Valved conduit device and method of assembling such device

Abstract

The needle assembly has a needle hub with a needle (108), a catheter tube (104) with a catheter hub (102), and a valve (136) and a valve opener (134) positioned in a lumen of the catheter hub. The valve may have a valve skirt (234), and a nose section (174) of the valve opener may be located therein. One or more relief (196) may be provided to the valve opener such that an elbow or diagonal section on the needle guard may protrude from a retention space within the valve opener through the relief. The valve opener and the needle guard may be oriented such that the needle guard does not hook the valve opener during retraction.

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 therapies, including infusing fluids 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 that adapts to the attachment of an IV line to the catheter. The blood control catheter includes an internal blood control valve that is opened by inserting a male Luer connector or other object into the proximal end of the catheter adapter. Non-limiting examples of blood control valves are disclosed in U.S. Patent Application Publication No. 2011 / 0046570, entitled "Systems and Methods for Providing Flushed Catheter Assemblies," 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 catheter hub to open the blood control valve. So connected, 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 direct the 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 can 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 in which "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 undesirable 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] Aspects of the invention include a catheter assembly including a catheter hub, a needle hub, a valve for restricting flow through the catheter hub, a valve opener for opening the valve when advanced by a medical device, and a needle guard for blocking the tip of the needle to prevent accidental needle sticks. The valve opener may have a plunger element, and the needle guard may have guard arms oriented in a manner to avoid snagging therebetween during retraction of the needle guard after a successful venipuncture.

[0006] Aspects of the present invention may include a needle assembly comprising: a needle hub having a needle having a needle tip having a needle bevel extending from a distal end of the needle hub; a catheter tube attached to the catheter hub, the catheter hub having a body including an inner surface defining an inner cavity, wherein in a ready-to-use position, the needle extends through the catheter tube and the needle tip extends beyond the distal end of the catheter tube, wherein the needle bevel is oriented to a 0 degree position; a valve positioned in the inner cavity of the catheter hub and in contact with an inner shoulder of the catheter hub, the valve comprising an outer periphery and a wall having three slits defining three flaps; a valve opener sized and shaped to open the three slits to open the valve, the valve opener comprising: a nose segment having an activation end and a continuous peripheral segment having a hole therethrough; two plunger elements including a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximally of the nose segment; and two stabilizer elements; wherein each stabilizer An element is connected to the two plunger elements so that the two stabilizer elements and the two plunger elements define a stabilization ring having a continuous surface, and the stabilization ring is separated from the continuous peripheral section of the nose section by two through channels, the two through channels including a first through channel and a second through channel; a needle guard, which includes a proximal wall and two elastic arms located in a holding space between the two stabilizer elements, wherein each elastic arm includes an elbow, and the needle guard has two elastic arms and two elbows, the two elbows including a first elbow and a second elbow; wherein (1) the first plunger element is oriented to a position of approximately 285 degrees to a position of approximately 0 degrees, and the second plunger element is oriented to be 180 degrees from the first plunger element, or (2) the first plunger element is oriented to a position of approximately 1 degree to a position of approximately 75 degrees, and the second plunger element is oriented to be 180 degrees from the first plunger element; and wherein, when viewed from an end view of the catheter hub in a distal direction, the 0 degree position is the top dead center position of the complete circle.

[0007] Preferably, the first plunger element is oriented to a position of about 285 degrees to about 75 degrees, including a 0 degree position, and the second plunger element is oriented 180 degrees from the first plunger element. Preferably, the second plunger element is oriented to a position of about 105 degrees to about 255 degrees, and the first plunger element is oriented 180 degrees from the first plunger element.

[0008] Preferably, the first plunger element is not aligned to the 90 degree position and the second plunger element is not aligned to the 270 degree position. The reference point for the two arms may be a plane drawn in the longitudinal direction through the midlines of the two arms. Two points on this plane may represent the two arms, which may be aligned or angled to a desired angular position. The 0 degree position is understood to be the top dead center position of a complete circle when viewed from an end view of the catheter hub in the distal direction.

[0009] In the ready-to-use position, the first elbow may be located in the first through-going passage of the valve actuator and the second elbow may be located in the second through-going passage of the valve actuator.

[0010] The two arms of the needle guard may bisect the two plunger elements.

[0011] The valve may comprise a proximally facing wall surface, and wherein the activation end of the valve opener may be urged against the proximally facing wall surface to urge the three flaps against an inner surface of the catheter hub in the use position.

[0012] The first elbow may be in contact with a periphery of the first through passage.

[0013] The first elbow may contact an inner surface of the catheter hub.

[0014] The first elbow may contact a perimeter of the first through passage and an inner surface of the catheter hub.

[0015] The first bend may contact an edge of the stabilization ring.

[0016] The valve may include a valve disc and a valve skirt extending in a proximal direction of the valve disc and defining a valve cavity.

[0017] The second elbow may contact an inner surface of the catheter hub.

[0018] The nose section of the valve actuator may have a frustoconical shape.

[0019] The second elbow may be in contact with a periphery of the second through passage.

[0020] The valve opener may include a protrusion extending radially along a longitudinal axis of the valve opener, and the inner surface of the catheter hub may include a shoulder for limiting proximal movement of the protrusion.

[0021] The protrusion on the valve opener or actuator may be a first protrusion, and wherein the valve opener may include a second protrusion spaced apart from the first protrusion.

[0022] The valve opener may include a protrusion on an outer surface of one of the two plunger elements extending radially of the longitudinal axis.

[0023] The skirt section may extend distally of the wall of the valve.

[0024] The first stabilizer element may have a distal edge and the second stabilizer element may have a distal end.

[0025] The distal edge of the first stabilizer element may be parallel to the distal edge of the second stabilization element.

[0026] The distal edge of the first stabilizer element may be angled with respect to the distal edge of the second stabilization element.

[0027] A protrusion may be located on each of the two plunger elements to define two protrusions, wherein the two protrusions may be located distally of the stabilization ring.

[0028] The needle guard, valve, and valve opener may be located entirely within the lumen of the catheter hub.

[0029] The protective cap may have a sleeve positioned around the catheter tubing and needle.

[0030] The bushing can wedge the proximal end of the catheter tube against the inner surface of the catheter hub.

[0031] The resilient element may be located inside the catheter hub between the bushing and the valve disc, and wherein the resilient element may be sized and shaped to push the valve disc in a proximal direction. For example, the resilient element may push a flap of the valve disc in a proximal direction after the male medical device has been removed to restrict flow across the valve disc.

[0032] The elastic element may be an elastic element such as an O-ring or a coil spring.

[0033] The wall of the valve may have a substantially flat or smooth distally facing wall surface.

[0034] Two protrusions may be located distally of the stabilization ring.

[0035] A method for assembling a needle assembly or manufacturing a needle assembly, which may be a catheter assembly with a needle, the method may include: providing a catheter hub with a catheter tube, the catheter tube 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 in the inner cavity and proximal to the sleeve, the valve including an outer periphery and a wall having three slits defining three flaps; positioning a valve opener inside the inner cavity of the catheter hub to slidably push the valve open when actuated by a medical device, the valve opener including a nose section, two plunger elements and two stabilizer elements, the nose section having an activation end and a continuous peripheral section, the continuous peripheral section having a hole passing therethrough, the two plunger elements including a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximal to the nose section; wherein each stabilizer element is connected to the two plunger elements so that the two stabilizer elements and the two plunger elements define a connecting portion. The invention relates to a stabilizing ring having a continuous surface and the stabilizing ring is separated from the continuous peripheral section of the nose section by two through-channels, the two through-channels including a first through-channel and a second through-channel; placing a needle guard including a proximal wall and two elastic arms in the holding space between the two stabilizer elements, wherein each elastic arm includes an elbow, and the needle guard has two elastic arms and two elbows, the two elbows including a first elbow and a second elbow; placing a needle attached to the needle hub through the catheter hub, the valve and the catheter tube so that the needle has a needle bevel The tip of the needle extends beyond the open distal end of the catheter tube in a ready for use position; (1) orienting the first plunger element to a position of approximately 285 degrees to a position of approximately 0 degrees and orienting the second plunger element to be 180 degrees from the first plunger element, or (2) orienting the first plunger element to a position of approximately 1 degree to a position of approximately 75 degrees and orienting the second plunger element to be 180 degrees from the first plunger element; and wherein the 0 degree position is the top dead center position of the complete circle when viewed from an end view of the catheter hub in a distal direction.

[0036] A catheter assembly, which may be more broadly referred to as a needle assembly or needle device, may include a catheter hub having a catheter tube and a hub. The hub may be configured to wedge the proximal end of the catheter tube against the inner wall surface of the catheter hub to retain the catheter tube to the catheter hub.

[0037] Inside the catheter hub, a diaphragm or valve, a valve actuator or valve opener, and a safety clip, such as a needle guard or tip protector, may be positioned. Optionally, the safety clip may be omitted. A needle with a profile change may be inserted through the proximal opening of the catheter hub, wherein the needle tip protrudes from the distal opening of the catheter tube in a ready-to-use position. A cannula hub or needle hub may be attached to the proximal end of the needle and may contact the proximal end of the catheter hub when assembled to the catheter hub in a ready-to-use position. The proximal opening of the catheter hub may be sized to have a female Luer taper, optionally with external threads, to engage with a male Luer tip in a Luer slide or Luer lock. The profile change may be a curl or material buildup.

[0038] The tip protector can be configured to cover the needle tip and be removed with the needle after use, and the valve and valve actuator can be retained with the catheter hub for controlling fluid flow therethrough. The valve actuator can be configured to be pushed distally into the valve by the male tip to open the valve for fluid flow, as discussed further below.

[0039] A flashback plug or blood plug subassembly may be connected to the needle hub to prevent blood from flowing out of the flashback chamber of the needle hub. The flashback plug may be disposed at the proximal end of the needle hub to allow air to escape but prevent blood from escaping from the proximal end of the body of the flashback plug, which may have a chamber and a hydrophobic filter. Alternatively, a syringe may be attached to the proximal end of the needle hub. A second valve and actuator, described further below, may also be placed within the needle hub.

[0040] A protective cap having a sleeve and a saddle may be provided to cover the needle during packaging and before use. The saddle may surround at least a portion of the catheter hub and the needle hub and be removably coupled to the needle hub. The protective cap may be removed from the catheter assembly before use.

[0041] In the example of a 360 degree arc or circle, the valve opener may have a pair of plunger elements that are generally aligned at the 0 degree (or 360 degree) position and the 180 degree position when the catheter assembly is in a ready-to-use position and after the needle is removed after a successful venipuncture. In other examples, the two plunger elements may be aligned along different angular positions, but not at the 90 degree and 270 degree positions.

[0042] The tip protector may have two arms that are substantially aligned at a position displaced or rotated, preferably displaced or rotated 15° to 90°, compared to the first plunger element and the second plunger element in the ready-to-use position of the catheter assembly. The tip protector may have two arms that are substantially aligned at a 90 degree position and a 270 degree position in the ready-to-use position of the catheter assembly. The reference point of the two arms may be a plane drawn through the midline of the two arms in the longitudinal direction. Two points on this plane may represent two arms that may be approximately located at a 90 degree position and a 270 degree position. When observed from the end view of the catheter hub in the distal direction, the 0 degree position is understood to be the top dead center position of a complete circle.

[0043] The needle bevel at the needle tip may be facing upward, toward the 0 degree position, in the ready-to-use position. These arrangements allow the needle guard or tip protector to be retracted with the needle after a successful venipuncture while avoiding or minimizing potential snagging between the tip protector and the valve opener if the needle guard tilts or pitches as it retracts, as discussed further below.

[0044] Any number of prior art guards configured to block the needle tip of the needle can be used with the present catheter assembly. In the illustrated embodiment, the tip protector is similar to one of the guards shown in U.S. Patent No. 6,616,630, the content of which is expressly incorporated herein by reference. In an example, the tip protector may have a proximal wall and two elastic arms, and wherein the contour change portion (such as a curl or a projection) on the needle may engage the periphery of the proximal wall defining the opening of the tip protector, so that the tip protector is retracted outwardly from the catheter hub in the proximal direction after successful venipuncture. The two arms may intersect, or they may extend along different sides of the needle and do not intersect along the side view. The tip protector may be changed to have only one arm.

[0045] The two needle guard arms may be deployed or biased outwardly from the needle shaft in the ready-to-use position so that the biasing arms of the needle guard engage the inside of the catheter hub, engage the valve opener (such as one or more edges of the valve opener), or a combination thereof in the ready-to-use position, as discussed further below. The elbow of the needle guard may alternatively be located within the clearance of the valve opener but not touching the valve opener or the catheter hub. In an example, only a portion of the tip guard or needle guard may extend into one or more clearances of the valve opener, while a proximal section of the tip guard (such as a proximal wall) may extend proximal to or be located proximal to the proximal surface of the tip guard, as discussed further below.

[0046] In an example, the needle guard may include a proximal wall including a perimeter defining an opening. The proximal wall may have a proximal facing wall surface and a distal facing wall surface opposite the proximal facing wall surface. At least one resilient arm may extend distally of the proximal wall. In an example, two resilient arms extend distally of the proximal wall.

[0047] One arm on the needle guard may be longer than the other arm. Each arm may include different arm widths, including a first arm segment of a first width and a second arm segment of a second width less than the first width. The two arms may originate from different ends of the proximal wall and may cross each other at their respective second arm segments. The two arms may extend distally of the proximal wall. When viewed from the side along the longitudinal direction of the needle guard, the two arms may intersect each other. When used with a needle, the two arms intersect each other when in a ready-to-use position and in a protective position. In an alternative embodiment, the two arms originate from different ends of the proximal wall and extend in a distal direction without crossing each other. The two arms may also have substantially the same arm width along the length of each respective arm.

[0048] Two distal walls may be provided, one at the end of each of the two arms. The distal walls may overlap one another in the axial direction of the needle guard by utilizing different arm lengths and / or angling one of the distal walls further distally at a bend or diagonal section between the distal wall and the resilient arm. In an example, if two arms are utilized, the bend or diagonal section of each arm may engage a corresponding guard engagement section inside the catheter hub, such as a recess or raised protrusion inside the valve actuator, or one or more restraining or limiting surfaces or choke points against one or both reliefs of the valve actuator to removably secure the needle guard inside the catheter hub in a prepared position and during the transition process of removing the needle from the catheter hub. The bend of the needle guard may alternatively be located within the relief of the valve opener, but not touching the valve opener or the catheter hub.

[0049] When the radial profile size of the needle guard measured at one or both bends is reduced, such as after the needle tip moves proximally of the two distal walls, the needle guard can be moved proximally of the obstruction or obstruction point to be removed from the catheter hub with the needle. As the two distal walls move radially, the needle guard reduces its radial profile and can then move through or proximally past the obstruction point. In forming the needle guard, the needle guard can be folded from stamped metal sheet to form the needle guard as shown. Ribs can be formed on the arms, proximal wall and / or distal wall to increase structural rigidity.

[0050] The valve opener can be used with the needle assembly described herein. The valve actuator or opener can have a nose section, a transition section, and two plunger elements extending proximally of the transition section or extending proximally from the nose section. The nose section can define a first continuous peripheral section. Other locations of the nose section away from the first continuous peripheral section can include slits or slots.

[0051] Two stabilizer elements may be attached to the two plunger elements to form a stabilization ring that may define a second continuous peripheral segment of the valve actuator in addition to the continuous peripheral segment at the nose segment. Each stabilizer element may include two edges. In an example, the two edges of each stabilizer element may be parallel to each other. The two stabilizer elements may be skewed or skewed so that although the two edges of each stabilizer element may be parallel to each other, the two edges from one stabilizer element are not parallel to the two edges of the other stabilizer element. The proximal edges of the two stabilizer elements may be offset along the axial direction or longitudinal direction of the valve actuator. The distal edges of the two stabilizer elements may be offset along the axial direction. In an example, the distal edge may be positioned obliquely relative to the axis of the catheter hub.

[0052] The valve opener may be provided with two clearances or two through-channels, each of which is defined or delimited by a transition section, two plunger elements and a corresponding stabilizer element. The two clearances or through-channels may be referred to as a first clearance or first through-channel and a second clearance or second through-channel. In an example, each clearance or through-channel has a periphery.

[0053] In an example, each perimeter of each relief may be defined by the structure of the transition section, the two plunger elements and the corresponding stabilizer element. Since the two stabilizer elements may be skewed or tilted in different directions, the two perimeters of the two reliefs or through-channels may be different, such as having different perimeter profiles or shapes. The edges of the two stabilizer elements are preferably inclined relative to the direction of the needle or the axis of the catheter hub.

[0054] The two perimeters of the two reliefs may each be defined by a continuous ring. In other words, the perimeter does not have a slit or slot to form an open perimeter. However, in the case where the stabilizer element comprises a slot or slit, the perimeter may be an open perimeter or a non-continuous perimeter.

[0055] In some examples, the two stabilizer elements may extend laterally without being skewed or skewed in the distal or proximal directions. When so configured, the edges of the two stabilizer elements may be parallel to each other. Additionally, the four edges of the two stabilizer elements may be parallel to each other and axially offset. That is, the proximal edge of one stabilizer element may be located more proximal or more distal than the proximal edge of the other stabilizer element, while the four edges are parallel to each other.

[0056] Two plunger element studs or extensions may extend proximally of the stabilizing ring. In examples, two plunger element studs may extend from the stabilizing ring and axially align with the plunger elements. In other examples, the two plunger element studs are not axially aligned with the two plunger elements. In still other examples, only one plunger element stud is aligned with one of the two plunger elements. For a valve opener or actuator having only one plunger element between the first and second continuous peripheral sections, only one of the two plunger element studs or none of the plunger element studs may be aligned with one plunger element.

[0057] In some examples, there may be more than two plunger element short posts or extensions extending proximally of the stabilizing ring. Two or more plunger element short posts or extensions may be equally spaced around the proximal periphery of the stabilizing ring, or randomly spaced around the proximal periphery of the stabilizing ring. The plunger element short posts may extend the overall length of the valve actuator. The number of plunger element short posts and / or the arc curve of each plunger element short post (which defines the width of each plunger element short post) can provide a larger overlapping surface with the male Luer tip than a smaller number of plunger element short posts or plunger element short posts with relatively small arc curves. In other examples, two plunger element short posts or extensions may be considered as parts of two plunger elements, and the stabilizer ring is located between the two ends of each of the two plunger elements.

[0058] The two plunger elements may each have at least two thicknesses to form a protrusion at the interface between the two thicknesses on the outer surface of each plunger element. The two protrusions may be located inside the recessed section of the catheter hub so that the shoulder at the proximal end of the recessed section can provide a stop surface to interact with the two protrusions to prevent the valve opener from shifting from the interior of the catheter hub and moving out of the interior of the catheter hub. In some examples, only one protrusion is used on one of the two plunger elements to prevent the valve opener from shifting in the proximal direction. In some other examples, each plunger element may have a single thickness, and the protrusions are formed by adding material to the plunger element only at the location of the protrusion during injection molding.

[0059] In an example, a planar surface section may be provided for the valve actuator on the same side of each stabilizer element.The planar surface section may originate near the nose section or transition section of the valve component and extend proximally to near the two protrusions.

[0060] Two planar surface sections may be provided, one on each side of the valve opener, corresponding to the two stabilizer elements, to minimize the overall profile of the transition section and the two plunger elements along the side profile. In an example, the cross-sectional dimensions of the nose section, the transition section, and the two plunger elements may be substantially constant or the same within typical manufacturing tolerances along a side view or a 90 degree rotation along the longitudinal axis of the valve opener.

[0061] A holding space may be provided for the valve opener or actuator, located between two plunger elements, inside a stabilizing ring, between two plunger element studs, or a combination thereof. Part or all of the needle guard may be located in the holding space in the ready-to-use position, and one or two elbows of the tip protector may protrude out of the gap. For example, the elbow of the needle guard may be located distally of the two stabilizer elements and in the through opening or gap in the ready-to-use position. In addition, in the ready-to-use position, the two elbows may contact the interior of the catheter hub, be separated from the interior of the catheter hub, may contact one or two peripheries of the gap, or be separated from the periphery of the gap and the inner surface of the catheter hub, or a combination thereof. Obviously, if the tip protector only incorporates one arm and one elbow, a single elbow may be arranged similarly.

[0062] In the ready-to-use position, the two bends of the needle guard may be located distally of the two stabilizer elements, and the proximal wall of the needle guard may be located proximal of the two stabilizer elements. In an example, the proximal wall may be flush with the proximal end surface of the plunger element stub, located proximal to the end surface, or located distal to the end surface. If the plunger element stub is not incorporated, the proximal wall of the needle guard may be flush with the proximal edge of one or both stabilizer elements, located proximal to the proximal edge of one or both stabilizer elements, or located distal to the proximal edge of one or both stabilizer elements.

[0063] The distance between the two inner surfaces of the two stabilizer elements can define a blocking gap, blocking point or restriction point for the needle guard to limit the proximal movement of the needle guard in the ready-to-use position and / or during needle retraction after intravenous entry. That is, before the needle tip moves proximally of one or two distal barrier walls of the needle guard, the blocking point or gap is too small for the needle guard to pass proximally of the blocking point, blocking point or restriction point because the diagonal measurement between the two elbows is greater than the blocking point. However, after the needle tip moves proximally of one or two distal barrier walls of the needle guard and the distal walls are no longer biased by the needle shaft, the two distal walls move radially inward to reduce the radial profile of the needle guard, which is smaller than the blocking point. At this time, with the radial profile measured at the two elbows being smaller, the needle guard can be moved proximally of the blocking point to remove the needle guard from the catheter hub together with the needle, such as after a successful venipuncture.

[0064] The channel may be defined by a wall surface at a nose section of the valve opener. A distal opening leads from the distal end to the channel, and the channel has a proximal opening. A needle may be located in or through the channel in a ready-to-use position.

[0065] The catheter hub may have an optional pair of wings extending radially of the hub body. When incorporated, the wings may increase stability by providing increased surface area for resting and securing the catheter hub against the patient's skin, such as after intravenous access.

[0066] The plunger element of the valve opener can be oriented at 0 and 180 degree positions, and the bevel at the needle tip can be oriented upward and aligned with the upper plunger element. The reference point of the two plunger elements can be a plane drawn through the center line of the two plunger elements in the longitudinal direction. Two points on this plane can represent two plunger elements, which can be roughly located at 0 and 180 degree positions, or other angular positions as described elsewhere in this article. When observed from the end view of the catheter hub in the distal direction, the 0 degree position is understood as the top dead center position of the complete circle. In addition, the two elbows and two arms of the needle guard can be oriented at 90 and 270 degree positions, and the elbows protrude beyond the two gaps of the valve opener, and the bevel at the needle tip can be oriented upward and aligned with the push piece on the catheter hub. In the example, the needle bevel can be aligned to the 0 degree position. Further, the plunger element of the valve opener can be oriented at 0 degree and 180 degree positions, the two elbows and two arms of the needle guard can be oriented at 90 degree and 270 degree positions, and the elbows can protrude beyond the two gaps of the valve opener, and the bevel at the needle tip can be oriented upward and aligned with the upper or first plunger element.

[0067] In a prepared position in which the needle hub contacts the catheter hub and the needle tip extends beyond the distal end or distal opening of the catheter tube, the catheter assembly is ready for use, such as to perform venipuncture or intravenous access. Located inside the catheter hub may be a valve having a valve body with an outer periphery, a valve disc, and a valve skirt extending in an axial direction from the valve disc. In an example, the valve disc may include one or more slits defining one or more flaps to be opened by a valve actuator. The type of slits and flaps incorporated into the valve disc and the number of each may vary, with three slits and three flaps being preferred. In an embodiment, the valve skirt may be positioned in a recessed section formed in the inner cavity of the catheter hub, which prevents the valve from moving axially once it is located inside the catheter hub.

[0068] In an example, a recessed section in the interior of the catheter hub has a distal shoulder and a proximal shoulder that define a groove 236 therebetween. The valve skirt has a length that is sized and shaped to fit within the groove or recessed section. In an example, the valve skirt may contact the proximal shoulder and the valve disc may contact the distal shoulder. From a different perspective, the valve located therein may contact and be restrained by the distal and proximal shoulders of the recessed section in a ready-to-use position, such that the valve skirt is axially fixed or cannot move axially.

[0069] In examples, the outer diameter or outer surface of the skirt segment can form a close fit or dimension-to-dimension fit with the inner recessed segment of the catheter hub. In other examples, a slight interference fit can be provided between the two. In still other examples, a small gap can be provided between the outer surface of the skirt segment and the inner surface at the recessed segment, wherein the valve skirt contacts the proximal shoulder of the recessed segment and the valve disc contacts the distal shoulder of the recessed segment.

[0070] The distal chamber may be disposed distally of the valve disc and proximally of the bushing. In some examples, a coil spring or elastic biasing element (such as an elastomeric ring or cylinder) may be disposed concentrically with the needle in the distal chamber to bias the flaps of the valve disc to assist the valve disc in closing one or more slits.

[0071] In an example, the valve disc may include a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps, as previously discussed. In the illustrated embodiment, the valve skirt may extend axially to the longitudinal axis of the valve and have an elongated wall generally perpendicular to the outer periphery of the valve disc, thereby forming a generally cylindrical valve body. In some embodiments, the valve skirt may be inclined so that the valve forms a frustoconical structure.

[0072] The valve skirt may define a valve cavity having an open proximal end through which an actuator nose or nose section of the valve actuator may be advanced and actuate a flap of the valve disc. In one embodiment, at least some portion of the actuator nose including the distal actuation end of the valve actuator may be located inside the valve cavity of the valve prior to actuation. Thus, the actuator nose may be narrower than the inner diameter of the valve skirt so that the actuation end fits within the valve cavity and abuts or touches the valve disc in a ready-to-use position. In examples, the relative dimensions are such that the nose section of the actuator does not touch the inner wall surface of the skirt section, although some touching is envisioned.

[0073] In an example, the actuation end of the valve opener contacts the proximal-facing surface of the valve disc in the ready-to-use position, and another portion of the valve actuator (such as one or two protrusions) abuts a shoulder inside the catheter hub to apply a load on the valve disc in the ready-to-use position, but not enough to open one or more slits, as discussed further below. In other examples, the actuation end may be spaced from the proximal-facing surface of the valve disc in the ready-to-use position, and one or more protrusions on the actuator contact the shoulder or are also spaced from the shoulder. When the one or more protrusions on the actuator are spaced from the shoulder and the actuation end is spaced from the valve disc, the actuator may float a small amount in the axial direction within the catheter hub.

[0074] In an example, a protrusion extends outwardly from the outer surface of one or both plunger elements. The protrusion may extend from the outer surface of each plunger element. Each protrusion resembles a ramp surface having a generally flat edge for abutting the shoulder. As discussed further below, the ramp surface of the protrusion and the direction of the ramp allow the actuator to be inserted into the interior of the catheter hub and seated in the second recessed section.

[0075] In an example, the actuator or valve opener has a longitudinal axis, and one or more actuating elements may extend axially or parallel to the longitudinal axis. In a specific example, two actuating elements may be diametrically opposite each other along the longitudinal axis. The two actuating elements may define an outer diameter having a size greater than the diameter of the nose section.

[0076] In examples, the actuating element is flexible and deflectable so that when pushed by the male Luer tip, the actuating element deflects or flexes. The actuating element can be made deflectable by selecting a material with the desired elastic properties. In other examples, the actuating element can be deflectable by incorporating one or more weakened sections, such as by incorporating a structurally thin section, by incorporating a cutout, by adopting a cross-section that is small 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 the desired elastic properties and by incorporating one or more weakened sections.

[0077] In still other examples, each actuating element has more than one different cross-sectional profile or shape along a length segment.For example, an elongated plunger element may have a square profile positioned adjacent to a crescent-shaped profile.

[0078] The nose section of the valve actuator can be configured to engage the valve to open the valve disc when an axial force is applied to the actuating element by the male tip toward the distal end of the catheter assembly (such as during insertion of an IV drip line male Luer connector). Generally, the nose section can be rigid relative to a more flexible valve, which allows the nose section and more specifically the end actuation valve to be actuated, such as to deflect one or more flaps and open one or more slits on the valve disc. The nose section can be made of an incompressible material (such as metal, rigid plastic or hard elastomer) for pushing against and opening the valve.

[0079] In one embodiment, the stabilizer or stabilizer element may be arcuate, 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 body of the valve actuator, which body may be spaced apart from the nose section of the valve actuator. In other words, the valve actuator may be elongated and may 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 wall of the actuator.

[0080] In an example, the stabilizer may define a continuous body segment or ring along the perimeter or radial direction of the valve actuator, which is separated from the continuous body segment of the nose segment which may also be continuous along the perimeter or radial direction. Two stabilizers or stabilizer elements may be coupled together with two plunger elements to form a ring structure. Optionally, the two stabilizers may be slightly offset and angled from each other.

[0081] 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 nose section can better align with the valve disc (such as a slit on the valve disc), allowing smooth actuation of the valve. The stabilizer can also provide engagement with the interior of the catheter hub via friction to prevent the actuator from sliding in the proximal direction after the male Luer tip is removed.

[0082] In one embodiment, the nose segment can be configured to remain engaged to the valve disc after actuation of the valve and after removal of the male Luer tip. For example, the nose segment can be wedged between one or more slits on the valve disc and held there by friction, as discussed further below. Surface features (such as protrusions, grooves, or barbs) can be provided on the valve actuator, such as on the nose segment, to maintain engagement between the actuator and the valve after actuation and after removal of the male Luer tip.

[0083] A relief, opening or through passage may be provided between the transition section (or from the nose section) and each of the two stabilizers. The two reliefs or through passages may provide clearance so that the interior or central portion of the valve actuator and the inner surface of the catheter hub may be in open communication. In other words, there are one or two reliefs or openings between the continuous section of the nose section and the continuous peripheral section defined by the two stabilizers and the plunger element (referred to as a stabilization ring or stabilization ring).

[0084] When the two arms are biased outwardly by the sides of the needle shaft, the stabilization ring of the valve actuator may have an inner diameter that is smaller than the diameter defined by the diagonal sections or elbows of the two arms of the needle guard. Thus, during installation of the needle guard into the holding space of the valve actuator, the diagonal sections or elbows of the needle guard may deflect to pass through the stabilization ring and into the open area defined by the relief.

[0085] When the tip guard is positioned between the two plunger elements, the two distal walls of the needle guard (more specifically, the two diagonal sections or elbows) can be located in the relief as discussed above to engage a guard engagement surface on the inner surface of the catheter hub, such as a groove or protrusion formed in the interior of the catheter hub, engage the distal edges of the two stabilizer elements, or be spaced from both the stabilizer and the inner surface of the catheter hub. Thus, the needle guard can be retained within the interior of the catheter hub in a ready-to-use position and during needle retraction after a successful venipuncture until the needle tip moves proximally of the two distal walls on the needle guard, at which time the needle guard can be closed over the needle tip and removed with the needle.

[0086] A second undercut or recessed section proximal to the first recessed section may be provided in the lumen of the catheter hub for accommodating the two diagonal sections or elbows. Thus, the needle guard may be prevented from sliding in the proximal direction during needle retraction after a successful venipuncture 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. Optionally or alternatively, the distal edge of one or both stabilizers may provide a constraining surface to prevent premature activation of the needle guard during needle retraction before the needle tip moves proximal to the two distal walls. In addition to the distal edge, both stabilizers also have a proximal edge.

[0087] In some examples, one or both stabilizer elements may have a slit or passageway, thus dividing the arcuate stabilizing element in two. Even with a slit on one or both stabilizer elements, the stabilizing ring (which may be a non-continuous ring, similar to a ring with one or more slits formed through the ring) may still provide a constraining surface to prevent the needle guard from being activated prematurely during needle retraction (such as before the needle tip moves proximally of the two distal walls).

[0088] The constraining surface may be referred to as a restriction 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 is first activated and radially collapsed to reduce its radial profile to then slide proximally of the blocking point. In an example, one or both bends of the needle guard may be restricted from moving in a proximal direction by the blocking point until one or both bends of the needle guard deflect to reduce the radial profile of the needle guard. In an example, when the radial profile of the needle guard is reduced, the needle guard may slide from a distal position of the stabilization ring through the aperture defined by the stabilization ring to a proximal position of the stabilization ring.

[0089] 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 cross-section of the actuating element can provide increased rigidity when pushed by a male Luer connector. 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 structural rigidity. One or more gaps may be provided between any two actuating elements. The gap may provide a void or space for a fluid flow flowing through it, such as during flushing blood or IV infusion. The gap between the actuating elements may define a holding space for accommodating a tip protector.

[0090] In some embodiments, most or most, if not all, of the tip guard fits within the holding space formed by the body of the actuator between the two plunger elements in the ready-to-use position. This allows the catheter hub to be more compact because less longitudinal space is required within the hub to fit both the actuator and the tip guard longitudinally in series, or when the two only partially overlap in the axial direction. The tip guard can fit completely within the holding space of the actuator to further reduce the space or length required in the catheter hub. As shown, the proximal wall of the needle guard can be substantially flush or flush with the proximal end surfaces of the two plunger elements.

[0091] When the tip guard only engages or contacts the distal edge of the relief or through-channel of the actuator, or is spaced from the edge but does not contact the inner surface of the catheter hub, then no deformation or diameter change is required on the inner wall of the catheter hub, and the tip guard can be placed further proximally in the female Luer tapered section while complying with the international Luer standard for conical fittings, and the overall length of the catheter hub can be further reduced.

[0092] The push tab on the catheter hub can be generally located at the 0 degree position relative to the arc or full circle end view of the catheter hub. The bevel of the needle tip can be similarly angled and aligned to the 0 degree position, which can also be referred to as the bevel up position or the top dead center position of the circle. In the bevel up position, the two arms of the needle guard and similarly the two elbows can be aligned at the 90 degree and 270 degree positions, while the two plunger arms can be aligned at the 0 degree and 180 degree positions. This unique arrangement is different from known prior art devices and is incorporated to minimize or avoid hooking of the elbow of the needle guard against the stabilizer during retraction of the needle guard after a successful venipuncture, wherein the needle guard can be tilted or pitched by the practitioner during needle retraction, as further discussed below.

[0093] To align with the needle guard or tip protector, the tip extension at the distal end of the nose section of the needle hub may also be rotated. That is, the tip extension may be oriented to a 90 degree position to push against the proximal wall of the needle guard. Thus, while the needle bevel may be oriented in a 0 degree bevel up position, the tip extension on the needle hub may be oriented in a 90 degree position.

[0094] Due to manufacturing tolerances, when a specific angular position is specified, it is understood to mean generally or approximately, and is not to be construed as an exact measurement or position unless the context indicates otherwise. While the tip extension at the distal end of the needle hub should be rotated or oriented to align with one of the two arms of the needle guard, the external tab used to capture the catheter hub between the nose section and the external tab can be maintained at the 180 degree position in the ready to use position, or rotated with the tip extension.

[0095] The tip guard may substantially fit within the retaining space of the actuator, with a proximal wall of the tip guard being substantially flush with a proximal end of the actuating element in an axial direction.

[0096] During retraction of the needle, the needle shaft may be angled or pitched intentionally or unintentionally, such as due to a practitioner's tendency during needle retraction after venipuncture. Regardless of why the needle may be angled, this action may cause the needle guard, which may be located on the needle tip, to tilt or pitch, which may cause one or both of the elbows on the two arms to hook onto the distal edge of the stabilizer of the valve opener if the elbow and stabilizer are aligned at the 0 and 180 degree positions. In other words, if the needle guard tilts or pitches during retraction, the elbow (if aligned at the 0 and 180 degree positions) may hook against the edge of the stabilizer if the valve opener is aligned with the plunger element at the 90 and 270 degree positions.

[0097] However, when the elbow is aligned at the 90 and 270 degree positions, the two stabilizers may be aligned at the 90 and 270 degree positions, and the two plunger elements may be aligned at the 0 and 180 degree positions, tilting or pitching will not cause one or both of the elbows to move against the edge of the stabilizer to hook against the edge of the stabilizer during retraction. If the elbow would hook against the stabilizer, the needle guard may cause the tip guard to pull against the valve actuator during needle retraction to possibly displace the valve actuator from the interior of the catheter hub.

[0098] Thus, when the various components are angled, any tilting of the needle during its retraction after a successful venipuncture, and therefore of the tip guard, will simply cause the tip guard to slide against the inner surface of one or both of the plunger elements. Since the inner surfaces of the two plunger elements do not have edges for catching, the needle guard can be easily retracted away from the valve opener without catching the valve opener in the process. Thus, the components of the valve opener are configured to operate freely without causing the elbow to catch on the edge of the stabilizer to thereby cause a malfunction.

[0099] After the needle and needle guard are removed, the valve actuator can be advanced distally into the valve through the syringe tip or Luer tip of the IV drip line to allow fluid to flow through the catheter hub. The Luer tip can be a threaded Luer connector that engages the catheter hub in a threaded engagement, which can have a female threaded Luer connector. The advancement actuator can advance the actuation end against the valve disc and deflect the flap radially and distally to open a fluid path to be formed through the catheter assembly. The valve is in a closed position when one or more slits of the valve disc are closed. In the closed position, the valve can block or restrict flow through the catheter hub.

[0100] In the valve actuator retracted position, the actuation end of the nose section is not pushed into and opens the one or more slits of the valve. This position is also understood as the pre-valve activation position or valve closed position. That is, the male Luer tip has not yet been inserted into the proximal opening of the catheter hub to advance the valve actuator to open the valve. In other words, this is the valve closed position.

[0101] When a male medical device (such as a male Luer tip) is initially inserted into the proximal opening of the catheter hub, the male tip initially contacts two actuating elements on the valve actuator to push a distally directed force on the two actuating elements to open the valve. The distally directed force moves the actuator in a distal direction until the geometry of the male tip and the proximal opening of the catheter hub prevent further distal advancement of the male tip. In an example, the female Luer taper of the catheter hub and the male Luer taper of the male tip cooperate and prevent the male tip from being further advanced 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.

[0102] When the actuator is moved distally by distal advancement of a male tip (such as a syringe tip), the nose of the valve actuator is pushed distally and can be pushed against the proximally facing surface of the valve disc. In particular, the nose of the actuator initially pushes against the proximally facing surface of the valve disc, and because the valve is axially fixed within the first recessed portion of the catheter hub, one or more flaps on the valve disc can be deflected radially and in the distal direction. Fluid from the male tip can then flow through the catheter hub, through the valve, and through the lumen of the catheter tube.

[0103] Alternatively, suction may be applied by a medical device such as a syringe or evacuated blood collection tube and blood may be drawn from the patient. This is often done to test a sample prior to commencing an infusion therapy. Additionally, typically, any remaining blood may first be flushed from the interior of the catheter hub prior to commencing an infusion therapy.

[0104] The valve actuator may remain engaged to the valve even after the male tip is removed from the proximal opening of the catheter hub. That is, the friction between the valve actuator and the valve disc may exceed the restoring force generated by the valve flap when attempting to return to its undeformed position. This activated position with engagement may be considered a one-time use or one-time actuation because the valve actuator and valve do not return to the pre-activation position when the male tip is removed.

[0105] In an alternative embodiment, the nose section may be configured so that when pushed into the valve during activation, the actuation or activation end does not extend distally beyond the flap of the valve disc. This configuration ensures that the valve actuator is pushed back by the flap of the valve disc when the male Luer device is removed. The conical configuration at the distal end of the actuator (i.e., incorporating the tapered nose section) may be of such a configuration that it can maintain a proximally directed force vector that is greater than the vertical force vector. The angle of the cone can be designed to provide the necessary force vector when the actuator has reached its maximum distal movement and its minimum distal movement. The difference between the maximum movement and the minimum movement of a standard Luer connector is approximately 2.5 mm.

[0106] Additionally, a coil spring or resilient element or ring may be incorporated at the distal chamber to increase the re-coiling or return force of the valve to facilitate pushing the valve actuator in the proximal direction to return to the pre-activation position or valve closed position after the male tip is removed. The resilient element may also help close the flaps of the valve disc. In this way, the valve and valve actuator may be repeatedly reclosed and reopened after initial activation, etc. Alternatively or in addition, the flaps on the valve disc may be made thicker to provide sufficient restoring force without the need for a resilient element.

[0107] Additional aspects of the needle guard may include two arms that are biased apart in the absence of a needle, which normally biases the arms apart to show the features of the distal wall and curved lip. The arms of the needle guard may have a smooth or flat profile between the elongated arm portion and the elbow, with only a single bend or change in direction.

[0108] Each elongated arm section of the first arm and the second arm may have sections with different arm widths. Each arm may include a cutout having a lip similar to a hook. The cutout on each arm or the cutout on both arms allows the two arms to straddle the needle to provide lateral stability when the needle transitions from a ready-to-use position with the needle tip exposed to a protected position with the needle tip shielded.

[0109] The curved lip on the second arm may be configured to abut the needle at a flat surface adjacent to an edge of the second arm when in the ready-to-use position. A cutout may be used to change the position where the surface of the curved lip, rather than the edge, contacts the needle. In some examples, the cutout may be omitted. Ribs may be formed with both arms, which are optional and may be included to increase the strength of the arms, and a tab may extend from the edge of the distal wall, which may be optional and may be included to limit lateral pivoting of the needle tip once the needle tip is captured within the needle guard.

[0110] In another aspect of this embodiment, the catheter hub may have two plunger elements of a valve opener or actuator, the two plunger elements being oriented at positions other than the 0 and 180 degree positions, where 0 degrees is at the top dead center of the full arc or circle. For example, the upper plunger element or the first plunger element may be oriented at any position from about the 1 degree position to about the 75 degree position, and the lower plunger element or the second plunger element may be oriented 180 degrees from the position of the upper plunger element or the first plunger element. In an example, the upper plunger element may be oriented at a position of about 22 degrees, and the lower plunger element may be oriented at a position of about 202 degrees. The reference point of the two plunger elements may be a plane drawn in the longitudinal direction through the midlines of the two plunger elements. Two points on the plane may represent two plunger elements, which may be approximately located at the 22 degree and 202 degree positions.

[0111] Thus, when observing an end view of a catheter assembly according to aspects of the present invention, the catheter assembly may include a valve actuator having two plunger elements, which may be referred to as a first or upper plunger element and a second or lower plunger element, and wherein the upper plunger element may be oriented from a 0 degree (or 360 degree) position to an approximately 75 degree position (including a 0 degree (or 360 degree) position and an approximately 75 degree position), and the lower plunger element may be oriented to be 180 degrees with the position of the upper plunger element. For example, the first or upper plunger position may be oriented at a 2 degree position, a 16 degree position, a 38 degree position, a 42 degree position, etc., and the lower plunger element may be oriented to be 180 degrees with the position of the upper plunger element.

[0112] Although not shown, the two arms of the needle guard may be oriented between the two plunger arms, roughly bisecting the two plunger arms.The two needle guard arms may be located roughly equidistant between the two plunger arms.

[0113] Thus, when the various components are angled, and in accordance with aspects of the present invention, any tilting of the needle during its retraction after a successful venipuncture, and therefore the tilting of the tip guard, will simply cause the tip guard to slide against the inner surface of one or both of the plunger elements without snagging. Since the inner surfaces 270 of the two plunger elements do not have edges for catching, the needle guard can be easily retracted away from the valve opener without snagging the valve opener in the process. Thus, when the valve actuator and needle guard are oriented as shown and described herein, the components of the valve opener are configured to operate freely without causing the elbow of the needle guard to snag the edge of the stabilizer to thereby cause a malfunction.

[0114] In other embodiments, the two plunger elements of the valve opener or actuator may be oriented at positions other than the 0 and 180 degree positions. For example, the upper plunger element may be oriented at any position from about 285 degree position to about 359 degree position (including about 285 degree position and about 359 degree position), and the lower plunger element may be oriented 180 degrees from the position of the upper plunger element. For example, the first or upper plunger position may be oriented at a 288 degree position, a 297 degree position, a 327 degree position, a 346 degree position, etc., and the lower plunger element may be oriented 180 degrees from the position of the upper plunger element.

[0115] The upper plunger element may be oriented at approximately the 338 degree position and the lower plunger element may be oriented at approximately the 158 degree position. The reference point for the two plunger elements may be a plane drawn in the longitudinal direction through the midlines of the two plunger elements. Two points on the plane may represent the two plunger elements, which may be approximately located at the 338 degree and 158 degree positions.

[0116] The two arms of the needle guard may be oriented between the two plunger arms, approximately bisecting the two plunger arms. The two needle guard arms may be located approximately equidistantly between the two plunger arms.

[0117] Thus, aspects of the invention include a catheter assembly including a valve actuator having two plunger elements, which may be referred to as a first or upper plunger element and a second or lower plunger element, and wherein the upper plunger element is orientable from a 285 degree position to approximately a 0 degree position, and the lower plunger element is orientable 180 degrees from the position of the upper plunger element. The 0 degree position is understood to be the top dead center position of a complete circle when viewed from an end view of the catheter hub in a distal direction.

[0118] Thus, when the various components are angled, and in accordance with aspects of the present invention, any tilting of the needle during its retraction after a successful venipuncture, and therefore tilting of the tip guard, will simply cause the tip guard to slide against the inner surface of one or both of the plunger elements. Since the inner surfaces of the two plunger elements do not have edges for catching, the needle guard can be easily retracted away from the valve opener without catching the valve opener in the process. Thus, when the valve actuator and needle guard are oriented as shown and described herein, the components of the valve opener are configured to operate freely without causing the elbow of the needle guard to catch on the edge of the stabilizer to thereby cause a malfunction.

[0119] Methods of making and using catheter assemblies and components thereof are within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0120] These and other features and advantages of the present apparatus, system and method will become more appreciated as the same becomes better understood with reference to the specification, claims and accompanying drawings, in which:

[0121] Figure 1 is an exploded perspective view of a catheter assembly provided according to aspects of the present invention.

[0122] Figure 2 is a perspective view of a needle guard that may be used with the catheter assembly of the present invention.

[0123] Figure 3A , Figure 3B and Figure 3C are different views of a valve opener according to aspects of the present invention.

[0124] Figure 4 is a perspective view of a catheter assembly with a removable protective cap.

[0125] Figure 5 yes Figure 4 A cross-sectional side perspective view of a catheter assembly.

[0126] Figure 6 is in a ready-to-use position Figure 4 Detailed partial cross-sectional side view of a catheter assembly shown without a protective cap.

[0127] Figure 7 is viewed in the distal direction rotated 90 degrees Figure 6 A cross-sectional side view of a catheter assembly.

[0128] Figure 8 is a detailed partial cross-sectional side perspective view of a catheter assembly of the present invention.

[0129] Fig. 9is a cross-sectional side view showing the needle and the needle guard covering the needle tip in the process of being removed.

[0130] Fig.10 Shown are the needle guard and needle removed and the valve in the closed position.

[0131] Fig.11 Shown is a male Luer tip inserted into a catheter hub to advance the valve opener to open the valve.

[0132] Fig.12 and Fig.13 is a perspective view of an alternative needle guard according to aspects of the present invention.

[0133] Fig.14 is an end view of the catheter assembly shown without a needle or needle hub.

[0134] Fig.15 is an end view of the catheter assembly shown without a needle or needle hub. DETAILED DESCRIPTION

[0135] The detailed description of elaboration hereinafter in conjunction with the accompanying drawings is intended to be the description of the current preferred embodiment of the conduit assembly with the valve for controlling fluid flow provided according to the aspect of this device, system and method, and is not intended to represent that wherein can build or utilize the unique form of this device, system and method. This description is set forth in conjunction with illustrated embodiment for building and using the features and steps of the embodiment of this device, system and method. However, it will be understood that the same or equivalent function and structure can be realized by also being intended to encompass the different embodiments within the spirit and scope of the present disclosure. As pointed out elsewhere herein, the same element number is intended to indicate the same or similar element or feature.

[0136] Reference now Figure 1 , shows an exploded perspective top view of a catheter assembly 100 provided according to aspects of the present disclosure. As shown, the catheter assembly 100, which may be more broadly referred to as a needle assembly or needle device, is shown to include a catheter hub 102 having a catheter tube 104 and a bushing 138. The bushing 138 may be configured to wedge the proximal end of the catheter tube 104 against the inner wall surface of the catheter hub 102 to retain the catheter tube 104 to the catheter hub 102.

[0137] Inside the catheter hub 102, a septum or valve 136, an actuator or valve opener 134, and a safety clip 132, such as a needle guard or tip protector, may be located. Optionally, the safety clip 132 may be omitted. The needle 108 having the profile change 144 may be inserted through the proximal opening of the catheter hub 102, with the needle tip protruding from the distal opening 112 of the catheter tube in a ready-to-use position, as shown in FIG. Figure 5-7A cannula hub or needle hub 106 can be attached to the proximal end of the needle 108 and can contact the proximal end of the catheter hub 102 when assembled to the catheter hub 102 in a ready-to-use position. The proximal opening 101 of the catheter hub 102 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.

[0138] The tip protector 132 is configured to cover the needle tip and is removed with the needle 108 after use, and the valve 136 and valve actuator 134 remain with the catheter hub 102 for controlling fluid flow therethrough. The valve actuator 134 is configured to be pushed distally into the valve 136 by the male tip to open the valve for fluid flow, as discussed further below.

[0139] A flashback plug or blood stopper assembly 114 may be connected to the needle hub 106 to block blood from flowing out of a flashback chamber 116 of the needle hub 106. The flashback plug 114 may be disposed at the proximal end of the needle hub 106 to allow air to escape but block blood from escaping from the proximal end of the body of the flashback plug 114, which has a chamber 114a and a hydrophobic filter 114b. Alternatively, a syringe may be attached to the proximal end of the needle hub 106. A second valve 136 and an actuator 134, described further below, may also be disposed within the needle hub 106.

[0140] A protective cap 124 having a sleeve 124a and a saddle 124b may be provided to cover the needle 108 during packaging and before use, as is conventional. The saddle 124b may surround at least a portion of the catheter hub 102 and the needle hub 106 and be removably coupled to the needle hub. The protective cap 124 will be removed from the catheter assembly before use.

[0141] In the example of a 360 degree arc or circle, the valve opener 135 has a pair of plunger elements that are generally aligned at the 0 degree (or 360 degree) position and the 180 degree position when the catheter assembly is in the ready-to-use position and after the needle is removed after a successful venipuncture. The tip protector 132 has two arms that are generally aligned at the 90 degree position and the 270 degree position when the catheter assembly is in the ready-to-use position. The reference point of the two arms can be a plane drawn through the midline of the two arms in the longitudinal direction. Two points on this plane can represent two arms that can be roughly located at the 90 degree position and the 270 degree position. When viewed from the end view of the catheter hub in the distal direction, the 0 degree position is understood to be the top dead center position of the complete circle. The needle bevel at the needle tip 110 faces upward in the ready-to-use position, toward the 0 degree position. These arrangements allow the needle guard or tip protector 132 to be retracted with the needle after a successful venipuncture while avoiding or minimizing potential snagging between the tip protector and the valve opener if the needle guard tilts or pitches as it retracts, as discussed further below.

[0142] Reference now Figure 2 , showing Figure 1 16,630, the contents of which are expressly incorporated herein by reference. For example, the tip guard 132 may have a proximal wall and two resilient arms, and wherein a profile change 144 (such as a curl or protrusion) on the needle 108 may engage the perimeter of an opening defined on the proximal wall of the tip guard 132 to retract the tip guard outwardly from the catheter hub in a proximal direction after a successful venipuncture. The two arms may be as described in U.S. Patent No. 6,616,630 and Figure 2 , or they may extend along different sides of the needle and not intersect along the side view. The tip protector may instead have only one arm.

[0143] The two needle guard arms may be deployed or biased outwardly from the needle shaft in the ready-to-use position such that the biasing arms of the needle guard engage the inside of the catheter hub, engage the valve opener (such as one or more edges of the valve opener), or a combination thereof in the ready-to-use position, as discussed further below. In an example, only a portion of the tip guard or needle guard 132 may extend into one or more gaps of the valve opener 134, while a proximal section of the tip guard (such as a proximal wall) may extend proximal to or be located proximal to a proximal surface of the tip guard 132, as discussed further below.

[0144] Figure 2 yes Figure 114. A rear isometric view of a needle guard 132 of FIG. The needle guard 132 is exemplary only, as needle guards having other or different features may be used in place of the exact needle guard 132 shown. In this embodiment, the needle guard 132 includes a proximal wall 142 including a perimeter 144 defining an opening 146. The proximal wall 142 has a proximal-facing wall surface 148 and a distal-facing wall surface opposite the proximal-facing wall surface. At least one resilient arm 150 extends distally of the proximal wall 142. As shown, two resilient arms 150, 152 extend distally of the proximal wall. One arm may be longer than the other arm. Each arm may also include different arm widths, including a first arm segment 156 of a first width and a second arm segment 158 ​​of a second width less than the first width. The two arms may originate from different ends of the proximal wall 142 and may cross each other at their respective second arm segments 158. Thus, when viewed from the side along the longitudinal direction of the needle guard 132, the two arms intersect each other. When used with a needle, the two arms 150, 152 intersect each other when in the ready-to-use position and in the protection position. In an alternative embodiment, the two arms 150, 152 originate from different ends of the proximal wall and extend in the distal direction without crossing each other. Thus, the two arms 150, 152 may also have substantially the same arm width along the length of each respective arm.

[0145] Two distal walls 162, 164 are provided, one at the end of each of the two arms 150, 152. The distal walls 162, 164 can overlap each other in the axial direction of the needle guard by utilizing different arm lengths and / or angling one of the distal walls further distally at an elbow or diagonal section 168 between the distal wall and the resilient arm. In an example, if two arms are utilized, the elbow or diagonal section 168 of each arm can engage a corresponding guard engagement section inside the catheter hub 102, such as a recess or raised protrusion inside the valve actuator 134, or one or more constraining or limiting surfaces or choke points against one or both reliefs of the valve actuator 134 to removably secure the needle guard inside the catheter hub in the prepared position and during the transition process of removing the needle 108 from the catheter hub 102. When the radial profile size of the needle guard 132 measured at one or both elbows 168 is reduced, such as after the needle tip moves proximally of the two distal walls 162, 164, the needle guard 132 can be moved proximally of the obstruction or obstruction point to be removed from the catheter hub 102 with the needle. As the two distal walls move radially, the needle guard reduces its radial profile and can then be moved through or proximally past the obstruction point. In forming the needle guard, the needle guard 132 can be folded from a stamped metal sheet to form the needle guard as shown. Ribs can be formed on the arms, proximal walls, and / or distal walls to increase structural rigidity.

[0146] Reference now Figure 3A , showing a top or plan view of a valve opener or actuator 134. The valve opener can be used with any needle assembly described herein, such as Figure 5 As shown, the valve actuator has a nose section 174, a transition section 176, and two plunger elements 178, 178 extending proximally of the transition section or extending proximally from the nose section. The nose section 174 defines a first continuous peripheral section 180. Other locations of the nose section 174 away from the first continuous peripheral section 180 may include slits or slots.

[0147] Two stabilizer elements 184, 184 are attached to two plunger elements 178 to form a stabilizing ring 186, which defines a second continuous peripheral section 188 of the valve actuator. Each stabilizer element 184 may include two edges 192a, 192b. In an example, the two edges 192a, 192b of each stabilizer element may be parallel to each other. As shown, the two stabilizer elements 184, 184 are skewed or skewed so that although the two edges 192a, 192b of each stabilizer element may be parallel to each other, the two edges 192a, 192b from one stabilizer element are not parallel to the two edges 192a, 192b of another stabilizer element. As shown, the proximal edges 192b of the two stabilizer elements 184, 184 are offset along the axial direction or longitudinal direction of the valve actuator. As shown, the distal edges 192a of the two stabilizer elements 184, 184 are offset along the axial direction. In an example, the distal edge is positioned obliquely relative to an axis of the catheter hub.

[0148] The valve opener 134 is provided with two clearances or two through-channels 196, each of which is defined or delimited by a transition section 176, two plunger elements 178 and corresponding stabilizer elements 184, 184. The two clearances or through-channels may be referred to as a first clearance or first through-channel and a second clearance or second through-channel. In an example, each clearance or through-channel has a periphery 200. In an example, each periphery may be defined by the structure of the transition section 176, two plunger elements 178 and corresponding stabilizer elements 184, 184. Since the two stabilizer elements 184, 184 may be deflected or skewed in different directions, the two peripheries 200 of the two clearances or through-channels 196 may be different, such as having different periphery profiles or shapes. The edges 192a, 192b of the two stabilizer elements 184, 184 are preferably tilted relative to the direction of the needle or the axis of the catheter hub. As shown, the two peripheries 200 are each defined by a continuous ring. In other words, in this embodiment, the perimeter 200 does not have slits or slots to form an open perimeter. However, where the stabilizer element 184 includes slots or slits, the perimeter may be an open perimeter or a non-continuous perimeter.

[0149] In some examples, the two stabilizer elements 184, 184 may extend laterally without being skewed or tilted in the distal or proximal direction. When so configured, the edges 192a, 192b of the two stabilizer elements 184, 184 are parallel to each other. In addition, the four edges of the two stabilizer elements may be parallel to each other and axially offset. That is, the proximal edge 192b of one stabilizer element may be located more proximal or more distal than the proximal edge 192b of the other stabilizer element, while the four edges are parallel to each other.

[0150] Continue to refer Figure 3A , two plunger element studs or extensions 178a are shown extending proximally of the stabilization ring 186. In examples, the two plunger element studs 178a may extend from the stabilization ring 186 and be axially aligned with the plunger elements 178. In other examples, the two plunger element studs 178a are not axially aligned with the two plunger elements 178. In still other examples, only one plunger element stud 178a is aligned with one of the two plunger elements 178. For a valve opener or actuator having only one plunger element 178 between the first and second continuous peripheral segments, only one of the two plunger element studs 178a or none of the plunger element studs may be aligned with one plunger element.

[0151] In some examples, there may be more than two plunger element stubs or extensions 178a extending proximally of the stabilizing ring 186. Two or more plunger element stubs or extensions 178a may be equally spaced around the proximal periphery of the stabilizing ring 186, or randomly spaced around the proximal periphery of the stabilizing ring 186. The plunger element stubs may extend the overall length of the valve actuator. The number of plunger element stubs and / or the arc curve of each plunger element stub (which defines the width of each plunger element stub) may provide a larger overlap surface with the male Luer tip than a smaller number of plunger element stubs or having a relatively smaller arc curve. In other examples, the two plunger element stubs or extensions 178a are considered to be part of the two plunger elements 178, 178, and the stabilizer ring 186 is located between the two ends of each of the two plunger elements.

[0152] Further references Figure 3A, the two plunger elements 178, 178 are each shown as having at least two thicknesses to form a protrusion 206 at the interface between the two thicknesses on the outer surface 208 of each plunger element. The two protrusions 206, 206 can be located inside the recessed section of the catheter hub 102, so that the shoulder at the proximal end of the recessed section can provide a stop surface to interact with the two protrusions 206, 206 to prevent the valve opener 134 from being displaced from the interior of the catheter hub and from being moved out of the interior of the catheter hub. In some examples, only one protrusion 206 is used on one of the two plunger elements to prevent the valve opener 134 from being displaced in the proximal direction. In some other examples, each plunger element 178 has a single thickness, and the protrusion 206 is formed by adding material to the plunger element only at the location of the protrusion during injection molding.

[0153] In the example, a planar surface section 212 is provided to the valve actuator 134 on the same side of each stabilizer element 184. The planar surface section 212 originates near the nose section 174 or transition section 176 of the valve component and extends proximally to near the two protrusions 206.

[0154] Now the reference is taken along line 3B-3B Figure 3A A cross-sectional side view of the valve opener 134 Figure 3B , two planar surface sections 212, 212 are provided, one on each side of the valve opener 134, corresponding to the two stabilizer elements 184, 184, so as to minimize the overall profile of the transition section 176 and the two plunger elements 178, 178 along the side profile, as shown Figure 3B Thus, in the example, the cross-sectional dimensions of the nose section 174, the transition section 176 and the two plunger elements 178, 178 are as shown in the side view or from the Figure 3A The orientation of a 90 degree rotation along the longitudinal axis of the valve opener is substantially constant or the same within typical manufacturing tolerances.

[0155] Continue to refer Figure 3B, showing a holding space 222, which may be located between two plunger elements 178, inside a stabilizing ring 186, between two plunger element studs 178a, or a combination thereof. As previously described, part or all of the needle guard 132 may be located in the holding space 222 in the ready-to-use position, and one or both elbows of the tip guard 132 may protrude beyond the relief 196. For example, the elbow of the needle guard may be located distally of the two stabilizer elements 184, 184 and located in the through openings or reliefs 196, 196 in the ready-to-use position. Furthermore, in the ready-to-use position, the two elbows may contact the interior of the catheter hub, be spaced from the interior of the catheter hub, may contact one or both perimeters of the relief, or be spaced from the perimeter of the relief and the inner surface of the catheter hub, or a combination thereof. Obviously, if the tip guard 132 incorporates only one arm and one elbow, a single elbow may be similarly arranged.

[0156] In the ready-to-use position, the two elbows 168, 168 of the needle guard can be located distally of the two stabilizer elements 184, 184, and the proximal wall 142 of the needle guard can be located proximal to the two stabilizer elements. In the example, the proximal wall 142 can be flush with the proximal end surface 204 of the plunger element short column 178a, located proximal to the end surface 204, or located distal to the end surface. If the plunger element short column is not incorporated, the proximal wall of the needle guard 132 can be flush with the proximal edge of one or two stabilizer elements 184, 184, located proximal to the proximal edge of one or two stabilizer elements 184, 184, or located distal to the proximal edge of one or two stabilizer elements 184, 184.

[0157] Further references Figure 3B The distance between the two inner surfaces 224, 224 of the two stabilizer elements 184, 184 defines a blocking gap, blocking point or restriction point for the needle guard 132 to limit the proximal movement of the needle guard in the ready-to-use position and / or during needle retraction after intravenous entry, as previously discussed. That is, at the needle tip 110 ( Figure 1 ) Before the needle guard moves proximally of one or both distal barrier walls 162, 164, the choke point or gap is too small for the needle guard to pass proximally of the choke point, choke point or restriction point because the diagonal measurement between the two bends is greater than the choke point. However, after the needle tip moves proximally of one or both distal barrier walls of the needle guard and the distal wall is no longer biased by the needle shaft, the two distal walls move radially inward to reduce the radial profile of the needle guard to be smaller than the choke point. At this point, the needle guard can move proximally of the choke point with the smaller radial profile measured at the two bends.

[0158] The passage 218 is defined by the nose section 174 of the valve opener. A distal opening 216 leads from the distal end to the passage 218, and the passage has a proximal opening. The needle is located in or through the passage 218 in the ready-to-use position.

[0159] Figure 3C yes Figure 3A and Figure 3B A perspective view of the valve opener 134 is shown.

[0160] Figure 4 yes Figure 1 1 is an isometric view of the assembled needle assembly 100 showing the removable cap 124 disposed on the needle 108 and engaging the needle hub 106. The catheter hub 102 is shown with an optional pair of wings 126, 126 extending radially of the hub body. When incorporated, the wings 126 can increase stability by providing increased surface area for resting and securing the catheter hub 102 against the patient's skin, such as after intravenous access. Figure 5 yes Figure 1 and Figure 4 180 degrees. As shown, the plunger element of the valve opener 134 is oriented at the 0 degree and 180 degree positions, and the bevel at the needle tip 110 is oriented upward and aligned with the upper plunger element. The reference point of the two plunger elements can be a plane drawn through the center lines of the two plunger elements in the longitudinal direction. The two points on this plane can represent two plunger elements, which can be approximately located at the 0 degree and 180 degree positions. When viewed from the end view of the catheter hub in the distal direction, the 0 degree position is understood to be the top dead center position of the complete circle. In addition, the two elbows and two arms of the needle guard 132 are oriented at the 90 degree and 270 degree positions, and the elbows protrude beyond the two gaps 196, 196 of the valve opener 134, while the bevel at the needle tip 110 is oriented upward and aligned with the push piece 250 ( Figure 7 ) Further, the plunger element of the valve opener 134 is oriented at the 0 degree and 180 degree positions, the two elbows and two arms of the needle guard 132 are oriented at the 90 degree and 270 degree positions, and the elbows protrude beyond the two gaps of the valve opener, while the bevel at the needle tip 110 is oriented upward and aligned with the upper plunger element.

[0161] Figure 6 yes Figure 5 1 is a schematic partial cross-sectional side view of a catheter assembly 100 , the catheter assembly 100 being shown without the protective cap 124 . Figure 7 is viewed in the distal direction and rotated 90 degrees clockwise Figure 6The catheter assembly 100 is shown in two different views with the catheter hub 102 at the proximal end of the catheter tube 104 and the catheter tube extending out of the distal end of the catheter hub 102, and with a needle 108 attached to a needle hub 106 (partially shown) protruding through the catheter hub 102 and the catheter tube 104 with the needle tip 110 extending out of the distal opening 112 of the catheter tube in a ready for use position.

[0162] In the prepared position where the needle hub 106 contacts the catheter hub 102 and the needle tip extends beyond the distal end or distal opening 112 of the catheter tube 104, the catheter assembly 100 is ready for use, such as to perform venipuncture or intravenous access. Located inside the catheter hub 102 is a valve 136, which has a valve body 230 with an outer periphery, a valve disc 232, and a valve skirt 234 extending in an axial direction from the valve disc. In an example, the valve disc 232 includes one or more slits defining one or more flaps to be opened by the valve actuator 134. The type of slits and flaps incorporated into the valve disc 232 and the number of each can vary, with three slits and three flaps being preferred. In an embodiment, the valve skirt 234 is positioned in a recessed section 236 formed in the inner cavity 173 of the catheter hub 102, which prevents the valve 136 from moving axially once it is located inside the catheter hub 102.

[0163] In the example, the recessed section 236 has a distal shoulder 236a and a proximal shoulder 236b ( Figure 6 ), which define a groove 236 therebetween. The valve skirt 234 has a length sized and shaped to fit within the groove or recessed section 236. In the example, the valve skirt 234 contacts the proximal shoulder 236b, while the valve disc 232 contacts the distal shoulder 236a. From different angles, Figure 7 The valve 136 may contact and be restrained by the distal shoulder 236a and the proximal shoulder 236b of the recessed section 236 in a ready-to-use position such that the valve skirt 234 is axially fixed or non-axially movable.

[0164] In examples, the outer diameter or outer surface of the skirt section 234 forms a tight fit or dimension-to-dimension fit with the recessed section 236 of the interior 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 surface of the skirt section 234 and the inner surface at the recessed section 236, wherein the valve skirt 234 contacts the proximal shoulder 236b and the valve disc 232 contacts the distal shoulder 236a of the recessed section.

[0165] Distal chamber 173a ( Figure 7) is disposed distally of the valve disc 232 and proximally of the bushing 138. In some examples, a coil spring or elastic biasing element (such as an elastomeric ring or cylinder) may be disposed concentrically with the needle in the distal chamber 173a to bias the flaps of the valve disc 232 to assist the valve disc in closing one or more slits.

[0166] In an example, the valve disc 232 includes a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps, as previously discussed. In the illustrated embodiment, the valve skirt 234 extends axially to the longitudinal axis of the valve and has an elongated wall that is generally perpendicular to the outer periphery of the valve disc 232, thereby forming a generally cylindrical valve body. In some embodiments, the valve skirt 234 may be inclined so that the valve forms a frustoconical structure.

[0167] The valve skirt 234 defines a valve cavity 238 having an open proximal end 240 through which the actuator nose or nose section 174 of the valve actuator 134 can advance and actuate the valve flap of the valve disc 232. In one embodiment, at least some portion of the actuator nose 174, including the distal actuation end 244 of the valve actuator 134, is located within the valve cavity 238 of the valve 136 prior to actuation. Thus, the actuator nose 174 can be narrower than the inner diameter of the valve skirt 234 so that the actuation end 244 fits within the valve cavity 238 and abuts or touches the valve disc in a ready-to-use position. In an example, the relative dimensions are such that the actuator nose section 174 does not touch the inner wall surface of the skirt section 234, although some touching is envisioned.

[0168] In an example, the actuating end 244 of the valve opener contacts the proximal-facing surface of the valve disc 232 in the ready-to-use position, and another portion of the valve actuator 134 (such as one or both protrusions 206 ( Figure 3A )) abuts a shoulder 246 on the interior of the catheter hub to apply a load on the valve disc in the ready-to-use position, but not sufficient to open one or more slits, as discussed further below. In other examples, the actuation end 244 is spaced from the proximal-facing surface of the valve disc 232 in the ready-to-use position, and the one or more protrusions 206 on the actuator contact the shoulder 246 or are also spaced from the shoulder 246. When the one or more protrusions on the actuator 134 are spaced from the shoulder 246 and the actuation end 244 is spaced from the valve disc 232, the actuator can float a small amount in the axial direction within the catheter hub.

[0169] In the example, the protrusion 206 extends outwardly from the outer surface of one or both plunger elements 178. As shown, the protrusion 206 extends from the outer surface of each plunger element 178. Each protrusion 206 resembles a ramp surface having a generally flat edge for abutting the shoulder 246. The ramp surface of the protrusion 206 and the direction of the ramp allow the actuator 134 to be inserted into the interior of the catheter hub and seated within the second recessed section 240, as discussed further below.

[0170] In the example, the actuator or valve opener 134 has a longitudinal axis, and one or more actuating elements 178 extend axially or parallel to the longitudinal axis. In a specific example, two actuating elements 178 are diametrically opposite each other along the longitudinal axis. As shown, the two actuating elements 178 define an outer diameter that has a size greater than the diameter of the nose section 174.

[0171] In an example, the actuating element 178 is flexible and deflectable so that when pushed by the male Luer tip, the actuating element deflects or flexes. The actuating element is deflectable by selecting a material with the desired elastic properties. In other examples, the actuating element is deflectable by incorporating one or more weakened sections, such as by incorporating a structurally thin section, by incorporating an incision, by adopting a cross-section that is small compared to other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element 178 is flexible and deflectable by selecting a material with the desired elastic properties and by incorporating one or more weakened sections.

[0172] In still other examples, each actuating element 178 has more than one different cross-sectional profile or shape along a length segment.For example, an elongated plunger element may have a square profile positioned adjacent to a crescent-shaped profile.

[0173] The nose section 174 of the valve actuator 134 can be configured to engage the valve 136 to open the valve disc 232 when an axial force is applied to the actuation element 178 from the male tip toward the distal end of the catheter assembly 100 (such as during insertion of an IV drip line male Luer connector). Generally, the nose section 174 is rigid relative to the more flexible valve 136, which allows the nose section 174 and more specifically the actuation end 244 to actuate the valve 136, such as to deflect one or more flaps and open one or more slits on the valve disc 232. The nose section 174 can be made of an incompressible material (such as metal, rigid plastic, or hard elastomer) for pushing against and opening the valve.

[0174] In one embodiment, the stabilizer or stabilizer elements 184, 184 are arcuate, forming an arc that follows the interior contour of the catheter hub 102 and connects one actuation element 178 to another actuation element 178. The stabilizer or stabilizer element 184 may form a substantially cylindrical section on the body of the valve actuator that is spaced apart from the nose section 174 of the valve actuator. In other words, the valve actuator may be elongated and may have sections that are continuous in the radial direction and sections that are discontinuous in the radial direction having a relief or through-passage through the wall of the actuator.

[0175] In the example, the stabilizers 184, 184 define a continuous body segment or ring 186 along the circumference or radial direction of the valve actuator, which is separated from the continuous body segment of the nose segment 174 that is also continuous along the circumference or radial direction. The two stabilizers or stabilizer elements 184, 184 can be connected together with the two plunger elements 178 to form a ring structure. Optionally, the two stabilizers can be slightly offset and angled from each other.

[0176] The stabilizer 184 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. By remaining centered, the nose section 174 can better align with the valve disc 232, such as a slit on the valve disc, thereby allowing smooth actuation of the valve 136. The stabilizer 184 can also provide engagement with the interior of the catheter hub 102 via friction to prevent the actuator 134 from sliding in a proximal direction after the male luer tip is removed.

[0177] In one embodiment, the nose segment 174 is configured to remain engaged to the valve disc 232 after actuation of the valve and after removal of the male Luer tip. For example, the nose segment 174 can be wedged between one or more slits on the valve disc and held there by friction, as discussed further below. Surface features (such as protrusions, grooves, or barbs) can be provided on the valve actuator 134, such as on the nose segment, to maintain engagement between the actuator and the valve after actuation and after removal of the male Luer tip.

[0178] A relief, opening or through passage 196 may be provided between the transition section 176 (or from the nose section) and each of the two stabilizers 184, 184. The two reliefs or through passages 196 may provide clearance so that the interior or central portion of the valve actuator 134 and the inner surface of the catheter hub 102 may be in open communication. In other words, there are one or two reliefs or openings 196 between a continuous section of the nose section and a continuous peripheral section (referred to as a stabilization ring or stabilization ring 186) defined by the two stabilizers 184, 184 and the plunger element 178.

[0179] When the two arms are biased outwardly by the sides of the needle shaft, the stabilization ring 186 of the valve actuator 134 can have an inner diameter that is smaller than the diameter defined by the diagonal sections or elbows 168 of the two arms 150, 178 of the needle guard 132. Therefore, during installation of the needle guard 132 into the holding space of the valve actuator 134, the diagonal sections or elbows of the needle guard 132 can be deflected to pass through the stabilization ring 186 and enter the open area defined by the relief 196.

[0180] When the tip guard 132 is positioned between the two plunger elements 178, the two distal walls 162, 164 of the needle guard 132 (more specifically, the two diagonal sections or elbows 168) can be located in the gap 196 as discussed above to engage a guard engagement surface on the inner surface of the catheter hub 102, such as a groove or protrusion formed in the interior of the catheter hub, engage the distal edges of the two stabilizer elements, or be spaced from both the stabilizer and the inner surface of the catheter hub. Thus, the needle guard can be maintained within the interior of the catheter hub in a ready-to-use position and during needle retraction after a successful venipuncture until the needle tip moves proximally of the two distal walls on the needle guard, at which time the needle guard can be closed over the needle tip and removed with the needle, as discussed above with reference to FIG. 3.

[0181] A second undercut or recessed section 248 proximal to the first recessed section 236 may be provided in the lumen 173 of the catheter hub 102 for accommodating the two diagonal sections or elbows 168. Thus, the needle guard 132 may be prevented from sliding in the proximal direction during needle retraction after a successful venipuncture by the shoulder 246 of the second recessed section 248 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. Optionally or alternatively, a distal edge 192a of one or both stabilizers 184, 184 may provide a restraining surface to prevent premature activation of the needle guard 132 during needle retraction before the needle tip moves proximal to the two distal walls 162, 164. In addition to the distal edge 192a, both stabilizers 184, 184 also have a proximal edge 192b.

[0182] In some examples, one or both stabilizer elements 184, 184 may have a slit or passageway, thereby dividing the arcuate stabilizing element into two. Even with a slit on one or both stabilizer elements 184, 184, the stabilizing ring 186 (which may be a non-continuous ring, similar to a ring with one or more slots formed through the ring) can still provide a constraining surface to prevent the needle guard 132 from being activated prematurely during needle retraction (such as before the needle tip moves proximally of the two distal walls 162, 164). The constraining surface may also be referred to as a restriction 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 to then slide proximally of the blocking point. In an example, one or both elbows 168 of the needle guard may be constrained from moving in a proximal direction by the blocking point until one or both elbows of the needle guard deflect to reduce the radial profile of the needle guard. In an example, the needle guard may slide from a distal position of the stabilization ring through an aperture defined by the stabilization ring to a proximal position of the stabilization ring when a radial profile of the needle guard is reduced.

[0183] 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 cross-section of the actuating element 178 can provide increased rigidity when pushed by a male Luer connector. Each actuating element 178 may include at least two longitudinal edges, and ribs may be provided along one or two of the longitudinal edges to further increase structural rigidity. One or more gaps may be provided between any two actuating elements 178. The gap may provide a gap or space for a fluid flow flowing through it, such as during flushing blood or IV infusion. The gap between the actuating elements 178 may define a holding space 222 for accommodating the tip protector 132.

[0184] In some embodiments, most or most (if not all) of the tip guard 132 fits within the retaining space 222 formed by the body of the actuator 134 between the two plunger elements 178 in the ready-to-use position, such as Figure 6 This allows the catheter hub 102 to be more compact because less longitudinal space is required within the hub to fit both the actuator 134 and the tip protector 132 longitudinally in series, or when the two only partially overlap in the axial direction. Figure 6 In , the tip protector 132 is shown as fully fitted within the retaining space of the actuator 134 to further reduce the space or length required in the catheter hub. As shown, the proximal wall 142 of the needle guard 132 is generally flush or flush with the proximal end surfaces of the two plunger elements 178.

[0185] When the tip protector 132 only engages or contacts the distal edge 192a of the actuator's relief or through-channel 196, or is spaced from the edge but does not contact the inner surface of the catheter hub, no deformation or diameter change is required on the inner wall of the catheter hub, and the tip protector 132 can be placed further proximally in the female Luer tapered section while complying with the international Luer standard for conical fittings, and the overall length of the catheter hub 102 can be further reduced.

[0186] like Figure 6 As shown in the view, the push tab 250 on the catheter hub 102 is generally in the 0 degree position relative to the arc end view of the catheter hub 102. The bevel of the needle tip 110 is similarly angled and aligned to the 0 degree position, which may also be referred to as the bevel up position. In the bevel up position, the two arms 150, 152 of the needle guard and similarly the two elbows 168, 168 are aligned at the 90 degree and 270 degree positions, while the two plunger arms 178, 178 are aligned at the 0 degree and 180 degree positions. This unique arrangement is different from known prior art devices and is incorporated to minimize or avoid catching of the elbow against the stabilizer during retraction of the needle guard after a successful venipuncture, wherein the needle guard 132 can be tilted or pitched by the practitioner, as further discussed below.

[0187] In order to align with the needle guard or tip protector 132, the tip extension 262 at the distal end of the nose section 264 of the needle hub 106 is also rotated. That is, the tip extension 262 is oriented to a 90-degree position to push the proximal wall of the needle guard. Therefore, although the needle bevel is oriented in a 0-degree bevel-up position, the tip extension 262 on the needle hub is oriented in a 90-degree position. Due to manufacturing tolerances, when a specific angular position is specified, it is understood to mean approximately or approximately, and will not be interpreted as an exact measurement or position unless the context indicates otherwise. Although the tip extension 262 at the distal end of the needle hub 106 should be rotated or oriented to align with one of the two arms 150, 152 of the needle guard 132, the external tab 268 for capturing the catheter hub between the nose section 264 and the external tab 268 can be maintained at a 180-degree position in the ready-to-use position, or rotated with the tip extension 262.

[0188] Reference now Figure 8 , showing the absence of the tip extension 262 Figure 6 and Figure 7174. A perspective view of the catheter assembly 100 of FIG. 175. One of the relief or through passages 196 is clearly shown proximal to the nose section 174 of the actuator 134 and has an elbow 168 of one of the arms located therein to engage with the interior of the catheter hub 102, engage with the distal edge of the stabilizer 184, engage neither the inner surface nor the distal edge, or a combination thereof, as previously discussed. In the illustrated embodiment, the tip guard 132 fits substantially within the retaining space of the actuator 134, and the proximal wall 142 of the tip guard is approximately flush with the proximal end of the actuating element 178 in the axial direction.

[0189] Now with Figure 5-8 Combination reference Fig. 9 , shows a schematic view of the needle 108 retracted proximally at an angle above the centerline after a successful venipuncture. The figure shows the needle tip 110 ( Figure 1 ) moves proximal to the two distal walls of the needle guard 132 and the needle guard blocks the needle tip. The angle of the needle shaft may be positioned intentionally or unintentionally, such as due to the practitioner's tendency during needle retraction after venipuncture. Regardless of why the needle may be angled, this action causes the needle guard 132 located at the needle tip to tilt or pitch, which may cause one or both of the elbows 168, 168 on the two arms to hook onto the distal edges 192a, 192a of the stabilizers 184, 184 if the elbow and stabilizer are aligned at the 0 and 180 degree positions. In other words, if the needle guard 132 tilts or pitches during retraction, the elbow (if aligned at the 0 and 180 degree positions) may hook against the edge of the stabilizer if the valve opener is aligned with the plunger element at the 90 and 270 degree positions. Note that for clarity, Fig. 9 Shown without one of the stabilizer elements 186 .

[0190] However, when the elbows 168, 168 are aligned at the 90 and 270 degree positions, the two stabilizers 184, 184 are aligned at the 90 and 270 degree positions, and the two plunger elements 178, 178 are aligned at the 0 and 180 degree positions, as shown in FIG. Figure 8 As shown in FIG, tilting or pitching does not cause one or both of the elbows to move against the edge of the stabilizer to hook against the edge of the stabilizer during retraction. If the elbow would hook against the stabilizer, the needle guard may cause the tip guard 132 to pull against the valve actuator 134 during needle retraction to possibly displace the valve actuator 134 from the interior of the catheter hub. Thus, when various components such as Figure 8 , and when angled as shown in the drawings and according to aspects of the present invention, any tilting of the needle 108 during its retraction after a successful venipuncture, and therefore the tilting of the tip guard 132, will simply cause the tip guard to abut against the inner surface 270 ( 271 of one or both of the plunger elements 178, 178) of the plunger element 178. Figure 3B) slide. Since the inner surfaces 270 of the two plunger elements 178, 178 do not have edges for snapping, the needle guard 132 can be easily retracted away from the valve opener without catching the valve opener in the process. Figure 8 When oriented as shown in FIG. 1 and elsewhere, the components of the valve opener are configured to operate freely without the elbow catching on the edge of the stabilizer and thereby causing malfunction.

[0191] Fig.10 is a partial cross-sectional side view of the catheter assembly 100 after the needle 108 and needle guard 132 have been removed and two stabilizer elements 186 are shown. Fig.11 The valve actuator 134 is shown being advanced distally into the valve 136 through the syringe tip or Luer tip 272 of the IV drip line to allow fluid to flow through the catheter hub. The Luer tip 272 may be a threaded Luer connector that engages the catheter hub 102 in a threaded engagement manner, and the catheter hub 102 may have a female threaded Luer connector. The actuator 134 is advanced to advance the actuation end 244 against the valve disc 232 and deflect the flap radially and distally to open the fluid path to be formed by the catheter assembly 100. As shown, the valve 136 is in a closed position, in which one or more slits of the valve disc 232 are closed. The retracted position of the valve actuator 134 is also shown, in which the actuation end 244 of the nose section 174 is not pushed in and opens one or more slits. This position is also understood to be a valve pre-activation position. That is, the male Luer tip has not yet been inserted into the proximal opening of the catheter hub to advance the valve actuator to open the valve. In other words, this is a valve closed position.

[0192] When a male medical device 272 (such as a male Luer tip) is initially inserted into the proximal opening of the catheter hub 102, the male tip initially contacts the two actuating elements 178 on the valve actuator 134 to push a distally directed force on the two actuating elements 178 to open the valve 136. The distally directed force moves the actuator 134 in a distal direction until the geometry of the male tip and the proximal opening of the catheter hub prevent further distal advancement of the male tip. In an example, the female Luer taper of the catheter hub 102 and the male Luer taper of the male tip cooperate and prevent the male tip from further distally advancing 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.

[0193] When the actuator 134 is moved distally by the distal advancement of the male tip, the nose section 174 of the valve actuator 134 is pushed distally and pushes against the proximally facing surface of the valve disc 232. In particular, the nose of the actuator 134 initially pushes against the proximally facing surface of the valve disc 232, and because the valve is axially fixed within the first recessed section 236 of the catheter hub, one or more flaps on the valve disc 232 deflect radially and in the distal direction. Fluid from the male tip can then flow through the catheter hub 102, through the valve 136, and through the lumen of the catheter tube 104.

[0194] Alternatively, suction may be applied by a medical device such as a syringe or a vacuum blood collection tube, and blood may be drawn from the patient. This is typically done to test a sample prior to commencing an infusion therapy. Additionally, typically, any remaining blood is first flushed from the interior of the catheter hub 102 prior to commencing an infusion therapy.

[0195] Fig.11 The actuation end 244 of the nose section 174 is shown protruding through the valve disc 232 and contacting or about to contact the bushing 138 in the valve actuation position. In this configuration, the valve actuator 134 can remain engaged to the valve 136 even after the male tip is removed. That is, the friction between the valve actuator 134 and the valve disc 232 exceeds the friction caused by the valve flap in attempting to return to the valve. Fig.10 The restoring force generated when the valve actuator 134 and valve 136 are in their undeformed position shown in FIG. This activated position can be considered a one-time use or one-time actuation because the valve actuator 134 and valve 136 will not return to their original position when the male tip is removed. Fig.10 The pre-activation position of

[0196] In an alternative embodiment, the nose section 174 is configured so that when pushed into the valve 136 during activation, the actuation or activation end 244 does not extend distally beyond the flap of the valve disc 232. This configuration ensures that when the male Luer device is removed, the valve actuator 134 is pushed back by the flap of the valve disc. The conical configuration at the distal end of the actuator 134 (i.e., incorporating the tapered nose section 174) can be such a configuration that it can maintain a proximally directed force vector that is greater than the vertical force vector. The angle of the cone can be designed to provide the necessary force vector when the actuator 134 has reached its maximum distal movement and its minimum distal movement. The difference between the maximum movement and the minimum movement of a standard Luer connector is approximately 2.5 mm.

[0197] Additionally, a spring or resilient element or ring may be incorporated into the distal chamber 173a to increase the recoiling or return force of the valve 136 to facilitate urging the valve actuator 134 in the proximal direction to return to the distal chamber 173a after the male tip is removed. Fig.10. The resilient element may also assist in closing the flaps of the valve disc 232. In this way, the valve 136 and valve actuator 134 may be repeatedly reclosed and reopened after initial activation, etc. Alternatively or in addition, the flaps on the valve disc may be made thicker to provide sufficient restoring force without the need for a resilient element.

[0198] Reference now Fig.12 and Fig.13 , showing two different perspective views of a needle guard 132 provided according to an alternative aspect of the present invention. The needle guard 132 of this embodiment is similar to the needle guard 132 of the embodiment of FIG. Figure 2 1 and the needle guards shown elsewhere, and can be used with the various catheter assemblies described herein. The two arms 150, 152 are shown as being biased apart in the absence of a needle, which typically biases the arms apart to illustrate the features of the distal walls 164, 164 and the curved lip 164a, as discussed further below. The arms 150, 152 of the needle guard 132 are shown as having a smooth or flat profile between the elongated arm portions 150a, 152a and the elbows 168, 168, with only a single bend or change of direction. As shown, each elongated arm segment 150a, 152a of the first arm 150 and the second arm 152 has a segment with a different arm width. Each arm 150, 152 also includes a cutout 280 having a lip 280a similar to a hook. One or more cutouts 280, 280 in the two arms allow the two arms 150, 152 to straddle the needle to provide lateral stability as the needle transitions from a ready-to-use position with the needle tip exposed to a protected position with the needle tip shielded.

[0199] Fig.12 A curved lip 162a having a straight edge 284 is shown on the first arm 150. However, the curved lip 162a is configured to abut the needle at a flat surface adjacent the edge when in the ready-to-use position. Fig.13 The curved lip 164a on the second arm 152 is shown with a cutout 288 that resembles an arc. The cutout 288 can be used to change the position where the surface of the curved lip 162a contacts the needle instead of the edge. In some examples, the cutout 288 can be omitted. Also shown are: a rib 277 formed with both arms, which is optional and can be included to increase the strength of the arms; and a tab 274 extending from the edge of the distal wall 164, 164, which is also optional and can be included to limit lateral pivoting of the needle tip once the needle tip is captured within the needle guard.

[0200] Fig.12 and Fig.13The needle guard 132 of , as well as other needle guards described herein, may each be made from a stamped metal sheet, such as a stamped stainless steel sheet, and use a stamping and bending process to form the needle guard in the shape shown.

[0201] Reference now Fig.14 , showing the needle hub 102 without the needle and needle hub to show the needle guard 132 and two plunger elements 178, 178 of the actuator or valve opener 134 according to further aspects of the present invention. With a few exceptions, the present catheter assembly 100 is similar to Figure 4-11 In this embodiment, the two plunger elements 178, 178 of the valve opener or actuator 134 can be oriented at positions other than the 0 degree and 180 degree positions, where 0 degree is at the top dead center of the full arc or circle. For expression, the angular position is the position of the midpoint of the width of the first plunger element and the midpoint of the width of the second plunger element relative to the circular radian of degrees of the circle. When viewed in the distal direction or the proximal direction, the degree can be specified from the viewing angle. For example, when in Fig.14 When viewed in the distal direction of the upper plunger element 178, the upper plunger element 178 can be oriented at any position from about 1 degree position to about 75 degree position (including about 1 degree position and about 75 degree position), and the lower plunger element can be oriented to be 180 degrees from the position of the upper plunger element 178. As shown, the upper plunger element 178 is oriented at about 22 degree position and the lower plunger element 178 is oriented at about 202 degree position. The reference point of the two plunger elements 178, 178 can be a plane drawn through the midline of the two plunger elements in the longitudinal direction. Two points on the plane can represent two plunger elements, which can be approximately located at 22 degree and 202 degree positions when viewed in the distal direction.

[0202] Therefore, when observing Fig.11 and Fig.14 In an embodiment of the present invention, aspects of the present invention include a catheter assembly including a valve actuator having two plunger elements 178, 178, which may be referred to as a first or upper plunger element and a second or lower plunger element, and wherein the upper plunger element 178 may be oriented from about a 0 degree (or 360 degree) position to about a 75 degree position (including about a 0 degree (or 360 degree) position and about a 75 degree position), and the lower plunger element 178 may be oriented 180 degrees from the position of the upper plunger element 178. For example, the first or upper plunger position may be oriented at a 2 degree position, a 16 degree position, a 38 degree position, a 42 degree position, etc., and the lower plunger element may be oriented 180 degrees from the position of the upper plunger element.

[0203] Although not shown, the two arms of the needle guard 132 may be oriented between the two plunger arms 178, 178, roughly bisecting the two plunger arms. The two needle guard arms may be located roughly equidistant between the two plunger arms.

[0204] Therefore, when various components such as Fig.14 , and when angled as shown in the drawings and according to aspects of the present invention, any tilting of the needle 108 during its retraction after a successful venipuncture, and therefore the tilting of the tip guard 132, will simply cause the tip guard to abut against the inner surface 270 ( 271 of one or both of the plunger elements 178, 178) of the plunger element 178. Figure 3B ) slide. Since the inner surfaces 270 of the two plunger elements 178, 178 do not have edges for catching, the needle guard 132 can be easily retracted away from the valve opener without catching the valve opener in the process. Fig.14 When oriented as shown in FIG. 1 , the components of the valve opener are configured to operate freely without the bend of the needle guard catching on the edge of the stabilizer and thereby causing malfunction.

[0205] Reference now Fig.15 , showing the needle hub 102 without the needle and needle hub to show the needle guard 132 and two plunger elements 178, 178 of the actuator or valve opener 134 according to further aspects of the present invention. With a few exceptions, the present catheter assembly 100 is similar to Figure 4-11 and Fig.14 of the catheter assembly. In this embodiment, the two plunger elements 178, 178 of the valve opener or actuator 134 can be oriented at positions other than the 0 degree and 180 degree positions. For example, and as discussed elsewhere regarding relative degree positions, the upper plunger element 178 can be oriented at any position from about 285 degree position to about 359 degree position (including about 285 degree position and about 359 degree position), and the lower plunger element can be oriented to be 180 degrees with the position of the upper plunger element 178. For example, the first or upper plunger position can be oriented at 288 degree position, 294 degree position, 307 degree position, 326 degree position, etc., and the lower plunger element can be oriented to be 180 degrees with the position of the upper plunger element. As shown, the upper plunger element 178 is oriented at about 338 degree position, and the lower plunger element 178 is oriented at about 158 ​​degree position. The reference point of the two plunger elements 178, 178 can be a plane drawn through the midlines of the two plunger elements in the longitudinal direction. Two points on the plane can represent the two plunger elements, which can be approximately located at 338 degrees and 158 degrees.

[0206] Although not shown, the two arms of the needle guard 132 may be oriented between the two plunger arms 178, 178, roughly bisecting the two plunger arms. The two needle guard arms may be located roughly equidistant between the two plunger arms.

[0207] Therefore, when observing Fig.11 and Fig.15 In an embodiment of the present invention, aspects of the present invention include a catheter assembly including a valve actuator having two plunger elements 178, 178, which may be referred to as a first or upper plunger element and a second or lower plunger element, and wherein the upper plunger element 178 is orientable from an approximately 285 degree position to an approximately 0 degree position, and the lower plunger element 178 is orientable 180 degrees from the position of the upper plunger element 178. The 0 degree position is understood to be the top dead center position of a complete circle when viewed from an end view of the catheter hub in a distal direction.

[0208] Therefore, when various components such as Fig.15 , and when angled as shown in the drawings and according to aspects of the present invention, any tilting of the needle 108 during its retraction after a successful venipuncture, and therefore the tilting of the tip guard 132, will simply cause the tip guard to abut against the inner surface 270 ( 271 of one or both of the plunger elements 178, 178) of the plunger element 178. Figure 3B ) slide. Since the inner surfaces 270 of the two plunger elements 178, 178 do not have edges for catching, the needle guard 132 can be easily retracted away from the valve opener without catching the valve opener in the process. Fig.15 When oriented as shown in FIG. 1 , the components of the valve opener are configured to operate freely without the bend of the needle guard catching on the edge of the stabilizer and thereby causing malfunction.

[0209] Methods of making and using catheter assemblies and components thereof are within the scope of the present invention.

[0210] 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. Therefore, it will be understood that catheter assemblies and components thereof constructed according to the principles of the disclosed devices, systems, and methods may be embodied differently than as specifically described herein. The present disclosure is also defined in the following claims.

[0211] Needle assemblies, catheter assemblies, needle and catheter assembly components, and methods for using and making catheter assemblies or needle assemblies according to aspects of the present invention may be encompassed by the following exemplary aspects:

[0212] Exemplary aspect 1: A needle assembly comprising: a needle hub having a needle having a needle tip having a needle bevel extending from a distal end of the needle hub; a catheter tube attached to the catheter hub, the catheter hub having a body including an inner surface defining an inner cavity, wherein in a ready-to-use position, the needle extends through the catheter tube and the needle tip extends beyond the distal end of the catheter tube, wherein the needle bevel is oriented to a 0 degree position; a valve positioned in the inner cavity of the catheter hub and in contact with an inner shoulder of the catheter hub, the valve comprising an outer periphery and a wall having at least one slit defining a plurality of flaps; a valve opener sized and shaped to open the plurality of slits to open the valve, the valve opener comprising: a nose segment having an activation end and a continuous peripheral segment having a hole therethrough; two plunger elements including a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximally of the nose segment; and two stabilizer elements; wherein each stabilizer element connected to the two plunger elements so that the two stabilizer elements and the two plunger elements define a stabilization ring having a continuous surface, and the stabilization ring is separated from the continuous peripheral section of the nose section by two through-channels, the two through-channels including a first through-channel and a second through-channel; a needle guard comprising a proximal wall and two elastic arms located in a holding space between the two stabilizer elements, wherein each elastic arm includes an elbow, and the needle guard has two elastic arms and two elbows, the two elbows including a first elbow and a second elbow; wherein (1) the first plunger element is oriented to a position of approximately 285 degrees to a position of approximately 0 degrees, and the second plunger element is oriented to be 180 degrees from the first plunger element, or (2) the first plunger element is oriented to a position of approximately 1 degree to a position of approximately 75 degrees, and the second plunger element is oriented to be 180 degrees from the first plunger element; and wherein the 0 degree position is the top dead center position of the complete circle when viewed from an end view of the catheter hub in the distal direction.

[0213] Exemplary aspect 2: The needle assembly according to exemplary aspect 1, wherein, in the ready-to-use position, the first bend is located in the first through-channel and the second bend is located in the second through-channel.

[0214] Exemplary aspect 3: The needle assembly according to any one of exemplary aspects 1 or 2, wherein the two arms of the needle guard bisect the two plunger elements.

[0215] Exemplary aspect 4: A needle assembly according to any one of exemplary aspects 1 to 3, wherein the valve includes a proximally facing wall surface, and wherein the activation end of the valve opener is pushed against the proximally facing wall surface to push the multiple flaps against the inner surface of the catheter hub in the use position.

[0216] Exemplary aspect 5: The needle assembly according to any one of exemplary aspects 1 to 4, wherein the plurality of slits defines three slits, and the three slits define three petals.

[0217] Exemplary aspect 6: The needle assembly according to any one of exemplary aspects 1 to 5, wherein the first bend contacts a periphery of the first through channel.

[0218] Exemplary aspect 7: The needle assembly according to any one of Exemplary aspects 1 to 6, wherein the first bend contacts an inner surface of the catheter hub.

[0219] Exemplary aspect 8: The needle assembly according to any one of exemplary aspects 1 to 7, wherein the first bend contacts a periphery of the first through channel and an inner surface of the catheter hub.

[0220] Exemplary aspect 9: The needle assembly according to any one of exemplary aspects 1 to 8, wherein the first bend contacts an edge of the stabilization ring.

[0221] Exemplary aspect 10: The needle assembly according to any one of exemplary aspects 1 to 9, wherein the valve includes a valve disc and a valve skirt extending in a proximal direction of the valve disc and defining the valve cavity.

[0222] Exemplary aspect 11: The needle assembly according to any one of Exemplary aspects 1 to 10, wherein the second bend contacts the inner surface of the catheter hub.

[0223] Exemplary aspect 12: The needle assembly according to any of exemplary aspects 1 to 11, wherein the nose section has a frustoconical shape.

[0224] Exemplary aspect 13: The needle assembly according to any one of exemplary aspects 1 to 12, wherein the second bend contacts a periphery of the second through channel.

[0225] Exemplary Aspect 14: The needle assembly according to any one of Exemplary Aspects 1 to 13, wherein the valve opener includes a protrusion extending radially along the longitudinal axis of the valve opener, and wherein the inner surface of the catheter hub includes a shoulder for limiting proximal movement of the protrusion.

[0226] Exemplary aspect 15: The needle assembly according to any one of exemplary aspects 1 to 14, wherein the protrusion is a first protrusion, and wherein the valve opener comprises a second protrusion spaced apart from the first protrusion.

[0227] Exemplary aspect 16: The needle assembly according to any one of exemplary aspects 1 to 15, wherein the valve opener comprises a protrusion extending radially of the longitudinal axis on an outer surface of one of the two plunger elements.

[0228] Exemplary aspect 17: The needle assembly according to any one of exemplary aspects 1 to 16, further comprising a skirt section extending distally of the wall.

[0229] Exemplary aspect 18: The needle assembly according to any of Exemplary aspects 1 to 17, wherein the first stabilizer element has a distal edge and the second stabilizer element has a distal edge.

[0230] Exemplary Aspect 19: The needle assembly according to any one of Exemplary Aspects 1 to 18, wherein a distal edge of the first stabilizer element is parallel to a distal edge of the second stabilization element.

[0231] Exemplary aspect 20: The needle assembly according to any one of exemplary aspects 1 to 19, wherein a distal edge of the first stabilizer element is angled with a distal edge of the second stabilization element.

[0232] Exemplary Aspect 21: The needle assembly according to any one of Exemplary Aspects 1 to 20, further comprising a protrusion on each of the two plunger elements to define two protrusions, wherein the two protrusions are located distally of the stabilization ring.

[0233] Exemplary aspect 22: The needle assembly according to any one of exemplary aspects 1 to 21, wherein the needle guard, the valve, and the valve opener are located entirely within the lumen of the catheter hub.

[0234] Exemplary aspect 23: The needle assembly according to any one of exemplary aspects 1 to 22, further comprising a protective cap having a sleeve positioned around the catheter tube and the needle.

[0235] Exemplary aspect 24: According to any one of exemplary aspects 1 to 23, the needle assembly further includes a sleeve and an elastic element, wherein the sleeve weds the proximal end of the catheter tube against the inner surface of the catheter hub, the elastic element is located inside the catheter hub between the sleeve and the valve disc, and wherein the elastic element is sized and formed to push the valve disc in a proximal direction.

[0236] Exemplary aspect 25: The needle assembly according to any one of exemplary aspects 1 to 24, wherein the elastic element is an elastic element or a spring.

[0237] Exemplary aspect 26: The needle assembly according to any of exemplary aspects 1 to 25, wherein the wall of the valve has a substantially flat or smooth distally facing wall surface.

[0238] Exemplary Aspect 27: The needle assembly according to any one of Exemplary Aspects 1 to 26, further comprising a protrusion on each of the two plunger elements to define two protrusions, wherein the two protrusions are located distally of the stabilization ring.

[0239] Exemplary aspect 28: The needle assembly according to any one of exemplary aspects 1 to 27, wherein the first plunger element is oriented to approximately a 285 degree position to approximately a 0 degree position, but is not oriented at a 270 degree position or a 90 degree position.

[0240] Exemplary aspect 29: The needle assembly of any of exemplary aspects 1 to 28, wherein the angular position is relative to a midpoint of a width of the first plunger element and a midpoint of a width of the second plunger element.

[0241] Exemplary aspect 30: The needle assembly according to any one of exemplary aspects 1 to 29, wherein each of the two resilient arms of the needle guard has a smooth or flat profile between the elongated arm portion and the elbow, with only a single bend or change in direction.

[0242] Exemplary aspect 31: The needle assembly according to any one of exemplary aspects 1 to 30, wherein each of the two elastic arms of the needle guard comprises a cutout having a hook-like lip.

[0243] Exemplary Aspect 32: The needle assembly of any of Exemplary Aspects 1 to 31, wherein each notch straddles the needle to provide lateral stability.

[0244] Exemplary aspect 33: The needle assembly according to any one of exemplary aspects 1 to 32, wherein the curved lip on the first arm of the two resilient arms has a straight edge.

[0245] Exemplary aspect 34: The needle assembly according to any one of exemplary aspects 1 to 33, wherein the curved lip on the second of the two elastic arms has a cutout similar to an arc.

[0246] Exemplary aspect 35: The needle assembly according to any one of exemplary aspects 1 to 34, wherein the cutout on the curved lip of the second arm changes the position at which the surface of the curved lip contacts the needle.

[0247] Exemplary aspect 36: The needle assembly according to any one of exemplary aspects 1 to 35, wherein the rib is provided on the two elastic arms.

[0248] Exemplary aspect 37: The needle assembly according to any one of exemplary aspects 1 to 36, wherein the tab extends from an edge of the distal wall of each of the two resilient arms.

[0249] Exemplary aspect 38: The needle assembly of any of exemplary aspects 1 to 37, wherein the tab limits lateral pivoting of the needle tip once the needle tip is captured within the needle guard.

[0250] Exemplary aspect 39: A method for assembling a needle assembly, comprising: providing a catheter hub having a catheter tube, the catheter tube having an open distal end and a proximal end attached to the catheter hub by a sleeve, the catheter hub including a hub body having an inner surface defining an inner cavity and a proximal opening; positioning a valve in the inner cavity and proximal to the sleeve, the valve including an outer periphery and a wall having three slits defining three flaps; positioning a valve opener inside the inner cavity of the catheter hub to slidably push the valve open when actuated by a medical device, the valve opener including a nose segment, two plunger elements, and two stabilizer elements, the nose segment having an activation end and a continuous peripheral segment having a hole therethrough, the two plunger elements including a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximal to the nose segment; wherein each stabilizer element is connected to the two plunger elements so that the two stabilizer elements and the two plunger elements define a stabilizing ring having a continuous surface, and the stabilizer element The retaining ring is separated from the continuous peripheral section of the nose section by two through-channels, the two through-channels including a first through-channel and a second through-channel; placing a needle guard including a proximal wall and two resilient arms in the holding space between the two stabilizer elements, wherein each resilient arm includes a bend and the needle guard has two resilient arms and two bends, the two bends including a first bend and a second bend; placing a needle attached to the needle hub through the catheter hub, the valve and the catheter tube so that the tip of the needle having a needle bevel extends beyond the open distal end of the catheter tube in a ready-to-use position; (1) orienting the first plunger element to a position of approximately 285 degrees to a position of approximately 0 degrees and orienting the second plunger element to be 180 degrees from the first plunger element, or (2) orienting the first plunger element to a position of approximately 1 degree to a position of approximately 75 degrees and orienting the second plunger element to be 180 degrees from the first plunger element; and wherein the 0 degree position is the top dead center position of a complete circle when viewed from an end view of the catheter hub in a distal direction.

[0251] Exemplary aspect 40: The assembly method of exemplary aspect 39, further comprising orienting the first elbow to a 90 degree position and orienting the second elbow to a 270 degree position.

[0252] Exemplary aspect 41: An assembly method according to any of exemplary aspects 39 or 40, wherein the valve includes a proximally facing wall surface and wherein the activation end of the valve opener is configured to push against the proximally facing wall surface to push the three flaps against the inner surface of the catheter hub in the use position.

[0253] Exemplary aspect 42: The assembly method of any one of exemplary aspects 39 to 41, wherein the first elbow is placed in contact with a perimeter of the first through passage.

[0254] Exemplary aspect 43: The method of assembly according to any of exemplary aspects 39 to 42, wherein the first elbow is placed in contact with the inner surface of the catheter hub.

[0255] Exemplary aspect 44: The assembly method of any one of exemplary aspects 39 to 43, wherein the first elbow is placed in contact with a perimeter of the first through passage and an inner surface of the catheter hub.

[0256] Exemplary aspect 45: The method of assembly according to any of exemplary aspects 39 to 44, wherein the first elbow is moved into contact with an edge of the stabilization ring.

[0257] Exemplary aspect 46: The assembly method according to any one of exemplary aspects 39 to 45, wherein the valve includes a valve disc and a valve skirt extending in a proximal direction of the valve disc and defining a valve cavity.

[0258] Exemplary aspect 47: The assembly method of any of exemplary aspects 39 to 46, wherein the activation end is placed within the valve cavity in a ready-to-use position.

[0259] Exemplary aspect 48: The method of assembly according to any one of exemplary aspects 39 to 47, wherein the second elbow contacts the inner surface of the catheter hub.

[0260] Exemplary aspect 49: The assembly method of any of Exemplary aspects 39 to 48, wherein the nose segment has a frustoconical shape.

[0261] Exemplary aspect 50: The assembly method of any one of exemplary aspects 39 to 49, wherein the second elbow contacts a periphery of the second through passage.

[0262] Exemplary Aspect 51: A method for minimizing hooking of a valve opener includes rotating an angular position of a first plunger element and a second plunger element.

[0263] Exemplary aspect 52: The method for minimizing according to exemplary aspect 51, further comprising rotating the angular position of the first elastic arm and the second elastic arm of the needle guard.

[0264] Exemplary aspect 53: A method for minimizing according to either of exemplary aspects 51 or 52, wherein each of the two resilient arms of the needle guard has a smooth or flat profile between the elongated arm portion and the elbow, with only a single bend or change in direction to minimize impact of the elbow on the stabilizer on the valve opener.

[0265] Exemplary Aspect 54: Additional methods for minimization as disclosed in the context of rotating the valve opening and preventing the needle guard from snagging on one or more stabilizers of the valve opener when the needle guard is retracted after a successful venipuncture.

Claims

1. A needle assembly, comprising: a needle hub having a needle with a needle tip having a needle bevel extending from a distal end of the needle hub; a catheter tube attached to a catheter hub, the catheter hub having a body including an inner surface defining a lumen, the needle extending through the catheter tube and the needle tip extending beyond a distal end of the catheter tube in a ready-to-use position, wherein the needle bevel is oriented to a 0 degree position; a valve positioned within the lumen of the catheter hub and in contact with an inner shoulder of the catheter hub, the valve comprising an outer perimeter and a wall having at least one slit defining a plurality of petals; a valve opener sized and shaped to open the plurality of slits to open the valve, the valve opener comprising: a nose section having an activation end and a continuous peripheral section having a hole therethrough; two plunger elements including a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximally of the nose section; and two stabilizer elements; wherein each stabilizer element is connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizing ring having a continuous surface, and the stabilizing ring is separated from the continuous peripheral section of the nose section by two through-channels, the two through-channels including a first through-channel and a second through-channel; a needle guard comprising a proximal wall and two resilient arms located in a holding space between the two stabilizer elements, wherein each resilient arm comprises a bend, and the needle guard has two resilient arms and two bends, the two bends comprising a first bend and a second bend; wherein (1) the first plunger element is oriented to a position of about 285 degrees to about 0 degrees, and the second plunger element is oriented 180 degrees from the first plunger element, or (2) the first plunger element is oriented to a position of about 1 degree to about 75 degrees, and the second plunger element is oriented 180 degrees from the first plunger element; and Wherein, when viewed from an end view of the catheter hub in a distal direction, the 0 degree position is the top dead center position of the complete circle.

2. The needle assembly according to claim 1, wherein: In the ready-to-use position, the first elbow is located in the first through passage and the second elbow is located in the second through passage.

3. A needle assembly according to any one of the preceding claims, wherein: The two arms of the needle guard bisect the two plunger elements.

4. A needle assembly according to any one of the preceding claims, wherein: The valve includes a proximally facing wall surface, and wherein the activation end of the valve opener is urged against the proximally facing wall surface to urge the plurality of petals against the inner surface of the catheter hub in a use position.

5. The needle assembly according to any one of claims 1 to 4, wherein: The first elbow contacts a periphery of the first through passage.

6. The needle assembly according to any one of claims 1 to 4, wherein: The first elbow contacts the inner surface of the catheter hub.

7. The needle assembly according to any one of claims 1 to 4, wherein: The first elbow contacts a perimeter of the first through passage and the inner surface of the catheter hub.

8. The needle assembly according to any one of claims 1 to 4, wherein: The first elbow contacts an edge of the stabilization ring.

9. A needle assembly according to any one of the preceding claims, wherein: The valve includes a valve disc and a valve skirt extending in a proximal direction of the valve disc and defining a valve cavity.

10. A needle assembly according to any one of the preceding claims, wherein: The valve opener includes a protrusion extending radially along a longitudinal axis of the valve opener, and wherein the inner surface of the catheter hub includes a shoulder for limiting proximal movement of the protrusion.

11. A needle assembly according to any one of the preceding claims, wherein: The distal edge of the first stabilizer element is parallel to the distal edge of the second stabilization element.

12. The needle assembly according to any one of claims 1 to 10, wherein: The distal edge of the first stabilizer element is angled with respect to the distal edge of the second stabilization element.

13. The needle assembly according to any of the preceding claims, further comprising a sleeve and a resilient element, wherein the sleeve wedges the proximal end of the catheter tube against the inner surface of the catheter hub, the resilient element being located inside the catheter hub between the sleeve and the valve disc, and wherein the resilient element is sized and shaped to push the valve disc in a proximal direction.

14. The needle assembly of claim 13, wherein: The elastic element is an elastic element or a spring.

15. A method of assembling a needle assembly, comprising: providing a catheter hub having a catheter tube having an open distal end and a proximal end attached to the catheter hub by a bushing, the catheter hub comprising a hub body having an inner surface defining a lumen and a proximal opening; positioning a valve in the lumen and proximal to the sleeve, the valve comprising an outer perimeter and a wall having three slits defining three flaps; a valve opener positioned inside the lumen of the catheter hub to slidably push the valve open when actuated by a medical device, the valve opener comprising a nose section having an activation end and a continuous peripheral section having a hole therethrough, the two plunger elements comprising a first plunger element and a second plunger element, each plunger element having two longitudinal edges extending proximally of the nose section; wherein each stabilizer element is connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizing ring having a continuous surface, and the stabilizing ring is separated from the continuous peripheral section of the nose section by two through-channels, the two through-channels comprising a first through-channel and a second through-channel; placing a needle guard including a proximal wall and two elastic arms in the holding space between the two stabilizer elements, wherein each elastic arm includes a bend, and the needle guard has two elastic arms and two bends, the two bends including a first bend and a second bend; placing a needle attached to a needle hub through the catheter hub, the valve, and the catheter tube such that the tip of the needle having a needle bevel extends beyond the open distal end of the catheter tube in a ready-to-use position; (1) orienting the first plunger element to a position of about 285 degrees to about 0 degrees and orienting the second plunger element to be 180 degrees from the first plunger element, or (2) orienting the first plunger element to a position of about 1 degree to about 75 degrees and orienting the second plunger element to be 180 degrees from the first plunger element; and Wherein, when viewed from an end view of the catheter hub in a distal direction, the 0 degree position is the top dead center position of the complete circle.

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