US20060202146A1 - Valved male luer connector having sequential valve timing - Google Patents
Valved male luer connector having sequential valve timing Download PDFInfo
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- US20060202146A1 US20060202146A1 US11/435,334 US43533406A US2006202146A1 US 20060202146 A1 US20060202146 A1 US 20060202146A1 US 43533406 A US43533406 A US 43533406A US 2006202146 A1 US2006202146 A1 US 2006202146A1
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- Prior art keywords
- valve
- connector
- male
- female
- distal
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/04—Access sites having pierceable self-sealing members
- A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
- F16K15/00—Check valves
- F16K15/18—Check valves with actuating mechanism; Combined check valves and actuated valves
- F16K15/182—Check valves with actuating mechanism; Combined check valves and actuated valves with actuating mechanism
- F16K15/1825—Check valves with actuating mechanism; Combined check valves and actuated valves with actuating mechanism for check valves with flexible valve members
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
- F16L29/00—Joints with fluid cut-off means
- F16L29/04—Joints with fluid cut-off means with a cut-off device in each of the two pipe ends, the cut-off devices being automatically opened when the coupling is applied
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/261—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is increasing upon disconnection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/267—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector
- A61M2039/268—Valves closing automatically on disconnecting the line and opening on reconnection thereof having a sealing sleeve around a tubular or solid stem portion of the connector wherein the stem portion is moved for opening and closing the valve, e.g. by translation, rotation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
Definitions
- This invention relates to an improved male luer connector device that attaches to a female luer valve to open a flow channel through the male luer. Once the engagement of the luers has been established, these valves are used to make connections in hospitals for intravenous (IV) devices in order to be used in medical liquid flow applications.
- IV intravenous
- Luer devices are used in particular in a variety of medical applications where there is a desire to interconnect together male and female connector parts onto tubing material that is connected to an IV.
- the most common types of IV fluid exchanges use a syringe fitted with a nozzle that is designed to be received into a corresponding receiver attached to the IV device.
- the receiver often has a hollow tubular cannula or post that routes fluid into a line inserted into the IV extending into the patient's veins.
- Typical luer connections utilize a male luer connector that is inserted into a female luer connector.
- the male luer connector is threaded onto corresponding threads of the female luer connector to engage the two so that fluid may be passed between them without escaping or leaking from the connection.
- these connections are subject to coming loose or disengaging, there is always a possibility that fluid being passed within these tubes can escape.
- hazardous drugs such as those used for chemotherapy treatments, the possibility of escaping fluids can be a dangerous problem.
- the residual amount of fluid remaining on the tip of the connectors can still be harmful. While this amount may be less than an amount escaping from the connectors, it can still be significant enough to cause harm to any person exposed.
- a luer connection that securely contains the fluid materials included therein when luers are engaged to one another.
- a luer connection that seals off the male luer connector in a male-female connection so that users of the connector are protected from hazardous drugs that remain on the luer tip surface when disengaged.
- the invention is directed to a male valved connector that creates a partial vacuum upon disengagement from a female connector to draw fluid disposed at an interface between the male and female connectors away from the interface.
- a male Luer connector for connection with a female Luer connector for medical fluid flow, the female connector having a front contact surface and an internal valve, the male Luer connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface and vacuum means for creating a partial vacuum at the distal end of the tubular housing during disengagement of the male connector from the female connector during a time period when the female valve is closed, whereby the vacuum means draws fluid residing at the interface away from the interface during disengagement of the male and female connectors.
- the vacuum means is located within the tubular housing, and comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing.
- the vacuum means also comprises a second valve controlling the flow of fluid through the distal end of the tubular housing and the vacuum means is also for controlling the second valve to remain open while the vacuum means creates the partial vacuum.
- the vacuum means is also for controlling the first valve to close first, and controlling the second valve to remain open after the female connector valve closes during disengagement of the female connector from the male connector.
- the vacuum means comprises an actuator that controls the opening and closing of the first and second valves and further comprises an actuation surface disposed so as to be moveable by the front contact surface of the female connector to control the actuator to open and close the first and second valves.
- the first valve comprises a proximal valve disposed at the proximal end of the tubular housing
- the second valve comprises a distal valve disposed at the distal end of the tubular housing
- the actuator is disposed within the tubular housing to open and close both the proximal and distal valves.
- the vacuum means further comprises a resilient member disposed to bias the actuator to close both the proximal and distal valves.
- the resilient member has an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the male connector is disengaged from the female connector, the cavity having a second volume smaller than the first volume when the male connector is engaged with the female connector, whereby the resilient member creates a partial vacuum when moving from the second volume to the first volume during closure of the distal valve occurring when the female and male connectors are being disengaged.
- the cavity has the second volume when the male and female connectors are engaged and the cavity moves to the first volume thereby creating the partial vacuum when the male and female connectors are being disengaged.
- the resilient member forms a valve seat for the distal valve and a valve seat for the proximal valve and the actuator provides a distal valve member for the distal valve that fits into the distal valve seat to close the distal valve and provides a proximal valve member for the proximal valve that fits into the proximal valve seat to close the proximal valve.
- the resilient member provides the actuation surface, the actuator is disposed within the resilient member in contact with the resilient member, and movement of the resilient member due to engagement with the front contact surface of the female connector causes corresponding movement of the actuator to open and close the distal and proximal valves.
- a male connector for connection with a female connector to establish a path for medical fluid flow
- the female connector having a front contact surface and an internal valve
- the male connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface, a first valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing, an internal plug disposed within the tubular housing, the internal plug having a first valve member that engages the first valve seat to prevent the flow of fluid past the first valve seat, and a resilient member disposed within the tubular housing so as to bias the internal plug to engage the first valve seat, the resilient member having an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the first valve is closed, the cavity having a second volume smaller than the first volume when the first valve is open, wherein the resilient member is disposed so that engagement of the female connector with the male connector causes the resilient member cavity to move to the second volume and dis
- a method for disengaging a male connector from a female connector comprising closing a first valve in the male connector at the proximal end of the male connector to isolate an interface between the male connector and the female connector from fluid at the proximal end of the male connector, and creating a partial vacuum at the interface of the male connector and female connector to draw fluid at the interface away from the interface.
- the method further comprises the step of closing the internal valve of the female connector during the step of creating a partial vacuum.
- the method also further comprises the step of closing a valve at the distal end of the male connector after the step of creating a partial vacuum.
- the method wherein the step of creating a partial vacuum comprises creating a partial vacuum within the male connector and drawing fluid at the interface into the male connector.
- FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting
- FIG. 2 is an enlarged sectional view taken on line 2 - 2 of FIG. 1 ;
- FIG. 3 is a view similar to FIG. 2 , with the components partially engaged;
- FIG. 4 is a view similar to FIG. 3 , with the components fully engaged;
- FIG. 5 is a view similar to a portion of FIG. 2 , showing an alternative integrated spring member
- FIG. 6 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 opened
- 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 opened;
- FIG. 11 is a view similar to FIG. 9 , showing an alternative slide actuated valve
- 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 cannula or post;
- FIG. 13 is an illustration of a male luer valve that does not contain a housing element
- FIGS. 14 and 15 are views similar to FIG. 11 illustrating a male luer which does not contain a sleeve and showing the movement from a closed position ( FIG. 14 ) to an open position ( FIG. 15 ) for the male luer during contact with a female luer having no core rod or cannula;
- FIGS. 16 and 17 are views similar to FIGS. 14 and 15 illustrating a male luer having a central sealing member internally of the resilient member and showing the movement from a closed position ( FIG. 16 ) to an open position ( FIG. 17 ) for the male luer during contact with a female luer having no core rod or cannula;
- FIG. 18 is a view similar to FIG. 11 illustrating a male luer which has a peripheral flange incorporated into the resilient member which upon contact with the contract surface of a female luer (which has no core rod or cannula) is urged backwards causing the resilient member to retract and open;
- FIGS. 19, 20 and 21 illustrate appearance and operation of male luers which have resilient members with smooth outer contact surfaces which upon contact with the contract surface of a female luer (which has no core rod or cannula) provide a sufficiently frictional connection such that the resilient member is urged backwards causing it to retract and open;
- FIGS. 22 and 23 are views similar to FIGS. 16 and 17 illustrating a male luer having a central sealing member internally of the resilient member which has a radially extending portion which protrudes into the wall of the resilient member and extends it outward, allowing it to extend into or through a guide in the housing of the male luer, which guide is engaged by a contact surface of a female luer having no core rod or cannula, such engagement causing the resilient member to retract and open to permit fluid flow between and through the luers; and
- FIGS. 24, 25 , 26 and 27 are side elevation views ( FIGS. 24 and 26 ) and end elevation view ( FIGS. 25 and 27 ) of another embodiment of a resilient member of a male luer which has a slightly bulbous tip with a slit opening, which slit is compressed and opened during contact with the interior surface of a female luer with a generally conical contact recess;
- FIG. 28 is a cutaway perspective view of multi-valved male Luer connector in accordance with aspects of the invention for use in obtaining sequential valve timing and generating a partial vacuum at the male Luer connector end to remove excess fluid from the tip during separation from a female connector;
- FIG. 29 is a side, cross-sectional view of the male connector of FIG. 28 showing it aligned with a compatible female valved connector prior to engagement;
- FIG. 30 is a view similar to FIG. 29 except that the male and female connectors have become partially engaged to the point where a distal valve of the male connector has opened while the proximal valve of the male connector and the valve of the female connector remain closed;
- FIG. 31 is a view similar to FIG. 30 except that the male and female connectors have become further partially engaged to the point where the distal valve of the male connector has opened and the valve of the female connector has opened while the proximal valve of the male connector remains closed;
- FIG. 32 is a view similar to FIG. 31 except that the male and female connectors have become fully engaged and both distal and proximal valves of the male connector are open and the valve of the female connector is also open for complete fluid flow through both connectors.
- FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting.
- the fitting is comprised of a male luer 10 that is intended to engage with a female luer that has an existing flush top female luer valve.
- the female luer 24 is not limited to a particular type but an exemplar luer is illustrated here.
- the female luer illustrated here is one where the valve shuts off.
- This female luer 24 contains a housing element 28 with a cannula or post 26 . On the outer surface of the forward end of the housing 28 there are threads 30 that permit engagement of the female luer 24 with the male luer 10 .
- the male luer 10 is comprised of a housing element 12 .
- the inner wall of the housing 12 contains threads 32 that engage the complimentary threads 30 of the female luer connector.
- Housing 12 has an inner tubular portion 16 of reduced diameter that projects forwardly that has a first necked area 36 and a second necked area 38 (See FIG. 2 ).
- the inner tubular portion defines an internal chamber 13 with a forward opening 33 (See FIG. 2 ).
- a valve member 18 is biased into an extended position sealing opening 33 by resilient member or spring 14 .
- Spring 14 acts between distal end of chamber 13 and valve member 18 .
- distal is the rearward end of the male luer and “proximal” is the forward end, i.e., the left and right ends in the views as illustrated in FIGS. 1 and 2 ).
- Valve member 18 includes a resilient portion 20 and a forward tip member 22 .
- FIG. 1 illustrates the two luers 10 , 24 in the unengaged position.
- Other types of female luer valves that do not contain a cannula or post.
- U.S. Pat. No. 5,676,346 by Leinsing and U.S. Pat. No. 5,782,816 by Werschmidt illustrate these types of luer valves.
- FIGS. 2 to 5 illustrate the male luer 10 and the female luer 24 as they become engaged with one another.
- FIG. 2 illustrates the two luers 10 , 24 when they are completely unengaged.
- the cannula or post 26 may have an opening 40 for entrance and exit of fluid between the two luers. Other duct systems (not shown) are possible and may be used.
- the cannula or post 26 is mounted in a chamber within a sleeve 34 .
- This sleeve 34 can be made of rubber or any other suitable resilient material and serves as a valve member stopper.
- Sleeve 34 has a forward end opening 35 which is sealed shut in the unengaged position of FIG. 2 .
- the male luer has a forward end that has a first necked area 36 and a second necked area 38 spaced rearwardly from the first necked area 36 .
- FIG. 3 illustrates the male luer 10 beginning to be inserted into the female luer 24 .
- the forward end 33 of housing 12 pushes the sleeve 34 back until the opening 35 is forced to open over the end of the cannula 26 .
- the cannula or post 26 then comes into contact with the tip of valve member 18 and begins to push it rearwardly so that the cannula or post 26 displaces the valve element front section 22 . This movement begins to separate the seal surface of the first necked area 36 from its seat.
- the second resilient portion 20 is collapsed, compressing the valve element cavity 19 . This unseals the first necked area 36 and displaces the liquid contained within the cavity 19 . This displaced liquid flows temporarily into the female luer valve 24 . As this pressure is applied, the valve member is compressed and pushed further inwardly into chamber 13 .
- FIG. 4 illustrates the positioning of the luer members when the female 24 and male 10 luers have been even further engaged.
- the cannula or post 26 begins to push even more onto the tip member 22 and collapse the first resilient member 14 so that the second necked area 38 is unsealed. At this point, more liquid is displaced by the further insertion of the cannula or post into the vacuum section 21 of the male luer as indicated by the arrows in FIG. 4 .
- the opening 40 on the cannula or post 26 permits fluid to pass into and out of the female luer 24 . This displaced liquid creates the volume which will be refilled when the action is reversed.
- FIG. 5 illustrates the same type of dual stage valve as above only that it is formed with the spring 14 integrally connected to the valve member 42 .
- the housing 12 contains the inner sleeve 16 and positioned inside of the inner sleeve 16 is an inner chamber 13 .
- the function of this embodiment is the same as the previously described embodiments with the exception that the spring 14 can be comprised of elastomeric or other types of material that are integrally connected with the valve member 42 .
- FIGS. 6 and 7 illustrate a male luer according to another embodiment of the present invention.
- This apparatus is a single stage luer valve with an integral resilient member.
- the male luer has a housing 12 with threads 32 on the inner wall of the housing for engagement to the complimentary threads on the female luer 30 .
- the inner chamber 13 is sealed by a valve member 42 that is integrally formed with the resilient member and the tip.
- This new valve member 42 therefore functions as in the previous embodiment except that all members are formed in one piece, rather than including a separate resilient member.
- This embodiment demonstrates a single stage luer valve in that once the female luer engages with the valve member 42 , the member 42 moves as a single piece rather than as several different pieces as described above.
- FIG. 7 illustrates the luer of FIG. 6 engaged with a female luer 24 and permitting fluid flow.
- FIG. 8 illustrates another embodiment of the present invention.
- the housing 12 of the male luer is similar to the previous embodiments.
- a resilient member or spring 14 contained within the inner sleeve 16 .
- the valve contained on the end of the resilient member is shown as a ball 46 .
- This ball may be made of various types of materials as for example, elastomeric material.
- the forward end opening of chamber 13 is exemplified as a part-spherical seat 47 to accommodate for ball valve 46 .
- the valve contained on the end of the resilient member or spring 14 can be of a variety of shapes.
- 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 according to yet another embodiment of the present invention, in which a modified male luer is releaseably securable to the female luer 24 of the previous embodiments.
- the modified male luer comprises a housing with a cylindrical outer wall 52 and an inner tubular support 54 which projects into the cylindrical housing from rear end 53 and extends along part of the length of the housing.
- Outer wall 52 has internal threads 32 for engaging the female luer threads 30 and a larger diameter than the inner support 54 which extends from the rear end 53 of the housing and projects out of the forward end of the housing.
- a resilient sleeve or bladder member 56 is secured between the tubular member 55 and support 54 at its rear end, and projects forwardly within tubular member 55 to its forward end opening 57 .
- Bladder member 56 has a forward end opening 58 which is sealed shut by the inwardly tapered end portion of the tubular member 55 when in the extended, unconnected position of FIG. 9 .
- the forward end portion 58 of bladder member 56 acts as a valve to seal the end opening 57 of the male luer in the position illustrated in FIG. 9 .
- Tubular member 55 of the male luer is of smaller diameter than the inner cylindrical wall 52 of the housing, to leave an annular gap between the member 55 and inner wall 52 .
- a sliding sleeve 60 is slidably mounted over the tubular member 55 in this annular gap.
- Sleeve 60 has diametrically opposed openings 62
- the tubular member 55 has opposing elongate, axially extending slots 64 .
- Oppositely directed guided portions 65 (e.g., tabs, wings or fins) on the inner bladder or sleeve member 56 project radially outwardly through the slots 64 and into the openings 62 .
- the corrugated portion 66 of bladder member 56 acts as a spring to bias the forward end of the bladder member 56 and the sliding sleeve 60 into the extended position.
- FIG. 10 illustrates a female luer 24 connected to male luer 50 .
- the forward end of the female luer housing As the forward end of the female luer housing is threaded into the cylindrical wall of the male housing, it will engage the forward end 67 of the sliding sleeve 60 , urging the sleeve, and thus the bladder member 56 , rearwardly and moving the forward end portion of the bladder member out of sealing engagement with the forward end opening of tubular member 55 .
- the forward end of tubular member 55 will force the sleeve 34 in the female luer rearwardly so that it passes over the end of cannula 26 , which then extends into the open forward end of the tubular member.
- FIG. 11 is a view similar to FIG. 9 , showing an alternative slide actuated valve except that the resilient sleeve or bladder member 56 does not have a corrugated portion and instead has a separate spring member 68 .
- the spring member 68 can any type as for example, those made of metal or elastomeric material.
- the function of the male luer valve is the same; it is merely the spring member 68 that replaces the previous corrugated member.
- 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 cannula or post.
- the outer surface of the forward end of the housing 28 engages and compresses the forward end 67 of the sliding sleeve 60 of the male luer valve.
- the bladder member 56 continues to move rearwardly and moves the forward end portion of the bladder member out of sealing engagement with the forward end opening of the tubular member 55 .
- 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 instead can be self-sustained. However, the function of the male luer valve is the same as that explained for FIG. 2 only that the engagement with the female luer housing does not occur with the male luer housing.
- FIGS. 14 and 15 illustrate an embodiment of a male luer 100 which does not contain a sliding sleeve 60 .
- the luer housing 102 has a tubular projecting conduit 118 over which is positioned resilient sleeve or member 106 .
- the base 114 of resilient member 106 is butted against the interior end wall 112 of housing 102 and secured in place by the inner end of tubular projecting member 104 .
- the resilient member 106 has one or more laterally projecting fins 108 which are disposed respectively in slots 110 in the tubular portion of member 104 .
- peripheral projections 132 function as O-ring seals and when the luers are engaged the projecting front edge 130 of the resilient member 106 engages the inner sloped surface 134 of member 104 to provide a sealing or “stopper” effect and keep the O-ring seal area free of the fluid flow and dry.
- the female luer 128 is not itself shown and only the movement of elements of the male luer 100 is illustrated. It will be understood that such movement is the result of the male/female luer engagement in the manner illustrated in other Figures such as (but not limited to) FIGS. 2, 3 , 12 and 15 .
- threads or other securing devices to retain the male and female luers in their engaged positions during flow of fluid through them are also for simplicity not shown in all Figures, but it will understood that such are present as illustrated in (but not limited to) FIGS. 2, 3 , 4 , 10 and 12 .
- FIGS. 16 and 17 illustrate an embodiment similar to that of FIGS. 14 and 15 , but in which there is an internal plug 138 within the conduit 118 with channels 148 past the plug 138 .
- These channels can be formed in the wall of conduit 118 or can be formed by having plug 138 mounted on spaced apart supports (not shown) connected to conduit 118 , or in any other convenient manner.
- the peripheral surface 142 of plug 138 contacts radial land 144 on the inner surface of resilient member 106 as shown at 140 when the male luer is closed ( FIG. 16 ).
- the contact surface 126 contacts the fins 108 and pushes them backward as shown at 108 ′ in FIG.
- FIGS. 18-21 illustrate embodiments of a “soft” male luer 100 in which the engagement with the female luer 128 results in the contact area 126 of the female luer being the interior surface of the luer which is in contact directly with the exterior surface 152 of the resilient member 106 , as illustrated in FIG. 21 .
- shoulder 150 and projections 109 which can be fins such as 108 , a peripheral flange, protruding structure which can engage the contact surface of the female luer.
- the shoulder 150 can be a continuous radial shoulder within the portion 102 ′ of the housing 102 or it can consist of spaced-apart projections aligned radially within portion 102 ′.
- FIGS. 18 and 19 are shown in FIGS. 18 and 19 as a member separate but attached to the rest of housing 102 , but it can also be integral with the rest of housing 102 ).
- Shoulder 150 serves as a limiting device to engage contact surface 126 of the female luer 128 and stop the relative movement of the two luers, thus limiting the depth to which the male and female luers can be engaged.
- Projections 109 can assist the compressions of the resilient member 106 by sharing engagement with the contact surface 126 with the surface 152 of the member 106 .
- the tip area 116 of the member 106 can be thickened as shown in FIGS. 18 and 19 to provide some expansion into the engaging neck of the female luer and thus create an additional sealing effect.
- the soft male luer 100 is illustrated as having an optional extended housing 102 , such that engagement of the surface 152 of member 106 in contact with surface 126 provides the entire engagement of the male and female luers. That engagement and the compression of member 106 over the rigid conduit 118 allow opening of tip 116 and flow through end 120 .
- FIGS. 22-27 Additional embodiments are shown in FIGS. 22-27 .
- an internal plug 154 similar in function to that of valve member 42 is shown.
- the plug 154 has a integral fins or radial flange 158 which is inserted into a radial pocket 156 in resilient member 106 .
- Engagement with the female luer causes the female luer's contact surface to push the resilient member 106 , its pocket 156 and fins or flange 158 backward as shown as 106 ′, 156 ′ and 158 ′ respectively, thus withdrawing plug head 160 of plug 154 to the position shown at 160 ′ thus opening end 120 for flow into conduit 124 .
- FIGS. 24-27 show a shaped resilient member 106 a which has a slit 162 in its tip 116 ′′.
- frictional engagement of the outer surface 152 of the resilient member 106 a with the contact surface 126 of the female luer causes the resilient member 106 a to deform as shown in the Figures, thus opening slit 162 as shown at 162 ′ to allow fluid flow into conduit 124 .
- a male connector 200 in accordance with aspects of the invention and a female connector 202 are shown in various configurations of engagement to demonstrate the sequential valve timing in accordance with aspects of the invention.
- the male connector 200 is shown in a cutaway perspective form and includes a resilient member 210 having an internal cavity 212 .
- the resilient member is uncollapsed and the internal cavity has a first internal volume.
- the resilient member is mounted within a housing 214 and within a tubular projecting member 216 .
- the base 218 of the resilient member is butted against the interior wall 220 of the housing and secured in place by the proximal end 222 of the tubular projecting member.
- An internal plug 224 is mounted within the resilient member.
- the plug includes a distal valve member 226 that mates with a valve seat 228 provided by the distal end 230 of the resilient member.
- the internal plug includes a proximal valve member 232 that mates with a proximal valve seat 234 provided by the resilient member, which in this embodiment, results in a type of poppet valve 208 .
- the internal plug includes integral fins or radial flanges 236 that are inserted into radial pockets 238 formed in the resilient member.
- the resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown in FIG. 28 unless opposing forces in the proximal direction cause partial collapse or compression of the resilient member, as is discussed below.
- FIG. 29 depicts the two luer connectors 200 and 202 just separated. In this position, a valve 204 in the female luer connector 202 is closed, and a first distal valve 206 and a second proximal valve 208 in the male luer connector 200 are closed. Flow through either connector is prevented because the respective valves are closed.
- the connector includes a resilient member 210 having an internal cavity 212 .
- the resilient member is uncollapsed and the internal cavity has a first internal volume.
- the resilient member is mounted within a housing 214 and within a tubular projecting member 216 .
- the base 218 of the resilient member is butted against the interior wall 220 of the housing and secured in place by the proximal end 222 of the tubular projecting member.
- An internal plug 224 is mounted within the resilient member.
- the plug includes a distal valve member 226 that mates with a valve seat 228 provided by the distal end 230 of the resilient member.
- the internal plug includes a proximal valve member 232 that mates with a proximal valve seat 234 provided by the resilient member, which in this embodiment, results in a type of poppet valve 208 .
- the internal plug includes integral fins or radial flanges 236 that are inserted into radial pockets 238 formed in the resilient member.
- the resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown in FIG. 28 unless opposing forces in the proximal direction cause compression of the resilient member, as is discussed below.
- engagement of the male connector 200 with a female connector 202 causes the female connector's contact surface 240 to push the actuation surface 244 of the resilient member in the proximal direction, which causes the resilient member's contact surface 244 , pockets 238 , and the fins 236 and internal plug 224 to also move in the proximal direction.
- the plug Upon the occurrence of enough proximal direction movement, the plug will disengage from the distal valve seat 228 thus opening the distal valve 206 and will disengage from the proximal valve seat 234 thus opening the proximal valve 208 , as is described in more detail below.
- the tubular projecting member 216 includes slots 242 through which the actuation surface 244 of the resilient member projects so that it may contact the female connector contact surface 240 .
- the tubular projecting member 216 is formed in the shape of a standard Luer in this embodiment, although other shapes are possible.
- the housing 214 may include internal threads 246 with which to engage threads 248 of the female connector for more secure locking of the two together.
- the female connector 202 includes an internal piston 250 having an opening at its proximal end 252 that forms the female valve 204 . As the piston is moved into the housing 254 of the female connector by a certain distance, it will open to thereby open the female valve and permit the flow of fluid through the female connector.
- FIG. 30 there is depicted the male 200 and female 202 connectors partially joined together.
- the forward contact surface 240 of the female luer connector has driven the actuation surface 244 of the male luer connector in the proximal direction far enough to open the first distal valve 206 while the second proximal valve 208 in the male connector remains closed.
- the cavity 212 of the resilient member in this position is now slightly collapsed and has an internal volume that is less than the first volume of the cavity shown in FIG. 28 .
- the distal end 256 of the tubular projecting member or male luer portion 216 has driven the piston 250 of the female luer connector 202 a partial distance in the distal direction.
- the valve 204 of the female Luer connector is still closed, despite the displacement of the piston.
- the distal valve 206 of the male connector has first opened while the proximal valve 208 of the male connector and the female connector valve 204 remain closed. This is due to the relative distances of movement and sizes of the various parts.
- the proximal valve seat 234 in the male connector resilient member 210 is designed to be long enough such that its valve 208 does not open until after the plug 224 has moved by a distance longer than the distance required to open the distal valve 206 .
- the length of movement of the proximal valve required for opening is longer than the length of movement of the distal valve to achieve opening.
- the distance of movement of the plug to open the distal valve of the male connector is selected to be less than the distance of movement of the piston 250 of the female connector that is required to open the female connector valve.
- FIG. 31 depicts the male 200 and female 202 luer connectors further joined together than in FIG. 30 .
- the distal end 256 of the male luer connector has driven the piston 250 of the female connector farther in the distal direction, so much so that the female connector valve 204 has now opened and fluid flow through the female connector may now occur.
- the contact surface 240 of the female connector has further driven the actuation surface 244 of the resilient member 210 further in the proximal direction further opening the distal valve 206 ; however, the proximal valve 208 is still closed.
- two valves of the three valves between the male and female connectors are now open.
- the length of movement of the proximal valve required for opening is longer than the length of movement of the distal valve 206 of the male connector 200 , and the length of movement to the female connector's valve 204 to achieve opening.
- the distance of movement of the internal plug 224 to open the distal valve of the male connector is selected to be less than the distance of movement of the piston 250 of the female connector that is required to open the female connector valve 204 , yet more to open the proximal valve 208 than to open the female connector's valve.
- FIG. 32 depicts the complete operative engagement of the male 200 and female 202 Luer connectors such that all three depicted valves are open and fluid flow can occur between and through both connectors.
- the female connector contact surface 240 has driven the actuation surface 244 of the male connector far enough in the proximal direction to open the proximal valve 208 .
- the compressible collapsible cavity 212 of the resilient member 210 is fully collapsed having now an even smaller internal volume that that shown in the preceding FIGS. 28 through 31 .
- the first valve that opens is the distal male connector valve.
- the second valve to open is the female connector valve, and the last valve to open is the proximal male connector valve.
- Fluid can now flow from the upstream line 260 , through the male connector 200 , through the female connector 202 , and out through the downstream line 262 .
- both upstream and downstream lines are shown as medical tubing, although other devices may be used.
- the upstream connecting device 258 of the male connector 200 is shown as a Luer female connector but other types of coupling devices may be used.
- the downstream coupling device 264 of the female connector 202 is shown as a male Luer connector but other types of coupling devices may be used.
- Disengagement or disconnection of the male connector 200 and the female connector 202 from each other will result in a sequence of valve closure that is opposite the sequence of valve opening as discussed above.
- the connectors are shown fully operatively engaged together in FIG. 32 and fluid flow through both valves can occur.
- a first stage of valve closure upon disengagement is shown in FIG. 31 .
- movement of the contact surface 240 of the female luer connector in the distal direction permits the actuation surface 244 of the resilient member 210 of the male Luer connector to also move in the distal direction due to the biasing force provided by the resilient member.
- FIG. 31 As is shown in FIG.
- the proximal valve 208 of the male connector has closed although the distal valve 206 of the male connector and the female connector valve 204 remain open.
- the male connector is now closed to any fluid existing in an upstream line such as may be connected to the male connector's proximal female connector 258 .
- the upstream line 260 is shown in exaggerated form in FIG. 31 . In this configuration then, the internal components of the male connector, and consequently the female connector, are isolated from any upstream fluids.
- FIG. 30 depicts the second stage of valve closure upon disconnection of the male connector 200 and female connector 202 .
- the distal end of the male luer connector 256 has retreated moving in the proximal direction which has allowed the piston 250 of the female luer connector to resile also in the proximal direction thereby closing the female connector valve 204 .
- Fluid flow through the female connector is now prevented.
- both the male and female connectors are now isolated from any fluids in the upstream line 260 and in the downstream line 262 .
- a partial vacuum is created within the male connector. This is because the cavity 212 of the resilient member 210 is increasing in internal volume as the resilient member resiles to the configuration of FIG. 29 from the configuration of FIG. 30 . As soon as the internal volume of the resilient member begins increasing, a partial vacuum forms which may be used to draw fluid into the male connector. By proper sequencing of the valves of the connector in conjunction with each other and with the valve of the female connector, the force of this partial vacuum is directed to the interface between the male connector and the female connector 202 to thereby draw fluid residing on that interface into the male connector.
- both the upstream line 260 having the male connector 200 at its distal end
- the downstream line 262 having the female connector 202 at its proximal end
- the respective connectors each of which has at least one internal valve to isolate the line.
- the male connector 200 will seal the distal end of the line, and even withdraws excess fluid from the distal end of the connector upon disengagement or disconnection from the female connector 202 . This is an especially useful feature in the case where caustic fluids may have been conducted by the upstream line and some of that fluid may have reached surfaces at the interface between the female and male connectors.
- caustic fluid may be transferred to the clinician handling the connectors.
- Such fluids may cause injury to health care workers and patients if applied to skin surfaces thus their containment in the upstream line by means of this vacuum, draw-back feature is especially useful.
- tubing 260 and 262 at the ends of the connectors in FIGS. 28 through 32 , this is for example purposes only and is not meant to be restrictive.
- Various conductive, container, or other components may be used in place of the tubing shown.
- the male connector 200 may form the nozzle end of a syringe instead of being connected to tubing.
- the female connector 202 may form part of a vial adapter or vial access device so that liquid from the syringe connected to the male connector may be injected into a vial of medical substance, mixed and then withdrawn back into the syringe, as an example.
- Other applications are possible.
- the various embodiments of the male luer described above provide for automatic sealing of the end opening in the male luer as the male and female luers are disconnected, reducing the risk of an operator coming into contact with the potentially hazardous fluid flowing through the connector.
Abstract
A male Luer connector that attaches to a standard female Luer connector to open a medical fluid flow channel between the two connectors. The male connector has two internal valves and a vacuum-generating structure. The two valves and the vacuum-generating structure are configured to draw back into the male connector any fluid residing on the interface between the male and female connectors during their disengagement from one another and to then seal the distal tip of the male connector. One valve is located at the proximal end of the male connector while another is located at the distal, interface end of the male connector. Both valves are opened by an actuator plug that is moved to open and close the valves by contact with the front surface of the female connector. A resilient member biases the male valves to the closed position and includes a variable internal volume that creates the partial vacuum upon disengagement of the male and female connectors. The male valves are timed to a particular sequence with the closing of an internal female connector valve so that the partial vacuum generated by the male connector will have the most fluid drawback effect.
Description
- This application is a continuation-in-part of application Ser. No. 10/389,652 filed Mar. 13, 2003, having a publication no. of 2003/0136932 A1, which is a continuation-in-part of application Ser. No. 09/927,109, filed on Aug. 10, 2001, having a publication no. of 2003/0032940, now U.S. Pat. No. 6,745,998 A1.
- This invention relates to an improved male luer connector device that attaches to a female luer valve to open a flow channel through the male luer. Once the engagement of the luers has been established, these valves are used to make connections in hospitals for intravenous (IV) devices in order to be used in medical liquid flow applications.
- Luer devices are used in particular in a variety of medical applications where there is a desire to interconnect together male and female connector parts onto tubing material that is connected to an IV. The most common types of IV fluid exchanges use a syringe fitted with a nozzle that is designed to be received into a corresponding receiver attached to the IV device. The receiver often has a hollow tubular cannula or post that routes fluid into a line inserted into the IV extending into the patient's veins.
- Typical luer connections utilize a male luer connector that is inserted into a female luer connector. The male luer connector is threaded onto corresponding threads of the female luer connector to engage the two so that fluid may be passed between them without escaping or leaking from the connection. Because these connections are subject to coming loose or disengaging, there is always a possibility that fluid being passed within these tubes can escape. When using hazardous drugs, such as those used for chemotherapy treatments, the possibility of escaping fluids can be a dangerous problem. Additionally, even if the fluid does not leak when the connectors are engaged, once they are disengaged, the residual amount of fluid remaining on the tip of the connectors can still be harmful. While this amount may be less than an amount escaping from the connectors, it can still be significant enough to cause harm to any person exposed.
- Therefore, there is a need for a luer connection that securely contains the fluid materials included therein when luers are engaged to one another. There is also a need for a luer connection that seals off the male luer connector in a male-female connection so that users of the connector are protected from hazardous drugs that remain on the luer tip surface when disengaged.
- Briefly, and in general terms, the invention is directed to a male valved connector that creates a partial vacuum upon disengagement from a female connector to draw fluid disposed at an interface between the male and female connectors away from the interface.
- In accordance with aspects of the present invention, there is provided a male Luer connector for connection with a female Luer connector for medical fluid flow, the female connector having a front contact surface and an internal valve, the male Luer connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface and vacuum means for creating a partial vacuum at the distal end of the tubular housing during disengagement of the male connector from the female connector during a time period when the female valve is closed, whereby the vacuum means draws fluid residing at the interface away from the interface during disengagement of the male and female connectors. In more detailed aspects, the vacuum means is located within the tubular housing, and comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing. The vacuum means also comprises a second valve controlling the flow of fluid through the distal end of the tubular housing and the vacuum means is also for controlling the second valve to remain open while the vacuum means creates the partial vacuum.
- In further detailed aspects in accordance with the invention, the vacuum means is also for controlling the first valve to close first, and controlling the second valve to remain open after the female connector valve closes during disengagement of the female connector from the male connector. The vacuum means comprises an actuator that controls the opening and closing of the first and second valves and further comprises an actuation surface disposed so as to be moveable by the front contact surface of the female connector to control the actuator to open and close the first and second valves. The first valve comprises a proximal valve disposed at the proximal end of the tubular housing, the second valve comprises a distal valve disposed at the distal end of the tubular housing, and the actuator is disposed within the tubular housing to open and close both the proximal and distal valves.
- In yet further aspects, the vacuum means further comprises a resilient member disposed to bias the actuator to close both the proximal and distal valves. The resilient member has an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the male connector is disengaged from the female connector, the cavity having a second volume smaller than the first volume when the male connector is engaged with the female connector, whereby the resilient member creates a partial vacuum when moving from the second volume to the first volume during closure of the distal valve occurring when the female and male connectors are being disengaged. In more detail, the cavity has the second volume when the male and female connectors are engaged and the cavity moves to the first volume thereby creating the partial vacuum when the male and female connectors are being disengaged.
- In even further detailed aspects, the resilient member forms a valve seat for the distal valve and a valve seat for the proximal valve and the actuator provides a distal valve member for the distal valve that fits into the distal valve seat to close the distal valve and provides a proximal valve member for the proximal valve that fits into the proximal valve seat to close the proximal valve. The resilient member provides the actuation surface, the actuator is disposed within the resilient member in contact with the resilient member, and movement of the resilient member due to engagement with the front contact surface of the female connector causes corresponding movement of the actuator to open and close the distal and proximal valves.
- In other aspects, there is provided a male connector for connection with a female connector to establish a path for medical fluid flow, the female connector having a front contact surface and an internal valve, the male connector comprising a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface, a first valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing, an internal plug disposed within the tubular housing, the internal plug having a first valve member that engages the first valve seat to prevent the flow of fluid past the first valve seat, and a resilient member disposed within the tubular housing so as to bias the internal plug to engage the first valve seat, the resilient member having an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the first valve is closed, the cavity having a second volume smaller than the first volume when the first valve is open, wherein the resilient member is disposed so that engagement of the female connector with the male connector causes the resilient member cavity to move to the second volume and disengagement of the female connector from the male connector causes the cavity to move from the second volume to the first volume thereby creating a partial vacuum.
- In accordance with aspects of a method in accordance with the invention, there is provided a method for disengaging a male connector from a female connector, the male connector including a distal end engaged with the female connector, a proximal end, and an internal valve and the female connector including a proximal end engaged with the male connector, a distal end, and an internal valve, the method comprising closing a first valve in the male connector at the proximal end of the male connector to isolate an interface between the male connector and the female connector from fluid at the proximal end of the male connector, and creating a partial vacuum at the interface of the male connector and female connector to draw fluid at the interface away from the interface. In further more detailed aspects, the method further comprises the step of closing the internal valve of the female connector during the step of creating a partial vacuum. The method also further comprises the step of closing a valve at the distal end of the male connector after the step of creating a partial vacuum. The method wherein the step of creating a partial vacuum comprises creating a partial vacuum within the male connector and drawing fluid at the interface into the male connector.
- These and other features and advantages of the present invention will become apparent from the following detailed description of preferred embodiments which, taken in conjunction with the accompanying drawings, illustrate by way of example the principles of the invention.
- The present invention will be better understood from the following detailed description of an exemplary embodiment of the invention, taken in conjunction with the accompanying drawings in which like reference numerals refer to like parts and in which:
-
FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting; -
FIG. 2 is an enlarged sectional view taken on line 2-2 ofFIG. 1 ; -
FIG. 3 is a view similar toFIG. 2 , with the components partially engaged; -
FIG. 4 is a view similar toFIG. 3 , with the components fully engaged; -
FIG. 5 is a view similar to a portion ofFIG. 2 , showing an alternative integrated spring member; -
FIG. 6 is a view similar toFIG. 5 , showing an alternative single stage valve; -
FIG. 7 is a view similar toFIG. 6 , showing the valve opened; -
FIG. 8 is a view similar toFIG. 5 , showing a ball type valve; -
FIG. 9 is a sectional view showing an alternative slide actuated valve; -
FIG. 10 is a view similar toFIG. 9 , showing the valve opened; -
FIG. 11 is a view similar toFIG. 9 , showing an alternative slide actuated valve; -
FIG. 12 is a view similar toFIG. 10 , showing an alternative valve for use with a female luer valve that does not have a cannula or post; -
FIG. 13 is an illustration of a male luer valve that does not contain a housing element; -
FIGS. 14 and 15 are views similar toFIG. 11 illustrating a male luer which does not contain a sleeve and showing the movement from a closed position (FIG. 14 ) to an open position (FIG. 15 ) for the male luer during contact with a female luer having no core rod or cannula; -
FIGS. 16 and 17 are views similar toFIGS. 14 and 15 illustrating a male luer having a central sealing member internally of the resilient member and showing the movement from a closed position (FIG. 16 ) to an open position (FIG. 17 ) for the male luer during contact with a female luer having no core rod or cannula; -
FIG. 18 is a view similar toFIG. 11 illustrating a male luer which has a peripheral flange incorporated into the resilient member which upon contact with the contract surface of a female luer (which has no core rod or cannula) is urged backwards causing the resilient member to retract and open; -
FIGS. 19, 20 and 21 illustrate appearance and operation of male luers which have resilient members with smooth outer contact surfaces which upon contact with the contract surface of a female luer (which has no core rod or cannula) provide a sufficiently frictional connection such that the resilient member is urged backwards causing it to retract and open; -
FIGS. 22 and 23 are views similar toFIGS. 16 and 17 illustrating a male luer having a central sealing member internally of the resilient member which has a radially extending portion which protrudes into the wall of the resilient member and extends it outward, allowing it to extend into or through a guide in the housing of the male luer, which guide is engaged by a contact surface of a female luer having no core rod or cannula, such engagement causing the resilient member to retract and open to permit fluid flow between and through the luers; and -
FIGS. 24, 25 , 26 and 27 are side elevation views (FIGS. 24 and 26 ) and end elevation view (FIGS. 25 and 27 ) of another embodiment of a resilient member of a male luer which has a slightly bulbous tip with a slit opening, which slit is compressed and opened during contact with the interior surface of a female luer with a generally conical contact recess; -
FIG. 28 is a cutaway perspective view of multi-valved male Luer connector in accordance with aspects of the invention for use in obtaining sequential valve timing and generating a partial vacuum at the male Luer connector end to remove excess fluid from the tip during separation from a female connector; -
FIG. 29 is a side, cross-sectional view of the male connector ofFIG. 28 showing it aligned with a compatible female valved connector prior to engagement; -
FIG. 30 is a view similar toFIG. 29 except that the male and female connectors have become partially engaged to the point where a distal valve of the male connector has opened while the proximal valve of the male connector and the valve of the female connector remain closed; -
FIG. 31 is a view similar toFIG. 30 except that the male and female connectors have become further partially engaged to the point where the distal valve of the male connector has opened and the valve of the female connector has opened while the proximal valve of the male connector remains closed; and -
FIG. 32 is a view similar toFIG. 31 except that the male and female connectors have become fully engaged and both distal and proximal valves of the male connector are open and the valve of the female connector is also open for complete fluid flow through both connectors. -
FIG. 1 is a side view of the two components of the male to female luer connection of the luer fitting. The fitting is comprised of amale luer 10 that is intended to engage with a female luer that has an existing flush top female luer valve. Thefemale luer 24 is not limited to a particular type but an exemplar luer is illustrated here. The female luer illustrated here is one where the valve shuts off. Thisfemale luer 24 contains ahousing element 28 with a cannula orpost 26. On the outer surface of the forward end of thehousing 28 there arethreads 30 that permit engagement of thefemale luer 24 with themale luer 10. In this embodiment themale luer 10 is comprised of ahousing element 12. The inner wall of thehousing 12 containsthreads 32 that engage thecomplimentary threads 30 of the female luer connector.Housing 12 has an innertubular portion 16 of reduced diameter that projects forwardly that has a firstnecked area 36 and a second necked area 38 (SeeFIG. 2 ). The inner tubular portion defines aninternal chamber 13 with a forward opening 33 (SeeFIG. 2 ). Avalve member 18 is biased into an extendedposition sealing opening 33 by resilient member orspring 14.Spring 14 acts between distal end ofchamber 13 andvalve member 18. (As used herein, “distal” is the rearward end of the male luer and “proximal” is the forward end, i.e., the left and right ends in the views as illustrated inFIGS. 1 and 2 ).Valve member 18 includes aresilient portion 20 and aforward tip member 22.FIG. 1 illustrates the twoluers - FIGS. 2 to 5 illustrate the
male luer 10 and thefemale luer 24 as they become engaged with one another.FIG. 2 illustrates the twoluers opening 40 for entrance and exit of fluid between the two luers. Other duct systems (not shown) are possible and may be used. The cannula or post 26 is mounted in a chamber within asleeve 34. Thissleeve 34 can be made of rubber or any other suitable resilient material and serves as a valve member stopper.Sleeve 34 has a forward end opening 35 which is sealed shut in the unengaged position ofFIG. 2 . The male luer has a forward end that has a firstnecked area 36 and a secondnecked area 38 spaced rearwardly from the firstnecked area 36.FIG. 3 illustrates themale luer 10 beginning to be inserted into thefemale luer 24. Once thethreads forward end 33 ofhousing 12 pushes thesleeve 34 back until theopening 35 is forced to open over the end of thecannula 26. The cannula or post 26 then comes into contact with the tip ofvalve member 18 and begins to push it rearwardly so that the cannula or post 26 displaces the valveelement front section 22. This movement begins to separate the seal surface of the firstnecked area 36 from its seat. As thetip member 22 begins to be pushed back, the secondresilient portion 20 is collapsed, compressing thevalve element cavity 19. This unseals the firstnecked area 36 and displaces the liquid contained within thecavity 19. This displaced liquid flows temporarily into thefemale luer valve 24. As this pressure is applied, the valve member is compressed and pushed further inwardly intochamber 13. -
FIG. 4 illustrates the positioning of the luer members when the female 24 and male 10 luers have been even further engaged. The cannula or post 26 begins to push even more onto thetip member 22 and collapse the firstresilient member 14 so that the secondnecked area 38 is unsealed. At this point, more liquid is displaced by the further insertion of the cannula or post into thevacuum section 21 of the male luer as indicated by the arrows inFIG. 4 . Theopening 40 on the cannula or post 26 permits fluid to pass into and out of thefemale luer 24. This displaced liquid creates the volume which will be refilled when the action is reversed. - Upon disconnection of the
male luer 10 valve from thefemale luer valve 24, the volume of liquid that was displaced during the connection of the two valves is restored to the original positions, thus creating a relative vacuum. When thefemale luer 24 is removed from themale luer 10, the main seal created by the secondnecked area 38 makes contact with its seat. This isolates thevacuum section 21 from the upstream liquid. As the cannula or post 26 is withdrawn,cavity 19 is restored asresilient portion 20 resiles to its uncollapsed natural shape. As this restoration occurs, liquid is drawn intocavity 19. Because the secondnecked area 38 is closed, this liquid will be drawn from the interface between themale luer 10 and thefemale luer 24. This effect is enhanced by the volume represented by the cannula or post 26, which must be replaced as the cannula or post 26 is withdrawn. The relative vacuum created will attempt to draw liquid into the vacuum section until the seal surface of the firstnecked area 36 again contacts its seat. -
FIG. 5 illustrates the same type of dual stage valve as above only that it is formed with thespring 14 integrally connected to thevalve member 42. Thehousing 12 contains theinner sleeve 16 and positioned inside of theinner sleeve 16 is aninner chamber 13. The function of this embodiment is the same as the previously described embodiments with the exception that thespring 14 can be comprised of elastomeric or other types of material that are integrally connected with thevalve member 42. -
FIGS. 6 and 7 illustrate a male luer according to another embodiment of the present invention. This apparatus is a single stage luer valve with an integral resilient member. In this embodiment, the male luer has ahousing 12 withthreads 32 on the inner wall of the housing for engagement to the complimentary threads on thefemale luer 30. Theinner chamber 13 is sealed by avalve member 42 that is integrally formed with the resilient member and the tip. Thisnew valve member 42 therefore functions as in the previous embodiment except that all members are formed in one piece, rather than including a separate resilient member. This embodiment demonstrates a single stage luer valve in that once the female luer engages with thevalve member 42, themember 42 moves as a single piece rather than as several different pieces as described above.FIG. 7 illustrates the luer ofFIG. 6 engaged with afemale luer 24 and permitting fluid flow. Once the twoluers female luer 24 collapses thevalve member 42 and permits fluid flow via theopening 40 in the cannula or post 26 and also via anopening 44 in the rear end of thevalve member 42. -
FIG. 8 illustrates another embodiment of the present invention. In this embodiment, thehousing 12 of the male luer is similar to the previous embodiments. Additionally, contained within theinner sleeve 16 is a resilient member orspring 14. However, in this embodiment, the valve contained on the end of the resilient member is shown as aball 46. This ball may be made of various types of materials as for example, elastomeric material. Additionally, the forward end opening ofchamber 13 is exemplified as a part-spherical seat 47 to accommodate forball valve 46. Those skilled in the art will recognize that the valve contained on the end of the resilient member orspring 14 can be of a variety of shapes. However, the shape of the tip of themale luer 10 needs to be one that corresponds to the shape of the tip of thefemale luer 24. -
FIGS. 9 and 10 illustrate a modified connector according to yet another embodiment of the present invention, in which a modified male luer is releaseably securable to thefemale luer 24 of the previous embodiments. The modified male luer comprises a housing with a cylindricalouter wall 52 and an innertubular support 54 which projects into the cylindrical housing fromrear end 53 and extends along part of the length of the housing.Outer wall 52 hasinternal threads 32 for engaging thefemale luer threads 30 and a larger diameter than theinner support 54 which extends from therear end 53 of the housing and projects out of the forward end of the housing. A resilient sleeve orbladder member 56 is secured between thetubular member 55 andsupport 54 at its rear end, and projects forwardly withintubular member 55 to its forward end opening 57.Bladder member 56 has a forward end opening 58 which is sealed shut by the inwardly tapered end portion of thetubular member 55 when in the extended, unconnected position ofFIG. 9 . Theforward end portion 58 ofbladder member 56 acts as a valve to seal the end opening 57 of the male luer in the position illustrated inFIG. 9 . -
Tubular member 55 of the male luer is of smaller diameter than the innercylindrical wall 52 of the housing, to leave an annular gap between themember 55 andinner wall 52. A slidingsleeve 60 is slidably mounted over thetubular member 55 in this annular gap.Sleeve 60 has diametrically opposedopenings 62, and thetubular member 55 has opposing elongate, axially extendingslots 64. Oppositely directed guided portions 65 (e.g., tabs, wings or fins) on the inner bladder orsleeve member 56 project radially outwardly through theslots 64 and into theopenings 62. Thus, when the sleeve is in the fully extended position ofFIG. 9 , it will pull the sliding sleeve forwardly into the illustrated position. Thecorrugated portion 66 ofbladder member 56 acts as a spring to bias the forward end of thebladder member 56 and the slidingsleeve 60 into the extended position. -
FIG. 10 illustrates afemale luer 24 connected to male luer 50. As the forward end of the female luer housing is threaded into the cylindrical wall of the male housing, it will engage theforward end 67 of the slidingsleeve 60, urging the sleeve, and thus thebladder member 56, rearwardly and moving the forward end portion of the bladder member out of sealing engagement with the forward end opening oftubular member 55. This permits the forward end opening 58 to spring open, as indicated. At the same time, the forward end oftubular member 55 will force thesleeve 34 in the female luer rearwardly so that it passes over the end ofcannula 26, which then extends into the open forward end of the tubular member. This allows fluid flow through the two luers, via the inner tubular support,open end 58 of thebladder member 56, and theopenings 40 in thecannula 26. When the luers are disconnected, the compressedcorrugated portion 66 of thebladder member 56 urges the forward end portion to move back into sealing engagement with the forward end of thetubular member 55, preventing any fluid leakage. -
FIG. 11 is a view similar toFIG. 9 , showing an alternative slide actuated valve except that the resilient sleeve orbladder member 56 does not have a corrugated portion and instead has aseparate spring member 68. Thespring member 68 can any type as for example, those made of metal or elastomeric material. The function of the male luer valve is the same; it is merely thespring member 68 that replaces the previous corrugated member. -
FIG. 12 is a view similar toFIG. 10 , showing an alternative valve for use with a female luer valve that does not have a cannula or post. The outer surface of the forward end of thehousing 28 engages and compresses theforward end 67 of the slidingsleeve 60 of the male luer valve. As the forward end of the femaleluer valve housing 28 continues to further displace the slidingsleeve 60, thebladder member 56, continues to move rearwardly and moves the forward end portion of the bladder member out of sealing engagement with the forward end opening of thetubular member 55. This permits the forward end opening 58 to spring open. This allows fluid flow through the two luers, via the inner tubular support,open end 58 of thebladder member 56. Once the luers are disconnected, the sealing engagement as previously described once again occurs. -
FIG. 13 is an illustration of a male luer valve that does not contain a housing element. This view is similar toFIG. 2 except that the male luer valve is not contained within a housing element and instead can be self-sustained. However, the function of the male luer valve is the same as that explained forFIG. 2 only that the engagement with the female luer housing does not occur with the male luer housing. -
FIGS. 14 and 15 illustrate an embodiment of amale luer 100 which does not contain a slidingsleeve 60. Theluer housing 102 has a tubular projectingconduit 118 over which is positioned resilient sleeve ormember 106. Thebase 114 ofresilient member 106 is butted against theinterior end wall 112 ofhousing 102 and secured in place by the inner end of tubular projectingmember 104. Theresilient member 106 has one or more laterally projectingfins 108 which are disposed respectively inslots 110 in the tubular portion ofmember 104. When the male luer is closed (FIG. 14 ) the opening at thetip 116 ofresilient member 106 is closed, sealing off theopen end 120 of themale luer 100. When the male luer is engaged by afemale luer 128 which has acontact surface 126 but no central core rod or cannula (FIG. 15 ) thesurface 126 engages thefins 128 and movement of the male luer into the female luer causes the fins to move backward intohousing 102 as indicated byarrow 107 with thefins 108 guided within theslots 110 as shown at 108′ to compress the bellows portion of the resilient member as shown at 106′. This opens the tip as shown at 116′ to allow fluid flow throughopening 120 into theflow channels conduit 118 andhousing 102 respectively. Theperipheral projections 132 function as O-ring seals and when the luers are engaged the projectingfront edge 130 of theresilient member 106 engages the inner slopedsurface 134 ofmember 104 to provide a sealing or “stopper” effect and keep the O-ring seal area free of the fluid flow and dry. - For simplicity in a number of the Figures the
female luer 128 is not itself shown and only the movement of elements of themale luer 100 is illustrated. It will be understood that such movement is the result of the male/female luer engagement in the manner illustrated in other Figures such as (but not limited to)FIGS. 2, 3 , 12 and 15. Similarly, threads or other securing devices to retain the male and female luers in their engaged positions during flow of fluid through them are also for simplicity not shown in all Figures, but it will understood that such are present as illustrated in (but not limited to)FIGS. 2, 3 , 4, 10 and 12. -
FIGS. 16 and 17 illustrate an embodiment similar to that ofFIGS. 14 and 15 , but in which there is aninternal plug 138 within theconduit 118 withchannels 148 past theplug 138. These channels can be formed in the wall ofconduit 118 or can be formed by havingplug 138 mounted on spaced apart supports (not shown) connected toconduit 118, or in any other convenient manner. Theperipheral surface 142 ofplug 138 contactsradial land 144 on the inner surface ofresilient member 106 as shown at 140 when the male luer is closed (FIG. 16 ). When the male luer enters the female luer thecontact surface 126 contacts thefins 108 and pushes them backward as shown at 108′ inFIG. 17 , thus compressing the resilient member as shown at 106′ and displacing theland 144 from contact with thesurface 142 of the fixedplug 138. Compression of the resilient member also openstip 116 of the resilient member as shown at 116′. Fluid flow throughopening 120 intoconduit 124 and aroundplug 138 throughchannels 148 as shown byarrows 146 is also permitted. The axial position and width ofland 114 can be varied to determine when contact with theplug edge 142 is made or lost, thus determining when the luer opens or closes, and also to provide a vacuum effect to prevent or minimize backflow of fluid. -
FIGS. 18-21 illustrate embodiments of a “soft”male luer 100 in which the engagement with thefemale luer 128 results in thecontact area 126 of the female luer being the interior surface of the luer which is in contact directly with theexterior surface 152 of theresilient member 106, as illustrated inFIG. 21 . InFIG. 18 two optional elements are shown:shoulder 150 andprojections 109 which can be fins such as 108, a peripheral flange, protruding structure which can engage the contact surface of the female luer. Theshoulder 150 can be a continuous radial shoulder within theportion 102′ of thehousing 102 or it can consist of spaced-apart projections aligned radially withinportion 102′. (Portion 102′ is shown inFIGS. 18 and 19 as a member separate but attached to the rest ofhousing 102, but it can also be integral with the rest of housing 102).Shoulder 150 serves as a limiting device to engagecontact surface 126 of thefemale luer 128 and stop the relative movement of the two luers, thus limiting the depth to which the male and female luers can be engaged.Projections 109 can assist the compressions of theresilient member 106 by sharing engagement with thecontact surface 126 with thesurface 152 of themember 106. Thetip area 116 of themember 106 can be thickened as shown inFIGS. 18 and 19 to provide some expansion into the engaging neck of the female luer and thus create an additional sealing effect. - In
FIGS. 20 and 21 the softmale luer 100 is illustrated as having an optionalextended housing 102, such that engagement of thesurface 152 ofmember 106 in contact withsurface 126 provides the entire engagement of the male and female luers. That engagement and the compression ofmember 106 over therigid conduit 118 allow opening oftip 116 and flow throughend 120. - Additional embodiments are shown in
FIGS. 22-27 . In the embodiment ofFIGS. 22 and 23 , aninternal plug 154 similar in function to that ofvalve member 42 is shown. Theplug 154 has a integral fins orradial flange 158 which is inserted into aradial pocket 156 inresilient member 106. Engagement with the female luer causes the female luer's contact surface to push theresilient member 106, itspocket 156 and fins orflange 158 backward as shown as 106′, 156′ and 158′ respectively, thus withdrawingplug head 160 ofplug 154 to the position shown at 160′ thus openingend 120 for flow intoconduit 124. -
FIGS. 24-27 show a shaped resilient member 106 a which has aslit 162 in itstip 116″. When contacted by thefemale luer 128, frictional engagement of theouter surface 152 of the resilient member 106 a with thecontact surface 126 of the female luer causes the resilient member 106 a to deform as shown in the Figures, thus openingslit 162 as shown at 162′ to allow fluid flow intoconduit 124. - Referring now to
FIGS. 28 through 32 , amale connector 200 in accordance with aspects of the invention and afemale connector 202 are shown in various configurations of engagement to demonstrate the sequential valve timing in accordance with aspects of the invention. - Referring now to
FIG. 28 , themale connector 200 is shown in a cutaway perspective form and includes aresilient member 210 having aninternal cavity 212. The resilient member is uncollapsed and the internal cavity has a first internal volume. The resilient member is mounted within ahousing 214 and within atubular projecting member 216. Thebase 218 of the resilient member is butted against theinterior wall 220 of the housing and secured in place by theproximal end 222 of the tubular projecting member. Aninternal plug 224 is mounted within the resilient member. The plug includes adistal valve member 226 that mates with avalve seat 228 provided by thedistal end 230 of the resilient member. The internal plug includes aproximal valve member 232 that mates with aproximal valve seat 234 provided by the resilient member, which in this embodiment, results in a type ofpoppet valve 208. The internal plug includes integral fins orradial flanges 236 that are inserted intoradial pockets 238 formed in the resilient member. The resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown inFIG. 28 unless opposing forces in the proximal direction cause partial collapse or compression of the resilient member, as is discussed below. -
FIG. 29 depicts the twoluer connectors valve 204 in thefemale luer connector 202 is closed, and a firstdistal valve 206 and a secondproximal valve 208 in themale luer connector 200 are closed. Flow through either connector is prevented because the respective valves are closed. - Reviewing the
male connector 200 in more detail, the connector includes aresilient member 210 having aninternal cavity 212. InFIG. 28 , the resilient member is uncollapsed and the internal cavity has a first internal volume. The resilient member is mounted within ahousing 214 and within atubular projecting member 216. Thebase 218 of the resilient member is butted against theinterior wall 220 of the housing and secured in place by theproximal end 222 of the tubular projecting member. Aninternal plug 224 is mounted within the resilient member. The plug includes adistal valve member 226 that mates with avalve seat 228 provided by thedistal end 230 of the resilient member. The internal plug includes aproximal valve member 232 that mates with aproximal valve seat 234 provided by the resilient member, which in this embodiment, results in a type ofpoppet valve 208. The internal plug includes integral fins orradial flanges 236 that are inserted intoradial pockets 238 formed in the resilient member. The resilient member provides a biasing force in the distal direction and tends to return itself and the internal plug to the configuration shown inFIG. 28 unless opposing forces in the proximal direction cause compression of the resilient member, as is discussed below. - Referring to both
FIGS. 28 and 29 , engagement of themale connector 200 with afemale connector 202 causes the female connector'scontact surface 240 to push theactuation surface 244 of the resilient member in the proximal direction, which causes the resilient member'scontact surface 244, pockets 238, and thefins 236 andinternal plug 224 to also move in the proximal direction. Upon the occurrence of enough proximal direction movement, the plug will disengage from thedistal valve seat 228 thus opening thedistal valve 206 and will disengage from theproximal valve seat 234 thus opening theproximal valve 208, as is described in more detail below. Thetubular projecting member 216 includesslots 242 through which theactuation surface 244 of the resilient member projects so that it may contact the femaleconnector contact surface 240. Thetubular projecting member 216 is formed in the shape of a standard Luer in this embodiment, although other shapes are possible. Thehousing 214 may includeinternal threads 246 with which to engagethreads 248 of the female connector for more secure locking of the two together. - The
female connector 202 includes aninternal piston 250 having an opening at itsproximal end 252 that forms thefemale valve 204. As the piston is moved into thehousing 254 of the female connector by a certain distance, it will open to thereby open the female valve and permit the flow of fluid through the female connector. - Turning now to
FIG. 30 , there is depicted the male 200 and female 202 connectors partially joined together. In this position, theforward contact surface 240 of the female luer connector has driven theactuation surface 244 of the male luer connector in the proximal direction far enough to open the firstdistal valve 206 while the secondproximal valve 208 in the male connector remains closed. Thecavity 212 of the resilient member in this position is now slightly collapsed and has an internal volume that is less than the first volume of the cavity shown inFIG. 28 . Thedistal end 256 of the tubular projecting member ormale luer portion 216 has driven thepiston 250 of the female luer connector 202 a partial distance in the distal direction. Thevalve 204 of the female Luer connector is still closed, despite the displacement of the piston. - Thus in this
FIG. 30 , as the twoconnectors distal valve 206 of the male connector has first opened while theproximal valve 208 of the male connector and thefemale connector valve 204 remain closed. This is due to the relative distances of movement and sizes of the various parts. Theproximal valve seat 234 in the male connectorresilient member 210 is designed to be long enough such that itsvalve 208 does not open until after theplug 224 has moved by a distance longer than the distance required to open thedistal valve 206. The length of movement of the proximal valve required for opening is longer than the length of movement of the distal valve to achieve opening. Similarly, the distance of movement of the plug to open the distal valve of the male connector is selected to be less than the distance of movement of thepiston 250 of the female connector that is required to open the female connector valve. -
FIG. 31 depicts the male 200 and female 202 luer connectors further joined together than inFIG. 30 . In this configuration, thedistal end 256 of the male luer connector has driven thepiston 250 of the female connector farther in the distal direction, so much so that thefemale connector valve 204 has now opened and fluid flow through the female connector may now occur. Thecontact surface 240 of the female connector has further driven theactuation surface 244 of theresilient member 210 further in the proximal direction further opening thedistal valve 206; however, theproximal valve 208 is still closed. Thus, two valves of the three valves between the male and female connectors are now open. Fluid flow through the female connector can now occur but fluid flow through the male connector remains prevented due to the continuing closure of the proximal, or upstream,valve 208. As is apparent, the length of movement of the proximal valve required for opening is longer than the length of movement of thedistal valve 206 of themale connector 200, and the length of movement to the female connector'svalve 204 to achieve opening. Thus in this embodiment, the distance of movement of theinternal plug 224 to open the distal valve of the male connector is selected to be less than the distance of movement of thepiston 250 of the female connector that is required to open thefemale connector valve 204, yet more to open theproximal valve 208 than to open the female connector's valve. -
FIG. 32 depicts the complete operative engagement of the male 200 and female 202 Luer connectors such that all three depicted valves are open and fluid flow can occur between and through both connectors. In this configuration, the femaleconnector contact surface 240 has driven theactuation surface 244 of the male connector far enough in the proximal direction to open theproximal valve 208. The compressiblecollapsible cavity 212 of theresilient member 210 is fully collapsed having now an even smaller internal volume that that shown in the precedingFIGS. 28 through 31 . Thus on engagement of the male connector having two valves, a distal or downstream valve and a proximal or upstream valve in accordance with aspects of the invention, with a female connector having an internal valve, the first valve that opens is the distal male connector valve. The second valve to open is the female connector valve, and the last valve to open is the proximal male connector valve. Fluid can now flow from theupstream line 260, through themale connector 200, through thefemale connector 202, and out through thedownstream line 262. In this case, both upstream and downstream lines are shown as medical tubing, although other devices may be used. Additionally, the upstream connectingdevice 258 of themale connector 200 is shown as a Luer female connector but other types of coupling devices may be used. Similarly, thedownstream coupling device 264 of thefemale connector 202 is shown as a male Luer connector but other types of coupling devices may be used. - Disengagement or disconnection of the
male connector 200 and thefemale connector 202 from each other will result in a sequence of valve closure that is opposite the sequence of valve opening as discussed above. As just discussed in detail, the connectors are shown fully operatively engaged together inFIG. 32 and fluid flow through both valves can occur. A first stage of valve closure upon disengagement is shown inFIG. 31 . As the separation of the male and female luer connectors begins, movement of thecontact surface 240 of the female luer connector in the distal direction permits theactuation surface 244 of theresilient member 210 of the male Luer connector to also move in the distal direction due to the biasing force provided by the resilient member. As is shown inFIG. 31 , theproximal valve 208 of the male connector has closed although thedistal valve 206 of the male connector and thefemale connector valve 204 remain open. Thus, in the configuration ofFIG. 31 , the male connector is now closed to any fluid existing in an upstream line such as may be connected to the male connector's proximalfemale connector 258. Theupstream line 260 is shown in exaggerated form inFIG. 31 . In this configuration then, the internal components of the male connector, and consequently the female connector, are isolated from any upstream fluids. -
FIG. 30 depicts the second stage of valve closure upon disconnection of themale connector 200 andfemale connector 202. As the separation of the male and female luer connectors further continues, the distal end of themale luer connector 256 has retreated moving in the proximal direction which has allowed thepiston 250 of the female luer connector to resile also in the proximal direction thereby closing thefemale connector valve 204. Fluid flow through the female connector is now prevented. Thus both the male and female connectors are now isolated from any fluids in theupstream line 260 and in thedownstream line 262. - As the
male connector 200 moves from the configuration ofFIG. 30 to the configuration ofFIG. 29 during which theresilient member 210 moves in the distal direction to close thedistal valve 206, a partial vacuum is created within the male connector. This is because thecavity 212 of theresilient member 210 is increasing in internal volume as the resilient member resiles to the configuration ofFIG. 29 from the configuration ofFIG. 30 . As soon as the internal volume of the resilient member begins increasing, a partial vacuum forms which may be used to draw fluid into the male connector. By proper sequencing of the valves of the connector in conjunction with each other and with the valve of the female connector, the force of this partial vacuum is directed to the interface between the male connector and thefemale connector 202 to thereby draw fluid residing on that interface into the male connector. - Because the valves have been sequenced so that the only valve remaining open at this time is the
distal valve 206 of the male connector, the existence of this partial vacuum will draw any fluid remaining at the interface between the twoconnectors resilient member 210 into the male connector before thedistal valve 206 closes. As the connectors are further separated, thecavity 212 of the resilient member further expands, drawing more fluid from the interface of the two connectors, until thedistal valve 206 eventually closes as is shown in the configuration ofFIG. 29 . Thus in the configuration ofFIG. 29 , both theupstream line 260, having themale connector 200 at its distal end, and thedownstream line 262, having thefemale connector 202 at its proximal end, are sealed by the respective connectors, each of which has at least one internal valve to isolate the line. In the case of isolation of theupstream line 260, themale connector 200 will seal the distal end of the line, and even withdraws excess fluid from the distal end of the connector upon disengagement or disconnection from thefemale connector 202. This is an especially useful feature in the case where caustic fluids may have been conducted by the upstream line and some of that fluid may have reached surfaces at the interface between the female and male connectors. If these connectors were fully separated and such caustic fluid remained on their surfaces, that caustic fluid may be transferred to the clinician handling the connectors. Such fluids may cause injury to health care workers and patients if applied to skin surfaces thus their containment in the upstream line by means of this vacuum, draw-back feature is especially useful. - Although shown with
tubing FIGS. 28 through 32 , this is for example purposes only and is not meant to be restrictive. Various conductive, container, or other components may be used in place of the tubing shown. For example, themale connector 200 may form the nozzle end of a syringe instead of being connected to tubing. Thefemale connector 202 may form part of a vial adapter or vial access device so that liquid from the syringe connected to the male connector may be injected into a vial of medical substance, mixed and then withdrawn back into the syringe, as an example. Other applications are possible. - The various embodiments of the male luer described above provide for automatic sealing of the end opening in the male luer as the male and female luers are disconnected, reducing the risk of an operator coming into contact with the potentially hazardous fluid flowing through the connector.
- Although some exemplary embodiments of the invention have been described above by way of example only, it will be understood by those skilled in the field that modifications may be made to the disclosed embodiments without departing from the scope of the invention, which is defined by the appended claims.
Claims (21)
1. A male Luer connector for connection with a female Luer connector for medical fluid flow, the female connector having a front contact surface and an internal valve, the male Luer connector comprising:
a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface; and
vacuum means for creating a partial vacuum at the distal end of the tubular housing during disengagement of the male connector from the female connector during a time period when the female valve is closed;
whereby the vacuum means draws fluid residing at the interface away from the interface during disengagement of the male and female connectors.
2. The male Luer connector of claim 1 wherein the vacuum means is located within the tubular housing.
3. The male Luer connector of claim 1 wherein the vacuum means comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing.
4. The male Luer connector of claim 1 wherein the vacuum means comprises a second valve controlling the flow of fluid through the distal end of the tubular housing.
5. The male Luer connector of claim 1 wherein:
the vacuum means comprises a first valve controlling the flow of fluid through the proximal end of the tubular housing;
the vacuum means comprises a second valve controlling the flow of fluid through the distal end of the tubular housing; and
the vacuum means is also for controlling the second valve to remain open while the vacuum means creates the partial vacuum.
6. The male Luer connector of claim 5 wherein the vacuum means is also for controlling the first valve to close first, and controlling the second valve to remain open after the female connector valve closes during disengagement of the female connector from the male connector.
7. The male Luer connector of claim 5 wherein:
the vacuum means comprises an actuator that controls the opening and closing of the first and second valves;
the vacuum means further comprises an actuation surface disposed so as to be moveable by the front contact surface of the female connector to control the actuator to open and close the first and second valves.
8. The male Luer connector of claim 7 wherein:
the first valve comprises a proximal valve disposed at the proximal end of the tubular housing;
the second valve comprises a distal valve disposed at the distal end of the tubular housing; and
the actuator is disposed within the tubular housing to open and close both the proximal and distal valves.
9. The male Luer connector of claim 8 wherein the vacuum means further comprises a resilient member disposed to bias the actuator to close both the proximal and distal valves.
10. The male Luer connector of claim 9 wherein the resilient member has an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the proximal and distal valves are closed, the cavity having a second volume smaller than the first volume when the distal valve is open;
whereby the resilient member creates a partial vacuum when moving from the second volume to the first volume during closure of the distal valve.
11. The male Luer connector of claim 10 wherein:
the cavity has the second volume when the male and female connectors are engaged; and
the cavity moves to the first volume thereby creating the partial vacuum when the male and female connectors are being disengaged.
12. The male Luer connector of claim 11 wherein:
the resilient member forms a valve seat for the distal valve and a valve seat for the proximal valve;
the actuator provides a distal valve member for the distal valve that fits into the distal valve seat to close the distal valve and provides a proximal valve member for the proximal valve that fits into the proximal valve seat to close the proximal valve.
13. The male Luer connector of claim 12 wherein:
the resilient member provides the actuation surface;
the actuator is disposed within the resilient member in contact with the resilient member;
movement of the resilient member due to engagement with the front contact surface of the female connector causes corresponding movement of the actuator to open and close the distal and proximal valves.
14. A male connector for connection with a female connector to establish a path for medical fluid flow, the female connector having a front contact surface and an internal valve, the male connector comprising:
a tubular housing having a distal end and a proximal end, the distal end configured to engage the female Luer connector and establish an interface;
a first valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing;
an internal plug disposed within the tubular housing, the internal plug having a first valve member that engages the first valve seat to prevent the flow of fluid past the first valve seat; and
a resilient member disposed within the tubular housing so as to bias the internal plug to engage the first valve seat, the resilient member having an inner variable-volume cavity through which fluid flows, the cavity having a first volume when the first valve is closed, the cavity having a second volume smaller than the first volume when the first valve is open;
wherein the resilient member is disposed so that engagement of the female connector with the male connector causes the resilient member cavity to move to the second volume and disengagement of the female connector from the male connector causes the cavity to move from the second volume to the first volume thereby creating a partial vacuum.
15. The male connector of claim 14 wherein the first valve seat is disposed at the proximal end of the housing;
whereby moving the resilient member cavity from the second volume to the first volume creates the partial vacuum at the distal end of the tubular housing to draw away medical fluid existing at an interface between the male and female connectors during disengagement.
16. The male connector of claim 15 wherein the resilient member is disposed so that the cavity moves to the first volume during a time period after the valve of the female connector has closed whereby the partial vacuum draws away medical fluid existing at an interface between the male and female connectors during disengagement.
17. The male connector of claim 16 wherein the first valve seat is a distal valve seat disposed for use in controlling the flow of fluid through the distal end of the tubular housing;
the male connector further comprising a proximal valve seat disposed for use in controlling the flow of fluid through the proximal end of the tubular housing;
wherein the first valve member is a distal valve member that engages the distal valve seat to prevent the flow of fluid past the distal valve seat, and further comprising a proximal valve member that engages the proximal valve seat to prevent the flow of fluid past the proximal valve seat; and
wherein the resilient member biases the internal plug to engage both the distal valve seat and the proximal valve seat, the first volume of the cavity existing when the proximal and distal valves are closed, the second volume of the cavity existing when the distal valve is open.
18. A method for disengaging a male connector from a female connector, the male connector including a distal end engaged with the female connector, a proximal end, and an internal valve and the female connector including a proximal end engaged with the male connector, a distal end, and an internal valve, the method comprising:
closing a first valve in the male connector at the proximal end of the male connector to isolate an interface between the male connector and the female connector from fluid at the proximal end of the male connector; and
creating a partial vacuum at the interface of the male connector and female connector to draw fluid at the interface away from the interface.
19. The method of claim 18 further comprising the step of closing the internal valve of the female connector before the step of creating a partial vacuum.
20. The method of claim 19 further comprising the step of closing a valve at the distal end of the male connector after the step of creating a partial vacuum.
21. The method of claim 19 wherein the step of creating a partial vacuum comprises creating a partial vacuum within the male connector and drawing fluid at the interface into the male connector.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US11/435,334 US20060202146A1 (en) | 2001-08-10 | 2006-05-15 | Valved male luer connector having sequential valve timing |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/927,109 US6745998B2 (en) | 2001-08-10 | 2001-08-10 | Valved male luer |
US10/389,652 US6964406B2 (en) | 2001-08-10 | 2003-03-13 | Valved male luer |
US11/010,096 US7044441B2 (en) | 2001-08-10 | 2004-12-10 | Valved male luer connector having sequential valve timing |
US11/435,334 US20060202146A1 (en) | 2001-08-10 | 2006-05-15 | Valved male luer connector having sequential valve timing |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/010,096 Continuation US7044441B2 (en) | 2001-08-10 | 2004-12-10 | Valved male luer connector having sequential valve timing |
Publications (1)
Publication Number | Publication Date |
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US20060202146A1 true US20060202146A1 (en) | 2006-09-14 |
Family
ID=35966970
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/010,096 Expired - Lifetime US7044441B2 (en) | 2001-08-10 | 2004-12-10 | Valved male luer connector having sequential valve timing |
US11/435,334 Abandoned US20060202146A1 (en) | 2001-08-10 | 2006-05-15 | Valved male luer connector having sequential valve timing |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US11/010,096 Expired - Lifetime US7044441B2 (en) | 2001-08-10 | 2004-12-10 | Valved male luer connector having sequential valve timing |
Country Status (15)
Country | Link |
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US (2) | US7044441B2 (en) |
EP (1) | EP1827567B1 (en) |
JP (2) | JP5285911B2 (en) |
KR (1) | KR101227399B1 (en) |
CN (1) | CN101111282B (en) |
AU (1) | AU2005325153B2 (en) |
BR (1) | BRPI0518974A2 (en) |
CA (1) | CA2591329C (en) |
ES (1) | ES2728599T3 (en) |
HK (1) | HK1117087A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
JP2008522729A (en) | 2008-07-03 |
HK1117087A1 (en) | 2009-01-09 |
JP5688046B2 (en) | 2015-03-25 |
ZA200705175B (en) | 2008-11-26 |
NO20073466L (en) | 2007-09-07 |
JP2012176265A (en) | 2012-09-13 |
EP1827567A1 (en) | 2007-09-05 |
US20050087715A1 (en) | 2005-04-28 |
KR20070086944A (en) | 2007-08-27 |
EP1827567B1 (en) | 2019-02-06 |
US7044441B2 (en) | 2006-05-16 |
CN101111282B (en) | 2010-09-22 |
CN101111282A (en) | 2008-01-23 |
RU2394608C2 (en) | 2010-07-20 |
CA2591329A1 (en) | 2006-07-27 |
BRPI0518974A2 (en) | 2008-12-16 |
AU2005325153A1 (en) | 2006-07-27 |
KR101227399B1 (en) | 2013-01-29 |
WO2006078355A1 (en) | 2006-07-27 |
AU2005325153B2 (en) | 2011-08-04 |
CA2591329C (en) | 2013-09-24 |
ES2728599T3 (en) | 2019-10-25 |
RU2007125990A (en) | 2009-01-20 |
NZ555751A (en) | 2010-11-26 |
JP5285911B2 (en) | 2013-09-11 |
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Legal Events
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