Valved male luer

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DESCRIPTION

Luer male with valve

Background of the invention

This invention relates to an improved Luer connector device that is fixed to a female Luer valve to open a flow channel through the male Luer. Once the Luer coupling has been established, these valves are used to make connections in hospitals for intravenous (IV) devices for use in applications of medicinal liquid fluids.

Luer devices are used in particular in a variety of medical applications where it is a desire to interconnect parts of male and female connector together on pipe materials that are connected to an IV device. The most common types of IV fluid exchanges use a syringe equipped with a nozzle that is designed to be received in a corresponding receiver attached to device IV. The receiver frequently has a hollow tubular cannula or strut that routes the fluid into a line inserted in the device IV that extends into the patient's veins.

Typical Luer connections use a male Luer connector that is inserted into a female Luer connector. The male Luer connector is threaded on the corresponding threads of the female Luer connector to couple the two so that the fluid can pass between them without leaks or leaks from the connection. Because these connections are likely to be loose or uncoupled, there is always a possibility that the fluid that is passing inside these tubes can escape. When dangerous drugs are used, such as those used for chemotherapy treatment, the possibility of fluid leakage can be a dangerous problem. Additionally, even if the fluid does not leak when the connectors are attached, once they are decoupled, the residual amount of fluid that remains at the tip of the connectors can still be harmful. Although this amount may be less than an amount that escapes the connectors, it may still be significantly sufficient to cause damage to any exposed person.

Therefore, there is a need for a Luer connection that safely contains the fluid materials included therein when the Luer are decoupled from each other. There is also a need for a Luer connection that seals the male Luer connector into a male-female connection so that the users of the connector are protected against dangerous drugs that remain on the surface of the Luer tip when uncoupled.

WO 03/013646 A2 describes a male Luer connector that is fixed to any standard female Luer valve to open a flow channel between the two Luer. The male Luer is composed of a tubular housing element, a flexible element contained within the housing and extending within a defined internal tubular part in the housing, and a valve element fixed to the flexible element that seals the tubular part. When the male Luer is coupled with any standard female Luer, the female Luer connector device drives the flexible element of the male Luer to a compressed position to open the front end of the male Luer and allow liquid to flow between the Luer.

Summary of the invention

It is an objective of the present invention to provide a new and improved male Luer connector device for coupling with a female Luer valve for connection to an IV device or other fluid type connections.

In accordance with the present invention, a male Luer is provided for connection with a female Luer valve having a contact surface, the male Luer comprising: a housing having a front end and a rear end; and disposed within the housing: a first tubular element located within the housing and having a front end and a rear end, the first tubular element defining a tubular conduit; a flexible element with front and rear ends arranged coaxially with the first tubular element, the flexible element being mobile between a compressed, retracted position and an extended position; a valve element disposed at the front end of the flexible element for closing so that the male Luer can be opened during said movement; and an internal plug inside the tubular conduit; in which when the male Luer is inserted into the female Luer the contact surface of the female Luer drives the flexible element to the compressed position to open the front end of the male Luer and allow the liquid to flow through and between the Luer, moving the liquid that circulates in the male Luer in a general axial path through the tubular duct of the male Luer, around the inner cap, to or from the female Luer, and in which the inner cap prevents the return of the liquid.

The configurations of the present invention described herein are advantageous for many reasons. When the male Luer fits or disengages with the appropriate female Luer valve, the male connector seals to protect any user from exposure to potentially dangerous fluids. The valve contained at the end of the male Luer closes on its own so that it ensures that minimal amounts of fluid remain on any exposed surface of the Luer. This advantage helps to ensure that dangerous drugs, such as

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those used in chemotherapy treatments, do not remain in the Luer. Also body fluids, such as blood, do not remain on the Luer to minimize exposure to potentially pathogenic blood. The valve designs allow either cleaning with mutual cotton or cleaning with cotton on one side because there are minimal cracks on the Luer and the tip element is substantially flush. Additionally, in one embodiment, the configuration of the male Luer provides another advantage because it creates a vacuum effect on the tip of the Luer when the male and female Luer are decoupled. This vacuum tip feature acts to minimize residual fluid on any surface and therefore minimize all types of exposure.

Brief description of the drawings

The present invention will be better understood from the detailed description below of an exemplary embodiment of the invention, taken in conjunction with the accompanying drawings in which equal reference numbers refer to equal parts and in which:

FIG. 1 is a side view of the two components of the male to female Luer connection of the Luer accessory; FIG. 2 is an enlarged sectional view taken on line 2-2 of FIG. 1; FIG. 3 is a view similar to FIG. 2, with partially coupled components; FIG. 4 is a view similar to FIG. 3, with the components fully coupled; FIG. 5 is a view similar to a part of FIG. 2, showing an alternative integrated spring element; FIG. 6 It is a view similar to FIG. 5, showing an alternative single stage valve; FIG. 7 is a view similar to FIG. 6, showing the valve open; FIG. 8 is a view similar to FIG. 5, showing a ball type valve; FIG. 9 is a sectional view showing an alternative slide actuated valve; FIG. 10 is a view similar to FIG. 9, showing the valve open; FIG. 11 is a view similar to FIG. 9, showing a valve actuated by alternative sliding; FIG. 12 is a view similar to FIG. 10, showing an alternative valve for use with a female Luer valve that does not have a strut or cannula; FIG. 13 is an embodiment of a male Luer valve that does not contain a housing element; FIGS. 14 and 15 are views similar to FIG. 11 illustrating a male Luer that does not contain a sleeve and that show movement from a closed position (FIG. 14) to an open position (FIG. 15) for the male Luer during contact with a female Luer that has no core bar or cannula; FIGS. 16 and 17 are views similar to FIGS. 14 and 15 illustrating a male Luer having a central sealing element internally to the flexible element and showing movement from a closed position (FIG. 16) to an open position (FIG. 17) for the male Luer during contact with a female Luer that has no core bar or cannula; FIG. 18 It is a view similar to FIG. 11 illustrating a male Luer that has a peripheral flange incorporated in the flexible element that after contact with the contact surface of a female Luer (which does not have a core bar or cannula) is forced backwards causing the flexible element to retract and open; FIGS. 19, 20 and 21 illustrate the appearance and operation of male Luer that have flexible elements with soft outer contact surfaces that after contact with the contact surface of a female Luer (which does not have a core bar or cannula) provide a connection by sufficient friction so that the flexible element is forced backwards causing it to retract and open; FIGS. 22 and 23 are views similar to FIGS. 16 and 17 illustrating a male Luer that has a central sealing element internally to the flexible element that has a radially extending portion that protrudes over the wall of the flexible element and extends outwardly, allowing it to extend to the interior or through a guide in the housing of the male Luer, a guide that engages with a contact surface of the female Luer that has no core bar or cannula, said coupling making the flexible element retract and open to allow fluid to flow between and through the Luer; and FIGS. 24, 25, 26 and 27 are side elevation views (FIGS. 24 and 26) and elevation views from the end (FIGS. 25 and 27) of another embodiment of a flexible element of a male Luer having a slightly bulbous tip with an opening slot, slot that is compressed and opened during contact with the inner surface of a female Luer with a general contact recess conical.

Detailed description of the preferred embodiments

Before describing embodiments of the present invention, Luer accessories known from WO 03/013646 will be described with reference to Figures 1 to 13, for use in the understanding of the present invention.

FIG. 1 is a side view of the two components of the male to female Luer connection of the Luer accessory. The accessory is made up of a male Luer 10 that is projected to fit with a female Luer that has an existing flush female Luer valve. The female Luer 24 is not limited to a particular type but is illustrated here as an exemplary Luer. The female Luer illustrated here is one in which the valve closes. This female Luer 24 contains a housing element 28 with a strut or cannula 26. On the other surface of the front end of the housing 28 there are threads 30 that allow the coupling of the female Luer 24 with the male Luer

10. In this embodiment the male Luer 10 is composed of a housing element 12. The inner wall of the housing

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12 It contains threads 32 that are coupled with the complementary threads 30 of the female Luer connector. The housing 12 has an inner tubular part 16 of reduced diameter that projects forward which has a first neck area 36 and a second neck area 38 (see FIG. 2). The inner tubular part defines an inner chamber 13 with a front opening 33 (see FIG. 2). A valve element 18 is pressed into an extended position sealing opening 33 by the flexible element or spring 14. The spring 14 acts between the distal end of the chamber 13 and the valve element 18. (As is used herein, "distal" is the most posterior end of the male Luer and "proximal" is the leading end, ie the left and right ends in views such as those illustrated in FIGS. 1 and 2.) The valve element 18 includes a flexible part 20 and a front tip element 22. FIG. 1 illustrates the two Luer 10, 24 in the uncoupled position. Other types of female Luer valves that do not contain a cannula or strut. By way of example, U.S. Patent Nos. 5,676,346 to Leinsing and 5,782,816 to Werschmidt illustrate these types of Luer valves.

FIGS. 2 to 5 illustrate the male Luer 10 and the female Luer 24 as they are coupled together. FIG. 2 illustrates the two Luer 10, 24 when they are completely decoupled. The cannula or strut 26 may have an opening 40 for the inlet and outlet of the fluid between the two Luer. Other duct systems (not shown) can be used. The cannula or strut 26 is mounted in a chamber within a sleeve 34. This sleeve 34 may be made of rubber or any other suitable flexible material and serves as a stop of the valve element. The sleeve 34 has an opening 35 at the front end which is sealed sealed in the disengaged position of FIG. 2. In male Luer it has a front end that has a first neck area 36 and a second neck area 38 rearwardly separated from the first neck area 36. FIG. 3 illustrates the male Luer 10 beginning to be inserted into the female Luer 24. Once the threads 30, 32 begin to engage, the front end 33 of the housing 12 pushes the sleeve 34 back until the opening 35 is forced to open on the end of the cannula 26. The cannula or strut 26 is then contacted with the tip of the valve element 18 and begins to push it back so that the cannula or strut 26 displaces the front section 22 of the valve element. This movement begins to separate the sealing surface from the first neck area 36 of its seat. When the tip element 22 begins to be pushed back, the second flexible part 20 collapses, compressing the cavity 19 of the valve element. This removes the seal from the first neck area 36 and displaces the liquid contained within the cavity 19. This displaced liquid temporarily flows into the female Luer valve 24. As this pressure is applied, the valve element is compressed and further pushed into the chamber 13.

FIG. 4 illustrates the placement of the Luer elements when the female Luer 24 and male 10 have engaged even more. The cannula or strut 26 begins to push even more on the tip element 22 and the first flexible element 14 collapses so that the second neck area 38 is unwound. At this point, more liquid is displaced by the additional insertion of the cannula. or strut inside the vacuum section 21 of the male Luer as indicated by the arrows in FIG. Four. The opening 40 in the cannula or strut 26 allows the fluid to pass into and out of the female Luer 24. This displaced liquid creates the volume to be filled when the action is reversed.

After disconnection of the valve of the male Luer 10 from the valve of the female Luer 24, the volume of the liquid that moved during the connection of the two valves is restored to the original positions, thus creating a relative vacuum. When the female Luer 24 is removed from the male Luer 10, the main seal created by the second neck area 38 makes contact with its seat. This isolates the vacuum section 21 of the upstream liquid. When the cannula

<dl><dt /><dd>or strut 26 is removed, the cavity 19 is restored since the flexible part 20 is restored to its natural form without collapsing. When this restoration happens, liquid is dragged into the cavity 19. Because the second neck area 38 is closed, this liquid is dragged from the interface between the male Luer 10 and the female Luer 24. This effect is enhanced by the volume represented by the cannula or strut 26, which must be replaced when the cannula</dd></dl>

<dl><dt /><dd>or strut 26 is removed. The relative vacuum created will attempt to absorb liquid into the vacuum section until the sealing surface of the first neck area 36 makes contact again with its seat.</dd></dl>

FIG. 5 illustrates the same type of double stage valve as the previous one only that is formed with the spring 14 integrally connected to the valve element 42. The housing 12 contains the inner sleeve 16 and located inside the inner sleeve 16 there is a inner chamber 13. The function of this apparatus is the same as that of the previously described apparatus with the exception that the spring 14 can be composed of elastomeric or other types of materials that are integrally joined with the valve element 42.

FIGS. 6 and 7 illustrate another male Luer.

This device is a single stage Luer valve with an integral flexible element. In this apparatus, the male Luer has a housing 12 with thread 32 on the inner wall of the housing for coupling with the complementary threads of the female Luer 30. The inner chamber 13 is sealed by the valve element 42 which is formed so integral with the flexible element and the tip. This new valve element 42 therefore functions as in the previous apparatus except that all the elements are formed in one piece, instead of including a separate flexible element. This apparatus demonstrates a single stage Luer valve in which a female Luer is coupled with the valve element 42, the element 42 moves as a single piece instead of as several different pieces as described above. FIG. 7 illustrates the Luer of FIG. 6 coupled with a female Luer 24 and allowing fluid flow. Once the two Luer 10, 24 are coupled, the cannula or strut 26 of the female Luer 24

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the valve element 42 collapses and allows the flow of fluid through the opening 40 in the cannula or strut 26 and also through an opening 44 at the rear end of the valve element 42.

FIG. 8 illustrates another device. In this apparatus, the housing 12 of the male Luer is similar to the previous apparatus. Additionally, contained within the inner sleeve 16 is a flexible element or spring 14. However, in this apparatus, the valve contained at the end of the flexible element is shown as a ball 46. This ball can be made of various types of materials such such as an elastomeric material. Additionally, the opening of the front end of the chamber 13 is exemplified as a partially spherical seat 47 to fit a ball valve 46. Those skilled in the art will recognize that the valve contained at the end of the flexible element or spring 14 can be of A variety of ways. However, the shape of the tip of the male Luer 10 needs to be one that corresponds to the shape of the tip of the female Luer 24.

FIGS. 9 and 10 illustrate a modified connector, in which a modified male Luer is removably secured to the female Luer 24 of the previous apparatus. The modified male Luer comprises a housing with a cylindrical outer wall 52 and an inner tubular support 54 projecting inside the cylindrical housing from the rear end 53 and extending along part of the length of the housing. The outer part 52 has internal threads 32 for coupling with the threads 30 of the female Luer and a diameter larger than the inner support 54 which extends from the rear end 53 of the housing and projects outside the front end of the housing. A flexible sleeve or folding element 56 is secured between the tubular element 55 and the support 54 at its rear end and projects forward within the tubular element 55 to its opening at the front end 57. The folding element 56 has an opening 58 of the front end which is sealed by the part of the inner conical end of the tubular element 55 when it is in the extended, unconnected position of FIG. 9. The front end portion 58 of the folding element 56 acts as a valve for sealing the opening of the end 57 of the male Luer in the position illustrated in FIG. 9.

The tubular element 55 of the male Luer is of a smaller diameter than the inner cylindrical wall 52 of the housing, to leave an annular space between the element 55 and the inner wall 52. A sliding sleeve 60 is slidably mounted on the element tubular 55 in this annular space. The sleeve 60 has diametrically opposed openings 62, and the tubular member 55 has grooves 64 that extend partially, elongate opposite. Guide parts 65 directed in opposition (for example, flanges, fins or flanks) on the folding element or inner sleeve 56 project radially outwardly through the grooves 64 and into the openings 62. Thus, when the sleeve is in the fully extended position of FIG. 9, will pull the sliding sleeve forward to the position illustrated. The corrugated part 66 of the folding element 56 acts as a spring to propel the front end of the folding element 56 and the sliding sleeve 60 towards the extended position.

FIG. 10 illustrates a female Luer 24 connected to the male Luer 50. When the front end of the female Luer housing is threaded into the cylindrical wall of the male housing, it will engage the front end 67 of the sliding sleeve 60, forcing the sleeve, and therefore to the folding element 56, back and moving the front end portion of the folding element out of the sealing coupling with the opening of the front end of the tubular element 55. This allows the opening 58 of the front end to open like a spring, as indicated. At the same time, the front end of the tubular element 55 forces the sleeve 34 on the female Luer backward so that it passes over the end of the cannula 26, which then extends into the open front end of the tubular element. This allows the flow of fluid through the two Luer, through the inner tubular support, open end 58 of the folding element 56, and the openings 40 in the cannula 26. When the Luer is disconnected, the compressed corrugated part 66 of the element Flexible 56 forces the front end portion to move back to its sealed coupling with the front end of the tubular member 55, preventing any fluid leakage.

FIG. 11 is a view similar to FIG. 9, which shows an alternative slide actuated valve except that the flexible sleeve or folding element 56 does not have a corrugated part and on the contrary has a separate spring element 68. The spring element 68 can be any type such as, for example, those made of metal or elastomeric material. The function of the male Luer valve is the same, it is simply the spring element 68 that replaces the previous corrugated element.

FIG. 12 is a view similar to FIG. 10, which shows an alternative valve for use with a female Luer valve that does not have a cannula or strut. The outer surface of the front end of the housing 28 engages and compresses the front end 67 of the sliding sleeve 60 of the male Luer valve. When the front end of the housing 28 of the female Luer valve continues to further displace the sliding sleeve 60, the folding element 56 continues to move backward and moves the front end portion of the folding element out of the sealed coupling with the opening of the front end of the tubular element 55. This allows the opening 58 of the front end to open like a spring. This allows the fluid to flow through the two Luer, through the inner tubular support, open end 58 of the folding element 56. Once the Luer is disconnected, the sealed coupling happens again again as described. previously.

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FIG. 13 is an illustration of a male Luer valve that does not contain a housing element. This view is similar to FIG. 2 except that the male Luer valve is not contained within a housing element and on the contrary can be autonomous. However, the function of the male Luer valve is the same as explained by FIG. 2 only that the coupling with the male Luer housing does not take place with the female Luer housing.

FIGS. 14 and 15 illustrate a male Luer 100 that does not contain a sliding sleeve 60. The housing of the Luer 102 has a tubular conduit 118 that projects over which a flexible sleeve or element 106 is placed. The base 114 of the flexible element 106 is abutted against the wall of the inner end 112 of the housing 102 and secured in place by the inner end of the projected tubular element 104. The flexible element 106 has one or more laterally projecting fins 108 that are respectively arranged in grooves 110 in the tubular part of the element 104. When the male Luer closes (FIG. 14) the opening in the tip 116 of the flexible element 106 it is closed, sealing the open end 120 of the male Luer 100. When the male Luer is coupled by a female Luer 128 which has a contact surface 126 but not a central rod or cannula (FIG. 15) the surface 126 is coupled with the fins 128 and the movement of the male Luer inside the female Luer causes the fins to move backward into the housing 102 as indicated by arrow 107 with the fins 108 being guided inside slots 110 as shown in 108 'to compress the bellows portion of the flexible element as shown in 106'. This opens the tip as shown in 116 'to allow fluid flow through the opening 120 into the flow channels 124 and 122 of the conduit 118 and the housing 102 respectively. The peripheral projections 132 function as O-ring seals and when the Luer are coupled, the projecting front edge 130 of the flexible element 106 engages with the interior inclined surface 134 of the element 104 to provide a sealing or "stop" effect and keeps the sealing area of ​​the O-ring free of fluid flow and dries.

For simplicity in a certain number of the Figures the female Luer 128 is not shown in itself and only the movement of the elements of the male Luer 100 is illustrated. It will be understood that said movement is a result of the male / female Luer coupling in the form illustrated in other figures such as (but not limited to) FIGS. 2, 3, 12 and 15. Similarly, for simplicity, not all threads or other fasteners are shown in all figures to retain the male and female Luer in their coupled position during the flow of fluid through them, but it will be understood that these are present as It is illustrated in (but not limited to) FIGS. 2, 3, 4, 10 and

12.

FIGS. 16 and 17 illustrate the embodiment of an apparatus of the present invention, which is similar to that of FIGS. 14 and 15, but in which there is an internal plug 138 inside the conduit 118 with channels 148 passing the plug 138. These channels can be formed in the wall of the conduit 118 or can be formed by having the plug 138 mounted on separate supports ( not shown) connected to conduit 118, or in any other convenient way. The peripheral surface 142 of the plug 138 makes contact with the radial lift 144 on the inner surface of the flexible element 106 as shown in 140 when the male Luer closes (FIG. 16). When the male Luer enters the female Luer the contact surface 126 makes contact with the fins 108 and pushes them back as shown in 108 'in FIG. 17, thus compressing the flexible element as shown in 106 'and displacing the lift 144 from the contact with the surfaces 142 of the fixed plug 138. Compression of the flexible element also opens the tip 116 of the flexible element as shown in 116' . Fluid flow is also effected through the opening 120 inside the conduit 124 and around the plug 138 through the channels 148 as shown by the arrows 146. The axial position and width of the lift 114 can be varied to determine when contact is made or lost with the edge of the plug 142, thus determining when the Luer opens or closes, and also providing a vacuum effect to prevent or minimize recoil. of fluid

FIGS. 18-21 illustrate a "soft" male Luer 100 in which the coupling with the female Luer 128 results in the contact area 126 of the female Luer being the inner surface of the Luer that is in direct contact with the outer surface 152 of the flexible element 106, as illustrated in FIG. 21. In FIG. 18 Two optional elements are shown: the projection 150 and the projections 109 which can be fins such as 108, a peripheral flange, an overhanging structure that can be coupled with the contact surface of the female Luer. The projection 150 may be a continuous radial projection with the part 102 'of the housing 102, may consist of separate projections aligned radially within the part 102'. (Part 102 'is shown in FIGS. 18 and 19 as a separate element but fixed to the rest of the housing 102, but may also form an integral part with the rest of the housing 102.) The projection 150 serves with a limiting device for coupling the contact surfaces 126 of the female Luer 128 and stop the relative movement of the two Luer, thus limiting the depth with which the male and female Luer can be coupled. The projections 109 can aid the compressions of the flexible element 106 by sharing the coupling with the contact surface 126 with the surface 152 of the element 106. The tip area 116 of the element 106 can be thickened as shown in FIGS. 18 and 19 to provide some expansion inside the coupling neck of the female Luer and thus create an additional sealing effect.

In FIGS. 20 and 21 the soft male Luer 100 is illustrated having an optional extended housing 102, so that the coupling of the surface 152 of the element 106 in contact with the surfaces 126 provides the complete coupling of the male and female Luer. This coupling and compression of element 106 through

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of the rigid conduit 118 allow the opening of the tip 116 and the flow through the end 120.

In the apparatus of FIGS. 22 and 23, an internal plug 154 similar to that of the valve element 42 is shown. The plug 154 has integral fins or radial flanges 158 which are inserted into a radial pocket 156 in the

5 flexible element 106. The coupling with the female Luer causes the contact surface of the female Luer to push the flexible element 106, its pocket 156 and the fins or flange 158 backwards as shown in 106 ', 156' and 158 'respectively, thus removing the head of the plug 160 or plug 154 to the position shown in 160 'thereby opening the end 120 for flow into the conduit 124.

10 FIGS. 24-27 show a flexible shaped element 106a having a groove 162 at its tip 116 ''. When it makes contact with the female Luer 128, the frictional engagement of the outer surface 152 of the flexible element 106a with the contact surface 126 of the female Luer causes the flexible element 106a to deform as shown in the Figures, thus opening the groove 162 as shown in 162 'to allow fluid flow into the conduit 124.

fifteen The various embodiments of the male Luer described above provide automatic sealing of the end opening in the male Luer when the male and female Luer are disconnected, reducing the risk of an operator coming into contact with the potentially dangerous fluids flowing through of the collector.

twenty Although some exemplary embodiments of the invention have been described above only by way of example, it will be understood by those skilled in the art that modifications can be made to the described embodiments without departing from the scope of the invention, which is defined by the appended claims.