Patent Publication Number: US-9427549-B2

Title: Valved catheter assemblies and related methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application is a continuation of application Ser. No. 14/012,568, filed Aug. 28, 2013, now U.S. Pat. No. 9,114,231, which claims the benefit of U.S. provisional Application No. 61/799,286 , filed Mar. 15, 2013, the contents of each of which are hereby expressly incorporated herein by reference for all purposes. 
    
    
     FIELD OF ART 
     The current system, device, and method relate to infusion devices, and specifically to intravenous (“IV”) catheters. In particular, the system, device, and method relate to a flushable peripheral intravenous catheter assembly having features to enable selective activation of fluid flow through the catheter assembly. 
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. For example, catheters are used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient, withdrawing blood from a patient, or monitoring various parameters of the patient&#39;s vascular system. 
     Catheters and/or needles are typically coupled to a catheter adapter to enable attachment of IV tubing to the catheter. Thus, following placement of the catheter or needle into the vasculature of a patient, the catheter adapter is coupled to a fluid source via a section of IV tubing. In order to verify proper placement of the needle and/or catheter in the blood vessel, the clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. 
     Once proper placement of the catheter is confirmed, the clinician must then attach the catheter adapter to a section of IV tubing, or continue to manually occlude the vein to prevent undesirable exposure to blood. The process of coupling the catheter adapter to the section of IV tubing requires the clinician to awkwardly maintain pressure on the vein of the patient while simultaneously coupling the catheter adapter and the IV tubing. A common, yet undesirable practice is to permit blood to temporarily and freely flow from the catheter adapter while the clinician locates and couples the IV tubing to the catheter adapter. Another common practice is to attach the catheter adapter to the IV tubing prior to placing the needle or catheter into the vein of the patient. While this method may prevent undesirable exposure to blood, positive pressure within the IV line may also prevent desirable flashback. 
     Some catheter assemblies further utilize a septum actuator and a split septum, wherein the septum actuator is mechanically advanced through a slit of the septum to provide a fluid pathway through the septum. However, once advanced through the septum, the septum actuator becomes lodged within the slit of the septum and is unable to return to its initial position. As such, the fluid pathway remains in an opened position thereby enabling uncontrolled flow of fluids through the septum. 
     SUMMARY 
     Features of the present disclosure generally relate to an IV catheter assembly having a valve for obstructing or restricting fluid flow through the catheter. A valve opener is disposed in the catheter to open the valve. A needle guard for covering the needle tip following successful venipuncture may be incorporated. To facilitate use, the present disclosure further includes features on the valve to facilitate venting, opening of the flaps, closing of the flaps, or combinations thereof. 
     An exemplary feature of the present disclosure includes a catheter assembly comprising a catheter hub comprising an interior cavity, an opening at a proximal end, and a catheter tube attached thereto and extending from a distal end and a needle having a needle shaft defining a needle axis projecting distally of an end of a needle hub, said needle projecting through the catheter tube and comprising a needle tip. A valve sized and shaped to obstruct fluid flow can be positioned inside the interior cavity of the catheter hub and in contact with the interior cavity, said valve comprising a valve perimeter surrounding a wall surface comprising a thickness, at least one slit defining at least two flaps, and a void having a void perimeter inwardly positioned relative to the valve perimeter and formed through only part of the thickness of the wall surface. A valve opening device is slidingly disposed in the catheter hub to actuate the valve, the valve opening device comprising a nose section having a tapered end for pushing the valve to open the slit of the valve and a plunger end having a plunger element extending proximally of the nose section; the plunger element being sufficiently rigid to transfer a distally directed force to the nose section to push the valve to open the slit. 
     The catheter assembly wherein the void has a tapered wall surface. 
     The catheter assembly wherein the void can have a blunt tip or a sharp tip. 
     The catheter assembly wherein the valve can further comprise a second void formed through part of the thickness on the wall surface opposite the void. 
     The catheter assembly wherein the valve can further comprise a plurality of reinforcing ribs located, at least in part, on the flaps. 
     The catheter assembly can further comprise a needle protective device spaced from the needle tip in a ready position and movable relative to the needle tip to a protective position, at least in part, distally of the needle tip to prevent unintended needle sticks. 
     The catheter assembly can further comprise a plurality of spaced apart vents cut through the valve perimeter. 
     Another feature of the present disclosure include a catheter assembly comprising a first hub comprising an interior cavity having a shoulder, a perimeter defining an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub and a needle having a needle shaft defining a needle axis projecting distally of an end of a second hub, said needle projecting through the catheter tube and comprising a needle tip. A valve sized and shaped to obstruct fluid flow comprising a valve body comprising an outer periphery can be positioned inside the catheter hub, said outer periphery comprising at least one vent and said valve body comprising at least one inner slit remote from said outer periphery. A valve opening device can be placed slidingly in the first hub to actuate the valve, the valve opening device comprising a nose section having a tapered end with an opening structured to push the valve to open the plurality of slits and at least one plunger element extending proximally of the nose section and slidable distally when a male implement projects into the opening of the first hub to transfer a distally directed force to the nose section to push the valve to open the at least one slit. In a particular example, the valve has at least one void disposed inwardly of the outer periphery. 
     The catheter assembly can further comprise a needle guard comprising a proximal wall with an opening sized to obstruct a change in profile on the needle. 
     The catheter assembly wherein the at least one vent can have a lengthwise slit. 
     The catheter assembly wherein the at least one vent is a V-shaped notch. 
     The catheter assembly wherein the void has two side tapered surfaces and one tapered end surface. 
     The catheter assembly can further comprise a second void positioned opposite the void. 
     The catheter assembly wherein the valve body can comprise a cylinder with an open end. 
     The catheter assembly wherein the vent can close when the valve is opened by the valve opening device. 
     A still yet further feature of the present disclosure is a catheter assembly comprising a first hub comprising an interior cavity having a shoulder, a perimeter defining an opening at a proximal end, and a catheter tube having a distal end opening extending distally of the first hub and a needle having a needle shaft defining a needle axis projecting distally of an end of a second hub, said needle projecting through the catheter tube and comprising a needle tip. A valve sized and shaped to obstruct fluid flow comprising a valve body comprising a wall structure comprising a proximal surface, a distal surface, and an outer periphery, said outer periphery comprising at least one vent and said wall structure of the valve body comprising a Y-shaped slit remote from said outer periphery, the Y-shaped slit comprising three flaps and the wall structure comprising reinforcing ribs on the distal surface on at least part of the three flaps; said valve being positioned inside the interior cavity of the first hub and remaining inside the interior cavity when the needle is removed from the catheter tube and the first hub. A valve opening device slidingly disposed in the first hub to actuate the valve to open the Y-shaped slit and a needle protective device positioned proximal of the valve and at least in part around the needle and distal of the proximal end of the second hub in a ready position, the needle protective device movable to prevent unintended needle sticks in a protective position. 
     The catheter assembly can further comprise at least two spaced apart vents along the outer periphery. 
     The catheter assembly wherein the at least one vent can be a slit. 
     The catheter assembly wherein the at least one vent can have a V-shaped notch. 
     The catheter assembly wherein the wall structure can further comprise a void formed through only part of a thickness of the wall structure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features and advantages of the present device, system, and method will become appreciated as the same becomes better understood with reference to the specification, claims and appended drawings wherein: 
         FIG. 1  shows a cross sectional side view of one embodiment of a valved catheter assembly in the ready position; 
         FIG. 2  shows a cross sectional side view of the embodiment of  FIG. 1  in the activated position; 
         FIG. 3  shows a cross sectional side view of another embodiment of a valved catheter assembly with the needle partially withdrawn; 
         FIG. 4 a    shows a side view of a valve embodiment with a void on the proximal surface; 
         FIG. 4 b    shows a side view of a valve embodiment with a void on the proximal surface in accordance with another aspect of the present disclosure; 
         FIG. 5  shows a side view of a valve with two voids on both the proximal and distal surfaces; 
         FIG. 6  shows a side view of a valve with a plurality of vents and slits; 
         FIG. 7  shows a side view of a another valve embodiment with a plurality of vents and slits; 
         FIG. 8  shows a side view of a valve having a void and a needle passing therethrough; 
         FIG. 9  shows a side view of another a valve without a void and a needle passing therethrough; 
         FIG. 10  shows a bottom or end view of one embodiment of a valve with reinforcing ribs on the distal surface; 
         FIG. 11  shows a cross sectional side view of the valve of  FIG. 10  with reinforcing ribs on the distal surface; 
         FIG. 12  is a schematic perspective view of yet another valve embodiment provided in accordance with aspects of the present disclosure; 
         FIG. 13  is a cross-sectional side view of the valve of  FIG. 12  sectioned along lines A-A; 
         FIG. 14  is an end view of the valve of  FIG. 12  taken from the end opposite the surface with the slits; and 
         FIG. 15  is a perspective view of a valve disk provided in accordance with further aspects of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of valved catheter assemblies provided in accordance with aspects of the present device, system, and method and is not intended to represent the only forms in which the present device, system, and method may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present device, system, and method 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 present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features. 
       FIG. 1  shows a valved catheter assembly  1  having a catheter hub  2 , which in the embodiment shown has a two-part hub body. A distal hub element or first hub part  3  of the catheter hub has a holding section  3   a , such as a nose section, in which a catheter tube  4  is press-fitted. The proximal end of the hub element  3  has an enlarged diameter relative to the distal end portion and forms a connecting section, for example a Luer conical fitting, with a rear hub element or second hub part  5 . The distal end of the rear hub part  5  overlaps the proximal end of the front or first hub part  3  and which is provided at its proximal end with a Luer thread  6 . Between the two hub parts  3  and  5 , a valve  7  in the form of a check valve shaped as a cylinder or disk is inserted and is fixed in place by the two hub elements  3  and  5 . In other embodiments, the valve  7  is held in place by securing the valve to the shoulder on hub element  3  using adhesives or welding while omitting the shoulder of hub element  5 . In still yet other examples, a single catheter hub body is used with internal shoulders or undercuts incorporated for retaining the valve  7  therein. In still another embodiment of the present disclosure, the valve is held in the catheter hub by an interference fit. 
     In the ready position of  FIG. 1 , a nose section of a needle hub  8  is inserted into the catheter hub  2 . A hollow needle  9  is fixed to the nose section and extends through the valve  7 , the catheter hub  2 , and the catheter tube  4  so that the needle tip  9   a  is exposed beyond the tapered end of the catheter tube  4 . Between needle hub  8  and the valve  7  and inside the catheter hub  2 , a valve opening device or valve actuator  10  with a truncated cone-shaped locating section or tapered nose end  10   a  for opening the valve  7  is slidably or displaceably arranged, as shown in  FIG. 2 . On the proximal side of the valve actuator  10 , a plunger section or pusher end  10   b  is provided for being pushed by the male Luer conical fitting of a medical implement, such a syringe tip or an IV tubing adaptor, to open the valve. The pusher end  10   b  adjoins the tapered nose end  10   a . In an example, the tapered nose section  10   a  incorporates a groove to facilitate engagement with the valve so that even if the medical implement no longer pushes on the valve actuator  10 , the tapered nose and remains engaged with the valve. This is depicted as the grooved section  210   b  of the valve actuator head  210  in  FIG. 3 . As explained above, a typical exchange of elements could be the use of valve opener  210  in the embodiment of  FIGS. 1 and 2 . In one example, there is only a single element or leg forming the pusher end. In another example, two legs with a hollow space therebetween are provided. The two proximal ends of the two legs provide a surface to be pushed by the medical implement. The space between the two legs is configured to receive a needle guard element  13 . Said differently, the needle guard element  13  is positioned in the space between the two legs. In other examples, a third housing having a cavity is positioned between the catheter hub  2  and the needle of  8 . The needle guard element  13  may be positioned in the cavity of the third housing and the third housing having mechanical features to engage the catheter hub and the needle hub. In some examples, the needle guard is omitted and the catheter assemblies only incorporate a valve and a valve opener. 
     On withdrawal of the hollow needle  9  from the catheter hub  2  following successful venipuncture, a change in profile provided near the needle tip  9   a  and having the form of a radial projection on the hollow needle which can be formed by light crimping, engages with the outer circumference of a bore in the rear wall  13   c  of the needle guard  13  so that the needle guard  13  is removed from the catheter hub with the needle  9 . Simultaneously, the arms  13   a  and  13   b  of the needle guard cover the needle tip to prevent needle sticks. In other examples, the change in profile can include a sleeve, a notch, or a material buildup on the shaft of the needle. In this separated position, the valve  7 , due to its elasticity, closes the through-hole for the hollow needle  9  so that no blood can flow out through the catheter  4 . As further discussed below with reference to  FIGS. 6 and 7 , valves provided herein can include three slits  54  starting from the middle of the valve and extending radially over a short radial distance towards the outer perimeter to form elastic flaps that can be expanded by the hollow needle and closed when the needle is removed. In some examples, the flaps remain open and engaged with a valve opener. 
       FIG. 2  shows the insertion of a syringe  14  in the catheter hub  2  to either inject a fluid, such as medicament, through the catheter hub or draw a sample of a bodily fluid like blood. As shown, the syringe tip  14   a  of the syringe  14  abuts the pusher end  10   b  of the valve actuating element  10  and pushes it against the valve  7  so that the tapered nose section  10   a  opens the slits  7   a  thereby opening the valve so that liquid can flow there-across. 
     As shown, the nose end  10   a  of the actuator  10  is inclined. Thus, as the syringe is removed and the forward force on the actuator is removed, the elasticity of the material of the valve  7  is sufficient for the three slits  7   a  to uncoil and push the actuator in the proximal direction to close the seal  7 . The valve  7  therefore automatically closes upon withdraw of the pushing force on the actuator. 
     A shoulder  5   a  is shown in the catheter hub  2  in  FIGS. 1 and 2 . The shoulder  5   a  acts as a stop for the actuator  10  when the flange on the actuator abuts the shoulder, which defines the proximal most position of the actuator. In other examples, the second hub section may incorporate other structural features, such as a tapered internal cavity, to stop the proximal travel of the actuator. 
     Also shown in the inner circumference of the bore of the hub element  5  is a second shoulder  5   b  just proximal of the first shoulder  5   a . The two radially outer areas of the spring arms of the needle guard are configured to abut the second shoulder  5   b  in the ready position in  FIG. 1 . When the needle hub  8  with the hollow needle  9  is removed from the catheter hub  2 , the needle guard  13  is held generally stationary by the shoulder  5   b  until the change in profile, such as a crimp, near the needle comes to abut on the rear wall of the needle guard and the needle tip moves proximally of the two distal walls on the needle guard  13 . At this point, the two spring arms spring inwards to cover the needle tip and separate from the second shoulder  5   b , whereupon the needle guard  13  with the hollow needle  9  can be removed from the catheter hub. Further information regarding the needle guard  13  is discussed in U.S. Pat. No. 7,736,339, the contents of which are expressly incorporated herein by reference. 
     In the embodiment according to  FIGS. 1 and 2 , the distal end section of the second hub part  5  is shrunk, welded or bonded onto the proximal end section of the first hub part  3  after the actuating element  10  and the valve  7  are inserted in the hub element  5 . It is also possible to join the two hub elements  3  and  5  to one another, for example, using threads, interference, or snap-fit. The needle guard  13  may be inserted together with the hollow needle  9  in the bore  5   c  of the hub element  5  during assembly via the proximal opening of the hub, wherein the radially outer areas of the spring arms snap in at the shoulder  5   b  under elastic deformation. 
       FIG. 3  is a cross-sectional side view of another embodiment of a valved catheter assembly provided in accordance with aspects of the present system, device, and method, which is generally designated  201 . The catheter assembly  201  incorporates similar components as the assembly shown in  FIGS. 1 and 2 , including a catheter tube  204  attached to a catheter hub  202 , a needle  209  attached to a needle hub  218 , a valve  207 , a valve opening device  210  comprising a tapered distal tip  210   a  with a grooved section  210   b , and a pusher end  260 , which in the present embodiment comprises a pair of legs (only one shown) positioned in a bore  275  in the interior of the catheter hub  202 . 
     A tip protector  232  for blocking the needle tip  272  is provided in a third housing  206 . In an embodiment, the third housing  206  incorporates a rear plate or panel  208  attached to a housing section  212  for closing an opening  227  on the housing section  212 , which has an interior cavity for accommodating the needle guard. The opening  227  on the housing section  212  allows the tip protector  232  to be placed therein during assembly. Thus, while the guard is located inside the third housing, it is also movable relative to the third housing. The rear plate  208  may be attached to the housing section  212  using adhesive, welding, or detents. Alternatively, the housing section  212  may incorporate an opening on a side, orthogonal to the rear plate  208 . 
     In one example, the third housing  206  incorporates a pair of arms  220  each comprising a hook  214 . The two hooks  214  are configured to engage the annular bump  236  inside the catheter hub to retain the third housing  206  to the catheter hub  202  in a ready to use position. The two arms  220  are preferably flexible to provide a gripping force against the bump  236 , which is higher than the frictional force to withdraw the needle through the tip protector  232 , hemostatic valve  207 , and catheter  204 . Alternatively, the two arms  220  can be biased radially outward to increase the gripping force. Further, the two arms can be biased inwardly against the needle shaft to decrease the gripping force after the needle is withdrawn proximal of the arms  220 . Still alternatively, only a single arm is used to attach the third housing to the catheter hub. External structural features are also contemplated for fixing, securing, or attaching the third hub to the catheter hub without projecting the arm into the interior cavity of the catheter hub. 
     Following successful catheterization, the needle  209  is retracted proximally away from the catheter tube  204  in the same manner as previously discussed. As the needle tip  272  moves proximally of the distal wall of the tip protector  232 , the tip protector  232 , comprising a needle tip opening  222 , engages the needle  209  and further proximal movement of the needle  209  causes the tip protector  232  to pull on the rear plate  208  of the third housing  206 , which then disengages the two hooks  214  from the two bumps  236 . Thus, the gripping force between the two hooks  214  and the two bumps  236  should be less than the gripping force between the tip protector  232  and the needle  209 . In yet other examples, a guard with a proximal wall located inside a third housing is used to engage a change in profile on the needle, similar to the guard of  FIG. 1 . 
     With reference now to  FIGS. 4 a  and 4 b   , a schematic cross-sectional side view of a first valve  40  embodiment ( FIG. 4 a   ) and a second valve embodiment  40  ( FIG. 4 b   ) in accordance with aspects of the present disclosure are shown. The valves  40  each comprises a valve body  300  comprising a perimeter  302  and a depth or thickness  304 . In one example, the perimeter is round or somewhat oblong. In another example, the perimeter is polygonal. Less preferably, the perimeter has an irregular shape. The valve has a wall structure or body comprising a proximal surface or first surface  42  and a distal surface or second surface  52 . The first surface  42  of the two valves  40 , both of which resemble a valve disk or disc, is formed or provided with a void  44  partly through the thickness  304  of the disk on the proximal surface at the center thereof. However, the void can be slightly offset or off-center. Each void  44  has a perimeter  306 , a wall surface  310 , and a depth  308 , which depth is about 0.25 to about 0.7 of the total thickness  304  of the valve  40 . The perimeter  306  of the void is understood to be recessed or inwardly located from the disk perimeter  302 . A through seam  312  is shown representing a mating line between the two or more flaps formed between the centrally formed slits, as further discussed below. In one example ( FIG. 4 a   ), the void  44  is formed so that it has a pointed or sharp tip  46 . In other embodiment ( FIG. 4 b   ), the void may have a flattened or blunted tip  50  along a cross-section. The blunted tip  50  has a base surface  314  that is generally parallel to the first surface  42  and/or the second surface  52  and an inner perimeter  316 . Both valves  40  are useable with catheter assemblies, such as the ones shown in  FIG. 1  and  FIG. 3 . The thickness of the valve disk as well as the outside dimension of the disk can vary to accommodate the particular application, such as to fit into different hubs and hubs with only a single hub body versus more than one hub part or body. In other embodiments, the valve disk  40  is located on an end of a cylinder, i.e., a cylinder valve, with the other end of the cylinder being opened. 
       FIG. 5  shows a cross-sectional side view of an alternative valve  40  provided in accordance with further aspects of the present disclosure. In the present embodiment, the valve  40  may have blunted  50  or sharp (not shown) tip voids  44  on one or both of the proximal  42  and distal  52  surfaces of the valve. In yet another embodiment, the valve  40  can have a pointed void  46  on one side and a blunted void  50  on another side, similar to a combination of the valve of  FIGS. 4 a  and 4 b   . Thus, the valve  40  of  FIG. 5  may be understood to include two voids with two point tips, two voids with two base surfaces and two perimeters formed around the base surfaces, or two voids with one void having a pointed tip and another void with a base surface with a perimeter formed around the base surface. The valve  40  of  FIG. 5  may be useable with the catheter assemblies of  FIG. 1  and  FIG. 3 . 
       FIGS. 6 and 7  depict two additional valve embodiments. Each of the two valves  40  incorporates three slits  54  that are formed such that one end of each of the three slits join at a common point  56  centrally of the valve. The three slits  54  define three flaps  320  that can flex and un-flex to either open a passage through the valve or close the passage. The flexibility of the flaps, such as their elasticity, can depend on the length of the slits, the material, and the thickness of the valve, among others. From this common point  56 , the slits  54  extend radially outward. As shown, the slits extend radially outwardly but not past the inner perimeter  316  of the void  44  with a base surface ( FIG. 7 ) or the void perimeter  306  ( FIG. 6 ), which is located radially inwardly of the disk perimeter  302 . The slits are spaced at even intervals of approximately 120 degrees around the common point  56 . In other embodiments, the slits can be placed in different intervals around the common point, such as a “T” configuration or in other than 120 degrees intervals. There may also be more than three slits, such as 4 to 6 slits. There may also be only one slit that runs through the center point of the disc forming two flaps. In other words, the single slit can be seen as two slits that meet at the center point of the disc. There can also be a “U” shaped slit that is centered on the same center point as the disc but the slit does not run through the center point. The slits extend through the width or thickness  304  of the valve, from the proximal surface  42  to the distal surface  52  (See, e.g.,  FIGS. 4 a  and 4 b   ), including through any portion of a void  44 , if one is present. The slits are cut to a length equal to about 0.25 to about 0.7 of the length of the radius of the valve. 
     In one example, vents  60  are formed on the perimeter  302  of the valve  40 . In some embodiments, there are four vents  60 , spaced at approximately 90 degree intervals around the perimeter of the valve. Other embodiments contemplate different numbers of vents at different spacing distances or only one vent. 
     As shown in  FIG. 6 , the vents  60  are cut inwardly from the circumferential perimeter  302  of the valve  40 . The vents  60  are cut at an acute angle “A” measured from a line running tangent to the circumference of the valve. In one example, the acute angle measured from the line running tangent is about 45 degrees but other angles are contemplated, such as 60 degrees and 30 degrees or at some angle in between. In some embodiments, the vents are formed by simple slits or simple cuts through the valve body  300  along or near the circumferential perimeter  302 . In other embodiments, the vents  60  are v-shaped notches, such as that shown in  FIG. 7 . The gap or size of each V-shaped notch is about 10 degree to about 15 degrees, but can be as much as 30 degrees. The cuts for the vents are relatively shallow, extending only about 0.1 to about 0.25 of the length of the radius of the valve from the circumferential perimeter  302  to the termination of each notch of the slit. The vents are configured to permit air to pass from the distal side to the proximal side of the valve following successful venipuncture. While the vents of  FIG. 7  appear large and susceptible to the flow of blood there-across, upon opening the slits with the actuator, the outward force on the slits will force the V-shaped vents to close. This closing action is represented by the arrows shown in  FIG. 6 , which depict a compressive force imparted to the valve  40  when a medical implement is inserted through the valve to open the slits, as further discussed below. 
     The valves discussed herein may be made from any elastic and flexible or semi-flexible material that is compatible with medical applications, such as being compatible with exposure to blood, medicaments, and other fluids commonly encountered during infusion procedures. 
     In operation, as shown in  FIG. 2 , the valve  7 , which can be any valve discussed elsewhere herein, is opened by the valve actuator  10 . The valve actuator  10  may be displaced or moved by the insertion of a medical implement, such as a male Luer member or a tip of a syringe  14 , into the catheter hub  2 . In some embodiments, the valve  7  is permanently opened by the insertion of the valve actuator  10 . For example, if the tip of the nose end  10   a  of the actuator  10  is inserted in through the slits sufficiently deep, the slits will remain open even after the syringe has been removed. This more permanent open position can further be facilitated by incorporating a recess or groove  210   b  on the nose section of the actuator to engage part of the flaps  320  formed by the slits. Conversely, when the actuator  10  merely opens the flaps  320 , the flaps are sufficiently resilient and will un-flex to close and move the actuator proximally upon withdraw of the syringe. 
     With reference again to  FIG. 6  and as previously alluded to, when a valve actuator is inserted into the valve, the valve actuator directs a radial outward force on the valve body  300 , as indicated by the arrows. The radially outward directed force, indicated by the arrows, causes the valve body  300  to compress radially outwardly against the outer constrain on the valve thus closing in any vent  60  around the perimeter that may be opened. Again, when the valve opener  10  enters the valve  40 , it does so by moving from a proximal surface or first surface  42  of the valve towards its distal or second surface  52  away from the proximal opening of the catheter hub (See, e.g.,  FIGS. 4 a  and 4 b   ). Because of the proximal to distal movement of the valve opener  10  when it enters the valve  40 , the vents  60  will each be caused to progressively close from its proximal side to its distal side, i.e., progressively along its depth starting from its proximal side, as well as progressively from its radial inward most gap and outwardly to its outer most radial gap, at or near the valve perimeter  302 . Thus, the vents  60  close progressively from the proximal end of each vent, corresponding with the proximal surface  42  of the valve  40 , to the distal end of each vent, corresponding with the distal surface  52  of the valve, and consequently has the effect of squeezing any blood out of the vents  60 . The removal of blood by the squeezing action will prevent coagulation in the vents, which will in turn reduce the possibility of infection. It also prevents hemolysis, which would render the blood sample unusable. 
     With the vents  60  open, the valve, when used in a catheter application, can vent air to allow some flashback. When a greater pressure differential is introduced on the proximal side of the valve, such as when a vacuum vial or tube for collecting blood samples is connected to the catheter hub, or, as shown in  FIG. 2 , a syringe  14  is connected and the plunger (not shown) withdrawn, blood is drawn toward the valve  7  due to the pressure differential. In the case of the above-described embodiments, the vents  60  are closed automatically upon insertion of the valve opener  10  in order to direct the blood solely through the slit opening and into the syringe or the vacuum vial. 
       FIG. 8  is a schematic cross-sectional side view of a valve  40  provided in accordance with aspect of the present disclosure inside a catheter hub (not shown but resembles condition of  FIG. 1 ) with a needle  9  projecting through the through seam  312  and where a plurality of slits  54  forming a plurality of flaps  320  intersect in a ready position. With at least one void  44  incorporated on the proximal side  42  of the valve  40 , the straight needle shaft  62  rests against the interior surfaces  64  of the flaps  320  along the through seams  312 . The tapered geometry provided by the tapered surface  310  of the void  44  allows the flaps  320  to un-flex without excess materials hanging up against the needle, thus allowing the needle shaft  62  to rest against the interior surfaces  64 . In this configuration, the force vector at the seam  312 , indicated by the arrows in  FIG. 8  and generated by the elasticity of the valve body  300 , is more perpendicular relative to the axis of the needle shaft. 
     As shown in  FIG. 9 , when the void is omitted from the valve surface, such as when utilizing a standard prior art valve disk with only slits to form flaps but without any void, the force vector, indicated by the arrows, is more proximal or directed to the proximal surface  42 . Among other things, this is because the portion of the valve surface  64  that forms the transition  66  from the proximal exterior surface  42  to the seam  312  tends to rotate around the point of contact  68  with the needle  9 . Forming the void eliminates this transition  66  and allows the needle  9  to slide more smoothly and readily along the seam and in contact with a larger area of the interior surfaces  64 . 
     Thus when a void or voids  44  are incorporated on the disc surface, then the force of the valve against the needle shaft can be axially neutralized. The void or voids can provide an unexpected solution to the problem of the valve pulling the needle proximally during sterilization of the IV catheter device. Under normal conditions, the axial force on the needle is equalized by the grip on the needle shaft by the tapered tip of the catheter. However, during sterilization with heat and high humidity, certain catheter materials can lessen their grip on the needle shaft and can create a condition that allows the needle to be pulled by the valve. This is an undesirable effect that can lead to the needle bevel being pulled inside the tapered tip of the catheter. This in turn leads to a painful insertion into the patient. 
       FIG. 10  is an end view of yet another valve  40  embodiment in accordance with aspects of the present disclosure and  FIG. 11  is a cross-sectional side view thereof. As shown, the valve  40  includes reinforcing ribs  70  on the distal surface  52 , which, in the present embodiment, is understood to be the surface or side where the needle comes out. The ribs  70  add to the material thickness of the valve at the flaps and therefore the flaps&#39; rigidity. In some embodiments, the ribs  70  are the same material as the rest of the valve, i.e., a unitarily formed body. In other embodiments, the ribs may be made of the same or a different material and joined to the body of the valve. For example, the ribs may be integrally formed with the valve body, or welded to the valve body after they are formed. 
     In use, the valve  40  of  FIG. 10  opens as normal by a valve opener, such as shown in  FIG. 2 . Upon removal of the syringe, the ribs  70  will add to the recoil action on the flaps  320  to increase the closing force of the valve to readily push the valve actuator  10  in the proximal direction. 
     As shown in  FIG. 11 , the ribs  70  sloped or inclined in the radial outward direction starting from the center  56  of the distal surface  52  to a distally extended position in the direction of the circumferential perimeter  72  of the valve  40 . In other embodiments, the slope may be reversed. In some examples, the upper surface  76  of each rib can be straight, concave, convex, or combinations thereof. The starting point  78  of each rib  70  can also start right at the center  56  of the valve rather than being spaced or recessed from the center. In still another example, the proximal surface  42  may incorporate a void  44 , similar to that shown in  FIG. 4 a    or  4   b . Still furthermore, vents may be incorporated around the outer perimeter, similar to that shown in  FIGS. 6 and 7 . 
     As shown in  FIG. 12 , the valve  600  may also be embodied as a cylinder. The valve  600  comprises a disk  602  having a first or distal surface  642 , a second or proximal surface  652 , and a thickness separating the two surfaces, which resembles thickness  304  of  FIG. 4 a   . The disk  602  is positioned at an end of a hollow cylinder section  603  having a length and a body wall thickness defining an interior space and having a hollow or open second end  677 . The disk  602  may resemble or incorporate features of any of the above discussed valve disk embodiments with various configurations of valve slits  654  and voids, ribs, and vents. In the present embodiment, vents  660  are incorporated in the hollow cylinder section  603  and run the entire length of the cylinder and are open to the outer perimeter  672  of the cylinder. The vent paths can be straight or curved. The valve  600  may be used with many catheter assemblies by simply sliding the valve into the interior cavity of a catheter hub with the disk surface  652  facing the proximal opening of the catheter hub. A stepped pin tool can be used to push the valve into the catheter hub. The smaller tip of the pin tool can enter the cylindrical portion  603  of the valve to push the proximal surface  652  and the larger step diameter portion can push against the proximal end surface  607  of the cylinder portion  603  to locate the valve  600  inside the catheter hub. 
     As shown in  FIG. 13 , the hollow cylinder section  603  has an outer diameter OD and an inner diameter ID defining a bore  605 . In some embodiments, the interior walls  682  of the bore  605  are smooth. In other embodiments, the interior walls  682  are textured. In some embodiments, the wall  610  of the cylinder is of uniform thickness around the perimeter  672 , except for the vent locations. In other embodiments, the wall  610  can be formed with varying thicknesses, which define the shape of the bore  605 . The vents  660  are cut to a depth of about half the thickness of the cylinder wall  610 . The slits  654  and the corresponding flaps  620  pass through the thickness of the valve disk section  602  and open into the hollow cylinder section  603 . 
     As shown in  FIG. 14 , the hollow cylinder wall  610  defines a proximal end face  607 . As discussed above, the slits  654  and the corresponding flaps  620  pass through the thickness of the valve disk and are visible from the proximal end. Likewise, the vents  660  run the length L of the valve and the proximal end of the vent  661  is visible. 
     With reference now to  FIG. 15 , a perspective view of a valve embodiment  700  provided in accordance with further aspects of the present disclosure is shown. The valve  700  comprises a valve body  702  comprising a perimeter  704 , a proximal or first surface  742 , a distal or second surface  756 , and a thickness defined by a gap or distance between the two surfaces. Although perimeter vents are not shown, vents  60  can be incorporated as shown in  FIGS. 6 and 7 . Centrally, a plurality of slits  706  defining a plurality of flaps  708  are provided. As shown, the valve  700  comprises three slits  706  and three flaps  708 . In other examples, fewer than three slits or more than four slits may be provided. The slits preferably meet at a central location  710 , which define a through seam extending from the proximal surface  742  to the distal surface  756 . 
     A perspective view of a void  712  is shown formed around the slits  706 . The void  712  provides the same advantages discussed above with reference to  FIGS. 4 a , 4 b   ,  5 ,  6 ,  7 , and  8 . As shown, the void  712  comprises a three-sided or three wings  750 ,  752 ,  754  structure with each wing comprising a set of three tapered surfaces  714   a ,  714   b ,  714   c  surrounding each slit  706 . The three tapered surfaces include two side tapered surfaces  714   a ,  714   b  and one end tapered surface  714   c . Generally, the two side surfaces  714   a ,  714   b  are longer or larger in surface area than the end tapered surface  714   c  although it is possible for the reverse to be true. If there are five slits  706 , as an example, then five wings would be provided with each wing comprising three tapered surfaces  714   a ,  714   b ,  714   c . The three tapered surfaces  714   a ,  714   b ,  714   c  can meet along a finite line at the slit  706 , similar to the sharp tip  46  of  FIG. 4 a   . Alternatively, the three tapered surfaces  714   a ,  714   b ,  714   b  can terminate at spaced distances so as to form planar surfaces proximate each slit  706 , similar to the base surface  314  of  FIG. 4 b   , which has an inner perimeter internally of the void perimeter. 
     In one example, the valve  700  is formed, such as molded, with the void  712 . The slits  706  are then formed by cutting through the valve body  702  at the center of the void. In another example, the void  712  is provided on both the proximal surface and the distal surface. The void  712 , like that of  FIGS. 4 a , 4 b   ,  5 ,  6 ,  7 , and  8 , comprises a perimeter  716  that is recessed or radially inwardly disposed relative to the valve perimeter  704 . Thus, the present disclosure is understood to include a valve disc comprising a perimeter, a proximal surface, and a distal surface, and wherein a void is formed centrally of the valve. The present disclosure is further understood to include a perimeter formed around the void and wherein the void perimeter is located radially inwardly of the valve perimeter. The valve can further include a plurality of slits formed at the void. In some examples, a void is formed at the proximal surface and another void at the distal surface. One or more vents may be formed at the valve perimeter. In one example, the one or more vents each comprises a simple cut. In another example, the one or more vents each comprises a notch. In other examples, any of the valves discussed elsewhere herein may incorporate the void  712  with multi-sided wings discussed with reference to  FIG. 15 . 
     Although limited embodiments of the valved catheter 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 parts of the valve may incorporate alternate materials, etc. Furthermore, it is understood and contemplated that features specifically discussed for one valved catheter assembly embodiment may be adopted for inclusion with another valved catheter assembly embodiment, provided the functions are compatible. For example, reinforcing ribs may be used in another embodiment shown with a void on the proximal surface. Another example is the slits  660  in  FIGS. 12, 13 and 14  may be notches as shown in  FIG. 7 . Accordingly, it is to be understood that the valved catheter assembly assemblies and their components constructed according to principles of the disclosed device, system, and method may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.