HK1217182B - Medical connector with closeable male luer - Google Patents

Description

Medical connector with closeable male luer connector

Description of divisional applications

The application is a second application, the parent application of which is a first application, the date of the first application is 2008, 5 and 15, the name of the invention is 'medical connector with a closable male luer connector', and the application number is 201210520734.3. The parent of the first divisional application has the chinese invention patent application of PCT international application number PCT/US2008/063797 and international publication number WO2008/14447 at the stage of entering the china, application number 200880024941.1 entitled "medical connector with closable male luer fitting", which was filed on the date of 1 month and 15 days 2010. The above-mentioned PCT international application has an international application date of 27/11/2008 and claims priority from US60/938,428 filed on 16/5/2007, US60/978,697 filed on 9/10/2007, US61/042,016 filed on 3/4/2008, and US12/117,568 filed on 8/5/2008.

RELATED APPLICATIONS

The parent applications of the present application are continuation of U.S. patent application Ser. No. 12/117,568, filed on 8/2008, which is related to and claims priority from U.S. provisional patent application Nos. 60/938,428, 60/978,697 and 61/042,016, filed on 16/2007, on 10/9/2007 and on 3/2008 on 4/2008, respectively, and are non-provisional applications for these applications, each of which is incorporated herein by reference in its entirety. This application is also incorporated herein by reference in its entirety for U.S. provisional patent application No. 60/696,894, filed on 6/7/2005, U.S. patent application nos. 11/417,604 and 11/482,176, filed on 3/5/2006 and 6/7/2006, respectively.

Technical Field

These inventions relate generally to medical connectors for flow-through fluids, and more particularly to medical connectors with male luer fittings.

Background

Systems consisting of connectors, valves and tubing are routinely used in hospitals and other medical facilities to facilitate the transfer of fluids to and from patients. Maintaining these systems sterile as the various components are engaged and disengaged and preventing fluid leakage is often a challenge.

To maintain a barrier to bacteria, debris, and fluid leakage, female or male fittings are typically provided with a closure, such as a septum, flexible seal, or other barrier, at the mating end thereof. When the male luer connector is engaged with the female connector, the closure of the female connector is temporarily opened, pierced or moved to allow liquid to flow between the two connectors. The male connector typically uses a needle or luer connector to open, pierce, or move a closure on the female connector.

In many systems, only the female connector is automatically isolated from the external environment when disconnected. Male luer connectors are generally not provided with an automatic closure mechanism. Male luer fittings sometimes use additional elements, such as a closure cap, to prevent liquid flow and to block entry of bacteria and debris. Because these closure mechanisms are not automated (or used at all), male luer fittings are sometimes unsealed, allowing liquid to drip out. This may increase the risk of unsanitary conditions inside and outside the liquid delivery system. Furthermore, in some medical applications, such as in certain chemotherapies, the fluids in the tubes and fittings may be harmful if discharged.

Furthermore, in the busy environment of hospitals and other medical facilities, medical personnel must often quickly manipulate multiple medical devices with one hand, making it difficult to retrieve the closure cap of a male luer connector and quickly attach the closure cap when the male connector is disconnected. In addition, male luer fittings are commonly used on the downstream end of gravity-fed liquid sources such as IV bags. When the fittings and tubes are initially connected to these liquid sources, they are typically empty (i.e., filled with air) and must be primed with liquid before they can be connected to the patient. During priming operations, liquid is allowed to flow from the upstream end of the tube to the male luer at the downstream end. As the liquid flows through the tube, air in the tube leaks to the environment through the male connector at the downstream end. Once the liquid itself reaches the male connector, it can also leak out. Because male luer connectors typically do not self-close after priming, male luer connectors typically drip off a small amount of liquid when the male connector is quickly moved into engagement with the female connector. For this reason, the male luer is usually held at the end of its priming procedure in a fluid sump or waste tank for receiving the drippings.

There is a need for a closeable male luer that automatically opens when engaged with a female connector and automatically closes when disengaged from the female connector to minimize or eliminate dripping during priming and other operations and to improve the barrier of the liquid delivery system against bacteria and other debris. There is also a need for a closeable male luer connector with a female connector having a locking or other structure that allows the female tip (female bore) of the male luer connector to engage with a corresponding male tip of a male connector or other medical device such as a syringe, but inhibits or substantially prevents the ability of the female tip of the male luer connector to separate from the corresponding male luer connector of the connector.

Disclosure of Invention

Various embodiments of medical connectors with closeable male luer connectors are disclosed herein. It is believed that the features of the various embodiments disclosed herein may be combined to form additional embodiments. Such combinations are within the scope of the present disclosure.

In one exemplary embodiment, a male luer connector has a primary housing including a first end and a second end. The second end of the housing includes a male luer and a protective cover surrounding at least a portion of the male luer. The protective cover has threads disposed on an inner wall thereof. A tubular valve member with a flow passage is disposed within the housing. The valve member has a nib at its second end. A pair of fluid orifices are disposed on opposite sides of the valve member in the tip vicinity. The tip is configured to abut an inner wall of the male luer fitting in an area on or near the second end of the male luer fitting. The valve member also has a pair of posts directed toward the second end. The post passes axially through a portion of the housing, with the post end toward the second end disposed in a space between the male luer and a protective cover on the second end of the housing. A length of medical tubing is connected to the connector. One end of the tube is attached to the first end of the valve member by bonding, welding or some other means. An elastomeric rubber member extends from the intermediate section on the outer surface of the housing to a region on or near the first end of the valve member within the housing.

In the substantially closed state, the resilient member is configured to draw the housing and the tubular valve member together along their respective axes. In this state, the tip of the valve element is pressed into close contact with the inner wall portion on the second end of the male luer, thereby blocking the flow of liquid from the medical tube through the tubular valve element. Liquid cannot normally escape through the opening on the second end of the male luer because the opening is closed by the tip of the valve element.

When a force is applied to separate the valve element from the housing, the resilient member is elongated and causes the tip of the valve element to move in a direction from the second end to the first end of the male luer. The separating force may be applied by hand, for example by gripping the outer wall of the housing with two fingers and the tube attached to the first end of the valve member with two further fingers, and then moving the fingers in opposition to each other. The separation force may also be applied automatically by a different manual action. The action of connecting, for example, a male luer connector to a female end (bore end) of another medical instrument can automatically separate the valve member from the housing. When the advancing end of the female connector enters the threads on the second end of the male luer connector housing, the female connector contacts the valve member post and exerts a force on the valve member post directed toward the first end. The force moves the valve member toward the first end against the bias directed toward the second end exerted by the resilient member. In the open state, liquid is allowed to flow through the opposed holes around the tip of the valve element and out of the fitting through the gap between the tip of the valve element and the inner wall on the second end of the male luer fitting. In some embodiments, the valve element is automatically urged toward the first end when the valve element contacts a fluid line (e.g., a spike disposed within the female connector) when the male connector and the female connector are brought together.

When the separation force is released, the resilient member again pulls the housing and valve member together, such as by releasing the hand-held action on the housing and tube or by removing the female connector from the second end of the housing. This causes the tip on the second end of the valve member to abut against the interior wall portion in the area adjacent the second end of the male luer and prevent liquid from exiting the valve.

Described herein is an embodiment that prevents separation of a female portion of a male luer connector from a corresponding male luer connector portion of a connector. In short, this luer fitting embodiment may include, without limitation, a rigid housing having a first end and a second end. The housing may further include a rigid tubular male portion on the first end, a rigid tubular female portion having a locking mechanism on the second end, and a longitudinal opening in the housing. The male portion is configured to engage a female connector. The female portion is configured to engage a male connector. The locking mechanism is configured to substantially permit rotation of the luer connector in a first direction relative to the male connector such that the female head is threadably engaged with the internal threads of the male connector, and is configured to substantially prevent rotation of the luer connector in a second direction relative to the male connector.

Another embodiment is described herein that prevents separation of a female portion of a male luer connector from a corresponding male luer connector portion of a connector. In short, without limitation, this luer fitting embodiment may include a rigid housing having a first end and a second end. The housing may further include a rigid tubular male portion on the first end, a rigid tubular female portion having a disengagement mechanism on the second end, and a longitudinal opening in the housing. The male portion may be configured to engage a female connector. The female portion may be configured to engage a male connector. The disengagement mechanism may substantially prevent removal of the corresponding male portion of the connector from the female portion of the luer connector.

In more detail, but without limitation, the disengagement mechanism may be configured to rotate the threaded male portion of the connector in a first tightening direction relative to the threaded female portion of the luer connector until the male portion of the connector is substantially fully threadedly engaged with the female portion of the luer connector. Further, without limitation, the disengagement mechanism may be configured to prevent the male head of the connector from rotating relative to the female head of the luer fitting in the second unscrewing direction after the male head of the connector has been substantially fully engaged with the female head of the luer fitting, thereby preventing the connector from being easily disengaged from the luer fitting.

In certain embodiments, this is accomplished as follows. As will be described in greater detail below, the female head of the luer fitting may include an end cap between the main housing body and the female fitting. The end cap may include a first end cap and a second end cap. The second end cap may be supported by a housing member and the first end cap may be supported by the second end cap and may be disposed partially inside the second end cap. The first end cap of the luer fitting may include one or more projections projecting radially outward from an outer surface thereof, which may engage with complementary projections projecting radially inward from an inner surface of the second end cap. In the first state, engagement of the projections may prevent the first end cap of the luer from freely rotating within the second end cap. The protrusion projecting outwardly from the first end cap of the luer may be configured to twist off or break off when a predetermined amount of torque is applied to the first end cap of the luer, which in some embodiments may occur when the male luer portion of the connector is substantially fully threadedly engaged with the first end cap of the luer. Once the protrusion on the first end cap of the luer is twisted off or broken off, the first end cap of the luer may rotate substantially freely within the second end cap so that the protrusion of the connector cannot rotate relative to the second end cap. In other words, when the protrusion of the connector is rotated relative to the luer fitting, the first end cap may rotate in unison with the protrusion of the connector, thereby substantially preventing the protrusion of the connector from disengaging from the first end cap and thus the luer fitting.

In some embodiments, a method of engaging a medical device with a fitting is provided, the method comprising the step of connecting a first end of the medical device with a first end of the fitting. The adapter may include a rigid housing having a first end configured to threadably engage a first end of a medical instrument. The first end may include a first portion including at least one engagement surface and a second portion coaxially aligned with the first portion and having at least one engagement surface. The first and second parts may be configured to be in a first locked configuration in which their respective engagement surfaces cooperate to prevent or resist rotation of the first and second parts relative to one another, and a second substantially unimpeded position in which the first and second parts are able to rotate relative to one another. The method further includes twisting the medical instrument relative to the adapter to helically thread the first end of the medical instrument past the first end of the adapter until the medical instrument reaches a point of substantially full threaded engagement with the adapter. The medical instrument is further twisted relative to the fitting in the pushing direction beyond the point of substantially full threaded engagement, thereby disengaging the cooperating engagement surfaces of the first and second portions, thereby allowing the first portion to rotate relative to the second portion without disengaging the medical instrument from the fitting.

Additional features and structures of the foregoing embodiments, as well as other connector embodiments having a closeable male luer fitting, are also disclosed herein. These embodiments generally include a mechanism that allows or prevents fluid flow through a male luer on the fitting, which is preferably automated when connected to a corresponding female fitting. These embodiments may also include features and structures that allow the female portion of a male luer connector to be connected with another connector or a corresponding male portion of a medical device, such as a syringe, but prevent or substantially prevent the female portion of the male luer connector from being separated from the corresponding male portion of the connector.

Drawings

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

FIG. 1A shows a perspective view of one embodiment of a male luer connector connected to a tube configured to receive liquid from a hanging gravity-fed IV bag, the relative dimensions of the connector and the connected tube being exaggerated in this and other figures relative to the dimensions of other items to facilitate viewing of certain details.

FIG. 1B shows a perspective view of the joint of FIG. 1A in an extended, substantially open configuration.

FIG. 1C shows a perspective view of an embodiment of the fitting of FIG. 1A connected to an exemplary female fitting that is connected to a tube inserted into a patient.

Figure 2 illustrates a perspective view of one embodiment of a closable male luer.

Fig. 3 shows a perspective view of a housing portion of the joint of fig. 2.

Fig. 4A shows a perspective view of a valve member portion of the connector of fig. 2.

FIG. 4B illustrates a perspective view of another embodiment of a valve member portion of the fitting of FIG. 2.

FIG. 4C shows a cross-sectional view of the embodiment of the valve member portion of the fitting of FIG. 4B.

Fig. 5 shows a perspective view of the elastic member of the joint of fig. 2.

Fig. 6 shows a perspective view of the sealing portion of the joint of fig. 2, the relative dimensions of the sealing portion being exaggerated relative to the joint elements shown in the other figures for clarity.

Fig. 7 shows a perspective view of certain elements of the joint of fig. 2 in a partially assembled configuration, the housing portion of fig. 5 not being shown in fig. 7.

Fig. 8 shows a cross-sectional view of the fitting of fig. 2 near the female portion of another medical device, at which stage fluid flow through the fitting of fig. 2 is prevented.

Fig. 9 illustrates a cross-sectional view of the fitting of fig. 2 in engagement with the medical device of fig. 8, with fluid flowing through the fitting in engagement.

Fig. 10 shows a cross-sectional view of the fitting of fig. 2 in the vicinity of another medical device having a closable female luer fitting, at which stage liquid is prevented from flowing through the fitting and the female luer fitting of fig. 2.

Fig. 11 shows a cross-sectional view of the fitting of fig. 10 after engagement, with liquid flowing through the fitting being engaged.

Figure 12 shows a perspective view of the hub of figure 2 near a syringe having a male luer hub spike, at which stage liquid is prevented from flowing through the hub.

Fig. 13 shows a perspective view of the elements of fig. 12 after engagement, at which stage liquid is still prevented from flowing through the joint.

Figure 14 shows a cross-sectional view of the male luer tip cone of the hub and syringe of figure 13.

Fig. 15 shows a perspective view of a closable male luer with a first end located near a syringe having a male luer tip and a second end located near a hypodermic needle having a female luer fitting.

Fig. 16 shows a perspective view of the elements of fig. 15 in engagement, at which stage liquid can flow through the joint.

Fig. 17 is a cross-sectional view of the hub of fig. 16, the male luer tip of the syringe, and a hypodermic needle, at this stage, with liquid flowing through the hub.

Fig. 18A is a perspective view of another embodiment of a closable male luer.

Fig. 18B is a cross-sectional view of the joint of fig. 18A.

Fig. 18C is a partial cross-sectional view of the joint of fig. 18A.

Fig. 19 is a perspective view of the hub of fig. 18A positioned adjacent a syringe having a male luer hub spike.

Fig. 20 is a perspective view of the elements of fig. 19 in engagement.

Fig. 21 is a perspective view of another embodiment of a closable male luer that engages a syringe having a male luer taper.

Fig. 22A is a cross-sectional view of another embodiment of a closable male luer.

Fig. 22B is a partial cross-sectional view of the joint of fig. 22A.

Figure 23A is a side view of another embodiment of a closable male luer with a protective cover.

Fig. 23B is a cross-sectional view of the joint of fig. 23A.

Figure 23C is a perspective view of one embodiment of a closable male luer near a closable female luer at a stage where liquid flow is prevented from flowing through the female luer.

Fig. 23D is a perspective view of the elements of fig. 23C in engagement.

Fig. 24A is a perspective view of another embodiment of a closable male luer.

Fig. 24B is a cross-sectional view of the joint of fig. 24A.

Fig. 25A is a side view of another embodiment of a closable male luer with a protective cover.

Fig. 25B is a cross-sectional view of the joint of fig. 25A.

Fig. 26A is a perspective view of another embodiment of a closable male luer having a flexibly connected female luer.

Fig. 26B is a perspective view of another embodiment of a closable male luer having a flexibly connected female luer.

Fig. 27 is a perspective view of another embodiment of a closable male luer.

Fig. 28 is a cross-sectional view of the joint of fig. 27.

Fig. 29 is another cross-sectional view of the fitting of fig. 27.

Fig. 30 is a cross-sectional view of the fitting of fig. 27 engaged with a syringe having a male luer fitting tip cone, at which stage liquid flow is prevented through the male luer fitting.

Fig. 31 is a cross-sectional view of the fitting and syringe of fig. 30 engaged with a tube having a female luer fitting connection, at this stage liquid flow is allowed through the assembly.

Fig. 32 is another cross-sectional view of the fitting, syringe and tube of fig. 31, at this stage, the fitting is in the process of being closed.

FIG. 33 is a perspective view of the fitting of FIG. 27 prior to engagement with an embodiment of an irrigation cap.

Fig. 34 is a perspective view of another embodiment of a closable male luer.

Fig. 35 is a cross-sectional view of the joint of fig. 34.

Fig. 36 is a perspective view of another embodiment of a closable male luer.

Fig. 37 is a cross-sectional view of the joint of fig. 36.

Fig. 38 is a cross-sectional view of another embodiment of a closable male luer.

Fig. 39 is a cross-sectional view of the fitting of fig. 38 engaged with a syringe having a male luer fitting spike, at this stage, liquid flow is prevented through the male luer fitting.

Fig. 39A is a cross-sectional view of the fitting and syringe of fig. 39 engaged with a tube having a female luer fitting connection, at this stage liquid flow is allowed through the assembly.

Fig. 40 is a cross-sectional view of another embodiment of a closable male luer.

Fig. 41 is a cross-sectional view of another embodiment of a closable male luer.

Fig. 42 is a perspective view of one embodiment of a closable male luer in a closed position.

Fig. 43 is a perspective view of the closable male luer of fig. 42 in an open position.

Fig. 44 is a cross-sectional view of the closable male luer of fig. 42.

Fig. 45 is a cross-sectional view of the closable male luer of fig. 43 along a cross-section perpendicular to the cross-section of fig. 41.

Fig. 46 is a perspective view, partially cut away, of the closeable male luer of fig. 42, taken along line 46-46.

Fig. 47 is a perspective view of a valve member component of the closeable male luer of fig. 42.

Fig. 48 is a perspective view of the female member of the closable male luer fitting of fig. 42.

Fig. 49 is an exploded view of an embodiment of a closable male luer.

Fig. 50 is an exploded view of an embodiment of a closable male luer.

Fig. 51 is a perspective view of an engagement configuration of one embodiment of an element of a non-reversible closable male luer fitting.

Fig. 52 is a cross-sectional view of the embodiment of fig. 51 taken along line 52-52.

Figure 53 is a side view of one embodiment of an element of a non-reversible closable male luer.

Fig. 54 is a side view of the element of fig. 53.

Fig. 55 is a side view of an embodiment of an element of a non-reversible closable male luer.

Fig. 56 is a side view of the element of fig. 55.

Fig. 57 is a perspective view of one embodiment of a closable male luer in a closed position.

Fig. 58 is a cross-sectional view of the closable male luer connector of fig. 57 taken along line 58-58.

Fig. 59 is a perspective view of the female member of the closable male luer fitting of fig. 57.

FIG. 60 is a side view of the female headpiece shown in FIG. 59.

FIG. 61 is a front view of the female headpiece shown in FIG. 59.

FIG. 62 is an enlarged side elevational view of the end cap portion of the female member shown in FIG. 59 threadably engaged in the male portion of the mating element.

Fig. 63 is a perspective view of another embodiment of a closable male luer in a closed position.

Fig. 64 is a side view of the closable male luer embodiment shown in fig. 63, again in a closed position, with certain internal features of the closable male luer shown in phantom.

Fig. 65 is an exploded perspective view of the elements of the closable male luer embodiment shown in fig. 63.

Fig. 66 is an end view of the female end of the closable male luer fitting embodiment shown in fig. 63.

Fig. 67 is a cross-sectional view of the closable male luer fitting embodiment shown in fig. 63, taken along line 67-67 in fig. 66.

Fig. 68 is an enlarged cross-sectional view of the closable male luer fitting embodiment shown in fig. 63, taken along line 68-68 of fig. 67.

Fig. 69 is a cross-sectional view of the closable male luer fitting embodiment shown in fig. 63, taken along line 69-69 in fig. 66.

Fig. 70 is an enlarged cross-sectional view of the closable male luer fitting embodiment shown in fig. 63, taken along line 70-70 in fig. 69.

Fig. 71 is a partial perspective view of the closable male luer embodiment shown in fig. 63.

Fig. 72 is a partial perspective view of the embodiment of the closable male luer connector shown in fig. 63.

Fig. 73 is a partial perspective view of the closable male luer connector shown in fig. 63.

Fig. 74 is a side view of the element shown in fig. 73.

Fig. 75 is a partial perspective view of the closable male luer embodiment shown in fig. 63.

Fig. 76 is an end view of the element shown in fig. 75.

Fig. 77 is a cross-sectional view of the element of fig. 75 taken along line 77-77 of fig. 76.

Figure 78A is a side view of an exemplary connector threadingly engaged with the closable male luer embodiment shown in figure 63.

Figure 78B is a side view of an exemplary connector substantially fully threadedly engaged with the closable male luer fitting embodiment shown in figure 63.

Fig. 78C is a side view of an exemplary connector substantially fully threadedly engaged with another embodiment of a closable male luer.

Fig. 79A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 79B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 79A in an open position.

Fig. 80A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 80B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 80A in an open position.

Fig. 81A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 81B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 81A in an open position.

Fig. 82A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 82B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 82A in an open position.

Fig. 83A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 83B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 83A in an open position.

Fig. 84A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 84B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 84A in an open position.

Fig. 85A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 85B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 85A in an open position.

Fig. 86A is a cross-sectional view of another embodiment of a luer fitting in a closed position.

Fig. 86B is a cross-sectional view of the embodiment of the luer fitting shown in fig. 86A in an open position.

Detailed Description

The following detailed description is directed to certain specific embodiments of the disclosure.

In some aspects of the embodiments described herein, various mechanisms for closing the second end of the male luer fitting are shown. In certain embodiments, the closure mechanism functions to prevent and/or inhibit liquid from leaking from or entering the male luer connector, while allowing liquid flow when the male luer connector is manually opened or engaged with a corresponding female luer connector. Terms such as "close" or "seal" as used herein should be understood to mean to impede or block liquid flow. These terms should not be construed as requiring that a particular structure or configuration achieve a complete liquid containment effect in any event.

Fig. 1A shows one embodiment of a closable male luer 10 in a closed position. The male luer 10 is connected to a gravity fed IV bag 9, filled with a liquid, suspended from a pole 11. A length of tubing 13 is connected to the bottom of the bag 9. The other end of the tube 13 is connected to the first end 12 of the male luer 10. As long as male luer 10 remains in the closed configuration, the closure mechanism on the inner surface of second end 14 of male luer 10 prevents the liquid contained within bag 9 from flowing through tube 13 and leaking out of male luer 10.

Fig. 1B shows the fitting 10 in an open position. Liquid can flow into the first end 12 of the fitting 10 and out the second end 14 of the fitting 10. The medical professional may place the male luer 10 in this configuration by pinching the second end of the closable male luer 10 with two fingers, pinching the tube 13 with the other two fingers and slightly moving the fingers in opposition to each other.

The IV infusion system of fig. 1A and 1B can be readily prepared for fluid communication with a patient. In most cases, the tube 13 is filled with air when it is initially connected to the IV bag 9. If the other end of the tube 13 is connected to a closed fitting, as shown in FIG. 1A, air cannot be vented and liquid cannot enter the tube 13 from the IV bag 9. Thus, the luer 10 is moved by hand into the open position until all air has been expelled through the male luer 10 and the liquid in the IV bag 9 fills the tube 13 and the fitting 10. This procedure is called "perfusion". Once the fluid line and fitting are properly primed, the medical practitioner can quickly release the opposing forces applied to the second end 14 and tube 13 of the male luer 10 and the closure mechanism of the male luer 10 can quickly prevent fluid flow through the luer 10.

Referring now to FIG. 1C, catheter 17 has been inserted into patient's arm 15. The catheter 17 penetrates the skin of the arm 15 and is preferably in fluid communication with the patient's blood. The catheter 17 is also connected to a length of medical tubing 19, the medical tubing 19 being connected to a medical female connector 21. An example of the female medical connector 21 shown in fig. 1C is manufactured by ICU medical corporation of santa claymond, caOne form of joint. Various embodiments of such a joint are shown and described in U.S. patent No. US5,685,866, which is incorporated herein by reference in its entirety. It is contemplated that many of the male luer fitting embodiments described herein may be used with other types of female fittings. The tubing 19, conduit 17 and female connector 21 are pre-filled with liquid using standard procedures. Luer fitting 10 as described aboveIs poured and engaged with the female connector 21. As described in more detail below, when the male connector 10 is engaged with the female connector 21, fluid is allowed to flow from the IV bag 9 into the patient. When the male connector 10 is separated from the female connector 21, fluid is again prevented from flowing out of the second end 14 of the male connector 10. Generally, the liquid is also prevented from flowing out of the opening of the female connector 21.

The embodiment shown in fig. 1A to 1C is described in more detail below. Each of the other embodiments described herein may be used in the liquid systems shown and in various modifications and alternatives thereof. It is further contemplated that various embodiments of a fitting according to the present invention may be used in a variety of other medical fluid systems. For example, the disclosed fitting may also be used to deliver body fluids such as blood, urine, or insulin, nutritional fluids, and/or therapeutic fluids such as those used in chemotherapy. The disclosed fitting may also be used to interconnect various other elements of a fluid delivery system.

Referring now to fig. 2-9, the closable male luer shown in fig. 1A-1C is shown in more detail. As shown in fig. 2, the assembled luer fitting 10 includes four parts: a housing 23, a valve member 16, an elastic member 18 and a sealing ring 20 (not visible in fig. 2). These parts are shown separately in fig. 3 to 6 and will be described in more detail with reference to these figures. Luer 10 may be made up of more or fewer parts that may be combined in different configurations.

Fig. 3 shows the housing 23 of the connector 10, apart from the rest of the luer connector 10. The housing 23 is generally a tubular structure having an axial passage 28 extending from the first end 12 of the fitting 10 through the upper housing 34, the intermediate portion 32, and the luer fitting tip 22 to the second end 14 of the housing 23. In certain embodiments, the length of the housing 23 from the first end 12 to the luer fitting tip 22 is about 1¹/₈In inches. Preferably, but not necessarily, the length of the housing 23 from the first end 12 to the second end 14 is less than or equal to about 1¹/₂Inches to minimize the weight and volume of the joint.The housing 23 may have any length suitable for a particular application. The luer taper 22 is connected to the remainder of the housing 23 at a base 25 surrounded by a protective cover 24. The tip 27 of the luer fitting tip 22, which is directed toward the second end of the luer fitting 10, extends a small distance beyond the edge 29 of the cover.

The protective cover 24 preferably has internal threads on the inner wall that help to securely connect the fitting 10 to another medical instrument in a detachable manner. In other embodiments, the protective cover 24 may include other structures or materials for providing a detachable connection, including quick-disconnect mechanisms and other mechanisms. The protective cover 24 has a plurality of recesses 31 on an outer surface to assist a user in gripping and twisting the protective cover 24 of the housing 23 with fingers. These depressions 31 have upwardly tapering side walls 33 to prevent fingers from sliding off the connector 10. At the end of each recess 31 toward the first end of the fitting 10, the surface of the shell 23 is approximately coplanar with the surface of the recess 31, while at the end of each recess 31 toward the second end 14 of the fitting 10, the surface of the shell 23 is offset from the surface of the recess 31, preferably above the surface of the recess 31. This arrangement allows a finger to be comfortably slid along the housing 23 in a direction toward the second end 14 of the joint 10 into position to pinch or twist the joint 10. Once the finger is in the desired position, the tapered wall 33 on the end of the recess 31 near the second end 14 of the fitting 10 prevents further movement of the finger in the direction of the second end 14. The series of depressions 31 extend around substantially the entire outer surface of the protective cover, so that a user's fingers, when placed on opposite sides of the fitting 10, will encounter the depressions 31, regardless of the orientation of the fitting 10 during use.

In the embodiment shown, the tip cone 22 has a wall extending conically. The pointed cone 22 becomes smaller in diameter from the base 25 to the second end 27. There is a hole at the second end 27 of the pointed cone 22. On the base 25 of the luer fitting tip 22, an internal bore 35 (see fig. 8) opens into the region of the fluid channel 28 in the middle portion 32 of the luer fitting 10. The luer fitting tip may be sized in accordance with applicable standards and/or regulations, such as ANSI standards.

The inner wall of the luer tip 22 preferably includes a boss 30 that extends radially inward toward the axis of the fluid channel 28 surrounded by the luer tip 22 such that the fluid channel 28 is narrower at its second end 27 than in the region adjacent the second end 27. In the illustrated embodiment, the surface of the boss 30 facing radially inward toward the central axis of the fitting 10 is tapered in a manner similar to the taper of the outer surface of the tip cone 22 (see fig. 8 and 9). In this structure, the inner diameter of the boss 30 is reduced in a direction from one side toward the first end to the other side of the boss 30 toward the second end. As will be described in greater detail below, the abutment 30 in the luer fitting tip 22 helps to block and/or prevent liquid flow through the fitting 10 when the second end of the valve member 16 abuts thereon.

The intermediate portion 32 of the housing 23 is located between the protective cover 24 and the upper shell 34. As shown, the intermediate portion 32 has a smaller outer diameter than the housing 24 or the upper housing 34. The intermediate portion 32 also has two substantially rectangular openings 36 spaced on opposite sides of the housing 23. When the joint 10 is assembled, the intermediate portion 32 is generally covered by a portion of the resilient member 18 (see, e.g., fig. 2). As a result, the intermediate portion 32 is generally not in contact with a finger during use. Thus, in some embodiments, a graspable surface need not be provided for the intermediate portion 32. Thus, the intermediate portion 32 may have a smaller diameter and a smoother surface than any other portion of the housing 23.

The upper housing 34 is generally divided into two wall portions 45a, 45b by two gaps 38 (only one shown in fig. 3). The upper housing 34 includes a series of recesses 37 similar in shape and function to the recesses 31 on the cover 24. The upper housing 34 may also include one or more projections 43 that extend into the gap 38. In the assembled state, the projection 43 helps to retain a portion of the resilient member 18 between the gap 38 in the wall portions 45a, 45b (see fig. 2). In some embodiments, the projections are tapered from a lesser thickness at their ends toward the first end of the fitting to a greater thickness at their ends toward the second end of the fitting. The taper of the projections 43 facilitates insertion and retention of the elastomeric member 18 portion in a desired position and orientation, while allowing the elastomeric member 18 to buckle during use. The tabs 43 also help prevent the valve member 16 from advancing too far toward the first end when the connector 10 is moved into the open position by contacting the set of tabs 44 near the second end of the valve member 16. The taper of the protrusion 43 allows the protrusion 44 of the valve member 16 to advance toward the second end and over the protrusion 43 of the housing 23 during assembly into the housing 23. The corners 47 on each wall portion facing the first end of the connector are preferably rounded to prevent poking, scratching or other damage or irritation to the fingers or resilient member 18 during use.

As shown in fig. 3, the outer surface of upper housing 34 includes a lower ledge 39 and the outer surface of protective cover 24 includes a ledge 41 configured to help retain the central portion of spring 18 around housing 23 (see fig. 2) in the assembled configuration. The projection 39 of the upper housing 23 is preferably substantially horizontal so as not to facilitate any sliding of the resilient member 18 towards the first end of the joint. The bosses 41 of the protective cover 41 are preferably tapered (see fig. 8) to help properly position the spring 18 on the housing 23 during manufacture of the fitting 10.

The housing 23 may be constructed of any of a number of different materials. In certain embodiments, the housing 23 may be constructed of a relatively rigid material, such as polycarbonate or other polymeric material. The housing 23 and/or valve member 16 of this embodiment or the constituent elements of other embodiments may also be constructed of a hydrophobic material, such as Bayer Makrolon, or any other suitable material.

Referring now to fig. 4A, the valve member 16 of the male luer 10 is shown apart from the other elements of the fitting 10. In certain embodiments, the valve member 16 includes a fluid passage 52 of varying diameter extending from the first end 48 of the valve member 16 to the second end 56 thereof, which is surrounded by additional structure. Near first end 48, valve member 16 and the corresponding portion of fluid passageway 52 are relatively wide to receive a length of standard diameter medical tubing inserted therein. Near the middle of the valve member 16, the tube 40 surrounding a portion of the fluid passage 52 is attached to a portion near the first end of the valve member 16. The tube is adjacent to two approximately parallel struts 42 along at least a portion of the tube 40. The struts 42 are preferably relatively thin and approximately flat. The first end of each strut 42 is connected to the valve member 16 at a generally medial section of the valve member 16, and the second end of each strut extends toward the second end 56 of the valve member 16. The second end 56 of the valve member 16 preferably extends further than the post end. Preferably, there is an open space between the inner wall of each strut 42 and the outer wall of the tube 40.

From near the middle of the valve member 16 to its first end 48, the fluid passage 52 includes a wider area having the protrusion 44 along its outer surface. The projection 44 forms two grooves 46 (only one shown in fig. 4A) longitudinally along opposite sides of the body of the valve member 16. In certain embodiments, the struts 42 are circumferentially spaced from the groove 46, as shown.

A circumferential groove 57 may be formed around the outer circumference of the body of the valve member 16 near the valve member 16 and the first end of the tube 40. The projection 49 may be formed along the edge of the groove 57 toward the first end of the connector, while the raised intermediate portion of the valve member 16 may form the edge of the groove 57 toward the second end of the connector. In some embodiments, the boss 49 does not extend uniformly around the outer periphery of the first end of the valve member 16, but rather has two larger portions that are spaced apart in diameter.

The amount of material necessary to construct the valve member 16 can be reduced by making a groove in the outer layer of that portion. The tube 40 may have a channel 52 disposed therein. The passage 52 preferably extends from an aperture 52 at a first end of the valve member 16 to a pair of apertures 50 (only one shown in fig. 4A) located substantially near a second end of the valve member 16. In the illustrated embodiment, the apertures 50 are generally rectangular in shape. The region of the tube 40 near the second end of the fitting may also be formed with only one hole or more than two holes, and other shapes may be employed for at least one of the holes. For example, the aperture 50 may be formed in a tear drop shape (e.g., narrow at one end and wide at the other), which facilitates the injection molding process in manufacture. Further, in some embodiments, valve member 16 may be devoid of a fluid flow path and function as a stop against fluid flow around valve member 16, rather than a mechanism for delivering fluid between the first and second ends of connector 10.

The tube 40 of the valve member 16 has a boss 58 at its second end. The projections 58 preferably extend radially further than adjacent tube 40 portions. In certain embodiments, the boss 58 may be constructed of the same or substantially the same material as the rest of the tube 40. The projection 58 preferably tapers from the first end of the valve member 16 to the second end of the tube 40. In some embodiments, the taper is formed at a 5 degree angle and has substantially the same taper as the radially inward surface of the boss 30 of the housing 23. Other or no tapers may be used.

Similar to the housing 23 of fig. 3, the valve member 16 may be constructed of a number of different materials. Examples of such materials include polycarbonate or other polymeric materials. The valve member 16 may be substantially the same length as the housing 23 or slightly shorter than the housing 23. For example, the valve member 16 may be about 1 inch in length. In some embodiments, the valve member 16 may be substantially shorter than the housing 23. The valve member 16 may be constructed of the same rigid material as the housing 23. For example, in certain applications, it may be desirable to use a semi-rigid or even more flexible material in the valve member 16, particularly for the boss 58 near the second end of the tube 40.

The valve member 16 may be manufactured by injection molding. In certain embodiments, at least two gates are used so that the molten plastic is distributed throughout the mold. Preferably, one gate may be positioned along one of the sides of the valve member 16 between the end of the post 42 facing the first end of the connector and the boss 49 and the other gate may be positioned adjacent the aperture 50 in the valve member 16. However, the gate position is not fixed, and other positions on the valve member 16 may be used as the gate when the valve member 16 is injection molded. Constructing the housing 23 and valve member 16 of this or other embodiments from the same materials reduces the likelihood of degradation of the connector 10 due to thermal expansion/contraction or chemical reaction between the connector 10 and its environment.

Although the valve member 16 of the illustrated embodiment is constructed as shown in fig. 4A, many other configurations are possible. In certain embodiments, the outer surface of the valve member 16 may be relatively smooth, and the valve member may primarily include the tube 40 defining the passage 52. In other embodiments, a different number of posts 42 may be provided along both sides of the valve member 16.

As can be seen in the embodiment shown in fig. 4B, the protrusion 150 near the first end of the valve member 16 may further include an external engagement surface 150, such as threads, for detachably coupling a medical instrument (not shown), such as a syringe, to the first end of the valve member 16.

In the embodiment shown in fig. 4C, the groove 52 may also be tapered along the inner surface. The tapering of the groove 52 may result in a groove width that decreases, with a larger dimension at the first end 180 of the valve member 16 and a decrease toward the second end 184 of the valve member. The internal taper of the groove 52 may fit well with the taper of a male luer. Such an internal taper can conform to ANSI standards and/or specifications, such as medical injector standards. In the illustrated embodiment, the tube 40 of the valve member 16 does not have a boss 58 extending radially outward beyond the wall of the tube 40 as in the embodiment of fig. 4A. Instead, the tube 40 wall tapers radially inwardly in the second end region. The second end 27a of the luer tip cone 22a may have a smaller cross-sectional second portion 170 that reduces the likelihood of liquid leakage along the inner surface of the second end 27a of the luer tip cone 22 a. Near the second end 27a of the luer fitting tip cone 22a, the larger cross-sectional area 160 may transition to the smaller cross-sectional portion 170 toward the fitting second end in a number of ways, such as having a steep step transition as shown in fig. 4C or having a tapered transition, or other transition shape. Certain cross-sectional diameters of the opening at the second end 27a of the luer fitting 22a include, for example, those of about 2mm or less, including about 0.5mm, 0.75mm, 1.0mm, 1.25mm, 1.5mm, and 1.75 mm. The diameter of the opening at the second end 27a may also be in the range of 0.4mm to 1.8mm, 0.5mm to 1.5mm, and 0.5 to 1.0 mm. Other diameters within or outside the listed range may also be used. Additionally, the size of the second end of the valve member 16 may be suitably selected to occupy the space in the opening of the second end 27a of the luer 22 a.

As shown in fig. 4B and 4C, the closable male luer 10 has a female end 180 and a male end 184. The closeable female connector 21 of fig. 1C (mentioned above) and 210 of fig. 10 and 11 (described in detail below), as well as other standard female connectors of similar construction, also have a female end and a male end. In many embodiments, these female connectors use seals and other fluid barriers to prevent fluid flow at the female end, but not at the male end. In many embodiments of the closable male luer shown herein, seals and other liquid barriers are not shown on the female end. However, the female end of any of the closable male luer fittings disclosed herein may be configured to include a closable female end. For example, a structure for selectively blocking fluid with female connector 21 or 210 or any other standard female connector may be incorporated into the female end of any of the closeable luer connectors described herein, thereby providing a connector that selectively seals or blocks fluid flow at both ends. In certain embodiments of this type having closable female and male ends, it may be advantageous for the resilient seal to be disposed in or near the bore opening, as shown in U.S. patent No. 5,685,866. By providing the seal in this manner, the bore opening can be cleaned with a wiping action of the sterilant prior to use to avoid unwanted accumulation of debris, bacteria, sterilant or other unwanted material on the seal and/or in the region between the seal and the fitting housing adjacent the seal.

Turning now to fig. 5, the resilient member 18 will be discussed in more detail. In the embodiment shown, the elastic member 18 is formed by two rings 60 and 62 separated by two elastic members 64. The rings 60, 62 and/or the elastic members 64 may be made of a deformable material configured to exert a restoring force when stretched. Thus, if the rings 60 and 62 are pulled in opposite directions, the elastic members 64 function to return the rings 60 and 62 to their unstretched configuration.

The elastic member 64 may be made of a variety of elastic materials. In certain embodiments, the elastomeric member 64 is made of a silicone rubber elastomeric material. In other embodiments, the spring 64 may be made of a shape memory material. In other embodiments, the spring 64 and/or the spring 18 may include a spring or other member capable of exerting a restoring force.

The rings 60, 62 may also be made from a variety of materials. In certain embodiments, rings 60 and 62 are made of the same deformable material that makes up spring 64. Thus, the rings 60 and 62 can be elongated to a diameter that can surround the appropriate portion of the housing 23 to which the respective ring 60, 62 is attached. The resiliency of the rings 60, 62 may function to effectively hold each ring 60, 62 in place on the housing 23. In other embodiments, rings 60 and 62 may be constructed of rigid or semi-rigid materials and may, for example, comprise semi-circular rings that can be snapped in and out of place. In some embodiments, the resilient member 18 may be integrally formed into the valve member 16 or the housing 23. In some embodiments, other structures and/or configurations may be used to selectively urge the valve member 16 and the housing 23 together in a manner other than the resilient member 18.

Turning now to fig. 6, the seal 20 is described in more detail. In certain embodiments, the seal portion 20 is generally cylindrical and has a bore 66 therethrough. In certain embodiments, the seal 20 further includes a pair of generally rectangular projections 68 projecting from the cylindrical sidewall at diametrically opposed locations. The projections 68 may have different shapes and/or locations. The sealing portion 20 may also have an overall thinner middle portion 67 surrounded at the thicker ends by two rings 69.

The seal 20 may be made from a variety of different materials. In some embodiments, the seal 20 is made of a silicon-based deformable material 70. Silicon-based deformable materials are those that are constructed using plastics and other rigid polymeric materials that are liquid-tight. The sealing portion 20 may be made of the same material as the elastic member 18.

Certain components of one embodiment of the male luer 10 are shown in fig. 7. As shown, the housing 23 is omitted. The valve member 16, the resilient member 18 and the sealing portion 20 are shown in their respective assembled positions.

Certain interconnections of the various parts of the male luer 10 will be discussed in more detail below. As shown, the small ring 62 of the resilient member 18 is received within the circumferential groove 57 of the valve member 16. In some embodiments, the small ring 62 may be stretched until it has a larger inner diameter than the boss 49 on the first end of the valve member 16. Once the small ring 62 has been pushed into position around the circumferential groove 57, the small ring may be loosened so that it tightly wraps around the circumferential groove 57, as shown.

The large loop 60 of the spring 18 extends around the middle portion of the housing 23 (as shown in fig. 2) and may be stretched and positioned in a manner similar to that described above with respect to the small loop 62. The resilient member 64 of the resilient member 18 may then extend between the small ring 62 and the large ring 60 of the resilient member 18 and preferably along and within a groove in the valve member 16. Once the resilient member 64 is located within these grooves, the resilient member is in effect restrained by the projections 44 along the outer wall of the grooves. As shown in fig. 2, the elastic member 64 may also extend along the gap 38 in the upper shell 34 of the outer shell 23. In the illustrated embodiment, the gap 38 is generally located above the trench 46. The resilient member 18 thereby provides a resilient connection between the housing 23 and the valve member 16, pulling the valve member 16 into engagement with the housing 23.

The seal 20, which is partially blocked by the resilient member 18 in fig. 7, is preferably tightly fitted over the tube 40 and between the legs 42 of the valve member 16.

Fig. 8 shows a cross section of the male luer of the present embodiment near an exemplary female connector 92. The interconnection and interaction between the housing 23, the valve member 16 and the sealing portion 20 can be seen in more detail in this cross-sectional view. The valve member 16 is configured to be positioned within the housing 23. As shown, the tube 40 of the valve member 16 may be inserted into and through the lumen 28. At the same time, the posts 42 are configured to pass through corresponding slots that longitudinally pass through the intermediate portion 32 of the housing 23. In the assembled configuration, the post 42 is adjacent the nosecone 22 along two sides, and the tube 40 is at least partially received within the nosecone 22. The projection 44 is stopped by the gap 38 formed in the housing 34 on the outer shell 23.

The closure mechanism 56 is adapted to close the fluid passageway 54 through the closable male luer 10 and prevent fluid communication with the external environment, preferably whenever the male luer 10 is not engaged with the female connector 92. In the illustrated embodiment, the fluid passageway 54 includes the lumen 28 and the passage 52 of the valve member 16. The closure mechanism 56 of the illustrated embodiment includes a boss 58 of the tube 40 and an internal taper of the boss 30 of the lumen 28. When the two surfaces are in contact, they can form a closure on or near the second end 20 of the male luer 10.

The generally mating inner tapered surfaces of the tube 40 boss 58 and the lumen 28 boss 30 help provide closure of the female connector 92. Preferably forming a relatively fluid tight closure. The mating engagement between the projections 30 and 58 can also be formed in many other ways. In some embodiments, the material of the boss 58 and the material of the boss 30 of the cavity 28 are designed to mate and are made of sufficiently compatible materials to form a liquid-tight enclosure. In other embodiments, the boss 58 and/or other portions of the valve member 16 may be formed of a deformable material that more closely conforms to the contour of the inner surface of the interior cavity 28, and the interior cavity 28 need not be tapered. In certain embodiments, the seal 20 is configured to prevent liquid from leaking out of the male luer 10. When the valve member 16 is engaged with the housing 23, the sealing portion 20 is located between the intermediate portion 32 of the housing 23 and the tube 40. As liquid flows along the outer surface of tube 40 within the interior cavity 28 of housing 23, the seal 20, and more specifically the rings 69 on either end of the seal 20, prevent the liquid from flowing through the intermediate portion 32.

The sealing portion 20 is preferably retained between the housing 23 and the valve member 16 by a projection 68 (see fig. 6) which is arranged to fit within the aperture 36 in the intermediate portion 32 of the housing 23. The projections 68 help to maintain the seal 20 in a properly aligned condition.

Referring to the embodiment shown in fig. 8, the structure of the exemplary female connector 92 will now be discussed in more detail. The female connector 92 may include an elongated body 72 having a fluid passage 74 therethrough, and the female connector 92 may have a tip 76 near a distal end thereof. In certain embodiments, the tip 76 of the female connector 92 has a radially extending surface 78 disposed on an outer surface thereof. The female connector 92 may have a liquid conduit located within the female connector 92. No liquid conduit is included or required in all female connectors compatible with the connector 10 described herein. Along the proximal inner surface 80 of the female connector 92, the fluid passage 74 is preferably tapered such that the diameter of the fluid passage 74 gradually decreases distally.

As shown in fig. 8, the housing 23, valve member 16, resilient member 18 and sealing portion 20 are in an assembled configuration with the closure mechanism 56 forming a sealing engagement between the boss 58 and the inner surface of the interior cavity 28. Further, the seal portion 20 is in a closing engagement between the valve member 16 and the housing 23. Liquid from the passage 52 can flow through the window or aperture 50 of the tube 40 of the valve member 16. In this position, the window 50 is in communication with the inner surface of the pointed cone 22, but not yet in communication with the external environment. The interior cavity 28 is closed at its second end by a closure mechanism 56 and at its first end by the seal 20.

As shown in fig. 8, the post 42 of the valve member 16 passes through a slot in the housing 23 so that its end extends adjacent the end of the cover 24 adjacent the second end of the connector. The struts 42 are configured to engage the proximal end 84 of the female connector 92 when the female connector 92 is pushed into engagement with the closable male luer connector 10.

In fig. 8, the male luer and female connectors are shown in an unengaged configuration. To engage the male luer 10 with the female connector 92, the radially extending surface 78 of the female connector 92 is threaded into the internal threads 26 of the male luer 10.

As shown in fig. 9, two luer fittings may be threadably engaged with one another until the taper of the inner surface 80 of the female fitting 92 is located adjacent the corresponding tapered outer surface of the tip cone 22. In other embodiments, two luer fittings may be threadably engaged until the second end of the tip cone 22 forms a closure with a corresponding surface (not shown) of the female fitting 92.

As the male luer 10 and female connector 92 are brought into threaded engagement with one another, the proximal end 84 of the tip of the female connector 92 contacts the post 42 of the valve member 16. When the male luer connector 10 and the female connector 92 are further twisted, the post 42, and thus the valve member 16, is moved by the female connector 92 toward the first end of the male connector, causing the valve member 16 to displace relative to the housing 23. Thus, the projection 58 moves from the second end of the pointed cone 22 of the housing 23 toward the first end of the male connector. When the two tapered surfaces are separated, a gap is formed between the valve member 16 and the housing 23, allowing liquid to enter the fluid passage 74 of the female connector 92 through the aperture 30', and vice versa. When used with certain embodiments of the female connector 92, the internal fluid conduit contacts the second end of the valve member 16 before the outer shell of the female connector 92 contacts the post 42 to open the male connector 10. In certain embodiments, the closure remains intact until the inner surface 80 of the tip of the female connector 92 has formed a closure engagement with the outer surface of the tip 22 of the male luer connector 10. Thus, the channel 54 of the male luer 10 need not be in fluid communication with the external environment.

The spring member 64 (not shown in fig. 9) of the spring member 18 expands and applies a restoring force as the valve member 16 moves relative to the housing 23. The restoring force may be resisted by the radially extending surface 78 of the female connector 92 contacting the internal threads 26 of the housing 23 as long as the female connector 92 is engaged with the male luer 10. However, when the female connector 92 is withdrawn from the male luer 10, the resilient member 18 returns the core member of the valve member 16 into sealing engagement with the internal cavity 28.

The closure portion 20 preferably maintains a fluid-tight barrier between the outer surface of the tube 40 and the inner surface of the internal cavity 28 despite relative movement between the housing 23 and the valve member 16. In certain embodiments, the position of the seal 20 is maintained by the projection 68. In other embodiments, the seal 20 may be positioned by adhering the outer surface of the deformable material 70 to the inner surface of the cavity 28 of the housing 23. Other means of securing the seal 20 may be used.

In the open configuration, the fluid passage 74 of the female connector 92 may be in fluid communication with the passage 52 of the valve member 16, as shown in fig. 9. Liquid can thus flow from the tube 13 connected to the male luer 10 into the passageway 52 of the valve member 16, through the window 50 of the lumen 28, out of the lumen 28 through the aperture 30' on the second end of the tip cone 22, and into the fluid passageway 74 of the female connector 92, and vice versa. The seal 20 prevents liquid from leaking out of the male luer 10 through the gap between the housing 23 and the valve member 16. A fluid-tight seal may also be formed between the tapered end 22 of the housing 23 and a corresponding tapered surface of the inner surface 80 of the female connector 92.

Turning to fig. 10, fitting 10 is shown adjacent to a closable female luer fitting 210. In the embodiment shown herein, the closable female luer fitting 210 includes a housing 213, a void 212, a fluid channel 218, a liquid conduit 216 having one or more apertures 215, a compressible seal 214 having a proximal surface 217, and a threaded engagement region 211. The closable female connector 210 is located with its proximal end near the second end 56 of the male connector 10. The threaded engagement region 211 of the closable box 210 may conform to standard dimensions of a luer fitting, such as those conforming to ANSI. The compressible seal 214 may be constructed of a water impermeable, resilient material that may decrease in size when subjected to a force. The liquid conduit 216 may be constructed of a rigid material, such as polycarbonate plastic, that resists deformation when a force sufficient to compress the seal 214 is applied to the closable female connector 210.

The fluid passage 218 may place the liquid conduit 216 in fluid communication with the second end 219 of the closable female connector 210. At least one aperture 215 in the liquid conduit 216 may be sealed by the compressible seal 214 to prevent the fluid passage 218 from being in fluid communication with the void 212 between the compressible seal 214 and the inner wall of the housing 213 and/or with the exterior of the housing 213. The size of the aperture 215 may be suitably small enough to allow liquid to flow between the fluid passage 218 and the void 212 at a suitable flow rate. One such dimension of the aperture 215 is approximately 1mm in diameter, although non-standard shapes and other dimensions may be used. Apertures of at least about 1mm or about 1mm to 3mm or less than about 1mm may also be used. The fitting 10 may be engaged with a tube 13 containing a liquid.

Referring to fig. 11, the fitting 10 may be threadably engaged with a closeable female fitting 210. The threaded region of the closable box 210 may engage the internal threads 26 of the pin 10 to engage the connectors 10, 210, as shown. In the illustrated engagement, the luer fitting tip 22 enters the closable female fitting 210 by compressing the compressible seal 214. As can be seen, the luer taper 22 contacts the compressible seal 214 at the proximal surface 217 of the compressible seal 214. The force applied to engage the fittings 10 and 210 and to engage the threaded zones 26 and 211 is sufficient to compress the seal 214 to expose the aperture 215 in the liquid conduit 216. With the seal 214 compressed, the fluid channel 218 is in fluid communication with the interior space of the luer fitting tip 22.

As the luer taper 22 is advanced further into the closable female connector 210, the liquid conduit 216 contacts the end of the valve member 16 facing the second end of the male connector. This contact and continued advancement of the luer taper 22 forces the valve member 16 toward the first end of the male connector. The resilient member 18 exerts a closing force on the valve member 16 in a direction towards the second end of the male connector. As a result, the end of the valve member 16 that is directed toward the second end of the male connector remains substantially in contact with the fluid conduit 216 throughout engagement. As the valve member moves toward the first end of the male connector, the projection 58 of the valve member 16 disengages from the inner surface of the housing 23 through which the aperture 30' passes. As a result, the window 50 is opened to allow fluid communication with the closable female connector 210. The compressed seal 214 prevents the flow of liquid over the luer fitting tip 22 into the closable female fitting 210. In this configuration, fluid may flow from the tube 13 on the end of the valve member 16 to the second end of the male connector and into the tube 40 through the window 50, into the lumen 28, out the bore 30' in the luer taper 22 and into the housing 213 which may enclose the female connector 210, into the bore 215 of the fluid conduit 216, and into the flow passage 217 in the fluid conduit 216. Thus, the second end of the fitting 210 is placed in fluid communication with the proximal end 219 of the closable female fitting 210. In addition, the seal 20 preferably maintains a fluid barrier between the outer surface of the tube 40 and the inner surface of the lumen 28, restricting fluid flow to the closable female connector 210. The female connector may not engage the post 42 when the valve member surface toward the second end of the connector is directly contacted by a female connector member, such as the fluid conduit 216.

The connectors 10, 210 may be screwed apart. During separation, the force exerted by the resilient member 18 may return the connector 10 to its pre-engaged state by guiding the valve member 16 so that the projection 58 on the end of the valve member 16 facing the second end of the male connector engages the inner surface of the luer taper 22. Likewise, the resilient material comprising the compressible sealing member may return to its shape in the closed position and the proximal surface 217 may seal the proximal end of the closable female connector 210.

Referring now to fig. 12, the adapter 10 may be connected to a syringe 250. In fig. 12, the syringe 250 and adapter 10 are brought into proximity as shown. The syringe may include a male luer 252, a plunger 258, a barrel 260, and a conventional finger plate 262. The luer fitting 252 may further include a female threaded protective cover 252 and a syringe luer fitting spike 256. In the illustrated embodiment of the connector 10, the threaded surface 150 is provided on the outer surface of the first end of the valve member 16.

Referring now to fig. 13, the adapter 10 may be threadably engaged with a syringe 250. The protective cover 254 may engage the end of the valve member 16 toward the first end of the connector to connect the connector 10 to the syringe 250. The barrel 260 of the injector 250 may be placed in fluid communication with the tube 40 inside the valve element 16.

Turning to fig. 14, the joint shown in fig. 13 is shown in cross-section. Syringe 250 is threadably engaged with connector 10 by engagement between cap 254 and threaded surface 150 of valve member 16. Luer taper 252 of syringe 250 extends into tube 40 of valve member 16. The barrel 260 of the injector, here shown with liquid in the barrel 260, is in fluid communication with the interior of the valve member 16. Liquid may flow through the tube 40 to the luer fitting tip 22 of the fitting 10. In the illustrated embodiment, liquid cannot flow out of the male luer tip 22 of the fitting 10 because the projections 58 are in contact with the inner surface of the lumen 28. The valve member 16 thus blocks the aperture 30' in the end of the housing 23 facing the second end of the connector. To change the syringe 250 and adapter 10 from the condition shown in fig. 12 to the condition shown in fig. 14, the valve member 16 may need to be temporarily opened to release air (as described in more detail below).

Referring to fig. 15, the adapter 10 is shown adjacent to and between a syringe 250 and a hypodermic needle with a hub 270. Similar to fig. 12, syringe 250 may include male luer 252, plunger 258, barrel 260, and conventional finger plate 262. The luer 252 may further include a female threaded protective cap 254 and a syringe luer taper 256. The needle with hub 270 may include a housing having a boss 264 on an engagement end and a needle 268.

Referring to fig. 16, the fitting 10 is shown in threaded engagement with a syringe 250 and a needle with a hub 270. Threaded surface 150 of valve element 16 of adapter 10 may engage threaded cap 154 of syringe 250. Thus, the luer taper 256 may extend into the tube 40 of the valve member 16. Similarly, the boss 264 may engage the internal threads 26 of the protective cover 24 of the fitting 10. The luer tip 22 of the connector 10 may extend into the housing 266 of the hub.

In fig. 17, the joint in fig. 16 is shown in cross-section. The adapter 10 is engaged with a syringe 250 and a needle with an outer hub 270. The syringe 250 is threadably engaged with the threaded surface 150 of the valve member 16 of the adapter 10. The needle with hub 270 is threadably connected to the internal threads 26 of the protective cover 24.

Luer taper 256 of syringe 250 extends into tube 40 of valve member 16. Syringe 250 barrel 260 is in fluid communication with tube 40 of valve element 16 via luer taper 256.

The hub 10 engages a needle with a hub 270. Housing 266 with the needle of hub 270 has a boss 264 at its proximal end. The boss 264 threadingly engages the internal threads 26 of the cover 24 of the fitting 10. When the luer taper 22 is inserted into the needle 268 housing 266, the proximal end of the housing 266 can contact the post 42 of the valve member 16. When the needle with hub 270 is fully engaged with connector 10, valve member 16 has been moved a distance that separates boss 58 from the tapered interior wall of lumen 28 sufficient to allow liquid to flow out of window 54 of valve member 16. The liquid may then flow out of the bore 30' in the luer taper 22 and into the housing 266 of the needle with the hub 270. The hollow needle 268 allows fluid to flow from within the housing 266 out the distal end of the needle 268. The seal 20 preferably maintains a fluid barrier between the outer surface of the tube 40 and the inner surface of the lumen 28, restricting fluid flow in the lumen and restricting flow to the bore 30' in the luer taper 22. Thus, at this stage, the syringe 250 is in fluid communication with the distal end of the needle 268. As previously shown in fig. 13 and 14, in certain embodiments, the fitting 10 generally does not allow fluid to flow from the syringe 250 without an element engaging the second end 14 of the fitting 10. The elements shown in fig. 15-17 are syringes with needle mounts 270, but other elements may be used, such as those that allow fluid flow and control of the female luer fitting engagement.

Fig. 18A shows a perspective view of another embodiment of a closable male luer. Rotatable joint 300 is comprised of a housing 310, an internal passage 322, and a seal 330. The housing is further comprised of a luer fitting tip 312, a luer fitting receptacle 316 on the first end of the fitting 300, an engagement portion 318, a handle portion 320, and a boss 340. The seal 330 may have an opening 350 laterally along its surface 314. The internal channel 322 may extend from the luer fitting receptacle 316 to the luer fitting spike 312. The housing 310 may be constructed of a water impermeable material such as polycarbonate plastic. The housing 310 may also be constructed of a hydrophobic plastic. Other examples of materials suitable for making the housing 310 are glass fiber filled GE Valox420 or polypropylene. Many other materials may be used depending on the application.

The illustrated housing 310 is configured to receive a male luer taper on a luer fitting receptacle 316 by threadingly engaging a male luer fitting at an engagement portion 318 thereof. The socket 316 may conform to ANSI standards for luer fittings sockets. The illustrated operating portion 320 has two projections extending radially from the central axis of the housing 310. The operating portion 320 is configured to assist a user in gripping and rotating the joint 300.

The illustrated housing 310 is also configured to provide a closeable male luer fitting at a second end thereof. The luer tip at the second end may be constructed in accordance with ANSI standards for male luer tip. The luer taper is connected to the body of the housing 310 at the boss 340. The projections 340 are configured to prevent the luer taper 312 from entering too far into the luer socket. The housing 310 may also have a recessed portion 342 behind the raised portion 340. The housing 310 may also have a seal 330 with a surface 314 facing the second end of the fitting. The seal 330 may be any water impermeable, resilient material including, but not limited to, silicone. The choice of material for the seal can be made by one skilled in the art. Luer taper 312 tapers from boss 430 in a direction toward its second end.

The seal 330 may also have an opening 350 on the surface 314 facing the second end of the fitting prior to engagement with any other components. The opening 350 may be a slit extending transverse to the longitudinal axis of the housing 310. Opening 350 may be located in the center of surface 314 or at another location on surface 314. The seal 330 may cover the entire second end of the luer taper 312, or only a portion thereof. The seal 330 may be attached to the housing by overmolding, or other attachment methods. In an overmolding process, the shell 310 may be injection molded in a first step, and then in a second step the shell may be reloaded into the mold (or held in the mold) and appropriately sized molding pins (not shown) may be inserted into a wider end, such as the second end, of the shell 310. A silicone material may then be injected into the mold to form the seal 330. In other embodiments, the seal 330 may be glued or bonded into the housing 310.

As seen in the embodiment shown in fig. 18A, the seal 330 may prevent liquid from flowing through the housing 310 when the luer taper 312 is not engaged with another element. Thus, when a liquid containing component (not shown) having a male luer connector is connected to the luer connector receptacle 316, the connector 300 may be used to control the flow of liquid through its luer connector tip cone 312. For example, when a fluid-containing component, such as a syringe, is engaged with the fitting 300, fluid is allowed to fill the fitting 300 housing 310 by flowing through the internal passageway 322, but the seal 330 may substantially prevent fluid flow out of the luer fitting tip 312. If the interior space of the housing is filled with air or other gas before liquid enters, it may be necessary to open the fitting 300 to allow air or other gas to escape before liquid can enter. In certain embodiments, as described in detail below, the inner surface of the seal 330 may be adapted to increase the resistance against widening of the opening 350, which may allow liquid to escape from the internal passage 322 when liquid (not shown) pressurizes the seal 330. Thus, when adapter 300 is connected to the male luer of a liquid carrier without other elements being connected to luer taper 312 of adapter 300, adapter 300 prevents liquid flow from the liquid carrier.

In some modes of use, the opening 350 in the surface 314 of the seal 330 is normally closed in the position shown when the luer fitting tip 312 contacts a suitable female fitting such as that sold by ICU medical company, santa claymond, caWhen connected, opening 350 may be opened. One illustrative engagement of the structure is discussed in detail below. The joining may be by includingMany other configurations of the joint outside the joint and are accomplished in many other ways.

Fig. 18B is a cross-sectional view of the fitting 300 shown in fig. 18A. The fitting 300 may have an internal channel 322 connecting the luer fitting receptacle 316 to the luer fitting tip cone 312. The engagement portion 318 may be configured to receive an internally threaded protective cover of a male luer fitting (see fig. 19). The handle portion 320 may extend radially away from the inner channel 322, as shown. The seal 330 may extend along at least a portion of the interior channel 322 and may be disposed across at least a portion of the second end of the fitting 300. The seal 330 may extend beyond the end of the luer taper 312. The cross-sectional area of the seal 330 may be approximately equal to the cross-sectional area of the housing 310 at the end of the luer taper 312. In embodiments where the luer taper 312 and the seal 330 are substantially circular, the outer diameter of the seal 330 may be equal to the outer diameter of the luer taper 312. The seal 330 is not limited to being circular (nor to any shape described herein), and other shapes may be used. In other embodiments, the seal 330 does not extend beyond the end of the housing 310 near the second end of the fitting 300, but rather has a maximum outer dimension equal to the inner dimension of the luer fitting tip 312. The seal 330 may have a closure 324. The closure 324 may allow liquid to flow through the seal 330 of the fitting 300, but is biased to substantially close the opening 350 in the seal 330. The configuration of the closure 324 may be adapted to prevent the flow of permitted liquid (not shown) from the opening 350 when the luer taper 312 is not engaged with another element, as described in more detail below.

As can be seen in fig. 18C, which is a partial view of the cross-sectional view shown in fig. 18B, the seal 330 may comprise the entire surface of the second end of the fitting 300. In other embodiments, the seal 330 may not extend beyond the housing 300. The interior channel 322 may extend to a seal on the second end of the fitting 300.

Fig. 19 shows a perspective view of the adapter 300 near the syringe 360. As described above, the syringe may include male luer 362, barrel 370, plunger 374, and finger plate 372. The luer hub receptacle 316 of the hub 300 may be sized and shaped to engage a standard luer hub positioned to receive the luer tip 364 of the syringe 360. The internal threads 368 of the shield 364 of the syringe 360 are properly aligned for threaded connection with the engagement portion 318. In this manner, the socket 316 may engage the luer fitting 362 and connect the fitting 300 to the syringe 360. There is no physical element that prevents fluid in barrel 370 from flowing out of luer fitting tip 364 until syringe 360 is engaged with fitting 300.

Referring now to fig. 20, a perspective view of adapter 300 threaded to syringe 360 is shown. The fitting 300 may be coupled to a syringe or other medical device by a number of other means, such as gluing, bonding, solvent, ultrasonic welding, epoxy, interference fit, mechanical connection, and/or integral construction. The socket 316 (not shown) receives at least a portion of the luer taper 364 of the syringe 360. The luer taper 364 extends at least partially into the interior channel 322. The threaded engagement 318 engages the internal threads 368 of the shield 364 of the syringe 360. Fluid from syringe 370 may then flow freely within housing 310 of adapter 300 via internal passageway 322. If air or other gas fills the interior space of the housing before liquid can flow in, the fitting 300 can be opened to allow air or other gas to escape before liquid can flow in. In some cases, the fitting 300 housing 310 may be filled with a gas such as air. Before the liquid enters the housing 310, it may be necessary to open the joint to vent the gas before the liquid can flow. The seal 330 prevents liquid from exiting the fitting 300. Luer taper 312 of adapter 300 may be used to connect the adapter-syringe 300 and 360 assembly to other components to achieve controlled fluid delivery. The adapter 300 may also be integrally formed with a syringe 360 (not shown) such that the housing 310 of the adapter is formed by the infusion end of the syringe. During use of the connector-syringe assembly, male luer taper 312 of connector 300 may actually replace luer taper 364 of the syringe for connection purposes.

Certain drugs, such as chemotherapeutic drugs, are contact toxins and are required to avoid contact with the skin. These drugs are typically stored in syringes having hypodermic needles, such as shown in fig. 15 and 16. Under certain conditions, if a closeable male luer is not used, toxic liquid may flow out of the syringe. Although measures have been taken to avoid accidental outflow of liquid, such as orienting a syringe with an attached needle such that gravity helps to retain the drug within the syringe, the drug also evaporates and diffuses out of the hypodermic needle in the gaseous state. The use of a closeable male luer between the syringe and the hypodermic needle prevents uncontrolled flow of liquid and gaseous drugs. Thus, the risk of accidental exposure to such toxic drugs is minimized.

Referring now to fig. 21, another embodiment of a closable male luer 300 is shown in which an internally threaded protective cover 380 is disposed on the housing 310. The cover 380 at least partially or completely surrounds the housing 310 generally in the recess 342 (visible in FIG. 18A). In some embodiments, protective cover 380 is not attached to fitting 300, but is free to rotate about the longitudinal axis of fitting 300. The projections 340 (visible in figure 18A) may prevent the protective cover 380 from moving toward the luer fitting tip 312 of the fitting 300. Further, the handle 320 of the hub 300 may prevent the shield 380 from moving toward the luer hub receptacle 316. Protective cover 380 may be threaded according to ANSI specifications for luer fittings. The protective cover 380 may facilitate the formation of a connection between the luer fitting tip 312 and the fitting 300 and other components (not shown).

Referring now to fig. 22A, a cross-section of a closable luer male connector 400 having a continuously tapered internal channel 402 is shown. The tapered interior channel 402 of the housing 404 allows for various injection molding manufacturing techniques. For example, if the taper is wider at the end having the luer fitting receptacle 406, the shaped pin may be shaped in a corresponding manner to be untapered so as to closely conform to the wall of the internal channel 402, forming a seal 408 that is shorter than the seal shown in fig. 18B.

Referring to fig. 22B, seal 408 in the illustrated embodiment has a closure 412 similar to closure 324 in fig. 18B. Further, the inner surface of seal 408 may be adapted to increase the resistance to liquid flow out of opening 410 when liquid (not shown) in internal passage 402 pressurizes seal 408. The inner surface of the closure 412 may include a ramp on which the liquid presses to urge the opening 410 to close more tightly.

Turning to fig. 23A, a side view of another embodiment of the joint of fig. 22A is shown. An internally threaded protective cover 420 is disposed around the outer surface of the housing 404.

As shown in fig. 23B, housing 404 may have a protrusion 424 that prevents axial movement of protective cover 420 toward luer fitting tip 416. The housing 404 may also have a steering portion 418 extending radially outward from the longitudinal axis of the fitting 400. The housing 404 also has an internal passage 428 extending from the luer fitting receptacle 414 to the seal 430. The handle 418 prevents the cover from moving toward the luer fitting receptacle 414 of the fitting 400. The handle may also be a convenient place suitable for resting a user's finger when rotating joint 400. Further, there may be a recess 426 of the joint 400. The recess 426 may be a portion of the fitting 400 having an outer diameter that is less than the outer diameter of the boss 424 or the operator 418. The cover 420 may be positioned on the fitting 400 such that a narrow portion of the cover 420 surrounds the recess 426 of the fitting 400. The cover 420 may not be fixed to the housing 404 and may therefore be free to rotate. The internal threads 422 of the protective cover may conform to ANSI standards for luer fittings, allowing the protective cover to assist the luer fitting tip cone 416 in engaging a female fitting of another component (not shown).

Fig. 23C shows the closeable male luer fitting of fig. 23B at a suitable female fitting 450 such as manufactured by ICU medical corporation of santa claymond, caThe vicinity of the joint. The female connector 450 is similar to the female connector shown in fig. 10.

Fig. 23D shows the engagement between the male luer 400 and the female fitting 450. The internal threads of the protective cover 420 may engage the threaded region 451 of the box 450. The luer taper 416 of the male luer 400 may be accessed into the female fitting 450 by compressing the compressible seal 454. As the male connector 400 enters, the stationary fluid conduit 456 of the female connector 450 may penetrate the opening 448 in the seal 430 of the male connector 400. The liquid conduit 456 may extend far enough into the male connector 400 that the aperture 455 enters the internal passageway 428 of the male connector 400. Once the bore 455 of the female connector 450 is in the internal passage 428 of the male connector, liquid may pass from the luer fitting receptacle 414 of the male connector 400 through the internal passage 428 of the male connector 400 to the bore 455 of the liquid conduit 456 of the female connector 450. The liquid may then flow through the holes 455 and into the liquid conduit 458 of the female connector 450. Thus, when the male connector 400 is engaged with the female connector 450, fluid may flow from the first end of the male connector 400 to the distal end of the female connector 450. When the connectors 400, 450 are separated, the fluid conduit 456 exits the internal passage 428 while the seal 430 is closed, thereby preventing fluid flow through the male connector 400. In addition, the compressible seal 411 of the female connector 450 returns to its original position and prevents liquid from flowing through the aperture 455 in the liquid conduit 456.

Referring now to fig. 24A, a closeable male luer 500 is shown in perspective view. The fitting 500 has a housing 510 and a seal 514. The housing is constituted by a manipulation portion 512. In this example figure, the handle 512 includes a shoulder 516. The wings 516 are adapted to provide a user with a place to grip and rotate the housing 510 of the joint 500.

Referring now to fig. 24B, the joint 500 of fig. 23A is shown in cross-section. Wings 516 extend outwardly from the longitudinal axis of connector 500 and toward the luer receiver 518 of the connector as shown. The internal passage 520 of the housing 510 has a continuous taper, as described in the embodiment of the fitting 400 of fig. 22A.

Turning to fig. 25A, a side view of a closable male luer 600 is shown. The fitting 600 has a housing 610, a seal 614 and a protective cover 620. The housing includes an internal channel 640, luer fitting tip cone 612, and a handle 616. The manipulating portion may be configured to include two side wings 630, as shown in fig. 24A. The cover may have internal threads 622, which may be constructed to conform to ANSI specifications for luer fittings. The seal 614 may be biased closed when not engaged.

Referring now to fig. 25B, a cross-section of the joint 600 of fig. 25A is shown. Cover 620 may surround housing 610 at recess 652 of housing 610. Tab 650 may prevent movement of protective cover 620 toward the second end of fitting 600, while handle 616 may prevent movement of the protective cover toward the first end of fitting 600. The internal threads 622 of the protective cover 620 may be used to engage other elements (not shown) when used with the luer fitting tip cone 612. As described with respect to FIG. 22A, the continuously tapered interior channel 640 is characterized as facilitating injection molding.

Referring to fig. 26A, a perspective view of a closable male luer fitting assembly 725 including a closable male luer 700 and a flexibly connected female luer 750 is shown. The closable male luer fitting 700 may include any number of the aspects and features described herein. Female luer fitting 750 is adapted to receive a standard male luer fitting (not shown). Female luer 750 is located adjacent male luer 700 and is flexibly connected to male luer 700. Female luer 750 includes an internal channel 752, a luer receptacle 754, and a junction 756. The internal channel 752 places the luer fitting receptacle 754 in fluid communication with the internal channel of the closable male luer fitting 700. Closable male luer 700 may be connected to female luer 750 by flexible section 760. In some embodiments, the segment 760 may include a corrugated resilient material flexible portion. In other embodiments, a flat flexible material may be used. In other embodiments, both a flexible outer section and a flexible tube may be used to connect closeable male luer 700 to female luer 750.

Flexible section 752 allows a user to orient female connector 750 of assembly 725 in a different posture than that of closeable male luer 700. As one example, closable male luer fitting 700 may remain stationary relative to the arm of a patient, while female fitting 750 is angled away from the arm to facilitate easy connection with a syringe or other component (not shown). By flexibly connecting closeable male luer 700 with female luer 750, the torque generated when female luer 750 is moved is received at a point between the two components of assembly 725 and is less likely to be transmitted to another element (not shown) attached to closeable male luer 700. Such elements may include i.v. sites where tilt adjustment of the connection may cause injury to the patient. In addition, the moment will be less likely to bend and/or move the end of the tube 40 away from the inner surface of the lumen 28 (see, e.g., FIG. 28).

Fig. 26B shows another embodiment of a closable male luer connector assembly 800 comprising a closable male luer connector 825 and a flexibly connected female luer connector 850. The connectors 825, 850 and their elements are similar in many respects to the embodiment shown in fig. 26 and may include any number of the aforementioned aspects and features. Closable male luer 825 and female luer 850 are flexibly connected by a connector 860. A connector 860 fluidly communicates connectors 825 and 850. The connector 860 shown herein comprises a corrugated plastic conduit. Connector 860 is configured to position closeable male luer 825 and female luer 850 at different angular orientations. For example, the closable male luer 825 may remain stationary, while the female luer 850 may be at an angle to the closable male luer 825. In another example, the female luer 850 may remain stationary and the closeable male luer may be at an angle to the female luer 850. In yet another example, both the closable male luer 825 and the female luer 850 may be arranged at an angle.

Fig. 27-32 illustrate another embodiment of a closable male luer 900 having a male end 902 and a female end 904. In some aspects, the joint 900 is similar in structure and assembly to the other embodiments described and illustrated herein. For example, the fitting 900 may include a housing 906, a cover 908, a spring member 910, an internal valve member 912, and an internal seal 914. All descriptions, illustrations, and features of each embodiment described herein can be used in other embodiments described herein. As described below, the fitting 900 is effective to prevent or minimize the potential for dripping of liquid from the male end 902 when the male end 902 is in the closing process.

As shown in fig. 28 and 29, the valve member 912 may have a variable cross-section internal fluid passage 916. In some embodiments, the valve member 912 has no internal passages, instead, liquid flows around the valve member 912. As shown, the cross-sectional area of the region 918 of the passage 916 generally within the male end 902 of the housing 906 may be relatively narrow, the cross-sectional area of the region 920 of the passage 916 generally in the middle of the joint 900 may be wider and have tapered walls as shown, the region 922 of the passage 916 near the female end 904 may have a greater internal volume than the second region 920, the region 924 of the passage 916 may be connected to the region 922 through a narrow opening 926, and the region 928 may be connected to the region 924. In some embodiments, region 928 can be connected to region 924 by a narrow opening (not shown). In some embodiments, the joint 900 may also include one or more posts 921 to facilitate opening of the joint 900.

As described above, the region 928 and the female end 904 of the housing 906 can be configured to include one or more elements of the closed female end of the connector 21, 210 (and/or any element of other types of closed female connectors) to allow the female end 904 of the connector 900 to be selectively opened or closed to liquid flow.

The inner conduit 932 may partially or completely surround the region 924 of the inner fluid passage 916. The conduit 932 may be secured to a base 934, and the base 934 may be secured on one side to the female end 904 and on the other side to an intermediate portion 936. In the illustrated embodiment, the outer peripheral surface of base 934 extends to the outer peripheral surface of housing 906, but it can be provided in many other ways. The middle portion 936 may be secured to the remainder of the housing 906. On the end of the valve element remote from the male end 902, the inner conduit 936 may surround the area 922 of the fluid passageway 916. In the illustrated embodiment, the cross-sectional area and internal volume of the inner conduit 938 of the valve member is greater than the inner conduit 932 surrounding the region 924. A seal 940 may be provided in the interface region between the inner conduits 932 and 938 to prevent or minimize liquid leakage from the channel 916 at the interface, but to allow relative axial movement between the inner conduits 932 and 938. In certain embodiments, the inner conduits 932 and 938 are rigid and do not flex or bend under normal operating conditions. In some embodiments, the housing portions 90, 908, 934 and 936 are molded as a single coherent housing. In other embodiments, they may be formed separately and then joined together to form the housing.

As shown in fig. 30, the female end 904 of the connector 900 may be connected to a male portion 944 of another medical device, such as a syringe 942. In this embodiment, as well as all other embodiments disclosed herein, any of a number of other types of medical instruments can be connected to the disclosed joint. In the configuration shown in fig. 30, the fitting 900 and syringe 942 are filled with a liquid, such as a chemotherapeutic drug. Under normal conditions, liquid cannot leak from the connector 900 because it is blocked on one side by the interface between the valve member 912 and the male end 902 and on the other side by the pressure or structure of the liquid in the medical instrument 942.

As shown in fig. 31, when the valve member 912 is forced away from the male end 902 when the connector 900 is connected to another medical instrument (e.g., a female connector housing 946 of a plastic IV tube), the inner conduit 938 moves toward the female end 904 and overlaps at least a portion of the inner conduit 932. Fluid is then allowed to flow between medical instruments 942 and 946 through fitting 900. In the open second configuration or position, the area 922 is smaller than it is in the closed first configuration or position (see fig. 30). However, the areas 918, 920, and 928 remain substantially the same size. In certain embodiments, including embodiments in which the valve member 912 has no internal flow passage, the volume change zone within the fitting 900 may be achieved by a sliding fit stack configuration without directing fluid flow through the valve member 912. For example, if the valve element is solid, the valve element may be forced into or out of the conduit 932, and a suitable opening (e.g., in the conduit 932 or base 934) may allow flow through the housing 906 to the male end 902. In certain embodiments, including embodiments in which the valve element 912 has no internal flow passage, the valve element may comprise a sleeve that overlies the conduit 932, and a suitable opening (e.g., in the conduit 932 or base 934) may allow liquid to flow through the housing 906 to the male end 902.

In some embodiments, the male end 902 may automatically close when the medical instrument 946 is disengaged from the connector 900 if the valve member 912 is moved within the housing 906 toward the male end under the biasing force of the resilient member 910. In some cases, movement of the valve element within the fluid passageway may push a small amount of liquid within the male end through the male end opening and out of the connector, resulting in dripping caused by the valve closing. However, in the illustrated embodiment, such dripping is substantially prevented or minimized.

As shown in fig. 32, as the medical instrument 946 and the valve member 912 are advanced in the direction of arrow 950, the overlap between the inner conduits 932 and 938 may decrease and the volume of the region 922 of the fluid passageway 916 may increase. The volume of region 922 may eventually return to approximately the original volume when it was in the closed configuration (see fig. 30). The volumetric expansion of region 922 during closure of the male luer facilitates the flow of liquid from anywhere in channel 916 into region 922.

In certain embodiments, the increased space within region 922 cannot be filled with liquids between region 922 and a syringe or other medical device 942 because structures in medical device 942 (e.g., a post seal in a syringe, not shown) prevent movement of such liquids. Further, in some embodiments, as shown in fig. 32, the opening 926 between the region 922 and the female end 904 is much smaller than the openings 952, 954 between the regions 922, 920 and the rest of the fluid channel 916 within the male luer fitting. In this configuration, there may be less fluid resistance within the male end 902 than within the female end 904. In some embodiments, the cross-sectional area of opening 926 is less than half the cross-sectional area of opening 954. In some embodiments, the cross-sectional area of opening 926 is less than one-quarter of the cross-sectional area of opening 954. This configuration is more likely to allow fluid to flow out of the male end 902 into the connector than from the female end 904.

Because of the vacancy in the area 922, fluid between the valve member 912 and the inner wall of the male end 902 is pulled toward the area 922 within the body of the connector 900 rather than being pushed out of the male connector opening. When the fitting 900 is closed, the increased volume in the interior of the fitting 900 draws liquid in from the opening 948 rather than expelling the liquid. In the illustrated embodiment, this is accomplished in part by providing region 922 with a cross-sectional area that is much larger than the cross-sectional area of opening 948. As the valve member 912 moves to the closed position, the volume of the region 922 decreases more rapidly than the volume of the opening 948. In certain embodiments, the rigid walls of the stacked inner conduits 938, 932 can withstand repeated movement and use over extended periods of time with minimal wear. The walls of the overlying innerducts 938, 932 do not substantially deform or weaken, which would otherwise affect the size of the void created within the joint when closed. In addition, the walls of the stacked inner conduits 938, 932 do not substantially bulge or flex under the high hydraulic pressure in the joint, nor do they normally deflect the valve member 912 within the interior cavity of the housing 906.

In certain embodiments of the closable male luer fitting described herein, it may be difficult to "prime" the fitting (i.e., replace air within the fitting with a liquid) without allowing air to enter one or more medical devices connected to the fitting. In these embodiments, a separate pouring cap may be attached to the male end of the adapter. The pouring cap can be constructed in a number of different ways.

Fig. 33 provides an example of a pour cap 956 that may be used with a closable male luer 900. A suitably configured pouring cap may be used with any of the embodiments of male luer connectors described herein. In certain embodiments, the pour cap 956 may include structure to open the closable male luer 900 (e.g., a rigid internal conduit, not shown, for abutting against the valve element 921 or the female end 962 with a housing wall configured to abut the internal leg of the protective cover 908) to allow liquid to escape from within the closable male luer 900. The pour cap 956 may also include an internal flow passage (not shown) through which liquid from the open male luer 900 may flow. The flow passage may lead to an outlet aperture 964. The irrigation cap 956 may also include a filter 958 through which leaking air may pass, but not the advancing liquid. In the illustrated embodiment, a filter 958 is positioned in the outlet aperture 964. Thus, air may be expelled from the male luer 900, out of the outlet aperture 964 through the pour cap 956, while liquid is substantially retained within the male luer 900 and pour cap 956. When priming is complete, the priming cap 956 may be removed and disposed of, which automatically closes the closable male luer 900, and another medical instrument may be connected to the closable male luer 900. Many other configurations and arrangements of pouring caps may also be used.

Fig. 34 and 35 illustrate another embodiment of a closable male luer 900a having a male end 902a, a housing 906a, a female end 904a, and a resilient member 910a and a post 921 a. As shown in fig. 35, the end 913a of the valve member 912a proximate the end of the male end 902a can have a first surface 915a with a larger cross-sectional area than a second surface 917a configured to abut the inner side of the end of the male end 902 a. This configuration may help create an interface that further prevents liquid from leaking out of the male luer 900a through the male tip 902 a. In the embodiment of fig. 35, the inner conduit 938a has a smaller cross-section than the inner conduit 932 a. The relative moment between conduits 932a and 938a produces a change in volume of region 922a, as in the embodiment shown in fig. 27-32. Elastomeric seal 940a prevents or minimizes liquid leakage at the interface between conduits 932a and 938 a. When the closable male luer 900a is in the closed first position, as shown, the volume of the region 922a is greater than the volume of the closable male luer 900a in the open second position. The inner channel 916a may have straight walls such that the channel 916a maintains a relatively constant cross-sectional area. In certain embodiments, the walls of the channel 916a may be tapered. In many respects, the closable male luer 900a functions in a similar manner to the closable male luer 900 of fig. 27-32.

Fig. 36-37 illustrate another embodiment of a closable male luer 900b having a male end 902b, a housing 906b, a female end 904b, and a resilient member 910 b. This embodiment also includes an actuator 925b for manually opening and closing the male luer 900 b. A variety of different manual actuators may be used, including those that use springs, buttons, handles, and other structures. In the illustrated embodiment, the valve member 912b includes at least one lateral side 927b that can be contacted by a finger and pushed forward toward the male end 902b or the female end 904 b. In the illustrated embodiment, the valve member 912b includes a post 921b within the cover 908 b. Likewise, when the lateral side 927b is moved toward the male end 902b, the male luer 900b may be closed unless the male luer 900b is connected to another medical instrument at the male end 902 b. When the lateral side 927b is moved toward the female end 904b, the male luer connector 900b may be opened even if another medical instrument is not yet connected to the male end 902b of the connector 900 b. As shown in fig. 36, the outer surface of the actuator 925b may be serrated or textured to avoid finger slippage, and the outer surface of the actuator 925b may be slightly lower than the outer peripheral surface of the housing 906b to avoid inadvertent opening or closing of the joint 900b, particularly during installation or other movement of the joint 900 b. In some embodiments, the valve member 912b may not include a post within the cover 908 b.

In certain applications, the actuator 925b or some other structure for manually opening and closing the fitting 900b may be particularly advantageous during priming of the closable male luer fitting 900 b. It allows the fitting 900b to vent air within the fitting 900b to the outside (which could otherwise force the vented air into the instrument) while opening the fitting 900b prior to its connection to another instrument. When a manual mechanism is provided to open and close the fitting 900b, the pouring cap may not be needed.

Fig. 38-39A illustrate another embodiment of a closable male luer 900c having a male end 902c, a housing 906c, a female end 904c, and a resilient member 910 c. This embodiment also includes internal structures for blocking or interrupting the flow of liquid. A resilient closure 933c is located generally in region 922 c. Closure 933c can include a front surface 935c, which in the illustrated embodiment is substantially planar, as well as a slit 931c and a side wall 937 c. Sidewall 937c may be corrugated to facilitate axial compression of closure 933 c. The sidewall 937c can be connected to a seal 940c, as shown, or the sidewall 937c can be connected to a forward end 971c of a conduit 932 c. Conduit 932c may be in fluid communication with a second conduit 939 c.

As shown in fig. 39A, when valve element 912c is moved toward female end 904c, an internal shoulder c on valve element 912c contacts a front surface 935c of closure member 933c, causing closure member 933c to compress or move toward female end 904 c. But the second conduit 939c remains generally stationary and abuts the other side of the front surface 935c of the closure 933 c. The oppositely directed force exerted on closure 933c by shoulder 941c and conduit 939c flexes the closure, slit 931c splits to allow liquid to flow through fitting 900 c. Selective opening of the closure 933c (or another internal liquid-blocking structure) can be accomplished in a number of ways and other structures. The female end of the selective opening permitting region 922c in the connector 900c is closed or substantially closed before the end 913c of the valve member 912c engages the opening 948c in the male end 902c of the connector 900 c. The closed end region 922c expands as the valve element 912c continues to move toward the male end 902c, and the increased volume allows fluid to flow from the male end 902c into the region 922 c.

Fig. 40 shows another embodiment of a closable male luer 900d having a male end 902d, a housing 906d, a female end 904d, and a resilient member 910 d. As with the embodiment of fig. 38-39, this embodiment also includes internal structure for blocking or interrupting fluid flow between the female end 904d of the fitting 900d and the lumen. At one end of valve member 912d, a liquid chamber 963 is disposed in fluid communication with passage 916d of valve member 912 d. In the closed position of the illustrated embodiment, the liquid chamber 963d has a hole 965d located in region 922d and a hole 967d located in channel 930d between region 922d and region 928d of the female end 904 d. In many cases, the flow of liquid is blocked or reduced between the female end 904d and the interior of the fitting 900d due to the closed peripheral fit between the conduit 963d and the channel 930 d. However, as valve element 912d moves toward female head end 904d, tip 969d of liquid chamber 963d moves out of passage 930d and toward female head end 904d, and aperture 967d is exposed in region 928d of female head end 904 d. This enables fluid communication between the female end 904d of the fitting 900d and the interior. When valve member 912d returns to its initial closed position, liquid chamber 963d returns to its initial position in region 922d, with tip 969d located in channel 930d, again preventing or blocking liquid flow between female end 904d and the interior of fitting 900 d. Once the bore 967d has entered the passage 930d, fluid flow between the female end 904d of the connector 900d and the interior is substantially blocked when the valve member 912d returns to its initial closed position, preferably before the head 913d of the valve member 912d engages the opening 948d of the male end 902d of the connector 900 d. As the fluid in the region 922d is prevented from flowing to the female end 904d of the fitting 900d, fluid is preferably drawn into the expansion region 922d from the male end 902 d. Numerous other structures and configurations may be used to accomplish the selective communication of fluid between the female end 904d of the fitting 900d and the interior.

Fig. 41 illustrates another embodiment of a closable male luer 900e having a male end 902e, a housing 906e, a female end 904e, and a resilient member 910 e. As with the embodiment of fig. 38-40, this embodiment also includes internal structure for obstructing or interrupting the flow of liquid between the female end 904d and the interior of the fitting 900 e. At one end of valve member 912e, poppet valve 963e is disposed in fluid communication with passage 916e of valve member 912 e. The poppet valve 963e may include a first end that engages an outer surface of the valve member 912e, and a second end 969 e. Alternatively, the poppet 963e may be integrally formed with the valve member 912 e. The walls of the poppet 963e are generally rigid and generally not deformed or weakened. In addition, the walls of the poppet 963e do not substantially bulge or bend under the higher hydraulic pressure within the fitting, nor do they generally deflect the second end 969e from the direction within the interior cavity of the fitting 900 e. Many configurations of poppet valve 963e are possible. For example, the walls of poppet valve 963e near surface 961e may include holes or slits to allow liquid to flow through. The walls may be formed of legs extending from surface 961e with spaces therebetween to facilitate liquid flow therethrough. In some embodiments, the poppet 963e includes 3 legs. In some embodiments, the poppet 963e includes 4 or more legs.

In the closed position of the illustrated embodiment, the second end 969e of the poppet 963e is located in the passage 930e between the region 922e and the region 928e of the female end 904 e. In many cases, the flow of liquid is blocked or reduced between the female end 904e of the fitting 900e and the access interior due to the closed peripheral surface fit between the second end 969e of the poppet 963e and the passage 930 e. However, as the valve element 912e moves toward the female end 904e, at least a portion of the second end 969e of the poppet valve 963e extends from the passage 930e and moves toward the female end 904e, which enables fluid communication between the female end 904d and the interior of the fitting 900 d. When the valve member 912e returns to its initial closed position, the poppet 963e generally returns to its position in the area 922e with the second end 969e located in the passage 930e, again blocking or obstructing fluid flow between the female end 904e and the interior of the fitting 900 e. The second end 969e may include at least one flange (not shown) extending in the direction of the male end 902e of the connector 900 e. When the fitting 900e is in the open position, the flanges will be at least partially retained within the passage 930e to help maintain axial alignment of the poppet 963 e. When valve element 912e returns to its initial position, fluid flow between female end 904d of connector 900e and the interior is substantially blocked once second end 969e enters passage 930e, preferably before tip 913e of valve element 912e engages opening 948e of male end 902e of connector 900 e. Preferably, fluid is drawn into the expansion region 922e from the male end 902e as fluid in the region 922e is prevented from flowing to the female end 904e of the connector 900 e. Many other structures and configurations may be used to accomplish selective fluid communication between the female end 904e of the fitting 900e and the interior.

Fig. 42 shows another embodiment of a closable male luer 1000. As shown in the illustrated embodiment, the closable male luer 1000 may have a first end 1012 and a second end 1014. First end 1012 may include a male luer taper 1022 and a valve element 1016 (shown in detail in fig. 47). Luer taper 1022 and valve element 1016 may be supported by housing 1023. Valve member 1016 may be connected to housing 1023 by a resilient member 1018. End cap 1030 may be connected to housing 1023 near second end 1014 of closable male luer 1000. End cap 1030 may have external threads 1036. The embodiment of the closable male luer 1000 shown in fig. 42 is in a closed position. In the closed position, valve element 1016 cooperates with male luer taper 1022 to block fluid flow through fitting 1000.

As shown in fig. 42, the housing 1023 can have a protective cover 1024 around the luer fitting spike 1022. The cover 1024 may have internal threads 1026. The internal threads 1026 and the luer taper 1022 may form a male luer fitting engagement that conforms to ANSI specifications for male luer fittings. The end cap 1030 may have a receptacle shape that conforms to ANSI standards for female luer connectors and may receive a male luer connector. The external threads 1036 may be configured to threadingly engage corresponding internal threads of a male luer fitting.

Valve element 1016 may be at least partially surrounded by housing 1023. As shown, the housing 1023 can have at least one side opening 1025 that exposes at least a portion of the valve element 1016 and/or allows at least a portion of the resilient element 1018 to enter the housing 1023. In some embodiments, the housing 1023 can define two side openings 1025 that can be disposed opposite one another on either side of the joint 1000. In some embodiments, the side opening 1025 may extend along only a portion of the housing 1023 (e.g., over a medial region of the housing 1023 as shown) to provide increased strength to the housing near the second end 1014. In the illustrated embodiment, the resilient member 1018 is connected to the valve member 1016 near a side opening of the housing 1023. Outer side wall 1027 of the housing may have a particular shape. For example, the outer surface of the housing may have a narrower portion near the middle of the housing 1023, or a substantially hourglass shape, or a larger cross-sectional portion near the ends. These shapes may provide a user with a sense of proper finger rest on the joint 1000 and/or provide a more comfortable gripping surface during use. In some embodiments, one or more outward protrusions (not shown) may be added to the resilient member 1018 to provide additional or more effective gripping surfaces on the joint 1000.

Housing 1023 may include luer fitting tip 1022 near first end 1012 of fitting 1000. The luer taper 1022 has a hole 1021 at a first end that allows liquid to flow from within the housing 1023 out of the luer taper 1022. Valve element 1016 may include a valve closure end 1044. The closed end 1044 may engage the interior of the luer taper 1022 to prevent liquid flow through the luer taper 1022. In certain embodiments, the interference fit between the valve element 1016 and the housing 1023 prevents liquid from flowing out of the luer taper 1022. In some embodiments, an interference fit is between the closed end 1044 and the bore 1021. In some embodiments, valve element 1016 may include a resilient portion disposed near first end 1012 of housing 1023 for engaging housing 1023 near the luer taper to prevent liquid flow therethrough.

As shown in the embodiment of fitting 1000 shown in fig. 42, valve closure face 1046 may traverse luer fitting tip 1022 when fitting 100 is in the closed position. In some embodiments, the valve closure face 104 may protrude further beyond the bore 1021 out of the luer fitting spike 1022 when the fitting 1000 is in the closed position. In certain embodiments, the valve closure face 1046 is recessed in the luer fitting spike 1022. In certain embodiments, the valve closure face 1046 is substantially flush with the end face of the luer fitting spike 1022. In certain embodiments, the valve closure face 1046 is configured to be swappable when the fitting 1000 is in the first or closed position.

As shown in fig. 43, luer 1000 may be manipulated into a second or open position. In the open position of the illustrated embodiment, valve element 1016 is retracted from luer fitting spike 1022, thereby opening hole 1021 in spike 1022. As will be described in detail below, when the connector is opened, liquid may flow from the luer connector receptacle on second end 1014, through the interior of connector 1000, and out luer connector tip 1022 on first end 1012. When closed, fluid is blocked or prevented from flowing through luer 1000 under normal operating conditions.

The elastic member 1018 may be constructed of an elastically deformable material. Thus, in some embodiments, housing 1023 may remain connected to valve element 1016 by resilient element 1018 when luer 1000 is moved to the open position.

In the example shown, a change in the relative positions of the housing 1023 and the valve element 1016 causes at least a portion of the resilient element 1018 to expand. The resilient member 1018 thus applies a closing force to the housing 1023 and the valve member 1016, being biased to return the luer fitting 1000 to the closed state. The amount of tension carried by the resilient member 1018 may be adjusted by varying the mutual distance between the housing 1023 and the valve member 1016 and/or by constructing the resilient member 1018 from a variety of materials having different resilient characteristics. In certain embodiments, the fitting 1000 is configured to be difficult to open, thereby preventing accidental or unintentional opening. In some embodiments, the difficulty of opening the joint is controlled at least in part by the tension carried by the elastic member 1018.

Fig. 44 shows a cross-sectional view of a closable male luer in a closed position. As shown, the valve closure end 1044 can pressurize the interior of the luer fitting tip 1022 to prevent liquid from flowing out of the luer fitting tip 1022. Valve member 1016 may include at least one post 1050. In some embodiments, the post 1050 may extend from approximately the center of the valve element 1016 toward the first end 1012. The connector 1000 may have two struts 1050, as shown, or the luer connector 1000 may have more or fewer struts as desired. Struts 1050 may be disposed around luer fitting spike 1022, but within housing 1023, as shown. The post 1050 may be located within the inner diameter of the internal threads 1026 and thus be configured to engage at least a portion of the luer fitting receptacle when the female luer fitting receptacle is engaged with the luer fitting spike 1022.

As shown in fig. 46, the elastic member 1018 may have a first ring 1074 and at least one fastening ring 1072. Although two fastening rings 1072 are shown, one or more may be used in different embodiments of the fitting 1000. The first ring 1074 may be disposed in a groove 1048 on the outer surface of the housing 1023 proximate the first end 1012. The resilient member 1018 may be sufficiently tight around the housing 1023 to hold the first ring 1074 in place when a force is exerted on the resilient member 1018 due to a change in the relative positions of the housing 1023 and the valve element 1016. As will be described in greater detail below, one or more fastening rings 1072 may be provided in various forms around valve element 1016.

The passage 1056 may pass through the portion of the valve element 1016 near the first end 1012. The cross-section of the channel 1056 may be circular, as shown in the illustrated embodiment, or the channel 1056 may have other geometries. The channel 1056 can have at least one port 1062 near the first end 1012. In the illustrated embodiment, the two ports 1062 are located on opposite sides of the valve member 1016 and are circular, although other positions and shapes may be used.

In the embodiment shown in fig. 44, with the fitting 1000 in the closed position, the relative positions of the valve element 1016 and the housing 1023 may create a chamber between the channel 1056 and the luer fitting receptacle 1058. The chamber 1054 may be in fluid communication with a channel 1056. The chamber 1054 may be wider than the channel 1056, as shown. In some embodiments, the diameter of the chamber 1054 can be equal to the diameter of the channel 1056, and in some embodiments smaller than the diameter of the channel. The chamber 1054 can also be configured with any other suitable shape having a non-circular cross-section. The chamber 1054 is defined by the plunger 1070 at an end adjacent the second end 1014 of the housing 1023.

Plunger 1070 may be the portion of end cap 1030 that extends toward valve element 1016. The plunger 1070 may have a conduit 1094 therethrough. The conduit 1094 may place the chamber 1054 in fluid communication with the luer hub 1058. The plunger 1070 may have an outer dimension sufficient to substantially close one end of the chamber 1054, as shown. In the illustrated embodiment, the plunger 1070 is circular to match the geometry of the chamber 1054, although other suitable geometries may be used.

Although substantially sealing one end of the chamber 1054, the plunger 1070 may have an outer dimension that does not contact the wall of the valve element 1016 forming the chamber 1054. Thus, to prevent liquid from leaking past the plunger 1070, an O-ring 1060 may be disposed in a groove 1069 behind the plunger 1070. O-ring 1060 may contact the wall of valve element 1016 as shown, preventing liquid from flowing out of chamber 1054. In some embodiments, the plunger 1070 is part of the endcap 1030. End cap 1030 may be attached to housing 1023 by sonic welding, adhesive, or any other suitable attachment means. In the illustrated embodiment, the end cap 1030 is coupled to the housing 1023 using a sonic weld 1031. One such weld 1031 has a generally triangular shape as shown, although other shapes are possible. The plunger 1070 can therefore be considered to be in a rest position relative to the housing 1023. In some embodiments, plunger 1070 is integrally formed with housing 1023 and end cap 1030 is a separate element adapted to be attached to housing 1023, such as by sonic welding. In some embodiments, end cap 1030 is integrally formed with housing 1023.

As shown in the embodiment of fig. 44, liquid may flow in luer fitting receptacle 1058 and to conduit 1094. Liquid can flow from the conduit 1094 to the chamber 1054 and from the chamber 1054 into the channel 1056. As shown in the illustrated embodiment, when connector 1000 is in the closed position, valve closing end 1044 of valve element 1016 can seal the hole in luer tip 1022 and prevent fluid from flowing out of the tip of luer tip 1022. Liquid can generally flow out of channel 1056 through port 1062 in valve element 1016. Liquid may be retained within luer taper 1022 but may be prevented from flowing back to second end 1014 outside valve member 1016 by sealing ring 1020. Thus, when the fitting 1000 is in the closed position, as shown, fluid communication may generally exist between the luer fitting receptacle 1058 and the interior of the luer fitting spike 1022, without allowing liquid to flow out of the first end 1012 of the fitting 1000.

Fig. 45 shows an embodiment of a fitting 1000 in an open position. Fitting 1000 may transition to the open position when a female luer fitting (not shown) is engaged with luer fitting tip 1022 of fitting first end 1012. When the female luer fitting is engaged with the first end 1012 of the fitting 1000, a portion of the female luer fitting may engage the internal threads 1026 and may be advanced to at least partially surround the luer fitting tip 1022. Thus, when the female luer connector is engaged with the internal threads 1026, a portion of the female luer connector may engage the post 1050 and urge the valve element 1016 toward the housing second end 1014. In the embodiment shown in fig. 45, valve member 1016 is disposed toward second end 1014, resulting in joint 1000 being in an open state.

In some embodiments, when valve element 1016 is moved toward second end 1014, valve closure end 1044 (see fig. 44) is disengaged from luer fitting tip 1022, including moving valve closure face 1046 away from bore 1021 of luer fitting tip 1022. Liquid can flow from the interior of the housing out of the hole in luer taper 1022. The sealing ring 1020 may still prevent liquid from exiting the interior of the luer fitting spike 1022 toward the second end 1014 of the fitting 1000. Thus, in the open position, fluid may enter luer taper 1022 from luer hub 1058 via conduit 1094, chamber 1054, channel 1056, one or more ports 1062 on valve element 1016, and exit through bore 1021 in the tip of luer taper 1022.

As can be seen in the illustrated embodiment, the valve member 1016 is positioned closer to the end cap 1030 as the post is moved toward the second end 1014 of the connector 1000. Thus, the wall of the valve element 1016 containing the terminus of the channel 1056 is closer to the portion of the plunger 1070 of the end cap 1030. The volume of chamber 1054 can be reduced when fitting 1000 is in the open position.

Thus, as the connector 1000 is being moved from the open position to the closed position, the volume of the chamber 1054 increases as the valve member 1016 moves toward the first end 1012 of the connector 1000. As the volume of chamber 1054 increases, valve closing end 1044 of valve element 1016 moves toward first end 1012 to close the bore of luer taper 1022. If no additional liquid is input to the fitting 1000 through the luer fitting socket 1058, the vacuum created by the increase in volume of the chamber 1054 may draw back the liquid present in the luer fitting spike 1022 through the port 1062, the channel 1056, and toward the chamber 1054. In this case, when the valve closure end 1044 is moved into position in the bore, liquid may be prevented from flowing out of the bore of the luer taper 1022 because liquid may instead be drawn back into the chamber 1054. In some embodiments, when the valve element 1016 moves toward the first end 1012 of the housing 1023, liquid on or near the valve closure face 1046 is urged into the fitting 1000, rather than remaining on the surface of the closure face 1046.

However, if additional liquid is still being input to fitting 1000 through luer fitting socket 1058, the additional liquid can enter and collect in chamber 1054 as valve element 1016 moves toward first end 1012 to close luer fitting tip 1022. In this case, when valve element 1016 seals against tip cone 1022, pressure from the newly introduced fluid is prevented from forcing the fluid out of luer tip cone 1022. Thus allowing liquid to flow through fitting 1000 when the female luer is engaged with first end 1012 of fitting 1000, but preventing liquid from flowing through fitting 1000 while the female luer is being separated and after the female luer has been separated.

As will be described in more detail below, it is desirable to prevent certain drugs from coming into contact with the skin. It is therefore desirable for the fitting 1000 to help retain liquid within the fitting 1000 when the fitting is separated from a female luer fitting or other connector. Thus, reducing the likelihood of liquid escaping through luer taper 1022 when separation occurs results in a corresponding reduction in the chance of toxic drug coming into contact with the skin of the user or patient.

Fig. 46 shows a cross-sectional view of the fitting 1000 with a portion of the housing removed. As shown, the resilient member 1018 may have a first ring 1074 disposed in a groove 1048 of the housing 1023. The resilient member may extend toward the second end 1014. Valve member 1016 may have a plurality of outwardly extending projections, embodied in the illustrated joint as an upper flange 1064, a lower flange 1066, and a notch flange 1068. The resilient member may have two fastening rings 1072 disposed around valve element 1016 and held in place by one or more flanges 1064, 1066, and 1068.

As shown in the illustrated embodiment, the fastening ring 1072 may be connected to the first ring 1074 by a strap 1096. The band 1096 may generally extend between the first end 1012 and the second end 1014, passing between the notch flanges 1068 of the valve element 1016. In some embodiments, fastening ring 1072 may be held in place by an edge of notch flange 1068 and lower flange 1066. The fastening loops 1072 may extend further from the strip 1096 toward the second end 1014, crossing each other as shown in the illustrated embodiment. In certain embodiments, a separate strap 1096 may be used to connect the first ring 1074 to each fastening ring 1072. Separation of the fastening ring 1072 when connected by the first ring 1074 and the separate strap 1096 can facilitate manufacture of the fitting 1000, particularly when the side groove 1025 does not extend all the way to the end of the housing 1023 near the second end 1014 of the fitting 1000. The portion of the fastening ring 1072 furthest from the straps 1096 may be surrounded by the lower and upper flanges 1064, 1066, which fasten it in place around the valve element 1016 as shown. Thus, when valve member 1016 is moved toward second end 1014 by engagement with the female connector described above, resilient member 1018 may exert a force on valve member 1016 that pulls it toward first end 1012. In the illustrated embodiment, the fastening rings 1072 are shown stacked, although many other arrangements and configurations are possible, including other arrangements of rings or configurations of springs having larger or smaller and differently configured or provided fastening rings 1072 or first rings 1074. As described above, in certain embodiments, the fastening rings 1072 cross each other. When two rings 1072 are present, they are made to intersect each other to form two intersection points 1075. In certain embodiments, the thickness of one or both of the fastening rings 1072 is reduced at the intersection point 1075 to form a substantially uniform fastening ring 1072 around the valve member 1016.

Fig. 47 illustrates one embodiment of valve element 1016 including valve closure face 1046 on an end face of valve closure end 1044. The port 1062 may be located near the sealing surface 1046 or may be withdrawn from the sealing surface as far as possible before the sealing ring 1020 (see fig. 46). The port 1062 may be circular, as shown, or may have other shapes. The post 1050 is shown extending toward the first end 1012 of the valve element 1016. There may be one, two or more struts 1050. In certain embodiments, joint 1000 does not include struts 1050. But rather the fitting 1000 is adapted to be otherwise opened when mated with a female fitting. For example, the female connector may include an engagement member (not shown) that engages the valve closure surface 1044 to open the connector 1000, or a manual slider or button may be suitably configured to open the connector 1000.

The notch lip 1068 may be formed by two parallel projections projecting from the body of the valve element 1016 or may be otherwise suitably sized to couple with the resilient member 1018. Lower lip 1066 may be perpendicular to notch lip 1068, as shown. The lower flange 1066 may also include more than one protrusion extending from the body of the valve element 1016 a distance, suitably greater or lesser, to facilitate connection with the resilient member 1018. The upper flange 1064 may be parallel to the lower flange 1066 and spaced apart by at least the height of the fastening ring 1072 to engage the fastening ring 1072 and prevent the fastening ring 1072 from being compressively moved to encircle different portions of the valve member 1016.

Fig. 48 illustrates one embodiment of end cap 1030. End cap 1030 may have a seal 1098 shaped and configured to substantially seal second end 1014 of housing 1023. The luer hub 1058 may extend beyond the seal 1098 in one aspect, and the luer hub 1058 may be appropriately sized to engage with a male luer hub (not shown) that conforms to ANSI standards for luer devices. The luer fitting receptacle 1058 may have external threads 1036 to engage a male luer fitting portion, as shown. In certain embodiments, a protrusion or other projection may be used to engage the male luer fitting.

In some embodiments, the plunger 1070 is on the end of a portion that protrudes in the other direction from the seal 1098. The plunger 1070 is sized and configured to substantially seal the chamber 1054 within the valve element 1016. The gap or recess 1069 between the seal 1098 and the plunger 1070 is sized and shaped to receive an O-ring 1060, as shown and described above.

Fig. 49 shows an exploded view of one embodiment of a fitting 1000. In the illustrated embodiment, the elastic member 1018 is shown with a fastening ring 1072 superimposed. End cap 1030 may be disposed proximate second end 1014 of fitting 1000. An O-ring may be disposed about a portion of end cap 1030 and plunger 1070 may be disposed within valve member 1016 accessible from second end 1014.

A resilient member 1018 is disposed around the housing 1023 and the valve member 1016, which are resiliently connected. A sealing ring 1020 is disposed about the valve closure end 1044 of valve member 1016 and within housing 1023. The sealing ring 1020 may have one or more protrusions 1019 corresponding to indentations on the valve member 1016 or the housing 1023 to substantially secure the sealing ring 1020 in place. In the illustrated embodiment, two protrusions 1019 extend from the sealing ring 1020 to connect with the housing 1023. More or fewer protrusions 1019 may be used or sealing ring 1020 may be configured to be secured to valve member 1016.

In another embodiment shown in fig. 50, the constituent elements are numbered substantially similarly to the above-described embodiment, but with a prime (') added to the corresponding numeral. As shown, the illustrated fitting 1000 ' has an elastic member 1018 ' in which fastening rings 1072 ' are not stacked, but are spaced apart. A plurality of straps 1096 'extend from the first ring 1074' to the fastening rings 1072 'and 1072' at different distances. Thus, the first strip 1096a 'is shorter than the second strip 1096 b'. The shorter strip 1096b ' is connected to a first fastening ring 1072a ' disposed proximate the first end 1014 ' of the fitting 1000 ' and to a first ring 1074 '. Likewise, a longer strap 1096b ' may extend from the first ring 1074 ' to the second fastening ring 1072b '.

A first fastening ring 1072a ' may be disposed between notch flange 1068 ' and lower flange 1066 '. A second fastening ring 1072b 'extending further toward second end 1014' may be disposed between lower flange 1066 'and upper flange 1068'. The configuration of the elastic member 1018' in the illustrated embodiment may be accomplished in a similar manner as the previous embodiments. Other configurations are also possible.

As mentioned above, some drugs, including those used during chemotherapy, may be harmful in some form of contact with the skin. For example, contact with the skin can sometimes result in chemical burns. Inhalation of some drugs in the form of a mist can be harmful. Thus, control over drug containment is highly desirable.

Currently, some potentially harmful drugs are dispensed in sealed vials. The drug is removed from the vial by inserting a needle and drawing the drug into a syringe. The needle is then withdrawn from the vial and the drug may be dispensed. However, by inserting the needle into the medicament to be drawn into the syringe, the medicament is distributed over the exterior of the needle, which may inadvertently come into contact with the skin and cause injury. Alternatively, a syringe with a retraction mechanism that penetrates the vial may be used. In such syringes, the drug is withdrawn through the mechanism and directly through the needle of the injection without an additional step of withdrawing the mechanism from the vial. Despite the use of such syringes, there is the potential for potential drug to remain on the needle used to inject the drug or on the mechanism after disconnection from the vial.

Additionally, some medications may be dispensed by connecting a needle to a syringe containing the medication. The interengaged needle and drug-containing syringe are sterilized and placed in a vacuum-sealable container. The container is then evacuated and sealed. This arrangement may result in the medicament being withdrawn through the syringe when the container is evacuated. In a sealed container, however, the drug may be aerosolized or otherwise attached to the outer surfaces of these elements.

Furthermore, if the ambient atmospheric pressure at the treatment site is different and in particular lower than the internal pressure of the drug in the container, uncontrolled drug ejection may occur. For example, the drug may leak when the needle penetrates a vial having an internal pressure higher than ambient atmospheric pressure to draw the drug into the syringe. Alternatively, the drug may leak when the needle is withdrawn from the vial and before the vial seal is fully closed.

A syringe that engages a closable male luer typically prevents the flow of medication except during the desired application. For example, in certain embodiments, a syringe with a closable male luer attached thereto will not leak medication when packaged for shipment, even if the package is vacuum sealed. Once the package is opened, the male luer may be engaged with the female luer of the IV tubing, e.g., medication is dispensed only when the engagement is made. After the drug flows from the syringe into the IV tubing through the engaged hub, the male luer hub may be separated from the female luer hub. As described above, the male luer fitting may be closed upon disconnection, preventing excess liquid from flowing through the fitting. When using a medical device such as that sold by ICU medical corporation of Santa Claiment, CalifA female luer connector such as a connector also prevents fluid from flowing out of the female luer connector.

In addition, a syringe with a closable male luer may be engaged with the needle as described above. The flow of liquid through the needle can then be controlled with the correct use of the closable male luer. The medication may also be placed in a syringe having an integrally formed and/or permanently attached closable male luer. Thus, direct access to the hazardous drug as described above may be substantially limited to the strictly controlled environment in which the drug is produced and stored. These medications may be placed in a syringe with a closable male luer fitting prior to dispensing for use, minimizing the risk of inadvertent exposure during use of the medication.

Fig. 51 shows an embodiment of a tip or end cap 1030 "having an example of a structure for preventing the female tip of the connector from being easily separated from a male luer connector inserted therein. The structure may have a variety of different embodiments and configurations, such as the illustrated retention barb 1090. Many of the elements shown in FIG. 51 are similar to those described above, except that a double prime (") is added for distinction.

The illustrated embodiment shows retention barbs 1090 partially encircling luer fitting receptacle 1058 "and partially protruding into receptacle 1058". Retention barb 109 may include a wire, a portion of which is arcuate, an angled portion 1091, a straight portion 1093, and a barb point 1092. The arcuate portion of the barb 1090 may correspond to the outer diameter of the luer fitting receptacle 1058 ", which may be along at least a portion of the external threads 1036". The angled portion 1091 may include a transition from an arc to a straight portion 1093 in the barb 1090, as shown in the illustrated embodiment. In the illustrated embodiment, the straight portion 1093 passes through a portion of the solid wall of the luer fitting receptacle 1058 "and terminates at a barb point 1092. In certain embodiments, the luer fitting receptacle 1058 "includes an elongated structure extending from a wall of the receptacle 1058", not necessarily including the other elements of the illustrated barb 1090.

As shown in fig. 51-53 and 55, in some embodiments, barb points 1092 and 1092 "may comprise angled barb faces 1092a, 1092 a". As best shown in fig. 51, in certain embodiments, the angled barb face 1092a may be disposed facing an outer surface of the luer fitting receptacle 1058 ". Conversely, as best shown in fig. 52, in certain embodiments, the angled barb face 1092a may be disposed not opposite the outer surface of the luer fitting receptacle 1058 ". Also, as best shown in fig. 55, in certain embodiments, the inclined barb face 1092a '"can be disposed outwardly (i.e., away from the local arc of the retention barb 1090'"). And in some embodiments (not shown), the angled barb face 1092a '"can be disposed inwardly (i.e., toward the local arc of the retention barb 1090'"). In certain embodiments, the barb 1090 is substantially symmetrical about its axis (e.g., it does not have a straight angled surface), or the barb 1090 has straight or rounded ends, without sharp points.

In certain embodiments, the barb 1090 may continue to extend around the luer fitting receptacle 1058 "but not penetrate it. In some embodiments, the barb 1090 may pass through the inner wall of the luer fitting receptacle 1058 "and may contact a male luer fitting inserted into the luer fitting receptacle 1058". Although the wires in the illustrated embodiment are arcuate, wires having other cross-sections or other materials than wires, such as plastic or metal sheets, may be used.

As described below, barb points 1092 may have a variety of shapes, each sufficient to accomplish the desired retention. The barbed point 1092 may extend from the outer wall of the luer socket 1058 ", or as shown, the straight portion 1093 may continue for a distance before the wire forms the barbed point 1092.

Syringe 1080 is shown adjacent to luer hub receptacle 1058 ". The syringe may include a syringe shield 1086 with syringe internal threads 1084. The syringe shield 1086 and threads 1084 may partially surround the syringe tip 1082, all of which substantially conform to luer ANSI standards. The external threads 1036 "may be configured to engage corresponding threads 1084 on an inner surface of the syringe shield 1086. Luer hub receptacle 1058 "may be configured to receive syringe tip 1082 to form a luer hub connection.

FIG. 52 illustrates a cross-sectional view of end cap 1030 ' of FIG. 51 taken along line 52-52, as shown, barbs 1090 may extend at least partially around luer receptacle 1058 ', in the illustrated embodiment barbs 1090 are disposed adjacent external threads 1036 ', barbs 1090 may partially surround luer receptacle 1058 ', barb points 1092 may extend outwardly away from luer receptacle 1058 ' and external threads 1036 ' prior to projecting into receptacle 1058 ' in straight portions 1093. in some embodiments, barb points 1092 may extend beyond a circular plane defined by external threads 1036 ', and in some embodiments barbs 1090 may be angled at a straight line angle α tangent to the outer wall of luer receptacle 1058 ', in some embodiments angle α is in the range of about 10 to about 35 degrees.

When a male luer such as syringe 1080 is connected to the illustrated end cap 1030 ", the first step in this connection is to twist the syringe 1080 and luer insert 1058" to engage the threaded surface 1036 ". When engagement occurs, the barb points 1092 may be angled as shown to slide along the interior of the syringe shield 1086 and be guided by the syringe threads 1084. The barb points 1092 may be placed in a tangential position relative to the luer hub 1058 "as shown to enhance compliance of the engagement. In addition, the angle of the barb point 1092 may be adjusted to simulate the tendency of the curvature of the curve of the luer fitting receptacle 1058 ".

Once engagement is complete and connection is complete, the syringe is typically separated from the luer hub by reverse twisting. However, when separation is attempted using the illustrated socket 1058 ", the reverse twist causes the barbed point 1092 to abut at least a portion of the syringe shield 1086, with at least a portion embedded therein as a result. The barb points 1092 may be angled to pass through the syringe shield 1086 when separation is attempted.

When the barb points 1092 pierce the syringe shield 1086, they substantially prevent further separation, making separation of the syringe 1080 and the adapter 1000 more difficult. Thus, once the fitting 1000 with the retention barbs 1090 is connected to a syringe or other medical device, it may be difficult, or impossible, to disconnect the fitting without applying more torque and/or structural damage to at least one of the devices.

Fig. 53 and 54 illustrate one embodiment of a retention barb 1090 having a pointed barb point 1092. As shown, the arc transitions through a sloped portion 1091 to a straight portion 1093 before terminating at a barb point 1092. Although straight portion 1093 may be at least partially embedded in end cap 1030 ", other configurations may be used.

In the illustrated embodiment, barb points 1092 may be oval shaped and/or lack a true point. For example, the barbs 1090 may have sharply rounded edges or other suitable structures. The illustrated embodiment may be formed by cutting the barb 1090 at an angle, resulting in the illustrated point 1092.

Fig. 55 and 56 illustrate another embodiment of the retention barb 1090 '", wherein the component parts are substantially similar except for the addition of a triple prime'". In the illustrated embodiment, barb point surface 1095 is at the tip of barb point 1092' ″. The barb point surface 1095 may be formed by cutting the tip of the barb point 1092' ″, thereby enhancing the ability of the barb 1090 to pierce the medical instrument during separation. Alternatively, the barb point surface 1095 can be formed by making a cut similar to the cut forming the barb point 1092 in fig. 53 and 54, except that the cut need not completely span the diameter of the barb 1090 '"before intersecting the end of the wire forming the barb 1090'". In some embodiments, this may result in a flat barb point surface 1095.

Although barbs 1090 are described as being used to lock luer 1000 to another medical device, many other methods of forming a difficult or irreversible connection between medical devices may be used. For example, one or more barb points, bump points, clips, and/or protrusions or other structures suitably formed on luer fitting receptacle 1058 may also be used.

Additionally, retention barbs or other anti-disassembly structures may be used with other medical devices besides the closable male luer 1000 described above. The barb may be attached to any suitable medical device having a portion adapted to be connected to another luer fitting. Any other suitable instrument may be configured to include a detachment prevention feature. For example, any of the instruments disclosed in the following U.S. patent applications and patents, or other instruments of the same or similar kind, may be configured to include a detachment prevention structure: U.S. patent No. 6,428,520 issued at 8/6 2002; U.S. patent No. 6,245,048 issued at 12.6.2001; U.S. patent No. 6,695,817 issued at 24/2/2004; U.S. patent No. 6,758,833 issued on 6/7/2004; U.S. Pat. No. 6,599,273 issued on 29/7/2003; U.S. patent publication No. 2006/0161115 published on 20.7.2006 and U.S. patent publication No. 2006/0173420 published on 3.8.2006; and U.S. provisional patent application No. 60/854,524, filed on 25/10 of 2006. Preventing disassembly is particularly advantageous when the contents of the liquid container to which the fitting is connected may be unsanitary, harmful and/or toxic.

Fig. 57 and 58 illustrate another embodiment of a closable male luer 1100, wherein the end cap 1130 may include features that prevent the female end of the connector from easily separating from a male luer inserted therein. The closable male luer 1100 shown in fig. 57 and 58 is similar to the closable male luer 1000 described above, except as described below. Another example of a locking mechanism 1136 defined on the end cap 1130 of the closable male luer 1100, as described in more detail below, the locking mechanism 1136 is configured to not only threadedly engage a corresponding internal thread of a male luer or other component, such as a syringe, but also to prevent or inhibit the male luer from separating or unscrewing from the corresponding male luer or other component to which the closable male luer 1100 is connected. Because the locking mechanism 1136 may generally be used with any end cap or closeable male luer, the following description focuses primarily on the locking mechanism 1136, rather than the features of the closeable male luer 1100 that are the same or similar to the features described above for the closeable male luer 1000.

The end cap 1130 may be formed by injection molding or any other suitable manufacturing method. The end cap 1130 may be made of a 20% glass fiber filled polycarbonate material, but may be formed of any one or more other materials, such as polycarbonate, glass fiber filled polycarbonate, other suitable rigid plastics, metals, alloys, and the like, or combinations thereof. Similar to the end cap 1030 of the closable male luer 1000 described above, the end cap 1130 may be connected to the housing 1123 by sonic welding, adhesive, or any other suitable connection means. In the embodiment shown in FIG. 58, end cap 1130 may be attached to housing 1123 with sonic welds 1131. One such weld 1131 is shown as being substantially triangular in shape, although other shapes are possible.

In some embodiments, as shown in fig. 59, the end cap 1130 may be formed to define a plunger 1170. The plunger 1170 is sized and configured to substantially seal the chamber 1132 within the valve member 1116. The gap or slot 1169 between the sealing portion 1198 and the plunger 1170 is sized and shaped to receive an O-ring or other annular seating member, as shown in fig. 58. Alternatively, the plunger 1170 can be shaped to substantially match the seal 1198 without the use of an additional annular seat. The plunger 1170 can be considered to be in a stationary position relative to the housing 1123. In certain embodiments, the plunger 1170 can be integrally formed with the housing 1123 and the end cap 1130 is a separate component that is suitably attached to the housing 1123, such as by sonic welding. In some embodiments, the end cap 1130 may be integrally formed with the housing 1123.

Similar to the closable male luer 1000 described above, the closable male luer 1100 may have a first end 1112 and a second end 1114. The first end 1112 may include a male luer taper 1122 and a valve element 1116. The luer taper 1122 and the valve member 1116 may be supported by the housing 1123. The valve member 1116 may be connected to the housing 1123 by a resilient member 1118. Similar to the end cap 1030 of the closable male luer 1000, the end cap 1130 of the closable male luer 1100 may be connected to the housing 1123 near the second end of the closable male luer 1100. The embodiment of the closable male luer 1100 shown in fig. 58 is in a closed position whereby the valve closed end 1144 is located within the bore 1121 in the luer tip 1122 thereby sealing the bore 1121 in the tip 1122. Thus, similar to the closable male luer 1000 described above, the valve element 1116 cooperates with the male luer taper 1122 to prevent liquid flow through the fitting 1100 in the closed position.

Further, the closable male luer 1100 may be manipulated to the second or open position in a similar manner to the closable male luer 1000 described above. In the open position of some embodiments, the valve member 1116 and the valve closing end 1144 are retracted from the luer fitting tip 112, thereby opening the aperture 1121 in the tip 1122. In the open position, liquid may flow through the interior of the fitting 1100 from the luer fitting receptacle of the second end 1114. As best shown in the cross-sectional view of fig. 58, the channel 1156 may be in fluid communication with a chamber 1132 that extends through a portion of the valve member 1116. The chamber 1132 may also be in fluid communication with the interior space of the luer fitting 1158 via a conduit 1194. Thus, as shown in the embodiment shown in fig. 58, liquid may flow in the luer fitting socket 1158 and to the conduit 1194. Liquid can flow from the conduit 1194 into the chamber 1132, from the chamber 1132 into the channel 1156. Under normal operating conditions, when the luer 1100 is closed, liquid is prevented or blocked from flowing through the luer 1100, as shown in fig. 58.

The end cap 1130 may have a sealing portion 1198 that is shaped and configured to substantially seal the second end 1114 of the housing 1123. The luer hub socket 1158 may extend outwardly from the sealing portion 1198. The luer fitting socket 1158 is sized to connect with a male luer fitting portion (not shown) that conforms to the luer connector ANSI standard or syringe. The luer fitting socket 1158 shown here may have a locking mechanism 1136, and in certain embodiments, the locking mechanism 1136 serves at least the following functions. The locking mechanism 1136 is capable of threadingly engaging corresponding internal threads of a male luer or other component, such as a syringe, when the end cap 1130 is turned or screwed into the male luer of such a component in a first direction (which may be clockwise). Further, when a torque is applied to the end cap 1130 (which may be counterclockwise) relative to the element to which the end cap 1130 and male luer 1100 are connected, the locking mechanism 1136 may prevent or inhibit the end cap 1130 or female portion of the male luer 1100 from rotating or unscrewing relative to a corresponding male luer portion of a mating element in a second direction.

In the illustrated embodiment, the locking mechanism 1136 may include a pair of oppositely disposed tabs 1140 located on the outer surface 1142 of the end cap 1130. In some embodiments, the locking mechanism 1136 may include only 1 tab 1140 on the outer surface 1142 of the end cap 1130. In some embodiments, the locking mechanism 1136 may include 3 tabs 1140 on the outer surface 1142 of the end cap 1130, which may be radially equally spaced. Each projection 1140 preferably includes an outer surface 1146, a top surface 1148, a bottom surface 1150, a secondary side 1152, and a primary side 1154. In certain embodiments, the locking mechanism 1136 can include more than 3 locking portions.

The projections 1140 may be positioned on the end cap 1130 such that the flat bottom surface 1150 is coplanar with the flat end surface 1160 of the end cap 1130. Each projection 1140 may be configured such that the outer surface 1146 defines a diameter slightly smaller than the diameter of the inner surface of the protective cover 1183 of the male luer or other element that mates with the end cap 1130, as best shown in fig. 62. In the illustrated embodiment, the outer surface 1146 defines a diameter of about 0.312 inches. This arrangement is preferred, although not required, so that the outer surface 1146 does not interfere with or exert a significant force on the inner surface of the protective cover of the male luer portion of the component with which the end cap 1130 is mated. In certain embodiments, the outer surface 1146 may be configured to provide an interference fit with the inner surface of the cover so as to substantially prevent, in whole or in part, the end cap 1130 from separating from the male luer portion of the component to which it is attached.

In the illustrated configuration, for each projection 1140, the intersection of the bottom surface 1150 and the major side 1154 can define a sharp first corner 1162. Likewise, the intersection of the top surface 1148 with the major side 1154 may define a sharp second angle 1164. The protruding length of the major side 1154 may be slightly greater than the distance between adjacent facing sidewalls of the internal threads of the mating element. In the illustrated embodiment, the protruding length of the major side 1154 is about 0.08 inches (i.e., the shortest distance between the second corner 1164 and the flat end surface 1160 is about 0.08 inches). To prevent a portion of the secondary side 1152 from interfering with the internal threads of the mating member, the length of the secondary side 1152 may be less than the protruding length of the primary side 1154 and less than the distance between adjacent facing sidewalls of the internal threads of the mating member.

Fig. 62 is an enlarged partial side view of the end cap 1130 of the female member of fig. 59 threaded into the male portion 1180 of the mating member 1182. As noted above, the mating element 1182 may be a male luer or other element such as a syringe. In fig. 62, the illustrated mating element 1182 is a syringe. The mating element 1182 or syringe is shown with a syringe shield 1183 having internal syringe threads 1184. As shown in fig. 62, syringe shield 1183 and threads 1184 may partially surround syringe tip 1185, with all components generally conforming to ANSI standards for luer fittings. Luer socket 1158 may be configured to receive syringe tip 1185, thereby forming a luer connection.

As shown, the projections 1140 may be configured such that when the end cap 1130 is threaded into the male luer portion 1180 of the mating element 1182, the projections 1140 form an interference fit with respect to the internal threads of the male luer portion 1180 of the mating element 1182, which prevents, substantially prevents, or inhibits the separation or dislodging of the end cap 1130 from the mating element 1182. It is desirable that the projection 1140 not significantly inhibit the ability of the user to screw or thread the end cap 1130 into the mating member 1182. In the illustrated embodiment, the first and second corners 1162, 1164 may exert a force on the sidewall 1186 of the internal threads 1184 of the male luer portion 1180 of the mating element 1182, such that one or both of the preferably pointed corners 1162, 1164 is elastically or plastically deformed and embedded into the sidewall 1186 of the internal threads 1184.

In some embodiments, as shown in fig. 60 and 61, the minor side 1152 of each projection 1140 may define a plane that is parallel to but offset from a horizontal plane (e.g., plane a) that intersects the central axis of the end cap 1130 and the line 62-62. The major side 1154 of each projection 1140 can define a plane that can be inclined at an angle X relative to plane a when the end cap 1130 is oriented as shown in fig. 60. In the illustrated embodiment, the major side 1154 of each projection 1140 may be inclined at an angle of, for example, about 12 ° to horizontal when the end cap 1130 is oriented as shown in fig. 60. In certain embodiments, the major side 1154 of each projection 1140 can be inclined at an angle of between about 0 ° and about 12 °, or between about 12 ° and about 20 °, or between about 20 ° and about 30 ° from horizontal when the end cap 1130 is oriented as shown in fig. 60. In some embodiments (not shown), each of the two side surfaces 1152 and 1154 may define a plane that intersects the longitudinal central axis of the end cap 1130.

As best shown in fig. 60, the top surface 1148 of each projection 1140 may be inclined at an angle Y relative to a vertical plane when the end cap 1130 is oriented as shown in fig. 60. In the illustrated embodiment, the top surface 1148 of each projection 1140 may be inclined at an angle of, for example, about 24 ° relative to a vertical plane when the end cap 1130 is oriented as shown in fig. 60. In certain embodiments, the top surface 1148 of each projection 1140 may be inclined at an angle of between about 10 ° and about 24 °, or between about 24 ° and about 40 °, or between about 40 ° and about 60 °, relative to a vertical plane when the end cap 1130 is oriented as shown in fig. 60.

While the locking mechanism 1136 has been described in particular detail and is shown and described as being used with the end cap 1130 shown in fig. 57-62, the configuration of the locking mechanism 1136 is not limited to this configuration. The locking mechanism 1136 may be constructed from any of a number of materials similar to those described herein or other materials known in the art as suitable for these applications. Furthermore, the geometry of the locking mechanism 1136 is not limited to the specific arrangement shown and described herein. For example, the projection 1140 may be configured to include only one projection 1140 or a plurality of projections 1140. In addition, the projection 1140 may be formed such that the top surface 1148 directly intersects the bottom surface 1150 (i.e., the projection 1140 has three sides, excluding the minor side 1152).

The projections 1140 may have any suitable geometry that provides an interference fit with the internal threads of a mating element so as to prevent, substantially prevent, or prevent the end cap 1130 from separating or disengaging the mating element, but not significantly inhibit the user's ability to screw or tighten the end cap 1130 into the mating element. Or more generally, the projections 1140 may have any suitable geometry that generally prevents, substantially prevents, or prevents the end cap 1130 from separating or disengaging from the mating component, but does not significantly inhibit the ability to screw or tighten the end cap 1130 into the mating component. For example, the outer surface 1146 may be configured such that it provides interference with and/or elastically or plastically deforms the housing inner surface of the mating component to inhibit separation of the end cap 1130 from the mating component. Also, the application of the locking mechanism is not limited to the end cap 1130. Any externally threaded end cap or other component may be configured to include the locking mechanism 1136 described herein. For example, one end of the catheter may include a locking mechanism as described herein to prevent, substantially prevent, or prevent separation or unthreading of the catheter from the luer locking element.

Fig. 63 illustrates another embodiment of a closable male luer fitting 1200 configured to prevent or inhibit the male head of a connector from separating or unscrewing from the closable male luer fitting 1200. Any element that includes luer fitting 1200 may include any structure, feature, element, and/or material described herein or otherwise known to those of skill in the art. Further, any of the other luer connectors described above may include any of the structures, features, and elements of luer connector 1200. For example, features relating to preventing or inhibiting separation may be used with any suitable medical or other infusion connector.

Fig. 63 and 64 are perspective and side views, respectively, of a closable male luer 1200 in a first or closed position. In fig. 64, some internal features of the closable male luer 1200 are shown in phantom. Fig. 65 is an exploded perspective view of an embodiment of the closable male luer 1200 shown in fig. 63. Referring to fig. 63 and/or 64, the closable male luer fitting 1200 may have a first end 1212 and a second end 1214. The first end 1212 may include a male luer fitting tip 1222 and a valve element 1216 (shown in more detail in fig. 65 and 71). The luer taper 1222 and the valve element 1216 may be supported by the housing 1223. The valve member 1216 may be connected to the housing 1223 by a resilient member 1218.

An end cap portion 1230 (sometimes referred to herein as an end cap or female member) may be connected to the housing 1223 near the second end 1214 of the closable male luer 1200. One or more elements of the end cap portion 1230 may be integral or unitary with the housing. Referring to FIG. 65, as will be described in greater detail below, in certain embodiments, end cap 1230 may include a first end cap 1232 (sometimes referred to herein as a first member) and a second end cap 1234 (sometimes referred to herein as a second member) that may be coupled together as described below. Referring to fig. 76, the second end cap 1234 may define an outer surface 1234a that is tapered, conical, or substantially conical in shape. In certain embodiments, however, the outer surface 1234a may be generally cylindrical, oval, a combination of conical and oval shapes, or any other desired shape. End cap 1230 may have external threads 1236. As described above, the embodiment of the closable male luer 1200 shown in fig. 63, 64 is in a closed position. In the closed position, the valve element 1216 may cooperate with the male luer taper 1222 to substantially prevent fluid flow through the fitting 1200.

As shown in fig. 63, the housing 1223 may have a protective cover 1224 surrounding the luer fitting spike 1222. The protective cover 1224 may have internal threads 1226. The internal threads 1226 may form a male luer connection with the luer taper 1222 that conforms to male luer ANSI specifications. End cap 1230 may have a socket shape conforming to female luer ANSI standards and may receive a male piece of another fitting or syringe. The external threads 1236 may be configured to threadably engage corresponding internal threads of the male head portion of the mating element.

The valve member 1216 can be at least partially surrounded by a housing 1223. As shown, the housing 1223 may have at least one side opening 1225 exposing at least a portion of the valve member 1216 and/or allowing at least a portion of the resilient member 1218 to enter the housing 1223. In some embodiments, the housing 1223 may define two side openings 1225 disposed opposite one another on the sides of the joint 1200. In some embodiments, the side opening 1225 may extend along only a portion of the housing 1223 (e.g., in a central region of the housing 1223 as shown) to provide increased strength in the housing near the second end 1214. In the illustrated embodiment, the resilient member 1218 may be coupled to the valve member 1216 adjacent the side opening of the housing 1223. The outer surface 1227 of the housing may have a particular shape. For example, the outer surface of the housing may have a narrower portion near the center region of the housing 1223, or a substantially hourglass-shaped outer surface, or a larger cross-sectional portion near the ends. These shapes may allow the user to feel that the fingers rest properly on the joint 1200 and/or provide a more comfortable gripping surface during use. In some embodiments, an outward protrusion (not shown) may be added to the resilient member 1218 to provide an additional or more effective gripping surface on the joint 1200.

Similar to other embodiments described herein, luer fitting tip 1222 near first end 1212 of fitting 1200 may have a bore 1221 in the tip that allows liquid to flow from within housing 1223 out of the luer fitting tip (not shown) when valve element 1216 is in the open position. Valve element 1216 can include a valve closing end 1244. The valve closed end 1244 may engage the interior of the luer fitting tip 1222 to inhibit liquid flow through the luer fitting tip 1222. In certain embodiments, the interference fit between the valve element 1216 and the housing 1223 inhibits the flow of liquid out of the luer fitting tip 1222. In some embodiments, an interference fit is between closed end 1244 and bore 1221. In some embodiments, the valve member 1216 may include a resilient portion disposed adjacent the first end 1212 of the housing 1223 for engaging the housing 1223 adjacent the luer taper 1222 to inhibit fluid flow therethrough.

As shown in the embodiment of connector 1200 shown in fig. 63, valve closure face 1246 may traverse luer connector tip 1222 when connector 1200 is in the closed position. In certain embodiments, the valve closing face 1246 can be configured to extend beyond the luer fitting tip 1222 further beyond the bore 1221 when the fitting 1200 is in the closed position. In certain embodiments, the valve closing face 1246 may be recessed in the luer fitting tip 1222. In certain embodiments, the valve closing face 1246 is substantially flush with the end face of the luer fitting spike 1222. In certain embodiments, the valve closing face 1246 is configured to be swappable when the fitting 1200 is in the first or closed position.

The luer fitting 1200 may be manipulated to a second or open position. In the open position, the valve element 1216 can be retracted from the luer collar tip 1222, thereby opening the aperture 1221 in the tip 1222. As will be described in more detail below, when the fitting 1200 is open, fluid may flow from the luer fitting receptacle of the second end 1214, through the interior of the fitting 1200, and out the luer fitting tip 1222 of the first end 1212. When closed, under normal operating conditions, liquid is blocked or prevented from flowing through the luer fitting 1200.

The resilient member 1218 may be constructed of a resiliently deformable material. Thus, in some embodiments, the housing 1223 may remain connected to the valve member 1216 by the resilient member 1218 when the luer fitting 1200 is moved to the open position. In the illustrated embodiment, a change in the relative positions of the housing 1223 and the valve member 1216 can cause at least a portion of the resilient member 1218 to elongate. The resilient member 1218 thereby exerts a closing force on the housing 1223 and the valve member 1216, and is biased to return the luer fitting 1200 to a closed state. The amount of tension applied by the resilient member 1218 may be adjusted by varying the distance between the housing 1223 and the valve member 1216, increasing the thickness of the resilient member 1218, and/or constructing the resilient member 1018 from a variety of materials having different spring characteristics. In some embodiments, the joint 1200 is configured to be difficult to open to prevent accidental or inadvertent opening. In some embodiments, the difficulty of opening the joint is controlled at least in part by the tension applied by elastic member 1218. In some embodiments, the resilient member 1218 may be provided in a resilient form that is disposed within the housing 1223 for biasing the valve member 1216 to the closed position. Movement of the fitting 1200 to the open position compresses the spring, and movement of the fitting 1200 to the closed position extends the spring to release some or all of the compression.

Fig. 66-70 illustrate the luer fitting 1200 in a first or closed position. As shown in these figures, the valve member 1216 can include at least one post 1250. In the illustrated embodiment, the valve member 1216 can include two struts 1250. In some embodiments, the valve member 1216 can include more than two posts 1250. In certain embodiments, each strut 1250 can extend from approximately the middle of the valve member 1216 to the first end 1212 of the luer fitting 1200. The posts 1250 may be located around the luer taper 1222 but within the housing 1223 as shown. The post 1250 may be within the inner diameter of the internal threads 1026 and may be configured to interface with at least a portion of the luer fitting receptacle when the female luer fitting receptacle is engaged with the luer fitting spike 1222.

Referring to fig. 63, the elastic member 1218 may include at least one ring 1274 and at least one fastening ring 1272. In other embodiments, however, the elastic member 1218 may include more than one ring 1274 or more than one fastening ring 1272. The first ring 1274 may be disposed in a groove 1248 on the outer surface of the housing 1223 toward the first end 1212. The resilient member 1218 may be sufficiently tight around the housing 1223 to hold the first ring 1274 in place when a change in the relative positions of the housing 1223 and the valve member 1216 applies a force to the resilient member 1218. Similar to other embodiments of luer fittings described above, the securing ring or collar 1272 may be disposed around the valve member 1216 in a different manner.

As best shown in fig. 67, the passageway 1256 may pass through a portion of the valve member 1216 adjacent the first end 1212. The cross-section of the channel 1256 may be circular, as shown in the illustrated embodiment, or the channel 1256 may have other geometries. The channel 1256 may have at least one port 1262 near the first end 1212. In the illustrated embodiment, the two ports 1262 are located on opposite sides of the valve member 1216 and are circular, although other locations and shapes may be used.

In the embodiment shown in fig. 67, with the fitting 1200 in the closed position, the relative positions of the valve member 1216 and the housing 1223 may form a chamber 1254 disposed between the channel 1256 and the luer fitting socket 1258. The chamber 1254 may be in fluid communication with the channel 1256. The chamber 1254 may be wider than the channel 1256, as shown. In some embodiments, the chamber 1254 may have the same diameter as the channel 1256. In some embodiments, the chamber 1254 may have a smaller diameter than the channel 1256. The chamber 1254 can also be formed with a non-circular cross-section in any suitable shape. The chamber 1254 is defined by a plunger 1270 at an end facing the second end 1214 of the housing 1223.

The plunger 1270 may be the portion of the end cap 1230 that extends toward the valve element 1216. Plunger 1270 may have a conduit 1294 therethrough. Conduit 1294 may place chamber 1254 in fluid communication with luer socket 1258. The plunger 1270 may have external dimensions sufficient to substantially close one end of the chamber 1254, as shown. In the illustrated embodiment, the plunger 1270 may be circular to match the geometry of the chamber 1254, although other suitable geometries may be used.

The plunger 1270 may have external dimensions comparable to the internal dimensions of the wall of the valve member 1216 forming the chamber 1254, but not contact the wall to allow relative movement between these elements. To prevent leakage of liquid through the plunger 1270, an O-ring 1260 may be disposed in the groove 1269 behind the plunger 1270. The O-ring 1260 can contact the wall of the valve member 1216, as shown, preventing liquid from flowing out of the chamber 1254. In certain embodiments, the plunger 1270 is part of the end cap 1230. End cap 1230 may be coupled to housing 1223 by sonic welding, adhesive, or any other suitable coupling means. In the illustrated embodiment, end cap 1230 is coupled to housing 1223 using sonic welds 1231. One such spot weld 1231 is substantially triangular in shape, as shown, although other shapes are possible. The plunger 1270 may therefore be considered to be in a stationary position relative to the housing 1223. In certain embodiments, the plunger 1270 is integrally formed with the housing 1223 and the end cap 1230 is a separate element adapted to be coupled to the housing 1223, such as by sonic welding. In some embodiments, the second end cap 1234 may be integrally formed with the housing 1223. However, as will be described in greater detail below, first end cap 1232 can be formed separately from second end cap 1234 or housing 1223.

As best shown in fig. 67, liquid may flow into the luer fitting socket 1258 and through the conduit 1294. Liquid can flow from conduit 1294 to chamber 1254 and from chamber 1254 into channel 1256. As shown in the illustrated embodiment, when the connector 1200 is in the closed position, the valve closed end 1244 of the valve element 1216 can seal the hole in the luer fitting tip 1222 to prevent liquid from flowing out of the end of the luer fitting tip 1222. Liquid can generally flow from the passage 1256 through a port 1262 in the valve member 1216. Liquid may be trapped within the luer taper 1222 but may be prevented from flowing back toward the second end 1214 on the outer surface of the valve member 1216 by the sealing ring 1220. Thus, when the fitting 1200 is in the closed position, as shown, there may be generally fluid communication between the luer fitting socket 1258 and the interior of the luer fitting spike 1222, but no liquid is permitted to flow out of the first end 1212 of the fitting 1200.

The connector 1200 may transition to the open position when a female luer connector (not shown) is mated with the luer connector tip 1222 of the connector first end 1212. When the female luer fitting is engaged with the first end 1212 of the fitting 1200, a portion of the female luer fitting may engage the internal threads 1226 and may be advanced to at least partially surround the luer fitting tip 1222. Thus, when the female luer connector is engaged with the internal threads 1226, a portion of the female luer connector may engage the post 1250 and urge the valve member 1216 toward the second end 1214 of the housing. Referring to fig. 63, when the valve element 1216 is disposed toward the second end 1214, the joint 1200 will be in the open position.

In some embodiments, when the valve element 1216 is moved toward the second end 1214, the valve closing end 1244 (see fig. 63) is separated from the luer fitting tip 1222, including moving the valve closing face 1246 away from the bore 1221 in the luer fitting tip 1222. Liquid can flow from within the housing through the aperture in the luer taper 1222. The sealing ring 1220 can prevent fluid from flowing out of the luer fitting tip 1222 toward the second end 1214 of the fitting 1200. Thus, in the open position, fluid may flow from the luer hub 1258, through the conduit 1294, the chamber 1254, the channel 1256, the one or more ports 1262 on the valve member 1216, into the luer taper 1222, and out the bore 1221 on the tip of the luer taper 1222.

As can be seen in the illustrated embodiment, the valve element 1216 can be moved toward or disposed closer to the end cap 1230 as the strut 1250 is moved toward the second end 1214 of the connector 1200. The wall of the valve member 1216 including the terminus of the passage 1256 is therefore closer to the portion of the plunger 1270 of the end cap 1230. Thus, when the fitting 1200 is in the open position, the volume of the chamber 1254 may be reduced.

Accordingly, as the connector 1200 transitions from the open position to the closed position, the volume of the chamber 1254 increases as the valve member 1216 moves toward the first end 1212 of the connector 1200. As the volume of the chamber 1254 increases, the valve closing end 1244 of the valve member 1216 is advanced toward the first end 1212 to seal the bore on the luer fitting tip 1222. If no additional fluid is introduced into the fitting 1200 through the luer fitting socket 1258, the vacuum created by the increase in volume of the chamber 1254 can draw back the fluid present in the luer fitting tip 1222 through the port 1262 and the channel 1256 toward the chamber 1254. In this case, when the valve closing end 1244 is moved into position in the bore, liquid may be prevented from flowing out of the bore of the luer 1222 because liquid may instead be drawn back into the chamber 1254. In some embodiments, when the valve element 1216 is moved toward the first end 1212 of the housing 1223, liquid on or near the valve closing face 1246 is encouraged to flow into the fitting 1200 rather than remaining on the surface of the closing face 1246.

However, if additional liquid is still being introduced into the connector 1200 through the luer socket 1258, the additional liquid can advance and accumulate in the chamber 1254 as the valve member 1216 is moved toward the first end 1212 to close the luer taper 1222. In this case, when valve element 1216 seals tip 1222, pressure from the newly introduced liquid is prevented from forcing the liquid out of luer fitting tip 1222. Thus allowing liquid to flow through the fitting 1200 when the female fitting is engaged with the first end 1212 of the fitting 1200, but preventing liquid from flowing through the fitting 1200 while the female fitting is being disconnected and after the female fitting has been disconnected.

As will be described in more detail below, it is desirable to prevent certain drugs from coming into contact with the skin. The fitting 1200 thus advantageously helps to retain liquid within the fitting 1200 when it is separated from a female luer fitting or other connector. Thus, reducing the likelihood of liquid escaping through luer taper 1222 when separation occurs results in a corresponding reduction in the chance of toxic drug from contacting the skin of a user or patient.

Fig. 71, 72 and 73 are perspective views of the valve member 1216, the resilient member 1218 and the housing 1223, respectively, of the embodiment of the closable male luer connector 1200 shown in fig. 63. As described above, the resilient member 1218 may have the first ring 1274 disposed in the recess 1248 of the housing 1223. The resilient member may extend toward the second end 1214. The valve member 1216 may have a plurality of outwardly extending protrusions to support the resilient member 1218. Referring particularly to fig. 71, the valve member 1216 can include 4 notch flanges 1268. The fastening ring 1272 (shown in fig. 72) may be secured over the valve member 1216 and held in place by the notch flange 1268. The configuration of the valve member 1216 is not so limited. The valve member 1216 may include any number of flanges in addition to or in lieu of the notch flanges 1268 used to secure the resilient member 1218 or the securing ring 1272 of the resilient member 1218 to the valve member 1216. In the illustrated embodiment, the inner surface 1268a of the notch flange 1268 may provide lateral support to the strip 1296 of the elastomeric member 1218 to prevent the strip 1296 from sliding laterally relative to the valve member 1216. Additionally, the rear surface 1268b of the notch flange 1268 prevents the fastening ring 1272 of the resilient member 1216 from sliding axially toward the valve closing face 1246 of the valve member 1216. In other embodiments, the elastic member 1218 may include at least two or substantially any number of loops or strips.

Additionally, referring to fig. 71, one or more ports 1262 may be disposed on or near the closing face 1246, or withdrawn as far as possible after the face 1246 and before the seal ring 1220. When one or more ports 1262 are provided on the closing face 1246, another port opening mechanism, such as an elastomeric seal, may be used. The port 1262 may be circular, as shown, or may be other shapes. The post 1250 is shown extending toward the first end 1212 of the valve element 1216. There may be one, two, or more struts 1250. In certain embodiments, the joint 1200 does not include struts 1250. Rather, the connector 1200 may be opened when placed in mating engagement with a female connector in other ways. For example, the female fitting may include an engagement member, such as, but not limited to, a valve pin or other protrusion (not shown) that may engage the valve closing face 1244 to open the fitting 1200, or a manual slider or button may be suitably provided to open the fitting 1200.

Referring to fig. 73 and 74, the first end cap 1232 can have a cover 1292 shaped and configured to substantially cover, and in some embodiments substantially seal, a portion of the second end 1214 of the housing 1223. The luer fitting socket 1258 may extend away from the cover 1292. The luer socket 1258 is sized to engage with a male luer fitting that conforms to the ANSI standard for luer fitting devices (see, e.g., fig. 12). The luer fitting socket 1258 may have external threads 1236 to engage a male luer fitting, as shown. In certain embodiments, a protrusion or other projection may be used to engage the male luer fitting.

In some embodiments, plunger 1270 is located at a partial end of first end cap 1232 opposite cover 1292. The plunger 1270 is sized and configured to not substantially seal the chamber 1254 within the valve member 1216. The gap or slot 1269 between the cover 1292 and the plunger 1270 is shaped and dimensioned to receive the O-ring 1260, as described above. Further, referring to fig. 73 and 74, the illustrated first end cap 1232 can include a pair of projections or bosses 1298 (also referred to herein as locking elements or engagement surfaces) that project radially outward from the outer surface 1300. In certain embodiments, first end cap 1232 can include a pair of bosses 1298 disposed diametrically opposite one another. In some embodiments, first end cap 1232 may include only one protrusion 1298 protruding from surface 1300. In certain embodiments, first end cap 1232 can include more than two protrusions 1298 protruding from surface 1300. As will be described in greater detail below, the protrusion 1298 may engage or interlock with a complementary protrusion or protrusion on the second end cap 1234 to prevent rotation of the first end cap 1232 relative to the second end cap 1234 when the two elements are assembled together, as best shown in fig. 64 or 69.

Additionally, first end cap 1232 may define an annular groove 1302, which, as described in more detail below, may interact with a complementary feature on second end cap 1234 to axially limit movement of first end cap 1232 relative to second end cap 1234. Additionally, as best shown in fig. 74, the first end cap 1232 may further define an angled or tapered surface 1304 and a rounded surface 1306 between the annular recess 1302 and the plunger 1270. As will be described in greater detail below, the angled or tapered surface 1304 and the rounded surface 1306 may facilitate the connection or assembly of the first end cap 1232 with the second end cap 1234. In some embodiments, first end cap 1232 may include only sloped or tapered surface 1304, or rounded surface 1306. In other embodiments, first end cap 1232 can be configured to not include either of these two features. In some embodiments, first end cap 1232 and/or second end cap 1234 may include any feature, lubricant, or material suitable for coupling first end cap 1232 to second end cap 1234 or facilitating rotation of first end cap 1232 relative to second end cap 1234 as described below.

In the illustrated embodiment, the boss 1298 is generally rectangular in cross-section. The geometry of protrusion 1298 is not so limited. Boss 1298 may define any suitable or desired cross-sectional shape, such as, but not limited to, square, circular, or oval. For example, in some embodiments, each boss 1298 defining a circular cross-section may be disposed in a straight line along a side of the second endcap 1234.

Referring to fig. 74-76, second end cap 1234 may include an array of projections or protrusions 1308 (also referred to herein as locking elements or engagement surfaces), which in some embodiments, project radially inward from an inner surface 1310 of second end cap 1234 to form a radial array of recesses or grooves 1309. Referring to fig. 64, first end cap 1232 can be assembled with second end cap 1232 such that each of the one or more protrusions 1298 formed on first end cap 1232 is positioned in one or more recesses or grooves 1309 formed between each of the plurality of protrusions 1308 on second end cap 1234. Accordingly, each of the one or more projections 1298 is sized and configured such that the approximate width of each of the one or more projections 1298 (represented by "W1" in FIG. 74) formed on surface 1300 of first end cap 1232 is less than the approximate width of the depression or groove 1309 (represented by "W2" in FIG. 76) formed between each projection 1308 on second end cap 1234.

In the illustrated embodiment, the cross-section of the boss 1308 is generally rectangular. The geometry of the projections 1308 is not so limited. The projections 1308 may define any suitable or desired cross-sectional shape, such as, but not limited to, square, circular, or oval.

Additionally, as described above, each boss 1298 on the first end cap 1232 can be configured to twist off or break off before any of the bosses 1308 on the second end cap 1234 twist off or break off. Thus, in some embodiments, each boss 1298 on the first end cap 1232 can be configured such that the minimum approximation of the force or torque required to twist off or break each boss 1298 from the surface 1300 of the first end cap 1232 is less than the minimum approximation of the force required to twist off or break any one boss 1308 from the inner surface 1310 of the second end cap 1234. In some embodiments, the minimum amount of force required to twist or break each protrusion 1298 off of the surface 1300 of the first end cap 1232 can be significantly less than the minimum amount of force required to twist or break any one protrusion 1308 off of the inner surface 1310 of the second end cap 1234.

In some embodiments, the protrusions or projections configured to twist off or snap off may be formed on second end cap 1234 rather than first end cap 1232, as described above. In other words, in some embodiments, the one or more projections formed on the second end cap 1234 can be sized and/or configured in the same manner as any of the projections 1298 described above, and the one or more projections formed on the first end cap 1232 can be sized and/or configured in the same manner as any of the projections 1308 described above, so that the projections formed on the second end cap 1234 twist off or break off before any of the projections formed on the first end cap 1232 twist off or break off. In short, the arrangement of the projections 1298 and 1308 can be reversed. Other complementary engagement surfaces may generally be used. In the illustrated embodiment, each element includes a radially projecting boss. In certain embodiments, one or the other of these elements may include a slot sized to receive a radially projecting boss.

In some embodiments, the approximate minimum amount of force required to twist or break each protrusion 1298 from the surface 1300 of the first end cap 1232 can be less than about 1/3 of the approximate minimum amount of force required to twist or break each protrusion 1308 from the inner surface 1310 of the second end cap 1234. In some embodiments, the approximate minimum amount of force required to twist or break each protrusion 1298 from the surface 1300 of the first end cap 1232 can be between about 1/3 to 1/2 of the approximate minimum amount of force required to twist or break each protrusion 1308 from the inner surface 1310 of the second end cap 1234.

In the illustrated embodiment in which two protrusions 1298 are formed on the surface 1300, the amount of torque required to twist off or break the two protrusions 1298 from both the surface 1300 of the first end cap 1232 may be about 4in-lb or more. In some embodiments, the amount of torque required to twist off or break off both bosses 1298 from the surface 1300 of the first end cap 1232 can be about 3in-lb or higher. In some embodiments, the amount of torque required to twist off or break off both bosses 1298 from the surface 1300 of the first end cap 1232 can be about 5in-lb or greater.

Referring to fig. 74, the cross-sectional area of each protrusion 1298 may be in accordance with the approximate length (represented by "L1" in fig. 74) and the approximate width (represented by "W1" in fig. 74) of each of the one or more protrusions 1298 on the surface 1300 of the first end cap 1232. Protrusion 1298 may be used to define a band around surface 1300, which is calculated by multiplying protrusion 1298 length L1 by the surface 1300 circumference. In certain embodiments, similar to the illustrated embodiment in which each protrusion 1298 is configured to twist off of the surface 1300 of the first end cap 1232 when a desired torque level is achieved, the total cross-sectional area of the protrusion 1298 may be substantially less than the strip surrounding the surface 1300.

In certain embodiments, the ratio of the total cross-sectional area of all projections 1298 to the value of the outer diameter (represented by "D1" in fig. 74) of surface 1300 of first end cap 1232 on which each of the one or more projections 1298 can be formed or attached can be about 1:46 or higher. The cross-sectional area of each protrusion 1298 can be any suitable value that results in each protrusion 1298 twisting off of surface 1300 when the desired torque level is achieved. For example, in certain embodiments, this ratio may be between about 1:60 and about 1: 30. In certain embodiments, this ratio may be between about 1:50 and about 1: 40.

Similar to the illustrated embodiment in which each protrusion 1298 is configured to twist off of the surface 1300 of the first end cap 1232 when a desired torque level is achieved, in certain embodiments, the width W1 of each of the one or more protrusions 1298 may be substantially less than the outer diameter of the surface 1300 of the first end cap 1232 on which each of the one or more protrusions 1298 may be formed or attached. The width W1 of each protrusion 1298 may be any suitable value that results in each of the one or more protrusions 1298 twisting off of the surface 1300 when a desired torque level is achieved. For example, the one or more projections 1298 may be sized to be comparable to or smaller than the diameter of the liquid opening on the plunger 1270 and/or the luer socket 1258. In certain embodiments, the ratio of the overall width of protrusion 1298 to outer diameter D1 may be about 1:15 or higher. In certain embodiments, this ratio may be between about 1:25 to about 1: 10. In certain embodiments, this ratio may be between about 1:16 to about 1: 13. In certain embodiments, a plurality of projections 1298 can be used, wherein the width W1 of each projection is different, but the total width is calculated to achieve a torque level that will twist the projections apart.

Similarly, in certain embodiments, similar to the illustrated embodiment in which each protrusion 1298 is configured to twist off of surface 1300 of first end cap 1232 when a desired torque level is achieved, the length L1 of each of the one or more protrusions 1298 may be substantially less than the value of the outer diameter D1 of surface 1300 of first end cap 1232 on which each of the one or more protrusions 1298 may be formed or attached. The length L1 of each protrusion 1298 may be any suitable value that results in each of the protrusions 1298 twisting off of the surface 1300 when the desired torque level is reached. In certain embodiments, the ratio of the overall length of the lobes to the outer diameter D1 may be about 1:4 or higher. In certain embodiments, this ratio is between about 1:5 and about 1: 3. In some embodiments, a plurality of projections 1298 can be used, each having a different width W1, but the total width calculated to achieve the torque level required to twist off the projections.

In certain embodiments, the one or more bosses 1298 may be configured such that the approximate width W1 of each of the one or more bosses 1298 may be substantially less than the approximate width of one or more of the plurality of bosses 1308 (represented by "W3" in fig. 76) formed on the inner surface 1310 of the second end cap 1234 to ensure that the one or more bosses 1298 twist off or break off before any of the bosses 1308 twist off or break off. Thus, in certain embodiments, the approximate width W1 of each of the one or more projections 1298 can be between about 1/3 or less and about 1/2 or less of the approximate width of each of the plurality of projections 1308. Additionally, in some embodiments, there are more protrusions 1308 on the second end cap 1234 than protrusions 1298 on the first end cap 1232, thereby requiring a greater moment to twist off a greater number of protrusions 1308 on the second end cap 1234.

In certain embodiments, the material selected to form each protrusion 1298 can be the same or different than the material selected to form each protrusion 1308. The strength of the material selected to form the projections 1298, 1308 can affect the amount of torque required to twist off the projections 1298 and 1308. Thus, in certain embodiments, the projections 1298, 1308 that need to be twisted off can be formed from a weaker, softer, or less stiff material than the material used to form the projections 1298, 1308 that need to remain intact. For example, in the illustrated embodiment, it may be desirable for protrusion 1298 to twist off of surface 1300 of first end cap 1232 when a desired level of moment between first end cap 1232 and second end cap 1234 is achieved. Thus, in the illustrated embodiment, the projections 1298 may be formed from a weaker material than the material used to form each projection 1308. The material selected to form each protrusion 1298, 1308 can be the same, however, as the cross-sectional area of the protrusion 1298, 1308 can also affect the amount of torque required to twist off the protrusion 1298, 1308.

In certain embodiments, similar to the illustrated embodiment described above which ensures that the one or more projections 1298 twist or break before any one projection 1308 twists or breaks, it can also be accomplished by configuring each of the projections 1298 such that the approximate cross-sectional area of each of the projections 1298 is less than the cross-sectional area of each of the projections 1308 adjacent to, and thus in contact with, each of the projections 1298. Referring to fig. 74, the cross-sectional area of each boss 1298 depends upon the length (represented by "L1" in fig. 74) and the width (represented by "W1" in fig. 74) of each such boss 1298. Similarly, referring to fig. 76 and 77, the cross-sectional area of each boss 1308 is dependent upon the length (represented by "L2" in fig. 77) and width (represented by "W3" in fig. 76) of each boss 1308.

In certain embodiments, where the one or more projections 1298 are designed to twist off before any one projection 1308 is twisted off, the cross-sectional area of each of the projections 1298 may be substantially smaller than the cross-sectional area of each of the projections 1308, without regard for material differences. The ratio of the cross-sectional area of each of the projections 1298 to the cross-sectional area of each of the projections 1308 can be significantly less than 1. For example, in certain embodiments, similar to the embodiments shown, this ratio may be about 1:14 or higher. In certain embodiments, this ratio may be between about 1:25 to about 1: 10. In certain embodiments, this ratio may be between about 1:16 and 1: 12.

Moreover, in certain embodiments, similar to the embodiment shown, the approximate length of each of the projections 1298 (represented by "L1" in FIG. 74) is substantially less than the approximate length of each of the projections 1308 (represented by "L2" in FIG. 77) formed on the inner surface 1310 of the second end cap 1234. Thus, in certain embodiments, the approximate length L1 of the one or more projections 1298 can be between about 1/3 or less and about 2/3 of the approximate length L2 of each of the projections 1308.

In some embodiments, the second end cap 1234 may define recesses or channels into which each of the protrusions 1298 formed on the first end cap 1232 may be inserted when the first end cap 1232 is coupled to the second end cap 1234. In some embodiments, the number of depressions or grooves formed in the second end cap 1234 may be equal to the number of protrusions 1298 formed in the first end cap 1232. In some embodiments, there may be more depressions or grooves formed in the second end cap 1234 than there are protrusions 1298 formed in the first end cap 1232.

Fig. 78A is a side view of an exemplary connector 1312 showing the male piece of connector 1312 threadably engaged with a first end cap 1232 portion of the closable male luer fitting 1200. FIG. 78A shows end cap 1230 prior to the breaking of the one or more protrusions 1298 that are radially outward from surface 1300. In fig. 78A, an exemplary connector 1312 is a syringe. The coupling 1312 may be any suitable fitting or medical device having a male member. As shown, coupling 1312 is only partially threadably engaged with first end cap 1232, and therefore, the torque exerted on first end cap 1232 by threading coupling 1312 onto first end cap 1232 is less than the minimum threshold torque required to twist or break each boss 1298 off of first end cap 1232. Thus, the first end cap 1232 cannot be rotatably secured to the second end cap 1234 until the minimum threshold moment required to twist off or break off each of the projections 1298 is reached, by abutment of each of the projections 1298 formed on the first end cap 1232 with one or more of the plurality of projections 1308 formed on the second end cap 1234.

When coupling 1312 is substantially fully threadedly engaged with first end cap 1232, further twisting of coupling 1312 will eventually place a moment on first end cap 1232 that exceeds the minimum threshold moment required to break boss 1298 from first end cap 1232. In some embodiments, the minimum threshold torque required to break the boss 1298 is about 4 in-lb. Once boss 1298 is snapped off of first end cap 1232, first end cap 1232 is then substantially free to rotate within second end cap 1234. However, first end cap 1232 may still be retained in the housing by the abutment of side surface 1302b with side surface 1314b of annular portion 1314. Also, O-ring 1260 prevents fluid exchange, not withstanding the ability to rotate first end cap 1232. In this manner, joint 1200 is prevented or inhibited from easily disengaging from coupling 1312 because the torque required for such disengagement will only cause first end cap 1232 to rotate with respect to outer housing 1223 and/or second end cap 1234. Moreover, in some embodiments, after connection 1312 is connected, there may be only a small (or no) exposed outer surface area of first end cap 1232 for contact by the user's fingers, thus applying a counter torque on first end cap 1232 and connection 1312 to enable separation may be difficult. This effectively "bonds" the two elements together.

The use of a protrusion configured in a twist-off fashion is not necessary. Many other configurations and arrangements can be used to allow a threaded connection between the housing head and the connector 1312 in the first stage and then allow rotation to prevent or inhibit separation in the second stage.

Fig. 78B is a side view of the connection 1312, showing the male piece of the connection 1312 substantially fully threadedly engaged with the first end cap 1232 of the male luer fitting 1200. FIG. 78B shows first end cap 1232 after the one or more protrusions 1298' have been broken off by a force exerted on the one or more protrusions 1298 by one or more of the plurality of protrusions 1308 formed on inner surface 1310 of second end cap 1234 in response to a torsional force transmitted to first end cap 1232 by substantially fully threadedly engaged coupling 1312. In this regard, as each boss 1298' is snapped off of the outer surface 1300 of the first end cap 1232, the first end cap 1232 will be able to rotate substantially freely within the second end cap 1234. Any twisting motion applied to coupling member 1312 in either direction with respect to housing 1223 in this configuration will cause first end cap 1232 to rotate integrally with coupling member 1312, thereby preventing coupling member 1312 from unscrewing or becoming separated from first end cap 1232. Thus, in this manner, luer fitting 1200 is configured such that it cannot be removed or separated from connector 1312 after luer fitting 1200 is substantially fully engaged with connector 1312.

After the one or more protrusions 1298 'have been twisted off or broken off from the first end cap 1232, the cover 1292 of the first end cap 1232 prevents each broken protrusion 1298' from falling out of the luer fitting 1200, as best shown in fig. 78B. Additionally, as best shown in fig. 68, the second end cap 1234 may be configured to prevent the broken protrusion 1298' from entering the interior space of the housing 1223. In particular, the second end cap 1234 can be configured to define an annular portion 1314 that can inhibit the broken protrusion 1298' from entering the interior space of the housing 1223.

Fig. 78C is a side view of an exemplary connector 1312 substantially fully threadedly engaged with another embodiment of a closable male luer 1200'. In certain embodiments, the closable male luer 1200' may be the same as the closable male luer 1200 described above, except as described below. In some embodiments, the second end cap 1234 ' may be configured to define an annular space 1238 ' adjacent the boss 1308 '. The annular space 1238 ' is sized and configured to allow the one or more protrusions 1298 ' to fall into and be received in the annular space 1238 ' when the one or more protrusions 1298 ' are snapped off of the first end cap 1232 '.

In some embodiments, the first end cap 1232 may be connected to the second end cap 1234, and thus to the luer fitting 1200, as described below. After second end cap 1234 is coupled to housing 1223 according to any of the methods described herein or any other suitable method, first end cap 1232 may then be coaxially aligned with second end cap 1234, but may also be rotated so that each of the noted bosses 1298 on first end cap 1232 are generally aligned with one or more gaps formed between bosses 1308 on second end cap 1234. Once first end cap 1232 is substantially axially and rotationally aligned, first end cap 1232 may be inserted into second end cap 1234 by pushing first end cap 1232 toward second end cap 1234 while maintaining the substantially axial and rotational alignment described above. Referring to fig. 68, 74 and 77, the first end cap 1232 may be pushed into the inner end until the first end cap 1232 is positioned relative to the second end cap 1234 such that the annular projection 1314 formed on the second end cap 1234 is radially adjacent (i.e., axially aligned with) the annular groove 1302 formed on the first end cap 1232. In particular, in this position, opposing side surfaces 1314a and 1314b of annular projection 1314 formed in second end cap 1234 may be positioned between perhaps opposing side surfaces 1302 and 1302b of annular recess 1302 formed in second end cap 1234.

As best shown in FIG. 68, in some embodiments, the first end cap 1232 and the second end cap 1234 may be formed such that there is a small gap between the substantially cylindrical surface 1314c of the annular recess 1314 and the substantially cylindrical surface 1302c of the annular recess 1302. This configuration may facilitate rotation of first end cap 1232 within second end cap 1234 when the one or more protrusions 1298 are twisted off or broken off, i.e., without friction between the two optional cylindrical surfaces 1302c and 1314 c.

Additionally, referring to FIG. 68, first end cap 1232 and second end cap 1234 are sized and configured to allow side surface 1302b of annular recess 1302 to overlap side surface 1314b of annular protrusion 1314 by an amount sufficient to prevent first end cap 1232 from being inadvertently pulled out of second end cap 1234. Additionally, first end cap 1232 and second end cap 1234 are sized and configured to allow first end cap 1232 to be inserted into second end cap 1234 by axially aligning and pushing first end cap 1232 into second end cap 1234, as described above. Thus, if side surface 1302b of annular groove 1302 overlaps too much with a side surface of annular projection 1314, it may be difficult to couple first end cap 1232 to second end cap 1234 in some configurations, as described above.

To facilitate insertion of first end cap 1232 into second end cap 1234, first end cap 1232 may be configured to have a sloped or tapered annular surface 1304 and/or a rounded annular surface 1306 in front of annular recess 1302, as best shown in fig. 74. Likewise, second end cap 1234 may be configured with a sloped or tapered annular surface 1316 to help align and substantially wedge first end cap 1232 into second end cap 1234, as best shown in fig. 77.

Additionally, as shown in the illustrated embodiment, the one or more protrusions 1298 and the plurality of protrusions 1308 may include features to facilitate insertion of first end cap 1232 into second end cap 1234 and/or be configured to facilitate insertion of first end cap 1232 into second end cap 1234. For example, in certain embodiments, as best shown in fig. 74, each boss 1298 may define a sloped or tapered front surface 1298a to help guide each boss 1298 into the gap formed between the bosses 1308 on the second end cap 1234. Similarly, in certain embodiments, as best shown in fig. 75 and 77, the projections 1308 on the second end cap 1234 may define a sloped or tapered surface 1308a to help guide each projection 1298 into the gap between each projection 1308. Further, in some embodiments, each boss 1308 can define a sloped or tapered front edge 1308b to at least assist in axial alignment of first end cap 1232 with second end cap 1234.

Any substantially rigid or semi-rigid element with luer 1200, including but not limited to first end cap 1232 and second end cap 1234, may include polycarbonate plastic, fiberglass filled polycarbonate, any other suitable water impermeable material, or any combination thereof. The luer fitting may also include a hydrophobic plastic. Other examples of materials suitable for forming any substantially rigid or semi-rigid element with luer 1200 are glass-filled GE Valox420 or polypropylene. Many other materials may be used depending on the application.

Fig. 79A is a cross-sectional view of another embodiment of a luer fitting 1400 in a closed position. Fig. 79B is a cross-sectional view of the embodiment of the luer fitting 1400 shown in fig. 79A in an open position. In certain embodiments, luer 1400 may have the same features and configurations as embodiments of luer 1000 described above, and/or any features or configurations described herein. Further, luer 1400 may include any feature, element, or configuration of any other luer described herein.

Similar to the luer 1000 described above, the valve element 1416 can include at least one post 1450. In certain embodiments, the strut 1450 can extend from substantially the middle of the valve member 1416 to the first end 1412. The fitting 1400 may have two struts 1450, as shown, or the luer fitting 1400 may have more or fewer struts as desired. The post 1450 may be located around the luer taper 1422, but within the housing 1423, as shown. The post 1450 may be located within the inner diameter of the internal thread 1426, and thus is configured to connect with at least a portion of the female luer socket when engaged with the luer taper 1422.

As shown in the embodiment of fig. 79A, the resilient member 1418 may be a coil spring supported between the end cap 1430 and the rear of the housing 1420. Referring to fig. 79A, the rear portion of the pocket 1420 defines an annular projection, as shown, or otherwise configured to axially and radially support the end of the resilient member 1418 such that the adjacent end of the resilient member 1418 remains substantially coaxially aligned with the valve member 1416. Further, although not shown, end cap 1430 may also include an annular projection or recess, or otherwise be configured to provide radial support to the end of resilient member 1418 such that resilient member 1418 remains substantially coaxially aligned with end cap 1430.

Referring to fig. 79A and 79B, the resilient member 1418 can be configured to bias the valve member 1416 to the closed position, as shown in fig. 79A. When the valve member 1416 is opened, the resilient member 1418 is axially compressed between the end cap 1430 and the rear of the housing 1420, as best shown in fig. 79B. The valve element 1416 may be caused to open, for example, when the medical connector 92 or a female head of a medical component is threadably engaged with the luer connector 1400 to axially displace the one or more posts 1450 toward the second end 1414 of the luer connector 1400. Accordingly, in the embodiment of luer fitting 1400 shown in fig. 79A and 79B, resilient member 1418 may provide the same or similar axial force as resilient member 1018 described above with respect to luer fitting 1000.

Moreover, because the resilient member 1418 is substantially completely enclosed within the housing 1423 of the male luer 1400, in some embodiments, the housing 1423 can be shaped to define a continuous annular surface (i.e., without any slits or other openings formed in the outer surface, other than the openings that can be formed in either of the two axial ends). In some embodiments, the annular surface of the housing 1423 can be shaped with a particular shape to provide enhanced tactile feedback and control to the user. In some embodiments, the central portion of the housing 1423 may be shaped to have a smaller cross-sectional diameter than the first and second ends 1412, 1414.

Fig. 80A is a cross-sectional view of another embodiment of a luer fitting 1400' in a closed position. Fig. 80B is a cross-sectional view of the embodiment of the luer fitting 1400' shown in fig. 80A in an open position.

Referring to fig. 80B, fitting 1400' is shown in threaded engagement with closeable female luer fitting 210, where closeable female luer fitting 210 may be the same as closeable female luer fitting 210 shown in fig. 10 and described above. In the embodiment shown in fig. 80B, the closable female luer fitting 210 may include a housing 213, a void space 212, a fluid channel 218, a liquid conduit 216 having one or more apertures 215, a compressible seal 214 having a proximal surface 217, and a threaded engagement region 211. The closable female connector 210 may be disposed with its proximal end adjacent the first end 1412 'of the male connector 1400'. The threaded engagement region 211 of the closable box 210 may be sized to luer connectors, such as those that meet ANSI standards. The compressible seal 214 may be constructed of a water impermeable resilient material that is movable into the housing 203 when subjected to a force. The liquid conduit 216 may be constructed of a rigid material, such as polycarbonate plastic, that resists deformation when a force sufficient to compress the seal 214 is applied to the closable female connector 210.

The fluid passage 218 may place the liquid conduit 216 in fluid communication with the second end 219 of the closable female connector 210. The at least one aperture 215 in the liquid conduit 216 may be sealed by the compressible seal 214 to prevent the fluid passage 218 from being in fluid communication with the void space 212 between the compressible seal 214 and the inner wall of the housing 213 and/or with the exterior of the housing 213. The aperture(s) 215 may be sized to allow liquid to flow between the fluid channel 218 and the ullage 212 at a suitable flow rate. One such dimension of the aperture 215 is about 1mm in diameter, although irregular shapes and other dimensions may be used. Apertures of at least about 1mm or about 1mm to 3mm or less than about 1mm may also be used.

Referring to fig. 80B, the threaded region 211 of the closable box 210 can engage the internal threads 1426 ' of the pin 1400 ' to engage the connectors 1400 ', 210 as shown. In the illustrated embodiment, the luer tip 1422' is pushed into the closable female connector 210 by compressing the compressible seal 214. As shown, the luer taper 1422' contacts the compressible seal 214 on the proximal surface 217 of the compressible seal 214. The force applied to engage the fittings 1400 ', 210 and the threaded regions 1426 ', 211 is sufficient to compress the seal 214, thereby exposing the aperture 215 in the liquid conduit 216 and opening the valve element 1416 ', as will be described below. With the seal 214 compressed, the fluid channel 218 is in fluid communication with the interior space of the luer taper 1422'.

As the luer taper 1422 'is pushed further into the closable female connector 210, the fluid conduit 216 contacts the end of the valve element 1416' adjacent the first end 1412 'of the male connector 1400'. By this contact and continued pushing in of the luer taper 1422 ', the valve element 1416' is moved toward the second end 1414 'of the male connector 1400'. The resilient member 1418 'applies a closing force to the valve member 1416' in a direction toward the first end 1412 'of the male connector 1400'. As a result, the tip of the valve element 1416' remains substantially in contact with the liquid conduit 216 throughout engagement. When the valve element 1416 'is moved toward the second end 1414' of the male connector 1400 ', the flange portion 1458' of the valve element 1416 'may be separated from the inner surface of the housing 1423' or the luer taper 1422 'to expose or open the aperture 1436'. As a result, opening 1454' is opened to fluid communication with closeable female connector 210. The compressed seal 214 may inhibit liquid from flowing over the luer taper 1422' into the closeable female connector 210. In this configuration, liquid may flow from the second end 1414 ' of the male connector 1400 ' to the first end 1412 ' of the male connector 1400 ', through the opening 1454 ', out the bore 1436 ' on the male connector tip 1422 ', into the housing 213, which may enclose the female connector 210, into the bore 215 on the liquid conduit 216 and into the flow channel 217 inside the liquid conduit 216.

The tabs 1400', 210 may be screwed apart. During disengagement, the force exerted by the resilient member 1418 'returns the connector 1400' to its pre-engaged state by directing the valve element 1416 'such that the flange portion 1458' of the end of the valve element 1416 'facing the first end 1412' of the male connector 1400 'engages the inner surface of the luer taper 1422'. Likewise, the resilient material used to form the compressible seal 214 may return the seal 214 to its closed position shape, and the proximal surface 217 may seal the proximal end of the closable female connector 210. Any of the elements of luer fitting 1400 or 1400' described herein may be constructed of any suitable material described herein, or any other material suitable for such elements.

Fig. 81A is a cross-sectional view of another embodiment of a luer fitting 1500 in a closed position. Fig. 81B is a cross-sectional view of the embodiment of the luer fitting 1500 shown in fig. 81A in an open position. In certain embodiments, luer 1500 may have any of the features and configurations described above with respect to embodiments of luer 1000, and/or any of the features and configurations described herein. Further, luer 1500 may include any feature, element, or configuration of any other luer described herein.

Similar to luer 1000 described above, valve member 1516 may include at least one post 1550. In some embodiments, the post 1550 may extend from approximately the middle of the valve member 1516 to the first end 1512. The fitting 1500 may have two posts 1550, as shown, or the luer fitting 1500 may have more or fewer posts as desired. The post 1550 may be located around the luer taper 1522, but within the housing 1523, as shown. The post 1550 may be located within the inner diameter of the internal thread 1526 such that it is configured to connect with at least a portion of the female luer connector socket when engaged with the luer taper 1522.

As shown in the embodiment shown in fig. 81A, the resilient member 1518 may be a resilient, axially resilient material that is coupled to and extends between the interior of the housing 1523 and the exterior surface of the chamber 1520. In some embodiments, the resilient member 1518 can be tapered, with a first end 1518a coupled to an outer surface of the chamber 1520 and a second end 1518b coupled to an inner surface of the housing 1523. In some embodiments, the resilient member 1518 can be formed by one or more substantially rectangular protrusions extending from the interior surface of the housing 1523 to the exterior surface of the chamber 1520. In some embodiments, the resilient member 1518 can be coupled to the valve member 1516 or the housing 1523 using an adhesive, a ring that can be shrunk over the resilient member 1518 and the outer surface of the chamber 1520, or by any other suitable coupling means or mechanism.

Referring to fig. 81A and 81B, the resilient member 1518 may be configured to bias the valve member 1516 to the closed position, as shown in fig. 81A. When the valve member 1516 is caused to open, the resilient member 1518 may be axially elongated, as best shown in fig. 81B. The valve member 1516 may be opened, for example, when the medical connector 92 or a female portion of a medical component is threadably engaged with the luer connector 1500 such that the one or more posts 1550 are axially displaced toward the second end 1514 of the luer connector 1500. Thus, in the embodiment of luer fitting 1500 shown in fig. 81A and 81B, resilient member 1518 may provide the same or similar axial force to the valve member as resilient member 1018 described above with respect to luer fitting 1000.

Additionally, because the resilient member 1518 is substantially completely enclosed within the housing 1523 of the male luer 1500, in some embodiments, the housing 1523 may be shaped to define a continuous annular surface. In some embodiments, the annular surface is contoured to provide a depression for a user to grip.

Fig. 82A is a cross-sectional view of another embodiment of a luer fitting 1500' in a closed position. Fig. 82B is a cross-sectional view of the embodiment of the luer fitting 1500' shown in fig. 82A in an open position.

Referring to fig. 82B, fitting 1500' is shown in threaded engagement with closeable female luer fitting 210. closeable female luer fitting 210 may be the same as closeable female luer fitting 210 shown in fig. 10 and described above. The closable female connector 210 may be disposed with its proximal end adjacent the first end 1512 'of the male connector 1500'. The threaded engagement region 211 of the closable box 210 can engage the internal threads 1526 ' of the pin 1500 ' to engage the connectors 1500 ', 210 as shown. In the illustrated embodiment, the luer fitting tip 1522' may be pushed into the closable female fitting 210 by compressing the compressible seal 215. As shown, the luer taper 1522' contacts the compressible seal 215 on the proximal surface 217 of the compressible seal 215. The force applied to engage the connectors 1500 ', 210 and the threaded regions 1526 ', 211 is sufficient to compress the seal 215, thereby exposing the aperture 215 in the liquid conduit 216 and opening the valve member 1516 ', as described below. With seal 215 compressed, fluid channel 218 is in fluid communication with the interior space of luer taper 1522'.

As the luer taper 1522 'is pushed further into the enclosable female connector 210, the fluid conduit 216 contacts the end of the valve member 1516' adjacent the first end 1512 'of the male connector 1500'. By this contact and continued advancement of the luer taper 1522 ', the valve member 1516' is moved toward the second end 1514 'of the male connector 1500'. The resilient member 1518 'exerts a closing force on the valve member 1516' in a direction toward the first end 1512 'of the male connector 1500'. As a result, the end of the valve member 1516' remains substantially in contact with the liquid conduit 216 throughout the engagement. When the valve element 1516 'is moved toward the second end 1514' of the male connector 1500 ', the flange portion 1558' of the valve element 1516 'may be separated from the inner surface of the housing 1523' or the luer taper 1522 ', thereby exposing or opening the aperture 1536'. As a result, opening 1554' is opened to fluid communication with closeable female connector 210. The compressed seal 215 inhibits liquid from flowing over the luer taper 1522' into the closable female connector 210. In this configuration, fluid may flow from the second end 1514 ' of the luer fitting 1500 ' to the first end 1512 ' of the male fitting 1500 ', through the opening 1554 ', out the bore 1536 ' of the luer taper 1522 ', into the housing 213 which may enclose the female fitting 210, into the bore 215 of the fluid conduit 216, and into the flow channel 217 in the fluid conduit 216.

The joints 1500', 210 may be disengaged by threads. During disengagement, the force exerted by the resilient member 1518 'may return the connector 1500' to its pre-engaged state by directing the valve member 1516 'such that the flange portion 1558' of the end of the valve member 1516 'engages the inner surface of the luer fitting taper 1522'. Likewise, the resilient material that may comprise the compressible sealing member 214 may return the sealing member 214 to its closed position shape, and the proximal surface 217 may seal the proximal end of the closable female connector 210. Any of the elements of luer fitting 1500 or 1500' described herein may be constructed of any suitable material disclosed herein or any other material suitable for such elements.

Fig. 83A is a cross-sectional view of another embodiment of a male luer 1600 in a closed position. Fig. 83B is a cross-sectional view of the embodiment of the luer fitting 1600 shown in fig. 83A in an open position. In certain embodiments, luer fitting 1600 may have any of the features and configurations described above with respect to embodiments of luer fitting 1000, and/or any of the features and configurations described herein. Further, luer 1600 may include any feature, element, or configuration of any other luer described herein.

Similar to luer 1000 described above, valve element 1616 may include at least one post 1650. In certain embodiments, the post 1650 may extend from a middle portion of the valve element 1616 to the first end 1612 of the luer fitting 1600. The fitting 1600 may have two struts 1650, as shown, or the luer fitting 1600 may have more or fewer struts as desired. Post 1650 may be located around luer fitting tip 1622, but within housing 1623, as shown. Post 1650 may be located within the inner diameter of internal threads 1626, such that it is configured to connect with at least a portion of a female luer fitting receptacle when engaged with luer fitting tip 1622.

As shown in the embodiment illustrated in fig. 83A, the resilient member 1618 may be a resilient, axially resilient material having a first end 1618a connected to the valve member 1616 and a second end 1618b secured to an outer surface of the housing 1623. In this configuration, because the first portion 1618a of the spring 1618 is located within the housing while the second portion 1618b is located outside of the housing, the housing 1623 may define slots through which the spring may pass. In some embodiments, the resilient member 1618 may be completely enclosed within the housing 1623 with a first end secured to the valve member 1616 and a second end secured to an inner surface of the housing 1623.

In some embodiments, the elastic element 1618 may include one or more straps with loops at both ends similar to the elastic element 1618 described above. In some embodiments, the resilient member 1618 may simply comprise one or more substantially rectangular strips having a first end connected to the valve element 1616 and a second end connected to the interior or exterior of the housing 1623. In some embodiments, the resilient member 1618 may be attached to the valve element 1616 or housing 1623 using an adhesive, a collar shrunk over the resilient member 1618 and valve element 1616, or by any other suitable attachment means or mechanism. Additionally, the valve member 1616 may define recesses, protrusions, or other features configured to axially secure a portion of the resilient member 1618 to the valve member 1616.

Referring to fig. 83A and 83B, the resilient member 1618 may be configured to bias the valve member 1616 to the closed position, as shown in fig. 83A. When the valve element 1616 is caused to open, the resilient element 1618 may be axially elongated, as best shown in fig. 83B. The valve 1616 may be opened, for example, when a female head of a medical connector or medical element is threadably engaged with the luer connector 1600 to axially displace the one or more posts 1650 toward the second end 1614 of the luer connector 1600. Thus, in the embodiment of the luer fitting 1600 shown in fig. 83A and 83B, the resilient member 1618 may provide the same or similar axial force to the valve member as the resilient member 1018 described above with respect to the luer fitting 1000.

In addition to the seal formed by the end of the valve element 1616 adjacent the first end 1612 of the luer 1600, an additional substantially liquid-tight seal may be provided by an additional substantially planar seal 1626 which, as shown in fig. 83A, may be supported within the cylindrical end 1630a of the end cap 1630. In some embodiments, the seal 1626 may be a planar, disk-shaped member defining a slit 1628 through a cross-section thereof, as shown in fig. 83A and 83B. In the illustrated embodiment, when the valve member passes through the seal 1626 and, in turn, moves the valve member to the open position, the slit 1628 in the seal 1626 may be opened, thereby allowing liquid to flow through the seal 1626, as shown in fig. 83B. The seal 1626 may be constructed of silicone rubber or any other flexible, resilient suitable material to automatically recover when the valve member 1616 is no longer in contact with the seal 1626. The redundancy with additional seal 1626 (i.e., in addition to forming a seal between valve element 1616 and male luer taper 1622) may provide the benefit of further reducing any risk of fluid leakage when luer 1600 is in the closed position.

Further, referring to fig. 83A and 83B, the luer fitting 1600 may include a seal 1632 configured to provide a seal between the chamber 1620 and the end cap 1630. Preferably, annular seal 1632 may be configured to be sealingly attached to inner end 1630a of end cap 1630 and the outer surface of chamber 1620 to substantially prevent any liquid from leaking into the interior space of housing 1623. In other words, the seal 1632 may be configured to substantially direct liquid or medicament passing through the end cap 1630 into the internal passage 1634 of the valve member 1616 to prevent leakage into the interior space of the housing 1623.

Additionally, the seal 1632 may be configured such that the volume V1 of the space defined within the seal 1632 when the valve member 1616 is in the closed position (see fig. 83A) is greater than the volume V2 of the space defined within the seal 1632 when the valve member 1616 is in the open position (see fig. 83B). In this configuration, when the valve member 1616 is moved to the closed position, the volume of space within the seal 1632 may increase from V1 to V2 to create a suction or negative pressure that may effect the drawing of liquid from the internal passage 1634 into the volume (V) of space defined by the seal 1632. Thus, similar to other embodiments described herein, this configuration of the luer fitting 1600 may eliminate or reduce the amount of potentially harmful medicament that may leak from the luer fitting 1600 when the valve member 1616 is closed.

Fig. 84A is a cross-sectional view of another embodiment of a male luer 1600' in a closed position. Fig. 84B is a cross-sectional view of the embodiment of the luer fitting 1600' shown in fig. 84A in an open position.

Referring to fig. 84B, fitting 1600' is shown in threaded engagement with a closeable female luer fitting 210. closeable female luer fitting 210 may be the same as closeable female luer fitting 210 shown in fig. 10 and described above. The closable female connector 210 may be disposed with its proximal end adjacent to the first end 1612 'of the male connector 1600'. The threaded engagement region 211 of the closable box 210 can engage the internal threads 1626 ' of the pin 1600 ' to engage the connectors 1600 ' and 210 as shown. In the illustrated embodiment, luer fitting tip 1622' may be pushed into closeable female fitting 210 by compressing compressible seal 215. As shown, the luer taper 1622' contacts the compressible seal 215 on the proximal surface 217 of the compressible seal 215. The force applied to engage the fittings 1600 ' and 210 and the threaded regions 1626 ' and 211 is sufficient to compress the seal 215 to expose the aperture 215 in the liquid conduit 216 and open the valve element 1616 ', as will be described below. With seal 215 compressed, fluid channel 218 is in fluid communication with the interior space of luer fitting tip 1622'.

As luer taper 1622 'is further advanced into closeable female connector 210, fluid conduit 216 contacts the end of valve element 1616' adjacent first end 1612 'of male connector 1600'. By this contact and continued advancement of luer taper 1622 ', valve element 1616' may be moved toward second end 1614 'of male connector 1600'. The resilient member 1618 'exerts a closing force on the valve member 1616' in a direction toward the first end 1612 'of the male connector 1600'. As a result, the end of the valve element 1616' remains substantially in contact with the liquid conduit 216 throughout engagement. As the valve element 1616 'is moved toward the second end 1614' of the male connector 1600 ', the flange portion 1658' of the valve element 1616 'may separate from the inner surface of the luer taper 1622'. As a result, opening 1654' is opened to fluid communication with closeable female connector 210. The compressed seal 215 inhibits liquid from flowing over the luer taper 1622' into the closeable female connector 210. In this configuration, liquid may flow from the second end 1614 ' of the luer fitting 1600 ' to the first end 1612 ' of the male fitting 1600 ', through the opening 1654 ', out the bore 1630 ' of the luer taper 1622 ', into the housing 213 that may enclose the female fitting 210, into the bore 215 of the liquid conduit 216, and into the flow channel 217 in the liquid conduit 216.

The tabs 1600' and 210 can be screwed apart. During separation, the force exerted by resilient member 1618 'may return connector 1600' to its pre-engaged state by directing valve element 1616 'such that flange portion 1658' of the end of valve element 1616 'facing first end 1612' of male connector 1600 'engages the inner surface of luer taper 1622'. Likewise, the resilient material used to form the compressible sealing member 214 may return the sealing member 214 to its closed position shape, and the proximal surface 217 may seal the proximal end of the closable female connector 210. Any of the elements of luer fitting 1600 or 1600' described herein may be constructed of any suitable material described herein, or any other material suitable for such elements.

Fig. 85A is a cross-sectional view of another embodiment of a luer connector 1700 in a closed position. Fig. 85B is a cross-sectional view of the embodiment of the luer fitting 1700 shown in fig. 85A in an open position. In certain embodiments, luer 1700 may have any of the features and configurations described above with respect to embodiments of luer 1000, and/or any of the features and configurations described herein. Further, luer 1700 may include any feature, element, or configuration of any other luer described herein.

Similar to the luer 1000 described above, the valve member 1716 may include at least one post 1750. In certain embodiments, the strut 1750 may extend from approximately the middle of the valve member 1716 to the first end 1712 of the luer 1700. The fitting 1700 may have two struts 1750 as shown, or the luer fitting 1700 may have more struts as desired. The posts 1750 may be located around the luer fitting tip 1722, but within the housing 1723, as shown. The post 1750 may be located within the inner diameter of the internal threads 1726 such that it is configured to engage at least a portion of a female luer fitting receptacle when engaged with a luer fitting tip 1722.

As shown in fig. 85A, the valve element 1716 of the luer fitting 1700 may also include a first member 1718 (also referred to herein as a resilient member) and a second member 1720. In certain embodiments, the first member 1718 can be substantially tubular in shape and constructed of a resilient, substantially liquid-impermeable, recoverable material. In the illustrated embodiment, the first member 1718 is resilient in both the axial and radial directions. An axial opening is defined through the first member 1718 that allows liquid to flow through the first member 1718 when the valve member 1716 is in the open position. In the illustrated embodiment, the first member 1718 can be concentrically disposed about the second member 1720, substantially completely surrounding the second member 1720. The first member 1718 can be configured and disposed such that the first end 1718a of the first member 1718 abuts the inner end surface 1730a of the end cap 1730. Similarly, the first member 1718 can be configured and arranged such that the second end 1718b of the first member 1718 abuts the end surface 1750a of one or more struts 1750 on the opposite end of the first member 1718. Further, in the closed position, the inner surface 1718c of the first member 1718 can abut at least a portion of the second member 1720 such that the first member 1718 and the second member 1720 form a substantially fluid tight seal when the valve member 1716 is in the closed position (as shown in fig. 85A).

Second member 1720 can be substantially rigid, as shown in fig. 85A and 85B, and can include one or more annular protrusions 1725 around a partial outer peripheral surface of second member 1720, although only one annular protrusion 1725 is shown. In the illustrated embodiment, the annular protrusion 1725 can be configured to mate with the interior geometry of the first member 1718 to provide a substantially fluid-tight seal against the inner surface 1718c of the first member 1718 when the valve element 1716 is in the closed position. In addition, the second member 1720 may have a first opening 1724 formed on a first end of the second member 1720a (i.e., the axial end of the second member 1720 proximate the first end 1712 of the male luer 1700). Similarly, second member 1720 can have a second opening 1726, the second opening 1726 being formed on a second end of second member 1720a (i.e., the axial end of second member 1720 proximate to second end 1714 of luer fitting 1700).

Referring to fig. 85A, the first member 1718 may be configured to bias the valve strut 1750 toward the first end 1712 of the luer fitting 1700, thereby causing the valve strut 1750 to abut the inner wall 1752. With additional reference to fig. 85A, the first member 1718 can be configured to be biased to a closed position (i.e., whereby the inner surface 1718c of the first member 1720 abuts the annular protrusion 1725 to an extent sufficient to substantially close the fluid pathway between the second end 1714 and the first end 1712 of the luer connector 1700). The amount of pressure applied by the first member 1718 to the annular protrusion 1725 can be increased by increasing the outer peripheral dimension of the annular protrusion 1725 relative to the outer peripheral dimension of the inner surface 1718c of the first member 1718, thereby increasing the sealing force between the first member 1718 and the second member 1720 when the valve element 1716 is in the closed position. Further, the degree of sealing may be improved, for example, by increasing the thickness or elasticity of the material used to construct the first member 1718 or by changing its configuration.

The valve member 1717 may be caused to open, for example, when the medical connector 92 (shown in fig. 85B) or a female head of a medical element is threadably engaged with the male luer 1700 to axially move the one or more posts 1750 toward the second end 1714 of the male luer 1700. The luer 1700 may be configured such that when the one or more struts 1750 are moved toward the second end 1714 of the luer 1700, the struts 1750 exert a force on the second end 1718b of the first member 1718 that reduces the length of the first member 1718 and causes it to bend or bulge outward in the middle. As the middle of first member 1718 bulges outward, inner surface 1718c may be stretched and move radially outward away from annular protrusion 1725. When the inner surface 1718c of the first member 1718 is no longer in contact with the annular protrusion 1725, the valve element is in the open position, as shown in FIG. 85B.

Referring to fig. 85B, when the valve element 1716 is in the open position, liquid or medicament flowing into the second end 1714 of the luer tip 1700 can flow through the second opening 1726, into the space between the first member 1718 and the second member 1720, around the protrusion 1725, through the first opening 1724 and the channel 1756, and out the tip of the luer tip 1722.

Conversely, when the medical connector 92 is unscrewed or removed from the luer connector 1700, the axial bias from the first member 1718 may elongate the first member 1718 to its pre-ballooned configuration, moving the strut 1750 toward the first end 1712, and in some embodiments, abutting the strut 1750 against the inner wall 1752. Similarly, when the medical connector 92 is unscrewed or removed from the luer connector 1700, the radially inward bias from the first member 1718 may cause the first member 1718 to contract and form a seal around the annular protrusion 1725, substantially preventing any additional liquid from flowing through the valve element 1716.

In certain embodiments, second member 1720 may be formed separately from luer fitting tip 1722. In certain embodiments, however, second member 1720 may be integrally formed with luer fitting tip 1722. Further, because the first member 1718 may be substantially completely enclosed within the housing 1723 of the male luer 1700, in certain embodiments, the housing 1723 may be formed to define a continuous annular surface. Any of the elements of luer fitting 1700 described herein may be formed from any of the suitable materials described herein, or from any other material suitable for such elements.

Fig. 86A is a cross-sectional view of another embodiment of a luer fitting 1800 in a closed position. Fig. 86B is a cross-sectional view of the embodiment of the luer fitting 1800 shown in fig. 86A in an open position. In certain embodiments, luer 1800 may have any of the same features and configurations as the embodiments of luer 1000 described above and/or any of the features, elements, or configurations of other luers described herein.

As shown in fig. 86A, the valve element 1816 can include at least one lever arm 1850. In particular, the luer fitting 1800 shown in fig. 86A includes two opposing lever arms 1850, although the luer fitting 1800 may include any number of suitable lever arms 1850. As shown, each lever arm 1850 is pivotally mounted on an axle 1852 that may be supported in a fixed position relative to the housing 1823, but which may rotate relative to the housing 1823 to rotate the lever arm 1850 relative to the housing 1823. In some embodiments, similar to the embodiment shown, the lever arm 1850 can extend out of the housing 1823 through a slot 1824 that can be formed in the housing 1823.

Each lever arm 1850 may be supported by the housing 1823 such that a first end 1850a of the lever arm 1850 may abut the chamber 1854 and a second end 1850b may be disposed adjacent the luer taper 1822. In particular, in the illustrated embodiment, the lever arm 1850 can be so supported by the housing 1823 that a bottom surface 1850c of the first end 1850 can abut an outer surface 1854a of the chamber 1854. Similarly, in the illustrated embodiment, the lever arms 1850 can be so supported by the housing 1823 that a bottom surface 1850d of the second end 1850b of each lever arm 1850 can be generally disposed within the housing 1823 about the luer taper 1822 as shown. The bottom surface 1850d of the second end 1850b of each lever arm 1850 may be located within the inner diameter of the internal threads 1826.

In this configuration, referring to fig. 86B, when the female portion of the medical fitting 92 is threadably engaged with the threads 1826 of the luer fitting 1800 and moved toward the second end 1814 of the luer fitting 1800, as shown by arrow a1 in fig. 86B, the distal end 92a of the medical fitting 92 may contact the bottom surface 1850d of the second end 1850B of each lever arm 1850. As the medical connector 92 is moved further toward the second end 1814, the distal end 92a of the medical connector 92 may force the second end 1850B of each lever arm 1850 in a radially outward direction, as indicated by arrow a2 in fig. 86B. Because each lever arm 1850 can rotate relative to the shaft 1852, the first end 1850a of each lever arm 1850 can rotate and move radially inward as the second end 1850B of each lever arm 1850 is pushed radially outward, as indicated by arrow A3 in FIG. 86B.

Forcing the first end 1850a of each lever arm 1850 inward may cause the bottom surface 1850c to exert a radially inward force on the outer surface 1854a of the chamber 1854, in the direction of arrow a3 shown in fig. 86B. Lever arm 1850 and chamber 1854 may be configured such that a reaction force applied to chamber 1854 by first end 1850a causes chamber 1854 and, thus, valve element 1816 to move axially toward second end 1814 of luer 1800 as first end 1850a is retracted inwardly against chamber 1854. As the valve element 1816 moves axially toward the second end 1814 of the luer fitting 1800, the valve element is caused to open so that liquid or medication can flow through the valve element 1816 and out the opening 1856 on the distal end of the luer taper 1822, as shown in fig. 86B.

A resilient member 1818, which may be formed of a coil spring, may be disposed between the endcap 1830 and the chamber 1854, as shown in fig. 86A and 86B. The rear portion of the chamber 1854 may define an annular projection or may be configured to support an end of the resilient member 1818 axially and radially such that the adjacent end of the resilient member 1818 remains substantially coaxially aligned with the valve member 1816. In addition, the end cap 1830 may also include an annular projection or recess, or otherwise be configured to provide radial support to an end of the resilient member 1818 so that the resilient member 1818 remains substantially coaxially aligned with the end cap 1813.

Referring to fig. 86A and 86B, the resilient member 1818 may be configured to bias the valve member 1816 to a closed position, as shown in fig. 86A. When the valve element 1816 is caused to open, the resilient element 1818 may be axially compressed between the end cap 1830 and the rear of the chamber 1854, as best shown in fig. 86B. Resilient member 1818 may bias chamber 1854 and valve element 1816 toward first end 1812 of luer 1800, thereby biasing valve element 1816 toward the closed position. In this configuration, when the medical connector 92 is removed from the luer connector 1800, the resilient member 1818 may bias the valve element 1816 toward the closed position and may also bias the lever arm 1850 to rotate relative to the shaft 1852, with the result that the first end 1850a rotates radially outward.

The seal 1868 between the interior surface of the chamber 1854 and a portion of the endcap 1830 may prevent fluid from leaking through the gap between the interior surface of the chamber 1854 and the portion of the endcap 1830. The chamber 1854 may be integrally formed with the valve element 1816 or may be separately formed and bonded, fused, or otherwise connected to the valve element 1816. Any of the elements of luer fitting 1800 described herein may be constructed of any suitable material disclosed herein, or any other material suitable for such elements.

Certain drugs, including those used during chemotherapy, may be harmful to the patient in certain applications. For example, contact with the skin can sometimes result in chemical burns. Inhalation of some drugs in the form of a mist may also be harmful. Therefore, control over drug storage is urgently required.

Some potentially harmful drugs are dispensed in sealed vials. The drug is removed from the vial by inserting a needle or drawing the drug into the syringe via an adapter. If a needle is used, the drug may be dispensed by withdrawing it from the vial. However, the withdrawn needle may carry residual drug disposed on the outside of the needle, or the vial adapter may contain residual drug on one or more of its exposed surfaces. Such drugs may inadvertently come into contact with the skin and cause injury. Alternatively, if a syringe is used to pierce a vial with an extraction mechanism, the drug can be extracted through the mechanism and sent directly to the syringe for injection, without the additional step of extracting the mechanism from the vial. However, despite the use of such syringes, there is still the potential for drug residue on the drug injection needle, the mechanism after vial separation, or the mechanism after syringe separation.

Any features of the numerous embodiments shown and/or described in these figures that are not explicitly described herein, such as distances, element characteristics, etc., are also intended to form part of this specification. Furthermore, although the present invention has been disclosed in the context of various embodiments, features, aspects and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. It should be understood, therefore, that the various features and aspects disclosed may be combined with or substituted for one another in order to achieve multiple different forms of the disclosed invention. Further, any element or combination of elements disclosed herein can be used in other structures of a medical connector configuration. Thus, the scope of the invention disclosed herein should not be limited by the particular disclosed embodiments described above.

As used throughout this specification, the terms "first end" and "second end" are convenient designations to be used on either the female or male side of the valve, or both. These designations are used interchangeably herein. For example, the numerous embodiment configurations described herein for preventing or inhibiting separation of two medical connectors can be used on either the male side or the female side (or both). The particular use of "first" or "second" in connection with a "female" or "male" connector should not be limited to such ends or ends.

Claims (8)

1. A medical connector, comprising:

a housing having an exterior engagement surface, a first end comprising a male head configured to engage a female connector, and a second end comprising a first opening;

a generally straight flow path between the first and second ends of the housing, and the flow path is blocked at the male portion;

the first end of the housing further comprises an outer protective cover fixed relative to the housing, the outer protective cover comprising an engagement portion disposed on an inner wall thereof;

a first generally tubular structure extending through the first opening of the housing, the first generally tubular structure including a second opening having a first outer diameter that is less than an inner diameter of the first opening and a radially extending flange extending from the first generally tubular structure and disposed proximate the first opening of the housing, the radially extending flange having a second outer diameter that is greater than the first outer diameter of the second opening of the first generally tubular structure, and the first generally tubular structure being configured to rotate relative to the housing to prevent disengagement of the medical connector from a second medical connector;

a second generally tubular structure within the housing overlying a portion of the first generally tubular structure.

2. The medical connector according to claim 1, wherein at least a portion of the radially extending flange rotates outside the housing.

3. A medical connector according to claim 1 or 2, wherein the second generally tubular structure comprises an axially movable valve member.

4. The medical connector according to claim 3, wherein the valve member extends at least partially axially through the housing and comprises:

a first open end and a second end;

a passage in the valve member; and

at least one opening adjacent the second end of the valve member, the opening extending outwardly from the passageway through the valve member.

5. The medical connector of claim 3, further comprising at least one post connected to the valve member and extending toward the second end of the valve member, the at least one post extending substantially parallel to the central axis of the valve member and at least partially surrounding a narrow portion of the valve member terminating at the second end.

6. The medical connector of claim 3, further comprising a seal disposed within the housing, the seal configured to inhibit the passage of liquid through the flow passage of the housing between the inner surface of the flow passage and the outer surface of the valve member.

7. The medical connector according to claim 3, wherein the valve member is rigid.

8. The medical connector according to any of claims 1-2, wherein the second end comprises a protrusion configured to break when a first medical implement is rotated relative to the second end beyond a point where the first medical implement is substantially fully engaged with the second end, the second end being configured to rotate relative to the housing to prevent the second medical connector from being disengaged from the second end of the medical connector when the protrusion is broken.