Needle assembly and related methods

Abstract

The present application relates to needle assemblies and related methods. Aspects of the present disclosure include a catheter device (100, 12) in which a hub (50) is disposed in an inner lumen (92) of a catheter hub (101). The hub (50) has a flexible portion (63) that extends out of a distal end (91) of the catheter hub (101). A catheter tube (140) is sleeved over the flexible portion (63). A needle hub (102) has a needle (110) that protrudes through the flexible portion (63) of the hub (50) and the catheter tube (140). The flexible portion (63) is bendable to form at least one curved portion (67) along the flexible portion (63). The at least one curved portion (63) has a minimum bend radius when a first surface of the flexible portion (63) is elongated and a second surface of the flexible portion (63) opposite the first surface is shortened.

Description

TECHNICAL FIELD

[0001] The present invention relates generally to needle devices, systems, and methods for use in the vascular delivery of drugs. More particularly, the present disclosure relates to catheter devices or assemblies and needle configurations for use in intravenous medical devices and methods for using and manufacturing such devices and systems. This application is a divisional application of parent application number 201780064923.5, filed August 18, 2017, entitled “Needle Assemblies and Related Methods.” BACKGROUND

[0002] Generally, vascular access devices are used to transfer fluids with a patient's vascular system. For example, catheters are used to infuse fluids, such as saline solutions, various medicinal agents, and total parenteral nutrition, into a patient, to withdraw blood from the patient, or to monitor various parameters of the patient's vascular system.

[0003] One common type of intravenous (IV) catheter is an over-the-needle peripheral IV catheter. As the name implies, the over-the-needle catheter tube is mounted around an introducer needle having a sharp distal tip. At least the inner surface of the distal portion of the catheter tube tightly wraps around or encircles the outer surface of the needle to prevent backstripping of the catheter tube during insertion of the catheter into a blood vessel. The catheter tube and introducer needle are assembled so that the needle tip of the introducer needle extends beyond the distal tip of the catheter tube, and the bevel of the needle faces upward away from the patient's skin. The catheter material can be partially transparent and can have stripes of transparent material and non-transparent stripes to provide x-ray contrast. The catheter and introducer needle are typically inserted at a small angle through the patient's skin into the blood vessel.

[0004] To verify proper placement of the needle and catheter in the blood vessel, the clinician typically looks for blood flashback as confirmation of access. The first blood flashback through the needle and into the transparent needle hub is sometimes referred to as primary blood flashback. This confirms that at least the needle has found the vein. Then, as the needle is withdrawn in the proximal direction away from the catheter tube, blood will flashback between the needle and the catheter tube. This is sometimes referred to as secondary flashback, which confirms that the catheter tube has found the vein. Once the catheter is confirmed to be properly placed in the blood vessel, the clinician can apply pressure to the blood vessel by pressing down on the patient's skin over the blood vessel distal of the introducer needle and catheter. This finger pressure occludes the blood vessel, thereby minimizing further blood flow through and possibly leaking out of the catheter hub.

[0005] In some IV catheter assemblies, the needle has an open notch through which blood can flow into the space between the needle and the catheter tube. This "instant flash" only confirms that the needle tip has entered the vein, but does not necessarily confirm that the catheter tube has entered the vein. Because there is primary blood flow between the needle and the catheter tube when the notch is employed, secondary flashback is not possible.

[0006] The clinician can then withdraw the introducer needle from the catheter. The introducer needle can be withdrawn into a needle tip shield or needle cap that covers the needle tip and prevents accidental needle sticks. When the needle has an open notch, blood between the distal opening and the open notch does not remain by capillary action, but instead drips off the needle.

[0007] After the needle is withdrawn from the catheter, the catheter hub can then be taped to the patient's skin with adhesive tape to securely hold the catheter hub in place, and the catheter tube accesses the blood vessel through the insertion site. Frequently, after the catheter hub has been secured to the patient, the axis of the catheter tube can not be aligned with the centerline of the catheter hub and / or be off-center from the centerline of the catheter hub. The difference in alignment between the catheter tube and the catheter hub centerline can cause the flexible tube to form a sharp bend, which can affect the patient's comfort at the insertion site, restrict flow through the catheter tube at the bend, or create a kink along the catheter tube. Any movement from the patient, such as, for example, stretching or flexing of the muscle near the insertion site, can increase the patient's discomfort and can cause a kink to form in the catheter tube. SUMMARY

[0008] Various embodiments of the needle safety assembly have several features, none of which is solely responsible for their desirable attributes. Without intending to limit the scope of the embodiments as set forth in the following claims, their more prominent features are now briefly discussed.

[0009] A catheter device or assembly provided in accordance with aspects of the present disclosure can include a catheter hub having a body defining a hollow lumen between a proximal end and a distal end, a hub sleeve, and a catheter tube extending from the hub sleeve.

[0010] The needle hub and needle extending from the needle hub can protrude through the flexible tube or catheter tube. The needle tip with a needle bevel at the distal end of the needle can extend out of the distal end opening of the catheter tube in a ready position. The needle can have a wall surface defining a needle shaft having a needle lumen.

[0011] An optional needle shield or needle guard covers the needle tip in a protection position to prevent needle sticks after the needle is withdrawn from the catheter hub following a successful venipuncture and can be secured inside the lumen in a ready position. The needle shield can also be provided outside or partially outside the lumen. These needle shields can be integrally formed or can be separately manufactured from multiple parts or components that are subsequently assembled together.

[0012] The needle can include a profile or contour change having a different surface profile or shape than the remaining needle shaft. The profile change can be embodied as a wrinkle or radial bulge included near the needle tip for interaction with a perimeter defining an opening on a proximal wall of the needle guard to prevent the needle guard from dislodging distally of the needle in the protected position.

[0013] Some needle guards can operate without a profile change on the needle, such as needle guards that can have a cant or tilt such that the opening surrounding the needle can catch the needle shaft without a profile change.

[0014] The needle shield can be located in the inner lumen of the catheter hub and the needle passes through the needle shield.

[0015] The needle shield can be located outside or substantially outside of the catheter hub, such as in a third housing or guard housing located between the catheter hub and the needle hub.

[0016] The catheter tube can be connected to the distal end of the catheter hub via a bushing. The bushing can press the proximal end of the catheter tube between the exterior of the bushing and the interior surface of the catheter hub to retain the catheter tube to the catheter hub.

[0017] The bushing can be a flexible, bendable, and / or deformable bushing. The bushing can include; a proximal seat; and an elongate seat extending from the proximal seat in a distal direction. The proximal seat can have any shape. For example, the proximal seat can be tapered, non-tapered, can have a combination of both tapered and non-tapered features or surfaces, can be extended, non-extended, regular, or irregular. The elongate seat can be referred to as a distal seat.

[0018] The bushing can be fixed to the inner lumen of the catheter hub. A portion of the distal seat, such as the elongate seat, can extend from the proximal seat and out of the distal end of the catheter hub. The distal seat can be corrugated or helical and can flex and / or bend.

[0019] The portion of the distal seat, such as the elongate seat, that extends out of the distal end of the catheter hub can bend with the catheter tube to prevent the catheter tube from kinking or collapsing against the distal end of the elongate seat, as discussed further below.

[0020] According to aspects of the present disclosure, the bushing can include a proximal seat and a distal seat. The proximal seat can secure the proximal end of the catheter tube to the catheter hub. The distal seat can also secure a portion of the catheter tube to the catheter hub and can flex to prevent kinking of the catheter tube. The distal seat can have a non-uniform or non-smooth outer surface. The non-uniform surface can be a corrugated surface, a helical surface, or both.

[0021] The bushing can resemble a funnel having a tapered section and an elongated nipple extending from the tapered section. Similar to a tapered seat, the tapered section can have a body with a wall surface that tapers relative to a longitudinal axis of the elongated nipple.

[0022] Alternatively, the bushing can resemble a tube having a non-tapered section and an elongated nipple extending from the non-tapered section. Similar to a non-tapered seat, the non-tapered section can have a body with a wall surface that is substantially parallel to a longitudinal axis of the elongated nipple.

[0023] In some examples, the non-tapered seat and non-tapered section can have a slight draft angle, but much less or more gradual than the taper angle of the tapered seat. The proximal seat can be embodied as a non-tapered seat.

[0024] The needle can extend from a distal end of the needle hub and through an inner lumen of the catheter hub, through the elongated seat of the proximal seat and the bushing, and into the catheter tube, with the needle tip extending out of a distal end of the catheter tube in a ready-to-use position.

[0025] A distal portion of the catheter tube can taper inwardly or have an opening that is smaller in size than an outer diameter of the needle to form a seal with the needle around the opening of the catheter tube to prevent fluid from entering a space between the catheter tube and the needle when the needle tip pierces the skin of a patient at an incision or insertion point. The space between the needle and the interior of the catheter tube can be annular or can be segmented by a baffle such as a ridge.

[0026] Blood entering the needle hub can be collected in a vented stopper or blood collection device for sampling. Retracting the needle tip in a proximal direction back into the catheter tube can allow fluid or blood to flow into the space between the needle and the interior of the catheter tube.

[0027] The catheter hub assembly can include a catheter hub, a catheter tube, and a bushing located in an interior of the catheter hub, with a portion of the elongated seat extending distally out of a distal end of the catheter hub.

[0028] The portion of the elongated seat extending out of the distal end of the catheter hub can be flexible, such as being able to bend or flex.

[0029] The catheter hub can have an inner lumen defined between an opening at a proximal end of the catheter hub and an opening at a distal end of the catheter hub. The bushing can be inserted through the opening at the proximal end of the catheter hub and secured at the distal end of the inner lumen of the catheter hub via a press fit, an interference fit, an adhesive, a combination thereof, or other fastening means.

[0030] The bushing can include a proximal seat, such as a tapered seat, a non-tapered seat, or a combination thereof, and an elongated seat extending from the proximal seat.

[0031] The proximal seat, which can be a tapered seat, a non-tapered seat, or a combination thereof, and the elongated seat can be integrally formed.

[0032] In some examples, the non-tapered seat can have one or more portions that have a slight draft angle, but much less or more gradual than the taper angle of the tapered seat.

[0033] Embodiments of the bushing having a proximal seat, which can have a non-tapered seat, can be used with a correspondingly shaped nose section of a needle hub to attach the proximal end of a catheter tube to the catheter hub. In examples, the non-tapered seat of the bushing is positioned in the bore of the nose section of the catheter hub and wedges the catheter tube against the inner wall surface of the bore and the exterior of the proximal seat.

[0034] Alternatively, the tapered or non-tapered seat and the elongated seat can be formed as separate pieces that are assembled together by welding or other fastening means. The material of the bushing is of a type that can withstand temperature fluctuations, impact, corrosive substances, heat, and atmosphere.

[0035] The bushing can be metallic or plastic, or a combination of materials.

[0036] A hydrophobic coating can be applied to at least some portions of the inner and outer surfaces of the bushing to prevent thrombosis, phlebitis, or blood clots.

[0037] A parylene coating can be applied to at least the inner surface of the elongated seat portion to prevent thrombosis.

[0038] The tapered seat can be conical or funnel-shaped with a defined thickness, where the body has a wider opening at the proximal end and a relatively narrower opening at the distal end of the funnel body. The narrower opening can transition to the elongated seat.

[0039] The non-tapered seat can be cylindrical and have the same diameter as the elongated seat. Alternatively, the non-tapered seat can have a different diameter than the elongated seat. The non-tapered seat can be rigid and non-flexible or semi-rigid.

[0040] The proximal seat, which can have a tapered seat, a non-tapered seat, or a combination thereof, can have slots to facilitate flexing and assembly of the bushing into the nose section of the catheter hub. The slots can be parallel to the longitudinal axis of the catheter hub. The slots can be spaced apart from each other.

[0041] The tapered seat can be rigid and non-flexible or semi-rigid to maintain its conical shape after insertion into the catheter hub, thereby wedging the proximal end of the catheter tube into the interior of the catheter hub.

[0042] Alternatively, the proximal seat, which can include a tapered or non-tapered seat, can be flexible and elastic. The proximal seat, such as a tapered or non-tapered seat, can be secured inside the inner lumen of the catheter hub by an interference fit or by using fastening means such as recessed surfaces, lugs, shoulders, washers, or stop nuts, etc.

[0043] A retention mechanism or retainer can also be provided inside the catheter hub to secure the tapered or non-tapered seat inside the inner lumen.

[0044] The bushing can be inserted into the inner lumen of the catheter hub from an opening at the proximal end of the catheter hub and pushed distally until the tapered or non-tapered seat slides past the retainer and snaps into a secure position between the distal end of the catheter hub and the retainer.

[0045] The retainer can be a raised circumferential ring or shoulder formed inside the inner lumen of the catheter hub for the proximal end of the tapered or non-tapered seat to rest against.

[0046] The raised circumferential ring or shoulder can have a bore diameter that is smaller or slightly smaller than the diameter of the wider opening at the proximal end of the tapered or non-tapered seat to provide a forced engagement of the tapered or non-tapered seat and prevent the tapered or non-tapered seat from sliding proximally out after snapping into place.

[0047] The circumferential ring can taper inward distally to help the bushing slide into the secure position.

[0048] The circumferential ring can have a recess or other surface feature to resist the distal end of the tapered or non-tapered seat and prevent the bushing from sliding proximally out of the inner lumen.

[0049] The retainer can be a series of lugs or protrusions.

[0050] The elongated seat of the bushing can be cylindrical and extend from a narrow opening at the distal end of the tapered or non-tapered seat.

[0051] The elongated seat can have a smooth portion transitioning from the distal end of the tapered or non-tapered seat, a less smooth portion, and a distal end that can be smooth and tapered (as shown) or can have a roughened surface.

[0052] The smooth portion can have an outer surface appearance that is generally flat or has less surface roughness compared to the less smooth portion.

[0053] The less smooth portion can be a flexible portion formed distally of the smooth portion of the elongated seat.

[0054] The smooth portion can be omitted, in which case the elongated seat includes only the less smooth portion extending from the tapered or non-tapered seat.

[0055] The less smooth or flexible portion can deform or bend more easily than the smooth portion. The smooth portion and the tapered or non-tapered seat can be rigid and inflexible or semi-rigid with some flexibility.

[0056] The flexible portion can be flexible and can be bent along the length of the flexible portion to form a bend, a curve, or a kink along the length of the flexible portion.

[0057] The flexible portion can be compressed to form a shorter flexible portion or pulled, such as stretched, to form a longer flexible portion.

[0058] The flexible portion can have a number of alternating ridges and grooves.

[0059] The smooth portion can be free of any alternating grooves and ridges.

[0060] The alternating ridges and grooves of the flexible portion can be rounded along the peaks and valleys to form a bellows structure with a corrugated profile.

[0061] The alternating ridges and grooves can be folded over one another to form an accordion-like structure.

[0062] The combination of the folded and rounded ridges and grooves can form the flexible portion.

[0063] The bellows structure can allow the elongated seat to move, flex, kink, and / or bend to adjust the flexible portion for alignment for use when the catheter tube is inserted into a patient, for securing, or for any number of reasons.

[0064] The bellows structure can also absorb motion and vibration.

[0065] The alternating ridges and grooves can allow the flexible portion to bend and form one or more curves or kinks along the length of the flexible portion.

[0066] The flexible portion of the elongated seat can be manipulated from an initial straight configuration to a new configuration with one or more bends, with compressed portions, and / or stretched portions.

[0067] The flexible portion can remain in its current configuration without elastically returning to its original configuration, the flexible portion can be elastic where the flexible portion can spring back or return to its original shape after being deformed, or the flexible portion can be freely manipulated but can not hold a new configuration or return to its original shape.

[0068] The bellows structure can transport liquids and gases under pressure in the operating conditions of the catheter assembly.

[0069] A hydrophobic coating can be applied to the bushing to form a surface layer on the interior of the elongated seat to repel blood and prevent thrombosis or coagulation from occurring due to blood collection on the corrugated profile surface.

[0070] The elongated seat can be inserted into the catheter tube such that the flexible portion is inside the catheter tube and the proximal end of the catheter tube is at the smooth portion. The catheter tube can extend to the tapered or non-tapered seat, or at least a portion of the way to the tapered or non-tapered seat.

[0071] The insertion end of the elongated seat can be tapered and can be provided at the free end of the flexible portion to assist in assembling the elongated seat into the catheter tube.

[0072] A seal can be formed at the interface between the inner lumen of the catheter tube and the bushing such that fluid cannot flow therebetween.

[0073] The diameter of the elongated seat can be the same as or larger than the diameter of the inner lumen of the catheter tube. Thus, the catheter tube can be stretched to fit over the elongated seat to form a tight, secure fit.

[0074] An adhesive or other securing means can be provided to further secure the catheter tube to the elongated seat and / or the tapered or non-tapered seat.

[0075] The flexible portion can be bent to form an elbow. If the flexible portion is long enough, more than one elbow can be formed. An elbow can be formed when one of the corrugated surfaces, such as the inner radius of the elongated seat, is shortened and the opposite surface, such as the outer radius of the elongated seat, is lengthened.

[0076] The bend radius of the elbow can depend on the diameter of the flexible portion and the geometry and dimensions of the ridges and grooves, such as, for example, the width of the ridges and the width of the grooves, which for a given length of the flexible portion can determine the number of ridges and grooves.

[0077] The minimum bend radius of the elbow can occur when the ridges contact each other along the interior of the elbow and are furthest apart along the exterior of the elbow.

[0078] The maximum bend angle of the bushing can be achieved at the minimum bend radius of the elbow.

[0079] The catheter tube can be attached to the elongated seat of the bushing.

[0080] The catheter tube can be fitted over the elongated seat to at least surround the flexible portion of the elongated seat to prevent the catheter tube from kinking or collapsing within the flexible portion.

[0081] If the smooth portion is present, the catheter tube can also be fitted over the smooth portion.

[0082] The catheter tube can be bent along the flexible portion with the elbow to prevent kinking, collapse, or restriction of flow of the catheter tube, even if the catheter tube is bent due to inadvertent movement or the like (such as during securement of the catheter assembly). Thus, the flexible portion can impart flexibility to the catheter tube while maintaining flow through the catheter tube and the catheter hub.

[0083] The flexible portion can impart flexibility to the catheter tube and prevent kinking of the catheter tube at a location outside of the catheter hub while maintaining flow through the catheter tube and the catheter hub.

[0084] The smooth portion can be rigid and non-bendable.

[0085] The elbow can also maintain the bent configuration of the catheter tube by reducing or eliminating any restoring force caused by the normally curved catheter tube. That is, any deviation of the catheter tube from the axis of the catheter hub can be imparted to the flexible portion of the elongate seat rather than the insertion point of the catheter tube to reduce discomfort to the patient.

[0086] The occurrence of phlebitis due to movement of the catheter tube at the insertion point can be reduced.

[0087] The distal end of the catheter hub can have a radiused opening that forms a recess to accommodate flexing of the catheter tube and the flexible portion of the elongate seat at a location outside of the catheter hub.

[0088] The shape of the recess is not limited, but can be embodied as any shape that provides sufficient clearance to accommodate movement of the catheter tube and the flexible portion at a location outside of the catheter hub, such as distally of the distal end.

[0089] The recess can allow the catheter tube to bend with the flexible portion of the hub inside the recess. The dimensions of the recess can be designed to restrict or allow the maximum bend of the flexible portion with the catheter tube.

[0090] The flexible portion of the elongate seat of the hub can have a continuous ridge that spirally continues around the length of the flexible portion from one end of the flexible portion to the other end of the flexible portion to form a spiral bellows structure along the length of the flexible portion rather than alternating ridges and grooves.

[0091] Thus, the present hub can be understood to include a spiral ridge that extends from one end of the flexible portion to the other end of the flexible portion.

[0092] The hub can include a tapered seat and an elongate seat extending from the tapered seat.

[0093] The elongate seat can include the flexible portion and an optional smooth portion extending between the tapered seat and the elongate seat.

[0094] An insertion end having a taper can be provided at the distal end of the flexible portion to help seat the catheter tube over the elongated seat of the hub.

[0095] A seal can be formed between the lumen of the catheter tube and the hub.

[0096] The hub can be bent along the flexible portion to form one or more bends or elbows.

[0097] The bend radius of the elbow can depend on the geometry and dimensions of the continuous ridge and groove. When bent, a portion of one side of the flexible portion will shorten while another portion at the opposite side will lengthen.

[0098] The hub can include a proximal seat, such as a non-tapered seat, and an elongated seat extending from the non-tapered seat. The elongated seat can include the flexible portion and an optional smooth portion extending between the proximal seat and the elongated seat.

[0099] The flexible portion of the elongated seat of the hub can have alternating ridges and grooves along the length of the flexible portion to form a corrugated structure or a continuous ridge that spirally continuous around the length of the flexible portion from one end of the flexible portion to the other end of the flexible portion to form a spiral corrugated tube structure.

[0100] Accordingly, the present hub can be understood to include a spiral ridge extending from one end of the flexible portion to the other end of the flexible portion or to include alternating ridges and grooves along the length of the flexible portion. The spiral ridge can extend from the proximal seat.

[0101] The non-tapered seat can be cylindrical and have substantially the same diameter as the smooth portion such that the smooth portion and the non-tapered seat are integral.

[0102] The hub can be secured inside the catheter hub using glue, an interference fit, or other securing means to prevent the hub from moving distally out of the catheter hub or into the catheter tube.

[0103] Alternatively, the non-tapered seat can have a different diameter, shape, or size than the smooth portion.

[0104] An insertion end having a taper can be provided at the distal end of the flexible portion to help seat the catheter tube over the elongated seat of the hub.

[0105] A seal can be formed between the lumen of the catheter tube and the hub.

[0106] The hub can be bent along the flexible portion to form one or more bends or elbows.

[0107] The bend radius of the elbow can depend on the geometry and dimensions of the continuous ridge and groove. When bent, a portion of one side of the flexible portion will shorten while another portion at the opposite side will lengthen.

[0108] The bushings can be formed by applying a deep draw process followed by a hydroforming process to create a corrugated surface.

[0109] A coating process can be applied to the bushings, such as to the inner surface of the bushings.

[0110] The catheter assembly can include a catheter hub and a catheter tube attached to one of the bushings such that at least a portion of the elongate seat extends out of a distal end of the catheter hub.

[0111] The needle hub with the needle can extend through the catheter tube.

[0112] The catheter hub can include a side fluid port and a fluid adapter attached to the side fluid port by tubing, the tubing being attached to the side fluid port by a second bushing. A portion of the elongate seat of the second bushing can extend out of or outside the side fluid port.

[0113] The second bushing can have a cylindrical seat. To prevent the second bushing from being pulled out of the catheter hub, the second bushing can be fixed to the catheter hub with glue, an interference fit, other fixation means, or combinations thereof.

[0114] The tubing can have an inner lumen for fluid flow between the side fluid port and the fluid adapter, which can be a needleless female luer adapter.

[0115] The two bushings can each form one or more bends or elbows along the flexible portion of the respective bushing.

[0116] The flexible portions of the two bushings can bend at or inside the catheter hub or the side fluid port, near their respective openings, and at locations outside the catheter hub or the side fluid port.

[0117] The portions of the tubing and the sleeve of the catheter tube over the flexible portions of the respective bushings can also bend along the flexible portions.

[0118] The proximal end of the catheter hub can be equipped with a septum, a seal, or a valve that can prevent flow across it after the needle and needle hub are removed.

[0119] A needle guard can be included between the needle hub and the catheter hub.

[0120] The catheter hub 101 can have a pair of wings.

[0121] Alternatively, the needle hub can have wings that extend distally along a side of the catheter hub opposite the side fluid port.

[0122] The needle tip of the needle can extend distally past the distal opening of the catheter tube.

[0123] Fluid can be infused through the tubing via the fluid adapter to the side port and then to the catheter hub.

[0124] If the proximal end of the catheter hub has a valve instead of a septum or seal, fluid can be infused through the valve and catheter tube. A clamp (not shown) can also be used to clamp the extension line between the side fluid port and the fluid adapter.

[0125] The catheter assembly can include a valve activator or actuator for opening the valve 122, which can have one or more slits defining a plurality of flaps that can open when a male medical implement, such as a syringe tip, male luer connector, or luer adapter, advances the activator.

[0126] The actuator can have a nose section for physically opening the valve and a plunger end including at least one plunger element or leg configured to be pushed by a male medical implement.

[0127] The valve, valve actuator, and needle guard can be omitted.

[0128] The valve can be housed within the interior cavity of the catheter hub and, when included, have the needle protruding therethrough in a ready position.

[0129] Three slits can be provided on the valve, forming three flaps. Four slits can be provided in an "X" shape to form four flaps. Different numbers of slits and flaps can be contemplated.

[0130] The valve can seat in a valve seat formed in the interior cavity of the catheter hub.

[0131] An undercut can be formed in the interior of the catheter hub to retain the valve inside the interior cavity.

[0132] A bump or protrusion can be provided around the exterior of the valve to form a pathway between the valve and the interior of the catheter hub for venting during blood reflux.

[0133] When the needle is withdrawn from the catheter hub after the flexible tube is placed in the vasculature of a patient, the one or more slits can close such that the valve seals itself, thereby restricting or limiting flow across the valve.

[0134] Thus, the valve can restrict backflow through the catheter hub.

[0135] The valve can be composed of a material that forms a seal or restriction at the interface with the needle and reforms the seal after the needle is withdrawn.

[0136] The valve can include silicone, silicone rubber, polypropylene, or other suitable materials.

[0137] An activator can be provided to press against the valve so as to protrude through the slit to open the flap or deflect the flap when the activator is moved distally by the medical implement to open the valve to allow fluid or solution to pass through the valve.

[0138] The activator can have a channel formed through the nose section for receiving the needle in the ready position and for fluid flow when the catheter hub is connected to the IV line.

[0139] The activator can have surface features to provide fluid mixing as fluid enters the catheter hub.

[0140] After the needle and needle hub are removed, a male medical implement such as a luer tip of a syringe, a male luer connector or adapter such as used in conjunction with an IV line, a luer access connector, or a vent spike can be inserted to push the activator distally into the seal to open the seal.

[0141] The activator can be advanced distally by a syringe tip that can press against a proximal end of a valve disc of the valve to push the nose section of the activator distally forward into the valve inside the skirt to open one or more slits.

[0142] The activator can have a wedge-shaped nose section to press open the valve and one or more extensions, plungers, or legs extending in a proximal direction from the nose section to be pressed against by the male medical implement.

[0143] The extensions can be embodied as one or more separate sections that can be pressed against by the male medical implement to advance the activator against the valve.

[0144] Two spaced apart extensions can be provided to accommodate a needle guard therebetween.

[0145] The valve disc and skirt can be positioned in a seam of a two-piece catheter body.

[0146] A needle shield can be supported or housed in an intermediate hub between the catheter hub and the needle hub.

[0147] The intermediate hub can be removably coupled with the catheter hub and can be referred to as a third hub or needle shield or needle guard housing.

[0148] The catheter hub can be provided with a valve that can only be actuated with fluid pressure so that an actuator can be omitted from inside the inner lumen of the catheter hub.

[0149] The valve can be flexed by head pressure from an IV bag hanging on an IV pole that pushes against the valve upward to open one or more flow paths or channels for fluid flow.

[0150] The valve can be positioned proximal to the proximal opening of the catheter hub to be opened by a male luer connected to the proximal open end of the catheter hub without an actuator or activator.

[0151] The portion of the elongate seat of the hub extending out of the distal end of the catheter hub can form one or more bends or elbows along the flexible portion of the hub.

[0152] The flexible portion can bend at, within, and / or outside of the catheter hub. The portion of the sheath of the catheter tube over the flexible portion can also bend along the flexible portion.

[0153] The safety catheter assembly can include a needle safety shield or guard 103 that is entirely or substantially outside of the catheter hub that includes a biasing or resilient member such as a resilient arm.

[0154] The intermediate hub, needle shield hub, or third hub can be at least partially between the catheter hub and the needle hub.

[0155] The needle can have a profile change 113.

[0156] The needle shield can be on or in the intermediate hub.

[0157] The intermediate hub can have a single wall or can have an opening in the wall.

[0158] The needle shield can be supported by a sleeve of the intermediate hub or can have the distal arm directly access the needle.

[0159] The sleeve can extend from a distal wall of the intermediate hub such that the resilient arms of the needle safety shield are supported on the sleeve.

[0160] The needle can include a profile change such as a protrusion associated with the flashback indicator or on a cap applied over the flashback indicator for engaging an opening on the proximal wall of the needle shield.

[0161] The profile or profile change can engage the proximal wall of the needle shield and pull the needle shield proximally such that the two resilient arms are pulled away from the sleeve or are no longer biased against the needle but can overlap to block the needle tip.

[0162] The hub extending out of the distal end of the catheter hub can form one or more bends or elbows along the flexible portion of the hub.

[0163] The flexible portion can bend at, within, or outside of the catheter hub. The portion of the sheath of the catheter tube over the flexible portion can also bend along the flexible portion.

[0164] Aspects of the present disclosure include a catheter device or assembly that can include: a catheter hub having an internal cavity; a bushing seated in the internal cavity and having a flexible portion that extends out of a distal end of the catheter hub; a catheter tube that is sleeved over the flexible portion.

[0165] The catheter device can further include a needle hub having a needle that includes a wall surface defining a needle shaft having a needle internal cavity and that includes a needle tip that protrudes through the flexible portion of the bushing and the catheter tube.

[0166] The elongate seat of the bushing can have the flexible portion. The bushing and / or the flexible portion can have a lengthwise direction or axis.

[0167] The flexible portion can be bendable to form at least one elbow along the flexible portion to prevent kinking in the catheter tube. The at least one elbow can have a minimum bend radius when a first surface of the flexible portion is elongated and a second surface of the flexible portion opposite the first surface is shortened.

[0168] The bend radius of the at least one elbow can define an elbow. The radial elbow of the elbow can depend on the diameter of the flexible portion and the geometry and dimensions of the ridges and grooves of the flexible portion. For example, for a given length of the flexible portion, the width of the ridges and the width of the grooves along the length of the flexible portion can determine the number of ridges and grooves. The minimum bend radius of the elbow can occur when the ridges contact each other along the interior of the elbow and are furthest apart from each other along the exterior of the elbow at the surface of the elbow.

[0169] The minimum bend radius of the elbow can occur when the ridges contact each other along the interior of the first bushing half or the gap or spacing can be shortened but not touching and the ridges are furthest apart from each other along the exterior of the second bushing half or more if an imaginary plane bisects the bushing, such as the diameter of the elongate seat of the bushing, along the lengthwise direction of the bushing to divide the bushing into two halves, which can be referred to as a first bushing half and a second bushing half.

[0170] The first bushing half and the second bushing half are mentioned only to distinguish the two segments of the elongate seat but are not a structural limitation. Thus, it can also be said that the maximum bend radius of the elbow can occur when the ridges are spread apart from each other along the exterior of the first bushing half and are shortened or closer together along the interior of the second bushing half. In other words, the at least one elbow can have a minimum bend radius when a first surface of the first bushing half of the elongate seat is elongated and a second surface of the second bushing half of the elongate seat is shortened.

[0171] Because the flexible portion of the hub can bend in any number of locations and bending directions (depending on the force applied to the catheter tube and / or the hub to induce bending and cause at least one curvature on the hub), different opposing surfaces of the hub can experience changes (such as deformations, stretches, compressions, etc.) to cause different portions of the hub to be referred to as a first hub half and a second hub half depending on the direction of the bend.

[0172] Accordingly, a catheter assembly of the present disclosure can include a catheter hub having a hub body defining an internal cavity, a hub having at least partially disposed in the internal cavity and having an elongate seat having a portion extending out of a distal end of the catheter hub, the elongate seat including a first hub half and a second hub half located on different sides of a plane extending longitudinally along a diameter of the hub, a catheter tube sleeved over the elongate seat including sleeved over the portion extending out of the distal end of the catheter hub or into a distal opening at a distal end of the elongate seat, a needle hub having a needle including a needle shaft having a needle internal cavity and including a needle tip, the needle shaft protruding through the elongate seat of the hub and the catheter tube in a ready to use position.

[0173] In some examples, the elongate seat is bendable to form at least one curvature along its length to prevent kinking in the catheter tube, the at least one curvature having a minimum bend radius when a first surface of the first hub half of the elongate seat is elongated and a second surface of the second hub half of the elongate seat is shortened.

[0174] The flexible portion can form a bellows structure having alternating ridges and grooves. The alternating ridges and grooves are rounded to form a bellows profile surface. Alternatively, the alternating ridges and grooves can be folded over one another to form an accordion structure. In other embodiments, a combination of folded and rounded ridges and grooves can form the flexible portion.

[0175] The flexible portion can be bent along the flexible portion to form one or more curvatures. A minimum bend radius of the one or more curvatures can be achieved when the alternating ridges at a first surface of the flexible portion are stretched further away from one another and the alternating ridges at a second surface of the flexible portion opposite the first surface are in contact with one another.

[0176] A hydrophobic coating can also be formed on an inner surface of the flexible portion. The hydrophobic coating can be a parylene coating. The parylene coating can prevent blood from collecting inside the flexible portion to prevent phlebitis or thrombus formation.

[0177] The flexible portion can also form a spiral bellows structure having a continuous ridge spirally formed continuously around the flexible portion from one end of the flexible portion to the other end of the flexible portion. A minimum bend radius of the flexible portion having the spiral bellows structure can be achieved when adjacent portions of the ridge at a first surface of the flexible portion are spread further apart from each other and adjacent portions of the ridge at a second surface of the flexible portion are touching, where the first surface is opposite the second surface. A hydrophobic coating can also be formed on an inner surface of the flexible portion. The hydrophobic coating can be a parylene coating.

[0178] The hub can also include a tapered or non-tapered seat coupled to the flexible portion. The tapered or non-tapered seat can be integrally formed with the flexible portion. The tapered or non-tapered seat is conical, having a wider opening at a proximal end and a narrower opening at a distal end.

[0179] A smooth portion can be coupled between the tapered or non-tapered seat and the flexible portion. That is, the smooth portion can extend from the distal end of the tapered or non-tapered seat. The smooth portion can be more rigid than the flexible portion. The tapered portion can extend from the distal end of the flexible portion.

[0180] The hub can be metallic. Alternatively, the hub can be plastic.

[0181] A retainer can be formed inside the inner lumen of the catheter hub to secure the tapered or non-tapered seat of the hub inside the inner lumen. The retainer can be a circumferential ring protruding from a surface of the inner lumen having a bore diameter smaller than the diameter of the tapered or non-tapered seat.

[0182] A recess can be defined in the distal end of the catheter hub. The recess can be frustoconical in shape. The shape of the recess is not limited and can be other shapes, such as a cylindrical shape.

[0183] A valve and an activator can be located in the inner lumen of the catheter hub and proximal to the valve. The activator can be configured to press open the valve. The activator can include at least one plunger element configured to be pushed by a male luer tip.

[0184] A needle shield can be provided to cover the needle tip. The needle shield can be located substantially in the inner lumen of the catheter hub, or in an intermediate hub proximal to the catheter hub.

[0185] A side port can be formed with the catheter hub, with another hub having a flexible portion extending out of a distal end of the side port. Thus, the catheter hub having a side port can have two hubs extending out of a distal end of the catheter hub and the side port. A catheter tube can be attached to the flexible portion of the hub extending out of the distal end of the catheter hub, and tubing can be attached to the flexible portion of the other hub extending out of the side port. A fluid adapter can be attached to a free end of the tubing.

[0186] Another aspect of the present disclosure includes a method for manufacturing a catheter assembly. The method can include forming a catheter hub having an internal cavity; and forming a bushing.

[0187] The bushing can be formed by a deep drawing process. A hydroforming process can be applied to create a corrugated surface on the flexible portion of the bushing.

[0188] The catheter tube can then be sleeved over the flexible portion. The bushing can be secured with the catheter tube in the internal cavity of the catheter hub with the flexible portion extending out of the distal end of the catheter hub.

[0189] A needle hub can be formed having a needle including a wall surface defining a needle shaft and including a needle tip, the needle shaft having a needle internal cavity. The needle can protrude through the flexible portion of the bushing and the catheter tube.

[0190] The flexible portion can be bendable to form at least one curvature along the flexible portion to prevent kinking in the catheter tube. The at least one curvature can have a minimum bend radius when a first surface of the flexible portion is elongated and a second surface of the flexible portion opposite the first surface can be shortened.

[0191] The method can further include coating an inner surface of the flexible portion of the bushing to form a hydrophobic coating.

[0192] The method can further include placing a needle guard having a proximal wall having a proximal opening and two resilient arms slidable over the needle shaft.

[0193] A valve can be used to restrict fluid flow through the catheter hub with an actuator in dynamic contact with the valve.

[0194] Alternative embodiments include placing the catheter tube inside the elongated seat and then securing the catheter tube to the bushing.

[0195] In an example, the bushing is made of a metallic material or from a polymer or polymer matrix material. The catheter tube can be inserted into a distal opening at a distal end of the elongated seat, such as sleeved into the bushing.

[0196] In an example, the proximal end of the catheter tube is inserted into a position along a less smooth portion of the elongated seat. In another example, the proximal end of the catheter tube is inserted into a position along a smooth portion of the elongated seat. Ultrasonic welding can then be used to weld the catheter tube to the bushing using a modified sonotrode, which is understood to be a tool that generates ultrasonic vibrations.

[0197] Another alternative embodiment includes placing the catheter tube inside the elongated seat of the hub and then securing the catheter tube to the hub with an adhesive or glue. In an example, glue is applied (such as sprayed, dipped, or painted) onto the inner surface of the elongated seat.

[0198] The proximal end of the catheter tube can then be inserted into the distal opening at the distal end of the elongated seat. The adhesive or glue can air dry or dry with the help of heat activation.

[0199] Thus, as described above, the catheter tube can be sleeved on or into the hub. For example, the catheter tube can be sleeved on or into the elongated seat.

[0200] Elbows, kinks, bends, and inflections can be understood as synonymous structures and caused by movement of the hub, such as when the flexible portion of the hub is moved. An elbow, kink, bend, or inflection is a structure that is not substantially linear as in a hub having a straight or linear nose section.

[0201] Aspects of the present disclosure can include a catheter assembly comprising: a catheter hub having a hub body defining an internal cavity; a hub having an elongated seat at least partially disposed in the internal cavity and having a portion extending out of a distal end of the catheter hub; a catheter tube sleeved on the elongated seat, including sleeved on the portion extending out of the distal end of the catheter hub or into a distal opening at the distal end of the elongated seat; a needle hub having a needle including a needle shaft having a needle internal cavity and including a needle tip, the needle shaft protruding through the elongated seat of the hub and the catheter tube in a ready to use position; and wherein the elongated seat is bendable to form at least one kink along its length to prevent kinking in the catheter tube, the at least one kink having a minimum bend radius when a first surface of the elongated seat is lengthened and a second surface of the elongated seat opposite the first surface is shortened.

[0202] A method for manufacturing a catheter assembly can include: forming a catheter hub having an internal cavity; sleeving a catheter tube on a corrugated surface of an elongated seat of a hub or into the elongated seat of the hub; securing the hub in the internal cavity of the catheter hub; extending a portion of the corrugated surface out of a distal end of the catheter hub; forming a needle hub having a needle including a needle shaft having a needle internal cavity and including a needle tip, the needle shaft protruding through the elongated seat of the hub and the catheter tube; and wherein the elongated seat is bendable to form at least one kink to prevent kinking of the catheter tube, the at least one kink having a minimum bend radius when a first surface of the elongated seat is lengthened and a second surface of the elongated seat opposite the first surface is shortened. BRIEF DESCRIPTION OF DRAWINGS

[0203] These and other features and advantages of the present devices, systems, and methods will become better understood with reference to the following description and appended claims, taken in conjunction with the accompanying drawings, where:

[0204] Figure 1 is a cross-sectional view of a safety IV catheter assembly provided in accordance with aspects of the present disclosure;

[0205] Figure 2 is an isometric view of a catheter hub assembly provided in accordance with aspects of the present disclosure;

[0206] Figure 3 is a cross-sectional view of the catheter hub assembly of Figure 2 ;

[0207] Figure 4 shows an embodiment of a flexible hub provided in accordance with aspects of the present disclosure in side view;

[0208] Figure 5 shows the flexible hub of Figure 4 attached to a catheter tube;

[0209] Figure 6 shows the flexible hub of Figure 4 with the catheter tube in a partially deflected state;

[0210] Figure 7 shows the flexible hub of Figure 4 with the catheter tube in a partially deflected state;

[0211] Figure 8 shows the flexible hub assembly of Figure 2 in a partially deflected state;

[0212] Figure 9A shows another embodiment of a flexible hub provided in accordance with aspects of the present disclosure;

[0213] Figure 9B shows yet another embodiment of a flexible hub provided in accordance with aspects of the present disclosure;

[0214] Figure 10 shows another embodiment of a safety IV catheter assembly;

[0215] Figure 11 shows yet another embodiment of a safety IV catheter assembly; and

[0216] Figure 12 shows still yet another embodiment of a safety IV catheter assembly. DETAILED DESCRIPTION

[0217] The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of the needle assembly and components for use with or to form a needle assembly provided in accordance with aspects of the devices, systems, and methods, and is not intended to represent the only forms in which the devices, systems, and methods can be constructed or utilized. The description sets forth the features and the steps for constructing and using an embodiment of the devices, systems, and methods in connection with the illustrated embodiments. It will be understood, however, that the same or equivalent

[0218] Figure 1 A catheter device or assembly 100 provided in accordance with aspects of the present disclosure is shown. The catheter device 100 can include a catheter hub 101 having a body 88 defining a hollow lumen 92 between a proximal end 93 and a distal end 91, a needle hub 102, and a needle 110 extending from the needle hub 102 and protruding through a flexible tube or catheter tube 140. A needle tip 112 with a needle bevel at a distal end of the needle 110 can extend out of a distal end opening 142 of the catheter tube 140 in a ready position. Figure 1 The needle 110 can be understood to have a wall surface defining a needle shaft 111 having a needle lumen.

[0219] Optionally, the catheter device 100 can include a needle shield or needle guard 103 to cover the needle tip 112 in a protected position to prevent needle sticks after the needle 110 is withdrawn from the catheter hub 101 after a successful venipuncture. The needle shield can be secured inside the lumen 92 in a ready to use position. The needle shield can also be provided outside or partially outside the lumen 92 as discussed further below with reference to Figure 12 Examples of needle shields can be found in U.S. Patent No. 8,827,965 and U.S. Patent Application No. 13 / 257,572 (published as US 2012 / 0046620 Al), the contents of which are expressly incorporated herein by reference. These needle shields can be integrally formed or can be separately manufactured from multiple parts or components that are subsequently assembled together.

[0220] The needle 110 can include a profile or contour change 113 having a different surface profile or shape than the remainder of the needle shaft. The profile change 113 can be embodied as a fold or radial bulge included near the needle tip 112 for interaction with the perimeter defining the opening on the proximal wall of the needle guard 103 to prevent the needle guard 103 from dislodging distally of the needle 110 in the protected position. Some needle guards 103 can operate without the profile change 113 on the needle 110, such as needle guards that can have a bevel or incline such that the opening surrounding the needle can catch the needle shaft without the profile change. In Figure 1 In embodiments, the needle shield 103 is located in the lumen of the catheter hub 101 and the needle 110 passes through the needle shield 103. In other examples, the needle shield 103 is located outside or substantially outside of the catheter hub, such as in a third housing or guard housing located between the catheter hub and the needle hub. Optionally, the needle guard 103 can be omitted.

[0221] The catheter tube 140 can be connected to the distal end of the catheter hub 101 via a hub 50. The hub 50 compresses the proximal end of the catheter tube 140 between the exterior of the hub and the interior surface of the catheter hub to retain the catheter tube to the catheter hub. In alternative embodiments, instead of clamping the proximal end of the catheter tube between the catheter hub and the exterior of the hub, the catheter tube 140 can be inserted inside the hub and secured to the hub, such as by gluing or welding the catheter tube and hub together, as discussed further below.

[0222] In examples, the hub 50 can be a flexible, bendable, and / or deformable hub. The hub 50 can include an anchor or proximal seat, such as a conical seat 55 or a non-conical seat (not shown); and an elongate seat 60, which can also be referred to as a distal seat, extending from the conical seat 55 in a distal direction. The shape of the proximal seat is not limited to conical or non-conical. For example, the shape of the proximal seat can have a combination of both conical and non-conical features, can be extended, non-extended, regular, or irregular. Figure 9B In one example and when the hub 50 is secured to the lumen 92 of the catheter hub 101, a portion of the elongate seat 60 extending from the conical seat 55 can extend out of the distal end 91 of the catheter hub 101. In examples, this portion of the elongate seat 60 extending out of the distal end 91 of the catheter hub 101 can bend with the catheter tube 140 to prevent the catheter tube 140 from kinking or collapsing against the distal end of the elongate seat 60, as discussed further below. The hub 50 can resemble a funnel having a conical section and an elongate tube head extending from the conical section. Similar to the conical seat 55, the conical section has a body with a wall surface tapering relative to the longitudinal axis of the elongate tube head.

[0223] In one example and when the hub 50 is secured to the lumen 92 of the catheter hub 101, a portion of the elongate seat 60 extending from the conical seat 55 can extend out of the distal end 91 of the catheter hub 101. In examples, this portion of the elongate seat 60 extending out of the distal end 91 of the catheter hub 101 can bend with the catheter tube 140 to prevent the catheter tube 140 from kinking or collapsing against the distal end of the elongate seat 60, as discussed further below. The hub 50 can resemble a funnel having a conical section and an elongate tube head extending from the conical section. Similar to the conical seat 55, the conical section has a body with a wall surface tapering relative to the longitudinal axis of the elongate tube head.

[0224] The needle 110 can extend from the distal end of the hub 102 and through the lumen 92 of the catheter hub 101, through the tapered seat 55 and the elongated seat 60 of the bushing 50, and into the catheter tube 140, with the needle tip 112 extending out of the distal end 142 of the catheter tube 140 in a ready to use position. The distal portion of the catheter tube 140 can be inwardly tapered or have an opening that is smaller in size than the outer diameter of the needle 110 to form a seal with the needle 110 around the opening of the catheter tube 140 to prevent fluid from entering the space between the catheter tube 140 and the needle 110 when the needle tip 112 pierces the skin of a patient at the incision or insertion point. The space between the needle 110 and the interior of the catheter tube 140 can be annular or can be segmented by a baffle such as a ridge.

[0225] Blood that flows into the needle lumen to the hub 102 when piercing the skin, such as when accessing a vein, is referred to as primary blood flashback. The blood that enters the hub 102 can be collected in a vented stopper or blood collection device 107 for sampling. Retracting the needle tip 112 in the proximal direction back into the catheter tube 140 can allow fluid or blood to flow into the space between the needle 110 and the interior of the catheter tube 140, which is referred to as secondary blood flashback.

[0226] Figure 2 is an isometric view of a catheter hub assembly 108 provided in accordance with aspects of the present disclosure. The catheter hub assembly 108 can include a catheter hub 101, a catheter tube 140, and a bushing 50 located in the interior of the catheter hub. Figure 3 is Figure 2 a cross-sectional view of the catheter hub assembly 108 of Figure 3 more clearly illustrates the bushing 50 located inside the lumen 92, with a portion of the elongated seat 60 extending distally out of the distal end of the catheter hub 101. In examples, this portion of the elongated seat 60 extending out of the distal end of the catheter hub is flexible, such as being able to bend or flex.

[0227] With continued reference to Figure 3 , the catheter hub 101 has a lumen 92 defined between an opening at the proximal end 93 of the catheter hub 101 and an opening at the distal end 91 of the catheter hub 101. The bushing 50 can be inserted through the opening at the proximal end 93 of the catheter hub 101 and secured at the distal end of the lumen 92 of the catheter hub 101 via a press fit, an interference fit, an adhesive, or a combination thereof. The bushing 50 can also be secured by other fastening means.

[0228] The bushing 50 can include a conical seat 55 and an elongated seat 60 extending from the conical seat 55. The conical seat 55 and the elongated seat 60 can be integrally formed. Alternatively, the conical seat 55 and the elongated seat 60 can be formed as separate pieces that are assembled together by welding or other fastening means. The bushing 50 is of a material that can withstand temperature fluctuations, impact, corrosive substances, heat, and atmosphere. In one example, the bushing 50 is metallic. In another example, the bushing 50 is plastic. A hydrophobic coating can be applied to at least some portions of the inner and outer surfaces of the bushing 50 to prevent thrombosis, phlebitis, or blood clots. In one example, a parylene coating is applied to at least the inner surface of the elongated seat portion to prevent thrombosis. In still other examples, the bushing can be made of a polymeric material or a polymer matrix material, such as medical grade silicone rubber.

[0229] The conical seat 55 can be conical or funnel shaped with a defined thickness, where the body has a wider opening at the proximal end 56 and a relatively narrower opening at the distal end 57 of the funnel body. The narrower opening transitions to the elongated seat 60. The conical seat 60 can be rigid and non-flexible or semi-rigid to maintain its conical shape after insertion into the catheter hub 101, thereby wedging the proximal end of the catheter tube 140 into the interior of the catheter hub 101. Alternatively, the conical seat 55 can be flexible and elastic, and the catheter tube can be secured to the interior of the bushing 50.

[0230] As discussed above, the conical seat 55 can be secured inside the inner lumen 92 of the catheter hub by an interference fit or other fastening means. A retention mechanism or retainer 95 can also be provided inside the catheter hub 101 to secure the conical seat 55 inside the inner lumen 92. For example, the retainer 95 can be a raised circumferential ring formed inside the inner lumen 92 of the catheter hub 101, thus forming a shoulder for the proximal end of the conical seat 55 to rest against.

[0231] The bushing 50 can be inserted into the lumen 92 of the catheter hub 101 from an opening at the proximal end 93 of the catheter hub 101 and pushed distally until the tapered seat 55 slides past the retainer 95 and snaps into a fixed position between the distal end 91 of the catheter hub 101 and the retainer 95. The raised circumferential ring or shoulder of the retainer 95 can have a bore diameter that can be smaller or slightly smaller than the diameter of the wider opening at the proximal end 56 of the tapered seat 55 to provide a forced engagement of the tapered seat and prevent the tapered seat 55 of the bushing from sliding proximally out after snapping into place. The circumferential ring can taper inwardly distally to help the bushing 50 slide into the fixed position. The circumferential ring can also have a recess or other surface feature to resist the distal end 57 of the tapered seat 55 and prevent the bushing 50 from sliding proximally out of the lumen 92. In other examples, the retainer 95 can be a series of bumps or protrusions or a separately formed element that is inserted into the catheter hub and secured to the catheter hub after the bushing is installed.

[0232] Figure 4 A side view of a bushing 50 provided in accordance with aspects of the present disclosure is shown. As shown, the elongated seat 60 of the bushing 50 can be cylindrical and extend from the narrow opening at the distal end 57 of the tapered seat 55. The elongated seat 60 can have a smooth portion 62 transitioning from the distal end 57 of the tapered seat 55, a less smooth portion 63, and a distal end 68 that can have a tapered smooth portion 64 (as shown) or can have a roughened surface. In examples, the smooth portion 62 at the proximal end of the elongated seat 60 has an outer surface appearance that is generally flat or has less surface roughness compared to the less smooth portion 63. The less smooth portion 63 can be a flexible portion formed distally of the smooth portion 62 of the elongated seat 60. Optionally, the smooth portion 62 can be omitted, in which case the elongated seat 60 includes only the less smooth portion 63 extending from the tapered seat 55. The smooth portion 62 and the tapered seat 55 can be rigid and non-flexible or semi-rigid with some flexibility.

[0233] In examples, the less smooth or flexible portion 63 can be more easily deformed or bent than the smooth portion 62 at the proximal end (if included). The flexible portion 63 is flexible and can be bent along the length of the flexible portion 63 to form a bend, curve, or kink 67 along the length of the flexible portion 63, as discussed further below with reference to FIGS. 6A-6C. Figure 6 and Figure 7 discussed further below. In another example, the flexible portion 63 can be compressed to form a shorter flexible portion 63 or pulled (such as stretched) to form a longer flexible portion 63.

[0234] Figures 4 to 8The flexible portion 63 is illustrated as having a number of alternating ridges 65 and grooves 66. The smooth portion 62 of the elongated seat 60, if included, can be free of any alternating grooves and ridges. The alternating ridges 65 and grooves 65 of the flexible portion can be rounded along the peaks and valleys to form a bellows structure having a corrugated profile. In other examples, the alternating ridges 65 and grooves 66 can be folded over one another to form an accordion-like structure. In other embodiments, a combination of folded and rounded ridges and grooves can form the flexible portion 63. The bellows structure allows the elongated seat 60 to move, flex, bend, and / or curve to adjust the flexible portion 63 for alignment, for use when the catheter tube is inserted into a patient, for securing, or for any number of reasons. The bellows structure can also absorb motion and vibrations. In particular, the alternating ridges 65 and grooves 66 allow the flexible portion 63 to bend and form one or more curves or bends 67 along the length of the flexible portion 63.

[0235] The flexible portion 63 of the elongated seat 60 can be manipulated from an initial straight configuration to a new configuration having one or more bends, having compressed portions, and / or stretched portions. In one embodiment, the new configuration can remain in its current modified configuration without elastically returning to its original configuration. In another embodiment, the flexible portion 63 can be elastic, where the flexible portion 63 springs back or returns to its original shape after being deformed. In yet other embodiments, the flexible portion 63 is allowed to be freely manipulated but neither can remain in a new configuration nor can return to its original shape. Rather, the flexible portion 63 is simply used to prevent the catheter tube 140 from kinking or collapsing.

[0236] The bellows structure can transport liquids and gases under pressure in the operating conditions of the catheter assembly 100. A hydrophobic coating can be applied to the bushing 50 to form a surface layer on the interior of the elongated seat 60 to repel blood and prevent thrombosis or blood clotting from occurring due to blood collection on the surface of the corrugated profile.

[0237] The elongated seat 60 can be inserted into the catheter tube 140 such that the flexible portion 63 is inside the catheter tube and the proximal end of the catheter tube is at the smooth portion 62. The catheter tube 140 can extend to the tapered seat 55 or to at least a portion of the way to the tapered seat 55. In other examples, the catheter tube can extend to the intersection between the tapered seat 55 and the elongated seat 60 or just short of the intersection. The insertion end 68 of the elongated seat 60 can be tapered and can be provided at the free end of the flexible portion 63 to aid in assembling the elongated seat 60 into the catheter tube.

[0238] A seal can be formed at the interface between the lumen 141 of the catheter tube 140 and the bushing 50 so that fluid cannot flow therebetween. The diameter of the elongated seat 60 can be the same as or greater than the diameter of the lumen 141 of the catheter tube 140. Thus, the catheter tube 140 can be stretched over the elongated seat 60 to form a tight, secure fit. An adhesive or other securing means can be provided to further secure the catheter tube 140 to the elongated seat 60 and / or the tapered seat 55.

[0239] With reference to Figure 5 An alternative embodiment includes placing the catheter tube 140 inside the elongated seat 60 and then securing the catheter tube to the bushing. In an example, the bushing is made of a metallic material or from a polymer or polymer matrix material. The catheter tube 140 can be inserted into a distal opening at the distal end 68 of the elongated seat 60. In an example, the proximal end of the catheter tube 140 is inserted into a position along the less smooth portion 63 of the elongated seat. In another example, the proximal end of the catheter tube 140 is inserted into a position along the smooth portion 62 of the elongated seat 60. Then, ultrasonic welding is used to weld the catheter to the bushing using a modified ultrasonic generator, which is understood to be a tool that produces ultrasonic vibrations.

[0240] With further reference to Figure 5 Another alternative embodiment includes placing the catheter tube 140 inside the elongated seat 60 and then securing the catheter tube to the bushing by an adhesive or glue. In an example, glue is applied (such as sprayed, dipped, or coated) onto the inner surface of the elongated seat 60. Then, the proximal end of the catheter tube 140 is inserted into a distal opening at the distal end 68 of the elongated seat. The adhesive or glue can be air dried or dried with the help of heat activation. Thus, as described above, the catheter tube can be sleeved over or into the bushing. For example, the catheter tube can be sleeved over or into the elongated seat 60.

[0241] With reference to Figure 6The flexible portion 63 can be bent to form an elbow 67 having a small radius, an intermediate radius, or a large radius. Elbow, elbowing, elbowing portion, and elbowing section can be understood as synonymous structures that are structures that are not substantially linear as in a bushing having straight or linear nose sections. If the flexible portion 63 is long enough, more than one elbow 67 can be formed, such as a serpentine shape or configuration. The elbow 67 can be formed when one of the corrugated surfaces, such as the inner radius of the elongated seat, is shortened and the opposite surface, such as the outer radius of the elongated seat, is lengthened. The bend radius of the elbow 67 can depend on the diameter of the flexible portion 63 and the geometry and dimensions of the ridges 65 and grooves 66, such as, for example, the width of the ridges 65 and the width of the grooves 66, which can determine the number of ridges and grooves for a given length of the flexible portion or less smooth portion 64. The smallest bend radius of the elbow 67 can occur when the ridges 65 are in contact with each other along the inside of the elbow 67 and are furthest apart from each other along the outside of the elbow 67. Thus, the maximum bend angle of the bushing can be achieved at the smallest bend radius of the elbow 67.

[0242] The bend radius of the at least one elbowing portion can define an elbow 67. The radial elbowing portion of the elbow 67 can depend on the diameter of the flexible portion and the geometry and dimensions of the ridges and grooves of the flexible portion. For example, the width of the ridges and the width of the grooves along the length of the flexible portion can determine the number of ridges and grooves for a given length of the flexible portion. At the surface of the elbow, the smallest bend radius of the elbow can occur when the ridges are in contact with each other along the inside of the elbow and are furthest apart from each other along the outside of the elbow.

[0243] If an imaginary plane bisects the diameter of the elongated seat of the bushing along its length to divide the bushing into two halves, which can be referred to as a first bushing half and a second bushing half, the smallest bend radius of the elbow can occur when the ridges are in contact with each other along the inside of the first bushing half or the gap or spacing can be shortened but not touching and the ridges are furthest apart from each other along the outside of the second bushing half or more. In terms of the surfaces of the elongated seat, a first surface of the first bushing half can be shortened and a second surface of the second bushing half can be extended or lengthened when the at least one elbowing portion is formed on the bushing.

[0244] The first and second bushing halves are mentioned only to distinguish the two sections of the elongated seat, but are not a structural limitation. Thus, it can also be said that the largest bend radius of the elbow can occur when the ridges are spread apart from each other along the outside of the first bushing half and are shortened or closer together along the inside of the second bushing half. In other words, the at least one elbowing portion can have the smallest bend radius when a first surface of a first bushing half of the elongated seat is lengthened and a second surface of a second bushing half of the elongated seat is shortened.

[0245] As the flexible portion of the liner can bend in any number of locations and bending directions (depending on the force applied to the catheter tube and / or the liner to induce bending and cause at least one curvature on the liner), different opposing surfaces of the liner can experience changes (such as deformations, stretches, compressions, etc.) to cause different portions of the liner to be referred to as a first liner half and a second liner half depending on the direction of the bend.

[0246] Figure 7 A catheter tube 140 is shown attached to the elongated seat 60 of the liner 50. The catheter tube 140 can be sleeved over the elongated seat 60 to at least encompass the flexible portion 63 of the elongated seat 60 to prevent the catheter tube from kinking or collapsing within the flexible portion 63. If a smooth portion 62 is present, the catheter tube 140 can also be sleeved over the smooth portion 62. The catheter tube 140 can bend along with the elbow 67 of the flexible portion 63 to prevent the catheter tube 140 from kinking, collapsing, or restricting flow, even if the catheter tube is bent due to inadvertent movement or the like (such as during securement of the catheter assembly). Thus, the flexible portion 63 can impart flexibility to the catheter tube 140 while maintaining flow through the catheter tube 140 and the catheter hub 101. In an example, the flexible portion 63 can impart flexibility to the catheter tube 140 and prevent kinking of the catheter tube at a location outside of the catheter hub 101 while maintaining flow through the catheter tube 140 and the catheter hub 101. The smooth portion 62 can be rigid and non-bendable.

[0247] The elbow 67 can also maintain the bent configuration of the catheter tube 140 by reducing or eliminating any restoring force caused by the normally curved catheter tube 140. That is, any deviation of the catheter tube 140 from the axis of the catheter hub 101 can be imparted to the flexible portion 63 of the elongated seat 60 rather than the insertion point of the catheter tube to reduce discomfort to the patient. In addition, the occurrence of phlebitis due to movement of the catheter tube 140 at the insertion point can be reduced.

[0248] Referring now to Figure 8 , a partial cross-sectional view of the catheter hub assembly 108 of Figure 2 is shown. In the view shown, the distal end 91 of the catheter hub 101 can have a rounded opening that forms a recess 109 to accommodate flexing of the catheter tube 140 and the flexible portion 63 of the elongated seat at a location outside of the catheter hub. The shape of the recess 109 is not limited and can be embodied in any shape as long as sufficient clearance is provided to accommodate movement of the catheter tube 140 and the flexible portion 63 at a location outside of the catheter hub, such as distally of the distal end 91. The recess 109 can allow the catheter tube 140 to bend with the flexible portion 63 of the liner 50 inside the recess 109. The dimensions of the recess 109 can be designed to restrict or allow the flexible portion 94 to bend with the maximum bend of the catheter tube 140.

[0249] Figure 9A Another embodiment of a bushing 51 is illustrated as provided in accordance with aspects of the present disclosure. The bushing 51 of the present embodiment is similar to the bushing 50 Figures 4 to 8 embodied in the foregoing discussion, except that the flexible portion 63 of the elongated seat 60 of the bushing 51 has a continuous ridge 65 that spirals continuously around the length of the flexible portion 63 from one end of the flexible portion 63 to the other end of the flexible portion 63 to form a spiral bellows structure along the length of the flexible portion 63 rather than alternating ridges 65 and grooves 66. Thus, the present bushing 51 can be understood to include a spiral ridge 65 that extends from one end of the flexible portion to the other end of the flexible portion.

[0250] The bushing 51 can include a tapered seat 55 and an elongated seat 60 extending from the tapered seat 55. The elongated seat 60 can include a flexible portion 63 and an optional smooth portion 62 extending between the tapered seat 55 and the elongated seat 60. An insertion end 68 having a taper can be provided at the distal end of the flexible portion 63 to help sleeve the catheter tube 140 over the elongated seat 60 of the bushing 51. A seal can also be formed between the lumen 141 of the catheter tube 140 and the bushing 51. Similar to the bushings discussed above Figures 4 to 8 with reference to the foregoing discussion, the bushing 51 can also be bent along the flexible portion 63 to form one or more bends or elbows 67. The bend radius of the elbows 67 can depend on the geometry and dimensions of the continuous ridge 65 and groove 66. When bent, one portion of one side of the flexible portion 63 will be shortened while another portion at the opposite side will be lengthened.

[0251] Figure 9B Yet another embodiment of a bushing 52 is illustrated as provided in accordance with aspects of the present disclosure. The bushing 52 of the present embodiment is similar to the bushing 50 Figures 4 to 9A embodied in the foregoing discussion in that the flexible portion 63 of the elongated seat 60 or the distal seat of the bushing 52 can have alternating ridges and grooves along the length of the flexible portion 63 to form a bellows structure or can have a continuous ridge 65 that spirals continuously around the length of the flexible portion 63 from one end of the flexible portion 63 to the other end of the flexible portion 63 to form a spiral bellows structure. Thus, the present bushing 52 can be understood to include a spiral ridge 65 that extends from one end of the flexible portion to the other end of the flexible portion or to include alternating ridges and grooves along the length of the flexible portion 63.

[0252] The bushing 52 can include a non-tapered seat 55 and an elongated seat 60 extending from the non-tapered seat 55. The non-tapered seat 55 can also be referred to as a proximal seat. The elongated seat 60 can include a flexible portion 63 and an optional smooth portion 62 extending between the non-tapered seat 55 and the elongated seat 60. As shown, the non-tapered seat 55 can be cylindrical and have substantially the same diameter as the smooth portion 62, in which case the smooth portion 62 is the non-tapered seat 55. The bushing 52 can be secured inside the catheter hub 101 using glue, an interference fit, or other securing means to prevent the bushing 52 from moving distally out of the catheter hub 101 or moving into the catheter tube 140. Alternatively, the non-tapered seat 55 can have a different diameter, shape, or size than the smooth portion 62. An insertion end 68 having a taper can be provided at a distal end of the flexible portion 63 to help sleeve the catheter tube 140 over the elongated seat 60 of the bushing 52. A seal can also be formed between the inner lumen 141 of the catheter tube 140 and the bushing 52. Similar to the above discussion Figures 4 to 8 With respect to the bushing under discussion, the bushing 52 can also be bent along the flexible portion 63 to form one or more bends or elbows 67. The bend radius of the elbows 67 can depend on the geometry and dimensions of the continuous ridge 65 and the groove 66. When bent, one portion of one side of the flexible portion 63 will shorten while another portion at the opposite side will lengthen.

[0253] In an example, the proximal seat can include one or more slits to facilitate flexing and thus aid in assembling the proximal seat into a catheter hub to secure a catheter tube to the catheter hub. The one or more slits can be spaced apart from each other. The one or more seats can be parallel to a longitudinal axis of the catheter hub.

[0254] The bushings 50, 51, or 52 described herein can be formed by applying a deep drawing process followed by a hydroforming process to produce a corrugated surface. A coating process can then be applied to the bushing, such as to the inner surface of the bushing 50, 51, or 52.

[0255] Figure 10An embodiment of a catheter assembly 127 is shown that includes a catheter hub 101 and a catheter tube 140 that is attached to one of the hubs 50, 51, or 52 described elsewhere herein such that at least a portion of the elongated seat 60 extends out of the distal end of the catheter hub 101. The assembly 127 also includes a needle hub 102 with a needle 110 extending through the catheter tube 140, a side fluid port 184, and a fluid adapter (not shown) that is attached to the side fluid port 184 by tubing 188 that is attached to the side fluid port 184 by the second hub 50, 51, or 52. A portion of the elongated seat 60 of the second hub 50, 51, or 52 extends out of or outside of the side fluid port 184. The tubing 188 can have an internal lumen for fluid flow between the side fluid port 184 and the fluid adapter, which can be a needleless female luer adapter.

[0256] As shown in FIGS. 1-3, the first hub 50 has a tapered seat 53. The second hub 51 has a non-tapered seat 55. The third hub 52 has a tapered seat 53. Figure 10 As shown in FIG. 3, the second hub has a cylindrical non-tapered seat 55. To prevent the second hub from being pulled out of the catheter hub 101, the second hub can be glued, interference fit, or combination thereof to the catheter hub.

[0257] The two hubs 50, 51, or 52 used with the catheter assembly 127 can each have one or more bends or elbows formed along the flexible portion of the respective hub 50, 51, or 52. The flexible portion 64 of the two hubs 50, 51, or 52 can bend at or inside the catheter hub 101 or the side fluid port 184, near its respective opening, and at a location outside of the catheter hub or the side fluid port. The portion of the tubing 188 and the sleeve of the catheter tube 140 over the flexible portion 63 of the respective hub can also bend along the flexible portion 63.

[0258] The proximal end 93 of the catheter hub 101 can be equipped with a septum, seal, or valve that can prevent flow across it after the needle 110 and needle hub 102 are removed. A needle guard 103 as discussed above can be included between the needle hub 102 and the catheter hub 101. The catheter hub 101 is shown as having a pair of wings. Alternatively, the needle hub can have wings that extend distally along the side of the catheter hub opposite the side fluid port 184, instead of wings on the side of the catheter hub with the side fluid port 184.

[0259] The needle tip 112 of the needle 110 extends distally past the distal opening of the catheter tube 140. Once inserted into the patient, blood flow can be monitored according to secondary reflux through the catheter tube 140. After a successful venipuncture, the needle 110 can be removed from the patient, such as by withdrawing the needle hub 102 in the proximal direction. Fluid can be infused through the fluid adapter via tubing 188 to the side port 184 and then to the catheter hub 101. Alternatively, if the proximal end of the catheter hub 101 has a valve instead of a septum or seal, fluid can be infused through the valve and catheter tube. A clamp (not shown) can also be used to clamp the extension tubing between the side fluid port 184 and the fluid adapter.

[0260] Reference Figure 11 The catheter assembly 100 is similar to the catheter assembly of Figure 1 except that the catheter assembly can also include a valve activator or actuator 104 for opening a valve 122 that can have one or more slits defining a plurality of flaps that can open when a male medical implement, such as a syringe tip, male luer connector or luer adapter, advances the activator 104. The actuator 104 can have a nose section for physically opening the valve 122 and a plunger end that includes at least one plunger element or leg 90 that is configured to be pushed by the male medical implement. Optionally, the valve 122, valve actuator 104 and needle guard 103 can be omitted. The valve 122 is housed within the interior cavity 92 of the catheter hub 101 and projects therefrom in the ready position when included, as shown in Figure 11 .

[0261] In some examples, three slits are provided on the valve 122, forming three flaps. In other examples, four slits are provided in an "X" shape to form four flaps. Different numbers of slits and flaps are contemplated. The valve 122 can seat in a valve seat formed in the interior cavity 92 of the catheter hub. For example, an undercut can be formed in the interior of the catheter hub to retain the valve inside the interior cavity. In some examples, a bump or protrusion can be provided around the exterior of the valve to form a pathway between the valve and the interior of the catheter hub for venting during blood reflux. When the needle 110 is withdrawn from the catheter hub 101 after the flexible tube 14 is placed in the vasculature of the patient, the one or more slits close so that the valve 122 seals itself, thereby restricting or limiting flow across the valve. Thus, the valve 122 restricts blood reflux through the catheter hub 101. The valve 122 can be composed of a material that forms a seal or restriction at the interface with the needle 110 and reforms the seal after the needle 110 is withdrawn. For example, but not by way of limitation, the valve 122 can include silicone, silicone rubber, polypropylene or other suitable material. Unless otherwise indicated, the various components discussed elsewhere herein can be made of conventional materials.

[0262] An activator 104 can be provided to press against the valve 122 so as to protrude through the slits to open the flaps or deflect the flaps when the activator is moved distally by a medical implement to open the valve 122 to allow fluid or solution to pass through the valve. The activator 104 has a passage formed through the nose section 94 for receiving the needle 110 in the ready position and for fluid flow when the catheter hub is connected to an IV line. The activator can have surface features to provide fluid mixing as fluid enters the catheter hub.

[0263] After the needle 110 and needle hub 102 are removed, a male medical implement such as a luer tip of a syringe, a male luer connector or adapter such as used in conjunction with an IV line, a luer access connector, or a vent spike can be inserted to push the activator 104 distally into the seal 122 to open the seal 122. For example, the activator 104 can be advanced distally by a syringe tip that pushes against the proximal end of the valve disk 80 of the valve through the activator 104 to push the nose section 94 of the activator 104 distally forward into the valve 122 inside the skirt 82 to open the one or more slits. In an example, the activator 104 can have a wedge-shaped nose section 94 to press open the valve 122 and an extension, plunger, or leg 90 that extends in a proximal direction from the nose section to be pushed against by the male medical implement. While a single extension or leg is useful to push against the activator 104, two or more extensions are preferred. The extension 90 can be embodied as one or more separate sections that can be pushed against by the male medical implement to advance the activator 104 against the valve 122. Two spaced apart extensions 90 can be provided to accommodate a needle guard therebetween. Examples of activators can be found in U.S. Patent Application No. 14 / 062,081 (published as US 2014 / 0052065 Al), the contents of which are expressly incorporated herein by reference.

[0264] The valve 122 can also be modified, or a different valve embodiment can be used with the present catheter assembly. For example, only the valve disk 80 without the skirt 82 can be positioned in the seam of the two-piece catheter body. In yet another example, the needle shield 103 can be supported or housed in an intermediate hub between the catheter hub 101 and the needle hub 102, such as shown in Figure 12 The intermediate hub can be removably coupled with the catheter hub 101 and can be referred to as a third hub or needle shield or needle guard housing.

[0265] In still other examples, the catheter hub 101 is provided with a valve that can only be actuated with fluid pressure such that an actuator can be omitted from the interior of the inner lumen of the catheter hub. For example, the valve can flex by way of a drop pressure from an IV bag suspended on an IV pole that pushes upward against the valve to open one or more flow paths or channels for fluid flow. In still other examples, the valve is positioned proximate to the proximal opening of the catheter hub to be opened by a male luer connected to the proximal open end of the catheter hub without an actuator or activator 104.

[0266] The portion of the elongate seat of the hub 50, 51, or 52 that extends out of the distal end of the catheter hub 101 can form one or more bends or elbows along the flexible portion of the hub 50, 51, or 52. The flexible portion 63 can bend at, within, and / or outside of the catheter hub 101. The portion of the catheter tube 140 that is sheathed over the flexible portion 63 can also bend along the flexible portion 63.

[0267] In Figure 12 , an example safety catheter assembly 162 is shown that is similar to the catheter device of Figure 11 , except that the needle safety shield 103 including a biasing or resilient member, such as a resilient arm, is entirely or substantially outside of the catheter hub 101. As shown, an intermediate hub, needle shield hub, or third hub 105 is at least partially located between the catheter hub 101 and the needle hub 102. Similar to other embodiments discussed elsewhere herein, the needle 110 has a profile change 113.

[0268] The needle shield 103 is located on or within the intermediate hub 105. The intermediate hub 105 can be closed (as shown), can have a single wall, or can have an opening in the wall. The needle shield 103 can be supported by a sleeve 106 of the intermediate hub 105, or can have the distal arm directly accessible to the needle 110. The sleeve 106 extends from the distal wall of the intermediate hub 105 such that the resilient arms of the needle safety shield 103 are supported on the sleeve 106. Alternatively, the needle 110 can include a profile change (such as a protrusion) associated with the flashback indicator 130 or on a cap applied over the flashback indicator 130 for engaging an opening on the proximal wall of the needle shield 103. In use, when the needle 110 is withdrawn, the profile or profile change 113 will engage the proximal wall 132 of the needle shield 103 and pull the needle shield 103 proximally such that the two resilient arms are pulled away from the sleeve 106 or are no longer biased against the needle 110 but can overlap to block the needle tip 112.

[0269] The bushings 50, 51, or 52 extending from the distal end of the conduit hub 101 may form one or more bends or elbows along the flexible portion of the bushings 50, 51, or 52. The flexible portion 63 may be bent at, within, or outside the conduit hub 101. The portion of the conduit body 140 that fits over the flexible portion 63 may also be bent along the flexible portion 63.

[0270] Methods for manufacturing and using needle devices and their components, as discussed elsewhere in this document, are conceived.

[0271] Although limited embodiments of various lined catheter assemblies have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, any needle-type catheter can benefit from the use of the lined catheters disclosed herein to ensure that flow rate is not reduced through the catheter body and that the patient can move freely without causing further discomfort at or near the insertion site. Furthermore, it should be understood and anticipated that the features discussed specifically for one lined catheter assembly can be incorporated into another catheter device, provided that functionality is compatible. Therefore, it should be understood that lined catheter devices and components constructed according to the principles of the disclosed devices, systems, and methods can be implemented in ways different from those specifically described herein.

[0272] This disclosure is also defined in the following respects:

[0273] Aspect 1. A catheter assembly comprising:

[0274] A duct hub having a hub body that defines an inner cavity;

[0275] A bushing, which is disposed in the inner cavity and has an elongated seat having a portion extending from the distal end of the conduit hub;

[0276] The catheter body, which is fitted onto the elongated seat, including the portion extending from the distal end;

[0277] A needle hub having a needle, the needle including a needle shaft having a needle lumen and a needle tip, the needle shaft protruding in a ready-to-use position through the elongated seat and the catheter body of the bushing; and

[0278] The elongated seat is bendable to form at least one curved portion along its length to prevent kinking in the conduit body. The at least one curved portion has a minimum bending radius when the first surface of the elongated seat is extended and the second surface of the elongated seat opposite to the first surface is shortened.

[0279] Aspect 2. The catheter assembly according to aspect 1, wherein the elongated seat includes a plurality of alternating ridges and grooves.

[0280] Aspect 3. The catheter assembly of Aspect 2, wherein the alternating ridges and grooves are folded over one another to form an accordion structure.

[0281] Aspect 4. The catheter assembly of Aspect 2, wherein the minimum bend radius is achieved when alternating ridges at a first surface of the elongate seat are splayed further apart from one another and alternating ridges at a second surface opposite the first surface are closer together.

[0282] Aspect 5. The catheter assembly of Aspect 2, wherein an inner surface of the elongate seat is provided with a hydrophobic coating.

[0283] Aspect 6. The catheter assembly of Aspect 5, wherein the hydrophobic coating is a parylene coating.

[0284] Aspect 7. The catheter assembly of Aspect 1, wherein the elongate seat forms a helical bellows structure having continuous ridges helically continuous around the elongate seat along a length of the elongate seat.

[0285] Aspect 8. The catheter assembly of Aspect 7, wherein the minimum bend radius is achieved when adjacent portions of the ridges at a first surface of the elongate seat are splayed further apart from one another and adjacent portions of the ridges at a second surface opposite the first surface are closer together.

[0286] Aspect 9. The catheter assembly of Aspect 7, an inner surface of the elongate seat is provided with a hydrophobic coating.

[0287] Aspect 10. The catheter assembly of Aspect 9, wherein the hydrophobic coating is a parylene coating.

[0288] Aspect 11. The catheter assembly of Aspect 1, wherein the hub further comprises a tapered seat coupled to the elongate seat, the tapered seat being conical with a wider opening at a proximal end and a relatively narrower opening at a distal end.

[0289] Aspect 12. The catheter assembly of Aspect 11, wherein the elongate seat comprises a smooth portion coupled to the tapered seat, the smooth portion extending from the distal end of the tapered seat and being more rigid than a bendable portion of the elongate seat.

[0290] Aspect 13. The catheter assembly of Aspect 12, wherein the tapered portion extends from a distal end of the bendable portion of the elongate seat.

[0291] Aspect 14. The catheter assembly of aspect 11, wherein the tapered seat is integrally formed with the elongated seat.

[0292] Aspect 15. The catheter assembly of aspect 11, wherein the bushing is metallic.

[0293] Aspect 16. The catheter assembly of aspect 11, wherein a retainer is formed inside the inner lumen of the catheter hub to secure the tapered seat.

[0294] Aspect 17. The catheter assembly of aspect 16, wherein the retainer is a circumferential ring protruding from a surface of the inner lumen having a bore diameter smaller than a diameter of the tapered seat.

[0295] Aspect 18. The catheter assembly of aspect 1, wherein a recess is provided at the distal end of the catheter hub between the catheter tube and the catheter hub.

[0296] Aspect 19. The catheter assembly of aspect 18, wherein the recess is frustoconical.

[0297] Aspect 20. The catheter assembly of aspect 1, further comprising a valve in the inner lumen of the catheter hub.

[0298] Aspect 21. The catheter assembly of aspect 20, further comprising an activator in the inner lumen of the catheter hub proximal of the valve, and wherein the activator is movable into the valve.

[0299] Aspect 22. The catheter assembly of aspect 21, wherein the activator comprises at least one plunger element configured to be pushed by a male luer tip.

[0300] Aspect 23. The catheter assembly of aspect 1, further comprising a needle shield for covering the needle tip.

[0301] Aspect 24. The catheter assembly of aspect 23, wherein the needle shield is located substantially in the inner lumen of the catheter hub.

[0302] Aspect 25. The catheter assembly of aspect 23, wherein the needle shield is located in an intermediate hub proximal of the catheter hub.

[0303] Aspect 26. The catheter assembly of aspect 6, wherein the flashback indicator is provided with a protrusion for engaging the needle shield.

[0304] Aspect 27. The catheter assembly of aspect 23, further comprising a profile change proximal of the needle tip.

[0305] Aspect 28. The catheter assembly of Aspect 1, further comprising a side port formed with the catheter hub and a second hub having an elongated seat extending out a distal end of the side port.

[0306] Aspect 29. The catheter assembly of Aspect 28, further comprising a tubing attached to the elongated seat of the second hub at the side port.

[0307] Aspect 30. The catheter assembly of Aspect 29, further comprising a fluid adapter attached to the tubing.

[0308] Aspect 31. A method for manufacturing a catheter assembly, the method comprising:

[0309] forming a catheter hub having an inner cavity;

[0310] forming a hub having a corrugated surface on an elongated seat;

[0311] sleeving a catheter tube over the corrugated surface;

[0312] securing the hub in the inner cavity of the catheter hub;

[0313] extending a portion of the corrugated surface out a distal end of the catheter hub;

[0314] forming a needle hub having a needle comprising a needle shaft having a needle inner cavity and comprising a needle tip, the needle shaft protruding through the elongated seat of the hub and the catheter tube; and

[0315] wherein the elongated seat is bendable to form at least one curvature to prevent kinking in the catheter tube, the at least one curvature having a minimum bend radius when a first surface of the elongated seat is lengthened and a second surface of the elongated seat opposite the first surface is shortened.

[0316] Aspect 32. The method of Aspect 31, further comprising coating the inner surface of the elongated seat with a hydrophobic coating.

[0317] Aspect 33. The method of Aspect 31, further comprising placing a needle guard having a proximal wall having a proximal opening and two resilient arms slidable over the needle shaft.

[0318] Aspect 34. The method of Aspect 31, further comprising a valve for limiting fluid flow through the catheter hub.

[0319] Aspect 35. The method of Aspect 31, further comprising an actuator in dynamic contact with the valve.

[0320] The present disclosure is also defined in the following claims.

Claims

1. A catheter assembly (100, 127), comprising: The conduit hub (101) has a hub body (88) that defines an inner cavity (92). A bushing (50) is at least partially disposed in the inner cavity (92) and has an elongated seat (60) having a portion extending out of the distal end (91) of the conduit hub (101), the elongated seat (60) comprising a first bushing half and a second bushing half located on different sides of a plane extending longitudinally along the diameter of the bushing. The catheter body (140) is fitted into the distal opening at the distal end (68) of the elongated seat (60); A needle hub (102) having a needle (110), the needle (110) including a needle shank (111) having a needle cavity and a needle tip (112), the needle shank (111) protruding in a ready-to-use position through the elongated seat (60) of the bushing (50) and the catheter body (140); and The elongated seat (60) is bendable to form at least one curved portion (67) along its length to prevent kinking in the conduit body (140), and the at least one curved portion (67) has a minimum bending radius when the first surface of the first bushing half of the elongated seat (60) is extended and the second surface of the second bushing half of the elongated seat (60) is shortened.

2. The catheter assembly according to claim 1, wherein, The distal end (91) of the conduit hub (101) has a rounded opening.

3. The catheter assembly according to claim 2, wherein, The rounded opening forms a recess (109) to accommodate the deflection of the flexible portion (63) of the conduit body (140) and the elongated seat (60) at a location outside the conduit hub (101).

4. The catheter assembly according to any one of claims 1 to 3, wherein, The bushing (50) is located inside the conduit hub (101), wherein a portion of the elongated seat (60) extends distally from the distal end of the conduit hub (101).

5. The catheter assembly according to claim 1, wherein, The elongated seat (60) includes a plurality of alternating ridges (65) and grooves (66).

6. The catheter assembly according to claim 5, wherein, The alternating ridges (65) and grooves (66) fold together to form an accordion structure.

7. The catheter assembly according to claim 5 or 6, wherein, The minimum bending radius is achieved when the alternating ridges (65) on the first surface of the elongated seat (60) extend further away from each other and the alternating ridges (65) on the second surface opposite to the first surface come closer together.

8. The catheter assembly according to any one of claims 1 to 3, wherein, The inner surface of the elongated base (60) is provided with a hydrophobic coating.

9. The catheter assembly of claim 8, wherein, The hydrophobic coating is a parylene coating.

10. The catheter assembly of claim 1, wherein, The elongated seat (60) forms a spiral bellows structure having a continuous ridge (65) that spirals continuously around the elongated seat (60) along its length.

11. The catheter assembly of claim 10, wherein, The minimum bending radius is achieved when adjacent portions of the continuous ridge (65) on the first surface of the elongated seat (60) extend further away from each other and adjacent portions of the continuous ridge (65) on the second surface opposite the first surface are closer together.

12. The catheter assembly according to claim 10 or 11, wherein the inner surface of the elongated seat (60) is provided with a hydrophobic coating.

13. The catheter assembly of claim 12, wherein, The hydrophobic coating is a parylene coating.

14. The catheter assembly according to any one of claims 1 to 3, wherein, The bushing also includes a conical seat (55) connected to the elongated seat (60), the conical seat being conical in shape and having a wider opening at the proximal end and a relatively narrower opening at the distal end.

15. A method for manufacturing catheter assemblies (100, 127), the method comprising: A catheter hub (101) with an inner lumen (92) is formed. The catheter body (140) is fitted into the elongated seat (60) of the bushing (50), the elongated seat (60) comprising a first bushing half and a second bushing half located on different sides of a plane extending longitudinally along the bushing. The bushing (50) is fixed in the inner cavity (92) of the conduit hub (101); A portion of the corrugated surface of the elongated seat extends out of the distal end (91) through an opening in the distal end (91) of the guide hub (101). A needle hub (102) is formed having a needle (110), the needle (110) including a needle shank (111) having a needle cavity and a needle tip (112), the needle shank (111) protruding through the elongated seat (60) of the bushing (50) and the catheter body (140); and The elongated seat (60) is bendable to form at least one curved portion (67) to prevent kinking of the conduit body (140). The at least one curved portion (67) has a minimum bending radius when the first surface of the first bushing half of the elongated seat (60) is extended and the second surface of the second bushing half of the elongated seat (60) is shortened.

16. The method of claim 15 further comprises coating the inner surface of the elongated seat (60) with a hydrophobic coating.

17. The method according to claim 15 or claim 16, further comprising placing a needle protector (103) having a proximal sidewall and two resilient arms slidable on the needle bar (111), the proximal sidewall having a proximal opening.

18. The method according to claim 15 or claim 16, further comprising a valve (122) for restricting fluid flow through the conduit hub (101).

19. The method according to claim 15 or claim 16, wherein, The distal end (91) of the conduit hub (101) has a rounded opening.

20. The method according to claim 19, wherein, The rounded opening forms a recess (109) to accommodate the deflection of the flexible portion (63) of the conduit body (140) and the elongated seat (60) at a location outside the conduit hub (101).

21. The method according to claim 15 or claim 16, wherein the bushing is located inside the conduit hub, wherein, A portion of the elongated seat extends distally beyond the distal end of the guide hub.

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