Catheter device with valve and related methods

Abstract

The needle assembly comprises a needle hub having a needle, a catheter tube having a catheter hub and a valve, and a valve opener disposed within an internal cavity of the catheter hub. The valve has a valve skirt, and the nose portion of the valve opener can be disposed therein. One or more reliefs may be provided in the valve opener, and the elbow or diagonal portion of the needle guard can project through the reliefs from a holding space within the valve opener. The valve opener and the needle guard can be oriented such that the valve opener is not caught by the needle guard while the needle guard is retracted.

Description

Technical Field

[0001] The disclosed invention generally relates to IV infusion devices including needle instruments, arterial catheters, and venous (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 generally used in various infusion therapies, including infusion into a patient, blood sampling from a patient, or monitoring of various parameters of a patient's vascular system. The catheter is generally connected to a catheter adapter that houses the attachment of the IV tube to the catheter. A blood control catheter includes a blood control valve that opens by inserting a male luer or the like 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, filed Aug. 20, 2009, entitled "Systems and Methods for Providing a Flushable Catheter Assembly". After the catheter is placed in the patient's vascular system, an IV fluid source can be connected to the catheter adapter or catheter hub to open the blood control valve. When connected in this way, fluid from the IV source can begin to flow through the catheter to the patient.

[0003] As is well known to those skilled in the art, normal blood pressure is 10 - 20 cmH2O. The infusion bag is usually placed about 100 cm above the patient's heart to direct the flow towards the patient. At approximately that height, the pressure exerted by the fluid from the infusion bag is much greater than the patient's blood pressure, so it can flow into the patient.

[0004] In some catheter adapters, the proper placement of the catheter in the blood vessel can be confirmed before the start of infusion by providing a flashback chamber in the catheter assembly that allows observation of the "flashback" of blood, for example. To confirm flashback in a catheter assembly that does not include a blood control valve, the clinician must manually occlude the blood vessel to prevent unwanted exposure to blood. In contrast, a blood control valve can eliminate the need for such manual occlusion and at the same time reduce the possibility of blood exposure during catheter placement.

SUMMARY OF THE INVENTION

[0005] Aspects of the invention include a catheter assembly comprising 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 needle tip of the needle to prevent inadvertent needle sticks. The valve opener can have a plunger element, and the needle guard can have a guard arm oriented to avoid snagging between the two during retraction of the needle guard after successful venipuncture.

[0006] Aspects of the present invention include a needle hub having a needle, the needle tip of the needle having a needle bevel that extends from the distal end of the needle hub, a catheter hub having a body that includes an inner surface defining an internal cavity, and a catheter tube attached to the catheter hub, wherein in a ready-to-use position, the needle extends through the catheter tube, the needle tip extends from the distal end of the catheter tube, and the needle bevel is oriented at a 0-degree position, a valve disposed in the internal cavity of the catheter hub and in contact with an internal shoulder of the catheter hub, the valve having an outer peripheral edge and a wall having three slits that define three flaps, a valve opener sized and shaped to open the valve by opening the three slits, the valve opener including a nose portion having an operating end and a continuous peripheral portion having a passable bore, two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges that extend proximally to the nose portion, and two stabilizer elements, each stabilizer element being connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced from the continuous peripheral portion of the nose portion by two through-passages including a first through-passage and a second through-passage, a needle guard having a proximal wall and two elastic arms disposed in a holding space between the two stabilizer elements, each elastic arm including an elbow, the needle guard having the two elastic arms and two elbows including a first elbow and a second elbow, and the needle assembly may include (1) the first plunger element is oriented from an approximately 285-degree position to an approximately 0-degree position, the second plunger element is oriented 180 degrees from the first plunger element, or (2) the first plunger element is oriented from an approximately 1-degree position to an approximately 75-degree position, the second plunger element is oriented 180 degrees from the first plunger element, and the 0-degree position is the top dead center position of a complete circle when viewed from an end view in the distal direction of the catheter hub.

[0007] Preferably, the first plunger element is oriented from approximately 285 degrees to approximately 75 degrees, including the 0-degree position, and the second plunger element is oriented 180 degrees from the first plunger element. Preferably, the second plunger element is oriented from approximately 105 degrees to approximately 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 with the 90-degree position, and the second plunger element is not aligned with the 270-degree position. The reference points of the two arms can be a plane drawn longitudinally through the midpoints of the two arms. Two points on this plane can represent the two arms that can be aligned or angled at the desired angular positions. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end face view of the catheter hub.

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

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

[0011] The valve can have a wall surface facing proximally, and the actuating end of the valve opener can be biased against the proximally facing wall surface in the use position to press the three flaps against the inner surface of the catheter hub.

[0012] The first elbow can contact the periphery of the first through-passage.

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

[0014] The first elbow can contact both the periphery of the first through-passage and the inner surface of the catheter hub.

[0015] The first elbow can contact the edge of the stabilizer ring.

[0016] The valve may include a valve disk and a valve skirt that extends in the proximal direction of the valve disk and defines a valve cavity.

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

[0018] The nose portion of the valve actuator may have a frustum shape.

[0019] The second elbow may contact the periphery of the second through passage.

[0020] The valve opener may have a protrusion extending in the radial direction of the longitudinal axis of the valve opener, and the inner surface of the catheter hub may have a shoulder for restricting the proximal movement of the protrusion.

[0021] The protrusion of the valve opener, i.e., the actuator, may be the first protrusion, and the valve opener may have a second protrusion spaced from the first protrusion.

[0022] The valve opener may have a protrusion extending in the radial direction of the longitudinal axis on the outer surface of one of the two plunger elements.

[0023] The skirt portion 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 stabilizer element.

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

[0027] To define two protrusions, a protrusion may be disposed on each of the two plunger elements, and the two protrusions may be disposed distally of the stabilizer ring.

[0028] The needle guard, valve, and valve opener can all be disposed within the internal cavity of the catheter hub.

[0029] The protective cap can have a sleeve disposed around the catheter tube and needle.

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

[0031] An elastic element can be disposed between the bushing and the valve disk inside the catheter hub, and the elastic element can be sized and shaped to press the valve disk in the proximal direction. For example, the elastic element can press the valve flap of the valve disk in the proximal direction to restrict the flow across the valve disk after the male medical device has been removed.

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

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

[0034] The two protrusions can be located distally of the stabilizer ring.

[0035] A method of assembling a needle assembly, i.e., a method of manufacturing a needle assembly which can be a catheter assembly having a needle, the method comprising providing a catheter hub having a catheter tube, wherein the catheter tube has a distal end with an opening and a proximal end attached to the catheter hub by a bush, the catheter hub comprising a hub body having an inner surface defining an inner cavity and a proximal opening, and disposing a valve having an outer peripheral edge and a wall having three slits defining three flaps on the proximal side of the bush in the inner cavity; disposing a valve opener inside the inner cavity of the catheter hub so as to slidably push open the valve when actuated by a male medical device, wherein the valve opener comprises a nose portion having an actuating end and a continuous peripheral portion having a passable bore, two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges extending proximal to the nose portion, and two stabilizer elements, each stabilizer element being connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced from the continuous peripheral portion of the nose portion by two through-passages including a first through-passage and a second through-passage, and disposing a needle guard having a proximal wall and two elastic arms 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 including a first elbow and a second elbow; disposing a needle attached to the needle hub through the catheter hub, the valve, and the catheter tube such that the tip of the needle having a needle bevel extends from the distal end with the opening of the catheter tube in a ready-to-use position; (1) orienting the first plunger element from an approximately 285-degree position to an approximately 0-degree position and orienting the second plunger element 180 degrees from the first plunger element, or (2) orienting the first plunger element from an approximately 1-degree position to an approximately 75-degree position and orienting the second plunger element 180 degrees from the first plunger element, wherein the 0-degree position is the top dead center position of a complete circle when viewed from an end view in the distal direction of the catheter hub.

[0036] More broadly, a catheter assembly, also referred to as a needle assembly or a needle device, may comprise a catheter hub having a catheter tube and a bushing. The bushing may be configured to press the proximal end of the catheter tube against the inner wall surface of the catheter hub to hold the catheter tube in the catheter hub.

[0037] Inside the catheter hub, a septum or valve, a valve actuator or valve opener, and a safety clip such as a needle guard or tip protector may be disposed. Optionally, the safety clip can also be omitted. A needle having a profile change portion is inserted through the proximal opening of the catheter hub, and the needle tip protrudes from the distal opening of the catheter tube in the 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 in the ready-to-use position. The proximal opening of the catheter hub may be a female luer taper, optionally an external thread size, configured to engage with a male luer tip of a luer slip or luer lock. The profile change portion may be a fold or an increased portion of the material.

[0038] The tip protector may be configured to cover the needle tip and be removed together with the needle after use, while the valve and valve actuator remain with the catheter hub to control the fluid flow therethrough. The valve actuator may be configured to be pressed distally inside the valve by a male tip, as will be described further below, to open the valve for fluid flow.

[0039] A flashback plug, i.e., a blood stopper assembly, can be connected to the needle hub to stop the outflow of blood from the flashback chamber of the needle hub. A flashback plug can be provided at the proximal end of the needle hub, thereby allowing air to be discharged while stopping the outflow of blood from the proximal end of the body of the flashback plug having a chamber and a hydrophobic filter. Alternatively, a syringe can also be attached to the proximal end of the needle hub. The second valve and actuator described later can also be arranged within the needle hub.

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

[0041] In the example of a 360-degree arc, i.e., a circle, the valve opener has a pair of plunger elements that generally align with the 0-degree (or 360-degree) position and the 180-degree position after the removal of the needle after successful venipuncture when the catheter assembly is in the ready-to-use position. In other examples, the two plunger elements can align along different angular positions but cannot align at the 90-degree and 270-degree positions.

[0042] The tip protector can have two arms that generally align in a position preferably moved, i.e., rotated, 15 degrees to 90 degrees compared to the first and second plunger elements in the ready-to-use position of the catheter assembly. The tip protector can have two arms that generally align with the 90-degree position and the 270-degree position in the ready-to-use position of the catheter assembly. The reference points of the two arms can be a plane drawn longitudinally through the midpoint of the two arms. Two points on this plane can represent the two arms at approximately the 90-degree position and the 270-degree position. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end view of the catheter hub.

[0043] The needle bevel at the needle tip can face upward toward the 0-degree position in the ready-to-use position. With these arrangements, the needle guard or tip protector can be retracted with the needle after successful venipuncture, and at the same time, as will be described later, when the needle guard is retracted and tilted or pitched, potential snagging between the tip protector and the valve opener is avoided or minimized.

[0044] Any number of prior art guards configured to block the needle tip of the needle can be used in this 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 contents of which are incorporated herein by reference. In one example, the tip protector can have a proximal wall and two elastic arms, and a profile change of the needle, such as a fold or bulge, engages the periphery defining the opening in the proximal wall of the tip protector, allowing the tip protector to be retracted proximally outside the catheter hub after successful venipuncture. The two arms can cross or extend along different sides of the needle and do not cross along the side view. Alternatively, the tip protector can have only one arm.

[0045] The two needle guard arms can be spread outward, i.e., biased, by the needle shaft in the ready-to-use position, such that the biased arms of the needle guard engage inside the catheter hub, engage the valve opener, such as the edge of the valve opener, or a combination thereof, as will be described later, in the ready-to-use position. The elbow of the needle guard can alternatively be placed within the relief of the valve opener but does not contact the valve opener or the catheter hub. In one example, only a portion of the tip protector or needle guard can extend into one or more gaps of the valve opener, while the proximal portion of the tip protector, such as the proximal wall, can extend proximally or be located proximally to the proximal surface of the tip protector, as will be described later.

[0046] In one example, the needle guard may include a proximal wall having a periphery defining an opening. The proximal wall may have a wall surface facing the proximal side and a wall surface facing the distal side opposite the proximal side wall surface. At least one elastic arm may extend distally from the proximal wall. In one example, two elastic arms extend distally from the proximal wall.

[0047] In the needle guard, one arm can be made longer than the other arm. Each arm may also include different arm widths, including a first arm portion of a first width and a second arm portion of a second width smaller 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 portions. The two arms may extend distally from the proximal wall. When viewed from the side along the longitudinal direction of the needle guard, the two arms may cross each other. When used with a needle, the two arms cross each other when in the ready-to-use position and when in the protected position. In an alternative embodiment, the two arms originate from different ends of the proximal wall and extend distally without crossing each other. The two arms can also have substantially the same arm width along the length of each arm.

[0048] The two distal walls can be provided, one at each end of the two arms. The distal walls can overlap each other along the axial direction of the needle guard by using different arm lengths and / or by angling one of the distal walls further distally at the elbow, i.e., the diagonal part, between the distal wall and the elastic arm. In one example, when two arms are used, the elbow, i.e., the diagonal part, of each arm engages with a corresponding guard engagement part inside the catheter hub such that it has a groove or a raised protrusion with respect to one or more restraint surfaces, i.e., limiting surfaces or choke points, of one or two reliefs of the valve actuator, and can removably fix the needle guard inside the catheter hub during the transition process of removing the needle from the catheter hub in the ready-to-use position. The elbow of the needle guard can alternatively be disposed within the relief of the valve opener but does not contact the valve opener or the catheter hub.

[0049] When the radial profile of the needle guard measured at one or two elbows becomes smaller, such as when the needle tip moves proximally to the proximal side of the two distal walls, the needle guard can move to the proximal side of the choking point, i.e., the choke point, and be removed from the catheter hub together with the needle. When the two distal walls move radially, the needle guard can reduce its radial profile and thereby pass through the choke point, i.e., move to the proximal side of the choke point. When forming the needle guard, the needle guard can be folded from a pressed metal sheet forming the guard as shown in the figure. To enhance structural rigidity, ribs can be formed on the arms, proximal walls, and / or distal walls.

[0050] The valve opener can be used with the needle assembly described herein. The valve actuator or opener can have a nose portion, a transition portion, and two plunger elements extending proximally from the transition portion, i.e., proximally from the nose portion. The nose portion can define a first continuous peripheral portion. Other positions of the nose portion, away from the first continuous peripheral portion, can have a slit or slot.

[0051] Two stabilizer elements can be attached to the two plunger elements to form a stabilizer ring, and the stabilizer ring can define a second continuous peripheral portion of the valve actuator in addition to the continuous peripheral portion of the nose portion. Each stabilizer element can have two edges. In one example, the two edges of each stabilizer element can be parallel to each other. The two stabilizer elements can be angled, i.e., inclined, such that while the two edges of each stabilizer element can 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 can be offset along the axial or longitudinal direction of the valve actuator. The distal edges of the two stabilizer elements can be offset along the axial direction. In one example, the distal edge can be arranged obliquely with respect to the axis of the catheter hub.

[0052] The valve opener can be provided with two reliefs, i.e., two through-passages, each defined or bounded by the transition portion, the two plunger elements, and their respective stabilizer elements. The two reliefs or through-passages may be referred to as the first relief or first through-passage and the second relief or second through-passage. In one example, each relief or through-passage has a periphery.

[0053] In one example, each periphery of each relief may be defined by the structure of a transition portion, two plunger elements, and respective stabilizer elements. Since the two stabilizer elements can be angled, i.e., inclined, in different directions, the two peripheries of the two reliefs, i.e., the two through-passages, can be different such that they have different peripheral contours, i.e., shapes. The edges of the two stabilizer elements are preferably angled with respect to the direction of the needle, i.e., the axis, of the catheter hub.

[0054] The two peripheries of the two reliefs can each be defined by a continuous loop. In other words, the periphery does not have a slit or slot for forming an open periphery. However, if the stabilizer element includes a slot or slit, the periphery can be an open periphery, i.e., a discontinuous periphery.

[0055] In some examples, the two stabilizer elements can extend laterally without being angled, i.e., inclined, in the distal or proximal direction. With such a configuration, the edges of the two stabilizer elements can be parallel to each other. Further, the four edges of the two stabilizer elements can be parallel to each other and axially offset. That is, while the four edges are parallel to each other, the proximal edge of one stabilizer element can be located proximal or distal to the proximal edge of the other stabilizer element.

[0056] The stubs, i.e., extensions, of the two plunger elements can extend proximal to the stabilizer ring. In one example, the stubs of the two plunger elements extend from the stabilizer ring and can be axially aligned with the plunger elements. In other examples, the stubs of the two plunger elements are not axially aligned with the two plunger elements. In still other examples, only one of the stubs of the plunger elements is aligned with one of the two plunger elements. In the case of a valve opener, i.e., an actuator, having only one plunger element between a first continuous peripheral portion and a second continuous peripheral portion, only one of the stubs of the two plunger elements can be aligned with one plunger element, or neither of the stubs of the plunger elements can be aligned with one plunger element.

[0057] In some examples, there may be stubs or extensions of two or more plunger elements that extend proximally to the stabilizer ring. The stubs or extensions of the two or more plunger elements may be equally spaced around the proximal edge of the stabilizer ring or may be randomly arranged around the proximal edge of the stabilizer ring. With the stubs of the plunger elements, the overall length of the valve actuator can be extended. The number of stubs of the plunger elements and / or the arc curve of the stubs of each plunger element that defines the width of each stub of the plunger element can provide a larger overlap surface with the ostium tip than in the case of stubs of plunger elements having a smaller number or relatively small arc curves. In other examples, the stubs or extensions of the two plunger elements may be considered part of the two plunger elements, and the stabilizer ring is disposed between the two ends of each of the two plunger elements.

[0058] Each of the two plunger elements may have at least two thicknesses, forming a protrusion at the boundary between the two thicknesses on the outer surface of each plunger element. The two protrusions may be disposed inside the concave portion of the catheter hub, whereby the shoulder at the proximal end of the concave portion can provide a stop surface that interacts with the two protrusions to prevent the valve opener from coming off from inside the catheter hub. In some examples, only one protrusion is employed on one of the two plunger elements to prevent the valve opener from coming off in the proximal direction. In still other examples, each plunger element may have a single thickness, and the protrusion is formed by adding material to the plunger element only at the site of the protrusion during injection molding.

[0059] In one example, a flat portion may be provided on the valve actuator on the same side as each stabilizer element. The flat portion may originate near the nose portion or transition portion of the valve member and extend proximally to near the two protrusions.

[0060] Two planar portions, one on each side of the valve opener corresponding to the two stabilizer elements, can be provided to minimize the overall profile along the transition portion and the side profiles of the two plunger elements. In one example, the cross-sectional dimensions of the nose portion, the transition portion, and the two plunger elements can be constant or the same within the range of typical manufacturing tolerances, generally along a direction rotated 90 degrees along the side view, i.e., along the longitudinal axis of the valve opener.

[0061] A retention space can be arranged inside the stabilizer ring, between the stubs of the two plunger elements, or in a combination thereof, in the valve opener, i.e., the actuator. Part or all of the needle guard can be arranged in the retention space in the ready-to-use position, and one or two elbows of the tip protector protrude from the relief. For example, the elbows of the needle guard can be arranged on the distal side of the two stabilizer elements in the ready-to-use position and can be arranged in the through-opening, i.e., the relief. Further, in the ready-to-use position, the two elbows can contact the inside of the catheter hub, or can be spaced from the inside of the catheter hub, or can contact one or both of the perimeters of the relief, or can be spaced from the perimeter of the relief and the inner surface of the catheter hub, or a combination thereof. Of course, if only one arm and one elbow are incorporated into the tip projector, only the elbow can be arranged similarly.

[0062] The two elbows of the needle guard can be arranged on the distal side of the two stabilizer elements, and the proximal wall of the needle guard can be arranged on the proximal side of the two stabilizer elements in the ready-to-use position. In one example, the proximal wall can be flush with the proximal end face of the stub of the plunger element, or can be arranged proximal to the end face, or can be arranged distal to the end face. If the stub of the plunger element is not incorporated, the proximal wall of the needle guard can be flush with the proximal edge of one or both of the stabilizer elements, or can be arranged proximal to the proximal edge of one or both of the stabilizer elements, or can be arranged distal to the proximal edge of one or both of the stabilizer elements.

[0063] The distance between the two inner surfaces of the two stabilizer elements may define a choke gap, a choke point, i.e., a limiting point, of the needle guard to limit the proximal movement of the needle guard at the ready-to-use position and / or during retraction of the needle following intravenous access. That is, before the needle tip moves proximal to one or two distal blocking walls of the needle guard, the choke point, i.e., the gap, is too small for the needle guard to pass proximal to the choke point, i.e., the limiting point, because the diagonal measurement between the two elbows is larger than the choke point. However, after the needle tip moves proximal to one or two distal blocking 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, and the profile becomes smaller than the choke point. At that point, the small radial profile measured at the two elbows allows the needle guard to move proximal to the choke point, whereby the needle guard is removed from the catheter hub together with the needle, such as after successful venipuncture.

[0064] The passageway may be defined by the wall surface at the nose portion of the valve opener. The distal opening opens into the passageway from the distal end, and the passageway has a proximal opening. The needle may be disposed within the passageway or may pass through the passageway at the ready-to-use position.

[0065] The catheter hub may have any pair of wings extending radially of the hub body. The wings, when incorporated, may add stability, such as after intravenous access, by providing an increased surface area for holding the catheter hub stationary against the patient's skin.

[0066] The plunger element of the valve opener can be oriented at the 0-degree position and the 180-degree position, the bevel of the needle tip can be oriented upward, and is aligned with the upper plunger element. The reference points of the two plunger elements can be a plane drawn longitudinally through the midpoint of the two plunger elements. Two points on this plane can represent two plunger elements that can be arranged at approximately the 0-degree position and the 180-degree position, or other angular positions as described elsewhere in this specification. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end face view of the catheter hub. Further, the two elbows and the two arms of the needle guard can be oriented at the 90-degree position and the 270-degree position, the elbows protrude from the two reliefs of the valve opener, the bevel of the needle tip can be oriented upward, and is aligned with the push tab of the catheter hub. In one example, the needle bevel can be aligned at the 0-degree position. Still further, the plunger element of the valve opener can be oriented at the 0-degree position and the 180-degree position, the two elbows and the two arms of the needle guard can be oriented at the 90-degree position and the 270-degree position, the elbows can protrude from the two reliefs of the valve opener, the bevel of the needle tip can be oriented upward, and is aligned with the upper or first plunger element.

[0067] In the ready-to-use position where the needle hub is in contact with the catheter hub and the needle tip extends from the distal end, i.e., the distal opening, of the catheter tube, the catheter assembly is ready for use such as for performing venipuncture or intravenous access. Disposed inside the catheter hub can be a valve having a valve body with an outer peripheral edge, a valve disk, and a valve skirt extending axially from the valve disk. In one example, the valve disk can have one or more slits defining one or more flaps that can be opened by a valve actuator. The types and respective numbers of slits and flaps incorporated in the valve disk vary, and three slits and three flaps are preferred. In one embodiment, the valve skirt can be disposed in a recess formed in the internal cavity of the catheter hub, whereby when the valve is positioned inside the catheter hub, axial movement of the valve can be impeded.

[0068] In one example, the recessed portion inside the catheter hub has a distal shoulder and a proximal shoulder that define a groove therebetween. The valve skirt has a length sized and shaped to fit within the groove, i.e., the recessed portion. In one example, the valve skirt may contact the proximal shoulder and the valve disk may contact the distal shoulder. Viewed another way, the valve disposed therein may contact and be constrained by the distal and proximal shoulders of the recessed portion in the ready-to-use position such that the valve skirt is axially fixed, i.e., cannot move axially.

[0069] In one example, the outer diameter, i.e., the outer surface, of the skirt portion may form a snug fit, i.e., a size-on-size fit, with the recessed portion inside the catheter hub. In other examples, a slight interference fit may be provided therebetween. In still other examples, a small clearance may be provided between the outer surface of the skirt portion and the inner surface of the recessed portion, with the valve skirt contacting the proximal shoulder and the valve disk contacting the distal shoulder of the recessed portion.

[0070] The distal cavity chamber may be provided on the distal side of the valve disk and the proximal side of the bushing. In some examples, a helical spring, i.e., an elastic biasing element such as an elastomeric ring or cylinder, may be provided in the distal cavity chamber concentric with the needle to assist in biasing the flap of the valve disk to close one or more slits.

[0071] In one example, the valve disk may have a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps as described above. In the illustrated embodiment, the valve skirt may extend axially with respect to the longitudinal axis of the valve, have an elongated wall generally perpendicular to the outer peripheral edge of the valve disk, and form a generally cylindrical valve body. In some embodiments, the valve skirt may be inclined such that the valve forms a frustoconical structure.

[0072] The valve skirt may define a valve cavity having a proximal end portion of the opening, and the actuator nose, i.e., the nose portion, of the valve actuator can advance and operate the valve flap of the valve disk through the proximal end portion of the opening. In one embodiment, at least a part of the actuator nose including the distal operating end of the valve actuator may be disposed inside the valve cavity of the valve before operation. Thus, the actuator nose can be narrower than the inner diameter of the valve skirt such that the operating end fits within the valve cavity and contacts, i.e., touches, the valve disk in the ready-to-use position. In one example, the relative dimensions are such that the nose portion of the actuator does not contact the inner wall surface of the skirt portion, and some contact is assumed.

[0073] In one example, the operating end of the valve opener contacts the surface facing the proximal side of the valve disk in the ready-to-use position, and other parts of the valve actuator, such as one or two protrusions, contact the shoulder inside the catheter hub and apply a load to the valve disk in the ready-to-use position, but as will be described further below, it is not sufficient to open one or more slits. In other examples, the operating end may be spaced from the surface facing the proximal side of the valve disk in the ready-to-use position, and the protrusion of the actuator either contacts the shoulder or is also spaced from the shoulder. When one or more protrusions of the actuator are spaced from the shoulder and the operating end is spaced from the valve disk, the actuator may float slightly axially within the catheter hub.

[0074] In one example, the protrusions extend outwardly from one or both outer surfaces of the plunger element. The protrusions may extend from the outer surface of each plunger element. Each protrusion has an inclined surface similar to an inclined surface having a generally flat edge for contacting the shoulder. Due to the inclined surface and the inclined direction of the protrusion, the actuator can be inserted into the interior of the catheter hub and seated within a second recess portion described further below.

[0075] In one example, the actuator, i.e., the valve opener, has a longitudinal axis, and one or more actuating elements may extend axially, i.e., parallel, to the longitudinal axis. In a specific example, two actuating elements may be radially opposed to each other along the longitudinal axis. The two actuating elements may define an outer diameter having a dimension larger than the diameter of the nose portion.

[0076] In one example, the actuating element is flexible and deflectable such that when pushed against the male luer tip, the actuating element deflects, i.e., bends. The actuating element may be made deflectable by selecting a material having the required elasticity. In other examples, the actuating element may be made deflectable by incorporating one or more weakening portions, such as incorporating structurally thin portions, incorporating notches, adopting a smaller cross-section compared to other portions of the same elongated actuating element, or combinations thereof. Alternatively, the actuating element may be made flexible and deflectable by selecting a material having the required elasticity and incorporating one or more weakening portions.

[0077] In yet other examples, each actuating element has a plurality of different cross-sectional shapes, i.e., profiles, along its length cross-section. For example, an elongated plunger element may have a square profile disposed adjacent to a crescent profile.

[0078] The nose portion of the valve actuator may be configured to engage the valve to open the valve disk when an axial force is applied by the male tip toward the distal end of the catheter assembly to the actuating element, such as during the insertion of the male luer connector of the IV drip line. Generally, the nose portion may be rigid compared to the more flexible valve, whereby the nose portion, more specifically the actuating end, can actuate the valve, such as by deflecting one or more flaps and opening one or more slits of the valve disk. The nose portion may be made of a non-compressible material, such as metal, hard plastic, hard elastomer, etc., to press against the valve to open it.

[0079] In one embodiment, the stabilizer, i.e., the stabilizer element, can be arc-shaped, form an arc along the internal profile of the catheter hub, and connect one actuating element to the other actuating element. The stabilizer, i.e., the stabilizer element, can form a substantially cylindrical portion in the body of the valve actuator, and the body can be spaced from the nose portion of the valve actuator. In other words, the valve actuator can be elongated and have a portion that is continuous along the radial direction and a portion that has a relief or through-passage that penetrates the wall of the actuator and is not continuous along the radial direction.

[0080] In one example, the stabilizer can define a peripheral or a body portion, i.e., a ring, that is continuous along the radial direction of the valve actuator, and the portion is spaced from the continuous body portion of the nose portion and is also continuous along the periphery or the radial direction. Two stabilizers, i.e., stabilizer elements, can be joined to the two plunger elements to form a ring structure. Optionally, the two stabilizers can be slightly offset from each other and angled.

[0081] The stabilizer can help the valve actuator stay centered within the catheter hub while the actuator is moving, such as when being pressed by a male luer tip. By staying centered, the nose portion can be better aligned with the valve disk, such as a slit in the valve disk, enabling smooth operation of the valve. The stabilizer can also provide engagement through friction with the interior of the catheter hub to prevent the actuator from sliding proximally after removal of the male luer tip.

[0082] In one embodiment, the nose portion may be configured to remain engaged with the valve disk after actuation of the valve and removal of the male luer tip. For example, as will be described further below, the nose portion may be pushed between one or more slits of the valve disk and held there by friction. The valve actuator, such as the nose portion, may be provided with surface features such as ridges, grooves, or catches to maintain the engagement between the actuator and the valve after actuation and removal of the male luer tip.

[0083] Reliefs, openings, i.e., through-passages, may be provided between the transition portion and each of the two stabilizers, i.e., between the nose portion and each of the two stabilizers. The two reliefs, i.e., through-passages, may provide a clearance such that the interior, i.e., the central portion, of the valve actuator and the inner surface of the catheter hub can communicate openly. In other words, there is one or two reliefs, i.e., openings, between the continuous portion of the nose portion and the continuous peripheral portion, defined by the two stabilizers and the plunger element and called the stabilizer ring.

[0084] The inner diameter of the stabilizer ring of the valve actuator may be smaller than the diameter defined by the diagonal portions, i.e., the elbows, of the two arms of the needle guard when the two arms are biased outwardly by the sides of the needle shaft. Thus, while the needle guard is installed in the holding space of the valve actuator, the diagonal portions, i.e., the elbows, of the needle guard may flex and pass through the stabilizer ring and into the open area defined by the relief.

[0085] When the tip protector is disposed between the two plunger elements, the two distal walls of the needle guard, more specifically the two diagonal portions or elbows, can be disposed in relief as described above, engage with a groove or projection formed inside the catheter hub, engage with the guard engagement surface on the inner surface of the catheter hub, or engage with 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 held inside the catheter hub during retraction of the needle after successful venipuncture until the needle tip moves proximal to the two distal walls of the needle guard, at which time the needle guard closes over the needle tip and can be removed with the needle.

[0086] The internal cavity of the catheter hub for accommodating the two diagonal portions or elbows can be provided with a second undercut or recess proximal to the first recess. Thus, the needle guard can be prevented from sliding proximally during retraction of the needle after successful venipuncture by the shoulder of the second recess or by other surface features inside the catheter hub such as the guard engagement surface inside the catheter hub. Optionally or alternatively, the distal edge of one or both stabilizers can provide a restraint surface for preventing premature activation of the needle guard during retraction of the needle before the needle tip moves proximal to the two distal walls. In addition to the distal edge, both stabilizers also have a proximal edge.

[0087] In some examples, one or both stabilizer elements can have a slit or channel, thereby dividing the arcuate stabilizer element into two. Even if there is a slit in one or both stabilizer elements, a stabilizer ring that can be a discontinuous ring similar to a ring having one or more slots formed through the ring can provide a restraint surface for preventing premature activation of the needle guard during retraction of the needle, such as before the needle tip moves proximal to the two distal walls.

[0088] The constricting surface provides a rigid structure that prevents the needle guard from moving proximally until the needle guard first activates, radially collapses to reduce its radial profile, and slides proximal to the choke point, or, if it does not slide, thereby defining a restriction point, choke gap, or choke point. In one example, one or two elbows of the needle guard can be constrained from moving proximally by the choke point until one or two elbows of the needle guard flex to reduce the radial profile of the needle guard. In one example, when the radial profile of the needle guard is reduced, the needle guard can slide through a bore defined by a stabilizer ring from a distal position of the stabilizer ring to a proximal position of the stabilizer ring.

[0089] The valve opener can be made of metal or plastic. When made of metal, the valve opener can be formed by bending or deep drawing, and the arcuate cross-section of the actuating element can provide additional rigidity when pushed by the male luer. Each actuating element can have at least two longitudinal edges, and ribs can be provided along one or both of the longitudinal edges to further add structural rigidity. One or more gaps can be provided between the two actuating elements. The gap can provide clearance or space for fluid flowing therethrough, such as during blood washing or intravenous infusion. The gap between the actuating elements can define a holding space for accommodating the tip protector.

[0090] In some embodiments, most or all, but not most, of the tip protector fits within the retention space formed by the body of the actuator between the two plunger elements in the ready-to-use position. This reduces the longitudinal space required to house both the actuator and the tip protector longitudinally in series within the catheter hub, or allows for a more compact design when they only partially overlap axially. The tip protector can fit entirely within the retention space of the actuator, further reducing the space or length required in the catheter hub. As shown, the proximal wall of the needle guard can generally be flush with the proximal end faces of the two plunger elements.

[0091] If the tip protector only engages or contacts the distal edge of the relief or through-passage of the actuator, or is spaced from the edge but does not contact the inner surface of the catheter hub, no diameter deformation or change is required on the inner wall of the catheter hub, and the tip protector can be positioned further proximally in the tapered portion of the female luer while complying with the international luer standard for conical fitting, and the overall length of the catheter hub can be further reduced.

[0092] The push tab of the catheter hub is generally positioned at the 0-degree position relative to the end view of the arc circle or complete circle of the catheter hub. Similarly, the bevel of the needle tip is angled and aligned at the 0-degree position, also sometimes referred to as the position above the bevel, i.e., the top dead center position of the circle. At the position above the bevel, the two arms of the needle guard, as well as the two elbows, can be aligned at the 90-degree and 270-degree positions, and the two plunger arms can be aligned at the 0-degree and 180-degree positions. This unique arrangement, unlike known prior art devices, is incorporated to minimize or avoid the elbows of the needle guard catching on the stabilizer during retraction of the needle guard after successful venipuncture, as described further below, when the needle guard can be tilted or pitched by the operator during retraction of the needle.

[0093] In order to align with the needle guard, i.e., the tip protector, the tip extension at the distal end of the nose portion of the needle hub can also rotate. That is, the tip extension can be oriented at a 90-degree position to press against the proximal wall of the needle guard. Thus, while the needle bevel can be oriented at a position above the 0-degree bevel, the tip extension of the needle hub can be oriented at a 90-degree position.

[0094] Due to manufacturing tolerances, when a specific angular position is specified, unless otherwise indicated by the context, it is generally understood to mean approximately and is not interpreted as an exact measurement or position. 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, while the external tab for capturing the catheter hub between the nose portion can remain at the 180-degree position in the ready-to-use position or can be rotated together with the tip extension.

[0095] The tip protector can fit substantially within the holding space of the actuator, and the proximal wall of the tip protector is substantially flat axially with the proximal end of the actuating element.

[0096] During needle retraction, the needle shaft can be angled, i.e., pitched, intentionally or unintentionally, depending on the operator's intention, etc., during needle retraction after venipuncture. Regardless of the reason the needle can be angled, this movement can cause the needle guard, which can be disposed to cover the needle tip, to tilt, i.e., pitch. As a result, if the elbows and stabilizers are aligned at the 0-degree and 180-degree positions, one or both of the elbows of the two arms can catch on the distal edge of the stabilizer of the valve opener. In other words, when the needle guard tilts, i.e., pitches, during retraction, if the plunger element of the valve opener is aligned at the 90-degree and 270-degree positions, the elbows when aligned at the 0-degree and 180-degree positions can catch on the edge of the stabilizer.

[0097] However, when the elbows are aligned at the 90-degree and 270-degree positions, the two stabilizers can be aligned at the 90-degree and 270-degree positions, and the two plunger elements can be aligned at the 0-degree and 180-degree positions, no movement or snagging of one or both of the elbows against the edge of the stabilizer occurs during retraction due to the tilt or pitch. If an elbow snags on the stabilizer, the needle guard may pull the tip protector against the valve actuator during needle retraction, potentially shifting the valve actuator out of the interior of the catheter hub.

[0098] Thus, when the various components are angled, any tilt of the needle during retraction of the needle after successful venipuncture, and thus the tilt of the tip protector, causes the tip protector to simply slide against the inner surface of one or both of the plunger elements. Since there are no snagging edges on the inner surfaces of the two plunger elements, the needle guard can be easily withdrawn from the valve opener without snagging the valve opener during the process. Thus, the components of the valve opener are configured to operate freely without the elbow snagging on the edge of the stabilizer and leading to failure.

[0099] After removing the needle and needle guard, the valve actuator can be advanced distally of the valve by the tip of the syringe or the luer tip of the IV drip line to allow fluid flow through the catheter hub. The luer tip can be a luer that threadedly engages a catheter hub that may have a female luer thread. Advancing the actuator causes the actuating end to advance against the valve disk, the flap to deflect radially and distally, and the fluid path formed through the catheter assembly to open. The valve is in a closed position when one or more slits in the valve disk are closed. In the closed position, the valve can block or restrict flow through the catheter hub.

[0100] When the valve actuator is in the retracted position, the working end of the nose portion is not pushed in and does not open one or more slits of the valve. This position is also understood as the pre-operation position of the valve or the closed position of the valve. That is, the male Luer tip is not inserted into the proximal opening of the catheter hub for advancing 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 first inserted into the proximal opening of the catheter hub, the male tip first contacts two actuating elements of the valve actuator, promotes a force directed distally to the two actuating elements, and opens the valve. The force directed distally moves the actuator in the distal direction until the geometry between the male tip and the proximal opening of the catheter hub stops further distal advancement of the male tip. In one example, the female Luer taper portion of the catheter hub and the male Luer taper portion of the male tip are connected to block further distal advancement of the male tip into the opening of the catheter hub. A seal by Luer engagement is provided to prevent liquid from leaking from the proximal opening of the catheter hub.

[0102] When the actuator moves distally due to the distal advancement of the male tip, such as the tip of a syringe, the nose of the valve actuator is biased distally and can be pressed against the surface facing the proximal side of the valve disk. Specifically, the nose of the actuator first presses against the surface facing the proximal side of the valve disk, and since the valve is axially fixed within the first concave portion of the catheter hub, one or more flaps of the valve disk can deflect radially and distally. Thereafter, the fluid from the male tip can flow through the catheter hub, through the valve, and through the lumen of the catheter tube.

[0103] Alternatively, aspiration can be performed with a male medical device such as a syringe or a vacuum blood collection tube to aspirate blood from a patient. This is often done to examine a specimen before starting infusion therapy. Also, usually, before starting infusion therapy, residual blood can first be flushed out from the inside of the catheter hub.

[0104] Even after removing the male tip from the proximal opening of the catheter hub, the valve actuator can remain engaged with the valve. That is, the friction between the valve actuator and the valve disk can exceed the restoring force generated by the valve flap of the valve that attempts to return to the undeformed position. The operating position with this engagement can be considered a single use, i.e., a single operation, since the valve actuator and the valve do not return to the pre-operated position when the male tip is removed.

[0105] In an alternative embodiment, the nose portion can be configured such that when pushed into the valve during operation, the operating end does not extend distally beyond the flap of the valve disk. This configuration can ensure that when the male luer device is removed, the valve actuator is pushed back by the flap of the valve disk. The conical configuration at the distal end of the actuator, i.e., the configuration incorporating a tapered nose portion, can be a configuration that can maintain a force vector directed proximally that is greater than the vertical force vector. The angle of the cone can be designed to provide the force vectors required when the actuator reaches its maximum and minimum distal displacements. The difference between the maximum and minimum displacements of a standard luer connector is approximately 2.5 millimeters.

[0106] Additionally, a helical spring or a stretchable element or a ring can be incorporated into the distal cavity chamber to increase the recoiling force, i.e., the return force, of the valve, facilitate pushing the valve actuator proximally after removal of the male tip, and return it to the pre-operated position, i.e., the valve closed position. The stretchable element can also help to close the flap of the valve disk. In this way, the valve and the valve actuator can be closed again after the first operation and can repeat the process of opening and closing again. Alternatively or additionally, by thickening the flap of the valve disk, sufficient restoring force can be provided without the need for a stretchable element.

[0107] A further aspect of the needle guard includes two arms that are biased apart in a needleless state that normally biases the arms apart, and exhibits features of a distal wall and a curved lip. The arms of the needle guard may have a smooth or flat profile between the elongate arm portion and the elbow and have only a single bend or change in direction.

[0108] Each elongate arm portion of the first and second arms may have portions of different arm widths. Each arm may also include a notch having a lip similar to a hook. The notch in each arm, or the notches in the two arms, allows the two arms to straddle the needle to provide lateral stability as the needle moves from a ready-to-use position with the needle tip exposed to a protected position with the needle tip guarded.

[0109] The curved lip in the second arm may be configured to contact the needle at a flat surface adjacent to the edge of the second arm when in the ready-to-use position. The notch may be utilized to change the position where the surface of the curved lip, rather than the edge, contacts the needle. In some examples, the notch may be omitted. Ribs may be formed with the two arms, but this is optional and may be included to add strength to the arms. Tabs may extend from the edge of the distal wall, but this may be optional and may be included to limit lateral rotation of the needle tip when the needle tip is captured within the needle guard.

[0110] In a further aspect of the present embodiment, the catheter hub may have two plunger elements of a valve opener or actuator that are oriented at positions other than the 0-degree position and the 180-degree position, where 0 degrees is at the top dead center of a complete arc or circle. For example, the upper or first plunger element may be oriented at any position from approximately the 1-degree position to approximately the 75-degree position, and the lower or second plunger element may be oriented 180 degrees from the position of the upper or first plunger element. In one example, the upper plunger element may be oriented at approximately the 22-degree position, and the lower plunger element may be oriented at approximately the 202-degree position. The reference points of the two plunger elements may be a plane drawn longitudinally through the midpoint of the two plunger elements. Two points on this plane may represent the two plunger elements that may be disposed at approximately the 22-degree position and the 202-degree position.

[0111] Thus, looking at an end view of the catheter assembly according to an aspect of the present invention, the catheter assembly may include a valve actuator having two plunger elements that may be referred to as a first or upper plunger element and a second or lower plunger element, where the upper plunger element may be oriented from a position of approximately 0 degrees (or 360 degrees) to approximately the 75-degree position (including these), 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 the 2-degree position, the 16-degree position, the 38-degree position, the 42-degree position, etc., and the lower plunger element may be oriented 180 degrees from 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 and substantially bisect the two plunger arms. The two needle guard arms may be disposed substantially evenly between the two plunger arms.

[0113] Thus, when various components are angled according to aspects of the present invention, any inclination of the needle during retraction of the needle after successful venipuncture, and thus the inclination of the tip protector, causes the tip protector to simply slide without catching on the inner surface of one or both of the plunger elements. Since there is no catching edge on the inner surfaces of the two plunger elements, the needle guard can be easily retracted from the valve opener without catching the valve opener during the process. Thus, when the valve actuator and the needle guard are oriented as described and illustrated herein, the components of the valve opener are configured to operate freely without the elbow of the needle guard catching on the edge of the stabilizer and leading to failure.

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

[0115] The upper plunger element can be oriented at approximately 338 degrees, and the lower plunger element is oriented at approximately 158 degrees. The reference points of the two plunger elements can be a plane drawn longitudinally through the mid - point of the two plunger elements. Two points on this plane can represent the two plunger elements at approximately 338 degrees and 158 degrees positions.

[0116] The two arms of the needle guard can be oriented between the two plunger arms and bisect the two plunger arms approximately. The two needle guard arms can be arranged approximately evenly between the two plunger arms.

[0117] Thus, an aspect of the invention includes a catheter assembly comprising a valve actuator having two plunger elements, a first or upper plunger element and a second or lower plunger element, the upper plunger element being orientable from a 285-degree position to an approximately 0-degree position, and the lower plunger element being orientable 180 degrees from the position of the upper plunger element. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end face view of the catheter hub.

[0118] Thus, when the various components are angled according to an aspect of the invention, during retraction of the needle after successful venipuncture, any inclination of the needle, and thus the inclination of the tip protector, causes the tip protector to simply slide relative to the inner surface of one or both of the plunger elements. Since there is no catching edge on the inner surface of the two plunger elements, the needle guard can be easily retracted from the valve opener without catching the valve opener during the process. Thus, when the valve actuator and the needle guard are oriented as described and illustrated herein, the components of the valve opener are configured to operate freely without the elbow of the needle guard catching on the edge of the stabilizer and leading to failure.

[0119] Methods of manufacturing and using the catheter assembly and its components are within the scope of the invention.

Brief Description of the Drawings

[0120] These and other features and advantages of the apparatus, system, and method will become recognized and better understood by reference to the specification, claims, and appended drawings.

[0121]

Figure 1

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Figure 2

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Figure 3A

Figure 3B

Figure 3C

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Figure 4

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Figure 5

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Figure 6

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Figure 7

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Figure 8

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Figure 9

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Figure 10

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Figure 11

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Figure 12

Figure 13

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Figure 14

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Figure 15

DETAILED DESCRIPTION OF THE INVENTION

[0135] The detailed description provided below in connection with the accompanying drawings is intended as a description of the presently preferred embodiments of a catheter assembly having a valve for controlling fluid flow, provided in accordance with aspects of the apparatus, system, and method, and is not intended to represent the only form in which the apparatus, system, and method may be constructed or used. In this specification, the following features and steps for constructing and using embodiments of the apparatus, system, and method in connection with the illustrated embodiments are defined. However, it should be understood that the same or equivalent functions and structures may be achieved by various embodiments intended to be encompassed within the spirit and scope of the present disclosure. As shown elsewhere in this specification, like reference numerals are intended to indicate like or similar elements or features.

[0136] Referring to FIG. 1, an exploded upper perspective view of a catheter assembly 100 provided in accordance with an aspect of the present disclosure is shown. As shown, the catheter assembly 100, which more broadly may be referred to as a needle assembly or a needle device, is shown including a catheter hub 102 having a catheter tube 104 and a bushing 138. The bushing 138 may be configured to press the proximal end of the catheter tube 104 against the inner wall surface of the catheter hub 102 to hold the catheter tube 104 in 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 disposed. Optionally, the safety clip 132 can also be omitted. The needle 108 having a profile change portion 144 may be inserted through the proximal opening of the catheter hub 102, and as shown with reference to FIGS. 5-7, the needle tip projects from the distal opening 112 of the catheter tube in the ready-to-use position. The cannula hub or needle hub 106 may be attached to the proximal end of the needle 108 and may contact the proximal end of the catheter hub 102 when assembled in the ready-to-use position. The proximal opening 101 of the catheter hub 102 may be a female luer taper, optionally an external thread size, configured to engage a male luer tip of a luer slip or luer lock.

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

[0139] The flashback plug, i.e., the blood stopper assembly 114, can be connected to the needle hub 106 to stop the outflow of blood from the flashback chamber 116 of the needle hub 106. The flashback plug 114 can be provided at the proximal end of the needle hub 106, whereby air can be discharged, but the outflow of blood from the proximal end of the body of the flashback plug 114 having the chamber 114a and the hydrophobic filter 114b can be stopped. Alternatively, a syringe can also be attached to the proximal end of the needle hub 106. The second valve 136 and the actuator 134, which will be described later, can also be arranged within the needle hub 106.

[0140] The protective cap 124 having the sleeve 124a and the saddle 124b can be provided to cover the needle 108 during packaging and before use, which is conventional. The saddle 124b can surround at least a part of the catheter hub 102 and the needle hub 106 and can be removably engaged with the needle hub. The protective cap 124 is removed from the catheter assembly before use.

[0141] In the example of a 360-degree arc or a circle, the valve opener 135 has a pair of plunger elements that generally align with the 0-degree (or 360-degree) position and the 180-degree position after the removal of the needle following successful venipuncture when the catheter assembly is in the ready-to-use position. The tip protector 132 has two arms that generally align with the 90-degree position and the 270-degree position in the ready-to-use position of the catheter assembly. The reference points of the two arms can be a plane drawn longitudinally through the midpoint of the two arms. The two points on this plane can represent the two arms at approximately the 90-degree position and the 270-degree position. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end view of the catheter hub. The needle bevel of the needle tip 110 faces upward toward the 0-degree position in the ready-to-use position. With these arrangements, the needle guard or tip protector 132 can be retracted together with the needle after successful venipuncture, and at the same time, when the needle guard is retracted and tilted or pitched as described later, potential snagging between the tip protector and the valve opener is avoided or minimized.

[0142] Next, referring to FIG. 2, a perspective view of the tip protector 132 of FIG. 1 is shown. Although various features of the tip protector 132 are shown, it should be noted that the tip protector may incorporate other features not shown or other features that may be modified from those shown. Further, any number of prior art guards configured to block the needle tip 110 of the needle may be used. In the illustrated embodiment, the tip protector 132 is similar to one of the guards shown in U.S. Patent No. 6,616,630, the contents of which are incorporated herein by reference. For example, the tip protector 132 may have a proximal wall and two elastic arms, and a profile change portion 144 of the needle 108, such as a fold or bulge, engages the periphery defining the opening in the proximal wall of the tip protector 132 so that the tip protector can be retracted proximally outside the catheter hub after successful venipuncture. The two arms may cross as described in and shown in U.S. Patent No. 6,616,630, or may extend along separate sides of the needle and not cross in a side view. Alternatively, the tip protector may have only one arm.

[0143] The two needle guard arms can be spread outwardly, i.e., biased, by the needle shaft in the ready-to-use position, such that the biased arms of the needle guard engage inside the catheter hub, engage the valve opener, such as the edge of the valve opener, or a combination thereof, as further described below in the ready-to-use position. In one example, only a portion of the tip protector, i.e., the needle guard 132, can extend into one or more gaps of the valve opener 134, while the proximal portion of the tip protector, such as the proximal wall, can extend proximally or be located proximally to the proximal surface of the most proximal surface of the tip protector 132, as further described below.

[0144] Figure 2 is an isometric view of the back of the needle guard 132 of FIG. 1. The needle guard 132 is exemplary, and a needle guard having other or different features may be used instead of the exact needle guard 132 shown. In the present embodiment, the needle guard 132 includes a proximal wall 142 having a periphery 144 that defines an opening 146. The proximal wall 142 has a wall surface 148 facing the proximal side and a wall surface facing the distal side opposite the wall surface facing the proximal side. At least one elastic arm 150 extends distally from the proximal wall 142. As shown, two elastic arms 150, 152 extend distally from the proximal wall. One arm can be made longer than the other arm. Each arm may also include different arm widths, including a first arm portion 156 of a first width and a second arm portion 158 of a second width smaller 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 portions 158. Thus, when viewed from the side along the longitudinal direction of the needle guard 132, the two arms cross each other. When used with a needle, the two arms 150, 152 cross each other when in the ready-to-use position and in the protected position. In an alternative embodiment, the two arms 150, 152 originate from different ends of the proximal wall and extend distally without crossing each other. Thus, the two arms 150, 152 can also have substantially the same arm width along the length of each arm.

[0145] The two distal walls 162, 164 are provided one at each end of the two arms 150, 152. The distal walls 162, 164 can overlap each other along the axial direction of the needle guard by utilizing different arm lengths and / or by angling one of the distal walls further distally at the elbow portion, i.e., the diagonal portion 168, between the distal wall and the elastic arm. In one example, when two arms are utilized, the elbow portion, i.e., the diagonal portion 168, of each arm engages a corresponding guard engagement portion inside the catheter hub 102, such as having a groove or a raised protrusion, against one or more restraint surfaces, i.e., limiting surfaces or choke points, of one or two reliefs of the valve actuator 134, so that the needle guard can be removably fixed inside the catheter hub during the transition process of removing the needle 108 from the catheter hub 102 in the ready-to-use position. When the radial profile of the needle guard 132 measured at one or two elbows 168 becomes smaller, such as when the needle tip moves proximally to the proximal side of the two distal walls 162, 164, the needle guard 132 can move to the proximal side of the choking point, i.e., the choke point, and be removed from the catheter hub 102 together with the needle. When the two distal walls move radially, the needle guard can reduce its radial profile and thereby pass through the choke point, i.e., move to the proximal side of the choke point. When forming the needle guard, the needle guard 132 may be folded from a pressed metal sheet forming the guard as shown. To enhance structural rigidity, ribs may be formed on the arms, proximal walls, and / or distal walls.

[0146] Next, referring to FIG. 3A, a top view or plan view of the valve opener, i.e., the actuator 134, is shown. The valve opener can be used with the needle assembly described herein, as shown in FIG. 5. As shown, the valve actuator has a nose portion 174, a transition portion 176, and two plunger elements 178, 178 that extend proximally from the transition portion, i.e., from the nose portion. The nose portion 174 defines a first continuous peripheral portion 180. Other positions of the nose portion 174 that are away from the first continuous peripheral portion 180 may have slits or slots.

[0147] Two stabilizer elements 184, 184 are attached to the two plunger elements 178 to form a stabilizer ring 186, and the stabilizer ring 186 defines a second continuous peripheral portion 188 of the valve actuator. Each stabilizer element 184 may have two edges 192a, 192b. In one 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 angled, i.e., inclined, such that while 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 the other stabilizer element. As shown, the proximal edges 192b of the two stabilizer elements 184, 184 are offset along the axial 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 one example, the distal edge is disposed obliquely with respect to the axis of the catheter hub.

[0148] The valve opener 134 is provided with two reliefs, i.e., two through-passages 196, each of which is defined or bounded by a transition portion 176, two plunger elements 178, and respective stabilizer elements 184, 184. The two reliefs, i.e., through-passages, may be referred to as a first relief, i.e., a first through-passage, and a second relief, i.e., a second through-passage. In one example, each relief, i.e., through-passage, has a periphery 200. In one example, each periphery may be defined by the structure of the transition portion 176, two plunger elements 178, and respective stabilizer elements 184, 184. Since the two stabilizer elements 184, 184 can be angled or inclined in different directions, the two peripheries 200 of the two reliefs, i.e., through-passages 196, can be different so as to have different peripheral contours or shapes. The edges 192a, 192b of the two stabilizer elements 184, 184 are preferably oblique with respect to the direction of the needle or axis of the catheter hub. As shown, each of the two peripheries 200 is defined by a continuous loop. In other words, in this embodiment, the periphery 200 does not have a slit or slot for forming an open periphery. However, if the stabilizer element 184 includes a slit or slot, the periphery can be an open or discontinuous periphery.

[0149] In some examples, the two stabilizer elements 184, 184 can extend laterally without being angled or inclined in the distal or proximal direction, i.e., without being tilted. With this configuration, the edges 192a, 192b of the two stabilizer elements 184, 184 are parallel to each other. Further, the four edges of the two stabilizer elements can be parallel to each other and axially offset. That is, while the four edges are parallel to each other, the proximal edge 192b of one stabilizer element can be located proximal or distal to the proximal edge 192b of the other stabilizer element.

[0150] Continuing to refer to FIG. 3A, the stubs or extensions 178a of the two plunger elements are shown extending proximally of the stabilizer ring 186. In one example, the stubs 178a of the two plunger elements can extend from the stabilizer ring 186 and be axially aligned with the plunger elements 178. In other examples, the stubs 178a of the two plunger elements are not axially aligned with the two plunger elements 178. In still other examples, only one of the stubs 178a of the plunger elements is aligned with one of the two plunger elements 178. In the case of a valve opener or actuator having only one plunger element 178 between the first continuous peripheral portion and the second continuous peripheral portion, only one of the stubs 178a of the two plunger elements can be aligned with one plunger element, or none of the stubs of the plunger elements can be aligned with one plunger element.

[0151] In some examples, there can be stubs or extensions 178a of more than two plunger elements extending proximally of the stabilizer ring 186. The stubs or extensions 178a of more than two plunger elements can be equally spaced around the proximal edge of the stabilizer ring 186 or randomly arranged around the proximal edge of the stabilizer ring 186. With the stubs of the plunger elements, the overall length of the valve actuator can be extended. The arc curves of the stubs of each plunger element defining the number of stubs of the plunger elements and / or the width of the stubs of each plunger element can provide a larger overlapping surface with the male luer tip than in the case of stubs of plunger elements having a smaller number or relatively small arc curves. In other examples, the stubs or extensions 178a of the two plunger elements are considered part of the two plunger elements 178, 178, and the stabilizer ring 186 is disposed between the two ends of each of the two plunger elements.

[0152] Referring further to FIG. 3A, the two plunger elements 178, 178 are each shown as having at least two thicknesses, and form projections 206 at the boundary between the two thicknesses on the outer surface 208 of each plunger element. The two projections 206, 206 can be disposed inside the recessed portion of the catheter hub 102, whereby the shoulder at the proximal end of the recessed portion can provide a stop surface that interacts with the two projections to prevent the valve opener 134 from disengaging from the inside of the catheter hub. In some examples, only one projection 206 is employed on one of the two plunger elements to prevent the valve opener 134 from disengaging in the proximal direction. In still other examples, each plunger element 178 has a single thickness, and the projection 206 is formed by adding material to the plunger element only at the site of the projection during injection molding.

[0153] In one example, the valve actuator 134 is provided with a planar portion 212 on the same side as each stabilizer element 184. The planar portion 212 extends proximally from near the nose portion 174 or the transition portion 176 of the valve member to near the two projections 206.

[0154] Next, referring to FIG. 3B, which is a cross-sectional side view of the valve opener 134 of FIG. 3A taken along line 3B-3B, the two planar portions 212, 212, one on each side of the valve opener 134 corresponding to the two stabilizer elements 184, 184, are provided to minimize the overall profile along the side profiles of the transition portion 176 and the two plunger elements 178, 178, as shown in FIG. 3B. Thus, in one example, the cross-sectional dimensions of the nose portion 174, the transition portion 176, and the two plunger elements 178, 178 are generally constant along the side view, that is, in a direction rotated 90 degrees along the longitudinal axis of the valve opener from the orientation of FIG. 3A, or are the same within the range of typical manufacturing tolerances.

[0155] Continuing to refer to FIG. 3B, a retention space 222 is shown that can be disposed between the two plunger elements 178, inside the stabilizer ring 186, between the stubs 178a of the two plunger elements, or combinations thereof. As previously explained, some or all of the needle guard 132 can be disposed in the retention space 222 in the ready-to-use position, and one or both of the elbows of the tip protector 132 protrude from the relief 196. For example, the elbows of the needle guard can be disposed distally of the two stabilizer elements 184, 184 in the ready-to-use position and can be disposed in the through openings, i.e., reliefs 196, 196. Further, in the ready-to-use position, the two elbows can contact the inside of the catheter hub, or be spaced from the inside of the catheter hub, or can contact one or both of the perimeters of the reliefs, or be spaced from the perimeter of the reliefs and the inner surface of the catheter hub, or combinations thereof. Of course, if only one arm and one elbow are incorporated into the tip projector 132, only the elbow can be similarly disposed.

[0156] The two elbows 168, 168 of the needle guard can be disposed distally of the two stabilizer elements 184, 184, and the proximal wall 142 of the needle guard can be disposed proximally of the two stabilizer elements in the ready-to-use position. In one example, the proximal wall 142 can be flush with the proximal end face 204 of the stub 178a of the plunger element, or can be disposed proximally of the end face 204, or can be disposed distally of the end face. If the stub of the plunger element is not incorporated, the proximal wall of the needle guard 132 can be flush with the proximal edge of one or both of the stabilizer elements 184, 184, or can be disposed proximally of the proximal edge of one or both of the stabilizer elements 184, 184, or can be disposed distally of the proximal edge of one or both of the stabilizer elements 184, 184.

[0157] Referring further to FIG. 3B, the distance between the two inner surfaces 224, 224 of the two stabilizer elements 184, 184 defines a choke gap, a choke point, i.e., a limiting point, of the needle guard 132 to limit proximal movement of the needle guard in the ready-for-use position and / or during retraction of the needle following intravenous access, as described above. That is, before the needle tip 110 (FIG. 1) moves proximal to one or both of the distal blocking walls 162, 164 of the needle guard, the choke point or gap is too small for the needle guard to pass proximal to the choke point or limiting point because the diagonal measurement between the two elbows is greater than the choke point. However, after the needle tip moves proximal to one or both of the distal blocking 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, and the profile becomes smaller than the choke point. At that point, due to the small radial profile measured at the two elbows, the needle guard can move proximal to the choke point.

[0158] The passage 218 is defined by the nose portion 174 of the valve opener. The distal opening 216 opens from the distal end into the passage 218, and the passage has a proximal opening. The needle is disposed within or passes through the passage 218 in the ready-for-use position.

[0159] FIG. 3C is a perspective view of the valve opener 134 of FIGS. 3A and 3B.

[0160] Figure 4 is an isometric view of the assembled needle assembly 100 of FIG. 1, showing a removable cap 124 disposed over needle 108 and engaging needle hub 106. Catheter hub 102 is shown as having any pair of wings 126, 126 extending radially of the hub body. Wings 126, when incorporated, can add stability after intravenous access, such as by providing an increased surface area for holding catheter hub 102 stationary against the patient's skin. FIG. 5 is an isometric cross-sectional view of needle assembly 100 of FIGS. 1 and 4. As shown, the plunger elements of valve opener 134 are oriented at the 0-degree and 180-degree positions, the bevel of needle tip 110 is oriented upwardly and is aligned with the upper plunger element. The reference points of the two plunger elements can be a plane drawn longitudinally through the midpoints of the two plunger elements. Two points on this plane can represent the two plunger elements that can be disposed at approximately the 0-degree and 180-degree positions. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end view of the catheter hub. Further, the two elbows and two arms of needle guard 132 are oriented at the 90-degree and 270-degree positions, the elbows project from the two reliefs 196, 196 of valve opener 134, the bevel of needle tip 110 is oriented upwardly and is aligned with push tab 250 (FIG. 7) of catheter hub 102. Still further, the plunger elements of valve opener 134 are oriented at the 0-degree and 180-degree positions, the two elbows and two arms of needle guard 132 are oriented at the 90-degree and 270-degree positions, the elbows project from the two reliefs of the valve opener, the bevel of needle tip 110 is oriented upwardly and is aligned with the upper plunger element.

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

[0162] In the ready-to-use position where the needle hub 106 contacts the catheter hub 102 and the needle tip extends from the distal end of the catheter tube 104, i.e., the distal opening 112, the catheter assembly 100 is ready for use such as for performing venipuncture or intravenous access. Disposed inside the catheter hub 102 is a valve 136 having a valve body 230 with an outer peripheral edge, a valve disk 232, and a valve skirt 234 extending axially from the valve disk. In one example, the valve disk 232 has one or more slits defining one or more flaps that can be opened by a valve actuator 134. The types and respective numbers of slits and flaps incorporated in the valve disk 232 vary, and three slits and three flaps are preferred. In one embodiment, the valve skirt 234 is disposed in a recess 236 formed in the internal cavity 173 of the catheter hub 102, whereby when the valve 136 is positioned inside the catheter hub 102, axial movement of the valve 136 is prevented.

[0163] In one example, the recess 236 has a distal shoulder 236a and a proximal shoulder 236b (FIG. 6) that define a groove 236 therebetween. The valve skirt 234 has a length sized and shaped to fit within the groove, i.e., the recess 236. In one example, the valve skirt 234 contacts the proximal shoulder 236b and the valve disk 232 contacts the distal shoulder 236a. Viewed another way, the valve 136 of FIG. 7 can contact and be constrained by the distal shoulder 236a and the proximal shoulder 236b of the recess 236 in the ready-to-use position such that the valve skirt 234 is axially fixed, i.e., cannot move axially.

[0164] In one example, the outer diameter, i.e., the outer surface, of the skirt portion 234 forms a size-on-size fit, i.e., a perfect fit, with the recess 236 in the interior 130 of the catheter hub 102. In other examples, a slight interference fit is provided therebetween. In still other examples, a small clearance is provided between the outer surface of the skirt portion 234 and the inner surface of the recess 236, with the valve skirt 234 contacting the proximal shoulder 236b and the valve disk 232 contacting the distal shoulder 236a of the recess.

[0165] The distal cavity chamber 173a (FIG. 7) is provided on the distal side of the valve disk 232 and the proximal side of the bushing 138. In some examples, a helical spring, i.e., an elastic biasing element, such as an elastomeric ring or cylinder, may be provided in the distal cavity chamber 173a concentric with the needle to assist in biasing the flap of the valve disk to close one or more slits.

[0166] In one example, the valve disk 232 has a valve diameter, a valve thickness measured orthogonally to the valve diameter, and, as described above, one or more slits that define two or more flaps. In the illustrated embodiment, the valve skirt 234 extends axially with respect to the longitudinal axis of the valve and has an elongated wall generally perpendicular to the outer peripheral edge of the valve disk 232, forming a generally cylindrical valve body. In some embodiments, the valve skirt 234 may be inclined such that the valve forms a frustoconical structure.

[0167] The valve skirt 234 defines a valve cavity 238 having an opening proximal end 240, and the actuator nose or nose portion 174 of the valve actuator 134 can be actuated to advance the valve flaps of the valve disk 232 through the opening proximal end 240. In one embodiment, at least a portion of the actuator nose 174 including the distal actuating end 244 of the valve actuator 134 is disposed inside the valve cavity 238 of the valve 136 before actuation. Thus, the actuator nose 174 can be narrower than the inner diameter of the valve skirt 234 such that the actuating end 244 fits within the valve cavity 238 and contacts, i.e., touches, the valve disk in the ready-to-use position. In one example, the relative dimensions are such that the nose portion 174 of the actuator does not contact the inner wall surface of the skirt portion 234, and some contact is assumed.

[0168] In one example, the actuating end 244 of the valve opener contacts the surface facing the proximal side of the valve disk 232 in the ready-to-use position, and other parts of the valve actuator 134, such as one or two protrusions 206 (FIG. 3A), contact the shoulder 246 inside the catheter hub and apply a load to the valve disk in the ready-to-use position, but as will be described further below, it is not sufficient to open one or more slits. In other examples, the actuating end 244 is spaced from the surface facing the proximal side of the valve disk 232 in the ready-to-use position, and the protrusion 206 of the actuator either contacts the shoulder 246 or is also spaced from the shoulder 246. When one or more protrusions of the actuator 134 are spaced from the shoulder 246 and the actuating end 244 is spaced from the valve disk 232, the actuator can float slightly axially within the catheter hub.

[0169] In one example, the protrusions 206 extend outwardly from one or both outer surfaces of the plunger element 178. As shown, the protrusions 206 extend from the outer surface of each plunger element 178. Each protrusion 206 has an inclined surface similar to a generally flat edge for contacting the shoulder 246. Due to the inclined surface and the inclination direction of the protrusion 206, the actuator 134 can be inserted into the interior of the catheter hub and seated in the second recessed portion 240 described further below.

[0170] In one example, the actuator, i.e., the valve opener 134, has a longitudinal axis, and one or more actuating elements 178 extend axially, i.e., parallel, to the longitudinal axis. In a specific example, the two actuating elements 178 are radially opposed to each other along the longitudinal axis. As shown, the two actuating elements 178 define an outer diameter having a dimension larger than the diameter of the nose portion 174.

[0171] In one example, the actuating element 178 is flexible and deflectable such that when pressed at the male luer tip, the actuating element deflects, i.e., bends. The actuating element can be made deflectable by selecting a material having the required elasticity. In other examples, the actuating element can be made deflectable by incorporating one or more weakening portions such as incorporating structurally thin portions, incorporating notches, employing a smaller cross-section compared to other portions of the same elongate actuating element, or combinations thereof. Alternatively, the actuating element 178 can be made flexible and deflectable by selecting a material having the required elasticity and incorporating one or more weakening portions.

[0172] In yet other examples, each actuating element 178 has a plurality of different cross-sectional shapes, i.e., profiles, along the length portion. For example, an elongate plunger element can have a square profile disposed adjacent to a crescent profile.

[0173] The nose portion 174 of the valve actuator 134 can be configured to engage the valve 136 to open the valve disk 232 when an axial force is applied by the male tip toward the distal end of the catheter assembly 100 to the actuating element 178, such as during the insertion of the male luer connector of the IV drip line. Generally, the nose portion 174 is rigid compared to the more flexible valve 136, whereby the nose portion 174, more specifically the actuating end 244, can actuate the valve 136, such as by deflecting one or more flaps and opening one or more slits of the valve disk 232. The nose portion 174 may be made of a non-compressible material such as metal, hard plastic, hard elastomer, etc. to press against the valve to open it.

[0174] In one embodiment, the stabilizers, i.e., stabilizer elements 184, 184, are arcuate in shape, form an arc along the internal profile of the catheter hub 102, and connect one actuating element 178 to the other actuating element 178. The stabilizers, i.e., stabilizer elements 184, may form a substantially cylindrical portion in the body of the valve actuator, the body being spaced from the nose portion 174 of the valve actuator. In other words, the valve actuator may be elongate and have a portion that is continuous along the radial direction and a portion that has a relief or through-passage that penetrates the wall of the actuator and is not continuous along the radial direction.

[0175] In one example, the stabilizers 184, 184 define a peripheral or radially continuous body portion, i.e., a ring 186, of the valve actuator, the portion being spaced from the continuous body portion of the nose portion 174 and also being continuous along the periphery or radially. The two stabilizers, i.e., stabilizer elements 184, 184, may be joined to the two plunger elements 178 to form a ring structure. Optionally, the two stabilizers may be slightly offset from each other and angled.

[0176] The stabilizer 184 can help the valve actuator 134 remain centered within the catheter hub 102 while the actuator is moving, such as when being pressed by a male luer tip. By remaining centered, the nose portion 174 can align better with the valve disk 232, such as a slit in the valve disk, enabling smooth operation of the valve 136. The stabilizer 184 can also provide engagement via friction with the interior of the catheter hub 102 to prevent the actuator 134 from sliding proximally after removal of the male luer tip.

[0177] In one embodiment, the nose portion 174 is configured to remain engaged with the valve disk 232 after actuation of the valve and removal of the male luer tip. For example, the nose portion 174 can be pushed between one or more slits of the valve disk and held therein by friction, as will be described further below. The valve actuator 134, such as the nose portion, can be provided with surface features such as ridges, grooves, or catches to maintain the engagement between the actuator and the valve after actuation and removal of the male luer tip.

[0178] A relief, an opening, i.e., a through-passage 196, can be provided between the transition portion 176 and each of the two stabilizers 184, 184, i.e., between the nose portion and each of the two stabilizers 184, 184. The two reliefs, i.e., through-passages 196, can provide a clearance such that the interior, i.e., the central portion, of the valve actuator 134 and the inner surface of the catheter hub 102 can communicate openly. In other words, there is one or two reliefs, i.e., openings 196, between the continuous portion of the nose portion and the continuous peripheral portion, called the stabilizer ring 186, defined by the two stabilizers 184, 184 and the plunger element 178.

[0179] The inner diameter of the stabilizer ring 186 of the valve actuator 134 can be smaller than the diameter defined by the diagonal portions, i.e., the elbows 168, of the two arms 150, 178 of the needle guard 132 when the two arms are biased outwardly by the sides of the needle shaft. Thus, while the needle guard 132 is placed in the holding space of the valve actuator 134, the diagonal portions, i.e., the elbows, of the needle guard 132 can flex and pass through the stabilizer ring 186 and into the open area defined by the relief 196.

[0180] When the tip protector 132 is disposed between the two plunger elements 178, the two distal walls 162, 164 of the needle guard 132, more specifically the two diagonal portions or elbows 168, can be disposed in the relief 196 as described above, engage with a groove or projection formed inside the catheter hub, engage with the guard engagement surface on the inner surface of the catheter hub 102, or engage with 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 held inside the catheter hub during withdrawal of the needle after successful venipuncture until the needle tip moves proximal to the two distal walls of the needle guard. At this time, the needle guard closes covering the needle tip and can be removed together with the needle as described above with reference to FIG. 3.

[0181] In the internal cavity 173 of the catheter hub 102 for accommodating the two diagonal portions or elbows 168, a second undercut or recess 248 can be provided proximal to the first concave portion 236. Thus, the needle guard 132 can be prevented from sliding proximally during withdrawal of the needle after successful venipuncture by the shoulder 246 of the second recess 248 or by other surface features inside the catheter hub, such as the guard engagement surface inside the catheter hub. Optionally or alternatively, the distal edges 192a of one or both of the stabilizers 184, 184 can provide a restraint surface for preventing premature actuation of the needle guard 132 during withdrawal of the needle before the needle tip moves proximal to the two distal walls 162, 164. In addition to the distal edges 192a, both stabilizers 184, 184 also have proximal edges 192b.

[0182] In some examples, one or both of the stabilizer elements 184, 184 may have a slit or channel, thereby dividing the arcuate stabilizer element into two. Even if there is a slit in one or both of the stabilizer elements 184, 184, the stabilizer ring 186, which can be a discontinuous ring similar to a ring having one or more slots formed through the ring, may provide a restraining surface for preventing the needle guard 132 from operating prematurely during retraction of the needle, such as before the needle tip moves proximal to the two distal walls 162, 164. The restraining surface provides a rigid structure that prevents the needle guard from moving proximally until the needle guard first activates, collapses radially, reduces its radial profile, and slides proximal to the choke point, or prevents it from sliding in at all, and is sometimes also referred to as a limit point, choke gap, or choke point. In one example, one or two elbows 168 of the needle guard may be restrained from moving proximally by the choke point until one or two elbows of the needle guard flex and reduce the radial profile of the needle guard. In one example, when the radial profile of the needle guard is reduced, the needle guard may slide through the bore defined by the stabilizer ring from the distal position of the stabilizer ring to the proximal position of the stabilizer ring.

[0183] The valve opener 134 can be made of metal or plastic. When made of metal, the valve opener 134 can be formed by bending or deep drawing methods, and the arcuate cross-section of the actuating element 178 can provide additional rigidity when pushed by the male luer. Each actuating element 178 can have at least two longitudinal edges, and ribs can be provided along one or both of the longitudinal edges to further add structural rigidity. One or more gaps can be provided between the two actuating elements 178. The gap can provide clearance or space for the fluid flowing therethrough, such as during blood washing or intravenous injection. The gap between the actuating elements 178 can define a holding space 222 for accommodating the tip protector 132.

[0184] In some embodiments, most or all, but at least most, of the tip protector 132 fits within a retention space 222 formed by the body of the actuator 134 between the two plunger elements 178 in the ready-to-use position, as shown in FIG. 6. This reduces the longitudinal space required to longitudinally serially house both the actuator 134 and the tip protector 132 within the hub, or allows for a more compact configuration when the two only partially overlap axially. In FIG. 6, the tip protector 132 is shown completely fitting within the retention space of the actuator 134, further reducing the required space or length within the catheter hub. As shown, the proximal wall 142 of the needle guard 132 is generally flush with the proximal end faces of the two plunger elements 178.

[0185] If the tip protector 132 only engages or contacts the distal edge 192a of the actuator relief or through passage 196, or is spaced from the edge but does not contact the inner surface of the catheter hub, no diameter deformation or change is required in the inner wall of the catheter hub, and the tip protector 132 can be positioned further proximally in the tapered portion of the female luer, while complying with the international luer standard for conical fitting, and the overall length of the catheter hub 102 can be further reduced.

[0186] As shown in the figure of FIG. 6, the push tab 250 of the catheter hub 102 is generally disposed at the 0-degree position with respect to the end face view of the circumferential arc of the catheter hub 102. Similarly, the bevel of the needle tip 110 is angled and aligned at the 0-degree position, which may also be referred to as the position above the bevel. At the position above the bevel, the two arms 150, 152 of the needle guard, as well as the two elbows 168, 168, are aligned at the 90-degree position and the 270-degree position, and the two plunger arms 178, 178 are aligned at the 0-degree position and the 180-degree position. This unique arrangement, unlike known prior art instruments, is incorporated to minimize or avoid the elbows being caught by the stabilizer during the retraction of the needle guard after successful venipuncture when the needle guard 132 can be tilted or pitched by the operator, as will be described further below.

[0187] To align with the needle guard or tip protector 132, the tip extension 262 at the distal end of the nose portion 264 of the needle hub 106 also rotates. That is, the tip extension 262 is oriented at the 90-degree position to press against the proximal wall of the needle guard. In this way, while the needle bevel is oriented at the position above the 0-degree bevel, the tip extension 262 of the needle hub is oriented at the 90-degree position. Due to manufacturing tolerances, when a specific angular position is specified, unless otherwise indicated by the context, it is generally understood to mean approximately and is not interpreted as an exact measurement or position. 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, while the external tab 268 for capturing the catheter hub between it and the nose portion 264 may remain at the 180-degree position in the ready-to-use position or be rotated together with the tip extension 262.

[0188] Next, referring to FIG. 8, a perspective view of the catheter assembly 100 of FIGS. 6 and 7 is shown without the distal extension 262. One of the relief or through-passages 196 is clearly shown proximal to the nose portion 174 of the actuator 134 and is one of the arms disposed there, which, as previously explained, engages within the catheter hub 102, the inner surface of the distal edge of the stabilizer 184, either the inner surface or the distal edge, or a combination thereof, and has an elbow 168. In the illustrated embodiment, the tip protector 132 fits substantially within the holding space of the actuator 134, and the proximal wall 142 of the tip protector is substantially flat axially with the proximal end of the actuating element 178.

[0189] Next, referring to FIG. 9 in combination with FIGS. 5-8, a schematic view is shown depicting the state where the needle 108 is retracted proximally at an angle obliquely upward from the center line after successful venipuncture. The figure shows that the needle tip 110 (FIG. 1) has moved proximal to the two distal walls of the needle guard 132 and the needle guard is blocking the needle tip. The angle of the needle shaft can be intentionally or unintentionally arranged depending on the intention of the operator during the retraction of the needle after venipuncture and the like. Regardless of the reason the needle can be angled, this movement causes the needle guard 132 disposed to cover the needle tip to tilt or pitch, such that when the elbows and stabilizers are aligned at the 0-degree and 180-degree positions, one or both of the elbows 168, 168 of the two arms can catch on the distal edges 192a, 192a of the stabilizers 184, 184. In other words, when the needle guard 132 tilts or pitches during retraction, if the plunger element of the valve opener is aligned at the 90-degree and 270-degree positions, the elbows when aligned at the 0-degree and 180-degree positions can catch on the edge of the stabilizer. Note that FIG. 9 shows one less stabilizer element 186 for clarity.

[0190] However, as shown in FIG. 8, when the elbows 168, 168 are aligned at the 90-degree position and the 270-degree position, the two stabilizers 184, 184 are aligned at the 90-degree position and the 270-degree position, and the two plunger elements 178, 178 are aligned at the 0-degree position and the 180-degree position, no movement or snagging of one or both of the elbows against the edge of the stabilizer occurs during retraction due to the inclination or pitch. If the elbow snags on the stabilizer, the needle guard may pull the tip protector 132 relative to the valve actuator 134 during retraction of the needle, potentially displacing the valve actuator 134 from inside the catheter hub. Thus, when the various components are angled according to the aspects of the present invention as shown in FIG. 8, any inclination of the needle 108, and thus the inclination of the tip protector 132, during retraction of the needle 108 after successful venipuncture causes the tip protector to simply slide against the inner surface 270 (FIG. 3B) of one or both of the plunger elements 178, 178. Since there are no snagging edges on the inner surface 270 of the two plunger elements 178, 178, the needle guard 132 can be easily retracted from the valve opener without snagging the valve opener during the process. Thus, when oriented as shown in FIG. 8 and the like, the components of the valve opener are configured to operate freely without the elbow snagging on the edge of the stabilizer and leading to failure.

[0191] FIG. 10 is a partial cross-sectional side view of catheter assembly 100 after removal of needle 108 and needle guard 132, showing both stabilizer elements 186. FIG. 11 shows valve actuator 134 advanced distally of valve 136 by the tip of a syringe or the luer tip 272 of an IV drip line to permit fluid flow through the catheter hub. Luer tip 272 can be a luer that threadedly engages catheter hub 102, which can have a female luer. Advancing actuator 134 causes actuation end 244 to advance relative to valve disk 232, causing the flap to flex radially and distally, opening the fluid pathway formed through catheter assembly 100. As shown, valve 136 is in a closed position where one or more slits in valve disk 232 are closed. Also shown is the retracted position of valve actuator 134 where actuation end 244 of nose portion 174 is not pushed in and one or more slits are not open. This position is also understood to be the pre-actuation position of the valve. That is, the male luer tip is not inserted into the proximal opening of the catheter hub to advance the valve actuator and open the valve. In other words, this is the valve closed position.

[0192] When a male medical device 272 such as a male luer tip is first inserted into the proximal opening of catheter hub 102, the male tip first contacts two actuation elements 178 of valve actuator 134, promoting a distally directed force on the two actuation elements 178 to open valve 136. The distally directed force moves actuator 134 in the distal direction until the geometry between the male tip and the proximal opening of the catheter hub stops further distal advancement of the male tip. In one example, the female luer taper of catheter hub 102 and the male luer taper of the male tip are joined to block further distal advancement of the male tip into the opening of the catheter hub. A seal by luer engagement is provided to prevent liquid from leaking out of the proximal opening of the catheter hub.

[0193] When the actuator 134 moves distally due to the advancement of the male tip distally, the nose 174 of the valve actuator 134 is biased distally and pressed against the surface facing the proximal side of the valve disk 232. Specifically, the nose of the actuator 134 first presses against the surface facing the proximal side of the valve disk 232. Since the valve is axially fixed within the first recessed portion 236 of the catheter hub, one or more flaps of the valve disk 232 bend radially and distally. Thereafter, fluid from the male tip can flow through the catheter hub 102, through the valve 136, and through the lumen of the catheter tube 104.

[0194] Alternatively, suction can be performed using a male-type medical device such as a syringe or a vacuum blood collection tube to aspirate blood from a patient. This is often done to examine a specimen before starting infusion therapy. Also, usually, before starting infusion therapy, residual blood is first flushed out from inside the catheter hub 102.

[0195] FIG. 11 shows that the operating end 244 of the nose portion 174 protrudes through the valve disk 232 and either contacts or is about to contact the bushing 138 in the valve operating position. In this configuration, even after the male tip is removed, the valve actuator 134 can remain engaged with the valve 136. That is, the friction between the valve actuator 134 and the valve disk 232 exceeds the restoring force generated by the valve flaps of the valve that attempt to return to the undeformed position shown in FIG. 10. This operating position can be considered a single-use or single-actuation because the valve actuator 134 and the valve 136 do not return to the pre-operating position of FIG. 10 when the male tip is removed.

[0196] In an alternative embodiment, the nose portion 174 is configured such that when pushed into the valve 136 during operation, the actuating end 244 does not extend distally beyond the flap of the valve disk 232. This configuration can ensure that when the male luer device is removed, the valve actuator 134 is pushed back by the flap of the valve disk. The conical configuration at the distal end of the actuator 134, i.e., the configuration incorporating the tapered nose portion 174, can be a configuration that can maintain a proximal-directed force vector that is greater than the vertical force vector. The angle of the cone can be designed to provide the force vectors required when the actuator 134 reaches its maximum and minimum distal displacements. The difference between the maximum and minimum displacements of a standard luer connector is approximately 2.5 millimeters.

[0197] Additionally, a spring or elastic element or ring can be incorporated into the distal cavity chamber 173a to increase the recoiling force, i.e., the return force, of the valve 136, facilitate pushing the valve actuator 134 in the proximal direction after removal of the male tip, and return it to the pre-operation position shown in FIG. 10, i.e., the valve closed position. The elastic element can also help to close the flap of the valve disk 232. In this way, the valve 136 and the valve actuator 134 can be closed again after the first operation and can repeat the process of opening and closing again. Alternatively or additionally, by thickening the flap of the valve disk, sufficient restoring force can be provided without the need for an elastic element.

[0198] Next, referring to FIGS. 12 and 13, two different perspective views of a needle guard 132 provided in accordance with an alternative aspect of the present invention are shown. The needle guard 132 of this embodiment is similar to the needle guard shown with respect to FIG. 2 and the like and can be used with various catheter assemblies described herein. The two arms 150, 152 are shown biased apart in a needleless state that normally biases the arms apart, and further show the features of the distal walls 164, 164 and the curved lips 164a, as will be described later. The arms 150, 152 of the needle guard 132 have a smooth or flat profile between the elongated arm portions 150a, 152a and the elbows 168, 168 and are shown to have only a single bend or change in direction. As shown, each of the elongated arm portions 150a, 152a of the first arm 150 and the second arm 152 has portions of different arm widths. Each arm 150, 152 also includes a notch 280 having a lip 280a similar to a hook. The notches 280, 280 of the two arms allow the two arms 150, 152 to straddle the needle and provide lateral stability as the needle moves from a ready-to-use position with the needle tip exposed to a protected position with the needle tip guarded.

[0199] FIG. 12 shows a curved lip 162a in the first arm 150 having a straight edge 284. However, the curved lip 162a is configured to contact the needle with a flat surface adjacent to the edge when in the ready-to-use position. FIG. 13 shows a curved lip 164a in the second arm 152 having a notch 288 similar to an arc. The notch 288 can be utilized to change the position where the surface of the curved lip 162a, rather than the edge, contacts the needle. In some examples, the notch 288 can be omitted. Also shown is a rib 277 formed with the two arms, which is optional and can be included to add strength to the arms, and a tab 274 extending from the edges of the distal walls 164, 164 is also optional and can be included to limit lateral rotation of the needle tip when the needle tip is captured within the needle guard.

[0200] The needle guards 132 of FIGS. 12 and 13, as well as other needle guards described herein, can each be made from a pressed metal sheet such as a pressed stainless steel sheet, and using pressing and bending processes, form a needle guard of the illustrated shape.

[0201] Referring now to FIG. 14, a needle hub 102 without a needle and needle hub is shown, showing a needle guard 132 and two plunger elements 178, 178 of an actuator or valve opener 134 according to a further aspect of the present invention. This catheter assembly 100 is, except for some parts, similar to the catheter assemblies of FIGS. 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 position and the 180 - degree position, where 0 degrees is at the top dead center of a complete arc or circle. Stated, the angular position is the circumferential position of the mid - point of the width of the first plunger element and the circumferential position of the mid - point of the width of the second plunger element with respect to the angle of the circle. The angle can be specified from the perspective when viewed in the distal or proximal direction. For example, when viewed in the distal direction of FIG. 14, the upper plunger element 178 can be oriented at any position from approximately the 1 - degree position to approximately the 75 - degree position (including these), and the lower plunger element can be oriented 180 degrees from the position of the upper plunger element 178. As shown, the upper plunger element 178 is oriented at approximately the 22 - degree position, and the lower plunger element 178 is oriented at approximately the 202 - degree position. The reference points of the two plunger elements 178, 178 can be a plane drawn longitudinally through the mid - points of the two plunger elements. The two points on this plane can represent the two plunger elements that can be arranged at approximately the 22 - degree position and the 202 - degree position when viewed in the distal direction.

[0202] Thus, referring to FIGS. 11 and 14, an aspect of the present invention includes a catheter assembly comprising a valve actuator having two plunger elements 178, 178, referred to as a first or upper plunger element and a second or lower plunger element, wherein the upper plunger element 178 can be oriented from a position of about 0 degrees (or 360 degrees) to a position of about 75 degrees (including these), and the lower plunger element 178 can be oriented 180 degrees from the position of the upper plunger element 178. For example, the first or upper plunger position can 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 can be oriented 180 degrees from the position of the upper plunger element.

[0203] Although not shown, the two arms of the needle guard 132 can be oriented between the two plunger arms 178, 178 and substantially bisect the two plunger arms. The two needle guard arms can be disposed substantially evenly between the two plunger arms.

[0204] Thus, when the various components are angled according to an aspect of the present invention as shown in FIG. 14, due to any inclination of the needle 108 during retraction of the needle 108 after successful venous puncture, and thus the inclination of the tip protector 132, the tip protector simply slides against the inner surface 270 (FIG. 3B) of one or both of the plunger elements 178, 178. Since there is no catching edge on the inner surface 270 of the two plunger elements 178, 178, the needle guard 132 can be easily retracted from the valve opener without catching the valve opener during the process. Thus, when the valve actuator and the needle guard are oriented as shown in FIG. 14, the components of the valve opener are configured to operate freely without the elbow of the needle guard catching on the edge of the stabilizer and leading to failure.

[0205] Next, referring to FIG. 15, a needle hub 102 without a needle and a needle hub is shown, showing a needle guard 132, an actuator or valve opener 134, and two plunger elements 178, 178 according to a further aspect of the present invention. This catheter assembly 100 is similar to the catheter assemblies of FIGS. 4-11 and 14, except for a part. 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 position and the 180-degree position. As described elsewhere with respect to the relative angular position, for example, the upper plunger element 178 can be oriented at any position from about 285 degrees to about 359 degrees (including these), and the lower plunger element can be oriented 180 degrees from the position of the upper plunger element 178. For example, the first or upper plunger position can be oriented at the 288-degree position, 294-degree position, 307-degree position, 326-degree position, etc., and the lower plunger element can be oriented 180 degrees from the position of the upper plunger element. As shown, the upper plunger element 178 is oriented at about 338 degrees, and the lower plunger element 178 is oriented at about 158 degrees. The reference points of the two plunger elements 178, 178 can be a plane drawn longitudinally through the midpoint of the two plunger elements. Two points on this plane can represent the two plunger elements at approximately 338 degrees and 158 degrees positions.

[0206] Although not shown, the two arms of the needle guard 132 can be oriented between the two plunger arms 178, 178 and substantially bisect the two plunger arms. The two needle guard arms can be arranged approximately evenly between the two plunger arms.

[0207] As such, referring to FIGS. 11 and 15, aspects of the present invention include a catheter assembly comprising a valve actuator having two plunger elements 178, 178 that can be referred to as a first or upper plunger element and a second or lower plunger element, the upper plunger element 178 can be oriented from an approximately 285-degree position to an approximately 0-degree position, and the lower plunger element 178 can be oriented 180 degrees from the position of the upper plunger element 178. The 0-degree position is understood as the top dead center position of a complete circle when viewed from the distal end face view of the catheter hub.

[0208] As such, when the various components are angled according to aspects of the present invention as shown in FIG. 15, any inclination of the needle 108 during retraction of the needle 108 after successful venipuncture, and thus the inclination of the tip protector 132, causes the tip protector to simply slide against the inner surface 270 (FIG. 3B) of one or both of the plunger elements 178, 178. Since there is no catching edge on the inner surface 270 of the two plunger elements 178, 178, the needle guard 132 can be easily retracted from the valve opener without catching the valve opener during the process. Thus, when the valve actuator and the needle guard are oriented as shown in FIG. 15, the components of the valve opener are configured to operate freely without the elbow of the needle guard catching on the edge of the stabilizer and leading to failure.

[0209] Methods of manufacturing and using the catheter assembly and its components are within the scope of the present invention.

[0210] Although specific, limited embodiments of the catheter assembly and its components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Accordingly, it should be understood that catheter assemblies and their components constructed in accordance with the principles of the disclosed apparatus, systems, and methods may include those other than those specifically described herein. The present disclosure is also defined in the following claims.

[0211] Needle assemblies, catheter assemblies, needles and components of catheter assemblies, and methods of use and manufacture of catheter assemblies or needle assemblies according to aspects of the present invention may be encompassed by the following exemplary aspects. Exemplary Aspect 1: A needle assembly, comprising a needle hub having a needle, wherein a needle tip of the needle has a needle bevel extending from a distal end of the needle hub, the needle hub, a catheter tube attached to a catheter hub having a body including an inner surface defining an internal cavity, wherein in a ready-to-use position, the needle extends through the catheter tube, the needle tip extends beyond a distal end of the catheter tube, and the needle bevel is oriented at a 0-degree position, the catheter tube, a valve disposed in the internal cavity of the catheter hub and in contact with an internal shoulder of the catheter hub, the valve having an outer peripheral edge and a wall having at least one slit defining a plurality of flaps, the valve, a valve opener sized and shaped to open the valve by opening the plurality of slits, the valve opener having a nose portion having an operating end and a continuous peripheral portion having a passable bore, two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges extending proximally to the nose portion, two plunger elements, and two stabilizer elements, each stabilizer element being connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced from the continuous peripheral portion of the nose portion by two through passages including a first through passage and a second through passage, the valve opener, a needle guard having a proximal wall and two elastic arms disposed in a holding space between the two stabilizer elements, each elastic arm including an elbow, the needle guard having the two elastic arms and the two elbows including a first elbow and a second elbow, the needle guard, wherein (1) the first plunger element is oriented from an approximately 285-degree position to an approximately 0-degree position, the second plunger element is oriented 180 degrees from the first plunger element, or (2) the first plunger element is oriented from an approximately 1-degree position to an approximately 75-degree position, the second plunger element is oriented 180 degrees from the first plunger element, and the 0-degree position is when viewed from an end view in the distal direction of the catheter hub.The needle assembly, which is at the top dead center position of a complete circle. Exemplary embodiment 2: In the ready-to-use position, the first elbow is disposed in the first through passage, and the second elbow is disposed in the second through passage. The needle assembly according to exemplary embodiment 1. Exemplary embodiment 3: The two arms of the needle guard bisect the two plunger elements. The needle assembly according to exemplary embodiment 1 or 2. Exemplary embodiment 4: The valve has a wall surface facing proximally, and the actuating end of the valve opener is biased against the proximally facing wall surface in the use position to press the plurality of flaps against the inner surface of the catheter hub. The needle assembly according to any one of exemplary embodiments 1 to 3. Exemplary embodiment 5: The plurality of slits define three slits that define three flaps. The needle assembly according to any one of exemplary embodiments 1 to 4. Exemplary embodiment 6: The first elbow is in contact with the periphery of the first through passage. The needle assembly according to any one of exemplary embodiments 1 to 5. Exemplary embodiment 7: The first elbow is in contact with the inner surface of the catheter hub. The needle assembly according to any one of exemplary embodiments 1 to 6. Exemplary embodiment 8: The first elbow is in contact with the periphery of the first through passage and the inner surface of the catheter hub. The needle assembly according to any one of exemplary embodiments 1 to 7. Exemplary embodiment 9: The first elbow is in contact with the edge of the stabilizer ring. The needle assembly according to any one of exemplary embodiments 1 to 8. Exemplary embodiment 10: The valve has a valve disk and a valve skirt that extends in the proximal direction of the valve disk and defines a valve cavity. The needle assembly according to any one of exemplary embodiments 1 to 9. Exemplary aspect 11: The second elbow portion is in contact with the inner surface of the catheter hub. The needle assembly according to any one of exemplary aspects 1 to 10. Exemplary aspect 12: The nose portion has a frustum shape. The needle assembly according to any one of exemplary aspects 1 to 11. Exemplary aspect 13: The second elbow portion is in contact with the periphery of the second through passage. The needle assembly according to any one of exemplary aspects 1 to 12. Exemplary aspect 14: The valve opener has a protrusion extending in the radial direction of the longitudinal axis of the valve opener, and the inner surface of the catheter hub has a shoulder for restricting the proximal movement of the protrusion. The needle assembly according to any one of exemplary aspects 1 to 13. Exemplary aspect 15: The protrusion is a first protrusion, and the valve opener has a second protrusion spaced from the first protrusion. The needle assembly according to any one of exemplary aspects 1 to 14. Exemplary aspect 16: The valve opener has a protrusion extending in the radial direction of the longitudinal axis on the outer surface of one of the two plunger elements. The needle assembly according to any one of exemplary aspects 1 to 15. Exemplary aspect 17: Further comprising a skirt portion extending distally of the wall. The needle assembly according to any one of exemplary aspects 1 to 16. Exemplary aspect 18: The first stabilizer element has a distal edge, and the second stabilizer element has a distal edge. The needle assembly according to any one of exemplary aspects 1 to 17. Exemplary aspect 19: The distal edge of the first stabilizer element is parallel to the distal edge of the second stabilizer element. The needle assembly according to any one of exemplary aspects 1 to 18. Exemplary Aspect 20: The distal edge of the first stabilizer element is angled with respect to the distal edge of the second stabilizer element. The needle assembly according to any one of exemplary aspects 1 to 19. Exemplary Aspect 21: Each of the two plunger elements further comprises a protrusion for defining two protrusions, and the two protrusions are disposed on the distal side of the stabilizer ring. The needle assembly according to any one of exemplary aspects 1 to 20. Exemplary Aspect 22: The needle guard, the valve, and the valve opener are all disposed within the internal cavity of the catheter hub. The needle assembly according to any one of exemplary aspects 1 to 21. Exemplary Aspect 23: Further comprising a protective cap having a sleeve disposed around the catheter tube and the needle. The needle assembly according to any one of exemplary aspects 1 to 22. Exemplary Aspect 24: Further comprising a bush for pushing the proximal end of the catheter tube against the inner surface of the catheter hub, and an elastic element disposed between the bush and the valve disk inside the catheter hub, wherein the elastic element is sized and shaped to press the valve disk in the proximal direction. The needle assembly according to any one of exemplary aspects 1 to 23. Exemplary Aspect 25: The elastic element is a stretchable element or a spring. The needle assembly according to any one of exemplary aspects 1 to 24. Exemplary Aspect 26: The wall of the valve has a generally flat or smooth wall surface facing the distal side. The needle assembly according to any one of exemplary aspects 1 to 25. Exemplary Aspect 27: Each of the two plunger elements further comprises a protrusion for defining two protrusions, and the two protrusions are disposed on the distal side of the stabilizer ring. The needle assembly according to any one of exemplary embodiments 1 to 26. Exemplary embodiment 28: The first plunger element is oriented from about the 285-degree position to about the 0-degree position, but not to the 270-degree position or the 90-degree position. The needle assembly according to any one of exemplary embodiments 1 to 27. Exemplary embodiment 29: The angular position is with respect to the midpoint of the width of the first plunger element and the midpoint of the width of the second plunger element. The needle assembly according to any one of exemplary embodiments 1 to 28. Exemplary embodiment 30: Each of the two elastic arms of the needle guard has a smooth or flat profile between the elongated arm portion and the elbow and has only a single bend or change in direction. The needle assembly according to any one of exemplary embodiments 1 to 29. Exemplary embodiment 31: Each of the two elastic arms of the needle guard includes a notch having a lip similar to a hook. The needle assembly according to any one of exemplary embodiments 1 to 30. Exemplary embodiment 32: Each notch straddles the needle to provide lateral stability. The needle assembly according to any one of exemplary embodiments 1 to 31. Exemplary embodiment 33: The curved lip of the first arm of the two elastic arms has a straight edge. The needle assembly according to any one of exemplary embodiments 1 to 32. Exemplary embodiment 34: The curved lip of the second arm of the two elastic arms has a notch similar to an arc. The needle assembly according to any one of exemplary embodiments 1 to 33. Exemplary embodiment 35: The notch in the curved lip of the second arm changes the position where the surface of the curved lip contacts the needle. The needle assembly according to any one of exemplary embodiments 1 to 34. Exemplary aspect 36: Ribs are disposed on the two elastic arms. The needle assembly according to any one of exemplary aspects 1 to 35. Exemplary aspect 37: The tab extends from the edge of the distal wall of each of the two elastic arms. The needle assembly according to any one of exemplary aspects 1 to 36. Exemplary aspect 38: When the needle tip is caught within the needle guard, the tab restricts lateral rotation of the needle tip. The needle assembly according to any one of exemplary aspects 1 to 37. Exemplary Aspect 39: A method of assembling a needle assembly, comprising providing a catheter hub having a catheter tube, wherein the catheter tube has a distal end with an opening and a proximal end attached to the catheter hub by a bushing, the catheter hub comprising a hub body having an inner surface defining an internal cavity and a proximal opening, and disposing a valve having an outer peripheral edge and a wall having three slits defining three flaps on the proximal side of the bushing in the internal cavity; disposing a valve opener inside the internal cavity of the catheter hub so as to slidably push open the valve when actuated by a male medical device, wherein the valve opener comprises a nose portion having an actuating end and a continuous peripheral portion having a passable bore, two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges extending proximally of the nose portion, and two stabilizer elements, each stabilizer element being connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced from the continuous peripheral portion of the nose portion by two through passages including a first through passage and a second through passage, and disposing a needle guard having a proximal wall and two elastic arms in a holding space between the two stabilizer elements, wherein each elastic arm includes an elbow, the needle guard having two elastic arms and two elbows including a first elbow and a second elbow; disposing a needle attached to a needle hub through the catheter hub, the valve, and the catheter tube such that a tip of the needle having a needle bevel extends from the distal end with the opening of the catheter tube in a ready-to-use position; (1) orienting the first plunger element from an approximately 285-degree position to an approximately 0-degree position and orienting the second plunger element 180 degrees from the first plunger element, or (2) orienting the first plunger element from an approximately 1-degree position to an approximately 75-degree position and orienting the second plunger element 180 degrees from the first plunger element, the 0-degree position being when viewed from an end view in the distal direction of the catheter hub,An assembly method including being at the top dead center position of a complete circle. Exemplary aspect 40: Further including orienting the first elbow at the 90-degree position and orienting the second elbow at the 270-degree position. The assembly method according to exemplary aspect 39. Exemplary aspect 41: The valve has a wall surface facing the proximal side, and the operating end of the valve opener is configured to bias against the wall surface facing the proximal side in the use position to press the three flaps against the inner surface of the catheter hub. The assembly method according to exemplary aspect 39 or 40. Exemplary aspect 42: The first elbow is disposed in contact with the periphery of the first through passage. The assembly method according to any one of exemplary aspects 39 to 41. Exemplary aspect 43: The first elbow is disposed in contact with the inner surface of the catheter hub. The assembly method according to any one of exemplary aspects 39 to 42. Exemplary aspect 44: The first elbow is disposed in contact with the periphery of the first through passage and the inner surface of the catheter hub. The assembly method according to any one of exemplary aspects 39 to 43. Exemplary aspect 45: The first elbow moves to contact the edge of the stabilizer ring. The assembly method according to any one of exemplary aspects 39 to 44. Exemplary aspect 46: The valve has a valve disk and a valve skirt that extends in the proximal direction of the valve disk and defines a valve cavity. The assembly method according to any one of exemplary aspects 39 to 45. Exemplary aspect 47: The operating end is disposed in the valve cavity in the ready-to-use position. The assembly method according to any one of exemplary aspects 39 to 46. Exemplary aspect 48: The second elbow is in contact with the inner surface of the catheter hub. The assembly method according to any one of exemplary aspects 39 to 47. Exemplary Aspect 49: The nose portion has a frustum of a cone shape. The assembly method according to any one of Exemplary Aspects 39 to 48. Exemplary Aspect 50: The second elbow portion is in contact with the periphery of the second through passage. The assembly method according to any one of Exemplary Aspects 39 to 49. Exemplary Aspect 51: A method for minimizing the catch of a valve opener, the method including rotating the angular positions of the first and second plunger elements. Exemplary Aspect 52: Further including rotating the angular positions of the first and second elastic arms of the needle guard. The minimizing method according to Exemplary Aspect 51. Exemplary Aspect 53: Each of the two elastic arms of the needle guard has a smooth or flat profile between the elongated arm portion and the elbow portion, having only a single bend or change in direction so as to minimize hitting the elbow against the stabilizer of the valve opener. The minimizing method according to Exemplary Aspect 51 or 52. Exemplary Aspect 54: An additional method for minimizing, disclosed in the context of preventing the needle guard from catching on the one or more stabilizers of the valve opener when retracting the needle guard after successful venipuncture by rotating the valve opening.

Claims

1. Needle assembly, A needle hub having a needle, wherein the needle tip of the needle has a needle slope extending from the distal end of the needle hub, A catheter tube attached to a catheter hub having a body including an inner surface defining an internal cavity, wherein, in a ready-to-use position, the needle extends through the catheter tube, the tip of the needle extends from the distal end of the catheter tube, and the bevel of the needle is oriented at the 0-degree position, A valve disposed in the internal cavity of the catheter hub and in contact with the internal shoulder of the catheter hub, the valve having an outer peripheral edge and a wall having at least one slit defining a plurality of flaps, A valve opener having a size and shape to open the valve by opening at least one slit, the valve opener comprising: a nose portion having an operating end and a continuous peripheral portion having a passable bore; two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges extending proximal to the nose portion; and two stabilizer elements, each stabilizer element connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced apart from the continuous peripheral portion of the nose portion by two through passages including a first through passage and a second through passage, A needle guard having a proximal wall and two elastic arms positioned in a holding space between the two stabilizer elements, wherein each elastic arm includes an elbow portion, and the needle guard has two elastic arms and two elbow portions including a first elbow portion and a second elbow portion. Equipped with, (1) The first plunger element is oriented from approximately 285 degrees to approximately 0 degrees, and the second plunger element is oriented at 180 degrees from the first plunger element, or (2) The first plunger element is oriented from approximately 1 degree to approximately 75 degrees, and the second plunger element is oriented at 180 degrees from the first plunger element. The needle assembly wherein the 0-degree position is the top dead center of a perfect circle when viewed from the distal end view of the catheter hub.

2. In the aforementioned preparation position for use, the first elbow portion is positioned in the first through passage, and the second elbow portion is positioned in the second through passage. The needle assembly according to claim 1.

3. The two elastic arms of the needle guard divide the two plunger elements. The needle assembly according to claim 1.

4. The valve has a wall surface facing proximal, and the operating end of the valve opener is biased against the wall surface facing proximal in the operating position to press the plurality of flaps against the inner surface of the catheter hub. The needle assembly according to claim 1.

5. The first elbow portion is in contact with the periphery of the first through passage. The needle assembly according to claim 1.

6. The first elbow portion is in contact with the inner surface of the catheter hub. The needle assembly according to claim 1.

7. The first elbow portion is in contact with the periphery of the first through passage and the inner surface of the catheter hub. The needle assembly according to claim 1.

8. The first elbow portion is in contact with the edge of the stabilizer ring. The needle assembly according to claim 1.

9. The valve comprises a valve disc and a valve skirt extending proximal to the valve disc and defining a valve cavity. The needle assembly according to claim 1.

10. The valve opener has a projection extending radially along its longitudinal axis, and the inner surface of the catheter hub has a shoulder for restricting the proximal movement of the projection. The needle assembly according to claim 1.

11. The distal edge of the first stabilizer element of the two stabilizer elements is parallel to the distal edge of the second stabilizer element of the two stabilizer elements. The needle assembly according to claim 1.

12. The distal edge of the first stabilizer element of the two stabilizer elements is angled with respect to the distal edge of the second stabilizer element of the two stabilizer elements. The needle assembly according to claim 1.

13. The catheter further comprises a bush that presses the proximal end of the catheter tube against the inner surface of the catheter hub, and an elastic element disposed between the bush and the valve disc inside the catheter hub, wherein the elastic element is sized and shaped to press the valve disc in the proximal direction. The needle assembly according to claim 9.

14. The elastic element is an expandable element or a spring. The needle assembly according to claim 13.

15. A method for assembling a needle assembly, To provide a catheter hub having a catheter tube, wherein the catheter tube has an open distal end and a proximal end attached to the catheter hub by a bush, and the catheter hub comprises a hub body having an internal cavity and an inner surface defining the proximal opening, A valve comprising an outer periphery and a wall having three slits defining three flaps is positioned proximal to the bush in the internal cavity. A valve opener is positioned inside the internal cavity of the catheter hub so as to slide open the valve when actuated by a male medical instrument, wherein the valve opener comprises a nose portion having an operating end and a continuous peripheral portion having a passable bore, two plunger elements including a first plunger element and a second plunger element, each having two longitudinal edges extending proximal to the nose portion, and two stabilizer elements, each stabilizer element connected to the two plunger elements such that the two stabilizer elements and the two plunger elements define a stabilizer ring having a continuous surface, the stabilizer ring being spaced apart from the continuous peripheral portion of the nose portion by two through passages including a first through passage and a second through passage. To arrange a needle guard having a proximal wall and two elastic arms in a holding space between the two stabilizer elements, where each elastic arm includes an elbow portion, and the needle guard has two elastic arms and two elbow portions including a first elbow portion and a second elbow portion. The needle attached to the needle hub is positioned by passing it through the catheter hub, the valve, and the catheter tube, so that the tip of the needle, which has a needle bevel, extends from the distal end of the opening of the catheter tube in the ready-to-use position. (1) The first plunger element is oriented from approximately 285 degrees to approximately 0 degrees, and the second plunger element is oriented at a position 180 degrees from the first plunger element, or (2) The first plunger element is oriented from approximately 1 degree to approximately 75 degrees, and the second plunger element is oriented at a position 180 degrees from the first plunger element. The aforementioned 0-degree position is the top dead center position of a perfect circle when viewed from the distal end view of the catheter hub. Assembly method, including the assembly method.

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