Abstract:
A valve assembly for use with a catheter assembly is provided. The valve assembly includes a valve housing defining a longitudinal axis and adapted for fluid engagement with a catheter assembly. The valve housing has an internal passageway for flow of fluids relative to the catheter assembly. A valve member is at least partially disposed within the valve housing and defines a valve passage. The valve member is adapted for movement within the valve housing between an open position wherein the valve passage is in general alignment with the internal passageway of the valve housing to permit flow of fluids through the valve housing, and a closed position to substantially occlude the internal passageway of the valve housing. An actuation mechanism is selectively movable in a general longitudinal direction to cause corresponding movement of the valve member between the open position and the closed position.

Description:
BACKGROUND 
     1. Technical Field 
     The present disclosure relates to valve assemblies for catheter systems. More particularly, the present disclosure relates to valve assemblies including linear actuation mechanisms for rotating a ball-valve to open and close a fluid passageway within the assemblies. 
     2. Background of Related Art 
     Access catheters may be single lumen, dual lumen or multi-lumen and may be used for a variety of procedures, including dialysis and urine collection. The main body of the catheter is designed for operable engagement with a patient and the proximal or outer end includes extensions, one for each lumen. It is common practice to make these extensions from flexible tubing so that the tubing may be manipulated outside the body and held in any convenient position using surgical dressings. The tubing generally carries a luer lock connector at its free end for attachment to fluid lines and for subsequent closing and sealing of the lumens when the catheter is not in use. Because these connectors have a tendency of failing, it is also common practice to place a clamp on each of the extensions to deform the tubing and to act as a second closure mechanism. 
     Flexible tubes and clamps are unsatisfactory for use in access catheters for a number of reasons. The most serious problem is that, because the clamps close the tubing through a pinching action, if the clamp is in place for a significant length of time, the tubing may not recover when the clamp is released. The resulting crease in the tubing causes flow problems, and in extreme cases, the catheter has to be removed because the tube is no longer patent. This problem is most prevalent on catheters that have thermoplastic tubular extensions made from polyvinylcholoride (PVC) or polyurethane (PU). 
     It has also been found that unless the clamps used to pinch closed the tubing are aligned accurately before engaging the tubing, the clamps may disengage by a minor impact. Furthermore, conventional clamps tend to have sharp edges which are required to crease the tubing. These sharp edges may result in cutting and/or shearing of the tubing, particularly when silicone rubber tubing is used. 
     Accordingly, a continuing need exists for a valve assembly for use in an access catheter that includes at least one actuation mechanism for regulating the flow through the catheter without detriment to the catheter or tubing. 
     SUMMARY 
     A valve assembly for use with a catheter assembly is provided. The valve assembly includes a valve housing adapted for fluid engagement with a catheter assembly, the valve housing defining a longitudinal axis and having an internal passageway for flow of fluids relative to the catheter assembly, a valve member at least partially disposed within the valve housing and defining a valve passage, the valve member adapted for movement within the valve housing between an open position wherein the valve passage is in general alignment with the internal passageway of the valve housing to permit flow of fluids through the valve housing, and a closed position to substantially occlude the internal passageway of the valve housing, and an actuation mechanism mounted to the valve housing and operatively connected to the valve member, the actuation mechanism selectively movable in a general longitudinal direction to cause corresponding movement of the valve member between the open position and the closed position. 
     The valve member may be adapted for rotational movement within the valve housing to move between the open position and the closed position thereof. The valve passage of the valve member may be generally misaligned relative to the internal passageway of the valve housing when in the closed position of the valve member. The valve member may define a generally spherical shape. The actuation mechanism may be movable relative to the valve housing between a first position corresponding to the open position of the valve member and a second position corresponding to the closed position of the valve member. The actuation mechanism may be adapted to be releasably locked relative to the valve housing when in at least one of the first and second positions thereof. 
     The valve housing may further include a cantilever member engageable with the actuation mechanism to selectively releasably secure the actuation mechanism in the one of the first and second positions thereof. A release member may be mounted with respect to the actuation mechanism and selectively movable to cause corresponding movement of cantilever member and release thereof from operative engagement with a lock member of the actuation mechanism, to hereby permit movement of the actuation mechanism. The release member may normally be biased to a position corresponding to a secured condition of the cantilever member relative to the actuation mechanism. The lock member may engage the cantilever member, the cantilever member adapted to pivot from the secured condition to an unsecured condition relative to the actuation mechanism upon movement of the release member to thereby permit movement of the actuation mechanism. 
     The actuation mechanism may be adapted to be releasably locked relative to the valve housing when in each of the first and second positions thereof. The valve assembly may further include first and second cantilever members, the first cantilever member may be adapted to releasably secure the actuation mechanism in the first position thereof, the second cantilever member adapted to releasably secure the actuation mechanism in the second position thereof. Each of the first and second cantilever members may be adapted to pivot to the unsecured condition relative to the actuation mechanism upon movement of the release member. The release member may normally be biased to an unactuated position thereof corresponding to the secured condition of the cantilever member. The valve housing may include a coupling adapted for connection to the catheter assembly. 
     Another embodiment of a valve assembly for use with a catheter assembly is also provided. The valve assembly includes a valve housing adapted for fluid engagement with a catheter assembly, the valve housing defining a longitudinal axis and having an internal passageway for flow of fluids relative to the catheter assembly, a valve member at least partially disposed within the valve housing and defining a valve passage, the valve member adapted for movement within the valve housing between an open position wherein the valve passage is in general alignment with the internal passageway of the valve housing to permit flow of fluids through the valve housing, and a closed position to substantially occlude the internal passageway of the valve housing, and an actuation mechanism mounted to the valve housing and operatively connected to the valve member, the actuation mechanism selectively movable between a first position corresponding to the open position of the valve member and a second position corresponding to the closed position of the valve member, the actuation mechanism being adapted to be releasably locked relative to the valve housing when in at least one of the first and second positions thereof. 
     The actuation mechanism may be adapted to be releasably locked in each of the first and second positions thereof. The valve housing may include first and second cantilever members, the first cantilever member adapted to releasably secure the actuation mechanism in the first position thereof, the second cantilever member adapted to releasably secure the actuation mechanism in the second position thereof. 
     A release member may be mounted with respect to the actuation mechanism and selectively movable to cause corresponding movement of one of the first and second cantilever members to cause release of the one of the first and second cantilever members from operative engagement with the actuation mechanism, to thereby permit movement of the actuation mechanism. The first and second cantilever members adapted to pivot from a secured condition to an unsecured condition relative to the actuation mechanism upon movement of the release member to thereby permit movement of the actuation mechanism, each cantilever member being normally biased toward the secured condition thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
         FIG. 1  is a perspective view of a catheter assembly including an embodiment of valve assemblies according to the present disclosure; 
         FIG. 2A  is a partial cross-sectional side view of the valve assembly of the catheter assembly of  FIG. 1 , in a first or open condition; 
         FIG. 2B  is a top view of the valve assembly of  FIG. 2A ; 
         FIG. 3  is a partial cross-sectional side view of the valve assembly of  FIGS. 2A and 2B , with a release member in a depressed condition; 
         FIG. 4A  is a partial cross-sectional side view of the valve assembly of  FIGS. 2A-3 , in a second or closed condition; 
         FIG. 4B  is a top view of the valve assembly of  FIG. 4A ; 
         FIG. 5  is cross-sectional side view of an alternative embodiment of a valve assembly according to the present disclosure, in a first or open condition; 
         FIG. 6  is a cross-sectional side view of the valve assembly of  FIG. 5 , with a release member in a depressed condition; 
         FIG. 7  is a cross-sectional side view of the valve assembly of  FIGS. 5 and 6 , in a intermediate condition; and 
         FIG. 8  is a cross-sectional side view of the valve assembly of  FIGS. 5-7 , in a second or closed condition. 
     
    
    
     DETAILED DESCRIPTION 
     Referring initially to  FIG. 1 , a catheter assembly including valve assemblies according to an embodiment of the present disclosure is shown generally as catheter assembly  5 . Briefly, catheter assembly  5  includes a dual lumen shaft  6  on a first end and a pair of tubular extensions  10 ,  12  on an opposite end. Tubular extensions  10 ,  12  are fluidly coupled to shaft  6  and include connectors  11 ,  13 , respectively, and valve assemblies  100 ,  100   a . Although the embodiments of the present disclosure will be described as relates to catheter assembly  5 , the valve assemblies of the present disclosure should not be read as limited to use with catheter assembly  5 . It is envisioned that the embodiments of the present disclosure may be modified for use with various fluid systems, including but not limited to, dialysis, urine collection, enteral feeding and breathing assistance. 
     Still referring to  FIG. 1 , valve assemblies  100 ,  100   a  are substantially identical to each other and will be described with reference to valve assembly  100 . With reference now to  FIGS. 2A and 2B , valve assembly  100  includes a valve housing  110 , a valve member  120  rotatably received within valve housing  110 , and an actuation mechanism  130  slidably mounted to valve housing  110  and operably engaged with valve member  120 . 
     With reference still to  FIGS. 2A and 2B , valve housing  110  includes first and second housing halves  112   a ,  112   b . Housing halves  112   a ,  112   b  may be formed as shown in  FIG. 2B , as mirror image first and second sides,  112   a ,  112   b , or housing  110  may be divided into top and bottom sections  212   a ,  212   b  ( FIG. 5 ). Housing halves  112   a ,  112   b  are affixed to one another using any conventional method, including, adhesive, glue, chemical bonding, ultrasonic welding, snap-fit connection, and mechanical fasteners. Housing  110  defines a longitudinal axis “X” and includes a proximal end  110   a , a distal end  110   b  and an internal passageway  113  therebetween. In one embodiment, proximal and distal ends  110   a ,  110   b  include connection fittings  111   a ,  111   b . In an alternative embodiment, proximal and/or distal ends  110   a ,  110   b  may be integrally formed within catheter assembly  5  ( FIG. 1 ). 
     Still referring to  FIGS. 2A and 2B , a spherical cut-out portion  115  is formed along internal passageway  113  of valve housing  110 . Cut-out portion  115  is sized and dimensioned to receive valve member  120 . As will be discussed in further detail below, valve member  120  defines a substantially spherical member in the form of a ball-valve  122 . Cut-out portion  115  includes an open top end  115   a  configured for receipt of a stem  124  extending from ball-valve  122 . As will also be discussed in further detail below, the length of open top end  115   a  of cut-out portion  115  is dependent upon the angle though which ball-valve  122  must move to rotate from an open position ( FIG. 2A ) to a closed position ( FIG. 4A ). The less the degree of rotation, the smaller open top end  115   a  may be. The converse is also true, the larger the degree of rotation needed to open or close ball-valve  122 , the larger open top  115   a  must be. 
     A top surface  110   c  of valve housing  110  is configured to slidingly receive actuation mechanism  130 . Top surface  110   c  defines a recessed portion  117 . Recessed portion  117  includes opposed rails or grooves  117   a  extending along a length thereof to operably engage lock member  132  of actuation mechanism  130 . Grooves  117   a  are configured to receive tabs  133  formed on lock member  132 . Grooves  117   a  extend the length of recessed portion  117  and are configured such that lock member  132  may traverse the length of recessed portion  117  from a first locked position ( FIG. 2A ) to a second locked position ( FIG. 4A ). Recessed portion  117  further includes opposed cantilever members  118 ,  119 . Cantilever members  118 ,  119  may be formed on one or both of housing halves  112   a ,  112   b  and may extend the width of recessed portion  117 . Cantilever members  118 ,  119  include inner first ends  118   a ,  119   a , respectively, securely affixed to housing  110  and outer second ends  118   b ,  119   b , respectively, extending along and spaced from housing  110 . Outer second ends  118   b ,  119   b  flex relative to housing  110 . In this manner, outer second ends  118   b ,  119   b  are configured to selectively engage engagement surfaces  134   b  formed on first section  134  of lock member  132 . 
     Turning briefly to  FIG. 2A , as noted above, valve member  120  includes a ball-valve  122  having a stem  124  extending therefrom. Ball-valve  122  is sized and dimensioned to be received in cut-out  115  of valve housing  110 . When ball-valve  122  is received in cut-out  115  stem  124  extends through open top end  115   a  to engage recess  136   a  formed in second section  136  of lock member  132 . Ball-valve  122  defines a passage  123  configured to align with internal passageway  113  of valve housing  110  when valve assembly  100  is in the first or open position ( FIG. 2A ) to permit the flow of fluid (not shown) through valve assembly  100 . Advancement of stem  124 , in the direction of arrow “A” within top open end  115   a  of cut-out  115  causes rotation of ball-valve  122 , and thus, misalignment of passage  123  and internal passageway  113 . As discussed above, top open end  115   a  of cut-out  115  is of a length sufficient to permit advancement of stem  124  to cause rotation of ball-valve  122  from a first position ( FIG. 2A ) where passage  123  and internal passageway  113  are completely aligned, to a second position ( FIG. 4A ) where passage  123  and internal passageway  113  are completely misaligned. 
     The diameters of ball-valve  122  and passage  123  determine the linear distance stem  124  must travel to ensure complete misalignment of passage  123  and internal passageway  113 . For example, if ball-valve  122  is ten millimeters (10 mm) in diameter and passage  123  measures five millimeters (5 mm) in diameter, stem  124  would be required to travel five point eight millimeters (5.8 mm) or through sixty degrees (60°) of rotation to rotate ball-valve  122  from the first position to the second position. Reducing the diameter of ball-valve  122  to about seven millimeters (˜7 mm) while maintaining passage  123  at five millimeters (5 mm) would require a minimum linear travel distance of stem  124  of seven millimeters (7 mm) or through ninety degrees (90°) of rotation. 
     With reference back to  FIGS. 2A and 2B , actuation mechanism  130  includes lock member  132 , a release member  138 , and a biasing member  140 . Actuation mechanism  130  is configured to be selectively positioned relative to valve housing  110  from at least the first or open position ( FIG. 2A ) to at least the second or closed position ( FIG. 4B ). In one embodiment, actuation mechanism  130  is configured for engagement by the thumb of a clinician (not shown). 
     Lock member  132  includes first and second sections  134 ,  136  and defines an opening  135  therebetween for receipt of release member  138 . First and second sections  134 ,  136  may be integrally formed, or instead may be securely affixed to one another using any conventional method, including, adhesive, glue, chemical bonding, ultrasonic welding, snap-fit connection, and mechanical fasteners. Preferably, first and second sections  134 ,  136  are not connected until release member  138  has been received therebetween. First section  134  defines a recessed portion  134   a  configured for operable engagement by a clinician. First section  134  further includes engagement surfaces  134   b  configured to engage outer second ends  118   b ,  119   b  of cantilever members  118 ,  119 , respectively, when actuation mechanism  130  is in respective first ( FIG. 2A ) and second ( FIG. 4A ) positions. A plurality of opposed tabs  133  ( FIG. 2B ) extend outwardly from first section  134  and are configured to be received within grooves  117   a  formed in recessed portion  117  of valve housing  110 . Tabs  133  permit actuation mechanism  130  to be slidably received within recess portion  117 . In an alternative embodiment, tabs  133  may be formed along the entire length of first section  134 . It is envisioned that second section  136  may also include tabs (not shown) configured to be slidably received in grooves  117   a . In this manner, first and second sections  134 ,  136  would be maintained relative to each other without being integrally formed or with the use of conventional securing methods. Second section  136  includes a recess  136   a  configured to receive an end of stem  124  of ball-valve  122  extending through open top end  115   a  of cut-out  115  of valve housing  110 . 
     Still referring to  FIGS. 2A and 2B , release member  138  defines a substantially “C” shaped member including an engagement surface  138   a  configured to be pressed by a clinician and opposed contact surfaces  138   b  configured to engage outer second ends  118   b ,  119   b  of cantilever members  118 ,  119 , respectively, formed on valve housing  110  when actuation mechanism  130  is in respective first and second positions. Release member  138  further includes a recess  139  configured to receive biasing member  140 . Biasing member  140  extends between second section  136  and release member  138  to bias release member  138  away from second section  136 . Biasing member  140  may be in the form of a spring, as shown, or may instead include a cantilever, pressure cylinder or other biasing element. 
     The operation of valve assembly  100  will now be described with reference to  FIGS. 2A-4B . Referring initially to  FIGS. 2A and 2B , valve assembly  100  is shown in a first or open condition. In this open condition, passage  123  of ball-valve  122  is completely aligned with internal passageway  113  of valve housing  110 . When valve assembly  100  is in the open condition, engagement surface  134   b  of first section  134  engages outer second end  118   b  of cantilever  118 , thereby maintaining actuation mechanism  130  locked in the first position. 
     Turning to  FIG. 3 , downward pressure by a clinician on engagement surface  138   a  of release member  138 , in the direction of arrow “B”, causes compression of biasing member  140  and approximation of release member  138  towards second section  136  of lock member  132 . The downward movement of release member  138  causes engagement of contact surfaces  138   b  thereof with outer second end  118   b  of cantilever  118 . Continued engagement of release member  138  with cantilever member  118  causes outer second end  118   b  of cantilever member  118  to flex away from and disengage engagement surface  134   b  of first section  134 . Disengagement of engagement surface  134   b  by outer second end  118   a  of cantilever member  118  unlocks actuation mechanism  130  and permits linear movement of actuation mechanism. Advancement of actuation mechanism  130  in the direction of arrow “C” causes the rotation of ball-valve  122 , thereby misaligning passage  123  of ball-valve  122  and internal passageway  113  of valve housing  110 . When the clinician releases release member  138 , biasing member  140  biases release member  138  back to an original position spaced from second section  136 . 
     Turning to  FIG. 4A and 4B  continued advancement of actuation mechanism  130  causes linear movement of stem  124  of ball-valve  122  which results in continued rotation of ball-valve  122  until passage  123  of ball-valve  122  and internal passageway  113  of valve housing  110  are completely misaligned and internal passageway  113  is totally obstructed by ball-valve  122 . In this closed or second position, opposed engagement surface  134   b  of first section  134  of lock member  132  engages outer second end  119   b  of cantilever  119 . In this manner, actuation mechanism  130  is locked within recessed portion  117  of housing  110  in a second or closed position. Valve assembly  100  may be reopened by depressing release member  138  and advancing actuation mechanism  130  in an opposite direction. 
     With reference now to  FIGS. 5-8 , an alternate embodiment of a valve assembly according to the present disclosure is shown generally as valve assembly  200 . Valve assembly  200  is substantially similar in form and function to valve assembly  100  and will only be described as relates to the difference therebetween. Similar reference numerals denote similar structure. Valve assembly  200  includes a housing  210  formed as housing top  212   a  and housing bottom  212   b . Valve assembly  200  further includes an actuation mechanism  230  having a release member  238 . Actuation mechanism  230  does not include a biasing member between release member  238  and a second section  236  of lock member  232 . In this manner, release member  230  is loosely retained between a first section  234  and second section  236  of lock member  232  when contact surfaces  238   b  of release member  238  do not engage outer second ends  218   b ,  219   b  of cantilever members  218 ,  219  ( FIG. 7 ). However, when actuation mechanism  230  is in either a first, open position ( FIG. 5 ) or a second, closed position ( FIG. 7 ) respective outer second ends  218   b ,  219   b  of cantilever members  218 ,  219 , respectively, engage contact surfaces  238   b  of release member  238 , biasing release member  238  away from second section  236 . In this manner, release member  238  provides a clinician with a visual indication of whether actuation mechanism  230  is locked in the first or second positions or is instead in an intermediary position. 
     Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure. For example, it is envisioned that actuation mechanism  130  may be configured for automatic actuation by an electric motor or slide. In this manner, actuation mechanism  130  could be automatically actuated by a clinician without having to manually depress release member  138  and advance actuation mechanism  130 . Additionally, actuation mechanism  130  may be configured for remote activation.