HK1250495B - Catheter devices with valves and related methods - Google Patents

Description

Catheter device with valve and related methods

Technical Field

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

Background Art

IV catheters are commonly used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or monitoring various parameters of a patient's vascular system. The catheter is typically connected to a catheter adapter, which is adapted to attach IV tubing to the catheter. The blood control catheter includes an internal blood control valve, which is activated by inserting a male Luer fitting or other object into the proximal end of the catheter adapter. A non-limiting example of a blood control valve is disclosed in U.S. Patent Application Publication No. 2011/0046570, filed on August 20, 2009, entitled "Systems and Methods for Providing a Flushable Catheter Assembly." After the catheter is placed in the patient's vasculature, an IV fluid source can be connected to the catheter adapter or catheter hub, thereby activating the blood control valve. Once connected, fluid from the IV source can begin flowing through the catheter into the patient.

As is well known in the art, typical blood pressure is 10 to 20 cm of water column. The infusion bag is usually placed about 100 cm above the patient's heart to direct the flow into the patient. Roughly at that height, the pressure exerted by the fluid from the infusion bag is much greater than the patient's blood pressure, and therefore can flow into the patient's body.

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

Summary of the Invention

One aspect of the present disclosure includes providing a compact design for a valve housing of a luer-activated valve.

Another aspect of the present disclosure includes providing a relatively strong construction for use with a high pressure injection device.

Still other aspects of the present disclosure are the opportunity to improve upon the state of the art in blood management or to provide a closed system infusion set including an intravenous catheter.

As described, the needle assembly of the present disclosure can include a number of different components. The needle assembly can include: a needle hub having a needle extending from a distal end of the needle hub; a catheter tubing attached to the catheter hub in a standby position with the needle extending therethrough; a valve positioned within an inner lumen of the catheter hub, the valve including a peripheral boundary that floats axially when moved by a proximal valve opener also positioned within the inner lumen of the catheter hub and positioned proximal to the valve; and a distal valve opener having two or more leg extensions extending in a proximal direction of a body of a hub.

In the needle assembly, two or more leg extensions of the distal valve opener may be axially fixed within the lumen of the catheter hub.

The needle assembly wherein the valve may include three slits and three flaps, and wherein the distal valve opener may include three leg extensions.

In the needle assembly, the three leg extensions may be aligned with the three petals.

In the needle assembly, the proximal valve opener may include a ring and two plunger elements with a gap therebetween.

The needle assembly may further include a tip protector positioned at least partially within the gap between the two plunger elements.

The tip guard may be optional, and the needle assembly may be practiced without the tip guard.

In the needle assembly, the plurality of sections of the valve may be deflectable in a distal direction and the plurality of sections of the valve may be deflectable in a proximal direction to open a fluid flow path through the valve.

In the needle assembly, the sections of the valve that are deflectable in the distal direction may comprise an outer edge of the valve, and the sections of the valve that are deflectable in the proximal direction may be flaps formed with the valve.

In the needle assembly, the body of the hub and the leg extensions may be integral.

In an example, only a portion of the tip guard or needle guard may extend into one or more gaps of the valve opener, while a proximal section of the tip guard may extend proximal to a proximal-most surface of the tip guard. For example, a portion of the needle guard may overlap the valve opener in an axial direction or position, while a proximal section of the tip guard (e.g., a proximal wall) extends proximal to or is located proximal to the proximal-most surface of the valve opener.

Yet another aspect of the present disclosure is a method of manufacturing a needle assembly, such as a catheter assembly, which may include providing a catheter hub having a catheter tube with a distal opening, the catheter hub including a hub body defining a lumen and a proximal opening; positioning a hub within the catheter hub and against the catheter tube, and positioning a valve proximal to the hub; the valve being floatable within the lumen of the catheter hub in an axial direction of the catheter hub and including two or more flaps; positioning a proximal valve opener proximal to the valve and within the lumen of the catheter hub; placing a needle attached to the needle hub through the catheter hub, the valve, and the catheter tube such that a tip of the needle extends out of the distal opening of the catheter tube; and wherein two or more leg extensions extend proximal to the body of the hub.

In the method, two or more leg extensions may be aligned with two or more flaps on the valve.

In the method, the proximal valve opener may include a ring and at least one plunger element.

In the method, the proximal valve opener may include two spaced-apart plunger elements with a gap therebetween.

In the method, the needle guard may be located at least partially in a gap between the two plunger elements.

In the method, two or more leg extensions may be fixed in the axial direction.

In the method, the proximal valve opener may be slidable in a distal direction to move the valve in a distal direction against the two or more leg extensions.

Additional aspects of the present invention may include a needle assembly comprising: a needle hub having a needle extending from a distal end of the needle hub; a catheter tube attached to the catheter hub in a standby position and having the needle extending therethrough; a valve positioned within an inner cavity of the catheter hub, the valve including a peripheral boundary that floats axially when moved by a proximal valve opener, the proximal valve opener also positioned within the inner cavity of the catheter hub and positioned proximal to the valve; a distal valve opener including a leg extension extending in a proximal direction of a base of a hub; and a needle guard including a proximal wall having an opening for passing the needle therethrough, the needle guard being at least partially located within a retaining space of the proximal valve opener.

The leg extension of the distal valve opener may be axially fixed within the lumen of the catheter hub.

The distal valve opener may abut against the bushing and be axially fixed.The seat of the distal valve may contact a surface of the tunnel section of the bushing.

The valve may include three slits and three flaps, and wherein the distal valve opener may include three spaced-apart leg extensions.

The three leg extensions of the distal valve opener can be aligned with the three flaps of the valve.

The proximal valve opener may have a nose section sized to abut against a proximal-facing surface of the valve. The proximal-facing surface may be part of the valve disc. The valve skirt may extend distally of the valve disc and define a distal retaining space.

The proximal valve opener may include two reliefs or through-passages, and wherein the needle guard may have two elbows, each elbow extending at least partially through a respective relief or through-passage. In some examples, the guard may have a single elbow, and the single elbow may extend through one of the two reliefs or through-passages.

The needle guard of the present disclosure may be integrally formed as one piece, or may be integrally formed from a plurality of parts. The needle guard may include one arm or two arms, and the two arms may intersect or not intersect in a side view.

The needle guard of the present disclosure may be located in a third housing. In an example, the third housing may be located between the catheter hub and the needle hub.

The distal valve opener may be formed separately from the bushing, or integrally formed with the bushing.

The distal valve opener may include one continuous leg extension, or may include two or more leg extensions, each leg extension having a proximal tip or nose section. The nose section of each leg extension may be tapered, or may include a ridge section.

The proximal valve opener may have a first continuous bounded section separated from a second continuous bounded section.

The space between the first and second continuous bounding sections of the proximal valve opener or actuator may include one or more plunger elements.

One or more plunger element pegs may extend proximally of the second continuous bounded section of the proximal valve opener or actuator.

The valve may comprise a skirt or valve skirt section extending distally of the valve disc.The skirt may comprise a generally cylindrical section and a frustoconical section.

The base of the bushing and the leg extension of the distal valve opener may be integrally formed.

The proximal valve opener may include two stabilizer elements connecting the two plunger elements, and wherein a gap between the two stabilizer elements may define a choke point for limiting proximal movement of the needle guard.

Aspects of the present disclosure may include a method of manufacturing a needle assembly. The manufacturing method may include the steps of providing a catheter hub having a catheter tube with a distal opening, the catheter hub including a hub body defining an inner lumen and a proximal opening; positioning a hub against the catheter tube within the catheter hub and positioning a valve proximal to the hub and proximal to a leg extension, the leg extension having a nose section for abutting a distally facing surface of the valve; the valve being axially displaceable within the inner lumen of the catheter hub in an axial direction of the catheter hub and including two or more flaps; positioning a proximal valve opener proximal to the valve and within the inner lumen of the catheter hub; placing a needle attached to the needle hub through the catheter hub, the valve, and the catheter tube so that the tip of the needle extends out of the distal opening of the catheter tube; and positioning a needle guard including a proximal wall having an opening for the needle to pass therethrough, the needle guard being at least partially located in a retaining space of the proximal valve opener.

The method may further include placing an elbow of the needle guard through a release or through-passage of the proximal valve opener.

In the method, the leg extension may be integrally formed with the bushing.

In the method, the proximal valve opener may have a nose section sized for abutting contact with a proximal-facing surface of the valve.

In the method, the proximal valve opener may have a first continuous bounded section separated from a second continuous bounded section.

In the method, the proximal valve opener may include two stabilizer elements connecting the two plunger elements, and wherein a gap between the two stabilizer elements may define a choke point for limiting proximal movement of the needle guard.

Still other aspects of the present invention may include a catheter assembly comprising: a needle hub having a needle with a needle tip extending from a distal end of the needle hub; a catheter tubing attached to the catheter hub in a standby position with the needle extending therethrough; a valve comprising a valve disc positioned within an interior cavity of the catheter hub; a first valve opener positioned distally of the valve disc; a second valve opener positioned proximally of the valve disc; and a needle guard comprising a proximal wall having an opening for the needle to pass therethrough, the needle guard being configured to cover the needle tip in a protected position.

Furthermore, an IV or hypodermic needle can utilize a valve in a housing having a female Luer connector. For example, the valve and valve opener of the present disclosure can be placed inside the needle hub. Furthermore, a needle-free valve integrated into a medical device or a stand-alone needle-free valve can utilize the valves described herein.

The needle assembly or needle device may include a catheter hub having a catheter tube attached to the hub body and a needle hub having a needle extending through the catheter hub and the catheter tube, with the needle tip extending out of the distal end or distal opening of the catheter tube in a standby position.

In the ready position, the catheter assembly is ready, such as to perform venipuncture or intravenous access. Sometimes, preparing the position first requires removing a protective cap (not shown) from the catheter assembly or needle assembly.

The valve and actuator for use with the catheter hub of the present disclosure may also be placed within the needle hub to act as a second valve.

The catheter hub may be provided with a needle guard or tip guard, a valve opener or actuator, a valve, and a hub.

The tip guard may be embodied as any of a number of prior art guards configured to block or cover the needle tip. The tip guard may have a proximal wall and two resilient arms, wherein a contour change on the needle (such as a corrugation or ridge) may engage the perimeter of an opening in the proximal wall of the tip guard to allow the tip guard to be withdrawn proximally out of the catheter hub after a successful venipuncture. The two arms may extend along different sides of the needle and may not intersect in a side view.

The needle guard arms can be deployed from the needle shaft in the ready position and engage the interior of the catheter hub (such as the guard engagement section of the catheter hub). The needle guard can be rolled or bent into its final configuration from stamped sheet metal. Alternatively, the needle guard can be formed from different components, all metal components, plastic components, or a combination thereof.

The valve opener or actuator may comprise a ring and at least one plunger element, such as a leg element or an elongated extension. The ring may contact the valve in the needle assembly standby position, but may be spaced or slightly spaced from the proximal surface of the valve.

Two plunger elements may extend from the ring in a proximal direction. In other examples, there may be more than two plunger elements, such as three or more plunger elements, with gaps between the plunger elements. The one or more plunger elements are sized and shaped to be contacted by the male Luer to transfer distally directed force from the male Luer to the ring, which then pushes against the valve to open the valve.

One or more plunger elements can each have an arcuate or arcuate cross-section along their width. In another example, at least one plunger element can be substantially flat or planar. The thickness of each of the two plunger elements is sufficiently small or thin so that the needle guard and the two plunger elements have sufficient clearance to fit within the interior cross-sectional space of the catheter hub without being physically bonded against the catheter hub and rendered immovable or fixed.

In examples, the thickness of each of the two plunger elements and the width of the needle guard are such that no undercuts or channels need to be formed in the inner wall surface of the catheter hub to accommodate them.

The valve opener can be made of metal material or plastic material. When made of metal material, the valve opener can be formed by a deep drawing method, and the arcuate cross-section of the plunger element can provide increased rigidity when pushed by the male Luer piece.

Each plunger element may include at least two longitudinal edges, and ribs may be provided along one or both of these longitudinal edges to further increase structural rigidity. One or more gaps may be provided between any two plunger elements. The gaps may provide clearance or space for a fluid stream flowing across them (such as during an IV infusion). The gaps may also be used to accommodate a needle guard.

The valve opener ring may include a body having a peripheral boundary. The peripheral boundary may be generally cylindrical. The peripheral boundary may have a tapered portion. The body may include a chamfer and an opening.

The distal edge or intersection of the body between the chamfer and the peripheral boundary may have a sharp edge or a blunt edge. In an example, the intersection is a blunt edge comprising a planar surface for pushing against the valve.

On the proximal side of the ring, the two plunger elements can be recessed inwardly from the outer periphery to form a shoulder. The outer periphery of the ring can have an outer diameter of a first size, and the two plunger elements can define an outer diameter of a second size, the second size being smaller than the first size. The shoulder can be positioned between the two different sizes.

The valve opener may have an inner diameter measured adjacent to the intersection. The inner diameter may change or vary along the chamfered section of the ring. The valve opener may also have a minimum inner diameter mID, which may be considered the minimum inner diameter of the valve opener.

The needle guard may be located between one or more gaps defined by the plunger elements. The plunger elements may each include an arcuate cross-section. The arcuate cross-section of each plunger element may be generally C-shaped, having a concave portion facing the needle guard internally and a convex portion facing away from the needle guard externally.

The radius of curvature of the two C-shaped plunger elements should be different from the radius of the male Luer tip and/or the radius of the lumen of the catheter hub. A gap may be provided on each side edge of the proximal wall of the needle guard and the adjacent plunger element.

The two plunger elements can each have an abutting proximal surface sized and shaped to be pressed against by a male Luer tip or syringe tip when the tip is inserted into the proximal opening of the catheter hub after a successful venipuncture, thereby pushing the valve opener distally to open the valve. The arcuate cross-section of each of the two plunger elements can provide a sufficiently thick profile to ensure overlap of the abutting surface with the male Luer tip and to ensure rigidity against buckling.

The C-shaped plunger element can avoid deflection when pushed by a syringe tip or other male Luer tip, avoid the syringe tip or Luer tip slipping and missing the end surface of the plunger element when inserting the syringe tip or Luer tip into the open proximal end of the catheter hub, and/or avoid the following situation: the syringe tip or Luer tip is pushed between two plunger elements during activation of the valve opener so that the two plunger elements are wedged between the tips and the inner surface of the catheter hub.

In some embodiments, the concave portion of the arcuate cross-section of each plunger element may face away from the needle guard on the outside, while the convex portion of each plunger element faces the needle guard on the inside.

The ring of the valve opener can be elastically deformed and then stretch when it reaches the recessed hub section of the catheter hub, which can accommodate the ring without deforming the ring. Alternatively, the catheter hub can be designed to stretch to allow assembly of the valve opener. A shoulder can be provided at the recessed hub section, which shoulder can form a physical stop for engaging a shoulder on the valve opener. This can allow the valve opener to be retained within the lumen of the catheter hub during needle withdrawal and during use when the valve opener is pushed distally to activate the valve and then moved proximally when the male Luer is removed, thereby allowing the valve to close.

The valve may have a valve disc comprising a valve body including a valve diameter, a valve thickness measured normal to the valve diameter between a proximal-facing surface and a distal-facing surface, and one or more slits defining two or more flaps.

Three slits may be provided through the thickness of the valve to define the three flaps. The three slits may originate from a single point and extend radially from approximately a center point or portion of the body of the valve in a manner similar to a three-pointed star to form the three flaps deflectable along the slits.

The valve may include a peripheral boundary between the valve opener and the hub, the peripheral boundary being floatable within the lumen of the catheter hub. The peripheral boundary of the valve may be movable proximally and distally within the lumen of the catheter hub and may not be constrained by the catheter hub in an axial direction of the catheter assembly.

The outer perimeter of the valve can be the same as, smaller than, or larger than, the outer perimeter of the ring of the valve opener. However, at least some portion or all of the distal edge or intersection of the ring can be recessed from the outer perimeter of the valve so that the distal edge can abut or touch the proximal-facing wall surface of the valve. Moreover, because the valve can float, the valve can be positioned inside a single hub-body type catheter hub and can avoid being wedged between multi-part hub bodies. However, the various components described herein can readily be used with a multi-piece catheter hub without departing from the scope of the present disclosure.

The bushing of the present disclosure may include a body including: a first body section; and a second body section extending from the first body section. The second body section may have: a conical shape section; and two or more leg extensions extending from the second body section, such as extending from the conical shape section.

The first body section can have an elongated body that can have a cylindrical shape with an optional tapered distal tip or nose section. In some examples, a generally cylindrical ring extends from the second body section, and two or more leg extensions extend from the cylindrical ring.

One or more gaps may be provided between two adjacent leg extensions.The bushing may comprise the same number of leg extensions as the valve comprises petals.

The leg extensions on the bushing can define an outer diameter that is less than the minimum inner diameter mID of the valve opener. The proximal tip of each leg extension can have a chamfer or blunt tip. In one example, a chamfer can be included at the proximal tip of each leg extension, and wherein the chamfer can taper inwardly from the exterior of the leg extension.

The bushing may be made of a metallic material and the leg extensions may be integrally formed with the body. Alternatively, the leg extensions may be welded to the body.

The bushing and valve can be oriented in the catheter hub so that the leg extensions on the bushing are aligned with the flaps on the valve. This allows the flaps on the valve to be pushed by the leg extensions on the bushing. Thus, if there are three flaps on the valve, the three flaps will be pushed into physical contact with the three leg extensions on the bushing.

The distal-facing wall surface of the valve may contact the leg extension and/or the resilient element, or may be spaced apart from the leg extension and/or the resilient element on the bushing in the valve closed position and push against the leg extension during use. In other examples, the valve may contact the proximal tip of the leg extension and/or the resilient element in the valve closed position, or may be spaced apart therefrom.

The three leg extensions can be equally spaced along the circumference of the second body section of the hub. In another example, the three leg extensions can be positioned and spaced according to the location of lugs on the valve so that when the valve is assembled inside the catheter hub, the valve can be pushed distally by a valve opener or valve actuator, and the leg extensions on the hub are aligned to push the lugs of the valve in a proximal direction to open the valve.

During proximal needle withdrawal following a successful venipuncture, the tip guard may be axially retained by engagement between one or both resilient arms on the tip guard and a guard engagement section on the catheter hub.

The guard engagement segment can be a surface discontinuity formed on the inner surface of the catheter hub.For example, the guard engagement segment can include a segment having a first inner diameter and a segment having a second inner diameter that is larger than the first inner diameter.

The guard engagement section can be embodied as an internal protrusion or groove, or a combination of both formed on the inner surface of the catheter hub. When a combination of grooves and protrusions is used for the guard engagement section to engage the needle guard or tip guard, the groove can be located distal to the protrusion. Two spaced-apart guard engagement sections can be provided for engaging the two resilient arms on the tip guard. The two guard engagement sections can be positioned diametrically opposite one another, just distal to the section of the female luer taper of the catheter hub.

In an example, the valve opener can include a single plunger element. The single plunger element can be embodied as a generally cylindrical body section having an inner surface that defines an opening having a path or channel. The cylindrical body section can be located proximal to the distal pushing end. A guard engagement segment is formed on the inner surface of the present valve opener. In other words, the inner surface of the valve opener, rather than the inner surface of the catheter hub, can be provided with the guard engagement segment. This allows the two resilient arms of the tip guard to engage the valve opener in a standby position and during needle withdrawal after a successful venipuncture.

The guard engaging section formed on or by the valve opener may be a protrusion, a recess, or an opening.

In yet another example, two openings can be provided through the wall of the cylindrical body portion of the valve opener for use with a guard engagement segment formed by or on the interior of the catheter hub. Each of these openings can include a perimeter, which can be a closed perimeter.

In an alternate position using a valve opener having two large openings provided through the wall of the valve opener, one or more resilient arms of the tip protector may protrude through these openings to engage the guard engagement segment inside the catheter hub instead of or in addition to engaging the openings of the valve opener.

A guard engagement segment may be formed on an inner surface of the catheter hub, and the proximal cylindrical body section includes an opening surrounding the guard engagement segment.

During needle withdrawal, the needle tip moves proximally of the two distal walls of the tip guard (one distal wall on each end of the resilient arm).The needle guard may instead have one distal wall and/or one arm.

The contour change on the needle can engage the inner perimeter of a hole or aperture through the proximal wall of the tip guard. Once engaged, the tip guard is moved proximally with the needle to be removed from the catheter hub. In the protected position, in which the tip guard covers or blocks the needle tip, the valve remains within the lumen of the catheter hub. Thus, the valve is located within the catheter hub in both the needle's ready position and the needle's protected position.

The male medical device or instrument can be a male Luer, a syringe tip, an IV set connector, or other male tip with a Luer taper and can be inserted into the open proximal end of the catheter hub. The male medical device can be connected to IV tubing, which can be connected to an IV fluid source for fluid delivery through the male medical device.

When a male medical device or male tip is initially inserted into the proximal opening of the catheter hub, the male tip initially contacts the two plunger elements on the valve opener to advance a distally directed force on the two plunger elements to open the valve. The arcuate cross-section of the plunger elements can have a diameter that is smaller than the inner diameter of the catheter hub, thereby providing a larger contact surface with the distal end of the male medical device.

The distally directed force can move the valve opener in the distal direction until the geometry of the male tip and the proximal opening of the catheter hub prevent the male tip from advancing further distally. A seal can be provided by the Luer engagement to prevent fluid from leaking out of the proximal opening of the catheter hub.

The ring can be urged distally and pressed against the proximally facing surface of the valve. The distal edge of the valve opener can initially press against the proximally facing surface of the valve. When the valve is axially movable within the catheter hub, the valve can be urged distally by the valve opener, which is urged distally by the male tip.

Due to the presence of the leg extensions on the sleeve, the outer edge or outer valve section of the valve can move distally while other portions of the valve that abut or contact the leg extensions are prevented from moving distally by the leg extensions. In effect, the outer edge of the valve can move distally while the flaps on the valve can be deflected radially outward and proximally from a center point or position by the leg extensions on the sleeve, thereby opening a flow path through the valve.

The chamfers on the ring and the leg extensions can encourage the flaps on the valve to deflect radially outward and in a proximal direction. Furthermore, the relative diameters defined by the leg extensions and the minimum inner diameter mID of the valve opener can allow the valve opener and bushing to deflect the valve therebetween to open the valve. Alternatively, when pushed distally, the outer periphery of the valve can remain in contact with the inner wall of the catheter hub, with the flaps opening only around the one or more slits.

Thus, one aspect of the present disclosure is understood to include a catheter assembly comprising a valve comprising one or more slits and two or more flaps, wherein the valve comprises a portion or section that moves in a distal direction and a portion or section that opens in a radial direction in a proximal direction to open a flow path through the valve.

In an example, the outer edge of the valve can be configured to move distally while the valve flap can be configured to move radially outward to open a flow path through the valve. Furthermore, by including a valve that can move in this manner to open a fluid flow path, the actuation distance that the valve opener must travel in the axial direction of the catheter assembly can be minimized compared to a valve having a flap that is opened only in the distal direction by the valve opener. Consequently, the size of the catheter hub (e.g., the length of the catheter hub) can be reduced compared to a catheter hub that utilizes a valve and a valve opener that opens the valve by deflecting the valve flap only in the distal direction.

A catheter assembly is disclosed that includes a valve, wherein the valve enclosure can float axially relative to a catheter hub. By including a valve having an axially floatable valve enclosure, a two-part catheter hub is not required to secure the valve enclosure therebetween and within the catheter hub, although a two-part hub can be used. Thus, a catheter hub having a monolithically formed hub body can be used with the present catheter assembly. Consequently, the size of the catheter hub (e.g., the outer diameter or outer dimensions of the catheter hub) can be reduced compared to catheter hubs utilizing a two-part hub body. The two-part hub body (wherein they are joined together along a seam) can thus be reduced to provide a catheter assembly having a relatively smaller outer profile.

The valve opener can be configured to push the valve against another structure (such as a leg extension on a bushing). This valve opener can be considered to have a multi-piece valve opening structure. For example, the portion with the ring and plunger element can be considered the proximal valve opener, and the bushing with the leg extension can be considered the distal valve opener. These two valve openers can cooperate to open the valve.

The proximal valve opener can be sized and shaped to push against an outer edge of the valve in a distal direction to move the valve against the distal valve opener. The distal valve opener can be sized and shaped to push a flap on the valve in a radially outward direction and push a portion of the flap in a proximal direction to open a fluid path or flow path through the valve.

In the example, the leg extensions 196 on the distal valve opener are axially fixed, and by pushing the valve's flaps in the distal direction against the leg extensions, the flaps are deflected radially outward by the leg extensions on the distal side of the valve. In other words, when the valve is actuated to open a flow path through the valve, the valve is physically urged by the actuator on the proximal side of the valve and the actuator on the distal side of the valve. In certain embodiments, the valve can be actuated to open a flow path through the valve by being physically urged by the ring on the proximal side of the valve and the leg extensions on the distal side of the valve.

The proximal tips of the leg extensions and the distal edge of the ring can be spaced apart from a plane drawn orthogonal to the longitudinal axis of the catheter assembly. In other words, the proximal tips of the leg extensions and the distal edge of the ring do not necessarily overlap from the perspective of this plane, and a gap can be provided between the two to accommodate the valve therebetween.

Alternatively, the proximal tip of the leg extension can overlap with the distal edge of the ring in the axial direction, which can produce the effect of deflecting the flap radially outward by a relatively larger amount than when there is no overlap. In addition, since the flap can be pushed against the axially fixed leg extension on the liner, the flap can be deflected backward in the proximal direction by these leg extensions. In other examples, the proximal tip of the leg extension only touches the distal edge of the ring along a plane drawn orthogonal to the longitudinal axis of the catheter assembly.

A catheter assembly may be provided that includes a valve, a proximal valve opener, a distal valve opener, a needle hub having a needle, and a catheter hub having a catheter tube.

The valve assembly may further comprise a tip protector for blocking the needle tip in the needle protection position.

After successful venipuncture, a male tip, such as a male Luer, may be inserted into the proximal opening of the catheter hub to advance the proximal valve opener in a distal direction, which moves the valve in a distal direction against the distal valve opener.

The valve flap can be pivoted proximally to open a fluid path through the valve. The valve flap can be deflected proximally by a leg extension of the bushing of the device. The flap can be deflected proximally by pushing the flap against a fixed leg extension on the distal valve opener.

A flap on the valve may be deflected in a proximal direction by a structure located distal to the valve and abutting a distally facing surface of the valve.

The distal valve opener may be a metal bushing having a body with a conical section having two or more leg extensions extending therefrom in a proximal direction. The bushing may also be made of a thermoplastic material.

When the male tip of a syringe or male medical device is removed from the catheter hub, the biasing or resilient properties of the valve (which may be made of an elastomer) allow the valve to rebound to its more relaxed state. Thus, the flap on the valve can rebound by moving distally, while the outer edge or outer segment of the valve body can rebound proximally. This rebound can push the proximal valve opener in a proximal direction, and a shoulder on the proximal valve opener can move toward or against a shoulder inside the lumen of the catheter hub.

Optionally, a coil spring, leaf spring, or elastomeric cylindrical member can be placed between the distal-facing surface of the valve and the inner distal step or shoulder of the catheter hub to facilitate closing the valve. This spring or elastomeric cylindrical member, if included, can provide additional biasing force to return the valve to the closed position when the male medical instrument is removed. Alternatively, the added component can be omitted. If included, the resilient member can be spaced from the valve in the illustrated standby position, or can contact the valve in the standby position.

The valve can be reopened by placing the male tip into the proximal opening of the catheter hub and pushing the proximal valve opener in the distal direction.

Methods of making and using catheter assemblies and components thereof described elsewhere herein are within the scope of the present disclosure.

The proximal opening of the catheter hub can be sized and shaped to receive a male medical device, such as a male Luer tip.

The tip protector is configured to be removed with the needle after use, and the valve and valve actuator can remain with the catheter hub for controlling fluid flow therethrough. The actuator can be configured to be pushed into the valve to open the valve to enable fluid flow.

A flashback plug can be provided at the proximal end of the needle hub, which allows venting but prevents blood from escaping the proximal end of the needle hub when it enters the flashback chamber during primary flashback. Alternatively, a syringe can be attached to the proximal end of the needle hub. The valve and actuator described further below can also be placed in the needle hub to serve as a secondary valve.

The needle hub may include a shoulder or other surface to physically contact the catheter hub (such as a proximal surface of the catheter hub) to axially register the two hubs to set the length of the needle tip protruding from the distal opening of the catheter tube.

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

The catheter hub may be provided with a pair of wings to facilitate securing the catheter hub to the patient after use.

A valve having a valve disc and a valve skirt can be positioned in a catheter hub. The valve disc can include one or more flaps and one or more slits to be opened by a valve actuator. In embodiments, the valve skirt can be positioned in a recessed section formed in the lumen of the catheter hub and, when actuated, can slide axially along the interior of the catheter hub to open and enable fluid flow.

The valve can be spaced apart from a reduced neck section of the catheter hub, which can anchor the tunnel section of the hub in place. The space between the reduced neck section and the valve skirt of the valve can be referred to as the distal lumen.

The valve disc of the valve may include: a valve outer diameter; a valve thickness measured orthogonally to the valve diameter; and one or more slits formed through the valve thickness to define two or more flaps. For example, one, two, or three slits may be provided through the thickness of the valve disc to define two, three, or more flaps.

The valve skirt can extend axially of the valve disc to form a generally cylindrical skirt section. In some embodiments, the valve skirt can be inclined so that the valve skirt forms a frustoconical structure. Thus, the valve skirt can have a generally cylindrical section and a frustoconical structure or section.

The valve skirt may have a distal opening having an area or size that is sized and shaped to receive a distal valve opener. A tapered or rounded inlet may be provided at the distal opening of the valve skirt to receive a nose of the distal valve actuator, thereby opening the valve disc of the valve disc when the valve is actuated.

The distal opening of the valve skirt can lead into the distal holding space of the valve skirt. In other words, the valve skirt can have an interior space, which can be the distal holding space.

The holding space can be defined by a first inner section having a first inner diameter and a second inner section having a second inner diameter, the second inner diameter being larger than the first inner diameter. A shoulder can be provided at the junction between the first inner section and the second inner section. In an example, the shoulder within the distal holding space can have a radius.

The valve can include a peripheral boundary between the proximal valve actuator and the hub, the peripheral boundary being able to float within the lumen of the catheter hub. For example, the peripheral boundary of the valve can move proximally and distally within the lumen of the catheter hub and is not constrained by the catheter hub in an axial direction of the catheter assembly, except for possible friction or contact with the catheter hub.

In an example, the cylindrical portion of the skirt section of the valve can be pressed against the inner surface of the lumen with a slight interference fit to form a seal therebetween. The generally flat outer profile of the cylindrical portion of the skirt can allow the valve to move in an axial direction when pushed by a proximal valve actuator while maintaining concentricity with the opening of the catheter hub.

In some examples, the outer perimeter of the cylindrical section of the valve can be the same as, smaller than, or larger than the outer perimeter of the nose section of the proximal valve actuator. The relative dimensions of the outer perimeters of the cylindrical section of the valve and the proximal valve actuator (e.g., the nose section) can be configured such that the valve actuator can push against the proximal-facing surface of the valve disc to move the valve axially.

Generally speaking, the relative dimensions of the nose section of the proximal valve actuator and the outer perimeter of the cylindrical section of the valve can be such that when the valve is pushed distally by a male medical device, the nose section pushes against the proximally facing surface of the valve at a position closer to the outer perimeter of the valve disc than to the center or central portion of the valve disc.

The distal valve actuator, such as a nose section of the distal valve actuator, may be configured to push against the valve disc at a location closer to the center or central portion of the valve disc than to the outer periphery of the valve disc.

The proximal valve actuator may push against a proximally facing surface of the valve disc, and the distal valve actuator may push against a distally facing surface of the valve disc.

Because the valve can float within the interior of the catheter hub (e.g., move axially along the longitudinal axis of the catheter hub), the valve can be positioned within a single-hub-body catheter hub. In other words, it is not necessary for the valve to be retained within the interior of the catheter hub by two or more catheter hub bodies (e.g., along a seam between the two or more hub bodies). However, the various components described herein can readily be used with a multi-piece catheter hub without departing from the scope of the present disclosure.

The proximal valve actuator can include a nose segment that can be generally cylindrical and terminate in an actuating end. The actuating end can have a blunt distal surface or a sharp edge. The nose segment can have a wall surface with a continuous perimeter or a continuous bounding segment without gaps or slits (such as a cylinder with a continuous wall). The nose segment can define an aperture. In some examples, a plurality of spaced apart slits and/or openings can be provided on the nose segment of the proximal valve actuator away from the continuous bounding segment to permit flow or fluid flushing.

The two actuating elements or plunger elements may extend proximally of the nose segment. For example, the two plunger elements may be integrally formed with the nose segment and may extend proximally from the nose segment. A gap or space may be provided between the two plunger elements for positioning a needle guard or tip guard therebetween. The gap of the proximal valve opener for positioning the needle guard may be referred to as a holding space.

The plunger elements may each comprise at least two longitudinal edges, and the edges may be spaced apart from one another.The longitudinal edges of the plunger elements may be aligned with the longitudinal axis of the valve opener.

The protrusion may extend outwardly from an outer surface of one or both plunger elements of the valve actuator. The protrusion may extend from an outer surface of each plunger element. Each protrusion may resemble a ramp surface having a generally flat edge for abutting a shoulder in a recessed section of the catheter hub to constrain the valve actuator from moving in a proximal direction.

The ramped surface of the protrusion and the direction of the ramp can allow the actuator to be inserted into the interior of the catheter hub from the open end and seated within the recessed section. Some embodiments of the valve actuator may use other shapes for the nose section, such as cuboid, rectangular, conical, pyramidal, chamfered, etc.

In some examples, the valve actuator or valve opener has a longitudinal axis, and the one or more actuating elements extend axially or parallel to the longitudinal axis. In certain examples, the two actuating elements are diametrically opposed to each other along the longitudinal axis. In other examples, the actuating elements are unequally spaced around the circumference of the nose segment.

The two actuating elements may define an outer diameter having a size that is substantially similar or the same as the diameter of the nose section.

In an example, the actuating element of the valve opener can be flexible and deflectable so that when pushed by the male Luer tip, the actuating element can deflect or flex. The actuating element can be deflected by selecting a material with the necessary resilient properties. In other examples, the actuating element can be deflected by including one or more weakened sections, such as by including a structurally thin section, by including a cut-out, by adopting a smaller cross-section than other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element can be flexible and deflectable by selecting a material with the necessary resilient properties and by including one or more weakened sections.

In yet other examples, each actuating element of the valve opener may have more than one different cross-sectional face or profile along a length segment.For example, an elongated plunger element may have a square face positioned adjacent to a crescent face.

In an example, the actuation element can be rigid and cannot be deflected or deformed by the male Luer tip when loaded (such as when pushed). Additionally, a stabilization element can be included to increase the stiffness of the actuation element.

The actuating elements may each include, at least at a proximal end, a cross-sectional surface that overlaps the pushing end of the male tip, such that the male tip can push the valve actuator into the valve.

The nose section of the valve actuator can be configured to engage the valve to open the valve disc when an axial force is applied to the actuation element from the male tip toward the distal end of the catheter assembly, such as during insertion of an IV drip line of a male luer connector.

Typically, the nose section of the proximal valve opener is rigid relative to the more flexible valve, which allows the nose section (and more specifically the actuation end) to actuate the valve, such as to deflect one or more flaps of the valve disc and open one or more slits in the valve disc. The nose section can be made of an incompressible material (such as metal, rigid plastic, or hard elastomer) for pushing against the valve and opening it.

The proximal valve actuator can include a pair of opposing straps or stabilizers connecting the two actuating elements at a position along the length of the two actuating elements, located between the nose section and the proximal-most end or end surface of the valve actuator. In some examples, the stabilizer can be located at the proximal ends of the two actuating elements such that the proximal edges of the stabilizer can be substantially flush with the proximal surfaces of the actuating elements. The two stabilizer elements can be referred to as a first or upper stabilizer element and a second or lower stabilizer element. The actuating elements and/or the stabilizer elements can be provided with one or more holes for molding purposes, such as for implementing a core pin.

In one embodiment, the stabilizer or stabilizer element can be arcuate, forming an arc that follows the inner contour of the catheter hub and connects one actuating element to the other. The stabilizer or stabilizer element can form a substantially cylindrical section on the body of the valve actuator, which can be separated from the nose section of the valve actuator. In other words, the valve actuator can be elongated and can have sections that are continuous in the radial direction and sections that have a relief or through-passage through the wall of the actuator that is discontinuous in the radial direction.

In an example, the stabilizer may define a continuous body segment in a circumferential or radial direction of the proximal valve actuator that is spaced from a continuous body segment of the nose segment, which may also include a continuous segment in the circumferential or radial direction.

Two stabilizers or stabilizer elements can be coupled together with two plunger elements to form a ring structure (which can be referred to as a stabilization ring). Optionally, the stabilizer elements can be slightly offset and angled relative to each other. In some embodiments, there can be one, three, or a different number of actuating elements or a different number of stabilizer elements.

In an example, the valve actuator (with the stabilizer or stabilizer element and the protrusion) may be made of plastic (such as by plastic injection molding).

The stabilizer can help the proximal valve actuator remain centered within the catheter hub as the actuator moves (such as when pushed by the male Luer tip after a successful venipuncture). By remaining centered, the nose section can better align with the valve disc (such as a slit on the valve disc), allowing for smooth valve actuation.

The stabilizer or stabilization ring may also provide engagement with the catheter hub (engagement with the interior of the catheter hub) via a friction or snug fit to prevent the actuator from sliding in a proximal direction after the male Luer tip is removed.

In one embodiment, the nose section of the proximal valve opener can be configured to push against the proximal facing surface of the valve disc, and the distal valve opener can be configured to push against the distal facing surface of the valve disc to open the slit and deflect the flap on the valve disc.

In an example, the nose section of the proximal valve actuator can be configured to push against an outer region of the proximal-facing surface of the valve disc, and the distal valve opener (e.g., the nose section of the distal valve actuator) can be configured to push against a central region of the distal-facing surface of the valve disc to open the slit and deflect the flap of the valve disc. The peripheral and central regions can be radially positioned relative to each other.

A relief, opening, or through-passageway can be provided between the nose segment and the stabilization ring. Two reliefs or through-passageways can provide clearance so that the interior or central portion of the valve actuator can be in open communication with the inner surface of the catheter hub. In other words, between successive sections of the nose segment, the continuous bounded section defined by the two stabilizers and two plunger elements (i.e., the stabilization ring) can be one or two reliefs, through-passageways, or openings.

The nose section of the valve opener can define an aperture, and the stabilization ring can define an aperture. The needle guard or tip guard can be located in a holding space of the valve actuator and can at least partially protrude from the holding space through the through passage to alternatively contact a perimeter of the release portion and contact an inner surface of the catheter hub, or contact a perimeter of the release portion and contact an inner surface of the catheter hub.

The stabilization ring of the valve actuator can have an inner diameter that is smaller than a diameter defined by diagonal sections or elbows of the two arms of the needle guard when the two arms are biased outwardly by the needle shaft in the standby position. Thus, during installation of the needle guard into the holding space of the valve actuator, the diagonal sections or elbows of the needle guard can be deflected to pass through the stabilization ring and into the open area defined by the release portion.

When the tip guard is positioned between the two plunger elements, the two distal walls of the needle guard (more specifically, the two diagonal sections or elbows) can be positioned in the relief to engage guard engagement surfaces on the inner surface of the catheter hub. This can allow the needle guard to protrude from the retaining space of the valve actuator through the two reliefs so that one or both elbows can engage a guard engagement surface of the catheter hub (such as a shoulder in a recessed section of the catheter hub, or other guard engagement surface in the catheter hub).

The needle guard can be retained within the interior of the catheter hub by protruding through two release portions of the proximal valve opener in the standby position and during withdrawal of the needle after a successful venipuncture, until the needle tip moves proximally of the two distal walls on the needle guard, at which time the needle guard can be closed over the needle tip and removed with the needle.

Each stabilizer element of the valve opener may have a distal edge or first edge and a proximal edge or second edge.

Instead of contacting a shoulder of the recessed section of the catheter hub or other guard engaging surface inside the catheter hub, the elbow of the needle guard can be spaced from the inner surface of the catheter hub or from the shoulder and retained by the confines of the release or through-passage (such as by the distal edges of two stabilizer elements).

The perimeter or distal edge of one or both stabilizer elements of the valve opener can provide a limiting surface to prevent premature activation of the needle guard during needle withdrawal before the needle tip moves proximal to both distal walls of the needle guard. Thus, the release portion or through-passage of the valve actuator can act as a choke or limit point to restrict the needle guard from proximal movement until the needle guard reduces its radial profile (e.g., after the needle tip moves proximal to the distal walls of the needle guard).

In some examples, the perimeter of the through-passageway can function as a choke point to limit proximal movement of the needle guard until after activation. In certain examples, one or both distal edges of the stabilizer element can function as a choke point. In other examples, a gap between two inner surfaces of two stabilizer elements can define a choke gap to limit premature activation of the needle guard.

In some examples, one or both stabilizer elements may include a slit or channel, thereby dividing the arc of each stabilizing element into two segments with a gap or slit between the two segments. Even with slits in one or both stabilizer elements, a segmented stabilizing ring (which may be a discontinuous ring, similar to a ring with one or more grooves formed therethrough) can still provide a restraining surface to prevent premature activation of the needle guard during needle withdrawal before the needle tip moves proximal to the two distal walls of the needle guard. Furthermore, the two segments of each stabilizer element can provide stability and reinforcement for the two plunger elements on the valve actuator.

The limiting surface of each distal edge can be referred to as a limiting point, a choke gap, or a choke point because it provides a rigid structure that prevents the needle guard from moving proximally unless or until the needle guard is first activated and radially collapses to reduce its radial profile and then slides proximally of the choke point. In an example, one or both elbows of the needle guard can be limited by the choke point from moving in the proximal direction until one or both elbows of the needle guard deflect to reduce the radial profile of the needle guard.

In an example, the needle guard may slide through the aperture defined by the stabilization ring from a distal position of the stabilization ring to a proximal position of the stabilization ring when the radial profile of the needle guard is reduced.

The valve opener can be made of a metal material or a plastic material. When made of a metal material, the valve opener can be formed by a deep drawing method, and the arcuate cross-section of the actuating element can provide increased rigidity when pushed by the male Luer fitting. When made of a metal material, the stabilizer elements can each be composed of two stabilizer segments with a slit or groove between the two segments. When using stabilization segments, the stabilization ring formed thereby can be discontinuous.

Each actuating element of the valve opener can include at least two longitudinal edges, and ribs can be provided along one or both of the longitudinal edges of the actuating element to further increase structural rigidity. One or more gaps can be provided between any two actuating elements. In some embodiments, most or most (if not all) of the tip guard can fit within a retaining space formed by the body of the valve actuator having a nose section for pushing against the valve.

In the standby position, the needle guard can be located in the retaining space between the two plunger elements. This arrangement can allow the catheter hub to be more compact because less longitudinal space is required within the hub to fit the actuator and tip guard together in a continuous lengthwise manner or when the two only partially overlap in the axial direction.

The tip guard can fit completely within the retaining space of the actuator, further reducing the space or length required in the catheter hub to accommodate both. The proximal wall of the needle guard can be substantially flush or coplanar with the proximal surfaces of the two plunger elements. In other examples, the proximal wall of the needle guard can be distal to the proximal surfaces or proximal to these proximal surfaces.

When the tip guard engages only the release portion of the actuator or the distal edge of the through passage, no deformation or diameter change is required on the interior wall of the catheter hub, and the tip guard can be placed further proximally in the female Luer taper section of the catheter hub while complying with international Luer standards for conical fittings, and the overall length of the catheter hub can therefore be reduced.

The distal valve actuator or valve opener of this embodiment can include a base, a leg extension and a proximal tip or nose section. The size of the base can be designed to have an outwardly tapered feature to mate with the tunnel section of the bushing.

In an example, the base of the distal actuator can be sized to have a contact fit with the tunnel section of the bushing. For example, the base can contact the proximal-facing surface of the tunnel section of the bushing.

The base of the distal actuator can have a rim for wedging against a reduced neck section at the distal lumen of the catheter hub. As shown, the reduced neck section can prevent the rim of the base from being displaced in the proximal direction.

In an example, the distal valve actuator may be formed by a deep drawing process, allowing the base to be deployed from the proximal end of a cylindrical tubular body or structure.

The leg extension of the distal valve actuator can be elongated and can extend in a proximal direction of the base and terminate in a nose section or proximal tip. In an example, the leg extension can be generally cylindrical and define an opening.

The wall defining the aperture of the distal actuator may be continuous along the perimeter.In some examples, slits or slots may be provided in or through the wall of the leg extension for fluid flow across the wall of the leg extension (such as for irrigation).

In an example, the proximal end of the leg extension can be folded to form a folded section (similar to pants with a cuff). The folded section can include two wall layers 520 and a rounded proximal edge formed by folding the surface upon itself, which can be referred to as a folded edge. A shoulder can be provided at the junction between the leg extension and the nose section.

In the standby position, the nose section of the distal valve actuator may protrude into the distal retaining space of the valve, with the rounded proximal edge of the actuator either contacting or spaced apart from the distal-facing surface of the valve disc.

In an example, a first inner section of the valve having a certain inner diameter contacts an outer surface of a wall of the actuator. In a specific example, the first inner section of the valve having a certain inner diameter can grip an outer surface of a wall of a leg extension of a distal valve actuator. A seal can be provided between the first inner section of the valve and the outer surface of the wall of the distal actuator. The seal can be a fluid-tight seal.

The tension or interference provided by the first inner section of the valve (which grips the exterior of the wall of the distal valve actuator) can be adjusted by selecting the inner diameter of the first inner section, the material type of the seal (which can be made of polyisoprene or any suitable biocompatible elastomeric material), the durometer of the molded seal, and/or the length of the first inner section. In an alternative embodiment, no seal exists between the first inner section and the exterior wall of the valve actuator (such as the distal valve actuator).

In the standby position, a shoulder at the nose section of the distal valve actuator can be located distally of a shoulder located between a first interior section and a second interior section of the distal retaining space of the valve. In an example, a folded section (which can have a diameter greater than a diameter of the leg extension) can be located in the second interior section.

When the folded section is located in the second interior section, the wall of the leg extension may contact the first interior section.The shoulder of the distal valve actuator may contact or be spaced apart from a shoulder inside the distal retaining space in the standby position.

The two arms and the two distal walls of the needle guard can be moved radially to reduce the radial profile of the needle guard. When the two distal walls of the needle guard are no longer biased by the needle, the distance between the two elbows of the needle guard can be reduced to reduce the radial profile of the needle guard.

The radial profile at these elbows can be smaller than the choke point defined by the two distal edges of the stabilization ring of the proximal valve actuator. In addition, because the proximal wall on the needle guard remains unchanged, the radial dimension of the needle guard segment distal to the stabilization ring can be smaller than the radial dimension of the proximal wall located proximal to the stabilization ring.

In an example, proximal movement of the needle can move the distal wall and two elbows of the needle guard through the aperture defined by the stabilization ring of the proximal valve actuator and out of the proximal opening of the catheter hub.

In some examples, the valve can be closed once the needle is removed from the valve disc. In some examples, there may or may not be a slight gap or fluid leakage through the slit when the valve is closed. However, leakage, if any, is minimal, and provides the medical practitioner with sufficient time to prepare the catheter hub for fluid transfer without the risk of fluid flowing out of the open proximal end of the catheter hub when the valve is closed.

In an example, blood backflow from the patient can accumulate at the distal holding space of the valve.Since a fluid-tight seal can be provided between the leg extension of the distal valve actuator and the first interior section of the valve, the distal lumen of the catheter hub can be relatively free of any blood backflow.

The distal end of the male tip can contact the proximal surface of the proximal valve actuator. After the male Luer tip is inserted into the catheter hub, the male Luer tip can be advanced further distally into the catheter hub until the Luer surface of the tip and the Luer surface of the catheter hub are in registration, thereby pushing the valve disc of the valve into the distal valve opener.

The valve may be urged against the distal valve opener when the male medical device is fully inserted into the proximal opening of the catheter hub and the proximal valve opener is advanced distally forward to further axially urge the valve distally forward.

In an example, the stabilization ring can provide a bearing surface or support for the proximal valve actuator as the actuator moves.

The nose section of the proximal valve actuator may push against the outer periphery of the proximal-facing surface of the valve disc to move the valve axially.

The cylindrical section of the valve skirt can slide axially against the inner surface of the lumen of the catheter hub. In one example, the valve skirt can be pushed distally until the frusto-conical section of the valve skirt contacts the reduced neck section of the catheter hub. In another example, registration of the two luer surfaces prevents the male tip from moving the valve skirt into contact with the reduced neck section.

In an example, when the valve is moved distally by the proximal valve opener, the valve disc can slide over the leg extensions and the nose section of the distal valve opener, and the distal valve opener can pierce the slit and deflect the flap.

In examples, the flaps may deflect proximally and radially when actuated.

The valve skirt and valve disc can move distally forward when actuated by a proximal valve opener (which can be moved distally forward by the male Luer tip), and the flaps of the valve disc can deflect proximally and radially, which is opposite to the direction of movement of the valve skirt.

In an example, when the valve is actuated by both the proximal and distal valve actuators, a portion of the two or more flaps of the valve may be located between a nose section of the proximal valve opener and a leg extension of the distal valve opener.

In some examples, when the valve is actuated by both the proximal and distal valve actuators, a portion of the two or more flaps of the valve may be located between the nose section of the proximal valve opener and the nose section of the distal valve opener.

In examples, the needle device has a disposable valve actuation mechanism or is disposable in that the valve may remain open and not return to its closed position once the male Luer tip is removed.

When the valve is actuated, the nose section of the distal valve actuator may move a certain penetration distance into the valve and proximal to the valve disc so that friction and other constraints prevent their separation.

The nose section of the distal valve actuator can be configured such that when the valve disc is pushed into the nose section of the distal valve actuator during activation, the actuating or activating end of the distal actuator does not extend too far proximal of the plane defined by the valve disc of the valve. This configuration can ensure that the valve is pushed back in a proximal direction by the flaps as they return to their more relaxed state when the male Luer device is removed.

The conical configuration at the nose section of the distal valve actuator can be such that it maintains an axially directed force vector that is greater than the perpendicular force vector. The angle of the cone can be designed to provide the necessary force vector when the distal actuator has reached its maximum proximal travel and its minimum proximal travel. The difference between the maximum and minimum travel of a standard Luer connector is approximately 2.5 mm. Therefore, current and future ISO standards for male standard Luer connectors can be consulted or considered when designing the angle of the distal actuator cone to ensure that separation between the valve and the distal valve actuator is achieved.

Alternatively or additionally, a resilient element (such as a spring or elastic element or ring) can be included at the distal chamber of the catheter hub to increase the rebound or restoring force of the valve, thereby facilitating the pushing of the valve and the proximal valve actuator in a proximal direction and away from the distal valve actuator to return to the pre-activated position or valve closed position after the male tip is removed.

A resilient element (which can be an elastic element or a coil spring) can also help close the valve disc's flaps. In this way, after initial activation, the valve can be reclosed and the proximal valve actuator can be returned to the proximal position and reopened, and so on. Alternatively or additionally, the valve flaps can be made thicker to provide sufficient restoring force without the need for a resilient element to close the valve after activation.

A combination structure may be provided. The combination structure may have a bushing end and an actuator end. The combination structure may be referred to as a bushing or a distal valve opener.

In an example, the hub end of the combined structure can have a sleeve and a base, which can have a tunnel shape for wedging the proximal end of the catheter tube against the interior of the catheter hub. The valve actuator end can include a base, a shoulder, a leg extension, and a nose section, and can be similar to a valve actuator.

In an example, the combined structure (which may alternatively be referred to as a bushing or valve actuator) may be integrally formed from a metal material, such as by deep drawing. Alternatively, the combined structure may be formed from two or more separately formed components that are subsequently attached to each other (such as by crimping or welding).

When the combination is inserted into a catheter hub to secure the catheter tubing, the base of the bushing end may be wedged against a shoulder inside the bore of the nose section, and the base of the actuator end may be wedged against the inner surface of the bore.

The nose section of the proximal valve opener may define a first continuous bounding section.Other locations of the nose section away from the first continuous bounding section may include a slit or slot.

The two stabilizer elements may be attached to the two plunger elements to form a stabilization ring.The stabilization ring may define a second continuous bounding section of the proximal valve actuator and may have an aperture.

Each stabilizer element can include two edges. In an example, the two edges of each stabilizer element can be parallel to each other. The stabilizer elements can be skewed or angled so that, while the two edges of each stabilizer element can be parallel to each other, the two edges from one stabilizer element may not be parallel to the two edges of another stabilizer element.

The proximal edges of the two stabilizer elements may be offset in an axial direction or lengthwise direction of the valve actuator.The distal edges of the two stabilizer elements may be offset in an axial direction.

Two reliefs or two through-passages can be provided on the valve opener, each defined by or bounded by a first continuous bounding section, two plunger elements, and a stabilization ring. The two reliefs or through-passages can be referred to as a first relief or first through-passage and a second relief or second through-passage. In an example, each relief or through-passage can have a bounding section.

In an example, each enclosure of the relief portion may be defined by a structure of a continuous enclosure segment of the nose segment, two plunger elements, and a respective stabilizer element.

Since the two stabilizer elements may be deflected or tilted in different directions, the two reliefs or the two perimeters of the through-passage may be different, such as having different perimeter profiles or shapes.

The two boundaries of the two relief portions can each be defined by a continuous ring. In other words, in the present disclosure, the boundaries of the two relief portions do not necessarily include slits or slots to form an open boundary. However, in the case where the stabilizer element includes a slot or slit, the boundaries of the relief portions can be open or discontinuous.

In some examples, the two stabilizer elements can extend laterally without being skewed or tilted in the distal or proximal direction. When so constructed, the edges of the two stabilizer elements can be parallel to each other. In addition, the four edges of the two stabilizer elements can be parallel to each other and axially offset. That is, the proximal edge of one stabilizer element can be located more proximal or distal than the proximal edge of the other stabilizer element, while the four edges are parallel to each other. The stabilizer element and/or the plunger element can include one or more holes for manufacturing purposes, such as for realizing a core pin.

Two plunger element posts or extensions can extend proximally of the stabilization ring. In some examples, the two plunger element posts can extend from the stabilization ring and be axially aligned with the plunger element located distally of the stabilization ring. In other examples, the two plunger element posts are not axially aligned with the two plunger elements located distally of the stabilization ring. In still other examples, only one plunger element post is aligned with one of the two plunger elements.

For a valve opener or actuator having only one plunger element between the first and second continuous confining sections, only one of the two plunger element pegs or neither of the plunger element pegs may be aligned with this one plunger element.

In some examples, there may be more than two plunger element pegs or extensions extending proximally of the stabilization ring. The two or more plunger element pegs or extensions may be equally spaced around the proximal perimeter of the stabilization ring or randomly spaced around the proximal perimeter of the stabilization ring. The plunger element pegs may extend the total length of the valve actuator.

A certain number of plunger element pegs and/or a certain curvature of each plunger element peg (the curvature may define the width of each plunger element peg) may provide a larger overlapping surface with the male Luer tip than a smaller number of plunger element pegs or plunger element pegs having a relatively smaller curvature.

The plunger elements may each include a protrusion on an outer surface of each plunger element. The two protrusions may be located inside the recessed section of the catheter hub such that a shoulder at the proximal end of the recessed section may provide a stop surface to prevent displacement of the valve opener in the proximal direction.

In some examples, only one protrusion is used on one of the two plunger elements of the actuator to prevent the valve opener from being displaced in the proximal direction.The protrusion may be formed at the site of the protrusion by adding material to the plunger element during injection molding.

The holding space may be located between two plunger elements, inside a stabilization ring, between two plunger element pegs, or a combination thereof.

A portion or all of the needle guard or tip guard may be located in the holding space in the standby position, and one or both elbows of the tip guard may project from one or both release portions.

The distance between the two inner surfaces of the two stabilizer elements can define a choke gap, choke point, or limit point for the needle guard to limit proximal movement of the needle guard in the standby position and/or during needle withdrawal after intravenous access. That is, before the needle tip moves proximal to one or both distal barrier walls of the needle guard, the choke point or gap can be relatively small such that the needle guard cannot pass through to reach proximal to the choke point or limit point.

After the needle tip is moved proximal to one or both distal barrier walls of the needle guard, the two distal walls move radially inward to reduce the radial profile of the needle guard, which can be smaller than the choke point. At that point, with the radial profile measured at the two elbows of the needle guard smaller, the needle guard can be moved proximal to the choke point.

In an example, the two edges of each stabilizer element may be parallel to each other. The two edges from one stabilizer element may also be parallel to the two edges of another stabilizer element.

The proximal edges of the two stabilizer elements can be aligned along the axial direction or longitudinal direction of the valve actuator. The distal edges of the two stabilizer elements can also be aligned along the axial direction. In other examples, the edges of the two stabilizer elements can be axially offset.

In some examples, two stabilizer segments with a slit or slot therebetween may be used rather than a single stabilizer element.

The valve opener of this embodiment can be made of metal. For example, a stamped metal sheet (such as stamped stainless steel) can be cold-worked using a deep-drawing process to form the illustrated shape. The various openings or gaps in the actuator can be punched or stamped, and then cold-worked to form the disclosed shapes.

Each plunger element of the valve actuator may include at least two longitudinal edges, and ribs may be provided along one or both of these longitudinal edges to further increase structural rigidity. One or more gaps may be provided between any two plunger elements. The gaps may provide a void or space for a fluid stream to flow across them, such as during an IV infusion. The gaps may also be used to accommodate a needle guard.

The plunger elements can each include a protrusion on an outer surface of each plunger element. These protrusions can be located within a recessed section of the catheter hub such that a shoulder at the proximal end of the recessed section can provide a stop surface to prevent displacement of the valve opener in a proximal direction. In an example, each protrusion can be formed on the corresponding plunger element by cold working a surface of a stamped metal sheet to push out a protruding surface.

The nose section of the valve opener may be narrowed to form a neck having two radiused sections that merge into the plunger element.

Each plunger element may extend in the proximal direction with a generally constant width and then flare to have a second set of rounded sections that may transition into the stabilizer segment.

A pair of radiused sections may be located proximal to the stabilizer segment to form the plunger element post.Both the plunger element and the plunger element post may have two spaced apart longitudinal edges which may be provided with ribs to add strength to the respective structures.

Starting approximately within the opening of the stabilization ring and extending in a proximal direction, each plunger element peg can be convex outwardly relative to the longitudinal axis to have an outwardly convex portion to form a curved surface along the cross-section of each peg. The convex portion can also be formed inwardly to form an inwardly convex portion. This feature can be included to form both concave and convex surfaces of the plunger element peg.

The valve actuators of the present disclosure may include a nose section formed by folding a wall layer to create a folded section.

The end surface of the folded layer can terminate roughly between the nose section of the valve actuator and the stabilization ring. In an example, the end surface can be positioned closer to the stabilization ring than the nose section, but the final position is not limited to this. In an example, the end surface can be defined as a shoulder on each of the two plunger elements. The two shoulders can provide a similar function to the protrusions on the valve actuator described elsewhere herein for use with the recessed section of the catheter hub.

In an example, a cutout or notch can be provided at the folded edge of the nose section of the proximal valve actuator. Alternatively, the notch can be omitted. The notch can be provided to allow for flow, such as for flushing and to reduce or eliminate fluid stagnation. In an example, eight equally spaced notches can be provided at the folded edge. In other examples, fewer than eight or more than eight notches can be provided, and the notches can be randomly spaced along the folded edge.

BRIEF DESCRIPTION OF THE DRAWINGS

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

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

2 is a schematic cross-sectional side view of the catheter assembly of FIG. 1 in a transitional position or state, wherein the needle is in the process of being removed from the catheter tubing and the catheter hub (such as after a successful venipuncture).

3 is a schematic cross-sectional side view of the catheter assembly of FIG. 1 , with the needle fully separated from the catheter hub and the needle tip covered by the needle guard.

4 is a schematic cross-sectional side view of the catheter assembly of FIG. 1 with the catheter hub now connected to the male luer and the proximal valve actuator advanced through the male luer to push the valve into the distal valve actuator to open the valve.

5A and 5B illustrate an end view and a cross-sectional side view, respectively, of a proximal valve actuator according to aspects of the present disclosure.

5C illustrates a cross-sectional end view taken along line 5C-5C of FIG. 1 showing the needle guard and the inwardly curved plunger element of the proximal valve opener.

5D is an alternative embodiment of the valve opener of FIG. 5C showing an outwardly curved plunger element.

5E illustrates an alternative embodiment of the valve opener of FIG. 5B , wherein the proximal section is a barrel for surrounding at least a portion of the needle guard.

6A and 6B illustrate an end view and a cross-sectional side view, respectively, of a distal valve actuator according to aspects of the present disclosure.

6C and 6D illustrate an end view and a cross-sectional side view, respectively, of an alternative distal valve actuator having a three-finger or plunger element for use with a valve having three lugs.

7 is an isometric view of the needle guard of FIG. 1 .

8A is a front view of an exemplary single slit-type disc valve.

8B is a front view of an exemplary triple-slit disc valve.

8C is a front view of a single slit type disc valve having a v-shaped slit at each end of the single slit.

9 is an exploded perspective view of a needle assembly according to aspects of the present disclosure.

10 is a partial cross-sectional side view of the needle assembly of FIG. 9 in an assembled state, and FIG. 10A is a top cross-sectional side view of the needle assembly of FIG. 9 .

11 is a partial cross-sectional side view of the needle assembly of FIG. 10 with the needle withdrawn from the catheter hub.

12 is a partial cross-sectional side view of the needle assembly of FIG. 11 , the needle assembly having been rotated 90 degrees.

13 is a partial cross-sectional side view of the needle assembly of FIG. 10 with the needle removed from the catheter hub and the male medical tip inserted into the proximal opening of the catheter hub.

14 is a partial cross-sectional side view of the needle assembly of FIG. 13 with the needle removed from the catheter hub and the male medical tip pushing the valve actuator into the valve to open fluid flow through the valve.

15 is a perspective view of an embodiment of a valve actuator.

16 is a perspective view of another valve actuator embodiment.

17 is a partial cross-sectional side view of the needle assembly with the valve actuator of FIG. 16 , shown without the needle for clarity.

18A to 18D are different views of the valve actuator of FIG. 9 .

19A to 19D are various views of another valve actuator embodiment.

20A-20B are different views of another valve actuator embodiment.

21A to 21C are different views of the valve of FIG. 9 .

DETAILED DESCRIPTION

The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of a presently preferred embodiment of a conduit assembly with a control valve provided in accordance with various aspects of the present apparatus, system, and method, and is not intended to represent the only form in which the present apparatus, system, and method may be constructed or used. This description sets forth features and steps for constructing and using embodiments of the present apparatus, system, and method in conjunction with the illustrated embodiments. However, it is to be understood that the same or equivalent functions and structures may be implemented by different embodiments that are also intended to be included within the spirit and scope of the present disclosure. As indicated elsewhere herein, the same reference numerals are intended to indicate the same or similar elements or features.

Referring now to FIG1 , a catheter assembly 100 (which may be more broadly referred to as a needle assembly or needle device) is shown, comprising: a catheter hub 102 having a catheter tubing 104 attached to a hub body 50; and a needle hub 106 having a needle 108 extending through the catheter hub 102 and the catheter tubing 104, with a needle tip 110 extending out of a distal end or distal opening 112 of the catheter tubing in a standby position. In the ready position, the catheter assembly 100 is ready for use, such as for performing a venipuncture or intravenous access. Sometimes, the ready position first requires removing a protective cap (not shown) from the catheter assembly or needle assembly 100.

A flashback plug 114 can be provided at the proximal end 118 of the needle hub 106, which allows ventilation but prevents blood from escaping from the proximal end 118 when it enters the flashback chamber 116 during primary flashback. Alternatively, a syringe can be attached to the proximal end of the needle hub. A valve and actuator, described further below, can also be placed within the needle hub to serve as a secondary valve. The needle hub 106 also includes a shoulder 120 or other surface that physically contacts the catheter hub 102 (such as a proximal surface 122 of the catheter hub) to axially register the two hubs 102, 106 to set the length of the needle tip 110 protruding from the distal opening 112 of the catheter tube 104.

Inside the catheter hub 102, a needle guard or tip guard 132, a valve opener or actuator 134, a valve 136, and a bushing 138 are provided within a lumen 130. The proximal opening of the catheter hub 102 can be sized to take the form of a female Luer taper. The bushing 138 has a base configured to wedge the proximal end of the catheter tubing 104 against the inner wall surface of the catheter hub 102 to retain the catheter tubing 104 to the catheter hub 102.

Tip guard 132 can be embodied as any of a number of prior art guards configured to block the needle tip 110 of a needle. In the exemplary embodiment shown, tip guard 132 can be embodied as one of the guards shown in U.S. Patent No. 6,616,630, the contents of which are expressly incorporated herein by reference. For example, tip guard 132 can have a proximal wall and two resilient arms, wherein a contour change 144 (such as a corrugation or ridge) on needle 108 engages the perimeter of an opening in the proximal wall of tip guard 132 to allow the tip guard to be withdrawn proximally out of the catheter hub after a successful venipuncture. The two arms can intersect, as described in U.S. Patent No. 6,616,630 and shown in FIG. 7 , or they can extend along different sides of the needle and not intersect in a side view. In the ready position, the needle guard arms are deployed from the needle shaft and engage the interior of the catheter hub (such as guard engagement section 210 ( FIG. 3 ) of catheter hub 102 ). In examples, only a portion of the tip guard or needle guard 132 may extend into one or more gaps of the valve opener 134, while a proximal section of the tip guard (such as a proximal wall) may extend proximal to or be located proximal to the proximal-most surface of the tip guard 132.

When needle tip 110 is pulled into needle guard 132 after a successful venipuncture, the arms of the needle guard collapse into their protective position to prevent accidental access to the needle tip. Simultaneously, the arms are released from engagement with the interior of the catheter hub. The same operation can be achieved with one of the arm-mounted needle guards described in U.S. Patent No. 6,616,630, which extends along the side of the needle shaft rather than across the needle as shown in some embodiments of U.S. Patent No. 6,616,630. Similarly, in the ready position, the needle shaft pushes the distal wall of one arm aside. When needle tip 110 moves proximal to the distal wall, the distal wall springs open in front of the needle tip to prevent accidental access to the needle tip and simultaneously releases the engagement between the needle guard and the interior of the catheter hub.

FIG5A shows a front view of a valve opener or actuator 134, and FIG5B shows a cross-sectional side view of the same valve opener taken along line 5B-5B of FIG5A. With further reference to FIG1, the valve opener 134 can include a ring 150 and at least one plunger element 152 (such as a leg element or elongated extension). The ring 150 is shown contacting the valve 136 in the needle assembly standby position of FIG1, but can be slightly spaced from the proximal-facing surface of the valve. In an exemplary embodiment, two plunger elements 152 can extend from the ring 150 in a proximal direction, each having a length measured along the longitudinal direction of the catheter assembly and a width measured orthogonal to the length. The at least one plunger element 152 is sized and shaped to be contacted by a male Luer fitting to transfer distally directed force from the male Luer fitting to the ring 152 to then open the valve 136, as discussed further below.

As can be seen from the front view of FIG. 5A and the side view of FIG. 5B , at least one plunger element 152 can have an arcuate shape or curved cross-section along its width. In another example, at least one plunger element 152 can be substantially flat or planar. The thickness of each of the two plunger elements 152 is sufficiently small or thin so that the needle guard 132 and the two plunger elements 152 have sufficient clearance to fit within the interior cross-sectional space of the catheter hub 102 without being physically bonded against the catheter hub and rendered immovable or fixed. In an example, the thickness of each of the two plunger elements 152 and the width of the needle guard eliminate the need for undercuts or channels in the inner wall surface of the catheter hub 102 to accommodate them. When the plunger elements 152 have an arcuate cross-section, they are mechanically stronger to withstand greater loads when pressed by the male tip to push the ring 150 against the valve 136. This allows for a thin and compact design of the infusion device and leaves more space within the standardized space of the female Luer taper.

The valve opener 134 can be made of a metal material or a plastic material. When made of a metal material, the valve opener 134 can be formed by a deep draw method, and the arcuate cross-section of the plunger element 152 can provide increased rigidity when pushed by the male Luer piece. Each plunger element 152 includes at least two longitudinal edges, and ribs can be provided along one or both of these longitudinal edges to further increase structural rigidity. One or more gaps 154 can be provided between any two plunger elements 152. The gap 154 can provide a gap or space for the fluid flow flowing across it (such as during IV infusion). The gap 154 can also be used to accommodate the needle guard 132, as shown in Figure 1.

The ring 150 of the valve opener 134 includes a body 158 having a peripheral boundary 160. In an example, the peripheral boundary 160 is generally cylindrical. In other examples, the peripheral boundary can have a tapered portion. Internally, the body 158 includes a chamfer 162 and an opening 164. The distal edge or intersection 166 of the body 158 between the chamfer 162 and the peripheral boundary 160 can have a sharp edge or a blunt edge. In an example, the intersection is a blunt edge that includes a planar surface for pushing against the valve 136, as discussed further below. On the proximal side of the ring 150, the two plunger elements 152 can be recessed inwardly from the peripheral boundary 160 to form a shoulder 170. In other words, the peripheral boundary 160 can have an outer diameter of a first size, and the two plunger elements 152 can define an outer diameter of a second size, which is smaller than the first size. The shoulder 170 is set between these two different sizes.

The valve opener 134 has an inner diameter measured adjacent to the intersection 166. The inner diameter changes or varies along the chamfer 162 section of the ring 150. The valve opener 134 also has a minimum inner diameter mID, which can be considered the minimum inner diameter of the valve opener. As shown, the minimum inner diameter mID can be located at a corresponding inner position of the shoulder 170. In other examples, the minimum inner diameter mID can be located at other inner positions of the valve opener 134, such as somewhere inside the ring 150 or somewhere between the plunger elements 152.

FIG5C is a cross-sectional end view of the needle assembly 100 of FIG1 taken along line 5C-5C, shown without the needle 108. FIG5C illustrates the proximally-facing wall surface of the proximal wall 280 of the needle guard 132 and the two plunger elements 152. As shown, the needle guard 132 is positioned between one or more gaps defined by the two plunger elements 152, and the proximal wall 280 extends proximal to the proximal-most edge of the valve opener 134. As previously mentioned, the plunger elements 152 can each include an arcuate cross-section. As shown, the arcuate cross-section of each plunger element 152 is generally C-shaped, having a concave portion facing the needle guard 132 on the inside and a convex portion facing away from the needle guard 132 on the outside. The arcuate surfaces of the two plunger elements 152 should have a radius of curvature that is different from, such as smaller than, the radius of curvature of the female luer fitting of the catheter hub 102. The radius of curvature of the two C-shaped plunger elements should also be different from the radius of the male Luer tip. A gap can be provided on each side edge 52 of the proximal wall 280 and the adjacent plunger element 152.

The present configuration of the valve opener 134 allows the two plunger elements 152 to define abutting proximal surfaces 54 that are sized and shaped to be urged against by a male Luer tip or syringe tip when the tip is inserted into the proximal opening of the catheter hub 102 after a successful venipuncture, thereby urging the valve opener 134 distally to open the valve 136. The arcuate cross-section of each of the two plunger elements 152 provides a sufficiently thick profile to ensure overlap of the abutting surface with the male Luer tip and to ensure rigidity against buckling. Thus, the C-shaped plunger element can avoid deflection when pushed by a syringe tip or other male Luer tip, avoid the syringe tip or Luer tip from slipping and missing the end surface 54 of the plunger element 152 when inserting the syringe tip or Luer tip into the open proximal end of the catheter hub, and/or avoid the following situation: the syringe tip or Luer tip is pushed between two plunger elements during activation of the valve opener 134 so that the two plunger elements are wedged between the tips and the inner surface of the catheter hub 102.

FIG5D shows a cross-sectional end view of the catheter hub 102 that is identical to the cross-sectional end view of FIG5C , but with an alternative curved cross-section on the plunger elements 152 of the valve opener 134. As shown, the two plunger elements 152 each include a C-shaped cross-section. However, in this embodiment, the concave portion of the curved cross-section of each plunger element 152 faces away from the needle guard 132 on the outside, while the convex portion of each plunger element faces the needle guard 132 on the inside. As with the embodiment of FIG5C , when a syringe tip or Luer tip is inserted into the catheter hub 102, the curved cross-sections of the two plunger elements 152 provide an abutment surface that overlaps the tip to push the valve opener 134 into the valve to open the valve after a successful venipuncture.

When installed within the lumen 130 of the catheter hub 102, the ring 150 of the valve opener 134 elastically deforms and then expands when it reaches the recessed hub section 174 of the catheter hub 102, which accommodates the ring without deforming it. Alternatively, the catheter hub 102 is designed to expand to allow assembly of the valve opener 134. A shoulder 176 ( FIG. 4 ) is provided at the recessed hub section 174, forming a physical stop for engaging the shoulder 170 on the valve opener 134. This allows the valve opener 134 to remain within the lumen 130 of the catheter hub 102 during needle withdrawal and during use, when the valve opener 134 is pushed distally to activate the valve and then moves proximally when the male luer is removed, thereby allowing the valve to close.

Referring again to FIG. 1 , valve 136 is located within the interior of catheter hub 102 , just distal to ring 150 of valve opener 134 . In an example, valve 136 is embodied as a valve disc 137 , which includes a valve body comprising a valve diameter, a valve thickness measured orthogonally to the valve diameter, and one or more slits defining two or more flaps. In a specific example, three slits are provided through the valve thickness to define the three flaps. The three slits can originate from a single point and extend radially from approximately a center point or center portion of the body of valve 136 in a manner similar to a three-pointed star to form three flaps that can deflect along these slits. Valve 136 can include a peripheral boundary between valve opener 134 and sleeve 138 , which can float within the interior lumen of the catheter hub. For example, the peripheral boundary of valve 136 can move proximally and distally within the interior lumen 130 of catheter hub 102 and is not constrained by the catheter hub in the axial direction of the catheter assembly. The outer perimeter of the valve 136 can be the same as, smaller than, or larger than, the outer perimeter of the ring 150 of the valve opener 150. However, at least some portion or all of the distal edge or intersection 166 of the ring 150 is recessed from the outer perimeter of the valve 136 so that the distal edge 166 can abut or touch the proximally facing wall surface of the valve 136, as discussed further below. Moreover, because the valve 136 can float, the valve can be positioned within a single-hub-body catheter hub 102. In other words, it is not necessary to retain the valve 136 within the interior of the catheter hub by two or more catheter hub bodies (such as along a seam between the two or more hub bodies). However, the various components described herein can readily be used with a multi-piece catheter hub without departing from the scope of the present disclosure.

FIG6A shows an end view of bushing 138, and FIG6B shows a cross-sectional side view of the same bushing taken along line 6B-6B of FIG6A. With further reference to FIG1, bushing 138 includes a body 190 comprising: a first body section 192; a second body section 194 extending from first body section 192 and having a conical shape; and two or more leg extensions 196 extending from second body section 194. First body section 192 can have an elongated body, which can have a cylindrical shape with an optional tapered distal tip or nose section. In some examples, a generally cylindrical ring extends from second body section 194, and two or more leg extensions 196 extend from the cylindrical ring. One or more gaps 200 are provided between two adjacent leg extensions 196. In an example, the bushing 138 includes the same number of leg extensions 196 as the valve 136 includes flaps. Thus, if the valve has three flaps, there may be three leg extensions 196 on the bushing 138. If the valve 136 has a single slit, there may be two leg extensions 196. The leg extensions 196 on the bushing 138 may define an outer diameter that is smaller than the minimum inner diameter mID of the valve opener 134. The proximal tip or nose section 204 of each leg extension 196 may have a chamfered or blunted tip. In one example, a chamfer 206 is included at the proximal tip or nose section 204 of each leg extension 196, wherein the chamfer 206 tapers inwardly from the exterior of the leg extension 196. The chamfer direction is configured to match the folding direction of the flaps on the valve 136. The bushing 138 may be made of a metal material, and the leg extensions 196 may be integrally formed with the body 190. Alternatively, the leg extensions 196 may be welded to the body 190 .

When positioned in the catheter hub 102, the sleeve 138 and valve 136 are oriented so that the leg extensions 196 on the sleeve are aligned with the flaps on the valve. In other words, the two components are aligned so that when the valve 136 is advanced distally from the proximal side by the valve opener 134, as discussed further below, the flaps on the valve are urged into physical contact with the leg extensions 196 on the sleeve 138. Thus, if there are three flaps on the valve, these three flaps will be urged into physical contact with the three leg extensions on the sleeve. The distal-facing wall surface of the valve 136 may contact the leg extensions and/or the resilient element 276, or may be spaced apart from the leg extensions 196 and/or the resilient element 276 on the sleeve 138 in the valve's closed position and press against the leg extensions during use. In other examples, the valve may contact the proximal tips of the leg extensions and/or the resilient element 276 in the valve's closed position, or may be spaced apart therefrom.

FIG6C shows an end view of an alternative sleeve 138, and FIG6D shows a cross-sectional side view of the sleeve taken along line 6D-6D of FIG6C . Like the sleeve of FIG6A , this embodiment includes a body 190 comprising a first body section 192 and a second body section 194. In this embodiment, as previously mentioned, three leg extensions 196 are provided for use with a valve including three slits defining three lugs. The three leg extensions 196 can be equally spaced along the circumference of the second body section 194. In another example, the three leg extensions 196 can be positioned and spaced according to the location of the lugs on the valve 136 so that when the valve is assembled within the catheter hub 102, the valve can be urged distally by the valve opener or valve actuator 134, and the leg extensions 196 on the sleeve 138 are aligned to push the lugs of the valve in a proximal direction to open the valve, as discussed further below. Referring now to FIG. 2 , the catheter assembly 100 is shown in a transitional position, whereby the needle 108 is in the process of being separated from the catheter hub 102 and the catheter tubing 104 (such as after a successful venipuncture). The needle tip 110 is shown just distal to the valve 136. During the proximal withdrawal of the needle 108, the tip guard 132 is axially retained by engagement between one or two resilient arms on the tip guard 132 and a guard engagement segment 210 ( FIGS. 3 and 4 ) on the catheter hub 102. In an example, the guard engagement segment 210 is a surface discontinuity formed on the inner surface of the catheter hub 102. For example, the guard engagement segment 210 may include a segment having a first inner diameter and a segment having a second inner diameter that is larger than the first inner diameter. The guard engagement segment 210 may be embodied as an internal protrusion, a groove, or a combination of both a groove and a protrusion formed on the inner surface of the catheter hub 102. When a combination of grooves and protrusions is used in the guard engagement section 210 to engage the needle guard or tip guard 132, it is preferred that the grooves be located distally of the protrusions. In an example, two spaced-apart guard engagement sections 210 are provided for engaging two resilient arms on the tip guard 132. The two guard engagement sections 210 can be positioned diametrically opposite each other, just distal to the section of the female luer taper of the catheter hub 102.

Figure 5E shows a valve opener 134 provided in accordance with an alternative embodiment of the present disclosure. This valve opener 134 is similar to the valve opener 134 of Figures 5A and 5B and includes: a nose segment 150 having an activation end 166; and two plunger elements 152 extending in a proximal direction of the nose segment 150. However, instead of including two plunger elements 152 with two free ends, this embodiment includes a band or ring connecting the two plunger elements 152 together. Two arcuate, curved segments, or stabilizer elements 253 can be attached to the two plunger elements 152 to form a band or ring 255. The band 255 can be referred to as a stabilization ring 255 and can connect the two plunger elements 152 together to form a stabilization structure. The stabilization ring 255 forms a continuous bounding section of the valve actuator that is separated from another continuous bounding section defined by the nose segment 150 of the valve actuator.

The present valve actuator embodiment 134 can also be viewed as a valve opener 134 having a single plunger element 152 extending from a nose section 150, and wherein the single plunger element 152 includes two or more reliefs or through-passages 61 formed through the wall of the plunger end. The needle guard 132 can engage the edges or perimeters of the reliefs 61 in the standby position and during needle withdrawal after a successful venipuncture. Alternatively, the tip guard or needle guard 132 can protrude from the holding space defined by the valve opener 134 through the reliefs 61 to engage the inner surface of the catheter hub 102.

Thus, in embodiments having two releases or through-passages 61, the perimeter of the two releases or through-passages can function as guard engagement sections 210 by allowing the elbows of the tip guard to engage therewith. Alternatively, the two elbows of the needle guard can protrude from the holding space defined by the valve opener through the two releases to engage guard engagement sections or segments formed on the inner surface of the catheter hub. Thus, the perimeter of the releases or the inner surface of the catheter hub can form anchoring sites for the arms of the tip guard to engage in the standby position and during needle withdrawal after a successful venipuncture.

5E can be embodied as a generally cylindrical body section 151 having an inner surface 153 defining an opening having a path or passage 154, which can also be a gap for fluid flow, and a proximal boundary or end edge 63. At least a portion of the opening of the proximal valve opener 134 can define a holding space 155 for receiving a portion or all of a needle guard. Similar to the guard engagement segment 210 shown in FIG. 4 , a guard engagement segment 210 can be formed on the inner surface 153 of the present valve opener 134. In other words, a protrusion, ridge, recess, or guard engagement segment 210 can be formed on the inner wall surface 153 of the valve opener to allow engagement between the needle guard and the inner surface of the valve opener.

When the present alternative valve opener 134 of FIG. 5E is used with a needle device or catheter assembly 100 (such as the assembly of FIG. 1 ), the guard engagement segment 210 can be on the catheter hub, on the inner wall of the valve opener, or formed as a circumference of a release that passes through the wall of the valve opener. The valve opener can include one or more releases or guard engagement segments. The catheter hub can also be formed with one or more guard engagement segments for use with one or more releases of the valve opener. This allows the two resilient arms of the tip guard 132 to engage the valve opener 134 or to engage the catheter hub by protruding through the release.

In yet another example, two openings 61 (only one shown), shown in phantom, through the wall of the cylindrical body portion 151 of the valve opener can be provided for use with a guard engaging segment 210 formed by or on the interior of the catheter hub 102. In a standby position using the valve opener of this alternative embodiment, one or more resilient arms of the tip guard 132 can protrude through the opening 61 or through both openings 61 to engage the guard engaging segment(s) 210 of the interior of the catheter hub 102 instead of or in addition to the opening 61 of the valve opener 134.

FIG3 shows the needle 108 completely removed from the catheter hub 102 and the tip guard 132 in the protective position covering the needle tip 110 ( FIG1 ). During the transition from the position of FIG2 to the position of FIG3 , the needle tip 110 moves proximally of the two distal walls 300 , 302 ( FIG7 ) of the tip guard 132 (one distal wall at each end of the resilient arms 288 , 290 ( FIG7 )). Alternatively, the needle guard 132 may have one distal wall and/or one arm. When the two distal walls, and therefore the two resilient arms, are no longer biased outward by the needle 108, the two arms 288 , 290 move radially to disengage from the guard engagement section 210 of the catheter hub 102 or the valve opener 134 ( FIG5E ), if used alternatively. Alternatively, one arm and one distal wall disengage from one guard engagement section 210.

As the needle continues to move proximally and the profile-changing portion 144 ( FIG. 1 ) engages the perimeter 282 ( FIG. 7 ) on the proximal wall of the tip guard 132 , the tip guard 132 moves proximally with the needle to the position shown in FIG. 3 . Alternatively, the needle guard can be clamped onto the needle shaft and removed from the catheter hub as a unit. Note that in the protected position, in which the tip guard 132 covers the needle tip, the valve 136 remains within the lumen of the catheter hub 102 . Thus, the valve 136 is located within the catheter hub 102 in both the needle-armed position and the needle-protected position. Viewed another way, the valve 136 is located within the catheter hub 102 in both the standby position of the catheter assembly 100 (in which the needle tip protrudes from the distal opening 112 ( FIG. 1 ) of the catheter tube 104 ) and the protected position of the catheter assembly (in which the needle is removed from the catheter hub and the needle tip is covered by the tip guard).

Referring now to FIG4 , the catheter hub 102 is shown with a male medical device 220 positioned in its proximal opening. The male medical device or instrument 220 can be a male luer, a syringe tip, an IV set connector, or other male tip with a luer taper. For example, the male medical device can be connected to IV tubing, which is connected to an IV fluid source for delivering fluid therapy to a patient through the male medical device 220, the catheter hub 102, and the catheter tubing 104.

5A , 5B , 6A , and 6B , with continued reference to FIG. 4 , when a male medical device 220 (herein, a male tip) is initially inserted into the proximal opening of the catheter hub 102 , the male tip initially contacts the two plunger elements 152 on the valve opener 134 , applying a distally directed force on the two plunger elements 152 to open the valve 136 . The arcuate cross-section of the plunger elements 152 can have a diameter smaller than the inner diameter of the catheter hub 102 , thereby providing a larger contact surface for the distal end of the male medical device 220 , as previously discussed. This can also be designed to contact the inner wall of the catheter hub at a tangent point. In this manner, the plunger elements 152 are stable and resist outward deflection. This arrangement can prevent the relatively thin plunger element from becoming wedged between the male medical device 220 and the inner wall of the catheter hub 102 . The distally directed force causes the valve opener 134 to move in the distal direction until the geometry of the male tip 220 and the proximal opening of the catheter hub prevent the male tip from advancing further distally. In the example, the female Luer taper of the catheter hub 102 registers with the male Luer taper of the male tip 220 and prevents the male tip from advancing further distally into the opening of the catheter hub. The Luer engagement provides a seal that prevents fluid from leaking out of the proximal opening of the catheter hub.

As the valve opener 134 is distally moved by distal advancement of the male tip 220, the ring 150 is urged distally and presses against the proximally facing surface of the valve 136. Specifically, the distal edge 166 of the valve opener 134 initially presses against the proximally facing surface of the valve 136. When the valve 136 is axially movable within the catheter hub 102, the valve 136 is urged distally by the valve opener 134 and the male tip 220. For example, the ring 150 contacts the valve 136 and presses it distally. However, due to the presence of the leg extension 196 on the bushing 138, the outer edge or outer valve section of the valve 136 moves distally, while the leg extension 196 prevents other portions of the valve 136 from moving distally that abut or contact the leg extension 196. In effect, the outer edge of the valve 136 (e.g., the outer section of the body of the valve 136) moves distally, while the flaps on the valve are simultaneously deflected radially outward and proximally from a center point or position by the leg extensions 196 on the hub 138, thereby opening a flow path 226 through the valve. Fluid from the male tip 220 can then flow through the lumen of the catheter hub 102, the valve 136, and the catheter tubing 104. Alternatively, suction can be applied by a male medical instrument (e.g., a syringe or vacutainer) and blood can be drawn from the patient. This is often done to test a sample before initiating an infusion therapy. Furthermore, any residual blood is typically flushed from the interior of the catheter hub 102 before initiating an infusion therapy.

With further reference to Figures 4, 5B, and 6B, the chamfers 162 on the ring 150 and the chamfers 206 on the leg extensions 196 facilitate deflection of the valve flaps radially outward and in a proximal direction. Furthermore, the relative diameters defined by the leg extensions 196 and the minimum inner diameter mID of the valve opener 134 allow the valve opener and bushing to deflect the valve 136 therebetween to open the valve. Alternatively, when pushed distally, the outer periphery of the valve may remain in contact with the inner wall of the catheter hub, with the flaps opening only around the one or more slits.

Thus, one aspect of the present disclosure is understood to include a catheter assembly comprising a valve comprising one or more slits and two or more flaps, wherein the valve comprises a portion or section that moves in a distal direction and a portion or section that opens in a radial direction in a proximal direction to open a flow path through the valve. In an example, the outer edge of the valve is configured to move distally while the flaps of the valve are configured to move radially outward to open a flow path through the valve. Moreover, by including a valve that can move in this manner to open a fluid flow path, the actuation distance that the valve opener 134 must travel in the axial direction of the catheter assembly is minimized compared to a valve having flaps that are opened only in the distal direction by the valve opener. Thus, the size of the catheter hub 102 (such as the length of the catheter hub) can be reduced compared to a catheter hub that utilizes a valve and a valve opener that opens the valve by deflecting the valve flap only in the distal direction.

Another aspect of the present disclosure is understood to include a catheter assembly comprising a valve, wherein the valve enclosure can float in an axial direction relative to the catheter hub. In other words, by including a valve having a valve enclosure that can float in an axial direction, a two-part catheter hub is not required to secure the valve enclosure therebetween and within the catheter hub. Thus, a catheter hub having a hub body formed in a single-piece manner can be used with the present catheter assembly. As a result, the size of the catheter hub 102 (such as the outer diameter or outer dimensions of the catheter hub) can be reduced compared to a catheter hub utilizing a two-part hub body. The two-part hub body (wherein they are joined together along a seam) can therefore be reduced to provide a catheter assembly having a relatively smaller outer profile.

Yet another aspect of the present disclosure is understood to include a valve opener 134 for opening a valve 136. The valve opener 134 is configured to push the valve against another structure (such as the leg extension 196 on the bushing 138). The valve opener 134 can be considered to have a multi-piece valve opening structure. For example, the portion having the ring 150 and the plunger element 152 can be considered the proximal valve opener 250, and the bushing 138 having the leg extension 196 can be considered the distal valve opener 252. The bushing 138 and the distal valve opener 252 can be integrally formed.

The two valve openers 250, 252 cooperate to open the valve 136. As described, the proximal valve opener 250 is sized and shaped to push against the outer edge of the valve 136 in a distal direction to move the valve against the distal valve opener 252. The distal valve opener 252 is sized and shaped to push the flaps on the valve in a radially outward direction and push a portion of the flaps in a proximal direction to open a fluid path or flow path 226 through the valve 136. In the example, the leg extensions 196 on the distal valve opener 252 are axially fixed, and by pushing the valve flaps against the leg extensions in a distal direction, the flaps are deflected radially outward by the leg extensions on the distal side of the valve 136. In other words, when the valve is actuated to open a flow path through the valve, the valve is physically urged by both the actuator located on the proximal side of the valve and the actuator located on the distal side of the valve. In certain embodiments, the valve may be actuated by being physically pushed by a ring on the proximal side of the valve and leg extensions on the distal side of the valve to open a flow path through the valve.

4, the proximal tips 204 of the leg extensions 196 and the distal edge 166 of the ring 150 are separated from a plane drawn orthogonal to the longitudinal axis of the catheter assembly. In other words, the proximal tips 204 of the leg extensions 196 do not overlap with the distal edge 166 of the ring 150 from the perspective of this plane, and a gap is provided between the two to accommodate the valve 136 therebetween. In another example, the proximal tips 204 of the leg extensions 196 do overlap with the distal edge 166 of the ring 150 in the axial direction, which has the effect of causing the flap to deflect radially outward by a relatively greater amount than when there is no overlap. In addition, because the flap is pushed against the axially fixed leg extensions 196 on the bushing, the flap is deflected rearwardly in the proximal direction by these leg extensions 196. In still other examples, the proximal tips 204 of the leg extensions 196 only touch the distal edge 166 of the ring 150 along a plane drawn normal to the longitudinal axis of the catheter assembly.

In yet another aspect of the present disclosure, a catheter assembly is provided that includes a valve, a proximal valve opener, a distal valve opener, a needle hub with a needle, and a catheter hub with a catheter tube. The valve assembly may also include a tip protector for blocking the needle tip in a protected position. After a successful venipuncture, a male tip (such as a male Luer fitting) can be inserted into the proximal opening of the catheter hub to advance the proximal valve opener distally, which moves the valve distally against the distal valve opener. However, rather than deflecting the flaps radially outward and distally to open a fluid path through the valve, the flaps pivot proximally to open a fluid path through the valve. For example, the tip of each valve flap (which typically originates from a point or origin near the center of the valve) is deflected proximally by a leg extension 196 of the hub of the device. In an example, the flaps are deflected proximally by pressing the flaps against fixed leg extensions 196 on the distal valve opener 252. In other words, the flap on the valve can be deflected in the proximal direction by a structure located distal to the valve and abutting the distal-facing surface of the valve 136. The distal valve opener 252 can be a metal bushing having a body with a conical section having two or more leg extensions extending therefrom in the proximal direction. The bushing can also be made of a thermoplastic material.

To replace the male tip 220 or simply close the valve 136 from the open position of FIG. 4 , the male tip 220 is removed distally away from the catheter hub 102. The biasing or resilient nature of the valve 136 (which may be made of an elastomer) allows the valve to rebound to its more relaxed state. Consequently, the flap on the valve rebounds by moving distally while the outer edge or outer segment of the valve body rebounds proximally, pushing the proximal valve opener 250 in the proximal direction and pushing the shoulder 170 on the proximal valve opener 250 toward or against the shoulder 176 inside the lumen of the catheter hub. Thus, after removing the male tip from the catheter hub, the valve 136 and the proximal valve opener 250 return substantially to the position shown in FIG. 3 .

Alternatively, a coil spring, leaf spring, or elastomeric cylinder 276 (not shown) of a material softer than the valve 136 may be optionally placed between the distal-facing surface of the valve and an inner distal step or shoulder 274 (shown schematically in Figures 1 to 4) of the catheter hub 102. This spring or elastomeric cylinder 276, if included, can provide additional biasing force to return the valve 136 to the closed position when the male medical instrument 220 is removed. The resilient member 276 (which can be an elastic element, spring, O-ring, or other pliable element with resilient or biasing properties) can be spaced apart from the valve 136 in the rest position shown in Figure 1, or can contact the valve in the rest position.

The valve 136 can be reopened by placing the male tip 220 into the proximal opening of the catheter hub 102 and pushing the proximal valve opener 250 in the distal direction, as described above with reference to FIG. 4 .

FIG7 is a rear isometric view of the needle guard 132 of FIG1 . The needle guard 132 is merely exemplary, as needle guards having other or different features may be used in place of the original needle guard 132 shown in FIG7 . In this embodiment, the needle guard 132 includes a proximal wall 280 including a perimeter 282 defining an opening 284 . The proximal wall 280 has a proximally facing wall surface 286 and a distally facing wall surface opposite the proximal facing wall surface. At least one resilient arm 288 extends distally from the proximal wall 280 . As shown, two resilient arms 288 and 290 extend distally from the proximal wall. One arm may be longer than the other. Each arm may also have different arm widths, including a first arm segment 292 having a first width and a second arm segment 294 having a second width that is less than the first width. The two arms may originate from different ends of the proximal wall 280 and may intersect at their respective second arm segments 294 . Thus, when viewed from the side along the length of the needle guard 132, the two arms intersect one another. When used with a needle, the two arms 288, 290 intersect one another when in the standby position and when in the protective position. In an alternative embodiment, the two arms 288, 290 originate from different ends of the proximal wall and extend in the distal direction without intersecting one another. Thus, the two arms 288, 290 may also have substantially the same arm width along the length of each respective arm.

Distal walls 300, 302 are provided at one end of each arm 288, 290. The distal walls 300, 302 can overlap each other in the axial direction of the needle guard by utilizing different arm lengths and/or angling one of the walls at an elbow 304 between the distal wall and the resilient arm. In an example, if two arms are utilized, the elbow 304 of each arm can engage a corresponding guard engagement section 210 on the interior of the catheter hub 102 to removably secure the needle guard to the catheter hub in the prepared position and during the transition process of removing the needle 108 from the catheter hub 102. The needle guard 132 can be folded from stamped metal sheet to form the guard as shown. Ribs can be formed on the arms, proximal wall, and/or distal wall to increase structural rigidity.

Referring now to FIG8A , a front view of an exemplary valve 136 provided according to aspects of the present disclosure is shown, which may be used with a catheter assembly and a hub having a female luer fitting as described elsewhere herein. The valve 136 is shown having a valve body 320 with a valve disc 137 having a width measured from one edge to the other of the valve body's perimeter 322, or between the proximal-facing surface 319 and the distal-facing surface 323. In this embodiment, due to the circular configuration of the exemplary valve, the width of the valve body is the same as its diameter. The valve body 320 has a thickness, which is a dimension extending into the page of FIG8A or orthogonal to the width. The valve 136 is shown having a single slit 324 formed through the thickness of the valve body 320, defining a first flap 326a and a second flap 326b. The first flap 326a and the second flap 326b can be deflected to open a flow path 226 through the valve body 320. The first and second flaps may be deflected by pushing the valve 136 into the leg extensions on the distal side of the valve using a valve opener on the proximal side of the valve, as previously discussed.

FIG8B is a front view of an exemplary valve 136 provided according to another aspect of the present disclosure, which valve may be used with a catheter assembly and a hub having a female Luer piece as described elsewhere herein. With a few exceptions, this valve 136 is similar to the valve of FIG8A . In this embodiment, three slits 324 are provided through the thickness of the valve body to form three flaps 326a, 326b, 326c. The three slits 324 can intersect at a single center point 328. The first flap 326a and the second flap 326b can be deflected to open a flow path 226 through the valve body 320. The first, second, and third flaps 326a, 326b, 326c can be deflected by utilizing a valve opener on the proximal side of the valve to push the valve 136 into the leg extension on the distal side of the valve, as previously discussed. When the three flaps are deflected, a fluid flow path 226 is provided. In the example, the flaps 326a, 326b, 326c near the center point 328 expand radially and proximally toward the perimeter 322 when deflected by the leg extensions on the distal side of the valve 136. Because there are three flaps 326a, 326b, 326c, the present valve is configured for use with a bushing having at least three leg extensions, as shown in Figures 6C and 6D.

FIG8C is a front view of an exemplary valve 136 provided according to yet another aspect of the present disclosure, which valve may be used with a catheter assembly and a hub having a female luer fitting as described elsewhere herein. With a few exceptions, this valve 136 is similar to the valve of FIG8A . In this embodiment, a single slit 324 forming the first and second flaps 326a, 328b is provided with reliefs 340, 340 at each end of the slit 324. In the illustrated embodiment, the reliefs 340, 340 are embodied as two short through-cuts 340a, 340b at each end of the slit 324, forming a V-shaped relief 340. The two reliefs 340, 340 provide clearance for the two flaps 326a, 326b to deflect more easily when pressed against the leg extensions, and provide less restriction near the ends of the slit 324 than would be the case without reliefs. Less preferably, a single short through cut may be included at each end of the slit 324 .

FIG9 is an exploded perspective view of a needle assembly or catheter assembly 400 according to further aspects of the present disclosure. The catheter assembly 400 (which may be more broadly referred to as a needle assembly or needle device) is shown to include a catheter hub 102 having a catheter tubing 104 with a distal opening 112, and a hub 138 having a distal valve opener 252. The hub 138 may be configured to wedge the proximal end of the catheter tubing 104 against the inner wall surface of the catheter hub 102 to retain the catheter tubing 104 to the catheter hub 102.

Inside the catheter hub, a septum or valve 136, a valve actuator 134 (such as a proximal valve actuator), and a safety clip 132 (such as a needle guard or tip guard) are provided. The needle 108 can be inserted through the proximal opening of the catheter hub, with the needle tip extending out of the distal opening 112 of the catheter tubing 104. The cannula hub or needle hub 106 can be interconnected with the proximal end of the needle 108 and contact the catheter hub 102 in a standby position. The proximal opening of the catheter hub 102 is sized and shaped to receive a male medical device (such as a male Luer tip).

Tip protector 132 is configured to be removed with needle 108 after use, and valve 136 and valve actuator 134 remain with catheter hub 102 for controlling fluid flow therethrough, as previously discussed. Actuator 134 is configured to be pushed into valve 136 to open the valve to enable fluid flow, as further discussed below.

A flashback plug 114 can be provided at the proximal end 118 of the needle hub 106, which allows ventilation but prevents blood from escaping from the proximal end 118 when it enters the flashback chamber 116 during primary flashback. Alternatively, a syringe can be attached to the proximal end of the needle hub. A valve and actuator, described further below, can also be placed within the needle hub to serve as a secondary valve. The needle hub 106 can include a shoulder or other surface to physically contact the catheter hub 102 (e.g., a proximal surface of the catheter hub) to axially register the two hubs 102, 106 to set the length of the needle tip 110 protruding from the distal opening 112 of the catheter tube 104.

A protective cap 124 having a sleeve 124a and a saddle 124b can be provided to cover the needle 108 during packaging and prior to use, as is conventional. The saddle 124b can surround at least a portion of the catheter hub 102 and the needle hub 106 and be removably coupled to the needle hub 106. The cap 124 should be removed from the needle assembly before use. The catheter hub 102 can be provided with a pair of wings to facilitate securing the catheter hub to the patient after use.

Figure 10 is a schematic partial cross-sectional side view of the catheter assembly 400 of Figure 9, wherein the catheter assembly is in an assembled state and wherein the protective cap 124 is removed. Figure 10A is a top cross-sectional side view of the catheter assembly 400 of Figure 9, wherein the catheter assembly is in an assembled state. The catheter assembly is shown as having: a catheter hub 102 having a pair of wings 102a, 102b and a catheter tube body 104 extending out of its distal end; and a needle 108, which is attached to the needle hub 106, and the needle protrudes through the catheter hub 102 and the catheter tube body 104 in the standby position of Figure 10A, and this situation is more carefully illustrated in the partial cross-sectional view of Figure 10. The needle 108 also protrudes through the valve 136, the valve actuator 134, and the needle guard 132 in the standby position.

In the prepared position, with the needle hub 106 registered with the catheter hub 10 and the needle tip extending out of the distal end (of FIG. 9 ) or distal opening 112 of the catheter tubing 104, the catheter assembly 100 is ready for use, such as to perform a venipuncture or intravenous access. Sometimes, the prepared position first requires removing the protective cap 124 ( FIG. 9 ) from the catheter assembly or needle assembly 100.

Located within the interior of the catheter hub 102 is a valve 136 having a valve disc 410 and a valve skirt 412 ( FIG. 21B ). The valve disc 410 includes one or more flaps 326 and one or more slits 324 to be opened by a valve actuator. In an embodiment, the valve skirt 412 is positioned within a recessed section 420 formed within the lumen 130 of the catheter hub 102 and, when actuated, can slide axially along the interior of the catheter hub 102 to open and enable fluid flow, as discussed further below. The valve 136 is separated from a reduced neck section 424 of the catheter hub 102, which anchors the tunnel section of the bushing 138 in place. The space between the reduced neck section 424 and the valve skirt can be referred to as the distal lumen 130 a.

With reference to Figures 21A-21C and with continued reference to Figure 10 , in an example, the valve 136 includes a valve disc 410 having a valve outer diameter and a valve thickness measured perpendicular to the valve diameter; and one or more slits 324 formed through the valve thickness to define two or more flaps 326, as previously described with reference to the valve 136 of Figures 8A-8C . For example, one, two, or three slits 324 may be provided through the thickness of the valve disc to define two, three, or more flaps. In the illustrated embodiment, the valve skirt 412 extends axially of the valve disc 410 to form a generally cylindrical skirt section 430. In some embodiments, the valve skirt 412 may be angled such that the valve skirt forms a frustoconical structure 432. The valve skirt 412 defines a distal opening 434 having an area or size that is sized and shaped to receive the distal valve opener 252, as discussed further below. A tapered or radiused inlet 434 may be provided at the distal opening 434 to receive a nose 440 of the distal valve actuator 252 to open the flap 326 of the valve disc, as discussed further below.

With further reference to FIG21A , distal opening 434 extends into distal retaining space 441 defined by valve skirt 412. Retaining space 441 is defined by a first inner section 442 having a first inner diameter and a second inner section 444 having a second inner diameter that is greater than the first inner diameter. A shoulder 446 is provided at the interface between first inner section 442 and second inner section 444. In an example, shoulder 448 may have a radius.

Referring again to FIG. 10 and continuing with FIG. 21A , the valve 136 can include a peripheral boundary between the proximal valve actuator 134 and the bushing 138 that can float within the lumen 130 of the catheter hub 102. For example, the peripheral boundary of the valve 136 can move proximally and distally within the lumen 130 of the catheter hub 102 and is not constrained by the hub in the axial direction of the catheter assembly, except for possible friction or contact with the hub. In an example, the cylindrical portion 430 of the skirt section 412 of the valve presses against the inner surface of the lumen 130 with a slight interference fit to form a seal therebetween. The generally flat outer profile of the cylindrical portion 430 can allow the valve 136 to move in the axial direction when urged by the proximal valve actuator 134 while maintaining concentricity with the opening of the catheter hub 102.

In some examples, the outer perimeter of the cylindrical section 430 of the valve 136 can be the same as, smaller than, or larger than the outer perimeter of the nose section 470 of the proximal valve actuator 134. The relative dimensions between the outer perimeter of the cylindrical section 430 of the valve and the proximal valve actuator 134 (e.g., the nose section 470) can be configured such that the valve actuator 134 can push against the proximal-facing surface 456 of the valve disc 410 to axially move the valve 136. Generally, the relative dimensions of the nose section 470 of the valve actuator 134 and the outer perimeter of the cylindrical section 430 are such that when the valve is pushed distally by a male medical device, the nose section 470 pushes against the proximal-facing surface 456 of the valve disc 410 closer to the outer perimeter than to the center or central portion 458 of the valve disc 410. Rather, the distal valve actuator 252 is configured to push against the valve disc 410 at a location closer to the center or central portion 458 of the valve disc 410 rather than the outer perimeter of the valve disc 410 , as discussed further below.

Because the valve 136 can float within the interior 130 of the catheter hub 102 (e.g., move axially along the longitudinal axis of the catheter hub), the valve can be positioned within the interior of a single-hub-body catheter hub 102. In other words, it is not necessary for the valve 136 to be retained within the interior of the catheter hub by two or more catheter hub bodies (e.g., along a seam between the two or more hub bodies). However, the various components described herein can readily be used with a multi-piece catheter hub without departing from the scope of the present disclosure.

Continuing with reference to FIG10 and FIG18A through FIG18D , the proximal valve actuator 134 includes a nose segment 470 that can be generally cylindrical and terminate in an actuating end 472. The actuating end 472 can have a blunt distal surface or a sharp edge. The nose segment 470 can have a wall surface with a continuous perimeter or a continuous bounding segment 580 without gaps or slits (such as a cylindrical member with a continuous wall). The nose segment 470 can define an aperture. In some examples, a plurality of spaced apart slits and/or openings can be provided on the nose segment 470 away from the continuous bounding segment 580 to permit flow or fluid flushing.

The two actuating elements or plunger elements 152 can extend proximally of the nose section 470. For example, the two plunger elements 152 can be integrally formed with the nose section 470 and can extend proximally from the nose section. A gap or space 154 can be provided between the two plunger elements 152 for positioning the needle guard or tip protector 132 therebetween. The gap for positioning the needle guard can be referred to as a holding space 474. The two plunger elements 152 can each include at least two longitudinal edges, and these edges can be spaced apart from each other. The longitudinal edges of the plunger elements 152 can be aligned with the longitudinal axis of the valve opener.

In the example, a protrusion 480 extends outward from an outer surface 482 of one or both plunger elements 152 ( FIGS. 18A-18D ). As shown, the protrusion 480 extends from the outer surface 482 of each plunger element 152. Each protrusion 480 resembles a ramp surface with a generally flat edge for abutting a shoulder 421 in the recessed section 420 ( FIG. 10 ) of the catheter hub 102 to constrain the valve actuator 134 from proximal movement. The ramped surface and the orientation of the ramp of the protrusion 480 allow the actuator 134 to be inserted into the interior 130 of the catheter hub 102 from the open end and seated within the recessed section 420, as discussed further below. Some embodiments of the valve actuator may utilize other shapes for the nose section 470, such as a cuboid, rectangular, conical, pyramidal, chamfered, and the like.

In examples, the valve actuator or valve opener 134 has a longitudinal axis, and the one or more actuating elements 152 extend axially or parallel to the longitudinal axis. In certain examples, the two actuating elements 152 are diametrically opposed to each other along the longitudinal axis. In other examples, the actuating elements 152 are unequally spaced around the perimeter of the nose segment 470. As shown in FIG. 18C , the two actuating elements 152 define an outer diameter having a size that is substantially similar to or the same as the diameter of the nose segment 470.

In an example, the actuator 152 is flexible and deflectable so that when pushed by the male Luer tip, the actuator can deflect or flex. The actuator 152 can be deflected by selecting a material with necessary resilience. In other examples, the actuator can be deflected by including one or more weakened sections, such as by including a structurally thin section, by including a notch, by adopting a smaller cross-section than other sections of the same elongated actuator, or a combination thereof. Alternatively, the actuator 152 can be flexible and can be deflected by selecting a material with necessary resilience and by including one or more weakened sections.

In yet other examples, each actuating element 152 has more than one different cross-sectional face or profile along a length segment.For example, an elongated plunger element may have a square face positioned adjacent to a crescent face.

In the example, the actuating elements 152 are rigid and cannot deflect or deform when loaded (e.g., when pushed by the male Luer tip). In addition, a stabilizing element can be included to increase the stiffness of the two actuating elements 152, as discussed further below. The two actuating elements 152 can each include a cross-sectional surface at least at a proximal end that overlaps with the pushing end of the male tip, so that the male tip can push the valve actuator into the valve 136, as previously discussed with reference to Figures 5C and 5D.

The nose section 470 of the valve actuator 134 can be configured to engage the valve 136 to open the valve disc 410 when an axial force is applied to the actuation element 152 from the male tip toward the distal end of the catheter assembly 400, such as during insertion of an IV drip line of a male luer connector. Typically, the nose section 470 is rigid relative to the more flexible valve 136, which allows the nose section 470 (and more specifically the actuation end 472) to actuate the valve 136, such as to deflect one or more flaps 326 and open one or more slits 324 on the valve disc 410. The nose section 470 can be made of an incompressible material (such as metal, rigid plastic, or hard elastomer) for pushing against and opening the valve.

The illustrated valve actuator embodiment 134 includes a pair of opposing straps or stabilizers 484, 484 (collectively or individually referred to as one or more stabilizers 484) that connect the two actuating elements 152 at locations along their lengths, located between the nose section 470 and the proximal-most end or end surface 486 of the valve actuator 134. In some examples, the stabilizers 484 can be located at the proximal ends of the two actuating elements 152 such that the proximal edges of the stabilizers 484 are substantially flush with the proximal end surfaces of the actuating elements. The two stabilizer elements 484, 484 can be referred to as a first or upper stabilizer element and a second or lower stabilizer element. The actuating elements 152 and/or the stabilizer elements 484 can be provided with one or more holes for molding purposes, such as for implementing a core pin.

In one embodiment, the stabilizer or stabilizer element 484 is arcuate, forming an arc that follows the inner contour of the catheter hub 102 and connects one actuating element 152 to the other actuating element 152. The stabilizer or stabilizer element 484 can form a substantially cylindrical section on the body of the valve actuator that is spaced apart from the nose section 470 of the valve actuator. In other words, the valve actuator 134 can be elongated and can have sections that are continuous in the radial direction and sections that have a relief or through-passage through the wall of the actuator that is discontinuous in the radial direction. As used herein, the terms "relief," "opening," and "through-passage" can be used interchangeably.

In an example, the stabilizer 484 defines a continuous body section 580 ( FIG. 18A ) along the perimeter or radial direction of the valve actuator 134 that is separated from the continuous body section of the nose section 470, which is also continuous along the perimeter or radial direction. Two stabilizers or stabilizer elements 484 can be coupled together with two plunger elements 152 to form a ring structure (referred to as a stabilization ring 490). Optionally, the two stabilizers 484 can be slightly offset and angled from each other, as shown in FIG. 18C . In some embodiments, there can be one, three, or a different number of actuating elements 152 or a different number of stabilizer elements 484. In an example, the valve actuator 134 (with the stabilizers or stabilizer elements 484 and the protrusions 480) is made of plastic (such as by plastic injection molding).

The stabilizer 484 can help the valve actuator 134 remain centered within the catheter hub 102 as the actuator 134 moves (such as when pushed by the male Luer tip after a successful venipuncture). By remaining centered, the nose section 470 can better align with the valve disc 410 (such as a slit on the valve disc), thereby allowing smooth actuation of the valve 136. The stabilizer 484 or stabilization ring 490 can also provide engagement with the interior of the catheter hub 102 via a friction or snug fit to prevent the actuator 134y from sliding in a proximal direction after the male Luer tip is removed.

In one embodiment, the nose section 470 is configured to push against the proximal-facing surface 456 ( FIG. 21A ) of the valve disc 410, and the distal valve opener 252 is configured to push against the distal-facing surface 457 of the valve disc 410 to open the slit 324 and deflect the flap 326. In an example, the nose section 470 of the proximal valve actuator 134 is configured to push against the outer region 460 of the proximal-facing surface 456 of the valve disc 410, and the distal valve opener 252 (such as the nose section 440 ( FIG. 10 ) of the distal valve actuator 252) is configured to push against the central region 458 of the distal-facing surface 457 of the valve disc 410 to open the slit 324 and deflect the flap 326.

A relief, opening, or through-passage 494 is provided between the nose segment 470 and the stabilization ring 490. The two reliefs or through-passages 494 provide clearance so that the interior or central portion of the valve actuator 134 can be in open communication with the inner surface of the catheter hub 102. In other words, one or two reliefs, through-passages, or openings 494 are located between a continuous section of the nose segment 470 and a continuous bounding section defined by the two stabilizers 444, 444 and the plunger element 152 (i.e., the stabilization ring 490 (Figures 18A-18C)). The nose segment 470 can define an aperture, and the stabilization ring 490 can define an aperture. The needle guard or tip guard 132 positioned in the retaining space 474 of the valve actuator 134 can at least partially protrude from the retaining space through the through passage 494 to alternatively contact the perimeter of the release portion 494 and contact the inner surface of the catheter hub, or contact the perimeter of the release portion 494 and contact the inner surface of the catheter hub, as further discussed below.

The stabilization ring 490 of the valve actuator 134 can have an inner diameter that is smaller than the diameter defined by the diagonal sections or elbows 304 of the two arms 288, 290 of the needle guard 132 when the two arms 288, 290 are biased outwardly by the sides of the needle shaft in the standby position. Thus, during installation of the needle guard 132 into the retaining space 474 of the valve actuator 134, the diagonal sections or elbows 304 of the needle guard 132 can be deflected to pass through the stabilization ring 490 and into the open area defined by the release 494.

When the tip guard 132 is positioned between the two plunger elements 152, the two distal walls 300, 302 ( FIG. 7 ) of the needle guard 132 (more specifically, the two diagonal sections or elbows 304) can be positioned in the reliefs 494 (as shown in FIG. 10 and discussed above) to engage guard engagement surfaces on the inner surface of the catheter hub 102. This allows the needle guard 132 to protrude from the retaining space 474 of the valve actuator 134 through the two reliefs 494 so that one or both elbows 304 engage a guard engagement surface of the catheter hub (such as a shoulder 421 in the recessed section 420 of the catheter hub 102, or other guard engagement surface in the catheter hub 102). Thus, the needle guard 132 can be retained within the interior of the catheter hub by protruding through the two releases 494 in the standby position and during needle withdrawal after a successful venipuncture, until the needle tip moves proximal to the two distal walls on the needle guard, at which time the needle guard 132 can be closed over the needle tip and removed with the needle, as discussed above with reference to FIG. 3 .

With further reference to Figures 18A to 18D, each stabilizer element 484 has a distal edge or first edge 496a and a proximal edge or second edge 496b. Instead of contacting the shoulder 421 of the recessed section 420 of the catheter hub or other guard-engaging surface within the catheter hub 102, the elbow 304 of the needle guard 132 can be spaced from the inner surface of the catheter hub or from the shoulder 421 and retained by the perimeter 544 of the two releases 494 (e.g., by the distal edges 496a of the two stabilizer elements 484). Thus, the perimeter 544 or distal edge 496a of one or both stabilizer elements 484 can provide a limiting surface to prevent premature activation of the needle guard 132 during needle withdrawal before the needle tip moves proximal to the two distal walls 300, 302 of the needle guard 132 (Figure 7). Thus, the release portion or through-passage 494 of the present valve actuator 134 can function as a choke point or limit point to restrict the needle guard from proximal movement until the needle guard 132 reduces its radial profile (e.g., after the needle tip moves proximal to the needle guard's distal walls 300, 302). In examples, the perimeter 584 of the through-passage 494 can function as a choke point to restrict proximal movement of the needle guard until after activation. In certain examples, one or both distal edges 496a of the stabilizer element 484 can function as a choke point. In other examples, a gap between the two inner surfaces of the two stabilizer elements 484 defines a choke gap that restricts premature activation of the needle guard.

In some examples, one or both stabilizer elements 484 can have a slit or channel, thereby dividing the arc of each stabilizing element into two segments with a gap or slit between the two segments. Even with slits in one or both stabilizer elements 484, the stabilizing ring 490 (which can be a discontinuous ring, similar to a ring with one or more grooves formed therethrough) can still provide a limiting surface to prevent premature activation of the needle guard 132 during needle withdrawal before the needle tip moves proximal to both distal walls 300, 302 ( FIG. 7 ). Furthermore, the two segments of each stabilizer element 484 can provide stability and reinforcement for both plunger elements 152 on the valve actuator 134.

The limiting surface of each distal edge 496a can be referred to as a limiting point, a choke gap, or a choke point, as described above, because it provides a rigid structure that prevents the needle guard from moving proximally unless or until the needle guard is first activated and radially collapses to reduce its radial profile and then slides proximally of the choke point. In an example, one or both elbows 304 ( FIG. 7 ) of the needle guard 132 can be limited by the choke point from moving in the proximal direction until one or both elbows of the needle guard deflect to reduce the radial profile of the needle guard. In an example, when the radial profile of the needle guard is reduced, the needle guard can slide from a distal position of the stabilization ring 490 through the opening defined by the stabilization ring to a proximal position of the stabilization ring.

The valve opener 134 can be made of a metal material or a plastic material. When made of a metal material, the valve opener 134 can be formed by bending or deep drawing, and the arcuate cross-section of the actuator element 152 can provide increased rigidity when pushed by the male Luer piece. When made of a metal material (such as one of the actuators of Figures 19A to 19D and Figures 20A to 20B), the stabilizer elements 484 can each be composed of two stabilizer segments with a slit or groove between the two segments. When using stabilization segments, the stabilization ring formed thereby can be discontinuous.

Each actuating element 152 can include at least two longitudinal edges, and ribs can be provided along one or both of the longitudinal edges of the actuating element to further increase structural rigidity. One or more gaps can be provided between any two actuating elements 152. The one or more gaps can provide a void or space for fluid to flow across them (such as during blood flushing or IV infusion). The gaps between the actuating elements 152 can define a holding space 474 to accommodate the tip protector 132, as discussed further below.

In some embodiments, in the standby position, most, if not all, of the tip guard 132 fits within a retaining space 474 ( FIGS. 18A-18D ) formed by the body of the actuator 134, between the two plunger elements 152, as shown in FIGS. 10 and 11 . This allows the catheter hub 102 to be more compact, as less longitudinal space is required within the hub to fit the actuator 134 and tip guard 132 together longitudinally or when the two only partially overlap in the axial direction. In FIGS. 11 and 12 , the tip guard 132 is shown fully fitted within the retaining space 474 of the actuator 134, further reducing the space or length required within the catheter hub 102. As shown, the proximal wall 280 of the needle guard 132 is substantially flush or coplanar with the proximal end surfaces 486 of the two plunger elements 152. In other examples, proximal wall 280 of needle guard 132 may be located distal to proximal surfaces 486 or proximal to these proximal surfaces.

When the tip guard 132 engages only the distal edge 446a of the release or through-passageway 494 in the actuator, no deformation or diameter change is required on the interior wall of the catheter hub 102, and the tip guard 132 can be positioned further proximally in the female luer taper section of the catheter hub while complying with international luer standards for conical fittings, and thus the overall length of the catheter hub 102 can be reduced.

Referring now to FIG. 15 in addition to FIG. 10 , the distal valve actuator or valve opener 252 of this embodiment includes a base 510, a leg extension 512, and a proximal tip or nose section 440. The base 510 can be sized to have an outwardly tapered feature to mate with the tunnel section of the bushing 138. In an example, the base 510 is sized to have a contact fit with the tunnel section of the bushing 138. For example, the base 510 can contact a proximally facing surface of the tunnel section of the bushing 138. The base 510 can have a rim 514 for wedging against the reduced neck section 424 at the distal lumen 130a of the catheter hub. As shown, the reduced neck section 424 prevents the rim 514 of the base 510 from displacing in the proximal direction.

In an example, the distal valve actuator 252 can be formed by a deep drawing process, allowing the base 510 to be deployed from the proximal end of a cylindrical tubular body or structure. The leg extension 512 can be elongated and extend in a proximal direction of the base 510 and terminate in a nose section or proximal tip 440. In an example, the leg extension 512 is generally cylindrical and defines an opening 518. The wall 520 defining the opening 518 can be continuous along the circumference. In some examples, a slit or slot can be provided in or through the wall 520 of the leg extension 512 to facilitate fluid flow across the wall 520 of the leg extension 512 (such as for irrigation). When a slit or slot is included, the distal valve opener or actuator 252 can have two or more leg extensions 512, each having a nose section or proximal tip.

In the illustrated embodiment, the proximal end of the leg extension 512 is folded to form a folded section 522 (similar to a pair of pants with a cuff). Thus, the folded section 522 includes two wall layers 520 and a rounded proximal edge 524 formed by folding the surface upon itself, which can be referred to as a folded edge. A shoulder 526 is provided at the interface between the leg extension 512 and the nose section 440.

As shown in FIG10 , in the standby position, the nose section 440 of the distal valve actuator 252 protrudes into the distal retaining space 441 ( FIG21A ) of the valve 136 , with the rounded proximal edge 524 either contacting or spaced apart from the distal-facing surface 457 of the valve disc 410 . In an example, a first inner section 442 of a certain inner diameter of the valve 136 contacts the outer surface of the wall 520 . In a specific example, the first inner section 442 of a certain inner diameter grips the outer surface of the wall 520 of the leg extension 512 . A seal can be provided between the first inner section 442 of the valve and the outer surface of the wall 520 of the distal actuator 252 . The seal can be a fluid-tight seal. The tension or interference provided by the first inner section 442 gripping the exterior of the wall 520 can be adjusted by selecting the inner diameter of the first inner section, the type of material of the seal (which can be made of polyisoprene or any suitable biocompatible elastomeric material), the durometer of the molded seal, and/or the length of the first inner section 442. In an alternative embodiment, no seal exists between the first inner section 442 and the exterior wall 520.

10 , the shoulder 526 at the nose section 440 of the distal valve actuator 252 is located distally of the shoulder 446 located between the first interior section 442 and the second interior section 444 of the distal holding space 441 of the valve 136. In the example, the folded section 522 (which has a diameter greater than the diameter of the leg extension 512) is located in the second interior section 444. When the folded section 522 is located in the second interior section 444, the wall 520 of the leg extension 512 can contact the first interior section 442. The shoulder 526 of the distal valve actuator 252 can contact or be spaced apart from the shoulder 446 inside the distal holding space 441 in the standby position.

FIG11 illustrates the needle assembly 400 of FIG10 during withdrawal of the needle 108 after intravenous access. As shown, the needle tip 110 has moved proximal to the distal walls 300, 302 of the needle guard, thereby removing the bias between the needle and the arms 288, 290 of the needle guard ( FIG7 ). The arms 288, 290 and the distal walls 300, 302 move radially to reduce the radial profile of the needle guard 132. For example, when the distal walls 300, 302 are no longer biased by the needle, the distance between the elbows 304 of the needle guard 132 decreases between the positions of FIG10 and FIG11 , reducing the radial profile of the needle guard 132. The radial profile at the elbows 304 is now smaller than the choke point defined by the distal edges 496a of the stabilization ring 490 of the proximal valve actuator 134. Furthermore, because the proximal wall 280 on the needle guard 132 remains unchanged, the radial dimension of the needle guard segment distal to the stabilization ring 490 is smaller than the radial dimension of the proximal wall 280 proximal to the stabilization ring 490 .

As the needle 108 moves further in the proximal direction, the profile change 144 on the needle engages the proximal wall 280 of the needle guard 132 to remove the needle guard from the catheter hub with the needle, as previously discussed. In the example, the proximal movement of the needle 108 causes the distal walls 300, 302 and two elbows 304 of the needle guard 132 to move through the opening defined by the stabilization ring 490 of the proximal valve actuator 134 and out of the proximal opening of the catheter hub 102.

In an example, once the needle 108 is removed from the valve disc 410, the valve 136 is closed, as shown in FIG11 . In some examples, when the valve is closed as shown, there may or may not be a slight gap or fluid leakage through the slit 324. However, leakage, if any, is minimal, and provides the medical practitioner with sufficient time to prepare the catheter hub 102 for fluid transfer without the risk of fluid flowing out of the open proximal end of the catheter hub when the valve is closed. In an example, blood backflow from the patient can accumulate in the distal retaining space 441 of the valve 136. Because a fluid-tight seal can be provided between the leg extension 512 of the distal valve actuator 252 and the first interior section 442 of the valve 136, the distal lumen 130a of the catheter hub 102 can be relatively free of any blood backflow.

FIG12 is similar to FIG11 , with the perspective rotated 90 degrees. As shown, the two elbows 304 of the needle guard are recessed into the retaining space 474 of the proximal valve actuator 134, so that once the needle tip 110 moves proximal of the two distal walls 300, 302 of the needle guard 132, it moves radially inward from the release portion 494 into the retaining space 474.

FIG13 is a partial cross-sectional side view of the needle assembly 400 of FIG10 , with the needle and needle hub completely removed from the catheter hub 102 and a male medical device 530 inserted into the proximal opening of the catheter hub 102. The male medical device 530 can be a male Luer tip of a syringe or an IV tubing adapter. As shown, the distal end 532 of the male tip 530 contacts the proximal surface 486 of the proximal valve actuator 134, but the male Luer tip of the tip and the female Luer tip of the catheter hub are not seated or aligned with each other. In other words, the male Luer tip 530 can still be advanced further distally into the catheter hub 102 from the position shown in FIG13 to push the valve disc 410 of the valve 136 into the distal valve opener 252.

FIG14 is similar to FIG13 , but with the male medical device 530 fully inserted into the proximal opening of the catheter hub 102 and the proximal valve opener 134 advanced distally and forward to further axially urge the valve forward distally against the distal valve opener 252. In the example, the stabilization ring 490 provides a bearing surface or support for the proximal valve actuator 134 as it moves. The nose section 470 of the actuator 134 presses against the outer periphery of the proximal-facing surface 456 of the valve disc 410 to axially move the valve 136. As shown, the cylindrical section 430 of the valve skirt 412 slides axially against the inner surface of the lumen 130. In the example, the valve skirt 412 is urged distally until the frustoconical section 432 of the valve skirt 412 contacts the reduced neck section 424 of the catheter hub 102. In another example, the registration of the two luer surfaces prevents the male tip 530 from moving the valve skirt into contact with the reduced neck section 424 .

In the example, when the valve 136 is moved distally by the proximal valve opener 134, the valve disc 410 slides over the leg extension 512 and the nose section 440 of the distal valve opener 252, and the distal valve opener 252 pierces the slit 324 and deflects the flap 326 (Figures 21A-21C). In the example, the flap 326 deflects proximally and radially when actuated. That is, when the valve skirt 412 and valve disc 410 are actuated by the proximal valve opener 134 (proximal valve opener 134 is moved distally and forwardly by the male luer tip 530), the flap 326 of the valve disc 410 deflects proximally and radially, in the opposite direction of movement of the valve skirt 412. In examples, when the valve is actuated by both the proximal and distal valve actuators, a portion of the two or more flaps 326 of the valve are located between the nose section 470 of the proximal valve opener 134 and the leg extension 512 of the distal valve opener 252. In some examples, when the valve is actuated by both the proximal and distal valve actuators, a portion of the two or more flaps 326 of the valve 136 are located between the nose section 470 of the proximal valve opener 134 and the nose section 440 of the distal valve opener 252.

In examples, needle device 400 has a disposable valve actuation mechanism or single-use because, upon removal of male Luer tip 530, valve 136 does not return to its closed position, similar to that shown in Figures 11 or 13. In some examples, when male Luer tip 530 is removed, proximal valve actuator 134 similarly does not return to its non-actuated position, as shown in Figures 10 and 11. As shown, when valve 136 is actuated, nose section 440 of distal valve actuator 252 moves a certain penetration distance into the valve and toward the proximal side of valve disc 410, such that friction and other constraints prevent them from separating.

In other embodiments, the nose section 440 of the distal valve actuator 252 can be configured such that when the valve disc 410 is pushed into the nose section 440 of the distal valve actuator 252 during activation, the distal actuator's actuating or activating end 524 does not extend too far proximal of the plane defined by the valve disc 410 of the valve 136. This configuration can ensure that the valve 136 is pushed back in a proximal direction by the flaps 326 when the flaps 326 return to their more relaxed state upon removal of the male luer device 530. The conical configuration at the nose section 440 of the distal valve actuator 252 can be such that it maintains an axially directed force vector that is greater than the perpendicular force vector. The angle of the cone can be designed to provide the necessary force vectors when the distal actuator 252 has reached its maximum proximal travel and its minimum proximal travel. The difference between the maximum and minimum travel of a standard Luer connector is approximately 2.5 mm. Therefore, current and future ISO standards for male standard Luer connectors can be consulted or considered when designing the angle of the actuator taper to ensure that separation between the valve and the distal valve actuator is achieved.

Alternatively or additionally, a resilient element (such as a spring or elastic element or ring) can be included in the distal chamber 130a of the catheter hub 102 to increase the springback or restoring force of the valve 132, thereby facilitating the pushing of the valve 136 and the proximal valve actuator 134 in a proximal direction and away from the distal valve actuator 252 to return to the pre-activated or valve-closed position after the male tip 530 is removed. The resilient element 276 (which can be similar to the elastic element or coil spring of FIG. 1 ) can also assist in closing the flaps of the valve disc. In this way, after initial activation, the valve 132 can be reclosed and the proximal valve actuator 134 can be returned to the proximal position and reopened, and so on. Alternatively or additionally, the flaps 326 can be made thicker to provide sufficient restoring force without the need for the resilient element 276.

FIG16 is a perspective view of a bushing 640 according to another aspect of the present disclosure. The structure of FIG16 may be considered a distal actuator according to another aspect of the present disclosure. However, the structure of FIG16 may be considered a combination of a bushing and distal actuator 640. As shown, the combined structure 640 of FIG16 has a bushing end 642 and an actuator end 644, which may be considered a distal valve opener 644. In an example, the bushing end 642 has a sleeve 648 and a base 650, which may have a tunnel shape for wedging the proximal end of the catheter tube against the interior of the catheter hub 102. The valve actuator end 644 may include a base 652, a shoulder 654, a leg extension 512, and a nose section 440, and may be similar to the valve actuator 252 of FIG15.

In an example, the combined structure 640 of FIG. 16 (which may alternatively be referred to as a bushing or valve actuator) can be integrally formed from a metal material, such as by deep drawing. Alternatively, the combined structure 640 can be formed from two or more separately formed components that are subsequently attached to one another (such as by crimping or welding). When inserted into the catheter hub to secure the catheter tubing, as shown in FIG. 17 , the base 650 of the bushing end 642 can wedge against a shoulder inside the opening of the nose section 103, and the base 652 of the actuator end 644 can wedge against the inner surface of the opening. In some examples, the leg extension 512 can include a slit or slot. If included, the distal valve actuator or valve opener 644 can have two or more leg extensions, each with a nose section or proximal actuation tip.

FIG17 is a partial cross-sectional side view of a needle assembly having the assembly 640 of FIG16 , shown without the needle for clarity. As shown, the hub end 642 secures the catheter tubing 104 to the nose section 103 of the catheter hub 102, and the actuator end 644 protrudes into the distal retaining space 441 of the valve 136, similar to the embodiments described above, such as with reference to FIG10 and FIG11 . Also shown are the needle guard 132 and the proximal valve opener 134, which are similar to those of FIG10 and FIG11 . The needle hub 106 is shown contacting the catheter hub 102 but without the needle for clarity; if shown, the needle would protrude from the distal end of the needle hub and pass through the catheter hub 102, the proximal valve actuator 134, the valve 136, the assembly 640, and the catheter tubing 104.

Referring now to Figures 18A and 18C, a perspective view and a top view or plan view of the valve opener or actuator 134 are shown. The valve opener 134 can be used with any needle assembly described elsewhere herein (such as, for example, those shown in Figures 10 to 14 and 17). As shown, the valve actuator 134 has a nose section 470 defining an orifice and an actuating end 472. Two plunger elements 152 extend proximally of the nose section 470. The nose section 470 defines a first continuous bounding section 580. Other locations of the nose section 470, distal to the first continuous bounding section 580, may include slits or slots.

Two stabilizer elements 484, 484 are attached to the two plunger elements 152 to form a stabilization ring 490, as previously discussed. The stabilization ring 490 defines a second continuous confining section 582 of the valve actuator and has an aperture. Each stabilizer element 484 may include two edges 496a, 496b. In the example, the two edges 496a, 496b of each stabilizer element may be parallel to each other. As shown, the two stabilizer elements 484 are skewed or inclined so that although the two edges 496a, 496b of each stabilizer element may be parallel to each other, the two edges 496a, 496b from one stabilizer element are not parallel to the two edges 496a, 496b of the other stabilizer element. As shown, the proximal edges 496b of the two stabilizer elements 484 are offset in the axial direction or longitudinal direction of the valve actuator. As shown, the distal edges 496a of the two stabilizer elements 484, 484 are offset in the axial direction.

Two releases or two through passages 494 are provided on the valve opener 134, each of which is defined or bounded by a first continuous bounded section 580, two plunger elements 152, and a stabilizing ring 490. The two releases or through passages 494 may be referred to as a first release or first through passage and a second release or second through passage. In the example, each release or through passage has a boundary 584. In the example, each boundary 584 may be defined by the structure of the continuous bounded section 580, the two plunger elements 152, and the corresponding stabilizer elements 484, 484. Because the two stabilizer elements 484, 484 may be tilted or inclined in different directions, the two boundaries 584 of the two releases or through passages 494 may be different, such as having different boundary profiles or shapes. As shown, the two boundaries 584 are each defined by a continuous ring. In other words, in this embodiment, the boundaries 584 do not have slits or slots to form open boundaries. However, where the stabilizer element 484 includes a slot or slit, the perimeter may be an open perimeter or a discontinuous perimeter.

In some examples, the two stabilizer elements 484, 484 can extend laterally without being skewed or tilted in the distal or proximal direction. When so constructed, the edges 496a, 496b of the two stabilizer elements 484, 484 are parallel to each other. In addition, the four edges 496a, 496b of the two stabilizer elements 484, 484 can be parallel to each other and axially offset. In other words, the proximal edge 496b of one stabilizer element can be located more proximal or distal than the proximal edge 496b of another stabilizer element, while the four edges are parallel to each other. The stabilizer element 484 and/or the plunger element 152 may include one or more holes for achieving manufacturing purposes, such as, for achieving a core pin.

18A and 18C , two plunger element pegs or extensions 152a are shown extending proximally of the stabilization ring 490. In examples, the two plunger element pegs 152a can extend from the stabilization ring 490 and be axially aligned with the plunger elements 152 located distally of the stabilization ring 490. In other examples, the two plunger element pegs 152a are not axially aligned with the two plunger elements 152 located distally of the stabilization ring 490. In still other examples, only one plunger element peg 152a is aligned with one of the two plunger elements 152. For a valve opener or actuator having only one plunger element 152 between the first and second continuous confining sections, only one of the two plunger element pegs 152a, or neither of the plunger element pegs, can be aligned with the one plunger element.

In some examples, there may be more than two plunger element pegs or extensions 152a extending proximally of the stabilization ring 490. The two or more plunger element pegs or extensions 152a may be equally spaced around the proximal perimeter of the stabilization ring 490 or randomly spaced around the proximal perimeter of the stabilization ring 490. The plunger element pegs may extend the total length of the valve actuator. A certain number of plunger element pegs and/or a certain curvature of each plunger element peg (the curvature defining the width of each plunger element peg) may provide a greater overlap surface with the male luer tip than a fewer number of plunger element pegs or plunger element pegs having a relatively smaller curvature.

Still further referring to FIG18C, the two plunger elements 152 are each shown having a protrusion 480 on an outer surface 482 of each plunger element 152. As previously described, the two protrusions 482 can be located within the recessed section 420 (FIG. 10) of the catheter hub 102 so that a shoulder 421 at the proximal end of the recessed section 420 can provide a stop surface to prevent displacement of the valve opener 134 in the proximal direction. In some examples, only one protrusion 480 is used on one of the two plunger elements 152 to prevent displacement of the valve opener 134 in the proximal direction. The protrusion 480 can be formed at the location of the protrusion 480 by adding material to the plunger element during injection molding.

Referring now to Figures 18B and 18D, which are side views and a cross-sectional view of the valve opener 134 of Figure 18C taken along line 18D-18D, there is shown a retaining space 474, which can be located between two plunger elements 152, within the interior of the stabilization ring 490, between two plunger element pegs 152a, or a combination thereof. As previously described, a portion or all of the needle guard or tip guard 132 can be located in the retaining space 474 in the standby position, and one or both elbows 304 of the tip guard 132 (Figure 7) can protrude from the release portion(s) 494.

The proximal wall 280 ( FIG. 7 ) of the needle guard 132 can be flush with the proximal end surface 486 of the plunger element post 152 a, located proximal to the end surface 486, or located distal to the end surface 486. If a plunger element post is not included, the proximal wall of the needle guard 132 can be flush with the proximal edge of one or both stabilizer elements 484, 484, located proximal to the proximal edge of one or both stabilizer elements 484, 484, or located distal to the proximal edge of one or both stabilizer elements 484, 484.

Still further referring to FIG. 18D , the distance between the two inner surfaces 586 of the two stabilizer elements 484, 484 defines a choke gap, choke point, or limit point for the needle guard to limit proximal movement of the needle guard in the standby position and/or during needle withdrawal after intravenous access, as previously discussed. That is, before the needle tip moves proximal to one or both distal barrier walls of the needle guard, the choke point or gap is too small for the needle guard to pass through to reach proximal to the choke point or limit point. However, after the needle tip moves proximal to one or both distal barrier walls of the needle guard, the two distal walls move radially inward to reduce the radial profile of the needle guard to a smaller profile than the choke point. At that point, the radial profile measured at the two elbows of the needle guard is smaller, so the needle guard can move proximal to the choke point.

Referring now to Figures 19A and 19B, perspective and side views of a valve opener or actuator 700 according to an alternative aspect of the present disclosure are shown. The valve opener 700 can be used with any of the needle assemblies disclosed elsewhere herein, such as a proximal valve opener spaced apart from the hub 138. As shown, the valve actuator 700 has a nose section 470 defining an aperture and two plunger elements 152 extending proximally of the nose section 470. The actuating end is located at the distal end of the nose section. The nose section 470 defines a first continuous bounding section 580. Other locations of the nose section 470, distal to the first continuous bounding section 580, may include slits or slots.

Two stabilizer elements 484, 484 are attached to the two plunger elements 152 to form a stabilization ring 490. Each stabilizer element 484 may include two edges 496a, 496b, which may be referred to as a distal edge 496a and a proximal edge 496b. In an example, the two edges 496a, 496b of each stabilizer element are parallel to each other. The two edges 496a, 496b from one stabilizer element 484 are also parallel to the two edges 496a, 496b of the other stabilizer element. As shown, the proximal edges 496b of the two stabilizer elements 484, 484 are aligned along the axial direction or longitudinal direction of the valve actuator. As shown, the distal edges 496a of the two stabilizer elements 484, 484 are also aligned along the axial direction. In other examples, the edges of the two stabilizer elements 484 may also be offset axially. In some examples, two stabilizer segments with a slit or groove therebetween may be used instead of a single stabilizer element 484.

Two releases or two through passages 494 can be provided on the valve opener 700, each defined by or bounded by a continuous bounding section 580, two plunger elements 152, and corresponding stabilizer elements 484, 484. The two releases or through passages 494 can be referred to as a first release or first through passage and a second release or second through passage. In an example, each release or through passage has a boundary 584. In an example, each boundary 584 can be defined by the structure of the continuous bounding section 580, two plunger elements 152, and corresponding stabilizer elements 484. The two boundaries 584 of the two releases or through passages 494 can be the same (as shown), or can have different boundary profiles or shapes.

The valve opener 700 of the present embodiment can be made of a metal material. For example, a stamped metal sheet (such as a stamped stainless steel sheet) can be cold worked using a deep drawing method to form the shape shown. Various openings or gaps can be punched or stamped and then cold worked to form the disclosed shapes. Each plunger element 152 includes at least two longitudinal edges, and ribs can be provided along one or both of these longitudinal edges to further increase the structural rigidity. One or more gaps 154 can be provided between any two plunger elements 152. The gap 154 can provide a gap or space for a fluid flow to flow across it, such as during an IV infusion. The gap 154 can also be used to accommodate a needle guard 132, as shown in Figures 1 and 10.

FIG19C is a top view of the actuator of FIG19B , rotated 90 degrees. Two plunger element posts or extensions 152 a are shown extending proximally of the stabilization ring 490. In examples, the two plunger element posts 152 a can extend from the stabilization ring 490 and be axially aligned with the plunger elements 152 located distally of the stabilization ring 490. In other examples, the two plunger element posts 152 a are not axially aligned with the two plunger elements 152 located distally of the stabilization ring 490. In still other examples, only one plunger element post 152 a is aligned with one of the two plunger elements 152.

In some examples, the valve opener 700 terminates at the stabilization ring 490 and the actuator is free of any plunger element pegs 152a. In still other examples, each plunger element peg 152a located proximal to each plunger element can be considered part of the same plunger element, and the stabilizer element 484 extends radially from both longitudinal edges of the two plunger elements 152 to a position distal to the proximal surface 486.

In some examples, there may be more than two plunger element pegs or extensions 152a extending proximally of the stabilization ring 490. The two or more plunger element pegs or extensions 152a may be equally spaced around the proximal perimeter of the stabilization ring 490 or randomly spaced around the proximal perimeter of the stabilization ring 490. The plunger element pegs may extend the overall length of the valve actuator 700. A certain number of plunger element pegs and/or a certain curvature of each plunger element peg (the curvature defining the width of each plunger element peg) may provide a greater overlap surface with the male luer tip than a fewer number of plunger element pegs or plunger element pegs with a relatively less curvature. In some examples, the plunger element pegs 152a have curved surfaces, which may be similar to the curved surfaces of the plunger elements of Figures 5C and 5D, wherein the concave and convex surfaces of these plunger elements may face inward or outward in either direction relative to the longitudinal axis of the valve actuator.

Still further referring to FIG19C, the two plunger elements 152 each include a protrusion 480 on an outer surface 482 of each plunger element. As previously described, the two protrusions 480 can be located inside the recessed section 420 (FIG. 10) of the catheter hub so that the shoulder 421 at the proximal end of the recessed section 420 can provide a stop surface to prevent displacement of the valve opener 700 in the proximal direction. In some examples, only one protrusion 480 is used on one of the two plunger elements 152 to prevent displacement of the valve opener 700 in the proximal direction. In examples, each protrusion 480 can be formed on the corresponding plunger element by cold working the surface of a stamped metal sheet to push out a protruding surface.

19D , which is a cross-sectional side view of the valve opener 134 of FIG. 19C taken along line 19D-19D, the nose section 470 is seen converging to form a neck having two rounded sections 702 that enter into the plunger element 152. Each plunger element 152 extends in a proximal direction at a generally constant width and then flares to have a second set of rounded sections 704 that transition into the stabilizer segment 484. A recessed surface 710 forming one of the protrusions 480 is shown on the plunger element 152.

Another pair of rounded sections 706 are located proximal to the stabilizer segment 484 to form the plunger element pile 152a. Both the plunger element 152 and the plunger element pile 152a have two spaced-apart longitudinal edges that may be provided with ribs to add strength to the respective structures. Starting approximately within the stabilization ring 490 and extending in the proximal direction, each plunger element pile 152a may be raised outwardly relative to the longitudinal axis to have an outwardly raised portion 714 to form a curved surface along the cross-section of each pile 152a. The raised portion 714 may also be formed inwardly to form an inwardly raised portion. This feature may be included to form concave and convex surfaces of the plunger element pile, as previously discussed with reference to Figures 5C and 5D.

19C and 19D , a retaining space 474 is shown, which can be located between two plunger elements 152, within the interior of the stabilization ring 490, between two plunger element pegs 152 a, or a combination thereof. As previously described, a portion or all of the needle guard or tip protector 132 ( FIG. 7 ) can be located in the retaining space 474 in the standby position, and one or both elbows 304 of the tip protector 132 can protrude from the release portion 494.

The proximal wall of the needle guard 132 ( FIG. 7 ) can be flush with the proximal end surface 486 of the plunger element post 152 a, located proximal to the end surface 486, or located distal to the end surface 486. If a plunger element post is not included, the proximal wall of the needle guard 132 can be flush with the proximal edge 496 b of one or both stabilizer elements 484, located proximal to the proximal edge 496 b of one or both stabilizer elements 484, or located distal to the proximal edge 496 b of one or both stabilizer elements 484.

Still further referring to FIG. 19D , the distance between the two inner surfaces 486 of the two stabilizer elements 484, 484 defines a limit point, choke gap, or choke point for the needle guard to limit proximal movement of the needle guard in the standby position and/or during needle withdrawal after intravenous access, as previously discussed. That is, before the needle tip moves proximal to one or both distal stop walls 300, 302 of the needle guard 132 ( FIG. 7 ), the choke point or gap is too small for the needle guard to pass proximal to the choke point. However, after the needle tip moves proximal to one or both distal stop walls of the needle guard, the two distal walls move radially inward to reduce the radial profile of the needle guard to a smaller profile than the choke point. At that point, with the radial profile measured at the two elbows 304 ( FIG. 7 ) smaller, the needle guard can move proximal to the choke point.

FIG20A is a perspective view of a proximal valve opener or actuator 760 provided in accordance with further aspects of the present disclosure. FIG20B is an end view of the valve actuator 760 of FIG20A , looking toward the nose section 470. The valve actuator 760 can be used with any of the needle devices discussed elsewhere herein, such as the needle devices of FIG1 and FIG10 .

With a few exceptions, the present valve actuator 760 is similar to the valve actuator of Figures 19A to 19C. In this embodiment, similar to the nose segment 440 of the distal actuator 252 of Figure 15, the nose segment 470 is formed by folding the wall layer to produce the folded segment 762. The end surface 764 of the folded layer ends roughly between the nose segment 470 and the stabilization ring 490. In the example, the end surface 764 is positioned closer to the stabilization ring 490 than to the nose segment 470, but the final position is not limited to this. In the example, the end surface 764 defines a shoulder 766 on each of the two plunger elements 152. The two shoulders 766 can provide a similar function to the protrusion 480 on the valve actuator 700 of Figures 19A to 19D.

In an example, a cutout or notch 780 can be provided at the folded edge 782 of the nose section 470. Alternatively, the notch 780 can be omitted. The notch 780 can be provided to permit flow, such as for flushing and reducing or eliminating fluid stagnation. In an example, eight equally spaced notches 780 can be provided at the folded edge 782. In other examples, fewer than eight or more than eight notches 780 can be provided, and the notches can be randomly spaced along the folded edge 782.

Figures 21A through 21C illustrate different views of the seal 136 according to aspects of the present disclosure. Figure 21A illustrates a cross-sectional side view of the valve. Figure 21B illustrates a perspective view of the valve. Figure 21C is a front view of the valve, looking toward the valve skirt 412 and the opening 434 at the distal end of the valve skirt.

Methods of making and using catheter assemblies and components thereof described elsewhere herein are within the scope of the present disclosure.

While limited embodiments of catheter assemblies and components thereof have been specifically described and illustrated herein, numerous modifications and variations will be apparent to those skilled in the art. For example, the needle guard may be one-piece or may be comprised of more than one part (e.g., multiple parts). Furthermore, it is understood and contemplated that features specifically discussed with respect to one catheter assembly or component may be incorporated into another catheter assembly or component, provided that the functionality is compatible. Therefore, it will be understood that catheter assemblies and components constructed in accordance with the principles of the disclosed devices, systems, and methods may also be embodied in manners other than those specifically described herein. The valves and valve openers described herein may also be used with a needle hub by positioning them within the female luer taper of the hub. The valves and valve openers may also be used in female connectors of infusion needles, blood collection devices, central venous catheters, or peripherally inserted central lines (PICCs). In other words, the valves and valve openers may be used in any medical device intended to infuse or collect bodily fluids using a female luer housing or hub. The present disclosure is also defined in the appended claims.

Claims (17)

1. A needle assembly (100, 400), comprising: A needle hub (106) having a needle (108) extending from the distal end of the needle hub (106). The catheter body (104) is attached to the catheter hub (102) in a standby position and the needle extends through the catheter body (104). A valve (136) is positioned in the cavity (130) of the conduit hub (102), the valve (136) including an axially floating outer boundary when moved by a proximal valve opener (134, 700, 760), the proximal valve opener (134, 700, 760) also being positioned in the cavity (130) of the conduit hub (102) and proximal to the valve (136); The distal valve opener (252, 644) includes a leg extension (196, 512) extending proximally along the base of the bushing (138, 642); and The needle protector (132) includes a proximal wall (280) having an opening (284) through which the needle (108) passes, and the needle protector (132) is at least partially located in the holding space of the proximal valve opener (134, 700, 760). 2. The needle assembly according to claim 1, wherein the leg extensions (196, 512) of the distal valve opener (252, 644) are axially fixed inside the cavity (130) of the catheter hub (102). 3. The needle assembly according to any one of claims 1-2, wherein the valve (136) comprises three slits (324) and three flaps (326), and wherein the distal valve opener (252, 644) comprises three spaced leg extensions (196, 512). 4. The needle assembly according to claim 3, wherein the three leg extensions (196, 512) are aligned with the three flaps (326). 5. The needle assembly according to any one of claims 1-2 and 4, wherein the proximal valve opener (134, 700, 760) has a nose-shaped section (150, 470) sized to abut against the proximal surface (319, 456) of the valve (136). 6. The needle assembly according to any one of claims 1-2 and 4, wherein the proximal valve opener (134, 700, 760) has two release portions, openings or through passages (61, 494), and wherein the needle protector (132) has two elbows (304), each elbow extending at least partially through the corresponding release portion, opening or through passage (61, 494). 7. The needle assembly according to any one of claims 1-2 and 4, wherein the proximal valve opener (134, 700, 760) has a first continuous boundary section (580) spaced apart from a second continuous boundary section (151, 582). 8. The needle assembly according to any one of claims 1-2 and 4, wherein the valve (136) includes a skirt section (412) extending distally to the valve disc (410). 9. The needle assembly according to any one of claims 1-2 and 4, wherein the base of the bushing (138, 642) and the leg extension (196, 512) are integrally formed. 10. The needle assembly according to any one of claims 1-2 and 4, wherein the proximal valve opener includes two stabilizer elements (253, 484) connecting two plunger elements (152), and wherein the gap between the two stabilizer elements (253, 484) defines a choke point for limiting proximal movement of the needle protector (132). 11. A method for manufacturing a needle assembly (100, 400), comprising: A catheter hub (102) is provided having a catheter body (104) with a distal opening (112), the catheter hub (102) including a hub body defining an inner lumen (130) and a proximal opening; The bushings (138, 642) are positioned inside the catheter hub (102) and abut against the catheter body (104), and the valve (136) is positioned proximal to the bushings (138, 642) and proximal to the leg extensions (196, 512), the leg extensions (196, 512) having nose-shaped sections (204, 440) for abutting the distally facing surfaces (323, 457) of the valve (136); the valve is axially displaceable within the lumen (130) of the catheter hub (102) along the axial direction of the catheter hub (102) and includes two or more flaps (326). The proximal valve opener (134, 700, 760) is positioned proximal to the valve (136) and inside the cavity (130) of the guide hub (102); The needle (108) attached to the needle hub (106) is positioned to pass through the catheter hub (102), the valve (136), and the catheter body (104), such that the tip (110) of the needle (108) extends from the distal opening (112) of the catheter body (104); and Position the needle protector (132), which includes a proximal wall (280) having an opening (284) through which the needle (108) passes, and the needle protector (132) is at least partially located in the holding space (155, 474) of the proximal valve opener (134, 700, 760). 12. The method of claim 11, further comprising: positioning the elbow (304) of the needle protector (132) through a release portion, opening, or through passage (61, 494) of the proximal valve opener (134, 700, 760). 13. The method according to claim 11 or 12, wherein the leg extension (196, 512) is integrally formed with the bushing (138, 642). 14. The method according to claim 11 or 12, wherein the proximal valve opener (134, 700, 760) has a nose-shaped section (150, 470) sized to abut against the proximal surface (319, 456) of the valve (136). 15. The method according to claim 11 or 12, wherein the proximal valve opener (134, 700, 760) has a first continuous boundary section (580) spaced apart from a second continuous boundary section (151, 582). 16. The method according to claim 11 or 12, wherein the proximal valve opener includes two stabilizer elements (253, 484) connecting two plunger elements (152), and wherein the gap between the two stabilizer elements (253, 484) defines a choke point for limiting proximal movement of the needle protector (132). 17. A catheter assembly (100, 400), comprising: A needle hub (106) having a needle (108) having a needle tip (110) extending from the distal end of the needle hub (106). The catheter body (104) is attached to the catheter hub (102) in a standby position and the needle extends through the catheter body (104). The valve (136) includes a valve disc (137, 410) positioned in the cavity (130) of the conduit hub (102), the valve including two or more flaps (326). The first valve opener (252, 644) is located on the far side of the valve disc (137, 410); The second valve opener (134, 700, 760) is positioned proximal to the valve disc (137, 410); and A needle protector (132) includes a proximal sidewall (280) having an opening (284) through which the needle (108) passes, the needle protector being configured to cover the needle tip (110) in a protected position, the needle protector being at least partially located in the holding space (155, 474) of the second valve opener (134, 700, 760).