. 54.

Fig. 60 is a perspective view of a luer tip seal embodiment of the male connector shown in fig. 54.

Figure 61 is an exploded perspective view of the components of the female connector embodiment shown in figure 53.

Figure 62 is a side view of the male connector embodiment shown in figure 53 adjacent to the female connector embodiment shown in figure 61.

Fig. 63 shows a cross-sectional side view of the connector system of fig. 62.

Fig. 63A shows a cross-sectional side view of the connector system of fig. 62.

Fig. 63B illustrates a cross-sectional side view of an embodiment of a connector system including the male housing of fig. 58A.

Fig. 64 is a side view of the male connector embodiment of fig. 53 engaged with the female connector embodiment of fig. 61.

Fig. 65 shows a cross-sectional side view of the connector system of fig. 64.

Fig. 66 illustrates a cross-sectional view of the male connector of fig. 3 adjacent a recess of another medical instrument.

Fig. 67 shows a cross-sectional view of the male connector of fig. 3 engaged with the medical instrument of fig. 66.

Fig. 68 shows a perspective view of the male connector of fig. 3in proximity to a syringe having a male luer tip.

FIG. 69 shows a perspective view of the components of FIG. 68 after engagement.

Fig. 70 shows a cross-sectional view of a male luer tip of the syringe of fig. 69 and a male connector.

Fig. 71 shows a perspective view of the male connector of fig. 3 with a first end positioned adjacent to a needle assembly with a female luer engagement and a second end positioned adjacent to a syringe with a male luer tip.

Fig. 72 shows a perspective view of the components of fig. 71 in engagement.

Fig. 73 is a cross-sectional view of the male connector, male luer tip of a syringe, and needle assembly of fig. 72.

Fig. 74 shows a cross-sectional side view of another embodiment of a male connector.

Figure 75 shows a cross-sectional side view of another embodiment of a female connector.

Fig. 76 shows a cross-sectional side view of the male connector of fig. 74 adjacent to the female connector of fig. 75.

Fig. 77 shows a cross-sectional view of the connector system of fig. 76.

Fig. 78 shows a cross-sectional side view of another embodiment of a female connector.

Fig. 79 shows a cross-sectional side view of the male connector of fig. 74 adjacent to the female connector of fig. 78.

Fig. 80 shows a cross-sectional side view of the connector system of fig. 79.

Figure 81 shows a cross-sectional side view of another embodiment of a male connector.

Fig. 82 shows a cross-sectional side view of another embodiment of a female connector.

Fig. 83 shows a cross-sectional side view of the male connector of fig. 81 adjacent to the female connector of fig. 82.

Fig. 84 shows a cross-sectional side view of the connector system of fig. 83.

Figure 85 shows a cross-sectional side view of another embodiment of a male connector.

Fig. 86 shows a cross-sectional side view of the male connector of fig. 85 adjacent to the female connector of fig. 82.

Fig. 87 shows a cross-sectional side view of the connector system of fig. 86.

Fig. 88 shows a cross-sectional side view of the connector system.

Fig. 89 shows a cross-sectional side view of the connector system of fig. 88.

Figure 90 shows a cross-sectional side view of another embodiment of a male connector. .

Figure 91 shows a cross-sectional side view of another embodiment of a female connector.

Fig. 92 shows a cross-sectional side view of the male connector of fig. 90 adjacent to the female connector of fig. 91.

Fig. 93 shows a cross-sectional side view of the connector system of fig. 93.

Figure 94 shows a cross-sectional side view of another embodiment of a male connector.

Fig. 95 shows a cross-sectional side view of the male connector of fig. 94 adjacent to the female connector of fig. 91.

Fig. 96 shows a cross-sectional side view of the connector system of fig. 95.

Detailed description of the invention

In some embodiments, the present application describes various means for enhancing fluid containment, such as by creating a dry separation, leaving mating ends of the connectors free of residual fluid, and/or preventing fluid ingress between mating ends of the connectors. In some embodiments, the closure mechanism functions to prevent and/or impede fluid from contacting, remaining on, and/or contaminating the mating ends of the connectors, while allowing fluid to flow when the connectors are engaged with one another. As used herein, terms such as "closed" or "sealed" are intended to have their ordinary meaning in the art and should be understood to encompass a barrier or impediment to fluid flow. These terms should not be construed as requiring a particular structure or configuration to achieve complete fluid containment in any event, but rather the terms refer to the degree of fluid containment required under the particular circumstances in which the device is intended to be used.

Fig. 1 shows a connector system 20 according to one embodiment of the present application having a male connector 100 and a female connector 400. The first end 112 of the male connector 100 is detachably engageable with the first end 402 of the female connector 400. First ends 112, 402 are configured such that flow passage 156 of male connector 100 can be fluidly connected to flow passage 418 of female connector 400 when first ends 112 and 402 are engaged with one another. When male connector 100 and female connector 400 are separated, flow passages 156, 418 are closed and no fluid is transmitted therethrough. The connection between the male connector 100 and the female connector 400 is configured such that one or both of the first ends 112, 402 are dry, leak-proof, and/or substantially or completely free of residual fluid after the connectors are separated. In this regard, "substantially free" is used in its ordinary meaning in the art and is applicable when the amount of residual fluid remaining on the outer surface after separation or closure is small enough not to pose a significant functional defect or health risk in the particular application in which the connector system is employed. In this regard, "dry" is used in its ordinary meaning in the art and applies when there is no residual fluid on the outer surface that is readily visible to the naked eye after separation or closure or when there is virtually no residual fluid on the outer surface that is readily detectable by standard instrumentation or testing procedures (e.g., blotting tests, microscopic observation, or other tests) after separation or closure. In some embodiments, the mating interface of the connectors 100, 400 is flow-blocking when the connectors 100, 400 are connected to each other, and at least one of the male connector 100 and the female connector 400 is substantially or completely free of residual fluid after connector disconnection.

In fig. 2A, an embodiment of a closeable male connector 100 is shown in a closed position. In certain embodiments, the male connector 100 may be connected to a tube that is connected to a fluid-filled gravity-fed IV bag 9 that hangs from the pole frame 11. A length of tubing 13 is attached to the bottom of the bag 9. The opposite end of tube 13 may be connected to first end 112 of male connector 100. The closure mechanism in the second end 114 of the male connector 100 may prevent fluid contained within the bag 9 from flowing through the tube 13 and leaking out of the male connector 100 as long as the male connector 100 remains in the closed configuration.

In fig. 2B, the male connector 100 is shown in an open position. Fluid can flow out into the first end 112 of the male connector 100 and out the second end 114 of the male connector 100. In this example of the male connector 100, the health care provider may move the male connector 100 to this configuration by pinching the second end of the closable male connector 100 with two fingers, pinching the tube 13 with the other two fingers, and gently moving the fingers in two directions opposite to each other.

As shown in fig. 2A and 2B, the IV delivery system may be readily prepared for fluid communication with a patient. In most cases, the tube 13 is filled with air when it is initially connected to the IV bag 9. If the other end of the tube 13 is connected to a closed connector as shown in fig. 2A, air cannot escape and fluid cannot enter the tube 13 from the IV bag 9. Thus, the male connector 100 is manually moved to the open position until all air has been purged through the male connector 100, filling the tube 13 and the male connector 100 from the IV bag 9. This process is called "priming". Once the fluid lines and connectors are properly filled, the health care provider can quickly remove the opposing force exerted on the second end 114 of the male connector 100 and the tube 13 and the closure mechanism of the male connector 100 can quickly prevent fluid from flowing through the male connector 100.

Referring now to fig. 2C, catheter 17 has been inserted into patient's arm 15. Conduit 17 extends through the skin of arm 15 and is preferably in fluid communication with the patient's blood. The catheter 17 is also connected to a length of medical tubing 19 that can be connected to the female connector 400. An example of a female connector 400 as shown in FIG. 2C is Clave manufactured by ICU Medical, Inc. of san Clementer, CalifA connector is provided. Various embodiments of such connectors are described and shown in U.S. patent No. US5,685,866, which is incorporated herein by reference in its entirety. It is contemplated that many of the male connector embodiments described herein can be used with other types of female connectors. Tube 19, conduit 17 and female connector 400 may be filled with fluid using standard operating procedures. Male connector 100 may be filled and placed in connection with female connector 400 as described above. As described in further detail below, when the male connector 100 and the female connector 400 are engaged, fluid is allowed to flow from the IV bag 9 into the patient. When male connector 100 and female connector 400 are separated, fluid is again prevented from flowing out of second end 114 of male connector 100. Fluid is also generally prevented from flowing out of the opening in the female connector 400.

Other embodiments of the connector system, some of which are disclosed herein, may be used in the fluid systems shown, as well as various modifications and alternatives thereof. Other embodiments of connector systems that may be used in whole or in part with the present invention are described, for example, in U.S. patent No. 7,815,614 and U.S. patent application No. 2008/0287920, which are incorporated herein by reference in their entirety. It is also contemplated that embodiments of connectors according to the present invention may be used in various other medical fluid systems. For example, the connector may also be used for transferring body fluids such as blood, urine or insulin, nutritional fluids and/or therapeutic fluids such as fluids used in chemotherapy. The connector may also be used to interconnect various other components of a fluid transfer system.

Fig. 3 shows an embodiment of a closable male connector 100. Any of the components making up male connector 100 may include any of the configurations, features, components, and/or materials of any of the other male connectors described herein and/or variations thereof. Additionally, any of the other connectors described herein may include any of the configurations, features, and components of the male connector 100. For example, features relating to preventing or inhibiting separation may be used with any suitable medical or other fluid connector.

Fig. 3 and 4 are perspective and side views, respectively, of the closable male connector 100 in a first or closed position. Fig. 4 shows in dashed lines certain internal structural features of an embodiment of the closeable male connector 100. Fig. 5 is an exploded perspective view of the component parts of the embodiment of the closeable male connector 100 shown in fig. 3. Referring to fig. 3 and 4, the closeable male connector 100 may have a first end 112 and a second end 114. The first end 112 may be configured to mate with the female connector 400. In some embodiments, first end 112 may include a protrusion 144 (see fig. 7) configured to be inserted into female connector 400. In certain embodiments, the first end 112 may include a male luer tip 122 and a valve element 116 (see fig. 5 and 11). Luer tip 122 and valve member 116 may be supported by male housing 123. The valve member 116 may be engaged to and/or biased against the male housing 123 at a particular location by a resilient member 118.

A cap portion 130 (also referred to as an end cap or female member) may be joined to the male housing 123 near the second end 114 of the closable male connector 100. One or more components of the cap portion 130 may be integral or unitary with the housing. Referring to fig. 5 and 6, in certain embodiments, the end cap 130 may include a first cap member 132 (also referred to as a first piece) and a second cap member 134 (also referred to as a second piece) that may be engaged with each other. Referring to fig. 18, in certain embodiments, the second cap 134 may include an outer surface 134a that is generally conical, or substantially frustoconical. In certain embodiments, however, the outer surface 134a may be substantially cylindrical or may have any other desired shape. The first cap member 132 may have external threads 136. As mentioned above, the embodiment of the closable male connector 100 as shown in fig. 3 and 4 is in the closed position. In the closed position, the valve member 116 may cooperate with the male luer tip 122 to block, substantially block, or shut off fluid flow through the male connector 100.

As shown in fig. 3, the male housing 123 may have a sleeve 124 surrounding the luer tip 122. The sleeve 124 may have a fastening structure or a connecting structure such as internal threads 126. The internal threads 126 and luer tip 122 may form a male luer fitting that conforms to ANSI specifications for a male connector. In certain embodiments, the fastening structure or connection structure 126 and/or the tip 122 are shaped to form a non-standard male fitting (e.g., not conforming to ANSI specifications for male luer connectors). The end cap 130 may have a receptacle shape conforming to ANSI standards for female connectors and capable of receiving a male connector of another connector, syringe, or other medical instrument. In certain embodiments, the end cap 130 is configured to be non-standard (e.g., non-ANSI-standard compliant). In some arrangements, the end cap 130 or any other connector of any of the connectors described herein may be configured to engage only a specially designed non-standard component (e.g., tip 122) of another connector, syringe, or other medical device as a safety precaution to ensure that a highly sensitive medical fluid, such as a chemotherapeutic drug, is not misdirected through a standard IV line into the wrong patient or into the wrong tubing of the correct patient. The external threads 136 may be configured to threadingly engage corresponding internal threads of the male connection portion of the engagement member. The luer tip 122 proximate the first end 112 of the male connector 100 may have a mating surface 128 at a distal end configured to form a substantially leak-free seal with at least a portion of the mating surface 466 of the compressible seal 460, as described further below. In the illustrated embodiment, the mating surface 128 is a thin circular ring at the end of the luer tip 122.

The valve member 116 may be at least partially surrounded by the male housing 123. As shown, the male housing 123 may have at least one side opening 125 exposing at least a portion of the valve member 116 and/or allowing at least a portion of the resilient member 118 to enter the male housing 123. In some embodiments, the male housing 123 may include two side openings 125, which may be disposed opposite each other on both sides of the male connector 100. In some embodiments, the side opening 125 can extend along a portion of the male housing 123 (e.g., in a central region of the male housing 123 as shown) to provide increased strength near the second end 114 of the housing. In the illustrated embodiment, the resilient member 118 may engage the valve member 116 near the side opening of the male housing 123. The outer surface 127 of the housing may be profiled. For example, the housing outer surface may include a narrower portion near the central region of the male housing 123 or a generally hourglass-shaped outer surface or a larger cross-sectional portion near the distal end. These shapes can provide tactile confirmation that the user's fingers are properly placed on the male connector 100 during use and/or provide a more comfortable gripping surface. In some embodiments, at least one outward protrusion (not shown) may be added to resilient member 118 to provide an additional or more effective gripping surface on male connector 100.

As shown in fig. 7, 9, and 11, the valve member 116 may have a closed end 144 that blocks fluid flow through the male connector 100 in the closed configuration. The valve member 116 may have a mating surface 146 that may include a first alignment structure, such as an aperture 147, that may mate with a second alignment structure, such as a complementary shaped or corresponding protrusion 490, at the first end 482 of the fluid conduit 480. In the illustrated embodiment, the aperture 147 is a generally circular recess. In some embodiments, the holes may have a variety of different shapes, such as rectangular, square, or polygonal. In some embodiments, the aperture may be at the first end 482 of the fluid line 480 and the protrusion may be disposed on the mating surface 146 of the valve member 116. The holes 147 and the projections 490 can help align and mate the mating surfaces of the male connector 100 with the mating surfaces of the female connector 400. In some embodiments, as shown, the first and second alignment structures are each shaped to matingly fit with each other such that there is substantially no gap therebetween when they are in contact with each other. In certain embodiments, as shown, the first and second alignment structures contact each other in a flow-blocking manner such that no significant amount of fluid can seep between the two during the transfer of fluid through the connector.

In some embodiments, as shown in fig. 7, the closed end 144 of the valve member 116 may include an outer region, such as an annular portion, having a smaller surface area than an inner region, such as the bore 147. The outer region may be substantially planar as shown, followed by a first abrupt or significant change in shape such as a first corner and a downward side, followed by another abrupt or significant change in shape such as a second corner, followed by a generally flat bottom. At least one of the corners may be generally arcuate or rounded, which may aid in drying in some embodiments. As shown, the plurality of changes in shape may be formed by one or more intersections of generally perpendicular surfaces. In certain embodiments, the one or more shape changes may also prevent, attenuate, or inhibit fluid intrusion between the contacted connector ends. Additionally, as shown, complementary non-planar mating surfaces, including mating surfaces with multiple shape changes, may resist or inhibit lateral movement (e.g., wobble or displacement) between the mating ends during connection, thereby preventing or inhibiting fluid infiltration between such ends.

In some embodiments, one or both of the respective contact ends of the male luer connector and the female connector may comprise a compressible resilient material. When the ends are brought together, one or both of the ends may be compressed, thereby further tightening the contact and reducing any gaps between the ends to further prevent or inhibit fluid intrusion between the mating structures. The elastic material may be applied or disposed at the ends in a variety of ways, including coating or overmolding processes, elastic shrinkage or recovery forces, glue, solvent bonding, and the like.

The luer tip seal 119 may be disposed within the luer tip 122 as shown in fig. 5, 7 and 9. In the illustrated embodiment, a luer tip seal 119 is disposed between the male housing 123 and the valve member 116 to form a seal between the valve member 116 and the luer tip seal 119 in the closed position. In certain embodiments, the interference fit between the valve member 116 and the luer tip seal 119 inhibits fluid flow out of the luer tip 122. The luer tip seal 119 may be made of an elastomeric material that helps form a seal as described below. In certain embodiments, the inner surface of the luer tip seal 119 may be conical in shape, decreasing in diameter toward the mating surface 176 of the luer tip seal 119. The end of the valve member 116 may also be conically shaped with a decreasing diameter toward the mating surface 146 of the valve member 116. The substantially mating tapered surfaces of the luer tip seal 119 and the valve member 116 may help provide a leak-proof or leak-free closure of the male connector 100. In certain embodiments, the natural outer diameter or outer cross-section of the mating surface 146 of the valve member 116 may be slightly larger than the natural inner diameter or inner cross-section of the luer tip seal 119 to further reduce or eliminate any gap therebetween and enhance the sealing effect therebetween.

As shown in the embodiment of the male connector 100 shown in fig. 3, the mating surface 146 of the valve member 116 is disposed substantially flush on both sides of the luer tip 122 when the male connector 100 is in the closed position. In some embodiments, as shown, the mating surface 146 of the valve member 116 may be wiped dry (e.g., may be cleaned with a sweeping, rotating, and/or wiping action of the sterilant applying instrument) between or prior to the connecting operations. The mating surfaces may be as shown without significant gaps, dimples, openings, protrusions that would prevent or unduly interfere with effective operative contact with the sterilant applying apparatus so as to effectively kill or remove microorganisms and debris to the extent clinically desirable. In certain embodiments, the mating surface 146 of the valve member 116 may be configured to extend further beyond the mating surface 128 of the luer tip 122 when the male connector 100 is in the closed position. In some embodiments, the mating surface 146 of the valve member 116 may be recessed within the luer tip 122.

The male connector 100 may be manipulated to a second position or an open position. In the open position, the valve member 116 may be retracted relative to the luer tip 122, thereby allowing fluid within the valve member 116 to flow out of the port 162 and around the closed end 144. As will be described in greater detail below, when the male connector 100 is in the open configuration, fluid can flow from the luer insert at the second end 114, through the interior of the male connector 100 and out of the valve element 116. Fluid may then enter the fluid line 480 of the female connector 400 as described below. When closed, fluid is blocked or blocked from flowing through the male connector 100 under normal operating conditions.

A biasing member in the form of a resilient member 118 may be provided. The elastic member 118 may be formed of an elastically deformable material. Thus, in some embodiments, the male housing 123 may be held in engagement with the valve member 116 by the resilient member 118 when the male connector 100 is moved to the open position. In the illustrated embodiment, a change in the relative positions of the male housing 123 and the valve member 116 may cause at least a portion of the resilient member 118 to elongate. As a result, the resilient member 118 exerts a closing force on the male housing 123 and the valve member 116, biased to return the male connector 100 to the closed state. The amount of tension exerted by the resilient member 118 may be adjusted by changing the mutual spacing of the male housing 123 and the valve member 116, increasing the thickness of the resilient member 118, and/or constructing the resilient member 118 from various materials having different resiliency. In some embodiments, the force required to open the male connector 100 is designed to be large enough to create a sufficiently reliable seal to prevent accidental or unintended opening. In some embodiments, the difficulty of opening the connector is controlled, at least in part, by the tension applied by the elastic member 118. In certain embodiments, the biasing member 118 may be in the form of a spring or other resilient or resilient compressible or extendable member that is positioned within the male housing 123 for biasing the valve member 116 to the closed position. Movement of the male connector 100 to the open position compresses such a biasing member, and movement of the male connector 100 to the closed position allows the biasing member to expand.

Fig. 6-11 illustrate the male connector 100 in a first or closed position. As shown in these figures, the valve member 116 may include at least one operating member such as a support body 150. In the illustrated embodiment, the valve member 116 includes two support bodies 150. In certain embodiments, the valve member 116 may include more than two support bodies 150. In some embodiments, each support body 150 may extend from approximately the center of the valve member 116 toward the first end 112 of the male connector 100. The support 150 may be located around the luer tip 122, but as shown within the male housing 123. Support 150 may be located within the inner diameter of internal threads 26. In certain embodiments, the support 150 may be positioned to contact at least a portion of the female luer receptacle when engaging the luer tip 122.

Referring to fig. 3, the elastic member 118 may include at least a first ring 174 and at least one fastening ring 172. In some embodiments, the resilient member 118 may include more than one ring 174 or more than one fastening ring 172. The first ring 174 may be seated within the stamped groove 148 in the outer surface of the male housing 123, proximate the first end 112. When a force is applied to the resilient member 118 due to a change in the relative positions of the male housing 123 and the valve member 116, the resilient member 118 may be tight enough around the male housing 123 to hold the first ring 174 in place. In certain embodiments of the connector, the fastening ring or rings 172 can be disposed about the valve member 116 in various forms, such as described in U.S. patent application publication No. 2008/0287920, which is incorporated herein by reference in its entirety.

As shown in fig. 7, the flow passage 156 can extend through a portion of the valve element 116 proximate the first end 112. The cross-section of the flow passage 156 may be circular as shown in the illustrated embodiment, or the flow passage 156 may have other cross-sectional shapes. The flow passage 156 may have at least one port 162 proximate the first end 112. In the illustrated embodiment, the two ports 162 are located on opposite sides of the valve member 116 and are circular, although other arrangements and shapes may be used.

In the embodiment shown in fig. 7, with the male connector 100 in the closed position, the relative positions of the valve member 116 and the male housing 123 can create a cavity disposed between the flow channel 156 and the luer receptacle 158. The cavity 154 may be in fluid communication with a flow passage 156. The cavity 154 may be wider than the flow channel 156 as shown. In certain embodiments, the cavity 154 may have substantially the same diameter as the flow passage 156. In certain embodiments, the cavity 154 may have a smaller diameter than the flow passage 156. The cavity 154 may also be designed with a non-circular cross-section in accordance with any other suitable shape. The cavity 154 may be defined by the plunger 170 at an end proximate the second end 114 of the male housing 123.

The plunger 170 may be the portion of the end cap 130 that extends toward the valve member 116. The plunger 170 may have a conduit 194 therethrough. The conduit 194 may place the cavity 154 in fluid communication with the luer receptacle 158. The plunger 170 may have an outer dimension sufficient to substantially close one end of the cavity 154 as shown. In the illustrated embodiment, the plunger 170 may be circular to match the shape of the cavity 154, although other shapes may be used if appropriate.

The outer dimension of the plunger 170 may be similar to the inner dimension of the wall of the valve member 116 that creates the cavity 154, but does not contact such wall to allow relative movement therebetween. To prevent fluid from escaping through the plunger 170, a seal, such as an O-ring 160, may be disposed in a recess 169 behind the plunger 170. The O-ring 160 may contact the wall of the valve member 116 as shown, preventing fluid flow out of the cavity 154. In certain embodiments, the plunger 170 is part of the end cap 130. The end cap 130 may be secured with the male housing 123 by sonic welding, glue, or any other suitable joining means. In the illustrated embodiment, the end cap 130 is joined to the male housing 123 by an acoustic horn 131. Such a welding head 131 is shown as having a substantially triangular shape, although other shapes are possible. The plunger 170 can thus be considered to be in a rest position relative to the male housing 123. In certain embodiments, the plunger 170 is integral or integrally formed with the male housing 123, and the end cap 130 is a separate piece that is suitably connected to the male housing 123, such as by sonic welding. In certain embodiments, the second cap 134 may be integral or integrally formed with the male housing 123. As will be described in greater detail below, the first cap 132 may also be formed separately from the second cap 134 or the male housing 123.

As shown in fig. 7, fluid can flow into luer receptacle 158 and to catheter 194. Fluid may flow from conduit 194 to chamber 154 and from chamber 154 into flow passage 156. As shown in the illustrated embodiment, when the male connector 100 is in the closed position, the valve closing end 144 of the valve member 116 can seal the aperture in the luer tip 122, preventing fluid from flowing out of the end of the luer tip 122. However, fluid may generally exit the flow passage 156 through a port 162 in the valve member 116. Fluid may be trapped within the luer tip 122 but may be prevented from flowing out of the luer tip 122 by the luer tip seal 119 and from flowing back out of the valve member 116 to the second end 114 by the seal 120. Thus, when male connector 100 is in the closed position as shown, there may generally be fluid communication between luer receptacle 158 and the interior of luer tip 122 without allowing fluid to flow out of first end 112 of male connector 100.

The male connector 100 may be changed to the open configuration when engaged with the female connector 400. When the first end 402 of the female connector 400 is engaged with the first end 112 of the male connector 100, the engagement portion 446 of the female connector 400 engages the sleeve 124 of the male connector 100. Luer tip 122 at least partially enters female connector 400 and fluid line 480 within female connector 400 contacts valve element 116 to urge valve element 116 toward second end 114 of male connector 100. The connection of the male connector 100 and the female connector 400 will be described in more detail below.

In some embodiments, when valve member 116 is moved toward second end 114, valve closing end 144 (see fig. 7 and 9) separates from luer tip 122, drawing port 162 away from luer tip seal 119. Thus, fluid may flow around the closed end 144 into the engaged female connector 400. The seal 120 may prevent fluid from exiting the interior of the luer tip 122 to the second end 114 of the male connector 100. Thus, in the open position, fluid can flow from luer receptacle 158, through conduit 194, lumen 154, flow channel 156, port 162 in valve member 116, into luer tip 122 and into the port in female connector 400.

As can be seen in the illustrated embodiment, the valve member 116 may be moved toward the second end 114 of the male connector 100, closer to the end cap 130. Thus, the wall of the valve member 116 that receives the end of the flow passage 156 is positioned closer to the plunger 170 portion of the end cap 130. The volume of the cavity 154 may be reduced when the male connector 100 is in the open position.

Accordingly, when the male connector 100 is being changed from the open position to the closed position, the volume of the cavity 154 may increase as the valve member 116 moves toward the first end 112 of the male connector 100. Because cavity 154 increases in volume, valve closing end 144 of valve member 116 advances toward first end 112 to seal the aperture in luer tip 122. If no additional fluid is input into the male connector 100 via the luer receptacle 158, the existing fluid within the luer tip 122 may be drawn back through the port 162 via the vacuum effect created when the cavity 154 increases in volume, flowing through the channel 156 to the cavity 154. In certain embodiments, fluid may be prevented from flowing out of the bore within luer tip 122 when valve closing end 144 is seated in the bore because fluid may instead be drawn back into cavity 154. In some embodiments, when the valve member 116 is moved toward the first end 112 of the male housing 123, fluid near the mating surface 146 of the valve member 116 is forced into the male connector 100 rather than remaining near the mating surface 146, thereby reducing the likelihood that the mating surface 146 will be exposed to fluid.

However, if additional fluid is still being input into the male connector 100 via the luer receptacle 158, the additional fluid can enter the cavity 154 and be collected therein as the valve member 116 is moved toward the first end 112 to close the luer tip 122. In this case, pressure from the new incoming fluid may be prevented from forcing fluid out of the luer tip 122 while the luer tip seal 119 seals the luer tip 122. Thus, fluid may be allowed to flow through the male connector 100 when the female connector 400 is engaged with the first end 112 of the male connector 100, but is inhibited from flowing through when the female connector 400 is being disconnected and after the female connector 400 has been disconnected.

In some embodiments it may be desirable to prohibit certain drugs from contacting the skin or being inhaled. Thus, when the male connector is being disconnected from the female connector 400 or other connection device, the male connector 100 advantageously helps to retain fluid within the male connector 100 while substantially eliminating residual fluid on the luer tip 122. The possibility of reducing residual fluid remaining on the luer tip 122 after detachment results in a corresponding reduction in the chance of exposure of the user or patient to the action of toxic drugs.

Fig. 11-15 are perspective views of the valve element 116, the resilient element 118, the seal 120, the luer tip seal 119, and the first cap member 132, respectively, of the embodiment of the closable male connector 100 shown in fig. 3. As described above, the resilient member 118 may have the first ring 174 disposed within the groove 148 of the male housing 123. The resilient member may extend toward the second end 114. Valve member 116 may have a plurality of protrusions extending outwardly to support resilient member 118. Referring particularly to fig. 10, the valve member 116 may include a plurality (e.g., four) of cut-out flanges 168. A fastening ring 172 (shown in fig. 12) may be secured around the valve member 116 and held in place by the cut-out flange 168. Valve member 116 may include any number of flanges in place of or in addition to cut-out flange 168 for securing elastic member 118 or fastening ring 172 of elastic member 118 to valve member 116. In the illustrated embodiment, the inner surface 168a of the cut-out flange 168 may provide lateral support to the strap 1296 of the resilient member 118 to prevent the strap 1296 from sliding laterally relative to the valve member 116. Additionally, the rear surface 168b of the cut-out flange 168 prevents the fastening ring 172 of the resilient member 118 from sliding axially toward the mating surface 146 of the valve member 116. In other embodiments, the elastic member 118 may include at least two or substantially any number of loops or strakes.

Referring additionally to FIG. 11, one or more of the ports 162 may be positioned in front of the seal 120, near the mating surface 146, or as far back as possible from the mating surface 146. The port 162 may be circular as shown or may have other shapes. The male connector 100 may be adapted to be opened when placed in mating connection with the female connector 400. For example, the female connector 400 may include an engagement member, such as, but not limited to, a complementary surface, tip, or other protrusion, that may engage the valve closing face 144 to open the male connector 100. In some embodiments, a manual slider or button may be suitably configured for opening the male connector 100. The support body 150 is shown extending toward the first end 112 of the valve member 116. There may be one, two or more supports 150. In some embodiments, the male connector 100 does not include the support 150.

Turning now to fig. 13, the seal 120 is described in greater detail. In certain embodiments, the seal 120 is substantially cylindrical and has an inner bore 180 therethrough. In certain embodiments, the seal 120 further includes a pair of generally rectangular projections 182 extending from the side walls of the cylindrical portion at diametrically opposed locations. The projections 182 may have different shapes and/or locations. The seal 120 may also have an overall smaller diameter central portion 184 surrounded by two larger diameter rings 186 at either end.

The seal 120 may be constructed of many different materials. In some embodiments, the seal 120 is fabricated from a silicon-based deformable material. Silicon-based deformable materials are materials that form substantially fluid-tight seals with plastics and other rigid polymeric materials. In certain embodiments, the seal 120 may be made of substantially the same material as the resilient member 118.

Referring to fig. 14, the luer tip seal 119 may be substantially cylindrical with an opening 178 extending along a longitudinal axis of the luer tip seal 119. In the illustrated embodiment, the inner edge opposite the mating face 176 of the luer tip seal 119 has a chamfered or beveled edge 179. For example, as shown, the diameter or cross-section of the rim 179 near the proximal end of the seal 119 may be greater than the diameter or cross-section at a location distally spaced from the proximal end of the seal 119, such that the wall of the seal 199 is thicker in the distal region than in the proximal region. In certain embodiments, as shown, the outer diameter or outer cross-section of seal 119 is generally similar in size to the length of seal 119 (e.g., the distance from the distal face to the proximal face). The luer tip seal 119 may be constructed of many different materials. In some embodiments, the luer tip seal 119 may be fabricated from a silicon-based deformable material. Silicon-based deformable materials are materials that form substantially fluid-tight seals with plastics and other rigid polymeric materials. In some embodiments, the luer tip seal 119 may be made of substantially the same material as the resilient member 118.

Referring to fig. 15 and 16, the first cap 132 may have a covering portion 192 shaped and configured to substantially cover and, in some embodiments, seal a portion of the second end 114 of the male housing 123. The luer receiving portion 158 may extend from the covering portion 192. The luer receiving portion 158 may be appropriately sized to engage with a male luer conforming to ANSI standards for luer instruments (see, e.g., fig. 20A). The luer receiving portion 158 may have external threads 136 for engaging the male luer as shown. In some embodiments, a protruding tab or other protrusion may be used to engage the male luer.

In some embodiments, the plunger 170 is substantially in a region of the first cap 132 that is opposite the cover 192. Plunger 170 may be sized and configured to substantially seal cavity 154 within valve member 116. The recess or slot 169 between the cover 192 and the plunger 170 is sized and shaped to receive a seal such as an O-ring 160. Additionally, in certain embodiments, such as, for example, the embodiment shown in fig. 15 and 16, the first cap member 132 may include a pair of projections or tabs 198 (also referred to herein as locking elements or engagement surfaces) that project radially outward from the outer surface 200. In certain embodiments, the first cap 132 may include a pair of tabs 198 disposed diametrically opposite one another. In certain embodiments, the first cap 132 may include only one tab 198 projecting from the surface 200. In certain embodiments, the first cap 132 may include more than two tabs 198 protruding from the surface 200. As will be described in greater detail below, the tabs 198 can engage or interlock with complementary tabs or projections on the second cap 134 to at least temporarily prevent rotation of the first cap 132 relative to the second cap 134 when the first and second caps are assembled together, as shown in fig. 4 or 9.

Additionally, the first cap member 132 may include an annular groove 202 that can interact with a complementary structure on the second cap member 134 to axially limit movement of the first cap member 132 relative to the second cap member 134, as described in more detail below. As also shown in fig. 16, the first cap member 132 may also include an angled or tapered surface 204 and a rounded surface 206, both located between the annular groove 202 and the plunger 170. As will be described in greater detail below, the sloped or tapered surface 204 and the rounded surface 206 may assist in engaging or assembling the first cap 132 to the second cap 134. In certain embodiments, the first cap 132 may include only the sloped or tapered surface 204 or the rounded surface 206. In other embodiments, the first cap 132 may be configured to include either of those two features. In certain embodiments, the first cap 132 and/or the second cap 134 may include any suitable structure, lubricant, or material to facilitate engagement of the first cap 132 and the second cap 134 or to facilitate rotation of the first cap 132 relative to the second cap 134 as described below.

In the illustrated embodiment, the tabs 198 are substantially rectangular in cross-section. The shape of the tab 198 is not so limited. The tabs 198 may include any suitable or desired cross-sectional shape, such as, but not limited to, square, circular, or oval. In certain embodiments, for example, a plurality of tabs 198 each defining a circular cross-section may be arranged linearly along one side of the first cap member 132.

Referring to fig. 16-17, the second cap 134 may include a set of protrusions or tabs 208 (also referred to herein as locking elements or engagement surfaces) that in some embodiments project in a radially inward direction from an inner surface 210 of the second cap 134, thereby creating a radial set of recesses or grooves 209. Referring to fig. 16, the first cap 132 may be assembled with the second cap 134 such that each of the one or more tabs 198 formed on the first cap 132 is seated in one or more recesses or grooves 209 formed between each of the plurality of tabs 208 formed on the second cap 134. Thus, each of the one or more tabs 198 may be sized and configured such that the approximate width (represented by W1 in fig. 16) of each of the one or more tabs 198 formed on the surface 200 of the first cap member 132 is less than the approximate width (represented by W2 in fig. 18) of the recess or groove 209 formed between each tab 208 on the second cap member 134.

In the illustrated embodiment, the tabs 208 are substantially rectangular in cross-section. The shape of the tab 208 is not limited thereto. The tab 208 may include any suitable or desired cross-sectional shape, such as, but not limited to, square, circular, or oval.

Additionally, each of the one or more tabs 198 on the first cap member 132 may be configured to shear or break before any of the plurality of tabs 208 on the second cap member 134 shear or break. Thus, in certain embodiments, each of the one or more tabs 198 on the first cap member 132 may be configured such that the substantially minimum amount of force or torque required to shear or break any tab 198 from the surface 200 of the first cap member 132 is less than the substantially minimum amount of force required to shear or break the tab 208 from the inner surface 210 of the second cap member 134. In certain embodiments, the minimum amount of force required to shear or break any tab 198 from the surface 200 of the first cap member 132 may be significantly less than the minimum amount of force required to shear or break a tab 208 from the inner surface 210 of the second cap member 134.

In certain embodiments, the tabs or protrusions configured to shear or break may be formed on the second cap 134 rather than on the first cap 132 as described above. In other words, in certain embodiments, the one or more tabs formed on the second cap 134 may be sized and/or configured the same as any of the tabs 198 described above, and the one or more tabs formed on the first cap 132 may be sized and/or configured the same as any of the tabs 208 described above, such that the tabs formed on the second cap 134 shear or break before the tabs formed on the first cap 132 shear or break. In some embodiments, the configuration of the tabs 198 and 208 described above may be substantially reversed. In general, other complementarily shaped engagement surfaces may be employed. In the illustrated embodiment, each component part includes a plurality of radially projecting tabs. In some embodiments, one or other of the components may include a slot sized to receive a radially projecting tab.

In certain embodiments, the substantially minimum amount of force required to cut or break each tab 198 from the surface 200 of the first cap member 132 may be less than or about equal to 1/3 of the substantially minimum amount of force required to cut or break each tab 208 from the inner surface 210 of the second cap member 134. In certain embodiments, the substantially minimum amount of force required to shear or break any tab 198 from the surface 200 of the first cap member 132 may be between about 1/3 and 1/2 of the substantially minimum amount of force required to shear or break any tab 208 from the inner surface 210 of the second cap member 134.

In the illustrated embodiment, where two tabs 198 are formed on the surface 200, the amount of torque required to shear or break the two tabs 198 from the surface 200 of the first cap member 132 may be about 4in-lbs or greater. In certain embodiments, the amount of torque required to shear or break the two tabs 198 from the surface 200 of the first cap member 132 may be about 3in-lbs or greater. In certain embodiments, the amount of torque required to shear or break the two tabs 198 from the surface 200 of the first cap member 132 may be about 5in-lbs or greater.

Referring to fig. 16, the cross-sectional area of each tab 198 may be based on the approximate length (represented by "L1" in fig. 16) and the approximate width (represented by "W1" in fig. 16) of each of the one or more tabs 198 on the surface 200 of the first cap 132. The tab 198 may be used to provide a band around the surface 200, which is calculated by the length L1 of the tab 198 times the circumference of the surface 200. In certain embodiments, where each of the one or more tabs 198 is configured to shear from the surface 200 of the first cap 132 when a desired torque level is reached, the combined cross-sectional area of the tabs 198 may be much smaller than the band surrounding the surface 200.

In certain embodiments, the ratio of the aggregate cross-sectional area of all of the one or more tabs 198 to the outer diameter value (represented by "D1" in fig. 16) of the surface 200 of the first cap 132 on which each of the one or more tabs 198 is formed or attached may be about 1:46 or greater. The cross-sectional area of each tab 198 may be any suitable value that causes each of the one or more tabs 198 to shear from the surface 200 when the desired torque level is reached. For example, in certain embodiments, the ratio may be between about 1:60 and about 1: 30. In certain embodiments, the ratio may be between about 1:50 and about 1: 40.

In certain embodiments, such as in the illustrated embodiment when each of the one or more tabs 198 is configured to shear from the surface 200 of the first cap member 132 when a desired torque level is achieved, the width W1 of each of the one or more tabs 198 may be substantially less than the outer diameter D1 of the surface 200 of the first cap member 132 to which each of the one or more tabs 198 is formed or attached. The width W1 of each tab 198 may be any suitable value that causes each of the one or more tabs 198 to shear from the surface 200 when the desired torque level is reached. For example, the one or more tabs 198 may be sized similar to or smaller than the diameter of the fluid opening within the plunger 170 and/or the luer receptacle 158. In certain embodiments, the ratio of the aggregate width of the tabs 198 to the outer diameter D1 may be about 1:15 or higher. In certain embodiments, the ratio may be between about 1:25 to about 1: 10. In certain embodiments, the ratio may be between about 1:16 to about 1: 13. In some embodiments, multiple tabs 198 may be employed, where the width W1 of each tab is different, but the aggregate width is calculated to achieve the level of torque required to shear the tabs.

Similarly, in certain embodiments, just as in the illustrated embodiment, where each of the one or more tabs 198 is configured to shear from the surface 200 of the first cap 132 when a desired torque level is achieved, the length L1 of each of the one or more tabs 198 may be substantially less than the outer diameter D1 of the surface 200 of the first cap 132 to which each of the one or more tabs 198 may be formed or attached. The length L1 of each tab 198 may be any suitable value that causes each of the one or more tabs 198 to shear from the surface 200 when the desired torque level is reached. In certain embodiments, the ratio of the aggregate length of the tabs 198 to the outer diameter D1 may be about 1:4 or higher. In certain embodiments, the ratio may be between about 1:10 to about 1: 2. In certain embodiments, the ratio may be between about 1:5 to about 1: 3. In some embodiments, multiple tabs 198 may be employed, where the width W1 of each tab is different, but the aggregate width is calculated to achieve the level of torque required to shear the tabs.

In certain embodiments, the one or more tabs 198 may be configured such that the approximate width W1 of each of the one or more tabs 198 may be substantially less than the approximate width of one or more of the tabs 208 (represented by W3 in FIG. 18) formed on the inner surface 210 of the second cap 134 to ensure that the one or more tabs 198 shear or break before any of the tabs 208. Thus, in certain embodiments, the approximate width W1 of each of the one or more tabs 198 can be between about 1/3 or less and about 1/2 or less of the approximate width W3 of each of the tabs 208. Additionally, in some embodiments, there are many more tabs 208 on the second cap 134 than tabs 198 on the first cap 132, thereby requiring more torque to shear off more tabs 208 on the second cap 134.

In some embodiments, the material selected to form each of the one or more tabs 198 may be the same or different than the material selected to form each of the one or more tabs 208. The strength of the material selected for forming the tabs 198, 208 may affect the amount of torque required to shear the tabs 198, 208. Thus, in some embodiments, the tabs 198, 208 that are desired to be sheared may be constructed of a softer, or less stiff material than the material used to form the tabs 198, 208 that is desired to remain unchanged. For example, in the illustrated embodiment it is desirable that the tabs 198 shear from a surface 200 on the first cap member 132 when a desired level of torque between the first cap member 132 and the second cap member 134 is achieved. Thus, in the illustrated embodiment, the tabs 198 may be formed of a material that is less strong than the material used to form each tab 208. The material selected to form each tab 198, 208 may be the same, however, because the cross-sectional area of the tabs 198, 208 can also affect the amount of torque required to shear the tabs 198, 208.

In certain embodiments, as in the illustrated embodiment, it may also be ensured, as described above, that the one or more tabs 198 shear or break before any tab 208 can do so by designing each of the one or more tabs 198 such that the general cross-sectional area of each of the one or more tabs 198 is less than the cross-sectional area of each tab 208 that is adjacent and thus will contact each of the one or more tabs 198. Referring to fig. 16, the cross-sectional area of each tab 198 depends on the length (represented by L1 in fig. 16) and the width (represented by W1 in fig. 16) of each of the one or more tabs 198. Similarly, referring to fig. 18 and 19, the cross-sectional area of each tab 208 is dependent upon the length (represented by L2 in fig. 19) and width (represented by W3 in fig. 18) of each of the one or more tabs 198.

In certain embodiments, where the one or more tabs 198 are configured to shear before any tab 208, the cross-sectional area of each of the one or more tabs 198 may be substantially smaller than the cross-sectional area of each of the one or more tabs 208, without regard to material differences. The ratio of the cross-sectional area of each of the one or more tabs 198 to the cross-sectional area of each of the one or more tabs 208 can be substantially less than 1. For example, in some embodiments, as in the illustrated embodiment, the ratio is about 1:14 or higher. In certain embodiments, the ratio may be between about 1:25 to about 1: 10. In certain embodiments, the ratio may be about 1:16 to 1: 12.

Additionally, in certain embodiments, as in the illustrated embodiment, the approximate length of each of the one or more tabs 198 (represented by L1 in fig. 16) is substantially less than the approximate length of each of the plurality of tabs 208 (represented by L2 in fig. 19) formed on the inner surface 210 of the second cap 134. Thus, in certain embodiments, the approximate length L1 of each of the one or more tabs 198 can be between about 1/3 or less than 1/3 to about 2/3 of the approximate length L2 of each of the plurality of tabs 208.

In certain embodiments, the second cap 134 may include a recess or groove into which each of the one or more tabs 198 formed on the first cap 132 may be inserted when the first cap 132 is coupled to the second cap 134. In certain embodiments, the number of depressions or grooves formed on the second cap 134 may be equal to the number of tabs 198 formed on the first cap 132. In certain embodiments, the number of depressions or grooves formed on the second cap 134 may be greater than the number of tabs 198 formed on the first cap 132.

Fig. 20A is a side view of an example of the engaged member 212 showing the male connector of the engaged member 212 in partial threaded engagement with the first cap 132 of the closable male connector 100. Fig. 20A shows the end cap 130 before one or more tabs 198 projecting radially outward from the surface 200 have been broken. In fig. 20A, the exemplary engaged component 212 is a syringe. The engaged member 212 may be any suitable connector or medical device having a male connector. As shown therein, the engaged member 212 is only partially threadedly engaged with the first cap 132 such that the torque applied to the first cap 132 by screwing the engaged member onto the first cap 132 is less than the minimum threshold torque required to shear or break each tab 198 from the first cap 132. Thus, until a minimum threshold torque value is reached that is required to shear or break each tab 198 from the first cap 132, the first cap 132 cannot be rotatably secured to the second cap 134 by each of the one or more tabs 198 formed on the first cap 132 abutting one or more of the plurality of tabs 208 formed on the second cap 134.

When the engaged member 212 is substantially fully threadedly engaged with the first cap 132, further threading of the engaged member 212 will eventually apply a torque to the first cap 132 that will exceed the minimum torque threshold required to shear the tab 198 from the first cap 132. In some embodiments, the minimum torque threshold required to shear the tab 198 is at least about 4in-lbs of torque. Once the tab 198 has been broken away from the first cap 132, the first cap 132 is able to rotate relatively freely within the second cap 134. The first cap member 132 may also be retained within the housing by the side 202b abutting the side 214b of the annular projection 214. Also, the O-ring 160 may prevent fluid exchange despite the ability of the first cap 132 to rotate. In this way, the male connector 100 is prevented or inhibited from easily disengaging the engaged components 212, as the torque required for such disengagement will only cause the first cap 132 to spin relative to the male housing 123 and/or the second cap 134, without unscrewing or otherwise disengaging the caps 132, 134 from one another. Moreover, in some embodiments, there is little or virtually no exposed outer surface area on the first cap member 132 for contact by the user's fingers after the engaged member 212 is attached, thereby making it difficult to apply opposing torques to the first cap member 132 and the engaged member 212 to effect separation. This effectively "joins" the two components.

There is no need to use tabs designed to shear, nor other structures and configurations to allow the threaded connection between the housing end and the engaged member 212 in the first stage and then allow rotation to prevent or inhibit separation without unscrewing in the second stage. The structures shown and described with respect to inhibiting the connectors 100, 400 from separating from each other are examples only, and many other structures and methods may be used to inhibit separation. Additionally, in some embodiments there is no structure or step to inhibit separation. In some embodiments, the first and/or second ends of the housing are allowed to rotate relative to the rest of the housing without requiring unscrewing or other separation during the stage of use.

Fig. 20B is a side view of the engaged member 212 showing the male connector of the engaged member 212 substantially fully threadedly engaged with the first cap member 132 of the male connector 100. Fig. 20B shows the first cap member 132 after the one or more tabs 198' have been broken by a force applied to each of the one or more tabs 198 by one or more of the plurality of tabs 208 formed on the inner surface 210 of the second cap member 134 in response to a torsional force imparted to the first cap member 132 by the substantially fully threadedly engaged member 212. At this point, as each tab 198' breaks away from the outer surface 200 of the first cap 132, the first cap 132 will be able to rotate fairly freely within the second cap 134 without unscrewing. Any twisting action exerted on the engaged member 212 in either rotational direction relative to the male housing 123 in this arrangement will cause the first cap member 132 to rotate with the engaged member 212. Thereby preventing the engaged member 212 from being unscrewed or otherwise disengaged from the first cap 132. Thus, in this way, the male connector 100 is configured such that it cannot be removed or separated from the engaged component 212 after the male connector 100 and the engaged component 212 have been substantially fully engaged with each other.

After one or more tabs 198 'have been sheared or broken from the first cap member 132, the covering 192 of the first cap member 132 can prevent each broken tab 198' from falling out of the male connector 100, as shown in fig. 20B. Additionally, as shown in fig. 7, the second cap 134 may be configured to prevent the broken tabs 198' from entering the interior space of the male housing 123. In particular, the second cap 134 can be configured to include an annular projection 214 that can prevent the broken tab 198' from moving into the interior space of the male housing 123.

Fig. 20C is a side view of an example of an engaged member 212 in substantially full threaded engagement with another embodiment of the closable male connector 100'. In certain embodiments, the closeable male connector 100' may be similar or identical to the closeable male connector 100 described herein. In certain embodiments, the second cap 134' may be configured to include an annular void 138' adjacent to the tab 208 '. The annular void 138' may be sized and configured such that the one or more tabs 198' can fall into and be received within the annular void 138' when the one or more tabs 198' have been broken off from the first cap member 132 '.

In certain embodiments, the first cap 132 may be coupled to the second cap 134, and thus to the male connector 100, as described below. After the second cap 134 has been attached to the male housing 123 according to any of the methods described herein or any other suitable method, the first cap 132 may then be coaxially aligned with the second cap 134 and also rotationally aligned such that each of the one or more tabs 198 on the first cap 132 are generally aligned with one or more gaps between the tabs 208 formed on the second cap 134. Once the first cap member 132 is substantially axially and rotationally aligned, the first cap member 132 can be inserted into the second cap member 134 by pushing the first cap member 132 against the second cap member 134 while maintaining the substantially axial and rotational alignment described above. Referring to fig. 7, 13 and 16, the first cap member 132 may be pressed into the inner end until the first cap member 132 is positioned relative to the second cap member 134 such that the annular protrusion 214 formed on the second cap member 134 is radially adjacent (i.e., axially aligned with) the annular groove 202 formed on the first cap member 132. In particular, in this position, the mutually opposed sides 214a, 214b of the annular projection 214 formed on the second cap member 134 can be located between the alternatively opposed sides 202a, 202b of the annular groove 202 formed in the second cap member 134.

As shown in FIG. 7, the first cap 132 and the second cap 134 may be formed in some embodiments such that a small gap exists between the surface of the annular protrusion 214 and the surface of the annular groove 202. This configuration enables the first cap 132 to rotate within the second cap 134 when the one or more tabs 198 have sheared or broken, i.e., there is no friction between the surfaces 202, 214.

Additionally, referring to FIG. 7, the first cap member 132 and the second cap member 134 may be sized and configured such that the side 202b of the annular groove 202 overlaps the side 214b of the annular protrusion 214 to an extent sufficient to prevent the first cap member 132 from being inadvertently pulled out of the second cap member 134. Additionally, the first cap 132 and the second cap 134 may be sized and configured such that, as described above, the first cap 132 may be inserted into the second cap 134 by axially aligning and pressing the first cap 132 into the second cap 134. Thus, if the side 202b of the annular groove 202 overlaps the side 214b of the annular protrusion 214 too much, it may be difficult in some configurations to engage the first and second caps 132, 134 with one another as described above.

To facilitate insertion of the first cap 132 into the second cap 134, the first cap 132 may be configured with a sloped or tapered annular face 204 and/or a rounded annular face 206 in front of the annular groove 202, as shown in fig. 16. Similarly, the second cap 134 may be configured with a sloped or tapered annular face 216 to help align and substantially compress the first cap 132 into the second cap 134, as shown in fig. 19.

Moreover, as shown in the illustrated embodiment, the one or more tabs 198 and the plurality of tabs 208 may include features and/or be configured to aid in the insertion of the first cap 132 into the second cap 134. For example, in certain embodiments, as shown in fig. 16, each tab 198 may include a beveled or tapered front face 198a to help guide each tab 198 into the space between tabs 208 formed on the second cap 134. Similarly, in certain embodiments, as shown in fig. 17 and 19, the tabs 208 on the second cap 134 may include a beveled or tapered surface 208a to help guide each tab 198 into the space between each tab 208. Additionally, in certain embodiments, each tab 208 may include a beveled or tapered leading edge 208b to at least assist in axially aligning the first cap 132 with the second cap 134.

Any of the substantially rigid or semi-rigid components comprising luer connector 100, including but not limited to first cap 132 and second cap 134, may comprise polycarbonate plastic, glass-filled polycarbonate, any other suitable water-impermeable material, or a combination thereof. The component parts that make up luer connector 100 may also include a hydrophobic plastic. Other examples of materials suitable for forming any substantially rigid or semi-rigid component forming the luer connector 100 are glass filled GEValox 420 or polypropylene. Many other materials may be used depending on the application.

Fig. 21 and 22 are perspective and side views, respectively, of the female connector 400 in a first or closed position. In certain embodiments, the female connector 400 may include any configuration, feature, or component of other female connectors described herein, and any other connector described herein may include any configuration, feature, or component of the female connector 400. For example, features relating to preventing or inhibiting separation may be used with any suitable medical or other fluid connector, on either or both of its male or female ends.

Figure 23 is an exploded perspective view of the component parts of the female connector embodiment shown in figure 21. A fluid line 480 having one or more ports 488 can be engaged to the female housing 440 near the second end 404 of the female connector 400. One or more of the components of the fluid line 480 may be integral or unitary with the female housing 440. The fluid line 480 may have a second end 484 including a male luer 485. The seal 460 may surround at least a portion of the fluid line 480. The seal 460 may block the port 488 on the fluid line 480 when the female connector 400 is in the closed configuration. The compressible seal 460 and the fluid line 480 may be at least partially housed within the female housing 440.

Referring to fig. 25, the female connector 400 may include a female housing 440 that houses a seal 460 and a fluid line 480 therein. Flow passage 418 extends through the center of fluid line 480. There is a gap 412 between the seal 460 and the female housing 440.

As shown in fig. 21, 22, and 26, the female connector 400 may have a first end 402 and a second end 404. The first end 402 may be configured to mate with the male connector 100. In some embodiments, female connector 400 may have a female housing 440 including an engagement portion 446 configured to connect to male connector 100, as discussed further below. The engagement portion 446 may include an engagement structure that is complementary to an engagement structure on the sleeve 124 of the male connector 100. In the illustrated embodiment, the engagement portion 446 includes external threads 411 that are engageable with internal threads 126 on the sleeve 124 of the male connector 100. The external threads 411 may form a female luer fitting that conforms to ANSI specifications for a female connector.

The female housing 440 of the female connector 400 may extend between the first end 402 and the second end 404. In the illustrated embodiment, the female housing 440 has a generally cylindrical body 442. In other embodiments, the body 442 may have a square cross-section, a polygonal cross-section, or any other shape. In certain embodiments, the engagement portion 446 may be integrally molded or otherwise formed with the female housing 440. In other embodiments, the joint 446 may be a separate piece that is connected to the female housing 440, such as by welding, glue, or fasteners. The compressible elastomeric seal 460 and the fluid line 480 are at least partially contained within the female housing 440. In some embodiments, at least a portion of the female connector and/or the male connector may be translucent, such as at least a portion of the housing and/or the seal 460, to allow visual observation of the internal fluid flow from the outside. The housing may include an outer gripping surface, such as ridge 403, to assist in gripping and/or twisting the female connector 400.

Referring to fig. 27, the fluid line 480 may have a first end 482 and a second end 484. The first end 482 may have a mating surface 486 configured to non-planarly engage in close conformity with the mating surface 146 of the valve member 116 to facilitate non-slip contact between the mating surfaces 146, 486 (e.g., to prevent lateral movement or wobble) and to inhibit fluid intrusion between the mating surfaces 146, 486, particularly when transitioning between the open and closed positions. In the region of the first end 482 there may be at least one port 488 which is in fluid communication with the flow passage 418 extending through the interior of the fluid conduit 480 (see fig. 25). In the illustrated embodiment, the fluid line 480 has a plurality of ports (e.g., two ports). In certain embodiments, the fluid line 480 may have more than two ports 488. The second end 484 of the fluid line 480 may be configured to be coupled to other medical instruments such as a connector or device. In the illustrated embodiment, the second end 484 has a male luer fitting 485 that includes a sleeve with internal threads that generally surrounds a male luer tip. In certain embodiments, the male luer 485 conforms to ANSI specifications for male medical connectors. The male luer 485 is capable of receiving a female coupling component of another medical device, such as a connector or syringe.

The second end 484 may also have features for engaging the female housing 440. In the illustrated embodiment, the second end 484 has a coupler 492, such as a tapered cam surface 492, that extends radially outward of and generally about the circumference of the fluid conduit 480. The couplers 492 may engage with complementary couplers on the female housing 440, such as grooves on the inner surface of the female housing 440. The coupler 492 may facilitate engagement of the fluid tube 480 with the female housing 440 and may help prevent axial separation of the fluid tube 480 from the female housing 440. The fluid line 480 may have anti-rotation members, such as tabs 494, that can engage with corresponding anti-rotation members, such as tabs, on the inner surface of the female housing 440. An anti-rotation member, such as tab 494, may help prevent rotation of fluid line 480 relative to the housing. In certain embodiments, the bonding and/or anti-rotation members may facilitate the manufacturing process because more expensive tooling and materials involved in other connection means are no longer required in this step, such as welding, bonding or adhering of the component parts that may also or alternatively be used. In some embodiments, the fluid line 480 may be connected to the female housing 440 in other ways, such as by welding, bonding, glue, or fasteners.

A generally rigid tube 487 having a flow passage 418 extending through the center of the tube 487 may extend generally from the first end 482 to the second end 484. In the illustrated embodiment, the tube 487 can include a projection 491 that proximally projects from a base 495 of the fluid conduit 480, with a first portion 489 of the base being generally cylindrical and a second portion 487 being generally frustoconical. In some embodiments, the tube may have other cross-sectional shapes such as square, polygonal, or elliptical. In some embodiments, the projections 491 can provide support for the seal 460 and aid in lateral positioning of the seal 460, and the projections 491 can cooperate with the seal 460 to selectively open and close the flow passage 418. As shown, the first portion may include a generally constant outer diameter or outer cross-sectional width to facilitate opening (e.g., by facilitating sliding of the seal), and the second portion may taper or flare outwardly toward a wider distal region to facilitate enhancing the sealing effect between the outer surface of tube 487 and the inner surface of bore 470 of seal 460 as seal 460 moves from the closed position to the open position.

In some embodiments, the projections 491 may be much shorter (e.g., shaped like a knurl or gasket), which may help position the seal 460 without puncturing or penetrating the proximal portion of the seal. The projection 491 may be omitted in some embodiments. In certain embodiments, including those embodiments that do not have a puncture or penetration of the protrusion 491, fluid delivered through the connector 402 in the open state can flow around the outer surface of the seal and distally out of the internal bore 412, through one or more openings in the base 495 or in the distal portion of the seal 460, into the flow passage 418.

In some embodiments, the connector 400 may include a pressure control element (e.g., a flexible variable volume region) and/or a flow blocking element (e.g., a flexible second valve) located within the base or elsewhere within the connector or in fluid communication with the connector 400. Some examples of control elements and flow resistors are shown and/or described in U.S. patent application publication No. 2010-0249723a1, published 9/30 2010, which is incorporated herein by reference in its entirety.

As shown in fig. 25, the flow passage 418 may extend through at least a portion of the fluid line 480. The cross-section of the flow passage 418 may be circular as shown in the illustrated embodiment, or the flow passage 418 may have other cross-sectional shapes. The flow passage 418 may have at least one port 488 near the first end 482. In the illustrated embodiment, the two ports 488 are located on opposite sides of the fluid line 480 and are circular, although other locations and shapes may be used. The port 488 may be disposed proximate to, but distally spaced from, the mating surface 486 of the fluid conduit 480, or may be spaced apart from the mating surface 486 as far as possible, but also allows fluid to enter the port 488 when the female connector 400 is mated with the male connector 100. In some embodiments, the size of the port 488 can be about 1 millimeter thick, although irregular shapes and other sizes can be used. Ports of at least about 1mm or about 1-3 mm or less than about 1mm may also be used.

The fluid line 480 may be constructed of a rigid material, such as polycarbonate plastic, that is capable of resisting deformation when a force sufficient to compress the seal 460 is applied to the female connector 400. A port 488 in the fluid line 480 can contact and be covered by the proximal end of the seal 460 to prevent or inhibit fluid communication between the flow passage 418 and the bore 412 between the seal 460 and the inner wall of the female housing 440.

Referring to fig. 28, an embodiment of the seal 460 is described in more detail. In some embodiments, the seal 460 is generally cylindrical and has an inner bore 470 extending therein. In certain embodiments, the seal 460 may have a seal portion 462 and a crimp portion 464. The seal 462 may have an inner diameter configured to block the first end 482 of the fluid line 480 to inhibit fluid flow out of the port 488.

In the illustrated embodiment, the deflate 464 has a plurality of large diameter portions separated by a plurality of small diameter portions, such that the longitudinal length of the deflate 464 shortens (e.g., by folding, collapsing, compressing, or otherwise moving) when a force is applied in the longitudinal distal direction. In some embodiments, the deflate 464 may be made of a resilient material, such that when the deflate force is removed, the restoring force biases the deflate 464 to its original length. In certain embodiments, the deflate 464 may have a variety of different configurations for providing a seal. In certain embodiments, the seal may include a first end 466 having a substantially circular portion and a second portion 463 distal from the first end 466. The second portion 463 may include an outer diameter that is smaller than the diameter of the first end 466. One or more compressible members 465 may be located distal of the second portion 463. In some embodiments, the outer diameter of the compressible member 465 may be greater than the outer diameter of the first end 466 or the second portion 463. The distal portion may include an outer diameter substantially equal to an outer diameter of the compressible member.

Shoulder 468 may be disposed between seal 462 and crimp 464. In the illustrated embodiment, shoulder 468 is a portion having an enlarged diameter. As shown in fig. 25, the shoulder 468 can engage a surface of the female housing 440 to prevent the seal 460 from over-extending or exiting the housing. The arrangement of the shoulder 468 on the seal 460 is configured such that the seal 462 is positioned over the port 488 on the fluid line 480 when the shoulder 468 is engaged with the female housing 440.

The seal 460 may be constructed of an elastically or resiliently deformable material. The seal 460 may be biased to return the female connector 400 to the closed configuration. The amount of compression resistance of the seal 460 can be adjusted in a number of ways, such as by changing the length of the compression 464 or the length of the cavity of the female housing 440 in which the seal 460 is located. The amount of compression resistance may also be adjusted by increasing the thickness of the seal 460 and/or by constructing the seal 460 from a variety of different materials having different resiliency. In some embodiments, the female connector 400 is configured to resist opening sufficiently to substantially prevent accidental or unintended opening. The resistance to opening of the connector may be controlled at least in part by the resistance to compression exerted by the seal 460. In some embodiments, the deflate 464 may be a spring-like formation that seats within the female housing 440 to bias the seal 460 toward the closed configuration. Movement of the female connector 400 to the open configuration compresses the spring, and movement of the female connector 400 to the closed configuration allows the spring to expand and relieve some or all of the compression.

As shown in fig. 21 and 24, the engagement portion 446 at the first end 402 of the female connector 400 may have a mating side 408 that is generally transverse to the longitudinal axis of the female connector 400. In the illustrated embodiment, the mating side 408 is generally annular. The mating side 408 may have an opening in the center for the seal 460, wherein the mating surface 466 of the seal 460 is exposed. The mating surface 466 of the seal 460 is configured to form a leak-proof and/or a side-motion-proof seal with the mating surface 128 of the male luer tip 122 and the mating surface 176 of the luer tip seal 119. The opening for the female connector's fluid line 480 is near the center of the seal 460. The first end 482 of the fluid line 480 may have a mating surface 486 configured to form a substantially leak-free seal with the mating surface 146 of the valve member 116.

As shown in the embodiment of the female connector 400 shown in fig. 21 and 24, the mating face 466 of the seal 460 may be substantially flush with the mating side 408 of the female connector 400 and the tip 466 of the seal 410 may substantially fully occupy the inner diameter or inner cross-section of the tip 114 of the female connector 100. In certain embodiments, as shown in fig. 32, the outer diameter of proximal sealing end 466 is approximately equal to the outer diameter of an ANSI standard medical male luer connector. In some embodiments, the mating surface 486 of the fluid line 480 may be substantially aligned with the mating side 408 of the female connector 400. In certain embodiments, the mating surface 466 of the compressible seal 460 and/or the mating surface 486 of the fluid line 480 may be configured to extend further beyond the mating side 408 of the female connector 400 in the closed position. In certain embodiments, the mating surface 466 of the seal 460 and/or the mating surface 486 of the fluid line 480 may be recessed within the joint 446. In some embodiments, the mating surface 466 of the compressible seal and/or a portion of the mating side 408 of the female connector 400 are substantially flush, extend beyond, and/or are recessed within the joint 446, depending on the purpose of the particular embodiment.

In some embodiments, the first end 482 of the fluid line 480 may have a projection 490 that mates with a complementary hole 147 in the mating surface 146 of the valve member 116. In the illustrated embodiment, the projections 490 are generally cylindrical projections having rounded edges. In certain embodiments, the protrusion may have a variety of different shapes, such as a protrusion having a generally rectangular, generally square, or generally rectangular cross-sectional shape to generally match the shape of the aperture 147 in the mating surface 146 of the valve member 116. In some embodiments, the protrusion may be disposed on the mating surface 146 of the valve member 116 and the hole may be at the first end 482 of the fluid line 480. The projections 490 and apertures 147 can help align the mating surfaces of the male connector 100 and the female connector 400 to prevent movement (e.g., lateral movement) therebetween.

The seal 460 may block the first end 482 of the fluid line 480 to block fluid flow out of the port 488 when the female connector 400 is in the closed configuration. The seal portion 462 of the seal 460 may be disposed within the engagement portion 446 of the female housing 440 as shown in fig. 25. In the illustrated embodiment, the seal 462 of the seal 460 is disposed between the female housing 440 and the fluid line 480. In some embodiments, the interference fit between the seal 460 and the fluid line 480 may prevent fluid from flowing out of the first end 402 of the female connector 400. The seal 460 may be made of an elastomeric material that can help form a seal.

The female connector 400 may be manipulated to a second or open configuration. In the open configuration, the sealing portion 462 of the seal 460 may be urged toward the second end 404 of the female connector 400, thereby allowing fluid to flow through the port 488 in the fluid line 480. In the open configuration, fluid can enter fluid line 480 through port 488 and flow through flow passage 418 and out through male luer 485 of fluid line 480. In some embodiments, including embodiments in which fluid flows around the outside of the seal 460 rather than through, the mating surface of the seal 460 may include a surface shape with an alignment feature at its forward end (e.g., any alignment feature described and/or illustrated herein with respect to the end of the projection 491). In some embodiments, the seal 460 has no opening and is closed at its mating end 466. In some embodiments, the housing includes apertures to allow air to be evacuated from the compression seal 460.

In certain embodiments it may be desirable to prohibit certain human exposure to certain drugs (e.g., skin contact or inhalation of vapors), particularly drugs used in the treatment of tumors or autoimmune disorders. While being disconnected and after having been disconnected from the male connector 100 or other connector, the female connector 400 may help retain fluid within the female connector 400 while blocking residual fluid on the first end 402 of the female connector 400. Reducing the likelihood of residual fluid remaining on female connector 400 after separation may result in a corresponding reduction in the chance of exposure of the user or patient's skin to toxic medications.

Referring to fig. 29, 30 and 30A, the male connector 100 is shown adjacent to the female connector 400. In the illustrated embodiment, both the male connector 100 and the female connector 400 are in a closed configuration. Female connector 400 is positioned with its first end 402 near first end 112 of male connector 100. The male connector 100 may be screwed with the female connector 400.

As shown in fig. 31 and 32, the male connector 100 may be changed to the open configuration when the female connector 400 is connected to the male connector 100. The first end 402 of the female connector 400 may engage the first end 112 of the male connector 100. The engaging portion 446 of the female connector 400 may engage with the sleeve 124 of the male connector 100 to connect the connectors 100, 400. The engagement portion 446 of the female connector 400 and the ferrule 124 with luer tip 122 on the male connector can be sized to conform to standards for connectors, such as those conforming to ANSI standards. In some embodiments, the engagement between the engagement portion 446 of the female connector 400 and the sleeve 124 may prevent lateral movement between the mating surface 146 of the valve member 116 and the mating surface 486 of the fluid conduit 480. In some embodiments, engagement between engagement portion 446 of female connector 400 and sleeve 124 may prevent tilting between mating surface 146 of valve member 116 and mating surface 486 of fluid line 480. Resistance to lateral movement and/or tilting between the mating surfaces 146, 486 may help reduce the likelihood that either mating surface 146, 486 will be exposed to fluid within the connector 100, 400.

As shown in fig. 32, the mating surface 486 of the fluid line 480 may engage the mating surface 146 of the valve member 116. When the male connector 100 and the female connector 400 are brought together, the fluid line 480 may push the valve element 116 toward the second end 114 of the male connector 100. When the valve member 116 is pushed toward the second end 114 of the male connector 100, the port 162 on the valve member 116 is moved away from the kelvin tip seal 119, allowing fluid to flow out through the port 162. Thus, the male connector 100 is in the open configuration when the valve member 116 is urged toward the second end 114.

With continued reference to fig. 32, the mating surface 176 of the luer tip seal 119 and the mating surface 128 of the male luer tip 122 may engage the mating surface 466 of the seal 460. When the male and female connectors 100, 400 are brought together, the male luer tip 122 with the luer tip seal 119 may urge the seal 460 toward the second end 404 of the female connector 400, compressing or otherwise deforming or moving the collapsed portion 464 of the seal 460. When the seal 460 is urged toward the second end 404 of the female connector 400, the port 488 on the fluid line 480 is exposed, allowing fluid to flow through the port 480. In this configuration, the female connector 400 is in an open configuration. In certain embodiments, fluid can flow around the outside of the seal rather than through the seal, as described herein, and into the port 482 on the projection 491 (which in certain embodiments may be omitted).

When the valve element 116 is urged toward the second end 114 of the male connector 100, the resilient member 118 is caused to elongate, creating a tensile force that applies a restoring force to the valve element 116 toward the first end 112 of the male connector 100. Thus, in the open configuration of the male connector 100, the valve member 116 may be biased toward the first end 112 toward the closed configuration. Similarly, when the seal 460 is urged toward the second end 404 of the female connector 400, the constriction 464 is compressed and a restoring spring force is applied to bias the seal 460 toward its initial length and toward the closed configuration.

In some embodiments, the resilient member 118 may apply a closing force to the valve member 116 toward the first end 112 of the male connector 100. The mating surface 146 of the valve member 116 may generally remain in contact with the mating surface 486 of the fluid line 480 throughout the connection between the male connector 100 and the female connector 400. In some embodiments, the mating surface 146 of the valve member 116 may have a cross-section substantially equal to the cross-section of the mating surface 486 of the fluid line 480. In some embodiments, the outer peripheral surface of the mating surface 486 of the fluid conduit 480 may contact and/or be generally shaped complementary to the outer peripheral surface of the mating surface 146 of the valve member 116 when the male connector 100 and/or the female connector 400 are in the open configuration.

In some embodiments, the mating surfaces of the male connector 100 and/or the female connector 400 may be at least partially compressible to help form a substantially leak-free or leak-proof seal between the mating surfaces. For example, the mating surface 146 of the valve member 116 may be made of an elastomeric material that seals with the mating surface 486 of the fluid conduit 480 (the fluid conduit itself may be flexible or rigid) so that fluids do not contact the mating surfaces of the male and female connectors 100, 400. In some embodiments, the mating surface 486 of the fluid line 480 may be made of an elastomeric material that is capable of sealing with the mating surface 146 of the valve member 116 (the valve member itself may be flexible or rigid). In certain embodiments, fluid can flow around the seal formed by the mating surfaces 146, 486. In certain embodiments, fluid engagement surfaces 146, 148 are prevented from flowing within the perimeter surface between the two engagement surfaces 146, 148. In certain embodiments, fluid can flow between male connector 100 and female connector 400, as described herein, without requiring puncturing or piercing a normally closed septum. For example, the diaphragm may include a constant opening through which a fluid line can pass, or fluid can flow around the outside of the diaphragm or other barrier. By isolating the mating surfaces from the fluid, the mating surface 146 of the valve member 116 and the mating surface 486 of the fluid line 480 may remain dry after the two connectors 100, 400 are separated, and contamination to health care providers or the surrounding environment may be reduced or eliminated.

In some embodiments, the mating surface 146 of the valve member 116 may have a cross-section that is about equal to or less than the cross-section of the inner bore 470 of the seal 460. In certain embodiments, the inner cross-section of the luer tip seal 119 may be less than or about equal to the inner cross-section of the inner bore 470 of the seal 460. In some embodiments, the engagement between the circumferential surface of the bore 470 and the first end 112 of the male connector 100 may help inhibit fluid leakage to the mating surface 466 of the seal 460. For example, in some embodiments, the perimeter surface of the bore 470 may engage the mating surface 176 of the luer tip seal 119 and form a substantially fluid tight seal between the flow path within the two connectors and the mating surface 466 of the seal 460. By isolating the mating surface 466 of the seal 460 from fluids, the mating surface 466 may remain dry during and after fluid transfer and may reduce the risk that health care personnel may be exposed to fluids.

In certain embodiments, the inner cross-section of the luer tip seal 119 may be less than or about equal to the outer cross-section of the stiffening tube 487 proximate the first end 482 of the fluid conduit 480. In some embodiments, the luer tip seal 119 may wipe against the outer surface of the hard tubing 487 as the hard tubing passes through the luer tip seal 119 during opening and/or closing of the valve member 116. In certain variations, wiping over the outer surface of the stiffening tube 487 as it passes through the luer tip seal 119 may help inhibit pooling or leakage of fluid within the area of the first end 402 of the female connector 400. As described above, in certain embodiments, the natural outer cross-section of the mating surface 146 of the valve member 116 may be slightly larger than the natural inner cross-section of the luer tip seal 119. In some embodiments, the luer tip seal 119 can wipe over the outer surface of the valve member 116 as the valve member 116 moves from the open configuration to the closed configuration. In some embodiments, wiping across the outer surface of the valve member 116 may help reduce the likelihood of fluid pooling or leaking in and/or after the mating surfaces 486, 146 of the fluid tube 480 and the valve member 116 are separated from each other in the region of the first end 112 of the male connector 100. By preventing the convergence or leakage of fluid in the area of the first end 112 of the male connector 100 and/or the area of the first end 402 of the female connector 400, the luer tip seal 119 may help reduce the likelihood that a health care provider may be exposed to the fluid.

As described above, the mating surface 146 of the valve member 116 may have a hole 147 that is capable of receiving a complementary shaped projection 490 on the mating surface 486 of the fluid line 480. In other embodiments, the aperture may be on fluid line 480 and the protrusion may be on valve element 116. The holes 147 and the projections 190 may help align the male connector 100 and the female connector 400 during connection so that these components are aligned for proper displacement of the components. In some embodiments, the holes and protrusions may have a circular cross-sectional shape. In certain embodiments, the holes and protrusions can have any of a number of different shapes, such as square or polygonal.

Referring to fig. 32, in the open configuration, fluid can flow (flow or away) between the tubes 13 at the second end 114 of the male connector 100, into the cap portion 130, through the cavity 154, through the flow passage 156, out the port 162 on the valve member 116, into the luer tip 122, into the port 488 on the fluid line 480, through the flow passage 418, and out the male luer 485 at the second end 404 of the female connector 400. In the open configuration, the second end of the male connector 100 is placed in fluid communication with the second end 404 of the female connector 400. Additionally, the seal 120 within the male connector 100 may maintain a flow blocking action between the inner surface of the luer tip 122 and the inner surface of the housing 123, restricting fluid flow within the flow passage of the female connector 400. In the illustrated example, the central mating interface between the male and female connectors is located within the neck of the female connector in the fully open configuration, or within the outer region of the proximal opening of the female connector, and within the male luer tip 122 or outer cannula.

In some embodiments, connectors 100 and 400 may be screwed apart. During engagement, the force accumulated by the elongation of the resilient member 118 can return the male connector 100 to its pre-engaged state by biasing the valve member 116 to engage the inner surface of the luer tip 122. Likewise, the resilient material of the seal 460 allows the seal 460 to return to its shape in the closed configuration, at which point the seal 462 may seal the port 488 on the fluid line 480.

Fig. 33 shows another example of a connector system 1000 that includes a male connector 1100 and a female connector 1400. In some embodiments, as shown, first end 1112 of male connector 1100 can detachably engage first end 1402 of female connector 1400 while allowing, but not requiring, rotation of male connector 1100 or female connector 1400. As shown, the first and second connectors 1100, 1400 are selectively engageable with one another in a substantially linear motion, wherein at least a portion (and in some cases a majority) of an outer surface of one fits over at least a portion (and in some cases a majority) of an outer surface of the other. In some embodiments, an audible sound may be generated when the connectors 1100, 1400 are engaged. In the illustrated embodiment, the male connector 1100 has an engagement member, such as a tab 1125 with a hook 1127 that engages a groove 1444 of the female connector 1400 to secure the connectors together. Many other types of engagement structures may be used to secure the connectors together. For example, the female connector 1400 may include a sleeve or other connection structure (such as the type of sleeve 112 shown on the male connector 1100) that fits over or outside a portion of the male connector 1400. In some embodiments, as shown, the connection is reversible or separable.

As explained further below, the first ends 1112, 1402 are configured such that the flow passages 1156 of the male connector 1100 are fluidly connectable to the flow passages 1418 of the female connector 1400 when the first ends 1112, 1402 are engaged with one another. Flow passages 1156, 1418 are blocked when male connector 1100 and female connector 1400 are separated. The engagement between male connector 1100 and female connector 1400 is configured such that first ends 1112, 1402 are substantially free of residual fluid after connector disengagement.

Fig. 34 shows an embodiment of the closeable male connector 1100 of fig. 33. Any configuration, features, components, and/or alternatives of the male connector 1100 may include, be interchangeable with, or be used with any configuration, features, components, materials, and/or alternatives of any other male connector. For example, connection structures (e.g., hook and groove structures) that are directed to preventing or inhibiting separation may be used with any suitable medical or other fluid connectors.

Fig. 34 and 35 are perspective and side views, respectively, of the closeable male connector 1100 in a first or closed position. Closable male connector 1100 may have a first end 1112 and a second end 1114. The first end 1112 may be configured to engage the female connector 1400. In some embodiments, the first end 1112 can include a connection structure and/or an alignment structure (e.g., a protrusion) configured to contact (be inserted into) another connection structure and/or alignment structure of the female connector 1400. In the illustrated embodiment, the first end 1112 has a male luer tip 1122 and a valve member 1116 (shown in more detail in fig. 36 and 39). In the closed position, the valve member 1116 may cooperate with the luer tip seal 1119 on the male luer tip 1122 to block or prevent fluid flow through the male connector 1100.

Fig. 36 is an exploded perspective view of the component parts of the closeable male connector 1100 shown in fig. 34. Referring to fig. 36, the end cap portion 1130 may be joined to the male housing 1123 near the second end 1114 of the closable male connector 1100, as generally described in other embodiments of the invention.

As shown in fig. 34, the male housing 1123 may have a sleeve 1124 substantially or completely surrounding the luer tip 1122. In some embodiments, the end of sleeve 1124 is spaced from end 1114 of the male connector to inhibit unintended lateral contact with male connector end 1114, thereby preventing end 1114 from becoming contaminated by other surfaces and/or preventing other surfaces from becoming contaminated by contacting end 1114. In some embodiments, the space between the end of the sleeve 1124 and the end 1114 of the male connector is at least as large as the cross-section of the flow passage in the valve member 1116. In certain embodiments, the sleeve 1124 may have an inner diameter or cross-section that may be greater than the outer diameter or cross-section of the male luer tip 1122. The sleeve 1124 may have an engagement structure for securing the male connector 1100 to the female connector 1400. In the illustrated embodiment, the sleeve 1124 has integral tabs 1125 and release buttons 1126 for securing the male connector 1100 to the female connector 1400. The tab 1125 may have a hook 1127 that engages a groove 1444 on the female connector 1400. The hook and groove engagement allows the connectors 1100, 1400 to engage one another without necessarily requiring rotation of the connectors, which can be done more quickly, with less manual precision required during engagement and/or can reduce the risk of twisting the connected fluid lines. A release structure such as release button 1126 can be manipulated (e.g., depressed) to eject hook 1127 from recess 1444 to disconnect the connectors. In certain embodiments, the engagement features may not be integral with the male housing 1123. For example, the tab and release button may be separate members that are connected to the male housing 1123. In some embodiments, other engagement features may be used to secure the connectors together, such as threads, pins, detents, grooves, and/or protrusions (e.g., bayonet connections).

The luer tip 1122 proximate the first end 1112 of the male connector 1100 may include a mating face 1128 at the end configured to form a leak-proof seal and/or a leak-free seal with at least a portion of the mating face 1466 of the seal 1460, as explained in other embodiments of the invention. In the illustrated embodiment, the mating face 1128 is a thin annular ring on the end of the luer tip 1122.

The valve member 1116 may be at least partially surrounded by the male housing 1123 as in the embodiment shown in fig. 36 and 37. As shown in fig. 37 and 39, the valve member 1116 may have a closed end 1144 that, in the closed configuration, prevents fluid flow through the male connector 1100. Valve member 1116 may have a mating surface 1146 that may include a protrusion 1147 that is capable of mating with a complementary generally shaped aperture 1490 at first end 1482 of fluid line 1480. In the illustrated embodiment, the projection 1147 is a generally cylindrical or generally discus-shaped projection having rounded edges. In some embodiments, the protrusions can have a variety of different shapes, such as protrusions having rectangular, square, and polygonal cross-sectional shapes to generally conform to the shape of the aperture 1490 at the first end 1482 of the fluid conduit 1480. In some embodiments, a protrusion can be on the first end 1482 of the fluid conduit 1480 and an aperture can be on the mating surface 1146 of the valve member 1116. The protrusion 1147 and the aperture 1490 can help align the mating surface of the male connector 1100 with the mating surface of the female connector 1400.

The valve member 1116 may have a segment 1117 with a passage extending within the segment 1117 (e.g., through the center). The valve fluid can flow through the tube segment 1117 of the valve 1116 and out through the port 1162 on the valve 1116. Tube segment 1117 can be made of an elastically deformable, resilient material. When male connector 1100 is in the open position, valve member 1116 is pushed toward second end 1114 of male connector 1100, compressing resilient tube segment 1117. In some embodiments the segment 1117 is slightly deformed so that the passage is not blocked by the compressed segment 1117. In some embodiments the segment 1117 may be deformed outwardly so that the passage is unobstructed. The tube segment 1117 may apply a return spring force at the closed end 1144 toward the first end 1112 of the male connector 1100. The closing force on the valve member 1116 is biased to return the male connector 1100 to the closed configuration.

The amount of spring force exerted by tube segment 1117 may be varied by varying parameters such as the length of tube segment 1117, the thickness of tube segment 1117, and/or by constructing tube segment 1117 from a variety of different materials having different spring properties. In some embodiments, the male connector 1100 is configured to require a sufficient opening force to resist accidental or unintended opening. In some embodiments, the force required to open the connector is controlled at least in part by the compressive force of the segment 1117. In some embodiments, the tube segment may have a coil spring within the male housing 1123 for biasing the closed end 1144 of the valve member 1116 toward the closed position. In some embodiments, the tube segments may have other biasing members such as resilient strips or actuators.

In certain embodiments, the valve member 1116 may have an end member 1145 proximate the closed end 1144 of the male luer tip 1122. In certain embodiments, the end piece 1145 may have a body end 1167 that includes an outer diameter or cross-section. In some embodiments, the end piece 1145 may have a flange 1149 extending from the body end 1167. In certain embodiments, the flange 1149 has at least one groove 1165. In certain embodiments, the end piece 1145 may have at least one port 1162. The end piece 1145 may include an extension 1166 extending from the body end 1167 to the closed end 1144 of the luer tip 1122. In some embodiments, the extension 1166 can have an outer diameter or cross-section that is less than the outer diameter or cross-section of the body end 1167. In some embodiments, extension 1166 may form an integral part with projection 1147. In certain embodiments, the end piece 1145 may be constructed of a rigid or semi-rigid material.

In some embodiments, the valve member 1116 may have a sleeve portion 1163. In certain embodiments, the sleeve portion 1163 has an inner diameter or cross-section and an outer diameter or cross-section. The sleeve portion 1163 may be formed of an elastically deformable elastic material. In some embodiments, the sleeve portion may have one or more indentations, protrusions or grooves to aid in compression and/or rebound. In some embodiments, the sleeve portion 1163 can be configured to engage the extension 1166. In some embodiments, the inner diameter or cross-section of the sleeve portion 1163 is smaller than the outer diameter or cross-section of the extension portion 1166, which may help the valve member 1116 to prevent leakage between the sleeve portion 1163 and the extension portion 1166.

In some embodiments, the valve member 1116 may include a securing portion 1164. The fastening portion 1164 may be formed of an elastically deformable elastic material. In some embodiments, the fastening portion 1164, the sleeve portion 1163, and/or the tube segment 1117 may be constructed of the same material and/or formed as a single piece. In certain embodiments, the fastening portion 1164 can be configured to engage at least one slot 1165 in the flange 1119, as shown in fig. 39. In some embodiments, the fastening portions 1164 may be biased in the stretched configuration.

In certain embodiments, end piece 1145 may be coupled to tube segment 1117 and/or sleeve portion 1163 by glue. In certain embodiments, fastening portion 1164 may be configured to exert a biasing force on sleeve portion 1163 and tube segment 1117 and bias sleeve portion 1163 toward tube segment 1117. The biasing force may secure the end member 1145 between the sleeve portion 1163 and the tube segment 1117. For example, in some embodiments, flange 1149 can engage tube segment 1117, and body end 1167 can engage sleeve portion 1163. Such engagement can help the end member 1145 resist disengagement from the sleeve portion 1167 and/or the tube segment 1117.

The luer tip seal 1119 may be disposed inside the luer tip 1122 as shown in fig. 36 and 37, as generally described in other embodiments. A luer tip seal 1119 may be disposed between the male housing 1123 and the valve member 1116 to form a seal over the port 1162 of the valve member 1116 in the closed position. In the illustrated embodiment, the luer tip seal 1119 has a pair of projections 1177 that are engageable with a slot 1129 on the male luer tip 1122 to secure the luer tip seal 1119 in place as the valve member 1116 is slid longitudinally within the male housing 1123. In certain embodiments, the luer tip seal 1119 may be secured to the male luer tip 1122 by glue, welding, an interference fit, a friction fit, or any other suitable method.

As shown in the embodiment 1100 of the male connector 1100 shown in fig. 34, the mating surface 1146 of the valve member 1116 is disposed substantially flush across the luer tip 1122 when the male connector 1100 is in the closed position. In some embodiments, the mating surface 1146 of the valve member 1116 may be configured to extend beyond the mating surface 1128 of the luer tip 1122 when the male connector 100 is in the closed position. In some embodiments, the mating surface 1146 of the valve member 1116 may be recessed within the luer tip 1122.

The male connector 1100 may be manipulated to a second position or an open position. In the open position, the valve member 1116 is withdrawn away from the luer tip 1122, thereby allowing fluid within the valve member 1116 to flow away from the port 1162 and around the closed end 1144. Fluid can flow from the luer insert at the second end 1114 through the interior of the male connector 1100 and out the valve member 1116 when the male connector 1100 is in the open configuration.

As shown in fig. 37, the flow passage 1156 may extend through at least a portion of the valve member 1116. The flow channel 1156 may have a circular cross-section, as shown in the illustrated embodiment, or the flow channel 1156 may have other cross-sectional shapes. The flow passage 1156 may have at least one port 1162 near the closed end 1144 of the valve member 1116. In the illustrated embodiment, the two ports 162 are located on generally opposite sides of the valve member 1116 and are rectangular, although other arrangements and shapes may be used.

In the embodiment shown in fig. 37, the male connector 1100 is in a closed position. One end of the valve member 1116 may abut the plunger 1170 of the first cap member 1132. In some embodiments, the end of the valve member 1116 can form a seal with the end of the plunger 1170 to substantially prevent fluid from seeping into the junction between the valve member 1116 and the plunger 1170. In some embodiments, the end of the valve member 1116 may be attached to the plunger 1170 by any suitable means, such as glue, sonic welding, solvent bonding, or the like.

The flow channel 1156 can be in fluid communication with the conduit 1194 of the first cap member 1132. Conduit 1194 may have a smaller cross-sectional area than flow channel 1156, as shown. In certain embodiments, the conduit 1194 may have a size that is substantially the same as the cross-sectional area of the flow passage 1156. In some embodiments, the conduit 1194 may be wider than the flow channel 1156. The conduit 1194 may be a tubular passage as shown, or may be designed with a non-circular cross-section according to any other suitable shape.

The plunger 1170 may have an outer dimension similar to the inner dimension of the end of the male housing 1123, but without abutting such walls to allow relative movement (e.g., rotation) between the components. In the embodiment shown in fig. 37, the plunger 1170 is circular to match the tubular shape of the male housing 1123, but other geometries may be used if appropriate. To inhibit fluid from escaping through the plunger 1170, a seal (e.g., an O-ring 1160) may be disposed in a groove 1169 behind the plunger 1170. The O-ring 1160 can contact the wall of the male housing 1123 as shown, preventing fluid flow around the plunger 1170. In some embodiments, the plunger 1170 is part of the end cap 1130. The end cap 1130 may be connected to the male housing 1123 by sonic welding, glue, or any other suitable connection method as described above. The plunger 1170 may be considered to be in a rest position relative to the male housing 1123. In some embodiments, the plunger 1170 is integrally formed with the male housing 1123 and the end cap 1130 is a separate piece that is suitably connected to the male housing 1123, such as by sonic welding. In certain embodiments, the second cap 1134 may include a ridge 1135. Additionally, in certain embodiments, the second cap 1134 may be integrally or monolithically formed with the male housing 1123. The first cap 1132 may be separately formed compared to the second cap 1134 or the male housing 1123.

As shown in fig. 37, fluid can flow into luer receptacle 1158 to conduit 1194. From conduit 1194, fluid can enter flow channel 1156. As shown in the illustrated embodiment, when the male connector 1100 is in the closed position, the closed end 1144 of the valve member 1116 can seal the aperture within the luer tip 1122 preventing fluid from flowing out the end of the luer tip 1122. However, fluid is generally able to exit the flow passage 1156 through the port 1162 in the valve member 1116. Fluid may remain within the luer tip 1122 but may be prevented from flowing out of the luer tip 1122 by the luer tip seal 1119 and may be prevented from flowing back outside the valve member 116 to the second end 114 by the tube segment 1117. Thus, when the male connector 1100 is in the closed position, as shown, fluid communication may exist between the luer receiver 1158 and the interior of the luer tip 1122 without allowing fluid to exit the first end 1112 of the male connector 1100.

The male connector 1100 may be changed to an open configuration when engaged with the female connector 1400. The luer tip 1122 is advanced at least partially into the female connector 1400 and the fluid line within the female connector 1400 engages the valve member 1116 to urge the closed end 1144 of the valve member 1116 toward the second end 1114 of the male connector 1100. Also, hooks 1127 on the sleeve 1124 of the male connector 1100 may engage grooves 1444 on the female connector 1400 to hold the connectors together. The connection between the male connector 1100 and the female connector 1400 will be described in more detail below.

When the valve member 1116 is moved toward the second end 1114, the valve closing end 1144 may separate from the luer tip 1122, drawing the port 1162 away from the luer tip seal 1119. Thus, fluid can flow around the closed end 1144 into the engaged female connector 1400. In some embodiments, the tube segment 1117 may prevent fluid flow between the interior of the luer tip 1122 and the valve member 1116 to the second end 1114 of the male connector 1100. Thus, in the open position, fluid may flow from the luer receiver 1158, through the conduit 1194, the flow channel 1156, the port or port 1162 within the valve member 1116, into the luer tip 1122, and into the port within the female connector 1400.

As can be seen in the embodiment shown in fig. 52, when the male connector 1100 is in the open position, the closed end 1144 of the valve member 1116 can be moved toward the second end 1114 of the male connector 1100, closer to the plunger 1170 portion of the end cap 1130. Thus, segment 1117 is compressed and flow passage 1156 may be reduced in volume in the open position.

Accordingly, as the male connector 1100 is transitioning from the open position to the closed position, the flow channel 1156 volume increases as the closed end 1144 of the valve member 1116 moves toward the first end 1112 of the male connector 1100. When the valve closed end 1144 of the valve member 1116 is advanced toward the first end 1112, the closed end 1144 may seal the aperture in the luer tip 1122. If no additional fluid is input into the male connector 1100 via the luer receptacle 1158, the existing fluid within the luer tip 1122 may be drawn back toward the flow channel 1156 via the port 1162 by the vacuum created as the volume of the flow channel 1156 increases. In this case, fluid may be inhibited from exiting the orifice within the luer tip 1122 when the closed end 1144 is moved into position in the orifice because fluid is instead drawn back into the flow passage 1156. In some embodiments, when the closed end 1144 is moved toward the first end 1112 of the male housing 1123, fluid near the mating face 1146 of the valve member 1116 is encouraged to flow into the male connector 1100 rather than being left near the mating face 1146, thereby preventing the mating face 1146 from being exposed to the fluid.

However, if additional fluid is also being input into the male connector 1100 via the luer receiver 1158, the additional fluid can enter the flow channel 1156 and collect there as the closed end 1144 moves toward the first end 1112 closing the luer tip 1122. When the luer tip seal 1119 seals the luer tip 1122, the pressure from the new input fluid may be prevented from forcing fluid out of the luer tip 1122. Thus, when female connector 1400 is connected with first end 1112 of male connector 1100, fluid is allowed to flow through male connector 1100, while such flow is prevented after female connector 1400 is being disconnected and female connector 1400 has been disconnected.

As noted above, in some embodiments it may be desirable to have certain medicaments resting on the skin or inhaled. The male connector 1100 may help retain fluid within the male connector 1100 when disconnected from the female connector 1100 or other connector while substantially eliminating residual fluid on the luer tip 1122. Thus, reducing the likelihood of residual fluid remaining on the luer tip 1122 after separation results in a corresponding reduction in the chance of exposure of the user or patient to toxic drugs.

Fig. 39-40 are perspective views of an example of the valve member 1116 and the luer tip seal 119, respectively, of the embodiment of the closable male connector 1100 shown in fig. 34. Referring particularly to FIG. 39, one or more of the ports 1162 may be located adjacent to the mating surface 1146. The port 1162 may be rectangular as shown or may have other shapes. Male connector 1100 may be adapted to be opened when placed in mating engagement with female connector 1400. For example, the female connector 1400 may include an engagement member such as, but not limited to, a surface with an aperture generally complementary to the projection 1147 that may engage the valve closing face 1144 to open the male connector 1100. In some embodiments, a manually operated slider, button, or other operating member may be suitably configured to open the male connector 1100.

Referring to fig. 40, luer tip seal 1119 may be generally cylindrical with an opening 1178 extending along a longitudinal axis of luer tip seal 1119. The side facing the first end 1112 of the male connector 1100 may have a mating face 1176 configured to mate with a corresponding face of the female connector 1400. The luer tip seal 1119 may be constructed of many different materials. In some embodiments, the luer tip seal 1119 may be fabricated from a silicon-based deformable material. Silicon-based deformable materials are materials that can form a fluid-tight seal with plastic or other rigid polymeric materials.

The end cap portion 1130 (see fig. 37) may be similar to the end cap portion 130 described in other embodiments. The cap portion 1130 and corresponding components are labeled with similar labels in this embodiment, except for the addition of 1000.

Fig. 41 and 42 are perspective and side views, respectively, of the female connector 1400 in a first or closed position. Any configuration, features, components, and/or alternatives of female connector 1400 may include or be interchangeable or used with any other configuration, features, components, materials, and/or alternatives of a female connector. Additionally, any of the other connectors described herein may include any configuration, features, and components of the female connector 1400. For example, features relating to preventing or inhibiting separation of the male and female connectors may be used with any suitable medical or other fluid connector.

Fig. 43 is an exploded perspective view of the component parts of the embodiment of the female connector 1400 shown in fig. 41. A fluid line 1480 having one or more side ports 1488 may be coupled to the female housing 1440 near the second end 1404 of the female connector 1400. One or more components of the fluid line 1480 may be integral or monolithic with the concave housing 1440. In certain embodiments, the fluid line 1480 may have a second end 1484 configured to mate with the second cap 1134. Fluid line 1480 and second cap 1134 may be joined by various methods such as glue, sonic welding, solvent bonding, snap fit, and the like. First cap 1420 may also be coupled to second cap 1134 and fluid line 1480. First cap 1420 is rotatable relative to second cap 1134 and fluid line 1480. A generally compressible or deformable seal 1460 may surround at least a portion of fluid line 1480. The seal 1460 may block the port 1488 on the fluid line 1480 when the female connector 1400 is in the closed configuration. The seal 1460 and the fluid line 1480 may be at least partially received in the female housing 1440.

As shown in fig. 41 and 42, the female connector 1400 may have a first end 1402 and a second end 1404. The first end 1402 may be configured to mate with the male connector 1100. In some embodiments, the female connector 1400 may have a female housing 1440 with a mating side 1408 that is configured to engage the male connector 1100. The first end 1402 may include an engagement structure that is complementary to an engagement structure on the sleeve 1124 of the male connector 1100. In the illustrated embodiment, female connector 1400 has selectively engageable engagement surfaces, such as recesses, dimples or grooves 1444 that engage corresponding selectively engageable engagement surfaces, such as snaps, detents, catches or hooks 1127, on male connector 1100 to releasably engage the connectors. Many other types of engagement elements may be used to engage the connectors together.

The female housing 1440 of the female connector 1400 can extend between the first end 1402 and the second end 1404. In the embodiment shown in fig. 45, the concave housing 1440 has a generally cylindrical body 1442. In certain embodiments, the body 1442 may have a substantially circular, substantially square, substantially polygonal cross-section, or any other suitable shape. A compressible or resilient seal 1460 and a fluid line 1480 are at least partially received in the female housing 1440.

Near the first end 1402 is a groove 1444 that extends around the perimeter of the concave housing 1440. The grooves 1444 may receive the hooks 1127 on the tabs 1125 of the male housing 1123. In some embodiments, the mating side 1408 of the female housing 1440 may be chamfered or rounded to allow the hook 1127 to slide around the first end 1402 of the female connector 1400 when the two connectors are engaged with each other.

The female housing 1440 may have engagement limits such as engagement flanges 1448 that protrude beyond the perimeter of the female housing 1440 to form a shoulder or stop to prevent the male connector 1100 from being inserted too far into the female connector 1400. In some embodiments, the engagement flange 1448 extends continuously around the entire circumference of the concave housing 1440. In some embodiments, the engagement flange 1448 can be broken or segmented and can extend less than the entire circumference of the female housing 1440, for example in the form of one or more projections or a set of broken segments. In certain embodiments, the engagement portion 446 can be integrally molded or otherwise formed with the female housing 440. In some embodiments, the engagement 1446 can be a separate component that is attached to the female housing 1440, for example, by welding, glue, or fasteners. In some embodiments, the connection limiter may be located closer to the first or proximal end than the second or distal end. The radially outermost extent of the connection limiter may be greater than or approximately equal to the inner diameter of the sleeve 1124 of the closable male luer connector 1123. In some embodiments, the female housing can have an extension 1447 between the connection limiter and the groove 1444.

Referring to fig. 46, fluid line 1480 may be similar to fluid line 480 (see, e.g., fig. 27) and the description of each fluid line 480, 1480 and its applications and alternatives applies to the other. Fluid line 1480 may have a first end 1482 and a second end 1484. The first end 1482 may have a mating surface 1486 configured to engage the mating surface 1146 of the valve member 1116. Proximate the first end 1482 may be at least one port 1488 that is fluidly coupled to a flow passage 1418 extending through a center of the fluid line 1480. In the illustrated embodiment, fluid line 1480 has two ports on generally opposite sides. In some embodiments, fluid line 1480 may have more than two ports 1488. A second end 1484 of the fluid line 1480 may be configured to be coupled to the first cap 1420 and the second cap 1134.

A tube 1487 may extend from the first end 1482 to the second end 1484 with a flow passage 1418 (see fig. 50) extending through the interior (center) of the tube 1487. In the embodiment shown in fig. 44, the tube 1487 is generally cylindrical near the first end 1482 and generally frustoconical near the second end 1484. In certain embodiments, the tube may have other cross-sectional shapes, such as, for example, generally square, generally polygonal, or generally elliptical.

As shown in fig. 44, the cross-section of the flow passage 1418 can be circular, or the flow passage 1418 can have other cross-sectional geometries. In the illustrated embodiment, the two ports 1488 are located on generally opposite sides of the fluid line 1480 and are rectangular, although other arrangements and shapes may be employed. Side port 1488 may be located adjacent mating face 1486 of fluid line 1480 or on the side of fluid line 1480 that is oriented away from mating face 1486 but still allows fluid to enter port 1488 when female connector 1400 is mated with male connector 1100. As shown, the proximal end or region of the fluid conduit 1480 may be blunt, non-tapered, generally planar, and closed to fluid flow. In certain embodiments, the size of port 1488 may be about 1 millimeter in length and/or width, although irregular shapes and other sizes may be employed. Ports of at least about 1mm or from about 1mm to about 3mm or less than or equal to about 1mm are also useful. The cross-sectional width (or outer diameter) of the proximal end of fluid line 1480 may be substantial as shown. For example, as shown, the cross-sectional width (or outer diameter) of the proximal end of the fluid line 1480 may be about equal to the outer diameter of the fluid line 1480, or greater than or equal to the inner diameter of the nib on the distal end of the female connector, or about equal to or greater than the inner diameter of the fluid line 1480 near the bottom of the fluid line, or about equal to the seal wall thickness at the proximal end or in the neck region of the housing, or substantially greater than the housing wall thickness.

The fluid line 1480 may be constructed of a rigid material, such as polycarbonate plastic, that is capable of resisting compression or deformation when a force sufficient to compress or deform the seal 1460 is applied to the female connector 1400. A port 1488 in the fluid line 1480 may be sealed by a seal 1460 to prevent fluid flow out of the flow passage 1418 when the female connector 1400 is in the closed configuration.

Similar to the male connector 1100, the female connector 1400 may include a first cap 1420 and a second cap 1134 proximate the second end 1404. In some embodiments, the second cap 1134 may be the same or similar to the second cap described in the male connector 1100. As shown in fig. 44 and 47, first cap 1420 may be configured with a protrusion at one end for mating with fluid line 1480 and a female luer 1485 at the other end. A flow path may extend longitudinally through the first cap 1420 such that the fluid line 1480 may be in fluid communication with the male luer 1485. The male luer 1485 includes a sleeve around the male luer tip to be internally threaded. The male luer 1485 may conform to ANSI specifications for a male connector. The male luer 1485 may receive another connector or a female connector of a syringe.

As shown in fig. 44, the second cap 1134 may be coupled to the second end 1484 of the fluid line 1480 and/or the concave housing 1440. In some embodiments, the second cap 1134 may be fixedly attached to the fluid line 1480 or the concave housing 1440 by sonic welding, glue, or any other suitable method. In the illustrated embodiment, first cap 1420 is rotatably coupled to second cap 1134 and fluid line 1480. In certain embodiments, the first cap 1420 and/or the second cap 1134 can be integral or monolithic with the concave housing 1440.

In some embodiments, the portion of the first cap 1420 that engages the fluid line 1480 may have an outer dimension similar to the dimension of the wall of the fluid line 1480, but not contact such wall to allow for relative movement between the components. To inhibit fluid from escaping between fluid line 1480 and first cap 1420, a flexible or resilient seal, such as an O-ring 1160, may be disposed in groove 1424 on first cap 1420. The channel 1424 may extend around the periphery of the first cap 1420, which engages the fluid line 1480 at the periphery. O-ring 1160 may contact a wall of fluid line 1480 as shown, preventing fluid from escaping flow passage 1418. The first cap 1420 can be rotated relative to the fluid line 1480 so that the male luer 1485 can be connected to another connector without twisting the entire female connector 1400.

Additionally, the first cap member 1420 may include an annular groove 1422 that is capable of interacting with mating structure on the second cap member 1134 to axially limit movement of the first cap member 1420 relative to the second cap member 1134. Referring to fig. 44, the first cap 1420 and the second cap 1134 may be sized and shaped to prevent the first cap 1420 from being inadvertently pulled out of the second cap 1134.

Also as shown in fig. 47, the first cap member 1420 may include an angled or rounded surface between the annular groove 1422 and the O-ring channel 1424. The sloped or rounded surface may assist in the engagement or assembly of the first cap 1420 with the second cap 1134. In certain embodiments, the first cap 1420 and/or the second cap 1134 may include any suitable feature, lubricant, or material to facilitate engagement of the first cap 1420 and the second cap 1134 or to facilitate rotation of the first cap 1420 relative to the second cap 134.

In some embodiments, the cap can include structure for preventing the male end 1485 of the female connector 1400 from separating and/or for assisting in the rotation of the male end 1485 of the female connector 1400. For example, the first cap 1420 may have a break tab for preventing the first cap 1420 from rotating relative to the second cap 1134 at an initial stage as described herein. Once the tabs are broken from the first cap 1420, the first cap 1420 is then able to rotate substantially freely within the second cap 1134. The first cap 1420 can be retained in the female connector 1400 by engagement of the annular groove 1422 with an annular projection on the second cap 1134. Also, the O-ring 1160 prevents or inhibits fluid leakage, although the first cap 1420 can rotate. The female connector 1400 may resist separation from the engaged components because the torque required for such separation will only spin the first cap 1420 relative to the female housing 1400 and/or the second cap 1134.

Referring to fig. 48, the seal 1460 is described in greater detail. In some embodiments, seal 1460 is generally cylindrical and has an inner bore 1470 extending therein. The seal 1460 may have a seal portion 1462 and a crimp portion 1464. Seal 1462 may have an inner diameter configured to block first end 1482 of fluid line 1480 to prevent fluid from flowing out of port 1488.

In the illustrated embodiment, at least the distal portion 1464 is generally cylindrical and is capable of deforming, compressing, or otherwise shortening in length. The deflate 1464 is made of a resilient or deformable material such that a restoring force biases the distal portion 1464 back to its original length when the distally directed force is removed. In certain embodiments, the deflate 1464 may have a variety of different types of configurations to provide a compressible seal, such as, for example, as in other embodiments described herein.

A shoulder or stop 1468 may be provided between the seal 1462 and the crimp 1464. The stop 1468 is an enlarged outer diameter portion in the illustrated embodiment. As shown in fig. 44, the stop 1468 can engage a surface of the female housing 1440 to prevent the compressible seal 1460 from over-extending or exiting the female housing. The placement of the stop 1468 on the seal 1460 is designed such that when the stop 1468 is engaged with the female housing 1440, the seal 1462 is positioned over the port 1488 on the fluid line 1480.

The seal 1460 may be constructed of a material that compresses or deforms elastically. The seal 1460 is biased to return the female connector 1400 to the closed configuration. The amount of compression resistance applied by the seal 1460 can be adjusted by varying the length of the compression portion 1464 or the length of the cavity in the female housing 1440 that receives the seal 1460. The amount of compression resistance can also be adjusted by increasing the thickness of the seal 1460 and/or using a variety of different materials with different elasticity. In some embodiments, the deflate 1464 may be configured as a spring-like portion that is positioned within the female housing 1440 for biasing the seal 1460 toward the closed configuration, as described in other embodiments.

As shown in fig. 41 and 44, the first end 1402 of the female connector 1400 may have a mating side 1408 that is generally transverse to the longitudinal axis of the female connector 1400. In the illustrated embodiment, the mating side 1408 has a generally annular shape. The mating side 1408 may have an opening for the seal 1460 in a central region where the mating surface 1466 of the seal 1460 is exposed. The mating surface 1466 of the seal 1460 is configured to form a leak-proof seal with the mating surface 1128 of the male luer tip 1122 and the mating surface 1176 of the luer tip seal 1119. The opening for the fluid line 1480 of the female connector may be near the center of the seal 1460. The first end 1482 of the fluid line 1480 may have a mating surface 1486 configured to form a leak-proof seal with the mating surface 1146 of the valve member 1116.

As shown in the female connector embodiment 1400 shown in fig. 41 and 44, the mating face 1466 of the seal 1460 may be substantially flush with the mating side face 1408 of the female connector 1400. In some embodiments, the mating face 1486 of the fluid line 1480 may be substantially aligned with the mating side 1408 of the female connector 1400. In some embodiments, the mating surface 1466 of the seal 1460 and/or the mating surface 1486 of the fluid lines 1480 may be configured to extend further beyond the mating side 1408 of the female connector 1400 in the closed position. In some embodiments, the mating surface 1466 of the seal 1460 and/or the mating surface 1486 of the fluid line 1480 may be recessed within the mating portion 1446.

In some embodiments, the first end 1482 of the fluid line 1480 may have an aperture 1490 that mates with a mating projection 1147 on a mating surface 1146 of the valve member 1116. In the illustrated embodiment, the aperture 1490 is a rounded hole. In some embodiments, the shape of the aperture can have a variety of different shapes, such as rectangular, square, or polygonal. In some embodiments, the aperture can be provided on the mating surface 1146 of the valve member 1116 and the protrusion can be on the first end 1482 of the fluid conduit 1480. The apertures 1490 and the protrusions 1147 may help align the corresponding mating surfaces of the male connector 1100 and the female connector 1400 and prevent lateral movement and fluid leakage therebetween.

The seal 1460 may block the first end 1482 of the fluid line 1480 to block fluid flow out of the port 1488 when the female connector 1400 is in the closed configuration. The sealing portion 1462 of the seal 1460 can be disposed within the mating portion 1446 of the female housing 1440 as shown in fig. 44. In the illustrated embodiment, the seal 1462 of the seal 1460 is disposed between the female housing 1440 and the fluid line 1480. In some embodiments, the interference fit between the seal 1460 and the fluid conduit 1480 can prevent fluid from flowing out of the first end 1402 of the female connector 1400. The seal 1460 may be made of an elastomeric material that helps form a seal.

The female connector 1400 may be manipulated to a second or open configuration. In the open configuration, the seal 1462 of the seal 1460 may be pushed back toward the second end 1404 of the female connector 1400, thereby allowing fluid to flow through the port 1488 in the fluid line 1480. In the open configuration, fluid can enter fluid line 1480 through port 1488 and flow through passage 1418 out through female luer 1485.

The female connector 1400 may help retain fluid within the female connector 1400 while being decoupled from the male connector 1100 or other connectors, while substantially or completely eliminating residual fluid on the first end 1402 of the female connector 1400. Preventing residual fluid from remaining on female connector 1400 after separation may result in a corresponding reduction in the chance of exposure of the user or patient to toxic medications.

Referring to fig. 49 and 50, the male connector 1100 is shown adjacent to the female connector 1400. In the illustrated embodiment, the male connector 1100 and the female connector 1400 are in a closed configuration. A first end 1402 of female connector 1400 is proximate a first end 1112 of male connector 1100. Male connector 1100 may be engaged with female connector 1400 by press fitting the connectors without twisting or rotating either connector.

As shown in fig. 51 and 52, the male connector 1100 may be changed to an open configuration when the female connector 1400 is connected to the male connector 1100. The first end 1402 of the female connector 1400 may engage the first end 1112 of the male connector 1100. A first biased engagement portion of the male connector 1100, such as a hook 1127 on a tab 1125, can engage a second engagement portion of the female connector 1400, such as a groove 1444, to engage the connectors with each other. The hook-and-groove engagement allows the connectors 1100, 1400 to engage each other without requiring a rotational connection, which reduces the risk of twisting of the connected fluid lines and does not require precise manual manipulation by a health care professional. The position of the first and second engagement portions on each connector may be reversed. In some embodiments, the hook 1127 may slide over the mating side 1408 of the female connector 1400 and fall into the groove 1444. An audible sound may be generated in some embodiments when the hook 1127 is form-fitted with the groove 1444 on the female connector 1400. The release button 1126 may be depressed to lift the hook 1127 out of the recess 1444 to disconnect the connector.

In some embodiments, the engagement between the hook 1127 of the male connector 1100 and the groove 1444 of the female connector 1400 may reduce the likelihood of side-shifting between the mating surface 1146 of the valve member 1116 and the mating surface 1486 of the fluid line 1480. In some embodiments, the engagement between the hook 1127 of the male connector 1100 and the groove 1444 of the female connector 1400 prevents tilting between the mating surface 1146 of the valve member 1116 and the mating surface 1486 of the fluid line 1480 during and/or after engagement. Reducing lateral movement and/or tilting between the mating faces 1146, 1486 may help reduce the likelihood that either mating face 1146, 1486 will be exposed to fluid from within the connector 1100, 1400.

The mating surface 1486 of the fluid line 1480 can engage the mating surface 1146 of the valve member 1116. These mating non-planar mating surfaces 1186, 1146 and/or interactions between the mating outer sleeve 1124 and the outer surface of the adjacent connector (e.g., the outer surface of the extension 1447 of the female connector) can inhibit lateral movement between the mating surfaces 1186, 1146 to inhibit fluid penetration or intrusion therebetween. When male connector 1100 and female connector 1400 are engaged, fluid line 1480 may push closed end 1144 of valve member 1116 toward second end 1114 of male connector 1100. When the closed end 1144 is urged toward the second end 1114 of the male connector 1100, the port 1162 on the valve member 1116 is moved away from the kelvin tip seal 1119, allowing fluid to flow out through the port 1162. The male connector 1100 is then moved to the open configuration when the closed end 1144 of the valve member 1116 is urged toward the second end 1114.

As shown in fig. 52, the mating surface 1176 of the luer tip seal 1119 and the mating surface 1128 of the male luer tip 1122 can engage the mating surface 1466 of the seal 1460. When the male and female connectors 1100, 1400 are joined together, the male luer tip 1122, along with the luer tip seal 1119, may press the seal 1460 toward the second end 1404 of the female connector 1400, forcing the compression portion 1464 of the seal 1460. When the seal 1460 is urged toward the second end 1404 of the female connector 1400, a port 1488 on the fluid line 1480 is opened, allowing fluid to flow through the port 1480. In this example, the female connector 1400 is in an open configuration. Because the seal 1460 includes an opening or internal bore 1470 at its proximal end, the tube 1487 in the female connector, the male luer tip 1122 in the male connector, and/or the valve member 116 of the male connector need not be pierced, cut, pierced, passed through or splayed, forced open, or otherwise significantly change the size, shape, or dimension of the proximal end of the seal 1460. In contrast, in some embodiments, as shown, the proximal end of the seal 1460 is moved upon entry of the male connector, but the shape of the proximal end of the seal 1460 remains intact during opening and closing. The size and shape of the internal bore 1470 and the size and shape of the opening, bore or opening in the proximal end of the seal 1460 and/or in the proximal end of the seal 1460 may be substantially the same during the closing and opening stages and during the transition between these stages.

As the closed end 1144 of the valve member 1116 is urged toward the second end 1114 of the male connector 1100, the tube segment 1117 of the valve member 1116 is compressed, creating a restoring force at the closed end 1144 toward the first end 1112 of the male connector 1100. Thus, in the open configuration of the male connector 1100, the closed end 1144 of the valve member 1116 may be biased toward the first end 1112 toward the closed configuration. Similarly, when the seal 1460 is urged toward the second end 1404 of the female connector 1400, the compression portion 1464 applies a resilient return force to bias the seal 1460 toward its initial length and toward the closed configuration. As shown, the valve member 1116 in some embodiments remains within the male connector housing or within the luer tip 1122 in both the open and closed positions and when transitioning between these two phases, thereby reducing the risk of exposing the valve member 1117 and thus the escape to undesirable environmental foreign objects (e.g., pathogens, poisons, or debris) and reducing the risk that fluid within the flow passage will escape into the environment.

In some embodiments, the valve member 1116 and the seal 1460 can apply a closing force to help maintain contact between the mating surfaces 1146, 1486 during engagement. In certain embodiments, the mating surface 1146 of the valve member 1116 may have a cross-section that is substantially equal to the cross-section of the mating surface 1486 of the fluid line 1480. In some embodiments, the outer peripheral surface of the mating surface 1486 of the fluid line 1480 may be in contact and/or generally complementary shape with the outer peripheral surface of the mating surface 1146 of the valve member 1116 when the male connector 1100 and/or the female connector 1400 are in the open configuration.

In some embodiments, the mating surfaces of the male connector 1100 and/or the female connector 1400 may be at least partially compressible to help form a substantially leak-free seal or leak-proof seal between the mating surfaces as described in other embodiments. For example, the mating surface 1146 of the valve member 1116 can be made of an elastomeric material that can seal with the mating surface 1486 of the fluid line 1480 (which can itself be flexible or rigid) so that fluids do not contact the mating surfaces of the male and female connectors 1100, 1400. In some embodiments, the mating surface 1486 of the fluid line 1480 can be made of an elastomeric material that can seal with the mating surface 1146 of the valve member 1116 (which can itself be rigid or flexible). In certain embodiments, fluid can flow around the seal formed by the two mating surfaces 1146, 1486. In certain embodiments, fluid is impeded from flowing between the mating surfaces 1146, 1148 within the perimeter of the mating surfaces 1146, 1148. In certain embodiments, fluid may flow between male connector 1100 and female connector 1400 without requiring puncture or penetration of a normally closed septum, as described herein. For example, the diaphragm may include a constant opening through which fluid lines may pass, or fluid may be able to flow around the outer surface of the diaphragm or other barrier. By isolating the mating surfaces from fluid, the mating surface 1146 of the valve member 1116 and the mating surface 1486 of the fluid line 1480 can remain dry after the two connectors are separated and can prevent undesirable contamination to health care providers or the surrounding environment.

In some embodiments, the mating surface 1146 of the valve member 1116 may have a cross-section that is about equal to or less than the cross-section of the inner bore 1470 of the seal 1460. In certain embodiments, the inner cross-section of the luer tip seal 1119 may be less than or about equal to the inner cross-section of the inner bore 1470 of the seal 1460. In some embodiments, the engagement between the circumferential surface of the inner bore 1470 and the first end 1112 of the male connector 1100 can help prevent fluid from leaking to the mating surface 1466 of the seal 1460. For example, in some embodiments, the perimeter surface of the internal bore 1470 can engage the mating surface 1176 of the luer tip seal 1119 and form a substantially fluid-tight seal between the flow passages in the two connectors and the mating surface 1466 of the seal 1460. By isolating the mating surface 1466 of the seal 1460 from the fluid, the mating surface 1466 may remain dry during and after fluid transfer and reduce the risk that health care personnel may be exposed to the fluid.

In certain embodiments, the inner cross-section of the luer tip seal 1119 may be less than or about equal to the outer cross-section of the tube 1487 near the first end 1482 of the fluid conduit 1480. In certain embodiments, the luer tip seal 1119 can "scrape" the outer surface of the tube 1487 as the tube passes through the luer tip seal 1119 during opening and/or closing of the valve member 1116. In certain variations, scraping the outer surface of the tube 1487 as the tube passes through the luer seal 1119 can help prevent fluid from pooling or leaking in the area of the first end 1402 of the female connector 1400. As explained above, in certain embodiments, the natural outer cross-section of the mating surface 1146 of the valve member 1116 may be slightly larger than the natural inner cross-section of the luer tip seal 1119. In some embodiments, the luer tip seal 1119 can scrape against an outer surface of the valve member 1116 as the valve member 116 moves from the open configuration to the closed configuration. In some embodiments, the scraping of the outer surface of the valve member 1116 can help reduce the likelihood of fluid pooling or leaking during and/or after separation between the mating surface 1486 of the fluid line 1480 and the mating surface 1146 of the valve member 1116 in the region of the first end 1112 of the male connector 1100. By preventing the pooling or leakage of fluid in the area of the first end 1112 of the male connector 1100 and/or in the area of the first end 1402 of the female connector 1400, the luer tip seal 1119 may help reduce the likelihood that a health care provider will be exposed to the action of the fluid.

The mating surface 1146 of the valve member 1116 may have a protrusion 1147 that is capable of receiving a complementary shaped aperture 1490 in the mating surface 1486 of the fluid conduit 1480. In some embodiments described herein, the protrusion may be on the fluid conduit 1480 and the aperture may be on the valve member 1116. The projections 1147 and the holes 490 can help align the male connector 1100 and the female connector 1400 during engagement so that these components are aligned for proper displacement of the parts. In some embodiments, the holes and protrusions may have a circular cross-sectional shape. In other embodiments, the holes and protrusions may be any of a number of different shapes, such as square or polygonal.

In some embodiments, the extension 1447 of the female housing 1440 can have an outer diameter or cross-section that is substantially similar to an inner diameter or cross-section of the sleeve 1124 of the male connector 1100. In some embodiments, engagement between the outer diameter or cross-section of extension 1447 and the inner diameter or cross-section of sleeve 1124 may help male connector 1100 and female connector 1400 resist tilting relative to each other off-axis, particularly during an initial engagement phase (e.g., to maintain the longitudinal axis of male connector 1100 aligned with the longitudinal axis of female connector 1400). In some embodiments, engagement between the outer cross-section of the extension 1447 and the inner cross-section of the sleeve 1124 can help prevent lateral movement between the connectors 1100, 1400 and between the mating surfaces 1486, 1146. Maintaining the longitudinal axes of the female connector 1400 and the male connector 1100 in general or substantial alignment and/or preventing lateral movement of the female connector 1400 and the male connector 1100 may help maintain sealing contact between the mating face 1486 of the fluid line 1480 and the mating face 1146 of the valve member 1116. Maintaining sealing contact between the two mating surfaces 1146, 1486 can help reduce the likelihood that fluid will contact either mating surface 1146, 1486.

Referring to fig. 52, in the open configuration, fluid can flow from second end 1114 of male connector 1100, into end cap portion 1130, through flow passages 1156, out port 1162 on valve member 1116, into luer tip 1122, into port 1488 on fluid line 1480, through flow passages 1418, through first cap 1420 on female connector 1400, and out male luer 1485 on second end 1404 of female connector 1400. Thus, in the open configuration, the second end of the male connector 1100 may be in fluid communication with the second end 1404 of the female connector 1400.

The connectors 1100, 1400 may be separated by operating a release button 1126 on a tab 1125 of the male connector 1100. In the illustrated embodiment, release button 1126 may be depressed to eject hook 1127 out of groove 1444 of female connector 1400. The force that builds up during the engaged compression of the tube segment 1117 of the valve member 1116 can return the male connector 1100 to the pre-engaged state by biasing the closed end 1144 of the valve member 1116 to engage the inner surface of the luer tip 1122. Likewise, the resilient material of the seal 1460 allows the seal 1460 to return to its shape in the closed configuration in which the seal 1462 may seal the port 1488 on the fluid line 1480. In some embodiments, during closing, the valve member of the male connector 1100 and the tube 1487 of the female connector 1400 and the respective fluid flow openings 1162, 1488 in these structures are located within the respective housings of the male and female connectors 1100, 1400 in contact with, behind, and/or sealed by a resilient or flexible seal, and then the mating ends of the devices are separated from each other upon separation, as shown.

Fig. 53-65 illustrate another embodiment of a connector system 2000 including a male connector 2100 and a female connector 2400. Certain reference numbers relating to components within fig. 53-65 are the same or similar to reference numbers described above for the connector system 1000 and corresponding male and female connectors 1100 and 1400 (e.g., male connector 2100 versus male connector 1100). It should be understood that these components may be functionally the same or similar to the components described above. The connector system 2000 of fig. 53-65 illustrates certain changes relative to the connector system 1000 of fig. 33-52.

In some embodiments, the male connector 2100 includes a plurality of release hand ridges 2126. In certain embodiments, the male connector 2100 and the female connector 2400 each include a second cap portion 2134 (see fig. 55) having an annular ridge 2135 (see fig. 56). The annular ridge 2135 may include one or more indentations (e.g., as shown in fig. 43) or be devoid of indentations (e.g., as shown in fig. 56). In certain embodiments, the male connector 2100 may include a valve element 2116 having a spring element 2117 and an end element 2145. The end piece 2145 may include a mating face 2146, a protrusion 2147, an annular flange 2149, and/or one or more ports 2162. In certain embodiments, the end piece 2145 may be formed from a generally rigid material, such as a hard plastic, or it may be formed from an elastomeric or flexible material.

In some configurations, the male connector 2100 can include a luer tip seal 2119 that can be disposed between the male housing 2123 and the valve member 2116. In some configurations, the luer tip seal 2119 can inhibit or seal fluid flow out of the port 2162 of the end piece 2145 when the male connector 2100 is in the closed configuration as shown in fig. 57. In certain embodiments, the luer tip seal 2119 may be substantially cylindrical and may include an annular flange 2177 and a central opening. The annular flange 2177 may be axially retained by one or more retention structures, such as positioned between a plurality of inner retention tabs 2171 and a plurality of outer retention tabs 2173 on the male luer tip 2122, as shown in fig. 57. In certain embodiments, the luer tip seal 2119 may be secured to the male luer tip 2122 by glue, welding, an interference fit, a friction fit, or any other suitable means.

Fig. 57 and 65 illustrate an embodiment of a male connector 2100 in a closed configuration and an open configuration, respectively. The spring member 2117 may bias the end piece 2145 of the valve element 2116 toward the first end 2112 of the male connector 2100. When the male connector 2100 is in the closed position, the inner retention tabs 2171 can contact the annular flange 2149 of the end piece 2145 and inhibit movement of the end piece 2145 toward the first end 2112 of the male connector 2100. When the male connector 2100 is in the open position, the end member 2145 of the valve element 2116 can be moved toward the second end 2114 of the male connector 2100. The annular flange 2149 of the end piece 2145 may be configured to have a shape that generally corresponds to the shape of the inner wall 2152 of the male connector 2100. In some configurations, contact between the outer surface of the annular flange 2149 and the inner wall 2152 can maintain a substantially constant alignment between the central axis of the flow passage 2156 and the central axis of the end piece 2145 as the end piece 2145 moves between the open and closed configurations.

Fig. 63B illustrates an embodiment of a connector system 2000 ' comprising a male connector 2100 ' and a female connector 2400 ' configured to connect to each other. Reference numerals for the component parts are the same or similar to those described above with respect to fig. 63, except that the reference numerals are followed by a prime'. Where such labeling occurs, it is to be understood that the component parts are the same or similar to the component parts previously described. As shown, the male connector 2100 ' can include a valve element 2116 ' at least partially received within a boss 2122 '. The valve element 2116 'may be biased toward the first end 2112' of the male connector 2100 'by a spring member 2117' or other bias providing member (e.g., a hose). Valve member 2116 ' may be retained within boss 2122 ' by a retention tab 2171 '. The retention tabs 2171 ' may include a ramp portion that can help facilitate high flow rates and/or substantially laminar, substantially non-turbulent fluid flow through the valve element 2116 ' when the male connector 2100 ' is in the open configuration. In an embodiment, the stop tab 2171 ' can help prevent or avoid turbulent flow through the valve member 2116 ' as fluid flows from the male connector 2100 ' to the female connector 2400 ' through the valve member 2116 '.

In certain embodiments, the seal 1160 'may be configured to engage an end of the plunger 1170' and sealingly contact a wall of the male housing 2123 'to prevent fluid flow around the plunger 1170'. In certain embodiments, a portion of the seal 1160 'may be configured to engage an annular groove on the outer surface of the plunger 1170'. The seal 1160 'may extend around an end of the plunger 1170' such that the spring member 2117 'may be held in place within the boss 2122' between the valve element 2116 'and the seal 1160'. In certain embodiments, the seal 1160 ' is configured to contact the wall of the male housing 2123 ' along an axial extent (e.g., an axial distance parallel to an axial centerline of the male housing 2123 ') that is greater than an axial extent of the covering portion 1192 ' of the first cap member 1132 '.

As shown in fig. 58A, the male connector 2100 ' may include a tab 2125 ' with a hand-touch release ridge 2126 ' and a hook 2127 ' designed to engage a portion of the female connector 2400 '. The tab 2125 ' can include one or more support structures, such as a longitudinal rib 2129, that extends between the hand-touch release ridge 2126 ' and the hook 2127 '. The tab 2125 ' with the ribs 2129 can be generally rigid and can prevent perfection between the ridges 2126 ' and the hooks 2127 '. In some embodiments, the tab 2125 ' with the rib 2129 can prevent the hook 2127 ' from accidentally disengaging from the female connector 2400 '.

The hand-touch release ridges 2126 ' of the tabs 2125 ' may extend radially from the axial centerline of the male connector 2100 '. The male connector 2100 ' may include a plurality of relief ridges 2126 ' or a single relief ridge 2126 '. In some embodiments, one or more of the relief ridges 2126 ' have a different height (e.g., extend radially from an axial centerline of the projection 2122 ') relative to one or more other relief ridges 2126 '. For example, and without limitation, the release ridges 2126 ' on the tabs 2125 ' may be arranged in a stepped fashion, wherein the height of the ridges 2126 ' increases in sequence from the shortest release ridge 2126 ' closest to the first end of the male connector 2100 ' to the highest release ridge 2126 ' closest to the second end of the male connector 2100 '. In some such arrangements, slippage of the user's fingers along the axial extent of the release ridges 2126' may be prevented when the user separates the male connector 2100 'from the female connector 2400'.

In certain embodiments, the radial distance between the highest hand release ridge 2126 ' and the axial centerline of the projection 2122 ' (e.g., the height of the highest hand release ridge 2126 ') is greater than or equal to about 120% and/or less than or equal to about 180% of the radial distance between the radially outermost point of the sleeve 2124 ' and the axial centerline of the projection 2122 '. In certain embodiments, the above ratio is about 165%. Many variations are possible. The radial thickness of each or at least one of the relief ridges 2126' from the radially outermost surface of the sleeve 2124 may in certain embodiments be greater than the radial thickness of the ribs 2129 from the radially outermost surface of the sleeve 2124. In certain embodiments, a high hand-touch release ridge 2126 '(e.g., a ridge 2126' having a large radial height) may reduce the likelihood that a user's finger of the male connector 2100' will contact a portion of the male housing 2123 'near the periphery of the release tab 2125' when the release tab 2125 'is disengaged from the female housing 2400'.

The male housing 2123 'may include a beveled portion 2175 at an end of the male housing 2123' opposite the mating surface 2128 'of the male portion 2122'. Ramp 2175 may help facilitate insertion of plunger 1170 ' into male housing 2123 ' during manufacture of male connector 2100 '. For example, the ramp 2175 can help guide (e.g., act as a channel) an end of the plunger 1170 'into an end of the boss 2122' opposite an end of the boss 2122 'having a mating surface 2128'.

In certain embodiments, conduit 1480 ' includes a conduit tip at or near first end 1402 ' of female connector 2400 '. The catheter tip may have a mating surface 1486'. The catheter tip may include an engagement section 1489. The engagement section 1489 may be a separate member that is bonded or otherwise attached to the end of the conduit 1480 ' closest to the first end 1402 ' of the female connector 2400 '. In some embodiments, junction 1489 and conduit 1402' form one integral piece. The junction 1489 may be constructed of a flexible or semi-flexible material.

In some embodiments, the engagement portion 1489 has a first surface (e.g., mating surface 1486') and a second surface. The mating face 1486 'may include alignment structures 1490' (e.g., convex, concave, or other surface shapes). The second surface may be opposite the mating surface 1486 'and may engage (e.g., be bonded or welded) the tip of the conduit 1480'. In some embodiments, the mating surfaces 1486 ' and second surfaces of the engagement portions 1489 may be adjacent to one another when connecting between the female connector 2400 ' and the male connector 2100 '. In some such arrangements, movement of the mating surface 1486' toward the second surface can compress the material of the engagement section 1489. This compression can bias mating surface 1486 'and alignment structures 1490' toward mating surface 2146 'of valve member 2116'. In some configurations, fluid is prevented from passing between mating surfaces 2146 'and 1486' and mating surfaces 2146 'and 1486' are prevented from being exposed to the fluid.

Conduit 1480 'of female connector 2400' may include a beveled portion 1493 located near an end of conduit 1480 'opposite mating face 1486'. In certain embodiments, the beveled portions 1493 prevent or avoid turbulence in the fluid flow through the female connector 2400'. In certain embodiments, beveled portions 1493 of conduit 1480 'help prevent buckling of conduit 1480' under compressive loads.

In some embodiments, the male connector 100 may be used with other connectors. Fig. 66 shows a cross-section of an example of a male connector 100 near an example of an open-ended female luer 92. The female luer 92 may include an elongate body 72 having a flow passage 74 therein, and the female luer 92 may have a first end 76. In certain embodiments, the first end 76 of the female luer 92 may have a radially extending surface 78 disposed on an outer surface thereof. The female luer 92 may have a fluid conduit located in the female luer 92. Not all female connectors compatible with the male connector 100 described herein contain or require fluid lines. Along the inner surface 80 of the female luer 92, the flow passage 74 flares or tapers outwardly such that the diameter of the flow passage 74 increases toward the first end 76.

Fig. 66 shows the male connector 100 in a closed configuration. The supports 150 of the valve member 116 extend through slots in the male housing 123 of 16 so that their distal ends extend to the vicinity of the end of the sleeve 124 near the first end 112 of the male connector 100. These supports 150 are configured to engage the mating end 84 of the female luer 92 when the female luer 92 is advanced into engagement with the male connector 100.

In fig. 66, the male connector 100 and the female luer 92 are shown in a separated configuration. To engage the male connector 100 and the female luer 92, the radially extending surface 78 of the female luer 92 is threaded into the internal threads 126 of the male connector 100.

As shown in fig. 67, the male connector 100 and the female luer 92 may be threadably engaged with one another until the bevel of the inner surface 80 of the female luer 92 is proximate the corresponding tapered outer surface of the male luer tip 122 of the male connector 100.

The sharp mating end 84 of the female luer 92 contacts the support body 150 of the valve member 116 when the male connector 100 and the female luer 92 are brought into close, threaded engagement with one another. As the male connector 100 and female luer 92 are moved further into threaded engagement, the support body 150 and, in turn, the valve member 116 are moved by the female luer 92 toward the second end 114 of the male connector 100, causing the valve member 116 to move relative to the male housing 123. The closed end 144 then moves from the end of the male luer tip 122 of the male housing 123 toward the second end 114 of the male connector 100. When the closed end 144 exits the male luer tip 122, a gap is formed between the valve member 116 and the male housing 123 and fluid is allowed to flow through the port 162 into the flow passage 74 of the female luer 92, or vice versa. In certain embodiments, the closure remains unchanged until the inner surface 80 of the female luer 92 has formed a closed engagement with the outer surface of the male luer tip 122 of the male luer 10. Thus, the flow passage 156 of the male connector 100 is not in fluid communication with the external environment.

In some embodiments, male connector 100 may be engaged with syringe 50, as shown in fig. 68. The syringe 50 and male connector 100 are shown adjacent to each other. The syringe may include a male connector 52, a plunger 58, a barrel 60, and a convenient finger-securing portion 62. The connector 52 may have an internally threaded sleeve 54 and a syringe luer tip 56. In the illustrated embodiment of the male connector 100, external threads 136 are provided on the outer surface of the second end 114 of the male connector 100.

Referring now to fig. 69, male connector 100 may be threadably engaged with syringe 50. Sleeve 54 may engage second end 114 of male connector 100 to connect male connector 100 to syringe 50. The barrel 60 of the injector 50 may be placed in communication with the flow passage 156 of the male connector 100.

Turning to fig. 70, the engagement structure shown in fig. 69 is shown in cross-section. Syringe 50 is threadably engaged with male connector 100 by engagement between sleeve 54 and external threads 136 of first cap 132. The luer tip 56 of the syringe 50 is inserted into the first cap 132. The barrel 60 of the injector may be in fluid communication with the flow channel 156 of the male connector 100. Fluid may flow through the valve member 116 and toward the luer tip 122 of the male connector 100. In the illustrated embodiment, fluid cannot flow out of the male connector 100 because the male connector 100 is in the closed configuration.

Referring to fig. 71, male connector 100 is shown positioned between syringe 50 and needle assembly 63 with cannula 70. Syringe 50, like the syringe of fig. 68, may include a male connector 52, a plunger 58, a barrel 60, and a convenient finger-securing portion 62. The connector 52 may further include an internally threaded sleeve 54 and a syringe luer tip 56. Needle assembly 63 may include a housing 66 having a protruding tab 64 at an engagement end and a needle 68.

Referring to FIG. 72, male connector 100 is shown in threaded engagement with syringe 50 and needle assembly 63. The external threads 136 of the first cap member 132 of the male connector 100 can engage the threaded sleeve 54 of the syringe 50. Thus, the luer tip 56 on the syringe 50 can be inserted into the luer receptacle 158 of the male connector 100. Similarly, the projecting tabs 64 on the needle assembly 63 can engage the internal threads 126 of the cannula 124 of the male connector 100. The luer tip 122 of the male connector 100 can be inserted into the housing 66 of the needle cannula.

Fig. 73 shows the engagement structure shown by the projection 72 in cross-section. Male connector 100 is engaged by syringe 50 and a needle with cannula 70. The syringe 50 is threadedly engaged with the external threads 136 of the first cap member 132 of the male connector 100. The needle assembly 63 is threadedly engaged with the internal threads 126 of the cannula 124 of the male connector 100.

The male connector 100 is engaged with the needle assembly 63. The housing 66 of the needle assembly 63 has a plurality of projecting tabs 64 near one end. The projecting tab 64 is capable of threadably engaging the internal threads 126 of the sleeve 124 of the male connector 100. As the luer tip 122 is advanced into the housing 66 of the needle assembly 63, the tabs 64 of the housing 66 can contact the support body 150 of the valve member 116. When needle assembly 63 is fully engaged with male connector 100, valve member 116 is moved a distance that separates closed end 144 from luer tip 122 sufficiently to allow fluid to flow out of port 162 of valve member 116. Fluid may then flow out of first end 112 of male connector 100 and into housing 66 of needle assembly 63. The hollow needle 68 can allow fluid to flow from within the housing 66 out the needle 68 tip. At this stage, the syringe 50 may be in fluid communication with the distal tip of the needle 68. As previously shown in fig. 69 and 70, in some embodiments, the male connector 100 may be in a closed configuration with no components engaged with the first end 112 of the male connector 100. The components shown in fig. 71-73 are needle assemblies, but other components may be used such as components that allow fluid flow and have female luer fitting portions.

Currently, certain potentially harmful drugs are dispensed in sealed vials. The medication is accessed by inserting the needle and drawing the medication into the syringe. Subsequently, the needle is withdrawn from the vial and the medication can be released. However, when the needle is inserted into the medicament to draw it into the syringe, the medicament is distributed over the outer surface of the needle which may inadvertently contact the skin and cause injury. In certain embodiments, a vial-fitting adapter of a vial may be pierced using a piercing system. In such vial adapter connectors, the drug is drawn through the mechanism and directly to the syringe or other medical injection device without the additional step of pulling the mechanism off the vial. Even with such vial adapter, there is still the possibility of potential drug remaining on the male end for withdrawal and subsequent injection of the drug or on the vial adapter after it can be separated from the male end.

With a closable medical connector of the type described herein, the flow of medication from the needled syringe is prevented except during the desired application. For example, in certain embodiments, a syringe with a male connector will not leak medication when the package is shipped, even if the package is vacuum sealed. Once the package is opened, the male connector may be engaged with a female connector, such as an IV tube, and dispense medication only when the connectors are engaged. The male connector may be disconnected from the female connector after the medication flows out of the syringe through the engaged connector and into the IV tubing. In some embodiments, the connectors may close upon disconnection, preventing excess fluid flow through the connectors. The mating end of the connector may be insulated from the medication so that residual medication does not flow onto the mating end after the connector is separated.

Fig. 74-77 illustrate another embodiment of a connector system 3000 that includes a male connector 3100 and a female connector 3400. Certain reference numerals relating to the components in fig. 74-77 are the same or similar to those previously described for the connector system 1000 and the corresponding male and female connectors 1100 and 1400 (e.g., male connector 3100 versus male connector 1100). It should be understood that these components may be functionally the same or similar to the components described above. The connector system 3000 of fig. 74-77 illustrates certain changes relative to the connector system 1000 of fig. 33-52. As with all embodiments described herein, it is contemplated that any feature, step, or structure described or illustrated in one or more embodiments may be used in addition to, or instead of, any feature, step, or structure of one or more other embodiments, as may be desired and adjusted.

In some embodiments, the male connector 3100 has a first end 3112 and a second end 3114. Male connector 3100 can have a tubular member 3187. The tubular member 3187 may have a closed end 3144 and an open end 3149. In some embodiments, both ends of tubular member 3187 are closed. In certain embodiments, such as embodiments that include other mechanisms for selectively closing the flow path on the first end, both ends of the tubular member 3187 may be open. The tubular member 3187 may have a generally cylindrical shape, an inner cross-section, an outer cross-section, and an axial centerline. In certain embodiments, one or more tapered and/or flared portions are formed along the axial length of the tubular member 3187. In certain embodiments, the tube 3187 has a generally rectangular prism shape, a generally triangular prism shape, a generally oval shape, a generally hexagonal prism shape, or any other shape suitable for a groove. The tubular member 3187 may include an internal flow path 3156 that extends between the closed end 3144 and the open end 3149 of the tubular member 3187. In certain embodiments, the inner flow channel 3156 may terminate at one or more ports 3162 near the closed end 3144. The one or more ports 3162 may extend from the inner flow passage 3156 through the wall of the tubular member 3187. In some embodiments, the internal flow passage 315 is in fluid communication with a conduit 1194.

In some embodiments, the male connector 3100 has a sleeve member 3163. The sleeve member 3163 may have a generally cylindrical shape, an inner cross-section, an outer cross-section, and an axial centerline. In some embodiments, sleeve member 3163 may be substantially coaxial with tubular member 3187. In certain embodiments, sleeve member 3163 may include one or more flared and/or tapered sections along its axial length. The inner cross-section of sleeve member 3163 may have a shape that is substantially the same as or similar to the outer cross-section of tube member 3187.

As shown in fig. 74, sleeve member 3163 may include a first sleeve portion 3165 generally adjacent the closed end of tubular member 3187 and a second sleeve portion 3164 spaced from the closed end of the tubular member and/or generally adjacent the end of tubular member 3187 opposite port 3162. In certain embodiments, the first sleeve portion 3165 is connected to the second sleeve portion 3164 by glue, sonic welding, solvent bonding, or other suitable attachment means. The first sleeve portion 3165 may be constructed of plastic or some other rigid or semi-rigid polymeric material. In some embodiments, the second sleeve portion 3164 may be constructed of a material that is less rigid or strong than the first sleeve portion 3165, such as rubber, silicone, or some other resilient, flexible, or semi-flexible material. In some embodiments, the first sleeve portion 3165 is constructed of a flexible or semi-flexible material. In some embodiments, the second sleeve portion 3164 is constructed of a rigid or semi-rigid material. In some embodiments, both the first sleeve portion 3165 and the second sleeve portion 3164 are constructed of a flexible material or a rigid material. The first sleeve portion 3165 can have a mating surface 3176 proximate the first end 3112 of the male connector 3100. In some embodiments, the tubular member 3187 has a mating surface 3146 of the mating surface 3176 of the first sleeve portion 3165.

The first sleeve portion 3165 may include one or more grooves on its inner wall (e.g., near the axial centerline of the sleeve portion 3163). In certain embodiments, at least one groove may be located near the closed end 3144 of the tube 3187 when the sleeve portion 3163 is in the closed position as shown in fig. 74. The seal 3119 may be at least partially received in the groove. In certain embodiments, seal 3119 may contact an outer surface of tubular member 3187 (e.g., away from an axial centerline of key 3187). In certain embodiments, contact between the seal 3119 and the tubing 3187 can create a circumferential seal around the tubing 3187. The seal may prevent fluid from contacting the mating surfaces 3146, 3176 of the male connector 3100 when the sleeve portion 3163 is in the closed position. In some embodiments, the seal 3119 may be located at least partially in a groove in an outer surface of the tubular member 3187 proximate the closed end 3144 of the tubular member 3187.

In certain embodiments, the second sleeve portion 3164 includes a flange 3189. The flange 3189 may be configured to engage a groove 3135 within the male housing 3123. In certain embodiments, the engagement between the flange 3189 and the groove 3135 may prevent the sleeve member 3163 from axially separating from the male housing 3123. In some embodiments, the portion of the sleeve member 3163 spaced from the first end 3112 of the male connector 3100 is connected to the male housing 3123 by glue, snap fit, solvent bond, sonic welding, or some other suitable attachment means.

In some embodiments, the female connector 3400 includes a resilient or flexible valve element 3416, a concave housing 3440, and a cap 3420. In the illustrated example, there is no internal tip, port or other rigid member within the valve element 3416 that supports the valve element 3416. As shown in fig. 75, the female connector 3400 may have a first end 3402 and a second end 3404 spaced apart from or opposite the first end 3402. The valve member 3416 can be configured to transition between an open configuration (e.g., as shown in fig. 77) and a closed configuration (e.g., as shown in fig. 75). In certain embodiments, the valve member 3416 is constructed of rubber, silicone, or some other flexible or semi-flexible material. In certain embodiments, the space between the valve member 3416 and the inner wall of the concave housing 3440 provides a flow chamber 3428.

As shown, the spacing or gap between the outer surface of the valve member 3416 and the inner surface of the housing 3440 may be large enough to provide high speed, low flow resistance in the region proximate the connection between the male and female connectors 3000, 3400. In some embodiments, the spacing between the outer surface of the valve member 3416 and the inner surface of the housing 3440 may be small enough to substantially eliminate or create only a small amount of dead space within the female connector 3400 (e.g., less than or substantially less than the cross-sectional width of the valve member 3416 near its closed end, or less than or substantially less than the cross-sectional width of the flow passage 3418 near the second end 3404). In some embodiments, the spacing between the outer and inner surfaces of the valve member 3416 can be adjusted or designed such that the amount of internal fluid in the female connector 3400 is about the same in both the open and closed positions to create a substantially neutral flow connector. As with all other disclosures herein, it is contemplated that this substantially neutral flow characteristic may be used in any of the other embodiments herein.

The valve element 3416 can include an elongated portion 3419. The elongated portion 3419 can have a substantially cylindrical shape, an axial centerline, an inner cross-section, and/or an outer cross-section. In certain embodiments, the elongated portion 3419 has a generally rectangular outer cross-section, a generally triangular outer cross-section, a generally oval outer cross-section, a generally hexagonal outer cross-section, any other suitable shape, or combinations thereof. In certain embodiments, the shape of the outer cross-section of the elongated portion 3419 varies along the axial centerline of the elongated portion 3419. The female housing 3440 can have an opening 3409 near the first end 3402 of the female connector 3402. The opening 3409 may have an inner cross-section. The inner cross-section of the opening 3409 may be sized and/or shaped to substantially match or correspond to the outer cross-section of the elongated portion 3419 of the valve member 3416. In certain such embodiments, contact between the outer cross-section of the elongated portion 3419 and the inner cross-section of the opening 3409 creates a substantially fluid-tight seal. Such a seal may prevent fluid from flowing between the flow cavity 3428 and the outer surface of the concave housing 3440 through the opening 3409 when the valve member 3416 is in the closed configuration.

The valve element 3416 may be resilient and/or may include a curved portion and/or an expanded portion 3415. In certain embodiments, the portion 3415 has a substantially cylindrical shape, an axial centerline, an inner cross-section, and/or an outer cross-section. In certain embodiments, portion 3415 includes one or more flared and/or tapered portions along its axial length. The portion 3415 may be divided into at least two regions by a plurality of axial openings and/or radial tangential openings within the portion 3415. For example, portion 3415 can have at least two axial voids forming at least two "legs" on portion 3415. In certain embodiments, the portion 3415 is free of openings or voids. In certain embodiments, the valve element 3416 includes a transition 3412 between the elongated portion 3419 and the portion 3415. The transition 3412 can be configured to affect the overall rigidity of the valve element 3416. For example, the transition 3412 may be shaped such that the transition 3412 creates a point or region of collapse for the valve element 3416 when the elongated portion 3419 is urged toward the portion 3415, as described in more detail below.

In certain embodiments, the portion 3415 can include a flange 3417. The flange 3417 may be configured to engage the channel 3445 within the female housing 3440. In certain embodiments, the engagement between the flange 3417 and the channel 3445 prevents the valve member 3416 from moving axially away from the female housing 3440 toward the first end of the female housing 3440. In certain embodiments, the female housing 3440 includes a tapered portion 3407. The tapered portion 3407 may help direct the elongated portion 3419 toward the opening 3409 as the valve element 3416 is transitioned from the open configuration to the closed configuration.

In some embodiments, the female connector 3400 may include one or more conduits or openings 3488. The conduit or opening 3488 can be in fluid communication with the flow lumen 3428. In some embodiments, the conduit is in fluid communication with a flow passage 1418 within the female connector 3400. In certain embodiments, the conduit or opening 3488 is in fluid communication with both the flow chamber 3428 and the flow passage 1418. The conduit or opening 3488 can pass through the concave housing 3440, the cap 3420, both the concave housing 3440 and the cap 3420, or neither.

The first end 3402 of the female connector 3400 may include one or more alignment structures. In certain embodiments, the one or more alignment structures may include protrusions, holes, indentations, or other surface structures. For example, the valve element 3416 may include an indentation 3490. The indentation 3490 may be sized and shaped to engage an alignment structure on the first end 3112 of the male connector 3100. In some embodiments, the indentation 3490 is sized and shaped to engage the protrusion 3147 on the tubular member 3187 of the male connector 3100. Also, the valve element 3416 may include a mating surface 3486 generally adjacent to the indentation 3490.

In certain embodiments, the concave housing 3440 includes one or more indentations 3490 a. The one or more indentations 3490a may be configured to detachably engage with the one or more protrusions 3147a on the first sleeve portion 3165. In some embodiments, the female housing includes an annular indent configured to detachably engage with an annular protrusion on the first sleeve portion 3165. The female housing 3440 may include a mating surface 3466 generally adjacent to the mating surface 3486 of the valve member 3416.

As shown in fig. 76-77, the female connector 3400 and the male connector 3100 may be mated with each other. In some embodiments, such engagement may cause the valve element 3416 to transition to the open configuration. At least a portion of the tube 3187 can be advanced into the female connector 3400 and push the elongated portion 3419 of the valve element 3416 toward the second end 3404 of the female connector 3400. Engagement between indentations 3490 on the tip of elongated portion 3419 and protrusion 3147 on tube 3187 can help prevent radial movement or deflection (e.g., deflection relative to the axial centerline of female connector 3400) as elongated portion 3419 is urged toward second end 3404 of female connector 3400.

Pressing the elongated portion toward the second end 3404 may cause the transition portion 3412 of the valve member 3416 to collapse. In certain embodiments, the collapse of the transitions 3412 and/or 3415 may result in opposing spring forces that may bias the elongated portions toward the closed configuration. For example, when the female connector 3400 and the male connector 3100 are separated (e.g., relatively withdrawn), the transition portion 3412 and or the portion 3415 may cause the elongated portion 3419 to remain in contact with the tubing 3187 until the valve element 3416 returns to the closed configuration. In some embodiments, the female housing 3440 is configured to wipe the outside of the elongated portion 3419 of the tube 3187 and the valve member 3416 when the female connector 3400 and the male connector 3100 are separated. In certain embodiments, the female connector 3400 may include a wiping surface, such as a narrow edge or a radially restricted O-ring, to wipe fluid off one or more sides inside or outside the connector.

In some embodiments, female connector 3400 may include an outlet 3430 that creates fluid communication between an interior of female connector 3400 and an exterior of female connector 3400. Vents 3430 can help prevent pressure from building within female connector 3400 when elongated portions 3419 are pushed toward second end 3404 of female connector 3400. In some embodiments, as shown, a portion of the outlet can be positioned on the housing in communication with an interior space at least partially surrounded or substantially surrounded by a portion of the valve element 3416.

The mating of the female connector 3400 and the male connector 3100 enables the mating surface 3466 of the female housing 3440 to contact the mating surface 3176 of the first sleeve portion 3165. The female housing 3440 can push the first sleeve portion 3165 toward the second end 3114 of the male connector 3100. Pushing the first sleeve portion 3165 toward the second end 3114 of the male connector 3100 can cause the second sleeve portion 3164 to collapse. In some embodiments, the collapsing of the second sleeve portion 3164 can cause a spring force within the second sleeve portion 3164 that biases the first sleeve portion 3165 toward the first end 3112 of the male connector 3100. Such a biasing force can help ensure that the first sleeve portion 3165 returns to the closed position when the male connector 3100 and the female connector 3400 are disconnected.

In some embodiments, one or more ports 3162 near the closed end 3144 of the tubing 3187 are withdrawn from the first sleeve portion 3165 when the first end 3402 of the female connector is moved toward the second end 3114 of the male connector. Withdrawal of the one or more ports 3162 from the first sleeve portion 3165 may create fluid communication between the luer receiver 1158 and the flow cavity 3428 within the female connector 3400. Fluid within the flow chamber 3428 can flow through one or more conduits or openings 3488 and through the flow passage 3418. In certain embodiments, mating of female connector 3400 with male connector 3100 may result in fluid communication between luer receiver 1158 and flow channel 3418. As shown in the example of fig. 77, the central mating interface between the male and female connectors in the fully open configuration may, in some embodiments, be located within the female connector and outside of the sleeve portion 3163 of the male connector.

Fig. 78-80 illustrate another embodiment of a connector system 4000 including a male connector 3100 and a female connector 4400. Some of the reference numbers for the components in fig. 78-80 are the same or similar to those previously described for connector system 3000 and the corresponding male connector 3100 and female connector 3400 (e.g., female connector 3400 versus female connector 4400). It is to be understood that the components may be functionally identical or similar to the previously described components. The connector system 4000 of fig. 78-80 illustrates certain modifications relative to the connector system 3000 of fig. 74-77.

As shown in fig. 78, the female connector 4400 may include a female housing 4400, a cap member 4420 and a valve member 4416. In some embodiments, the female connector has a first end 4402 and a second end 4404. The space between the inner wall of the concave housing 4400 and the outer surface of the valve member 4416 can define a cavity 4428. In some embodiments, the cap 4420 includes a flow passage 4418 extending from the second end 4404 through the cap 4420 toward the first end 4402. In certain embodiments, the valve member 4416 is configured to transition between an open configuration (as shown in fig. 80) and a closed configuration (as shown in fig. 78). The valve element 4416 may include an elongated portion 4419 having many or all of the same characteristics as the elongated portion 3419. In some embodiments, valve member 4416 includes an extension 4415. The portion 4415 may include one or more ports 4488. The port 4488 may be generally circular, generally rectangular, generally triangular, or any other suitable shape. In some embodiments, the port 4488 is open (e.g., a slot or groove) that opens when the valve member 4416 transitions from the closed configuration to the open configuration. A port 4488 may provide fluid communication between the chamber 4428 and the flow passage 4418.

In some embodiments, the female connector 4400 mates with the male connector 3100 in a similar manner as the female connector 3400. Accordingly, the performance of similar components of the female connector 4400 and the female connector 3400 may be the same or similar. Entry of the tube 3187 into the cavity 4428 of the female connector 4400 can push the elongated portion 4419 toward the second end 4404 of the female connector 4400. Movement of the elongated portion 4419 toward the second end 4404 of the female connector 4400 may cause the transition portion 4412 of the valve member 4416 to collapse. In some embodiments, movement of the elongate portion 4419 toward the second end 4404 of the female connector 4400 may cause the extension 4415 of the valve member 4416 to collapse, compress, or otherwise move the extension 4415 to open one or more ports 4488 on the extension. In some embodiments, one or more ports 4488 are open when extension 4415 is compressed and extension 4415 is uncompressed. Opening the one or more ports 4488 may create fluid communication between the chamber 4428 and the flow channel 4418. In some embodiments, mating between female connector 4400 and male connector 3400 may result in fluid communication between luer 1158 and flow channel 4418, as shown in fig. 80. In some embodiments, the area within the valve member 4416 into which fluid may flow may be sufficiently small or may be sufficiently compressed when in the closed configuration to substantially eliminate negative inflow or pressure into the connector when the connector is moved to the closed state.

Fig. 81-84 illustrate another embodiment of a connector system 5000, which includes a male connector 5100 and a female connector 5400. Some of the reference numbers for the components in fig. 81-84 are the same or similar to those previously described for connector system 20 and corresponding male and female connectors 100 and 400 (e.g., female connector 400 versus female connector 5400). It should be understood that the components or portions of the connector system 5000 may be functionally the same or similar to the components or portions described above. The connector system 5000 of fig. 81-84 illustrates certain variations with respect to the connector system 20 of fig. 1-32.

As shown in fig. 81, the male connector 5100 may have a first end 5112 and a second end 5114. The male connector 5100 may include a male housing 5123 generally proximate the first end 5112 and a cap 5132 generally proximate the second end 5114. The cap 5132 may be attached to the male housing 5123 by glue, sonic welding, solvent bonding, any other suitable adhesion means, or any combination thereof. In certain embodiments, the second end 5114 of the male connector 5100 includes a female luer fitting with external threads 5136. In certain embodiments, the second end 5114 includes a luer receptacle 5158.

In some embodiments, the first end 5112 of the male connector 5100 includes a male luer tip 5122. The male housing 5123 can include a sleeve 5124 that surrounds the male luer tip 5122. The sleeve 5124 may have internal threads 5126. The male luer tip 5122 and/or the cannula 5124 can be integral with the male housing 5123. In certain embodiments, the male luer tip 3122 and/or the cannula 5124 can be removed from the male housing 5123. The internal threads 5126 and luer tip 5122 may form a male luer engagement that conforms to ANSI specifications for a male connector. In certain embodiments, the internal threads 5126 and/or luer tip 5122 form a non-standard male luer engagement (e.g., it does not conform to ANSI specifications for a male connector). In certain embodiments, non-compliance may help reduce the likelihood of the male connector 5100 accidentally connecting with other connectors not designed to deliver the same type of medical fluid (e.g., potentially high risk medical fluids may be delivered using a non-standard connection). This may reduce the risk of accidental input of high-risk fluids through the connector or the accumulation of high-risk participation liquids at the outer end of the connector, thereby reducing the risk of exposing the patient and/or caregiver to dangerous and/or toxic substances used with the connector system 5000. As with all of the features described herein, non-standard (e.g., not ANSI-compliant) configurations may be used with any of the other embodiments described herein, including but not limited to connector systems 02, 1000, 3000, 4000, 5000, 6000, 7000, 8000, and 9000.

The valve member 5116 can be received within the male housing 5123 and/or the cap 5132. In some embodiments, the valve member 5116 has a closed end 5144 and an open end 5145. In some embodiments, both ends of the valve member 5116 are closed. In some embodiments, both ends of the valve member 5116 are opened. In certain embodiments, the valve member 5116 can have an axial centerline, an inner cross-section, and an outer cross-section. The valve member 5116 can be configured to transition between an open configuration (e.g., as shown in fig. 84) and a closed configuration (e.g., as shown in fig. 81 and 83).

The valve member 5116 can include a flow passage 5156. The flow passage 5156 may extend through both ends of the valve member 5116. In some embodiments, the flow passage 5156 extends from an opening at the open end 5145 of the valve member 5116 to one or more ports 5162 near the closed end 5144 of the valve member 5116. The male connector 5100 can include a seal 5119 configured to engage a groove in an interior surface of the male luer tip 5122 (e.g., proximate an axial centerline of the valve member 5116). The seal 5119 may be a flexible or semi-flexible O-ring or some other component suitable for providing a fluid seal. In some embodiments, the seal 5119 creates a fluid-tight seal around the outer cross-section of the valve member 5116 when the valve member 5116 is in the closed position as shown in fig. 81. The valve member 5116 may include a step 5149. In some embodiments, the step 5149 defines an axial location on the valve member 5116 where the outer cross-section of the valve member 5116 decreases. The reduced outer cross-sectional portion of the valve member 5116 can define an annular cavity 5163 between the outer cross-section of the valve member 5116 and the inner surface of the male luer tip 5122. The annular cavity 5163 may be defined axially between the step 5149 and the seal 5119.

In some embodiments, the valve member 5116 can include one or more support bodies 5150. The support body 5150 may be a separate piece connected to the valve 5116. In certain embodiments, the support body 5150 and the valve 5116 form a single piece. The support body 5150 and/or the valve member 5116 can include one or more alignment features. The alignment feature may be a protrusion, an indentation, a groove, or any other suitable feature or combination of features. For example, the valve member 5116 can include an indent 5147. Also, the support body 5150 may include one or more protrusions 5147 a. In certain embodiments, the valve member 5116 can include a mating surface 5146 generally adjacent to the indent 5147. Additionally, in certain embodiments, the seal 5119 includes a mating surface 5176 that is generally adjacent to the mating surface 5146 of the valve member 5116.

In some embodiments, the male connector 5100 may include a resilient member 5118. The resilient member 5118 may be housed within the male housing 5123 and/or the cap 5132. In some embodiments, the resilient member 5118 is constructed of rubber, silicone, some other flexible/semi-flexible material, or some combination thereof. The resilient member 5118 may include a connection structure, such as a flange 5115, configured to allow the resilient member to be connected to the male housing 5123 and/or the cap 5132. The flange 5115 can be configured to fit within a receiving structure, such as a groove 5169, formed on the inner wall of the male housing 5123 and/or the cap 5132. The engagement between the flange 5115 and the groove 5169 can prevent the portion of the resilient member 5118 adjacent the source 5115 from moving axially.

In some embodiments, the resilient member 5118 includes a first portion 5113 that extends axially from the flange 5115 toward the first end 5112 of the male connector 5100. In some embodiments, the resilient member 5118 includes a second portion 5117 that extends axially from the flange 5115 toward the second end 5114 of the male connector 5100. The first portion 5113 and/or the second portion 5117 can have a generally cylindrical shape. In certain embodiments, first portion 5113 and/or second portion 5117 are formed from a set of O-rings interconnected by a flexible or semi-flexible material portion. In certain embodiments, first portion 5113 and/or second portion 5117 is constructed of flexible and/or semi-flexible material portions having a uniform thickness along their axial length. In certain embodiments, the thickness of the first portion 5113 and/or the second portion 5117 varies along the axial length of the first portion 5113 and/or the second portion 5117.

In some embodiments, the valve element 5116 includes one or more stop ribs 5142. One or more of the stopping protrusions 5142 may be configured to prevent the axial end of the first portion 5113 of the elastic member 5118 from being radially displaced. In some embodiments, the open end 5145 of the valve member 5116 can extend into the cap member 5132. In some embodiments, the second portion 5117 of the resilient member 5118 can be configured to fit closely, snugly, or intimately about the open end 5145 of the valve member 5116. In some embodiments, the end of the second portion 5117 furthest from the flange 5115 can form a sealing stop around the open end 5145 of the valve member 5116.

In some embodiments, the end of the second portion 5117 of the resilient member 5118 furthest from the flange 5115 can have a soft, resilient or flared portion 5111. The portion 5111 may be configured to plug the luer receptacle 5158 and substantially seal the second end 5114 of the male connector 5100. In certain embodiments, the portion 5111 includes a valve. The valve may include, for example, one or more slits, one or more apertures, or any combination thereof. In certain embodiments, the valve within the portion 5111 is normally closed. In certain embodiments, the valve within the portion 5111 is normally open and biased closed by engagement between the portion 5111 and the luer receptacle 5158. In some embodiments, the portion 5111 can be configured to allow the open end 5145 of the valve member 5116 to pass through the valve within the portion 5111. According to some configurations, the portion 5111 is generally aligned with and substantially completely fills the second end 5144 of the male connector 5100. In some embodiments, the portion 5111 extends beyond the second end 5144 of the male connector 5100. In some embodiments, portion 5111 is swappable.

As shown in fig. 82, the female connector 5400 can have a first end 5402 and a second end 5404. In some embodiments, the female connector includes a female housing 5440 and a cap 5481. The cap 5481 can be attached to the female housing 5440 by a snap connection, glue, sonic welding, solvent bonding, other suitable attachment methods, or any combination thereof. The cap 5481 can include a male luer 5485 at the second end 5404 of the female connector 5400. In some embodiments, the cap 5481 includes a flow passage 5418 extending from the second end of the female connector 5400 toward the interior of the female housing 5440. The female housing 5440 can include a female luer engagement 5446 at the first end 5402 of the female connector 5400. Additionally, the female luer engagement portion 5446 may include an alignment portion. The alignment feature may be one or more indentations 5490 a. The indents 5490a are configured to releasably engage with one or more protrusions 5147a on the support body 5150, as shown in fig. 83.

In some embodiments, female connector 5400 includes a hose piece 5487. Hose piece 5487 can have a generally cylindrical shape, an inner cross-section, an outer cross-section, an axial centerline, one or more flared portions, and/or one or more tapered portions. The tube 5487 can be received in the female housing 5440 and/or the cap 5481. The tube 5487 can have a closed end and an open end. In some embodiments, the closed end is generally proximate to the first end 5402 of the female connector 5400. The closed end of key 5487 may include an alignment feature. In some embodiments, the alignment feature on tube 5487 is a protrusion 5490. The projection 5490 can be configured to detachably engage with the indent 5147 on the valve element 5116 of the male connector 5100. In some embodiments, both ends of the tube 5487 are closed. In some embodiments, the tube includes an extension 5489. The extension 5489 can be configured to affect the overall rigidity of the tube 5487. For example, the width of the extension 5489 can affect the amount of force required to axially displace the closed end of the tube 5487.

In certain embodiments, the tubing 5487 can define a fluid conduit 5480. The fluid conduit 5480 can extend from an open end of the tube 5487 to a closed end of the tube 5487. In certain embodiments, the tube 5487 includes one or more ports 5488 near the closed end of the tube 5487. The fluid conduit 5480 can extend from the open end of the tubing to the one or more ports 5488. Fluid conduit 5480 can be in fluid communication with flow channel 5418. In certain embodiments, tube 5487 includes one or more joints, such as, for example, flange 5483. The flange 5483 can be configured to engage with a receptacle within the cap 5481 and/or the female housing 5440. The receiving portion may be, for example, a slot 5443 in the cap 5481. The engagement between the flange 5483 and the groove 5443 can inhibit the tube 5487 from moving away from the female connector 5400. In some embodiments, the engagement between the flange 5483 and the slot 5443 helps secure the open end of the tube 5487 and helps prevent the open end of the tube 5487 from moving toward the first end 5402 of the female connector 5400.

In certain embodiments, the female connector 5400 can include a compressible seal 5460. Compressible seal 5460 may include a sealing portion 5462 and a compressible portion 5464. In some embodiments, the seal 5460 is constructed of plastic or some other rigid and/or semi-rigid polymer. In certain embodiments, the seal 5460 is constructed of rubber, silicone, some other flexible or semi-flexible material, or some combination thereof. The sealing portion 5462 may have a generally cylindrical shape, an inner cross-section, and an outer cross-section. The inner cross-section of the sealing portion 5462 may be substantially equal to the outer cross-section of the tube 5487. In some embodiments, the sealing portion 5462 has an inner cross-section substantially equal to an outer cross-section of the tube 5487 near the first end 5402 of the female connector 5400. In certain embodiments, engagement between the closed end of the tube 5487 and the seal 5462 can substantially seal the one or more ports 5488.

In certain embodiments, compressible portion 5464 is a compression spring. In certain embodiments, compressible portion 5464 is a rigid compressible tube (e.g., rubber tube), a braided compressible tube, or any other suitable compressible shape and material. The sealing portion 5462 may include a stop feature such as, for example, an annular ridge 5467. In certain embodiments, the inner wall 5449 of the concave housing 5440 and the annular ridge 5467 prevent radial movement of the compressible portion 5464. In certain embodiments, the cap 5481 can include a stop feature such as, for example, an annular ridge 5477. Annular ridge 5477 and inner wall 5449 prevent radial movement of compressible portion 5464. In certain embodiments, the sealing portion 5463 may include a stop 5468, such as, for example, a shoulder. The stop 5468 can engage the female housing 5440 and can limit movement of the sealing portion 5462 toward the first end 5402 of the female connector 5400.

As shown in fig. 83-84, the female connector 5400 can be configured to mate with the male connector 5100. As shown in fig. 83, the male connector 5100 may be configured such that the male luer tip 5122 contacts the sealing portion 5462 of the compressible seal 5460 before the support body 5150 contacts the female luer engagement portion 5446. In some configurations, at least a portion of the male luer tip 5122 can be advanced into the female connector 5400. Advancing the male luer tip 5122 into the female connector 5400 can cause the compressible seal 5460 to move toward the second end 5404 of the female connector 5400.

When the female connector 5400 is mated with the male connector 5100, the indent 5147 of the closed end 5144 of the valve member 5116 can engage the protrusion 5490 on the closed end of the hose piece 5487. In some embodiments, the closed end 5144 of the valve member 5116 can be moved into the female connector 5400 when the male connector 5100 is mated with the female connector 5400. For example, the closed end 5144 of the valve member 5116 can enter the female connector at the same rate that the male luer tip 5122 enters the female connector before the support body 5150 contacts the female luer engagement portion 5446. Movement of the closed end 5144 of the valve member 5116 into the female connector can cause the extension 5489 of the hose member 5487 to compress. Compression of the extension 5489 can generate a spring force within the extension 5489 that can bias the closed end of the hose piece 5487 toward the first end 5402 of the female connector 5400. In some embodiments, the biasing force of the extension 5489 can help ensure that the indent 5147 of the closed end 5144 of the valve member 5116 remains engaged with the protrusion 5490 on the closed end of the hose member 5487 as the male luer tip 5122 is advanced toward the second end 5404 of the female connector 5400. This continued engagement between the closed end of the hose member 5487 and the closed end 5144 of the valve member 5116 prevents fluid from contacting the mating surfaces 5176, 5466 of the valve member 5116 and hose member 5487, respectively.

In some embodiments, the compression spring rate of the hose piece 5487 is less than the compression spring rate of the first portion 5113 of the resilient member 5118. For example, the amount of axial force required to push the valve member 5116 toward the second end 5114 of the male connector (e.g., a force generally parallel to the axial centerline of the valve member 5116) can be greater than the amount of axial force required to push the closed end of the hose piece 5487 toward the second end 5404 of the female connector 5400.

In certain embodiments, the male luer tip 5122 and the valve element 5116 push the closed ends of the sealing member 5460 and the hose element 5487, respectively, toward the second end of the female connector 5400 until the one or more protrusions 5147a of the support body 5150 engage the one or more indents 5490a on the female luer engagement portion 5446. When the one or more protrusions 5147a and the one or more indentations 5490a engage one another, the valve member 5116 may be inhibited from moving further toward the second end 5404 of the female connector 5400. The male luer tip 5122 may continue to move into the female connector 5400 and push the compressible seal 5460 toward the second end 5404 of the female connector 5400. Further forward movement of the male luer tip 5122 and the compressible seal 5460 relative to the flexible key 5487 toward the second end 5404 can cause the closed end of the hose piece 5487 to move at least partially into the annular cavity 5163 within the male luer tip 5122.

In some embodiments, further advancement of the male luer tip 5122 into the female connector 5400 can cause the male housing 5123 to move toward the second end 5404 of the female connector 5400 relative to the closed end 5144 of the valve member 5116. Movement of the male housing 5123 relative to the valve member 5116 toward the second end 5404 of the female housing 5044 causes the first portion 5113 of the resilient member 5118 to compress. Compression of the first portion 5113 may result in a spring force that biases the valve member 5116 toward the first end 5112 of the male connector 5100. Such a biasing force can help ensure that the indent 5147 of the closed end 5144 of the valve member 5116 remains engaged with the protrusion 5490 on the closed end of the hose member 5487 as the male luer tip 5122 is advanced toward the second end 5404 of the female connector 5400.

In some embodiments, the seal 5119 is withdrawn from the one or more ports 5162 of the valve member 5116 as the male luer tip 5122 is advanced relative to the valve member 5116 toward the second end 5404 of the female connector 5400, thereby causing fluid communication between the flow passage 5156 and the annular cavity 5163 via the one or more ports 5162. Also, in some embodiments, entry of the closed end of the hose piece 5487 into the annular cavity 5163 can withdraw the sealing portion 5462 of the compressible seal 5460 from the one or more ports 5488. The passage of one or more ports 5488 into the annular cavity 5163 may create fluid communication between the fluid conduit 5480 and the annular cavity 5163.

According to some configurations, movement of the male connector 5100 toward the female connector 5400 after the support body 5150 contacts the female luer engagement portion 5446 may cause the open end 5145 of the valve member 5116 to move toward the second end 5144 of the male connector 5400 relative to the cap member 5132. In some embodiments, the valve member 5116 has an axial length such that the open end 5145 passes the second end 5144 of the male connector 5100 when the male connector 5100 is fully connected with the female connector 5400 (e.g., when the internal threads 5126 of the male connector 5100 are fully engaged with the female luer engagement portion 5446). In some embodiments, when the male connector 5100 and the female connector 5400 are fully connected to each other, the open end 5145 of the valve member 5116 passes through the valve on the portion 5111 of the resilient member 5118.

As shown in fig. 84, the valve member 5116 may have an axial length such that the open end 5145 is retained within the male connector 5100 when the male connector 5100 is fully engaged with the female connector 5400. In some embodiments, the resilient member 5118 is configured such that when the male luer tip 5052 is advanced into the luer receptacle 5158, the valve on the portion 5111 is opened and the portion 5111 is withdrawn from the open end 5145 of the valve member 5116. In some embodiments, when the male connector 5100 and the female connector 5400 are fully connected as shown in fig. 84 and the male luer tip 5052 is advanced into the luer receptacle 5158, the interior of the male luer tip 5052 is placed in fluid communication with the flow passage 5418 of the female connector 5400 via the flow passage 5156, the one or more ports 5162, the annular cavity 5163, and the one or more ports 5488 and fluid conduit 5480.

In some embodiments, the portion 5111 withdraws the second portion 5117 of the compressible resilient member 5118 from the open end 5145 of the valve member 5116. Compression of the second portion 5117 may generate a spring force within the second portion 5117. Such a spring force may bias the portion 5111 toward the second end 5114 such that the portion 5111 moves back toward the second end 5114 of the male connector 5100 as the male luer tip 5052 is withdrawn from the male connector 5100. The second end 5114 of the portion 5111 back-line male connector 5100 may cause the valve on the portion 5111 to close.

Fig. 85-87 illustrate another embodiment of a connector system 6000 including a male connector 6100 and a female connector 5400. Certain reference numbers relating to the components in fig. 85-87 are the same or similar to the reference numbers described above for the connector system 5000 and the corresponding male and female connectors 5100, 5400 (e.g., male connector 5100 versus male connector 6100). It should be understood that the components or portions of the connector system 6000 may be identical or similar in function to the components or portions described above. The connector system 6000 of fig. 85-87 illustrates certain changes relative to the connector system 5000 of fig. 81-84.

In some embodiments, the male connector 6100 can include a spring 6118. The resilient member 6118 may include an attachment structure such as, for example, an annular flange 6115. The flange 6115 can be configured to fit in a receiving structure, such as a slot 6169, for example. In certain embodiments, the slot 6169 may be formed by two annular ridges on the inner wall of the male housing 6123. In certain embodiments, the slot 6169 can be a slot cut into the inner wall of the male housing 6123. In some embodiments, the containment structure may be a series of raised ridges similar to the hold-down tabs 2171, 2173. Male connector 6100 is sold by Carefusion corporationCertain aspects of the closure male luer connector are representative, with additions and modifications. Male connector 6100 is used with female connector 5400 as shown in this example, but any female connector described herein or any component thereof or any other suitable femaleThe connector may also be used with a male connector 6100.

In certain embodiments, the elastic member 6118 includes an end portion 6111. In certain embodiments, the male connector 6100 includes a valve member 6116. The valve member 6116 may have an open end 6145 and a closed end 6144. In certain embodiments, the end 6111 is configured to fit tightly, or tightly around the open end 6154 of the valve member 6116. The end 6111 can include a valve. The valve may be, for example, one or more slits, one or more small openings, or any combination thereof. In certain embodiments, the valve is normally closed. The end 6111 and valve can be configured to allow the open end 6145 of the valve member 6116 to pass through the valve.

As shown in fig. 87, the valve member 6116 can be configured such that the open end 6145 of the valve member 6116 moves toward the second end 6114 of the male connector 6100 forward relative to the resilient member 6118 when the male connector 6100 and the female connector 5400 are fully connected (e.g., when the internal threads 6162 are fully engaged with the female luer portion 5446 of the female connector 5400). Advancement of the open end 6145 of the valve member 6116 may cause the open end 6145 to open and pass the valve at end 6111. In some configurations, the luer receiver 6158 may be in fluid communication with the flow channel 5158, as shown in fig. 87. In certain embodiments, the movement of the open end 6145 of the valve member 6116 back toward the first end 6112 of the male connector 6100 may cause the open end 6145 to move back past the valve at end 6111. In certain such embodiments, the valve at end 6111 can return to a closed position when the open end 6145 moves back past the valve toward the first end 6112 of the male connector 6100.

Fig. 88-89 illustrate another embodiment of a connector system 7000 that includes a male connector 7100 and a female connector 2400. Some of the reference numbers for the components in fig. 88-89 are the same or similar to those previously described with respect to the connector system 2000 and corresponding male and female connectors 2100, 2400 (e.g., male connector 7100 versus male connector 2100). It should be understood that the component parts or portions of the connector system 7000 may be identical or similar in function to the component parts or portions described above. The connector system 7000 of fig. 88-89 illustrates certain variations from the connector system 2000 of fig. 53-65.

The male connector 7100 can include a first end 7112 and a second end 7114. The male connector 7100 may include a cap 7132 and a male housing 7123. The cap 7132 may be secured to the male housing 7123 by glue, sonic welding, solvent bonding, snap connections, other suitable attachment structures or means, or combinations thereof. The second end 7114 of the male connector 7100 may include a female luer connector. The female luer fitting may include external threads 7136. In certain embodiments, the female luer fitting includes a luer receiving port 7158. The luer receiving port 7158 may include an inner cross-section. The male connector 7100 can include one or more occlusive structures that selectively seal the receiving port 7158. In certain embodiments, the occlusive structure is capable of transitioning between a sealed configuration and an open configuration.

In certain embodiments, the occlusive structure may be an elastomeric seal 7185. The resilient seal 7185 may include a sealing portion 7111 proximate the second end 7114 of the male connector 7100. The sealing portion 7111 may substantially plug the inner cross-section of the luer receiving port 7158. In certain embodiments, the seal 7111 can comprise a valve. The valve may be, for example, one or more slits, one or more pinholes, or any combination thereof. In certain embodiments, the valve within the seal 7111 is normally closed. In certain embodiments, the valve within the seal 7111 is normally open and biased closed due to engagement between the seal 7111 and the luer receiving port 7158. The resilient seal 7158 may be configured to transition between an open configuration (e.g., when a valve within the seal portion 7111 is opened as shown in fig. 89) and a closed configuration (e.g., when a valve within the seal portion 7111 is closed as shown in fig. 88).

In some embodiments, the resilient seal 7185 includes a stop portion 7115. The stop portion 7115 may be an annular projection, one or more radial projections, an annular flange, or any other suitable structure or combination of structures. In some embodiments, the retaining portion 7115 is configured to engage a retaining structure 7169 on the cap 7123. The retention structure 7169 may be a tapered portion, an inwardly projecting structure (e.g., a flange or set of flange portions), or any other structure suitable for retaining the retention portion 7115 of the elastomeric seal 7185. In some embodiments, the engagement between the retaining portion 7115 and the retaining structure 7169 prevents the resilient seal 7185 from moving out of the cap 7132. In some embodiments, the engagement between the retention portion 7115 and the retention feature 7169 helps to maintain the sealing portion 7111 in a fixed axial position when the resilient seal 7815 is in the closed configuration.

In some embodiments, the male connector 7100 includes a channel member 7157. The channel member 7157 may be at least partially housed within a resilient seal 7185. In certain embodiments, the channel member 7157 can include a connecting portion 7168 configured to connect the channel member 7157 to the cap member 7132. In certain embodiments, the connecting portion 7168 is an annular protrusion configured to engage an engagement structure 7167 on the cap 7132. The engagement formation may be an annular groove. In certain embodiments, the channel piece 7157 may be attached to the cap piece 7132 by a snap connection, glue, solvent bonding, sonic welding, other suitable attachment means, or any combination thereof. In certain embodiments, the channel piece 7157 may be secured to the male housing 7123 by a snap connection, glue, solvent bonding, sonic welding, other suitable attachment means, or any combination thereof.

The channel member 7157 may define a tubing 7194. The tubing 7194 may extend through the channel member 7157. In some embodiments, the channel member 7157 has a closed end 7145 and an open end. The channel member 7157 may have one or more ports 7163 proximate the closed end 7145. In some embodiments, the tubing 7194 extends from the open end of the channel member 7157 to one or more ports 7163. In certain embodiments, the tubing 7194 is in fluid communication with the flow channel 7156 in the male housing 7123. In certain embodiments, the resilient seal 7185 is configured to prevent fluid from exiting the tubing 7194 through the one or more ports 7163 when the resilient member 7185 is in the closed configuration.

The first end 7112 of the male connector 7100 can be configured to mate with the first end 2402 of the female connector 2100 in the same or similar manner as the male connector 2100. In certain embodiments, the luer receiving port 7158 may be configured to receive a male luer tip 7052. The sealing portion 7111 of the resilient seal 7185 may be configured to be withdrawn from one or more ports 7163 near the closed end 7145 of the channel piece 7157 as the male luer tip 7052 is advanced into the luer receiving port 7158. Withdrawing the seal 7111 from one or more ports 7163 can create a spring force in the resilient seal 7185. Such spring force may bias the sealing portion 7111 toward the second end 7114 of the male connector 7100 such that the resilient seal 7185 returns to the closed configuration when the male luer tip 7052 is withdrawn from the male connector 7100. Additionally, the extraction of the sealing portion 7111 from one or more ports 7163 can place the interior of the male luer tip 7052 in fluid communication with the flow passages 1418 of the female connector 2400 when the male connector 7100 is fully mated with the female connector 2400 as shown in fig. 89.

A second end 7114 similar or identical to the second end shown in fig. 88 (e.g., the second end including the resilient seal 7185 and the channel member 7157) may be used in combination with any of the male connectors 100, 1100, 2100, 3100, 5100, 6100, 8100, 9100 described herein. The connector system 7000 in the illustrated example or modified can provide connectors (e.g., a male connector and a female connector) that are sealed at a plurality of openings.

Fig. 90-93 illustrate another embodiment of a connector system 8000 that includes a male connector 8100 and a female connector 8400. Certain reference numerals relating to the components in fig. 90-93 are the same as or similar to those described above for the connector system 2000 and the corresponding male and female connectors 2100, 2400 (e.g., male connector 9100 versus male connector 2100). It should be understood that the components or portions of the connector system 8000 may be functionally identical or similar to the components or portions described above. The connector system 8000 of fig. 90-93 illustrates certain variations with respect to the connector system 2000 of fig. 53-65.

As shown in fig. 90, male connector 8100 may have a first end 8112 and a second end 8114. The male connector 8100 can include a first cap 8132 and a second cap 8134. The first cap 8132 may be proximate the second end 8114 and may be connected with the second cap 8134 by glue, sonic welding, solvent bonding, snap fit, other suitable attachment features or means, or some combination thereof. In certain embodiments, the first cap 8132 and the second cap 8134 form a single piece. The male connector 8100 may include a male housing 8123 configured to connect with the second cap 8134 by glue, sonic welding, solvent bonding, snap fit, other suitable attachment features or means, or some combination thereof. The male housing 8123 may include a sleeve 2124. In some embodiments, the male connector 8100 has one or more engagement elements, such as, for example, one or more tabs 2125 with hooks 2127.

In some embodiments, the male connector 8100 includes a male luer tip 8122. The male luer tip 8122 may have a first tip portion 8122a that is connected to a second tip portion 8122b by glue, sonic welding, solvent bonding, snap fitting, other suitable attachment features or means, or combinations thereof. In certain embodiments, the first tip portion 8122a and the second tip portion 8122b form a unitary piece. The male luer tip 8122 may be housed in the sleeve 2124 in some embodiments. In some embodiments, the male luer tip 8122 extends at the sleeve 2124 toward the first end 8112 of the male connector 8100.

In some configurations, the male connector 8110 may include a valve element 8116. The valve element 8116 may have a generally cylindrical shape, an axial centerline, an axial length, an inner cross-section, and/or an outer cross-section. In certain embodiments, the valve element 8116 is configured to transition between a closed configuration (e.g., as shown in fig. 90) and an open configuration (e.g., as shown in fig. 93). The valve element 8116 may be at least partially received in the male luer tip 8122. The valve element 8116 may have a closed end and an open end. In some embodiments, the open end of the valve element 8116 is on the end of the valve element 8116 closest to the second end 8114 of the male connector. In some embodiments, the valve member has two closed ends. In some embodiments, the valve member has two open ends. In certain embodiments, as shown in fig. 90, the closed end of the valve member 8116 has a mating surface 8146. The mating face 8146 may be sized and shaped to engage the mating face 8486 on the female connector 8400 in a manner that forms a tight flow-blocking interface. For example, the mating face 8146 may include one or more alignment features, such as, for example, one or more protrusions or indentations. In certain embodiments, the mating face 8146 has a non-planar shape (e.g., a convex shape, a concave shape, or a shape having a plurality of recesses and/or a plurality of projections) that is configured to substantially match, conform to, or correspond to another non-planar shape on the mating face 8486 of the female connector 8400. In certain embodiments, either or both of the mating, compliant, or corresponding surfaces 8146, 8486 may extend substantially beyond the movable or penetrable front outer surface of the valve member that is exposed to the environment when the connector is closed.

The valve element 8116 may include a flow passage 8156. The valve element 8116 may include one or more ports 8162 proximate the closed end of the valve element 8116. In certain embodiments, the flow passage 8156 extends between one or more ports 8162 and the open end of the valve element 8116. In certain variations, the male luer tip 8122 may include a luer tip seal 8119. The luer tip seal 8119 may be sized to fit around the outer cross-section of the valve element 8116. In certain embodiments, the luer tip seal 8119 is a soft O-ring or some other suitable member for providing a fluid-tight seal. The valve element 8116 may include a seal 8120. The seal may be a flexible O-ring or some other suitable member for providing a fluid tight seal. The seal 8120 may be configured as a surface structure that engages an outer cross-sectional surface of the valve member 8116. For example, the outer surface of the valve member 8116 may include an annular groove 8169. Seal 8120 may be sized to engage annular groove 8169. In certain embodiments, the seal 8120 is configured to engage an inner cross-section of the male luer tip 8122 to create a substantially fluid-tight seal. In certain embodiments, the engagement between the seal 8120 and the inner cross-section of the male luer tip 8122 can inhibit fluid from leaking past the seal 8120 in either axial direction.

Voids (e.g., annular void 8163 as shown in fig. 90) in the inner cross-section of the male luer tip 8122, the outer cross-section of the valve element 8116, the luer tip seal 8119, and the seal 8120 can facilitate fluid communication between the flow passage 8156 and the female connector 8400 when the valve element 8116 is in the open configuration. In certain embodiments, the volume of the annular gap 8163 may be a function of the axial translation of the valve member 8116. The seal 8120 may be configured to wipe against the inner cross-section of the male luer tip 8122 as the valve element 8116 moves axially. In certain embodiments, the luer tip seal 8119 prevents fluid from leaking from the annular gap 8163 to the outer surface of the male luer tip 8122 when the valve member 8116 is in the closed configuration.

In certain embodiments, male connector 8100 includes a plunger 8170. The plunger 8170 may have a generally cylindrical shape, an inner cross-section, an outer cross-section, an axial centerline, and an axial length. In certain embodiments, the plunger 8170 includes a conduit 8194. The conduit 8194 can extend through the axial length of the plunger 8170. In certain embodiments, the flow passage 8156 has a cross-section defined by an inner cross-section of the valve element 8116. The inner cross-section of the valve member 8116 can be configured to substantially conform to the outer cross-section of the plunger 8170. In certain embodiments, the plunger 8170 may include a seal, such as, for example, an O-ring 8160. The O-ring 8160 may be configured to engage surface structures on the outer cross-section of the plunger 8170. For example, O-ring 8160 may be configured to engage annular groove 8169. In certain embodiments, the O-ring 8160 is configured to engage an inner cross-section of the valve element 8116 to form a substantially fluid-tight seal. The O-ring 8160 may be configured to prevent fluid flow through the open end of the valve element 8116 bypassing the conduit 8194.

The male connector 8100 may include a resilient or flexible cap 8118. In some embodiments, the resilient member 8118 may be a soft sleeve configured to wrap the outer cross-section of the valve member 8116. The resilient member 8118 may include a first anchor portion 8113. The first anchor portion 8113 may be configured to engage a hole 8167 in the first tip portion 8122a and/or the second tip portion 8122 b. In certain embodiments, the resilient member 8118 may include a second anchor portion 8117. The second anchor portion 8117 may be an annular ring configured to engage a shoulder 8171 on the valve member 8116. In certain embodiments, elastic member 8118 includes a resilient portion 8115. The resilient portion 8115 may be connected to the first anchor portion 8113 and/or the second anchor portion 8117.

The female connector 8400 may be substantially equal to or similar to the female connector 2400. The female connector 8400 can have a first end 8402 and a second end 8404. In certain embodiments, the female connector 8400 includes a female housing 8440 generally proximate to the first end 8402 of the female connector 8400. The female housing 8440 may have a generally cylindrical shape, an inner cross-section, an outer cross-section, an axial center, and an axial length. In certain embodiments, the female housing 8440 includes a groove 8444 proximate the first end 8402 of the female connector 8400. In certain embodiments, groove 8444 is annular. In certain embodiments, groove 8444 comprises a plurality of semi-annular groove segments.

In certain embodiments, the female connector 8400 includes a fluid line portion 8480. The fluid line portion 8480 may be configured to connect to the female housing 8440 near the second end 8404 of the female connector 8400. In certain embodiments, the fluid conduit portion 8480 and the concave housing 8440 can form a single piece. The fluid line portion 8480 may include a tube 8487 having a generally cylindrical shape, an inner cross-section, an outer cross-section, an axial centerline, and an axial length. In certain embodiments, the tube 8487 has one or more tapered, flared, and/or stepped portions along its axial length. In some configurations, the axial length of the tube 8487 can be approximately equal to the axial length of the concave housing 8440. In certain embodiments, the axial length of the tube 8487 is greater than or equal to about 75% of the axial length of the female housing 8440 and/or less than or equal to about 125% of the axial length of the female housing 8440. In certain embodiments, the axial length of the tube 8487 is about at least about 85% of the axial length of the 85% concave housing 8440. As shown, the axial length of the tube 8487 can be greater than the axial length of the female housing 8440. In certain embodiments, the tube 8487 has a mating surface 8486 proximate to the first end 8402 of the female connector 8400. The mating surface 8486 may include one or more mating structures. For example, the mating face can have one or more protrusions and/or indentations configured to engage with one or more protrusions and/or indentations on the first end 8112 of the male connector 8100. In certain embodiments, the mating surface 8486 has a concave shape to correspond to the convex shape of the mating surface 8146.

The tube 8487 can include one or more ports 8488 near the first end 8402 of the concave housing 8440. In certain embodiments, the tube 8487 and/or the fluid conduit portion 8480 may define a flow passage 8418. The flow passages 8418 can extend from the one or more ports 8488 to a second end 8404 of the female connector 8400.

The female connector 8400 may include a seal 8460. The seal may have a generally cylindrical shape, an inner cross-section, an outer cross-section, an axial centerline, and an axial length. In certain embodiments, the axial length of the seal 8460 is approximately equal to the axial length of the female housing 8440. The seal 8460 may be configured to transition between an open configuration (e.g., as shown in fig. 93) and a closed configuration (e.g., as shown in fig. 91). In certain embodiments, the seal 8460 is configured to be at least partially located in the female housing 8440. The seal 8460 may include a shoulder 8468 configured to engage with the female housing 8440 and retain the seal 8460 within the female housing 8440. The seal 8460 may include a seal portion 8462 near the first end 8402 of the female connector 8400. The inner cross-sectional size and/or shape of the seal 8462 may be configured to match or substantially correspond to the size and/or shape of the outer cross-section of the tube 8487. In certain embodiments, the seal 8462 is configured to prevent fluid flow through the one or more ports 8488 when the seal 1460 is in the closed configuration.

In certain embodiments, as shown, the outer cross-sectional width or outer diameter of the tube 8487 may be substantial. For example, as shown, the area of the proximal mating surface 8486 of the tube 8487 that is exposed when the female connector 8400 is closed (or within the seal 8460) may comprise a majority or an approximate majority of the area that is within and defined by the outer perimeter of the proximal end 8466 of the seal 8460. In some embodiments, as shown, the cross-sectional width of the proximal mating surface 8486 of the tube 8487 that is exposed when the female connector 8400 is closed (or within the seal 8460) can be about half, or approximately about half, of the proximal opening of the female connector. As shown, the proximal mating surface 8486 of the tube 8487 may have a cross-sectional width that is about equal to or greater than the size of the inner and/or outer diameter of the distal prong of the female connector. As shown, in certain embodiments, the difference between the outer diameter (or cross-sectional width) of the tube 8487 at its proximal end or in the area within the housing neck in the closed position and the inner diameter (or cross-sectional width) of the housing proximal opening is about equal to or slightly greater than the wall thickness of the seal 8460 at or near the proximal end. In certain embodiments, the outer cross-section of the tube 8487 can be greater than or equal to about 10% of the outer cross-sectional dimension of the female housing 8440 and/or less than or equal to about 60% of the outer cross-sectional dimension of the female housing 8440 at the first end 8402 of the female connector 8400. In certain embodiments, the outer cross-section of the tube 8487 is at least about 30% of the outer cross-sectional dimension of the female housing 8440 at the first end 8402 of the female connector 8400. The outer cross-section of the tube 8487 may be greater than or equal to about 20% of the outer cross-section of the seal 8462 and/or less than or equal to about 80% of the outer cross-section of the seal 8462. In certain embodiments, the outer cross-section of the tube 8487 is about 55% or greater than 55% of the outer cross-section of the seal 8462. Many variations in the relative sizes of the outer cross-sections of the tube 8487, concave housing 8440, and seal 8462 are possible. In certain embodiments, an outer cross-section of the tube 8487 at the first end 8402 of the female connector 8400 is configured to be substantially equal to an outer cross-section of the valve element 8116 at the first end 8112 of the male connector 8100. In certain embodiments, the inner cross-section of the female housing 8440 at the first end 8402 of the female connector is configured to be larger than the outer cross-section of the male luer tip 8122 at the first end 8112 of the male connector 8100.

As shown in fig. 92 and 93, the female connector 8400 and the male connector 8100 can be configured to mate with each other. In certain embodiments, advancement of the male luer tip 8122 into the female housing 8440 can push the seal portion 8462 of the seal 8460 relative to the one or more ports 8488 toward the second end 8404 of the female connector 8400. Withdrawal of the seal 9462 from the one or more ports 8488 can create fluid communication between the flow passage 8418 and the annular space 8163. In certain embodiments, advancement of the male luer tip 8122 into the concave housing 8440 can cause the tube 8487 to move into the male luer tip 8122. Movement of the tube 8487 into the male luer tip 8122 can urge the valve element 8116 toward the second end 8114 of the male connector 8100 relative to the male luer tip 8122. In some such embodiments, the seal 8120 is moved toward the second end 8114 of the male connector 8100 relative to the male luer tip 8122. Such seal 8120 movement can increase the axial length of the annular gap 8163. In certain embodiments, full engagement of the male connector 8100 with the female connector 8400 (e.g., engagement between the hooks 2127 and the grooves 8444 as shown in fig. 93) can facilitate fluid communication between the conduit 8194 and the flow passage 8418 using the one or more ports 8488, the one or more ports 8162, and the annular void 8163.

In certain embodiments, the resilient portion 8115 can be configured to elongate when the valve element 8116 is urged toward the second end 8114 of the male connector 8100. In certain embodiments, extension of the spring back 8115 may cause the spring back 8115 to apply a return force to the valve element 8116. In certain such embodiments, the restoring force of the resilient portion 8115 can cause the valve element 8116 to move toward the first end 8112 of the male connector 8100 as the tube 8487 or other source of pushing pressure is withdrawn from the male luer tip 8122. Such movement of the valve element 8116 toward the first end 8112 can return the valve element 8116 to the closed configuration. In certain embodiments, the restoring force of the resilient portion 8115 can help ensure that the mating surfaces 8486, 8186 remain in contact with each other as the tube 8487 is advanced into and out of the male luer tip 8122. Such contact can help prevent fluid from contacting the mating surfaces 8486, 8186 when the valve element 8116 is in the open configuration.

Fig. 94-96 illustrate another embodiment of a connector system 9000 comprising a male connector 9100 and a female connector 8400. Certain reference numerals relating to the components in fig. 94-96 are the same as or similar to those described above with respect to the connector system 8000 and corresponding male and female connectors 8100, 8400 (e.g., male connector 9100 versus male connector 8100). It should be understood that the components or portions of the connector system 9000 may be functionally the same or similar to the previously described components or portions. The connector system 9000 of fig. 94-96 illustrates some variations of the connector system 8000 of fig. 90-93.

The male connector 9100 can be substantially similar to the male connector 8100. In certain embodiments, the male connector 9100 includes a valve element 9116 that can be at least partially received in the male luer tip 9122. In certain embodiments, the valve member 9116 includes a first valve portion 9116a and a second valve portion 9116 b. In certain embodiments, the first valve portion 9116a and the second valve portion 9116b are interconnected by glue, sonic welding, solvent bonding, snap fitting, other suitable attachment structures or means, or a combination thereof. In certain embodiments, the first valve portion 9116a and the second valve portion 9116b form a single piece. Similarly, in certain embodiments, the male luer tip 9122 includes a first tip portion 9122a and a second tip portion 9122 b. In certain embodiments, the first and second tip portions 9122a, 9122b are interconnected by glue, sonic welding, solvent bonding, other suitable attachment features or means, or a combination thereof. In some embodiments, the first and second tip portions 9122a, 9122b form a single piece. The valve member 9116 can include stabilizing structure such as, for example, an annular flange 9149. The annular flange 9149 can be configured to engage an inner wall of the male luer tip 9122. In certain embodiments, such engagement can help prevent off-axis deflection of the valve element 9116 within the male luer tip 9122.

In some embodiments, the male connector 9100 can include a spring 9118. The spring 9118 can include a first anchor portion 9113. In certain embodiments, the first anchor portion 9113 is configured to engage a hole 9167 in the first tip portion 9122a and/or a hole in the second tip portion 9122b such that the anchor portion 9113 is seated between and held in place by at least two portions of the housing. The first anchor portion 9113 can be configured to resist disengagement of the spring 9118 from the male luer tip 9122 when the first anchor portion 9113 is installed within the male luer tip 9122. The spring 9118 may include a second anchor portion 9117. In some embodiments, the first and second anchors 9113, 9117 comprise portions of a generally continuous loop or ridge that extends generally around the spring 9118. The resilient portion 9115 may also function as a fluid seal in certain embodiments. In certain embodiments, the second anchor portion 9117 is configured to engage a groove or aperture 9171 in the first valve portion 9116a and/or a groove or aperture in the second valve portion 9116 b. The second anchor portion 9117 can be configured to prevent the resilient member 9118 from disengaging from the valve member 9116 when the second anchor portion 9117 is installed in the valve member 9116.

The elastic piece 9118 may include a resilient portion 9115 connecting the first and second anchors 9113, 9117. In certain embodiments, the first and second anchor portions 9113, 9117 and the resilient portion 9115 are each annular. A plurality of first and second anchors 9113, 9117 and/or a plurality of resilient portions 9115 may be used in some embodiments.

In certain embodiments, rebound 9115 is configured to function in a manner similar to or similar to the rebound 8115 system described above. For example, the resilient portions 9115 can be configured to elongate when the valve member 9116 is urged toward the second end 9114 of the male connector 9100, as shown in fig. 96. In certain embodiments, extension of the resilient portions 9115 may cause the resilient portions 9115 to exert a return force on the valve member 9116. In some such embodiments, the return force of the resilient portion 9115 can cause the valve member 9116 to move toward the first end 9112 of the male connector 9100 when the bias source is withdrawn from the male luer tip 9122.

Any features of the embodiments shown and/or described in the figures, such as distances, component part fits, etc., not explicitly described herein, are also intended to form part of this document. Moreover, while the invention has been described in conjunction with various embodiments, features, aspects and examples, it will be appreciated by those skilled in the art that the invention extends beyond the specifically described embodiments to other alternative embodiments and/or inventive uses and obvious modifications and equivalents thereof. It is therefore to be understood that the various features and aspects of the described embodiments may be combined with, or substituted for, one another in order to achieve a variety of the described invention. For example and without limitation, ANSI-compliant and/or non-ANSI-compliant connection structures may be used to effect connections between the connector system, connector, and sub-assembly. Moreover, the components described herein, or any combination thereof, may be used in other structures or configurations of medical connectors. Accordingly, it is intended that the scope of the invention herein described should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims.

Claims

1. A fluid-transferring coupling system comprising:

a first connector comprising:

a first housing having a first central axis, a first end, a second end, and a boss;

a valve member disposed at least partially within the interior space of the boss, the valve member configured to transition between an open position and a closed position, and the valve member including a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, and a first mating surface at the first end of the valve member, wherein the first end of the valve member is configured to prevent fluid flow from the valve flow passage through the first end of the valve member when the valve member is in the closed position;

a biasing member configured to bias the valve member toward the closed position; and

a luer tip seal disposed inside the first housing and having a mating face;

a second connector configured to transition between an open configuration and a closed configuration, the second connector comprising:

a second housing having a second central axis, a first end configured to receive the boss of the first housing, and a second end;

a fluid line at least partially disposed in the interior space of the second housing, the fluid line having a first end, a second end, a line channel extending within the fluid line between the first and second ends of the fluid line, at least one port proximate the first end of the fluid line and extending through the fluid line into the line channel, and a second mating surface configured to detachably mate with the first mating surface of the valve member;

a seal positioned at least partially within the interior space of the second housing, the seal having a first end, a second end, an offset between the first and second ends of the seal, a mating surface at the first end, and an aperture at the first end of the seal sized and shaped to correspond to the size and shape of the first end of the fluid line, the seal configured to prevent fluid from exiting the line channel through the at least one port of the fluid line when the second connector is in the closed configuration;

wherein the first connector and the second connector are configured to connect with each other to transition the valve member to the open position and the second connector to the open configuration when the first connector is connected with the second connector, and the first mating surface of the valve member and the second mating surface of the fluid line are configured to engage with each other to contact an outer peripheral surface of the first mating surface of the valve member with an outer peripheral surface of the second mating surface of the fluid line to prevent fluid from infiltrating between the first mating surface of the valve member and the second mating surface of the fluid line when fluid flows through the first connector and the second connector, wherein when the second connector is in the closed configuration, the first end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal member is substantially flush with the first end of the second housing to allow sterile wiping, and wherein the luer tip seal is configured to scrape fluid when the luer tip valve member transitions between the open position and the closed position An outer surface of the passageway, and wherein a mating surface of the luer tip seal is configured to engage a mating surface of the seal.

2. The connection system of claim 1, wherein the biasing member is a spring.

3. The connection system of claim 1, wherein the biasing member is a hose.

4. The connection system of claim 1, wherein the fluid conduit is constructed of a rigid or semi-rigid material.

5. The connection system of claim 1, wherein the protrusion is a Golwell tip in accordance with ANSI.

6. The connection system of claim 5, wherein the first end of the second connector is a female luer tip as ANSI.

7. The connection system of claim 1, wherein at least a portion of the fluid line is configured to enter a male portion of the first connector when the first connector is connected to the second connector.

8. The connection system of claim 1, wherein at least one of the first mating surface and the second mating surface is comprised of a flexible material.

9. The connection system of claim 1, wherein the first connector includes a ferrule portion having at least one mating feature configured to engage an engagement feature of the second connector.

10. The connection system of claim 9, wherein the interior cross-sectional area of the collar portion is greater than the exterior cross-sectional area of the second connector portion proximate the first end of the second connector.

11. The connection system of claim 9, wherein the at least one mating feature is a hooked tab configured to engage with an engagement feature of a second connector.

12. The connection system of claim 11, wherein the tab includes a release structure configured to urge the at least one mating structure out of engagement with the second connector.

13. The connection system of claim 12, wherein the release structure is a dome protrusion on the at least one tab.

14. The connection system of claim 12, wherein the release structure is at least one rib protruding from the at least one tab.

15. The connection system of claim 9, wherein the engagement structure is an annular groove on an outer surface of the second connector.

16. The connection system of claim 11, wherein the tab comprises a longitudinal rib.

17. The connection system of claim 9, wherein the second connector includes an abutment structure configured to limit passage of the ferrule portion past the first end of the second connector.

18. The connection system of claim 17, wherein an outer cross-sectional area of the abutment structure is greater than an inner cross-sectional area of the sleeve portion, the abutment structure including one or more flanges on an outer surface of the second connector.

19. The connection system of claim 1, wherein at least a portion of the fluid line is configured to enter into the male portion of the first connector when the first connector is connected to the second connector.

20. The connection system of claim 1, wherein at least a portion of the male portion of the first connector is configured to enter into the interior space of the second housing when the first connector is connected with the second connector.

21. A method of transferring fluid from a fluid source to a fluid receptacle, comprising:

connecting the fluid source to a first connector, the first connector comprising:

a first housing having a first central axis, a first end, a second end, and a boss, the second end configured to sealingly engage the fluid source;

a valve member at least partially positioned within the interior space of the boss, the valve member configured to transition between an open position and a closed position, and the valve member including a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, and a first mating surface at the first end of the valve member, wherein the first end of the valve member is configured to prevent fluid flow from the valve flow passage through the first end of the valve member when the valve member is in the closed position;

a luer tip seal disposed inside the first housing and having a mating face;

connecting the fluid receptacle to a second connector, the second connector configured to transition between an open configuration and a closed configuration and comprising:

a second housing having a second central axis, a first end configured to receive the boss of the first housing, and a second end configured to connect to the fluid receptacle;

a fluid conduit at least partially disposed in the interior space of the second housing, the fluid conduit having a first end, a second end, a conduit channel extending within the fluid conduit between the first end and the second end of the fluid conduit, at least one port proximate to the first end of the fluid conduit and extending through the fluid conduit into the conduit channel, and a second mating surface configured to sealingly mate with the first mating surface of the valve member such that an outer peripheral surface of the first mating surface contacts an outer peripheral surface of the second mating surface;

connecting the first connector to the second connector, wherein the valve member transitions from the closed position to the open position and the second connector transitions to the open configuration when the first connector and the second connector are connected to each other;

transferring fluid from the fluid source through the first connector and through the second connector to the fluid receptacle;

separating the first connector from the second connector, wherein the first mating surface of the valve member and the second mating surface of the fluid passageway remain free of fluid after being separated from each other;

wherein, when the second connector is in the closed configuration, the first end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal is substantially flush with the first end of the second housing, thereby allowing for sterile wiping, and wherein the luer tip seal is configured to scrape an outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein a mating surface of the luer tip seal is configured to engage a mating surface of the seal.

22. The method of claim 21, wherein coupling the fluid source to the second end of the first connector further comprises coupling a male luer of the fluid source to the second end of the first connector.

23. The method of claim 21, wherein connecting the fluid receptacle to the second end of the second connector further comprises connecting a female luer of the fluid receptacle to the second end of the second connector.

24. The method of claim 21, further comprising connecting the mating structure of the first connector with the engagement structure of the second connector.

25. The method of claim 21, further comprising inserting at least a portion of the fluid line into the boss when the first connector is connected to the second connector.

26. The method of claim 21, further comprising inserting at least a portion of the male portion into the first end of the second connector when the first connector is connected to the second connector.

27. A method of manufacturing a fluid transfer connector system, comprising:

providing a first connector, the first connector comprising: a first housing having a first central axis, a first end, a second end, and a boss; a valve member at least partially located within the interior space of the boss, the valve member configured to transition between an open position and a closed position and including a first end and a second end, a valve flow passage extending within the valve member between the first end and the second end of the valve member, at least one port proximate the first end of the valve member, a luer tip seal disposed within the first housing and having a mating face; and a first mating surface at the first end of the valve member, wherein the first end of the valve member is configured to prevent fluid flow from the valve passageway through the first end of the valve member when the valve member is in the closed position; a biasing member configured to bias the valve member toward the closed position; and

providing a second connector configured to transition between an open configuration and a closed configuration and comprising: a second housing having a second central axis, a first end configured to receive the boss of the first housing, and a second end; a fluid conduit at least partially disposed in the interior space of the second housing, the fluid conduit having a first end, a second end, a conduit channel extending in the fluid conduit between the first and second ends of the fluid conduit, at least one port proximate the first end of the fluid conduit and extending through the fluid conduit into the conduit channel, and a second mating surface structured to detachably engage the first mating surface of the valve member; a seal member positioned at least partially within the interior space of the second housing, the seal member having a first end, a second end, an offset between the first and second ends of the seal member, a mating surface at the first end of the seal member, and an aperture at the first end of the seal member sized and shaped to correspond to the size and shape of the first end of the fluid line, the seal member configured to prevent fluid from flowing out of the line channel through the at least one port of the fluid line when the second connector is in the closed configuration;

configuring the first connector to connect with the second connector, thereby transitioning the valve member to the open position and transitioning the second connector to the open configuration;

wherein the first mating surface of the valve member and the second mating surface of the fluid passageway are configured to engage each other such that an outer peripheral surface of the first mating surface of the valve member contacts an outer peripheral surface of the second mating surface of the fluid passageway to prevent fluid from infiltrating between the mating surfaces when fluid flows through the first connector and the second connector; wherein, when the second connector is in the closed configuration, the first end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal is substantially flush with the first end of the second housing, thereby allowing for sterile wiping, and wherein the luer tip seal is configured to scrape an outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein a mating surface of the luer tip seal is configured to engage a mating surface of the seal.

28. A closeable male connector configured to connect with a female connector, the male connector comprising:

a housing having a first central axis, a first end, a second end, and a boss;

a luer tip seal disposed inside the first housing and having a mating face; and

a biasing member configured to bias the valve member toward the closed position;

wherein the first mating surface is sized and shaped to detachably engage a second mating surface on the female connector to transition the valve member to the open position when the male connector is connected to the second connector, and the first mating surface is configured to engage the second mating surface to contact an outer peripheral surface of the first mating surface with an outer peripheral surface of the second mating surface to prevent fluid from infiltrating between the first mating surface and the second mating surface when fluid flows through the male connector and the female connector;

wherein the first mating surface of the valve member is disposed substantially flush on both sides of the first end of the housing when the valve member is in the closed position, thereby allowing for sterile wiping, and wherein the luer tip seal is configured to scrape against an outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein the mating surface of the luer tip seal is configured to engage the mating surface of the seal.

29. A closeable female connector configured to connect to a male connector having a male portion, the female connector further configured to transition between an open configuration and a closed configuration, the female connector comprising:

a housing having a central axis, a first end configured to receive the male portion of the male connector, and a second end;

a fluid conduit at least partially located in the interior space of the housing, the fluid conduit having a first end, a second end, a conduit channel extending within the fluid conduit between the first end and the second end of the fluid conduit, at least one port proximate to the first end of the fluid conduit and extending through the fluid conduit into the conduit channel, and a mating surface;

a seal member positioned at least partially within the interior space of the housing, the seal member having a first end, a second end, an offset between the first and second ends of the seal member, a mating surface at the first end, and an aperture at the first end of the seal member sized and shaped to correspond to the size and shape of the first end of the fluid line, the seal member configured to prevent fluid from exiting the line channel through at least one port of the fluid line when the female connector is in the closed configuration;

wherein the mating surface of the fluid passageway is configured to detachably engage the mating surface of the valve member of the male connector, the mating surface of the fluid passage is configured to engage with the mating surface of the valve member of the male connector such that an outer peripheral surface of the mating surface of the fluid passage contacts an outer peripheral surface of the mating surface of the valve member of the male connector, thereby preventing fluid from passing between the mating surface of the fluid passageway and the mating surface of the valve member of the male connector when fluid flows through the male connector and the female connector, wherein the first end of the fluid conduit is substantially flush with the first end of the housing and the first end of the seal is substantially flush with the first end of the housing when the female connector is in the closed configuration, thereby allowing for sterile wiping, wherein the mating face of the seal is configured to engage a luer tip seal of the male connector and the fluid passageway is configured to be scraped by the luer tip seal of the male connector as the valve member transitions between the open and closed positions.

30. A medical fluid transfer connector system, the system having an open phase and a closed phase and comprising:

a first connector comprising:

a first housing having a first central axis, the first housing including a first end having a convex portion and a second end;

a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end, a first flow passage extending through the valve member, at least one port proximate the closed end of the valve member and extending through the valve member into the first flow passage, and a first mating surface at the closed end;

a luer tip seal disposed inside the first housing and having a mating face; and

a biasing member functionally associated with the valve member;

a second connector comprising:

a second housing having a second central axis, the second housing including a first end configured to receive the boss and a second end;

a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including a closed end, a second flow passage extending through the fluid conduit, at least one port proximate the closed end of the fluid conduit and extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end configured to engage the first mating surface;

a seal disposed within the second housing, the seal including a first end, a second end, a mating surface at the first end, and a bias between the first end and the second end, the first end including an aperture that is open during an open stage and a closed stage, and the first end having a size and shape that substantially corresponds to a size and shape of the closed end of the fluid conduit, the seal configured to prevent fluid flow through at least one port of the fluid conduit;

wherein the first mating surface of the valve member and the second mating surface of the fluid passageway are configured to engage each other such that an outer peripheral surface of the first mating surface of the valve member contacts an outer peripheral surface of the second mating surface of the fluid passageway to prevent fluid from infiltrating between the first mating surface of the valve member and the second mating surface of the fluid passageway when fluid flows through the connectors, wherein when the second connector is in the closed configuration, the closed end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal is substantially flush with the first end of the second housing to allow for sterile wiping, and wherein the luer tip seal is configured to scrape against an outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein the mating surfaces of the luer tip seal are configured to engage the mating surfaces of the seal.

31. A medical fluid transfer connector system, the system having an open phase and a closed phase and comprising:

a first connector comprising:

a first housing having a first central axis, the first housing including a first end having a convex portion and a second end, the convex portion having an inner cross-sectional area;

a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end having a cross-sectional area, a first flow passage extending within the valve member, at least one port proximate the closed end of the valve member and extending through the valve member into the first flow passage, and a first mating surface at the closed end;

a luer tip seal disposed inside the first housing and having a mating face;

a biasing member functionally associated with the valve member;

a second connector comprising:

a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including an open end, a closed end, a second flow passage extending between the open end and the closed end, at least one port proximate the closed end of the fluid conduit and extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end and configured to engage the first mating surface;

a seal disposed within the second housing, the seal including a first end, a second end, a mating face at the first end, a bias between the first end and the second end, and an orifice at the first end of the seal, a cross-sectional area of the orifice in an open phase being greater than or equal to an inner cross-sectional area of the protrusion;

wherein the first mating face and the second mating face are configured to engage each other such that an outer peripheral surface of the first mating face contacts an outer peripheral surface of the second mating face to prevent fluid from infiltrating between the mating faces when fluid flows through the connectors, wherein when the second connector is in the closed configuration, the closed end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal is substantially flush with the first end of the second housing to allow sterile wiping, and wherein the luer tip seal is configured to scrape an outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein the mating surface of the luer tip seal is configured to engage the mating face of the seal.

32. A medical fluid transfer connector system, the system having an open phase and a closed phase and comprising:

a first connector comprising:

a valve member disposed at least partially within the interior space of the boss, the valve member including a closed end having a cross-sectional area, a first flow passage extending between the valve member and the second end of the first housing, at least one port proximate the closed end of the valve member extending through the valve member into the first flow passage, and a first mating surface at the closed end;

a luer tip seal disposed inside the first housing and having a mating face;

a biasing member functionally associated with the valve member;

a second connector comprising:

a fluid conduit disposed at least partially in the interior space of the second housing, the fluid conduit including an open end, a closed end, a second flow passage extending between the open end and the closed end, at least one port proximate the closed end of the fluid conduit and extending through the fluid conduit into the second flow passage, and a second mating surface on the closed end and configured to engage the first mating surface;

a seal member disposed within the second housing, the seal member including a first end, a second end, a mating surface at the first end, a bias between the first end and the second end, and an orifice at the first end of the seal member, the orifice having a cross-sectional area in an opening phase that is greater than or equal to a cross-sectional area of the valve member;

wherein the first mating surface of the valve member and the second mating surface of the fluid passageway are configured to engage one another such that the outer peripheral surface of the first mating surface of the valve member contacts the outer peripheral surface of the second mating surface of the fluid passageway to prevent fluid from infiltrating between the mating surfaces when fluid flows through the connectors, wherein when the second connector is in the closed configuration, the closed end of the fluid line is substantially flush with the first end of the second housing and the first end of the seal is substantially flush with the first end of the second housing to allow sterile wiping, and wherein the luer tip seal is configured to scrape against the outer surface of the fluid passageway as the valve member transitions between the open and closed positions, and wherein the mating surfaces of the luer tip seal are configured to engage the mating surfaces of the seal.

33. A medical system for delivery of medical fluids, the system comprising:

a first connector comprising:

a luer tip seal disposed inside the first housing and having a mating face;

a biasing member functionally associated with the valve member;

a second connector comprising:

a fluid conduit disposed at least partially within the interior space of the second housing, the fluid conduit including a closed end, a second flow passage extending through the fluid conduit, at least one port proximate the closed end of the fluid conduit and extending through the fluid conduit into the second flow passage, and a second mating surface at the closed end configured to engage the first mating surface of the valve member;

a seal disposed within the second housing, the seal configured to prevent fluid flow through the at least one port of the fluid line, the seal including a biasing portion and a mating face at a first end of the seal;