HK1258005B - Catheter devices with valves and related methods - Google Patents

Description

Conduit devices with valves and related methods

Technical Field

The disclosed inventions generally relate to needle devices, arterial catheters, 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 Technology

IV catheters are commonly used for a variety of infusion therapies, including infusing fluids into a patient, aspirating 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 an IV tubing to the catheter. Blood control catheters include an internal blood control valve, which is opened by inserting a male Luer or other object into the proximal end of the catheter adapter. A non-limiting example of a blood control valve is disclosed in U.S. Patent Application Publication No. 2011/0046570, filed August 20, 2009, entitled "Systems and Methods for Providing a Fluidable Catheter Assembly". After the catheter is placed in a patient's blood vessel, an IV fluid source can be connected to the catheter adapter or catheter hub to open the blood control valve. Once connected, fluid from the IV source can begin to flow through the catheter into the patient.

As is well known in the art, typical blood pressure is 10 to 20 cmH2O. The infusion pack is typically placed approximately 100 cm above the patient's heart to direct the flow into the patient's body. Roughly at that height, the pressure exerted by the fluid from the infusion pack is much greater than the patient's blood pressure, and therefore allows it to flow into the patient's body.

Some catheter adapters allow for verification of proper catheter placement within the vessel before fluid infusion begins, such as by providing a reflux chamber in the catheter assembly in which blood “backflow” can be observed. To confirm reflux in catheter assemblies that do not include a blood control valve, clinicians must manually occlude the vein to prevent unintended blood exposure. In contrast, a blood control valve eliminates the need for this manual occlusion while also reducing the likelihood of blood exposure during catheter placement.

Summary of the Invention

One aspect of this disclosure may include providing a compact design for the valve housing of a Luer element activated valve.

Another aspect of this disclosure may include providing a relatively robust construction for use with a high-pressure injection apparatus.

Other aspects of this disclosure may include providing opportunities to improve current levels of blood control technology or providing a closed-system infusion device including an intravenous catheter.

As described, the needle assembly of this disclosure may include a number of different components. The needle assembly may include: a needle hub having a needle extending from a distal end of the hub; a catheter body attached to the hub in a standby position, allowing the needle to extend through the catheter body; and a valve positioned within the lumen of the hub, the valve including an axially floating outer boundary that can also be positioned within the lumen of the hub and proximal to the valve. A distal valve opener may be further provided, having two or more leg extensions extending proximally along the body of the bushing. The valve may be actuated by both the proximal and distal valve openers.

The valve may have an outer boundary that is axially fixed within the conduit hub. The valve can be opened using only a proximal valve opener. For example, the proximal valve opener can be inserted into the valve via the tip of a male Luer element to deflect one or more discs on the valve.

Any part of the valve can be axially fixed through the inner surface structure of the guide hub.

In the needle assembly, two or more leg extensions of the distal valve opener can be axially fixed inside the inner cavity of the catheter hub.

In the needle assembly, the valve may include three slits and three flaps, and the distal valve opener may include three leg extensions. These three leg extensions may have axially extending edges spaced apart from each other. These axially extending edges may be parallel to each other.

In the needle assembly, the three leg extensions can be aligned with the three valve discs.

In the needle assembly, the proximal valve opener may include a ring or nose-shaped section and two plunger elements with a gap between them. The ring or nose-shaped section may include an activation or actuation end. A stabilizer ring may be located proximal to the nose-shaped section. The stabilizing ring may have a continuous boundary section defining an opening.

The nose section of the valve opener may include a continuous boundary section.

A valve opener may include one, two or more relief or through passages.

A needle protector located within the holding space of the valve opener may extend through the release section or through passage of the valve opener to contact the interior of the guide hub or the enclosure of the release section or through passage. The needle protector may also protrude through one or both release sections of the valve opener without contacting the interior of the guide hub or any enclosure of the valve opener.

When the needle protector is positioned within the holding space of the valve opener, the needle protector may have a proximal sidewall flush with the nearest end of the valve opener, positioned either distal to or proximal to the nearest end. When positioned in this manner, the elbow of the needle protector may protrude through the release portion or through passage of the valve opener. If the needle protector has two elbows on two deflectable arms, then the two elbows may protrude through two release portions of the valve opener (one elbow for each release portion).

There may be two or more release parts or through passages of the valve opener, and the needle protector may extend through or contact two or more boundaries of the two or more release parts or through passages.

The needle protector may include a resilient arm at least partially located within the holding space of a valve opener having a first through passage and a second through passage. The needle protector may include an elbow that is positioned such that: it protrudes through the first through passage; it protrudes through the first through passage and contacts a section of the boundary of the first through passage; it protrudes through the first through passage and contacts the inner surface of the guide hub; or a combination of the section protruding through the first through passage and contacting the boundary of the first through passage and contacting the inner surface of the guide hub.

The needle assembly disclosed herein may include a tip protector located at least partially within the gap between two plunger elements of a valve opener. The gap of the valve opener may define a holding space for receiving at least a portion of the needle protector or tip protector.

A tip protector can be optional, and the needle assembly can be practiced without a tip protector.

Tip protectors can be formed as a single piece or by integrating multiple parts or components together. Tip protectors can have one arm or two arms. The two arms can extend on different sides of the needle or can cross each other, such as intersecting when viewed from one side.

In the needle assembly, a section of the valve can be deflected in the distal direction, and a section of the valve can be deflected in the proximal direction to open a fluid flow path through the valve.

In the needle assembly, the distally deflectable sections of the valve may include the outer edge of the valve, and the proximally deflectable sections may be flaps formed on the valve. The flaps may be formed on a valve disc. The flaps may be formed by including one or more slits.

In the needle assembly, the bushing body and one or more leg extensions may be integral. In some examples, the bushing body (such as the bushing base or tunnel section) may be integrally formed with one or more leg extensions. Each leg extension may have a nose-shaped section. In some examples, a leg extension may be included, which may have a wall defining an opening.

In the example, only a portion of the tip protector or needle protector may extend into one or more gaps of the valve opener, and the proximal section of the tip protector may extend proximal to the nearest side surface of the tip protector. For example, a portion of the needle protector may overlap the valve opener in the axial direction, while the proximal section of the tip protector (such as a proximal wall) extends proximal to or is located proximal to the nearest side surface of the valve opener.

In the example, only a portion of the tip protector or needle protector may extend distally to the stabilizing ring of the valve opener, while a proximal section of the tip protector may extend proximally to the stabilizing ring. This distal portion of the tip protector to the stabilizing ring may include one or two elbows. These one or two elbows may protrude through one or both release sections of the valve opener.

Other aspects of this disclosure may include a method of manufacturing a needle assembly (such as a catheter assembly). The method may include: providing a catheter hub having a catheter body with a distal opening, the catheter hub including a hub body defining an inner lumen and a proximal opening; positioning a bushing inside the catheter hub and abutting against the catheter body, and positioning a valve proximal to the bushing; the valve being floatable within the inner lumen of the catheter hub in an axial direction 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 body such that the tip of the needle extends from the distal opening of the catheter body; and wherein two or more leg extensions extend proximal to the body of the bushing.

In this method, two or more leg extensions of the distal valve opener can be aligned with two or more discs on the valve. Alternatively, a single leg extension can abut the valve disc from the distal side of the valve disc.

In the method, the proximal valve opener may include a ring or nose-shaped section and at least one plunger element. A stabilizing ring may be located proximal to at least one plunger element. In some examples, two or more plunger elements may be present, and the stabilizing ring may be located proximal to two or more plunger elements.

The nose section or ring of the valve opener may include an actuating or actuating end. The nose section may define an opening. Fluid can flow through the opening. A needle can pass through the opening of the nose section in a standby position.

In the method, the proximal valve opener may include two spaced-apart plunger elements with a gap between them. The gap may define a holding space.

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

In the method, two or more leg extensions of the distal valve opener can be fixed in the axial direction.

In the method, the proximal valve opener is slidable in the distal direction to allow a valve with two or more discs to move distally against two or more leg extensions. The valve may have three slits and three discs. The three slits may converge at a single point. The valve may have a valve skirt extending proximally toward the valve disc.

The valve skirt can define a valve cavity. The valve cavity can accommodate at least a portion of the proximal valve opener in a standby position. The nose section of the proximal valve opener can be located within the valve cavity.

The intravenous infusion needles or subcutaneous injection needles described herein can utilize valves within a housing having a female Luer connector. For example, the valves and valve openers of this disclosure can be placed inside the needle hub. Furthermore, needleless valves integrated into medical devices or stand-alone needleless valves can utilize the valves described herein.

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

The various components described in this article can be located within the lumen of the conduit hub.

In the ready position, the catheter assembly is prepared for use, such as to perform venipuncture or intravenous access. Sometimes, the ready position first requires removing the protective cap from the catheter or needle assembly. The protective cap may be included for packaging.

Valves and valve actuators intended for use with the conduit hub of this disclosure may also be placed within the needle hub as a second valve.

The conduit hub may be equipped with a needle protector or tip protector, a valve opener or actuator, a valve, and a bushing.

Optionally, a needle guard or tip protector including a resilient portion may be located outside the catheter hub, such as in a separate hub different from the catheter hub and needle hub.

The tip protector disclosed herein can be specifically implemented as any number of prior art protectors configured to block or cover the tip of a needle.

The tip protector may have a proximal wall and two resilient arms, wherein a contour-changing portion on the needle (such as a fold or ridge) may engage to define the perimeter of an opening on the proximal wall of the tip protector, allowing the tip protector to be withdrawn proximally from the catheter hub after successful venous puncture. The two arms may intersect, or they may extend along different sides of the needle and not intersect in a lateral view.

The radial profile (such as shape or size) of the needle protector can change as the two arms on the needle protector move radially due to the axial movement of the needle. For example, the radial profile of the needle protector can be reduced as the tip of the needle moves proximal to the two arms to allow the two arms to move radially.

One or more needle protector arms can be deployed from the needle bar in a ready position and engage the interior of the conduit hub (e.g., the protector engagement section of the conduit hub). The needle protector can be rolled or bent from a stamped sheet metal into the final configuration. Alternatively, the needle protector can be formed from different components, all metal components, plastic components, or combinations thereof, which are then assembled to form the needle protector.

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

One or more plunger elements may extend from the annular or nose-shaped section in a proximal direction. In other examples, more than two plunger elements may be present, such as three or more plunger elements, with gaps between them. The size and shape of each of the one or more plunger elements may be designed to be contacted by a male Luer element to transfer a distally directed force from the male Luer element to the annular or nose-shaped section of the valve opener, which then pushes against the proximal surface of the valve to open the valve, such as to open two or more discs.

One or more plunger elements of the valve opener may each have an arcuate or curved cross-section along its width. In another example, the plunger elements may have a generally flat or planar cross-section. The thickness of the plunger elements should be small or thin enough that the needle protector and the two plunger elements have sufficient clearance to fit within the internal cross-sectional space of the guide hub, without physically abutting against the interior of the guide hub and thus being immovable or fixed.

In the example, the thickness of the plunger element of the valve opener or actuator and the width of the needle protector make it unnecessary to form an undercut or channel in the inner wall surface of the conduit hub to accommodate them.

The valve opener disclosed herein can be made of metal, plastic, or both. When made of metal, the valve opener can be formed by a deep draw method, and the arcuate cross-section of the plunger element can provide increased stiffness when pushed by the male Luer element.

Each plunger element of the valve opener 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. These gaps may provide voids or spaces for the fluid flow across them (e.g., during IV infusion). The gaps may also be used to accommodate needle protectors, such as to act as retention spaces.

The annular or nose-shaped section of the valve opener may include a body with an outer boundary. The outer boundary may be generally cylindrical. The outer boundary may have a tapered portion. The body may include chamfers and openings.

The distal edge or intersection of the body between the chamfer and the outer boundary can have a sharp edge or a blunt edge. In the example, the intersection is a blunt edge that includes a planar surface that acts as an actuating end for pressing against the valve.

The valve opener of this embodiment can be configured to push against the proximal surface of a valve or a multi-part opener for pushing against both the proximal surface of the valve and the distal surface of the valve. The valve can have two or more flaps that can be radially and proximally or radially and distally deflected when activated.

On the proximal side of the ring or nose-shaped segment, two plunger elements may be radially recessed from the outer boundary to form or define a shoulder. The outer boundary of the ring may have a first-sized outer diameter, and the two plunger elements may define a second-sized outer diameter, which may be smaller than the first size. The shoulder may be positioned between these two different sizes.

The valve opener may have an inner diameter measured near the intersection or active end. The inner diameter may vary or change along the chamfered section of the ring or nose section. The valve opener may also include a minimum inner diameter mID, which can be considered as the minimum inner diameter of the valve opener.

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

The radii of curvature of the two C-shaped plunger elements of the valve opener may differ from the radius of the tip of the male Luer element and/or the radius of the inner cavity of the guide hub. Clearance may be provided on each side edge of the needle protector's proximal wall and on adjacent plunger elements.

The two plunger elements of the valve opener may each have an adjacent proximal surface, the size and shape of which are designed to be pressed against the valve opener distally by the tip of the male Luer element or syringe tip when the male Luer tip or syringe tip is inserted into the proximal opening of the catheter hub after successful venous puncture, thereby opening the valve. The arcuate cross-section of each of the two plunger elements can provide a sufficiently thick profile to ensure that the adjacent surface overlaps with the male Luer tip and to ensure buckling-resistant stiffness.

The C-shaped plunger element prevents deflection when pressed by the syringe tip or other male Luer element tip, prevents the syringe tip or Luer element tip from slipping and missing the end surface of the plunger element when the syringe tip or Luer element tip is inserted into the open proximal end of the catheter hub, and/or prevents the syringe tip or Luer element tip from pressing between two plunger elements during activation of the valve opener to cause the two plunger elements to wedge between the tip 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 protector on the outside, while the convex portion of each plunger element faces towards the needle protector on the inside.

The annular or nose-shaped section of the valve opener can elastically deform and then extend as it reaches a recessed hub section of the conduit hub, which can accommodate the annular section without deforming it. Alternatively, the conduit hub can be designed to extend to allow assembly of the valve opener. A shoulder can be provided at the recessed hub section, forming a physical stop for engaging the shoulder on the valve opener. This allows the valve opener to be held within the lumen of the conduit hub during needle withdrawal and during use when the valve opener is pushed distally to activate the valve and subsequently moved proximally when the male Luer element is removed, thus allowing the valve opener to be held within the lumen of the conduit hub when the valve is closed.

The valve may have a valve disc including a valve body comprising a valve diameter, a valve thickness orthogonal to the valve diameter between a proximal-facing surface and a distal-facing surface, and one or more slits defining two or more lobes on the valve disc. Three slits extending through the valve thickness may be provided to define three lobes. The three slits may originate from a single point and extend radially from approximately the center point or central portion of the valve body in a manner resembling a three-pointed star, forming three lobes that can deflect along these slits.

The valve may include an outer boundary between the proximal valve opener and the bushing, said outer boundary being able to float within the cavity of the conduit hub. The valve's outer boundary can move proximally and distally within the cavity of the conduit hub and is not constrained by the conduit hub in the axial direction of the conduit assembly. In some examples, the valve may be axially fixed for being pushed against it by the proximal valve opener.

The outer perimeter of the valve may be the same as, smaller than, or larger than the outer perimeter of the annular or nose-shaped section of the valve opener. At least some or all of the distal edge, intersection, or active end of the annular or nose-shaped section may be recessed from the outer radial perimeter of the valve, such that the distal edge may abut or touch the proximal wall surface of the valve. Moreover, because the valve is floatable, it can be positioned inside a single-hub type conduit hub and can avoid being wedged between multiple hub bodies. However, the various components described herein can be readily used with multi-piece conduit hubs without departing from the scope of this disclosure.

The bushing disclosed herein may include a body comprising: a first body segment; and a second body segment extending from the first body segment. The second body segment may have: a conical segment; and two or more leg extensions extending from the second body segment, such as extending from the conical segment.

The first main body section may have an elongated body, which may be cylindrical in shape and may have an optional tapered distal tip or nose-shaped section. In some examples, a generally cylindrical ring extends from the second main body section, and two or more leg extensions extend from the cylindrical ring.

As used herein, the terms first, second, third, etc., are understood to describe different structures in order to distinguish them from one another. However, unless the context otherwise indicates, these terms are not structurally restrictive.

One or more gaps may be provided between two adjacent leg extensions. The number of leg extensions included in the bushing may be the same as the number of discs included in the valve. The leg extensions may be spaced apart from each other. The leg extensions may be attached to a common structure at respective fixed ends, which are opposite to their respective free ends.

The leg extension on the bushing or the leg extension of the distal valve opener may define an outer diameter smaller than the minimum inner diameter mID of the valve opener ring. The proximal tip of each leg extension may have a chamfer or blunt tip at the proximal end or proximal tip. In one example, a chamfer may be included at the proximal tip of each leg extension, and wherein the chamfer may taper inward from the outside of the leg extension.

The bushing can be made of metal, and the leg extension can be integrally formed with the main body. Alternatively, the leg extension can be welded to the main body of the bushing.

The bushing and valve can be oriented in the conduit hub such that the leg extensions on the bushing are aligned with the discs on the valve. This allows the discs on the valve to be pushed by the leg extensions on the bushing. Thus, if there are three discs on the valve, these three discs can be pushed into physical contact with the three leg extensions on the distal valve opener.

The distal wall surface of the valve may be accessible to the leg extension and/or resilient element (such as a spring or elastic element) of the distal valve opener, or may be spaced apart from the leg extension and/or resilient element to allow the valve to move in the proximal direction.

The distal-facing wall surface of the valve can be pushed distally against the outrigger extension during use. In some examples, the valve may, in the closed position, contact or be spaced apart from the proximal tip and/or resilient element of the outrigger extension.

The three leg extensions of the valve opener can be equidistantly spaced along the perimeter of the second body section of the bushing. In another example, the three leg extensions can be positioned and spaced according to the position of the lugs or flaps on the valve, such that when the valve is assembled inside the guide hub, the valve can be pushed distally by the proximal valve opener or valve actuator, and the leg extensions on the distal valve opener are aligned to push the lugs or flaps of the valve proximally to open the valve. The lugs or flaps can be formed by machining the valve slits to have narrow slots.

During the proximal withdrawal of the needle after successful venous puncture, the tip protector can be axially retained by engagement between one or both resilient arms on the tip protector and the protector engagement section on the catheter hub.

The guard engagement section may be a surface discontinuity formed on the inner surface of the conduit hub. For example, the guard engagement section may include a section having a first inner diameter and a section having a second inner diameter, the second inner diameter being larger than the first inner diameter. The shape of the guard engagement section may be annular or circular, or may be smaller than a complete circle.

The guard engagement section can be specifically implemented as an internal protrusion or groove, or a combination of both, formed on the inner surface of the guide hub. When a combination of grooves and protrusions is used in the guard engagement section to engage a needle guard or tip protector, 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 opposed to each other, just distal to the section of the female Luer tapered portion of the guide hub.

In the example, the valve opener may include a single plunger element. The single plunger element may be implemented as a generally cylindrical body section having an inner surface defining an opening with a path or channel. The cylindrical body section may be located proximal to a distal push end, which may also be annular or circular. A protector engagement section may be formed on the inner surface of this valve opener. In other words, the inner surface of the valve opener, rather than the inner surface of the catheter hub, may be provided with a protective engagement segment. This allows a tip protector or needle protector (such as the two resilient arms of a needle protector) to engage the valve opener in the standby position and during needle withdrawal after successful venipuncture.

The guard engagement section formed on or by the valve opener can be a protrusion, a recess, an opening, or a combination thereof.

Another aspect of this disclosure includes a valve opener comprising: a nose-shaped section having an active end; and two plunger elements extending proximally along the nose-shaped section. A band or ring may be provided to connect the two plunger elements together. The band may be referred to as a stabilizing ring, and the two plunger elements may be connected together to form a stabilizing structure.

The stabilization ring can form a continuous boundary section of the valve actuator, which is separated from another continuous boundary section defined by the nose section of the valve actuator.

Two stabilizers (which may also be referred to as stabilizer elements) can be connected to two plunger elements to form a stabilization ring, which may have continuous boundary sections.

The valve actuator may have a first continuous boundary section, a section having one or more release parts, and a second continuous boundary section separated from the first continuous boundary section.

At the release section or through passage of the valve opener, the valve opener may have one plunger element with two longitudinal edges or two plunger elements, each with two longitudinal edges. In some examples, three or more plunger elements, each with two longitudinal edges, may be present.

The valve opener may terminate with a stabilizing ring at its proximal side or proximal end. In another example, one or more plunger element posts or extensions may extend proximal to the stabilizing ring.

The total length of the valve opener can be adjusted by adding one or more plunger element studs or extensions that extend proximally to the stabilization ring.

The first continuous enclosure section may be a nose-shaped section of a valve actuator. The nose-shaped section may include an actuating end for pushing against the valve to open it. A second continuous enclosure section may be provided, and it may be a stabilizing ring connected to one plunger element or to two or more plunger elements.

A valve opener provided therein may include two plunger elements, each with two elongated edges, located between a first continuous boundary section and a second continuous boundary section. In some examples, the two plunger element posts may extend proximally to the second continuous boundary section.

A valve actuator or valve opener provided therein may include a single plunger element extending from a nose-shaped segment having an active end, and wherein the single plunger element may include two or more release portions or through passages formed through a wall extending through the plunger end. A needle protector or tip protector may engage the edge or enclosure of the release portions in the standby position and during needle withdrawal after successful venipuncture.

When a tip protector engages the enclosure of a valve opener, it should be understood that the tip protector may engage only a section or part of the enclosure. For example, when the elbow of a needle protector engages the enclosure of a valve opener, the elbow may only contact a portion or section of the enclosure. The enclosure may be used for a release section or a through passage.

Alternatively, the tip protector may protrude through the release portion of the valve opener but not contact the interior of the guide hub or the perimeter of the release portion.

Alternatively, the tip protector may protrude through the release portion of the valve opener, contact the interior of the guide hub, and contact one or both boundaries of the release portion.

In a specific example, the portion of the tip protector that protrudes through the release section can be one or both elbows of the tip protector.

Alternatively, a tip protector or needle protector may protrude from the retaining space defined by the valve opener through the release portion to engage the inner surface of the guide hub. A ridge, groove, or recess may be formed on the inner surface of the guide hub to allow the elbow of the needle protector to protrude from the retaining space of the valve protector through the release portion.

Sometimes the elbow of each arm of the needle protector can be referred to as the diagonal section.

The enclosure of the two release sections or through passages can function as a protector engagement section by allowing the elbows of the tip protector to engage with the enclosure. Alternatively, the two elbows of the needle protector can protrude through the two release sections from the retention space defined by the valve opener to engage a protector engagement section or segment formed on the inner surface of the catheter hub. Also alternatively, one or both elbows can be restricted in the proximal direction by a choke point or choke gap.

In other examples, at least one elbow of the needle protector or tip protector may protrude through the release portion or through passage of the valve opener, but in the standby position does not engage the enclosure or contact the interior of the guide hub. In other examples, both elbows of the needle protector protrude through the two release portions or through passages of the valve opener, but in the standby position do not engage the enclosure of the two release portions or contact the interior of the guide hub.

In some examples, one or both elbows of the needle protector may contact the perimeter of one or more release sections and/or the interior of the catheter hub.

When the valve opener has a single plunger element between the first continuous boundary section and the stabilizing ring (the valve opener may include a second continuous boundary section), one or more elbows of the needle protector may be located between the first continuous boundary section and the stabilizing ring. If the needle protector has two elbows, then the two elbows may be located between the first continuous boundary section and the second continuous boundary section.

The second continuous enclosure section may represent the nearest end of the valve opener. In some examples, one or two plunger element posts or extensions may extend proximally to the second continuous enclosure section to extend the length of the valve opener beyond the proximal end of the second continuous enclosure section.

In some examples, the stabilization ring does not form a continuous boundary, or the two plunger element piles or extensions may extend proximally to a discontinuous boundary section.

Therefore, the perimeter of the release section or the inner surface of the catheter hub can form an anchoring point for engaging the arm of the tip protector with the anchoring point in the standby position and during needle withdrawal after successful venipuncture.

The perimeter of the release section or the through passage of the valve opener can present or serve as a limiting point, choke point, or choke gap for one or both elbows of the needle protector, respectively. That is, the measured dimension to the needle side of one elbow can be larger than the dimension measured at the perimeter of the release section of the valve opener, such that the perimeter at the release section provides interference to prevent the needle protector from proximal movement during needle withdrawal after successful venipuncture.

Once the elbow of the needle protector moves radially away from the release section, the radial profile of the needle protector decreases and can be smaller than the inner diameter of the valve opener at the release section. The needle protector can then move proximally to the release section or the through passage, such as moving proximally through the stabilization ring.

If the needle protector has two elbows, the dimensions defined by these two elbows can be larger than the enclosure of the valve opener at the two release points, such that the enclosure at the two release points can act as or provide a limiting or choking point to prevent the needle protector from proximal movement during needle withdrawal after successful venipuncture. Once the two elbows of the needle protector move radially away from the two release points of the valve opener, the needle protector can move proximal to the two release points or the passageway, such as proximal movement through the opening defined by the stabilizing ring.

In the example, the valve opener may include a nose-shaped section and a single plunger element. The single plunger element of the valve opener may be specifically implemented as a generally cylindrical body section having: an inner surface defining an opening with a path or channel; and a proximal boundary or end edge. A protector engagement section may be formed on the inner surface of the valve opener. In other words, a protrusion, bulge, or recess may be formed on the inner wall surface of the valve opener to allow engagement between the needle protector and the inner surface of the valve opener.

When this alternative valve opener is used with a needle device or conduit assembly, the guard engagement segment may be on the conduit hub, on the inner wall of the valve opener, or formed as a enclosure of a release portion that passes through the wall of the valve opener.

A valve opener may include one or more release sections or protector engagement segments.

The guide hub may also be formed with one or more guard engagement sections for use with one or more release sections of the valve opener.

The number of segments of the guard can be equal to the number of elbows formed by the needle guard.

The two resilient arms of the tip protector can engage the interior of the valve opener or the conduit hub by protruding through a release portion formed through the wall of the valve opener.

In yet another example, two openings may 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 guide hub. Each of these openings may include a perimeter, which may be a closed perimeter.

In the alternative position using the valve opener (having two openings or releases provided to pass through the wall of the valve opener), one or more resilient arms of the tip protector may protrude through these openings or releases to engage the guard engagement segment inside the conduit hub in addition to engaging the opening of the valve opener.

The guard engagement segment may be formed on the inner surface of the guide hub, and the proximal cylindrical body section of the valve opener may include an opening that surrounds the guard engagement segment in at least one direction. In the example, when viewed radially outward away from the needle, the opening on the valve opener may surround the guard engagement segment formed on the guide hub.

During needle withdrawal after use, the needle tip can move proximally to either of the two distal walls (one distal wall at each end of the resilient arm) of the tip protector or needle guard. The needle guard can be modified to have one distal wall and/or one arm. The needle guard may also have two arms but only one elbow and one distal wall.

A contour-changing portion on the needle (which may be a pleat, ridge, material accumulation portion, or sleeve) can engage the boundary of a hole or opening passing through the proximal wall of the tip protector. Once engaged, the tip protector can be moved proximally with the needle to remove it from the catheter hub. In the protected position where the tip protector covers or blocks the needle tip, the valve remains inside the cavity of the catheter hub. Therefore, the valve can be located inside the catheter hub in both the needle's ready position and the needle's protected position.

A male medical device or instrument can be a male Luer element according to current or future ISO standards, a syringe tip, an IV group connector, or other male tips with a tapered portion of a Luer element, and can be inserted into the open proximal end of a catheter hub. The male medical device can be connected to IV tubing, which can be connected to an IV fluid source for fluid delivery via the male medical device. A male tip can be understood as a male Luer element tip.

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

In some examples, the male tip may be adjacent to the proximal ring and the valve opener may be advanced against the valve by pushing on the proximal ring (such as the stabilizing ring).

A force directed distally can move the valve opener distally until the geometry of the male tip and the proximal opening of the conduit hub prevent the male tip from advancing further distally. A seal can be provided by a Luer element engagement to prevent fluid leakage from the proximal opening of the conduit hub.

The annular or nose-shaped section of the valve opener can be actuated distally and press against the proximal surface of the valve. The distal edge of the valve opener can initially press against the proximal surface of the valve. When the valve is axially movable within the guide hub, the valve can be actuated distally by the valve opener, and the valve opener can be actuated distally by the male tip. The valve may have a valve disc. The valve skirt may extend from the valve disc in a proximal direction, a distal direction, or both proximal and distal directions.

Because of the leg extensions on the bushing or remote valve opener, the outer edge or outer valve section of the valve can move distally, while the leg extensions prevent other parts of the valve adjacent to or contacting the leg extensions from moving distally. In effect, the outer edge of the valve can move distally, while the valve discs can be deflected radially outward and proximally by the leg extensions on the bushing from the center point or center position, thereby opening the flow path through the valve.

Chamfering on the ring or nose section and on the leg extension can promote the valve flaps to deflect radially outward and in a proximal direction.

The relative diameter defined by one or more leg extensions and the minimum inner diameter mID of the valve opener ring allow the proximal and distal valve openers to deflect the valve between them to open it. Alternatively, when pushed distally, the valve's outer boundary can remain in contact with the inner wall of the guide hub, with the flaps opening only around one or more slits.

Therefore, one aspect of this disclosure is understood to include a conduit assembly comprising a valve including one or more slits and two or more flaps, wherein the valve may include a portion or section movable in a distal direction and a portion or section opening in a radial direction in a proximal direction to open a flow path through the valve.

In the example, the outer edge of the valve can be configured to move distally, while the valve disc can be configured to move radially outward to open the flow path through the valve. Furthermore, by including a valve that can move in this manner to open the fluid flow path, the actuation distance that the valve opener must travel in the axial direction of the conduit assembly to open the valve can be minimized compared to a valve with a disc that opens only in the distal direction via a valve opener. Therefore, the aforementioned conduit dimensions (such as the length of the conduit hub) can be reduced compared to a conduit hub that utilizes a valve and a valve opener that opens the valve by deflecting the valve disc only in the distal direction. Alternatively, the length or size of the conduit hub can be minimized by the overlap in the axial direction between the valve opener and the needle guard.

A conduit assembly is disclosed, which may include a valve, wherein the valve enclosure is axially floatable relative to a conduit hub. By including a valve with a valve enclosure that is axially floatable, a two-part conduit hub is not required to fix the valve enclosure therebetween and within the conduit hub, although a two-part hub can be used. Therefore, a conduit hub having a hub body formed monolithically can be used with this conduit assembly. Thus, the size of the conduit hub (e.g., the outer diameter or outer dimension of the conduit hub) can be reduced compared to a conduit hub utilizing a two-part hub body. The two-part hub bodies (where they are joined together along a seam) can therefore be reduced to provide a conduit assembly with a relatively smaller outer profile.

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

The size and shape of the proximal valve opener can be designed to push against the outer edge or outer periphery of the valve in the distal direction, so that the valve moves against the distal valve opener. The size and shape of the distal valve opener can be designed to push against the central region or section of the valve in the radially outward direction, and a portion of two or more discs can be deflected in the proximal direction to open the fluid path or flow path through the valve.

In the example, the leg extension on the distal valve opener can be axially fixed, and the valve discs can be radially deflected outward by pushing them against the leg extension in the distal direction. In other words, when the valve is actuated to open the flow path through the valve, the valve can be physically pushed by an actuator located on both the proximal and distal sides of the valve. In a particular embodiment, the valve can be actuated to open the flow path through the valve by being physically pushed by a ring located on the proximal side and a leg extension located on the distal side of the valve. Alternatively, the distal side can be pushed by a single leg extension with an opening.

The proximal tip of the outrigger extension and the distal edge of the ring can be separated from a plane drawn orthogonal to the longitudinal axis of the catheter assembly. In other words, the proximal tip of the outrigger extension and the distal edge of the ring can be separated and do not need to overlap from the perspective of this plane, and a gap can be provided between them to accommodate the valve.

Alternatively, the proximal tip of the leg extension can overlap the distal edge of the annulus axially, which can produce a relatively larger amount of radial outward deflection of the flap compared to the absence of overlap. Furthermore, since the flap can be pressed against the axially fixed leg extensions on the bushing, the flap can be deflected proximally by these leg extensions. In other examples, the proximal tip of the leg extension may touch the distal edge of the annulus only along a plane drawn orthogonal to the longitudinal axis of the catheter assembly.

A catheter assembly may be provided, comprising a valve, a proximal valve opener, a distal valve opener, a needle hub with a needle, and a catheter hub with a catheter body.

The valve assembly may also include a tip protector for blocking the needle tip in the needle-protected position.

After successful venipuncture, a positive tip (such as a positive Luer element) can be inserted into the proximal opening of the catheter hub to advance the proximal valve opener in the distal direction, which causes the valve to move distally against the distal valve opener.

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

The valve discs can be deflected in the proximal direction by a structure located on the distal side of the valve and adjacent to the distal-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 syringe or the male tip of a male medical device is removed from the proximal opening of the catheter hub, the biasing or resilient nature of the valve (which may be made of an elastomer) allows the valve to spring back to its more relaxed state. Therefore, the flaps on the valve can spring back by moving distally, while the outer edge or outer section of the valve body can spring back proximally. This springback can push the proximal valve opener in a proximal direction, and the shoulder on the proximal valve opener can move toward or against the interior of the lumen of the catheter hub.

Optionally, a helical spring, leaf spring, or elastomeric cylindrical element or component may be positioned between the distal surface of the valve and the internal distal step or shoulder of the catheter hub to facilitate valve closure. This spring or elastomeric cylindrical element (if included) may provide additional biasing force to return the valve to the closed position upon removal of the positive medical device. A syringe or elastomeric opener may also push the proximal valve opener in a proximal direction. If included, the elastomeric element (such as a spring or elastomeric cylindrical element) may be spaced apart from or may contact the valve in the standby position.

The valve disclosed herein may be a single-use valve, or a valve that can be repeatedly opened and closed, or at least once. The valve can be opened a second time by placing the male tip into the proximal opening of the guide hub and pushing the proximal valve opener distally.

Inside the catheter hub, a diaphragm or valve, an actuator or valve opener, and a safety clip (such as a needle protector or tip protector) may be provided. Optionally, the safety clip may be omitted, or it may be placed outside the catheter hub (such as in a third housing). The third housing may be different from both the needle hub and the catheter hub.

A reflux plug or blood stopper assembly can be attached to the needle hub to prevent blood from flowing out of the reflux chamber of the needle hub. The reflux plug can be provided at the proximal end of the needle hub to allow ventilation but prevent blood from overflowing from the proximal end of the reflux plug body, and the reflux plug may include a hydrophobic filter.

The valve can be used with the conduit hub described herein, the valve having a valve body including a valve disc and a valve skirt extending axially from the valve disc. In an example, the valve disc may include one or more slits defining one or more flaps to be opened/closed by a valve actuator. The type and number of slits and flaps included in the valve disc may be similar to those shown and described elsewhere herein.

The valve may include a valve body having a valve disc having a proximal surface and a distal surface. The valve disc may include two or more lobes that can deflect proximally or distally.

The valve according to aspects of this disclosure can be made of any known elastomeric material. In one example, the valve is made of polyisoprene. In other examples, the valve can be made of any suitable biocompatible elastomeric material. Medical-grade lubricants can be applied to the valve to enhance its functionality.

In one embodiment, the valve skirt can be positioned within a recessed section formed in the inner cavity of the conduit hub, which prevents axial movement of the valve once it is inside the conduit hub. For example, the valve skirt can be positioned within a groove defined by the recessed section and does not move axially in the standby position or during valve activation or actuation by a valve opener.

The recessed section of the duct hub can be understood as the first recessed section (if the duct hub includes a second recessed section within the duct hub).

In the example, the recessed section of the conduit hub may have a distal shoulder and a proximal shoulder, which define a groove between them. The valve skirt may have a length, the size and shape of which are designed to fit between the proximal and distal shoulders. The valve skirt may fit within the groove.

In the example, the valve skirt can contact the proximal shoulder of the recessed section, while the valve disc can contact the distal shoulder of the recessed section.

The valve provided herein can contact the distal and proximal shoulders of the recessed section of the guide hub, and is thereby constrained in the standby position and during activation such that the valve skirt is axially fixed or cannot move axially.

In the example, the outer diameter or outer surface of the skirt section of the valve forms a tight fit or a size-on-size fit with the recessed section inside the guide hub. In other examples, a slight interference fit may be provided between the skirt section and the recessed section of the guide hub. In still other examples, a small clearance may be provided between the outer surface of the skirt section and the inner surface of the guide hub at the recessed section, wherein the valve skirt contacts the proximal shoulder and the valve disc contacts the distal shoulder of the recessed section.

When the valve disc includes a valve skirt, the outer boundary of the valve disc can be considered as part of the valve skirt.

Alternatively, since any force acting on the valve will be primarily in the distal direction, there may be no proximal shoulder in the recessed section of the guide hub.

When the needle is withdrawn after use, there may be some proximal force on the valve, but this proximal force should be low and insufficient to move the valve out of its interference fit in the guide hub, even without the proximal shoulder.

A distal chamber may be provided distal to the valve disc and proximal to the bushing, which may be used to retain the catheter body to the catheter hub. In some examples, a helical spring or resilient biasing element (such as an elastomeric ring or cylindrical body) may be provided concentrically with the needle in the distal chamber to bias the valve disc flaps to help the valve disc close one or more slits. A resilient biasing element (if included) may also move the proximal valve opener in a proximal direction.

In the example, the valve disc may include a valve diameter, a valve thickness orthogonal to the valve diameter, and one or more slits defining two or more lobes. The distance between the proximal-facing surface and the distal-facing surface may define the valve disc thickness. The valve skirt may extend axially to the longitudinal axis of the valve and may have an elongated wall substantially perpendicular to the outer boundary of the valve disc, thereby forming a generally cylindrical valve body. In some embodiments, the valve skirt may be inclined, such that the valve forms a truncated conical structure.

The valve skirt can have a complex profile, such as having a cylindrical portion connected to a truncated conical portion.

The skirt-like portion can extend proximally or distally from the valve disc, or both. Therefore, there can be a proximal cylindrical valve body, a distal cylindrical valve body, or both a proximal cylindrical valve body and a distal cylindrical valve body.

The valve skirt can define a valve cavity with an open proximal end. The size of the open proximal end of the valve skirt can be designed to grip the outer surface of the nose segment, to grip the outer surface loosely, or to be large enough that it cannot reach the outer surface of the nose segment.

The open proximal end of the valve skirt allows the actuator nose or nose-shaped section of the valve actuator to protrude through it and advance axially within the valve cavity to actuate two or more valve discs of the valve. In one embodiment, at least a portion of the actuator nose (including the distal actuating end of the valve actuator) may be located inside the valve cavity of the valve before actuation by the tip of the male Luer element.

The actuator nose of the valve opener can be narrower than the outer perimeter of the valve, such that the actuating end of the nose section fits within the valve cavity and abuts or touches the valve disc in the standby position. In some examples, the actuating end can be spaced apart from the valve disc in the standby position.

In the example, the relative dimensions between the valve and the actuator are such that the nose section of the valve actuator does not touch the inner wall surface of the skirt section of the valve, although a certain degree of contact is conceived.

In the example, the actuating end of the valve actuator contacts the proximal surface of the valve disc in the standby position, and another part of the valve actuator (such as one or two protrusions) abuts the inner shoulder of the guide hub in the standby position to apply a load on the valve disc, but not enough to open one or more slits.

In the example, the proximal surface of the valve disc is biased by the valve opener in the standby position, but this bias is below a threshold required to deflect one or more discs on the valve disc. In the example, one or more protrusions on the exterior of the valve actuator may abut a shoulder in the guide hub, causing the distal section of the valve opener (such as the active end) to be biased against the proximal surface of the valve in the standby position.

In other examples, the actuating end of the valve actuator may be spaced from the proximal surface of the valve disc in a standby position, and one or more protrusions on the valve actuator may either contact or be spaced from the shoulder. When one or more protrusions on the valve actuator are spaced from the shoulder of the guide hub and the actuating end is spaced from the valve disc, the actuator may float slightly axially within the guide hub.

In the example, the valve actuator may include a nose-shaped section, which is elongated and may be generally cylindrical or have a draft angle or tapered portion terminating at an actuating end. The actuating end may have a blunt distal surface or may have a sharp edge.

The nose section of the valve opener may have a wall surface with a continuous perimeter without notches or slits (such as a cylinder with continuous walls). In some examples, multiple spaced slits, notches, and/or openings may be provided on the nose section to allow flow or fluid flushing. The nose section of the valve opener may define an orifice. Fluid can flow through the orifice. A needle may pass through the orifice of the nose section in a standby position.

Two actuating elements or plunger elements may extend proximally to the nose-shaped segment. For example, two plunger elements may be integrally formed with the nose-shaped segment and may extend from the nose-shaped segment in a proximal direction.

A gap or space may be provided between the two plunger elements for positioning a needle protector or tip protector therebetween. The gap may define a retaining space. Each of the two plunger elements may include at least two elongated edges, and these edges may be spaced apart from each other.

In the example, the protrusion can extend outward from the outer surface of one or both plunger elements.

Protrusions may extend from the outer surface of each plunger element. Each protrusion may resemble a ramp surface with generally flat edges to serve as a shoulder abutting a recessed section of the conduit hub. The ramp surface of the protrusion and the orientation of the ramp allow for the insertion of a valve actuator into the interior of the conduit hub and for the valve actuator to be seated within a second recessed section of the conduit hub.

In the example, the transition section of the actuator can extend from the nose-shaped section of the valve opener and widens axially in the proximal direction. Two actuating elements can extend from the transition section.

Some embodiments may use other shapes for the nose segment, such as cuboid, rectangle, cone, pyramid, etc. The nose segment may define an opening. Fluid can flow through the opening. A needle may protrude through the opening of the nose segment.

In the example, the actuator or valve opener has a longitudinal axis, and one or more actuating elements may extend axially or parallel to the longitudinal axis. In a particular example, two actuating elements may be diametrically opposed to each other along the longitudinal axis.

In one example, the two actuating elements may define an outer diameter of a size larger than the diameter of the nose-shaped segment. In other examples, the two actuating elements may define an outer diameter of a size smaller than the diameter of the nose-shaped segment.

In the example, the actuating element or plunger element proximal to the nose section of the valve opener can be flexible and deflectable, such that the actuating element can deflect or flex when pushed by the tip of the male Luer element. The actuating element can be deflected by selecting a material with the required resilience properties (such as a crystalline thermoplastic material).

In other examples, the actuating element can be deflected by including one or more weakened sections, such as by including structurally thin sections, by including cut-outs, by using a smaller cross-section compared to other sections of the same elongated actuating element, or a combination thereof.

Alternatively, the actuating element can be flexible and can be deflected by selecting a material with the required resilience and by including one or more weakened sections.

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

In the example, the actuating elements may be rigid and unable to deflect or deform when loaded (e.g., when pushed by the tip of the male Luer element). Furthermore, stabilizing elements may be included to increase the stiffness of the two actuating elements. Each of the two actuating elements may each include a cross-sectional profile at least at its proximal end, which overlaps with 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, such as when an axial force is applied to the actuating element from the male tip toward the distal end of the conduit assembly during insertion of the IV Luer adapter.

Typically, the nose section of a valve opener is rigid relative to the more flexible valve, which allows the nose section (and more specifically the actuating end) to actuate the valve, such as to deflect one or more discs and open one or more slits on the valve disc. The nose section may be made of an incompressible material (such as metal, plastic, or an elastomer harder than the valve material) for pushing against and opening the valve.

The illustrated valve actuator embodiment may include a pair of opposing band or stabilizer elements that connect the two actuators at a position along the length of the two actuators, located between the nose section and the proximal ends of the actuators. In some examples, the stabilizer element may be located at the proximal ends of the two actuators such that the proximal edge of the stabilizer element is substantially flush with the proximal surfaces of these actuators.

In one embodiment, the stabilizer element (or more generally referred to as a stabilizer) may be arc-shaped, forming an arc that follows the inner contour of the guide hub and connects one actuating element to another. The stabilizer may form a substantially cylindrical section on the body of the valve actuator, which may be spaced apart from the nose-shaped section of the valve actuator. In other words, the valve actuator may be elongated and may have: sections that are continuous in the radial direction; and sections with a release portion or through passage that is discontinuous in the radial direction.

In the example, the stabilizer may define a continuous body segment separated from the continuous body segment of the nose-shaped segment along the boundary or radial direction of the valve actuator. The continuous body segment of the nose-shaped segment is also continuous along the boundary or radial direction.

Two stabilizers may be coupled to two plunger elements to form a ring structure. Optionally, the two stabilizers may be slightly offset from each other and at an angle. In some embodiments, one, three, or different numbers of actuating elements or stabilizers may be present. In the example, the valve actuator (having stabilizers and protrusions) may be made of plastic (e.g., made by plastic injection molding).

The stabilizer helps keep the valve actuator centered within the guide hub as the actuator moves (e.g., when pushed by the tip of the male Luer element). By keeping it centered, the nose section can be better aligned with the valve disc (e.g., a slit on the valve disc), thus allowing for smooth valve actuation.

After the male Luer tip is removed, the stabilizer can also provide engagement with the interior of the guide hub via friction to prevent the actuator from slipping out of the proximal end of the guide hub.

In one embodiment, the nose section of the valve can be configured to remain engaged with the valve disc after actuation and after removal of the male Luer tip. For example, the nose section can be wedged between one or more slits on the valve disc and held there by friction. The valve actuator can be provided with surface features (such as ridges, grooves, or barbs), such as on the nose section, to maintain engagement between the actuator and the valve after actuation and after removal of the male Luer tip.

A release section, opening, or through passage can be provided between the transition section and each of the two stabilizers. Two release sections or through passages can provide a gap allowing open communication between the interior or central portion of the valve actuator and the inner surface of the guide hub. In other words, one or two release sections, through passages, or openings can be provided between the continuous sections of the nose-shaped section and the stabilizing ring. This can improve the flushing characteristics of the device.

The stabilization ring of the valve actuator (such as the stabilization ring) may have an inner diameter smaller than the diameter defined by the diagonal dimensions of the distal sections of the two arms when the two arms of the needle protector are biased outward by the sides of the needle bar. Therefore, during the installation of the needle protector into the holding space of the valve actuator, the needle protector can deflect within a smaller diameter to pass through the stabilization ring and enter the open area defined by the release section.

The valve actuator described herein may include a nose section, a transition section, and two plunger elements extending proximally to the transition section. The nose section may define a first continuous boundary section. Other locations of the nose section away from the first continuous boundary section may include slits or slots.

Two stabilizer elements can be attached to two plunger elements on a valve opener to form a stabilizing ring, which can define a second continuous boundary section of the valve opener. Each stabilizer element can include two edges, which can include a first or distal edge and a second or proximal edge. In the example, the two edges of each stabilizer element can be parallel to each other.

The two stabilizer elements can be modified to be skewed or tilted, such that while the two edges of each stabilizer element, or the same stabilizer element, can be parallel to each other, the two edges from one stabilizer element can be non-parallel to the two edges of the other stabilizer element. The proximal edges of the two stabilizer elements can be offset along the axial or longitudinal direction of the valve actuator. The distal edges of the two stabilizer elements can be offset along the axial direction.

The valve opener may have two release sections or two through passages. Each release section may be defined by a transition section, two plunger elements, and a corresponding stabilizer element, or by the boundaries of the above. These two release sections or through passages may be referred to as the first release section or the first through passage and the second release section or the second through passage.

In the example, each release section or through passage may have a boundary. Each boundary may be defined by the structure of a transition section or nose section, two plunger elements, and a corresponding stabilizer element. Because the two stabilizer elements may deflect or tilt in different directions, the two boundaries of the two release sections or through passages of the same valve opener may be different, such as having different boundary profiles or shapes.

The enclosure of the release section or through passage can have a continuous loop. In other words, the enclosure can be closed and does not have slits or slots to break the continuity of the enclosure. However, when the stabilizer element is formed by two stabilizer segments and there is a slot or slit between the two segments, the enclosure of the release section can be an open enclosure or a discontinuous enclosure.

In some examples, the two stabilizer elements can extend laterally to connect to the two plunger elements without skewing or tilting in the distal or proximal direction. When constructed in this way, the edges of the two stabilizer elements can be parallel to each other. Alternatively, 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 these four edges are parallel to each other.

The near and far edges of the stabilizer element can be anything other than linear or straight. For example, these two edges can have curves, wavy surfaces, serrated edges, or combinations thereof.

Two plunger element posts or extensions may extend proximally to the stabilizing ring. The two plunger element posts may extend from the stabilizing ring and be axially aligned with two plunger elements located distal to the stabilizing ring.

In some examples, two plunger element posts may extend proximally to the stabilizing ring and are not axially aligned with the two plunger elements located distally to the stabilizing ring. In other examples, only one plunger element post is aligned with one of the two plunger elements located distally to the stabilizing ring.

For a valve opener or actuator having only one plunger element between the nose-shaped section with the active end and the stabilizing ring, only one of the plunger element posts or none of the plunger element posts are aligned with this single plunger element. Two or more plunger element posts may exist.

In some examples, there may be more than two plunger element posts or extensions extending proximally to the stabilization ring. The two or more plunger element posts or extensions may be equidistant from the proximity of the stabilization ring or randomly spaced around the proximity of the stabilization ring.

The plunger element stud can extend the overall length of the valve actuator.

Compared to fewer plunger element posts or for plunger element posts with relatively smaller curvature, a certain number of plunger element posts and/or a certain curvature for each plunger element post (the curvature defining the width of each plunger element post) can provide a larger overlap surface with the tip of the male Luer element.

The two plunger elements may each have at least two thicknesses to create a protrusion at the junction between these two thicknesses on the outer surface of each plunger element. These two protrusions may be located inside the recessed section, such that a shoulder at the proximal end of the recessed section inside the guide hub can provide a stop surface to prevent displacement of the valve opener in the proximal direction.

In some examples, only one protrusion may be used on one of the two plunger elements of the valve opener to prevent displacement of the valve opener in the proximal direction. In other examples, each plunger element may have a single thickness, and the protrusion is formed at the location of the protrusion by adding material to the plunger element during injection molding. In still other examples, there may be more protrusions than plunger elements.

In the example, the planar surface section may have the valve actuator located on the same side of each stabilizer element. The planar surface section may originate approximately from the nose section or transition section of the valve member and extend proximally to approximately two protruding locations.

Two planar surface segments corresponding to the two stabilizer elements can be provided on each side of the valve opener as a way to minimize the overall thickness profile of the transition section and the two plunger elements along the side profile. Therefore, in the example, the cross-sectional dimensions of the nose section, the transition section, and the two plunger elements can be substantially constant or identical within typical manufacturing tolerances along the side view.

The space can be provided between the two plunger elements, inside the stabilizing ring, between the two plunger element studs, or a combination thereof.

Part or all of the needle protector or tip protector may be located in the holding space in the spare position, and then one or both elbows of the tip protector may protrude from one or more release sections (if the tip protector includes two elbows).

When positioned within the holding space, the proximal wall of the needle protector may be flush with the proximal end surface of the plunger element post, located proximal to the end surface, or located distal to the end surface. If the stabilization ring does not include the plunger element post, the proximal wall of the needle protector may be flush with the proximal edges of one or both stabilizer elements, located proximal to the proximal edges of one or both stabilizer elements, or located distal to the proximal edges of one or both stabilizer elements.

The distance between the two inner surfaces of the two stabilizer elements can define a choke gap, choke point, or limiting point for the needle protector to restrict proximal movement of the needle protector in the standby position and/or during needle withdrawal after intravenous access. That is, the choke point or gap can present a smaller space before the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, making it impossible for the needle protector to pass through to reach the proximal side of the choke point or limiting point.

After the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, the two distal walls can move radially inward to reduce the radial profile of the needle protector, which can be smaller than the choke gap. As the radial profile measured at the two elbows becomes smaller, the needle protector can move proximal to the choke point. In the example, the needle protector can be proximally removed from the holding space and guide hub by a profile-changing section on the needle that abuts the boundary on the proximal wall of the needle protector and then pulls the needle protector out of the valve actuator's holding space and guide hub at the proximal wall.

In the example, when the radial profile of the needle protector is reduced, the needle protector can move proximal to the choke gap or choke point and can move proximal through the opening defined by the stabilization ring.

The stabilizer elements on the valve actuator used to form the stabilization ring may be discontinuous, and each stabilizer element may include a slit or a slot.

The stabilizer element on the valve opener may include two stabilizer segments spaced apart from each other by a slit or slot. Each stabilizer segment can be understood to include an inner edge spaced apart from another inner edge of the other stabilizer segment. The two inner edges of the two stabilizer segments may define a slit or slot therebetween. In addition to the inner edges, each stabilizer segment may also have two side edges that may be approximately orthogonal to the longitudinal axis of the valve opener. The two stabilizer segments may be similar or identical, or they may be different.

When two stabilizer elements are used to form a stabilizing ring, one stabilizer element can be a continuous part connecting two plunger elements together, and the other stabilizer element can be discontinuous, such as being made of two stabilizer segments with a slit or slot between them. Therefore, the stabilizing ring can have a single slit or slot instead of two or more slits or slots.

The width of the slit or slot may be less than the maximum width of the needle protector. Width in this respect can be understood as the dimension perpendicular to the longitudinal axis of the needle protector. In some examples, the width of the slit or slot may be less than the width of the multiple distal walls of the needle protector or the width of a single distal wall (if only a single distal wall is included). The width of the slit or slot may also be less than the width of the needle protector at the elbow.

The relative dimensions between the slits or slots on the valve opener and the width of the needle protector can be selected such that the stabilizing ring can restrict the movement of the needle protector (e.g., restricting the two elbows on the needle protector) through the slits or slots proximal to the stabilizing ring during needle retraction but before the needle protector is activated. In other words, even if the stabilizer element of the valve opener includes one or more slits or slots, the stabilizing ring can still provide a limiting surface or choke point to restrict proximal movement of the needle protector.

In the example, the elbow of the needle protector cannot slide proximally through the slit or slot of the stabilizing ring. In other examples, the slit or slot of the stabilizing ring may have a tapered gap, such that although a portion of the needle protector can slide through the slit or slot, the narrowing tapered portion of the slit or slot prevents the needle protector from moving completely through the slit or slot.

The valve opener disclosed herein may include one or two stabilizer elements to form a complete ring or a less complete ring, and when stabilizer segments are used for one or two stabilizer elements, the ring may have gaps or grooves. Thus, the one or two stabilizer elements may be continuous or may be segmented to have slits or grooves between segments.

The needle protector, having one arm and one elbow, two arms but only one elbow, or two arms and two elbows, can be used with any of the various valve actuators described herein. The needle protector may be located in the holding space of the valve actuator, and one or both elbows may extend at least partially through the release portion or through passage of the valve actuator.

Although a stabilization ring may include one or more slits (such as two slits), a stabilization ring may provide a restraining point or choke point similar to a stabilization ring without any slits or slots.

A stabilization ring with discontinuous boundary sections can also provide stability during axial movement of the valve actuator by acting as a support against the inner surface of the guide hub to guide the valve actuator.

Each stabilizer element may include two discontinuous edges, which may be referred to as the distal edge and the proximal edge, or the first edge or the second edge. In the example, the two edges of each stabilizer element may be parallel to each other. In a valve opener with two stabilizer elements, the two edges from one stabilizer element may also be parallel to the two edges of the other stabilizer element.

The proximal edges of the two stabilizer elements can be aligned along the axial 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 also be offset axially.

Two release sections or two through passages may be provided on the valve opener, each defined or bounded by a transition section or nose section, two plunger elements, and a corresponding stabilizer element. These two release sections or through passages may be referred to as a first release section or first through passage and a second release section or second through passage.

In the example, each release section or through passage may have a boundary. In the example, each boundary may be defined by the structure of a transition section or nose section, a plunger element, and a corresponding stabilizer element. The two boundaries of two release sections or through passages may be identical or may have different boundary profiles or shapes. When a slit or slot is included (each stabilizer element has one slit or slot), the two boundaries of the release section are discontinuous.

Valve openers can be made of metallic materials. For example, a stamped sheet of metal (such as a stamped stainless steel sheet) can be cold-worked using a deep-drawing method to form the desired shape. Various openings or gaps in the needle protector can be punched or stamped and then cold-worked to form the desired shape.

Each plunger element of the valve opener 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 of the valve opener. These gaps may provide voids or spaces for fluid flow across them, such as during IV infusion. The gaps may also form part of a retention space to accommodate a needle protector.

Two plunger element posts may extend from the stabilizing ring and are axially aligned with the plunger element located distal to the stabilizing ring of the valve opener. In other examples, the two plunger element posts are not axially aligned with the two plunger elements located distal to the stabilizing ring. In still other examples, only one plunger element post may be aligned with one of the two plunger elements of the valve opener.

In some examples, the valve opener may terminate at the stabilization ring, and the valve actuator may not have any plunger element studs. In other examples, each plunger element stud located proximal to each plunger element may be considered part of the same plunger element, and the stabilizer segment is a tab extending radially from the two longitudinal edges of the two plunger elements to a location distal to the proximal surface of the actuator or valve opener.

In the example, two plunger elements extend from the nose section of the valve opener, and a stabilizing ring is located between the nose section and the nearest side surface of the two plunger elements.

In some examples, there may be more than two plunger element posts or extensions extending proximally to the stabilization ring. The two or more plunger element posts or extensions may be equidistant from the proximity of the stabilization ring or randomly spaced around the proximity of the stabilization ring.

The plunger element post can extend the overall length of the valve actuator. Compared to a smaller number of plunger element posts or for plunger element posts with a relatively smaller curvature, a certain number of plunger element posts and/or a certain curvature for each plunger element post (the curvature may define the width of each plunger element post) can provide a larger overlap surface with the tip of the male Luer element.

In some examples, the plunger element post may have a curved profile with concave and convex surfaces that face in either direction relative to the longitudinal axis of the valve actuator. In other words, the convex surface may face inward or outward relative to the longitudinal axis of the valve actuator.

Each of the two plunger elements may include a protrusion on its outer surface. These protrusions may be located inside a recessed section of the conduit hub, such that a shoulder at the proximal end of the recessed section provides 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 to prevent displacement of the valve opener in the proximal direction.

In the example, each protrusion on the valve opener can be formed by cold-working the surface of a stamped metal plate at the corresponding plunger element to push out a protruding surface.

The nose section of the valve opener may have a tapered portion extending proximally and into the transition section. Two plunger elements may contract from the transition section to form a neck with two rounded corner sections.

Each plunger element of the valve opener may extend with a generally constant width along the proximal direction from a transition section or nose section, and then widen into a set of rounded sections. The widened sections may transition into two stabilizer elements. The two stabilizer elements may each comprise two stabilizer segments, or each may be formed as a single part.

Two pairs of rounded corner sections can be located near the stabilizer element or stabilizer segment to form two plunger element piles. Both the plunger element and the plunger element piles can have two spaced longitudinal edges, which can be provided with ribs to increase the strength of the respective structure.

Starting from within the stabilization ring of the valve actuator and extending proximally, the plunger element post can be cold-worked to form an outwardly convex portion relative to the longitudinal axis of the valve opener, creating a curved surface along the cross-section of the plunger element post. Alternatively, an inwardly convex portion can be formed. The convex portion may be included to form concave and convex surfaces of one or more plunger element posts (if more than one post is included) to reinforce the structure of one or more posts.

The distance between the two inner surfaces of the two stabilizer elements of the valve opener can define a limiting point, choke gap, or stop point for the needle protector to restrict proximal movement of the needle protector in the standby position and/or during needle withdrawal after intravenous access. That is, before the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, the size of the choke point or gap can be relatively small, preventing the needle protector from reaching the proximal side of the choke point. However, after the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, the two distal walls can move radially inward to reduce the radial profile of the needle protector, which can be smaller than the choke point. As the radial profile becomes smaller after actuating one or more arms of the needle protector, the needle protector can move proximal to the choke point.

In the example, the needle protector may have a distal portion larger than the choke point, and the distal portion of the needle protector may transition to a relatively smaller profile and be smaller than the choke point. In the example, the distal portion of the needle protector is the location between the two elbows of the needle protector.

When the tip protector is positioned between the two plunger elements, the two distal walls of the needle protector (more specifically, two sections with diagonal dimensions) can be located in the release section to engage the protector engagement surface on the inner surface of the guide hub. This allows the needle protector to protrude from the valve actuator's holding space through the two release sections to engage the protector engagement surface of the guide hub or the boundary of the two release sections.

A second undercut or recessed section proximal to the first recessed section can be provided within the lumen of the catheter hub to accommodate two sections of the needle protector with diagonal dimensions.

The needle guard can be prevented from sliding proximally during needle withdrawal after successful venipuncture by the shoulder of the recessed section or by some other surface feature on the inside of the catheter hub (such as the guard engagement surface on the inside of the catheter hub).

Optionally or alternatively, the distal edges of one or both stabilizers may provide a limiting surface to prevent premature activation of the needle protector before the needle tip moves to the proximal side of the two distal sidewalls during needle retraction. In addition to the distal edges, the stabilizers may also have proximal edges.

Valve openers can be made of metal or plastic. When made of metal, valve openers can be formed by deep drawing or bending, and the curved cross-section of the actuating element can provide increased stiffness when pushed by a male Luer element.

Each actuating 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 stiffness. One or more gaps may be provided between any two actuating elements. These gaps may provide voids or spaces for fluid flow across them (e.g., during blood flushing or IV infusion). The gaps between actuating elements may define a retention space to accommodate a tip protector.

In some embodiments, in the standby position, most or most (if not all) of the tip protector can fit within the retaining space formed by the actuator body, between the two plunger elements. This allows for a more compact guide hub because less longitudinal space is required within the hub to fit continuously longitudinally or, when the actuator and tip protector only partially overlap in the axial direction.

The needle protector can fit perfectly within the actuator's holding space to further reduce the space or length required in the catheter hub. In the standby position, the proximal wall of the needle protector can be substantially flush with or on the same level as the proximal surfaces of the two plunger elements. To accommodate this nesting between the needle protector and the valve actuator, the valve actuator can be provided with a release section that allows one or both elbows on the needle protector to protrude from the valve actuator's holding space.

The release section or through passage allows the tip protector to engage the interior of the guide hub. Alternatively, the release section or through passage allows the tip protector to protrude only from the holding space and contact or be separated from the enclosure of the release section. Proximal to the release section, a stabilizer can provide additional stiffness and/or a larger engagement surface to the guide hub.

When the tip protector engages only with the boundary of the release section or through passage (such as the distal edge of the release section of the actuator), no deformation or change in diameter is required on the inner wall of the guide hub, and the tip protector can still be placed in the tapered section of the female Luer element, while conforming to the international Luer element standard for tapered fittings for current and future international standards.

Alternatively, one or more grooves or recessed sections may be included on the exterior of the Luer tapered portion of the guide hub to accommodate any of the various components discussed herein. For example, one or more grooves may be provided on the distal side of the Luer tapered portion of the guide hub to engage any of the protrusions, shoulders, elbows, or other structures and components discussed elsewhere herein.

The actuating element or plunger element of the valve actuator may extend beyond the proximal edge of one or more stabilizer elements to a distance substantially the same as the proximal wall of the tip protector. In the illustrated embodiment, the tip protector may substantially fit within the retaining space of the actuator, and the proximal wall of the tip protector is substantially at the same level as the proximal end of the actuating element in the axial direction.

In the valve actuator retracted position (in which the male tip has not advanced the actuator to open the valve), the actuating end of the actuator's nose section may be spaced out or not pressed into the valve to open one or more slits. This position can also be the valve pre-activation position. That is, the valve actuator retracted position can be a position in which the actuating end is not pressed into the valve to open the slits (whether before or after the first activation of the valve), and the male Luer tip has been removed after the actuator has advanced.

Advancing the actuator in the distal direction can cause the actuator's actuating end to advance against the valve disc and deflect the flaps radially and distally to open the fluid path to be formed through the conduit assembly.

When a male medical device (such as a male Luer tip) is initially inserted into the proximal opening of the catheter hub, the male tip may initially contact the actuating or plunger element, plunger element stud, or stabilizer ring on the actuator to advance a distally directed force on the actuator to open the valve. The distally directed force may move the actuator distally until the geometry of the male tip 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 conduit hub and the male Luer taper of the male tip can mate and prevent the male tip from advancing further distally into the opening of the conduit hub. The Luer engagement provides a seal to prevent fluid leakage from the proximal opening of the conduit hub when the two components are mated or registered.

As the actuator moves distally by advancing through the male tip, the nose of the valve actuator can be propelled distally and pressed against the proximal surface of the valve disc. Specifically, the nose of the actuator can initially press against the proximal surface of the valve disc, and because the valve can be axially fixed within a recessed section of the conduit hub, one or more flaps on the valve disc can deflect radially and distally. Fluid from the male tip can then flow through the conduit hub, through the valve, and through the lumen of the conduit body. A valve skirt extending axially from the valve disc can be provided.

Alternatively, suction can be applied using a positive-type medical device (such as a syringe or vacuum blood collection tube), and blood can be aspirated from the patient proximally through an open valve. This is often done to test the sample before starting infusion therapy. Furthermore, any residual blood can usually be flushed from the inside of the catheter hub before starting infusion therapy.

Even after the male tip is removed following actuation, the valve actuator remains engaged to keep the valve open. That is, the friction between the valve actuator and the valve disc exceeds the restoring force generated by the valve attempting to return to its undeformed position. This activated position can be considered a one-time use or one-time actuation because the valve actuator and valve do not return to the pre-activated position upon removal of the male tip.

In an alternative embodiment, the nose section of the actuator can be configured such that when pushed into the valve during activation, the actuating or activating end does not extend distally beyond the valve disc flaps. This configuration allows the valve actuator to be pushed back to its pre-activated position by the flaps when the male Luer element device is removed. The conical configuration at the distal end of the actuator can be such that it maintains a proximal force vector greater than the vertical force vector. The angle of the cone can be designed to provide the necessary force vector when the actuator has reached its maximum and minimum distal displacement. The difference between the maximum and minimum displacement of a standard Luer element connector is approximately 2.5 mm. Therefore, national standards for Luer element fittings can be consulted when designing the size of the actuator tip.

Alternatively, a spring, elastic element, or ring can be included in the distal chamber of the conduit hub to increase the valve's rebound or restoring force, thereby promoting a proximal pushback of the valve actuator after removal of the male tip to return the actuator to the pre-activated position. A biasing member (which can be a spring or elastic element) can also help close the valve disc flaps and return the valve to the closed position. In this way, after initial activation, the valve and valve actuator can be re-closed and reopened, and so on. Alternatively, the flaps can be made thicker to provide sufficient restoring force without the elastic element. Also alternatively, the flaps can be thicker, and a biasing element can be used to provide restoring force on the valve and valve actuator.

The distal and proximal edges of a stabilizer or stabilizer element may not be parallel to the proximal edge of the plunger element or plunger element post (if the latter is included). The distal and proximal edges of the upper or first stabilizer may be parallel to each other, and the distal and proximal edges of the lower or second stabilizer may be parallel to each other, but the corresponding edges of the upper and lower stabilizers do not necessarily have to be non-parallel. In other words, the upper stabilizer may have a tilt angle toward the distal side, while the lower stabilizer may have a tilt angle toward the proximal side.

The actuator may include a generally cylindrical nose-shaped section or may include a truncated conical nose or a combination of both cylindrical and conical sections, and an active end at its distal end. An actuator arm or plunger element may extend longitudinally from the nose-shaped section. Stabilizer elements may be included, and these stabilizer elements may have generally even edges without off-setting edges. In an alternate position of the needle assembly or catheter assembly, the nose-shaped section may contact the valve disc of the valve or may be slightly spaced from the proximal surface of the valve disc. The valve may also include a valve skirt having a valve cavity and a nose-shaped section (or at least the active end of the nose-shaped section) located within the valve cavity.

A release or through passage in the wall of the valve actuator can provide an access route for the tip protector to engage with or otherwise retain within the conduit hub, as previously described. In one embodiment, two through passages or releases may be provided on opposite sides of the actuator body to allow the two arms of the tip protector to access the interior of the conduit hub. Other embodiments have different numbers of through passages or releases, such as one, three, or more. For example, a single release or through passage may be present in a cylindrical actuator element.

The majority of the tip protector can fit within the retaining space of the valve actuator, with only a portion of the tip protector extending proximally beyond the proximal end of the actuator. For example, the proximal wall of the tip protector and a portion of the two arms can extend proximally to the proximal end of the actuator.

One or more ribs or protrusions may be formed on the outer surface of the actuator arm or plunger element to engage with a shoulder in a recessed section of the conduit hub in both the standby and use positions to retain the valve actuator inside the conduit hub.

The interior of the conduit hub may include one, two, or more grooves. Each groove may include a recessed section formed into the wall of the conduit hub. Each recessed section may include a shoulder. A first groove (if included) may be used to retain a valve. A first groove (if included) may be used to engage one or more protrusions on a valve actuator to limit proximal movement of the valve actuator. A third groove (if included) may be used to engage a tip protector. Additional grooves may be included.

The valve may have one or more ridges (such as mating surfaces) formed on the outer surface of the valve skirt. Microchannels may be provided on the exterior of the valve to facilitate ventilation between the valve and the inner surface of the conduit hub. Medical-grade lubricant may be applied to the valve to facilitate movement.

The mating surface on the valve may include protrusions or grooves, or a combination of both, formed on the outer surface of the valve. For example, the mating surface may include segments with a first outer diameter (e.g., peaks/protrusions) and a second outer diameter (e.g., valleys/grooves), wherein these segments are repeated once or multiple times on the outer perimeter of the valve. In another example, the groove and/or protrusion may be formed as a single continuous, helical structure on the exterior of the valve.

In some embodiments, the mating surface on the valve may extend circumferentially along the outer surface of the valve to form a ring or spiral thread. In other embodiments, the mating surface may include several separate sections formed on the outer surface, such as separate protrusions/recesses or threaded sections on a broken screw.

The guide hub may have a corresponding mating surface on its inner surface to mate with the mating surface of the valve. The mating surface of the guide hub may be similar to the mating surface of the valve, but with reverse features to mate with the valve mating surface.

By forming mating surfaces on the valve and guide hub, the valve can be better held in the correct position within the guide hub, even when the valve actuator applies force to the valve. In the absence of recessed sections with proximal and distal shoulders, the valve can be axially secured within the guide hub using the mating surfaces and corresponding surfaces inside the guide hub.

Two engaging arms may be formed on the proximal end of the valve, extending radially inward from the inner surface of the valve skirt. The engaging arms may be configured to mate with engaging shoulders formed on the valve actuator. The two engaging arms on the valve may be configured to engage with two engaging shoulders formed by the two release portions of the valve actuator. In other embodiments, different numbers of engaging shoulders and engaging arms may be used (e.g., one, three, or more).

In the ready position, the actuator nose may be located within the valve's holding space, adjacent to the proximal surface of the valve disc. A valve skirt may surround the nose, wherein an engaging arm on the valve partially extends into the actuator's release portion or through passage and engages with an engaging shoulder. In one embodiment, the engaging arm may have a sufficiently low profile to not interfere with the needle and tip protector, such that these arms do not interfere with the movement of the needle and tip protector.

One aspect of this disclosure may include a needle assembly comprising: a needle hub having a needle having a needle tip extending from a distal end of the needle hub; a catheter body attached to the catheter hub, the catheter hub having a body including an inner wall surface defining an inner lumen, the needle extending through the catheter body in a standby position and the needle tip extending from a distal end of the catheter body; a valve positioned within the lumen of the catheter hub, the valve including a peripheral boundary, at least one slit, and two or more flaps; and a valve opener sized and shaped to open at least one slit to open the valve, the valve opener including a nose-shaped segment. The nose-shaped segment has an activation end and a continuous boundary segment; two plunger elements, each plunger element having two elongated edges; two stabilizer elements connecting the two plunger elements to form a stabilizing ring including the continuous boundary segment; a holding space; and two through passages located between the nose-shaped segment and the stabilizing ring; a needle protector including two resilient arms at least partially located inside the holding space, wherein the needle protector includes two elbows protruding through the two through passages and contacting the boundary of each through passage or contacting the inner wall surface of the conduit hub.

The needle protector may be located at least partially within the retaining space of the valve opener, such that the elbow or diagonal section of the arm of the needle protector extends through one of the passageways of the valve opener. The elbow or diagonal section of the needle protector may be in one of the following states: contacting the boundary of the passageway, separated from the boundary of the passageway, contacting the inner surface of the guide hub, separated from the inner surface of the guide hub, or a combination of contacting the boundary of the passageway and contacting the inner surface of the guide hub.

Other aspects of this disclosure may include a needle protector comprising a resilient arm at least partially located within the retaining space of a valve opener, wherein the pivoted needle protector may include an elbow that is positioned such that: protrudes through a first through passage; protrudes through the first through passage and contacts the boundary of the first through passage; protrudes through the first through passage and contacts the inner surface of a conduit hub; or a combination of protruding through the first through passage and contacting the boundary of the first through passage and contacting the inner surface of a conduit hub.

The elbow or diagonal section may be a first elbow, and the needle protector may include a second elbow, wherein the second elbow may extend through another of the through-passages of the valve opener, said other through-passage may be referred to as the second through-passage. The second elbow or diagonal section of the needle protector may be in the following states: contacting the boundary of the second through-passage, separated from the boundary of the second through-passage, contacting the inner surface of the guide hub, separated from the inner surface of the guide hub, or a combination of contacting the boundary of the second through-passage and contacting the inner surface of the guide hub.

In some examples, the valve actuator or valve opener may have only one through passage, and the needle protector may include a resilient arm at least partially located inside the retaining space of the valve opener, wherein the needle protector includes an elbow that is in one of the following states: protruding through the single through passage; protruding through the single through passage and contacting the boundary of the single through passage; protruding through the single through passage and contacting the inner surface of the conduit hub; or a combination of protruding through the single through passage and contacting the boundary of the single through passage and contacting the inner surface of the conduit hub.

The valve may include: a valve disc; and a valve skirt extending in a proximal direction and defining a valve cavity. Optionally, the valve may include a valve skirt extending in a distal direction of the valve disc.

The active end of the valve opener can be located in the valve cavity in the standby position.

The active end can contact the proximal surface of the valve disc in the standby position.

The valve opener may include a radially extending protrusion along the longitudinal axis of the valve opener, wherein the protrusion may contact a shoulder on the inner surface of the guide hub in a standby position.

The valve opener can simultaneously contact both the valve disc and the shoulder in the standby position.

The protrusion may extend radially from the plunger element on the valve opener. The protrusion may have a sloping surface with straight edges.

The protrusion can be considered as a first protrusion, and the valve opener can include a second protrusion spaced apart from the first protrusion, and the active end can apply a load to the valve disc without opening at least one slit.

The bushing can be wedged into the proximal end of the catheter body to abut against the inner surface of the catheter hub.

The resilient element can be located inside the conduit hub between the bushing and the valve disc, and the size and shape of the resilient element can be designed to push two or more valve discs in the proximal direction.

The resilient element can be an elastic element, an elastic cylindrical element, a helical spring, or a leaf spring. A helical spring may include multiple interconnected coils.

Another aspect of this disclosure may include a method of assembling a needle assembly. The method includes the steps of: providing a catheter hub having a catheter body having an open distal end and a proximal end attached to the catheter hub by a bushing, the catheter hub including a hub body having an inner surface defining an inner lumen and a proximal opening; positioning a valve proximal to the bushing, the valve including at least one slit and two or more flaps; positioning a valve opener proximal to the valve and inside the lumen of the catheter hub to slidably push open the valve when actuated by a male medical device, the valve opener including: a nasal segment having an active end and a continuous boundary segment; and two plunger elements, each... A plunger element has two longitudinal edges; two stabilizer elements connecting the two plunger elements to form a stabilizing ring including a continuous boundary section; a holding space; and two through passages located between the nose section and the stabilizing ring; a needle attached to a needle hub positioned to pass through the conduit hub, valve, and conduit body such that the tip of the needle extends from a distal opening of the conduit body in a standby position; and a needle protector at least partially placed inside the holding space of the valve opener such that the elbow of each of the two arms of the needle protector extends through the two through passages of the valve opener.

In some examples, placement of the needle protector may include: placing the needle protector at least partially within the retaining space of the valve opener such that an elbow or diagonal segment on the arm of the needle protector extends through one of the passageways of the valve opener. The elbow or diagonal segment may be in the following states: contacting the boundary of the passageway, separated from the boundary of the passageway, contacting the inner surface of the guide hub, separated from the inner surface of the guide hub, or a combination of contacting the boundary of the passageway and contacting the inner surface of the guide hub.

The needle protector may include a second elbow or diagonal section extending through the other of two through-paths. The second elbow or diagonal section may protrude through the other through-path in a manner similar to that of the elbow or diagonal section, which may be the first elbow.

The needle protector may include a proximal wall and a enclosure defining an opening on the proximal wall, wherein two arms extend distal to the proximal wall. The needle protector may be located entirely within the catheter hub.

The needle protector can be located entirely within the conduit hub, wherein the proximal end of the needle protector is located at the same level as the proximal surface of the valve opener or is located proximal to the proximal surface of the valve opener, or the proximal surface of the needle protector can be located distal to the proximal surface of the valve opener.

The valve may include: a valve disc; and a valve skirt extending in a proximal direction and defining a valve cavity, wherein the active end of the valve opener may be located in the valve cavity in a standby position.

The active end of the valve opener can contact the proximal surface of the valve disc in the standby position, and wherein two spaced protrusions on the valve opener abut a shoulder in a recessed section of the guide hub.

Each of the two stabilizer elements may include two parallel edges. Methods of manufacturing and using the conduit assembly and its components described elsewhere herein are within the scope of this disclosure.

An aspect of this disclosure may include a needle assembly comprising: a needle hub having a needle having a needle tip extending from a distal end of the needle hub; and a catheter body attached to the catheter hub, the catheter hub having a body including an inner surface defining a lumen, the needle extending through the catheter body in a standby position and the needle tip extending from a distal end of the catheter body.

The needle assembly may also include a valve located within the lumen of the catheter hub, the valve including an outer boundary, at least one slit, and two or more flaps.

The needle assembly may further include: a valve opener, the valve opener being sized and shaped to open at least one slit to open a valve, the valve opener including: a nose segment having an activation end and a continuous boundary segment; two plunger elements, each plunger element having two elongated edges; two stabilizer elements connecting the two plunger elements to form a stabilizing ring including the continuous boundary segment; a retaining space; a first through passage and a second through passage located between the nose segment and the stabilizing ring.

The valve opener may include: a nose section having an activation end and a continuous boundary section; a plunger element having two longitudinal edges; a stabilizing ring having a continuous boundary section at the end of the plunger element; a holding space; and a through passage located between the nose section and the stabilizing ring.

The space can be located between the two plunger elements or inside the stabilizing ring.

A stabilization ring may define a continuous boundary segment or may include one or more slits (such as discontinuous rings).

The terms first, second, third, etc., are understood as designations to distinguish different elements, structures, or components from one another, but unless the context otherwise indicates, these terms are not necessarily structurally restrictive. For example, the first arm and the second arm are different arms, and they may or may not have the same structure unless further limitations are imposed upon them or modified by further limitations.

The needle assembly may also include a needle protector, the needle protector including a resilient arm located at least partially inside the holding space of the valve opener, wherein the needle protector may include an elbow that protrudes through the first through passage and contacts the boundary of the through passage, the inner surface of the conduit hub, or both the boundary of the through passage and the inner surface of the conduit hub.

A method of assembling a needle assembly may include: providing a catheter hub having a catheter body having an open distal end and a proximal end attached to the catheter hub by a bushing, the catheter hub including a hub body having an inner surface defining an inner lumen and a proximal opening.

The method may further include: positioning a valve proximal to the bushing, the valve including at least one slit and two or more flaps; and positioning a valve opener proximal to the valve and inside the lumen of the catheter hub to slidably push open the valve when the valve is actuated by a male medical device.

A valve opener that can be used with the methods of this disclosure may include: a nose-shaped section having an activation end and a continuous boundary section; two plunger elements, each having two longitudinal edges; two stabilizer elements connecting the two plunger elements to form a stabilizing ring including the continuous boundary section; a holding space; and two through passages located between the nose-shaped section and the stabilizing ring.

The two plunger element extensions can extend towards the proximal side of the stabilizing ring.

A valve opener that can be used with the methods of this disclosure may include: a nose section having an activation end and a continuous boundary section; a plunger element having two longitudinal edges; a stabilizing ring having a continuous boundary section at the end of the plunger element; a holding space; and a through passage located between the nose section and the stabilizing ring.

The method may further include: positioning a needle attached to a needle hub through the conduit hub, valve, and conduit body, such that the tip of the needle extends from the open distal end of the conduit body in a standby position; and placing a needle protector at least partially inside the retaining space of the valve opener, such that an elbow or diagonal section on the arm of the needle protector extends through one of the two through passages of the valve opener and contacts the boundary of the through passage, the inner surface of the conduit hub, or both the boundary of the through passage and the inner surface of the conduit hub.

Other aspects of this disclosure may include a catheter assembly comprising: a needle hub having a needle having a needle tip; a catheter body attached to the catheter hub, the catheter hub having a body including an inner surface defining an inner lumen through which the needle extends; a valve positioned within the lumen of the catheter hub, the valve including at least one slit and two or more flaps; a valve opener including: a nasal segment having an active end; at least one plunger element having a proximal surface for being pushed by a male medical device; and a needle protector including a resilient arm extending distally along a proximal sidewall including a boundary defining an opening, the needle tip being configured to block the needle tip.

Methods of using, making and/or assembling catheter assemblies and needle assemblies and their components are within the scope of this disclosure.

Attached Figure Description

These and other features and advantages of this apparatus, system, and method will become better understood as a result of its reference to the specification, claims, and drawings, in which:

Figure 1 is a schematic cross-sectional side view of the catheter assembly in the ready position, with the needle tip extending from the distal end of the catheter body.

Figure 2 is a schematic cross-sectional side view of the catheter assembly of Figure 1 in a transitional position or state, where the needle is being removed from the catheter body and hub (e.g., after a successful venipuncture).

Figure 3 is a schematic cross-sectional side view of the catheter assembly of Figure 1, in which the needle has been completely separated from the catheter hub and the needle tip is covered by a needle guard.

Figure 4 is a schematic cross-sectional side view of the conduit assembly of Figure 1, wherein the conduit hub is now connected to the male Luer element and through which the proximal valve actuator is advanced to push the valve into the distal valve actuator to open the valve.

Figures 5A and 5B show an end view and a cross-sectional side view of a proximal valve actuator according to an aspect of this disclosure, respectively.

Figure 5C shows a cross-sectional end view taken along line 5C-5C of Figure 1, which shows the inwardly curved plunger element of the needle protector and the proximal valve opener.

Figure 5D is an alternative embodiment of the valve opener of Figure 5C, showing an outwardly arcing plunger element.

Figure 5E shows an alternative embodiment of the valve opener of Figure 5B, wherein the proximal section is a cylindrical member for surrounding at least a portion of the needle protector.

Figures 6A and 6B show an end view and a cross-sectional side view of a distal valve actuator according to an aspect of this disclosure, respectively.

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

Figure 7 is an isometric view of the needle protector in Figure 1.

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

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

Figure 8C is a front view of a single-slit disc valve, which has a V-shaped slit at each end of a single slit.

Figure 9 is an exploded perspective view of a needle assembly according to another aspect of this disclosure.

Figure 9A is an isometric sectional view of the needle assembly of Figure 9 in the assembled state.

Figure 9B is an isometric view of the needle assembly in Figure 9.

Figures 10A and 10B show partial cross-sectional side views of the needle assembly of Figure 9 in its assembled state along different view planes.

Figure 11 shows a partial perspective sectional view of the needle assembly of Figure 9 in an assembled state.

Figure 12A shows a partial cross-sectional side view of the needle assembly of Figure 9 after the needle has been removed.

Figure 12B shows a partial cross-sectional side view of the needle assembly of Figure 12A, in which the valve opener advances distally against the valve to open it.

Figure 13A is a perspective view of a valve opener provided according to another aspect of this disclosure.

Figures 13B and 13C show different views of the valve opener of Figure 13A, in which the needle protector is located in the holding space of the valve opener.

Figure 14A shows a valve according to another aspect of this disclosure, the valve having a valve disc and a valve skirt.

Figure 14B is a partial side sectional view of the needle assembly, in which the valve of Figure 14A is located inside the guide hub.

Figure 14C is a partial perspective sectional view of the needle assembly in Figure 14B.

Figures 15A to 15C depict the valve opener of this disclosure.

Figures 16 to 16C depict another valve opener of this disclosure.

Detailed Implementation

The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of a currently preferred embodiment of a conduit assembly with a control valve provided according to 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 can be constructed or used. This description sets forth the 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 this disclosure. As indicated elsewhere herein, the same reference numerals are intended to indicate the same or similar elements or features.

Referring now to Figure 1, 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 body 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 body 104, the needle tip 110 extending in a ready position out of a distal or distal opening 112 of the catheter body. In a ready position, the catheter assembly 100 is prepared, for example, to perform venous puncture or endovenous access. Sometimes, the ready position requires first removing a protective cap (not shown) from the catheter assembly or needle assembly 100.

A reflux plug 114 may be provided at the proximal end 118 of the needle hub 106, which allows ventilation but prevents blood from overflowing from the proximal end 118 as it enters the reflux chamber 116 during primary reflux. Alternatively, a syringe may be attached to the proximal end of the needle hub. Valves and actuators, further described below, may also be placed within the needle hub as a second valve. The needle hub 106 also includes a shoulder 120 or other surfaces that physically contact the catheter hub 102 (such as the proximal surface 122 of the catheter hub) to axially align the two hubs 102, 106 to set the length of the needle tip 110 protruding from the distal opening 112 of the catheter body 104.

Inside the catheter hub 102, a needle protector or tip protector 132, a valve opener or actuator 134, a valve 136, and a bushing 138 are provided in the inner cavity 130. The proximal opening of the catheter hub 102 can be designed to take the form of a female Luer taper. The bushing 138 is configured to wed into the proximal end of the catheter body 104 against the inner wall surface of the catheter hub 102 to hold the catheter body 104 to the catheter hub 102.

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

When the needle tip 110 is pulled into the needle protector 132 after a successful venipuncture, the arms of the needle protector collapse into their protective position to prevent accidental access to the needle tip. Simultaneously, the engagement of the arms with the catheter hub is released. The same function can also be achieved by one of the arm-type needle protectors described in U.S. Patent No. 6,616,630, which extends along the side of the needle bar instead of crossing the needle as shown in some embodiments of No. 6,616,630. Again, in the ready position, the needle bar pushes the distal wall of one arm to one side. As the needle tip 110 moves proximal to this distal wall, the distal wall springs open in front of the needle tip to prevent accidental access and simultaneously releases the engagement between the needle protector and the catheter hub.

Figure 5A shows a front view of the valve opener or actuator 134, and Figure 5B shows a cross-sectional side view of the same valve opener taken along lines 5B-5B of Figure 5A. Further referring to Figure 1, the valve opener 134 may include a ring or nose section 150 and at least one plunger element 152 (such as a leg element or elongated extension). The nose section or ring 150 is shown contacting the valve 136 in the needle assembly standby position of Figure 1, but may be slightly spaced from the proximal surface of the valve. In an exemplary embodiment, two plunger elements 152 may extend from the ring or nose section 150 in a proximal direction, and each has a length measured along the longitudinal direction of the conduit assembly and a width orthogonal to the length. At least one plunger element 152 is sized and shaped to be contacted by a male Luer element to transfer a distally directed force from the male Luer element to the ring 150 to then open the valve 136, as discussed further below.

As can be imagined from the front view of Figure 5A and the side view of Figure 5B, at least one plunger element 152 may have an arcuate or curved cross-section along its width. In another example, at least one plunger element 152 may be generally flat or planar. The thickness of each of the two plunger elements 152 is small or thin enough that the needle guard 132 and the two plunger elements 152 have sufficient clearance to fit within the internal cross-sectional space of the conduit hub 102 without physically abutting against the conduit hub and thus being immovable or fixed. In the example, the thickness of each of the two plunger elements 152 and the width of the needle guard eliminate the need to form an undercut or channel in the inner wall surface of the conduit hub 102 to accommodate them. When the plunger element 152 has an arcuate cross-section, it will be mechanically stronger to withstand greater loads when pushed by the male tip to press the ring or nose section 150 against the valve 136. This allows for a thin and compact design of the infusion device, and leaves more space in the standardized space of the female Luer taper section.

The valve opener 134 can be made of a metallic or plastic material. When made of a metallic material, the valve opener 134 can be formed by a deep drawing method, and the arcuate cross-section of the plunger element 152 can provide increased stiffness when pushed by the male Luer element. 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 stiffness. One or more gaps 154 can be provided between any two plunger elements 152. The gaps 154 can provide voids or spaces for the fluid flow across them (e.g., during IV infusion). The gaps 154 can also be used to accommodate the needle protector 132, as shown in Figure 1.

The annular or nose-shaped section 150 of the valve opener 134 includes a body 158 having a peripheral boundary 160. In one example, the peripheral boundary 160 is generally cylindrical. In other examples, the peripheral boundary may have a tapered portion. Internally, the body 158 includes a chamfer 162 and an opening 164. The distal edge, intersection, or active end 166 of the body 158 between the chamfer 162 and the peripheral boundary 160 may have a sharp or blunt edge. In one example, the active end or intersection 166 is a blunt edge including a planar surface for pressing against the valve 136, as discussed further below. On the proximal side of the annular 150, two plunger elements 152 may be recessed inward from the peripheral boundary 160 to form a shoulder 170. In other words, the peripheral boundary 160 may have a first-sized outer diameter, and the two plunger elements 152 may define a second-sized outer diameter, which is smaller than the first size. The shoulder 170 is disposed between these two different sizes.

Valve opener 134 has an inner diameter measured near the intersection or active end 166. The inner diameter changes or varies along the chamfered section 162 of the ring or nose section 150. Valve opener 134 also has a minimum inner diameter mID, which can be considered as the minimum inner diameter of the valve opener. As shown, the minimum inner diameter mID may be located at a corresponding internal location on the shoulder 170. In other examples, the minimum inner diameter mID may be located at other internal locations of valve opener 134, such as somewhere inside the ring 150 or somewhere between the plunger elements 152.

Figure 5C is a cross-sectional end view of the needle assembly 100 of Figure 1 taken along line 5C-5C, and the needle assembly is shown without the needle 108. Figure 5C shows the proximal wall surface 280 of the needle protector 132 and two plunger elements 152. As shown, the needle protector 132 is located between one or more gaps defined by the two plunger elements 152, and the proximal wall 280 extends proximal to the nearest edge of the valve opener 134. As previously mentioned, each plunger element 152 may 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 protector 132 internally and a convex portion facing away from the needle protector 132 externally. The arcuate surfaces of the two plunger elements 152 should have radii of curvature different from the radius of curvature of the female Luer element of the conduit hub 102, such as a radius of curvature smaller than that of the female Luer element of the conduit hub. The radii of curvature of the two C-shaped plunger elements should also differ from the radius of the tip of the male Luer element. Clearance may be provided on each side edge 52 near the sidewall 280 and on the adjacent plunger element 152.

The configuration of valve opener 134 allows two plunger elements 152 to define adjacent proximal surfaces 54, the dimensions and shapes of which are designed to be pressed against the valve opener 134 distally to open valve 136 when the male Luer tip or syringe tip is inserted into the proximal opening of catheter hub 102 after successful venous puncture. The arcuate cross-section of each of the two plunger elements 152 provides a sufficiently thick profile to ensure overlap of the adjacent surface with the male Luer tip and to ensure buckling-resistant stiffness. Therefore, the C-shaped plunger element can avoid deflection when pushed by the syringe tip or other male Luer element tip, avoid the syringe tip or Luer element tip slipping and missing the end surface 54 of the plunger element 152 when the syringe tip or Luer element tip is inserted into the open proximal end of the catheter hub, and/or avoid the situation where the syringe tip or Luer element tip pushes between the two plunger elements during the activation of the valve opener 134 so that the two plunger elements wedge between the tip and the inner surface of the catheter hub 102.

Figure 5D shows a cross-sectional end view of the catheter hub 102 that is the same as the cross-sectional end view of Figure 5C, but with an alternative arcuate cross-section on the plunger element 152 of the valve opener 134. As shown, each of the two plunger elements 152 includes a C-shaped cross-section. However, in this embodiment, the concave portion of the arcuate 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 towards the needle guard 132 on the inside. As in the embodiment of Figure 5C, when the syringe tip or Luer element tip is inserted into the catheter hub 102, the arcuate cross-sections of the two plunger elements 152 provide an abutment surface that overlaps with the tip to push the valve opener 134 into the valve to open the valve after a successful venipuncture.

When installed inside the cavity 130 of the conduit hub 102, the annular or nose-shaped segment 150 of the valve opener 134 elastically deforms and then extends as it reaches the recessed hub segment 174 of the conduit hub 102, which can accommodate the annular or nose-shaped segment without deforming the annular segment. Alternatively, the conduit hub 102 is designed to extend to allow assembly of the valve opener 134. A shoulder 176 (FIG. 4) is provided at the recessed hub segment 174, forming a physical stop for engaging the shoulder 170 on the valve opener 134. This allows the valve opener 134 to be held within the cavity 130 of the conduit hub 102 when the valve is closed, during needle withdrawal and during use when the valve opener 134 is pushed distally to activate the valve and subsequently moved proximally when the male Luer element is removed.

Referring again to Figure 1, valve 136 is located inside conduit hub 102, directly distal to the nose section or ring 150 of valve opener 134. In this example, valve 136 is specifically implemented as a valve disc, which includes a valve body comprising a valve diameter, a valve thickness orthogonal to the valve diameter, and one or more slits defining two or more flaps. As used herein, valve discs and valve disks are similar or identical unless the context otherwise indicates. In a particular example, three slits are provided through the valve thickness to define three flaps. The three slits may originate from a single point and extend radially from approximately the center point or central portion of the body of valve 136 in a manner resembling a three-pointed star, forming three flaps that can deflect along these slits. Valve 136 may include an outer boundary between valve opener 134 and bushing 138, which may float within the interior of the conduit hub. For example, the outer boundary of valve 136 can move proximally and distally within the lumen 130 of conduit hub 102 and is not constrained by the conduit hub in the axial direction of the conduit assembly. The outer boundary of valve 136 may be the same as, smaller than, or larger than the outer boundary of valve opener 134 or ring 150. However, at least part or all of the distal edge, intersection, or active end 166 of the nose section or ring 150 is recessed from the outer boundary of valve 136, such that the distal edge 166 may abut or touch the proximally facing wall surface of valve 136, as discussed further below. Moreover, because valve 136 can float, the valve can be positioned inside a single hub-body type conduit hub 102. In other words, it is not necessary to hold valve 136 inside the conduit hub by two or more conduit hub bodies (e.g., along the joint of two or more hub bodies). However, the various components described herein can be readily used with multi-piece conduit hubs without departing from the scope of this disclosure.

Figure 6A shows an end view of bushing 138, and Figure 6B shows a cross-sectional side view of the same bushing taken along line 6B-6B of Figure 6A. Further referring to Figure 1, bushing 138 includes a body 190, which includes: a first body segment 192; a second body segment 194 extending from the first body segment 192 and having a conical shape; and two or more leg extensions 196 extending from the second body segment 194. The first body segment 192 may have an elongated body, which may have a cylindrical shape and optionally a tapered distal tip or nose-like segment. In some examples, a generally cylindrical ring extends from the second body segment 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 the example, the number of leg extensions 196 included in bushing 138 is the same as the number of flaps included in valve 136. Therefore, if the valve has three flaps, three leg extensions 196 may be present on bushing 138. If valve 136 has a single slit, two leg extensions 196 may be present. The leg extensions 196 on bushing 138 may define an outer diameter smaller than the minimum inner diameter mID of valve opener 134. The proximal tip 204 of each leg extension 196 may have a chamfered or blunt tip. In one example, a chamfer 206 is included at the proximal tip 204 of each leg extension 196, and wherein the chamfer 206 tapers inward from the outside of the leg extension 196. This chamfer direction is configured to match the folding direction of the flaps on valve 136. Bushing 138 may be made of a metallic material, and the leg extensions 196 may be integrally formed with body 190. Alternatively, the outrigger extension 196 can be welded to the main body 190.

When positioned in the conduit hub 102, the bushing 138 and valve 136 are oriented such that the leg extension 196 on the bushing aligns with the flaps on the valve. In other words, these two components are aligned such that when the valve 136 is advanced from the proximal side to the distal side by the valve opener 134, as discussed further below, the flaps on the valve are pressed into physical contact with the leg extension 196 on the bushing 138. Thus, if there are three flaps on the valve, these three flaps will be pressed into physical contact with the three leg extensions on the bushing. The distally facing wall surface of the valve 136 may access the leg extension 196 and/or the resilient element 276, or may be spaced apart from the leg extension 196 and/or the resilient element 276 on the bushing 138 in the valve closed position and pressed against the leg extension during use. In other examples, the valve may access, or be spaced apart from, the proximal tip of the leg extension and/or the resilient element 276 in the valve closed position. If separated from the outrigger extension 196 and/or the resilient element 276, then the valve 136 can be axially displaced to contact it.

Figure 6C shows an end view of the alternative bushing 138, and Figure 6D shows a cross-sectional side view of the bushing taken along line 6D-6D of Figure 6C. Like the bushing of Figure 6A, this embodiment includes a body 190, which includes 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 may be equidistantly spaced along the perimeter of the second body section 194. In another example, the three leg extensions 196 may be positioned and spaced according to the lug positions on the valve 136, such that when the valve is assembled inside the conduit hub 102, the valve can be pushed distally by a valve opener or valve actuator 134, and the leg extensions 196 on the bushing 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, with the needle 108 in the process of disengagement from the catheter hub 102 and catheter body 104 (e.g., after a successful venipuncture). The needle tip 110 is shown just distal to the valve 136. During the retraction of the needle 108 in a proximal direction, the tip protector 132 is axially held in place by engagement between one or both resilient arms on the tip protector 132 and a protector engagement section 210 (FIGs 3 and 4) on the catheter hub 102. In the example, the protector engagement section 210 is a surface discontinuity formed on the inner surface of the catheter hub 102. For example, the protector engagement section 210 may include a section having a first inner diameter and a section having a second inner diameter, the second inner diameter being larger than the first inner diameter. The protector engagement section 210 may be specifically implemented as an internal protrusion or groove, or a combination of both grooves and protrusions formed on the inner surface of the catheter hub 102. When a combination of grooves and protrusions is used for the guard engagement section 210 to engage the needle guard or tip guard 132, it is preferable that the groove is located distal to the protrusion. In the example, two spaced-apart guard engagement sections 210 are provided to engage two resilient arms on the tip guard 132. The two guard engagement sections 210 may be positioned diametrically opposed to each other, just distal to the section of the female Luer tapered portion of the conduit hub 102.

Figure 5E illustrates a valve opener 134 provided according to 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-shaped section 150 having an active end 166; and two plunger elements 152 extending proximal to the nose-shaped section 150. However, this embodiment includes a band or ring connecting the two plunger elements 152 together, rather than two plunger elements 152 having two free ends. Two arcuate, curved sections, or stabilizer elements 253 may be attached to the two plunger elements 152 to form a band or ring 255. The band 255 may be referred to as a stabilizing ring 255 and may connect the two plunger elements 152 together to form a stabilizing structure. The stabilizing ring 255 forms a continuous boundary section of the valve actuator, which is spaced apart from another continuous boundary section defined by the nose-shaped section 150 of the valve actuator.

This valve actuator embodiment 134 can also be viewed as a valve opener 134 having a single plunger element 152 extending from the nose section 150, wherein the single plunger element 152 includes two or more release portions or through passages 61 formed through a wall at the plunger end. The needle protector 132 can engage the edge or enclosure 65 of the release portion 61 in the standby position and during needle withdrawal after successful venipuncture. Alternatively, the tip protector or needle protector 132 can protrude through the release portion 61 from the holding space defined by the valve opener 134 to engage the inner surface of the catheter hub 102. Alternatively, the tip protector 132 can protrude through the release portion 61 but not contact the interior of the catheter hub or the enclosure 65. Alternatively, the tip protector 132 can protrude through the release portion 61, contact the interior of the catheter hub, and contact one or both enclosures of the release portion. The portion of the tip protector that protrudes through one or two release portions can be one or both elbows of the tip protector.

The needle protector 132 (FIG. 7) of this embodiment can be at least partially positioned within the retaining space 155 of the valve opener 134. When located within the retaining space 155, the needle protector or tip protector can protrude through one or both release portions 61 of the valve opener. One or more portions of the needle protector protruding through may contact the interior of the guide hub, be spaced apart from the interior of the guide hub, contact one or both enclosures 65 of the release portion, be spaced apart from one or both enclosures of the release portion, or a combination of the above. This protruding portion of the needle protector can be one or both elbows of the needle protector.

Therefore, in embodiments having two release sections or through passages 61, the perimeter of the two release sections or through passages can function as a protector engagement section 210 by allowing the elbow of the tip protector to engage with the perimeter. Alternatively, the two elbows of the needle protector can protrude through the two release sections from the holding space defined by the valve opener to engage the protector engagement section or segment formed on the inner surface of the catheter hub. Thus, the perimeter of the release section or the inner surface of the catheter hub can form an anchoring point for engaging the arm of the tip protector with the anchoring point in the standby position and during needle withdrawal after successful venipuncture.

In the example, the single plunger element 152 of the valve opener 134 of FIG. 5E can be specifically implemented as a generally cylindrical body section 151, the body section 151 having: an inner surface 153 defining an opening having a path or channel 154, which may also be a gap for fluid flow; and a proximal enclosure or end edge 63. Similar to the guard engagement section 210 shown in FIG. 4, the guard engagement section 210 can be formed on the inner surface 153 of this valve opener 134. In other words, a protrusion, bulge, recess, or guard engagement section 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 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 protector engagement segment 210 may be on the catheter hub, on the inner wall of the valve opener, or formed as a boundary of a release portion through the wall of the valve opener. The valve opener may include one or more release portions or protector engagement segments. The catheter hub may also be formed with one or more protector engagement segments for use with one or more release portions of the valve opener. This allows the two resilient arms of the tip protector 132 to engage the valve opener 134 or to engage the catheter hub by protruding through the release portion.

In yet another example, two openings 61 (only one shown, indicated by dashed lines) through the wall of the cylindrical body portion 151 of the valve opener may be provided for use with a guard engagement segment 210 formed by or on the interior of the conduit hub 102. In an alternative position using the valve opener of this alternative embodiment, one or more resilient arms of the tip protector 132 may protrude through opening 61 or through both openings 61 to engage the opening 61 of the valve opener 134 or engage one or more guard engagement segments 210 inside the conduit hub 102 in addition to engaging the opening 61 of the valve opener 134.

Figure 3 shows the needle 108 completely removed from the catheter hub 102 with the tip protector 132 covering the needle tip 110 in the protected position (Figure 1). During the transition from the position in Figure 2 to the position in Figure 3, the needle tip 110 moves proximally to the two distal walls 300, 302 (Figure 7) of the tip protector 132 (one distal wall at each end of the resilient arms 288, 290 (Figure 7)). Alternatively, the needle protector 132 may have one distal wall and/or one arm. When both distal walls, and therefore both resilient arms, are no longer biased outward by the needle 108, the two arms 288, 290 move radially to disengage from the protector engagement section 210 of the OR valve opener 134 (Figure 5E) of the catheter hub 102 (if the OR valve opener 134 is used alternatively). Alternatively, one arm and one distal wall disengage from one protector engagement section 210.

As the needle continues to move proximally and the contour-changing portion 144 (FIG. 1) engages the perimeter 282 (FIG. 7) on the proximal wall of the tip protector 132, the tip protector 132 moves proximally together with the needle to the position shown in FIG. 3. Alternatively, the needle protector can be clamped onto the needle bar and removed from the catheter hub as a unit. Note that in the protected position where the tip protector 132 covers the needle tip, the valve 136 remains inside the cavity of the catheter hub 102. Thus, the valve 136 is located inside the catheter hub 102 in both the ready position and the protected position of the needle. From another perspective, the valve 136 is located inside 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 body 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 protector).

Referring now to Figure 4, the catheter hub 102 is shown as having a male medical device 220 positioned in its proximal opening. The male medical device or instrument 220 may be a male Luer element, a syringe tip, an IV connector, or other male tip having a tapered portion of the Luer element. For example, the male medical device may be connected to an IV tubing connected to an IV fluid source for delivering fluid therapy to a patient via the male medical device 220, the catheter hub 102, and the catheter tubing 104.

Referring to Figures 5A, 5B, 6A, and 6B, and continuing to refer to Figure 4, when the male medical device 220 (the male tip herein) 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 to open the valve 136 by advancing a distally pointing force on the two plunger elements 152. The arcuate cross-section of the plunger elements 152 may have a diameter smaller than the inner diameter of the catheter hub 102, thereby providing a larger contact surface to 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 the tangent point. In this way, the plunger elements 152 are stable and resistant to being deflected outwards. This arrangement avoids wedging the relatively thin plunger elements between the male medical device 220 and the inner wall of the catheter hub 102. A distally directed force moves the valve opener 134 distally until the geometry of the male tip 220 and the proximal opening of the conduit hub prevent the male tip from advancing further distally. In the example, the female Luer element tapered portion of the conduit hub 102 aligns with the male Luer element tapered portion of the male tip 220 and prevents the male tip from advancing further distally into the opening of the conduit hub. A seal is provided by the Luer element engagement to prevent fluid leakage from the proximal opening of the conduit hub.

As the valve opener 134 moves distally by advancing through the male tip 220, the ring 150 is induced to move distally and press against the proximal surface of the valve 136. Specifically, the distal edge 166 of the valve opener 134 initially presses against the proximal surface of the valve 136. When the valve 136 is axially movable within the guide hub 102, the valve opener 134 induced to move distally, and the male tip 220 induced to move the valve opener 134 distally. For example, the ring 150 contacts the valve 136 and pushes 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 simultaneously prevents other portions of the valve 136 adjacent to or contacting the leg extension 196 from moving distally. In practice, the outer edge of valve 136 (such as the outer section of the body of valve 136) moves distally, while simultaneously the flaps on the valve are deflected radially outward and proximally from the center point or central position by the leg extension 196 on bushing 138, thereby opening a flow path 226 through the valve. Fluid from the male tip 220 can then flow through the lumen of catheter hub 102, valve 136, and catheter body 104. Alternatively, suction can be applied by a male medical instrument (such as a syringe or vacuum blood collection tube) and blood can be aspirated from the patient. This is often done to test the sample before infusion therapy begins. Furthermore, any residual blood is typically flushed from the inside of catheter hub 102 before infusion therapy begins.

Referring further to Figures 4, 5B, and 6B, the chamfer 162 on the ring 150 and the chamfer 206 on the leg extension 196 promote radial outward and proximal deflection of the valve discs. Furthermore, the relative diameter defined by the leg extension 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 valve's outer boundary can remain in contact with the inner wall of the guide hub, with the discs opening only around one or more slits.

Therefore, one aspect of this disclosure is understood to include a conduit assembly comprising a valve including one or more slits and two or more flaps, wherein the valve includes a portion or section movable in a distal direction and a portion or section opening in a proximal direction in a radial direction to open a flow path through the valve. In the example, the outer edge of the valve is configured to move distally, while the valve flaps are configured to move radially outward to open a flow path through the valve. Moreover, by including a valve that can move in this way to open a fluid flow path, the actuation distance that the valve opener 134 must travel in the axial direction of the conduit assembly is minimized compared to a valve having flaps that open only in the distal direction by means of a valve opener. Therefore, the size of the conduit hub 102 (e.g., the length of the conduit hub) can be reduced compared to a conduit hub that utilizes a valve and a valve opener that opens the valve by deflecting the valve flaps only in the distal direction.

Another aspect of this disclosure is understood to include a conduit assembly comprising a valve, wherein the valve enclosure is axially floatable relative to the conduit hub. In other words, by including a valve with a valve enclosure that is axially floatable, a two-part conduit hub is not required to hold the valve enclosure therebetween and within the conduit hub. Therefore, a conduit hub having a hub body formed monolithically can be used with this conduit assembly. Consequently, the size of the conduit hub 102 (e.g., the outer diameter or outer dimension of the conduit hub) can be reduced compared to a conduit hub utilizing a two-part hub body. The two-part hub bodies (where they are joined together along a seam) can thus be reduced to provide a conduit assembly with a relatively smaller outer profile.

Another aspect of this disclosure is understood to include a valve opener 134 for opening valve 136. Valve opener 134 is configured to push the valve against another structure (such as a leg extension 196 on bushing 138). This valve opener 134 can be considered as having a multi-piece valve opening structure. For example, this portion having ring 150 and plunger element 152 can be considered as a proximal valve opener 250, and bushing 138 having leg extension 196 can be considered as a distal valve opener 252. The two valve openers 250, 252 cooperate to open valve 136. As described, the proximal valve opener 250 is sized and shaped to push against the outer edge of 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 a disc on the valve in a radially outward direction and a portion of the disc in a proximal direction to open a fluid path or flow path 226 through valve 136. In the example, the leg extension 196 on the distal valve opener 252 is axially fixed and is pushed against the leg extension in the distal direction by valve discs that are radially deflected outward by the leg extension on the distal side of valve 136. In other words, when the valve is actuated to open the flow path through the valve, the valve is physically pushed by an actuator located on the proximal side of the valve and an actuator located on the distal side of the valve. In a particular embodiment, the valve can be actuated to open the flow path through the valve by being physically pushed by a ring located on the proximal side of the valve and a leg extension located on the distal side of the valve.

In the valve open position of Figure 4, the proximal tip 204 of the leg extension 196 and the distal edge 166 of the ring 150 are separated from a plane drawn orthogonal to the longitudinal axis of the conduit assembly. In other words, the proximal tip 204 of the leg extension 196 and the distal edge 166 of the ring 150 do not overlap when viewed from this plane, and a gap is provided between them to accommodate the valve 136 therein. In another example, the proximal tip 204 of the leg extension 196 and the distal edge 166 of the ring 150 do overlap in the axial direction, which has the effect of causing a relatively larger amount of radial outward deflection of the flap compared to when there is no overlap. Furthermore, the flap is deflected proximally by these leg extensions 196 as it is pressed against the axially fixed leg extensions 196 on the bushing. In other examples, the proximal tip 204 of the outrigger extension 196 touches the distal edge 166 of the ring 150 only along a plane drawn orthogonal to the longitudinal axis of the conduit assembly.

In other aspects of this 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 body. The valve assembly may also include a tip protector for blocking the needle tip in a protected position. After successful venipuncture, a maleic tip (such as a maleic Luer element) can be inserted into the proximal opening of the catheter hub to advance the proximal valve opener distally, causing the valve to move distally against the distal valve opener. However, the discs are pivoted proximally to open a fluid path through the valve, rather than being deflected radially outward and distally to open a fluid path through the valve. For example, the tips of each disc of the valve (which typically originate from a point or origin near the center of the valve) are deflected proximally by a leg extension 196 of the bushing of the device. In this example, the discs are deflected proximally by pushing the discs against the fixed leg extension 196 on the distal valve opener 252. In other words, the valve flaps can be deflected in a proximal direction by a structure located on the distal side of the valve and adjacent to the distal-facing surface of 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 a 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 shown in FIG. 4, remove the male tip 220 distally away from the conduit hub 102. The biasing or resilient nature of the valve 136 (which may be made of an elastomer) allows the valve to spring back to its more relaxed state. Therefore, the flaps on the valve will spring back by moving distally, while the outer edge or outer section of the valve body springs back proximally, which pushes the proximal valve opener 250 proximally and pushes the shoulder 170 on the proximal valve opener 250 toward or against the interior of the conduit hub's cavity. Thus, after removing the male tip from the conduit hub, the valve 136 and the proximal valve opener 250 essentially return to the position shown in FIG. 3.

Alternatively or optionally, a resilient element 276 (not shown) of a softer material than valve 136 may be placed between the distal surface of the valve and the internal distal step or shoulder 274 of the catheter hub 102 (schematically shown in Figures 1 through 4). The resilient element 276 may be a helical spring, a leaf spring, or an elastomer cylindrical member. The resilient material 276 (if included) may provide additional biasing force to return valve 136 to the closed position when the positive medical device 220 is removed. The resilient member or resilient element 276 may be spaced apart from or in contact with valve 136 in the standby position shown in Figure 1.

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

Figure 7 is a rear isometric view of the needle protector 132 of Figure 1. The needle protector 132 is merely exemplary, as needle protectors with other or different features may be used instead of the spurious needle protector 132 shown in Figure 7. In this embodiment, the needle protector 132 includes a proximal sidewall 280, which includes a boundary 282 defining an opening 284. The proximal sidewall 280 has a proximal wall surface 286 and a distal wall surface opposite the proximal wall surface. At least one resilient arm 288 extends distally to the proximal sidewall 280. As shown, two resilient arms 288, 290 extend distally to the proximal sidewall. One arm may be longer than the other. Each arm may also include different arm widths, including a first arm segment 292 with a first width and a second arm segment 294 with a second width less than the first width. The two arms may originate from different ends of the proximal sidewall 280 and may intersect each other at their respective second arm segments 294. Therefore, when viewed from the side along the longitudinal direction of the needle protector 132, the two arms intersect each other. When used with a needle, the two arms 288, 290 intersect each other in both the standby position and the protected position. In an alternative embodiment, the two arms 288, 290 originate from different ends near the sidewall and extend distally without intersecting each other. 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 protector by utilizing different arm lengths and/or by making one of these walls form an angle at the elbow or diagonal segment 304 between the distal wall and the resilient arm. In the example, if two arms are used, the elbow or diagonal segment 304 of each arm can engage a corresponding protector engagement segment 210 inside the catheter hub 102 in the ready position and during the transition process of removing the needle 108 from the catheter hub 102, engage inside the valve actuator 134, or abut against one or more restraining or limiting surfaces or choke points of one or both release portions of the valve actuator 134 to removably secure the needle protector inside the catheter hub. When the radial profile of the needle protector 132, measured at one or both elbows 304, decreases (e.g., after the needle tip moves to the proximal side of the two distal sidewalls 300, 302), the needle protector 132 can move proximal to the blocking or choking point to be removed from the needle hub 102 along with the needle. The needle protector reduces its radial profile as the two distal sidewalls move radially. The needle protector 132 may be formed by folding a stamped sheet metal to create the protector as shown. Ribs may be formed on the arms, proximal sidewalls, and/or distal sidewalls to increase structural rigidity.

Referring now to FIG. 8A, a front view of an exemplary valve 136 provided according to aspects of this disclosure is shown. Valve 136 may be used with a conduit assembly and a hub having a female Luer element described elsewhere herein. Valve 136 is shown having a valve body 320 having a width measured from one edge to the other of a peripheral boundary 322 of the valve body. In this embodiment, due to the circular configuration of the exemplary valve, the width of the valve body is the same as the diameter of the valve body. Valve body 320 has a thickness that is a dimension extending into the page of FIG. 8A or orthogonal to the width. Valve 136 is shown having a single slit 324 formed to extend through the thickness of valve body 320, the single slit 324 defining a first flap 326a and a second flap 326b. These flaps may be collectively referred to using the element number 326. The first flap 326a and the second flap 326b may be deflected to open a flow path 226 through valve body 320. The first and second flaps can be deflected by pushing the valve 136 into the leg extension on the distal side of the valve using the valve opener on the proximal side of the valve, as previously discussed.

Figure 8B is a front view of an exemplary valve 136 provided according to another aspect of this disclosure, which may be used with a conduit assembly and a hub having a female Luer element as described elsewhere herein. With a few exceptions, this valve 136 is similar to the valve of Figure 8A. 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 may 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 pushing the valve 136 into a leg extension on the distal side of the valve using a valve opener on the proximal 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, and 326c near the center point 328 extend radially toward the outer boundary 322 and in a proximal direction as they are deflected by the leg extensions on the distal side of the valve 136. Because of the presence of three flaps 326a, 326b, and 326c, this valve is configured for use with a bushing having at least three leg extensions, as shown in Figures 6C and 6D.

Figure 8C is a front view of an exemplary valve 136 provided according to yet another aspect of this disclosure, which may be used with a conduit assembly and a hub having a female Luer element as described elsewhere herein. With a few exceptions, this valve 136 is similar to the valve of Figure 8A. In this embodiment, a single slit 324 for forming a first flap 326a and a second flap 328b is provided with release portions 340, 340 at both ends of the slit 324. In the example, the release portions 340, 340 are specifically implemented as two short through cuts 340a, 340b at each end of the slit 324, forming a V-shaped release portion 340. The two release portions 340 and 340 provide clearance for the two flaps 326a, 326b to allow these flaps to deflect more easily when pushed against the leg extension, and to have less restriction at the locations near the ends of the slit 324 than without the release portions. Less preferably, a single short through cut may be included at each end of the slit 324.

Figure 9 is an exploded perspective top view of a catheter assembly 400 provided according to another aspect of the present disclosure. As shown in Figure 9, 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 body 104; and a bushing 138. The bushing 138 may be configured to wed into the proximal end of the catheter body 104 against the inner wall surface of the catheter hub 102 to retain the catheter body 104 to the catheter hub 102.

Inside the catheter hub 102, a diaphragm or valve 136, an actuator or valve opener 134, and a safety clip 132 (such as a needle protector or tip protector) are provided. A needle 108 (having a profile-changing portion 144) can be inserted through a proximal opening of the catheter hub 102, with the needle tip protruding from a distal opening 112 of the catheter body in a standby position, as shown in FIG. 9A. A cannula hub or needle hub 106 can be attached to the proximal end of the needle 108 in the standby position and can contact its proximal end when assembled to the catheter hub 102. The proximal opening of the catheter hub 102 can be sized to have a female Luer element tapered portion (optionally with external threads) to engage with a male Luer element tip using a Luer element sliding or Luer element locking method.

The tip protector 132 is configured to be removed along with the needle 108 after use, while the valve 136 and valve actuator 134 remain with the conduit hub 102 for controlling the flow of fluid through it. The actuator 134 is configured to be pushed distally into the valve 136 by the male tip to open the valve and allow fluid flow, as discussed further below.

A reflux plug or blood stopper assembly 114 can be attached to the needle hub 106 to prevent blood from flowing out of the reflux chamber 116 of the needle hub 106. The reflux plug 114 can be provided at the proximal end of the needle hub 106 to allow ventilation but prevent blood from overflowing from the proximal end of the body of the reflux plug 114, which has a chamber 114a in which a hydrophobic filter 114b is assembled. Alternatively, a syringe can be attached to the proximal end of the needle hub 106. A second valve 136 and an actuator 134, further described below, can also be housed within the needle hub 106.

It is standard practice to provide a protective cap 124 with a sleeve 124a and a saddle 124b to cover the needle 108 during packaging and before use. The saddle 124b may surround at least a portion of the catheter hub 102 and the needle hub 106 and is removably engaged with the needle hub.

Figure 9A is an isometric cross-sectional view of the needle assembly 400 of Figure 9 in an assembled state. The catheter hub 102 is shown as having an optional pair of wings 126 extending radially toward the hub body. When included, the wings 126 can increase stability, such as after intravenous access, by providing an increased surface area for resting and securing the catheter hub 102 against the patient's skin.

Figure 9B is an isometric view of the assembled needle assembly 400 of Figure 9, showing a removable cap 124 set on the needle and engaging the needle hub 106.

With a few exceptions, the catheter assembly 400 of this disclosure is similar to the catheter assembly 100 of FIG. 1. Referring to FIG. 10A, a schematic cross-sectional side view of the catheter assembly 400 of FIG. 9 is shown. The catheter assembly 400 includes: a catheter hub 102 having a catheter body 104 (partially shown) extending distally therefrom; and a needle 108 attached to a needle hub 106 (partially shown), the needle protruding through the catheter hub 102 and the catheter body 104 in a standby position.

In a ready position where the needle hub 106 contacts the catheter hub 102 and the needle tip extends from the distal or distal opening 112 of the catheter body 104 (Figure 9), the catheter assembly 400 is ready for, for example, to perform venipuncture or intravenous access. Typically, the protective cap (not shown) is removed from the catheter assembly or needle assembly 400 before the device depicted in Figure 10A is seen.

Valve 136 is located inside conduit hub 102 and has: a valve body 320 having an outer diameter; a valve disc 410; and a valve skirt 412 extending axially from the valve disc. In the example, valve disc 410 includes one or more slits defining one or more flaps to be opened/closed by valve actuator 134. The type and number of slits and flaps included in valve disc 410 can be similar to those shown in the different valve embodiments 136 of Figures 8A to 8C. In the embodiment, valve skirt 412 is positioned in a recessed section 420 formed in the cavity 130 of conduit hub 102, which prevents axial movement of valve 136 once it is inside conduit hub 102.

In the example, the recessed section 420 has a distal shoulder 420a and a proximal shoulder 420b (FIG. 10B), which define a groove therebetween. A valve skirt 412 has a length, its dimensions and shape designed to fit within the groove. In the example, the valve skirt 412 contacts the proximal shoulder 420b, while the valve disc 410 contacts the distal shoulder 420a. Viewed from different angles, the valve 136 of FIG. 10A can contact the distal shoulder 420a and proximal shoulder 420b of the recessed section 420, and is thus constrained in the standby position such that the valve skirt 412 is axially fixed or unable to move axially.

In one example, the outer diameter or outer surface of the skirt-shaped section 412 forms a close fit or size-on-size fit with the recessed section 420 of the interior 130 of the conduit hub 102. In other examples, a slight interference fit is provided between the two. In still other examples, a small gap is provided between the outer surface of the skirt-shaped section 412 and the inner surface of the recessed section 420, wherein the valve skirt 412 contacts the proximal shoulder 420b and the valve disc 410 contacts the distal shoulder 420a of the recessed section.

A distal chamber 130a is provided on the distal side of the valve disc 410 and the proximal side of the bushing 438. In some examples, a coil spring or resilient biasing element (such as an elastomeric ring or tubular body) may be provided in the distal chamber 130a concentric with the needle to bias the flaps of the valve disc 410 to help the valve disc close one or more slits, similar to the resilient element 276 of Figures 1 through 4.

In the example, the valve disc 410 includes: a valve diameter; a valve thickness orthogonal to the valve diameter; and one or more slits 324 defining two or more lobes, as previously discussed. In the illustrated embodiment, the valve skirt 412 extends axially to the longitudinal axis of the valve and has an elongated wall generally perpendicular to the outer boundary of the valve disc 410, thereby forming a generally cylindrical valve body. In some embodiments, the valve skirt 412 may be inclined, such that the valve forms a truncated conical structure.

The valve skirt 412 defines a valve cavity 424 having an open proximal end 426, through which the actuator nose or nose-shaped segment 430 of the valve actuator 134 can advance and actuate the valve disc 410. In one embodiment, at least a portion of the actuator nose 430 (including the distal actuating end 436 of the valve actuator 134) is located inside the valve cavity 424 of the valve 136 before actuation. Therefore, the actuator nose 430 can be narrower than the inner diameter of the valve skirt 412, such that the actuating end 436 engages within the valve cavity 424 in a standby position and abuts or touches the valve disc. In this example, these relative dimensions ensure that the nose-shaped segment 430 of the actuator does not touch the inner wall surface of the skirt segment 412, although a degree of contact is contemplated.

In the example, the actuating end 436 contacts the proximal surface of the valve disc 410 in the standby position, and another portion of the valve actuator 134 (such as one or two protrusions 442 (FIG. 10B)) abuts the shoulder 452 inside the guide hub in the standby position to apply a load to the valve disc, but not enough to open one or more slits, as discussed further below. In other examples, the actuating end 436 is spaced from the proximal surface of the valve disc 410 in the standby position, and one or more protrusions 442 on the actuator either contact or are spaced from the shoulder 452. When one or more protrusions on the actuator 134 are spaced from the shoulder 452 and the actuating end 436 is spaced from the valve disc 410, the actuator can float slightly in the axial direction within the guide hub.

In the example, valve actuator 134 includes a nose-shaped section 430, which is elongated and may be generally cylindrical or have a draft angle or tapered portion terminating at an actuating end 436. The actuating end 436 may have a blunt distal surface or a sharp edge. The nose-shaped section 430 may have a wall surface with a continuous perimeter or continuous boundary section without gaps or slits (e.g., a cylinder with continuous walls). The nose-shaped section 430 may define an opening. In some examples, multiple spaced slits and/or openings may be provided on the nose-shaped section 430 to allow flow or fluid flushing.

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

In the example, protrusion 442 extends outward from the outer surface of one or both plunger elements 152. As shown, protrusion 442 extends from the outer surface of each plunger element 152. Each protrusion 442 is analogous to a ramp surface with generally flat edges for abutting a shoulder 452. The ramp surface of the protrusion 442 and the orientation of the ramp allow the actuator 134 to be inserted into the interior of the conduit hub and seated within the second recessed section 450, as discussed further below.

In the example, the transition section 440 extends from the nose-shaped section 430 and widens axially in the proximal direction. Two actuating elements 152 may extend from the transition section 440. These two actuating elements may extend from the nose-shaped section. Some embodiments may use other shapes for the nose-shaped section 430, such as cuboid, rectangular, conical, pyramidal, chamfered, etc.

In the example, the actuator or valve opener 134 has a longitudinal axis, and one or more actuating elements 152 extend axially or parallel to the longitudinal axis. In a particular example, two actuating elements 152 are diametrically opposed to each other along the longitudinal axis. As shown, the two actuating elements 152 define an outer diameter of a size larger than the diameter of the nose-shaped segment 430.

In the example, the actuating element 152 is flexible and deflectable, such that it deflects or flexes when pressed by the tip of the male Luer element. The actuating element is able to deflect by selecting a material with the required resilience. In other examples, the actuating element can be deflected by including one or more weakened sections, such as by including structurally thin sections, by including cut-outs, by employing a smaller cross-section compared to other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element 152 may be flexible and deflectable by selecting a material with the required resilience and by including one or more weakened sections.

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

In the example, the actuating element 152 is rigid and cannot deflect or deform when loaded (e.g., when pushed by the tip of the male Luer element). Furthermore, stabilizing elements may be included to increase the stiffness of both actuating elements 152. Each of the two actuating elements 152 may each include a cross-sectional profile at least at its proximal end, which overlaps with the pushing end of the male tip, such that the male tip can push the valve actuator into the valve, as previously discussed with reference to Figures 5C and 5D.

The nose section 430 of the valve actuator 134 can be configured to engage the valve 136 to open the valve disc 410, such as when an axial force is applied to the actuating element 152 from the male tip toward the distal end of the catheter assembly 100 during insertion of an IV drip line into a male Luer connector. Typically, the nose section 430 is rigid relative to the more flexible valve 136, which allows the nose section 430 (and more specifically the actuating end 436) to actuate the valve 136, such as to deflect one or more flaps and open one or more slits on the valve disc 410. The nose section 430 may be made of an incompressible material (such as metal, rigid plastic, or rigid elastomer) for pushing against and opening the valve.

The illustrated valve actuator embodiment 134 includes a pair of opposing bands or stabilizers 444, 444 (collectively or individually referred to as one or more stabilizers 444) connecting the two actuating elements 152 at a position along the length of the two actuating elements 152, located between the nose-shaped section 133 and the proximal ends of the actuating elements. In some examples, the stabilizers 444 may be located at the proximal ends of the two actuating elements 152 such that the proximal edges of the stabilizers 444 are generally flush with the proximal surfaces of these actuating elements. The two stabilizer elements 444, 444 may be referred to as a first or upper stabilizer element and a second or lower stabilizer element.

In one embodiment, the stabilizer or stabilizer element 444, 444 is arc-shaped, forming an arc that follows the inner contour of the guide hub 102 and connects one actuating element 152 to another. The stabilizer or stabilizer element 444 may form a substantially cylindrical section on the body of the valve actuator, spaced apart from the nose-shaped section 430 of the valve actuator. In other words, the valve actuator may be elongated and may have: sections that are continuous in the radial direction; and sections having a release portion or through passage through the wall of the actuator, which is discontinuous in the radial direction.

In the example, stabilizer 444 defines a continuous body section separated from the continuous body section of nose-shaped section 430 along the boundary or radial direction of the valve actuator, and the continuous body section of nose-shaped section 470 is also continuous along the boundary or radial direction. Two stabilizers or stabilizer elements 444, 444 may be coupled together with two plunger elements 152 to form a ring structure. Optionally, the two stabilizers may be slightly offset from each other and at an angle, as shown in FIG10a. In some embodiments, one, three, or different numbers of actuation elements 152 or stabilizers 444 may be present. In the example, valve actuator 134 (having stabilizers or stabilizer elements 444 and protrusions 442) is made of plastic (e.g., made by plastic injection molding).

Stabilizer 444 helps keep valve actuator 134 centered within conduit hub 102 during actuator movement (e.g., when pushed by the male Luer tip). By maintaining centering, nose section 430 can be better aligned with valve disc 410 (e.g., a slit on the valve disc), thereby allowing smooth actuation of valve 136. After removal of the male Luer tip, stabilizer 444 can also provide engagement with the interior of conduit hub 102 via friction to prevent actuator 134y from sliding in the proximal direction.

In one embodiment, the nose section 430 is configured to remain engaged with the valve disc 410 after actuation of the valve and after removal of the male Luer tip. For example, the nose section 430 may wedge between one or more slits on the valve disc and be held there by friction, as discussed further below. Surface features (such as ridges, grooves, or barbs) may be provided on the valve actuator 134 (such as on the nose section) to maintain engagement between the actuator and the valve after actuation and after removal of the male Luer tip.

A release portion, opening, or through passage 448 is provided between the transition section 440 or the nose section and each of the two stabilizers 444, 444. The two release portions or through passages 448 provide clearances such that the interior or central portion of the valve actuator 134 can be in open communication with the inner surface of the conduit hub 102. In other words, one or both release portions, through passages, or openings 448 are located between a continuous section of the nose section and a continuous boundary section defined by the two stabilizers 444, 444 and the plunger element 152 (referred to as one or more stabilizing rings 456 (FIG. 12A)).

The stabilizing ring 456 of the valve actuator 134 may have an inner diameter smaller than the diameter defined by the diagonal segments or elbows 304 of the two arms 288, 290 of the needle protector 132 when the two arms 288, 290 are biased outward by the sides of the needle bar. Therefore, during the installation of the needle protector 132 into the holding space of the valve actuator 134, the diagonal segments or elbows of the needle protector 132 may deflect to pass through the stabilizing ring 456 and enter the open area defined by the release portion 448.

When the tip protector 132 is positioned between the two plunger elements 152, the two distal walls 300, 302 (FIG. 7) of the needle protector 132 (more specifically, the two diagonal segments or elbows 304) can be located in the release portion 448 (as discussed above) to engage the protector engagement surface on the inner surface of the catheter hub 102. This allows the needle protector 132 to protrude from the retention space of the valve actuator 134 through the two release portions 448 to engage with the protector engagement surface of the catheter hub. Thus, the needle protector can be held inside the catheter hub in the standby position and during needle withdrawal after a successful venipuncture until the needle tip moves to the proximal side of the two distal walls on the needle protector, at which point the needle protector can be closed around the needle tip and removed together with the needle, as discussed above with reference to FIG. 3.

A second undercut or recessed section 450 proximal to the first recessed section 420 may be provided within the lumen of the catheter hub 102 to accommodate two diagonal sections or elbows 304. Thus, the needle protector 132 may be prevented from sliding proximally during needle withdrawal after successful venipuncture by means of the shoulder 452 of the second recessed section 450 or by some other surface feature on the interior of the catheter hub (such as a protector engagement surface on the interior of the catheter hub). Optionally or alternatively, the distal edge 446a (FIG. 12B) of one or both stabilizers 444, 444 may provide a limiting surface to prevent premature activation of the needle protector 132 before the needle tip moves proximal to the two distal walls 300, 302 during needle withdrawal. In addition to the distal edge 446a, both stabilizers 444, 444 also have a proximal edge 446b.

In some examples, one or both stabilizer elements 444, 444 may have slits or channels, thus dividing the arcuate stabilizing element into two segments, similar to the stabilizer elements of Figures 16A to 16C. Nevertheless, even if one or both stabilizer elements 444, 444 have slits, the stabilizing ring 456 (which may be a discontinuous ring, similar to a ring with one or more grooves formed through the ring) can still provide a restraining surface to prevent premature activation of the needle protector 132 before the needle tip moves to the proximal side of the two distal sidewalls 300, 302 (Figure 7) during needle withdrawal. The restraining surface may also be referred to as a restraining point, a choke gap, or a choke point because it provides a rigid structure that prevents the needle protector from moving proximal to its side (unless or until the needle protector is first activated and collapses radially to reduce its radial profile and then slides proximal to the choke point). In the example, one or both elbows 304 (Figure 7) of the needle protector can be restricted by a stop point to prevent movement in the proximal direction until one or both elbows of the needle protector deflect to reduce the radial profile of the needle protector. In the example, when the radial profile of the needle protector is reduced, the needle protector can slide from a distal position of the stabilizing ring through the opening defined by the stabilizing ring to a proximal position of the stabilizing ring.

Referring further to Figure 10B, which is a top cross-sectional view of the same conduit assembly 400 of Figure 10A rotated 90 degrees from the view of Figure 10A, with the tip protector 132 shown mating between the actuating elements 152. In an embodiment, one or more actuating elements 152 are sized and shaped to be contacted by a male Luer element to transfer a force proximal to the male Luer element via the nose 430 to then open the valve 136, as previously discussed.

The valve opener 134 can be made of a metallic or plastic material. When made of a metallic material, the valve opener 134 can be formed by bending or deep drawing methods, and the arcuate cross-section of the actuating element 152 can provide increased stiffness when pressed by a male Luer member. Each actuating element 152 may include at least two longitudinal edges, and ribs may be provided along one or both of the longitudinal edges to further increase structural stiffness. One or more gaps may be provided between any two actuating elements 152. The gaps may provide voids or spaces for fluid flow across their flow (e.g., during blood flushing or IV infusion). The gaps between the actuating elements 152 may define a holding space to accommodate the tip protector 132, as shown in Figure 10B.

In some embodiments, in the standby position, most or most (if not all) of the tip protector 132 fits within the retaining space formed by the body of the actuator 134, between the two plunger elements 152, as shown in FIG10B. This allows for a more compact catheter hub 102 because less longitudinal space is required within the hub to fit continuously longitudinally or, when the actuator 134 and the tip protector 132 only partially overlap in the axial direction. In FIG10B, the tip protector 132 is shown fully fitted within the retaining space of the actuator 134 to further reduce the space or length required in the catheter hub. As shown, the proximal sidewall 280 of the needle protector 132 is generally flush with or on the same level as the proximal surfaces of the two plunger elements 152.

When the tip protector 132 engages only with the release portion or the distal edge 446a of the through passage 448 in the actuator, no deformation or change in diameter is required on the inner wall of the guide hub, and the tip protector 132 can be placed further proximally in the tapered section of the female Luer member, while conforming to the international Luer member standard for tapered fittings, and the overall length of the guide hub 102 can be further reduced.

Figure 11 is a perspective view of the catheter assembly 400 of Figures 10A and 10B. A release portion or through passage 448 is clearly shown proximal to the nose section 430 of the actuator 134 to allow the tip protector 132 to engage internally with the catheter hub 102, as previously discussed. A stabilizer 444 is visible proximal to the release portion 448, which provides additional rigidity and/or a larger engagement surface for the catheter hub 102. The actuating element 152 extends beyond the proximal edge 446b of the stabilizer 444 (Figures 12A and 12B) to a substantially the same distance as the proximal wall 280 of the tip protector 132. In the illustrated embodiment, the tip protector 132 substantially fits within the retention space of the actuator 134, and the proximal wall 280 of the tip protector is approximately at the same level as the proximal end of the actuating element 152 in the axial direction.

Figure 12A is a partial cross-sectional side view of the valve assembly 400 after the needle and needle guard have been removed from the catheter hub 102 (e.g., after a successful venipuncture). As shown, the valve 136 is in the closed position, in which one or more slits 324 of the valve disc 410 are closed. The valve actuator 134 is also shown in the retracted position, in which the actuating end 436 of the nose section 430 is not pushed into one or more slits and opened. This position is also understood to be the valve pre-activated position. That is, the male Luer tip has not yet been inserted into the proximal opening of the catheter hub to advance the valve actuator to open the valve. In other words, this is the valve closed position.

Figure 12B is a partial cross-sectional side view of the valve assembly 400 of Figure 12A, wherein the valve has been actuated to open one or more slits 324. This view shows the valve actuator 134 being advanced distally into the valve 136 through the tip of a syringe tip or an IV drip line (not shown) to allow fluid flow through the conduit hub. Advancing the actuator 134 causes the actuating end 436 to advance against the valve disc 410 and deflect the flap radially and distally to open the fluid path to be formed through the conduit assembly 400.

When a male medical device (such as a male Luer tip) is initially inserted into the proximal opening of the catheter hub 102, the male tip initially contacts two actuating elements 152 on the actuator 134, causing a distally directed force on these two actuating elements 152 to advance and open the valve 136. The distally directed force causes the actuator 134 to move distally until the geometry of the male tip and the proximal opening of the catheter hub prevent further distal advancement of the male tip. In this example, the female Luer tapered portion of the catheter hub 102 mates with the male Luer tapered portion of the male tip and prevents further distal advancement of the male tip into the opening of the catheter hub. A seal is provided by the Luer engagement to prevent fluid leakage from the proximal opening of the catheter hub.

As the actuator 134 moves distally by advancing through the male tip, the nose 430 of the valve actuator 134 is propelled distally and presses against the proximal surface of the valve disc 410. Specifically, the nose of the actuator 134 initially presses against the proximal surface of the valve disc 410, and because the valve is axially fixed within the first recessed section 420 of the conduit hub, one or more flaps on the valve disc 410 are deflected radially and distally. Fluid from the male tip can then flow through the conduit hub 102, through the valve 136, and through the lumen of the conduit body 104.

Alternatively, suction can be applied using a positive-type medical device (such as a syringe or vacuum blood collection tube) to aspirate blood from the patient. This is often done to test the sample before starting infusion therapy. Furthermore, any residual blood is usually flushed from the inside of the catheter hub 102 before starting infusion therapy.

Referring again to Figure 12B, the actuating end 436 of the nose section 430 is shown protruding through the valve disc 410 in the valve actuated position and either contacting or just about to contact the bushing 138. In this configuration, the valve actuator 134 remains engaged with the valve 136 even after the male tip is removed. That is, the friction between the valve actuator 134 and the valve disc 410 exceeds the restoring force generated by the valve disc as it attempts to return to its undeformed position as shown in Figure 12A. This activated position can be considered a one-time use or one-time actuation position because the valve actuator 134 and the valve 136 do not return to the pre-activated position of Figure 12A when the male tip is removed.

In an alternative embodiment, the nose section 430 is configured such that when pushed into valve 136 during activation, the actuating or activating end 436 does not extend distally beyond the flaps of valve disc 410. This configuration ensures that the valve actuator 134 is pushed back by the flaps of the valve disc when the male Luer element device is removed. The conical configuration at the distal end of actuator 134 can be such that it maintains a proximal force vector greater than the vertical force vector. The angle of the cone can be designed to provide the necessary force vector when actuator 134 has reached its maximum and minimum distal movement. The difference between the maximum and minimum movement of a standard Luer element connector is approximately 2.5 mm.

Alternatively, a spring or resilient element or ring (similar to the restoring element 276 in FIG. 1) can be included in the distal chamber 130a to increase the rebound or restoring force of valve 136, thereby promoting a proximal pushback of valve actuator 134 to return to the pre-activated position or valve closed position shown in FIG. 12A after removal of the male tip. The resilient element can also help close the flaps of valve disc 410. In this way, after initial activation, valve 136 and valve actuator 134 can be closed and reopened, and so on. Alternatively or additionally, the flaps 326 on the valve disc can be made thicker to provide sufficient restoring force without the need for a resilient element.

Referring again to the stabilization ring 456 in Figures 12A and 12B, note that the distal edge 446a and proximal edge 446b of the stabilizers 444, 444 are not parallel to the proximal edges of the two plunger elements 152. Conversely, the distal edge 446a and proximal edge 446b of the upper stabilizer 444 are parallel to each other, and the distal edge 446a and proximal edge 446b of the lower stabilizer 444 are parallel to each other, but the corresponding edges of the upper and lower stabilizers 444, 444 are not parallel to each other. In other words, the upper stabilizer 444 has a distal tilt, while the lower stabilizer 444 has a proximal tilt.

Figure 13A is a perspective view of an embodiment of a valve actuator 134 provided according to another aspect of this disclosure. The actuator 134 includes a generally cylindrical nose or nose-shaped segment 430 (such as a truncated conical nose) and an activation end 436 at its distal end. An actuator arm 152 extends longitudinally from the nose-shaped segment 430. The valve actuator 134 provides similar functionality to the actuators 134 of Figures 1 through 4 and Figures 10A through 12B, with some structural differences, such as the stabilizer 444 being generally even without off-setting edges. In the ready position and if used with the conduit assemblies of Figures 10A and 10B, the nose-shaped segment 430 may contact the valve disc or may be slightly spaced from the proximal surface of the valve disc 410.

The release portion or through passage 448 provides the tip protector 132 with an access passage for engaging the interior of the conduit hub 102, as previously described. In one embodiment, two through passages or release portions 448 are provided on opposite sides of the body of the actuator 134 to allow the two corresponding arms of the tip protector 132 to enter the interior of the conduit hub 102. Other embodiments may have a different number of through passages, such as including one, three or more. For example, there may be three through passages spaced apart between three actuating elements. The distal end of the release portion or through passage 448 forms an engagement shoulder 550 of the valve arm, which is discussed in further detail in Figures 14B and 14C.

In the illustrated embodiment, stabilizer 444 connects two actuation elements 152 and forms a ring structure (also referred to as stabilization ring 456) on the proximal end of actuator 134. Stabilizer 444 can provide additional rigidity and/or engagement surfaces for the actuator to interact with the needle guard and/or the interior of the conduit hub 102. In some embodiments, stabilization ring 456 comprises one, two, or more individual segments that form a substantially cylindrical segment of the actuator body. These stabilizers may have aligned or offset edges, as shown in the embodiment of FIG. 10A.

Figures 13B and 13C illustrate a side view and a top view of the actuator embodiment 134 of Figure 13A. A large portion of the tip protector 132 is shown mating within the retention space of the actuator 134, with a portion of the tip protector extending proximally beyond the proximal end of the actuator. For example, a portion of the proximal wall 280 of the tip protector 132 and portions of the two arms 288, 290 extend radially through the release portion 448 of the actuator 134. One or more ribs or protrusions 552 may be formed on the outer surface of the actuator arm 152 and may engage with a shoulder 452 on a second recessed section 450 (Figure 10A) of the conduit hub in both the standby and use positions to retain the actuator 134 within the conduit hub 102.

Figure 14A illustrates valve embodiment 136, which has one or more ridges 602 formed on the outer surface of the valve skirt 412. Figure 14B illustrates the valve 136 of Figure 14A, which is connected to the actuator 134 of Figures 13A to 13C when it is in the ready position in the conduit hub 102.

The valve 136 of Figure 14A performs a similar function to the valves 136 of Figures 1, 10A to 10B, and 12A to 12B, and has many of the same structures (such as the skirt 412, valve disc 410, and valve slit 324). Valve 136 also includes a distal skirt section 413 extending distally to the valve disc 410. Additionally, engagement surfaces 602 (such as one or more ridges) are formed on the outer surface to provide greater engagement with the conduit hub 102, as shown in Figure 14B.

The mating surface 602 may include protrusions or grooves, or a combination of both, formed on the outer surface of the valve 136. For example, the mating surface 602 may include segments with a first outer diameter (e.g., peaks/protrusions) and a second outer diameter (e.g., valleys/grooves), wherein these segments are repeated once or multiple times on the outer perimeter of the valve. In another example, the grooves and/or protrusions may be formed as a single continuous, helical structure on the exterior of the valve.

In some embodiments, the mating surface 602 extends circumferentially along the outer surface of the valve 136, thereby forming a ring or spiral thread. In other embodiments, the mating surface 602 includes several separate sections formed on the outer surface, such as separate protrusions/recesses or threaded sections on a broken screw.

The conduit hub 102 may have a corresponding mating surface 610 on its inner surface to mate with the valve mating surface 602 of the valve 136. The mating surface 610 may be similar to the mating surface 602 of the valve 136, but have reverse features to mate with the valve mating surface 610.

By forming mating surfaces on valve 136 and conduit hub 102, the valve can be better held in the correct position in conduit hub 102 even when actuator 134 applies force to valve 136. In the absence of recessed sections with proximal and distal shoulders, mating surface 602 can be used to axially secure valve 136 within conduit hub.

In the illustrated embodiment, two engagement arms 612 are formed on the proximal end of the valve 136, extending radially inward from the inner surface of the valve skirt 412. The engagement arms 612 are configured to mate with engagement shoulders 550 formed on the actuator 134. In the illustrated embodiment, two opposing engagement shoulders 550 are configured to engage with two engagement shoulders 550 formed by two release portions or through passages 448 in the actuator 134. In other embodiments, different numbers of engagement shoulders and engagement arms (e.g., one, three, or more) may be used.

Referring to Figure 14B, in the ready position, the nose 430 of the actuator 134 is located within the holding space 620 of the valve 136, adjacent to the proximal surface of the valve disc 410. A valve skirt 412 surrounds the nose 430, wherein an engaging arm 612 partially extends into the release portion or through passage 448 of the actuator and engages with an engaging shoulder 550. In one embodiment, the engaging arm 612 has a sufficiently low profile to not interfere with the needle and tip protector 132, such that the arm 612 does not interfere with the movement of the needle and tip protector 132.

Figure 14C is a perspective sectional view of the needle assembly in Figure 14B.

The valve 136 of the conduit assembly 600 of Figures 14B and 14C can be configured for single-use or one-time actuation. Optionally, the valve disc 410 of valve 136 can be made sufficiently resilient, such as by making the flaps thicker so that they return to their closed position after the male Luer tip is removed, and axial load is no longer applied to the valve actuator. In another example, a resilient element (similar to the resilient element 276 of Figure 1) may be included to aid in closing the flaps on the valve. The actuator has a conical nose, which is preferred for multi-purpose valve designs. The conical shape will maintain a proximal-pointing force against the flaps against the conical surface when not pushed further than the distal end of the open flap, which can push the actuator back to its initial position until the flaps close again and stop flow.

Referring now to Figure 15A, a top or plan view of the valve opener or actuator 134 is shown. The valve opener can be used with any needle assembly described elsewhere herein (such as those shown in Figures 9 through 12B). As shown, the valve actuator has: a nose section 430; a transition section 440; and two plunger elements 152 extending proximally to or from the nose section of the transition section. The nose section 430 defines a first continuous enclosure section 700. Other locations of the nose section 430 remote from the first continuous enclosure section 700 may include slits or slots.

Two stabilizer elements 444, 444 are attached to two plunger elements 152 to form a stabilization ring 456, which defines a second continuous boundary section 702 of the valve actuator. Each stabilizer element 444 may include two edges 446a, 446b. In the example, the two edges 446a, 446b of each stabilizer element may be parallel to each other. As shown, the two stabilizer elements 444, 444 are skewed or tilted such that although the two edges 446a, 446b of each stabilizer element may be parallel to each other, the two edges 446a, 446b from one stabilizer element are not parallel to the two edges 446a, 446b of the other stabilizer element. As shown, the proximal edge 446b of the two stabilizer elements 444, 444 is offset along the axial or longitudinal direction of the valve actuator. As shown, the distal edge 446a of the two stabilizer elements 444, 444 is offset along the axial direction.

Two release sections or two through passages 448 are provided on the valve opener 134, each defined or bounded by a transition section 440, two plunger elements 152, and corresponding stabilizer elements 444, 444. These two release sections or through passages may be referred to as a first release section or first through passage and a second release section or second through passage. In the example, each release section or through passage has a boundary 708. In the example, each boundary may be defined by the structure of the transition section 440, the two plunger elements 152, and the corresponding stabilizer elements 444, 444. Because the two stabilizer elements 444, 444 may be skewed or tilted in different directions, the two boundaries 708 of the two release sections or through passages 448 may be different, such as having different boundary profiles or shapes. As shown, each of the two boundaries 708 is defined by a continuous ring. In other words, in this embodiment, these boundaries 708 do not have slits or slots to form an open boundary. However, when the stabilizer element 444 includes a slot or slit, the enclosure can be an open enclosure or a discontinuous enclosure.

In some examples, the two stabilizer elements 444, 444 can extend laterally without skewing or tilting in the distal or proximal direction. When constructed in this way, the edges 446a, 446b of the two stabilizer elements 444, 444 are parallel to each other. Additionally, the four edges of the two stabilizer elements can be parallel to each other and axially offset. That is, the proximal edge 446b of one stabilizer element can be located more proximal or distal than the proximal edge 446b of the other stabilizer element, while these four edges are parallel to each other.

Referring further to Figure 15A, the two plunger element posts or extensions 152a are considered to extend proximally toward the stabilizing ring 456. In one example, the two plunger element posts 152a may extend from the stabilizing ring 456 and are axially aligned with the plunger element 152 located distal to the stabilizing ring 456. In other examples, the two plunger element posts 152a are not axially aligned with the two plunger elements 152 located distal to the stabilizing ring 456. In still other examples, only one plunger element post 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 consecutive boundary sections, only one of the two plunger element posts 152a or neither of the plunger element posts can be aligned with that single plunger element.

In some examples, there may be more than two plunger element posts or extensions 152a extending proximally to the stabilizing ring 456. Two or more plunger element posts or extensions 152a may be equidistantly spaced or randomly spaced around the proximal periphery of the stabilizing ring 456. The plunger element posts may extend the overall length of the valve actuator. Compared to a smaller number of plunger element posts or for plunger element posts with a relatively smaller curvature, a certain number of plunger element posts and/or each plunger element post with a certain curvature (the curvature defining the width of each plunger element post) can provide a larger overlap surface with the tip of the male Luer element.

Referring further to FIG. 15A, each of the two plunger elements 152 is considered to have at least two thicknesses to create a protrusion 442 on the outer surface 710 of each plunger element at the junction between these two thicknesses. As previously described, the two protrusions 442 may be located inside the recessed section 450 (FIG. 10B) such that a shoulder 452 at the proximal end of the recessed section 450 provides a stop surface to prevent displacement of the valve opener 134 in the proximal direction. In some examples, only one protrusion 442 is used on one of the two plunger elements to prevent displacement of the valve opener 134 in the proximal direction. In still other examples, each plunger element 152 has a single thickness, and the protrusion 442 is formed only at the location of the protrusion 480 by adding material to the plunger element during injection molding.

In the example, the planar surface section 714 provides a valve actuator 134 on the same side of each stabilizer element 444. The planar surface section 714 originates approximately from the nose section 430 or transition section 440 of the valve member and extends proximally to approximately two protrusions 442.

Referring now to Figure 15B, which is a cross-sectional side view of the valve opener 134 of Figure 15A taken along line 15B-15B, two planar surface segments 714 corresponding to the two stabilizer elements 444 are provided on each side of the valve opener 134 as a way to minimize the overall profile of the transition section 440 and the two plunger elements 152 along the side profile, as shown in Figure 15B. Therefore, in this example, the cross-sectional dimensions of the nose section 430, the transition section 440, and the two plunger elements 152 are substantially constant or identical within typical manufacturing tolerances, either along the side view or at a 90-degree angle to the orientation of Figure 15A along the longitudinal axis of the valve opener.

Referring again to Figure 15B, a retaining space 720 is shown, which may be located between the two plunger elements 152, inside the stabilizing ring 456, between the two plunger element posts 152a, or a combination thereof. As previously described, part or all of the needle protector or tip protector 132 may be located in the retaining space 720 in a standby position, and one or both elbows of the tip protector 132 protrude from the release portion 448.

The proximal wall of the needle protector 132 may be flush with the proximal end surface 726 of the plunger element post 152a, located proximal to or distal to the end surface 726. If the plunger element post is excluded, the proximal wall of the needle protector 132 may be flush with the proximal edges of one or both stabilizer elements 444, 444, located proximal to or distal to the proximal edges of one or both stabilizer elements 444, 444.

Referring further to Figure 15B, the distance between the two inner surfaces 728 of the two stabilizer elements 444, 444 defines a choke gap, choke point, or limiting point for the needle protector to restrict proximal movement of the needle protector during needle withdrawal in the standby position and/or after intravenous access, as previously discussed. That is, before the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, the choke point or gap is too small for the needle protector to pass through to reach the proximal side of the choke point, choke point, or limiting point. However, after the needle tip moves to the proximal side of one or both distal blocking walls of the needle protector, the two distal walls move radially inward to reduce the radial profile of the needle protector, which is smaller than the choke point. At that point, with the radial profile measured at both elbows being smaller, the needle protector can move proximal to the choke point.

Figure 15C is a perspective view of the valve opener 134 of Figures 15A and 15B.

Referring now to FIG16A, a top view and a plan view of a valve opener or actuator 134 according to an alternative aspect of the present disclosure are shown. The valve opener 134 can be used with any of the needle assemblies disclosed elsewhere herein. As shown, the valve actuator has a nose section 430, a transition section 440, and two plunger elements 152 extending proximally to the transition section 440. The nose section 430 defines a first continuous enclosure section 800. Other locations of the nose section 430 remote from the first continuous enclosure section 800 may include slits or slots.

Two stabilizer elements 444, 444 (FIG. 16B) are attached to two plunger elements 152 to form a stabilizing ring 456. However, each stabilizer element 444, 444 is discontinuous and has a slit or slot 804. In other words, each stabilizer element 444 in this embodiment includes two stabilizer segments 810, 812, which are spaced apart from each other by the slit or slot 804. Each stabilizer segment 810 is further understood to include an inner edge 814, which is spaced apart from another inner edge 814 of the other stabilizer segment 812. The two inner edges 814 define a slit or slot 804 therebetween. The two stabilizer segments 810, 812 may be similar or identical, or they may be different.

The width of the slit or slot 804 is less than the widest width of the needle protector 132 (FIG. 7). In some examples, the width of the slit or slot 804 is less than the width of the distal walls 300, 302. The width of the slit or slot may also be less than the width of the needle protector at the elbow 304. The relative dimensions between the slits or slots 804 on the valve opener 134 and the width of the needle protector 132 are selected such that the stabilization ring 456 is sized to restrict proximal movement of the needle protector 132 (e.g., the two elbows 304 on the needle protector) to prevent movement proximal to the stabilization ring during needle withdrawal but before needle protector activation. In other words, even though the two stabilization rings include slits or slots, they can still act as limiting surfaces or choke points.

As previously mentioned, the valve opener 134 may include one or two stabilizer elements 444. The one or two stabilizer elements 444 may also be continuous or segmented, such that there are slits or slots 804 between these segments. The needle protector having one arm and one elbow, two arms but only one elbow, or two arms and two elbows can be used with any of a variety of valve actuators.

Although the stabilizing ring 456 of this valve embodiment includes one or more slits (e.g., two slits 804), the stabilizing ring 456 provides, along the two stabilizer elements 444, 444, a limiting or choking point for the needle protector or tip protector similar to other valve actuators 134 described elsewhere herein and discussed further below. The stabilizing ring 456 (which has discontinuous boundary sections) can also provide stability during axial movement of the valve actuator 134 by acting as a support against the inner surface of the guide hub to guide the valve actuator 134.

Each stabilizer element 444 may include two discontinuous edges 446a, 446b, which may be referred to as the distal edge 446a and the proximal edge 446b. In the example, the two edges 446a, 446b of each stabilizer element are parallel to each other. The two edges 446a, 446b from one stabilizer element 444 are also parallel to the two edges 446a, 446b of the other stabilizer element. As shown, the proximal edges 446b of the two stabilizer elements 444 are aligned along the axial or longitudinal direction of the valve actuator. As shown, the distal edges 446a of the two stabilizer elements 444 are also aligned along the axial direction. In other examples, the edges of the two stabilizer elements 444 may also be axially offset.

Two release sections or two through passages 448 are provided on the valve opener 134, each defined or bounded by a transition section 440, two plunger elements 152, and corresponding stabilizer elements 444, 444. These two release sections or through passages 448 may be referred to as a first release section or first through passage and a second release section or second through passage. In the example, each release section or through passage has a boundary 820. In the example, each boundary 820 may be defined by the structure of the transition section 440, the two plunger elements 152, and the corresponding stabilizer elements 444, 444. The two boundaries 820 of the two release sections or through passages 448 may be identical (as shown) or may have different boundary profiles or shapes. The two boundaries 820 are discontinuous, such as being discontinuous, due to the slit or slot 804 (one slit or slot 804 is present on each stabilizer element 444).

The valve opener 134 of this embodiment can be made of a metallic material. For example, a deep-drawn stamped sheet metal (such as a stamped stainless steel sheet) can be formed into the shape shown. Various openings or gaps can be punched or stamped and then cold-worked to form the disclosed shape. 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 gaps 154 can provide voids or spaces for the fluid flow across them, such as during IV infusion. The gaps 154 can also be used to accommodate the needle protector 132, as shown in FIG1.

Referring further to Figure 16A, the two plunger element posts or extensions 152a are considered to extend proximally toward the stabilizing ring 456. In one example, the two plunger element posts 152a may extend from the stabilizing ring 456 and are axially aligned with the plunger element 152 located distal to the stabilizing ring 456. In other examples, the two plunger element posts 152a are not axially aligned with the two plunger elements 152 located distal to the stabilizing ring 456. In still other examples, only one plunger element post 152a is aligned with one of the two plunger elements 152.

In some examples, the valve opener 134 terminates at the stabilization ring 456, and the actuator has no plunger element post 152a. In other examples, each plunger element post 152a located proximal to each plunger element can be considered as part of the same plunger element, and the stabilizer segments 810, 812 are protrusions extending radially from the two longitudinal edges of the two plunger elements 152 to the distal position of the proximal surface 824.

In some examples, there may be more than two plunger element posts or extensions 152a extending proximally to the stabilization ring 456. Two or more plunger element posts or extensions 152a may be equidistantly spaced or randomly spaced around the proximal periphery of the stabilization ring 456. The plunger element posts may extend the total length of the valve actuator 134. Compared to a smaller number of plunger element posts or for plunger element posts with a relatively smaller curvature, a certain number of plunger element posts and/or a certain curvature for each plunger element post (the curvature defining the width of each plunger element post) can provide a larger overlap surface with the tip of the male Luer element. In some examples, the plunger element posts 152a have curved surfaces that may resemble the curved surfaces of the plunger elements in 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.

Referring further to FIG. 16A, each of the two plunger elements 152 includes a protrusion 442 on the outer surface 826 of each plunger element. As previously described, the two protrusions 442 may be located inside the recessed section 450 (FIG. 10B) of the conduit hub, such that a shoulder 452 at the proximal end of the recessed section 450 provides a stop surface to prevent displacement of the valve opener 134 in the proximal direction. In some examples, only one protrusion 442 is used on one of the two plunger elements 152 to prevent displacement of the valve opener 134 in the proximal direction. In examples, each protrusion 442 may be formed at the respective plunger element by cold-working the surface of a stamped sheet of metal to push out the protruding surface.

Referring now to Figure 16B, which is a cross-sectional side view of the valve opener 134 of Figure 16A taken along line 16B-16B, the nose-shaped section 430 is considered to have a tapered portion extending in the proximal direction and into the transition section 440. Two plunger elements 152 taper from the transition section to form necks with two rounded sections 830. Each plunger element 152 extends in the proximal direction with a generally constant width and then widens to have a second set of rounded sections 832, which transition into stabilizer sections 810, 812. A recessed surface forming one of the protrusions 442 is shown on the plunger element 152.

Another pair of rounded corner sections 834 are located proximal to the stabilizer sections 810, 812 to form plunger element posts 152a. Both the plunger element 152 and the plunger element posts 152a have two spaced longitudinal edges, which may be provided with ribs to increase strength to the respective structures. Starting from within the stabilizing ring 456 and extending proximal, each plunger element post 152a is cold-worked to form an outwardly raised portion 838 relative to the longitudinal axis, to form a curved surface along the cross-section of each post 152a. An inwardly raised portion 838 may also be formed to create an inwardly raised portion. This feature may be included to form concave and convex surfaces of the plunger element posts, as previously discussed.

Referring again to Figure 16B, a retaining space 842 is shown, which may be located between the two plunger elements 152, inside the stabilizing ring 456, between the two plunger element posts 152a, or a combination thereof. As previously described, part or all of the needle protector or tip protector 132 may be located in the retaining space 842 in a spare position, and one or both elbows of the tip protector 132 may protrude from the release portion.

The proximal wall of the needle protector 132 may be flush with the proximal end surface 824 of the plunger element post 152a, located proximal to or distal to the end surface 824. If the plunger element post is excluded, the proximal wall of the needle protector 132 may be flush with the proximal edge 446b of one or both stabilizer elements 444, 444, located proximal to or distal to the proximal edge 446b of one or both stabilizer elements 444, 444.

Referring further to Figure 16B, the distance between the two inner surfaces 850 of the two stabilizer elements 444, 444 defines a limiting point, choke gap, or stop for the needle protector to restrict proximal movement of the needle protector during needle withdrawal in the standby position and/or after intravenous access, as previously discussed. That is, before the needle tip moves to the proximal side of one or both distal walls of the needle protector, the choke point or gap is too small for the needle protector to pass through to the proximal side of the choke point. However, after the needle tip moves to the proximal side of one or both distal walls of the needle protector, the two distal walls move radially inward to reduce the radial profile of the needle protector , which is smaller than the choke point. At that point, with a smaller radial profile measured at both elbows, the needle protector can move proximal to the choke point.

Figure 16C is a perspective view of the valve opener 134 of Figures 16A and 16B.

The methods of manufacturing and using conduit assemblies and components described elsewhere herein are within the scope of this disclosure.

While limited embodiments of catheter assemblies and their components have been clearly described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, a needle protector may be a single piece or may be integrated from more than one part (e.g., from multiple parts). Furthermore, it is to be understood and contemplated that features explicitly described for one catheter assembly or component may be incorporated by another catheter assembly or component, provided that the functionality is compatible. Therefore, it will be understood that catheter assemblies and their components constructed according to the principles of the disclosed devices, systems, and methods can also be implemented in ways different from those explicitly described herein. Valves and valve openers described herein can also be used with needle hubs by placing them inside the female Luer element tapered portion of the needle hub. Valves and valve openers can also be used in female connectors of infusion needles or blood collection devices or central venous catheters or peripherally inserted central venous catheters (PICC) or arterial catheters or dialysis needles. In other words, valves and valve openers can be used in any medical device intended to infuse or collect bodily fluids using a female Luer element housing or hub. This disclosure is also defined in the appended claims.

Claims (23)

1. A needle assembly (100, 400, 500), comprising: A needle hub (106) having a needle (108) having a needle tip (110) extending from the distal end of the needle hub (106); A catheter body (104) is attached to a catheter hub (102), the catheter hub (102) having a body including an inner surface defining a lumen (130), a needle (108) extending through the catheter body (104) in a standby position, and a needle tip (110) extending from a distal end (112) of the catheter body (104); A valve (136) is positioned in the inner cavity (130) of the conduit hub (102), the valve (136) including an outer boundary (322), at least one slit (324) and two or more flaps (326); A valve opener (134), the valve opener (134) being sized and shaped to open the at least one slit (324) to open the valve (136), the valve opener (134) comprising: nose-shaped sections (150, 430) having an activation end (166, 436) and a continuous boundary section; two plunger elements (152), each plunger element (152) having two elongated edges; and two stabilizer elements (253, 444) connecting the two plunger elements (152) to form a stabilizing ring (255). 456); retaining spaces (155, 720) between the two plunger elements (152); a first through passage (61, 448); and a second through passage (61, 448) both located between the nose-shaped segment (150, 430) and the stabilizing ring (255, 456); one or more plunger element posts or extensions (152a) extending proximally to the stabilizing ring (255, 456); A needle protector (132) includes resilient arms (288, 290) at least partially located within the holding space (155, 720) of the valve opener (134), wherein the needle protector (132) includes an elbow (304) in a state where i) protrudes through the first through passage (61, 448); ii) protrudes through the first iii) a passageway (61, 448) that protrudes through the first passageway (61, 448) and contacts the boundary (65, 708) of the first passageway (61, 448); or iv) a combination of a passageway (61, 448) that protrudes through the first passageway (61, 448) and contacts the boundary (65, 708) of the first passageway (61, 448) and contacts the inner surface of the conduit hub (102); The plunger element is rigid and cannot be deflected or deformed when loaded; The enclosure (65, 708) of the two through passages (61, 448) serves as the guard engagement section (210) by allowing the elbow (304) of the needle guard (132) to engage with the enclosure. 2. The needle assembly according to claim 1, wherein the valve (136) comprises: a valve disc (410); and a valve skirt (412) extending in a proximal direction along the valve disc (410) and defining a valve cavity (424). 3. The needle assembly according to claim 2, wherein the activation end (436) is located in the valve chamber (424) in the standby position. 4. The needle assembly according to claim 3, wherein the activation end (436) contacts the proximal surface of the valve disc (410) in the standby position. 5. The needle assembly according to claim 4, wherein the valve opener (134) includes a protrusion (442) extending radially along the longitudinal axis of the valve opener (134), and wherein the inner surface of the conduit hub (102) includes a shoulder (452) for limiting proximal movement of the protrusion (442). 6. The needle assembly of claim 5, wherein the protrusion (442) is a first protrusion, and wherein the valve opener (134) includes a second protrusion (442) spaced apart from the first protrusion (442). 7. The needle assembly according to claim 2, further comprising a skirt-shaped section (413) extending distally to the valve disc (410). 8. The needle assembly according to claim 5 further includes a bushing (138) that is wedged into the proximal end of the catheter body (104) to abut against the inner surface of the catheter hub (102). 9. The needle assembly of claim 8 further includes a resilient element (276) located inside the conduit hub (102) between the bushing (138) and the valve disc (410), wherein the resilient element (276) is sized and shaped to push the valve disc (410) in a proximal direction. 10. The needle assembly according to claim 9, wherein the resilient element (276) is an elastic element. 11. The needle assembly of claim 10, wherein the elastic element is a spring. 12. The needle assembly of claim 1, wherein the stabilization rings (255, 456) define a continuous boundary section. 13. The needle assembly of claim 1, wherein the plunger element is rigid and cannot be deflected or deformed when pressed by the tip of the male Luer element. 14. A method for assembling a pin assembly, comprising: A catheter hub (102) is provided having a catheter body (104) having an open distal end (112) and a proximal end attached to the catheter hub (102) by a bushing (138), the catheter hub (102) including a hub body having an inner surface defining a lumen (130) and a proximal opening; Position the valve (136) near the bushing (138), the valve (136) comprising at least one slit (324) and two or more flaps (326); A valve opener (134) is positioned inside the lumen (130) of the catheter hub (102) to slidably push open the valve (136) upon actuation by a male medical device. The valve opener (134) includes: a nasal section (150, 430) having an activation end (436) and a continuous boundary section; two plunger elements (152), each having two longitudinal edges; and two stabilizer elements (253, 444). 444) Connecting the two plunger elements (152) to form a stabilizing ring (255, 456); retaining space (155, 720) between the two plunger elements (152); a first through passage (61, 448); and a second through passage (61, 448), both the first through passage (61, 448) and the second through passage (61, 448) being located between the nose-shaped segment (150, 430) and the stabilizing ring (255, 456); 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 open distal end (112) of the catheter body (104) in the standby position; and The needle protector (132) is placed at least partially inside the holding space (155, 720) of the valve opener (134) such that an elbow or diagonal segment (304) on the arm (288, 290) of the needle protector (132) extends through the first through passage (61, 448) of the valve opener (134); the elbow or diagonal segment (304) is in the following states: i) contacting the boundary (65, 708) of the first through passage (61, 448); ii) separated from the boundary (65, 708) of the first through passage (61, 448); iii) contacting the inner surface of the catheter hub (102); iv) separated from the inner surface of the catheter hub (102); or v) a combination of contacting the boundary (65, 708) of the first through passage (61, 448) and contacting the inner surface of the catheter hub (102); The plunger element is rigid and cannot deflect or deform when loaded; The valve opener (134) further includes one or more plunger element posts or extensions (152a) extending proximally to the stabilizing ring (255, 456). The enclosure (65, 708) of the two through passages (61, 448) serves as the guard engagement section (210) by allowing the elbow (304) of the needle guard (132) to engage with the enclosure. 15. The method of claim 14, wherein the needle protector (132) includes a proximal sidewall (280) and a boundary (282) defining an opening (284) on the proximal sidewall (280), the arm (288) is a first arm, and further includes a second arm (290), wherein the first arm and the second arm (288, 290) extend distally to the proximal sidewall (280). 16. The method of claim 14, wherein the valve (136) comprises: a valve disc (410); and a valve skirt (412) extending in a proximal direction along the valve disc (410) and defining a valve cavity (424), and wherein the activated end (166, 436) of the valve opener (134) is located in the valve cavity (424) in the standby position. 17. The method of claim 16, wherein the active end (436) contacts the proximal surface of the valve disc (410) in the standby position, and wherein the valve opener (134) includes two spaced protrusions (442), and the recessed section (450) of the conduit hub (102) includes a shoulder (452). 18. The method of claim 17, wherein each of the two stabilizer elements (253, 444) comprises two parallel edges (446a, 446b). 19. The method according to claim 14, wherein the needle protector (132) has a proximal sidewall (280), and wherein the proximal sidewall (280) is flush with the proximal surface of the valve opener (134), located proximal to the nearest side surface of the valve opener (134), or located distal to the nearest side surface of the valve opener (134). 20. The method of claim 14, wherein the stabilization rings (255, 456) define a continuous boundary section. 21. The method of claim 14, wherein the plunger element is rigid and cannot be deflected or deformed when pushed by the tip of the male Luer element. 22. A catheter assembly (100, 400, 500), comprising: A needle hub (106) having a needle (108) having a needle tip (110); The catheter body (104) is attached to the catheter hub (102), the catheter hub (102) having a body including an inner surface defining a lumen (130), and the needle (108) extending through the catheter body (104); A valve (136) is positioned in the inner cavity (130) of the conduit hub (102), the valve (136) comprising at least one slit (324) and two or more flaps (326); A valve opener (134) comprising: a nasal segment (150, 430) having an activation end (166, 436); at least two plunger elements (152) having a proximal surface for being pushed by a male medical device; at least two stabilizer elements (253, 444) connected to the at least two plunger elements (152) to form a stabilizing ring (255, 456); and one or more plunger element posts or extensions (152a) extending proximally to the stabilizing ring (255, 456). A needle protector (132) includes resilient arms (288, 290) extending distally along a proximal sidewall (280), the proximal sidewall (280) including a boundary (282) defining an opening (290), the needle protector being configured to block the needle tip (110). The needle protector (132) extends through the release part or through passage (61, 448) of the valve opener (134); The plunger element is rigid and cannot deflect or deform when loaded; The enclosure (65, 708) of the through passage (61, 448) serves as the guard engagement section (210) by allowing the elbow (304) of the needle guard (132) to engage with the enclosure. 23. The catheter assembly of claim 22, wherein the plunger element is rigid and cannot be deflected or deformed when pushed by the tip of the male Luer element.