Catheter devices with valves and related methods

Abstract

Catheter assemblies (100, 400, 800) and related methods. Each catheter assembly (100, 400, 800) includes a catheter sleeve (102) that encloses a valve (136) and a valve opener (134) in a lumen (130). The side port (810) of the catheter sleeve (102) has a lumen (814) leading to the lumen (130). The valve (136) has a diaphragm valve body (820) and a tube valve body (830). When the valve opener (134) is pushed into the diaphragm valve body (820), the flap (326) deflects to open the valve (136). Fluid injected into the side port (810) deforms the pipe valve body (830) and flows into the inner cavity (130). The extension (900) may be attached to the catheter assembly (100, 400, 800) and include an extension sleeve (910) having a valve (136) and a valve opener (134). A stopper (920) in the extension sleeve (910) expels air and blocks blood.

Description

Technical Field

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

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

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

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

[0005] One aspect of the present disclosure can include providing a compact design for a valve housing for a luer activated valve.

[0006] Another aspect of the present disclosure may include providing a relatively strong construction for use with a high pressure injection device.

[0007] Yet another additional aspect of the present disclosure may include providing improvements to the current state of the art in blood control or closed system infusion devices including intravenous catheters.

[0008] As described, the needle assembly of the present disclosure can include many different components. The needle assembly can include: a needle hub having a needle extending from the distal end of the needle hub; a catheter tube body, the catheter tube body is attached to the catheter hub in a standby position and the needle extends through the catheter tube body; a valve, the valve is positioned in the inner cavity of the catheter hub, the valve includes an outer periphery that floats axially when moved by a proximal valve opener, and the proximal valve opener can also be positioned in the inner cavity of the catheter hub and positioned proximal to the valve. A distal valve opener can be further provided, which has two or more leg extensions extending in the proximal direction of the body of the sleeve. The valve can be actuated by both the proximal valve opener and the distal valve opener.

[0009] The valve may have an outer perimeter that is axially fixed within the interior of the catheter sheath. The valve may be opened using only a proximal valve opener. For example, the proximal valve opener may be moved into the valve through a male Luer tip to deflect one or more flaps on the valve.

[0010] Any portion of the valve may be axially secured by the inner surface structure of the catheter hub.

[0011] In the needle assembly, two or more leg extensions of the distal valve opener may be axially fixed within the lumen of the catheter hub.

[0012] In the needle assembly, the valve may include three slits and three flaps, and wherein the distal valve opener may include three leg extensions. The three leg extensions may have axially extending edges spaced apart from each other. The axially extending edges may be parallel to each other.

[0013] In the needle assembly, the three leg extensions may be aligned with the three flaps of the valve.

[0014] In the needle assembly, the proximal valve opener may include a ring or nose section and two plunger elements with a gap between the two plunger elements. The ring or nose section may include an activation or actuation end. The stabilizer ring may be located proximal to the nose section. The stabilizing ring may have a continuous perimeter section defining an aperture.

[0015] The nose section of the valve opener may include a continuous perimeter section.

[0016] The valve opener may include one, two or more than two reliefs or through passages.

[0017] The needle guard located in the holding space of the valve opener can extend through the release portion or the through passage of the valve opener to contact the interior of the catheter hub or the perimeter of the release portion or the through passage. The needle guard can also protrude through one or both release portions of the valve opener without touching the interior of the catheter hub or any perimeter of the valve opener.

[0018] When the needle guard is positioned within the holding space of the valve opener, the needle guard may have a proximal wall that is flush with the proximal-most end of the valve opener, is positioned distally of the proximal-most end, or is positioned proximal to the proximal-most end. When so positioned, the elbow of the needle guard may protrude through the release portion or through-passage of the valve opener. If the needle guard has two elbows on the two deflectable arms, then the two elbows may protrude through the two release portions of the valve opener, one elbow for each release portion.

[0019] There may be two or more releases or through passages of the valve opener, and the needle guard may extend through or contact two or more perimeters of the two or more releases or through passages.

[0020] The needle guard may include a resilient arm at least partially located within a holding space of a valve opener having a first through passage and a second through passage. The needle guard may include an elbow that protrudes through the first through passage; protrudes through the first through passage and contacts a segment of a perimeter of the first through passage; protrudes through the first through passage and contacts an inner surface of the catheter sheath; or a combination of protruding through the first through passage and contacts a segment of a perimeter of the first through passage and an inner surface of the catheter sheath.

[0021] The needle assembly of the present disclosure may include a tip protector that is at least partially located in a gap between two plunger elements of the valve opener. The gap of the valve opener may define a holding space for accommodating at least a portion of the needle guard or the tip protector.

[0022] The tip protector may be optional, and the needle assembly may be practiced without the tip protector.

[0023] The tip guard may be integrally formed, or formed by integrating multiple parts or components together. The tip guard may have one arm or two arms. The two arms may extend on different sides of the needle, or may cross each other, such as intersecting each other when viewed from one side.

[0024] In the needle assembly, a section of the valve may be deflectable in a distal direction and a section of the valve may be deflectable in a proximal direction to open a fluid flow path through the valve.

[0025] In the needle assembly, the sections of the valve that can be deflected in the distal direction may include the outer edge of the valve, and the sections of the valve that can be deflected in the proximal direction may be flaps formed with the valve. The flaps may be formed on the valve disc. The flaps may be formed by including one or more slits.

[0026] In the needle assembly, the body of the hub and one or more leg extensions can be integral. In some examples, the body of the hub (such as the base or funnel-shaped section of the hub) can be integrally formed with the one or more leg extensions. Each leg extension can have a nose section. In some examples, a leg extension is included that can have a wall defining an aperture.

[0027] In an example, only a portion of the tip guard or the needle guard may extend into one or more gaps of the valve opener, while a proximal section of the tip guard may extend proximal to a proximal-most surface of the tip guard. For example, a portion of the needle guard may overlap the valve opener in an axial direction, while a proximal section of the tip guard (such as a proximal wall) extends proximal to or is located proximal to a proximal-most surface of the valve opener.

[0028] In an example, only a portion of the tip guard or needle guard may extend distally of the stabilization ring of the valve opener, and at the same time a proximal section of the tip guard may extend proximal to the stabilization ring. The portion of the tip guard distal to the stabilization ring may include one or two elbows. One or two elbows may protrude through one or two releases in the valve opener.

[0029] Yet another aspect of the present disclosure may include a method of manufacturing a needle assembly, such as a catheter assembly. The method may include providing a catheter sleeve having a catheter tube with a distal opening, the catheter sleeve including a sleeve body, the sleeve body defining an inner cavity and a proximal opening; positioning a hub inside the catheter sleeve and against the catheter tube body, and positioning a valve proximal to the hub; the valve is floatable inside the inner cavity of the catheter sleeve along the axial direction of the catheter sleeve and includes two or more flaps; positioning a proximal valve opener proximal to the valve and inside the inner cavity of the catheter sleeve; placing a needle attached to the needle sleeve through the catheter sleeve, the valve, and the catheter tube body so that the tip of the needle extends out of the distal opening of the catheter tube body; and wherein two or more leg extensions extend in a proximal direction of the body of the hub.

[0030] In the method, two or more leg extensions of the distal valve opener may be aligned with two or more flaps on the valve.Alternatively, a single leg extension may abut the valve disc from the distal side of the valve disc.

[0031] In the method, the proximal valve opener may include a ring or nose section and at least one plunger element. The stabilizing ring may be located proximal to at least one plunger element. In some examples, there may be two or more plunger elements, and the stabilizing ring may be located proximal to the two or more plunger elements.

[0032] The nose section or ring of the valve opener may include an activation or actuation end. The nose section may define an aperture. A fluid may flow through the aperture. A needle may pass through the aperture of the nose section in a standby position.

[0033] In the method, the proximal valve opener may include two spaced-apart plunger elements with a gap therebetween. The gap may define a holding space.

[0034] In this method, the needle guard may be located at least partially in the gap and between the two plunger elements.

[0035] In the method, two or more leg extensions of the distal valve opener may be fixed in an axial direction.

[0036] In the method, the proximal valve opener may be slidable in a distal direction to move a valve having two or more flaps against two or more leg extensions in a distal direction. The valve may have three slits and three flaps. The three slits may converge at a single point. The valve may have a valve skirt extending proximally of the valve disc.

[0037] The valve skirt of the valve may define a valve cavity. The valve cavity may accommodate at least a portion of the proximal valve opener in the standby position. The nose section of the proximal valve opener may be located in the valve cavity.

[0038] The infusion or hypodermic needle described herein can utilize a valve in a housing having a female Luer connector. For example, the valve and valve opener of the present disclosure can be placed inside the needle sleeve. Moreover, a needle-free valve integrated into a medical device or a stand-alone needle-free valve can utilize the valve described herein.

[0039] The needle assembly or needle device of the present disclosure may include: a catheter hub having a catheter tube attached to the hub body; and a needle hub having a needle extending through the catheter hub and the catheter tube, with the needle tip extending out of the distal end or distal opening of the catheter tube in a standby position.

[0040] The various components described herein may be located within the lumen of the catheter hub.

[0041] In the preparation position, the catheter assembly is ready, such as to perform venipuncture or intravenous access. Sometimes, the preparation position first requires removing the protective cap from the catheter assembly or needle assembly. The protective cap can be included for packaging.

[0042] The valves and valve actuators used with the catheter hubs of the present disclosure may also be placed within the needle hub as a secondary valve.

[0043] A needle guard or tip guard, a valve opener or actuator, a valve, and a hub may be provided with the catheter hub.

[0044] Alternatively, the needle guard or tip guard including the resilient portion may be located external to the catheter hub, such as in a separate hub than the catheter hub and the needle hub.

[0045] The tip protector of the present disclosure may be embodied as any of a number of prior art protectors configured to block or cover the needle tip of a needle.

[0046] The tip guard can have a proximal wall and two resilient arms, and wherein a contour change on the needle, such as a corrugation or ridge, can engage the perimeter of the opening on the proximal wall of the tip guard to retract the tip guard proximally out of the catheter sheath after a successful venipuncture. The two arms can intersect, or they can extend along different sides of the needle and not intersect in a side view.

[0047] When the two arms on the needle guard move radially due to the axial movement of the needle, the radial profile (such as shape or size) of the needle guard can change. For example, when the tip of the needle moves proximal to the two walls, the radial profile of the needle guard can decrease to allow the two arms to move in the radial direction.

[0048] One or more needle guard arms can be deployed from the needle shaft in a ready position and engage the interior of the catheter hub, such as a guard engagement section of the catheter hub. The needle guard can be rolled or bent from stamped sheet metal into a final configuration. Alternatively, the needle guard can be formed from different parts, all metal parts, plastic parts, or a combination thereof, which are then assembled to form the needle guard.

[0049] The valve opener or actuator may include a ring or nose section and at least one plunger element, such as a leg element or elongated extension. The ring may contact the valve in the needle assembly standby position. Alternatively, the ring may be spaced or slightly spaced from the proximal surface of the valve in the standby position.

[0050] One or more plunger elements may extend from the ring or nose section in a proximal direction. In other examples, there may be more than two plunger elements, such as three or more plunger elements, with gaps between the plunger elements. The size and shape of each of the one or more plunger elements may be designed to be contacted by the male Luer to transfer a distally directed force from the male Luer to the ring or nose section of the valve opener to then push against the proximal-facing surface of the valve to open the valve, such as to open two or more flaps.

[0051] The one or more plunger elements of the valve opener can each have an arc or arcuate cross-section along the width. In another example, the plunger element can be generally flat or planar along the cross-section. The thickness of the plunger element should be small or thin enough so that the needle guard and the two plunger elements have enough clearance to fit within the interior cross-sectional space of the catheter sleeve without physically bonding against the interior of the catheter sleeve and becoming immovable or fixed.

[0052] In an example, the thickness of the plunger element of the valve opener or actuator and the width of the needle guard are such that no undercuts or grooves need to be formed in the inner wall surface of the catheter hub to accommodate them.

[0053] The valve opener of the present disclosure can be made of metal material, plastic material or both. When made of metal material, the valve opener can be formed by a deep drawing method, and the arcuate cross section of the plunger element can provide increased rigidity when pushed by the male Luer.

[0054] 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 a void or space for a fluid stream to flow therethrough (such as during an IV infusion). The gap may also be used to accommodate a needle guard, such as to act as a holding space.

[0055] The ring or nose section of the valve opener may include a body having an outer perimeter. The outer perimeter may be generally cylindrical. The outer perimeter may have a tapered portion. The body may include a chamfer and an opening.

[0056] The distal edge or intersection of the body between the chamfer and the outer perimeter may have a sharp edge or a blunt edge. In an example, the intersection is a blunt edge comprising a planar surface that acts as a push against the actuation end of the valve.

[0057] The valve opener of this embodiment can be configured to push against the proximal-facing surface of the valve or multi-part opener to push against both the proximal-facing surface of the valve and the distal-facing surface of the valve. The valve can have two or more flaps that can deflect radially and proximally or radially and distally when activated.

[0058] On the proximal side of the ring or nose section, the two plunger elements may be recessed radially inwardly from the outer perimeter to form or define a shoulder. The outer perimeter of the ring may have an outer diameter of a first size, and the two plunger elements may define an outer diameter of a second size, which may be smaller than the first size. The shoulder may be provided between the two different sizes.

[0059] The valve opener may have an inner diameter measured adjacent to the intersection or activation end. The inner diameter may change or vary along the chamfered section of the ring or nose section. The valve opener may also include a minimum inner diameter mID, which may be considered the minimum inner diameter of the valve opener.

[0060] The needle guard may be located between one or more gaps defined by the plunger elements of the valve opener. The plunger elements may each include an arcuate cross-section. The arcuate cross-section of each plunger element may be generally C-shaped, having a concave portion facing inwardly toward the needle guard and a convex portion facing outwardly away from the needle guard.

[0061] The radius of curvature of the two C-shaped plunger elements of the valve opener may be different from the radius of the male Luer tip and / or the radius of the inner cavity of the catheter hub. A gap may be provided on each side edge of the proximal wall of the needle guard and the adjacent plunger element.

[0062] The two plunger elements of the valve opener can each have an abutting proximal surface sized and shaped to be pushed against by a male Luer tip or syringe tip when the tip is inserted into the proximal opening of the catheter hub after a successful venipuncture to push the valve opener distally against the valve to open the valve. The arcuate cross-section of each of the two plunger elements can provide a sufficiently thick profile to ensure that the abutting surface overlaps the male Luer tip and ensures rigidity to prevent buckling.

[0063] The C-shaped plunger element can avoid deflection when pushed by a syringe tip or other male Luer tip, avoid the syringe tip or Luer tip slipping and missing the end surface of the plunger element when inserting the syringe tip or Luer tip into the open proximal end of the catheter sleeve, and / or avoid the following situation: pushing the syringe tip or Luer tip between the two plunger elements during activation of the valve opener so that the two plunger elements are wedged between the tip and the inner surface of the catheter sleeve.

[0064] In some embodiments, the concave portion of the arcuate cross-section of each plunger element may face outwardly, away from the needle guard, while the convex portion of each plunger element faces inwardly toward the needle guard.

[0065] The ring or nose section of the valve opener can be elastically deformed and then expanded when it reaches the recessed sleeve section of the catheter sleeve, which can accommodate the ring without deforming the ring. Alternatively, the catheter sleeve can be designed to expand to allow assembly of the valve opener. A shoulder can be provided at the recessed sleeve section, and the shoulder can form a physical stop for engaging the shoulder on the valve opener. This can allow the valve opener to be retained in the inner cavity of the catheter sleeve during needle withdrawal and during use, when the valve opener is pushed distally to activate the valve and then moves proximally when the male Luer is removed, thereby allowing the valve to close.

[0066] The valve may have a valve disc including a valve body including a valve diameter, a valve thickness such as measured orthogonally to the valve diameter between a proximal-facing surface and a distal-facing surface of the valve disc, and one or more slits defining two or more flaps on the valve disc. Three slits may be provided through the valve thickness to define the three flaps. The three slits may originate from a point and extend radially from an approximately center point or center portion of the body of the valve in a manner similar to a three-pointed star to form three flaps along which the three flaps may be deflected.

[0067] The valve may include an outer perimeter between the proximal valve opener and the bushing, which may float within the lumen of the catheter sleeve. The outer perimeter of the valve may move proximally and distally within the lumen of the catheter sleeve and is not constrained by the catheter sleeve in the axial direction of the catheter assembly. In some examples, the valve may be axially fixed for being pushed against the valve by the proximal valve opener.

[0068] The outer perimeter of the valve can be the same as, or smaller than, or larger than, the outer perimeter of the ring or nose section of the valve opener. At least a portion or all of the distal edge, intersection, or activation end of the ring or nose section can be recessed from the outer radial perimeter of the valve so that the distal edge can abut or touch the proximal wall surface of the valve. Moreover, because the valve can float, the valve can be positioned inside a single sleeve body type catheter sleeve and can avoid being wedged between multi-part sleeve bodies. However, without departing from the scope of the present disclosure, the various components described herein can be easily used with a multi-piece catheter sleeve.

[0069] The bushing of the present disclosure may include a body including: a first body section; and a second body section extending from the first body section. The second body section may have: a conical section; and two or more leg extensions extending from the second body section, such as extending from the conical section.

[0070] The first body section can have an elongated body that can have a cylindrical shape with an optional tapered distal tip or nose section.In some examples, a generally cylindrical ring extends from the second body section, and two or more leg extensions extend from the cylindrical ring.

[0071] As used herein, the terms first, second, third, etc. are understood to describe different structures so as to be distinguished from each other. However, unless the context indicates otherwise, these terms are not structurally restrictive.

[0072] One or more gaps may be provided between two adjacent leg extensions. The bushing may comprise the same number of leg extensions as the valve comprises flaps. The leg extensions may be spaced apart from one another. The leg extensions may be attached to a common structure at respective fixed ends, the respective fixed ends being opposite the respective free ends.

[0073] The leg extensions on the bushing or the leg extensions of the distal valve opener can define an outer diameter that is less than the minimum inner diameter mID of the ring of the valve opener. The proximal tip of each leg extension can have a chamfer or blunt tip at the proximal end or proximal tip. In one example, a chamfer can be included at the proximal tip of each leg extension, and wherein the chamfer can taper from the outside of the leg extension inward.

[0074] The bushing may be made of a metallic material and the leg extensions may be integrally formed with the body. Alternatively, the leg extensions may be welded to the body of the bushing.

[0075] The sleeve and valve can be oriented in the catheter sleeve so that the leg extensions on the sleeve are aligned with the flaps on the valve. This can allow the flaps on the valve to be pushed by the leg extensions on the sleeve. Thus, if there are three flaps on the valve, the three flaps can be pushed into physical contact with the three leg extensions on the distal valve opener.

[0076] The distal-facing wall surface of the valve may contact a leg extension and / or a resilient element (such as a spring or elastic element) of a distal valve opener, or may be spaced apart from the leg extension and / or the resilient element to move the valve in a proximal direction.

[0077] The distally facing wall surface of the valve may be pushed distally against the leg extension during use.In some examples, the valve may touch the proximal tip of the leg extension and / or the resilient element in the closed position of the valve, or may be spaced apart therefrom.

[0078] The three leg extensions of the valve opener can be equally spaced along the circumference of the second body section of the bushing. In another example, the three leg extensions can be arranged and spaced according to the position of the lugs or flaps on the valve so that when the valve is assembled inside the catheter sleeve, 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 in the proximal direction to open the valve. The lugs or flaps can be formed by machining the valve slit to have a slit.

[0079] During proximal retraction of the needle following a successful venipuncture, the tip guard may be axially retained by engagement between one or both resilient arms on the tip guard and a guard engagement section on the catheter hub.

[0080] The guard engagement segment can be a surface discontinuity formed on the inner surface of the catheter sleeve. For example, the guard engagement segment can include a segment having a first inner diameter and a segment having a second inner diameter, the second inner diameter being greater than the first inner diameter. The guard engagement segment can be annular or circular in shape, or can be smaller than a complete circle.

[0081] The guard engagement section can be embodied as an internal protrusion or groove, or a combination of both a groove and a protrusion formed on the inner surface of the catheter hub. When a combination of a groove and a protrusion is used for the guard engagement section to engage a needle guard or a tip guard, the groove can be located distal to the protrusion.

[0082] Two spaced-apart guard engagement sections may be provided for engaging the two resilient arms on the tip guard. The two guard engagement sections may be positioned diametrically opposite each other, just distal to the section of the female Luer connector of the catheter hub.

[0083] In an example, the valve opener may include a single plunger element. The single plunger element may be embodied as a generally cylindrical body section having an inner surface that defines an aperture having a path or groove. The cylindrical body section may be located proximal to the distal push end, which may also be annular or circular. A guard engagement section may be formed on the inner surface of the present valve opener. In other words, the inner surface of the valve opener, rather than the inner surface of the catheter sleeve, may be provided with a guard engagement section. This allows a tip guard or a needle guard (such as, two resilient arms of a needle guard) to engage the valve opener in a standby position and during needle retraction after a successful venipuncture.

[0084] The guard engagement section formed on or by the valve opener may include a protrusion, a recess, an opening, or a combination thereof.

[0085] Another aspect of the present disclosure includes a valve opener comprising: a nose section having an activation end; and two plunger elements extending in a proximal direction of the nose section. A band or ring may be provided to connect the two plunger elements together. The band may be referred to as a stabilization ring and may connect the two plunger elements together to form a stable structure.

[0086] The stabilization ring may form a continuous perimeter segment of the valve actuator that is spaced apart from another continuous perimeter segment defined by a nose segment of the valve actuator.

[0087] Two stabilizers (which may also be referred to as stabilizer elements) may be connected to the two plunger elements to form a stabilization ring, which may have a continuous circumferential section.

[0088] The valve actuator may have a first continuous perimeter segment, a segment having one or more relief portions, and a second continuous perimeter segment spaced apart from the first continuous perimeter segment.

[0089] At the release portion or through passage of the valve opener, the valve opener can have one plunger element with two longitudinal edges or two plunger elements with two longitudinal edges respectively. In some examples, three or more plunger elements with two longitudinal edges respectively can be arranged.

[0090] The valve opener may terminate with a stabilizing ring at its proximal side or end. In another example, one or more plunger element protrusions or extensions may extend proximally from the stabilizing ring.

[0091] The overall length of the valve opener may be adjusted by adding one or more plunger element protrusions or extensions that extend proximally of the stabilization ring.

[0092] The first continuous perimeter section may be a nose section of the valve actuator. The nose section may include an activation end for pushing against the valve to open the valve. A second continuous perimeter section may be provided and is a stabilizing ring connected to one plunger element or to two or more plunger elements.

[0093] The valve opener provided therein may include two plunger elements each with two longitudinal edges located between the first continuous perimeter segment and the second continuous perimeter segment. In some examples, the two plunger element protruding sections may extend proximally of the second continuous perimeter segment.

[0094] A valve actuator or valve opener disposed therein may include a single plunger element extending from a nose section having an activation end, and wherein the single plunger element may include two or more releases or through passages formed through a wall of the plunger end. A needle guard or tip guard may engage an edge or perimeter of the release in a standby position and during retraction of the needle after a successful venipuncture.

[0095] When the tip guard engages the perimeter of the valve opener, it should be understood that the tip guard may engage only a segment or portion of the perimeter. For example, when the elbow of the needle guard engages the perimeter of the valve opener, the elbow may contact only a portion or segment of the perimeter. The perimeter may be used for a release or a through passage.

[0096] Still alternatively, the tip protector may protrude through the release portion of the valve opener but not contact the interior of the catheter hub or the perimeter of the release portion.

[0097] Still alternatively, the tip protector may protrude through the release portion of the valve opener, contact the interior of the catheter hub, and contact one or both perimeters of the release portion.

[0098] In certain examples, the portion of the tip guard that protrudes through the release may be one or both elbows of the tip guard.

[0099] Alternatively, the tip guard or needle guard may protrude from the holding space defined by the valve opener through the release portion to engage the inner surface of the catheter hub. A ridge, groove or recess may be provided on the inner surface of the catheter hub for the elbow of the needle guard to protrude from the holding space of the valve guard through the release portion to engage.

[0100] The elbow of each arm of the needle guard may sometimes be referred to as a diagonal section.

[0101] The perimeter of the two releases or through-passages may function as guard engagement sections by allowing the elbows of the tip guard to engage therewith. Alternatively, the two elbows of the needle guard may protrude from the holding space defined by the valve opener through the two releases to engage the guard engagement sections or segments formed on the inner surface of the catheter hub. Still alternatively, one or both elbows may be constrained in the proximal direction by a choke point or choke gap.

[0102] In still other examples, at least one elbow of the needle guard or tip guard may protrude through a release or through passage of the valve opener but neither engage the perimeter nor contact the interior of the catheter hub in the standby position. In other examples, both elbows of the needle guard protrude through both releases or through passages of the valve opener but do not engage the perimeter of both releases or contact the interior of the catheter hub in the standby position.

[0103] In some examples, one or both elbows of the needle guard may contact one or more perimeters of one or more releases and / or the interior of the catheter hub.

[0104] When the valve opener has a single plunger element between the first continuous perimeter segment and the stabilization ring (the valve opener may include a second continuous perimeter segment), the one or more elbows of the needle guard may be located between the first continuous perimeter segment and the stabilization ring. If the needle guard has two elbows, the two elbows may be located between the first continuous perimeter segment and the second continuous perimeter segment.

[0105] The second continuous perimeter segment may represent the proximal end of the valve opener. In some examples, one or both plunger element protrusions or extensions may extend proximally of the second continuous perimeter segment to extend the length of the valve opener beyond the proximal end of the second continuous perimeter segment.

[0106] In some examples, the stabilization ring does not form a continuous perimeter, and one or both plunger element protrusions or extensions may extend proximally of a discontinuous perimeter segment.

[0107] Thus, the perimeter of the release portion or the inner surface of the catheter hub may form an anchoring point for engagement of the arms of the tip protector to in the standby position and during retraction of the needle after a successful venipuncture.

[0108] The perimeter of the release portion or the through passage of the valve opener can present or act as a limit point, choke point or choke gap for one or both elbows of the needle guard, respectively. That is, the dimension measured to the side of the needle of one elbow can be greater than the dimension measured at the outer perimeter of the valve opener at the release portion, so that interference is provided by the perimeter at the release portion to prevent proximal movement of the needle guard during retraction of the needle after a successful venipuncture.

[0109] Once the elbow of the needle guard moves radially away from the release, the radial profile of the needle guard can be reduced and can be smaller than the inner diameter of the valve opener at the release. The needle guard can then be moved proximally of the release or through passage, such as through the stabilization ring in a proximal direction.

[0110] If the needle guard employs two elbows, the dimension defined by the two elbows can be larger than the circumference of the valve opener at the two releases, so that the circumference at the two releases can act as or provide a limit or choke point to prevent the needle guard from moving proximally during needle retraction after a successful venipuncture. Once the two elbows of the needle guard move radially away from the two releases of the valve opener, the needle guard can move proximally of the two releases or through-passage, such as moving proximally through the opening defined by the stabilization ring.

[0111] In an example, the valve opener may include a nose section and a single plunger element. The single plunger element of the valve opener may be embodied as a generally cylindrical body section having: an inner surface defining an opening having a path or slot; and a proximal perimeter or end edge. The guard engagement section may be formed on the inner surface of the valve opener. In other words, a protrusion, ridge, or recess may be formed on the inner wall surface of the valve opener to allow engagement between the needle guard and the inner surface of the valve opener.

[0112] When the present alternative valve opener is used with a needle device or catheter assembly, the guard engagement section may be on the catheter hub, on the inner wall of the valve opener, or at the perimeter of a relief formed through the wall of the valve opener.

[0113] The valve opener may include one or more release or guard engagement sections.

[0114] The catheter hub may also be formed with one or more guard engagement sections for use with one or more release portions of a valve opener.

[0115] The number of guard engagement sections may be equal to the number of elbows formed with the needle guard.

[0116] The two resilient arms of the tip protector may engage the interior of the valve opener or the catheter hub by protruding through a relief formed through the wall of the valve opener.

[0117] In yet another example, two openings can be provided through the wall layer of the cylindrical body portion of the valve opener for use with a guard engagement section formed by or on the interior of the catheter sleeve. Each of these openings can include a perimeter, which can be a closed perimeter.

[0118] In a standby position using a valve opener having two openings or releases disposed through a wall of the valve opener, one or more resilient arms of the tip protector may protrude through these openings or releases to engage an interior guard engagement section of the catheter sleeve as an alternative to or in addition to engaging the opening of the valve opener.

[0119] The guard engagement segment can be formed on the inner surface of the catheter hub, and the proximal cylindrical body section of the valve opener can include an opening surrounding the guard engagement segment in at least one direction. In an example, when looking radially outward away from the needle, the opening on the valve opener can surround the guard engagement segment formed on the catheter hub.

[0120] During retraction of the needle after use, the needle tip may move proximally of the tip guard or two distal walls of the needle guard (one distal wall on each end of the resilient arm). The needle guard may alternatively have one distal wall and / or one arm. The needle guard may also have two arms but only one elbow and one distal wall.

[0121] The contour change on the needle (which may be a wrinkle, ridge, material accumulation or sleeve) may engage the perimeter of the hole or perforation through the proximal wall of the tip protector. Once engaged, the tip protector may be moved proximally with the needle to be removed from the catheter sleeve. In the protective position in which the tip protector covers or blocks the needle tip, the valve may remain inside the lumen of the catheter sleeve. Thus, the valve may be located inside the catheter sleeve in both the ready position of the needle and the protective position of the needle.

[0122] The male medical implement or instrument may be a male Luer piece, syringe tip, IV set connector, or other male tip with a Luer connector of current or future ISO standards and may be inserted into the open proximal end of the catheter sheath. The male medical implement may be connected to an IV tube, which may be connected to an IV fluid source for fluid delivery through the male medical implement. The male tip may be understood to be a male Luer tip.

[0123] When the male medical device or male tip is initially inserted into the proximal opening of the catheter sheath, the male tip may initially contact two plunger elements or two plunger element protruding segments on the valve opener to advance a distally directed force on the two plunger elements or two plunger element protruding segments to push the actuation end into the valve to open the valve. The arc cross-section of the plunger element or the plunger element protruding segment may have a diameter that is smaller than the inner diameter of the catheter sheath, thereby providing a larger contact surface to the distal end of the male medical device.

[0124] In some examples, the male tip can abut a proximal ring, and the valve opener can be advanced against the valve by pushing on a proximal ring, such as a stabilization ring.

[0125] The distally directed force can move the valve opener in the distal direction until the geometry of the male tip and the proximal opening of the catheter hub prevents the male tip from advancing further distally. A seal can be provided by a Luer joint to prevent fluid from leaking out of the proximal opening of the catheter hub.

[0126] The ring or nose section of the valve opener can be advanced distally and pushed against the proximal surface of the valve. The distal edge of the valve opener can initially push against the proximal surface of the valve. When the valve can move axially inside the catheter sleeve, the valve can be advanced distally by the valve opener and the valve opener can be advanced distally by the male tip. The valve can have a valve disc. The valve skirt can extend from the valve disc in the proximal direction, the distal direction, or both the proximal direction and the distal direction.

[0127] Due to the presence of the leg extensions on the sleeve or distal valve opener, the outer edge or outer valve section of the valve can move distally while other portions of the valve that abut or contact the leg extensions are prevented from moving distally by the leg extensions. In fact, the outer edge of the valve can move distally while the flaps on the valve can be deflected radially outward and in a proximal direction from a center point or center position by the leg extensions on the sleeve, thereby opening a flow path through the valve.

[0128] The chamfers on the ring or nose section and the chamfers on the leg extensions may facilitate deflection of the flaps on the valve radially outward and in a proximal direction.

[0129] The relative diameter defined by the leg extension or legs and the minimum inner diameter mID of the ring of the valve opener can allow the proximal valve opener and the distal valve opener to deflect the valve therebetween to open the valve. Alternatively, when pushed distally, the outer perimeter of the valve can remain in contact with the inner wall of the catheter sheath, with only the flaps around the one or more slits opening.

[0130] Thus, one aspect of the present disclosure is understood to include a catheter assembly comprising a valve including one or more slits and two or more flaps, wherein the valve may include a portion or section that moves in a distal direction and a portion or section that opens in a radial direction in a proximal direction to open a flow path through the valve.

[0131] In an example, the outer edge of the valve can be configured to move distally, while the flap of the valve can be configured to move radially outward to open a flow path through the valve. Moreover, by including a valve that can move in this manner to open a fluid flow path, the actuation distance that the valve opener must travel in the axial direction of the catheter assembly to open the valve can be minimized compared to a valve having a flap that is opened only in the distal direction by a valve opener. Therefore, the size of the catheter sleeve, such as the length of the catheter sleeve, can be reduced compared to a catheter sleeve that utilizes a valve and a valve opener that opens the valve by deflecting the valve flap only in the distal direction. Alternatively, the length or size of the catheter sleeve can be minimized by an overlap between the valve opener and the needle guard in the axial direction.

[0132] A catheter assembly is disclosed that may include a valve, and wherein the valve perimeter may float in an axial direction relative to a catheter sleeve. By including a valve having a valve perimeter that may float in an axial direction, a two-part catheter sleeve is not required to secure the valve perimeter therebetween and within the catheter sleeve, but a two-part sleeve may also be used. Thus, a catheter sleeve having a sleeve body formed in a monolithic manner may be used with the present catheter assembly. Thus, the size of the catheter sleeve, such as the outer diameter or outer dimension of the catheter sleeve, may be reduced compared to a catheter sleeve utilizing a two-part sleeve body. The two-part sleeve body (wherein they are joined along a seam) may therefore be reduced to provide a catheter assembly having a relatively smaller outer profile.

[0133] The valve opener can be configured to push the valve against another structure, such as a leg extension on a bushing or on a distal valve opener. The present valve opener can be considered to have a multi-piece valve opening structure. For example, the portion with the ring and plunger elements can be considered a proximal valve opener, and the bushing with the leg extensions can be considered a distal valve opener. The two valve openers can cooperate to open the valve.

[0134] The proximal valve opener may be sized and shaped to push against an outer edge or periphery of the valve in a distal direction to move the valve against the distal valve opener. The distal valve opener may be sized and shaped to push a central area or section on the valve in a radially outward direction, and a portion of two or more flaps may be deflected in a proximal direction to open a fluid path or flow path through the valve.

[0135] In an example, the leg extension on the distal valve opener can be axially fixed, and by pushing the flaps of the valve against the leg extension in the distal direction, the flaps can be radially deflected outward by the leg extension on the distal side of the valve. In other words, when the valve is actuated to open a flow path through the valve, the valve can be 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 specific embodiment, the valve can be actuated to open a 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. Alternatively, the distal side can be pushed by a single leg extension having an aperture.

[0136] The proximal tip of the leg extension and the distal edge of the ring can be spaced apart from a plane drawn orthogonal to the longitudinal axis of the catheter assembly. In other words, the proximal tip of the leg extension and the distal edge of the ring can be spaced apart and do not overlap from the perspective of this plane, and a gap can be provided between the two to accommodate the valve therebetween.

[0137] Alternatively, the proximal tip of the leg extension can overlap with the distal edge of the ring in the axial direction, which can produce the effect of making the flap radially deflected outwardly by a relatively larger amount than when there is no overlap. In addition, since the flap can be pushed against the axially fixed leg extension on the liner, the flap can be deflected backward in the proximal direction by these leg extensions. In other examples, the proximal tip of the leg extension and the distal edge of the ring can only contact along a plane drawn orthogonal to the longitudinal axis of the catheter assembly.

[0138] A catheter assembly may be provided that includes a valve, a proximal valve opener, a distal valve opener, a needle hub having a needle, and a catheter hub having a catheter tube.

[0139] The valve assembly may further comprise a tip protector for blocking a needle tip of the needle in the needle protection position.

[0140] After successful venipuncture, a male tip, such as a male luer, may be inserted into the proximal opening of the catheter hub to advance the proximal valve opener in a distal direction, which may cause the valve to move distally against the distal valve opener.

[0141] The flap of the valve can be pivoted in a proximal direction to open a fluid path through the valve. The flap of the valve can be deflected in a proximal direction by a leg extension of a bushing of the present device. The flap can be deflected in a proximal direction by pushing the flap against a fixed leg extension on a distal valve opener.

[0142] A flap on the valve may be deflected in a proximal direction by a structure located distally of the valve and abutting a distally facing surface of the valve.

[0143] 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.

[0144] When the male tip of a syringe or a male medical device is removed from the proximal opening of the catheter sleeve, the biasing or resilient properties of the valve of the present disclosure (which may be made of an elastomer) allow the valve to rebound to its more relaxed state. Thus, the flap on the valve can rebound by moving distally, while the outer edge or outer section of the valve body can rebound proximally. This rebound can push the proximal valve opener in the proximal direction, and the shoulder on the proximal valve opener can move toward or against the shoulder inside the lumen of the catheter sleeve.

[0145] A coil spring, leaf spring, or elastomeric barrel or element may be optionally placed between the distal surface of the valve and the inner distal step or shoulder of the catheter sleeve to facilitate closing the valve. This spring or elastomeric barrel (if included) can provide additional biasing force to return the valve to the closed position when the male medical device is removed. The spring or elastomeric opener can also push the proximal valve opener in the proximal direction. If included, the elastic member (such as, spring or elastomeric barrel) can be spaced apart from the valve in the standby position, or can contact the valve in the standby position.

[0146] The valve of the present disclosure can be a one-time use valve, or can be opened and closed repeatedly or at least more than once. The valve can be opened a second time by placing the male tip into the proximal opening of the catheter hub and pushing the proximal valve opener in the distal direction.

[0147] Inside the catheter sheath, a diaphragm or valve, an actuator or valve opener and a safety clip, such as a needle guard or tip guard, may be provided. Optionally, the safety clip may be omitted or may be placed outside the catheter sheath, such as in a third housing. The third housing may be different from the needle sheath and the catheter sheath.

[0148] A flashback plug or blood plug assembly may be connected to the needle guard to prevent blood from flowing out of the flashback chamber of the needle guard. The flashback plug may be disposed at the proximal end of the needle guard to allow air to escape but prevent blood from escaping from the proximal end of the body of the flashback plug, and the flashback plug may include a hydrophobic filter.

[0149] A valve may be used with the catheter sleeve described herein, the valve having a valve body including a valve disc and a valve skirt extending in an axial direction from the valve disc. In an example, the valve disc may include one or more slits defining one or more flaps to be opened / closed by a valve actuator. The types of slits and flaps included in the valve disc and the number of each may be similar to those shown and described elsewhere herein.

[0150] The valve may include a valve body having a valve disc having a proximally facing surface and a distally facing surface. The valve disc may include two or more flaps that may be deflected proximally or distally.

[0151] The valve according to aspects of the present disclosure may be made of any known elastomeric material. In an example, the valve is made of a polyisoprene material. In other examples, the valve may be made of any suitable biocompatible elastomeric material. A medical grade lubricant may be applied to the valve to aid in the functionality of the valve.

[0152] In an embodiment, the valve skirt can be positioned in a recessed section formed in the lumen of the catheter sheath, which can prevent the valve from axial movement once it is inside the catheter sheath. For example, the valve skirt can be positioned inside a groove defined by the recessed section and does not move axially both in a standby position and during activation or actuation of the valve by a valve opener.

[0153] If the catheter hub comprises a second recessed section within the interior of the catheter hub, the recessed section of the catheter hub may be understood as a first recessed section.

[0154] In an example, the recessed section of the catheter hub may have a distal shoulder and a proximal shoulder, the distal shoulder and the proximal shoulder defining a groove therebetween. The valve skirt of the valve may have a length, sized and shaped to fit between the proximal shoulder and the distal shoulder. The valve skirt may fit within the groove.

[0155] In an example, a valve skirt of the valve may contact a proximal shoulder of the recessed section, and a valve disc may contact a distal shoulder of the recessed section.

[0156] The valves provided herein may contact distal and proximal shoulders of a recessed section of a catheter hub and thereby be constrained in a standby position and during activation such that a valve skirt of the valve is axially fixed or non-axially movable.

[0157] In examples, the outer diameter or outer surface of the skirt section of the valve forms a fit or size-on-size fit with the recessed section of the interior of the catheter sleeve. In other examples, a slight interference fit can be provided between the skirt section and the recessed section of the catheter sleeve. In still other examples, a small gap can be provided between the outer surface of the skirt section and the inner surface of the catheter sleeve at the recessed section, wherein the valve skirt contacts the proximal shoulder and the valve disc contacts the distal shoulder of the recessed section.

[0158] When the valve disc includes a valve skirt, the outer perimeter of the valve disc may alternatively be considered part of the valve skirt.

[0159] Alternatively, there may be no proximal shoulder in the recessed section of the catheter hub, since any forces acting on the valve will be primarily in the distal direction.

[0160] When the needle is withdrawn after use, there may be some proximally directed forces on the valve, but these proximally acting forces should be low and not sufficient to move the valve out of its interference fit in the catheter hub even without the proximal shoulder.

[0161] The chamber of the distal cavity can be disposed distal to the valve disc and proximal to the bushing, which can be used to hold the catheter tube to the catheter sleeve. In some examples, a coil spring or a resilient biasing element (such as an elastomeric ring or a cylindrical member) can be disposed in the chamber of the distal cavity, concentric with the needle, to bias the flaps of the valve disc to help the valve disc close the one or more slits. The resilient biasing element (if included) can also move the proximal valve opener in a proximal direction.

[0162] In an example, the valve disc may include a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps. The distance between the proximal facing surface and the distal facing surface may define the valve disc thickness. The valve skirt may extend axially relative to the longitudinal axis of the valve and may have an elongated wall that is generally perpendicular to the outer periphery of the valve disc, thereby forming a generally cylindrical valve body. In some embodiments, the valve skirt may be inclined so that the valve forms a frustoconical structure.

[0163] The valve skirt may have a complex profile, such as having a cylindrical portion connected to a frustoconical portion.

[0164] The skirt may extend proximally or distally from the valve disc, or both.Thus, there may be a proximal cylindrical valve body, a distal cylindrical valve body, or both a proximal cylindrical valve body and a distal cylindrical valve body.

[0165] The valve skirt may define a valve cavity having an open proximal end. The open proximal end of the valve skirt may be sized to grasp the outer surface of the nose section, may loosely grasp the outer surface, or may be large enough not to contact the outer surface of the nose section.

[0166] The open proximal end of the valve skirt allows an actuator nose or nose segment of the valve actuator to protrude therethrough and advance axially within the valve cavity to actuate two or more flaps of the valve disc. In one embodiment, at least some portion of the actuator nose, including the distal actuation end of the valve actuator, may be located inside the valve cavity of the valve prior to actuation by the male Luer tip.

[0167] The actuator nose of the valve opener can be narrower than the outer perimeter of the valve so that the actuating end of the nose section fits in the valve cavity of the valve 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.

[0168] In an example, the relative dimensions between the valve and the actuator are such that the nose section of the valve actuator does not contact the inner wall surface of the skirt section of the valve, although some contact is contemplated.

[0169] In an example, an actuating end of the valve actuator contacts a proximal-facing surface of the valve disc in a standby position, and another portion of the valve actuator (such as, one or two protrusions) abuts a shoulder inside the catheter sleeve in a standby position to apply a load on the valve disc, but the load is insufficient to open one or more slits.

[0170] In an example, the proximal-facing surface of the valve disc is biased by the valve opener in the standby position, but the bias is below a threshold for deflecting one or more flaps on the valve disc. In an example, one or more protrusions on the exterior of the valve actuator can abut a shoulder in the catheter hub to cause a distal end section (such as an activation end) of the valve opener to be biased against the proximal-facing surface of the valve in the standby position.

[0171] In other examples, the actuation end of the valve actuator can be spaced apart from the proximally facing surface of the valve disc in the standby position, and one or more protrusions on the valve actuator can either contact the shoulder or be spaced apart from the shoulder. When the one or more protrusions on the valve actuator are spaced apart from the shoulder of the catheter hub and the actuation end is spaced apart from the valve disc, the actuator can float in the axial direction within the catheter hub by a small amount.

[0172] In an example, the valve actuator may include a nose section that is elongated in structure and may be generally cylindrical or have a draft angle or taper terminating in an actuation end. The actuation end may have a blunt distal end surface or may have a sharp edge.

[0173] The nose section of the valve opener can have a wall surface having a continuous circumference without notches or slits, such as a cylindrical member with a continuous wall. In some examples, a plurality of spaced apart slits, notches and / or openings can be provided on the nose section to allow flow or fluid flushing. The nose section of the valve opener can define an aperture. Fluid can flow through the aperture. The needle can protrude through the aperture of the nose section in a standby position.

[0174] The two actuating elements or plunger elements may extend proximally of the nose section. For example, the two plunger elements may be integrally formed with the nose section and may extend in a proximal direction from the nose section.

[0175] A gap or space may be provided between the two plunger elements for positioning a needle guard or tip guard therebetween. The gap may define a holding space. The two plunger elements may each include at least two longitudinal edges, and the edges may be spaced apart from each other.

[0176] In examples, the protrusion may extend outwardly from an outer surface of one or both plunger elements.

[0177] A protrusion may extend from the outer surface of each plunger element. Each protrusion may resemble a ramped surface with a generally flat edge for abutting a shoulder of the recessed section of the catheter sheath. The ramped surface of the protrusion and the direction of the ramp may allow the valve actuator to be inserted into the interior of the catheter sheath and seated in the second recessed section of the catheter sheath.

[0178] In an example, a transition section of the actuator may extend from a nose section of the valve opener and widen axially in a proximal direction.Two actuation elements may extend from the transition section.

[0179] Some embodiments may use other shapes for the nose section, such as cubic, rectangular, conical, pyramidal, etc. The nose section may define an opening. A fluid may flow through the opening. A needle may protrude through the opening of the nose section.

[0180] In an example, the actuator or valve opener has a longitudinal axis, and one or more actuating elements can extend axially or parallel to the longitudinal axis. In a specific example, two actuating elements can be diametrically opposed to each other along the longitudinal axis.

[0181] In an example, the two actuation elements may define an outer diameter having a size that is larger than the diameter of the nose section. In other examples, the two actuation elements may define an outer diameter having a size that is smaller than the diameter of the nose section.

[0182] In an example, the actuating element or plunger element of the valve opener proximal to the nose section can be flexible and deflectable so that when pushed by the male Luer tip, the actuating element can deflect or flex. The actuating element can be deflectable by selecting a material with the necessary rebound properties, such as a crystalline thermoplastic material.

[0183] In other examples, the actuation element may be deflectable by including one or more weakened sections, such as by including a structurally thin section, by including a cutout, by having a smaller cross-section compared to other sections of the same elongated actuation element, or a combination thereof.

[0184] Alternatively, the actuation element may be flexible and deflectable by selecting a material with the necessary resilient properties and by including one or more weakened sections.

[0185] In still other examples, each actuating element may have more than one different cross-sectional profile or contour along a length segment. For example, an elongated plunger element may have a square contour positioned adjacent to a crescent-shaped contour.

[0186] In an example, the actuating element can be rigid and not deflectable or deformable when loaded (such as when pushed by the male Luer tip). In addition, a stabilizing element can be included to increase the stiffness of the two actuating elements. The two actuating elements can each include a cross-sectional profile at least at the proximal end that overlaps the pushing end of the male tip so that the male tip can push the valve actuator into the valve.

[0187] The nose section of the valve actuator can be configured to engage the valve to open the valve disc when an axial force is applied to the actuation element from the male tip toward the distal end of the catheter assembly, such as during insertion of an IV Luer adapter.

[0188] Typically, the nose section of the valve opener is rigid relative to the more flexible valve, which allows the nose section (and more specifically the actuation end) to actuate the valve, such as to deflect one or more flaps and open one or more slits on the valve disk. The nose section can be made of an incompressible material (such as metal, plastic, or an elastomer that is harder than the valve material) for pushing against the valve and opening the valve.

[0189] The illustrated valve actuator embodiment can include a pair of opposing straps or stabilizer elements that connect the two actuation elements at a location along the length of the actuation elements that is located between the nose section and the proximal ends of the actuation elements. In some examples, the stabilizer element can be located at the proximal ends of the two actuation elements such that the proximal edges of the stabilizer elements are generally flush with the proximal end surfaces of the actuation elements.

[0190] In one embodiment, the stabilizer element (or more generally referred to as a stabilizer) can be arc-shaped, thereby forming an arc that follows the inner contour of the catheter sleeve and connects one actuating element to another actuating element. The stabilizer can form a substantially cylindrical section on the body of the valve actuator, which can be spaced apart from the nose section of the valve actuator. In other words, the valve actuator can be elongated and can have sections that are continuous in the radial direction and sections that are discontinuous in the radial direction with a release portion or a through passage.

[0191] In an example, the stabilizer may define a continuous body section in a circumferential or radial direction of the valve actuator that is spaced apart from a continuous body section of the nose section that is also continuous in the circumferential or radial direction.

[0192] Two stabilizers can be connected with two plunger elements to form a ring structure. Optionally, the two stabilizers can be slightly offset and angled from each other. In some embodiments, there can be one, three or different numbers of actuating elements or stabilizers. In an example, the valve actuator (with stabilizers and protrusions) can be made of plastic, such as, made by injection molding.

[0193] The stabilizer can help the valve actuator remain centered within the catheter sheath when the actuator moves (such as when pushed by the male Luer tip). By remaining centered, the nose section can be better aligned with the valve disc (such as, a slit on the valve disc), allowing smooth actuation of the valve.

[0194] The stabilizer may also provide engagement with the interior of the catheter hub via friction to prevent the actuator from sliding out of the proximal end of the catheter hub after the male Luer tip is removed.

[0195] In one embodiment, the nose section of the valve can be configured to remain engaged to the valve disc after actuation of the valve and after removal of the male Luer tip. For example, the nose 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.

[0196] A release, opening or through passage may be provided between the transition section and each of the two stabilizers. The two releases or through passages may provide clearance so that the interior or center portion of the valve actuator may be in open communication with the inner surface of the catheter sleeve. In other words, one or two releases, through passages or openings may be provided between the continuous section of the nose section and the stabilizing ring. This may improve the flushing characteristics of the device.

[0197] A stabilization ring of the valve actuator, such as the stabilization ring, can have an inner diameter that is smaller than the diameter defined by the diagonal dimension of the distal sections of the two arms of the needle guard when the two arms are biased outwardly by the sides of the needle shaft. Thus, during installation of the needle guard into the holding space of the valve actuator, the needle guard can be deflected inside the smaller diameter to pass through the stabilization ring and into the open area defined by the release portion.

[0198] The valve actuator described herein may include a nose section, a transition section, and two plunger elements extending proximally of the transition section. The nose section may define a first continuous perimeter section. Other locations of the nose section away from the first continuous perimeter section may include slits or slots.

[0199] Two stabilizer elements can be attached to two plunger elements on the valve opener to form a stabilizing ring that can define a second continuous perimeter segment of the valve opener. Each stabilizer element can include two edges that can include a first or distal edge and a second or proximal edge. In one example, the two edges of each stabilizer element can be parallel to each other.

[0200] The two stabilizer elements may alternatively be skewed or inclined so that while the two edges of each stabilizer element or the same stabilizer element may be parallel to each other, the two edges from one stabilizer element may not be parallel to the two edges of the other stabilizer element. The proximal edges of the two stabilizer elements may be offset in the axial direction or lengthwise direction of the valve actuator. The distal edges of the two stabilizer elements may be offset in the axial direction.

[0201] The valve opener can be provided with two releases or two through passages. Each release can be defined or delimited by a transition section, two plunger elements, and a corresponding stabilizer element. The two releases or through passages can be referred to as a first release or first through passage and a second release or second through passage.

[0202] In an example, each release portion or through passage can have a perimeter. Each perimeter can be defined by the structure of the transition section or nose section, the two plunger elements, and the corresponding stabilizer element. Because the two stabilizer elements can be deflected or tilted in different directions, the two perimeters of the two release portions or through passages of the same valve opener can be different, such as having different perimeter profiles or shapes.

[0203] The perimeter of the relief or through passage may have a continuous loop. In other words, the perimeter may be closed and have no slits or slots to break the continuity of the perimeter. However, in the case where the stabilizer element is formed by two stabilizer segments and has a slot or slit between the two segments, the perimeter of the relief may be an open perimeter or a discontinuous perimeter.

[0204] In some examples, the two stabilizer elements can extend laterally to connect to the two plunger elements without being skewed or tilted in the distal or proximal direction. When so configured, the edges of the two stabilizer elements can be 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 of one stabilizer element can be located more proximally or distally than the proximal edge of the other stabilizer element, while the four edges are parallel to each other.

[0205] The proximal and distal edges of the stabilizer element may also be other than linear or straight lines. For example, the two edges may have a curve, a wavy surface, a serrated edge, or a combination thereof.

[0206] Two plunger element protruding sections or extensions may extend proximally of the stabilization ring.Two plunger element protruding sections may extend from the stabilization ring and be axially aligned with two plunger elements located distally of the stabilization ring.

[0207] In some examples, two plunger element protrusions can extend proximally of the stabilization ring and are not axially aligned with the two plunger elements located distally of the stabilization ring. In other examples, only one plunger element protrusion is aligned with one of the two plunger elements located distally of the stabilization ring.

[0208] For a valve opener or actuator having only one plunger element between the nose section with the activation end and the stabilizing ring, only one or none of the plunger element protruding sections are aligned with the one plunger element. There may be two or more plunger element protruding sections.

[0209] In some examples, there may be more than two plunger element protruding segments or extensions extending proximally of the stabilization ring. The two or more plunger element protruding segments or extensions may be equally spaced around the proximal perimeter of the stabilization ring or randomly spaced around the proximal perimeter of the stabilization ring.

[0210] The plunger element protruding section may extend the overall length of the valve actuator.

[0211] The number of plunger element protruding segments and / or the arc curve of each plunger element protruding segment (which arc curve defines the width of each plunger element protruding segment) can provide a larger overlapping surface with the male Luer tip compared to a smaller number of plunger element protruding segments or for plunger element protruding segments having a relatively smaller arc curve.

[0212] The two plunger elements may each have at least two thicknesses to produce a protrusion on the outer surface of each plunger element at the junction between the two thicknesses. The two protrusions may be located inside the recessed section so that a shoulder at the proximal end of the recessed section inside the catheter sleeve can provide a stop surface to prevent displacement of the valve opener in the proximal direction.

[0213] In some examples, only one protrusion may be used on one of the two plunger elements of the valve opener to prevent the valve opener from shifting in the proximal direction. In still other examples, each plunger element may have a single thickness, and the protrusion is formed at the site of the protrusion by adding material to the plunger element during injection molding. In still other examples, there may be more protrusions than the number of plunger elements.

[0214] In an example, the planar surface section may be provided with a valve actuator on the same side of each stabilizer element.The planar surface section may originate approximately from a nose section or transition section of the valve member and extend proximally to approximately the location of the two protrusions.

[0215] Two planar surface sections corresponding to the two stabilizer elements may be provided, one 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. Thus, in an example, the cross-sectional dimensions of the nose section, the transition section, and the two plunger elements may be substantially constant or the same within typical manufacturing tolerances along a side view.

[0216] The holding space may be provided between two plunger elements, inside the stabilization ring, between two plunger element protruding sections, or a combination thereof.

[0217] A portion or all of the needle guard or tip guard may be located in the holding space in the standby position, and if the tip guard includes two elbows, one or both elbows of the tip guard may project outwardly from one or more releases.

[0218] When located in the holding space, the proximal wall of the needle guard may be flush with the proximal end surface of the plunger element protruding segment, located proximal to the end surface, or located distal to the end surface. If the stabilization ring does not include a plunger element protruding segment, the proximal wall of the needle guard may be flush with the proximal edge of one or both stabilizer elements, located proximal to the proximal edge of one or both stabilizer elements, or located distal to the proximal edge of one or both stabilizer elements.

[0219] The distance between the two inner surfaces of the two stabilizer elements can define a choke gap, a choke point or a limit point for the needle guard to limit the proximal movement of the needle guard in the standby position and / or during the retraction of the needle after intravenous access. That is, before the needle tip moves to the proximal side of one or both distal blocking walls of the needle guard, the choke point or gap can present a smaller space for the needle guard to pass to the proximal side of the choke point or limit point.

[0220] After the needle tip moves proximal to one or both distal barrier walls of the needle guard, the two distal walls can move radially inward to reduce the radial profile of the needle guard, which can be smaller than the choke gap. As the radial profile measured at the two elbows becomes smaller, the needle guard can move proximal to the choke point. In an example, the needle guard can be moved proximally out of the holding space and catheter sleeve by a profile change on the needle that abuts the perimeter on the proximal wall of the needle guard and then pulls the needle guard out of the holding space and catheter sleeve of the valve actuator at the proximal wall.

[0221] In an example, the needle guard may move proximally of a choke gap or choke point and may move proximally through an aperture defined by the stabilization ring as the radial profile of the needle guard decreases.

[0222] 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 slot.

[0223] The stabilizer element on the valve opener may include two stabilizer segments separated from each other by a slit or slot. Each stabilizer segment may be understood to include an inner edge that is spaced apart from another inner edge of another 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 may be different.

[0224] When two stabilizer elements are used to form the stabilization ring, one stabilizer element may be a continuous piece connecting the two plunger elements together, and the other stabilizer element may be discontinuous, such as made of two stabilizer segments with a slit or slot between them. Thus, the stabilization ring may have a single slit or slot instead of two or more slits or slots.

[0225] The width of the slit or slot may be less than the widest width of the needle guard. Width in this regard may be understood as the dimension perpendicular to the longitudinal axis of the needle guard. In some examples, the width of the slit or slot may be less than the width of multiple distal walls of the needle guard, or the width of one distal wall (if only one distal wall is included). The width of the slit or slot may also be less than the width of the needle guard at the elbow.

[0226] The relative dimensions between the slits or slots on the valve opener and the width of the needle guard can be selected so that the stabilization ring can limit proximal movement of the needle guard, such as by limiting the two elbows on the needle guard from proximal movement of the stabilization ring through the slits or slots during needle retraction but prior to activation of the needle guard. In other words, even if the stabilizer element of the valve opener includes one or more slits or slots, the stabilization ring can still provide a constraining surface or choke point to limit proximal movement of the needle guard.

[0227] In examples, the elbow of the needle guard cannot slide proximally through the slit or slot of the stabilization ring. In other examples, the slit or slot of the stabilization ring may have a tapered gap such that while some portion of the needle guard may slide through the slit or slot, the narrowing taper of the slit or slot prevents the needle guard from moving completely through the slit or slot.

[0228] The valve opener of the present disclosure may include one or two stabilizer elements to form a complete ring or less than a complete ring, and the ring may have gaps or slots when stabilizer segments are used for one or two stabilizer elements. Thus, one or two stabilizer elements may be continuous or may be segmented with slits or slots between segments.

[0229] A needle guard having one arm and one elbow, two arms but only one elbow, or two arms and two elbows may be used with any of the various valve actuators described herein. The needle guard may be located in a retaining space of the valve actuator, and one or both elbows may extend at least partially through a release or through passage of the valve actuator.

[0230] Although the stabilization ring may include one or more slits, such as two slits, the stabilization ring may provide a restriction or choke point similar to a stabilization ring without any slits or slots.

[0231] A stabilization ring having a discontinuous circumferential segment may also provide stability during axial movement of the valve actuator by acting as a bearing to guide the valve actuator against the inner surface of the catheter hub.

[0232] Each stabilizer element can include two discontinuous edges, which can be referred to as a distal edge and a proximal edge, or a first edge and a second edge. In one example, the two edges of each stabilizer element can be parallel to each other. In a valve opener with two stabilizer elements, the two edges from one stabilizer element can also be parallel to the two edges of the other stabilizer element.

[0233] The two proximal edges of the two stabilizer elements can be aligned along the axial direction or the 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 axially offset.

[0234] Two releases or two through passages may be provided on the valve opener, each defined or delimited by a transition section or nose section, two plunger elements, and a corresponding stabilizer element. The two releases or through passages may be referred to as a first release or first through passage and a second release or second through passage.

[0235] In an example, each release or through passage may have a perimeter. In an example, each perimeter may be defined by the structure of the transition section or nose section, the plunger element, and the corresponding stabilizer element. The two perimeters of two releases or through passages may be the same, or may have different perimeter profiles or shapes. When slits or slots are included, there is one slit or slot on each stabilizer element, and the two perimeters of the release are open, such as discontinuous.

[0236] The valve opener can be made of a metal material. For example, a stamped metal sheet (such as a stamped stainless steel sheet) can be cold worked using a deep drawing method to form a desired shape. The various openings or gaps of the needle guard can be punched or stamped, and then cold worked to form the desired shape.

[0237] Each plunger element of the valve opener may include at least two longitudinal edges, and ribs may be optionally 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 a void or space for a fluid stream to flow therethrough, such as during an IV infusion. The gap may also form part of a holding space to accommodate a needle guard.

[0238] The two plunger element protrusions can extend from the stabilization ring and be axially aligned with the plunger element located distal to the stabilization ring of the valve opener. In other examples, the two plunger element protrusions are not axially aligned with the two plunger elements located distal to the stabilization ring. In still other examples, only one plunger element protrusion can be aligned with one of the two plunger elements of the valve opener.

[0239] In some examples, the valve opener may terminate at a stabilizing ring and the valve opener may not have any plunger element protrusions. In still other examples, each plunger element protrusion 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 both longitudinal edges of the two plunger elements at a position distal to the proximal end surface of the actuator or valve opener.

[0240] In an example, two plunger elements extend from a nose section of the valve opener, and a stabilization ring is located between the nose section and proximal-most surfaces of the two plunger elements.

[0241] In some examples, there may be more than two plunger element protruding segments or extensions extending proximally of the stabilization ring. The two or more plunger element protruding segments or extensions may be equally spaced around the proximal perimeter of the stabilization ring or randomly spaced around the proximal perimeter of the stabilization ring.

[0242] The plunger element protrusion segment can extend the total length of the valve actuator. The number of plunger element protrusion segments and / or the arc curve of each plunger element protrusion segment (which arc curve can define the width of each plunger element protrusion segment) can provide a larger overlapping surface with the male Luer tip compared to a smaller number of protrusion segments or for plunger element protrusion segments with relatively smaller arc curves.

[0243] In some examples, the plunger element protruding section can 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 can face inwardly or outwardly relative to the longitudinal axis of the valve actuator.

[0244] The two plunger elements can each include a protrusion on the outer surface. These protrusions can be located inside the recessed section of the catheter sleeve so that a shoulder at the proximal end of the recessed section can provide a stop surface to prevent displacement of the valve opener in the proximal direction. In some examples, only one protrusion is used on one of the two plunger elements to prevent displacement of the valve opener in the proximal direction.

[0245] In an example, each protrusion on the valve opener may be formed at the corresponding plunger element by cold working the surface of a stamped metal sheet to push out the protruding surface.

[0246] The nose section of the valve opener may have a tapered surface extending in a proximal direction and into the transition section.The two plunger elements may neck down from the transition section with two radiused sections.

[0247] Each plunger element of the valve opener can extend from a transition section or nose section in a proximal direction with a generally constant width and then neck up with a set of rounded sections. The necked-up sections can transition into two stabilizer elements. The two stabilizer elements can each include two stabilizer sections, or each can be formed as a single piece.

[0248] Two pairs of rounded sections may be located proximally of the stabilizer element or stabilizer section to form two plunger element protruding sections.Both the plunger element and the plunger element protruding section may have two spaced apart longitudinal edges, which may be provided with ribs to add strength to the respective structure.

[0249] Starting from within the stabilization ring of the valve actuator and extending in a proximal direction, the plunger element protruding section can be cold worked to form an outward ridge relative to the longitudinal axis of the valve opener to form a curved surface along a cross-section of the plunger element protruding section. Alternatively, the ridge can be formed inwardly to form an inward ridge. The ridge can be included to form concave and convex surfaces of a plunger element protruding section or multiple protruding sections (if more than one protruding section is included) to strengthen the structure of one or more protruding sections.

[0250] The distance between the two inner surfaces of the two stabilizer elements of the valve opener can define a limit point, a choke gap or a choke point for the needle guard to limit the proximal movement of the needle guard in the standby position and / or during the retraction of the needle after intravenous access. That is, before the needle tip moves proximal to one or two distal barrier walls of the needle guard, the size of the choke point or gap can be designed to be small enough to prevent the needle guard from passing to the proximal side of the choke point. However, after the needle tip moves proximal to one or two distal barrier walls of the needle guard, the two distal walls can move radially inward to reduce the radial profile of the needle guard, which can be smaller than the choke point. With the smaller radial profile after actuating one or more arms of the needle guard, the needle guard can move proximal to the choke point.

[0251] In an example, the needle guard may have a distal portion that is larger than the choke point, and wherein the distal portion of the needle guard may transition to have a relatively smaller profile and be smaller than the choke point. In an example, the distal portion of the needle guard is a location between the two elbows of the needle guard.

[0252] When the tip guard is positioned between the two plunger elements, the two distal walls of the needle guard (more specifically, the two sections with diagonal dimensions) can be located in the release portion to engage the guard engagement surface on the inner surface of the catheter hub. This allows the needle guard to protrude from the holding space of the valve actuator through the two release portions to engage with the guard engagement surface of the catheter hub or the perimeter of the two release portions.

[0253] A second undercut or recessed section proximal to the first recessed section may be provided in the lumen of the catheter hub for accommodating two diagonally sized sections of the needle guard.

[0254] The needle guard may be prevented from sliding in a proximal direction during needle retraction following a successful venipuncture by a shoulder of the recessed section or by some other surface feature on the interior of the catheter hub, such as a guard engagement surface on the interior of the catheter hub.

[0255] Optionally or alternatively, the distal edge of one or both stabilizers may provide a restraining surface to prevent early activation of the needle guard during needle retraction before the needle tip moves proximal of the two distal walls.In addition to the distal edge, the stabilizer may also have a proximal edge.

[0256] The valve opener can be made of a metal material or a plastic material. When made of a metal material, the valve opener can be formed by a deep drawing or bending method, and the arc-shaped cross-section of the actuating element can provide increased rigidity when pushed by the male Luer.

[0257] 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 rigidity. One or more gaps may be provided between any two actuating elements. These gaps may provide clearance or space for fluid flow flowing therethrough, such as during flushing blood or IV infusion. The gaps between the actuating elements may define a holding space to accommodate a tip protector.

[0258] In some embodiments, in the standby position, a substantial portion or majority, if not all, of the tip guard may fit within the retaining space formed by the body of the valve actuator, between the two plunger elements. This may allow the catheter sheath to be more compact, as less longitudinal space is required within the sheath to fit both the actuator and the tip guard in a continuous lengthwise manner or when the actuator and the tip guard only partially overlap in the axial direction.

[0259] The tip guard may fit completely within the retaining space of the actuator to further reduce the space or length required in the catheter hub. In the standby position, the proximal wall of the needle guard may be substantially flush or flush with the proximal end surfaces of the two plunger elements. To accommodate this nesting between the needle guard and the valve actuator, the valve actuator may be provided with a release so that one or both elbows on the needle guard may protrude outwardly from the retaining space of the valve actuator.

[0260] The release or through passage allows the tip guard to engage with the interior of the catheter sheath. Alternatively, the release or through passage allows the tip guard to protrude only outward from the holding space and contact or be spaced apart from the perimeter of the release. On the proximal side of the release, the stabilizer can provide additional rigidity and / or a larger engagement surface for the catheter sheath.

[0261] When the tip protector engages only the perimeter of the release or through-passage, such as the distal edge of the release of an actuator, then no deformation or diameter change is required on the inner wall of the catheter hub and the tip protector can still be placed in the female Luer section while complying with international Luer standards for conical fittings for current and future international standards.

[0262] Optionally, one or more grooves or recessed sections can be included on the exterior of the Luer connector of the catheter hub to accommodate any of the various components discussed herein. For example, one or more grooves can be provided on the distal side of the Luer connector section of the catheter hub to engage any of the protrusions, shoulders, elbows, or various structures and components discussed elsewhere herein.

[0263] The actuating element or plunger element of the valve actuator can extend past the proximal edge of the one or more stabilizer elements to substantially the same distance as the proximal wall of the tip guard. In the illustrated embodiment, the tip guard can substantially fit within the retaining space of the actuator, and the proximal wall of the tip guard is substantially flush with the proximal end of the actuating element in the axial direction.

[0264] In the valve actuator retracted position (in which the male tip does not advance the actuator to open the valve), the actuating end of the nose section of the actuator may be spaced apart or not pushed into the valve and open one or more slits of the valve. This position may also be a valve pre-activation position. That is, the valve actuator retracted position may be a position in which the actuating end is not pushed into the valve to open the slit of the valve, either before or after the first activation of the valve, and the male Luer tip has been removed after the actuator has been advanced.

[0265] Advancing the actuator in a distal direction may cause the actuating end of the actuator to advance against the valve disc and deflect the flap radially and distally to open a fluid path to be formed through the catheter assembly.

[0266] When a male medical implement (such as a male Luer tip) is initially inserted into the proximal opening of the catheter hub, the male tip may initially contact an actuating or plunger element, a plunger element protruding segment, or a 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 in a distal direction until the geometry of the male tip and the proximal opening of the catheter hub prevents the male tip from advancing further distally.

[0267] In an example, the male Luer connector of the catheter hub and the male Luer connector of the male tip can mate and block the male tip from further distally advancing into the opening of the catheter hub. A seal is provided by the Luer engagement to prevent fluid from leaking out of the proximal opening of the catheter hub when the two components are mated or registered.

[0268] When the actuator moves distally by the male tip, the nose of the valve actuator can be advanced distally and pushes against the proximal surface of the valve disc. Especially, the nose of the actuator can initially push against the proximal surface of the valve disc, and because the valve can be axially fixed in the recessed section of the catheter sleeve, one or more flaps on the valve disc can be radially and deflected in the distal direction. Then, the fluid from the male tip can flow through the catheter sleeve, through the valve and through the lumen of the catheter body. A valve skirt can be provided, which extends in the axial direction from the valve disc.

[0269] Alternatively, suction may be applied by a medical instrument (such as a syringe or a vacuum blood collection tube) and blood may be drawn from the patient through the open valve in a proximal direction. This is often done to test a sample before initiating an infusion therapy. Also, any residual blood may typically first be flushed from the interior of the catheter sheath before initiating an infusion therapy.

[0270] Even after the male tip is removed after actuation, the valve actuator may remain engaged to keep the valve open. That is, the friction between the valve actuator and the valve disc may exceed the restoring force generated by the valve in its attempt to return to its undeformed position. This activation position may be considered a one-time use or one-time actuation because the valve actuator and valve do not return to the pre-activation position when the male tip is removed.

[0271] In an alternative embodiment, the nose section of the actuator can be configured so that when pushed into the valve during activation, the actuation or activation end does not extend distally past the flap of the valve disc. This configuration can be adopted so that the valve actuator is pushed by the flap to return to its pre-activated position when the male Luer device is removed. The conical configuration at the distal end of the actuator can be such a configuration that the configuration can maintain a proximally directed 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 distal movement and its minimum distal movement. The difference between the maximum and minimum movement of a standard Luer connector is approximately 2.5 mm. Therefore, the international standard for Luer fittings can be consulted when designing the size of the tip of the actuator.

[0272] Additionally, a spring or elastic element or ring can be included at the distal chamber of the catheter sleeve to increase the rebound force or restoring force of valve, thereby being convenient to push the valve actuator in the proximal direction to return the actuator to the pre-activated position after removing the male tip. A biasing element (which can be a spring or elastic element) can also help to close the flap of the valve disc and return the valve to the valve closed position. In this way, after initial activation, the valve and the valve actuator can be closed again, and reopened, and so repeatedly. Alternatively, the flap can be made thicker, to provide enough restoring forces without the need for elastic elements. Also alternatively, the flap can be thicker, and the biasing element is used to provide restoring force on valve and valve actuator.

[0273] The distal edge and the proximal edge on the stabilizer or stabilizer element may not be parallel to the proximal edge of the plunger element or the plunger element protrusion (if included). The distal edge and the proximal edge of the upper or first stabilizer may be parallel to each other, and the distal edge and the proximal edge 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 parallel to each other. In other words, the upper stabilizer may have a distal inclination, and the lower stabilizer may have a proximal inclination.

[0274] The actuator may include a generally cylindrical nose section or may include a truncated conical nose or a combination of a cylindrical section and a conical section, and an activation end at its distal end. An actuating arm or plunger element may extend lengthwise from the nose section. Stabilizer elements may be included, and these stabilizer elements may have generally flush edges without offset edges. In the standby position of the needle assembly or catheter assembly, the nose section may contact the valve disc of the valve or may be slightly spaced apart from the proximal surface of the valve disc. The valve may also include a valve skirt having a valve cavity and a nose section located in the valve cavity, or at least an activation end of the nose section.

[0275] Another embodiment of the catheter assembly can include a catheter sleeve, which includes a side port, which can have a tubular port body that extends laterally from the wall of the catheter sleeve and limits the port lumen. A side opening can be formed through the sidewall of the catheter sleeve so that the port lumen is communicated with the inner chamber of the catheter sleeve. A removable cap can be placed on the end of the side port.

[0276] The valve may be a mixing valve having a diaphragm valve body and a tube valve body. The diaphragm valve body may include a diaphragm or a valve disc defining a diaphragm having a slit and a flap.

[0277] The valve skirt may extend proximally from the valve disc to a transition shoulder where the outer diameter of the valve may be reduced. A diaphragm valve body cavity may be defined within the valve skirt proximally of the valve disc. The tube valve body may define an elongated tube of elastomeric material extending proximally from the transition shoulder. The elongated valve tube cavity may be defined within the tube valve body and may communicate with and include the diaphragm valve body cavity. The wall in the diaphragm valve skirt may be thicker than the wall in the tube valve body.

[0278] The inner cavity of the catheter sleeve can include a distal shoulder, a proximal shoulder and an intermediate shoulder. The first recessed section can be defined between the distal shoulder and the intermediate shoulder, and the second recessed section can be defined between the intermediate shoulder and the proximal shoulder. The inner diameter of the first recessed section can be greater than the inner diameter of the second recessed section and greater than the diameter of the inner cavity immediately adjacent to the first recessed section distal side. The diameter of the second recessed section can be greater than the inner cavity immediately adjacent to the second recessed section proximal side.

[0279] The first recessed section and the second recessed section can be shaped as complementary to the valve so that the valve is fitted therein, the distal end of the valve abuts the distal step, the proximal end of the valve abuts the proximal step, and the transition step of the valve abuts the intermediate shoulder. Therefore, the valve can resist moving proximally or distally relative to the catheter sleeve. The diaphragm valve body can be positioned in the catheter sleeve, on the far side of the side port opening, and the tube valve body can terminate at the proximal side of the side opening. The tube valve body can be configured to be biased against the inner surface of the inner cavity and engage the inner surface of the inner cavity, so as to seal and engage this inner surface. In addition, the tube valve body can extend across and cover the side opening to seal the side opening and block the inner cavity from being communicated with the side port lumen.

[0280] The valve opener may include an elongated nose section configured such that when the valve opener is disposed within the lumen of the catheter sheath, the nose section extends into the valve lumen and the diaphragm lumen, and a distal tip or actuating end of the nose section is adjacent to the valve disc. The nose may define a nose cavity that communicates the distal opening with the release portion.

[0281] When the needle guard is disassembled and removed from the catheter hub, the needle is withdrawn. The needle tip protector can be capped over the needle tip and withdrawn from the valve opener and catheter hub along with the needle guard, leaving the valve closed and the valve opener in place within the catheter hub with its actuating end adjacent to the valve disc. In this configuration, the closed valve disc can prevent blood from flowing proximally past or through the valve.

[0282] When male medical implement, such as male Luer piece, syringe tip, IV kit connector or other male tip (preferably with Luer connector (Luer taper)) is pushed into the proximal end of catheter sleeve, medical implement can engage plunger element protruding section, push valve opener with force to far side relative to catheter sleeve and valve, so that first partially open the valve disc of diaphragm valve body, then, if necessary, open valve disc completely.Therefore, fluid F can be communicated in inner cavity from male medical implement and enter catheter tube body and further enter patient through valve opener (comprising nasal lumen) and valve disc.When such fluid F is infused by diaphragm valve body, pipe valve body can continue to block side port opening.Also as shown, when fully advanced, the tip of the nose of valve opener can contact liner, and thus can be blocked from further moving far side relative to catheter sleeve.In certain embodiments, resilient element can be adopted to help valve to be kept in place and / or valve flap is biased to closed position.

[0283] A fluid source can be attached to the side port. The fluid source can include any desired source and connector structure. When connected, fluid F from the fluid source can be injected into the port lumen, and fluid F can flow from the port lumen through the side opening and contact the tube valve body of the valve. Fluid pressure can be enough to partially collapse the tube valve body so that the proximal end of the tube valve body is separated from the inner wall of the catheter sleeve, and fluid F can flow proximally from the side opening around the proximal end of the tube valve body to the inner cavity of the catheter body, and further through the release path of the valve opener, fluid F flows distally from the release path through the nasal lumen and the valve disc opened to enter the catheter body. The valve can be configured to be harder at the proximal end of the tube valve body than at the proximal end of the tube valve body, so that the tube valve body will deflect, rather than the diaphragm valve body deflection.

[0284] In another embodiment, the valve can be configured such that the diaphragm valve body is proximal to the tube valve body. The valve disc can be positioned adjacent to the transition shoulder, and the diaphragm valve skirt can extend proximally from the valve disc. The valve diaphragm body cavity can be defined within the diaphragm valve skirt and can extend from the proximal end to the valve disc. The tube valve body can extend distally from the valve disc and the transition shoulder such that the tube valve lumen is defined within the tube valve body from the valve disc to the distal end of the tube valve body. In the illustrated embodiment, the valve disc can separate the tube valve lumen from the diaphragm valve body cavity.

[0285] The catheter sleeve can include a distal shoulder, a proximal shoulder and an intermediate shoulder, and a first recessed portion between the distal shoulder and the intermediate shoulder and a second recessed portion between the intermediate shoulder and the proximal shoulder. The second recessed portion can have an internal diameter greater than the internal diameter of the first recessed portion 840. The first recessed portion and the second recessed portion can be shaped as complementary to the valve so that the valve can be fitted in the inner chamber of the catheter sleeve, and its distal end abuts the distal shoulder, the proximal end abuts the proximal shoulder, and the transition shoulder abuts the intermediate shoulder. In this configuration, the valve can be blocked relative to the catheter sleeve 102 to move proximally or distally. The distal end of the pipe valve body can be at the far end of the side port opening, and the pipe valve body can extend across the port opening and seal the port opening. The valve disc can be arranged on the proximal side of the port opening.

[0286] The valve opener 134 can have a relatively short nose, but it extends into the diaphragm cavity so that the actuation end is adjacent to the valve disc. When the male medical device pushes the valve opener distally relative to the catheter body and the valve, the engagement end engages the flap, forcing the valve disc open so that the fluid F from the device can be infused. During such infusion, the tube valve body can be unaffected by the fluid flow and can therefore remain closed so that the side port lumen is blocked from communicating with the lumen of the catheter sheath.

[0287] When a fluid source is attached to the side port and fluid F is injected into the side port lumen, the fluid F is forced through the port opening and into contact with the tube valve body, which preferably deflects with the pressure, allowing such fluid to flow distally into the lumen and further into the catheter tube body. It should be understood that the fluid F can be infused via the side port while the valve disc remains closed or while the valve disc is open. Thus, the valve tube body can operate independently of the diaphragm valve body.

[0288] In another embodiment of the valve, the tube valve body and the diaphragm valve body can be formed separately. The distal end of the tube valve body can engage the distal shoulder, and the distal end of the diaphragm valve body can engage the intermediate shoulder, and the proximal end of the tube valve body can engage the distal end of the diaphragm valve body. As in other embodiments, fluid F delivered under pressure from a fluid source attached to the side port flows through the side port opening, displacing the tube valve body and entering the inner cavity, and the fluid F is guided from the inner cavity into the catheter tube and into the patient.

[0289] The distal shoulder may have a width approximately equal to the width of the tube valve body, so that when the tube valve seals the side port opening, the inner surface of the tube valve body may be substantially flush with the inner surface of the lumen. Therefore, when blood or other body fluids flow proximally from the catheter tube body into the lumen, such fluid flow is unlikely to lift the distal end of the tube valve body or otherwise deform it, which may cause the valve seal with the side port opening to fail. Additional embodiments may not use the distal shoulder, but rely on the resilience of the tube valve body to maintain its position of engagement with the inner wall of the catheter lumen. In other embodiments, the width of the distal shoulder may vary, such as at least 1 / 5, 1 / 4, 1 / 3, 1 / 2, 2 / 3 or 3 / 4 of the width of the tube valve body wall. However, other embodiments may not use the distal shoulder.

[0290] The catheter sleeve can be configured to allow fluid communication when a medical device 220 is attached thereto, in which, when the needle sleeve is removed and no other medical device is attached to the catheter sleeve, blood flow is controlled to block proximal flow through the catheter sleeve. In some cases, an extension can be attached to this blood control catheter sleeve. The extension can include a medical device, such as a male Luer connector, which leads to a tube that terminates at the extension sleeve. A stopper can be used to close the extension sleeve. When the Luer connector is attached to the blood control catheter sleeve, the valve is opened and blood can flow through the tube and enter the extension sleeve. The stopper prevents this blood from flowing out of the extension sleeve. However, when the stopper is removed, such as in order to connect another medical device, the extension sleeve is not equipped to prevent blood from flowing proximally through the extension sleeve and out of the extension, which may expose the clinician to blood contact.

[0291] Another embodiment of the extension may include an extension sleeve including a valve and a valve opener, and another embodiment of the plug. The valve may include a diaphragm or a valve disc, and a valve skirt extending proximally from the valve disc. The extension sleeve may define a sleeve cavity, which may have a distal shoulder against which the valve disc may rest. The valve opener may fit within the sleeve cavity so that its nose extends into the valve adjacent to the valve skirt and its actuating end is located at or adjacent to the diaphragm or valve disc. The plug in turn may also fit within the sleeve cavity distal to the valve opener.

[0292] The plug may be elongated and may define a plug lumen therein. The proximal portion of the plug may have a diameter greater than the inner diameter of the extension sleeve and may therefore not fit into the extension sleeve. The registration portion may extend distally from the proximal portion and may have an outer diameter less than the proximal inner diameter of the extension sleeve. However, the extension sleeve may taper, such as with a Luer connector, and the registration portion may engage and register with the inner surface of the extension sleeve as the plug is advanced distally within the extension sleeve so that the plug is retained in place in the extension sleeve in a press-fit manner.

[0293] The middle portion of the plug can extend distally from the registration portion and can have a smaller diameter so that it can fit in and extend through the valve opener. The offset surface can be arranged between the registration portion and the middle portion. The distal portion of the plug can extend distally from the middle portion and can have a smaller outer diameter. The outer diameter of the distal portion can be smaller than the inner diameter of the nasal lumen defined in the elongated nose of the valve opener, or about the same as the inner diameter of the nasal lumen. The distal opening is arranged at the distal end of the plug and leads to a distal passage that is connected to the rest of the plug lumen. The distal opening and the distal passage can be very small, for example, having a cross-sectional diameter smaller than the internal passage of the needle, so that blood can be blocked from flowing therethrough, or at least can be slowed down when flowing therethrough. However, air can easily flow through the distal opening and the distal passage.

[0294] The filter seat can be formed adjacent to the proximal portion, such as between the proximal portion and the registration portion. A hydrophobic filter can be secured in the filter seat. The hydrophobic filter can be configured to allow air to flow therethrough, but resist blood from flowing therethrough. Thus, blood and air can flow through the distal passage into the plug lumen, but blood will be blocked by the filter, while air will be allowed to flow through the filter and out of the open proximal end of the plug.

[0295] The plug can be placed in the extension sleeve so that the distal portion extends through the nasal lumen of the valve opener and through the valve disc. The flap of the valve disc can maintain a seal around the distal portion, but when the extension is attached to the catheter sleeve, the distal opening is open to any blood and air that may flow into the tube. In this position, the offset surface of the plug can be adjacent to and / or engaged with the proximal end of the valve opener, the actuating end of the nose of the valve opener can be held proximal to the valve disc, and the registration portion can be in press-fit contact with the inner surface of the extension sleeve.

[0296] In the case where the plug is arranged in the extension sleeve, the extension can be attached to the catheter sleeve. When this connection is made, the Luer adapter can trigger the valve of the catheter sleeve to open, thereby allowing blood to flow through the tube and enter the extension sleeve lumen distal to the valve. Such blood can contact the distal opening and valve disc of the plug. Blood can be blocked from flowing between the valve disc and the distal part, but some blood can flow through the distal opening and the distal passage and enter the plug lumen. Before the extension is attached to the catheter sleeve, the air in the extension can also be pushed proximally by the blood and pass through the tube with the blood and enter the extension sleeve lumen distal to the valve, but can easily flow through the distal opening and the plug lumen to reach and flow through the hydrophobic filter, so as to be discharged from the proximal end of the plug. However, the blood entering the plug lumen can be prevented from further flowing proximally by the hydrophobic filter. In this way, when the extension is attached to the catheter sleeve, air can be easily discharged from the extension, but blood can be contained. It should be understood that while the plug embodiments may employ distal openings and distal passages configured to resist or restrict blood flow therethrough, other embodiments may not necessarily restrict such blood flow, but may rely more completely on other structures, such as a hydrophobic filter. And in other embodiments, the hydrophobic filter may be placed elsewhere in the plug and / or the plug may include multiple hydrophobic filters.

[0297] Once the air has been exhausted from the extension, the plug can be removed by pulling the extension sleeve lumen distally. When the plug is pulled distally, the distal portion will be removed from the valve and the valve disc can be closed, thereby forming a seal that prevents blood from flowing therethrough. The plug can then be discarded because blood is blocked from flowing through the extension sleeve. When needed, a medical device, such as a male Luer connector or a syringe attached to a fluid source, can then be attached to the extension sleeve. The medical device can force the valve opener distally relative to the valve, thereby opening the valve so that fluid can be infused via the extension sleeve.

[0298] In some embodiments, the extension sleeve may be provided without a plug. The valve will block blood and air from flowing proximally through and out of the extension sleeve, but, as discussed above, this will cause the valve to fail when a medical device is attached thereto. In yet other additional embodiments, the extension sleeve may initially be provided without a plug and may be attached to the blood control catheter assembly in this configuration. When necessary, the clinician may engage the plug with the extension sleeve as needed to vent air that may be within the extension while maintaining blood control. Still in other embodiments, the extension may include multiple tubes extending from the device, each of which terminates at a dedicated extension sleeve. Such extension sleeves may each include a plug, the sleeves may share a single plug, or no plug may be provided, and a separately provided plug may be adopted or added as needed or desired.

[0299] Plugs having features as discussed herein may be used in other applications. For example, some embodiments of catheter sleeves, extension sleeves, or other medical sleeves may be configured to selectively receive a plug when it is desired to vent air or other gases that may be in an attached tube and / or within the medical sleeve. Thus, embodiments are not limited to use with extension sleeves, but may be used with other medical devices and medical sleeves of various types and configurations.

[0300] In other additional embodiments, the extension sleeve can be configured differently than specifically discussed herein, and valves and / or valve openers having features and structures different from those specifically discussed herein can be employed. For example, in one embodiment, the extension sleeve can be configured with a side port, and similar different embodiments of valves and valve openers can be employed. In addition, at least some extension sleeve embodiments can be configured without regard to accommodating a needle assembly. In such embodiments, neither the valve nor the valve opener need include structures configured to accommodate a needle or needle tip protector. Therefore, it is expected that such structures can be different from the structures depicted in the specifically discussed embodiments.

[0301] Aspects of the present disclosure may include a needle assembly comprising: a needle guard with a needle having a needle tip extending from a distal end of the needle guard; a catheter tube attached to the catheter guard, the catheter guard having a body including an inner wall surface defining an inner lumen, the needle extending through the catheter tube body and the needle tip extending out of the distal end of the catheter tube body in a standby position; a valve positioned in the inner lumen of the catheter guard, the valve comprising an outer perimeter, at least one slit and two or more flaps; a valve opener sized and shaped to open the at least one slit to open the valve , the valve opener comprising: a nose section having an activation end and a continuous perimeter section, two plunger elements each having two longitudinal edges, two stabilizer elements connecting the two plunger elements to form a stabilization ring comprising the continuous perimeter section, a holding space and two through passages between the nose section and the stabilization ring; a needle guard comprising two resilient arms at least partially located inside the holding space, wherein the needle guard comprises two elbows protruding through the two through passages and contacting the perimeter of each through passage or the inner wall surface of the catheter sleeve.

[0302] The needle guard may be at least partially located within the holding space of the valve opener such that an elbow or diagonal section on an arm of the needle guard extends through one of the through passages of the valve opener. The elbow or diagonal section of the needle guard may be in contact with a perimeter of the through passage, spaced apart from a perimeter of the through passage, in contact with an inner surface of the catheter hub, spaced apart from an inner surface of the catheter hub, or a combination of contact with a perimeter of the through passage and an inner surface of the catheter hub.

[0303] Still another aspect of the present disclosure may include a needle guard comprising a resilient arm at least partially located within a retaining space of a valve opener, wherein the needle guard may include an elbow protruding through the first through passage, protruding through the first through passage and contacting a perimeter of the first through passage, protruding through the first through passage and contacting an inner surface of the catheter hub, or a combination of protruding through the first through passage and contacting a perimeter of the first through passage and an inner surface of the catheter hub.

[0304] The elbow or diagonal section may be a first elbow, and the needle guard may include a second elbow, and wherein the second elbow may extend through another of the through passages of the valve opener, which may be referred to as the second through passage. The second elbow or diagonal section of the needle guard may contact a perimeter of the second through passage, be spaced apart from a perimeter of the second through passage, contact an inner surface of the catheter sheath, be spaced apart from an inner surface of the catheter sheath, or a combination of contacting a perimeter of the second through passage and an inner surface of the catheter sheath.

[0305] In some examples, the valve actuator or opener may have only one through passage, and the needle guard may include a resilient arm at least partially located within the retaining space of the valve opener, wherein the needle guard includes an elbow that protrudes through the only through passage, protrudes through the only through passage and contacts the perimeter of the only through passage, protrudes through the only through passage and contacts the inner surface of the catheter sleeve, or a combination of protruding through the only through passage and contacting the perimeter of the only through passage and the inner surface of the catheter sleeve.

[0306] The valve may comprise a valve disc and a valve skirt, the valve skirt extending in a proximal direction and defining a valve cavity.The valve may optionally comprise a valve skirt extending in a distal direction of the valve disc.

[0307] In the standby position, the activation end of the valve opener may be located within the valve cavity of the valve.

[0308] In the standby position, the activation end may be in contact with the proximally facing surface of the valve disc.

[0309] The valve opener may include a protrusion extending radially along a longitudinal axis of the valve opener, and wherein in the standby position the protrusion may contact a shoulder on an inner surface of the catheter hub.

[0310] In the standby position, the valve opener may contact the valve disc and the shoulder simultaneously.

[0311] The protrusion may extend radially of the plunger element on the valve opener. The protrusion may have a slope surface with a straight edge.

[0312] The protrusion may be considered a first protrusion, and wherein the valve opener may include a second protrusion from the first protrusion, and wherein the activation end may apply a load on the valve disc without opening the at least one slit.

[0313] The hub may wedge the proximal end of the catheter tube against the inner surface of the catheter hub.

[0314] The resilient element may be located inside the catheter hub, between the bushing and the valve disc, and wherein the resilient element may be sized and shaped to urge two or more flaps of the valve in a proximal direction.

[0315] The resilient element may be an elastic element, an elastic cylinder, a helical spring or a leaf spring. The helical spring may comprise a plurality of interconnected coils.

[0316] Another aspect of the present disclosure may include a method of assembling a needle assembly. The method may include the following steps: providing a catheter hub having a catheter tube body having an open distal end and a proximal end attached to the catheter hub by a hub, the catheter hub including a hub body having an inner surface defining an inner cavity and a proximal opening; positioning a valve including at least one slit and two or more flaps proximal to the hub; positioning a valve opener proximal to the valve and within the inner cavity of the catheter hub to slidably push the valve open when actuated by a medical device, the valve opener including a nose section having an activation end and a continuous perimeter section , two plunger elements each having two longitudinal edges, two stabilizer elements connecting the two plunger elements to form a stabilization ring including a continuous circumferential segment, a holding space, and two through passages between the nose segment and the stabilization ring; placing a needle attached to the needle guard through the catheter hub, the valve, and the catheter tube body so that in the standby position the tip of the needle extends out of the distal opening of the catheter tube body; and placing a needle guard at least partially within the holding space of the valve opener so that an elbow on each of the two arms of the needle guard extends through the two through passages of the valve opener.

[0317] In some examples, placement of the needle guard can include placing the needle guard at least partially within the holding space of the valve opener such that an elbow or diagonal segment on an arm of the needle guard extends through one of the through passages of the valve opener. The elbow or diagonal segment can be in contact with a perimeter of the through passage, spaced apart from the perimeter of the through passage, in contact with an inner surface of the catheter hub, spaced apart from the inner surface of the catheter hub, or a combination of contact with a perimeter of the through passage and an inner surface of the catheter hub.

[0318] The needle guard may include a second elbow or diagonal section extending through the other of the two through passages.The second elbow or diagonal section may protrude through the other through passage in a similar manner to the elbow or diagonal section (which may be the first elbow).

[0319] The needle guard may include a proximal wall and a perimeter defining an opening in the proximal wall, and wherein the two arms extend distally of the proximal wall.The needle guard may be located entirely within the interior of the catheter hub.

[0320] The needle guard may be located completely within the interior of the catheter hub, with the proximal end of the needle guard positioned flush with the proximal end surface of the valve opener, or located proximal to the proximal end surface of the valve opener, or the proximal end surface of the needle guard may be located distal to the proximal end surface of the valve opener.

[0321] The valve may include a valve disc and a valve skirt, the valve skirt extending in a proximal direction and defining a valve cavity, and wherein the activation end of the valve opener may be located in the valve cavity in the standby position.

[0322] The activated end of the valve opener can be in contact with the proximally facing surface of the valve disc in the standby position, and wherein two spaced apart protrusions on the valve opener abut shoulders in the recessed section of the catheter hub.

[0323] The two stabilizer elements may each include two parallel edges.Methods of making and using the catheter assemblies and components thereof described elsewhere herein are within the scope of the present disclosure.

[0324] Aspects of the present disclosure may include a needle assembly comprising: a needle guard and a needle having a needle tip extending from a distal end of the needle guard; a catheter tube attached to the catheter guard, the catheter guard having a body including an inner surface defining an inner lumen, the needle extending through the catheter tube in a standby position and the needle tip protruding from the distal end of the catheter tube.

[0325] The needle assembly may also include a valve positioned within the lumen of the catheter hub, the valve including an outer perimeter, at least one slit, and two or more petals.

[0326] The needle assembly may also include a valve opener, the size and shape of which are designed to open at least one slit to open the valve, and the valve opener may include a nose section having an activation end and a continuous peripheral section, two plunger elements each having two longitudinal edges, two stabilizer elements connecting the two plunger elements to form a stabilization ring including a continuous peripheral section, a retaining space, a first through passage and a second through passage located between the nose section and the stabilization ring.

[0327] The valve opener may include a nose segment having an activation end and a continuous peripheral segment, a plunger element having two longitudinal edges, a stabilization ring including a continuous peripheral segment at the end of the plunger element, a retaining space, and a through passage between the nose segment and the stabilization ring.

[0328] The holding space may be located between the two plunger elements or inside the stabilization ring.

[0329] The stabilization ring may define a continuous perimeter segment or may include one or more slits, such as a discontinuous ring.

[0330] Unless the context indicates otherwise, the terms first, second, third, etc. should be understood as designated names to distinguish different elements, structures or components from each other, but not necessarily to limit the structure. For example, a first arm and a second arm are two different arms that may or may not have the same structure unless further defined or modified by further definition.

[0331] The needle assembly may further include a needle guard including a resilient arm at least partially located within the retaining space of the valve opener, wherein the needle guard may include an elbow protruding through the first through passage and contacting a perimeter of the through passage, an inner surface of the catheter hub, or both the perimeter of the through passage and the inner surface of the catheter hub.

[0332] A method of assembling a needle assembly may include providing a catheter hub having a catheter tube with an open distal end and a proximal end attached to the catheter hub by a hub, the catheter hub including a hub body having an inner surface defining a lumen and a proximal opening.

[0333] The method may also include positioning a valve comprising at least one slit and two or more flaps proximal to the sleeve; positioning a valve opener proximal to the valve and within the inner cavity of the catheter sleeve to slidably push the valve open when actuated by a medical device.

[0334] A valve opener that can be used with the method of the present disclosure may include a nose section having an activation end and a continuous peripheral section, two plunger elements each having two longitudinal edges, two stabilizer elements connecting the two plunger elements to form a stabilization ring including the continuous peripheral section, a retaining space, and two through passages located between the nose section and the stabilization ring.

[0335] Two plunger element extensions may extend proximally of the stabilization ring.

[0336] A valve opener that can be used with the method of the present disclosure may include a nose segment having an activation end and a continuous peripheral segment, a piston element having two longitudinal edges, a stabilization ring including a continuous peripheral segment at the end of the piston element, a retaining space, and a through passage located between the nose segment and the stabilization ring.

[0337] The method may also include placing a needle attached to the needle guard through the catheter hub, the valve, and the catheter tube so that in the standby position the tip of the needle extends out of the open distal end of the catheter tube; and placing a needle guard at least partially within the holding space of the valve opener so that an elbow or diagonal section on an arm of the needle guard extends through one of the two through passages of the valve opener and contacts the perimeter of the through passage, the inner surface of the catheter hub, or both the perimeter of the through passage and the inner surface of the catheter hub.

[0338] Still another aspect of the present disclosure may include a catheter assembly comprising: a needle sheath having a needle having a needle tip; a catheter tube attached to the catheter sheath, the catheter sheath having a body including an inner surface defining an inner cavity, the needle extending through the catheter tube body; a valve positioned in the inner cavity of the catheter sheath, the valve including at least one slit and two or more flaps; a valve opener including a nose section having an activation end, at least one plunger element, the at least one plunger element having a proximal end surface for being pushed by a male medical instrument; a needle guard including a resilient arm extending in a distal direction of a proximal wall, the proximal wall including a perimeter defining an opening, the needle tip configured to block the needle tip.

[0339] Another aspect of the present disclosure may include a catheter assembly, the catheter assembly includes a catheter body attached to a catheter sleeve, the catheter sleeve includes an inner cavity and a side port. The side port may have a side port lumen. The catheter body and the side port lumen may be in communication with the inner cavity. The side port opening may allow the inner cavity to communicate with the side port lumen. The valve may be positioned in the inner cavity of the catheter sleeve. The valve may include a diaphragm valve body and a tube valve body. The diaphragm valve body may have at least one slit and two or more flaps. The tube valve body may be elongated and tubular. The valve opener may include a nose section with an activation end. The valve opener may be positioned in the inner cavity so that the activation end may be proximal to the flap of the diaphragm valve body. The size and shape of the valve opener may be designed so that when it moves distally relative to the valve, the activation end pushes the flap to open the valve. The tube valve body may be biased against the surface of the inner cavity and may cross the side port opening to seal the side port opening.

[0340] The diaphragm valve body may include a valve disc, and the tube valve body may extend in a proximal direction from the valve disc.

[0341] The diaphragm valve body may be positioned in the lumen distal to the side port opening, and the proximal end of the tube valve body may be positioned in the lumen proximal to the side port opening.

[0342] The tube valve body can be configured such that when fluid under pressure is injected into the side port lumen, the tube valve body deflects radially inward and away from the surface of the lumen so that fluid from the side port lumen can flow through the tube valve body and into the lumen. When fluid under pressure is no longer injected, the tube valve body can be biased to return to contact with the surface of the lumen to reestablish the seal.

[0343] The diaphragm valve body may include a valve disc, and the tube valve body may extend in a distal direction from the valve disc.

[0344] The diaphragm valve body may be positioned within the lumen proximal to the side port opening, the proximal end of the tube valve body may be positioned within the lumen proximal to the side port opening, and the distal end of the tube valve body may be distal to the side port opening.

[0345] The tube valve body can be configured so that when fluid under pressure is injected into the side port lumen, the tube valve body will deflect radially inward and away from the surface of the inner cavity, so that the fluid from the side port lumen can flow through the tube valve body and into the inner cavity. Such fluid injected into the side port lumen can be communicated to the inner cavity regardless of whether the diaphragm valve body is open.

[0346] Once fluid injection through the side port has ceased, the tube valve body may be biased to automatically return to contact with the surface of the lumen to reestablish the seal.

[0347] The valve skirt may extend from the valve disc in a proximal direction.

[0348] The tube valve body and the diaphragm valve body may be formed separately.

[0349] In yet another aspect, the present disclosure provides a medical set assembly, which includes a medical set, and the medical set may include an inner cavity communicating with a proximal opening and a distal opening. The valve may be positioned in the inner cavity of the medical set. The valve may include a valve disc, which may have at least one slit and two or more flaps. The valve opener may include a nose section, and the nose section may have an activation end. The valve opener may be positioned in the inner cavity so that the activation end may be proximal to the flap of the valve disc. The size and shape of the valve opener may be designed so that when it moves distally relative to the valve, the activation end pushes the flap to open the valve. The blood plug may include a distal portion defining a distal passage terminating at the distal opening. The plug lumen may be proximal to the distal passage and communicated with the distal passage. The filter may be configured to allow air to flow therethrough, but block blood from flowing therethrough. The distal portion may be configured to extend through the valve so that the distal opening is communicated with the distal opening of the medical set.

[0350] The blood plug can be selectively removed from the medical set.

[0351] The blood plug may be sized and configured to be selectively inserted through the proximal opening of the medical sleeve.

[0352] The medical sheath may be an extension sheath, and the tube may be attached to the extension sheath to communicate with the distal opening of the extension sheath.The medical implement may be connected to the distal end of the tube.

[0353] The blood stopper may have a registration portion, and an outer diameter of the blood stopper in the registration portion may be smaller than an inner diameter of the lumen at the proximal opening of the medical sleeve, but larger than an inner diameter of the lumen distal to the proximal opening of the medical sleeve.

[0354] The valve opener nose section may have a nose lumen, and the distal portion of the blood plug may be sized and configured to extend through the nose lumen and extend distally from the nose section.

[0355] Yet another aspect of the present disclosure is a medical method, comprising providing a medical sleeve, which may include an inner cavity communicating with a proximal opening and a distal opening, a valve positioned in the inner cavity and including a valve disc having at least one slit and two or more flaps, and a valve opener including a nose section having an activation end. The valve opener may be positioned in the inner cavity so that the activation end is proximal to the flap of the valve disc. The size and shape of the valve opener may be designed so that when it moves distally relative to the valve, the activation end pushes the flap to open the valve.

[0356] The method may include placing the medical set in communication with the patient's vascular system so that blood and air flow through the distal opening of the medical set and enter the inner cavity distal to the valve disc. A blood plug may be provided, and the blood plug may include a distal portion defining a distal passage terminating at the distal opening, a plug lumen proximal to the distal passage and in communication with the distal passage, and a filter. The filter may be configured to allow air to flow therethrough, but block blood from flowing therethrough. The blood plug may be advanced distally through the proximal end of the medical set so that the distal portion extends through the valve disc, and the distal opening is in communication with blood and air. Air flows through the distal opening and the distal passage and further flows through the filter, but blood is blocked from flowing through the filter. The blood plug may be removed from the medical set.

[0357] Prior to placing the medical cuff in communication with the patient's vasculature, the blood plug may be advanced distally through the proximal end of the medical cuff.

[0358] The flap may effectuate a seal around the distal portion of the blood plug.

[0359] In some aspects, the blood plug can be removed from the medical set, and when the blood plug is removed, the valve disc can establish a seal, blocking fluid from flowing proximally through the valve disc. The valve disc can also establish such a seal before and after the blood plug is advanced distally through the proximal end of the medical set.

[0360] In some embodiments, after the medical cuff is placed in communication with the patient's vasculature, the blood plug can be advanced distally through the proximal end of the medical cuff.

[0361] In some aspects, the blood stopper can be engaged with the medical set so that the medical set and the blood stopper can move together as a unit.

[0362] The medical method may additionally include advancing a medical implement through the proximal opening of the medical sheath such that the medical implement pushes the valve opener distally relative to the valve to open the valve.

[0363] Methods of using, making and / or assembling catheter assemblies and needle assemblies and components thereof are within the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0364] These and other features and advantages of the present apparatus, system and method will become better understood as the same becomes better understood with reference to the specification, claims and accompanying drawings, in which:

[0365] Figure 1 is a schematic cross-sectional side view of a catheter assembly in a prepared position with the needle tip extending out of the distal end of the catheter tube.

[0366] Figure 2 is in a transitional position or state Figure 1 Schematic cross-sectional side view of a catheter assembly of FIG. 1 with a needle in the process of being removed from a catheter tube and a catheter hub (such as after a successful venipuncture).

[0367] Figure 3 yes Figure 1 Schematic cross-sectional side view of a catheter assembly of , wherein the needle has been completely separated from the catheter hub and the needle tip is covered by the needle guard.

[0368] Figure 4 yes Figure 1 Schematic cross-sectional side view of a catheter assembly of , wherein the catheter hub is now connected to the male luer and the proximal valve actuator is advanced through the male luer to push the valve into the distal valve actuator to open the valve.

[0369] Figure 5A and Figure 5B An end view and a cross-sectional side view, respectively, of a proximal valve actuator according to aspects of the present disclosure are shown.

[0370] Figure 5C Shown along Figure 1 A cross-sectional end view taken along line 5C-5C showing the inner arc-shaped plunger element of the needle guard and the proximal valve opener.

[0371] Figure 5D yes Figure 5C An alternative embodiment of a valve opener showing an outer arc-shaped plunger element.

[0372] Figure 5E Shows Figure 5B An alternative embodiment of the valve opener of , wherein the proximal section is a cylindrical member for surrounding at least a portion of the needle guard.

[0373] Fig. 6A and Figure 6B An end view and a cross-sectional side view, respectively, of a distal valve actuator according to aspects of the present disclosure are shown.

[0374] Figure 6C and Fig.6D An end view and a cross-sectional side view, respectively, of an alternative distal valve actuator having three fingers or plunger elements for use with a valve having three lugs are shown.

[0375] Figure 7 yes Figure 1 Isometric view of a needle guard.

[0376] Fig. 8A is a front view of an exemplary single slit-type butterfly valve.

[0377] Figure 8B is a front view of an exemplary three-slit butterfly valve.

[0378] Figure 8C is a front view of a single slit type butterfly valve having a v-shaped slit at each end of a single slit.

[0379] Fig. 9 is an exploded perspective view of a needle assembly according to further aspects of the present disclosure.

[0380] Fig.9A It is in assembled state Fig. 9 Isometric cutaway view of the needle assembly.

[0381] Fig. 9B yes Fig. 9 Isometric view of the needle assembly.

[0382] Fig. 10A and Fig. 10B Shown in assembled state Fig. 9 Partial cross-sectional side views of a needle assembly along different viewing planes.

[0383] Fig.11 Shown in assembled state Fig. 9 A partial perspective cutaway view of a needle assembly.

[0384] Fig. 12A Shown after needle removal Fig. 9 A partial cross-sectional side view of a needle assembly.

[0385] Fig. 12B Shows Fig. 12A A partial cross-sectional side view of a needle assembly of FIG. 1 , wherein the valve opener is advanced distally against the valve to open the valve.

[0386] FIG. 13A to FIG. 13C A valve opener of the present disclosure is depicted.

[0387] Fig.14Ais a schematic cross-sectional side view of another embodiment of a catheter assembly in a prepared position with a needle tip extending out of a distal end of the catheter tube.

[0388] Fig. 14B yes Fig.14A Schematic cross-sectional top view of a catheter assembly.

[0389] Fig.15 is a cross-sectional side view of another embodiment of a valve.

[0390] Fig.16 is a perspective view of one embodiment of a valve opener of the present disclosure.

[0391] Fig.17 yes Fig.14A Partial cross-sectional side view of the catheter assembly after the needle is removed.

[0392] Fig.18A Shows Fig.17 A catheter assembly wherein a valve opener is advanced distally against a valve portion to partially open the valve.

[0393] Fig.18B Shows Fig.17 A catheter assembly wherein a valve opener is fully advanced distally against the valve to open the valve.

[0394] Fig.18C Shows Fig.18B A catheter assembly wherein a fluid source is attached to a side port and fluid is injected therein.

[0395] Fig.19 is a cross-sectional view of yet another embodiment of a valve.

[0396] Fig. 20 is a perspective view of another embodiment of a valve opener.

[0397] Fig.21 is a partial cross-sectional side view of a catheter assembly of the present disclosure, which employs Fig.19 The valve and Fig. 20 A valve opener is shown with a fluid source attached to the side port and fluid injected therein.

[0398] Fig. 22 is a cross-sectional view of yet another embodiment of a valve.

[0399] Fig.23 Is adopted Fig. 22 A partial cross-sectional side view of a catheter assembly of the present disclosure having a valve showing a fluid source attached to a side port and injecting fluid therein.

[0400] Fig.24 The extension is shown attached to the catheter assembly.

[0401] Fig.25 is an exploded view of an extension assembly of the present disclosure.

[0402] Fig.26 yes Fig.25 Side cross-sectional view of an embodiment of a plug of an extension assembly.

[0403] Fig. 27 Shown is a catheter assembly attached to Fig.25 Assembled extension components.

[0404] Fig.28 yes Fig. 27 A partial cross-sectional view of an extension assembly, depicted as fully assembled.

[0405] Fig.29 Shows Fig.28 An extension assembly wherein the plug is removed.

[0406] Fig.30 Shows Fig.29 An extension assembly wherein a valve opener advances distally against the valve to open the valve. DETAILED DESCRIPTION

[0407] The detailed description set forth below in conjunction with the accompanying drawings is intended to be a description of the current preferred embodiment of the conduit assembly with the control valve provided according to the various aspects of this device, system and method, and is not intended to represent that this device, system and method can be constructed or the only form used. This description sets forth the features and steps of the embodiments for constructing and using this device, system and method in conjunction with the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures can be completed by different embodiments, and these embodiments are also intended to be included in the spirit and scope of this disclosure. As indicated elsewhere herein, similar element numbers are intended to indicate similar or similar elements or features.

[0408] Reference now Figure 1 , shows a catheter assembly 100 (which may be more broadly referred to as a needle assembly or needle device), which includes: a catheter sleeve 102 having a catheter tube body 104 attached to a sleeve body 50; and a needle sleeve 106 having a needle 108 extending through the catheter sleeve 102 and the catheter tube body 104, the needle having a needle tip 110 that extends out of the distal end or distal opening 112 of the catheter tube body in the standby position. In the prepared position, the catheter assembly 100 is ready, such as to perform venipuncture or intravenous access. Sometimes, the prepared position first requires removing a protective cap (not shown) from the catheter assembly or needle assembly 100.

[0409] A flashback plug 114 can be disposed at the proximal end 118 of the needle guard 106, which allows air to escape but prevents blood from escaping from the proximal end 118 when entering the flashback chamber 116 during the primary flashback. Alternatively, a syringe can be attached to the proximal end of the needle guard. The valve and actuator described further below can also be placed in the needle guard as a second valve. The needle guard 106 also includes a shoulder 120 or other surface that physically contacts the catheter guard 102 (such as, the proximal end surface 122 of the catheter guard) to axially align the two guards 102, 106 to set the length of the needle tip 110 protruding outward from the distal opening 112 of the catheter body 104.

[0410] Inside the catheter hub 102, a needle guard or tip guard 132, a valve opener or actuator 134, a valve 136, and a hub 138 are provided in the inner cavity 130. The proximal opening of the catheter hub 102 can be sized to have a female Luer connector. The hub 138 is configured to wedge the proximal end of the catheter tube 104 against the inner wall surface of the catheter hub 102 to retain the catheter tube 104 to the catheter hub 102.

[0411] The tip protector 132 can be embodied as many prior art protectors configured to block the needle tip 110 of the needle. In the exemplary embodiment shown, the tip protector 132 can be embodied 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, the tip protector 132 can have a proximal wall and two resilient arms, and wherein a contour change 144 (such as a corrugation or ridge) on the needle 108 engages the perimeter of the opening on the proximal wall of the tip protector 132 to retract the tip protector from the catheter sheath in a proximal direction after a successful venipuncture. The two arms can be as described in U.S. Patent No. 6,616,630 and Figure 7 , or they may continue along different sides of the needle and not intersect in a side view. The needle guard arms are deployed from the needle shaft in the ready position and engage the interior of the catheter hub, such as the guard engagement section 210 ( Figure 3 In an example, only a portion of the tip guard or needle guard 132 may extend into one or more gaps of the valve opener 134, while a proximal section of the tip guard (such as a proximal wall) may extend or be located proximal to a proximal-most surface of the tip guard 132.

[0412] When the needle tip 110 is pulled into the needle guard 132 after a successful venipuncture, the arms of the needle guard collapse to their protective position to block accidental access to the needle tip. At the same time, the engagement of the arms with the interior of the catheter sleeve is released. The same operation can also be achieved by one of the needle guards with one arm described in U.S. Patent No. 6,616,630, which extends along the side of the needle shaft instead of crossing the needle as shown in some embodiments of the '630 patent. Similarly, in the ready position, the needle shaft pushes the distal wall of the one arm to one side. When the needle tip 110 moves to the proximal side of the distal wall, the distal wall then pops open in front of the needle tip to block accidental access to the needle tip and simultaneously releases the engagement between the needle guard and the interior of the catheter sleeve.

[0413] Figure 5A A front view of the valve opener or actuator 134 is shown, and Figure 5B shows the same valve opener along Figure 5A A cross-sectional side view taken along line 5B-5B of FIG. Figure 1 , the valve opener 134 may include a ring or nose segment 150 and at least one plunger element 152 (such as a leg element or elongated extension). The nose segment or ring 150 is shown in Figure 1 In the needle assembly standby position, the valve 136 is contacted, but can be slightly spaced from the proximal surface of the valve. In an exemplary embodiment, two plunger elements 152 can extend from the ring or nose section 150 in a proximal direction, and each has a length measured in the longitudinal direction of the catheter assembly and a width measured orthogonal to the length. At least one plunger element 152 is sized and shaped to be contacted by a male luer to transfer a distally directed force from the male luer to the ring 150 to then open the valve 136, as discussed further below.

[0414] As from Figure 5A Front view and Figure 5BIn the side view visualization, at least one plunger element 152 can have an arc or arc section along the width. In another example, at least one plunger element 152 can be substantially flat or planar. The thickness of each of the two plunger elements 152 is small or thin enough so that the needle guard 132 and the two plunger elements 152 have enough clearance to fit in the internal cross-sectional space of the catheter sleeve 102 without being physically combined against the catheter sleeve and becoming immovable or fixed. In the example, the thickness of each of the two plunger elements 152 and the width of the needle guard make it unnecessary to form an undercut or groove in the inner wall surface of the catheter sleeve 102 to accommodate them. When the plunger element 152 has an arc section, it will be mechanically stronger to withstand greater loads when being pushed by the male tip to push the ring or nose section 150 against the valve 136. This allows for a thin and compact design for an infusion device and leaves more room in the standardized space of a female Luer connector.

[0415] The valve opener 134 can be made of a metal material or a plastic material. When made of a metal material, the valve opener 134 can be formed by a deep drawing method, and the arcuate cross-section of the plunger element 152 can provide increased rigidity when pushed by the male Luer. Each plunger element 152 includes at least two longitudinal edges, and ribs can be provided along one or both of these longitudinal edges to further increase structural rigidity. One or more gaps 154 can be provided between any two plunger elements 152. The gap 154 ​​can provide a gap or space for a fluid flow flowing therethrough (such as during an IV infusion). The gap 154 ​​can also be used to accommodate a needle guard 132, such as Figure 1 as shown in .

[0416] The ring or nose section 150 of the valve opener 134 includes a body 158 having an outer perimeter 160. In an example, the outer perimeter 160 is generally cylindrical. In other examples, the outer perimeter may have a tapered portion. Internally, the body 158 includes a chamfer 162 and an opening 164. The distal edge, intersection or activation end 166 of the body 158 between the chamfer 162 and the outer perimeter 160 may have a sharp edge or a blunt edge. In an example, the activation end or intersection 166 is a blunt edge including a planar surface for pushing against the valve 136, as discussed further below. On the proximal side of the ring 150, the two plunger elements 152 may be recessed inwardly from the outer perimeter 160 to form a shoulder 170. In other words, the outer perimeter 160 may have an outer diameter of a first size, and the two plunger elements 152 may define an outer diameter of a second size, the second size being less than the first size. The shoulder 170 is disposed between these two different sizes.

[0417] The valve opener 134 has an inner diameter measured adjacent to the intersection or activation end 166. The inner diameter changes or varies along the chamfer 162 section of the ring or nose section 150. The 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 can be located at a corresponding inner position of the shoulder 170. In other examples, the minimum inner diameter mID can be located at other internal positions of the valve opener 134, such as somewhere inside the ring 150 or somewhere between the plunger elements 152.

[0418] Figure 5C yes Figure 1 5C-5C is a cross-sectional end view of the needle assembly 100 and the needle assembly is shown without the needle 108. Figure 5C The proximal-facing wall surface of the proximal wall 280 of the needle guard 132 and the two plunger elements 152 are shown. As shown, the needle guard 132 is located between one or more gaps defined by the two plunger elements 152, and the proximal wall 280 extends to the proximal side of the most proximal edge of the valve opener 134. As previously mentioned, the plunger elements 152 can each include an arcuate cross-section. As shown, the arcuate cross-section of each plunger element 152 is generally C-shaped, having a concave portion facing inwardly toward the needle guard 132 and a convex portion facing outwardly away from the needle guard 132. The arcuate surfaces of the two plunger elements 152 should have a radius of curvature that is different from the radius of the female Luer piece of the catheter sleeve 102, such as a radius of curvature that is smaller than the female Luer piece of the catheter sleeve. The radius of curvature of the two C-shaped plunger elements should also be different from the radius of the male Luer tip. A gap can be provided on each side edge 52 of the proximal wall 280 and an adjacent plunger element 152.

[0419] The present configuration of the valve opener 134 allows the two plunger elements 152 to define adjacent proximal surfaces 54, which are sized and shaped to be pushed against by the tip when the male Luer tip or syringe tip is inserted into the proximal opening of the catheter sleeve 102 after a successful venipuncture to push the valve opener 134 distally to open the valve 136. The arcuate cross-section of each of the two plunger elements 152 provides a sufficiently thick profile to ensure that the adjacent surface overlaps with the male Luer tip and ensures rigidity to prevent buckling. Therefore, the C-shaped plunger element can avoid deflection when pushed by the syringe tip or other male Luer tip, avoid the syringe tip or Luer tip slipping and missing the end surface 54 of the plunger element 152 when the syringe tip or Luer tip is inserted into the open proximal end of the catheter sleeve, and / or avoid the following situation: the syringe tip or Luer tip is pushed between the two plunger elements during the activation of the valve opener 134 so that the two plunger elements are wedged between the tip and the inner surface of the catheter sleeve 102.

[0420] Figure 5DThe catheter sleeve 102 is shown with Figure 5C The same cross-sectional end view of FIG. 1 but with an alternative arcuate cross-section on the plunger element 152 of the valve opener 134. As shown, the two plunger elements 152 each include a C-shaped cross-section. However, in this embodiment, the concave portion of the arcuate cross-section of each plunger element 152 faces outwardly away from the needle guard 132, while the convex portion of each plunger element faces inwardly toward the needle guard 132. Figure 5C As in the embodiment of the present invention, when a syringe tip or Luer 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.

[0421] When installed inside the lumen 130 of the catheter hub 102, the ring or nose section 150 of the valve opener 134 elastically deforms and then expands when it reaches the recessed hub section 174 of the catheter hub 102, which can accommodate the ring or nose section without deforming the ring. Alternatively, the catheter hub 102 is designed to expand to allow assembly of the valve opener 134. The shoulder 176 ( Figure 4 ) is disposed at a recessed hub section 174, with shoulder 174 forming a physical stop for engaging shoulder 170 on the valve opener 134. This allows the valve opener 134 to be retained within the lumen 130 of the catheter hub 102 during needle withdrawal and during use, when the valve opener 134 is pushed distally to activate the valve and then moves proximally when the male luer is removed, thereby allowing the valve to close.

[0422] Reference again Figure 1, valve 136 is located inside the catheter sleeve 102, just distal to the nose section or ring 150 of the valve opener 134. In an example, the valve 136 is specifically implemented as a valve disc, which includes a valve body, the valve body including a valve diameter, a valve thickness measured orthogonally to the valve diameter, and one or more slits defining two or more flaps. As used herein, unless the context otherwise indicates, the valve disc and the valve disc are similar or identical. In a specific example, three slits are provided through the valve thickness to define three flaps. The three slits can originate from a point and extend radially from the approximate center point or center portion of the body of the valve 136 in a manner similar to a three-point star to form three flaps that can be deflected along these slits. The valve 136 can include an outer perimeter between the valve opener 134 and the bushing 138, and the outer perimeter can float inside the inner cavity of the catheter sleeve. For example, the outer perimeter of valve 136 can move proximally and distally in the inner chamber 130 of catheter sleeve 102, and is not constrained by catheter sleeve along the axial direction of catheter assembly. The outer perimeter of valve 136 can be identical with the outer perimeter of valve opener 134 or the ring 150 of valve opener, or be less than or greater than the outer perimeter of valve opener 134 or the ring 150 of valve opener. However, at least a part or all of the distal edge, intersection or activation end 166 of nose section or ring 150 are recessed from the outer perimeter of valve 136, so that the distal edge 166 can abut or touch the wall surface facing the proximal side of valve 136, as further discussed below. And, because valve 136 can float, valve can be positioned in the inside of single set body type catheter sleeve 102. In other words, it is not necessary to keep valve 136 in the inside of catheter sleeve by two or more catheter sleeve bodies, such as, along the seam of two or more set bodies. However, the various components described herein may readily be used with a multi-piece catheter hub without departing from the scope of the present disclosure.

[0423] Fig. 6A An end view of the bushing 138 is shown, and Figure 6B shows the same bushing along Fig. 6A A cross-sectional side view taken along line 6B-6B of FIG. Figure 1, the bushing 138 includes: a body 190, the body 190 includes a first body section 192, a second body section 194 extending from the first body section 192, the second body section 194 having a conical shape; and two or more leg extensions 196 extending from the second body section 194. The first body section 192 can have an elongated body that can have a cylindrical shape with an optional conical distal tip or nose section. In some examples, a generally cylindrical ring extends from the second body section 194, and two or more leg extensions 196 extend from the cylindrical ring. One or more gaps 200 are provided between two adjacent leg extensions 196. In an example, the number of leg extensions 196 included in the bushing 138 is the same as the number of flaps included in the valve 136. Therefore, if the valve has three flaps, there can be three leg extensions 196 on the bushing 138. If the valve 136 has a single slit, there can be two leg extensions 196. The leg extensions 196 on the bushing 138 can define an outer diameter that is less than the minimum inner diameter mID of the valve opener 134. The proximal tip 204 of each leg extension 196 can have a chamfer 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 inwardly from the outside of the leg extension 196. This chamfer direction is configured to match the folding direction of the flap on the valve 136. The bushing 138 can be made of a metal material, and the leg extensions 196 can be integrally formed with the body 190. Alternatively, the leg extensions 196 can be welded to the body 190.

[0424] When positioned in the catheter sleeve 102, the sleeve 138 and the valve 136 are oriented so that the leg extension 196 on the sleeve is aligned with the flap on the valve. In other words, the two components are aligned so 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 flap on the valve is pushed into physical contact with the leg extension 196 on the sleeve 138. Therefore, if there are three flaps on the valve, these three flaps will be pushed into physical contact with the three leg extensions on the sleeve. The distally facing wall surface of the valve 136 can touch the leg extension 196 and / or the resilient element 276, or can be spaced apart from the leg extension 196 and / or the resilient element 276 on the sleeve 138 in the valve closed position and push against the leg extension during use. In other examples, the valve can touch the proximal tip of the leg extension and / or the resilient element 276 in the valve closed position, or can be spaced apart from it. If spaced apart from the leg extension 196 and / or the resilient element 276, the valve 136 may be axially displaced into contact therewith.

[0425] Figure 6C An end view of an alternative bushing 138 is shown, and Fig.6D shows the same bushing along Figure 6C A cross-sectional side view taken along line 6D-6D of FIG. and Fig. 6A Like the sleeve of the catheter sleeve 102, the present embodiment includes a body 190, which includes a first body section 192 and a second body section 194. In the present embodiment, as previously mentioned, three leg extensions 196 are provided for use with a valve including three slits defining three lugs. The three leg extensions 196 can be equally spaced along the circumference of the second body section 194. In another example, the three leg extensions 196 can be set and spaced according to the position of the lugs on the valve 136, so that when the valve is assembled inside the catheter sleeve 102, the valve can be pushed distally by the valve opener or valve actuator 134, and the leg extensions 196 on the sleeve 138 are aligned to push the lugs of the valve in the proximal direction to open the valve, as further discussed below. Now refer to Figure 2 , the catheter assembly 100 is shown in a transition position whereby the needle 108 is in the process of being separated from the catheter sheath 102 and the catheter tube 104, such as after a successful venipuncture. The needle tip 110 is shown just distal to the valve 136. During the retraction of the needle 108 in the proximal direction, the guard engagement section 210 ( Figure 3 and Figure 4 ) to axially maintain the tip protector 132. In an example, the guard engagement section 210 is a surface discontinuity formed on the inner surface of the catheter sleeve 102. For example, the guard engagement section 210 may include a section with a first inner diameter and a section with a second inner diameter, and the second inner diameter is greater than the first inner diameter. The guard engagement section 210 can be embodied as an internal protrusion or groove, or a combination of the groove and the protrusion formed on the inner surface of the catheter sleeve 102. When the combination of the groove and the protrusion is used for the guard engagement section 210 to engage the needle guard or the tip protector 132, then preferably, the groove is located at the distal end of the protrusion. In an example, two spaced guard engagement sections 210 are provided for engaging the two resilient arms on the tip protector 132. The two guard engagement sections 210 can be positioned to be diametrically opposed to each other, just at the distal end of the section of the female Luer connector of the catheter sleeve 102.

[0426] Figure 5E FIG. 1 shows a valve opener 134 provided in accordance with an alternative embodiment of the present disclosure. The valve opener 134 is similar to Figure 5A and Figure 5BThe present invention relates to a valve opener 134, and includes: a nose segment 150 having an activation end 166; and two plunger elements 152 extending in the proximal direction of the nose segment 150. However, instead of including two plunger elements 152 with two free ends, this embodiment includes a band or ring connecting the two plunger elements 152 together. Two arc-shaped, curved segments, or stabilizer elements 253 can be attached to the two plunger elements 152 to form a band or ring 255. The band 255 can be referred to as a stabilizing ring 255, and can connect the two plunger elements 152 together to form a stable structure. The stabilizing ring 255 forms a continuous perimeter segment of the valve actuator, which is spaced apart from another continuous perimeter segment defined by the nose segment 150 of the valve actuator.

[0427] The present 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, and wherein the single plunger element 152 includes two or more releases or through passages 61 formed through the wall of the plunger end. The needle guard 132 can engage the edge or perimeter 65 of the release 61 in the standby position and during needle retraction after a successful venipuncture. Alternatively, the tip guard or needle guard 132 can protrude through the release 61 from the holding space defined by the valve opener 134 to engage the inner surface of the catheter sleeve 102. Still alternatively, the tip guard 132 can protrude through the release 61 but not contact the interior or perimeter 65 of the catheter sleeve. Still alternatively, the tip guard 132 can protrude through the release 61, contact the interior of the catheter sleeve, and contact one or two perimeters of the release. The portion of the tip guard that can protrude through one or two releases can be one or two elbows of the tip guard.

[0428] The needle guard 132 ( Figure 7 ) can be at least partially positioned in the holding space 155 of the valve opener 134. When positioned in the holding space 155, the needle guard or tip guard can protrude through one or both releases 61 of the valve opener. The one or more portions of the needle guard protruding through can contact the interior of the catheter hub, be spaced from the interior of the catheter hub, can contact one or both perimeters 65 of the release, or be spaced from one or both perimeters of the release, or a combination of the above. The protruding portion of the needle guard can be one or both elbows of the needle guard.

[0429] Thus, in an embodiment having two releases or through passages 61, the perimeter of the two releases or through passages can function as guard engagement sections 210 by allowing the elbow of the tip guard to engage the perimeter. Alternatively, the two elbows of the needle guard can protrude through the two releases from the holding space defined by the valve opener to engage the guard engagement sections or segments formed on the inner surface of the catheter sheath. Thus, the perimeter of the release or the inner surface of the catheter sheath can form an anchor point for the arms of the tip guard to engage in the standby position and during needle retraction after a successful venipuncture.

[0430] In the example, Figure 5E The single plunger element 152 of the valve opener 134 can be embodied as a generally cylindrical body section 151 having an inner surface 153 defining an opening having a path or groove 154, which can also be a gap for fluid flow, and a proximal perimeter or end edge 63. Similar to Figure 4 , the guard engagement section 210 may be formed on the inner surface 153 of the present valve opener 134. In other words, a protrusion, ridge, recess, or guard engagement section 210 may 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.

[0431] When the general Figure 5E The present alternative valve opener 134 is used with a needle device or catheter assembly 100 (such as, Figure 1 When used with a component of a valve opener, the guard engagement section 210 can be on the catheter sleeve, on the inner wall of the valve opener, or at the perimeter of a release formed through the wall of the valve opener. There can be one or more releases or guard engagement sections integrated with the valve opener. There can also be one or more guard engagement sections formed with the catheter sleeve for use with one or more releases of the valve opener. This allows the two resilient arms of the tip guard 132 to engage the valve opener 134 or engage the catheter sleeve by protruding through the release.

[0432] In yet another example, two openings 61 (only one shown) shown in phantom through the wall of the cylindrical body portion 151 of the valve opener may be provided for use with a guard engagement segment 210 formed with or on the interior of the catheter hub 102. In a standby position using the valve opener of this alternative embodiment, one or more resilient arms of the tip guard 132 may protrude through the opening 61 or through both openings 61 to engage the guard engagement segment(s) 210 of the interior of the catheter hub 102 in addition to or in lieu of the opening 61 that engages the valve opener 134.

[0433] Figure 3 The needle 108 is shown completely removed from the catheter hub 102 and the tip protector 132 is covering the needle tip 110 in a protected position ( Figure 1 ). Figure 2 Transition to Figure 3 When the needle tip 110 is in the position, the two distal walls 300, 302 ( Figure 7 )(Resilience arms 288, 290( Figure 7 ) at each end of the catheter hub 102). Alternatively, the needle guard 132 may have one distal wall and / or one arm. When the two distal walls, and therefore the two resilient arms, are no longer biased outward by the needle 108, the two arms 288, 290 move radially to engage the two guard engagement sections 210 or valve openers 134 ( Figure 5E ) (if the valve opener 134 is used instead) two guard engagement sections 210 are disengaged. Alternatively, one arm and one distal wall are disengaged from one guard engagement section 210.

[0434] As the needle continues to move in the proximal direction and the profile change portion 144 ( Figure 1 ) engages the perimeter 282 on the proximal wall of the tip protector 132 ( Figure 7 ), the tip protector 132 moves proximally with the needle. Figure 3 . Alternatively, the needle guard can be clamped onto the needle shaft and removed from the catheter sleeve as a unit. Note that in the protection position in which the tip guard 132 covers the needle tip, the valve 136 remains inside the lumen of the catheter sleeve 102. Therefore, the valve 136 is located inside the catheter sleeve 102 in both the ready position of the needle and the protection position of the needle. From another perspective, the valve 136 is located inside the catheter sleeve 102 in both the standby position of the catheter assembly 100 and the protection position of the catheter assembly, wherein in the standby position, the needle tip is removed from the distal opening 112 ( Figure 1 ) protrudes outward, in the protected position, the needle is removed from the catheter hub and the needle tip is covered by the tip protector.

[0435] Reference now Figure 4 , the catheter sleeve 102 is shown with a male medical implement 220 positioned in its proximal opening. The male medical implement or device 220 can be a male Luer, a syringe tip, an IV set connector, or other male tip with a Luer connector. For example, the male medical implement can be connected to an IV tube that is connected to an IV fluid source for fluid delivery through the male medical implement 220, the catheter sleeve 102, and the catheter tubing 104 to deliver fluid therapy to a patient.

[0436] refer to Figure 5A, Figure 5B , Fig. 6A , Figure 6B And continue to refer to Figure 4 When the male medical device 220 (herein the male tip) is initially inserted into the proximal opening of the catheter sleeve 102, the male tip initially contacts the two plunger elements 152 on the valve opener 134 to advance the distally directed force on the two plunger elements 152 to open the valve 136. The arc section of the plunger element 152 can have a diameter less than the inner diameter of the catheter sleeve 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 sleeve at the tangent point. In this way, the plunger element 152 is stable and can resist outward deflection. This arrangement can avoid wedging the relatively thin plunger element between the male medical device 220 and the inner wall of the catheter sleeve 102. The distally directed force moves the valve opener 134 in the distal direction until the geometry of the male tip 220 and the proximal opening of the catheter sleeve stops the further distal advancement of the male tip. In the example, the female Luer connector of the catheter hub 102 is aligned with the male Luer connector of the male tip 220 and blocks the male tip from further distally advancing into the opening of the catheter hub. A seal is provided by the Luer engagement to prevent fluid from leaking out of the proximal opening of the catheter hub.

[0437] When the valve opener 134 is moved distally by the male tip 220 being advanced distally, the ring 150 is pushed distally and pushes against the proximally facing surface of the valve 136. In particular, the distal edge 166 of the valve opener 134 initially pushes against the proximally facing surface of the valve 136. When the valve 136 is axially movable inside the catheter sheath 102, the valve 136 is pushed distally by the valve opener 134 and the valve opener 134 is pushed distally by the male tip 220. For example, the ring 150 contacts the valve 136 and pushes the valve 136 in the distal direction. However, due to the presence of the leg extension 196 on the sleeve 138, the outer edge or outer valve section of the valve 136 moves distally, while other portions of the valve 136 that abut or contact the leg extension 196 are stopped from moving distally by the leg extension 196. In practice, the outer edge of the valve 136 (such as, the outer section of the body of the valve 136) moves distally, and the flap on the valve is deflected radially outward and in the proximal direction from the center point or center position by the leg extension 196 on the sleeve 138, thereby opening a flow path 226 through the valve. The fluid from the male tip 220 can then flow through the catheter sleeve 102, through the valve 136, and through the lumen of the catheter tube body 104. Alternatively, suction can be applied by a male medical device (such as, a syringe or a vacuum blood collection tube) and blood can be aspirated from the patient. This is often done to test a sample before starting an infusion therapy. Moreover, any residual blood is typically first flushed from the interior of the catheter sleeve 102 before starting an infusion therapy.

[0438] Further references Figure 4 , Figure 5B and Figure 6B , the chamfer 162 on the ring 150 and the chamfer 206 on the leg extension 196 facilitate the deflection of the flaps on the valve radially outward and in the proximal direction. Moreover, 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 the bushing to deflect the valve 136 therebetween to open the valve. Alternatively, when pushed distally, the outer perimeter of the valve can remain in contact with the inner wall of the catheter sheath, with only the flaps around the one or more slits opening.

[0439] Therefore, one aspect of the present disclosure is understood to include a catheter assembly, the catheter assembly includes a valve, the valve includes one or more slits and two or more flaps, wherein the valve includes a portion or section that moves in a distal direction and a portion or section that opens in a radial direction and in a proximal direction to open a flow path through the valve. In an example, the outer edge of the valve is configured to move distally, while the flap of the valve is configured to move radially outward to open a flow path through the valve. Moreover, by including a valve that can be moved 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 catheter assembly is minimized compared to a valve with a flap that is opened only in a distal direction by a valve opener. Therefore, compared to a catheter sleeve that utilizes a valve and a valve opener that opens a valve only in a distal direction by deflecting the valve flap, the size of the catheter sleeve 102, such as, the length of the catheter sleeve, can be reduced.

[0440] Other aspects of the present disclosure are understood to include a catheter assembly, which includes a valve, and wherein the valve perimeter can float in the axial direction relative to the catheter sleeve. In other words, by including a valve with a valve perimeter that can float in the axial direction, it is not necessary to fix the valve perimeter between and inside the catheter sleeve with a two-part catheter sleeve. Therefore, a catheter sleeve with a sleeve body formed in a monomeric manner can be used together with this catheter assembly. Therefore, compared with a catheter sleeve utilizing a two-part sleeve body, the size of the catheter sleeve 102 can be reduced, such as, the outer diameter or outer dimension of the catheter sleeve. The two-part sleeve body (wherein they are combined along the seam) can therefore be reduced to provide a catheter assembly with a relatively small outer profile.

[0441] Yet another aspect of the present disclosure is understood to include a valve opener 134 for opening a valve 136. The valve opener 134 is configured to push the valve against another structure, such as a leg extension 196 on a bushing 138. The present valve opener 134 may be considered to have a multi-piece valve opening structure. For example, the portion having the ring 150 and the plunger element 152 may be considered to be a proximal valve opener 250, and the bushing 138 having the leg extension 196 may be considered to be a distal valve opener 252. The two valve openers 250, 252 cooperate to open the valve 136. As described, the size and shape of the proximal valve opener 250 is designed to push against the outer edge of the valve 136 in a distal direction to move the valve against the distal valve opener 252. The size and shape of the distal valve opener 252 is designed to push a flap on the valve in a radially outward direction and push a portion of the flap in a proximal direction to open a fluid path or flow path 226 through the valve 136. In the example, the leg extension 196 on the distal valve opener 252 is axially fixed and pushes the flaps of the valve in the distal direction against the leg extension, which are radially deflected outward by the leg extension on the distal side of the valve 136. In other words, when the valve is actuated to open a flow path through the valve, the valve is physically pushed by the actuator on the proximal side of the valve and the actuator on the distal side of the valve. In a specific embodiment, the valve can be actuated to open a flow path through the valve by being physically pushed by the ring on the proximal side of the valve and the leg extension on the distal side of the valve.

[0442] exist Figure 4 In the valve open position, the proximal tip 204 of leg extension 196 and the distal edge 166 of ring 150 are spaced apart from the plane drawn by the longitudinal axis of the catheter assembly. In other words, the proximal tip 204 of leg extension 196 and the distal edge 166 of ring 150 do not overlap from the perspective of this plane, and a gap is provided between the two to accommodate valve 136 therebetween. In another example, the proximal tip 204 of leg extension 196 and the distal edge 166 of ring 150 do overlap in the axial direction, which has a relatively large amount of effect of radially deflecting the flap outwards when there is no overlap. In addition, because the flap is pushed against the axially fixed leg extension 196 on the liner, the flap is deflected backwards by these leg extensions 196 towards the proximal direction. In other examples in addition, the proximal tip 204 of leg extension 196 and the distal edge 166 of ring 150 only contact along the plane drawn by the longitudinal axis of the catheter assembly.

[0443] In some other aspects of the present disclosure, a catheter assembly is provided, which includes a valve, a proximal valve opener, a distal valve opener, a needle sleeve with a needle, and a catheter sleeve with a catheter body. The valve assembly can also include a tip protector for blocking the tip of the needle in the needle protection position. After successful venous puncture, a male tip (such as a male Luer piece) can be inserted into the proximal opening of the catheter sleeve to advance the proximal valve opener in the distal direction, which moves the valve against the distal valve opener in the distal direction. However, the flap pivots in the proximal direction to open the fluid path through the valve, rather than deflecting the flap radially outward and in the distal direction to open the fluid path through the valve. For example, the tip of each of the flaps of the valve (they typically originate from a point or origin near the center position of the valve) is deflected in the proximal direction by the leg extension 196 of the sleeve of the present device. In the example, the flap is deflected in the proximal direction by pushing the flap against the fixed leg extension 196 on the distal valve opener 252. In other words, the flap on the valve can be deflected in the proximal direction by a structure located distally of the valve and adjacent to the distally facing surface of the valve 136. The distal valve opener 252 can be a metal bushing having a body with a conical section having two or more leg extensions extending therefrom in the proximal direction. The bushing can also be made of a thermoplastic material.

[0444] To replace the male tip 220 or simply Figure 4 The valve 136 is closed in its open position and the male tip 220 is removed in the distal direction away from the catheter sleeve 102. The biasing or resilient nature of the valve 136 (which may be made of an elastomer) allows the valve to rebound to its more relaxed state. Therefore, the flap on the valve will rebound by moving distally, while the outer edge or outer section of the valve body rebounds proximally, which pushes the proximal valve opener 250 in the proximal direction and pushes the shoulder 170 on the proximal valve opener 250 toward or against the shoulder 176 inside the inner cavity of the catheter sleeve. Therefore, after the male tip is removed from the catheter sleeve, the valve 136 and the proximal valve opener 250 are essentially returned to the open position. Figure 3 The location shown in .

[0445] Alternatively or optionally, a resilient element 276 of a material (not shown) softer than the valve 136 may be placed between the distal surface of the valve and the inner distal step or shoulder 274 of the catheter hub 102 (which is located at the distal end of the valve). Figures 1 to 4 The resilient member 276 may be a coil spring, a leaf spring, or an elastomeric cylinder. The resilient material 276, if included, may provide additional biasing force to return the valve 136 to the closed position when the medical device 220 is removed. The resilient member or resilient member 276 may be located in a Figure 1 The valve 136 in the standby position shown in is spaced apart from, or can contact, the valve in the standby position.

[0446] The valve 136 may be reopened by placing the male tip 220 into the proximal opening of the catheter hub 102 and pushing the proximal valve opener 250 in the distal direction, as described above with reference to Figure 4 As described.

[0447] Figure 7 yes Figure 1 1 is a rear isometric view of a needle guard 132 of FIG. Needle guard 132 is exemplary only, as needle guards having other or different features may be used instead. Figure 7 2. The needle guard 132 as it is shown in FIG. 2. In this embodiment, the needle guard 132 includes a proximal wall 280, which includes a perimeter 282 defining an opening 284. The proximal wall 280 has a proximal-facing wall surface 286 and a distal-facing wall surface opposite to the proximal-facing wall surface. At least one resilient arm 288 extends distally of the proximal wall 280. As shown, two resilient arms 288, 290 extend distally of the proximal wall. One arm can be longer than the other arm. Each arm can also include different arm widths, including a first arm segment 292 having a first width and a second arm segment 294 having a second width, the second width being less than the first width. The two arms can originate from different ends of the proximal wall 280 and can cross each other at their respective second arm segments 294. Therefore, when viewed from the side along the longitudinal direction of the needle guard 132, the two arms intersect each other. When used with a needle, the two arms 288, 290 intersect each other when in the standby position and when in the protective position. In an alternative embodiment, the two arms 288, 290 originate from different ends of the proximal wall and extend in the distal direction without intersecting each other. Therefore, the two arms 288, 290 may also have substantially the same arm width along the length of each respective arm.

[0448] Distal walls 300, 302 are disposed at one end of each arm 288, 290. The distal walls 300, 302 can overlap each other in the axial direction of the needle guard by utilizing different arm lengths and / or angling one of the walls at an elbow or diagonal section 304 between the distal wall and the resilient arm. In an example, if two arms are utilized, the elbow or diagonal section 304 of each arm can engage a corresponding guard engagement section 210 of one or more restraining or limiting surfaces or choke points within the catheter sheath 102, within the valve actuator 134, or against one or both release portions of the valve actuator 134 in the ready position and during the transition process of removing the needle 108 from the catheter sheath 102 to removably secure the needle guard within the catheter sheath. When the radial profile of the needle guard 132 measured at one or both elbows 304 is reduced in size, such as after the needle tip is moved proximal to both distal walls 300, 302, the needle guard 132 can be moved proximal to the choke or stop point to be removed from the needle guard 102 along with the needle. As the two distal walls move radially, the needle guard has its radial profile reduced. The needle guard 132 can be folded from a stamped sheet of metal to form the guard as shown. Ribs can be formed on the arms, proximal walls, and / or distal walls to increase structural rigidity.

[0449] Reference now Fig. 8A , shows a front view of an exemplary valve 136 provided in accordance with aspects of the present disclosure that can be used with a catheter assembly and a sleeve having a female Luer described elsewhere herein. The valve 136 is shown having a valve body 320 having a width measured from one edge to the other of an outer perimeter 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. The valve body 320 has a thickness that extends to Fig. 8A 326a and 326b. The valve 136 is shown as having a single slit 324 formed through the thickness of the valve body 320, the single slit 324 defining a first flap 326a and a second flap 326b. These flaps may be collectively referred to generally using the element number 326. The first flap 326a and the second flap 326b may be deflected to open the flow path 226 through the valve body 320. The first flap and the second flap may be deflected by pushing the valve 136 into the leg extension on the distal side of the valve using a valve opener on the proximal side of the valve, as previously discussed.

[0450] Figure 8B 1 is a front view of an exemplary valve 136 provided in accordance with further aspects of the present disclosure that can be used with a catheter assembly and a set having a female Luer as described elsewhere herein. With a few exceptions, the present valve 136 is similar to Fig. 8AThe valve of the present invention is provided with three slits 324 through the thickness of the valve body to form three flaps 326a, 326b, 326c. The three slits 324 can intersect at a single center point 328. The first flap 326a and the second flap 326b can be deflected to open the flow path 226 through the valve body 320. The first flap 326a, the second flap 326b and the third flap 326c can be deflected by pushing the valve 136 into the 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, 326c near the center point 328 expand radially and in the proximal direction toward the outer perimeter 322 when deflected by the leg extension on the distal side of the valve 136. Since there are three flaps 326a, 326b, 326c, the present valve is configured for use with a bushing having at least three leg extensions, such as Figure 6C and Fig.6D as shown in .

[0451] Figure 8C 1 is a front view of an exemplary valve 136 provided in accordance with yet further aspects of the present disclosure that can be used with a catheter assembly and a set having a female Luer as described elsewhere herein. With a few exceptions, the present valve 136 is similar to Fig. 8A In this embodiment, a single slit 324 for forming the first flap 326a and the second flap 328b is provided with reliefs 340, 340 at both ends of the slit 324. In the example, the reliefs 340, 340 are embodied as two short through cuts 340a, 340b at each end of the slit 324, forming a V-shaped relief 340. The two reliefs 340 and 340 provide clearance for the two flaps 326a, 326b to enable the flaps to deflect more easily when pushed against the leg extension, and have less restriction at points near both ends of the slit 324 than when no relief is included. Less preferably, a single short through cut may be included at each end of the slit 324.

[0452] Fig. 9 FIG. 4 is an exploded perspective top view of a catheter assembly 400 provided according to another aspect of the present disclosure. Fig. 9 As shown in FIG. 4 , a 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 tube 104; and a hub 138. The hub 138 may be configured to wedge the proximal end of the catheter tube 104 against the inner wall surface of the catheter hub 102 to retain the catheter tube 104 to the catheter hub 102.

[0453] Inside the catheter hub 102, a septum or valve 136, an actuator or valve opener 134, and a safety clip 132 (such as a needle guard or tip guard) are provided. The needle 108 (which has a profile change 144) can be inserted through the proximal opening of the catheter hub 102, and the needle tip extends from the distal opening 112 of the catheter tube in a standby position, such as Fig.9A . The cannula or needle hub 106 can be attached to the proximal end of the needle 108 in a standby position and can contact the proximal end of the catheter hub 102 when assembled thereto. The proximal opening of the catheter hub 102 can be sized to have a female Luer connector, optionally with external threads, to engage with a male Luer tip in a Luer slip or Luer lock manner.

[0454] The tip protector 132 is configured to be removed with the needle 108 after use, and the valve 136 and valve actuator 134 remain with the catheter hub 102 for controlling fluid flow therethrough. The actuator 134 is configured to be pushed distally by the male tip into the valve 136 to open the valve for fluid flow, as discussed further below.

[0455] A flashback plug or blood plug subassembly 114 can be connected to the needle guard 106 to prevent blood from flowing out of the flashback chamber 116 of the needle guard 106. The flashback plug 114 can be disposed at the proximal end of the needle guard 106 to allow air to escape but prevent blood from escaping from the proximal end of the body of the flashback plug 114, the flashback plug 114 having a chamber 114a and a hydrophobic filter 114b assembled in the chamber. Alternatively, a syringe can be attached to the proximal end of the needle guard 106. A second valve 136 and an actuator 134, described further below, can also be placed within the needle guard 106.

[0456] A protective cap 124 having a sleeve 124a and a saddle 124b may be provided to cover the needle 108 during packaging and prior to use, as is conventional. The saddle 124b may surround at least a portion of the catheter hub 102 and the needle hub 106 and be removably coupled to the needle hub.

[0457] Fig.9A yes Fig. 9 FIG. 4 is an isometric cross-sectional view of a needle assembly 400 in an assembled state. The catheter hub 102 is shown with an optional pair of wings 126 extending radially from the hub body. When included, the wings 126 can increase stability by providing an increased surface area for resting and securing the catheter hub 102 against the patient's skin, such as after intravenous access.

[0458] Fig. 9B yes Fig. 94 is an isometric view of the assembled needle assembly 400 showing the removable cap 124 disposed on the needle and engaging the needle guard 106.

[0459] With few exceptions, the catheter assembly 400 of the present disclosure is similar to Figure 1 The catheter assembly 100. Reference Fig. 10A , showing Fig. 9 Schematic cross-sectional side view of a catheter assembly 400. The catheter assembly 400 includes a catheter hub 102 having a catheter tube 104 (partially shown) extending out of its distal end; and a needle 108 attached to a needle hub 106 (partially shown) and extending through the catheter hub 102 and the catheter tube 104 in a standby position.

[0460] When the needle guard 106 contacts the catheter guard 102 and the needle tip extends out of the catheter tube 104 ( Fig. 9 In the prepared position of the distal end or distal opening 112, the catheter assembly 400 is ready, such as to perform venipuncture or intravenous access. Fig. 10A Prior to using the device depicted in , a protective cap (not shown) is removed from the catheter assembly or needle assembly 400.

[0461] The valve 136 is located inside the catheter hub 102, and the valve 136 has: a valve body 320 having an outer perimeter; a valve disc or disk 410; and a valve skirt 412 extending from the valve disc in an axial direction. In an example, the valve disc 410 includes one or more slits, and the one or more slits define one or more flaps to be opened / closed by the valve actuator 134. The type of slits and flaps included in the valve disc 410 and the number of each can vary depending on the valve body. FIG. 8A to FIG. 8C The valve skirt 412 is similar to those shown in the different valve embodiments 136. In an embodiment, the valve skirt 412 is positioned in a recessed section 420 formed in the lumen 130 of the catheter hub 102, which prevents the valve 136 from axial movement once it is located inside the catheter hub 102.

[0462] In the example, the recessed section 420 has a distal shoulder 420a and a proximal shoulder 420b ( Fig. 10B ), the distal shoulder 420a and the proximal shoulder 420b define a groove therebetween. The valve skirt 412 has a certain length and is sized and shaped to fit into the groove. In the example, the valve skirt 412 contacts the proximal shoulder 420b, while the valve disc 410 contacts the distal shoulder 420a. When viewed from different angles, Fig. 10A The valve 136 may contact the distal shoulder 420a and the proximal shoulder 420b of the recessed section 420 and thereby constrain the valve skirt 412 to be axially fixed or non-axially movable in the standby position.

[0463] In examples, the outer diameter or outer surface of the skirt section 412 forms a snug fit or size-on-size fit with the recessed section 420 of the interior 130 of the catheter hub 102. In other examples, a slight interference fit is provided between the two. In still other examples, a small gap is provided between the outer surface of the skirt section 412 and the inner surface at the recessed section 420, wherein the valve skirt 412 contacts the proximal shoulder 420b and the valve disc or dish 410 contacts the distal shoulder 420a of the recessed section.

[0464] The chamber 130a of the distal cavity is disposed distally of the valve disc 410 and proximally of the bushing 438. In some examples, a coil spring or a resilient biasing element (such as an elastomeric ring or a cylinder) may be disposed in the chamber 130a of the distal cavity, 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 Figures 1 to 4 The resilient element 276 is provided.

[0465] In an example, the valve disc 410 includes: a valve diameter; a valve thickness measured orthogonally to the valve diameter; and one or more slits defining two or more flaps, as previously discussed. In the illustrated embodiment, the valve skirt 412 extends axially relative to the longitudinal axis of the valve and has an elongated wall generally perpendicular to the outer perimeter of the valve disc 410, forming a generally cylindrical valve body. In some embodiments, the valve skirt 412 may be inclined so that the valve forms a frustoconical structure.

[0466] The valve skirt 412 defines a valve cavity 424 having an open proximal end 426 through which an actuator nose or nose section 430 of the valve actuator 134 can be advanced and actuate a flap of the valve disc 410. In one embodiment, at least some portion of the actuator nose 430, including the distal actuation end 436 of the valve actuator 134, is located within the valve cavity 424 of the valve 136 prior to actuation. Thus, the actuator nose 430 can be narrower than the inner diameter of the valve skirt 412 so that the actuation end 436 fits within the valve cavity 424 and abuts or contacts the valve disc in the standby position. In examples, these relative dimensions are such that the actuator nose section 430 does not contact the inner wall surface of the skirt section 412, with some contact being contemplated.

[0467] In an example, the actuation end 436 contacts the proximal-facing surface of the valve disc 410 in the standby position, and another portion of the valve actuator 134 (such as one or both protrusions 442 ( Fig. 10B)) abuts a shoulder 452 inside the catheter sleeve in the standby position to apply a load on the valve disc, but the load is insufficient to open one or more slits, as discussed further below. In other examples, the actuation end 436 is spaced apart from the proximal-facing surface of the valve disc 410 in the standby position, and the one or more protrusions 442 on the actuator either contact the shoulder 452 or are also spaced apart from the shoulder 452. When the one or more protrusions on the actuator 134 are spaced apart from the shoulder 452 and the actuation end 436 is spaced apart from the valve disc 410, the actuator can float in the axial direction within the catheter sleeve by a small amount.

[0468] In an example, the valve actuator 134 includes a nose section 430 that is elongated in structure and can be generally cylindrical or have a draft angle or taper that terminates at an actuation end 436. The actuation end 436 can have a blunt distal end surface or have a sharp edge. The nose section 430 can have a wall surface that has a continuous circumference or continuous perimeter section without gaps or slits, such as a barrel with a continuous wall. The nose section 430 can define an aperture. In some examples, a plurality of spaced apart slits and / or openings can be provided on the nose section 430 to allow flow or fluid flushing.

[0469] Two actuating elements or plunger elements 152 can extend proximally of the nose section 430. For example, the two plunger elements 152 can be integrally formed with the nose section 430 and can extend from the nose section in a proximal direction. A gap or space can be provided between the two plunger elements 152 for positioning the needle guard or tip guard 132 therebetween. In other words, the two plunger elements 152 each include at least two longitudinal edges, and these edges are spaced apart from each other. The longitudinal edges of the plunger elements 152 can be aligned with the longitudinal axis of the valve opener.

[0470] In the example, the protrusion 442 extends outwardly from the outer surface of one or both plunger elements 152. As shown, the protrusion 442 extends from the outer surface of each plunger element 152. Each protrusion 442 resembles a ramp surface with a generally flat edge for abutting the shoulder 452. The ramp surface of the protrusion 442 and the direction of the ramp allow the actuator 134 to be inserted into the interior of the catheter hub and seated within the second recessed section 450, as discussed further below.

[0471] In an example, the transition section 440 extends from the nose section 430 and widens axially in the proximal direction. Two actuation elements 152 may extend from the transition section 440. The two actuation elements may extend from the nose section. Some embodiments may use other shapes for the nose section 430, such as a cubic, rectangular, conical, pyramidal, chamfered, or similar shapes.

[0472] In an 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 specific 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 that is larger than the diameter of the nose section 430.

[0473] In an example, the actuating element 152 is flexible and deflectable so that when pushed by the male Luer tip, the actuating element deflects or flexes. The actuating element is deflectable by selecting a material with the necessary rebound properties. In other examples, the actuating element is deflectable by including one or more weakened sections, such as by including a structurally thin section, by including a cutout, by adopting a small cross-section compared to other sections of the same elongated actuating element, or a combination thereof. Alternatively, the actuating element 152 can be flexible and deflectable by selecting a material with the necessary rebound properties and by including one or more weakened sections.

[0474] In still other examples, each actuating element 152 has more than one different cross-sectional profile or shape along a length segment. For example, an elongated plunger element may have a square profile positioned adjacent to a crescent-shaped profile.

[0475] In an example, the actuation element 152 is rigid and does not deflect or deform when loaded (such as when pushed by the male Luer tip). In addition, a stabilizing element may be included to increase the stiffness of the two actuation elements 152. The two actuation elements 152 may each include a cross-sectional profile at least at the proximal end that overlaps with the pushing end of the male tip so that the male tip can push the valve actuator into the valve, as previously described with reference to Figure 5C and Figure 5D discussed.

[0476] The nose section 430 of the valve actuator 134 can be configured to engage the valve 136 to open the valve disc or disk 410 when an axial force is applied to the actuation element 152 by the male tip toward the distal end of the catheter assembly 100, such as during insertion of an IV drip line 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 actuation end 436) to actuate the valve 136, thereby deflecting one or more flaps and opening one or more slits on the valve disc 410. The nose section 430 can be made of an incompressible material, such as metal, rigid plastic, or hard elastomer, for pushing against and opening the valve.

[0477] 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) that connect the two actuation elements 152 at a location along the length of the actuation elements, which is located between the nose section 133 and the proximal ends of the actuation elements. In some examples, the stabilizer 444 can be located at the proximal ends of the two actuation elements 152 so that the proximal edges of the stabilizer 444 are generally flush with the proximal end surfaces of the actuation elements. The two stabilizer elements 444, 444 can be referred to as a first or upper stabilizer element and a second or lower stabilizer element.

[0478] In one embodiment, the stabilizer or stabilizer elements 444, 444 are arcuate, forming an arc that follows the inner contour of the catheter hub 102 and connects one actuation element 152 to another actuation element 152. The stabilizer or stabilizer element 444 can form a substantially cylindrical section on the body of the valve actuator that is spaced apart from the nose section 430 of the valve actuator. In other words, the valve actuator can be elongated and can have sections that are continuous in the radial direction and sections that are discontinuous in the radial direction with a relief or through passage through the wall of the actuator.

[0479] In an example, the stabilizer 444 is a continuous body section defined along the perimeter or radial direction of the valve actuator, which is spaced apart from the continuous body section of the nose section 430, which is also continuous along the perimeter or radial direction. Two stabilizers or stabilizer elements 444, 444 can be combined with two plunger elements 152 to form a ring structure. Optionally, the two stabilizers can be slightly offset and angled from each other, as shown in Figure 10a. In some embodiments, there can be one, three or different numbers of actuating elements 152 or stabilizers 444. In an example, the valve actuator 134 (with stabilizers or stabilizer elements 444 and protrusions 442) is made of plastic, such as, made by injection molding.

[0480] The stabilizer 444 can help the valve actuator 134 remain centered within the catheter sheath 102 as the actuator moves (such as when pushed by the male Luer tip). By remaining centered, the nose section 430 can be better aligned with the valve disc 410 (such as a slit on the valve disc), allowing for smooth actuation of the valve 136. After the male Luer tip is removed, the stabilizer 444 can also provide engagement with the interior of the catheter sheath 102 via friction to prevent the actuator 134 from sliding in a proximal direction.

[0481] In one embodiment, the nose segment 430 is configured to remain engaged to the valve disc 410 after actuation of the valve and after removal of the male Luer tip. For example, the nose segment 430 can be wedged between one or more slits on the valve disc and held there by friction, as discussed further below. Surface features, such as ridges, grooves, or barbs, can be provided on the valve actuator 134, such as on the nose segment, to maintain engagement between the actuator and the valve after actuation and after removal of the male Luer tip.

[0482] A relief, opening or through passage 448 is provided between the transition section 440 or from the nose section and each of the two stabilizers 444, 444. The two reliefs or through passages 448 provide clearance so that the interior or central portion of the valve actuator 134 can be in open communication with the inner surface of the catheter sleeve 102. In other words, one or two reliefs, through passages or openings 448 are located between a continuous section of the nose section and a continuous perimeter section defined by the two stabilizers 444, 444 and the plunger element 152 (referred to as one or more stabilization rings 456 ( Fig. 12A ))between.

[0483] The stabilizing ring 456 of the valve actuator 134 can have an inner diameter that is smaller than the diameter defined by the diagonal segments or elbows 304 of the two arms 288, 290 of the needle guard 132 when the two arms 288, 290 are biased outwardly by the sides of the needle shaft. Thus, during installation of the needle guard 132 into the holding space of the valve actuator 134, the diagonal segments or elbows of the needle guard 132 can be deflected to pass through the stabilizing ring 456 and into the open area defined by the release 448.

[0484] When the tip protector 132 is positioned between the two plunger elements 152, the two distal walls 300, 302 ( Figure 7 ), more specifically, the two diagonal sections or elbows 304, can be located in the release 448, as discussed above, to engage the guard engagement surface on the inner surface of the catheter hub 102. This allows the needle guard 132 to protrude from the holding space of the valve actuator 134 through the two releases 448 to engage the guard engagement surface of the catheter hub. Thus, the needle guard can be retained within the interior of the catheter hub in the standby position and during needle retraction after a successful venipuncture until the needle tip moves proximal to the two distal walls on the needle guard, at which time the needle guard can be capped over the needle tip and removed with the needle, as described above with reference to Figure 3 discussed.

[0485] A second undercut or recessed section 450 proximal to the first recessed section 420 may be provided in the lumen of the catheter sheath 102 for accommodating the two diagonal sections or elbows 304. Thus, the needle guard 132 may be prevented from sliding in a proximal direction during needle retraction after a successful venipuncture by a shoulder 452 of the second recessed section 450 or by some other surface feature on the interior of the catheter sheath (such as a guard engagement surface on the interior of the catheter sheath). Optionally or alternatively, the distal edge 446a ( Fig. 12B ) can provide a restraining surface to prevent early activation of the needle guard 132 during needle retraction before the needle tip moves proximal to the two distal walls 300, 302. In addition to the distal edge 446a, the two stabilizers 444, 444 also have a proximal edge 446b.

[0486] In some examples, one or both stabilizer elements 444, 444 may have a slit or slot, thereby dividing the arcuate stabilizing element into two segments. Nevertheless, even if one or both stabilizer elements 444, 444 have a slit, the stabilizing ring 456 (which may be a discontinuous ring, similar to a ring with one or more slots formed therethrough) may still provide a constraining surface to prevent the needle tip from moving between the two distal walls 300, 302 ( Figure 7 ) is activated early before the needle guard 132 is proximal to the choke point. The constraining surface may also be referred to as a limit point, a choke gap, or a choke point because it provides a rigid structure that prevents the needle guard from moving to its proximal side unless or until the needle guard is first activated and radially collapses to reduce its radial profile so as to then slide to the proximal side of the choke point. In an example, one or both elbows 304 ( Figure 7 ) to prevent movement in the proximal direction until one or both elbows of the needle guard deflect to reduce the radial profile of the needle guard. In examples, when the radial profile of the needle guard is reduced, the needle guard can slide from a distal position of the stabilization ring through the opening defined by the stabilization ring to a proximal position of the stabilization ring.

[0487] Further references Fig. 10B , Fig. 10B yes Fig. 10A The same catheter assembly 400 from Fig. 10A A top cross-sectional view with the view rotated 90 degrees, wherein the tip protector 132 is shown fitted between the actuation elements 152. In an embodiment, the one or more actuation elements 152 are sized and shaped for contact by the male luer to transfer a proximally directed force from the male luer through the nose 430 to then open the valve 136, as previously discussed.

[0488] The valve opener 134 can be made of a metal material or a plastic material. When made of a metal material, the valve opener 134 can be formed by a bending or deep drawing method, and the arcuate cross-section of the actuating element 152 can provide increased rigidity when pushed by the male Luer. 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 rigidity. One or more gaps may be provided between any two actuating elements 152. These gaps can provide gaps or spaces for fluid flow flowing therethrough, such as during flushing blood or IV infusion. The gaps between the actuating elements 152 can define a holding space to accommodate the tip protector 132, such as Fig. 10B as shown in .

[0489] In some embodiments, in the standby position, a substantial portion or majority (if not all) of the tip protector 132 fits within the retention space formed by the body of the actuator 134 between the two plunger elements 152, such as Fig. 10B This allows the catheter hub 102 to be more compact because less longitudinal space is required within the hub to mount both the actuator 134 and the tip guard 132 in a continuous lengthwise manner or when the actuator 134 and the tip guard 132 only partially overlap in the axial direction. Fig. 10B In the embodiment, the tip protector 132 is shown as being fully fitted within the holding space of the actuator 134 to further reduce the space or length required in the catheter hub. As shown, the proximal wall 280 of the needle protector 132 is generally flush or flush with the proximal end surfaces of the two plunger elements 152.

[0490] When the tip protector 132 engages only with the distal edge 446a of the release or through passage 448 in the actuator, no deformation or diameter change is required on the inner wall of the catheter hub, and the tip protector 132 can be placed further proximally in the female Luer section while complying with international Luer standards for conical fittings, and the overall length of the catheter hub 102 can be further reduced.

[0491] Fig.11 yes Fig. 10A and Fig. 10B 446b ( 446b ) of the catheter assembly 400. The 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 with the interior of the catheter sleeve 102, as previously discussed. The stabilizer 444 can be seen proximal to the release portion 448, which is used to provide additional rigidity and / or a larger engagement surface for the catheter sleeve 102. The actuating element 152 extends past the proximal edge 446b ( Fig. 12A and Fig. 12B) to substantially the same distance as the proximal wall 280 of the tip guard 132. In the illustrated embodiment, the tip guard 132 is substantially fitted within the retaining space of the actuator 134, and the proximal wall 280 of the tip guard is substantially flush with the proximal end of the actuating element 152 in the axial direction.

[0492] Fig. 12A 4 is a partial cross-sectional side view of the valve assembly 400 after the needle and needle guard have been removed from the catheter sleeve 102 (such as, after a successful venipuncture). As shown, the valve 136 is in a closed position, in which the one or more slits 324 of the valve disc 410 are closed. The valve actuator 134 retracted position is also shown, in which the actuating end 436 of the nose section 430 is not pushed into the one or more slits and opens the one or more slits. This position is also understood to be a valve pre-activated position. That is, the male Luer tip has not yet been inserted into the proximal opening of the catheter sleeve to advance the valve actuator to open the valve. In other words, this is the valve closed position.

[0493] Fig. 12B yes Fig. 12A 4 shows a partial cross-sectional side view of a valve assembly 400 in which the valve has been actuated to open one or more slits 324. This view shows the luer tip of a syringe tip or IV drip line (not shown) with the valve actuator 134 advanced distally into the valve 136 to allow fluid to flow through the catheter sheath. Advancing the actuator 134 causes the actuation end 436 to advance against the valve disc or valve disk 410 and deflect the flap radially and distally to open a fluid path to be formed through the catheter assembly 400.

[0494] When initially inserting a male medical device (such as, male Luer tip) into the proximal opening of the catheter sleeve 102, the male tip initially contacts two actuating elements 152 on the actuator 134 to advance the distally directed force on the two actuating elements 152 to open the valve 136. The distally directed force moves the actuator 134 in a distal direction until the geometry of the proximal opening of the male tip and the catheter sleeve prevents the male tip from advancing further distally. In an example, the female Luer connector of the catheter sleeve 102 cooperates with the male Luer connector of the male tip and blocks the male tip from advancing further distally into the opening of the catheter sleeve. A seal is provided by the Luer engagement to prevent fluid from leaking out of the proximal opening of the catheter sleeve.

[0495] As the actuator 134 moves distally by advancing the male tip distally, the nose 430 of the valve actuator 134 is advanced distally and pushes against the proximally facing surface of the valve disc 410. In particular, the nose of the actuator 134 initially pushes against the proximally facing surface of the valve disc 410, and because the valve is axially fixed within the first recessed section 420 of the catheter sleeve, one or more flaps on the valve disc 410 are radially and distally deflected. Fluid from the male tip can then flow through the catheter sleeve 102, through the valve 136, and through the lumen of the catheter tube 104.

[0496] Alternatively, suction may be applied by a public medical device (such as a syringe or a vacuum blood collection tube) and blood may be drawn from the patient. This is often done to test the sample before initiating an infusion therapy. Furthermore, any residual blood is typically first flushed from the interior of the catheter sheath 102 before initiating an infusion therapy.

[0497] Continue to refer Fig. 12B , the actuation end 436 of the nose section 430 is shown protruding through the valve disc 410 in the valve actuation position and either contacting or just about to contact the bushing 138. In this configuration, the valve actuator 134 remains engaged to the valve 136 even after the male tip is removed. That is, the friction between the valve actuator 134 and the valve disc 410 exceeds the friction caused by the valve flap in its attempt to return to the Fig. 12A This activated position can be considered a one-time use or one-time actuation because the valve actuator 134 and valve 136 do not return to their original position when the male tip is removed. Fig. 12A pre-activated position.

[0498] In an alternative embodiment, the nose section 430 is configured such that when pushed into the valve 136 during activation, the actuation or activation end 436 does not extend distally past the flap of the valve disc 410. This configuration can ensure that the valve actuator 134 is pushed back by the flap of the valve disc when the male Luer device is removed. The conical configuration at the distal end of the actuator 134 can be such a configuration that it maintains a proximally directed force vector that is greater than the vertical force vector. The angle of the cone can be designed to provide the necessary force vector when the actuator 134 has reached its maximum distal movement and its minimum distal movement. The difference between the maximum movement and the minimum movement of a standard Luer connector is approximately 2.5 mm.

[0499] Additionally, a spring or elastic element or ring (similar to Figure 1 The resilient element 276 is provided to increase the spring back or restoring force of the valve 136, thereby facilitating the valve actuator 134 to be pushed in the proximal direction to return to the position after the male tip is removed. Fig. 12A4. The valve 136 and valve actuator 134 can be reclosed and reopened after initial activation, and so on. Alternatively or additionally, the flap 326 on the valve disc can be made thicker to provide sufficient restoring force without the need for a resilient element.

[0500] Continue to refer Fig. 12A and Fig. 12B 456, it is noted that the distal edges 446a and the proximal edges 446b on the stabilizers 444, 444 are not parallel to the proximal edges of the two plunger elements 152. Instead, the distal edge 446a and the proximal edge 446b of the upper stabilizer 444 are parallel to each other, and the distal edge 446a and the proximal edge 446b of the lower stabilizer 444 are parallel to each other, but the corresponding edges of the upper stabilizer 444 and the lower stabilizer 444 are not parallel to each other. In other words, the upper stabilizer 444 has a distal inclination, while the lower stabilizer 444 has a proximal inclination.

[0501] Reference now Fig.13A , a top or plan view of a valve opener or actuator 134 is shown. The valve opener may be similar to the valve opener described elsewhere herein such as Figures 9 to 12B As shown, the valve actuator has a nose section 430, a transition section 440, and two plunger elements 152 extending proximally from the transition section or extending proximally from the nose section. The nose section 430 defines a first continuous perimeter section 700. Other locations of the nose section 430 away from the first continuous perimeter section 700 may include slits or slots.

[0502] Two stabilizer elements 444, 444 are attached to two plunger elements 152 to form a stabilizing ring 456, which defines a second continuous perimeter section 702 of the valve actuator. Each stabilizer element 444 may include two edges 446a, 446b. In one 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 inclined so 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 another stabilizer element. As shown, the proximal edges 446b of the two stabilizer elements 444, 444 are offset in the axial direction or longitudinal direction of the valve actuator. As shown, the distal edges 446a of the two stabilizer elements 444 may be offset in the axial direction.

[0503] Two releases or two through passages 448 are provided on the valve opener 134, each of which is limited or delimited by a transition section 440, two plunger elements 152, and corresponding stabilizer elements 444, 444. The two releases or through passages may be referred to as a first release or first through passage and a second release or second through passage. In the example, each release or through passage may have a perimeter 708. In the example, each perimeter may be defined by the structure of the transition section 440, two plunger elements 152, and corresponding stabilizer elements 444, 444. Because the two stabilizer elements 444, 444 may be deflected or tilted in different directions, the two perimeters 708 of the two releases or through passages 448 may be different, such as having different perimeter profiles or shapes. As shown, the two perimeters 708 are each limited by a continuous ring. In other words, in the present embodiment, the perimeter 708 does not have a slit or slot to form the perimeter of the opening. However, where the stabilizer element 444 includes a slot or slit, the perimeter may be an open perimeter or a non-continuous perimeter.

[0504] In some examples, the two stabilizer elements 444, 444 can extend laterally without being deflected or tilted in the distal or proximal direction. When so configured, the edges 446a, 446b of the two stabilizer elements 444, 444 can be 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 the four edges are parallel to each other.

[0505] Further references Fig.13A , two plunger element protrusions or extensions 152a are shown extending proximally of the stabilization ring 456. In one example, the two plunger element protrusions 152a can extend from the stabilization ring 456 and be axially aligned with the two plunger elements 152 located distally of the stabilization ring 456. In other examples, the two plunger element protrusions 152a are not axially aligned with the two plunger elements 152 located distally of the stabilization ring 456. In still other examples, only one plunger element protrusion 152a is aligned with one of the two plunger elements 152. For a valve opener or actuator having only one plunger element 152 between the first and second continuous perimeter segments, only one or none of the two plunger element protrusions 152a can be aligned with one plunger element.

[0506] In some examples, there can be more than two plunger element protrusions or extensions 152a extending proximally of the stabilization ring 456. The two or more plunger element protrusions or extensions 152a can be equally spaced around the proximal perimeter of the stabilization ring 456 or randomly spaced around the proximal perimeter of the stabilization ring 456. The plunger element protrusions can extend the total length of the valve actuator. The number of plunger element protrusions and / or the arc curve of each plunger element protrusion (which defines the width of each plunger element protrusion) can provide a greater overlap surface with the male Luer tip than a smaller number or for plunger element protrusions with a relatively smaller arc curve.

[0507] Still further reference Fig.13A , the two plunger elements 152 are each shown as having at least two thicknesses to produce a protrusion 442 at the intersection between the two thicknesses on the outer surface 710 of each plunger element. As previously described, the two protrusions 442 can be located within the recessed section 450 ( Fig. 10B ), such that the shoulder 452 at the proximal end of the recessed section 450 can provide a stop surface to prevent displacement of the valve opener 134 in the proximal direction. In some examples, only one protrusion 442 is employed 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 by adding material to the plunger element during injection molding.

[0508] In an example, the planar surface section 714 may be disposed on the same side of each stabilizer element 444 as the valve actuator 134. The planar surface section 714 originates near the nose section 430 or transition section of the valve member 440 and extends proximally to near the two protrusions 442.

[0509] Reference now Fig. 13B , which is taken along line 13B-13B Fig.13A 13B . Thus, in one example, the cross-sectional dimensions of the nose section 430, the transition section 440, and the two plunger elements 152 along the side view or from the side are as follows: Fig.13A The orientation is rotated 90 degrees along the longitudinal axis of the valve opener and is generally constant or the same within typical manufacturing tolerances.

[0510] Continue to refer Fig. 13B, a holding space 720 is shown, which may be located between two plunger elements 152, inside the stabilizing ring 456, between two plunger element protruding segments 152a, or a combination thereof. As previously described, a portion or all of the needle guard or tip guard 132 may be located in the holding space 720 in the standby position and one or both elbows of the tip guard 132 protrude outwardly from the release portion 448.

[0511] The proximal wall of the needle guard 132 may be flush with the proximal end surface 726 of the plunger element protruding segment 152a, located proximal to the end surface 726, or located distal to the end surface. If the plunger element protruding segment is not included, the proximal wall of the needle guard 132 may be flush with the proximal edge of one or both stabilizer elements 444, 444, located proximal to the proximal edge of one or both stabilizer elements 444, 444, or located distal to the proximal edge of one or both stabilizer elements 444, 444.

[0512] Still further reference Fig. 13B , the distance between the two inner surfaces 728 of the two stabilizer elements 444, 444 defines a choke gap, choke point or limit point for the needle guard to limit the proximal movement of the needle guard in the standby position and / or during needle retraction after intravenous access, as previously discussed. That is, before the needle tip moves proximal to one or both distal blocking walls of the needle guard, the choke point or gap is too small for the needle guard to pass proximal to the choke point, choke point or limit point. However, after the needle tip moves proximal to one or both distal blocking walls of the needle guard, the two distal walls move radially inward to reduce the radial profile of the needle guard, which is smaller than the choke point. At this point, with the radial profile measured at the two elbows being smaller, the needle guard can move proximal to the choke point.

[0513] Fig. 13C yes Fig.13A and Fig. 13B A perspective view of the valve opener 134 is shown.

[0514] 14-18, another embodiment of a catheter assembly 800 includes a catheter hub 102 that supports an elongated catheter tube 104 extending distally therefrom. A needle hub 106 is selectively attached to the proximal end of the catheter hub 102 and supports a needle 108 that extends through the catheter hub 102 into and through the catheter tube 104. A flashback plug 114 is attached to the proximal end of the needle hub 106, and a flashback chamber 116 is defined within the needle hub 106 distal to the flashback plug 114. A needle tip protector 132 is located within the lumen 130 of the catheter hub 102, and in the illustrated embodiment, is at least partially located within a valve opener 134 that is configured to open a valve 136 when the valve opener 134 is moved distally relative to the catheter hub 102.

[0515] In the illustrated embodiment, the catheter sheath 102 includes a side port 810 including a tubular port body 812 extending laterally from the wall of the catheter sheath 102 and defining a port lumen 814. A side opening 816 is formed through the side wall of the catheter sheath 102 and communicates the port lumen 814 with the lumen 130 of the catheter sheath 102. A removable cap 814 is preferably placed on the end of the side port 810. The assembly may be referred to as a ported catheter.

[0516] Special References Fig.15 , can be used with Fig.14A The illustrated valve 136 used with the catheter hub of FIG. 1 is a mixing valve having a diaphragm valve body 820 and a tube valve body 830. The diaphragm valve body 820 includes a diaphragm at its distal end, a valve disc 410 defining a diaphragm having a slit 324 and flaps 326. In a preferred embodiment, the valve disc 410 has a three-slit slit 324 defining three flaps 326.

[0517] The valve skirt 412 extends proximally from the valve disc 410 to a transition shoulder 824 where the outer diameter of the valve 136 is reduced. A diaphragm valve body cavity 424 is defined within the valve skirt 412 proximally of the valve disc 410. The tube valve body 830 defines an elongated tube of elastomeric material extending proximally from the transition shoulder 824. An elongated valve lumen 826 is defined within the tube valve body 830 and, in the illustrated embodiment, communicates with and includes the diaphragm valve body cavity 424. In the illustrated embodiment, the walls in the diaphragm valve skirt 412 are thicker than the walls in the tube valve body 830.

[0518] Continue to refer to Figure 14 to Fig.17, the inner cavity 130 of the catheter sleeve 102 includes a distal shoulder 420a, a proximal shoulder 420b and an intermediate shoulder 420c. The first recessed section 840 is defined between the distal shoulder 420a and the intermediate shoulder 420c, and the second recessed portion 842 is defined between the intermediate shoulder 420c and the proximal shoulder 420b. The inner diameter of the first recessed section 840 is greater than the inner diameter of the second recessed section 842 and is greater than the diameter of the inner cavity 130 immediately adjacent to the distal side of the first recessed section 840. The diameter of the second recessed section 842 is greater than the inner cavity 130 immediately adjacent to the proximal side of the second recessed section 842.

[0519] The first recessed section 840 and the second recessed section 842 are shaped as accommodating valve 136, so that valve 136 is matched therein, the distal end of valve 136 abuts distal shoulder 420a, the proximal end of valve abuts proximal shoulder 420b, and the transition shoulder 824 of valve abuts intermediate shoulder 420c. Therefore, valve 136 will resist relative to catheter sleeve 102 to the near side or to the distal movement. As shown in the illustrated embodiment, diaphragm valve body 820 is positioned at the distal side of side port opening 816 in catheter sleeve 102, and pipe valve body 830 terminates at the proximal side of side opening 816. Pipe valve body 830 is configured to bias against the inner surface of inner chamber 130 to seal against the inner surface. In addition, pipe valve body 830 extends across and covers side opening 816, to seal side opening 816 and block inner chamber 130 and communicate with side port lumen 814.

[0520] Continue to refer to Figure 14 to Fig.17, the valve opener 134 includes an elongated nose segment 430 configured such that when the valve opener 134 is disposed within the lumen 130 of the catheter sheath 102, the nose segment 430 extends into the valve lumen 826 (and the diaphragm valve lumen 424), and the distal tip or actuation end 436 of the nose segment 430 is adjacent to the valve disc 410 on the proximal side of the valve disc. The nose 430 defines a nose cavity 431 that communicates a distal opening with the release portion 448. In one example, the nose segment 430 has a length that is substantially the same length as the remainder of the valve opener 134, which includes a stabilizer and an actuation element. In some examples, the length of the nose segment 430 can be shorter or longer than the rest of the valve opener, but long enough to extend into the valve 136, which can have both a valve disc 410 and an elongated cylindrical valve body 830 for use with the side port 810. In a particular example, the length of the nose segment 430 is longer than the length of the valve 136 so that when the valve actuator 134 is advanced in a distal direction to open the flap of the valve disc 410, there is sufficient length to advance the nose segment 430 into the valve cavity 826 without any other portion of the valve opener contacting the proximal end edge of the valve body 830 in a manner that would limit the distal advancement of the valve opener 134. In one example, the nose segment is approximately 35% to 70% of the total length of the valve opener.

[0521] like Fig.17 , the needle 108 is withdrawn as the needle guard 106 is disassembled and removed from the catheter guard 102. The needle tip protector 132 caps the tip of the needle 108 and is withdrawn from the valve opener 134 and the catheter guard 102 along with the needle guard 106, leaving the valve 136 closed and the valve opener 134 in place within the catheter guard 102 with its actuation end 436 adjacent the valve disc 410. In this configuration, the closed valve disc 410 prevents blood from flowing proximally past or through the valve 136.

[0522] Next reference Fig.18A and Fig.18B When a male medical implement 220 (such as a male Luer, syringe tip, IV set connector or other male tip (preferably having a Luer fitting)) is pushed into the proximal end of the catheter hub 102, the medical implement 220 engages the plunger element protrusion 152a, forcing the valve opener 134 distally relative to the catheter hub 102 and the valve 136 to first partially open the valve disc 410 of the diaphragm valve body 820 (see Fig.18A ), and then fully open the valve disc 410 (see Fig.18B ). Therefore, the fluid F can be connected from the male medical device 220 to the inner cavity 130 and through the valve opener 134 (including the nasal lumen 431) and the valve disc 410 to the catheter tube 104 and further to the patient. Fig.18A and Fig.18B As shown in , the tube valve body 830 continues to block the side port opening 816 when such fluid F is infused, so that the fluid dispensed from the male medical device does not flow out through the side port opening. As also shown, when fully advanced, the tip of the nose 430 of the valve opener 134 contacts the sleeve 138 and is thereby blocked from further distal movement relative to the catheter sleeve 102. In some embodiments, a resilient element (see Figure 1 to Figure 2 276) to help hold the valve 136 in place and / or bias the valve flap 326 to a closed position.

[0523] Next reference Fig.18C , a fluid source 844 can be attached to the side port 810. The fluid source 844 can include any desired source and connector structure. For example, the cap 818 can be removed, and a syringe filled with a liquid medicament can be attached to the side port 810 by inserting the syringe tip into the side lumen 814. When connected, a fluid F from a fluid source 844 can be injected into the port lumen 814, and the fluid F will flow from the port lumen 814 through the side opening 816 and contact the pipe valve body 830 of the valve 136. The fluid pressure applied during fluid injection (e.g., by depressing the syringe plunger) is preferably sufficient to partially collapse the pipe valve body 830, so that the proximal end of the pipe valve body 830 is separated from the inner wall of the catheter sleeve 102 and the seal with the inner wall of the catheter sleeve 102 is destroyed. The fluid F then flows proximally from the side opening 816 around the proximal end of the tube valve body 830 into the lumen 130 of the catheter body 102 and further through the release passage 448 of the valve opener 134 from which the fluid F flows distally through the nasal lumen 431 (which preferably extends through the valve cavity 826) and opens the valve disc 410 into the catheter tube 104. In some embodiments, the valve 136 is configured to be stiffer at the diaphragm valve skirt 412 than at the proximal end of the tube valve body 830 so that the tube valve body 830 will deflect instead of the diaphragm valve body 820. When the application of fluid pressure ceases, such as when the syringe plunger is no longer depressed and / or when the syringe is removed from the side port 810, the elastic properties of the tube valve body 830 will bias the tube valve body 830 back into contact with the inner surface of the catheter hub 102, thereby reestablishing the seal of the side port opening 816. In some embodiments, fluid pressure from fluid that may be injected by the male medical device 220 may help to push the tube valve body 830 back into contact with the inner surface of the catheter hub 102 .

[0524] Next reference Figures 19 to 21In another embodiment, the valve 136 is configured such that the diaphragm valve body 820 is proximal to the tube valve body 830. In the illustrated embodiment, the valve disc 410 is positioned adjacent to the transition shoulder 824, and the diaphragm valve skirt 412 extends proximally from the valve disc 410. A valve diaphragm body cavity 424 is defined within the diaphragm valve skirt 412 from a proximal end to the valve disc 410. The tube valve body 830 extends distally from the valve disc 410 and the transition shoulder 824 such that a tube valve cavity or lumen 826 is defined within the tube valve body 830 from the valve disc 410 to a distal end of the tube valve body 830. In the illustrated embodiment, the valve disc 410 separates the tube valve lumen 826 from the diaphragm valve body cavity 424.

[0525] The illustrated catheter sleeve 102 comprises a distal shoulder 420a, a proximal shoulder 420b and an intermediate shoulder 402c, and a first recessed portion 840 between the distal shoulder 420a and the intermediate shoulder 420c and a second recessed portion 842 between the intermediate shoulder 420c and the proximal shoulder 420b. The internal diameter of the second recessed portion 842 is greater than the internal diameter of the first recessed portion 840. The first recessed portion 840 and the second recessed portion 842 are shaped to accommodate valve 136, so that valve 136 is fitted in the inner chamber 130 of the catheter sleeve 102, and its distal end abuts the distal shoulder 420a, and the proximal end abuts the proximal shoulder 420b, and the transition shoulder 824 abuts the intermediate shoulder 420c. In this configuration, valve 136 is blocked from moving proximally or distally relative to the catheter sleeve 102. In the illustrated embodiment, the distal end of the tube valve body 830 is distal to the side port opening 816, and the tube valve body 830 extends across and seals the port opening 816. The valve disc 410 is disposed proximal to the port opening 816.

[0526] Continue to refer Figures 19 to 21 And with particular reference to Fig. 20 , the valve opener 134 has a nose 430 that is much shorter than the nose of the embodiment depicted in Figures 14 to 18. In the illustrated embodiment, the nose 430 extends into the diaphragm cavity 424 so that the actuation end 436 is adjacent to the valve disc 410. The nose segment 430 is configured to open the valve disc 410 of the valve, and the valve also has a valve body 830 for sealing the side opening 816 of the side port 810 of the ported catheter. However, the length of the nose segment 430 is much shorter than the length of the rest of the valve opener 134, approximately 5% to 30% of the total length of the valve opener 134. When the medical device 220 pushes the valve opener 134 distally relative to the catheter body 102 and the valve 136 (see Fig.21), the engagement end 436 engages the flap 326, forcing the valve disc 410 open so that the fluid F from the device 220 can be infused. During such infusion, the tube valve body 830 is not affected by the fluid flow and therefore remains closed, so that the side port lumen 814 is blocked from communicating with the lumen 130 of the catheter hub 102.

[0527] like Fig.21 As best shown in FIG. 8 , when a fluid source 844 (such as a syringe tip or a medical implement) is attached to the side port 810 and a fluid F (such as a liquid medication) is injected into the side port lumen 814, the fluid F is pushed through the port opening 816 and the pressure collapses a portion of the tube valve body 830 so as to break the seal between the valve body 830 and the interior of the catheter hub to allow such fluid to flow distally into the lumen 130 and further into the catheter tubing 104. Although Fig.21 The valve opener 134 is shown advanced to open the valve disc 410, but it should be understood that in the illustrated embodiment, fluid F can be infused via the side port 810 while the valve disc 410 remains closed. Therefore, in this embodiment, the tube valve body 830 can operate independently of the diaphragm valve body 820.

[0528] Next reference Fig. 22 and Fig.23 In another embodiment of the valve 136, the tube valve body 820 and the diaphragm valve body 820 can be formed separately, that is, separated from each other. In the illustrated embodiment, the distal end of the tube valve body 830 abuts the distal shoulder 420a, and the distal end of the diaphragm valve body 820 abuts the intermediate shoulder 420c, while the proximal end of the tube valve body 830 abuts the distal end of the diaphragm valve body 820 along the outer axial circumference. As in other embodiments, the fluid F delivered under pressure from the fluid source 844 attached to the side port 810 flows through the side port opening 816, displacing the tube valve body 830 and entering the inner cavity 130, and the fluid F is guided from the inner cavity 130 into the catheter tube 104 and into the patient.

[0529] In the illustrated embodiment, the width of the distal shoulder 420a is approximately the same as the width of the tube valve body 830, so that when the tube valve 830 seals the side port opening 816, the inner surface of the tube valve body 830 is generally flush with the inner surface of the lumen 130. Therefore, when blood or other body fluids flow proximally from the catheter tube 104 into the lumen 130, such fluid flow is less likely to lift the distal end of the tube valve body 830 or otherwise deform the distal end of the tube valve body 830, which deformation may fail the valve seal with the side port opening 816. However, it should be understood that additional embodiments may not employ a distal shoulder, but instead will rely on the resiliency of the tube valve body to maintain its position in engagement with the inner wall of the catheter lumen 130. In still other embodiments, the width of the distal shoulder 420a may vary, such as at least 1 / 5, 1 / 4, 1 / 3, 1 / 2, 2 / 3, or 3 / 4 of the width of the tube valve body wall. However, other embodiments may not employ a distal shoulder.

[0530] The embodiments discussed above have provided catheter hubs 102 in which blood flow is controlled so as to block blood flow proximally through the catheter hub 102 when the needle hub 106 is removed and no other medical device is attached to the catheter hub 102. However, such blood control catheter hubs 102 are configured to allow fluid communication when a medical device 220 is attached thereto. Fig.24 , in some cases, an extension 900 can be attached to such a blood control catheter sleeve 102. The extension can include a medical device 220 that is a male threaded Luer connector with a spin lock collar and has a protruding section that is connected to a tube 902, which in the illustrated embodiment terminates at an extension sleeve 910. A plug 920 can be used to close the extension sleeve 910, which can have a female Luer piece structure. When the Luer connector 220 is attached to the blood control catheter sleeve 102, the valve 136 is open, and blood B can flow from the sleeve 102 and flow through the medical device 220, and further through the tube 902 into the extension sleeve 910. The illustrated plug 920 prevents such blood from flowing out of the extension sleeve 910. However, when the plug 920 is removed, such as in order to connect another medical device, Fig.24 The extension sheath 910 is not equipped to prevent blood B from flowing proximally through the extension sheath 910 and out of the extension 900, thereby potentially exposing the clinician to blood contact.

[0531] Next reference Figure 25 to Figure 28, another embodiment of the extension 900 includes an extension sleeve 910 including a valve 136 and a valve opener 134, and another embodiment of a plug 920. In the illustrated embodiment, the valve 136 includes a valve disc 410 and a valve skirt 412 extending proximally from the valve disc. The extension sleeve 910 defines a sleeve lumen 912 having a distal shoulder 420a against which the valve disc 410 rests. The valve opener 134 fits within the sleeve lumen 912 of the extension sleeve 910 such that its nose 430 extends into the valve 136 adjacent to the valve skirt 412 and its actuating end 436 is located at or adjacent to the proximal side of the diaphragm or valve disc 410. The plug 920 also fits within the sleeve lumen 912, as will be discussed in more detail below.

[0532] Special References Fig.26 and Fig.28 , the plug 920 is preferably elongated and defines a plug lumen 922 therein. The diameter of the proximal portion 924 of the plug is greater than the inner diameter of the extension sheath 910, and therefore does not fit into the extension sheath 910. The registration portion 926 extends distally from the proximal portion 924 and has an outer diameter that is less than the proximal-most inner diameter of the extension sheath 910. However, the extension sheath 910 is preferably tapered, such as with a Luer fitting, and as the plug 920 is advanced distally within the extension sheath 910, the registration portion 926 eventually engages and registers with the inner surface of the extension sheath 910, such that the plug 920 is retained in place in the extension sheath 910 in a press-fit manner.

[0533] The middle portion 928 of the plug 920 extends distally from the registration portion 926 and has a smaller or smaller diameter so that it fits within the valve opener 134. In the illustrated embodiment, the outer diameter of the middle portion 928 decreases at a gentle slope moving distally. Preferably, the offset surface 930 is disposed between the registration portion 926 and the middle portion 928. The distal portion 932 of the plug 920 extends distally from the middle portion 928 and has an even smaller or smaller outer diameter. In the illustrated embodiment, a transition portion 933 is defined between the middle portion 928 and the distal portion 932, where the outer diameter is significantly reduced. Preferably, the outer diameter of the distal portion 932 is less than or approximately equal to the inner diameter of the nasal lumen 431 defined within the elongated nose 430 of the valve opener 134. The distal opening 934 is provided at the distal end of the stopper 920 and leads to a distal passage 936 that communicates with the remainder of the stopper lumen 922. Preferably, the distal opening 934 and the distal passage 936 are very small, for example having a cross-sectional diameter smaller than the internal passage of the needle 108, so that blood B is obstructed from flowing therethrough, or at least slowed down when flowing therethrough. However, air A can easily flow through the distal opening 934 and the distal passage 936.

[0534] A filter seat 938 is formed within the stopper lumen 922, preferably between the proximal portion 924 and the registration portion 926. Preferably, a hydrophobic filter 940 is affixed to the filter seat 938. The hydrophobic filter 940 is configured to allow air A to flow therethrough, but to block blood B from flowing therethrough. Thus, blood B and air A can flow through the distal passage 936 into the stopper lumen 922, but blood B will be blocked by the filter 940, while air A will be allowed to flow through the filter 940 and out of the open proximal end of the stopper 920. Of course, in other embodiments, the filter 940 or filters may be placed at other locations within the stopper lumen 922. In a preferred embodiment, the filter 940 is placed in a portion of the stopper lumen 922 having an inner diameter greater than the inner diameter of the distal passage 936, increasing the surface area available for efficient filtration.

[0535] Next, specific reference Fig. 27 and Fig.28 Preferably, the plug 920 is placed in the extension sleeve 910 so that the distal portion 932 extends through the nose lumen 431 of the valve opener 134 and through the valve disc 410 to open the valve flap 326, so that when the extension 900 is attached to the catheter sleeve 102, the distal opening 934 is open to any blood B and air A that may flow into the tube 902, such as for blood flashback. In this position, the offset surface 930 of the plug 92 is adjacent to and / or engaged with the proximal end of the valve opener 134, the actuating end 436 of the nose 430 of the valve opener 134 is retained proximal to the valve disc 410, and the registration portion 926 is in press-fit contact with the inner surface of the extension sleeve 910. Therefore, preferably, when the extension 900 is attached to the catheter sleeve 102, the distal opening 934 is open to any blood B and air A that may flow into the tube 902. Fig.28 When assembled as shown in , the extension sleeve 910 and the plug 920 can move together as a unit while remaining in the assembled configuration. In a preferred embodiment, the flap 326 of the valve disc 410 maintains a seal around the distal portion 932.

[0536] In the illustrated embodiment, the distal portion 932 of the blood stopper 920 is longer than the nasal lumen 431 of the valve actuator 134. Therefore, the distal portion 932 can extend distally from the valve actuation end 436 and pass through the valve disc 410, while the valve actuation end 436 of the valve actuator 134 remains proximal to the valve disc 410. In some embodiments, the outer diameter of at least the proximal region of the distal portion 932 approaches, matches, or slightly exceeds the inner diameter of the nasal lumen 431, so that when the stopper is inserted through the valve actuator 134, a press fit is established between the distal portion and the inner surface of the nasal cavity 431. However, in other embodiments, this press fit relationship may not be employed. Furthermore, in some embodiments, the length of the distal portion 932 is selected so that when the transition portion 933 prevents the distal portion 932 from being further advanced distally through the nasal lumen 431, the distal-most portion of the distal portion 932 will push against the valve flap 326 so that the distal opening 934 is positioned to accept the blood and air flow received by the sleeve 910 from the tube 902. In other embodiments, the proper positioning of the distal portion 932 relative to the nasal portion 430 and sleeve 910 may be achieved by other structures and / or by the clinician who sets up the device.

[0537] In the plug 920 Fig.28 In the case of being arranged in the extension sleeve 910 as depicted in FIG. 1 , the extension 900 may be attached to the catheter sleeve 102, such as Fig. 27 . When such a connection is made, the Luer adapter 220 (which may have a male Luer tip with a spin-lock collar) will trigger the valve 136 of the catheter hub 102 to open, thereby allowing blood B to flow through the tube 902 and into the extension cannula lumen 912 distal to the valve 136. In some examples, the valve opener 134 may be combined with the catheter hub to open the valve 136 using the Luer adapter 220. However, it should be understood that this embodiment can be used with medical structures that may or may not have their own blood flow control structure.

[0538] Blood flowing through the tube 902 into the extension sleeve lumen 912 distal to the valve 136 will come into contact with the distal opening 934 of the plug 920 and the valve disc 410. Preferably, blood B will be prevented from flowing between the valve disc 410 and the distal portion 932, but some blood B may flow through the distal opening 934 and the distal passage 936 and into the plug lumen 922. Air A within the extension 900 before the extension 900 is attached to the catheter hub 102 will also be forced proximally by the blood B and pass through the tube 902 and into the extension sleeve lumen 912 distal to the valve 136 with the blood B, but will easily flow through the distal opening 934 and the distal passage 936 and into the plug lumen 922, from which the air A will advance and pass through the hydrophobic filter 940 to be discharged from the proximal end of the plug 920. However, blood B that enters the plug lumen 922 will be prevented from flowing further proximally by the hydrophobic filter 940. In this manner, when the extension 900 is attached to the catheter hub 102, air A is expelled from the extension 900, but blood B is contained.

[0539] It should be understood that while the illustrated plug embodiment employs a distal opening 934 and a distal passage 936 configured to resist or restrict blood flow therethrough, other embodiments may not necessarily restrict such blood flow, but may rely more entirely on other structures such as a hydrophobic filter 940. And in other embodiments, the hydrophobic filter 940 may be placed elsewhere in the plug 920 and / or the plug 920 may include multiple hydrophobic filters 940.

[0540] Next reference Fig.29 and Fig.30 , once air A has been expelled from the extension 900, the plug 920 can be removed by pulling the extension sleeve lumen 912 distally. When the plug 920 is pulled proximally, the distal portion 932 will be removed from the valve 136, and the valve disc 410 will close, forming a seal that prevents blood from flowing therethrough. The plug 920 can then be discarded after being removed from the extension sleeve, because the blood B is blocked by the valve 136 from flowing through the extension sleeve 910. When needed, a medical device 220, such as a male Luer connector or a syringe attached to a fluid source F, can then be attached to the extension sleeve 910. Insertion of the medical device 220 pushes the valve opener 134 distally relative to the valve 136, thereby opening the valve 136 so that the fluid F can be infused via the extension sleeve 910, as previously described.

[0541] It should be understood that in additional embodiments, the extension sleeve 910 can be provided without the plug 920. In such an embodiment, the valve 136 will block the blood B and air A from flowing proximally through and out of the extension sleeve 910, but, as discussed above, the valve 136 will fail when the medical device 220 is attached thereto. In still further additional embodiments, the extension sleeve 910 can initially be provided without the plug 920 and can be attached to the blood control catheter assembly 102 in such a configuration. When necessary, the clinician can engage the plug 920 with the extension sleeve 910 as needed to vent the air A that may be within the extension 900 while maintaining blood control. In still further embodiments, the extension 900 can include a plurality of tubes 902 extending from the device 220, each tube 902 terminating in a dedicated extension sleeve 910. Such extension sleeves 910 may each include a plug 920, the sleeves 910 may share a single plug 920, or may not be provided with a plug and a separately provided plug 920 may be employed or added as needed or desired.

[0542] It should also be understood that the plug 920 having features as discussed herein can be used in other applications. For example, some embodiments of the catheter sheath 102 can be configured to selectively receive the plug 920 when it is desired to vent air or other gases that may be in the attached tube 104. Thus, the embodiments are not limited to use with extension sheaths, but can be used with other medical devices and medical sheaths of various types and configurations.

[0543] It should also be understood that in additional embodiments, the extension sleeve 910 may be configured differently than specifically depicted in the illustrated embodiment, and may employ valves 136 and / or valve openers 134 having features and structures different from those depicted in the illustrated embodiment. For example, in one embodiment, the extension sleeve may be configured with a side port 810 having a valve opening 134 configured as described in accordance with FIGS. 14 to 15. Fig.23 The features of any of the embodiments of the present invention can be incorporated into the embodiments of the present invention, and similarly different embodiments of the valve 136 and the valve opener 134 can be employed. In addition, at least some extension sleeve embodiments can be configured without regard to accommodating a needle assembly. In such embodiments, neither the valve 136 nor the valve opener 134 need include structures configured to accommodate a needle or needle tip protector 132. Therefore, it is expected that such structures can vary from the structures depicted in the specifically discussed embodiments.

[0544] Methods of making and using catheter assemblies, extensions, and components thereof described elsewhere herein are within the scope of the present disclosure.

[0545] Although limited embodiments of catheter assemblies, extensions, and components thereof have been explicitly described and illustrated herein, many modifications and variations are obvious to those skilled in the art. For example, the needle guard may be one-piece, or may be integrated from more than one part (such as from a plurality of parts). In addition, it is understood and contemplated that features explicitly discussed for one catheter assembly or one component (e.g., an extension) may be included by another catheter assembly or another component, provided that the functions are compatible. Therefore, it will be understood that the catheter assembly and its components constructed according to the principles of the disclosed apparatus, system, and method may also be specifically implemented in a manner different from that explicitly described herein. By positioning the valve and valve opener described herein inside the female Luer connector of the needle sleeve, the valve and valve opener may also be used with the needle sleeve. The valve and valve opener may also be used in the female connector of an infusion needle or a blood collection device or a central venous catheter or a peripherally inserted central venous catheter (PICC) or an arterial catheter or a dialysis needle or with various types and configurations of extensions and connectors. The blood control plug can also be used in various types and configurations of extensions and connectors, as well as various types of catheters and catheter assemblies. In other words, the valve and valve opener can be used in any medical device intended to use a female Luer housing or sleeve for infusion or collection of body fluids. The present disclosure is also defined in the appended claims.

[0546] Needle assemblies, catheter assemblies, parts of needles and catheter assemblies, and methods for using and making catheter assemblies or needle assemblies according to aspects of the present invention may be covered by the following exemplary aspects:

[0547] Exemplary aspect 1: A catheter assembly comprises: a catheter body, the catheter body being attached to a catheter sleeve, the catheter sleeve comprising an inner cavity and a side port, the side port having a side port lumen, the catheter body and the side port lumen being connected to the inner cavity, and the side port opening connecting the inner cavity with the side port lumen; a valve positioned in the inner cavity of the catheter sleeve, the valve comprising a diaphragm valve body and a tube valve body, the diaphragm valve body having at least one slit and two or more flaps, the tube valve body being an elongated tubular; and a valve opener, the valve opener comprising a nose section having an activation end, the valve opener being positioned in the inner cavity so that the activation end is proximal to the flap of the diaphragm valve body, the size and shape of the valve opener being designed so that when the valve opener moves distally relative to the valve, the activation end pushes the flap to open the valve; wherein the tube valve body is biased against a surface of the inner cavity and crosses the side port opening to seal the side port opening.

[0548] Exemplary aspect 2: The catheter assembly according to aspect 1, wherein the diaphragm valve body includes a valve disc, and wherein the tube valve body extends from the valve disc in a proximal direction.

[0549] Exemplary aspect 3: The catheter assembly according to any one of aspects 1 or 2, wherein the diaphragm valve body is positioned in the lumen distal to the side port opening, and the proximal end of the tube valve body is positioned in the lumen proximal to the side port opening.

[0550] Exemplary Aspect 4: A catheter assembly according to any one of Aspects 1 to 3, wherein the tube valve body is configured such that when fluid under pressure is injected into the side port lumen, the tube valve body will deflect radially inward and away from the surface of the inner cavity, so that the fluid from the side port lumen can flow through the tube valve body and enter the inner cavity.

[0551] Exemplary Aspect 5: The catheter assembly according to any one of Aspects 1 to 4, wherein the tube valve body is deflectable by fluid pressure and is configured to deflect when fluid under pressure is injected into the side port tube cavity.

[0552] Exemplary Aspect 6: The catheter assembly according to any one of Aspects 1 to 5, wherein the valve disc is located at the distal-most end of the valve so that when the valve disc is actuated, the nose section having the actuation end is located in both the tube valve body and the valve skirt of the diaphragm valve body.

[0553] Exemplary Aspect 7: The catheter assembly of any one of Aspects 1 to 6, wherein the at least one slit comprises three slits defining three petals.

[0554] Exemplary aspect 8: The catheter assembly according to any one of aspects 1 to 7, wherein an inclined surface is provided between the interior of the valve skirt of the diaphragm valve body and the interior of the tube valve body.

[0555] Exemplary aspect 9: The catheter assembly according to any one of aspects 1 to 8, wherein the outer diameter of the diaphragm valve body is greater than the outer diameter of the tube valve body.

[0556] Exemplary aspect 10: The catheter assembly according to any one of aspects 1 to 9, wherein the diaphragm valve body is located in a recessed section within the inner cavity of the catheter hub.

[0557] Exemplary Aspect 11: The catheter assembly of any one of Aspects 1 to 10, wherein the diaphragm valve body contacts an inner shoulder of the catheter hub.

[0558] Exemplary Aspect 12: The catheter assembly of any one of Aspects 1 to 11, wherein the length of the tube valve body proximal to the valve skirt of the diaphragm valve body is approximately two to four times the length of the valve skirt.

[0559] Exemplary Aspect 13: The catheter assembly of any one of Aspects 1 to 12, wherein the valve skirt and the diaphragm valve body are integrally formed.

[0560] Exemplary Aspect 14: The catheter assembly of any one of Aspects 1 to 13, wherein the length of the nose section of the valve opener is greater than the combined length of the diaphragm valve body and the tube valve body.

[0561] Exemplary Aspect 15: The catheter assembly according to any one of Aspects 1 to 14, wherein the valve opener includes a stabilizer connecting the two plunger elements, and wherein the stabilizer is located proximal to the valve.

[0562] Exemplary Aspect 16: The catheter assembly according to any one of Aspects 1 to 15, further comprising a cap located on the side port.

[0563] Exemplary Aspect 17: The catheter assembly according to any one of Aspects 1 to 16, further comprising a pair of wings extending laterally along the catheter hub.

[0564] Exemplary Aspect 18: The catheter assembly according to any one of Aspects 1 to 17, further comprising a needle guard located between the two plunger elements of the valve opener.

[0565] Exemplary Aspect 19: The catheter assembly of any one of Aspects 1 to 18, wherein the side opening has a maximum opening size, and wherein the port lumen has a lumen opening size, and wherein the lumen opening is larger than the maximum opening size of the side opening.

[0566] Exemplary Aspect 20: The catheter assembly of any one of Aspects 1 to 19, wherein the nose section of the valve opener is located inside the valve and the actuation end is pushed against the valve disc, and wherein the tube valve body is deflected by fluid pressure within the port lumen of the side port.

[0567] Exemplary Aspect 21: The catheter assembly of any one of Aspects 1 to 20, wherein the diaphragm valve body includes a valve disc, and wherein the tube valve body extends in a distal direction from the valve disc.

[0568] Exemplary Aspect 22: A catheter assembly according to any one of Aspects 1 to 21, wherein the diaphragm valve body is positioned within the inner cavity proximal to the side port opening, and the proximal end of the tube valve body is positioned within the inner cavity proximal to the side port opening, and the distal end of the tube valve body is located distal to the side port opening.

[0569] Exemplary Aspect 23: A catheter assembly according to any one of Aspects 1 to 22, wherein the tube valve body (830) is configured such that when fluid under pressure is injected into the side port lumen (814), the tube valve body (830) will deflect radially inward and away from the surface of the inner cavity (130), allowing the fluid from the side port lumen (814) to flow through the tube valve body (830) and into the inner cavity (130).

[0570] Exemplary Aspect 24: The catheter assembly of any one of Aspects 1 to 23, wherein a valve skirt (412) extends from the valve disc (410) in a proximal direction.

[0571] Exemplary Aspect 25: A catheter assembly according to any one of Aspects 1 to 24, wherein the tube valve body (830) and the diaphragm valve body (820) are formed separately, wherein the distal end edge of the tube valve body is located at a first distance from the valve disc, and the proximal end edge of the valve skirt is located at a second distance from the valve disc, and wherein the first distance is greater than the second distance.

[0572] Exemplary Aspect 26: The catheter assembly of any one of Aspects 1 to 25, wherein the length of the tube valve body distal to the valve disc is approximately three to five times the length of the valve skirt.

[0573] Exemplary Aspect 27: The catheter assembly of any one of Aspects 1 to 26, wherein the valve skirt of the diaphragm valve body is located proximal to the tube valve body.

[0574] Exemplary Aspect 28: The catheter assembly of any one of Aspects 1 to 27, wherein the tube valve body has an outer diameter, and the diaphragm valve body located proximal to the tube valve body has an outer diameter.

[0575] Exemplary Aspect 29: The catheter assembly of any one of Aspects 1 to 28, wherein an outer diameter of the diaphragm valve body is greater than an outer diameter of the tube valve body.

[0576] Exemplary Aspect 30: The catheter assembly according to any one of Aspects 1 to 29, wherein the diaphragm valve body is located in a recessed portion inside the catheter hub, and the recessed portion is located proximal to the tube valve body.

[0577] Exemplary Aspect 31: The catheter assembly of any one of Aspects 1 to 30, wherein the nose segment of the valve opener has a length, and wherein the length of the nose segment is shorter than the length of the tube valve body but longer than the length of the valve skirt of the diaphragm valve body.

[0578] Exemplary Aspect 32: The catheter assembly of any one of Aspects 1 to 31, wherein the nose section of the valve opener is pushed against the valve disc of the diaphragm valve body and the activation end of the valve opener is located proximal to the distal end of the tube valve body.

[0579] Exemplary Aspect 33: The catheter assembly according to any one of Aspects 1 to 32, wherein the valve disc of the diaphragm valve body is located proximal to the side opening of the catheter hub.

[0580] Exemplary aspect 34: A medical sleeve assembly comprises: a medical sleeve, the medical sleeve comprising an inner cavity, the inner cavity being connected to a proximal opening and a distal opening; a valve positioned in the inner cavity of the medical sleeve, the valve comprising a valve disc having at least one slit and two or more flaps; and a valve opener, the valve opener comprising a nose section having an activation end, the valve opener being positioned in the inner cavity so that the activation end is proximal to the flaps of the valve disc, the size and shape of the valve opener being designed so that when the valve opener moves distally relative to the valve, the activation end pushes the flaps to open the valve; and a blood stopper, the blood stopper comprising a distal portion defining a distal passage terminating at the distal opening, a stopper lumen located proximal to the distal passage and connected to the distal passage, and a filter, the filter being configured to allow air to flow therethrough but block blood from flowing therethrough; wherein the distal portion is configured to extend through the valve so that the distal opening is connected to the distal opening of the medical sleeve.

[0581] Exemplary Aspect 35: The catheter assembly of Aspect 34, wherein the blood plug is selectively removable from the medical set.

[0582] Exemplary Aspect 36: The catheter assembly of any of Aspects 34 or 35, wherein the blood plug is sized and configured to be selectively inserted through the proximal opening of the medical sheath.

[0583] Exemplary Aspect 37: The catheter assembly according to any one of Aspects 34 to 36, wherein the medical sheath is an extension sheath, a tube is attached to the extension sheath to communicate with the distal opening of the extension sheath, and the medical instrument is connected to the distal end of the tube.

[0584] Exemplary Aspect 38: A catheter assembly according to any one of Aspects 34 to 37, wherein the blood plug has a registration portion, and the outer diameter of the blood plug in the registration portion is smaller than the inner diameter of the inner cavity at the proximal opening of the medical sleeve, but larger than the inner diameter of the inner cavity distal to the proximal opening of the medical sleeve.

[0585] Exemplary Aspect 39: The catheter assembly of any one of Aspects 34 to 38, wherein the valve opener nose section has a nose lumen, and the distal portion of the blood plug is sized and configured to extend through the nose lumen and extend distally from the nose section.

[0586] Exemplary aspect 40: A medical method comprises: providing a medical sleeve, the medical sleeve comprising: an inner cavity, the inner cavity being connected to a proximal opening and a distal opening; a valve, the valve being positioned in the inner cavity and comprising a valve disc having at least one slit and two or more flaps; and a valve opener, the valve opener comprising a nose section having an activation end, the valve opener being positioned in the inner cavity so that the activation end is located proximal to the flaps of the valve disc, the size and shape of the valve opener being designed so that when the valve opener moves distally relative to the valve, the activation end pushes the flaps to open the valve; placing the medical sleeve in communication with the patient's vascular system so that blood and air flow through the nose section. The invention relates to a method of manufacturing a blood plug comprising: providing a blood plug through a distal opening of the medical sleeve and into a lumen distal to the valve disc; providing a blood plug comprising a distal portion defining a distal passage terminating at the distal opening, a plug lumen located proximal to and in communication with the distal passage, and a filter configured to allow air to flow therethrough but block blood from flowing therethrough; advancing the blood plug distally through the proximal end of the medical sleeve so that the distal portion extends through the valve disc and the distal opening is in communication with the blood and air, wherein air flows through the distal opening and the distal passage and further through the filter, but blood is blocked from flowing through the filter; and removing the blood plug from the medical sleeve.

[0587] Exemplary Aspect 41: The medical method of Aspect 40, wherein the blood plug is advanced distally through the proximal end of the medical cuff prior to placing the medical cuff in communication with the patient's vasculature.

[0588] Exemplary Aspect 42: The medical method according to any one of Aspects 40 or 41, wherein the flap achieves a seal around a distal portion of the blood plug.

[0589] Exemplary Aspect 43: The medical method according to any one of Aspects 40 to 42, wherein when the blood plug is removed from the medical set, the valve disc establishes a seal that blocks fluid from flowing proximally past the valve disc.

[0590] Exemplary Aspect 44: The medical method of any one of Aspects 40 to 43, additionally comprising advancing a medical implement through the proximal opening of the medical sheath such that the medical implement pushes the valve opener distally relative to the valve to open the valve.

[0591] Exemplary aspect 45: A method for forming a catheter assembly, comprising: attaching a catheter body to a catheter sleeve, the catheter sleeve comprising an inner cavity and a side port, the side port having a side port lumen and a side port opening, the catheter body, the side port lumen, the inner cavity and the side port opening being connected to each other; positioning a valve in the inner cavity of the catheter sleeve, the valve comprising a diaphragm valve body and a tube valve body, the diaphragm valve body having at least one slit and two or more flaps, and the tube valve body being an elongated tubular and biased against a surface of the inner cavity so as to movably seal the side port opening; and positioning a valve opener in the inner cavity, the valve opener comprising a nose section having an activation end, such that the activation end is proximal to the flap of the diaphragm valve body, the size and shape of the valve opener being designed such that when the valve opener moves distally relative to the valve, the activation end pushes the flap to open the valve.

[0592] Exemplary aspect 46: The method of forming according to aspect 45, wherein the valve is positioned such that the valve disc is distal to the tube valve body.

[0593] Exemplary Aspect 47: The method of forming according to any of Aspects 45 or 46, wherein the valve is positioned such that the valve disc is located proximal to the tube valve body.

[0594] Exemplary aspect 48: A method for forming a medical set assembly, comprising: placing a valve in an inner cavity of the medical set, the valve comprising a valve disc having at least one slit and two or more flaps, and the inner cavity of the medical set is connected to a proximal opening and a distal opening; placing a valve opener in the inner cavity of the medical set, the valve opener comprising a nose section, the nose section having an activation end located proximal to the flaps of the valve disc, the size and shape of the valve opener being designed so that when the valve opener moves distally relative to the valve, the activation end pushes the flap to open the valve; and placing a blood plug in the inner cavity of the medical set, the blood plug comprising a distal portion defining a distal passage terminating at the distal opening, a plug lumen located proximal to the distal passage and connected to the distal passage, and a filter, the filter being configured to allow air to flow therethrough but block blood from flowing therethrough; wherein the distal portion is configured to extend through the valve so that the distal opening is connected to the distal opening of the medical set.

[0595] Exemplary Aspect 49: The forming method according to Aspect 48, wherein the distal portion is located between the two plunger elements at the activation end of the valve opener.

Claims

1. A catheter assembly (100, 400, 800), comprising: a catheter tube (104) attached to a catheter sheath (102), the catheter sheath (102) comprising an inner lumen (130) and a side port (810), the side port (810) having a side port lumen (814), the catheter tube (104) and the side port lumen (814) being in communication with the inner lumen (130), and a side port opening (816) connecting the inner lumen (130) with the side port lumen (814); a valve (136) positioned in the inner cavity (130) of the catheter sheath (102), the valve (136) comprising a diaphragm valve body (820) and a tube valve body (830), the diaphragm valve body (820) having at least one slit (324) and two or more flaps (326), and the tube valve body (830) being elongated and tubular; as well as a valve opener (134), the valve opener (134) comprising a nose section (150, 430) having an activation end (166, 436), the valve opener (134) being positioned in the inner cavity (130) such that the activation end (166, 436) is proximal to a flap (326) of the diaphragm valve body (820), the valve opener (134) being sized and shaped such that when the valve opener (134) moves distally relative to the valve (136), the activation end (166, 436) pushes the flap (326) to open the valve (136); The tube valve body (830) is biased against a surface of the lumen (130) and traverses the side port opening (816) to seal the side port opening (816).

2. The catheter assembly according to claim 1, wherein: The diaphragm valve body (820) includes a valve disc (410), and wherein the tube valve body (830) extends from the valve disc (410) in a proximal direction.

3. The catheter assembly according to any one of claims 1 or 2, wherein: The diaphragm valve body (820) is positioned in the lumen (130) distally of the side port opening (816), and the proximal end of the tube valve body (830) is positioned in the lumen (130) proximally of the side port opening (816).

4. The catheter assembly according to any one of claims 1 to 3, wherein: The tube valve body (830) is configured such that when fluid under pressure is injected into the side port lumen (814), the tube valve body (830) will deflect radially inward and away from the surface of the inner cavity (130), allowing the fluid from the side port lumen (814) to flow through the tube valve body (830) and into the inner cavity (130).

5. The catheter assembly according to any one of claims 1 to 4, wherein: The diaphragm valve body (820) includes a valve disc (410), and wherein the tube valve body (830) extends from the valve disc (410) in a proximal direction.

6. The catheter assembly according to any one of claims 1 to 5, wherein: The diaphragm valve body (820) is positioned within the inner cavity (130) proximal to the side port opening (816), and the proximal end of the tube valve body (830) is positioned within the inner cavity (130) proximal to the side port opening (816), and the distal end of the tube valve body (830) is located distal to the side port opening (816).

7. The catheter assembly according to any one of claims 1 to 6, wherein: The tube valve body (830) is configured such that when fluid under pressure is injected into the side port lumen (814), the tube valve body (830) will deflect radially inward and away from the surface of the inner cavity (130), allowing the fluid from the side port lumen (814) to flow through the tube valve body (830) and into the inner cavity (130).

8. The catheter assembly according to any one of claims 5 to 7, wherein a valve skirt (412) extends from the valve disc (410) in a proximal direction.

9. The catheter assembly according to any one of claims 1 to 8, wherein: The tube valve body (830) and the diaphragm valve body (820) are separately formed.

10. A medical kit assembly, comprising: A medical sleeve (102, 910), the medical sleeve (102, 910) comprising an inner cavity (130), the inner cavity (130) being in communication with a proximal opening and a distal opening; a valve (136) positioned in the lumen (130) of the medical sleeve (102, 910), the valve (136) comprising a valve disc (410) having at least one slit (324) and two or more flaps (326); and a valve opener (134), the valve opener (134) comprising a nose section (150, 430) having an activation end (166, 436), the valve opener (134) being positioned in the inner cavity (130) such that the activation end (166, 436) is proximal to a flap (326) of a valve disc (410), the valve opener (134) being sized and shaped such that when the valve opener (134) moves distally relative to the valve (136), the activation end (166, 436) pushes the flap (326) to open the valve (136); as well as a blood stopper (920) comprising a distal portion (932) defining a distal passageway (936) terminating at a distal opening (934), a stopper lumen (922) located proximal to the distal passageway (936) and in communication with the distal passageway (936), and a filter (940) configured to allow air to flow therethrough but block blood from flowing therethrough; The distal portion (932) is configured to extend through the valve (136) so that the distal opening (934) is in communication with the distal opening of the medical sleeve (102, 910).

11. The medical kit according to claim 10, wherein: The blood plug (920) is selectively removable from the medical set (102, 910).

12. The medical kit according to any one of claims 10 or 11, wherein: The blood stopper (920) is sized and configured to be selectively inserted through the proximal opening of the medical set (102, 910).

13. The medical set according to any one of claims 10 to 12, wherein the medical set is an extension set (910), a tube (902) is attached to the extension set (910) so as to communicate with a distal opening of the extension set (910), and a medical device (220) is connected to a distal end of the tube (902).

14. The medical kit according to any one of claims 10 to 12, wherein: The blood stopper (920) has a registration portion (926), and the outer diameter of the blood stopper (920) in the registration portion (926) is smaller than the inner diameter of the inner cavity (130) at the proximal opening of the medical sleeve (102, 910), but larger than the inner diameter of the inner cavity (130) distal to the proximal opening of the medical sleeve (102, 910).

15. The medical kit according to any one of claims 10 to 12, wherein: The valve opener (134) nose section (150, 430) has a nose lumen (431), and the distal portion (932) of the blood plug (920) is sized and configured to extend through the nose lumen (431) and extend distally from the nose section (430).

16. A method of forming a catheter assembly, comprising: Attaching a catheter tube (104) to a catheter sheath (102), the catheter sheath (102) comprising an inner lumen (130) and a side port (810), the side port (810) having a side port lumen (814) and a side port opening (816), the catheter tube (104), the side port lumen (814), the inner lumen (130) and the side port opening (816) being in communication with each other; Positioning a valve (136) in the lumen (130) of the catheter hub (102), the valve (136) comprising a diaphragm valve body (820) having at least one slit (324) and two or more flaps (326) and a tube valve body (830) being elongated and tubular and biased against a surface of the lumen (130) to removably seal the side port opening (816); as well as The valve opener (134) is positioned in the inner cavity (130), and the valve opener (134) includes a nose section (150, 430) having an activation end (166, 436), so that the activation end (166, 436) is proximal to the flap (326) of the diaphragm valve body (820), and the size and shape of the valve opener (134) are designed so that when the valve opener (134) moves distally relative to the valve (136), the activation end (166, 436) pushes the flap (326) to open the valve (136).

17. The forming method according to claim 16, wherein: The valve (136) is positioned such that the valve disc (410) is located distally of the tubular valve body (830).

18. The forming method according to any one of claims 16 or 17, wherein: The valve (136) is positioned such that the valve disc (410) is located proximal to the tube valve body (830).

19. A method of forming a medical kit assembly, comprising: Placing a valve (136) in the inner cavity (130) of the medical sleeve (102, 910), wherein the valve (136) comprises a valve disc (410) having at least one slit (324) and two or more valve flaps (326), and the inner cavity (130) of the medical sleeve (102, 910) is in communication with the proximal opening and the distal opening; placing a valve opener (134) in the inner cavity (130) of the medical sleeve (102, 910), the valve opener (134) comprising a nose section (150, 130) having an activation end (166, 436) located proximal to a flap (326) of a valve disc (410), the valve opener (134) being sized and shaped such that when the valve opener (134) moves distally relative to the valve (136), the activation end (166, 436) pushes the flap (326) to open the valve (136); and placing a blood stopper (920) in the lumen (130) of the medical set (102, 910), the blood stopper (920) comprising a distal portion (932) defining a distal passageway (936) terminating at a distal opening (934), a stopper lumen (922) located proximal to the distal passageway (936) and communicating with the distal passageway (936), and a filter (940) configured to allow air to flow therethrough but block blood from flowing therethrough; The distal portion (932) is configured to extend through the valve (136) so that the distal opening (934) is in communication with the distal opening of the medical sleeve (102, 910).

20. The forming method of claim 19, wherein the distal portion (932) is located between two plunger elements (152a, 152b) at an activation end (166, 436) of the valve opener (134).

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