Catheter devices with valves and related methods

Abstract

Needle assemblies and related methods having a needle hub with a needle, a catheter tube with a catheter hub and having the needle extending through the catheter tube in a ready to use position. A valve is positioned in an interior cavity of the catheter hub, the valve having sections that can deflect in a distal direction and sections that can deflect in a proximal direction to open a fluid flow path through the valve. The valve can be deflected by a multi-piece valve opener.

1 - 17 . (canceled) 
     
     
         18 . A needle assembly comprising:
 a needle hub with a needle extending from a distal end of the needle hub;   a catheter tube attached to a catheter hub and having the needle extending through the catheter tube in a ready to use position;   a valve positioned in an interior cavity of the catheter hub, said valve comprising a valve disc comprising a plurality of slits defining a plurality of flaps;   a first valve opener located in the interior cavity of the catheter hub and having a leg extension extending in a proximal direction towards a distally facing surface of the valve disc;   a second valve opener located in the interior cavity of the catheter hub and having a nose section at a distal end, the nose section positioned adjacent a proximally facing surface of the valve disc; and   a needle guard comprising a proximal wall with an opening having the needle passing therethrough located, at least in part, in a holding space of the second valve opener.   
     
     
         19 . The needle assembly of  claim 18 , wherein the first valve opener is attached to a bushing and the bushing wedges the catheter tube against an interior surface of the catheter hub. 
     
     
         20 . The needle assembly of  claim 18 , wherein the first valve opener is unitarily formed with a bushing and the bushing wedges the catheter tube against an interior surface of the catheter hub. 
     
     
         21 . The needle assembly of  claim 18 , wherein the first valve opener has three spaced apart leg extensions aligned with three flaps of the valve. 
     
     
         22 . The needle assembly of  claim 18 , wherein the first valve opener has a base with a tapered cone and a rim, the tapered cone sized to abut a bushing and the rim sized to wedge against a shoulder of the catheter hub. 
     
     
         23 . The needle assembly of  claim 18 , wherein the second valve opener has two reliefs, openings or through passages and wherein the needle guard has two elbows, one each extending at least partly through a respective relief, opening or through passage. 
     
     
         24 . The needle assembly of  claim 18 , wherein the second valve opener has a first continuous perimeter section spaced from a second continuous perimeter section. 
     
     
         25 . The needle assembly of  claim 18 , wherein the valve comprises a skirt section extending distally of a valve disc and the first valve opener has a nose section located in a distal holding space of the valve. 
     
     
         26 . The needle assembly of  claim 18 , wherein the valve has a skirt section that is sized and shaped to slide within the interior of the catheter hub when the valve is pushed by the second valve opener. 
     
     
         27 . The needle assembly of  claim 18 , wherein the needle guard comprises two arms extending distally of the proximal wall and a distal wall on each of the two arms. 
     
     
         28 . The needle assembly of  claim 18 , wherein the second valve opener has two spaced apart plunger elements and the needle guard is located between the two spaced apart plunger elements. 
     
     
         29 . The needle assembly of  claim 28 , wherein the second valve opener comprises a ring and two through passages, wherein the needle guard has two arms and an elbow on each arm, and wherein each elbow is positioned in one of the two through passages. 
     
     
         30 . The needle assembly of  claim 29 , wherein the proximal wall is located proximally of the ring. 
     
     
         31 . A catheter assembly comprising:
 a needle hub with a needle having a needle tip extending from a distal end of the needle hub;   a catheter tube attached to a catheter hub and having the needle extending through the catheter tube in a ready to use position, the catheter hub having a hub body with an interior cavity;   a valve comprising a valve disc with a plurality of valve flaps positioned in the interior cavity of the catheter hub,   a first valve opener positioned distally of the valve disc and having a leg extension with aq bore; and   a second valve opener positioned proximally of the valve disc and having a nose section at a distal end located adjacent a distally facing surface of the valve disc.   
     
     
         32 . The catheter assembly of claim  14 , further comprising a needle guard comprising a proximal wall with an opening having the needle passing therethrough, said needle guard configured to cover said needle tip in a protective position. 
     
     
         33 . The catheter assembly of claim  15 , wherein the needle guard is located in the interior cavity of the catheter hub, between two plunger elements of the second valve opener. 
     
     
         34 . A method of manufacturing a needle assembly comprising:
 providing a catheter hub with a catheter tube with a distal tube opening, said catheter hub comprising a hub body defining an interior cavity;   positioning a bushing inside the catheter hub and against the catheter tube to wedge the catheter tube to the catheter hub;   positioning a valve proximally of the bushing, said valve comprising a valve disc comprising a plurality of slits defining a plurality of valve flaps;   positioning a proximal valve opener proximal of the valve disc and inside the interior cavity of the catheter hub, said proximal valve opener comprising a nose section sized and shaped to push the valve into an open position;   positioning a distal valve opener comprising a leg between the bushing and the valve disc; and   placing a needle, which is attached to a needle hub, through the catheter hub, the valve, and the catheter tube so that a needle tip of the needle extends out the distal tube opening of the catheter tube.   
     
     
         35 . The method of  claim 34 , further comprising passing the needle through an opening on a proximal wall of a needle guard, said needle guard configured to cover said needle tip in a protective position. 
     
     
         36 . The method of  claim 34 , wherein the valve is axially displaceable inside the interior cavity of the catheter hub along an axial direction of the catheter hub and comprises two or more flaps. 
     
     
         37 . The method of  claim 35 , further comprising placing an elbow of the needle guard through a relief, opening or through passage of the proximal valve opener. 
     
     
         38 . The method of  claim 34 , wherein the leg is unitarily formed with the bushing. 
     
     
         39 . The method of  claim 34 , wherein the proximal valve opener has a ring and two through passages. 
     
     
         40 . The method of  claim 34 , wherein the proximal valve opener has a first continuous perimeter section spaced from a second continuous perimeter section. 
     
     
         41 . The method of  claim 35 , wherein the proximal valve opener comprises two stabilizer elements connecting two plunger elements and wherein a gap between the two stabilizer elements define a choke point for limiting proximal movement of the needle guard.