Catheter devices with valves and related methods

Abstract

Needle assemblies (100) and related methods in which a valve opener (134) is pushed into a valve (136) to open one or more slits (143) to separate a plurality of flaps (145) on the valve to open the valve to create an internal reaction force within the plurality of flaps. After the valve opener is removed from the valve, the plurality of flaps of the valve are retracted to the closed position with the internal reaction force, thereby sealing the valve until the flaps are reopened in case of reuse. The needle assemblies each include a needle hub (106) having a needle (108), a catheter conduit (104) having a catheter hub (102), the valve, and the valve opener located in a lumen (130) of the catheter hub.

Description

Technical Field

[0001] The disclosed invention generally relates to needle devices, arterial catheters, and intravenous (IV) infusion devices, including IV catheters. In particular, an IV catheter assembly having a valve and a valve actuator for opening the valve is disclosed. Background Art

[0002] IV catheters are commonly used for various infusion treatments, including injecting fluid into a patient, extracting blood from a patient, or monitoring various parameters of a patient's vascular system. The catheter is typically connected to a catheter adapter, which is suitable for attaching an IV tube to the catheter. The blood control catheter includes an internal blood control valve, which is opened by inserting a male Luer connector (Luer) or other object into the proximal end of the catheter adapter. A non-limiting example of a blood control valve is disclosed in U.S. Patent Application Publication No. 2011 / 0046570, entitled "Systems and Methods for Providing a Flushable Catheter Assembly", filed on August 20, 2009. After the catheter is placed in the patient's vascular system, an IV fluid source can be connected to a catheter adapter or a catheter hub, thereby opening the blood control valve. Therefore, the fluid from the IV source can begin to flow into the patient through the catheter.

[0003] As is known in the art, typical blood pressure is 10 to 20 cm H2O. The infusion bag is usually placed about 100 cm above the patient's heart to introduce flow into the patient. At about this height, the pressure exerted by the fluid from the infusion bag is much greater than the patient's blood pressure, and therefore may flow into the patient.

[0004] Some catheter adapters allow verification of proper placement of the catheter in the blood vessel before fluid infusion begins, such as by providing a flashback chamber of the catheter assembly where "flashback" of blood can be observed. To confirm flashback in a catheter assembly that does not include a blood control valve, the clinician must manually occlude the vein to prevent undesired exposure to blood. In contrast, a blood control valve can eliminate the need for such manual occlusion, while also reducing the possibility of blood exposure during catheter placement. Summary of the invention

[0005] One aspect of the present disclosure includes providing a multi-use blood control system having a reversible valve seal.

[0006] Another aspect of the present disclosure includes providing an intravenous catheter having a low-profile catheter hub.

[0007] Yet another aspect of the present disclosure is to provide an improvement to the prior art blood control or closed system infusion set including an intravenous catheter.

[0008] As described, the needle assembly of the present disclosure may include a plurality of different components. The needle assembly may include: a needle hub having a hub body and a needle having a needle tip extending from a distal end of the hub body; a catheter conduit attached to the catheter hub and having the needle extending through the catheter conduit in a ready-to-use position; a valve located in the lumen of the catheter hub, the valve including a valve body having an outer periphery, an inner surface defining a lumen, a distal opening, a wall structure at a proximal end of the valve body, at least one slit at the wall structure and a plurality of valve flaps, and at least one internal protrusion on each of the plurality of valve flaps, each internal protrusion extending axially distally in the lumen of the valve from a distally facing wall surface of the wall structure; a valve opener including a head section having a push end, the push end being sized and shaped to open the at least one slit when displaced distally by a male Luer tip to open the valve; and a needle guard located in the lumen of the catheter hub and disposed on the needle.

[0009] The needle guard may include a wall located on one side of the needle and movable distal to the needle tip to prevent accidental needle sticks of the needle tip in a guarded position.

[0010] In some examples, the valve may be implemented only within the inner protrusion, without the outer protrusion. In other examples, the valve may further include a plurality of outer protrusions extending in the proximal direction from the proximal-facing surface of the wall structure.

[0011] Each of the plurality of valve flaps may have at least one external protrusion thereon.

[0012] The valve may include an inclined wall surface within the inner cavity for contact by the internal projection.

[0013] The inner cavity may have a first generally cylindrical wall section located adjacent to the inclined wall surface.The inner cavity may have a second generally cylindrical wall section located adjacent to the inclined wall surface and distal to the first generally cylindrical wall section.

[0014] An internal protrusion, an external protrusion, or both an internal and external protrusion on a wall structure at the proximal end of the valve, such as on a flap of the wall structure, can extend the thickness of the wall structure. The thickness can be measured from the outermost surface at the proximal side of the wall structure to the outermost surface at the distal side where the flap is disposed. When the thickness of the wall structure is extended (e.g., the internal protrusion), the flap can be deflected by the valve opener to bring the inner surface of the valve into contact with the convex medical device without deflecting the flap by the same amount as when the protrusion is not incorporated.

[0015] The first generally cylindrical wall section may have a first inner diameter. The second generally cylindrical wall section may have a second inner diameter. The first inner diameter may be greater than the second inner diameter.

[0016] The valve may have a distal opening at a distal end of the valve body, the distal opening leading to the second generally cylindrical wall section.

[0017] The at least one slit may include three slits. The plurality of valve flaps may include three valve flaps.

[0018] The valve opener may include: two actuating elements such that the needle guard is located between the two actuating elements; and a stabilizer connecting the two actuating elements.

[0019] Another aspect of the present disclosure is a catheter assembly. The catheter assembly may include: a needle hub having a needle having a needle tip; a catheter conduit attached to the catheter hub, the catheter hub having a body, the body including an inner surface defining an inner cavity, the needle extending through the catheter conduit; a valve located in the inner cavity of the catheter hub, the valve including a valve body having an outer surface and an inner surface defining an inner cavity, a distal opening at a distal end of the valve body, and a wall structure at a proximal end of the valve body, the wall structure including a plurality of slits defining a plurality of valve flaps; and a plurality of valve flaps located at positions within the inner cavity of the valve. a plurality of internal protrusions on the valve disc and a plurality of external protrusions on the valve disc at a position outside the inner cavity of the valve; a valve opener located within the inner cavity of the catheter hub and proximal to the valve, the valve opener including a head section with an activation end, at least one plunger element, the at least one plunger element having a proximal surface for being pushed by a convex medical device; a needle guard having a proximal wall and a barrier wall, wherein the barrier wall is positioned on one side of the needle and is movable to the distal side of the needle tip to prevent accidental needle sticks of the needle tip in a protective position.

[0020] The at least one inner protrusion may be aligned with the at least one outer protrusion such that a thickness measured at the aligned at least one inner protrusion and at least one outer protrusion is thicker than a thickness of the wall structure.

[0021] Each of the plurality of valve flaps may have at least one inner protrusion aligned with at least one outer protrusion.

[0022] The valve may include an inclined wall surface within the inner cavity for contact by the internal projection.

[0023] The inner cavity of the valve may have a first generally cylindrical wall section located adjacent to the inclined wall surface, and a second generally cylindrical wall section located adjacent to the inclined wall surface and distal to the first generally cylindrical wall section.

[0024] The valve may have a distal opening to the second generally cylindrical wall section.

[0025] The valve opener may further include a stabilization ring defining a continuous peripheral segment.

[0026] Another aspect of the present disclosure is a method for assembling a needle assembly. The method may include: providing a catheter hub having a catheter conduit, the catheter conduit having an open distal end and a proximal end attached to the catheter hub by a sleeve, the catheter hub including a hub body, the hub body having an inner surface defining an inner cavity and a proximal opening; positioning a valve proximal to the sleeve, the valve including an inner surface defining an inner cavity, a distal opening, at least one slit, and a plurality of valve flaps at the proximal end of the valve, and a plurality of internal protrusions, wherein at least one internal protrusion is positioned on each of the plurality of valve flaps in the inner cavity of the valve; positioning a valve opener in a pre-activated position within the inner cavity of the catheter hub and proximal to the valve, when a convex medical device is engaged When the valve opener is pushed into the valve, the valve opener is capable of sliding distally to deflect the multiple valve flaps in the distal direction, thereby compressing the multiple internal protrusions against the inner surface of the valve, thereby generating an internal reaction force, and the internal reaction force is configured to return the valve flaps to the closed position when the valve opener is moved proximally to the pre-activated position; placing a needle attached to a needle hub through the catheter hub, the valve and the catheter tubing so that the tip of the needle extends out of the open distal end of the catheter tubing in a ready-to-use position; and placing a needle guard within the inner cavity of the catheter hub and on the needle.

[0027] The valve opener may include a head section having an actuating end. The actuating end may contact the valve in a ready-to-use position.

[0028] The valve opener may include a head section having an actuating end. In the ready-to-use position, the actuating end may be spaced apart from the valve.

[0029] The catheter assembly may be more broadly referred to as a needle assembly or needle device. The catheter assembly may include a catheter hub having a catheter conduit attached to a hub body via a hub and cannula hub, or a needle hub having a needle extending through the catheter hub, and the catheter conduit having a needle tip extending out of a distal end or distal opening of the catheter conduit in a ready-to-use position.

[0030] In the ready position, the catheter assembly is ready for use, such as for performing venipuncture or venous access. Sometimes, the ready position may first require removing a protective cap from the catheter assembly or needle assembly.

[0031] Inside the catheter hub, a diaphragm or valve, an actuator or valve opener, and a safety clip, such as a needle guard or tip protector, may be provided. The needle may be inserted through the proximal opening of the catheter hub, with the needle tip protruding from the distal opening of the catheter tubing in a ready-to-use position.

[0032] The proximal opening of the catheter hub can be sized to have a female Luer taper, optionally with external threads, to engage with a male Luer tip in a Luer slip or Luer lock connector. In use, after successful venipuncture, when the male Luer tip is engaged, the valve opener can be pushed into the valve to open the slit, thereby separating the multiple valve flaps on the valve to open the valve. The valve flaps deflect radially and distally, thereby generating an internal reaction force within the multiple valve flaps.

[0033] When the valve is in the open position, a fluid path for fluid flow is formed between the male Luer tip and the distal opening of the catheter tube. After the distally directed force on the valve opener is removed from the valve, such as after the male Luer tip is removed, the internal reaction force causes the multiple valve flaps to return to the closed position.

[0034] In the closed position, the valve can form a seal that prevents or limits proximal fluid flow, such as blood flow, through the valve and out of the proximal opening of the catheter hub. After the valve is closed, the same or a different male Luer tip can engage the catheter hub and push the valve opener in a distal direction to reopen the valve. Thus, the catheter assembly can provide multi-pathway blood control.

[0035] A flashback plug may be provided at the proximal end of the needle hub that allows air to escape when blood enters the flashback chamber during primary flashback, but prevents blood from overflowing the proximal end of the plug. Alternatively, a syringe may be attached to the proximal end of the needle hub. The needle hub also includes a shoulder or other surface that physically contacts the catheter hub, such as the proximal surface of the catheter hub, to axially align the two hubs, thereby setting the length of the needle tip that protrudes from the distal opening of the catheter tubing.

[0036] A protective cap having a sleeve and a saddle may be provided to cover the needle during packaging and before use, as is conventional. The saddle may surround at least a portion of the catheter hub and the needle hub and be removably coupled to the needle hub.

[0037] The catheter assembly or needle assembly may be in a ready position, a transition stage, and a removal stage in which the needle is completely removed from the catheter hub and the tip protector covers the needle tip in a protecting position.

[0038] During removal of the needle, the tip guard may be activated. The tip guard may implement any number of prior art guards configured to block the tip of the needle. The tip guard may implement one of the guards shown in U.S. Patent No. 6,616,630, the contents of which are expressly incorporated herein by reference.

[0039] For example, a needle guard may have a proximal wall and two resilient arms, and wherein a profile change on the needle, such as a curl or protrusion, engages a perimeter defining an opening on the proximal wall of the needle guard to retract the needle guard outwardly from the catheter hub in a proximal direction after a successful venipuncture.

[0040] The two arms may intersect as described in US Patent No. 6,616, 630. The needle guard arms may deploy through the shaft of the needle in the ready position and engage the guard engaging section of the valve opener and / or the interior of the catheter hub to retain the needle guard within the catheter in the ready-to-use position.

[0041] In one example, only a portion of the tip guard or needle guard may extend into the valve opener, while a proximal section (eg, a proximal wall) of the needle guard may extend proximally or be located proximal to a proximal-most surface of the valve opener.

[0042] In other examples, one of the needle guards described in the '630 patent can be used with the catheter assembly of the present invention. For example, one of the needle guards can be utilized that has only one arm that extends along one side of the shaft of the needle, rather than through the needle. Likewise, the distal wall of the one arm can be located on one side of the shaft of the needle in the ready position. When the needle tip moves proximal to the distal wall, the distal wall can move distal to the needle tip to prevent accidental contact with the needle tip and, at the same time, release engagement between the needle guard and the valve opener or between the needle guard and an engagement surface on the interior of the catheter hub.

[0043] In advancing from the transition stage to the removal stage, the needle tip moves proximally of the two distal walls, one distal wall at each end of the resilient arms of the needle guard, respectively.

[0044] Alternatively, the needle guard may have one distal wall and / or one arm. Since the two distal walls, and therefore the two resilient arms, are no longer biased outwardly by the needle, for embodiments where the two distal walls are directly biased by the needle shaft, the two arms move radially to disengage from the guard engagement section of the valve opener (e.g., the two bridges of the valve opener) and / or from the engagement surface formed in the interior of the catheter hub. As the needle continues to move in the proximal direction and the contour changes on the needle engage the perimeter on the proximal wall of the needle guard, the needle guard moves proximally with the needle to the removal stage position.

[0045] Alternatively, the needle guard can be clamped onto the shaft of the needle without profile change and removed from the catheter hub as a unit. Notably, in the protection position where the needle guard covers the needle tip, the valve remains within the lumen of the catheter hub. Thus, in both the needle ready position and the needle protection position, the valve is located within the catheter hub.

[0046] The valve may be located within the catheter hub, or in other words, in the inner cavity of the catheter hub, just distal to the head section of the valve opener. The valve may have a valve body having an outer perimeter having a diameter and a length measured orthogonally to the diameter. The valve body may have an elongated portion. The elongated portion may be cylindrical. In some embodiments, the elongated portion of the valve body may be tilted so that the valve forms a truncated cone structure. The valve may be made of any known elastomeric material, with those materials certified for medical use being preferred. In some embodiments, the valve may be made of polyisoprene material. In some embodiments, the valve may be made of any suitable biocompatible elastic material. The valve body may have a distal end and a proximal end. The intersection between the end surface at the distal end and the elongated surface of the valve body may form a fillet, a chamfer, or a straight edge. The valve body may be positioned in a recessed section formed in the inner cavity of the catheter hub, which prevents the valve from moving axially when located within the catheter hub.

[0047] In some examples, a retainer or retaining ring made of a more rigid material than the valve may be incorporated to retain the valve within the catheter hub. For example, the retainer or retaining ring may snap into a shoulder, lip, or groove to secure the valve inside the catheter hub.

[0048] In one example, the recessed section of the inner cavity has a distal shoulder and a proximal shoulder that define a slot therebetween. The valve body length may be sized and shaped to fit within the slot. In some examples, there may be slight interference between the valve body and the space defined by the proximal shoulder and the distal shoulder to retain the valve. The proximal end of the valve may contact the proximal shoulder, and the distal end may contact the distal shoulder, optionally with the shoulder slightly compressed against the valve body. Viewed differently, the valve may contact the distal shoulder and the proximal shoulder of the recessed section and thereby be constrained in a ready-to-use position such that the valve body is axially fixed or cannot move axially.

[0049] In one example, the outer perimeter of the valve may form a close fit or a size-corresponding fit with a recessed section of the inner cavity of the catheter hub. In other examples, a slight interference fit is provided between the two. In still other examples, a small gap is provided between the outer perimeter of the valve and the inner surface at the recessed section, wherein the proximal end of the valve contacts the proximal shoulder and the distal end contacts the distal shoulder of the recessed section. At the recessed section, the outer perimeter may form a seal with the interior of the catheter hub. A distal cavity chamber may be provided distal to the distal end of the valve and proximal to the bushing. The distal cavity chamber may have a wall surface defining a chamber. The wall surface may include a tapered section and may include a maximum inner diameter that is smaller than the inner diameter at the recessed section.

[0050] The proximal end of the valve includes a wall structure. The distal end of the valve body may not have a wall structure. The wall structure at the proximal end closes or is used to block the hole through the valve body at the proximal end of the valve body.

[0051] At least one slit is formed through the thickness of the wall structure, the thickness being measured between the distally facing wall surface and the proximally facing wall surface. If one slit is used, it defines two valve flaps. In some examples, multiple slits are used, thereby defining multiple valve flaps. There may be three slits, thereby defining three valve flaps. The three slits may originate from a central locating point and extend radially from near the central locating point of the body of the valve, similar to a three-pointed star, to form three valve flaps that can be deflected along the slits. In some embodiments, there may be four or more slits, thereby defining four or more valve flaps accordingly.

[0052] The two or more valve flaps may each have an external protrusion extending therefrom. The external protrusion may extend axially in a proximal direction from the proximally facing planar surface of the wall structure. In some embodiments, each valve flap may have more than one external protrusion extending therefrom, such as two or more spaced apart external protrusions.

[0053] There may be three external protrusions, one on each valve flap. The external protrusions may be manufactured as part of the valve. In some embodiments, the external protrusions may be fastened to the valve flap, for example, by a medical grade adhesive. The external protrusions may be made of the same material as the valve or another elastic polymer, such as rubber or silicone. More preferably, the external protrusions are molded integrally with the valve flap. The external protrusions extend the reach of the valve in the proximal direction, so that, for example, when the male Luer tip has a minimum length, a relatively short male Luer tip is connected to the catheter hub to advance the valve opener. Therefore, compared with a valve having the same total length but without external protrusions on the proximal-facing surface of the wall structure, the valve of the present invention has a surface extending further in the proximal direction, so that the valve opener can abut the valve to open the valve flap, and the valve opener does not need to undergo the same distal advancement through the standard male Luer tip. In other words, the male Luer tip can advance the valve opener into the external protrusion to open the valve flap, without having to abut the flat planar surface of the wall structure to open the valve flap. Thus, when the distance that the valve opener advances toward the valve is less than the distance required to otherwise form an opening between or in the at least one slit, an external protrusion extending outwardly in a proximal direction from the proximal-facing surface of the wall structure may allow the valve to open. The external protrusion may have an arcuate shape with rounded edges, similar to a radially cut section of a donut or a section of a ring. In some embodiments, the external protrusions may each have a different shape. By way of example and not limitation, some of these shapes may have a circular, square, rectangular, triangular, or irregularly shaped cross-section. In some examples, the external protrusions may be omitted from the valve flap, or there may be fewer external protrusions than the number of valve flaps.

[0054] In one example, the valve flaps may each have an internal protrusion extending in a distal direction from a distally facing wall surface within the lumen of the valve. In some embodiments, each valve flap may have a plurality of internal protrusions extending in a distal direction from a distally facing wall surface. There may be three internal protrusions, one on each valve flap. In some embodiments, there may be as many internal protrusions as external protrusions. In some embodiments, the number of internal and external protrusions is different from each other. In some embodiments, the internal and external protrusions may each be manufactured as a single piece. In some embodiments, the internal and external protrusions may be aligned along the proximal end. In some embodiments, the internal and external protrusions may be offset along the proximal end.

[0055] The internal protrusions may be manufactured as part of the valve. In some embodiments, the internal protrusions may be fastened to the valve flap, for example by a medical grade adhesive. The internal protrusions may be made of the same material as the valve and / or the external protrusions. The internal protrusions may have the same shape as the external protrusions. In some embodiments, the internal protrusions may have a different shape than the external protrusions. In some embodiments, each or some of the internal protrusions may have a different shape than the others.

[0056] When the valve flap of the valve is opened by the valve opener, which is pushed in the distal direction by the male Luer tip, the internal protrusion may contact the inner wall of a portion of the inner cavity that defines the valve. The size of the internal protrusion and the geometry of the inner wall can be selected to control the amount of compression of the valve flap and the internal protrusion against the inner wall when the valve flap is deflected by the valve opener. This will in turn generate a restoring force to return the valve flap to its closed position when the male Luer tip is removed. Therefore, the internal protrusion can be considered or viewed as an actuator that helps the valve flap return to its closed position to close the valve and limit or restrict the flow through the valve. The actuator can help prevent or delay plastic deformation and heat setting, which may affect the ability of the valve flap to return to its closed state, thereby increasing the life and reusability of the valve.

[0057] The lumen may be defined by a generally cylindrical wall segment and a tapered wall extending from the generally cylindrical wall segment. In one example, the valve body may terminate at the distal end of the tapered wall. In other embodiments, a bore segment may extend from the tapered wall. The bore segment may define an opening or passage extending from the distal end of the valve into the lumen. The wall may extend at an angle in a distal direction from the generally cylindrical wall segment. In some embodiments, the wall may be parallel to the distal end and not tapered. In some embodiments, the wall may have multiple tapers or angles, such as having one or more turning lines or curves.

[0058] In some embodiments, the wall may have a curve, rather than a single slope taper, so as to be concave in the distal direction. In some embodiments, the wall may be eliminated and the generally cylindrical wall section may extend further distally. For embodiments without a tapered wall, the internal protrusion may be sized and shaped to directly contact the inner surface of the valve when the valve flap is deflected by the valve opener.

[0059] The tapered wall has a minimum diameter along its distal side or end. The minimum diameter defines an opening, which may be sized and shaped to accommodate a needle. When coupled to the distal side of the wall, the aperture segment coincides with the minimum diameter of the wall, and the aperture segment may be circular. The aperture segment may be generally cylindrical and may be sized and shaped to accommodate a needle. In other examples, the aperture segment may be non-circular, such as triangular, square, or polygonal in cross-section, having five or more sides. When coupled, the aperture segment may be considered a generally cylindrical distal segment, and the inner surface may be considered a generally cylindrical proximal segment.

[0060] The valve opener may have a head section that advances and actuates the valve flap of the valve. The head section may be an elongated structure and may be generally cylindrical or have a draft angle or taper that terminates at an actuating end. The head section may have a wall surface having a continuous perimeter or a continuous peripheral section without gaps or cracks, such as a cylinder with a continuous wall. The actuating end of the head section may have a blunt distal surface or a sharp edge. In a ready-to-use position, the actuating end of the valve opener may be spaced apart from the proximal end of the valve including the external protrusion. In an alternative embodiment, the actuating end may contact the valve, such as contacting the external protrusion, but without substantially deflecting the valve flap.

[0061] The head segment may be sized and shaped so that the distal actuation end uniformly contacts the external protrusion when advancing the valve flap. In some examples, the valve opener may incorporate fins or guide ribs on the exterior that interact with corresponding channels or tracks formed on or in the catheter hub to ensure little or no undesired rotational displacement. This may allow streamlined flow or more fluid to flow from the valve opener through the passage at the deflected valve flap of the valve. The head segment has a hole. The hole in the head segment and the hole in the valve may have diameters of equal size. In some examples, the hole in the valve opener is larger than the hole in the valve. An exemplary valve opener is disclosed in U.S. Publication No. 2018 / 0214682A1, the contents of which are expressly incorporated herein by reference.

[0062] In some embodiments, a plurality of spaced-apart slits and / or openings may be provided on the head section to allow flow or fluid flushing through the spaced-apart slits. In some embodiments, when the head section advances and actuates the valve flap, the actuating end deflects the valve flap in the distal direction to open the valve without pushing the internal protrusion against the inner wall. In such embodiments, the male Luer tip that pushes the valve opener in the distal direction may have a minimum necessary length, but is still able to open the valve. As previously described, the external protrusion protrudes axially in the proximal direction to occupy a portion of the axial length. In other embodiments, when the actuating end advances and actuates the valve flap, the head section may push the internal protrusion against the inner wall or contact with the inner wall. In such embodiments, the male Luer tip may have a length longer than the minimum necessary length, until a certain maximum length that the male Luer tip may have. Therefore, the catheter assembly is configured to operate with male Luer tips having different tip lengths.

[0063] Thus, aspects of the present invention should be understood to include a catheter assembly or needle assembly comprising a valve and a valve opener, and wherein the valve comprises a valve body comprising an elongated section having a distal end and a proximal end, a wall structure at the proximal end, and wherein an external protrusion extends proximally from a proximally facing surface of the wall structure, and an internal protrusion extends distally from a distally facing surface of the wall structure. The wall structure may have a plurality of slits forming a plurality of valve flaps. Each valve flap may have at least one external protrusion. Each valve flap may have at least one internal protrusion. The valve flap may be deflected by a valve opener that may be moved distally by a male Luer tip inserted into a proximal opening of a catheter hub.

[0064] The two actuating elements or plunger elements may extend proximally of the head section. For example, the two plunger elements may be integrally formed with the head section and may extend from the head section in a proximal direction. A gap or space may be provided between the two plunger elements for positioning a needle guard or a tip protector therebetween. In other words, the two plunger elements or actuating elements each include at least two longitudinal edges, and these edges are spaced apart from each other. The longitudinal edges of the plunger elements may be aligned with, for example parallel to, the longitudinal axis of the valve opener.

[0065] In one example, the actuator or valve opener has a longitudinal axis, and the one or more actuating elements extend axially or parallel to the longitudinal axis. In a specific example, the two actuating elements are radially opposite to each other along the longitudinal axis. As shown, the two actuating elements define an outer diameter that has a size equal to the diameter of the head section.

[0066] In one example, the actuating element is flexible and deflectable such that when pushed by the male Luer tip, the actuating element deflects or bends. The actuating element is capable of deflection by selecting a material with desired elastic properties. In other examples, the actuating element is capable of deflection by incorporating one or more weakened sections, such as by incorporating a structurally thin section, by incorporating a cutout, by adopting a small profile compared to other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element can be flexible and deflectable by selecting a material with desired elastic properties and by incorporating one or more weakened sections.

[0067] In still other examples, each actuating element has more than one different cross-sectional profile or contour along a length segment.For example, an elongated plunger element may have a square profile positioned adjacent to a crescent-shaped profile.

[0068] In one example, the actuating element is rigid and cannot deflect or deform when loaded (e.g., when pushed by the male Luer tip). In addition, a stabilizing element can be incorporated to increase the stiffness of the two actuating elements. The two actuating elements can each include a cross-sectional profile at least at the proximal end that overlaps the pushing end of the male Luer tip so that the male Luer tip can push the valve actuator into the valve.

[0069] The head section of the valve opener can be configured to engage the valve to open the valve when the male Luer tip applies an axial force to the actuating element toward the distal end of the catheter assembly, such as during insertion of an IV drip tube male Luer connector. In general, the head section can be rigid relative to a more flexible valve, which allows the head section, and more specifically the actuating end, to actuate the valve, such as to deflect one or more valve flaps and open one or more gaps on the valve. The head section can be made of an incompressible material, such as metal, rigid plastic, or hard elastomer, for pushing and opening the valve.

[0070] The valve opener shown may include a pair of opposing bands or stabilizers that connect the two actuating elements at a location along the length of the actuating elements between the head section and the proximal end of the actuating elements. In some examples, the stabilizer may be located at the proximal ends of the two actuating elements so that the proximal edge of the stabilizer is approximately flush with the proximal surface of the actuating elements. The two stabilizer elements may be referred to as a first or upper stabilizer element and a second or lower stabilizer element.

[0071] In one embodiment, the stabilizer or stabilizer element may be arcuate, thereby forming an arc that follows the inner contour of the catheter hub and connects one actuating element to another actuating element. The stabilizer or stabilizer element may form a substantially cylindrical section on the valve opener, which section may be spaced apart from the head section of the valve opener. In other words, the valve opener may be elongated and have sections that are continuous in the radial direction and sections that are discontinuous in the radial direction with a clearance or through-passage through the exterior of the valve opener.

[0072] In one example, the stabilizer defines a continuous body section along the periphery or radial direction of the valve opener, which is spaced apart from a head section, which is also continuous along the periphery or radial direction. The two stabilizers or stabilizer elements can be coupled together with two plunger elements to form a ring structure. The two stabilizer elements can be slightly offset and angled to each other. In some embodiments, there can be one, three or different numbers of actuating elements or stabilizers. In one example, the valve actuator with the stabilizer or stabilizer element is made of plastic, such as by plastic injection molding.

[0073] The stabilizer can help the valve actuator remain centered within the catheter hub when the actuator is moved, such as when pushed by the male Luer tip. By remaining centered, the head section can be better aligned with the valve (e.g., the slit), allowing smooth actuation of the valve. The stabilizer can also provide engagement with the lumen of the catheter hub via friction to prevent the actuator from sliding in the proximal direction after the male Luer tip is removed.

[0074] A relief, opening or through passage is provided between the head section and each of the two stabilizers. The two reliefs or through passages provide clearance so that the interior or central portion of the valve actuator can be in open communication with the inner surface of the catheter hub. In other words, there are one or two reliefs, through passages or openings between a continuous section of the head section and a continuous peripheral section defined by the two stabilizers and the plunger element (referred to as a stabilization ring).

[0075] When the two arms are biased outwardly by the sides of the needle, the stabilization ring of the valve opener can have an inner diameter that is smaller than the diameter defined by the diagonal sections or bends of the two arms of the needle guard. Thus, during installation of the needle guard into the holding space of the valve opener, the diagonal sections of the needle guard can be deflected to pass through the stabilization ring and into the open area defined by the relief.

[0076] When the needle guard is located between the two plunger elements, the two distal walls of the needle guard, more specifically the two diagonal sections, can be located in the relief as described above to engage the guard engagement surface on the inner surface of the catheter hub. This allows the needle guard to protrude from the holding space of the valve opener through the two reliefs to engage with the guard engagement surface of the catheter hub. Thus, in the ready-to-use position, and during needle retraction after a successful venipuncture, the needle guard can be retained inside the catheter hub until the needle tip moves proximal to the two distal walls on the needle guard, at which time the needle guard can be closed on the needle tip and removed together with the needle.

[0077] A second undercut or recessed section may be provided in the lumen of the catheter hub proximal to the first recessed section for accommodating the two diagonal sections or bends. Thus, after a successful venipuncture, the needle guard may be prevented from sliding in the proximal direction during retraction of the needle by a shoulder of the second recessed section, or by some other surface feature on the interior of the catheter hub, such as a guard engagement surface on the interior of the catheter hub.

[0078] The distal edge of one or both stabilizers may provide a restraining surface to prevent early activation of the needle guard during retraction of the needle, before the needle tip moves proximal to the two distal walls. In addition to the distal edge, both stabilizers may also have a proximal edge. The distal edge and the proximal edge may not be parallel to the proximal ends of the two plunger elements. Alternatively, the distal edge and the proximal edge of the upper stabilizer may be parallel to each other, and the distal edge and the proximal edge of the lower stabilizer may be parallel to each other, but the corresponding edges of the upper and lower stabilizers may not be parallel to each other. In other words, the upper stabilizer may have a distal inclination, and the lower stabilizer may have a proximal inclination.

[0079] In some examples, one or both stabilizer elements may have a gap or channel, thereby dividing the arcuate stabilizing element into two segments. However, even with a gap in one or both stabilizer elements, the stabilizing ring (which may be a non-continuous ring, similar to a ring with one or more notches formed through the ring) can still provide a constraining surface to prevent the needle guard from being activated early during retraction of the needle, before the needle tip moves proximal to the two distal walls. This constraining surface may also be referred to as a constraining point, a blocking gap, or a blocking point, because it provides a rigid structure that prevents the needle guard from moving proximally thereof unless or until the needle guard first activates and radially collapses to reduce its radial profile, thereby subsequently sliding proximally to the blocking point.

[0080] In one example, one or both bends of the needle guard can be restricted from moving in a proximal direction by a choke point until the one or both bends of the needle guard deflect to reduce a radial profile of the needle guard. In one example, the needle guard can slide through an aperture defined by the stabilization ring from a distal position of the stabilization ring to a proximal position of the stabilization ring when the radial profile of the needle guard is reduced.

[0081] The valve opener can be made of a metal material or of a plastic material. When made of a metal material, the valve opener can be formed by a bending or deep drawing method, and the arcuate profile of the actuating element can provide additional rigidity when pushed by the male Luer tip. Each actuating element may include at least two longitudinal edges, and ribs may be provided along one or two of the longitudinal edges to further increase the structural rigidity. One or more gaps may be provided between any two actuating elements. These gaps may provide gaps or spaces for fluid flows flowing therethrough, for example during flushing of blood or IV infusion. The gaps between the actuating elements may define a holding space to accommodate a needle guard.

[0082] In some embodiments, in the ready-to-use position, most or most of the needle guard, if not all, fits between the two plunger elements within the holding space formed by the body of the valve opener. This allows the catheter hub to be more compact because less longitudinal space is required within the catheter hub to longitudinally fit both the actuator and the tip guard consecutively, or when the two only partially overlap in the axial direction. The proximal wall of the needle guard is generally flush or flush with the proximal end surfaces of the two plunger elements.

[0083] When the needle guard engages only the distal edge of the relief or through passage in the valve opener, then no deformation or diameter change is required on the inner wall of the catheter hub, and the needle guard can be placed further proximally in the female Luer taper section while complying with international Luer standards for tapered fittings, and the overall length of the catheter hub can be further reduced.

[0084] When a convex medical device (e.g., a male Luer tip) is initially inserted into the proximal opening of the catheter hub, the male Luer tip initially contacts two actuating elements on the valve opener to apply a distally directed force on the two actuating elements, thereby opening the valve. The distally directed force causes the valve opener to move in a distal direction until the geometry of the male Luer tip and the proximal opening of the catheter hub prevents the male Luer tip from advancing further distally. In one example, the female Luer taper of the catheter hub and the male Luer taper of the male Luer tip match and prevent the male Luer tip from advancing further distally into the opening of the catheter hub. A seal is provided by the Luer engagement to prevent fluid from leaking out of the proximal opening of the catheter hub.

[0085] As the valve opener moves distally by advancing distally of the male Luer tip, the head section of the valve actuator is pushed distally and pushes the proximal end of the valve. In particular, the head section of the valve opener initially pushes the proximal end of the valve, and because the valve is axially fixed in the first recessed section of the catheter hub, one or more valve flaps on the valve deflect radially and in the distal direction. When the one or more valve flaps are pushed, a reversible force or internal force can be generated in the valve. The fluid from the male Luer tip can then flow through the lumen of the catheter hub, the valve, and the catheter tubing.

[0086] Alternatively, suction may be applied by a male medical device such as a syringe or evacuated blood collection tube and blood drawn from the patient. This is typically done for test samples before infusion therapy begins. Additionally, any residual blood is typically flushed from the interior of the catheter hub before infusion therapy begins.

[0087] After the male Luer tip is removed, the valve opener can be disengaged from the valve. The valve flap can then return to its undeformed position due to the internal forces initially generated by the opening of the valve. Thus, the valve can be used or actuated multiple times, with the valve opener and valve returning to the pre-activated position when the male tip is removed.

[0088] The head section can be configured so that when pushed into the valve during activation, the actuation or activation end does not extend distally beyond the valve flap of the valve. This configuration ensures that when the male Luer tip is removed, the valve opener is pushed back by the valve flap. The distal movement of the male Luer tip is a minimum distal movement. In other embodiments, there may be a maximum distal movement. The difference between the maximum and minimum movement of a standard Luer connector can be approximately 2.5 mm.

[0089] Methods of making and using the catheter assemblies and components thereof described elsewhere herein are within the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0090] These and other features and advantages of the apparatus, systems and methods of the present invention will be appreciated as the foregoing becomes better understood with reference to the specification, claims and accompanying drawings, in which:

[0091] Figure 1 is a schematic side cross-sectional view of a catheter assembly in a ready position with the needle tip extending out of the distal end of the catheter tubing.

[0092] Figure 2 is in a transitional position or state Figure 1 Schematic side cross-sectional view of a catheter assembly of , with a needle in the process of being removed from the catheter tubing and catheter hub, such as after a successful venipuncture.

[0093] Figure 3 yes Figure 1Schematic side cross-sectional view of a catheter assembly of , wherein the needle has been completely separated from the catheter hub and the needle tip is covered by the needle guard.

[0094] Figure 4 yes Figure 1 Schematic side cross-sectional view of a catheter assembly in which the catheter hub is connected to the male Luer tip and the valve opener is advanced a minimum distance through the male Luer tip to open the valve.

[0095] Figure 5 yes Figure 1 Schematic side cross-sectional view of a catheter assembly with the catheter hub connected to the male Luer tip and the valve opener advanced a maximum distance into the valve through the male Luer tip.

[0096] Figure 6 Shows Figure 1 A perspective view of the valve of the catheter assembly.

[0097] Figure 7 Shows Figure 1 A cross-sectional perspective view of a valve of a catheter assembly.

[0098] Figure 8 Shows Figure 1 A front view or distal view of a valve of a catheter assembly.

[0099] Fig. 9 Shows Figure 1 Side view of the valve of the catheter assembly.

[0100] Fig.10 Shows Figure 1 A posterior or proximal view of the valve of a catheter assembly.

[0101] Fig.11 Shows Figure 1 A side cross-sectional view of a valve of a catheter assembly.

[0102] Fig.12 Shows Figure 1 A rear cross-sectional view of the valve of the catheter assembly. DETAILED DESCRIPTION

[0103] The detailed description set forth below in conjunction with the accompanying drawings is intended to be a description of the currently preferred embodiments of the conduit assembly with a control valve provided in accordance with various aspects of the apparatus, system and method of the present invention, and is not intended to represent the only form that can be constructed or utilize the apparatus, system and method of the present invention. This description sets forth the features and steps of the embodiments for constructing and using the apparatus, system and method of the present invention in conjunction with the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures can be realized by different embodiments that are equally intended to be included in the spirit and scope of the present disclosure. As indicated elsewhere herein, the same reference numerals are intended to indicate the same or similar elements or features.

[0104] Reference now Figure 1 , shows a catheter assembly 100, which may be more broadly referred to as a needle assembly or needle device, comprising: a catheter hub 102, wherein a catheter conduit 104 is attached to a hub body 50 via a hub 138; and a cannula hub or needle hub 106, wherein a needle 108 extends through the catheter hub 102 and the catheter conduit 104, wherein a needle tip 110 extends out of a distal end or distal opening 112 of the catheter conduit in a ready-to-use position. In the ready position, the catheter assembly 100 is ready for use, such as for performing a venipuncture or venous access. Sometimes, the ready position may first require the removal of a protective cap (not shown) from the catheter assembly or needle assembly 100.

[0105] Inside the catheter hub 102, a diaphragm or valve 136, an actuator or valve opener 134, and a safety clip 132, such as a needle guard or tip protector, may be provided. The needle 108 may be inserted through the proximal opening 121 of the catheter hub 102, with the needle tip protruding from the distal opening 112 of the catheter tubing 104 in a ready-to-use position. The proximal opening 121 of the catheter hub 102 may be sized to have a female Luer taper, optionally with external threads, to engage a male Luer tip (also known as a Luer needle or Luer pusher) 500 in a Luer slip or Luer lock (see Figure 4-5 ).

[0106] In use, after successful venipuncture and when the male Luer tip 500 is engaged, the valve opener 134 is pushed into the valve 136 to open the one or more slits 143 (see Figure 6 and Fig.10 ), thereby separating the plurality of valve flaps 145 on the valve 136 (see Figure 4-6 , Fig.10 ) to open the valve 136. The valve flaps 145 deflect radially and distally, thereby generating an internal reaction force within the plurality of valve flaps 145. When the valve 136 is in the open position (see Figure 4-5), forming a fluid path for fluid flow between the male Luer tip 500 and the distal opening 112 of the catheter tube 104. After the distally directed force on the valve opener 134 is removed, for example, after the male Luer tip 500 is removed, the internal reaction force causes the plurality of valve flaps 145 to return to the closed position (see Figure 6-11 ). In the closed position, the valve 136 can form a seal that prevents or limits proximal fluid flow, such as blood flow, through the valve and out of the proximal opening 121 of the catheter hub 102. After the valve 136 is closed, the same or a different male Luer tip 500 can engage the catheter hub 102 and push the valve opener 134 in a distal direction to reopen the valve 136. Thus, the catheter assembly 100 can provide multi-pathway blood control.

[0107] A backflow plug 114 may be provided at the proximal end 118 of the needle hub 106 (see Figure 1 and Figure 3 ), the flashback plug 114 allows air to escape when blood enters the flashback chamber 116 during primary flashback, but prevents blood from overflowing the proximal end of the plug. Alternatively, a syringe (not shown) can be attached to the proximal end 118 of the needle hub 106. The needle hub 106 also includes a shoulder 120 or other surface that physically contacts the catheter hub 102, such as a proximal surface 122 of the catheter hub, to axially align the two hubs 102, 106, thereby setting the needle tip 110 protruding from the distal opening 112 of the catheter tube 104 (see Figure 1 and Figure 3 )'s length.

[0108] A protective cap (not shown) having a sleeve and a saddle may be provided to cover the needle 108 during packaging and prior to use, as is conventional. The saddle may surround at least a portion of the catheter hub 102 and the needle hub 106 and be removably coupled to the needle hub 106.

[0109] Overall reference Figure 1-3 , various stages of removing the needle 108 from the catheter tubing 104 and the catheter hub 102 are shown, such as during retraction following a successful venipuncture. Figure 1 shows the needle assembly in the ready position, Figure 2 shows the transition phase, and Figure 3The needle 108 is shown in a stage of complete removal from the catheter hub 102, and the tip guard 132 covers the needle tip 110 in a protective position. During the removal of the needle 108, the tip guard 132 can be activated. The tip guard 132 can implement any number of prior art guards configured to block the needle tip 110 of the needle. In the exemplary embodiment shown, the tip guard 132 can implement one of the guards shown in U.S. Patent No. 6,616,630, the contents of which are expressly incorporated herein by reference. For example, the needle guard 132 can have a proximal wall 280 and two resilient arms 288, 290, and wherein the profile change 144 on the needle 108 (see Figure 3 ), such as a curl or protrusion, engages the perimeter of the opening on the proximal wall 280 defining the needle guard 132 to retract the needle guard 132 outwardly from the catheter hub 102 in the proximal direction after a successful venipuncture. The two arms 288, 290 may intersect, as described in U.S. Pat. No. 6,616,630 and Figure 3 As shown in .

[0110] The needle guard arms 288, 290 may be extended through the shaft of the needle 108 in the ready position and engage the valve opener 134 and / or the internal guard engagement section of the catheter hub (not shown) to retain the needle guard within the catheter in the ready for use position. In one example, only a portion of the tip guard or needle guard 132 may extend into the valve opener 134, while a proximal section of the needle guard 132 (e.g., the proximal wall 280) may extend proximally or be located proximal to the proximal-most surface of the valve opener 134. In other examples, one of the needle guards described in the '630 patent (not shown) may be used with the catheter assembly of the present invention. For example, one of the needle guards having only one arm that extends along one side of the shaft of the needle 108, rather than through the needle 108, may be utilized. Likewise, the distal wall of the one arm may be located on one side of the shaft of the needle 108 in the ready position. When the needle tip 110 moves proximal to the distal wall, the distal wall may move distal to the needle tip 110 to prevent accidental contact with the needle tip 110 and, at the same time, release the engagement between the needle guard 132 and the valve opener 134 or between the needle guard 132 and the engagement surface inside the catheter hub.

[0111] In from Figure 2 Location to Figure 3In the transition from one position to another, the needle tip 110 moves proximal to the two distal walls 300, 302 and, accordingly, one distal wall at each end of the resilient arms 288, 290 of the needle guard 132. Alternatively, the needle guard 132 may have one distal wall and / or one arm. Since the two distal walls 300, 302 and, therefore, the two resilient arms 288, 290 are no longer biased outwardly by the needle 108, for embodiments in which the two distal walls are directly biased by the needle shaft, the two arms 288, 290 move radially to disengage from the guard engagement section of the valve opener 134 (e.g., the two bridges of the valve opener) and / or from the engagement surface formed in the interior of the catheter hub. As the needle continues to move in the proximal direction and the profile on the needle changes 144 (see Figure 3 ) engages the periphery of the proximal wall 280 of the needle guard 132, and the needle guard 132 moves proximally with the needle 108 Figure 3 . Alternatively, the needle guard 132 can be clamped onto the shaft of the needle 108 without the profile change 144 and removed from the catheter hub 102 as a unit. Notably, in the protective position in which the needle guard 132 covers the needle tip 110, the valve 136 remains within the lumen 130 of the catheter hub 102. Thus, in both the ready position of the needle 108 and the protective position of the needle 108, the valve 136 is located within the catheter hub 102. From another perspective, in the ready-for-use position of the catheter assembly 100 (see FIG. 1 ), the valve 136 is located within the catheter hub 102. Figure 1 ) and the protective position of the catheter assembly (see Figure 3 ) In both, the valve 136 is located within the catheter hub 102, in the ready-to-use position, the needle tip 110 extends out of the distal opening 112 of the catheter conduit 104, and in the protected position, the needle 108 is removed from the catheter hub 102 and the needle tip 110 is covered by the needle guard 132.

[0112] Reference again Figure 1 , the valve 136 can be located within the catheter hub 102, or in other words, in the lumen 130 of the catheter hub 102, just distal to the head section 150 of the valve opener 134. The valve 136 can have a valve body 137 having an outer perimeter 153 having a diameter (see Figure 8 ) and a length 155 measured orthogonally to the diameter (see Fig. 9 ). The valve body 137 may have an elongated portion. The elongated portion may be cylindrical. In some embodiments, the elongated portion of the valve body 137 may be tilted so that the valve 136 forms a truncated cone structure. The valve 136 may be made of any known elastomeric material, with those materials certified for medical use being preferred. In some embodiments, the valve may be made of a polyisoprene material. In some embodiments, the valve may be made of any suitable biocompatible elastomeric material.

[0113] The valve body 137 may have a distal end 139 and a proximal end 141. The intersection between the end surface at the distal end 139 and the elongated surface of the valve body 137 may form a rounded corner (see Fig. 9 ), chamfered or straight edges. The valve body 137 can be positioned in a recessed section 420 formed in the lumen 130 of the catheter hub 102, which prevents the valve 136 from moving axially when located within the catheter hub 102. In some examples, a retainer or retaining ring made of a more rigid material than the valve can be incorporated to retain the valve within the catheter hub. For example, the retainer or retaining ring can snap into a shoulder, lip, or groove to secure the valve inside the catheter hub.

[0114] In one example, the recessed section 420 of the lumen 130 has a distal shoulder 420a and a proximal shoulder 420b (see Figure 4-5 ), which define a slot therebetween. Valve body length 155 (see Fig. 9 ) may be sized and shaped to fit within the groove. In some examples, there may be slight interference between the valve body and the space defined by the proximal shoulder and the distal shoulder to retain the valve. The proximal end 141 of the valve 136 may contact the proximal shoulder 420b, while the distal end 139 may contact the distal shoulder 420a, optionally with the shoulders slightly compressed against the valve body. Viewed differently, the valve 136 may contact the distal shoulder 420a and the proximal shoulder 420b of the recessed section 420 and thereby be restrained in a ready-to-use position such that the valve body 137 is axially fixed or non-axially movable.

[0115] In one example, the outer perimeter 153 of the valve 136 (see Figure 8 ) can form a close fit or corresponding size fit with the recessed section 420 of the inner cavity 130 of the catheter hub 102. In other examples, a slight interference fit is provided between the two. In still other examples, a small gap is provided between the outer perimeter 153 of the valve 136 and the inner surface at the recessed section 420, wherein the proximal end 141 of the valve 136 contacts the proximal shoulder 420b and the distal end 139 contacts the distal shoulder 420a of the recessed section 420. At the recessed section, the outer perimeter 153 can form a seal with the interior of the catheter hub. The distal cavity chamber 130a (see Figure 4-5 ) may be disposed distally of the distal end 139 of the valve 136 and proximally of the bushing 138. The distal chamber 130a may have a wall surface defining the chamber. The wall surface may include a tapered section and may include a maximum inner diameter that is smaller than the inner diameter at the recessed section 420.

[0116] Reference now Figure 6 and Fig.10, respectively, a perspective view and a front view of a valve 136 having a proximal end 141 are shown. In this embodiment, the proximal end 141 of the valve 136 includes a wall structure 175. The distal end of the body 137 may be free of a wall structure. The wall structure 175 at the proximal end closes or serves to block the hole through the valve body 137 at the proximal end of the valve body. At least one slit 143 is formed through the thickness of the wall structure 175, which is formed at the distally facing wall surface 175a (see Figure 7 and Fig.12 ) and the proximal-facing wall surface 175b. If one slit 143 is used, it defines two valve flaps. In some examples, multiple slits 143 are used, thereby defining multiple valve flaps 145. Figure 6 and Fig.10 As shown in , there may be three slits 143, thereby defining three valve flaps 145. The three slits 143 may originate from a central positioning point and extend radially from the vicinity of the central positioning point of the body 137 of the valve 136, which is similar to a three-point star to form three valve flaps 145 that can be deflected along the slits 143. In some embodiments, there may be four or more slits 143, thereby defining four or more valve flaps 145 accordingly. The two or more valve flaps 145 may each have an external protrusion 147 extending therefrom. The external protrusion 147 may extend axially in the proximal direction from the proximally facing planar surface 175b of the wall structure 175 ( Fig.10 ). In some embodiments, each valve flap 145 may have more than one external protrusion 147 extending therefrom, such as two or more spaced-apart external protrusions. Figure 6 and Fig.10 As shown in FIG. 1 , there may be three external protrusions, one on each valve flap 145. The external protrusion 147 may be manufactured as part of the valve 136. (See FIG. Fig.11 ) In some embodiments, the external protrusion 147 can be fastened to the valve flap 145, for example, by a medical grade adhesive. The external protrusion 147 can be made of the same material as the valve 136 or another elastic polymer, such as rubber or silicone. Preferably, the external protrusion 147 is integrally molded with the valve flap 145.

[0117] The external protrusion 147 extends the reach of the valve in the proximal direction, such that, for example, when the male Luer tip 500 has a minimum length, a relatively short male Luer tip is connected to the catheter hub 102 to advance the valve opener 134 ( Figure 4 ). Thus, compared to a valve having the same overall length but without the external protrusion 147 on the proximal-facing surface of the wall structure 175, the valve of the present invention has a surface extending further in the proximal direction, so that the valve opener 134 ( Figure 1) can abut the valve to open the valve flap without the valve opener having to undergo the same distal advancement through a standard male Luer tip. In other words, the male Luer tip can advance the valve opener into the external protrusion 147 to open the valve flap without having to abut the flat planar surface of the wall structure 175 to open the valve flap. Therefore, when the distance that the valve opener 134 advances toward the valve 136 is less than the distance required to otherwise form an opening between or in the at least one slit 143, the external protrusion 147 extending outwardly in the proximal direction from the proximal-facing surface 175b of the wall structure 175 can allow the valve 136 to open. Figure 6 , 9 As shown in Figures 10 and 11, the external protrusions 147 may have an arcuate shape with rounded edges, similar to a radially cut section of a donut or a section of a ring. In some embodiments, the external protrusions 147 may each have a different shape. By way of example and not limitation, some of these shapes may have a circular, square, rectangular, triangular, or irregularly shaped cross-section. In some examples, the external protrusions may be omitted from the valve flap, or there may be fewer external protrusions than the number of valve flaps.

[0118] Reference now Figure 7 and Figure 11-12 , showing the lumen 151 of the valve 136. In one example, the valve flaps 145 can each have an internal protrusion 149 extending in a distal direction from the distally facing wall surface 175a within the lumen 151 of the valve 136. In some embodiments, each valve flap 145 can have a plurality of internal protrusions 149 extending in a distal direction from the distally facing wall surface 175a. Figure 7 and Figure 11-12 As shown in , there may be three internal protrusions 149, one on each valve flap 145. In some embodiments, there may be as many internal protrusions 149 as external protrusions 147. In some embodiments, the number of internal protrusions and external protrusions is different from each other. In some embodiments, the internal protrusions 149 and external protrusions 147 can each be manufactured as a single piece. In some embodiments, the internal protrusions 149 and external protrusions 147 can be aligned along the proximal end 141. In some embodiments, the internal protrusions 149 and external protrusions 147 can be offset along the proximal end 141. Fig.11 As shown in , the internal protrusion 149 can be manufactured as part of the valve 136. In some embodiments, the internal protrusion 149 can be fastened to the valve flap 145, for example, by a medical grade adhesive. The internal protrusion 149 can be made of the same material as the valve 136 and / or the external protrusion 147. The internal protrusion 149 can have the same shape as the external protrusion 147, such as Figure 7 and Fig.12, and described elsewhere herein. In some embodiments, the inner protrusions 149 may have a different shape than the outer protrusions 147. In some embodiments, each or some of the inner protrusions 149 may have a different shape than the others.

[0119] When the valve flap 145 of the valve 136 is opened by the valve opener 134, the internal protrusion 149 can contact the inner wall 157 of a portion of the inner cavity 151 defining the valve 136, and the valve opener 134 is pushed in the distal direction by the male Luer tip ( Figure 5 ). The size of the internal protrusion 149 and the geometry of the inner wall 157 can be selected to control the amount of compression of the valve flap 145 and the internal protrusion 149 against the inner wall 157 when the valve flap is deflected by the valve opener. This in turn will generate a restoring force to return the valve flap to its closed position when the male Luer tip is removed. Therefore, the internal protrusion 149 can be considered or viewed as an actuator that helps the valve flap return to its closed position to close the valve and limit or restrict flow through the valve. The actuator can help prevent or delay plastic deformation and heat setting, which may affect the ability of the valve flap to return to its closed state, thereby increasing the life and reusability of the valve 136.

[0120] The lumen 151 can be defined by a generally cylindrical wall section 159 and a tapered wall 157 extending from the generally cylindrical wall section 159. In one example, the valve body 137 can terminate at a distal end of the tapered wall 157. In other embodiments, a bore section 160 can extend from the tapered wall 157. The bore section 160 can define an opening or passage extending from the distal end of the valve into the lumen 151. The wall 157 can extend at an angle in a distal direction from the generally cylindrical wall section 159, such as Fig.11 In some embodiments, the wall 157 may be parallel to the distal end 139 and not tapered. In some embodiments, the wall 157 may have multiple tapers or angles, such as having one or more turning lines or curves.

[0121] In some embodiments, wall 157 may have a curve, rather than a single slope taper as shown, so as to be concave in the distal direction ( Figure 4-5 ). In some embodiments, wall 157 can be eliminated and a generally cylindrical wall segment 159 can extend further distally. For embodiments without tapered wall 157, internal protrusion 149 can be sized and shaped to directly contact inner surface 159 of valve 136 when the valve flap is deflected by the valve opener. Tapered wall 157 has a minimum diameter 161 along its distal side or distal end. Minimum diameter 161 defines an opening that can be sized and shaped to accommodate needle 108 ( Figure 1 ).like Figure 8, when coupled to the distal side of the wall 157, the hole segment 160 coincides with the minimum diameter 161 of the wall 157, and the hole segment 160 may be circular. The hole segment 160 may be generally cylindrical and may be sized and shaped to accommodate the needle 108. In other examples, the hole segment 160 may be non-circular, such as triangular, square, or polygonal in cross-section, thereby having five or more sides. When combined, the hole segment 160 may be considered to be a generally cylindrical distal segment, and the inner surface 159 may be considered to be a generally cylindrical proximal segment.

[0122] Reference now Figure 4-5 , the valve opener 134 may have a head section 430 that can advance and actuate the valve flap 145 of the valve 136. The head section 430 can be an elongated structure and can be generally cylindrical or have a draft angle or taper that terminates at an actuation end 436. The head section 430 can have a wall surface that has a continuous perimeter or continuous peripheral section without gaps or gaps, such as a cylinder with a continuous wall. The actuation end 436 of the head section 430 can have a blunt distal surface or a sharp edge. In the ready-to-use position (see Figure 1 ), the actuation end 436 of the valve opener 134 can be spaced apart from the proximal end 141 of the valve 136 including the external protrusion 147. In alternative embodiments, the actuation end 436 can contact the valve, such as contacting the external protrusion 147, but will not substantially deflect the valve flap.

[0123] The head section 430 may be sized and shaped so that the distal actuation end 436 uniformly contacts the external protrusion 147 when advancing the valve flap 145. In some examples, the valve opener 134 may incorporate fins or guide ribs on the exterior that interact with corresponding channels or tracks formed on or in the catheter hub to ensure little or no undesired rotational displacement. This may allow streamlined flow or more fluid to flow from the valve opener 134 through the passage at the deflected valve flap of the valve 136. The head section 430 has a hole 165. The hole 165 of the head section 430 and the hole 160 of the valve 136 may have diameters of equal size. In some examples, the hole 165 of the valve opener is larger than the hole 160 of the valve. An exemplary valve opener is disclosed in U.S. Publication No. 2018 / 0214682A1, the contents of which are expressly incorporated herein by reference.

[0124] In some embodiments, a plurality of spaced-apart slits and / or openings may be provided on the head section 430 to allow flow or fluid flushing through the spaced-apart slits. Figure 4In the embodiment of the present invention, when the head section 430 advances and actuates the valve flap 145, the actuation end 436 deflects the valve flap 145 in the distal direction to open the valve without pushing the internal protrusion 149 against the inner wall 157. In such embodiments, the male Luer tip 500 that pushes the valve opener 134 in the distal direction can have a minimum necessary length, but still be able to open the valve 136. As previously described, the external protrusion 147 protrudes axially in the proximal direction to occupy a portion of the axial length. In other embodiments, for example, Figure 5 In an embodiment of the present invention, when the actuation end 436 advances and actuates the valve flap 145, the head section 430 can push the inner protrusion 149 against or contact the inner wall 157. In such embodiments, the male luer tip 500 can have a length that is longer than the minimum necessary length, up to a certain maximum length that the male luer tip 500 can have, such as Figure 5 The male Luer tip 500. Thus, the catheter assembly is configured to operate with male Luer tips having different tip lengths.

[0125] An internal protrusion, an external protrusion, or both an internal and external protrusion on the wall structure at the proximal end of the valve (e.g., on a flap of the wall structure) can extend the thickness of the wall structure. The thickness can be measured from the outermost surface at the proximal side of the wall structure to the outermost surface at the distal side where the flap is disposed. When the thickness of the wall structure is extended (e.g., the internal protrusion), the flap can be deflected by the valve opener to bring the inner surface of the valve into contact with the convex medical device without deflecting the flap by the same amount as when the protrusion is not incorporated.

[0126] Thus, aspects of the present invention should be understood to include a catheter assembly or needle assembly comprising a valve and a valve opener, and wherein the valve comprises a valve body comprising an elongated section having a distal end and a proximal end, a wall structure at the proximal end, and wherein an external protrusion extends proximally from a proximally facing surface of the wall structure, and an internal protrusion extends distally from a distally facing surface of the wall structure. The wall structure may have a plurality of slits forming a plurality of valve flaps. Each valve flap may have at least one external protrusion. Each valve flap may have at least one internal protrusion. The valve flap may be deflected by a valve opener that may be moved distally by a male Luer tip inserted into a proximal opening of a catheter hub.

[0127] The two actuating elements or plunger elements 152 may extend proximally of the head section 430. For example, the two plunger elements 152 may be integrally formed with the head section 430 and may extend from the head section 430 in a proximal direction. A gap or space may be provided between the two plunger elements 152 for positioning the needle guard or tip protector 132 therebetween. In other words, the two plunger elements or actuating elements 152 each include at least two longitudinal edges, and these edges are spaced apart from each other. The longitudinal edges of the plunger elements 152 may be aligned with, for example, parallel to, the longitudinal axis of the valve opener 134.

[0128] In one example, the actuator or valve opener 134 has a longitudinal axis, and the one or more actuating elements 152 extend axially or parallel to the longitudinal axis. In a specific example, the two actuating elements 152 are radially opposite to each other along the longitudinal axis. As shown, the two actuating elements 152 define an outer diameter that has a size equal to the diameter of the head section 430.

[0129] In one example, the actuating element 152 is flexible and deflectable such that when pushed by the male Luer tip 500, the actuating element deflects or bends. The actuating element can be deflected by selecting a material having the desired elastic properties. In other examples, the actuating element can be deflected by incorporating one or more weakened sections, such as by incorporating a structurally thin section, by incorporating a cutout, by adopting a small profile compared to other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element 152 can be flexible and deflectable by selecting a material having the desired elastic properties and by incorporating one or more weakened sections.

[0130] In still other examples, each actuation element 152 has more than one different cross-sectional profile or contour along a length segment.For example, an elongated plunger element may have a square contour positioned adjacent to a crescent-shaped contour.

[0131] In one example, the actuation elements 152 are rigid and may not deflect or deform when loaded (e.g., when pushed by the male luer tip 500). In addition, a stabilizing element may be incorporated to increase the stiffness of the two actuation elements 152. The two actuation elements 152 may each include a cross-sectional profile at least at the proximal end that overlaps with the pushing end of the male luer tip 500 so that the male luer tip 500 can push the valve actuator 134 into the valve 136.

[0132] The head segment 430 of the valve opener 134 can be configured to engage the valve 136 to open the valve 136 when the male Luer tip 500 applies an axial force to the actuation element 152 toward the distal end of the catheter assembly 100, such as during insertion of an IV drip male Luer connector. In general, the head segment 430 can be rigid relative to the more flexible valve 136, which allows the head segment 430, and more specifically the actuation end 436, to actuate the valve 136, such as to deflect one or more valve flaps 145 and open one or more slits 143 on the valve 136. The head segment 430 can be made of an incompressible material, such as a metal, a rigid plastic, or a hard elastomer, for pushing and opening the valve 136.

[0133] Figure 1-5 The valve opener 134 shown in FIG. 1 includes a pair of opposing bands or stabilizers 444 (collectively or individually referred to as stabilizers 444) that are located along the length of the actuating element 152 at the head section 430 and the proximal end 135 of the actuating element 152 (see FIG. Figure 3 ) are connected to the two actuating elements 152 at a position between the two actuating elements 152. In some examples, the stabilizer 444 can be located at the proximal ends 135 of the two actuating elements 152 so that the proximal edge of the stabilizer 444 is substantially flush with the surface of the proximal ends 135 of the actuating elements 152. The two stabilizer elements 444 can be referred to as a first or upper stabilizer element and a second or lower stabilizer element.

[0134] In one embodiment, the stabilizer or stabilizer element 444 can be arcuate, thereby forming an arc that follows the inner contour of the catheter hub 102 and connects one actuation element 152 to another actuation element 152. The stabilizer or stabilizer element 444 can form a substantially cylindrical section on the valve opener 134, which section can be spaced apart from the head section 430 of the valve opener 134. In other words, the valve opener 134 can be elongated and have sections that are continuous in the radial direction and sections that are discontinuous in the radial direction with a relief or through passage through the exterior of the valve opener 134.

[0135] In one example, the stabilizer 444 defines a continuous body section along the periphery or radial direction of the valve opener 134, which is spaced apart from the head section 430, which is also continuous along the periphery or radial direction. The two stabilizers or stabilizer elements 444 can be coupled together with the two plunger elements 152 to form a ring structure. The two stabilizer elements 444 can be slightly offset and angled with each other. In some embodiments, there can be one, three or different numbers of actuating elements 152 or stabilizers 444. In one example, the valve actuator 134 with stabilizers or stabilizer elements 444 is made of plastic, such as by plastic injection molding.

[0136] The stabilizer 444 can help the valve actuator 134 remain centered within the catheter hub 102 when the actuator is moved, such as when pushed by the male luer tip 500. By remaining centered, the head section 430 can be better aligned with the valve 136 (e.g., the gap 143), thereby allowing smooth actuation of the valve 136. The stabilizer 444 can also provide engagement with the lumen 130 of the catheter hub 102 via friction to prevent the actuator 134 from sliding in the proximal direction after the male luer tip 500 is removed.

[0137] A relief, opening or through passage 448 is provided between the head section 430 and each of the two stabilizers 444. The two reliefs or through passages 448 provide clearance so that the interior or central portion of the valve actuator 134 can be in open communication with the inner surface of the catheter hub 102. In other words, there is a continuous section of the head section 430 and a continuous peripheral section defined by the two stabilizers 444 and the plunger element 152 (referred to as a stabilization ring or stabilization ring 456 (see Figure 1-3 )) are one or two gaps, through passages or openings 448 between them.

[0138] Return to reference Figure 1-3 , when the two arms 288, 290 are biased outwardly by the sides of the needle 108, the stabilizing ring 456 of the valve opener 134 can have an inner diameter that is smaller than the diameter defined by the diagonal section or bend 304 of the two arms 288, 290 of the needle guard 132. Therefore, during installation of the needle guard 132 into the holding space of the valve opener 134, the diagonal section 304 of the needle guard 132 can be deflected to pass through the stabilizing ring 456 and into the open area defined by the relief 448.

[0139] When the needle guard 132 is located between the two plunger elements 152, the two distal walls 300, 302 of the needle guard 132, more specifically the two diagonal sections 304, can be located in the gap 448 as described above to engage the guard engagement surface (not shown) on the inner surface of the catheter hub 102. This allows the needle guard 132 to protrude from the holding space of the valve opener 134 through the two gaps 448 to engage with the guard engagement surface of the catheter hub 102. Therefore, in the ready-to-use position, and during the retraction of the needle 108 after a successful venipuncture, the needle guard 132 can be retained inside the catheter hub 102 until the needle tip 110 moves proximal to the two distal walls 300, 302 on the needle guard 132, at which time the needle guard 132 can be closed on the needle tip 110 and removed together with the needle 102, as shown. Figure 3 as shown in .

[0140] Still refer to Figure 1-3, a second undercut or recessed section 450 may be provided in the lumen 130 of the catheter hub 102 proximal to the first recessed section 420 for accommodating the two diagonal sections or bends 304. Thus, after a successful venipuncture, the needle guard 132 may be prevented from sliding in the proximal direction during retraction of the needle 108 by the shoulder 452 of the second recessed section 450, or by some other surface feature on the interior of the catheter hub 102, such as a guard engagement surface (not shown) on the interior of the catheter hub 102. The distal edge 446a of one or both stabilizers 444 (see Figure 4-5 ) can provide a restraining surface to prevent early activation of the needle guard 132 during retraction of the needle 108, before the needle tip 110 moves proximal to the two distal walls 300, 302. In addition to the distal edge 446a, the two stabilizers 444 can also have a proximal edge 446b (see Figure 4-5 ). The distal edge 446a and the proximal edge 446b may not be parallel to the proximal ends 135 of the two plunger elements 152. Alternatively, the distal edge 446a and the proximal edge 446b of the upper stabilizer 444 may be parallel to each other, and the distal edge 446a and the proximal edge 446b of the lower stabilizer 444 may be parallel to each other, but the corresponding edges of the upper and lower stabilizers 444 may not be parallel to each other. In other words, the upper stabilizer 444 may have a distal inclination, and the lower stabilizer 444 may have a proximal inclination.

[0141] In some examples, one or both stabilizer elements 444 may have a slit or channel, thereby dividing the arcuate stabilizer element into two segments. However, even with a slit in one or both stabilizer elements 444, the stabilizer ring 456 (which may be a non-continuous ring, similar to a ring with one or more notches formed through the ring) can still provide a restraining surface to prevent the needle guard 132 from being activated early during retraction of the needle 108 before the needle tip 110 moves proximal to the two distal walls 300, 302 (see Figure 3 ). This constraining surface may also be referred to as a constraining point, a blocking gap, or a blocking point because it provides a rigid structure that prevents the needle guard 132 from moving proximally unless or until the needle guard 132 is first activated and radially collapsed to reduce its radial profile and subsequently slide proximally of the blocking point. In one example, one or both bends 304 ( Figure 7 ) may be restricted from moving in the proximal direction by the choke point until the one or both bends 304 of the needle guard 132 deflect to reduce the radial profile of the needle guard 132. In one example, the needle guard 132 may slide through the hole defined by the stabilization ring 456 from a distal position of the stabilization ring 456 to a proximal position of the stabilization ring 456 when the radial profile of the needle guard 132 is reduced.

[0142] The valve opener 134 can be made of a metal material or of a plastic material. When made of a metal material, the valve opener 134 can be formed by a bending or deep drawing method, and the arcuate profile of the actuating element 152 can provide additional rigidity when pushed by the male Luer tip 500. Each actuating element 152 can include at least two longitudinal edges, and ribs can be provided along one or two of the longitudinal edges to further increase the structural rigidity. One or more gaps can be provided between any two actuating elements 152. These gaps can provide gaps or spaces for fluid flow flowing therethrough, such as during flushing blood or IV infusion. The gaps between the actuating elements 152 can define a holding space to accommodate the needle guard 132.

[0143] In some embodiments, in the ready-to-use position, most or most (if not all) of the needle guard 132 fits between the two plunger elements 152 within the holding space formed by the body of the valve opener 134, such as Figure 1 This allows the catheter hub 102 to be more compact because less longitudinal space is required within the catheter hub 102 to longitudinally fit both the actuator 134 and the tip protector 132 in series, or when the two only partially overlap in the axial direction. Figure 1 As shown in FIG. 1 , the proximal wall 280 of the needle guard 132 is generally flush or level with the proximal end surfaces of the two plunger elements 152 .

[0144] When the needle guard 132 is only in contact with the gap or through passage 448 in the valve opener 134 (see Figure 4-5 ) of the distal edge 446a (see Figure 4-5 ) are engaged, then no deformation or diameter change is required on the inner wall of the catheter hub 102, and the needle guard 132 can be placed further proximally in the female Luer taper section while complying with international Luer connector standards for tapered fittings, and the overall length of the catheter hub 102 can be further reduced.

[0145] Reference again Figure 4-5When a male medical device (e.g., male Luer tip 500) is initially inserted into the proximal opening of the catheter hub 102, the male Luer tip 500 initially contacts the two actuating elements 152 on the valve opener 134 to exert a distally directed force on the two actuating elements 152, thereby opening the valve 136. The distally directed force moves the valve opener 134 in a distal direction until the geometry of the male Luer tip 500 and the proximal opening 121 of the catheter hub 102 prevents the male Luer tip 500 from further distal advancement. In one example, the female Luer taper of the catheter hub 102 and the male Luer taper of the male Luer tip 500 mate and prevent the male Luer tip 500 from further distal advancement into the opening of the catheter hub 102. A seal is provided by the Luer engagement to prevent fluid from leaking out of the proximal opening 121 of the catheter hub 102.

[0146] When the valve opener 134 is moved distally by advancing distally of the male Luer tip 500, the head section 430 of the valve actuator 134 is pushed distally and pushes the proximal end 141 of the valve 136. In particular, the head section 430 of the valve opener 134 initially pushes the proximal end 141 of the valve 136, and because the valve 136 is axially fixed within the first recessed section 420 of the catheter hub 102, one or more valve flaps 145 on the valve 136 deflect radially and in the distal direction. When the one or more valve flaps 145 are pushed, a reversible force or internal force may be generated within the valve 136. Fluid from the male Luer tip 500 may then flow through the lumen of the catheter hub 102, the valve 136, and the catheter tubing 104.

[0147] Alternatively, suction may be applied by a male medical device such as a syringe or a vacuum blood collection tube and blood may be drawn from the patient. This is typically done for test samples prior to the start of an infusion therapy. Additionally, any remaining blood is typically flushed from the interior of the catheter hub 102 prior to the start of an infusion therapy.

[0148] After the male Luer tip 500 is removed, the valve opener 134 can be disengaged from the valve 136. The valve flap 145 can then return to its undeformed position due to the internal forces initially generated by the opening of the valve 136. Thus, the valve 136 can be used or actuated multiple times, with the valve opener 134 and valve 136 returning to their original positions when the male tip is removed. Figure 1 The pre-activated position shown in .

[0149] like Figure 4As shown in , the head section 430 can be configured so that when pushed into the valve 136 during activation, the actuation or activation end 436 does not extend distally beyond the valve flap 145 of the valve 136. This configuration ensures that when the male Luer tip 500 is removed, the valve opener 134 is pushed back by the valve flap 145. The distal movement of the male Luer tip 500 is minimal distal movement. In other embodiments, for example, Figure 5 In an embodiment of the present invention, there may be a maximum distal movement. The difference between the maximum movement and the minimum movement of a standard Luer connector may be approximately 2.5 mm.

[0150] Methods of making and using the embodiments of the catheter assemblies and components thereof described herein are within the scope of the present invention.

[0151] Needle assemblies, catheter assemblies, parts of needle assemblies and catheter assemblies according to the present invention and methods for using and making catheter assemblies or needle assemblies may be covered by the following exemplary aspects:

[0152] Exemplary aspect 1: A needle assembly comprising:

[0153] a needle hub having a hub body and a needle having a needle tip extending from a distal end of the hub body;

[0154] a catheter conduit attached to the catheter hub and having the needle extending through the catheter conduit in a ready-to-use position;

[0155] a valve positioned in the lumen of the catheter hub, the valve comprising a valve body having an outer periphery, an inner surface defining a lumen, a distal opening, a wall structure at a proximal end of the valve body, at least one slit and a plurality of valve flaps at the wall structure, and at least one internal projection on each of the plurality of valve flaps, each internal projection extending axially distally in the lumen of the valve from a distally facing wall surface of the wall structure; and

[0156] A valve opener includes a head section having a pushing end sized and shaped to open the at least one slit when displaced distally by a male Luer tip to open the valve.

[0157] Exemplary aspect 2: The needle assembly according to aspect 1, further comprising a plurality of external protrusions extending in a proximal direction from the proximal-facing surface of the wall structure.

[0158] Exemplary aspect 3: The needle assembly according to any one of aspects 1 or 2, wherein each of the plurality of valve flaps has at least one external protrusion.

[0159] Exemplary Aspect 4: A needle assembly according to any one of Aspects 1 to 3, wherein the valve includes an inclined wall surface located in the inner cavity, and when the multiple valve flaps are deflected by the valve opener, the inclined wall surface is in a position to be contacted by the at least one internal protrusion.

[0160] Exemplary Aspect 5: A needle assembly according to any one of Aspects 1 to 4, wherein the inner cavity has a first generally cylindrical wall segment positioned adjacent to the inclined wall surface, and a second generally cylindrical wall segment positioned adjacent to the inclined wall surface and away from the first generally cylindrical wall segment.

[0161] Exemplary Aspect 6: The needle assembly of any one of Aspects 1 to 5, wherein the first generally cylindrical wall segment has a first inner diameter, and wherein the second generally cylindrical wall segment has a second inner diameter, and wherein the first inner diameter is greater than the second inner diameter.

[0162] Exemplary aspect 7: The needle assembly according to any one of aspects 1 to 6, wherein, when viewed in a proximal direction from the distal opening, the distal opening opens into the second generally cylindrical wall segment.

[0163] Exemplary aspect 8: The needle assembly according to any one of aspects 1 to 7, wherein the at least one slit comprises three slits converging at a central position, and the plurality of valve flaps comprises three valve flaps.

[0164] Exemplary aspect 9: The needle assembly according to any one of aspects 1 to 8, wherein the valve opener comprises: two actuating elements, such that the needle guard is located between the two actuating elements; and a stabilizer connecting the two actuating elements.

[0165] Exemplary Aspect 10: The needle assembly of any one of Aspects 1 to 9, wherein the distal opening is at least partially aligned at a central axis of the valve body.

[0166] Exemplary Aspect 11: The needle assembly of any one of Aspects 1 to 10, wherein the lumen has an inner diameter, and wherein the distal opening has an opening diameter that is smaller than the inner diameter.

[0167] Exemplary aspect 12: The needle assembly according to any one of aspects 1 to 11, wherein the distal wall on the valve includes a distally facing wall surface and a proximally facing wall surface, and wherein the distal opening is formed through the distal wall.

[0168] Exemplary Aspect 13: The needle assembly according to any one of Aspects 1 to 12 may also include a needle guard device located in the inner cavity of the catheter hub and placed on the needle, the needle guard device including a wall positioned on one side of the needle and capable of moving to the distal side of the needle tip to prevent accidental needle sticks of the needle tip in a protective position.

[0169] Exemplary Aspect 14: The needle assembly of any of Aspects 1 to 13, wherein the valve can be implemented using only the internal protrusions, and also without the external protrusions.The wall structure without the external protrusions is generally flat or planar.

[0170] Exemplary Aspect 15: The needle assembly of any one of Aspects 1 to 14, wherein the valve may further include a plurality of external protrusions extending in a proximal direction from the proximal-facing surface of the wall structure.

[0171] Exemplary Aspect 16: The needle assembly of any one of Aspects 1 to 15, wherein each of the plurality of valve flaps may have at least one external protrusion located thereon.

[0172] Exemplary Aspect 17: A needle assembly according to any one of Aspects 1 to 16, wherein an internal protrusion, an external protrusion, or both an internal and external protrusion on the wall structure at the proximal end of the valve, such as on the valve flap of the wall structure, can expand or increase the thickness of the wall structure.

[0173] Exemplary aspect 18: The needle assembly of any one of aspects 1 to 17, wherein the thickness of the wall structure is measurable from an outermost surface at a proximal side of the wall structure to an outermost surface at a distal side where the valve flap is provided.

[0174] Exemplary Aspect 19: A needle assembly according to any one of Aspects 1 to 18, wherein, when the thickness of the wall structure expands or increases the thickness of the internal protrusion and / or the external protrusion, the valve flap can be deflected by the valve opener using a convex medical device without having to deflect the valve flap the same amount as when no protrusion is incorporated into the wall structure.

[0175] Exemplary Aspect 20: The needle assembly of any one of Aspects 1 to 19, wherein a valve flap having an inner protrusion and / or an outer protrusion is deflected by the valve opener and the valve flap can contact an inner surface of the valve body, such as an inner surface forming an inner cavity.

[0176] Exemplary Aspect 21: The needle assembly of any one of Aspects 1 to 20, wherein the valve body comprises a first generally cylindrical wall section having a first inner diameter and a second generally cylindrical wall section having a second inner diameter, and wherein the first inner diameter is greater than the second inner diameter.

[0177] Exemplary Aspect 22: The needle assembly of any one of Aspects 1 to 21, wherein the valve body comprises a first generally cylindrical wall section having a first inner diameter and a second generally cylindrical wall section having a second inner diameter, and wherein the first inner diameter is smaller than the second inner diameter.

[0178] Exemplary Aspect 23: The needle assembly of any one of Aspects 1 to 22, wherein the valve body may have a second generally cylindrical wall section distal to the first generally cylindrical wall section.

[0179] Exemplary Aspect 24: The needle assembly according to any one of Aspects 1 to 23, wherein the valve opener comprises: two actuating elements, such that the needle guard is located between the two actuating elements; and a stabilizer connecting the two actuating elements.

[0180] Exemplary Aspect 25: The needle assembly of any one of Aspects 1 to 24, wherein the valve opener comprises a head section having an actuation end, and wherein the actuation end contacts the valve in the ready-to-use position.

[0181] Exemplary Aspect 26: The needle assembly of any one of Aspects 1 to 25, wherein the valve opener comprises a head section having an actuation end, and wherein the actuation end is spaced apart from the valve in the ready-to-use position.

[0182] Exemplary Aspect 27: The needle assembly of any one of Aspects 1 to 26, wherein the proximal opening of the catheter hub has a Luer opening, optionally with or without external threads.

[0183] Exemplary Aspect 28: The needle assembly of any one of Aspects 1 to 27, wherein, when the valve is installed within the catheter hub, the wall structure of the valve is oriented proximally of the distal opening.

[0184] Exemplary Aspect 29: The needle assembly of any one of Aspects 1 to 28, wherein the plurality of slits are located between the plurality of external protrusions.

[0185] Exemplary Aspect 30: The needle assembly of any one of Aspects 1 to 29, wherein the wall structure on the valve has a planar surface, and wherein the plurality of external protrusions extend proximally of the planar surface.

[0186] Exemplary Aspect 31: The needle assembly of any one of Aspects 1 to 30, wherein the catheter hub has a groove, and wherein the valve body is located within the groove.

[0187] Exemplary Aspect 32: The needle assembly of any of Aspects 1 to 31, wherein the external protrusions may each comprise an arcuate shape with rounded edges, similar to a radially cut segment of a donut or a segment of a ring.

[0188] Exemplary Aspect 33: The needle assembly of any one of Aspects 1 to 32, wherein the external protrusions may each have a different shape than the other external protrusions, or all of the external protrusions may have the same shape.

[0189] Exemplary Aspect 34: The needle assembly of any one of Aspects 1 to 33, wherein the external protrusion may have a cross-section that is a circular shape, a square shape, a rectangular shape, a triangular shape, a segment of a circular ring, or an irregular shape.

[0190] Exemplary Aspect 35: The needle assembly of any one of Aspects 1 to 34, wherein the external protrusion may be omitted from the valve flap and the valve includes only the internal protrusion.

[0191] Exemplary Aspect 36: The needle assembly of any one of Aspects 1 to 35, wherein the number of the external protrusions is the same as or less than the number of the valve flaps.

[0192] Exemplary Aspect 37: The needle assembly of any of Aspects 1 to 36, wherein the internal protrusions may each comprise an arcuate shape with rounded edges, similar to a radially cut section of a donut or a section of a ring.

[0193] Exemplary Aspect 38: The needle assembly of any one of Aspects 1 to 37, wherein the internal protrusions may each have a different shape than the other internal protrusions, or all of the internal protrusions may have the same shape.

[0194] Exemplary Aspect 39: The needle assembly of any one of Aspects 1 to 38, wherein the inner protrusion may have a cross-section that is a circular shape, a square shape, a rectangular shape, a triangular shape, a segment of a circular ring, or an irregular shape.

[0195] Exemplary Aspect 40: The needle assembly of any one of Aspects 1 to 39, wherein the inner protrusion may be omitted from the valve flap and the valve includes only the outer protrusion.

[0196] Exemplary Aspect 41: The needle assembly of any one of Aspects 1 to 40, wherein the number of the external protrusions is the same as or less than the number of the valve flaps.

[0197] Exemplary Aspect 42: The needle assembly of any one of Aspects 1 to 41, wherein each pair of inner and outer protrusions is aligned at the wall structure.

[0198] Exemplary Aspect 43: The needle assembly of any one of Aspects 1 to 42, wherein each pair of inner and outer protrusions are offset and misaligned at the wall structure.

[0199] Exemplary Aspect 44: The needle assembly of any one of Aspects 1 to 43, wherein when the valve flap of the valve is opened by the valve opener, the internal protrusion contacts an inner wall defining a portion of the lumen of the valve.

[0200] Exemplary Aspect 45: The needle assembly of any one of Aspects 1 to 44, wherein the valve opener is advanced in a distal direction through the male Luer tip.

[0201] Exemplary Aspect 46: The needle assembly of any of Aspects 1 to 45, wherein the size of the internal protrusion and the geometry of the inner wall can be selected to control the amount of compression of the valve flap and the internal protrusion against the inner wall of the valve body when the valve flap is deflected by the valve opener.

[0202] Exemplary Aspect 47: The needle assembly of any one of Aspects 1 to 46, wherein, upon removal of the male Luer tip, a restoring force for returning the valve flap to its closed position is generated by compression of the internal protrusion against the inner wall.

[0203] Exemplary Aspect 48: The needle assembly of any of Aspects 1 to 47, wherein the internal protrusion is an activator to assist in returning the valve flap to its closed position, thereby closing the valve and limiting or restricting flow through the valve.

[0204] Exemplary Aspect 49: The needle assembly of any one of Aspects 1 to 48, wherein the activator prevents or delays plastic deformation and heat setting.

[0205] Exemplary aspect 50: The needle assembly of any one of aspects 1 to 49, wherein the valve has an inner surface defining an inner cavity and an inner wall modifying a profile of the inner surface.

[0206] Exemplary Aspect 51: The needle assembly of any one of Aspects 1 to 50, wherein the inner wall of the valve comprises a curved surface that is concave in the distal direction.

[0207] Exemplary Aspect 52: The needle assembly of any of Aspects 1 to 51, wherein the tapered wall has a minimum diameter along a distal side or end thereof, the minimum diameter defining an opening sized and shaped to receive the needle.

[0208] Exemplary Aspect 53: The needle assembly of any one of Aspects 1 to 52, wherein the bore segment coincides with a minimum diameter of the inner wall.

[0209] Exemplary aspect 54: A catheter assembly or needle assembly comprising a valve and a valve opener, and wherein the valve comprises a valve body comprising an elongated section having a distal end and a proximal end, a wall structure at the proximal end, and wherein an external protrusion extends proximally from a surface of the wall structure facing proximally, and an internal protrusion extends distally from a surface of the wall structure facing distally. The wall structure may have a plurality of slits forming a plurality of valve flaps. Each valve flap may have at least one external protrusion. Each valve flap may have at least one internal protrusion. The valve flap may be deflected by a valve opener that may be moved distally by a male Luer tip inserted into a proximal opening of a catheter hub.

[0210] Exemplary aspect 55: A catheter assembly comprising:

[0211] a needle hub having a needle having a needle tip;

[0212] a catheter conduit attached to a catheter hub, the catheter hub having a body including an inner surface defining a lumen, the needle extending through the catheter conduit;

[0213] a valve positioned in the lumen of the catheter hub, the valve comprising a valve body having an outer surface and an inner surface defining an inner lumen, a distal opening at a distal end of the valve body, and a wall structure at a proximal end of the valve body, the wall structure comprising a plurality of slits defining a plurality of valve flaps;

[0214] a plurality of internal protrusions located on the plurality of valve flaps at locations inside the inner cavity of the valve, and a plurality of external protrusions located on the plurality of valve flaps at locations outside the inner cavity of the valve;

[0215] a valve opener positioned within the lumen of the catheter hub and proximal to the valve, the valve opener comprising a head section having an activation end, at least one plunger element having a proximal surface for being pushed by a male medical device;

[0216] A needle guard having a proximal wall and a barrier wall, wherein the barrier wall is positioned on one side of the needle and is movable distal to the needle tip to prevent accidental needle sticks of the needle tip in a protective position; and

[0217] wherein at least one inner projection is aligned with at least one outer projection to define an aligned projection segment, and wherein a thickness measured at the aligned projection segment is thicker than a thickness of the wall structure without the aligned projection segment.

[0218] Exemplary aspect 56: A method of assembling a needle assembly, comprising:

[0219] providing a catheter hub having a catheter conduit having an open distal end and a proximal end attached to the catheter hub by a hub, the catheter hub comprising a hub body having an inner surface defining a lumen and a proximal opening;

[0220] Positioning a valve in the lumen proximal to the bushing, the valve comprising a valve body having an inner surface defining a lumen, a distal opening at a distal end of the valve body, a wall structure at a proximal end of the valve body, at least one slit and a plurality of valve flaps on the wall structure, and a plurality of internal protrusions in the lumen of the valve, wherein at least one internal protrusion is positioned on each of the plurality of valve flaps;

[0221] positioning a valve opener within the lumen of the catheter hub and at a proximal position proximal to the valve, the valve opener being capable of sliding distally when pushed into the valve by a convex medical device to deflect the plurality of valve flaps in a distal direction, thereby compressing the plurality of internal projections against the inner surface of the valve to generate an internal reaction force, the internal reaction force being configured to return the plurality of valve flaps to a closed position when the valve opener is moved proximally to the proximal position; and

[0222] A needle attached to a needle hub is placed through the catheter hub, the valve, and the catheter tubing such that the tip of the needle extends out of the open distal end of the catheter tubing in a ready-to-use position.

[0223] Exemplary Aspect 57: The method according to Aspect 56, further comprising the step of placing a needle guard within the inner cavity of the catheter hub to block the tip of the needle.

[0224] Exemplary Aspect 58: The method of any of Aspects 56 or 57, wherein the at least one slit comprises three slits and the plurality of valve flaps comprises three valve flaps.

[0225] Exemplary Aspect 59: The method of any one of Aspects 56 to 58, wherein the valve opener comprises a head section having an actuation end, and wherein the actuation end contacts the valve in the ready-to-use position.

[0226] Exemplary Aspect 60: The method of any one of Aspects 56 to 59, wherein the valve opener comprises a head section having an actuation end, and wherein the actuation end is spaced apart from the valve in the ready-to-use position.

[0227] Exemplary Aspect 61: The method according to any one of Aspects 56 to 60, further comprising placing a vent plug at the proximal opening of the needle hub.

[0228] Exemplary Aspect 62: The method of any one of Aspects 56 to 61, further comprising placing the needle assembly within a thermoplastic package, and sealing the needle assembly within the thermoplastic package.

[0229] Although limited embodiments of catheter assemblies and components thereof have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the needle guard may be one-piece, or may be integrated from more than one piece, such as from multiple pieces. In addition, it is to be understood and contemplated that the features specifically discussed for one catheter assembly or one component may be adopted to be included by another catheter assembly or another component, as long as the functions are compatible. Therefore, it is to be understood that the catheter assembly and its components constructed according to the principles of the disclosed apparatus, system and method may be implemented differently from those specifically described herein. The valves and valve openers described herein may also be used with needle hubs by positioning them in the female Luer conical connector of the needle hub. The valves and valve openers may also be used in female connectors of infusion needles or blood collection devices or central venous catheters or peripherally inserted central catheters (PICCs) or arterial catheters or dialysis needles. In other words, the valves and valve openers may be used in any medical device intended for infusion or body fluid collection having a female Luer connector housing or hub. The present disclosure is also defined in the following claims.

Claims

1. A needle assembly, comprising: a needle hub having a hub body and a needle having a needle tip extending from a distal end of the hub body; a catheter conduit attached to the catheter hub and having the needle extending through the catheter conduit in a ready-to-use position; a valve positioned in the lumen of the catheter hub, the valve comprising a valve body having an outer periphery, an inner surface defining an inner lumen, a distal opening, a wall structure at a proximal end of the valve body, at least one slit and a plurality of valve flaps at the wall structure, and at least one internal projection on each of the plurality of valve flaps, each internal projection extending axially distally in the lumen of the valve from a distally facing wall surface of the wall structure; a valve opener including a head section having a pushing end sized and shaped to open the at least one slit when displaced distally by the male Luer tip to open the valve; as well as A needle guard is located in the lumen of the catheter hub and disposed over the needle, the needle guard comprising a wall positioned on one side of the needle and movable distally of the needle tip to prevent accidental needle sticks of the needle tip in a protected position. 2 . The needle assembly of claim 1 , further comprising a plurality of external projections extending in a proximal direction from a proximally facing surface of the wall structure.

3. The needle assembly according to claim 2, wherein: Each of the plurality of valve flaps has at least one external protrusion.

4. The needle assembly according to any one of claims 1 to 3, wherein: The valve includes an inclined wall surface in the inner cavity, the inclined wall surface being in a position to be contacted by the at least one internal protrusion when the plurality of valve flaps are deflected by the valve opener.

5. The needle assembly according to claim 4, wherein: The inner cavity has a first generally cylindrical wall section positioned adjacent to the inclined wall surface, and a second generally cylindrical wall section positioned adjacent to the inclined wall surface and distal to the first generally cylindrical wall section.

6. The needle assembly according to claim 5, wherein: The first generally cylindrical wall section has a first inner diameter, and wherein the second generally cylindrical wall section has a second inner diameter, and wherein the first inner diameter is greater than the second inner diameter.

7. The needle assembly according to any one of claims 5 or 6, wherein: When viewed in a proximal direction from the distal opening, the distal opening opens into the second generally cylindrical wall section.

8. The needle assembly according to any one of claims 1 to 7, wherein: The at least one slit includes three slits converging at a central position, and the plurality of valve flaps includes three valve flaps.

9. The needle assembly according to any one of claims 1 to 8, wherein: The valve opener includes: two actuating elements such that the needle guard is located between the two actuating elements; and a stabilizer connecting the two actuating elements.

10. A catheter assembly, comprising: a needle hub having a needle having a needle tip; a catheter conduit attached to a catheter hub, the catheter hub having a body including an inner surface defining a lumen, the needle extending through the catheter conduit; a valve positioned in the lumen of the catheter hub, the valve comprising a valve body having an outer surface and an inner surface defining an inner lumen, a distal opening at a distal end of the valve body, and a wall structure at a proximal end of the valve body, the wall structure comprising a plurality of slits defining a plurality of valve flaps; a plurality of internal protrusions located on the plurality of valve flaps at locations inside the inner cavity of the valve, and a plurality of external protrusions located on the plurality of valve flaps at locations outside the inner cavity of the valve; a valve opener positioned within the lumen of the catheter hub and proximal to the valve, the valve opener comprising a head section having an activation end, at least one plunger element having a proximal surface for being pushed by a male medical device; A needle guard having a proximal wall and a barrier wall, wherein the barrier wall is positioned on one side of the needle and is movable distal to the needle tip to prevent accidental needle sticks of the needle tip in a protective position; and wherein at least one inner projection is aligned with at least one outer projection to define an aligned projection segment, and wherein a thickness measured at the aligned projection segment is thicker than a thickness of the wall structure without the aligned projection segment.

11. The catheter assembly according to claim 10, wherein: Each of the plurality of valve flaps has at least one inner protrusion aligned with at least one outer protrusion.

12. The catheter assembly according to any one of claims 10 or 11, wherein: The plurality of slits includes three slits, and the plurality of valve flaps includes three valve flaps.

13. The catheter assembly according to any one of claims 11 or 12, wherein: The valve includes an inclined wall surface in the inner cavity, the inclined wall surface being in a position to be contacted by at least one of the plurality of internal protrusions when the plurality of valve flaps are deflected by the valve opener so as to be contacted by the internal protrusions.

14. The catheter assembly according to any one of claims 10 to 13, wherein: The inner cavity of the valve has a first generally cylindrical wall section located adjacent to the inclined wall surface, and a second generally cylindrical wall section located adjacent to the inclined wall surface and distal to the first generally cylindrical wall section.

15. The catheter assembly of claim 14, wherein: When viewed in a proximal direction from the distal opening, the distal opening opens into the second generally cylindrical wall section.

16. The catheter assembly according to any one of claims 10 to 15, wherein: The valve opener also includes a stabilization ring defining a continuous peripheral segment.

17. A method of assembling a needle assembly, comprising: providing a catheter hub having a catheter conduit having an open distal end and a proximal end attached to the catheter hub by a hub, the catheter hub comprising a hub body having an inner surface defining a lumen and a proximal opening; Positioning a valve in the lumen proximal to the bushing, the valve comprising a valve body having an inner surface defining a lumen, a distal opening at a distal end of the valve body, a wall structure at a proximal end of the valve body, at least one slit and a plurality of valve flaps on the wall structure, and a plurality of internal protrusions in the lumen of the valve, wherein at least one internal protrusion is positioned on each of the plurality of valve flaps; positioning a valve opener within the lumen of the catheter hub and at a proximal position proximal to the valve, the valve opener being capable of sliding distally when pushed into the valve by a convex medical device to deflect the plurality of valve flaps in a distal direction, thereby compressing the plurality of internal projections against the inner surface of the valve to generate an internal reaction force, the internal reaction force being configured to return the plurality of valve flaps to a closed position when the valve opener is moved proximally to the proximal position; placing a needle attached to a needle hub through the catheter hub, the valve, and the catheter tubing such that the tip of the needle extends out of the open distal end of the catheter tubing in a ready-to-use position; and A needle guard is placed within the lumen of the catheter hub for blocking the tip of the needle.

18. The method according to claim 17, wherein: The at least one slit includes three slits, and the plurality of valve flaps includes three valve flaps.

19. The method according to any one of claims 17 or 18, wherein: The valve opener includes a head section having an actuation end, and wherein the actuation end contacts the valve in the ready-to-use position.

20. The method according to any one of claims 17 to 19, wherein: The valve opener includes a head section having an actuation end, and wherein the actuation end is spaced apart from the valve in the ready-to-use position.

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