US20060202146A1 - Valved male luer connector having sequential valve timing - Google Patents

Abstract

A male Luer connector that attaches to a standard female Luer connector to open a medical fluid flow channel between the two connectors. The male connector has two internal valves and a vacuum-generating structure. The two valves and the vacuum-generating structure are configured to draw back into the male connector any fluid residing on the interface between the male and female connectors during their disengagement from one another and to then seal the distal tip of the male connector. One valve is located at the proximal end of the male connector while another is located at the distal, interface end of the male connector. Both valves are opened by an actuator plug that is moved to open and close the valves by contact with the front surface of the female connector. A resilient member biases the male valves to the closed position and includes a variable internal volume that creates the partial vacuum upon disengagement of the male and female connectors. The male valves are timed to a particular sequence with the closing of an internal female connector valve so that the partial vacuum generated by the male connector will have the most fluid drawback effect.

Description

CROSS REFERENCES TO OTHER APPLICATIONS
• This application is a continuation-in-part of application Ser. No. 10/389,652 filed Mar. 13, 2003, having a publication no. of 2003/0136932 A1, which is a continuation-in-part of application Ser. No. 09/927,109, filed on Aug. 10, 2001, having a publication no. of 2003/0032940, now U.S. Pat. No. 6,745,998 A1.
BACKGROUND
• This invention relates to an improved male luer connector device that attaches to a female luer valve to open a flow channel through the male luer. Once the engagement of the luers has been established, these valves are used to make connections in hospitals for intravenous (IV) devices in order to be used in medical liquid flow applications.
• Luer devices are used in particular in a variety of medical applications where there is a desire to interconnect together male and female connector parts onto tubing material that is connected to an IV. The most common types of IV fluid exchanges use a syringe fitted with a nozzle that is designed to be received into a corresponding receiver attached to the IV device. The receiver often has a hollow tubular cannula or post that routes fluid into a line inserted into the IV extending into the patient's veins.
• Typical luer connections utilize a male luer connector that is inserted into a female luer connector. The male luer connector is threaded onto corresponding threads of the female luer connector to engage the two so that fluid may be passed between them without escaping or leaking from the connection. Because these connections are subject to coming loose or disengaging, there is always a possibility that fluid being passed within these tubes can escape. When using hazardous drugs, such as those used for chemotherapy treatments, the possibility of escaping fluids can be a dangerous problem. Additionally, even if the fluid does not leak when the connectors are engaged, once they are disengaged, the residual amount of fluid remaining on the tip of the connectors can still be harmful. While this amount may be less than an amount escaping from the connectors, it can still be significant enough to cause harm to any person exposed.
• Therefore, there is a need for a luer connection that securely contains the fluid materials included therein when luers are engaged to one another. There is also a need for a luer connection that seals off the male luer connector in a male-female connection so that users of the connector are protected from hazardous drugs that remain on the luer tip surface when disengaged.
SUMMARY OF THE INVENTION
• Briefly, and in general terms, the invention is directed to a male valved connector that creates a partial vacuum upon disengagement from a female connector to draw fluid disposed at an interface between the male and female connectors away from the interface.
• In accordance with aspects of the present invention, there is provided a male Luer connector for connection with a female Luer connector for medical fluid flow, the female connector having a front contact surface and an internal valve, the male Luer connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface and vacuum means for creating a partial vacuum at the distal end of the tubular housing during disengagement of the male connector from the female connector during a time period when the female valve is closed, whereby the vacuum means draws fluid residing at the interface away from the interface during disengagement of the male and female connectors. In more detailed aspects, the vacuum means is located within the tubular housing, and comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing. The vacuum means also comprises a second valve controlling the flow of fluid through the distal end of the tubular housing and the vacuum means is also for controlling the second valve to remain open while the vacuum means creates the partial vacuum.
• In further detailed aspects in accordance with the invention, the vacuum means is also for controlling the first valve to close first, and controlling the second valve to remain open after the female connector valve closes during disengagement of the female connector from the male connector. The vacuum means comprises an actuator that controls the opening and closing of the first and second valves and further comprises an actuation surface disposed so as to be moveable by the front contact surface of the female connector to control the actuator to open and close the first and second valves. The first valve comprises a proximal valve disposed at the proximal end of the tubular housing, the second valve comprises a distal valve disposed at the distal end of the tubular housing, and the actuator is disposed within the tubular housing to open and close both the proximal and distal valves.
• In yet further aspects, the vacuum means further comprises a resilient member disposed to bias the actuator to close both the proximal and distal valves. The resilient member has an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the male connector is disengaged from the female connector, the cavity having a second volume smaller than the first volume when the male connector is engaged with the female connector, whereby the resilient member creates a partial vacuum when moving from the second volume to the first volume during closure of the distal valve occurring when the female and male connectors are being disengaged. In more detail, the cavity has the second volume when the male and female connectors are engaged and the cavity moves to the first volume thereby creating the partial vacuum when the male and female connectors are being disengaged.
• In even further detailed aspects, the resilient member forms a valve seat for the distal valve and a valve seat for the proximal valve and the actuator provides a distal valve member for the distal valve that fits into the distal valve seat to close the distal valve and provides a proximal valve member for the proximal valve that fits into the proximal valve seat to close the proximal valve. The resilient member provides the actuation surface, the actuator is disposed within the resilient member in contact with the resilient member, and movement of the resilient member due to engagement with the front contact surface of the female connector causes corresponding movement of the actuator to open and close the distal and proximal valves.
• In other aspects, there is provided a male connector for connection with a female connector to establish a path for medical fluid flow, the female connector having a front contact surface and an internal valve, the male connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface, a first valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing, an internal plug disposed within the tubular housing, the internal plug having a first valve member that engages the first valve seat to prevent the flow of fluid past the first valve seat, and a resilient member disposed within the tubular housing so as to bias the internal plug to engage the first valve seat, the resilient member having an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the first valve is closed, the cavity having a second volume smaller than the first volume when the first valve is open, wherein the resilient member is disposed so that engagement of the female connector with the male connector causes the resilient member cavity to move to the second volume and disengagement of the female connector from the male connector causes the cavity to move from the second volume to the first volume thereby creating a partial vacuum.
• In accordance with aspects of a method in accordance with the invention, there is provided a method for disengaging a male connector from a female connector, the male connector including a distal end engaged with the female connector, a proximal end, and an internal valve and the female connector including a proximal end engaged with the male connector, a distal end, and an internal valve, the method comprising closing a first valve in the male connector at the proximal end of the male connector to isolate an interface between the male connector and the female connector from fluid at the proximal end of the male connector, and creating a partial vacuum at the interface of the male connector and female connector to draw fluid at the interface away from the interface. In further more detailed aspects, the method further comprises the step of closing the internal valve of the female connector during the step of creating a partial vacuum. The method also further comprises the step of closing a valve at the distal end of the male connector after the step of creating a partial vacuum. The method wherein the step of creating a partial vacuum comprises creating a partial vacuum within the male connector and drawing fluid at the interface into the male connector.
• These and other features and advantages of the present invention will become apparent from the following detailed description of preferred embodiments which, taken in conjunction with the accompanying drawings, illustrate by way of example the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• The present invention will be better understood from the following detailed description of an exemplary embodiment of the invention, taken in conjunction with the accompanying drawings in which like reference numerals refer to like parts and in which:
• FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting;
• FIG. 2 is an enlarged sectional view taken on line2-2 ofFIG. 1;
• FIG. 3 is a view similar toFIG. 2, with the components partially engaged;
• FIG. 4 is a view similar toFIG. 3, with the components fully engaged;
• FIG. 5 is a view similar to a portion ofFIG. 2, showing an alternative integrated spring member;
• FIG. 6 is a view similar toFIG. 5, showing an alternative single stage valve;
• FIG. 7 is a view similar toFIG. 6, showing the valve opened;
• FIG. 8 is a view similar toFIG. 5, showing a ball type valve;
• FIG. 9 is a sectional view showing an alternative slide actuated valve;
• FIG. 10 is a view similar toFIG. 9, showing the valve opened;
• FIG. 11 is a view similar toFIG. 9, showing an alternative slide actuated valve;
• FIG. 12 is a view similar toFIG. 10, showing an alternative valve for use with a female luer valve that does not have a cannula or post;
• FIG. 13 is an illustration of a male luer valve that does not contain a housing element;
• FIGS. 14 and 15 are views similar toFIG. 11 illustrating a male luer which does not contain a sleeve and showing the movement from a closed position (FIG. 14) to an open position (FIG. 15) for the male luer during contact with a female luer having no core rod or cannula;
• FIGS. 16 and 17 are views similar toFIGS. 14 and 15 illustrating a male luer having a central sealing member internally of the resilient member and showing the movement from a closed position (FIG. 16) to an open position (FIG. 17) for the male luer during contact with a female luer having no core rod or cannula;
• FIG. 18 is a view similar toFIG. 11 illustrating a male luer which has a peripheral flange incorporated into the resilient member which upon contact with the contract surface of a female luer (which has no core rod or cannula) is urged backwards causing the resilient member to retract and open;
• FIGS. 19, 20 and21 illustrate appearance and operation of male luers which have resilient members with smooth outer contact surfaces which upon contact with the contract surface of a female luer (which has no core rod or cannula) provide a sufficiently frictional connection such that the resilient member is urged backwards causing it to retract and open;
• FIGS. 22 and 23 are views similar toFIGS. 16 and 17 illustrating a male luer having a central sealing member internally of the resilient member which has a radially extending portion which protrudes into the wall of the resilient member and extends it outward, allowing it to extend into or through a guide in the housing of the male luer, which guide is engaged by a contact surface of a female luer having no core rod or cannula, such engagement causing the resilient member to retract and open to permit fluid flow between and through the luers; and
• FIGS. 24, 25,26 and27 are side elevation views (FIGS. 24 and 26) and end elevation view (FIGS. 25 and 27) of another embodiment of a resilient member of a male luer which has a slightly bulbous tip with a slit opening, which slit is compressed and opened during contact with the interior surface of a female luer with a generally conical contact recess;
• FIG. 28 is a cutaway perspective view of multi-valved male Luer connector in accordance with aspects of the invention for use in obtaining sequential valve timing and generating a partial vacuum at the male Luer connector end to remove excess fluid from the tip during separation from a female connector;
• FIG. 29 is a side, cross-sectional view of the male connector ofFIG. 28 showing it aligned with a compatible female valved connector prior to engagement;
• FIG. 30 is a view similar toFIG. 29 except that the male and female connectors have become partially engaged to the point where a distal valve of the male connector has opened while the proximal valve of the male connector and the valve of the female connector remain closed;
• FIG. 31 is a view similar toFIG. 30 except that the male and female connectors have become further partially engaged to the point where the distal valve of the male connector has opened and the valve of the female connector has opened while the proximal valve of the male connector remains closed; and
• FIG. 32 is a view similar toFIG. 31 except that the male and female connectors have become fully engaged and both distal and proximal valves of the male connector are open and the valve of the female connector is also open for complete fluid flow through both connectors.
DETAILED DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting. The fitting is comprised of amale luer10 that is intended to engage with a female luer that has an existing flush top female luer valve. Thefemale luer24 is not limited to a particular type but an exemplar luer is illustrated here. The female luer illustrated here is one where the valve shuts off. Thisfemale luer24 contains ahousing element28 with a cannula orpost26. On the outer surface of the forward end of thehousing28 there arethreads30 that permit engagement of thefemale luer24 with themale luer10. In this embodiment themale luer10 is comprised of ahousing element12. The inner wall of thehousing12 containsthreads32 that engage thecomplimentary threads30 of the female luer connector.Housing12 has an innertubular portion16 of reduced diameter that projects forwardly that has a firstnecked area36 and a second necked area38 (SeeFIG. 2). The inner tubular portion defines aninternal chamber13 with a forward opening33 (SeeFIG. 2). Avalve member18 is biased into an extendedposition sealing opening33 by resilient member orspring14.Spring14 acts between distal end ofchamber13 andvalve member18. (As used herein, “distal” is the rearward end of the male luer and “proximal” is the forward end, i.e., the left and right ends in the views as illustrated inFIGS. 1 and 2).Valve member18 includes aresilient portion20 and aforward tip member22.FIG. 1 illustrates the twoluers10,24 in the unengaged position. Other types of female luer valves that do not contain a cannula or post. By way of example, U.S. Pat. No. 5,676,346 by Leinsing and U.S. Pat. No. 5,782,816 by Werschmidt illustrate these types of luer valves.
• FIGS.2 to5 illustrate themale luer10 and thefemale luer24 as they become engaged with one another.FIG. 2 illustrates the twoluers10,24 when they are completely unengaged. The cannula or post26 may have anopening40 for entrance and exit of fluid between the two luers. Other duct systems (not shown) are possible and may be used. The cannula or post26 is mounted in a chamber within asleeve34. Thissleeve34 can be made of rubber or any other suitable resilient material and serves as a valve member stopper.Sleeve34 has a forward end opening35 which is sealed shut in the unengaged position ofFIG. 2. The male luer has a forward end that has a firstnecked area36 and a secondnecked area38 spaced rearwardly from the firstnecked area36.FIG. 3 illustrates themale luer10 beginning to be inserted into thefemale luer24. Once thethreads30,32 begin to engage, theforward end33 ofhousing12 pushes thesleeve34 back until theopening35 is forced to open over the end of thecannula26. The cannula or post26 then comes into contact with the tip ofvalve member18 and begins to push it rearwardly so that the cannula or post26 displaces the valveelement front section22. This movement begins to separate the seal surface of the firstnecked area36 from its seat. As thetip member22 begins to be pushed back, the secondresilient portion20 is collapsed, compressing thevalve element cavity19. This unseals the firstnecked area36 and displaces the liquid contained within thecavity19. This displaced liquid flows temporarily into thefemale luer valve24. As this pressure is applied, the valve member is compressed and pushed further inwardly intochamber13.
• FIG. 4 illustrates the positioning of the luer members when the female24 and male10 luers have been even further engaged. The cannula or post26 begins to push even more onto thetip member22 and collapse the firstresilient member14 so that the secondnecked area38 is unsealed. At this point, more liquid is displaced by the further insertion of the cannula or post into thevacuum section21 of the male luer as indicated by the arrows inFIG. 4. Theopening40 on the cannula or post26 permits fluid to pass into and out of thefemale luer24. This displaced liquid creates the volume which will be refilled when the action is reversed.
• Upon disconnection of themale luer10 valve from thefemale luer valve24, the volume of liquid that was displaced during the connection of the two valves is restored to the original positions, thus creating a relative vacuum. When thefemale luer24 is removed from themale luer10, the main seal created by the secondnecked area38 makes contact with its seat. This isolates thevacuum section21 from the upstream liquid. As the cannula or post26 is withdrawn,cavity19 is restored asresilient portion20 resiles to its uncollapsed natural shape. As this restoration occurs, liquid is drawn intocavity19. Because the secondnecked area38 is closed, this liquid will be drawn from the interface between themale luer10 and thefemale luer24. This effect is enhanced by the volume represented by the cannula or post26, which must be replaced as the cannula or post26 is withdrawn. The relative vacuum created will attempt to draw liquid into the vacuum section until the seal surface of the firstnecked area36 again contacts its seat.
• FIG. 5 illustrates the same type of dual stage valve as above only that it is formed with thespring14 integrally connected to thevalve member42. Thehousing12 contains theinner sleeve16 and positioned inside of theinner sleeve16 is aninner chamber13. The function of this embodiment is the same as the previously described embodiments with the exception that thespring14 can be comprised of elastomeric or other types of material that are integrally connected with thevalve member42.
• FIGS. 6 and 7 illustrate a male luer according to another embodiment of the present invention. This apparatus is a single stage luer valve with an integral resilient member. In this embodiment, the male luer has ahousing12 withthreads32 on the inner wall of the housing for engagement to the complimentary threads on thefemale luer30. Theinner chamber13 is sealed by avalve member42 that is integrally formed with the resilient member and the tip. Thisnew valve member42 therefore functions as in the previous embodiment except that all members are formed in one piece, rather than including a separate resilient member. This embodiment demonstrates a single stage luer valve in that once the female luer engages with thevalve member42, themember42 moves as a single piece rather than as several different pieces as described above.FIG. 7 illustrates the luer ofFIG. 6 engaged with afemale luer24 and permitting fluid flow. Once the twoluers10,24 are engaged, the cannula or post26 of thefemale luer24 collapses thevalve member42 and permits fluid flow via theopening40 in the cannula or post26 and also via anopening44 in the rear end of thevalve member42.
• FIG. 8 illustrates another embodiment of the present invention. In this embodiment, thehousing12 of the male luer is similar to the previous embodiments. Additionally, contained within theinner sleeve16 is a resilient member orspring14. However, in this embodiment, the valve contained on the end of the resilient member is shown as aball46. This ball may be made of various types of materials as for example, elastomeric material. Additionally, the forward end opening ofchamber13 is exemplified as a part-spherical seat47 to accommodate forball valve46. Those skilled in the art will recognize that the valve contained on the end of the resilient member orspring14 can be of a variety of shapes. However, the shape of the tip of themale luer10 needs to be one that corresponds to the shape of the tip of thefemale luer24.
• FIGS. 9 and 10 illustrate a modified connector according to yet another embodiment of the present invention, in which a modified male luer is releaseably securable to thefemale luer24 of the previous embodiments. The modified male luer comprises a housing with a cylindricalouter wall52 and an innertubular support54 which projects into the cylindrical housing fromrear end53 and extends along part of the length of the housing.Outer wall52 hasinternal threads32 for engaging thefemale luer threads30 and a larger diameter than theinner support54 which extends from therear end53 of the housing and projects out of the forward end of the housing. A resilient sleeve orbladder member56 is secured between thetubular member55 andsupport54 at its rear end, and projects forwardly withintubular member55 to its forward end opening57.Bladder member56 has a forward end opening58 which is sealed shut by the inwardly tapered end portion of thetubular member55 when in the extended, unconnected position ofFIG. 9. Theforward end portion58 ofbladder member56 acts as a valve to seal the end opening57 of the male luer in the position illustrated inFIG. 9.
• Tubular member55 of the male luer is of smaller diameter than the innercylindrical wall52 of the housing, to leave an annular gap between themember55 andinner wall52. A slidingsleeve60 is slidably mounted over thetubular member55 in this annular gap.Sleeve60 has diametrically opposedopenings62, and thetubular member55 has opposing elongate, axially extendingslots64. Oppositely directed guided portions65 (e.g., tabs, wings or fins) on the inner bladder orsleeve member56 project radially outwardly through theslots64 and into theopenings62. Thus, when the sleeve is in the fully extended position ofFIG. 9, it will pull the sliding sleeve forwardly into the illustrated position. Thecorrugated portion66 ofbladder member56 acts as a spring to bias the forward end of thebladder member56 and the slidingsleeve60 into the extended position.
• FIG. 10 illustrates afemale luer24 connected to male luer50. As the forward end of the female luer housing is threaded into the cylindrical wall of the male housing, it will engage theforward end67 of the slidingsleeve60, urging the sleeve, and thus thebladder member56, rearwardly and moving the forward end portion of the bladder member out of sealing engagement with the forward end opening oftubular member55. This permits the forward end opening58 to spring open, as indicated. At the same time, the forward end oftubular member55 will force thesleeve34 in the female luer rearwardly so that it passes over the end ofcannula26, which then extends into the open forward end of the tubular member. This allows fluid flow through the two luers, via the inner tubular support,open end58 of thebladder member56, and theopenings40 in thecannula26. When the luers are disconnected, the compressedcorrugated portion66 of thebladder member56 urges the forward end portion to move back into sealing engagement with the forward end of thetubular member55, preventing any fluid leakage.
• FIG. 11 is a view similar toFIG. 9, showing an alternative slide actuated valve except that the resilient sleeve orbladder member56 does not have a corrugated portion and instead has aseparate spring member68. Thespring member68 can any type as for example, those made of metal or elastomeric material. The function of the male luer valve is the same; it is merely thespring member68 that replaces the previous corrugated member.
• FIG. 12 is a view similar toFIG. 10, showing an alternative valve for use with a female luer valve that does not have a cannula or post. The outer surface of the forward end of thehousing28 engages and compresses theforward end67 of the slidingsleeve60 of the male luer valve. As the forward end of the femaleluer valve housing28 continues to further displace the slidingsleeve60, thebladder member56, continues to move rearwardly and moves the forward end portion of the bladder member out of sealing engagement with the forward end opening of thetubular member55. This permits the forward end opening58 to spring open. This allows fluid flow through the two luers, via the inner tubular support,open end58 of thebladder member56. Once the luers are disconnected, the sealing engagement as previously described once again occurs.
• FIG. 13 is an illustration of a male luer valve that does not contain a housing element. This view is similar toFIG. 2 except that the male luer valve is not contained within a housing element and instead can be self-sustained. However, the function of the male luer valve is the same as that explained forFIG. 2 only that the engagement with the female luer housing does not occur with the male luer housing.
• FIGS. 14 and 15 illustrate an embodiment of amale luer100 which does not contain a slidingsleeve60. Theluer housing102 has a tubular projectingconduit118 over which is positioned resilient sleeve ormember106. Thebase114 ofresilient member106 is butted against theinterior end wall112 ofhousing102 and secured in place by the inner end of tubular projectingmember104. Theresilient member106 has one or more laterally projectingfins108 which are disposed respectively inslots110 in the tubular portion ofmember104. When the male luer is closed (FIG. 14) the opening at thetip116 ofresilient member106 is closed, sealing off theopen end120 of themale luer100. When the male luer is engaged by afemale luer128 which has acontact surface126 but no central core rod or cannula (FIG. 15) thesurface126 engages thefins128 and movement of the male luer into the female luer causes the fins to move backward intohousing102 as indicated byarrow107 with thefins108 guided within theslots110 as shown at108′ to compress the bellows portion of the resilient member as shown at106′. This opens the tip as shown at116′ to allow fluid flow throughopening120 into theflow channels124 and122 ofconduit118 andhousing102 respectively. Theperipheral projections132 function as O-ring seals and when the luers are engaged the projectingfront edge130 of theresilient member106 engages the inner slopedsurface134 ofmember104 to provide a sealing or “stopper” effect and keep the O-ring seal area free of the fluid flow and dry.
• For simplicity in a number of the Figures thefemale luer128 is not itself shown and only the movement of elements of themale luer100 is illustrated. It will be understood that such movement is the result of the male/female luer engagement in the manner illustrated in other Figures such as (but not limited to)FIGS. 2, 3,12 and15. Similarly, threads or other securing devices to retain the male and female luers in their engaged positions during flow of fluid through them are also for simplicity not shown in all Figures, but it will understood that such are present as illustrated in (but not limited to)FIGS. 2, 3,4,10 and12.
• FIGS. 16 and 17 illustrate an embodiment similar to that ofFIGS. 14 and 15, but in which there is aninternal plug138 within theconduit118 withchannels148 past theplug138. These channels can be formed in the wall ofconduit118 or can be formed by havingplug138 mounted on spaced apart supports (not shown) connected toconduit118, or in any other convenient manner. Theperipheral surface142 ofplug138 contactsradial land144 on the inner surface ofresilient member106 as shown at140 when the male luer is closed (FIG. 16). When the male luer enters the female luer thecontact surface126 contacts thefins108 and pushes them backward as shown at108′ inFIG. 17, thus compressing the resilient member as shown at106′ and displacing theland144 from contact with thesurface142 of the fixedplug138. Compression of the resilient member also openstip116 of the resilient member as shown at116′. Fluid flow throughopening120 intoconduit124 and aroundplug138 throughchannels148 as shown byarrows146 is also permitted. The axial position and width ofland114 can be varied to determine when contact with theplug edge142 is made or lost, thus determining when the luer opens or closes, and also to provide a vacuum effect to prevent or minimize backflow of fluid.
• FIGS. 18-21 illustrate embodiments of a “soft”male luer100 in which the engagement with thefemale luer128 results in thecontact area126 of the female luer being the interior surface of the luer which is in contact directly with theexterior surface152 of theresilient member106, as illustrated inFIG. 21. InFIG. 18 two optional elements are shown:shoulder150 andprojections109 which can be fins such as108, a peripheral flange, protruding structure which can engage the contact surface of the female luer. Theshoulder150 can be a continuous radial shoulder within theportion102′ of thehousing102 or it can consist of spaced-apart projections aligned radially withinportion102′. (Portion102′ is shown inFIGS. 18 and 19 as a member separate but attached to the rest ofhousing102, but it can also be integral with the rest of housing102).Shoulder150 serves as a limiting device to engagecontact surface126 of thefemale luer128 and stop the relative movement of the two luers, thus limiting the depth to which the male and female luers can be engaged.Projections109 can assist the compressions of theresilient member106 by sharing engagement with thecontact surface126 with thesurface152 of themember106. Thetip area116 of themember106 can be thickened as shown inFIGS. 18 and 19 to provide some expansion into the engaging neck of the female luer and thus create an additional sealing effect.
• InFIGS. 20 and 21 the softmale luer100 is illustrated as having an optionalextended housing102, such that engagement of thesurface152 ofmember106 in contact withsurface126 provides the entire engagement of the male and female luers. That engagement and the compression ofmember106 over therigid conduit118 allow opening oftip116 and flow throughend120.
• Additional embodiments are shown inFIGS. 22-27. In the embodiment ofFIGS. 22 and 23, aninternal plug154 similar in function to that ofvalve member42 is shown. Theplug154 has a integral fins orradial flange158 which is inserted into aradial pocket156 inresilient member106. Engagement with the female luer causes the female luer's contact surface to push theresilient member106, itspocket156 and fins orflange158 backward as shown as106′,156′ and158′ respectively, thus withdrawingplug head160 ofplug154 to the position shown at160′ thus openingend120 for flow intoconduit124.
• FIGS. 24-27 show a shaped resilient member106awhich has aslit162 in itstip116″. When contacted by thefemale luer128, frictional engagement of theouter surface152 of the resilient member106awith thecontact surface126 of the female luer causes the resilient member106ato deform as shown in the Figures, thus openingslit162 as shown at162′ to allow fluid flow intoconduit124.
• Referring now toFIGS. 28 through 32, amale connector200 in accordance with aspects of the invention and afemale connector202 are shown in various configurations of engagement to demonstrate the sequential valve timing in accordance with aspects of the invention.
• Referring now toFIG. 28, themale connector200 is shown in a cutaway perspective form and includes aresilient member210 having aninternal cavity212. The resilient member is uncollapsed and the internal cavity has a first internal volume. The resilient member is mounted within ahousing214 and within atubular projecting member216. Thebase218 of the resilient member is butted against theinterior wall220 of the housing and secured in place by theproximal end222 of the tubular projecting member. Aninternal plug224 is mounted within the resilient member. The plug includes adistal valve member226 that mates with avalve seat228 provided by thedistal end230 of the resilient member. The internal plug includes aproximal valve member232 that mates with aproximal valve seat234 provided by the resilient member, which in this embodiment, results in a type ofpoppet valve208. The internal plug includes integral fins orradial flanges236 that are inserted intoradial pockets238 formed in the resilient member. The resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown inFIG. 28 unless opposing forces in the proximal direction cause partial collapse or compression of the resilient member, as is discussed below.
• FIG. 29 depicts the twoluer connectors200 and202 just separated. In this position, avalve204 in thefemale luer connector202 is closed, and a firstdistal valve206 and a secondproximal valve208 in themale luer connector200 are closed. Flow through either connector is prevented because the respective valves are closed.
• Reviewing themale connector200 in more detail, the connector includes aresilient member210 having aninternal cavity212. InFIG. 28, the resilient member is uncollapsed and the internal cavity has a first internal volume. The resilient member is mounted within ahousing214 and within atubular projecting member216. Thebase218 of the resilient member is butted against theinterior wall220 of the housing and secured in place by theproximal end222 of the tubular projecting member. Aninternal plug224 is mounted within the resilient member. The plug includes adistal valve member226 that mates with avalve seat228 provided by thedistal end230 of the resilient member. The internal plug includes aproximal valve member232 that mates with aproximal valve seat234 provided by the resilient member, which in this embodiment, results in a type ofpoppet valve208. The internal plug includes integral fins orradial flanges236 that are inserted intoradial pockets238 formed in the resilient member. The resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown inFIG. 28 unless opposing forces in the proximal direction cause compression of the resilient member, as is discussed below.
• Referring to bothFIGS. 28 and 29, engagement of themale connector200 with afemale connector202 causes the female connector'scontact surface240 to push theactuation surface244 of the resilient member in the proximal direction, which causes the resilient member'scontact surface244, pockets238, and thefins236 andinternal plug224 to also move in the proximal direction. Upon the occurrence of enough proximal direction movement, the plug will disengage from thedistal valve seat228 thus opening thedistal valve206 and will disengage from theproximal valve seat234 thus opening theproximal valve208, as is described in more detail below. Thetubular projecting member216 includesslots242 through which theactuation surface244 of the resilient member projects so that it may contact the femaleconnector contact surface240. Thetubular projecting member216 is formed in the shape of a standard Luer in this embodiment, although other shapes are possible. Thehousing214 may includeinternal threads246 with which to engagethreads248 of the female connector for more secure locking of the two together.
• Thefemale connector202 includes aninternal piston250 having an opening at itsproximal end252 that forms thefemale valve204. As the piston is moved into thehousing254 of the female connector by a certain distance, it will open to thereby open the female valve and permit the flow of fluid through the female connector.
• Turning now toFIG. 30, there is depicted the male200 and female202 connectors partially joined together. In this position, theforward contact surface240 of the female luer connector has driven theactuation surface244 of the male luer connector in the proximal direction far enough to open the firstdistal valve206 while the secondproximal valve208 in the male connector remains closed. Thecavity212 of the resilient member in this position is now slightly collapsed and has an internal volume that is less than the first volume of the cavity shown inFIG. 28. Thedistal end256 of the tubular projecting member ormale luer portion216 has driven thepiston250 of the female luer connector202 a partial distance in the distal direction. Thevalve204 of the female Luer connector is still closed, despite the displacement of the piston.
• Thus in thisFIG. 30, as the twoconnectors200 and202 are being engaged with one another, thedistal valve206 of the male connector has first opened while theproximal valve208 of the male connector and thefemale connector valve204 remain closed. This is due to the relative distances of movement and sizes of the various parts. Theproximal valve seat234 in the male connectorresilient member210 is designed to be long enough such that itsvalve208 does not open until after theplug224 has moved by a distance longer than the distance required to open thedistal valve206. The length of movement of the proximal valve required for opening is longer than the length of movement of the distal valve to achieve opening. Similarly, the distance of movement of the plug to open the distal valve of the male connector is selected to be less than the distance of movement of thepiston250 of the female connector that is required to open the female connector valve.
• FIG. 31 depicts the male200 and female202 luer connectors further joined together than inFIG. 30. In this configuration, thedistal end256 of the male luer connector has driven thepiston250 of the female connector farther in the distal direction, so much so that thefemale connector valve204 has now opened and fluid flow through the female connector may now occur. Thecontact surface240 of the female connector has further driven theactuation surface244 of theresilient member210 further in the proximal direction further opening thedistal valve206; however, theproximal valve208 is still closed. Thus, two valves of the three valves between the male and female connectors are now open. Fluid flow through the female connector can now occur but fluid flow through the male connector remains prevented due to the continuing closure of the proximal, or upstream,valve208. As is apparent, the length of movement of the proximal valve required for opening is longer than the length of movement of thedistal valve206 of themale connector200, and the length of movement to the female connector'svalve204 to achieve opening. Thus in this embodiment, the distance of movement of theinternal plug224 to open the distal valve of the male connector is selected to be less than the distance of movement of thepiston250 of the female connector that is required to open thefemale connector valve204, yet more to open theproximal valve208 than to open the female connector's valve.
• FIG. 32 depicts the complete operative engagement of the male200 and female202 Luer connectors such that all three depicted valves are open and fluid flow can occur between and through both connectors. In this configuration, the femaleconnector contact surface240 has driven theactuation surface244 of the male connector far enough in the proximal direction to open theproximal valve208. The compressiblecollapsible cavity212 of theresilient member210 is fully collapsed having now an even smaller internal volume that that shown in the precedingFIGS. 28 through 31. Thus on engagement of the male connector having two valves, a distal or downstream valve and a proximal or upstream valve in accordance with aspects of the invention, with a female connector having an internal valve, the first valve that opens is the distal male connector valve. The second valve to open is the female connector valve, and the last valve to open is the proximal male connector valve. Fluid can now flow from theupstream line260, through themale connector200, through thefemale connector202, and out through thedownstream line262. In this case, both upstream and downstream lines are shown as medical tubing, although other devices may be used. Additionally, the upstream connectingdevice258 of themale connector200 is shown as a Luer female connector but other types of coupling devices may be used. Similarly, thedownstream coupling device264 of thefemale connector202 is shown as a male Luer connector but other types of coupling devices may be used.
• Disengagement or disconnection of themale connector200 and thefemale connector202 from each other will result in a sequence of valve closure that is opposite the sequence of valve opening as discussed above. As just discussed in detail, the connectors are shown fully operatively engaged together inFIG. 32 and fluid flow through both valves can occur. A first stage of valve closure upon disengagement is shown inFIG. 31. As the separation of the male and female luer connectors begins, movement of thecontact surface240 of the female luer connector in the distal direction permits theactuation surface244 of theresilient member210 of the male Luer connector to also move in the distal direction due to the biasing force provided by the resilient member. As is shown inFIG. 31, theproximal valve208 of the male connector has closed although thedistal valve206 of the male connector and thefemale connector valve204 remain open. Thus, in the configuration ofFIG. 31, the male connector is now closed to any fluid existing in an upstream line such as may be connected to the male connector's proximalfemale connector258. Theupstream line260 is shown in exaggerated form inFIG. 31. In this configuration then, the internal components of the male connector, and consequently the female connector, are isolated from any upstream fluids.
• FIG. 30 depicts the second stage of valve closure upon disconnection of themale connector200 andfemale connector202. As the separation of the male and female luer connectors further continues, the distal end of themale luer connector256 has retreated moving in the proximal direction which has allowed thepiston250 of the female luer connector to resile also in the proximal direction thereby closing thefemale connector valve204. Fluid flow through the female connector is now prevented. Thus both the male and female connectors are now isolated from any fluids in theupstream line260 and in thedownstream line262.
• As themale connector200 moves from the configuration ofFIG. 30 to the configuration ofFIG. 29 during which theresilient member210 moves in the distal direction to close thedistal valve206, a partial vacuum is created within the male connector. This is because thecavity212 of theresilient member210 is increasing in internal volume as the resilient member resiles to the configuration ofFIG. 29 from the configuration ofFIG. 30. As soon as the internal volume of the resilient member begins increasing, a partial vacuum forms which may be used to draw fluid into the male connector. By proper sequencing of the valves of the connector in conjunction with each other and with the valve of the female connector, the force of this partial vacuum is directed to the interface between the male connector and thefemale connector202 to thereby draw fluid residing on that interface into the male connector.
• Because the valves have been sequenced so that the only valve remaining open at this time is thedistal valve206 of the male connector, the existence of this partial vacuum will draw any fluid remaining at the interface between the twoconnectors200 and202 and on the distal tip or end230 of theresilient member210 into the male connector before thedistal valve206 closes. As the connectors are further separated, thecavity212 of the resilient member further expands, drawing more fluid from the interface of the two connectors, until thedistal valve206 eventually closes as is shown in the configuration ofFIG. 29. Thus in the configuration ofFIG. 29, both theupstream line260, having themale connector200 at its distal end, and thedownstream line262, having thefemale connector202 at its proximal end, are sealed by the respective connectors, each of which has at least one internal valve to isolate the line. In the case of isolation of theupstream line260, themale connector200 will seal the distal end of the line, and even withdraws excess fluid from the distal end of the connector upon disengagement or disconnection from thefemale connector202. This is an especially useful feature in the case where caustic fluids may have been conducted by the upstream line and some of that fluid may have reached surfaces at the interface between the female and male connectors. If these connectors were fully separated and such caustic fluid remained on their surfaces, that caustic fluid may be transferred to the clinician handling the connectors. Such fluids may cause injury to health care workers and patients if applied to skin surfaces thus their containment in the upstream line by means of this vacuum, draw-back feature is especially useful.
• Although shown withtubing260 and262 at the ends of the connectors inFIGS. 28 through 32, this is for example purposes only and is not meant to be restrictive. Various conductive, container, or other components may be used in place of the tubing shown. For example, themale connector200 may form the nozzle end of a syringe instead of being connected to tubing. Thefemale connector202 may form part of a vial adapter or vial access device so that liquid from the syringe connected to the male connector may be injected into a vial of medical substance, mixed and then withdrawn back into the syringe, as an example. Other applications are possible.
• The various embodiments of the male luer described above provide for automatic sealing of the end opening in the male luer as the male and female luers are disconnected, reducing the risk of an operator coming into contact with the potentially hazardous fluid flowing through the connector.
• Although some exemplary embodiments of the invention have been described above by way of example only, it will be understood by those skilled in the field that modifications may be made to the disclosed embodiments without departing from the scope of the invention, which is defined by the appended claims.

Claims (21)

1. A male Luer connector for connection with a female Luer connector for medical fluid flow, the female connector having a front contact surface and an internal valve, the male Luer connector comprising:

a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface; and

vacuum means for creating a partial vacuum at the distal end of the tubular housing during disengagement of the male connector from the female connector during a time period when the female valve is closed;

whereby the vacuum means draws fluid residing at the interface away from the interface during disengagement of the male and female connectors.

2. The male Luer connector ofclaim 1 wherein the vacuum means is located within the tubular housing.

3. The male Luer connector ofclaim 1 wherein the vacuum means comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing.

4. The male Luer connector ofclaim 1 wherein the vacuum means comprises a second valve controlling the flow of fluid through the distal end of the tubular housing.

5. The male Luer connector ofclaim 1 wherein:

the vacuum means comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing;

the vacuum means comprises a second valve controlling the flow of fluid through the distal end of the tubular housing; and

the vacuum means is also for controlling the second valve to remain open while the vacuum means creates the partial vacuum.

6. The male Luer connector ofclaim 5 wherein the vacuum means is also for controlling the first valve to close first, and controlling the second valve to remain open after the female connector valve closes during disengagement of the female connector from the male connector.

7. The male Luer connector ofclaim 5 wherein:

the vacuum means comprises an actuator that controls the opening and closing of the first and second valves;

the vacuum means further comprises an actuation surface disposed so as to be moveable by the front contact surface of the female connector to control the actuator to open and close the first and second valves.

8. The male Luer connector ofclaim 7 wherein:

the first valve comprises a proximal valve disposed at the proximal end of the tubular housing;

the second valve comprises a distal valve disposed at the distal end of the tubular housing; and

the actuator is disposed within the tubular housing to open and close both the proximal and distal valves.

9. The male Luer connector ofclaim 8 wherein the vacuum means further comprises a resilient member disposed to bias the actuator to close both the proximal and distal valves.

10. The male Luer connector ofclaim 9 wherein the resilient member has an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the proximal and distal valves are closed, the cavity having a second volume smaller than the first volume when the distal valve is open;

whereby the resilient member creates a partial vacuum when moving from the second volume to the first volume during closure of the distal valve.

11. The male Luer connector ofclaim 10 wherein:

the cavity has the second volume when the male and female connectors are engaged; and

the cavity moves to the first volume thereby creating the partial vacuum when the male and female connectors are being disengaged.

12. The male Luer connector ofclaim 11 wherein:

the resilient member forms a valve seat for the distal valve and a valve seat for the proximal valve;

the actuator provides a distal valve member for the distal valve that fits into the distal valve seat to close the distal valve and provides a proximal valve member for the proximal valve that fits into the proximal valve seat to close the proximal valve.

13. The male Luer connector ofclaim 12 wherein:

the resilient member provides the actuation surface;

the actuator is disposed within the resilient member in contact with the resilient member;

movement of the resilient member due to engagement with the front contact surface of the female connector causes corresponding movement of the actuator to open and close the distal and proximal valves.

14. A male connector for connection with a female connector to establish a path for medical fluid flow, the female connector having a front contact surface and an internal valve, the male connector comprising:

a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface;

a first valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing;

an internal plug disposed within the tubular housing, the internal plug having a first valve member that engages the first valve seat to prevent the flow of fluid past the first valve seat; and

a resilient member disposed within the tubular housing so as to bias the internal plug to engage the first valve seat, the resilient member having an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the first valve is closed, the cavity having a second volume smaller than the first volume when the first valve is open;

wherein the resilient member is disposed so that engagement of the female connector with the male connector causes the resilient member cavity to move to the second volume and disengagement of the female connector from the male connector causes the cavity to move from the second volume to the first volume thereby creating a partial vacuum.

15. The male connector ofclaim 14 wherein the first valve seat is disposed at the proximal end of the housing;

whereby moving the resilient member cavity from the second volume to the first volume creates the partial vacuum at the distal end of the tubular housing to draw away medical fluid existing at an interface between the male and female connectors during disengagement.

16. The male connector ofclaim 15 wherein the resilient member is disposed so that the cavity moves to the first volume during a time period after the valve of the female connector has closed whereby the partial vacuum draws away medical fluid existing at an interface between the male and female connectors during disengagement.

17. The male connector ofclaim 16 wherein the first valve seat is a distal valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing;

the male connector further comprising a proximal valve seat disposed for use in controlling the flow of fluid through the proximal end of the tubular housing;

wherein the first valve member is a distal valve member that engages the distal valve seat to prevent the flow of fluid past the distal valve seat, and further comprising a proximal valve member that engages the proximal valve seat to prevent the flow of fluid past the proximal valve seat; and

wherein the resilient member biases the internal plug to engage both the distal valve seat and the proximal valve seat, the first volume of the cavity existing when the proximal and distal valves are closed, the second volume of the cavity existing when the distal valve is open.

18. A method for disengaging a male connector from a female connector, the male connector including a distal end engaged with the female connector, a proximal end, and an internal valve and the female connector including a proximal end engaged with the male connector, a distal end, and an internal valve, the method comprising:

closing a first valve in the male connector at the proximal end of the male connector to isolate an interface between the male connector and the female connector from fluid at the proximal end of the male connector; and

creating a partial vacuum at the interface of the male connector and female connector to draw fluid at the interface away from the interface.

19. The method ofclaim 18 further comprising the step of closing the internal valve of the female connector before the step of creating a partial vacuum.

20. The method ofclaim 19 further comprising the step of closing a valve at the distal end of the male connector after the step of creating a partial vacuum.

21. The method ofclaim 19 wherein the step of creating a partial vacuum comprises creating a partial vacuum within the male connector and drawing fluid at the interface into the male connector.

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