HK1117087B - Valved male luer connector having sequential valve timing - Google Patents

Description

Valve-controlled male luer connector with sequential valve timing

Cross-referencing

This application is a continuation-in-part of the 10/389,652 application published under 2003/0136932a1, applied on 3/13/2003, and the latter application is a continuation-in-part of the 09/927,109 application published under 2003/0032940, now U.S. patent No. 6,745,998a1, applied on 8/10/2001.

Technical Field

The present invention relates to an improved male luer connector device that attaches to a female luer valve to open a fluid passageway through a male luer. Once the two screws are engaged, these valves can be used in hospitals to establish connections for Intravenous (IV) devices for medical fluid applications.

Background

Screw devices are particularly useful in a variety of medical applications where it is desirable to interconnect male and female connector components to tubing connected to an IV. The most common type of IV fluid exchange uses a syringe fitted with a nozzle designed to be insertable into a corresponding receptacle attached to the IV set. The receiver typically has a hollow tubular cannula or post that can deliver fluid into a catheter inserted into an IV extending into a patient's vein.

A general screw connection is formed by inserting a male screw into a female screw. The male luer connector is threaded with the threads of a corresponding female luer connector and the two engage so that fluid can pass therethrough without flowing or leaking from the connection. Because the connection often becomes loose or separated, there is a possibility of leakage of the fluid flowing through the tube. The possibility of fluid leakage is a dangerous problem when using hazardous drugs, such as those used in chemotherapy. In addition, even if the fluid does not leak when the connectors are engaged, residual fluid remaining at the tip of the connectors may be dangerous once the connectors are separated. Although the amount of liquid remaining is less than the amount of liquid leaking out of the fitting, this is still sufficient to cause harm to any person in contact.

Therefore, there is a need for a screw connection that ensures that the liquid material is contained therein when the screws are intermeshed. There is also a need for a luer connection that enables a male luer connector to seal within a female luer connector so that the user using the connector is protected from hazardous drugs remaining on the face of the luer tip when disconnected.

Disclosure of Invention

Briefly, and in general terms, it is an object of the present invention to provide a male valve controlled connector that creates a partial vacuum to draw fluid away from the interface between the male and female connectors when the male connector is separated from the female connector.

In accordance with an aspect of the present invention, there is provided a male luer connector for connection to 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 being engageable with the female luer connector and establishing an interface, and vacuum means for creating a partial vacuum at the distal end of the tubular housing upon separation of the male connector from the female connector during closure of the female valve, whereby the vacuum means draws fluid remaining at the interface from the interface upon separation of the male and female connectors. In a more detailed aspect, the vacuum device is located within the tubular housing and includes a first valve that controls fluid flow through the proximal end of the tubular housing. The vacuum device further includes a second valve controlling fluid flow through the distal end of the tubular housing, the vacuum device also being adapted to control the second valve to remain open when the vacuum device creates a partial vacuum.

In a still further detailed aspect according to the invention, the vacuum device further controls the first valve to close first and the second valve to remain open after the female connector valve closes during disconnection of the female connector from the male connector. The vacuum device includes an actuator that controls the opening and closing of the first and second valves, and further includes an actuator surface provided to be movable relative to the front contact surface of the female connector to control the actuator to open or close the first and second valves. The first valve comprises a proximal valve located at the proximal end of the tubular housing, the second valve comprises a distal valve located at the distal end of the tubular housing, and the actuator is located within the tubular housing to open and close the proximal and distal valves.

In other aspects, the vacuum device further comprises a resilient member biasing the actuator to close the proximal and distal valves. The resilient member has a variable volume interior chamber through which fluid can flow, the interior chamber having a first volume when the male connector is disconnected from the female connector, the interior chamber having a second volume less than the first volume when the male connector engages the female connector, whereby a partial vacuum is created when the resilient member moves from the second volume to the first volume during closure of the distal valve when the male and female connectors are disconnected. More specifically, the cavity has a second volume when the male and female connectors are engaged and moves to the first volume when the male and female connectors are being separated to create a partial vacuum.

In still 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 the distal valve with a distal valve member adapted to the distal valve seat to close the distal valve and provides the proximal valve with a proximal valve member adapted to the proximal valve seat to close the proximal valve. The resilient member provides an actuation surface and the actuator is located within and in contact with the resilient member, movement of the resilient member due to engagement with the front contact surface of the female connector causing corresponding movement of the actuator to open and close the distal and proximal valves.

In other aspects, a male connector for connecting to a female connector to establish a medical fluid flow path is provided, 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 being engageable with the female luer connector and establishing an interface, a first valve seat disposed for controlling fluid flow through the distal end of the tubular housing, an internal plug disposed within the tubular housing, the internal plug having a first valve member engaging the first valve seat to prevent fluid flow past the first valve seat, and a resilient member disposed within the tubular housing to bias the internal plug to engage the first valve seat, the resilient member having a variable volume lumen through which fluid can flow, the lumen having a first volume when the first valve is closed, the lumen having a second volume less than the first volume when the first valve is open, wherein engagement of the resilient member is positioned such that disengagement of the male and female connector causes the lumen to move to the second volume and disengagement of the female connector causes the lumen to move back from the second volume to the first volume, thereby creating a partial vacuum.

In accordance with an aspect of the method according to the invention, there is provided a method of separating a male connector from a female connector, the male connector comprising a distal end engaging the female connector, a proximal end and an internal valve, and the female connector comprising a proximal end engaging the male connector, a distal end and an internal valve, the method comprising closing a first valve at the proximal end of the male connector within the male connector to isolate an interface between the male and female connectors from liquid at the proximal end of the male connector, and creating a partial vacuum at the interface between the male connector and the female connector to draw liquid at the interface away from the interface. In other detailed aspects, the method further comprises the step of closing a valve within the female connector during the step of creating the partial vacuum. The method further includes the step of closing the distal valve of the male connector after the step of creating the partial vacuum. The step of creating a partial vacuum in the method includes 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 be apparent from the following detailed description of the preferred embodiment, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

Drawings

The present invention will be better understood from the following detailed description of exemplary embodiments thereof, taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like parts, and in which:

FIG. 1 is a side view of a male and female threaded connection of two components of a threaded fitting;

FIG. 2 is an enlarged cross-sectional view taken along line 2-2 of FIG. 1;

FIG. 3 is a view similar to FIG. 2 with the parts partially engaged;

FIG. 4 is a view similar to FIG. 3 with the parts fully engaged;

FIG. 5 is a view similar to the portion of FIG. 2, showing another integrated spring member;

FIG. 6 is a view similar to FIG. 5 showing another single stage valve;

FIG. 7 is a view similar to FIG. 6 showing the valve open;

FIG. 8 is a view similar to FIG. 5 showing a ball type valve;

FIG. 9 is a cross-sectional view showing another drive slide valve;

FIG. 10 is a view similar to FIG. 9, showing the valve open;

FIG. 11 is a view similar to FIG. 9 showing another drive slide valve;

FIG. 12 is a view similar to FIG. 10 showing an alternative valve for use with a female luer valve without a cannula or post;

FIG. 13 is a male luer valve that does not include a housing member;

FIGS. 14 and 15 are similar to FIG. 11, showing the male luer without the sleeve and showing movement of the male connector from a closed position (FIG. 14) to an open position (FIG. 15) during contact with the female connector without the mandrel or sleeve;

FIGS. 16 and 17 are similar to FIGS. 14 and 15, showing the male luer with a central sealing member inside the resilient member and showing movement of the male connector from a closed position (FIG. 16) to an open position (FIG. 17) during contact with the female connector without the mandrel or sleeve;

FIG. 18 is a view similar to FIG. 11 showing the male connector with the peripheral flange incorporated within the resilient member, once in contact with the contact surface of the female connector (without the mandrel or sleeve), the resilient member being pushed back causing the resilient member to retract and open;

figures 19, 20 and 21 show the appearance and operation of a male luer with a resilient member having a smooth outer contact surface that, once in contact with the contact surface of the female connector (without the mandrel or sleeve), provides sufficient frictional connection that the resilient member is pushed back causing it to retract and open;

FIGS. 22 and 23 are similar to FIGS. 16 and 17 and illustrate the male luer having a central sealing member inside the resilient member, the resilient member having a radially extending portion that extends into the wall of the resilient member and extends outwardly so that it extends into or through a conduit in the housing of the male luer so that the contact surface of the female luer without the mandrel or sleeve engages the conduit, the engagement causing the resilient member to retract and open allowing fluid flow therebetween and through the luer; and

FIGS. 24, 25, 26 and 27 are side (FIGS. 24 and 26) and end (FIGS. 25 and 27) views of another embodiment of a male luer elastic member having a slightly rounded distal end with a notch that is compressed open to form a substantially conical contact recess when in contact with the inner surface of a female luer;

FIG. 28 is a cross-sectional view of a multi-valve male luer connector for achieving sequential valve timing and creating a partial vacuum at the male luer connector end to remove excess fluid from the tip during disconnection from the female connector in accordance with aspects of the present invention;

FIG. 29 is a side cross-sectional view of the male connector of FIG. 28 shown aligned with a compatible female valve control connector prior to engagement;

FIG. 30 is a view similar to FIG. 29 except that the male and female portions are engaged, at which point the 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 to FIG. 30, except that the male and female connectors are further partially engaged, at which point the distal valve of the male connector has opened, the valve of the female connector has also opened, and the proximal valve of the male connector remains closed; and

FIG. 32 is a view similar to FIG. 31, except that the male and female connectors are fully engaged and both the distal and proximal valves of the male connector are open and the valve of the female connector is open to allow full fluid flow through both connectors.

Detailed Description

Fig. 1 is a side view of a male and female luer connection of a solenoid. The fitting includes a male luer 10 for engaging a female luer having an existing top female luer water valve. The female luer 24 is not limited to a particular type, and the luers shown herein are exemplary only. The female luer shown herein is a valve-closed female luer. The female luer 24 includes a housing member 28 with a cannula or post 26. The outer surface of the forward end of the housing 28 has threads 30 that allow the female luer 24 to engage the male luer 10. In this embodiment, the male thread 10 comprises a housing element 12. The interior wall of the housing 12 contains mating threads 30 that engage a female threaded connector. The housing 12 has a reduced diameter, forwardly extending tubular interior 16 having a first necked area 36 and a second necked area 38 (see fig. 2). The tubular interior defines an interior chamber 13 (see fig. 2) having a forward opening 33. Valve member 18 is biased into the extended position by resilient member or spring 14, sealing opening 33. Spring 14 acts between the distal end of chamber 13 and valve member 18. (As used herein, "distal" refers to the trailing end of the male thread and "proximal" refers to the leading end, i.e., the left and right ends of the drawings in FIGS. 1 and 2). Valve member 18 includes a resilient portion 20 and a forward tip member 22. Figure 1 shows the two spirals 10 and 24 in a separated position. Other types of female luer valves that do not include a cannula or post. These types of solenoid valves are shown, for example, in U.S. patent No. 5,676,346 to Leinsing and in U.S. patent No. 5,782,816 to Werschmidt.

Fig. 2 to 5 show the male and female screws 10 and 24 engaged with each other. Fig. 2 shows the two spirals 10 and 24 completely separated. The cannula or post 26 may have an opening 40 to allow the entry and exit of liquid between the two spirals. Other piping systems (not shown) may also be used. The cannula or post 26 is mounted in an internal chamber within the sleeve 34. The sleeve 34 may be made of rubber or any other suitable resilient material and serves as a plug for the valve member. The sleeve 34 has a forward end opening 35 which is sealed closed in the spaced apart position shown in figure 2. The male luer has a forward end comprising a first necked area 36 and a second necked area 38 spaced rearwardly from the first necked area 36. Fig. 3 shows the male luer 10 beginning to be inserted into the female luer 24. Once threads 30 and 32 begin to engage, front end 33 of housing 12 pushes back on sleeve 34 until opening 35 is forced open over the end of sleeve 26. The cannula or post 26 then contacts and begins to push back the tip of the valve member 18, causing the cannula or post 26 to move the valve member front 22. This movement begins to separate the sealing surface of the first necked area 36 from its base. When the tip member 22 begins to push back, the second resilient portion 20 contracts, compressing the valve member cavity 19. This causes the first necked area 36 to unseal, allowing the liquid contained within the lumen 19 to move. The displaced liquid temporarily flows into the female threaded valve 24. As a result of the applied pressure, the valve member is compressed and pushed further inwardly into the chamber 13.

Fig. 4 shows the positioning of the screw member when the female screw 24 and the male screw 10 are further engaged. The cannula or post 26 is further pushed against the tip member 22 causing the first resilient member 14 to contract thereby unsealing the second necked area 38. At this point, more liquid moves into the vacuum portion 21 of the male luer as indicated by the arrow in FIG. 4 due to further insertion of the cannula or post. An opening 40 in the cannula or post 26 allows fluid to enter and exit the female luer 24. When the motion is reversed, the volume created by the displaced liquid will be refilled.

When the male luer 10 valve is disengaged from the female luer valve 24, the amount of liquid displaced when the two valves are connected will return to the original position, thus creating a relative vacuum. When the female luer 24 is removed from the male luer 10, the primary seal created by the second necked area 38 contacts its seat. This isolates the vacuum section 21 from upstream liquid. As the cannula or post 26 is retracted, the lumen 19 is restored as the resilient portion 20 returns to its natural, uncontracted shape. When recovery occurs, liquid is drawn into the lumen 19. With the second constriction 38 closed, the liquid is sucked away from the interface between the male luer 10 and the female luer 24. This effect can be enhanced by the volume represented by the cannula or post 26, which must be returned to the original position when the cannula or post 26 is withdrawn. The resulting relative vacuum strives to draw liquid into the vacuum portion until the sealing surface of the first constriction region 36 again contacts its seat.

FIG. 5 shows a dual stage valve of the same type as described above, except that spring 14 is integrally connected to valve member 42. The outer shell 12 includes an inner sleeve 16, the inner sleeve 16 having an inner chamber 13 therein. The present embodiment functions the same as the previous embodiments, except that spring 14 may comprise an elastomeric material or other type of material integrally connected with valve member 42.

Fig. 6 and 7 show a male luer according to another embodiment of the present invention. The device is a single stage screw valve with an integral resilient member. In this embodiment, the male luer has a housing 12 with threads 32 on the inner wall for engaging the mating threads 30 of the female luer. Inner chamber 13 is sealed by valve member 42 which is an integral combination of a resilient member and a tip. The new valve member 42 thus functions the same as the previous embodiment, except that all of the components are formed in one piece, rather than including a separate resilient member. The present embodiment shows a single stage solenoid valve, with member 42 moving as a unit once the female screw engages valve member 42, rather than moving in several distinct sections as described above. Figure 7 shows the helix of figure 6 engaged with the female helix 24 to allow fluid flow therethrough. Once the two spirals 10, 24 are engaged, the sleeve or post 26 of the female spiral 24 retracts the valve member 42, allowing fluid flow through the opening 40 of the sleeve or post 26 and through the opening 44 at the rear end of the valve member 42.

Fig. 8 shows another embodiment of the present invention. In this embodiment, the housing 12 of the male luer is similar to the previous embodiments. Also contained within the inner sleeve 16 is a resilient member or spring 14. However, in this embodiment, the valve included on the end of the resilient member is shown as a ball 46. The ball may be made of various types of materials, such as elastomeric materials. Additionally, the front opening of the inner chamber 13 is shown as a partially spherical seat 47 that receives the ball valve 46. Those skilled in the art will appreciate that the valve contained at the end of the resilient member or spring 14 may be of various shapes. The shape of the tip of the male luer 10 needs to correspond to the shape of the tip of the female luer 24.

Fig. 9 and 10 show an improved fitting according to another embodiment of the invention, wherein the improved male luer is releasably secured to the female luer 24 of the previous embodiment. The improved male luer includes a housing having an outer cylindrical wall 52 and an inner tubular support 54 extending into the cylindrical housing from a rear end 53 and extending part of the length of the housing. The outer wall 52 has internal threads 32 that engage the female helical threads 30 and has a diameter greater than the diameter of an inner support 54 extending from the rear end 53 of the housing and out the front end of the housing. An elastomeric sleeve or bladder member 56 is secured at its rear end between the tubular member 55 and the support 54 and extends forwardly within the tubular member 55 to its front end opening 57. The balloon member 56 has a forward end opening 58 that is sealed closed by the inwardly tapered end of the tubular member 55 in the extended, disengaged position shown in fig. 9. The forward end opening 58 of bladder member 56 acts as a valve to seal the male luer end opening 57 in the position shown in fig. 9.

The tubular member 55 of the male luer has a diameter smaller than the diameter of the cylindrical inner wall 52 of the housing so as to leave an annular gap between the member 55 and the inner wall 52. A sliding sleeve 60 is slidably mounted in the annular gap over the tubular member. The sleeve 60 has diametrically opposed openings 62 and the tubular member 55 has diametrically opposed elongated and axially extending slots 64. Oppositely directed guide portions 65 (e.g., tabs, wings, fins) on the inner bladder or sleeve member 56 extend radially outwardly through the slots 64 and into the opening 62. Thus, when the sleeve is in the fully extended position shown in FIG. 9, the sliding sleeve will be advanced into the position shown. The corrugated portion 66 of balloon member 56 acts as a spring to bias the forward end of balloon member 56 and sliding sleeve 60 into the extended position.

Fig. 10 shows the female luer 24 connected to the male luer 50. As the forward end of the female luer housing is threaded into the cylindrical wall of the male luer housing, it will engage the forward end 67 of the sliding sleeve 60, pushing the sleeve, and thus the bladder member 56, rearwardly and the forward end of the bladder member is no longer in sealing engagement with the forward end opening of the tubular member 55. This allows the front opening 58 to spring open as shown. At the same time, the forward end of the tubular member 55 forces the sleeve 34 in the female luer back through the end of the cannula 26 and into the open forward end of the tubular member. This causes fluid to flow through the two spirals via the inner tubular support, the open end 58 of the balloon member 56 and the opening 40 of the sleeve 26. When the two spirals are separated, the compressed bellows portion 66 of bladder member 56 urges the forward end portion back into sealing engagement with the forward end of tubular member 55 to prevent any fluid leakage.

FIG. 11 is a view similar to FIG. 9, showing another actuated slide valve except that the resilient sleeve or bladder member 56 does not have a bellows portion, but instead has a separate spring member 68. The spring member 68 may be of any type, such as a spring made of metal or an elastic material. The male spiral valve has the same function; only the spring member 68 replaces the previously described corrugated member.

FIG. 12 is a view similar to FIG. 10 showing another valve used with a female luer valve without a cannula or post. The outer surface of the forward end of the housing 28 engages and compresses the forward end 67 of the male luer valve sliding sleeve 60. As the forward end of the female luer valve housing 28 continues to move the sliding sleeve 60 further, the bladder member 56 continues to move rearwardly and the forward end portion of the bladder member is no longer in sealing engagement with the forward end opening of the tubular member 55. This causes the front end opening 58 to spring open. Fluid is caused to flow through the two spirals via the open end 58 of the inner tubular support, balloon member 56. Once the spirals are separated, the aforementioned sealing engagement is again restored.

FIG. 13 shows a male luer valve that does not include a housing member. This view is similar to fig. 2, except that the male luer valve is not contained within a housing member, but instead is self-contained. The function of the male luer valve is the same as described in fig. 2, except that the female luer housing does not engage the male luer housing.

Fig. 14 and 15 show an embodiment of a male luer 100 that does not include a sliding sleeve 60. The spiral housing 102 has a tubular projecting conduit 118 on which the flexible sleeve or member 106 is located. The base 114 of the resilient member 106 is connected to the inner end wall 112 of the housing 102 and is secured by the inner end of the tubular projecting member 104. The resilient member 106 has one or more laterally extending fins 108 that are each located in a slot 110 in the tubular portion of the member 104. When the male luer is closed (fig. 14), the opening at the tip 116 of the resilient member 106 closes, sealing the open end 120 of the male luer 100. When the male luer engages a female luer 128 having an interface 126 without a central core or sleeve (fig. 15), the face 126 engages the fins 128 and the movement of the male luer into the female luer causes the fins to move back into the housing 102 as indicated by arrow 107, the fins shown at 108 'guided in the grooves 110 compressing the crimped portion shown at 106' of the resilient member. This causes the tip shown at 116' to open to allow fluid flow through the opening 120 into the conduit 118 and fluid passages 124 and 122 of the housing 102, respectively. The peripheral protrusion 132 acts as an O-ring seal and when the threads are engaged, the projecting front edge 130 of the resilient member 106 engages the inner ramp 134 of the member 104 to provide a sealing or "choking" effect and keep the O-ring seal area dry and free of fluid flow.

For simplicity, in many of the figures, the female luer 128 is not the female luer shown, but only the movement of the elements of the male luer 100 is shown. It will be appreciated that these movements are the result of the male/female screws engaging in the manner shown in other figures such as, but not limited to, figures 2, 3, 12 and 15. Also, for simplicity, the threads or other locating means that maintain the male and female screws in an engaged position during fluid flow therethrough are not shown in all of the drawings, but it will be understood that such means exist as shown in, but not limited to, FIGS. 2, 3, 4, 10 and 12.

The embodiment shown in fig. 16 and 17 is similar to the embodiment shown in fig. 14 and 15, but with an internal plug 138 within the conduit 118 and a passage 148 through the internal plug 138. These passages may be formed in the wall of the conduit 118 or may be formed by fitting the inner plug 138 to a spaced support (not shown) attached to the conduit 118, or in any other convenient manner. The outer peripheral surface 142 of the inner plug 138 contacts a radially directed edge 144 on the inner surface of the resilient member 106 as shown at 140 when the male luer is closed (fig. 16). As the male luer enters the female luer, the contact surface 126 contacts and pushes back on the fin 108, as shown at 108 'in FIG. 17, thereby compressing the resilient member shown at 106' and moving the leading edge 144 out of contact with the surface 142 of the fixed plug 138. The compression of the resilient member also opens the tip 116 of the resilient member as shown at 116'. Fluid flow may also enter conduit 124 through opening 120 and around plug 138 through channel 148 as indicated by arrow 146. The axial position and width of the leading edge 114 can be varied to determine when contact is made or lost with the plug edge 142, to determine when the spiral opens or closes, and also to provide a vacuum effect that prevents or minimizes backflow of liquid.

Fig. 18-21 illustrate an embodiment of a "soft" male luer 100 in which engagement with the female luer 128 is such that the contact surface 126 of the female luer is the interior surface of the luer that is in direct contact with the exterior surface 152 of the resilient member 106, as shown in fig. 21. Two optional elements are shown in fig. 18: shoulder 150 and protrusion 109, which may be fins such as 108, peripheral flanges, protrusion structures, may engage the contact surface of the female luer. The shoulder 150 may be a continuous radial shoulder within the portion 102 'of the housing 102 or may comprise radially aligned spaced apart projections within the portion 102'. (the portion 102' is shown in fig. 18 and 19 as a separate member but attached to the remainder of the housing 102, but may be integral with the remainder of the housing 102.) the shoulder 150 serves as a limiting means for engaging the contact surface 126 of the female luer 128 and preventing relative movement of the luers, thereby limiting the depth of engagement of the male and female luers. Protrusion 109 facilitates compression of resilient member 106 by cooperatively engaging contact surface 126 with surface 152 of member 106. The tip 116 of the member 106 may be thickened as shown in fig. 18 and 19 to spread into the engaging elongated portion of the female luer, thereby creating an additional sealing effect.

In fig. 20 and 21, the soft male luer 100 is shown with an optional deployment housing 102 such that engagement of the member surface 152 in contact with the surface 126 fully engages the male and female luers. This engagement and compression of member 106 on rigid conduit 118 causes tip 116 to open and fluid to flow through end 120.

Other embodiments are shown in fig. 22-27. In the embodiment of fig. 22 and 23, an internal plug 154 is shown that functions similarly to valve member 42. The plug 154 has an integral fin or radial flange 158 that is inserted into a radial sleeve 156 in the resilient member 106. Engagement with the female luer causes the contact surfaces of the female luer to push back on the resilient member 106, the sleeve 156 and the fins or flanges 158, shown as 106 ', 156' and 158 ', respectively, thereby withdrawing the plugs 160 to 106' of the plug 154 to the position shown, thereby opening the tip 120 for flow into the conduit 124.

Fig. 24-27 show a specially shaped resilient member 106a having a notch 162 in the tip 116 ". Upon contact with the female luer 128, the outer surface 152 of the resilient member 106a frictionally engages the contact surface 126 of the female luer, causing the resilient member 106a to deform as shown, thereby opening a slit 162, shown at 162', to allow fluid flow into the conduit 124.

Referring now to fig. 28-32, a male connector 200 and a female connector 202 in accordance with aspects of the present invention are shown in various engagement configurations to illustrate sequential valve timing in accordance with aspects of the present invention.

Referring now to fig. 28, the male connector 200 is shown in cross-section and includes a resilient member 210 having an internal cavity 212. The resilient member is uncompressed and the internal cavity has a first internal volume. The resilient member is mounted within the housing 214 and within the tubular projecting member 216. The base 218 of the resilient member is attached to the inner wall 220 of the housing and is held by the proximal end 222 of the tubular projecting member. The internal plug 224 is mounted within the resilient member. The internal plug includes a distal valve member 226 that engages a valve seat 228 provided at a distal end 230 of the resilient member. The internal plug includes a proximal valve member 232 that cooperates with a proximal valve seat 234 provided by the resilient member, thus forming a poppet valve 208 in this embodiment. The internal plug includes an integral fin or radial flange 236 that is inserted into a radial sleeve 238 formed in the resilient member. The resilient member provides a biasing force toward the distal end and tends to return it and the internal plug to the configuration shown in fig. 28 unless opposing forces toward the proximal end cause the resilient member to partially contract or compress, as described below.

Fig. 29 shows the two screw joints 200 and 202 just separated. In this position, the valve 204 of the female luer connector 202 is closed and the first distal valve 206 and the second proximal valve 208 of the male luer connector 200 are closed. Flow through either connector is blocked because each valve is closed.

Looking in more detail at the male connector 200, the connector includes a resilient member 210 having an internal cavity 212. In fig. 28, the elastic member is uncontracted and the lumen has a first internal volume. The resilient member is mounted within the housing 214 and the tubular projecting member 216. The base 218 of the resilient member is attached to the inner wall 220 of the housing and is held by the proximal end 222 of the tubular projecting member. The inner plug 224 is mounted within the resilient member. The internal plug includes a distal valve member 226 that engages a valve seat 228 provided at a distal end 230 of the resilient member. The internal plug includes a proximal valve member 232 that cooperates with a proximal valve seat 234 provided by the resilient member, thus forming a poppet valve 208 in this embodiment. The internal plug includes an integral fin or radial flange 236 that is inserted into a radial sleeve 238 formed in the resilient member. The resilient member provides a biasing force toward the distal end and tends to return it and the internal plug to the configuration shown in fig. 28 unless opposing forces toward the proximal end cause the resilient member to compress, as described below.

Referring to fig. 28 and 29, engagement of the male connector 200 and the female connector 202 causes the female connector contact surface 240 to push the resilient member driving surface 244 proximally, causing the resilient member contact surface 244, the sleeve 238, and the fins 236 and the inner plug 224 to also move proximally. Sufficient proximal movement allows the plug to no longer engage the distal valve seat 228, thereby opening the distal valve 206, and no longer engage the proximal valve seat 234, thereby opening the proximal valve 208, as described in further detail below. The tubular projecting member 216 includes a slot 242 through which an actuation surface 244 of the resilient member projects so that it can contact the female connector contact surface 240. The tubular projecting member 216 is in this embodiment a standard helical shape, although other shapes are possible. The housing 214 may include internal threads 246 that engage the box threads 248 for more securely holding the two threads.

The female luer 202 includes an inner piston 250 having an opening at a proximal end 252 that forms the female valve 204. When the piston moves a distance into the housing 254 of the female connector, the piston will open thereby opening the female valve and allowing fluid flow through the female connector.

Turning now to FIG. 30, a partially engaged male connector 200 and female connector 202 are shown. In this position, the front contact surface 240 of the female luer connector has driven the actuation surface 244 of the male luer connector proximally far enough that the first distal valve 206 is open while the second proximal valve 208 in the male luer connector remains closed. In this position, the interior cavity 212 of the resilient member is slightly compressed and has an interior volume that is less than the first volume of the interior cavity shown in fig. 28. The tubular projecting member distal end 256 or the male luer portion 216 has driven the piston 250 of the female luer connector 202 a partial distance distally. The valve 204 of the female luer connector remains closed despite the movement of the piston.

Thus, in FIG. 30, when the two connectors 200 and 202 are being engaged with each other, the distal valve 206 of the male connector is first opened while the proximal valve 208 of the male connector and the female connector valve 204 remain closed. This is because of the relative movement distance and size of the components. The proximal valve seat 234 of the male connector resilient member 210 is designed to be long enough so that the valve 208 will not open until the plug 224 has moved a distance greater than the distance required to open the distal valve 206. The length of movement required for the proximal valve to open is greater than the length of movement required for the distal valve to open. Likewise, the length of travel of the plug to open the distal valve of the male connector may be selected to be less than the length of travel of the female connector piston 250 required to open the female connector valve.

Fig. 31 shows the male 200 and female 202 luer connectors engaged further than shown in fig. 30. In this configuration, the distal end 256 of the male luer connector has driven the piston 250 of the female connector a greater distance distally so that now the female connector valve 204 is open and fluid flow through the female connector is also possible. The contact face 240 of the female connector has driven the conductive face 244 of the resilient member 210 further proximally a longer distance, further opening the distal valve 206; but the proximal valve 208 is still closed. Thus, two of the three valves between the male and female connectors are now open. Fluid flow can now pass through the female connector, but fluid flow cannot pass through the male connector because the proximal or upstream valve 208 is still closed. It is apparent that the length of travel required for the proximal valve to open is greater than the length of travel required for the distal valve 206 of the male connector 200 and the female connector valve 204 to open. Thus, in this embodiment, the distance of travel of the internal plug 244 to open the distal valve of the male connector may be selected to be less than the distance of travel of the female connector piston 250 required to open the female connector valve 204, but greater than the distance of travel required to open the proximal valve 208.

Fig. 32 shows the male 200 and female 202 luer connectors fully operatively engaged so that all three of the valves are open and fluid flow can occur between and through the two connectors. In this configuration, the female connector contact surface 240 has driven the transmission surface 244 of the male connector far enough towards the proximal end that the proximal valve 208 can be opened. The compressible collapsible cavity 212 of the resilient member 210 is fully collapsed and its internal volume is now smaller than that shown in figures 28 to 31 above. Thus, when a male luer having two valves, a distal or downstream valve and a proximal or upstream valve, according to aspects of the present invention, is engaged with a female connector having an internal valve, the first valve to open is the distal valve of the male connector. The second valve to open is the female connector valve and the last valve to open is the proximal valve of the male connector. Fluid flow may exit from the upstream conduit 260, through the male connector 200, the female connector 202, and through the downstream conduit 262. Here, both the upstream and downstream conduits are shown as medical conduits, although other devices may be used. Additionally, the upstream connection 258 of the male connector 200 is shown as a luer female connector, but other connections may be used. Likewise, the downstream connection 264 of the female connector 202 is shown as a male luer connector, but other connection means may be used.

The separation or disconnection of the male connector 200 and the female connector 202 from each other will cause the valves to close in reverse order to the valve opening sequence described above. As will be described in detail, the fittings shown in fig. 32 are fully operatively engaged and fluid flow is permitted through both valves. Figure 31 shows the first stage of valve closure when separated. When the male and female luer connectors begin to separate, distal movement of the contact surface 240 of the female luer connector causes the driving surface 244 of the resilient member 210 of the male luer connector to also move distally due to the biasing force provided by the resilient member. As shown in fig. 31, the proximal valve 208 of the male connector has closed, although the distal valve 206 of the male connector and the female connector valve 204 remain open. Thus, in the configuration shown in FIG. 31, the male connector is closed to any fluid present in the upstream conduit, such as fluid that may be connected to the male connector proximal female connector 258. The upstream piping is shown in enlarged form in fig. 31. In this configuration, the internal components of the male connector, and subsequently the female connector, are isolated from upstream fluids.

Fig. 30 shows a second stage of valve closure when the male connector 200 and the female connector 202 are disconnected. As the male and female luer connectors are further separated, the distal end of the male luer connector 256 has retracted proximally, causing the piston 250 of the female luer connector to also spring back proximally, closing the female connector valve 204. The flow of fluid through the female connector is now impeded. Thus, the male and female connectors are now isolated from the fluid in both the upstream line 260 and the downstream line 262.

When the male connector 200 is moved from the configuration shown in fig. 30 to the configuration shown in fig. 29, during which the resilient member 210 moves distally to close the distal valve 206, a partial vacuum is created within the male connector. This is because the internal volume of the lumen 212 of the resilient member 210 increases as the resilient member springs back from the configuration shown in fig. 30 to the configuration shown in fig. 29. Once the internal volume of the resilient member begins to increase, a partial vacuum is created that is used to draw fluid into the male connector. By properly sequencing the valves of the male connector and the female connector, the force of the partial vacuum is directed to the interface between the male connector and the female connector 202, thereby drawing fluid remaining on the interface into the male connector.

Since the valves have been sequenced so that the only valve remaining open at this time is the distal valve 206 of the male connector, the presence of the partial vacuum will draw fluid remaining at the interface between the two connectors 200 and 202 and the distal tip or end 230 of the resilient member 210 into the male connector before the distal valve 206 is closed. As the connectors are further engaged, the interior cavity 212 of the resilient member expands further, drawing more fluid from the interface of the connectors until the distal valve 206 eventually closes, as shown in the configuration of FIG. 29. Thus, in the configuration shown in FIG. 29, an upstream conduit 260 having a male connector 200 at its distal end and a downstream conduit 262 having a female connector 202 at its proximal end are sealed by the respective connectors, each having at least one internal valve to isolate the conduits. With the upstream tubing 260 spaced, the male connector 200 will seal the distal end of the tubing, drawing excess fluid back from the distal end of the connector even when disconnected or disconnected from the female connector 202. This feature is particularly useful in situations where corrosive fluids may have been introduced by the upstream piping and some of the fluids may have reached the interface surfaces between the male and female connectors. If the joints are completely separated, these corrosive fluids remain on the joint surfaces and may flow to the physician manipulating the joints. This liquid can cause injury to health care workers and patients if it flows to the skin surface, and it is particularly useful to keep the liquid in the upstream conduit by a vacuum suck back feature.

Although the fitting ends are shown as conduits 260 and 262 in fig. 28-32, this is used for exemplary purposes only and is not limiting. Various conductive containers or other components may be used in place of the illustrated tubing. For example, the male connector 200 may form the nozzle end of a syringe rather than being connected to tubing. The female connector 202 may form part of a vial connector or vial access device so that liquid from a syringe connected to the male connector may be injected into a vial of medical substance, mixed and then drawn back into the syringe. Other applications are also possible.

The various embodiments of the male luer described above automatically seal the distal opening of the male luer when the male and female luers are disconnected, reducing the risk of an operator coming into contact with potentially hazardous fluids flowing through the connector.

Although some exemplary embodiments of the present invention have been described above by way of example only, it will be appreciated by those skilled in the art that modifications may be made to the disclosed embodiments without departing from the scope of the invention as specified in the appended claims.

Claims (16)

1. A male luer connector for connection of a medical fluid to a female luer connector, 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 being engageable with the female luer connector and establishing an interface; and

a vacuum device that creates a partial vacuum at the distal end of the tubular housing when the male connector is disconnected from the female connector during closure of the female valve;

thereby when the male connector and the female connector are separated, the vacuum device sucks liquid remained on the interface from the interface; and is

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

wherein the first valve is a poppet valve.

2. The male luer connector of claim 1 wherein the vacuum device is located within the tubular housing.

3. The male luer connector of claim 1 wherein the vacuum means includes a second valve that controls fluid flow through the distal end of the tubular housing.

4. The male luer connector of claim 1 wherein:

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

the vacuum device also controls the second valve to remain open when the vacuum device creates a partial vacuum.

5. The male luer connector of claim 4 wherein the vacuum means also controls the first valve to close first and the second valve to remain open after the female connector valve closes during disconnection of the female connector from the male connector.

6. The male luer connector of claim 4 wherein:

the vacuum device includes an actuator that controls the opening and closing of the first and second valves;

the vacuum device also includes an actuator surface positioned to move relative to the front contact surface of the female connector to control the actuator to open or close the first and second valves.

7. The male luer connector of claim 6 wherein:

the poppet valve comprises a proximal valve located at the proximal end of the tubular housing;

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

an actuator is located within the tubular housing for opening and closing the proximal and distal valves.

8. The male luer connector of claim 7 wherein the vacuum means further comprises a resilient member arranged to bias the actuator to close the proximal and distal valves.

9. The male luer connector of claim 8 wherein the resilient member has a variable volume lumen through which fluid can flow, the lumen having a first volume when the proximal and distal valves are closed and a second volume less than the first volume when the distal valve is open;

whereby a partial vacuum is created when the resilient member moves from the second volume to the first volume during closing of the distal valve.

10. The male luer connector of claim 9 wherein:

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

as the male and female connectors are being separated, the internal cavity moves to the first volume to create a partial vacuum.

11. The male luer connector of claim 10 wherein:

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

the actuator provides the distal valve with a distal valve member adapted to the distal valve seat to close the distal valve and provides the proximal valve with a proximal valve member adapted to the proximal valve seat to close the proximal valve.

12. The male luer connector of claim 11 wherein:

the elastic component provides a transmission surface;

the driver is positioned in the elastic component and is contacted with the elastic component;

movement of the resilient member by 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.

13. A male connector for connecting to a female connector to establish a medical fluid passageway, 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 being engageable with the female luer connector and establishing an interface;

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

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

a resilient member located within the tubular housing to bias the inner plug to engage the first valve seat, the resilient member having a variable volume lumen through which fluid can flow, the lumen having a first volume when the first valve is closed and a second volume less than the first volume when the first valve is open;

wherein the position of the resilient member is such that engagement of the male and female connectors causes the lumen of the resilient member to move to the second volume and disengagement of the female connector from the male connector causes the lumen to move from the second volume back to the first volume, thereby creating a partial vacuum;

wherein the first valve member is a poppet valve.

14. The male connector of claim 13, wherein the first valve seat is located at a proximal end of the housing;

whereby movement of the resilient member lumen from the second volume to the first volume creates a partial vacuum at the distal end of the tubular housing that, when disconnected, draws away medical fluid present at the interface between the male and female connectors.

15. The male connector of claim 14, wherein the resilient member causes the lumen to move to the first volume during a period after the female connector valve closes, whereby upon disconnection the partial vacuum draws away medical fluid present at the interface between the male and female connectors.

16. The male connector of claim 15, wherein the first valve seat is a distal valve seat for controlling fluid flow through the distal end of the tubular housing;

the male connector further comprises a proximal valve seat configured to control fluid flow 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 fluid flow past the distal valve seat, and further comprising a proximal valve member that engages the proximal valve seat to prevent fluid flow past the proximal valve seat; and

wherein the resilient member biases the inner plug to engage the distal and proximal valve seats, the inner cavity having a first volume when the proximal and distal valves are closed and a second volume when the distal valve is open.