Abstract:
Needleless access port valves are generally discussed herein with particular discussions extended to needleless access port valves comprising a self-closing slip port. The slip port is configured to receive a medical implement and has a first flattened configuration before insertion of the medical implement and a second less flattened configuration after the medical implement is inserted therein and received thereby. The slip port is self-closing subsequent to removing the medical implement. The slip port of the type described may be incorporated in a Y-site or an injection site.

Description:
[0001]     Needleless access port valves are generally discussed herein with particular discussions extended to needleless access port valves comprising a self-closing slip port.  
       BACKGROUND  
       [0002]     Needleless access port valves are widely used in the medical industry for accessing an IV line and/or the internals of a patient or subject. Generally speaking, prior art valves utilize a valve housing in combination with a moveable internal plug or piston to control the flow of fluid through a valve. The plug or piston may be moved by a syringe or a medical implement to open the inlet of the valve for accessing the interior cavity of the valve. When a fluid is delivered through the valve, fluid flow typically flows around the outside of the plug or piston in the direction towards the outlet. Upon removal of the syringe or medical implement, the plug or piston returns to its original position, either un-aided or aided by a biasing means, such as a spring or a diaphragm.  
         [0003]     In some prior art valves, when the syringe or medical implement pushes the plug or piston, the plug or piston is pierced by a piercing device, such as a spike. The spike typically incorporates one or more fluid channels for fluid flow flowing through the pierced piston and then through the fluid channels in the spike. In yet other prior art valves, a self-flushing or positive flush feature is incorporated to push residual fluids confined inside the interior cavity of the valve to flow out the outlet when the syringe or medical implement is removed.  
         [0004]     While prior art needleless access port valves are viable options for their intended applications, there remains a need for alternative needleless access port valves.  
       SUMMARY  
       [0005]     The present invention may be implemented by providing a needleless injection port valve comprising a valve body, a first port comprising an exterior surface and an interior surface defining a lumen, and a second port; the first port comprising a first configuration in which a first section of the interior surface contacts a second section of the interior surface, and a first section of the exterior surface adjacent the first section of the interior surface is spaced apart from a second section of the exterior surface adjacent the second section of the interior surface by a first distance; and the first port comprising a second configuration in which the first and second sections of the interior surface are caused to be spaced apart from one another by at least one of a medical implement and a force acting on the exterior surface of the first port, and the first and second sections of the exterior surface are spaced apart from one another by a second distance, which is larger than the first distance.  
         [0006]     The present invention may also be practiced by providing a needleless injection port valve comprising a valve body, a first port comprising an exterior surface and an interior surface defining a lumen, and a second port; wherein the lumen has a shape of a funnel having a first length measured along a first plane and a second length measured along a second plane; and wherein the first length decreases and the second length increases when the first port moves from a closed position to an open position.  
         [0007]     In yet other aspects of the present invention, there is provided a needleless injection port valve comprising a valve body, a first port comprising an exterior surface and an interior surface defining a lumen, and a second port; wherein at least two threaded sections are positioned on the exterior surface of the first port, and wherein the two threaded sections move away from one another when the first port moves from a closed position to an open position.  
         [0008]     Other aspects and variations of the valve assemblies summarized above are also contemplated and will be more fully understood when considered with respect to the following disclosure. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     These and other features and advantages of the present invention will become appreciated as the same become better understood with reference to the specification, claims and appended drawings wherein:  
         [0010]      FIG. 1  is a semi-schematic front view of a needleless injection port valve provided in accordance with aspects of the present invention;  
         [0011]      FIG. 2  is a semi-schematic side view of the valve of  FIG. 1 ;  
         [0012]      FIG. 3  is a semi-schematic cross-sectional side view of the valve of  FIG. 2  taken along the same viewing plane;  
         [0013]      FIG. 4  is a semi-schematic front view of an alternative needleless injection port valve provided in accordance with aspects of the present invention;  
         [0014]      FIG. 5  is a semi-schematic side view of the valve of  FIG. 4 ;  
         [0015]      FIG. 6  is a semi-schematic cross-sectional side view of the valve of  FIG. 5  taken along the same viewing plane;  
         [0016]      FIG. 7  is a semi-schematic cross-sectional view of the valve of  FIG. 4  taken along the same viewing plane;  
         [0017]      FIG. 8  is a semi-schematic front view of yet another alternative needleless injection port valve provided in accordance with aspects of the present invention;  
         [0018]      FIG. 9  is a semi-schematic side view of the valve of  FIG. 8 ;  
         [0019]      FIG. 10  is a semi-schematic cross-sectional side view of the valve of  FIG. 9  taken from the same viewing plane; and  
         [0020]      FIG. 11  is a semi-schematic cross-sectional view of the valve of  FIG. 8  taken from the same viewing plane. 
     
    
     DETAILED DESCRIPTION  
       [0021]     The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of needleless access port valves or backcheck valves (herein “valves”) provided in accordance with aspects of the present invention and is not intended to represent the only forms in which the present invention may be constructed or utilized. The description sets forth the features and the steps for constructing and using the valves of the present invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.  
         [0022]     Referring now to  FIG. 1 , a semi-schematic partial perspective view of an exemplary needleless injection port valve provided in accordance with aspects of the present invention is shown, which is generally designated  10 . In one exemplary embodiment, the needleless injection port valve  10 , herein Y-site valve or “valve  10 ”, comprises a valve body  12  comprising a first port  14 , a second port  16 , and a third port  18 , which may sometime be referred to as an inlet port or a slip port. As is well known in the art, the first port  14  and the second port  16  are in constant fluid communication with one another while the slip port  18  is only in fluid communication with the two ports  14 ,  16  when opened by a medical implement, as further discussed below. Note that the name designation for the three ports (i.e., first, second, and third) can vary. In other words, a first port can alternatively be labeled a second port.  
         [0023]     In one exemplary embodiment, the first and second ports  14 ,  16  are tubing ports adapted to receive tubing from an IV set or the like. Fluid flow through the tubing (not shown) is typically in the direction of the first port  14  towards the second port  16 . The slip port  18  is a port for either supplementing or introducing fluid, via a medical implement, such as a syringe, to blend or commingle with fluid flow from between two ports. Alternatively, a fluid or blood sample can be withdrawn from the slip port. In one exemplary embodiment, the slip port  18  comprises a self-closing opening  20  formed from a resilient material. In a preferred embodiment, the valve  10 , and hence the slip port  18 , is integrally formed from a thermoplastic elastomer (TPE). In one exemplary embodiment, the TPE is a member of the copolyamide (COPA) family of thermoplastic elastomers. In a preferred embodiment, the COPA is copolyamide thermoplastic elastomer having a commercial trade name PEBAX®. However, other TPEs may also be used to make the valve housing  12 , including thermoplastic polyurethanes (TPUs), styrenic thermoplastic elastomers, thermoplastic polyolefins (TPOs), copolyesters (COPEs), and thermoplastic vulcanizate elastomeric alloys (TPVs). Optionally, the TPEs may be cross-linked either chemically or by irradiation to alter their characteristics. In one exemplary embodiment, one or more colors are incorporated in the material. Preferably, the material has a translucent pantone green tone. Alternatively, an opaque material with one or more color tones may also be incorporated.  
         [0024]     In one exemplary embodiment, the opening  20  has a shape of a slit formed by either cutting or molding the slit. A fluid tight seal is then provided by shrinking the slip port  18  or by post mold mechanical setting to set the slit. The final slip port configuration resembles a flattened cylindrical port in which the opening  20  comprises a generally linear slit located at an upper port section  21  that gradually tapers outwardly into a base port section  23 . Luer threads  22  are optionally incorporated for engaging corresponding threads on a male luer connector (not shown). When penetrated by a medical implement (not shown), the opening  20 , and hence the port  18  at the upper port section  21 , expands to accommodate the male tip of a medical implement. As the opening  20  expands, the threads  22  project outwardly to engage corresponding threads on the threaded collar of the medical implement. In the closed configuration shown, the inlet  20  has a smooth contour for easy swabbing or cleaning, if necessary. The inlet is resilient and self-closes when not caused to be opened by externally applied forces or by a medical implement.  
         [0025]     In one exemplary embodiment, levers  24  for squeezing are incorporated. The levers  24  are preferably integrally formed with the valve body  12 . The levers  24  each comprises an outer actuating pad  26  connected to the valve body via a rib section  28 . A pair of applied forces on the two actuating layers  26  in opposite directions will open the slit  20  and permit the male tip of a medical implement to penetrate the lumen defined by the slip port  18 , as further discussed below.  
         [0026]     Referring now to  FIG. 2 , a semi-schematic side view of the valve  10  of  FIG. 1  is shown. In one exemplary embodiment, the first port  14  and the second port  16  are positioned at an angle  34  of about 120 degrees to 160 degrees from one another with 135 degrees being more preferred. The slip port  18  is positioned about 135 degrees to about 180 degrees from the second port  16  with about 160 degrees being more preferred. However, other angular orientations between the three ports  14 ,  16 ,  18  may be incorporated without deviating from the spirit and scope of the present invention.  
         [0027]      FIG. 3  is a semi-schematic cross-sectional view of the valve  10  of  FIG. 1  taken from the viewing plane of  FIG. 2 . As shown from the cross-hatching, the valve  10  is integrally formed with the slit  20  molded or post mold cut and treated by material shrinkage or post mold mechanical set. A tubing stop  38  is integrally formed in the interior cavity  39  of the valve for delimiting movement of the tubing in both the first port  14  and the second port  16 . Inserted tubes (not shown) are configured to abut the end edges  40  of the tubing stop  38  to delimit further advancement into the interior cavity  39  of the valve.  
         [0028]     In one exemplary embodiment, the slit  20  comprises an upper slit section  42  and a lower slit section  44 . Due to the geometry of the slit interiorly, i.e., the lumen, when the outer actuating pads  26  are squeezed to open the slit  20 , only the upper slit section  42  opens to receive a medical implement. The lower slit section  44 , and particularly the exit point  45  of the lower slit section, remains closed until further penetrated by a male tip of a medical implement. As further discussed below, the lumen is wider along the upper slit section  42  and narrows as it extends distally towards the lower slit section  44 , as further discussed below. The resiliency of the slip port  18  ensures a fluid tight contact between opposing surfaces of the slit so as to prevent fluid from discharging out of the slit  20 .  
         [0029]     Referring now to  FIG. 4 , a semi-schematic side view of an alternative needleless injection port valve  46  provided in accordance with aspects of the present invention is shown. In one exemplary embodiment, the valve  46  comprises a valve body  48  comprising an inlet port  50  and an outlet port  52 . The valve  46  is preferably formed, at least in part, from the same material or materials as the valve  10  disclosed with reference to  FIG. 1 . The inlet port  50  acts as a slip port and is configured to couple to a medical implement, such as a syringe, for adding or sampling fluid. The outlet port  52  is configured to couple to an IV set or a catheter assembly.  
         [0030]     In one embodiment, the inlet port  50  comprises a self-closing opening  20  made self-closing by the resiliency of the material selected to form the valve. The self-closing opening  20  resembles a slit and the outer structure of the port defining the slit resembles a flattened open cylinder end (as best seen in  FIGS. 5 and 6 ). The flattened upper section or upper port section  54  tapers outwardly as it extends distally towards the lower port section  56 . Luer threads  58  are optionally incorporated on the inlet port  50 , which are adapted to engage corresponding threads on a medical implement when the upper port section  54  is expanded by the medical implement, as further discussed below.  
         [0031]     The convex shape bottom port section  58  of the inlet port  50  extends distally towards the main central body section  60  which then extends towards a collar  62 . As further discussed below, the collar  62  overlaps a projection on the outlet assembly  64 , which comprises the outlet port  52 , in a tongue-and-groove configuration to couple the valve body  48  to the outlet assembly  64 . A pair of levers  24  comprising actuating pads  26  and rib sections  28  are incorporated for opening the slit  20  of the inlet port  50 . The pads  26  are preferably formed in a generally perpendicular configuration to the line defined by the slit.  
         [0032]     In an exemplary embodiment, the valve body  48 , which comprises the inlet port  50 , the two levers  24 , the central body section  60 , and the collar  62 , is integrally formed from an elastomer material while the outlet assembly  64  is integrally formed from a rigid plastic material, such as polycarbonate, polyurethane, or the like. More preferably, the valve body  48  is over molded to the outlet assembly  64 .  
         [0033]      FIG. 5  is a semi-schematic side view of the valve  46  of  FIG. 4  viewed from a different plane. It can be seen that the flat upper port section  54  tapers outwardly towards the lower port section  56  (shown in dot-dashed lines), which extends into the central body section  60 .  
         [0034]      FIG. 6  is a semi-schematic cross-sectional side view of the valve of  FIG. 5  taken from the same viewing plane. As previously discussed, in a preferred embodiment, the valve  46  is manufactured by over-molding the valve body  48  to the outlet assembly  64 . The attachment is provided by forming a channel  66  between the collar  62  and the central valve body  60  over a ring-shaped projection  68  in a tongue-and-groove configuration. Interiorly, a cavity or lumen  70  defined by the interior surface of the outlet port  72  and the valve body  48  is provided for fluid flow from the inlet port  50  towards the outlet port  52 , or vice versa. The flow between the two ports is regulated by the configuration of the slit  20 , and more specifically by the configuration of the upper slit section  42  and the lower slit section  44 . As shown, the upper and lower slit sections  42 ,  44  are in a closed configuration, which would prevent fluid from flowing between the two ports.  
         [0035]     The outlet assembly  64  is shown comprising a luer threaded collar  76  and the outlet port  52 . However, the outlet assembly  64  may be practiced without the threaded collar  76 , which makes it a luer slip.  
         [0036]      FIG. 7  is a semi-schematic cross-sectional side view of the valve  46  of  FIG. 4  taken from the same viewing plane. The opening  20  comprises a funnel shape lumen having an upper section  42 , a lower section  44 , and an apex at the exit point  45 . When the slit  20  is closed ( FIG. 6 ), the funnel shape lumen has a generally triangular  2 -dimensional configuration ( FIG. 7 ). In other words, the lumen has three distinct sides. However, when the two levers  24  are squeezed, a force is distributed at least along the two darkened surface areas  78   a ,  78   b  adjacent the levers (shown darkened for discussion purposes only) and forces the two end edges  80 ,  82  of the funnel shape lumen to move toward one another. This movement causes the side walls  84   a ,  84   b  (the latter not shown) of the funnel shape lumen tangential to the slit  20  to fold and transform the 2-D funnel into a 3-D funnel as the slit  20  is opened. Because the exit point  45  is relatively narrow and the walls perpendicular to the two end edges  80 ,  82  at the apex small, the applied forces on the levers  24  should not open the funnel shape lumen at the exit point  45 . As is readily apparent to a person of ordinary skill in the art, this configuration allows the slip port to be partially opened for receiving a medical implement while preventing fluid from discharging out the opening  20 .  
         [0037]     After opening the slit, a medical implement (not shown) may then be inserted through the opening  20  to access the interior cavity  70  of the valve  46  and be in fluid communication with the outlet port  52 . When inserting the medical implement, the male tip of the medical implement abuts the exit point  45  of the lumen and mechanically opens the exit point. Fluid may then be delivered into the interior cavity  70  of the valve or be withdrawn from the interior cavity of the valve by the medical implement.  
         [0038]     When a medical implement is connected to the inlet port  50 , the interior fluid space increases from the space defined by the interior cavity  70  of the valve to include the fluid space defined by the medical implement. However, when the medical implement is removed, the fluid space reverses and decreases in size. This change in fluid space causes the valve  46  to flush out access fluid inside the interior cavity and operates as a self-flushing or positive displacement valve.  
         [0039]      FIG. 8  is a semi-schematic side view of an alternative needleless injection port valve  86  provided in accordance with aspects of the present invention. Like the valve  46  of  FIG. 4 , the present valve  86  comprises an inlet port  50 , an outlet port  52 , and a valve body  48  comprising a pair of push levers  24 . In one exemplary embodiment, various curves and contours  88 ,  90  are incorporated for aesthetic appeal. For example, a pair of central gripping dimples  88  may be incorporated for aesthetic appeal. In this instance, the gripping dimples  88  also provide a functional use.  
         [0040]      FIG. 9  is a semi-schematic side view of the valve  86  of  FIG. 8  from a different viewing plane. Similar to the valves discussed above, the inlet port  50  comprises a flattened upper port section  54  and a lower taper port section  56 . The flattened area is configured to expand when the levers  24  are squeezed and is configured to further open when a tip of a medical implement is inserted inside the funnel shape lumen.  
         [0041]      FIG. 10  is a semi-schematic cross-sectional side view of the valve  86  of  FIG. 9  taken from the same viewing plane. In one exemplary embodiment, the valve  86  is a unitary construction design in which the inlet port  50 , outlet port  52 , and valve body  48  are integrally molded from an elastomeric material. As previously discussed, the slit  20  may be molded or post mold cut and treated either by material shrinkage or post mold mechanical set. The slit  20  inherently biases close and is open-able only if forced by prying the slit open or squeezing the levers. As with the valve of  FIG. 4 , the present valve is a positive displacement valve.  
         [0042]      FIG. 11  is a semi-schematic cross-sectional side view of the valve of  FIG. 8  taken from the same viewing plane. The opening  20  comprises a funnel shape lumen having an upper section  42 , a lower section  44 , and an apex at the exit point  45 . In a closed position (See, e.g.,  FIG. 10 ), the funnel shape lumen has a generally triangular 2-dimensional configuration. When pressure is applied on the levers  24  to squeeze the levers together, a force is distributed at least along the two darkened surface areas  78   a ,  78   b  adjacent the levers (shown for discussion purposes only). The force causes the two edges  80 ,  82  to merge closer together while concurrently causes the two side walls  84   a ,  84   b  (the latter not shown) to flex. The slit  20  opens as a result of the flexing side walls  84   a ,  84   b  and transforms into a 3-D funnel shape lumen. A medical implement may then be inserted into the opening  20  to access the interior cavity  70  of the valve. Upon removal of the medical implement, the opening  20  self-closes and fluid inside the interior cavity  70  of the valve is displaced out of the exit opening of the outlet port  52 , similar to the valve  46  described above with reference to  FIG. 4 .  
         [0043]     Although limited embodiments of the needleless access valve assemblies and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the various valves may incorporate luer-slips rather than luer threads, the material selected could be opaque or semi-opaque, different colors may be used, the dimensions can vary, etc. Furthermore, it is understood and contemplated that features specifically discussed for one valve embodiment may be adopted for inclusion with another valve embodiment, provided the functions are compatible. For example, certain curvatures and contours incorporated in one valve may be incorporated in another valve for aesthetic appeal and improved functionality, such as for improved gripping purposes; and rather than making an integrally molded valve, an over-molded design in which an elastomer material and a hard plastic material may be used. Accordingly, it is to be understood that the valve assemblies and their components constructed according to principles of this invention may be embodied other than as specifically described herein. The invention is also defined in the following claims.