US20070088294A1 - Medical connector with closeable male luer - Google Patents

Abstract

A luer connector comprising a housing with a hollow bore having first and second ends. The hollow bore also has a male luer tip and a tapering interior surface. The luer connector also comprises a rigid valve member configured to at least partially extend through the housing. The valve member has a first opened end and a second closed end. The valve member also comprises a passageway within the valve member and an outwardly extending flange near the second end adapted to seal the hollow bore at the second end of the housing when placed in contact with a tapering interior surface of the housing. The valve member further comprises at least one opening near the closed end of the valve member extending outward from the passageway through the valve member and at least one strut attached to the valve member. At least a portion of the strut extends substantially parallel to the central axis of the valve member. The luer connector also comprises a retaining member configured to couple the valve member and the housing and a sealing element disposed within the housing. The sealing element is configured to inhibit fluid communication through the hollow bore of the housing between the interior of the male luer tip of the housing and the first end of the housing.

Description

RELATED APPLICATIONS
• This application is related to, and claims benefit under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 60/696,894, filed Jul. 6, 2005 and to U.S. Provisional Patent Application No. 60/707,319, filed Aug. 11, 2005, each of which is incorporated in its entirety by reference herein.
BACKGROUND OF THE INVENTIONS
• 1. Field of the Inventions
• This invention relates generally to medical connectors through which fluids flow, and in particular, to medical connectors with male luers.
• 2. Description of the Related Art
• Systems of connectors, valves, and tubing are routinely used in hospitals and other medical settings for facilitating the transfer of fluids to and from patients. It is often a challenge to keep such systems sterile and to prevent leakage of fluids when the various components are engaged and disengaged.
• In order to maintain a barrier to bacteria, debris, and fluid leakage, female connectors often have been provided with closures, such as septa, flexible seals, or other impediments, at their mating ends. When a male luer connector is engaged with the female connector, the closure of the female connector is temporarily opened, pierced, or moved to allow fluid to flow between the two connectors. Male connectors typically employ needles or luers to open, pierce, or move the closure on the female connectors.
• In many systems, only the female connectors are automatically blocked from the external environment when disengaged. Male luer connectors are generally not provided with automatic closing mechanisms. Male luer connectors sometimes employ additional components, such as caps, to stop the flow of fluid and impede the entry of bacteria and debris. Because such closure mechanisms are not automatic (or not used at all), male luer connectors are sometimes left unsealed, allowing fluid to drip out. This may increase the risk of unsanitary conditions inside and outside of the fluid transfer system. In addition, in some medical applications such as certain chemotherapy treatments, the fluids in the tubing and connectors can be harmful if released.
• Moreover, in the busy environment of hospitals and other medical settings, health care providers must often quickly manipulate multiple medical implements with one hand, making it difficult to retrieve male luer caps and rapidly attach them upon disengagement of male connectors. In addition, male luer connectors are often employed at the downstream end of gravity-fed fluid sources such as IV bags. When the connectors and tubing are initially connected to such sources, they are generally empty (i.e., filled with air) and must be primed with fluid before they can be connected to a patient. During the priming procedure, fluid is allowed to flow from the upstream end of the tubing toward the male luer connector on the downstream end. As the flow flows through the tubing, the air in the tubing escapes through the male connector on the downstream end into the environment. Once the fluid itself reaches the male connector, it can also escape and spill out. Because male luer connectors do not usually close automatically after priming, the male luer often drips out a small amount of fluid as the male connector is rapidly moved into mating engagement with a female connector. For this reason, the male luer is generally held over a sink or trash can at the end of the priming procedure to contain the dripping fluid.
• There is a need for a closable male luer connector that automatically opens when engaged with a female connector and automatically closes when disengaged from such connector to minimize or eliminate dripping during priming and other procedures and to improve the barrier of the fluid transfer system against bacteria and other debris.
SUMMARY OF THE INVENTION
• Disclosed are various embodiments of medical connectors with closable male luers. It is contemplated that the features of the various embodiments disclosed herein are combinable to form additional embodiments. Such combinations are within the scope of this disclosure.
• In an exemplary embodiment, a male luer connector has a main housing with first and second ends. The second end of the housing comprises a male luer and a shroud surrounding at least a portion of the male luer. The shroud has screw threads disposed on an internal wall thereof. A tubular valve member with a fluid pathway is disposed within the housing. The valve member has a tip on its second end. In the region near the tip, a pair of fluid holes is positioned on opposite sides of the valve member. The tip is configured to abut snugly against an internal wall of the male luer in a region at or near the second end of the male luer. The valve member also has a pair of struts directed towards the second end. The struts extend axially through a portion of the housing, and the ends of the struts towards the second end are positioned within a space between the male luer and the shroud on the second end of the housing. A length of medical tubing is connected to the connector. An end of the tubing is attached to the first end of the valve member by adhesive, welding, or some other means. A resilient, elastomeric member extends from a mid-section region on the outside of the housing to a region at or near the first end of the valve member within the housing.
• In a substantially closed state, the resilient member is configured to pull the housing and the tubular valve member together along their respective axes. In this state, the tip of the valve member is pressed into close contact with a portion of the internal wall on the second end of the male luer, and fluid flow from the medical tubing through the tubular valve member is impeded. Fluid generally cannot escape through the opening on the second end of the male luer because such opening is blocked by the tip of the valve member.
• When a force is applied to separate the valve member from the housing, the resilient member is stretched and the tip of the valve member is displaced in the direction of the first end from the second end of the male luer. This separating force can be applied manually, for example, by grasping the external wall of the housing with two fingers and grasping the tubing adhered to the first end of the valve member with two other fingers, and then moving the fingers in opposite direction. The separating force can also be applied automatically by a different manual action. For example, the action of connecting the male luer to a female end of another medical implement can automatically separate the valve member from the housing. As the advancing end of the female connector proceeds up the screw threads on the second end of the housing of the male luer connector, the female connector makes contact with and exerts a force directed towards the first end against the struts of the valve member. This force moves the valve member towards the first end against the biasing force directed towards the second end exerted by the resilient member. In this opened state, fluid is permitted to flow through the opposing holes, around the tip of the valve member, and out of the connector through the gap between the tip of the valve member and the internal wall on the second end of the male luer. In some embodiments, the valve member is automatically advanced in the direction of the first end when the valve member contacts a fluid conduit (e.g., a spike positioned within a female connector) as the male and female connectors are brought together.
• When the separating force is removed, for example, by releasing the manual grip on the housing and the tubing, or by detaching the female connector from the second end of the housing, the resilient member once again draws the housing and the valve member together. This causes the tip on the second end of the valve member to abut closely against a portion of the internal wall in a region near the second end of the male luer, and impedes fluid flow out of the valve.
• Also disclosed herein are other features and configurations for the foregoing embodiment, as well as additional embodiments for other connectors with closable male luers. Such embodiments generally include means for permitting or impeding fluid flow through a male luer on a connector, preferably automatically upon connection with a corresponding female connector.
BRIEF DESCRIPTION OF THE DRAWINGS
• Certain embodiments of this invention will now be discussed in detail with reference to the following figures. These figures are provided for illustrative purposes only, and the invention is not limited to the subject matter illustrated in the figures.
• FIG. 1A shows a perspective view of an embodiment of a male luer connector attached to tubing configured to receive fluid from a hanging gravity-fed IV bag. In this and other figures, the relative size of the connector and attached tubing is increased in comparison to other objects to facilitate viewing certain details.
• FIG. 1B shows a perspective view of the connector ofFIG. 1A in a stretched, substantially opened configuration.
• FIG. 1C shows a perspective view of an embodiment of the connector ofFIG. 1A being connected to an exemplary female connector attached to tubing inserted into a patient.
• FIG. 2 shows a perspective view of an embodiment of a closeable male luer connector.
• FIG. 3 shows a perspective view of a housing portion of the connector ofFIG. 2.
• FIG. 4A shows a perspective view of a valve member portion of the connector ofFIG. 2.
• FIG. 4B shows a perspective view of another embodiment of a valve member portion of the connector ofFIG. 2.
• FIG. 4C shows a cross-sectional view of the embodiment of the valve member portion of the connector ofFIG. 4B.
• FIG. 5 shows a perspective view of a resilient member of the connector ofFIG. 2.
• FIG. 6 shows a perspective view of a sealing portion of the connector ofFIG. 2. The relative size of the sealing portion is increased in comparison with the components of the connector shown in other figures to facilitate viewing.
• FIG. 7 shows a perspective view of certain components of the connector ofFIG. 2 in a partially assembled configuration. The housing portion ofFIG. 5 is not shown inFIG. 7.
• FIG. 8 shows a cross-sectional view of the connector ofFIG. 2 adjacent a female portion of another medical implement. At this stage, fluid is impeded through the connector ofFIG. 2.
• FIG. 9 shows a cross-sectional view of the connector ofFIG. 2 in engagement with the medical implement ofFIG. 8. Fluid is flowing through the engaged connectors.
• FIG. 10 shows a cross-sectional view of the connector ofFIG. 2 adjacent another medical implement with a closeable female luer connector. At this stage, fluid is impeded through the connector ofFIG. 2 and the female luer connector.
• FIG. 11 shows a cross-sectional view of the connectors ofFIG. 10 after engagement. Fluid is flowing through the engaged connectors.
• FIG. 12 shows a perspective of the connector ofFIG. 2 adjacent a syringe with a male luer tip. At this stage, fluid is impeded through the connector.
• FIG. 13 shows a perspective view of the components ofFIG. 12 after engagement. At this stage, fluid is still impeded through the connector.
• FIG. 14 shows a cross-sectional view of the connector and the male luer tip of the syringe ofFIG. 13.
• FIG. 15 shows a perspective view of the a closeable male luer connector located with its first end adjacent a syringe with a male luer tip and with its second end located adjacent a hypodermic needle with a female luer attachment portion.
• FIG. 16 shows a perspective view of the components ofFIG. 15 in engagement. At this stage, fluid can flow through the connector.
• FIG. 17 is a cross-sectional view of the connector, male luer tip of the syringe, and hypodermic needle ofFIG. 16. At this stage, fluid can flow through the connector.
• FIG. 18A is a perspective view of another embodiment of a closeable male luer connector.
• FIG. 18B is a cross-sectional view of the connector ofFIG. 18A.
• FIG. 18C is a detail of the cross-sectional view of the connector ofFIG. 18A.
• FIG. 19 is a perspective view of the connector ofFIG. 18A located adjacent a syringe with a male luer tip.
• FIG. 20 is a perspective view of the components ofFIG. 19 in engagement.
• FIG. 21 is a perspective view of another embodiment of a closeable male luer connector engaged with a syringe with a male luer tip.
• FIG. 22A is a cross-sectional view of another embodiment of a closeable male luer connector.
• FIG. 22B is a detail of the cross-sectional view of the connector ofFIG. 22A.
• FIG. 23A is a side view of another embodiment of a closeable male luer connector with a shroud.
• FIG. 23B is a cross-sectional view of the connector ofFIG. 23A.
• FIG. 23C is a perspective view an embodiment of a closeable male luer connector adjacent a closeable female connector. At this stage, fluid flow is impeded through the female luer connector.
• FIG. 23D is a perspective view of the components ofFIG. 23C in engagement.
• FIG. 24A is a perspective view of another embodiment of a closeable male luer connector.
• FIG. 24B is a cross-sectional view of the connector ofFIG. 24A.
• FIG. 25A is a side view of another embodiment of a closeable male luer connector with a shroud.
• FIG. 25B is a cross-sectional view of the connector ofFIG. 25A.
• FIG. 26A is a perspective view of another embodiment of a closeable male luer with a flexibly connected female luer connector.
• FIG. 26B is a perspective view of another embodiment of a closeable male luer with a flexibly connected female luer connector.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• In one aspect of the present inventions, a variety of means are shown for closing the second end of a male luer connector. In some embodiments, these closing mechanisms function to prevent and/or impede fluid from escaping from or entering into the male luer, while allowing fluid flow when the male luer is manually opened or engaged with a corresponding female luer. As used herein, terms such as “closed” or “sealed” should be understood as obstructions or barriers to fluid flow. These terms should not be understood to require that a particular structure or configuration achieves a complete fluid closure in all circumstances.
• InFIG. 1A, an embodiment of a closablemale luer connector10 is shown in a closed position. Theluer connector10 is attached to a gravity-fedIV bag9 filled with fluid hanging from apole stand11. At the bottom of thebag9, a section oftubing13 is attached. The opposite end of thetubing13 is connected to thefirst end12 of theluer connector10. A closing mechanism on the interior of thesecond end14 of theluer connector10 prevents the fluid contained within thebag9 from flowing through thetubing13 and leaking out of theluer connector10, as long as theluer connector10 remains in a closed configuration.
• InFIG. 1B, theconnector10 is illustrated in an open position. Fluid can flow out into thefirst end12 of theconnector10 and out of thesecond end14 of theconnector10. A health care provider can move themale luer connector10 into this configuration by grasping the second end of the closablemale luer10 with two fingers, grasping thetubing13 with two other fingers, and gently moving the fingers in opposite directions.
• The IV delivery system illustrated inFIGS. 1A and 1B can be easily readied for fluid communication with a patient. In most circumstances, thetubing13 is filled with air when it is initially connected to theIV bag9. If the other end of thetubing13 is connected to a closed connector, as illustrated inFIG. 1A, the air cannot escape and fluid cannot enter thetubing13 from theIV bag9. Theluer connector10 is therefore manually moved into the opened position until all of the air has been purged through theluer10 and the fluid in theIV bag9 fills thetubing13 andconnector10. This procedure is known as “priming.” As soon as the fluid line and connector are properly primed, the health care provider can quickly release the opposing forces applied to thesecond end14 of theluer connector10 and thetubing13, and the closing mechanism of theluer connector10 can rapidly stop the flow of fluid through theluer connector10.
• Referring now toFIG. 1C, acatheter17 has been inserted into a patient'sarm15. Thecatheter17 penetrates the skin of thearm15 and is preferably fluidly connected with the patient's bloodstream. Thecatheter17 is also connected to a length ofmedical tubing19 attached to a femalemedical connector21. The example of a femalemedical connector21 illustrated inFIG. 1C is a version of the Clave® connector manufactured by ICU Medical, Inc., San Clemente, Calif. Various embodiments of a connector of this type are illustrated and described in U.S. Pat. No. 5,685,866, which is incorporated herein by reference in its entirety. It is contemplated that many of the male luer embodiments disclosed herein can be used with other types of female connectors. Thetubing19,catheter17, andfemale connector21 were previously primed with fluid using standard procedures. Theluer connector10 is primed as described previously and brought into engagement with thefemale connector21. As described in further detail below, when themale connector10 andfemale connector21 are engaged, fluid is permitted to flow from theIV bag9 into the patient. When themale connector10 andfemale connector21 are disengaged, fluid is once again prevented from flowing out of thesecond end14 of themale connector10. In general, fluid is also prevented from flowing out of the opening in thefemale connector21.
• The embodiment illustrated inFIGS. 1A-1C is described in further detail below. Each of the other embodiments disclosed herein can be used in the illustrated fluid system, and in various modifications and alternatives thereof. Further, it is contemplated that the various embodiments of connectors in accordance with the inventions can be used in a wide variety of additional medical fluid systems. For example, the disclosed connectors can also be used to transfer bodily fluids such as blood, urine, or insulin, nourishing fluids, and/or therapeutic fluids such as fluids used in chemotherapy treatments. The disclosed connectors can also be used to interconnect various other components of fluid transfer systems.
• Referring now toFIGS. 2-9, the closeable male luer ofFIGS. 1A-1C is illustrated in greater detail. As illustrated inFIG. 2, the assembledluer connector10 comprises four portions: ahousing23, avalve member16, aresilient member18, and a sealing ring20 (not visible inFIG. 2). These portions are individually illustrated inFIGS. 3 through 6, and will be discussed in further detail with reference to these figures. Theluer connector10 can be constructed of more or fewer portions, and such portions can be combined into different configurations.
• FIG. 3 illustrates thehousing23 of theconnector10, apart from the other portions of theluer connector10. Thehousing23 is generally a tube-like structure with anaxial passageway28 that extends from thefirst end12 of theconnector10 through theupper housing34, and themiddle portion32, and theluer tip22, to thesecond end14 of thehousing23. In some embodiments, the length of thehousing23 from thefirst end12 to theluer tip22 is approximately 1⅛ inches. Thehousing23 is preferably, but not necessarily, less than or equal to about 1½ inches from thefirst end12 to thesecond end14 so that the weight and bulk of the connector are minimized. Thehousing23 can have any suitable length for a particular application. Theluer tip22 connects to the remainder of thehousing23 at a base25 that is surrounded by ashroud24. Theend27 of theluer tip22 towards the second end of theluer connector10 extends some distance beyond theedge29 of the shroud.
• Theshroud24 preferably hasinner threads26 on an interior wall that help securely attached theconnector10 in a removable fashion to another medical implement. In other embodiments, theshroud24 can include other structures or materials for providing a releasable connection, including quick-release mechanisms and other means. Theshroud24 includes a plurality ofdepressions31 on an outer surface to assist the user in firmly grasping and twisting theshroud24 of thehousing23 with the fingers. Thedepressions31 have upwardly taperingsidewalls33 that prevent the fingers from sliding off theconnector10. On an end towards the first end of theconnector10 of eachdepression31, the surface of thehousing23 is approximately co-planar with the surface of thedepression31, while on an end towards thesecond end14 of theconnector12 of eachdepression31, the surface of thehousing23 is offset from, and preferably lies above, the surface of thedepression31. This configuration allows the fingers to comfortably slide in a direction towards thesecond end14 of theconnector10 along thehousing23 into a position for gripping or twisting theconnector10. Once the fingers are in the desired position, atapered wall33 on an end towards thesecond end14 of theconnector10 of thedepression31 resists further movement by the fingers in the direction of thesecond end14. A series ofdepressions31 extend around substantially the entire outer surface of the shroud so that the user's fingers, when positioned on opposite sides of theconnector10, will likely encounter adepression31 regardless of the orientation of theconnector10 during use.
• In the illustrated embodiment, thetip22 has a tapered external wall. The diameter of thetip22 becomes gradually smaller from the base25 towards thesecond end27. Thetip22 includes a hole at itssecond end27. At thebase25 of theluer tip22, an interior hole35 (seeFIG. 8) leads into a region of thefluid passageway28 in themiddle portion32 of theluer connector10. The dimensions of the luer tip can be made to comply with applicable standards and/or regulations, such as the ANSI standards.
• The interior wall of theluer tip22 preferably includes ashelf30 that extends radially inwardly toward the axis of thefluid passageway28 surrounded by theluer tip22, making thefluid passageway28 narrower at itssecond end27 than in the region adjacent to thesecond end27. In the illustrated embodiment, the surface of theshelf29 that faces radially inwardly toward the central axis of theconnector10 is tapered in a manner similar to the taper of the outer surface of the tip22 (seeFIGS. 8 and 9). In this configuration, the inner diameter of theshelf29 narrows in a direction from the side towards the first end to the side of theshelf29 towards the second end. As described in further detail below, theshelf29 in theluer tip22 helps to block and/or impede fluid flow through theconnector10 when the second end of thevalve member16 abuts against it.
• Themiddle portion32 of thehousing23 lies between theshroud24 and theupper housing34. As illustrated, themiddle portion32 has a smaller outer diameter than either theshroud24 orupper housing34. Themiddle portion32 also has two generallyrectangular openings36 disposed on opposite sides of thehousing23 from each other. When theconnector10 is assembled, themiddle portion32 is generally covered by a portion of the resilient member18 (see, e.g.,FIG. 2). As a result, themiddle portion32 does not generally come into contact with the fingers during use. Thus, in some embodiments, a grippable surface need not be used for themiddle portion32. Themiddle portion32 can therefore have a smaller diameter and smoother surface than either of the other sections of thehousing23.
• Theupper housing34 is generally split into twowall sections45a,45bby two gaps38 (only one shown inFIG. 3). Theupper housing34 includes a series ofdepressions37 similar in shape and function to thedepressions31 on theshroud24. Theupper housing34 may also comprise one ormore protrusions43 that extend into thegaps38. In the assembled configuration, theprotrusions43 help to retain a portion of theresilient member18 between thegaps38 in thewall sections45a,45b(seeFIG. 2). In some embodiments, theprotrusions43 are tapered from a smaller thickness on their ends towards the first end of the connector to a larger thickness on their ends towards the second end of the connector. The tapering of theprotrusions43 helps in the insertion and retention of the portion of theresilient member18 in a desired position and orientation, while allowing for bending and contortion of theresilient member18 during use. Theprotrusions43 also help prevent thevalve member16 from advancing too far in the direction of the first end as theconnector12 is moved into the opened position by contacting the set ofprotrusions44 toward the second end of thevalve member16. The tapering of theprotrusions43 allows theprotrusions44 of thevalve member16 to be advanced towards the second end during assembly into thehousing23 past theprotrusions43 of thehousing23. Thecorners47 towards the first end of the connector on each of the wall sections are preferably rounded to prevent snagging, scratching, or other damage or irritation to the fingers orresilient member18 during use.
• As shown inFIG. 3, the exterior surface of theupper housing34 includes alower shelf39 and the exterior surface of theshroud24 includes ashelf41 configured to help retain a central portion of theresilient member18 around thehousing23 in the assembled configuration (seeFIG. 2). Theshelf39 of theupper housing34 is preferably substantially horizontal to discourage any sliding of theresilient member18 in the direction of the first end of the connector. Theshelf41 of theshroud41 is preferably tapered (seeFIG. 8) to assist in the proper positioning of theresilient member18 on thehousing23 during manufacturing of theconnector10.
• Thehousing23 can be constructed from any of a number of different materials. In some embodiments, thehousing23 can be constructed from a relatively rigid material, such as polycarbonate or other polymeric material. Thehousing23 and/orvalve member16 of this embodiment, or components of other embodiments, can also be constructed of a hydrophobic material, such as Bayer Makrolon, or any other suitable material.
• Referring now toFIG. 4A, thevalve member16 of themale luer10 is illustrated apart from the other components of theconnector10. In some embodiments, thevalve member16 comprises afluid passageway52 of varying diameter extending from thefirst end48 of thevalve member16 to thesecond end56 thereof, surrounded by additional structures. Near thefirst end48, thevalve member16 and corresponding section of thefluid passageway52 are relatively wide to accommodate a section of standard-diameter medical tubing inserted therein. Near the middle of thevalve member16, atube40 surrounding a portion of thefluid passageway52 is attached to the portion near the first end of thevalve member16. The tube is adjacent to two approximatelyparallel struts42 along at least a portion of thetube40. Thetube40 can have a circular cross-section or other appropriate cross-section. Thestruts42 are preferably relatively thin and approximately planar. A first end of eachstrut42 connects to thevalve member16 at approximately the middle section of thevalve member16, and a second end of each strut extends toward thesecond end56 of thevalve member16. Thesecond end56 of thevalve member16 preferably extends further than the ends of the struts. There is preferably an open space between the inner wall of eachstrut42 and the outer wall of thetube40.
• From near the middle of thevalve member16 to thefirst end48 thereof, thefluid passageway52 comprises a wider region withprotrusions44 along its external surface.Protrusions44 form two channels46 (only one is shown inFIG. 4A) lengthwise along opposing sides of the body of thevalve member16. In some embodiments, thestruts42 are spaced circumferentially from thechannels46, as illustrated.
• Near the first end of thevalve member16 andtube40, acircumferential channel48 may be formed around the perimeter of the body of thevalve member16. Raisedtabs49 can be formed along the edge of thechannel48 toward the first end of the connector, while the raised middle portion of thevalve member16 can form the edge of thechannel48 toward the second end of the connector. In some embodiments, the raisedtabs49 do not extend evenly about the perimeter of the first end of thevalve member16, but instead have two larger sections that are spaced diametrically from each other.
• The amount of material necessary to construct thevalve member16 can be reduced by indentations made in the outer layers of this portion. Thetube40 can have apassage50 disposed therethrough. Thispassage50 preferably extends from ahole52 at the first end of thevalve member16 to a pair of holes50 (only one shown inFIG. 4A) positioned substantially adjacent to the second end of thevalve member16. In the illustrated embodiment, theseholes52 are generally rectangular in shape. The region of thetube40 near the second end of the connector can also be formed with only one hole or more than two holes, and other shapes for one or more of the holes can also be employed. For example, theholes52 can be formed with a tear-drop shape (e.g., narrow on one end and wider on an opposite end), which facilitates an injection molding process of manufacture. Further, in some embodiments, thevalve member16 can be constructed without a fluid path and function as a blocking plunger for fluid flowing around thevalve member16 rather than a means for conveying fluid between the first and second ends of theconnector10.
• Thetube40 of thevalve member16 comprises, at its second end, aflange section58. Theflange section58 preferably extends further in the radial direction than the adjacent portion of thetube40. In some embodiments, theflange section58 can be formed of the same or substantially the same material as the rest of thetube40. Theflange section58 preferably tapers from the first end of thevalve member16 towards the second end of thetube40. In some embodiments, the taper is formed at a 5-degree angle, and has a substantially identical taper to that of the radially inwardly facing surface of theshelf30 of thehousing23. Other amounts of taper, or no taper, can also be used.
• Thevalve member16, like thehousing23 ofFIG. 3, may be constructed from a number of different materials. Examples of such materials include polycarbonate or other polymeric materials. Thevalve member16 can be approximately the same length or somewhat shorter than thehousing23. For example, the length of thevalve member16 can be approximately 1 inch. In some embodiments, thevalve member16 can be substantially shorter than the length of thehousing23. Thevalve member16 can be formed from the same rigid materials as thehousing23. In certain applications, for example, semi-rigid or even more flexible materials may be desirable for use in thevalve member16, and more particularly for theflange section58 toward the second end of thetube40.
• Thevalve member16 can be manufactured through injection molding. In some embodiments, at least two gates are used to facilitate distribution of molten plastic throughout the mold. Preferably, one gate can be located along one of the sides of thevalve member16 between the end of thestruts42 towards the first end of the connector and the raisedtabs49 and another can preferably be located near theholes52 in thevalve member16. The locations of the gates are not fixed, however, and other locations on thevalve member16 can be used for gates when injection molding thevalve member16. Constructing both thehousing23 and thevalve member16 of this or other embodiments out of the same material lessens the chance of deteriorated performance of theconnector10 due to thermal expansion/contraction or chemical interaction between theconnector10 and its environment.
• Although thevalve member16 of the illustrated embodiment is configured as shown inFIG. 4A, many other configurations are possible. In some embodiments, thevalve member16 can be relatively smooth on its external surface, and can principally comprise thetube40 defining thepassage50. In still other embodiments, different numbers ofstruts42 can be disposed along the sides of thevalve member16.
• As can be seen in the embodiment illustrated inFIG. 4B, the raisedtabs150 near the first end of thevalve member16 can also comprise an externalengaging surface150, such as a screw thread, for removably attaching a medical implement (not shown), such as a syringe, with the first end of thevalve member16.
• In the embodiment illustrated inFIG. 4C, thechannel48 additionally can be tapered along the internal surface. The taper of thechannel48 can result in a decrease in width of the channel with a larger size at thefirst end180 of thevalve member16 and a smaller size towards thesecond end184 of the valve member. The internal taper of thechannel48 can compliment and closely fit with the taper of a male luer. Such an internal taper can conform to ANSI standards and/or regulations, such as the standard for medical syringes. In the illustrated embodiment, thetube40 of thevalve member16 does not have aflange section58 that extends radially outwardly beyond the wall of thetube40, as in the embodiment ofFIG. 4A. Instead, the wall of thetube40 tapers radially inwardly in the region of the second end. Thesecond end27aof the luer tip22acan have a smaller cross-sectionalsecond portion170 which decreases the likelihood of fluid escaping along the internal surface of thesecond end27aof the luer tip22a. Near thesecond end27aof the luer tip22a, a largercross-sectional region160 can transition to the smallercross-sectional portion170 towards the second end of the connector in many different ways, such as with an abrupt stair-step transition as illustrated inFIG. 4C or with a gradual tapering transition, or other transitions. Some sample cross-sectional diameters of the opening at thesecond end27aof the luer22ainclude those of about 2 mm or less, including about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, and 1.75 mm. The diameters of the opening in thesecond end27acan also be in the ranges of 0.4 mm-1.8 mm, 0.5 mm-1.5 mm, and 0.5-1.0 mm. Other diameters, either inside or outside the listed ranges can also be used. Additionally, the second end of thevalve member16 can be sized appropriately to occupy the space in the opening of thesecond end27aof the luer22a.
• Turning now toFIG. 5, theresilient member18 is discussed in greater detail. In the illustrated embodiment, theresilient member18 is formed from tworings60,62 separated by twoelastic members64. Therings60,62 and/or theelastic members64 can be made of a deformable material configured to exert a restoring force when stretched. Thus, if therings60,62 are pulled in opposing directions, theelastic members64 function to restore therings60,62 to their unextended configuration.
• Theelastic members64 can be constructed from a number of elastic materials. In some embodiments, theelastic members64 are made from a silicon rubber elastic material. In other embodiments, theelastic members64 can be made from a shape-memory material. In still other embodiments, theelastic members64 and/or theresilient member18 can comprise springs or other structures capable of exerting a restoring force.
• Therings60,62 can also be constructed from a number of materials. In some embodiments, therings60,62 are constructed from the same deformable elastic material that comprises theelastic members64. Thus, therings60,62 can be stretched into a diameter to extend around the appropriate portion of thehousing23 to which eachrespective ring60,62 is attached. The resilience of therings60,62 can function to effectively hold eachring60,62 in place on thehousing23. In other embodiments, therings60,62 can be constructed from rigid or semi-rigid materials, and can, for example, comprise half-circles that can be snapped into and out of position. In some embodiments, theresilient member18 can be integrated into thevalve member16 orhousing23.
• Turing now toFIG. 6, the sealingportion20 is described in greater detail. In some embodiments, the sealingportion20 is substantially cylindrical and has abore66 extending therethrough. In some embodiments, the sealingportion20 further comprises a pair of generallyrectangular protrusions68 extending from the sidewalls of the cylindrical portion at diametrically opposed positions. Theprotrusions68 can have different shapes and/or positions. The sealingportion20 can also have a generally smaller-diametermiddle portion67 surrounded by tworings69 at either end with larger diameters.
• The sealingportion20 can be constructed from a number of different materials. In some embodiments, the sealingportion20 is made from a silicon-baseddeformable material70. Silicon-based deformable materials are among those that form fluid-tight closures with plastics and other rigid polymeric materials. The sealingportion20 can be made from the same material as theresilient member18.
• InFIG. 7, certain components of themale luer10 of an embodiment are shown. As illustrated, thehousing23 is omitted. Thevalve member16, theresilient member18, and the sealingportion20 are shown in their respective assembled locations.
• Certain interconnections between the various portions of themale luer10 will now be discussed in further detail. As shown, thesmaller ring62 of theresilient member18 fits within thecircumferential channel54 of thevalve member16. In some embodiments, thesmaller ring62 can be stretched until it has a larger inner diameter than the raisedtabs49 at the first end of thevalve member16. Once thesmall ring62 has been advanced into position about thecircular channel54, it can be released, so that it wraps tightly about thecircular channel54, as shown.
• Thelarger ring60 of theresilient member18 extends around themiddle portion32 of the housing23 (as shown inFIG. 2), and can be stretched and positioned in a manner similar to that described above with respect to thesmall ring62. Theelastic members64 of theresilient member18 can then extend between thesmall ring62 and thelarger ring60 of theresilient member18 and preferably extend along and within thechannels46 in thevalve member16. Once located within these channels, theelastic members64 are, in effect, trapped by theprotrusions44 along the channel outer walls. As seen inFIG. 2, theelastic members64 can also extend along thegaps38 in theupper housing34 of thehousing23. Thegaps38 are generally located above thechannels46 in the illustrated embodiment. Theresilient member18 thereby provides an elastic connection between thehousing23 andvalve member16, pulling thevalve member16 into engagement with thehousing23.
• The sealingportion20, which is partially hidden by theresilient member18 inFIG. 7, preferably fits snugly around thetube40 and lies in between thestruts42 of thevalve member16.
• FIG. 8 illustrates a cross-section of the male luer of the present embodiment adjacent an exemplaryfemale connector92. In this cross-sectional view, the interconnections and interactions between thehousing23,valve member16 and sealingportion20 can be seen in greater detail. Thevalve member16 is configured to be positioned within thehousing23. As illustrated, thetube40 of thevalve member16 can be inserted into and through thelumen28. Meanwhile, thestruts42 are configured to pass through corresponding slots that extend lengthwise through themiddle portion32 of thehousing23. In an assembled configuration, thestruts42 are adjacent to thetip22 along two sides, and thetube40 is at least partially contained within thetip22. Theprotrusions44 are captured within thegaps38 formed in theupper housing34 of thehousing23.
• Aclosing mechanism56 is adapted to close the fluid passage extending through the closablemale luer10 from fluid communication with the external environment, preferably whenever themale luer10 is not engaged with thefemale connector92. In the illustrated embodiment, thefluid passageway52 comprises thelumen28 as well as thepassage54 of thevalve member16. Theclosing mechanism56 of the illustrated embodiment comprises both theflange section58 of thetube40 and the internal taper of the raisedportion29 of thelumen28. As these two surfaces contact, they can form a closure at or near thesecond end20 of themale luer10.
• The substantially matched internal tapering surfaces of the raisedportion58 of thetube40 and the raisedportion29 of thelumen28 assist in providing closure of thefemale connector92. Preferably a relatively fluid-tight closure is formed. The engagement between the raisedportions29 and58 can also be created in a number of other ways. In some embodiments, the material of theflange section58 and the material of the raisedportion29 of thelumen28 are configured to fit closely together, and are made of sufficiently compatible materials, to form a fluid-tight closure. In other embodiments, theflange section58, and/or additional portions of thevalve member16, can be constructed from a deformable material that more closely follows the contours of the internal surface of thelumen28, and thelumen28 need not have a taper. The sealingportion20 is configured, in some embodiments, to prevent fluid from escaping from within themale luer connector10. When thevalve member16 engages thehousing23, the sealingportion20 sits between themiddle portion32 of thehousing23 and thetube40. When fluid flows within thelumen28 of thehousing23 and along the outer surface of thetube40, the fluid is prevented from flowing past themiddle portion32 by the sealingportion20, and more particularly by therings69 at either end of the sealingportion20.
• The sealingportion20 is preferably held in position between thehousing23 andvalve member16 by the protrusions68 (seeFIG. 6) configured to fit within theholes36 in themiddle portion32 of thehousing23. Theprotrusions68 help to maintain the sealingportion20 in proper alignment.
• With reference to the embodiment illustrated inFIG. 8, the structure of an exemplaryfemale connector92 will now be discussed in further detail. Thefemale connector92 can comprise anelongate body72 having afluid passageway74 therethrough, and thefemale connector92 can have atip76 near its distal end. In some embodiments, thetip76 of thefemale connector92 has aradially extending surface78 disposed on its external surface. Thefemale connector92 can have a fluid conduit positioned within thefemale connector92. The fluid conduit is not included or required in all female connectors compatible with theconnectors10 disclosed herein. Along a proximalinner surface80 of thefemale connector92, thefluid passageway74 is preferably tapered such that the diameter of thefluid passageway74 decreases in the distal direction.
• As shown inFIG. 8, thehousing23, thevalve member16, theresilient member18, and the sealingportion20 are in an assembled configuration, in which theclosing mechanism56 forms a closing engagement between theflange section58 and the interior of thelumen28. In addition, the sealingportion20 is in closing engagement between thevalve member16 and thehousing23. Fluid from thepassage50 can flow through thewindows54 of thetube40 of thevalve member16. In this position, thewindows54 communicate with the interior of thetip22, but not yet with the external environment. Thelumen28 is closed at its second end by theclosing mechanism56 and at its first end by the sealingportion20.
• As shown inFIG. 8, thestruts42 of thevalve member16 extend through slots in thehousing23 such that their ends extend to positions near the end of theshroud24 toward the second end of the connector. These struts42 are configured to engage the proximal ends84 of thefemale connector92 as thefemale connector92 advances into engagement with the closablemale luer10.
• InFIG. 8, the male and female luers are shown in an unengaged configuration. To engage themale luer10 andfemale connector92, theradially extending surface78 of thefemale connector92 are screwed into theinner threads26 of themale luer10.
• As shown inFIG. 9, the two luers can be threadedly engaged towards one another until the taper of theinner surface80 of thefemale connector92 lies adjacent the correspondingly tapered external surface of thetip22. In other embodiments, the two luers can be threadedly engaged until the second end of thetip22 forms a closure with a corresponding surface (not shown) of thefemale connector92.
• As themale luer connector10 andfemale connector92 move towards each other into threaded engagement, theproximal end84 of the tip of thefemale connector92 contacts thestruts42 of thevalve member16. As themale luer connector10 andfemale connector92 move further into threaded engagement, thestruts42, and thereby thevalve member16, are moved in the direction of the first end of the male connector by thefemale connector92, displacing thevalve member16 relative to thehousing23. Thus, theflange section58 moves from the second end of thetip22 of thehousing23 towards the first end of the male connector. As these two tapered surfaces separate, a space forms between thevalve member16 and thehousing23 and fluid is allowed to pass through thehole30 into thefluid passageway74 of thefemale connector92, or vice versa. When used with some embodiments of thefemale connector92, an internal fluid conduit contacts the second end of thevalve member16 before the housing of thefemale connector92 contacts thestruts42 to open themale connector10. In some embodiments, the closure remains intact until theinner surface80 of the tip of thefemale connector92 has formed a closing engagement with the outer surface of thetip22 of themale luer10. Thus, thepassage50 of themale luer10 need not be in fluid communication with the external environment.
• As thevalve member16 moves relative to thehousing23, the elastic members64 (not shown inFIG. 9) of theresilient member18 distend and exert a restoring force. As long as thefemale connector92 engages themale luer10, this restoring force can be resisted by theradially extending surface78 of thefemale connector92 contacting theinner threads26 of thehousing23. However, when thefemale connector92 is withdrawn from themale luer10, theresilient member18 returns the valve element of thevalve member16 to closing engagement with thelumen28.
• Despite the relative movement between thehousing23 and thevalve member16, the sealingportion20 preferably maintains a fluid barrier between the outer surface of thetube40 and the inner surface of thelumen28. In some embodiments, the position of the sealingportion20 is maintained by theprotrusions68. In other embodiments, the sealingportion20 can be positioned by gluing the outer surface of thedeformable material70 to the inner surface of thelumen28 of thehousing23. Other means of fixing the sealingportion20 can also be used.
• As shown inFIG. 9, in the opened configuration, thefluid passageway74 of thefemale connector92 can fluidly communicate with thepassage50 of thevalve member16. Fluid can thereby flow fromtubing13 attached to themale luer10, into thepassage50 of thevalve member16, through thewindows54 into thelumen28, out from thelumen28 through thehole30 at the second end of thetip22 into thefluid passageway74 of thefemale connector92, and vice versa. Fluid is prevented from escaping themale luer10 through the gap between thehousing23 andvalve member16 by the sealingportion20. A fluid-tight closure can also be formed between corresponding tapers of thetip22 of thehousing23 and theinner surface80 of thefemale connector92.
• Turning toFIG. 10, theconnector10 is displayed adjacent to a closeablefemale luer connector210. In the sample embodiment illustrated here, the closeablefemale luer connector210 comprises anouter housing213, avoid space212, afluid passageway218, afluid conduit216 with one ormore holes215, acompressible seal element214 with aproximal surface217, and a threadedengagement region211. The closeablefemale connector210 is positioned with its proximal end adjacent thesecond end56 of themale connector10. The threadedengagement region211 of the closeablefemale connector210 can conform to standard sizing for luer connectors, such as those that meet ANSI standards. Thecompressible seal element214 can be composed of water-impermeable, resilient material which can reduce in size when a force is exerted upon it. Thefluid conduit216 can be composed of a rigid material, such as polycarbonate plastic, which is capable of resisting deformation when a force sufficient to compress theseal element214 is exerted upon the closeablefemale connector210. Thefluid passageway218 can place thefluid conduit216 in fluid communication with thesecond end219 of the closeablefemale connector210. At least onehole215 in thefluid conduit216 can be sealed by thecompressible seal element214 to prevent thefluid passageway218 from being in fluid communication with thevoid space212 between thecompressible seal element214 and the inner wall of thehousing213 and/or with the exterior of thehousing213. The hole or holes215 can be sized appropriately small enough to permit fluid to pass between thefluid passageway218 and thevoid space212 at an appropriate flow rate. One such size for the hole or holes215 is approximately one millimeter in diameter, although irregular shapes and other sizes can be used. Holes of at least about 1 mm or approximately 1 mm-3 mm, or less than about 1 mm can also be used. Theconnector10 can be engaged with atubing13 containing a fluid.
• With reference toFIG. 11, theconnector10 can be threadedly engaged with the closeablefemale connector210. The threadedregion211 of the closeablefemale connector210 can engage with theinner threads26 of themale connector10 to engage theconnectors10,210, as illustrated. In the illustrated engagement, theluer tip22 advances into the closeablefemale connector210 by compressing thecompressible seal element214. As can be seen, theluer tip22 contacts thecompressible seal element214 on theproximal surface217 of thecompressible seal element214. The force exerted to engage theconnectors10,210 and engage the threadedregions26,211 is sufficient to compress theseal element214 to expose theholes215 in thefluid conduit216. With theseal element214 compressed, thefluid passageway218 is in fluid communication with the interior space of theluer tip22.
• As theluer tip22 advances further into the closeablefemale connector210, thefluid conduit216 contacts the end of thevalve member16 towards the second end of the male connector. Thevalve member16 is displaced towards the first end of the male connector by the contact and continued advancement of theluer tip22. Theresilient member18 exerts a closing force in a direction towards the second end of the male connector on thevalve member16. As a result, the tip of thevalve member16 towards the second end of the male connector generally maintains contact with thefluid conduit216 throughout the engagement. As the valve member is moved in a direction towards the first end of the male connector, theflange section58 of thevalve member16 separates from the interior surface of thehousing23 through which thehole30 passes. As a result, thewindows54 are opened to fluid communication with the closeablefemale connector210. Thecompressed seal element214 inhibits fluid flow into the interior of the closeablefemale connector210 beyond theluer tip22. In this configuration, fluid can flow from thetubing13 at the end of thevalve member16 toward the second end of the male connector and into thetube40 through thewindows54 into the interior of thelumen28, out thehole30 in theluer tip22, into the interior of theouter housing213 of the closeablefemale connector210, in theholes215 of thefluid conduit216 and into thefluid channel217 in the interior of thefluid conduit216. Thus, the second end of theconnector210 is placed in fluid communication with theproximal end219 of the closeablefemale connector210. Additionally, the sealingportion20 preferably maintains a fluid barrier between the outer surface of thetube40 and the inner surface of thelumen28, confining the flow of fluid towards the closeablefemale connector210. When the surface of the valve member towards the second end of the connector is directly contacted by a female connector member such as thefluid conduit216, thestruts42 may not be engaged by the female connector.
• Theconnectors10,210 can be threadedly disengaged. During engagement, the force exerted by theresilient member18 can return theconnector10 to its pre-engaged state by directing thevalve member16 to engage theflange section58 of the end of thevalve member16 toward the second end of the male connector with the internal surface of theluer tip22. Likewise, the resilient material of which the compressible seal is composed can return to its shape in the closed position and theproximal surface217 can seal the proximal tip of the closeablefemale connector210.
• Referring now toFIG. 12, theconnector10 can be engaged with asyringe250. InFIG. 12, thesyringe250 andconnector10 are displayed adjacent to each other. The syringe can comprise amale luer connector252, aplunger258, areservoir260, and convenient finger anchors262. Theluer connector252 can further comprise an internally threadedshroud254 and asyringe luer tip256. In the illustrated embodiment of theconnector10, a threadedsurface150 is disposed on the outside surface of the first end of thevalve member16.
• With reference now toFIG. 13, theconnector10 can be threadedly engaged with thesyringe250. Theshroud254 can engage with theend16 of the valve member toward the first end of the connector to connect theconnector10 to thesyringe250. Thereservoir260 of thesyringe250 can be placed in fluid communication with thetube40 interior to thevalve member16.
• Turning toFIG. 14, the engagement illustrated inFIG. 13 is shown in a cross-sectional view. Thesyringe250 is threadedly engaged with theconnector10 by the engagement between theshroud254 and the threadedsurface150 of thevalve member16. Theluer tip252 of thesyringe250 is extended into thetube40 of thevalve member16. Thereservoir260 of the syringe, shown here with a fluid in thereservoir260, is in fluid communication with the interior of thevalve member16. The fluid can pass through thetube40 and towards theluer tip22 of theconnector10. In the illustrated embodiment, the fluid cannot exit theconnector10 out itsmale luer tip22 because theflange section58 is in contact with the interior surface of thelumen28. Accordingly, thehole30 in the tip of thehousing23 towards the second end of the connector is blocked by thevalve member16. In order for thesyringe250 andconnector10 to transition from the stage shown inFIG. 12 to the stage shown inFIG. 14, thevalve member16 may need to be temporarily opened to release air (as described in more detail below).
• Referring toFIG. 15, theconnector10 is shown adjacent to and between asyringe250 and a hypodermic needle withsheath270. Thesyringe250, like that ofFIG. 12, can comprise amale luer connector252, aplunger258, areservoir260, and convenient finger anchors262. Theluer connector252 can further comprise an internally threadedshroud254 and asyringe luer tip256. The needle withsheath270 can comprise ahousing266 with raisedtabs264 on the engagement end and aneedle268.
• With reference toFIG. 16, theconnector10 is shown threadedly engaged with both thesyringe250 and needle withsheath270. The threadedsurface150 of thevalve member16 of theconnector10 can engage with the threaded shroud154 of thesyringe250. Accordingly, theluer tip256 can protrude into thetube40 of thevalve member16. Similarly, the raisedtabs264 can engage with theinner threads26 of theshroud24 of theconnector10. Theluer tip22 of theconnector10 can protrude into thehousing266 of the needle sheath.
• InFIG. 17, the engagement shown inFIG. 16 is illustrated in a cross-sectional view. Theconnector10 is engaged by asyringe250 and a needle with asheath270. Thesyringe250 is threadedly engaged with the threadedsurface150 of thevalve member16 of theconnector10. The needle withsheath270 is threadedly engaged with theinner threads26 of theshroud24.
• Theluer tip256 of thesyringe250 protrudes into thetube40 of thevalve member16. Thereservoir260 of thesyringe250 is in fluid communication with thetube40 of thevalve member16 through theluer tip256.
• Theconnector10 is engaged with the needle with asheath270. Thehousing266 of the needle withsheath270 has raisedtabs264 near its proximal end. The raisedtabs264 threadedly engage theinner threads26 of theshroud24 of theconnector10. As theluer tip22 advances into thehousing266 of theneedle268, the proximal end of thehousing266 can contact thestruts42 of thevalve member16. When the needle withsheath270 is fully engaged with theconnector10, thevalve member16 has been displaced a distance which separates theflange section58 from the tapered interior wall of thelumen28 sufficiently to permit fluid to flow out thewindows54 of thevalve portion16. The fluid can then flow out thehole30 in the end of theluer tip22 and into thehousing266 of the needle withsheath270. Thehollow needle268 permits the fluid to flow from within thehousing266 out the distal tip of theneedle268. The sealingportion20 preferably maintains a fluid barrier between the outer surface of thetube40 and the inner surface of thelumen28, confining the fluid in the lumen and the direction of flow toward thehole30 in theluer tip22. Thus, at this stage, thesyringe250 is in fluid communication with the distal tip of theneedle268. As was previously illustrated inFIGS. 13 and 14, in some embodiments, theconnector10 will generally not permit fluid to flow out of thesyringe250 without a component engaged with thesecond end14 of theconnector10. The component illustrated inFIGS. 15-17 is a needle with asheath270; however, other components, such as those which permit fluid flow and possess a female luer engagement portion, can also be used.
• FIG. 18A displays a perspective view of another embodiment of a closeable male luer. Therotatable connector300 is comprised of ahousing310, aninternal passageway322 and aseal element330. The housing is further comprised of aluer tip312, aluer receiver316 at the first end of theconnector300, anengagement portion318, amanipulation portion320, and a raisedportion340. Theseal element330 can have anopening350 along itsface314 in a transverse direction. Theinternal passageway322 can extend from theluer receiver316 to theluer tip312. Thehousing310 can be composed of a water-impermeable material, such as a polycarbonate plastic. Thehousing310 can also be composed of a hydrophobic plastic. Other examples of materials suitable for construction of thehousing310 are glassed-filledGE Valox 420 or polypropylene. Depending on the application, many other materials can also be used.
• Thehousing310 illustrated is configured to receive a male luer tip at theluer receiver316 by threadedly engaging the male luer at itsengagement portion318. Thereceiver316 can conform to ANSI standards for a luer receiver. The illustratedmanipulation portion320 has two tabs extending radially from the central axis of thehousing310. Themanipulation portion320 is configured to aid the user in grasping and rotating theconnector300.
• Thehousing310 illustrated is also constructed to provide a closeable male luer at its second end. Theluer tip312 at the second end can be constructed to ANSI standards for a male luer tip. The luer tip joins the main body of thehousing310 at the raisedportion340. The raisedportion340 is constructed to inhibit theluer tip312 from advancing too far into a luer receiver. Thehousing310 can also have a recessedportion342 behind the raisedportion340. Theluer tip312 can also have aseal element330 which has aface314 towards the second end of the connector. Theseal element330 can be any water-impermeable, resilient material, including without limitation, silicone. The selection of the material for construction of the seal can be accomplished by one skilled in the art. Theluer tip312 can taper smaller in a direction from the raisedportion340 as it approaches its second end.
• Theseal element330 can also have anopening350 in theface314 toward the second end of the connector prior to engagement with any other component. Theopening350 can be a slit in a transverse direction to the longitudinal axis of thehousing310. Theopening350 can be centered across theface314, or located in another position on theface314. Theseal element330 can cover the entire second end of theluer tip312, or only a portion thereof. Theseal element330 can be attached to the housing by an overmolding process, among other attachment methods. In such an overmolding process, thehousing310 can be formed by injection molding in a first step, and then in a second step, thehousing310 can be re-inserted into a mold (or remain in a mold) and an appropriately sized molding pin (not shown) can be inserted through a wider end of thehousing310, such as the second end. Silicone material can then be injected into the mold to form theseal element330. In other embodiments, theseal element330 can be glued or otherwise adhered into thehousing310.
• As can be seen from the illustrated embodiment inFIG. 18A, theseal element330 can inhibit fluid from flowing through thehousing310 when theluer tip312 is not engaged with another component. Thus, when a fluid-containing component (not shown) with a male luer connector is connected to theluer receiver316, theconnector300 can be used to control flow of fluid through itsluer tip312. For example, when a fluid-containing component such as a syringe is engaged with theconnector300, fluid is permitted to fill thehousing310 of theconnector300 by flowing through theinternal passageway322, but theseal element330 can substantially inhibit flow of fluid out theluer tip312. If the interior space of the housing is filled with air or another gas before the fluid enters, theconnector300 may need to be opened to allow the air or other gas to escape before the fluid can enter. In some embodiments, as described in detail below, the internal surface of theseal element330 can be adapted to increase the resistance against the widening of theopening350, which could allow fluid to escape when the fluid (not shown) exerts a pressure against theseal element330 from theinternal passageway322. Thus, theconnector300 inhibits flow of fluid from a fluid-bearing component when theconnector300 is attached to the male luer of the fluid-bearing component without another component connected to theluer tip312 of theconnector300.
• In some modes of use, theopening350 on theface314 of theseal element330, normally closed in the position shown, can be opened when theluer tip312 comes in contact with a suitable female connector, such as a Clave® connector sold by ICU Medical, San Clemente, Calif. An illustrated engagement of this configuration is discussed in detail below. The engagement can be achieved in many other ways, and with many other structures, including connectors other than the Clave connector.
• FIG. 18B is a cross-sectional view of theconnector300 illustrated inFIG. 18A. Theconnector300 can have aninternal passageway322 which connects theluer receiver316 to theluer tip312. Theengagement portion318 can be configured to receive an internally threaded shroud of a male luer connector (seeFIG. 19). The manipulatingportion320 can extend radially away from theinternal passageway322, as shown. Theseal element330 can extend along at least part of theinternal passageway322, and can be disposed across at least part of the second end of theconnector300. Theseal element330 can extend beyond the end of theluer tip312. Theseal element330 can have a cross-sectional area approximately equal to thehousing310 at the end of theluer tip312. In those embodiments where theluer tip312 andseal element330 are generally circular, the outside diameter of theseal element330 can be equal to the outside diameter of theluer tip312. Theseal element330 is not confined to a circular shape (nor are any other structures disclosed herein), and other shapes can be used. In other embodiments, theseal element330 does not extend beyond the end of thehousing310 towards the second end of theconnector300, but can have a maximum outer dimension equal to that of the inner dimension of theluer tip312. Theseal element330 can have aclosing portion324. The closingportion324 can permit fluid flow through theseal element330 of theconnector300, but is biased to generally close theopening350 in theseal element330. The structure of the closingportion324 can be adapted to resist permitting fluid (not shown) from exiting theopening350 when theluer tip312 is not engaged with another component, as described in further detail below.
• As can be seen inFIG. 18C, which is a detail of the cross-sectional view presented inFIG. 18B, theseal element330 can comprise the entire face of the second end of theconnector300. In other embodiments, theseal element330 may not extend beyond thehousing300. Theinternal passageway322 can extend to the seal at the second end of theconnector300.
• FIG. 19 illustrates a perspective view of theconnector300 adjacent asyringe360. As in previous descriptions, the syringe can comprise amale luer connector362, afluid reservoir370, aplunger374, and finger anchors372. Theluer receiver316 of theconnector300, which can be of appropriate size and shape to engage with standard luer connectors, is positioned to receive theluer tip364 of thesyringe360. Theinternal threads368 of theshroud364 of thesyringe360 are properly aligned to threadedly connect with theengagement portion318. In this way, thereceiver316 can engage theluer connector362 and connect theconnector300 to thesyringe360. Before engagement of thesyringe360 with theconnector300, the fluid within thereservoir370 is not inhibited from exiting theluer tip364 by any physical component.
• Referring now toFIG. 20, a perspective view of theconnector300 threadedly connected to asyringe360 is shown. Theconnector300 can be connected to thesyringe360, or other medical implement, by many other means, such as glue, adhesive, solvent, ultrasonic welding, epoxy, interference fits, mechanical connections, and/or unitary constructions. The receiver316 (not shown) contains at least part of theluer tip364 of thesyringe360. Theluer tip364 extends at least partially into theinternal passageway322. The threadedengagement portion318 is engaged with theinternal threads368 of theshroud364 of thesyringe360. Fluid from thereservoir370 can then flow freely within thehousing310 of theconnector300, by way of theinternal passageway322. If the interior space of the housing is filled with air or another gas before the fluid enters, theconnector300 can be opened to allow the air or other gas to escape before the fluid can enter. In some cases, thehousing310 of theconnector300 may be filled with a gas, such as air. Before the fluid enters thehousing310, the connector may need to be opened to allow the gas to escape before the fluid can flow. Theseal element330 inhibits fluid from leaving theconnector300. Theluer tip312 of theconnector300 can be used to connect the connector-syringe300,360 combination to other components for controlled fluid transfer. Theconnector300 can also be formed integrally with the syringe360 (not shown), such that thehousing310 of the connector is formed by the fluid-delivery end of the syringe. During use of this combination connector-syringe, themale luer tip312 of theconnector300 can, in effect, replace theluer tip364 of the syringe for connection purposes.
• Certain medications, such as chemotherapy medications, are contact toxins, and avoiding exposure to the skin is desirable. Such medications are often stored in a syringe with a hypodermic needle, such as depicted inFIGS. 15 and 16. Under certain conditions, without the use of a closeable male luer connector, it can be possible for the toxic fluid to flow out of the syringe. Even if steps are taken to avoid accidental fluid flow, such as orienting the syringe with attached needle such that gravity aids the retention of the medication within the syringe, the medication can also vaporize and seep out of the hypodermic needle in a gaseous state. The use of a closeable male luer between the syringe and hypodermic needle inhibits the uncontrolled flow of medication, in both liquid and gaseous states. Accordingly, risk of accidental exposure to such toxic medications is minimized.
• Referring now toFIG. 21, the closeablemale luer connector300 is illustrated in another embodiment, wherein an internally threadedshroud380 is disposed on thehousing310. Theshroud380 at least partially or entirely encircles thehousing310 at approximately the recessed portion342 (visible inFIG. 18A). In some embodiments, theshroud380 is not attached to theconnector300, and instead can rotate freely about the longitudinal axis of theconnector300. The raised portion340 (visible inFIG. 18A) can inhibit the movement of theshroud380 towards theluer tip312 of theconnector300. Additionally, themanipulation portion320 of theconnector300 can inhibit the movement of theshroud380 towards theluer receiver316. Theshroud380 can be threaded consistent with ANSI specifications for luer connectors. Theshroud380 can assist theluer tip312 in forming a connection between theconnector300 and other components (not shown).
• With reference now toFIG. 22A, the cross-section of a closeablemale luer connector400 with a continuously taperinginternal passageway402 is illustrated. The housing's404 taperinginternal passageway402 permits for varied injection molding techniques of manufacture. For example, if the taper is wider at an end with aluer receiver406, a molding pin can be tapered in a corresponding manner to closely fit against the wall of theinternal passageway402, producing aseal408 that is shorter than the seal illustrated inFIG. 18B.
• With reference toFIG. 22B, theseal408 in the illustrated embodiment has aclosing portion412 similar to that of the closingportion324 inFIG. 18B. In addition, the internal surface of theseal408 can be adapted to increase resistance against permitting fluid from exiting theopening410 when a fluid (not shown) in theinternal passageway402 exerts a pressure against theseal408. The internal surface of the closingportion412 can include slanted surfaces against which such fluid presses to urge theopening410 more tightly closed.
• Turning toFIG. 23A, a side view of another embodiment of theconnector400 ofFIG. 22A is displayed. An internally threadedshroud420 is disposed about the outer surface of thehousing404.
• As can be seen inFIG. 23B, thehousing404 can have a raisedportion424 which inhibits axial movement of theshroud420 toward theluer tip416. Thehousing404 can also have amanipulation portion418 which extends radially outwardly from the longitudinal axis of theconnector400. Thehousing404 also has aninternal passageway428 extending from theluer receiver414 to theseal element430. Themanipulation portion418 can inhibit movement of the shroud towards theluer receiver414 of theconnector400. The manipulation portion can also be a convenient place for the user to place his or her fingers while turning theconnector400. Additionally, there can be a recessedportion426 of theconnector400. The recessedportion426 can be a portion of theconnector400 with a smaller outer diameter than the outer diameter of the raisedportion424 or themanipulation portion418. Theshroud420 can be disposed on theconnector400 such that a narrow portion of theshroud420 encircles theconnector400 about the recessedportion426. Theshroud420 can be unaffixed to thehousing404 and thus free to rotate. Theinternal threads422 of the shroud can conform to ANSI standards for luer connectors, allowing the shroud to assist theluer tip416 in engaging the female connector of another component (not shown).
• FIG. 23C depicts the closeablemale luer connector400 ofFIG. 23B in the proximity to a suitablefemale connector450, such as a Clave® connector sold by ICU Medical, San Clemente, Calif. Thefemale connector450 is similar to that illustrated inFIG. 10.
• FIG. 23D illustrates an engagement between themale luer connector400 andfemale connector450. The internal threads of theshroud420 can engage with a threadedregion451 of thefemale connector450. Theluer tip416 of themale luer connector400 can advance into thefemale connector450 by compressing acompressible seal454. As themale connector400 advances, a stationaryfluid conduit456 of thefemale connector450 can penetrate theopening448 in theseal element430 ofmale connector400. Thefluid conduit456 can advance far enough into themale connector400 that theholes455 advance into theinternal passageway428 of themale connector400. Once theholes455 of thefemale connector450 are disposed within theinternal passageway428 of the male connector, fluid can flow from theluer receiver414 of themale connector400 through theinternal passageway428 of themale connector400 to theholes455 of thefluid conduit456 of thefemale connector450. The fluid can then flow through theholes455 and into afluid conduit458 of thefemale connector450. Thus, fluid can flow from the first end of themale connector400 to the distal end of thefemale connector450 when the two are engaged. When theconnectors400,450 are disengaged, thefluid conduit456 withdraws from theinternal passageway428 and theseal element430 closes, thereby inhibiting fluid flow through themale connector400. Additionally, the compressible seal411 of thefemale connector450 returns to its original position, and inhibits flow through theholes455 in thefluid conduit456.
• With reference now toFIG. 24A, a closeablemale luer connector500 is displayed in a perspective view. Theconnector500 has ahousing510 and aseal514. The housing is comprised of amanipulation portion512. In this exemplary illustration, themanipulation portion512 includeswings516. Thewings516 are adapted to provide a place for the user to grasp and rotate thehousing510 of theconnector500.
• Referring now toFIG. 24B, theconnector500 ofFIG. 23A is shown in cross-section. Thewings516 are shown as extending outward from the longitudinal axis of theconnector500 and towards theluer receiver518 of the connector. Theinternal passageway520 of thehousing510 has a continual taper, as described in the embodiment of theconnector400 inFIG. 22A.
• Turning toFIG. 25A, a side view of a closeablemale luer connector600 is illustrated. Theconnector600 has ahousing610, aseal element614, and ashroud620. The housing comprises aninternal passageway640, aluer tip612, and amanipulation portion616. The manipulation portion can be constructed to comprise twowings630, as described inFIG. 24A. The shroud can haveinternal threading622, and such threading can be constructed to comply with ANSI specifications for luer connectors. Theseal element614 can be biased closed when not engaged.
• With reference now toFIG. 25B, a cross-sectional view of theconnector600 fromFIG. 25A is displayed. Theshroud620 can encircle thehousing610 at a recessedportion652 of thehousing610. A raisedportion650 can inhibit motion of theshroud620 in the direction of the second end of theconnector600 while themanipulation portion616 can inhibit motion of the shroud in the direction of the first end of theconnector600. Theinternal threading622 of theshroud620 can be used to engage other components (not shown) when used in conjunction with theluer tip612. The continuously taperinginternal passageway640 has characteristics that assist in injection molding as discussed with regard toFIG. 22A.
• Referring toFIG. 26A, a perspective view of a closeablemale luer assembly725 comprising a closeablemale luer700 and a flexibly connectedfemale luer connector750 is displayed. The closeablemale luer700 can embody any number of the aspects and features described in this application. Thefemale luer connector750 is adapted to receive a standard male luer connector (not shown). Thefemale luer connector750 is located adjacent themale luer connector700 and flexibly connected to it. Thefemale luer connector750 comprises aninternal passageway752, aluer receiver754, and anengagement portion756. Theinternal passageway752 places theluer receiver754 in fluid communication with an internal passageway of the closeablemale luer connector700. The closeablemale luer connector700 can be attached to thefemale luer connector750 through aflexible segment760. In some embodiments, such asegment760 can include an accordion-like flexible portion of resilient material. In other embodiments, a straight, flexible material can be used. In other embodiments, both a flexible outer segment and a flexible tube can be used to connect the closeablemale luer700 with thefemale luer750.
• With continued reference toFIG. 26A, theflexible segment752 permits the user to orient thefemale connector750 of theassembly725 in a different attitude than that of the closeablemale luer connector700. As an example, the closeablemale luer700 can remain stationary against a patient's arm while thefemale connector750 is angled away from the arm to assist in easy connection with a syringe or other component (not shown). By flexibly connecting the closeablemale luer700 to thefemale luer connector750, the moment generated by moving thefemale luer connector750 is accepted at a point between the two components of theassembly725 and is less likely to be transmitted to another component (not shown) attached to the closeablemale luer connector700. Such a component could include an I.V. site, where angling of the connection could result in harm to the patient. Moreover, the moment will be less likely to bend and/or dislodge the tip of thetube40 from the interior of the lumen28 (see, e.g.,FIG. 28).
• FIG. 26B illustrates another embodiment of a closeablemale luer assembly800 comprising a closeablemale luer connector825 and a flexibly connectedfemale luer connector850. Theconnectors825,850 and their components are similar in many respects to the embodiment depicted inFIG. 26 and can embody any number of the aspects and features described above. The closeablemale luer connector825 and thefemale luer connector850 are flexibly connected by a connectingmember860. The connectingmember860 places theconnectors825,850 in fluid communication. The connectingmember860 illustrated here comprises an accordion-shaped plastic conduit. The connectingmember860 is configured to permit the closeablemale connector825 and thefemale luer connector850 to be positioned at different angular orientations. By way of example, the closeablemale luer connector825 can remain stationary while thefemale luer connector850 can be positioned at an angle to the closeablemale luer connector825. In another example, thefemale luer connector850 can remain stationary while the closeable male luer connector can be positioned at an angle to thefemale luer connector850. In yet another example, the closeablemale luer connector825 and thefemale luer connector850 can both be placed at an angle.
• As described above, some medications, including those used during chemotherapy, can be harmful through certain forms of exposure to a patient. For example, exposure to the skin can sometimes result in a chemical burn. Inhalation of aerosolized forms of some medications can be harmful. Thus, control over the containment of the medication is highly desirable.
• At present, some potentially harmful medications are distributed in sealed vials. The medication is removed from the vial by inserting a needle, and drawing the medication into a syringe. The needle is then withdrawn from the vial and the medication can be dispensed. However, by inserting the needle into the medication for drawing into the syringe, medication is disposed on the outside of the needle, which can inadvertently come in contact with the skin and cause harm. Alternatively, an injector which penetrates the vial with a withdrawal mechanism can be used. In such an injector, the medication is drawn through the mechanism and passed directly to a needle for injection without the additional step of withdrawing the mechanism from the vial. Even if such an injector is used, there is still the possibility of latent medication remaining on the needle used to inject the medication, or on the mechanism after the vial is decoupled.
• Additionally, some medications can be distributed by attaching a needle to a syringe with the medication located therein. The engaged syringe with medication and needle is sterilized and placed into a vacuum-sealable container. The container is then evacuated and sealed. This type of arrangement can result in the draw of medication out through the syringe when the container is evacuated. While in the sealed container, the medication may aerosolize or coat the outer surface of the components.
• Additionally, when the ambient atmospheric pressure of the treatment location is different, particularly lesser, than that of the internal pressure of the medication within a container, there is the possibility that an uncontrolled spray of the medication occurs when fluid communication between the medication and the ambient atmosphere occurs. For example, medication may escape when a vial with a greater internal pressure than the ambient atmosphere is penetrated by a needle for drawing the medication into a syringe. Alternatively, medication may escape when the needle is withdrawn from the vial before the vial seal completely closes.
• With a closeable male luer, flow of the medication out of a syringe with a needle is inhibited, except during desired application. For example, in some embodiments, a syringe with a closeable male luer connected will not leak medication when packaged for shipment, even if the package is vacuum-sealed. Once the package is opened, the male luer connector can be engaged with a female luer connector of an IV tube, for example, and the medication dispensed only when the connection is engaged. Following flow of the medication from the syringe through the engaged connectors and into the IV tube, the male luer connector can be disengaged from the female luer connector. As described above, the male luer connector can close on disengagement, preventing excess flow through the connector. When a closeable female luer connector, such as a Clave® connector sold by ICU Medical, San Clemente, Calif., is used, flow is inhibited from exiting the female connector as well.
• Additionally, a syringe with a closeable male luer can be engaged with a needle as described above. Flow through the needle can thus be controlled by proper use of the closeable male luer connector.
• Medication can also be disposed within a syringe with an integrally formed, and/or permanently attached, closeable male luer.
• Thus, direct exposure of the dangerous medications described can be essentially limited to the highly controlled environments where the medications are produced and contained. Such medications can be placed in a syringe with a closeable male luer connector prior to distribution for use, minimizing the risk of inadvertent exposure of the medication during use of the medication.
• Any features of the embodiments shown and/or described in the figures that have not been expressly described in this text, such as distances, proportions of components, etc. are also intended to form part of this disclosure. Additionally, although this invention has been disclosed in the context of various embodiments, features, aspects, and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to perform varying modes of the disclosed inventions. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a proper reading of the claims.

Claims (1)

1. A luer connector comprising:

a housing with a hollow bore having a first end, a second end, a male luer tip with a tapering interior surface;

a rigid valve member configured to at least partially extend through the housing, the valve member having a first opened end and a second closed end and comprising:

a passageway within the valve member;

an outwardly extending flange near the second end adapted to seal the hollow bore at the second end of the housing when placed in contact with the tapering interior surface of the housing;

at least one opening near the closed end of the valve member extending outwardly from the passageway through the valve member;

at least one strut connected to the valve member and extending towards the second end of the valve member, the at least one strut extending substantially parallel to the central axis of the valve member and at least partially surrounding a narrow section of the valve member ending in the second closed end;

a retaining member configured to couple the valve member and the housing; and

a sealing element disposed within the housing and configured to inhibit fluid communication through the hollow bore of the housing between the interior of the male luer tip of the housing and the first end of the housing.

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