Needle Assembly and Associated Methods

Abstract

The present disclosure relates to a catheter device (100, 127, 162) in which a bushing (50) is disposed in an internal cavity (92) of a catheter hub (101). A catheter tube (140) and a reinforcing sleeve (60) are placed over the bushing (50), and the catheter tube and reinforcing sleeve combination is wedged to the catheter hub. The reinforcing sleeve (60) overlaps the catheter tube (140) at least at the distal end of the catheter hub (101). A needle hub (102) with a needle (110) protrudes through the bushing (50) and the catheter tube (140) in the ready-to-use position.

Description

[Technical Field]

[0001] The present invention relates generally to needle devices, systems, and methods for use in delivering pharmaceutical agents to blood vessels. 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. [Background technology]

[0002] Generally, vascular access devices are used to provide fluid communication with a patient's vascular system. For example, catheters are used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient, to withdraw blood from a patient, or to monitor various parameters of a patient's vascular system.

[0003] A common type of intravenous (IV) catheter is the over-the-needle peripheral IV catheter. As the name suggests, the over-the-needle catheter tube is attached over an introducer needle with a sharp distal tip. At least the inner surface of the distal portion of the catheter tube tightly encases or surrounds the outer surface of the needle to prevent the catheter tube from turning over during insertion into the blood vessel. The catheter tube and introducer needle are assembled so that the tip of the introducer needle extends beyond the distal tip of the catheter tube and the bevel of the needle faces up and away from the patient's skin. The catheter material is partially transparent and can have stripes of transparent material and opaque stripes to provide x-ray contrast. The catheter and introducer needle are generally inserted at a shallow angle through the patient's skin into the blood vessel.

[0004] To confirm proper placement of the needle and catheter within the vein, clinicians typically look for blood flashback as confirmation of access. The initial blood flashback occurs through the needle and into the clear needle hub, sometimes referred to as primary blood flashback. This confirms, at a minimum, that the needle has located the vein. Next, as the needle is withdrawn proximally, away from the catheter tubing, blood flashes back between the needle and the catheter tubing. This is referred to as secondary flashback and confirms that the catheter tubing has located the vein. Once proper insertion of the catheter into the vein has been confirmed, the clinician may apply pressure to the vein by holding the patient's skin over the vein distal to the introducer needle and catheter. This digital pressure occludes the vessel, minimizing blood flow through the catheter and the potential for blood leakage through the catheter hub.

[0005] Some IV catheter assemblies have an open notch in the needle that allows blood to flow into the space between the needle and the catheter tubing. This "instant flush" ensures that only the tip of the needle enters the vein, not necessarily the catheter tubing. With a notch, secondary flashback is impossible because there is primary blood between the needle and the catheter tubing.

[0006] The clinician can then withdraw the introducer needle from the catheter. The introducer needle can be retracted into a needle tip shield or needle cap, which covers the needle tip and prevents accidental needle sticks. If the needle has an open notch, blood between the distal opening and the open notch will not be retained by capillary action and may drip out of the needle.

[0007] After removing the needle from the catheter, the catheter hub can be taped to the patient's skin to securely hold the catheter hub in place with the catheter tubing accessing the blood vessel through the insertion point. Often, after the catheter hub is secured to the patient, the axis of the catheter tubing is not aligned with and / or offset from the centerline of the catheter hub. Misalignment between the catheter tubing and the centerline of the catheter hub can cause the flexible tubing to form a tight bend, affecting patient comfort at the insertion point, restricting flow through the catheter tubing at the bend, or forming a kink along the catheter tubing. Any movement by the patient, such as stretching or flexing of muscles near the insertion point, can increase patient discomfort and cause the catheter tubing to kink. Summary of the Invention

[0008] Various embodiments of the needle assembly have several features, no single one of which is solely responsible for their desirable attributes, and without limiting the scope of the present embodiments as defined in the claims which follow, their more prominent features will now be discussed briefly.

[0009] A catheter assembly provided according to an aspect of the present disclosure may include a catheter hub having a hub body defining an internal cavity. The catheter assembly may further include a bushing disposed within the internal cavity. The catheter assembly may further include a catheter tube sleeved over the bushing. The catheter assembly may further include a sleeve sleeved over the bushing. The sleeve may overlap the catheter tube at least at a distal end of the catheter hub. The catheter assembly may further include a needle hub having a needle including a needle shaft having a needle lumen and a needle tip. The needle shaft may protrude through the bushing and the catheter tube in the ready-to-use position.

[0010] The catheter tube and sleeve may have first and second lengths, respectively, along the needle shaft extension direction, and the first length may be greater than the second length. The catheter tube or sleeve may be in direct contact with the bushing.

[0011] The sleeve may be placed over the catheter tube or within the catheter tube, and the sleeve may have a larger diameter when the sleeve is over the catheter tube than when the sleeve is within the catheter tube.

[0012] The catheter tube or sleeve may be heat shrink tubing.

[0013] The bushing may further include a tapered seat coupled to the catheter tube or sleeve. The tapered seat may be conical with a wider opening at the proximal end and a relatively narrow opening at the distal end. The bushing may be metallic.

[0014] The catheter assembly may further include a needle guard having a proximal wall with a proximal opening and two resilient arms slidably attached to the needle shaft.

[0015] The catheter assembly may further include a valve for restricting fluid flow through the catheter hub.

[0016] Another aspect of the present disclosure is a method for manufacturing a catheter assembly. The method can include forming a catheter hub having an internal cavity. The method can further include placing a catheter tube over a bushing. The method can further include placing a sleeve over the bushing. The method can further include securing the bushing to the internal cavity of the catheter hub. The method can further include forming the needle hub with a needle. The needle can include a needle shaft having a needle lumen and a needle tip. The needle shaft can protrude through the bushing and the catheter tube.

[0017] The method may further include slidably disposing a needle guard over the needle shaft, the needle guard having a proximal wall with a proximal opening and two resilient arms.

[0018] The method may further include disposing a valve within the interior cavity of the catheter hub to restrict fluid flow through the catheter hub.

[0019] Yet another aspect of the invention is a method for resisting kinking of a catheter tube, comprising, in addition to placing a catheter tube over the distal section, placing a non-metallic reinforcing sleeve over the distal section of a bushing and securing the bushing inside a catheter hub, the catheter hub being part of a catheter assembly that includes a needle hub having a needle extending distally therethrough, through which the catheter hub, reinforcing sleeve and catheter tube can be threaded in a ready-to-use position.

[0020] In one embodiment, the reinforcing sleeve can be positioned around the outside of the catheter hub, or alternatively, the reinforcing sleeve can be positioned within the lumen of the catheter hub.

[0021] Another aspect of the present disclosure is a catheter assembly that may include a catheter hub having a hub body defining an internal cavity. The catheter assembly may further include a bushing disposed in the internal cavity. The catheter assembly may further include a catheter tube disposed over the bushing. The catheter assembly may further include a sleeve disposed over the bushing. The catheter assembly may further include a needle hub having a needle. The needle may include a needle shaft having a needle lumen and a needle tip. The needle shaft may protrude through the bushing and the catheter tube in the ready-to-use position. A sleeve may be disposed over or within the catheter tube and the bushing. The sleeve and the catheter tube may each have a different length along the catheter tube.

[0022] The sleeve may be placed over the catheter tube or may be placed within the catheter tube, and the sleeve may have a larger diameter when the sleeve is over the catheter tube than when the sleeve is within the catheter tube.

[0023] A sleeve disposed over the catheter tube can have a distal tip, the distal tip of the sleeve being located proximal to the distal tip of the catheter tube.

[0024] The distal tip of the sleeve is tapered. The tapered tip of the sleeve is formed by a tripping process.

[0025] The tipping process can be similar to the tipping process for forming a tapered tip of a catheter tube. As an example, the sleeve can be placed over a metal pin, or the metal pin can be placed within the lumen of the sleeve. The sleeve then undergoes a tipping process, which involves heating the sleeve and applying it to a die, anvil, or tool to form the tip.

[0026] In some instances, the catheter tube is first placed over the metal tip, and then a sleeve is placed over both the catheter tube and the metal tip, after which the sleeve undergoes a tipping process.

[0027] The catheter tube or sleeve may be in direct contact with the bushing.

[0028] The catheter tube or sleeve may be heat shrink tubing.

[0029] The bushing may further include a tapered seat coupled to the catheter tube or sleeve. The tapered seat may be conical with a wider opening at the proximal end and a relatively narrow opening at the distal end. The bushing may be made from metal.

[0030] In another example, the bushing is plastic. A hydrophobic coating can optionally be applied to a portion of the inner and outer surfaces of the bushing to prevent or inhibit thrombus formation, phlebitis, or blood clots. In one example, a parylene coating can be applied to at least the inner surface of the elongated distal seat of the bushing. In yet another example, the bushing can be made from a polymeric or polymeric matrix material, such as medical-grade silicone rubber.

[0031] The catheter assembly may further include a needle guard having a proximal wall with a proximal opening and two resilient arms slidably attached to the needle shaft.

[0032] The catheter assembly may further include a valve for restricting fluid flow through the catheter hub.

[0033] Yet another aspect of the present invention is a catheter assembly comprising: The catheter assembly comprises: a catheter hub having a hub body with an outer surface and an inner surface defining an internal cavity; a bushing having a distal section and a proximal section disposed within the internal cavity; a catheter tube having a first length, an inner lumen, and a distal opening overlying the bushing; a reinforcing sleeve having a second length disposed over the bushing; the reinforcing sleeve overlaps at least a portion of the catheter tube at the distal end of the catheter hub; The catheter assembly further comprises: a needle hub with a needle extending out from a distal end of the needle hub; The needle includes a needle shaft having a needle lumen and a needle tip; A catheter assembly in which, in the ready-to-use position, the needle shaft protrudes through the bushing, the catheter tube, and the reinforcing sleeve.

[0034] The first length may be greater than the second length.

[0035] The catheter tube or reinforcing sleeve may be in direct contact with the bushing.

[0036] The reinforcing sleeve may be placed over or within the catheter tube.

[0037] The reinforcing sleeve may be made from a heat shrink material, such as heat shrink tubing, that may surround a portion of the sheath of the catheter tube and, optionally, at least a portion of the sheath of the catheter hub.

[0038] In one embodiment, the second length, or 20% to 70% of the length of the reinforcing sleeve, can extend distally of the catheter hub.

[0039] In one example, the portion of the inner capillary, or optionally the outer capillary, that extends distally of the distal end of the catheter hub is about 10% to about 85%, more preferably 25% to 65%, of the length of the inner capillary.

[0040] To facilitate placement, the catheter tube can be heated or cooled and / or the inner capillary can be cooled or heated.

[0041] The reinforcing capillary or sleeve may be made from the same material as the catheter tube. In one example, the inner capillary may be made from a material other than metal, such as, for example, by an extrusion process, from a polymeric material, such as, but not limited to, silicone rubber, latex, polyurethane (PUR), polyethylene terephthalate (PET), fluorinated ethylene propylene (FET), or silicone. In some examples, particularly if the sleeve is an outer sleeve used on the exterior of the catheter tube, the material may be Teflon. In yet other examples, the material may be made from a thermoplastic elastomer, such as thermoplastic urethane or polyether block amide (PEBA).

[0042] In some examples, an antimicrobial agent may optionally be incorporated into the reinforcing capillary tube or sleeve. In one example, an antimicrobial metal may be added to or combined with a polymeric material and extruded as part of the sleeve. Exemplary antimicrobial metals include precious metals such as silver, gold, platinum, copper, and zinc. Physiological antimicrobial metal compounds may preferably include silver, as well as gold oxides and salts. These agents include silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds such as chloroplatinic acid or its salts (e.g., sodium and calcium chloroplatinate) may also be used. Alternatively, copper and zinc oxides and salts, as noted above for silver, may also be used. Preferred physiological antimicrobial metal compounds that can be used in the preferred pistons of the present invention include silver acetate, silver oxide, ionic silver, silver sulfate, gold chloride, and a combination of silver oxide and gold chloride. The amount of antimicrobial agent may range from 2% to 8% by weight of the combined materials. A coloring agent may also be added together with the antibacterial agent.

[0043] A needle guard having a proximal wall with a proximal opening and two resilient arms may be slidably attached to the needle shaft.

[0044] A valve for restricting fluid flow through the catheter hub including at least one slit defining at least two flaps can be disposed inside the catheter hub.

[0045] The valve actuator can be located within the catheter hub proximal to the valve, and can include a nose portion having a fluid passageway and at least one plunger element for being pushed by a male Luer tip.

[0046] Yet another aspect of the present invention is a method for manufacturing a catheter assembly, the method comprising: forming a catheter hub having a body with an interior surface defining an interior cavity; placing a catheter tube having a first length over the bushing; placing a reinforcing sleeve having a second length over the bushing; Securing the bushing within the interior cavity of the catheter hub; and forming a needle hub having a needle including a needle shaft having a needle lumen and a needle tip, with the needle shaft protruding through the bushing and catheter tube in the ready-to-use position.

[0047] The method may further include slidably disposing a needle guard over the needle shaft, the needle guard having a proximal wall with a proximal opening and two resilient arms. The method may include removably engaging the needle guard with an interior of the catheter hub.

[0048] The method may further include disposing a valve within the interior cavity of the catheter hub to restrict fluid flow through the catheter hub, and disposing a valve actuator proximal to the valve.

[0049] Yet another aspect of the present invention is a catheter assembly comprising: a catheter hub having a hub body having an exterior surface and an interior surface defining an interior cavity; a bushing having an elongated distal seat and a tapered seat disposed within the internal cavity; a catheter tube having a first length fitted over the bushing; a reinforcing sleeve having a second length that is shorter than the first length and placed over the bushing; a needle hub having a needle extending from a distal end thereof; The needle includes a needle shaft having a needle lumen and a needle tip; the needle shaft protruding through the bushing, the catheter tube and the reinforcing sleeve in the ready-to-use position; The reinforcing sleeve is a catheter assembly that is placed over or within the catheter tube.

[0050] The reinforcing sleeve may include indicia, which may be a different color than the color of the catheter tube or may be one or more markings.

[0051] The reinforcing sleeve may comprise an antimicrobial agent.

[0052] At least a portion of the catheter hub can be covered with heat shrink material, for example, the nose of the catheter hub can be surrounded by heat shrink material which can then be activated, such as by heat, to form a tight fit around the nose.

[0053] Heat shrink tubing can be made from a range of thermoplastics such as polyolefin, polyvinyl chloride (PVC), Viton, neoprene, polytetrafluoroethylene (PTFE), polyurethane (PUR), or fluorinated ethylene propylene (FEP), to name a few non-limiting examples.

[0054] A needle guard can be provided. The needle guard can have a surface that is positioned on the side of the needle, and the needle tip and the surface are movable relative to each other so that the surface is positioned distal to the needle tip to block the needle tip from an inadvertent needle stick. The needle can have a profile change, such as a crimp, to engage the needle guard around its periphery. Alternatively, the needle guard cant over to grip the needle in a protective position without a profile change.

[0055] The needle guard can be positioned inside the catheter hub and biased by the needle to engage the needle hub in the ready-to-use position. In another example, the needle guard is held in the catheter hub by a valve opener. For example, the valve opener can have two plunger elements or legs and two bands connecting different edges of the two plunger elements, thereby forming a continuous section and two through openings. The two elbows of the needle guard can be located in the two through openings and held in the catheter hub.

[0056] If the catheter assembly includes a reinforcing capillary tube or sleeve, the feature can be used as an inner sleeve that fits within the bore of the catheter tube to support it from kinking, or an outer sleeve that fits over the outside of the catheter tube to support it from kinking. [Brief explanation of the drawings]

[0057] These and other features and advantages of the apparatus, systems, and methods of the present invention will be appreciated as the same becomes better understood with reference to the following specification, claims, and accompanying drawings.

[0058] [Figure 1A] FIG. 1A is a cross-sectional view of one embodiment of an IV catheter assembly provided in accordance with aspects of the present disclosure. [Figure 1B]FIG. 1B is a cross-sectional view of another embodiment of an IV catheter assembly provided in accordance with aspects of the present disclosure. [Figure 2] FIG. 2 is an isometric view of a catheter hub assembly provided in accordance with an embodiment of the present disclosure. [Figure 3] 3 is a cross-sectional view of the catheter hub assembly of FIG. 2. [Figure 4] FIG. 4 is a side view illustrating one embodiment of a bushing provided in accordance with aspects of the present disclosure. [Figure 5] FIG. 5 shows the bushing of FIG. 4 attached to a catheter tube. [Figure 6] FIG. 6 shows the bushing of FIG. 4 with the catheter tube partially deflected. [Figure 7] FIG. 7 shows the hub assembly of FIG. 2 with the catheter tube partially deflected. [Figure 8] FIG. 8 shows another embodiment of an IV catheter assembly. [Figure 9] FIG. 9 illustrates yet another embodiment of an IV catheter assembly. [Figure 10] FIG. 10 illustrates yet another embodiment of an IV catheter assembly. DETAILED DESCRIPTION OF THE INVENTION

[0059] The detailed description set forth below in connection with the accompanying drawings is intended as a description of presently preferred embodiments of needle assemblies and components for use with or forming needle assemblies provided in accordance with aspects of the device, system, and method of the present invention, and is not intended to represent the only manner in which the device, system, and method of the present invention may be constructed or utilized. The description defines features and steps for constructing and using embodiments of the device, system, and method in connection with the illustrated embodiments. However, it will be understood that the same or equivalent functions and structures may be achieved by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As shown elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

[0060] FIG. 1A illustrates a catheter device or assembly 100 provided in accordance with an embodiment of the present disclosure. The catheter device 100 may include a catheter hub 101 having a body 88 with exterior and interior surfaces defining a hollow interior cavity 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 in the ready-to-use position. A needle tip 112 having a needle bevel at the distal end of the needle 110 may extend from a distal end opening 142 of the catheter tube 140 in the ready-to-use position of FIG. 1A. The needle 110 may be understood to have a wall defining a needle shaft 111 having a needle lumen. A push tab may be provided on the hub body 88 to assist in pushing the catheter hub 101 during catheterization, and a pair of wings may extend laterally from the hub body 88 to facilitate securing the catheter hub to the patient after successful venipuncture.

[0061] The catheter device 100 may optionally include a needle shield or needle guard 103 that covers the needle tip 112 in a protected position after the needle 110 is withdrawn from the catheter hub 101 following successful venipuncture to prevent needlestick injuries. The needle guard 103 may be secured within the interior cavity 92 in a usable position. Alternatively, the needle guard 103 may be provided outside or partially outside the interior cavity 92, as described further below with reference to FIG. 10 . The needle guard 103 may have a proximal wall having a perimeter defining an opening for accommodating the needle, two arms extending distally from the proximal wall, and an end or distal wall for covering the needle tip 112 in a protected position to prevent inadvertent needlestick injuries.

[0062] In one embodiment, the needle guard 103 has a surface that is positioned on the side of the needle shaft 111 in the ready-to-use position and is movable distal to the needle tip 112 in the protective position to shield the needle tip 112 from an inadvertent needle stick. Examples of needle shields are found in U.S. Pat. No. 8,827,965 and U.S. Patent Application No. 13 / 257,572, published as US 2012 / 0046620 A1, the contents of which are expressly incorporated herein by reference. Thus, the needle guard has a surface that is positioned on the side of the needle, and the needle tip and the surface are movable relative to each other so that the surface is positioned distal to the needle tip to block the needle tip from an inadvertent needle stick. These needle shields or guards can be formed as a unit or can be made separately from multiple parts or components and then assembled together.

[0063] The needle 110 can include a profile or change in profile 113 having a surface contour or shape different from the rest of the needle shaft. The change in profile 113 can embody a crimp or radial bulge incorporated near the needle tip 112 to interact with a perimeter defining an opening on the proximal wall of the needle guard 103 to stop the needle guard 103 from being displaced distally off the needle 110 in the protective position. Some needle guards 103 can operate without a change in profile 113 on the needle 110, such as by canting or tilting the opening surrounding the needle 110 to grip the needle shaft 111, as disclosed, for example, in U.S. Patent No. 6,709,419, the contents of which are expressly incorporated herein by reference. In the embodiment of FIG. 1A, the needle shield 103 is located in the internal cavity 92 of the catheter hub 101, and the needle 110 passes therethrough, e.g., through an opening in the proximal wall and between the two arms to bias the two arms outward so that the elbows of the arms engage annular protrusions on the interior of the catheter hub. In other examples, the needle shield 103 is located outside or substantially outside the catheter hub 101, 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. In other examples, the needle guard is retained in the catheter hub by a valve opener, such as the valve opener shown in FIG. 9. For example, the valve opener can have two plunger elements or legs and two bands connecting different edges of the two plunger elements, thereby forming a continuum and two through-holes. The two elbows of the needle guard can be located in or at the two through-holes and retained in the catheter hub.

[0064] Optionally, a valve and valve opener, as shown in FIG. 9 , can be included in the catheter hub 101. A needle 110 extending from the needle hub 102 can extend through both the valve opener and the valve in the ready-to-use position. If included, the valve can be wedged within the internal cavity to control fluid flow therethrough. The valve opener can be slidably mounted within the catheter hub proximal to the valve. The valve opener can enter a valve having one or more slits defining two or more flaps, e.g., three or four flaps, to open the valve for fluid flow. For example, after successful venipuncture, a male Luer adapter of an IV fluid line can be connected to the proximal opening of the catheter hub, and the valve opener can be advanced into the valve to deflect two or more valve flaps and open fluid communication between the IV bag and the catheter tubing. Exemplary valves and valve openers are described in U.S. Pat. No. 10,166,370 and U.S. Publication No. 2018 / 0214682, the contents of which are expressly incorporated herein by reference.

[0065] The catheter tube 140 can be connected to the distal end of the catheter hub 101 via a bushing 50. The bushing 50 holds the catheter tube 140 in the catheter hub 101 by compressing the proximal end of the catheter tube 140 between the outer surface of the bushing 50 and the inner surface of the catheter hub 101.

[0066] In one example, the bushing 50 can be a bushing that cannot flex, bend, and / or deform. The bushing 50 can be a conventional bushing, such as a conventional metal bushing. The bushing 50 can include an anchor 55 or proximal seat 55, which can be referred to as a proximal portion, having a tapered seat 55 having a funnel shape, and an elongated distal seat 70 (FIG. 4), which can be referred to as a distal portion, having an elongated body with a smooth surface, such as a smooth cylinder, extending distally from the tapered seat 55. In other examples, the shape of the proximal seat 55 is not limited to being tapered or non-tapered. For example, the shape of the proximal seat can have a combination of both tapered and non-tapered features, elongated, non-elongated, regular, or irregular features. The distal seat 70 can be elongated and can embody a hollow cylinder.

[0067] As one example, when the bushing 50 is secured to the internal cavity 92 of the catheter hub 101 to wedge the catheter tube 140 thereto, a portion of the elongated distal seat 70 may extend at least partially into the bore of the nose section 118 of the catheter hub. In another example, a majority of the elongated distal seat 70 is recessed into the bore of the nose section 118. The proximal end of the catheter tube 140 is compressed between the outside of the elongated distal seat 70 and the bore or inner surface of the nose section 118, and possibly also at the proximal seat 55. The region or section of the catheter device 100 where the bushing 50 wedges the catheter hub against the inner surface of the nose section 118 may be referred to as the fixation section 120.

[0068] In one embodiment, the anchoring section 120 may include a reinforcing capillary or sleeve 60 in addition to the catheter tube 140. The reinforcing capillary or sleeve 60 may include an elongated flexible tube having an exterior and an interior defining a hollow interior. The reinforcing capillary or sleeve 60 may house the catheter tube 140 within the bore of the reinforcing capillary 60, or the reinforcing capillary 60 may be disposed on or outside the catheter tube. In the example of FIG. 1A, the reinforcing capillary 60 is an inner capillary or inner sleeve 60a, which is understood to be disposed within the catheter tube such that the exterior of the reinforcing capillary or sleeve 60 contacts the interior of the catheter tube 140.

[0069] The inner capillary tube 60a can be disposed in the bore of the catheter tube 140, and both the catheter tube 140 and the inner capillary tube 60a can be connected to the distal end of the catheter hub 101 via a bushing 50 at the fixing section 120. The bushing 50 presses the proximal end of the catheter tube 140 between the outside of the inner sleeve 60a and the bore of the nose 118 of the catheter hub 101 to hold the catheter tube 140 to the catheter hub 101 and also hold the inner sleeve 60a. In other words, the bushing 50 can wedge both the catheter tube 140 and the inner capillary tube 60a against the nose 118. At least a portion of the inner sleeve 60a can extend distal to the distal end 91 of the nose 118. The portion of the inner capillary tube 60a extending out of the distal end 91 of the catheter hub 101 is flexible and can bend with the catheter tube 140, but its location at the nose reinforces the catheter tube to prevent kinking or collapse of the catheter tube 140 at or near the nose of the catheter hub, as discussed further below. In one example, the portion of the inner capillary tube 60a extending distally of the distal end 91 is about 10% to about 85%, more preferably 25% to 65%, of the length of the inner capillary tube 60a. The catheter tube 140 can be heated and / or the inner capillary tube 60a can be cooled to facilitate installation.

[0070] When the catheter tube 140 is bent, such as when taping the catheter hub to a patient, the upper side of the bent section is subjected to tensile stress and the lower side is subjected to compressive stress. If the compressive stress exceeds the yield strength of the catheter tube, kinking occurs and the catheter tube folds. The inner capillary 60a can resist the force exerted on the catheter tube 140 by bending, such as when tilting the catheter hub against the patient's skin to apply an adhesive dressing to secure the catheter hub after successful venipuncture. The inner capillary 60a can increase resistance to bending and even tolerate a relatively large bend angle before the capillary tube 140 breaks or kinks due to tensile and / or compressive stresses.

[0071] During assembly, the inner capillary tube 60a can be placed over the bushing 50, and the catheter tube 140 can then be placed over the inner capillary tube 60a. Heat can be applied to the catheter tube and / or inner sleeve to facilitate assembly. Once the inner capillary tube 60a is placed over the bushing, the inner capillary tube 60a can be cooled, while the catheter tube 140 can be heated to facilitate assembly. The inner capillary tube 60a can have an inner diameter approximately the same as or smaller than the diameter of the elongated distal seat 70 ( FIG. 4 ) before being placed over the bushing 50. Once the inner capillary tube 60a is placed over the bushing 50, the inner diameter of the inner capillary tube 60a can expand approximately to the diameter of the elongated distal seat 70, applying a compressive force to the elongated distal seat 70 and forming a snug fit. Following the placement of both the inner capillary tube 60a and the catheter tube 140 onto the bushing 50, the bushing 50 can be inserted into a bore in the nose portion 118 of the catheter hub 101 to wedge the combined catheter tube and inner capillary tube into the nose portion.

[0072] The inner capillary 60a may have a length of approximately 1 cm to 4 cm, more preferably 1.5 cm to 2.5 cm. The length of the inner capillary 60a may be longer than the length of the elongated distal seat 70, which is aligned with the catheter tube 140. The inner capillary 60a may have an inner diameter that may vary depending on the gauge size of the catheter tube. For example, for a G16 metal bushing with an outer diameter of 1.37 mm, the inner diameter of the inner capillary 60a may be 1.34 mm. As another example, for a G18 metal bushing with an outer diameter of 1.05 mm, the inner diameter of the inner capillary 60a may be 0.98 mm. In one example, the inner capillary 60a may have a length, and approximately 15% to approximately 85% of the length may extend distal to the distal end of the nose portion 118. The inner capillary 60a may have a length that is shorter than the length of the catheter tube 140.

[0073] The inner capillary tube 60a may be made from the same material as the catheter tube. In one example, the inner capillary tube may be made from a non-metallic material, such as by an extrusion process, from a polymeric material, such as, but not limited to, silicone rubber, latex, polyurethane (PUR), polyethylene terephthalate (PET), fluorinated ethylene propylene (FET), or silicone. In some examples, the material may be Teflon, particularly if the sleeve is an outer sleeve used on the exterior of the catheter tube. In yet other examples, the material may be made from a thermoplastic elastomer, such as thermoplastic urethane or polyether block amide (PEBA).

[0074] The needle 110 extends from the distal end of the needle hub 102, passes through the tapered seat 55 and elongated distal seat 70 of the bushing 50, through the interior cavity 92 of the catheter hub 101, and can be placed into the catheter tube 140 with the needle tip 112 extending from the distal end opening 142 of the catheter tube 140 in the ready-to-use position. The distal portion of the catheter tube 140 can be tapered inward or have an opening sized smaller than the outer diameter of the needle 110 to form a seal with the needle 110 at 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 penetrates the patient's skin at the incision or insertion point. The space between the needle 110 and the interior of the catheter tube 140 can be annular and optionally defined by baffles, such as ridges, or lined with a material that reacts with or absorbs blood to enhance awareness of secondary blood flashback, as described below.

[0075] When piercing the skin, such as when entering a vein, blood that flows into the needle lumen of the needle 110 and into the needle hub 102 is known as primary blood flashback. The blood that flows into the needle hub 102 can be collected in a vent plug or blood collection device 107 for sampling. When the needle tip 112 is retracted proximally into the catheter tube 140 after primary blood flashback, fluid or blood can flow into the space between the needle 110 and the interior of the catheter tube 140, which is known as secondary blood flashback.

[0076] Thus, one aspect of the present invention can be understood to include a kink-resistant catheter assembly including a catheter hub having a hub body with an outer surface and an inner surface defining an internal cavity. A nose portion having a bore at the distal end of the catheter hub. A metal bushing wedging the proximal end of the catheter tube against the inner surface defining the bore of the nose portion. A reinforcing capillary tube or sleeve is disposed inside the catheter tube. The exterior of the reinforcing capillary tube or sleeve can contact the interior of the catheter tube or can be spaced from the interior of the catheter tube in a location not wedged by the bushing against the interior of the nose portion. The reinforcing capillary tube or sleeve is mounted on an elongated distal seat of the bushing. The reinforcing capillary tube or sleeve can terminate short of the proximal seat or can contact a portion of the tapered surface of the proximal seat. The catheter tube is mounted over the reinforcing capillary tube and the elongated distal seat of the bushing. The metal bushing wedging both the catheter tube and the reinforcing capillary tube against the inner surface of the bore of the nose portion. The inner capillary tube has a length that is shorter than the length of the catheter tube. The inner capillary tube has a length, and about 15% to about 85% of its length can extend distal to the distal end of the nose of the catheter hub. The inner capillary tube can resist forces exerted on the catheter tube by bending the catheter tube, such as when tilting the catheter hub against a patient's skin to apply an adhesive dressing to secure the catheter hub after successful venipuncture. The inner capillary tube increases resistance to bending, even allowing the capillary tube to tolerate a relatively large bending angle before bending or kinking due to tensile and / or compressive stresses occurs.

[0077] The kink-resistant catheter assembly may further include a needle extending from the needle hub, through the catheter tube and inner reinforcing sleeve, and exiting the distal opening of the catheter tube. If incorporated, the needle guard may be located within the catheter hub or in a third housing located between the catheter hub and the needle hub. The catheter assembly may further optionally include a valve and a valve opener located within the catheter hub. The needle guard may be located proximal to the valve. For example, the needle guard may be located between the two plunger elements of the valve opener or within the third housing.

[0078] In some examples, an antimicrobial agent may optionally be incorporated into the inner reinforcing sleeve 60a or the outer reinforcing sleeve 60b. In one example, an antimicrobial metal may be added to or combined with a polymeric material and extruded as part of the sleeve. Exemplary antimicrobial metals include precious metals such as silver, gold, platinum, copper, and zinc. Physiological antimicrobial metal compounds may preferably include silver, as well as gold oxides and salts. These agents include silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfadiazine, silver sulfate, gold chloride, and gold oxide. Platinum compounds such as chloroplatinic acid or its salts (e.g., sodium and calcium chloroplatinate) may also be used. Alternatively, copper and zinc oxides and salts, as noted above for silver, may also be used. Preferred physiological antimicrobial metal compounds that may be used in preferred pistons of the present invention include silver acetate, silver oxide, ionic silver, silver sulfate, gold chloride, and combinations of silver oxide and gold chloride. The amount of antimicrobial agent can range from 2% to 8% by weight of the combined materials. A colorant can also be added along with the antimicrobial agent.

[0079] 1B illustrates a catheter device or assembly 100 provided in accordance with a further aspect of the present disclosure. In this embodiment, a reinforcing capillary tube or sleeve 60 is mounted over a catheter tube 140, or the catheter tube is disposed inside the bore of the sleeve 60, and the reinforcing sleeve may be referred to as an outer capillary tube or outer sleeve 60b. The outer capillary tube 60b may be disposed outside the bore of the catheter tube 140, and both the catheter tube 140 and the outer capillary tube 60b may be connected to the distal end of the catheter hub 101 via a bushing 50 at the fixation section 120. Thus, the outer sleeve 60b may have an inner surface that defines a bore, and the catheter tube 140 may be located within the bore of the outer sleeve 60b and, in some cases, contact the inner surface of the outer sleeve.

[0080] The bushing 50 can press the proximal end of the outer capillary tube 60b at the securing section 120 between the outer surface of the catheter tube 140 and the interior of the nose 118 of the catheter hub 101 to partially retain the outer capillary tube 60b within the catheter hub 101. The retaining force applied to the outer capillary tube 60b can also act on the catheter tube 140 located between the outer capillary tube 60b and the bushing 50 to hold the catheter tube 140 in place. The portion of the outer capillary tube 60b extending from the distal end 91 of the catheter hub 101 can bend with the catheter tube 140 to prevent kinking or bending of the catheter tube 140 at or near the nose of the catheter hub. The outer capillary tube 60b can resist forces exerted on the catheter tube 140 by bending, such as when the catheter hub is tilted against a patient's skin to apply an adhesive dressing to secure the catheter hub after successful venipuncture. The outer capillary 60b may provide increased resistance to bending and may also be able to tolerate a relatively large bend angle before the capillary tube 140 buckles or kinks due to tensile and / or compressive stresses.

[0081] During assembly, the catheter tube 140 can be placed over the bushing 50, and the outer capillary tube 60b can then be placed over both the catheter tube 140 and the bushing 50. Optionally, the outer sleeve 60b can be placed over the catheter tube 140, and the combination then attached to the distal seat 70 of the bushing 50. The outer capillary tube 60b can have an inner diameter or inner diameter that is approximately equal to or smaller than the outer diameter of the catheter tube 140 before being placed over the catheter tube 140. In embodiments, the outer capillary tube 60b can have an inner diameter that is slightly larger than the outer diameter of the catheter tube. When the outer capillary tube 60b is placed over the catheter tube 140, the inner diameter of the outer capillary tube 60b expands and can exert a compressive force on not only the catheter tube 140, but also on the elongated distal seat 70 of the bushing where the outer capillary tube 60b overlaps. This engagement creates a snug or slight interference fit between the outer capillary tube 60b and the catheter tube 140. Heat and cold can be applied to soften the outer sleeve and / or catheter tube and / or to stiffen or shrink the components during assembly. Following attachment of the catheter tube and sleeve to the bushing, the bushing 50 can be inserted into a bore in the nose 118 of the catheter hub 101 to wedge them against the interior of the nose.

[0082] The outer capillary 60b can have a length of approximately 1 cm to 4 cm, with 1.5 cm to 2.5 cm being more preferred. The length of the outer capillary 60b can be longer than the length of the elongated distal seat 70. The outer capillary 60b can have an inner diameter that can vary depending on the gauge size of the catheter tubing.

[0083] In some embodiments, the catheter tube 140 can have the same outer diameter along its length but different sizes or shapes at its two ends. In some examples, the catheter tube 140 can have a first outer diameter and a second outer diameter at its two ends, where the first outer diameter is larger than the second outer diameter. For example, the second outer diameter can be located at the proximal end for mating with an outer reinforcing sleeve. The second outer diameter can provide space for the outer capillary tube 60b so that, when mated, the overlapping portion can have approximately the same outer diameter as the rest of the catheter tube. In other examples, the catheter tube 140 can have a uniform outer diameter, and the sleeve is positioned over the uniform outer diameter. The distal end of the outer sleeve can be wedge-shaped or tapered to provide a smooth transition from the catheter tube to the outer sleeve and allow for entry into the patient when the insertion depth into the outer sleeve is required for adequate venipuncture.

[0084] The outer sleeve 60b may be extruded from a non-metallic material, such as a polymeric material. The outer sleeve may be made from the same material as the inner sleeve 60a described above. In some examples, the outer sleeve 60b may be molded or coated with indicia, such as markings or a color different from the color of the catheter tube. This indicia can act as a "stop" indicator to notify the physician not to advance the catheter tube further into the patient's skin.

[0085] In some examples, the outer reinforcing capillary tube or sleeve can be made from heat-shrink tubing, which is understood to mean a heat-shrinkable non-metallic material having a tubular shape. For example, the heat-shrink tubing can be placed over the proximal end of the catheter tube over the distal seat of the metal bushing, and then heated with an IR light, resistance heater, heat lamp, or the like to conform to the catheter tube. The heat-shrink tubing can be made from various thermoplastics, including, but not limited to, polyolefin, polyvinyl chloride (PVC), Viton, neoprene, polytetrafluoroethylene (PTFE), polyurethane (PUR), and fluorinated ethylene propylene (FEP). The heat-shrink tubing and catheter tube can be wedged into the bore in the nose of the catheter hub. In an alternative embodiment, the heat-shrink material can cover the catheter housing in addition to reinforcing the portion of the catheter tube adjacent the nose of the catheter hub. For example, heat shrink material can be placed around the nose 118 of the catheter tube and over the proximal end of the catheter tube just distal to the nose 118, with an appropriate length to provide kink support. When incorporated, this embodiment can advantageously cover the gap between the catheter hub and the catheter tube, where the catheter tube protrudes from the hub body 101. If the heat shrink material also covers the hub body, in addition to a portion of the catheter tube, the heat shrink material can also cover at least a portion of the nose of the catheter hub, and possibly a portion of the hub body proximal to the nose. This can prevent blood trapping and clotting in the gap between the catheter tube and the catheter hub.

[0086] Referring now to Figure 2, an isometric view of a catheter hub assembly 108 provided in accordance with one embodiment of the present disclosure is shown. The catheter hub assembly 108 may include a catheter hub 101, a catheter tube 140, a reinforcing capillary tube 60, which may be an inner capillary tube 60a, but may alternatively be an outer capillary tube 60b, and a bushing 50 located within the catheter hub. Figure 3 is a cross-sectional view of the catheter hub assembly 108 of Figure 2, more clearly showing the bushing 50 located within the interior cavity 92 of the catheter hub.

[0087] 3, the catheter hub 101 has an internal cavity 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 to the distal end of the internal cavity 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.

[0088] The tapered sheet 55 and the elongated distal sheet 70 can be integrally formed. Alternatively, the tapered sheet 55 and the elongated distal sheet 70 can be formed as separate pieces and assembled together by welding or other fastening means. The material selected for the bushing 50 is one that can withstand temperature fluctuations, impact, corrosive substances, heat, and the elements. In one embodiment, the bushing 50 is made of metal. In another embodiment, the bushing 50 is made of plastic. A hydrophobic coating can optionally be applied to portions of the inner and outer surfaces of the bushing 50 to prevent thrombus formation, phlebitis, or blood clots. In one embodiment, a parylene coating is applied to at least the inner surface of the elongated distal sheet 70 to prevent thrombus formation. In yet another example, the bushing can be made of a polymer or polymer matrix material, such as medical-grade silicone rubber.

[0089] The tapered seat 55 may be conical or funnel-shaped with a defined thickness, with a body having a wider opening at the proximal end 56 and a relatively narrow opening at the distal end 57 of the funnel-shaped body. The narrower opening transitions into the elongated distal seat 70. The tapered seat 55 may be rigid and inflexible 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, particularly the fixation section 120. In other examples, the tapered seat 55 may be flexible and resilient.

[0090] As mentioned above, the tapered seat 55 may be secured within the catheter hub's internal cavity 92 by an interference fit, press fit, or other fastening means. A retention mechanism or retainer 95 may be provided within the catheter hub 101 to secure the tapered seat 55 within the internal cavity 92. For example, the retainer 95 may be a raised circumferential ring or lip formed within the internal cavity 92 of the catheter hub 101, thus forming a shoulder for the proximal end of the tapered seat 55 to abut against.

[0091] The bushing 50 can be inserted into the internal cavity 92 of the catheter hub 101 through an opening at the proximal end 93 of the catheter hub 101 and pushed distally until the tapered seat 55 elastically deforms, sliding over the retainer 95 and snapping into a fixed position within the bore and the retainer 95. The raised circumferential ring or shoulder of the retainer 95 can have an inner diameter that is smaller or slightly smaller than the maximum outer diameter of the wider opening at the proximal end 56 of the tapered seat 55, providing a positive engagement of the tapered seat 55 against the retainer 95 and preventing the tapered seat 55 of the bushing 50 from sliding out proximally after it snaps into place. The circumferential ring can taper gradually inward in the distal direction to aid in sliding the bushing 50 into a fixed position. The circumferential ring can also have recesses or other surface features to resist the distal end 57 of the tapered seat 55 and prevent the bushing 50 from sliding proximally out of the internal cavity 92. Alternatively, the retainer 95 may be a series of bumps or protrusions or separately formed elements that are inserted into and secured to the catheter hub 101 after the bushing 50 is installed.

[0092] 4 is a side view of a bushing 50 provided in accordance with an embodiment of the present disclosure. As shown, the elongated distal seat 70 of the bushing 50 may be cylindrical and extend from a narrow opening at the distal end 57 of the tapered seat 55. The elongated distal seat 70 and the tapered seat 55 may be rigid and inflexible, or semi-rigid with some flexibility. The distal or insertion end 68 of the elongated distal seat 70 may be rounded or chamfered to facilitate insertion into a catheter tube or stiffening sleeve.

[0093] 5, the catheter tube 140 and the reinforcing capillary 60, or as shown by example, the inner capillary 60a, can extend up to, or at least partway through, the tapered seat 55. In other examples, the catheter tube 140 and the inner capillary 60a can extend up to, or very close to, the intersection between the tapered seat 55 and the elongated distal seat 70, such that the proximal end opening of the catheter tube is distal to the proximal end opening of the reinforcing capillary. In other examples, the reinforcing capillary 60 can be an outer sleeve 60b and disposed outside the catheter tube 140.

[0094] A seal can be formed at the interface between the lumen 141 of the catheter tube 140, the inner capillary 60a, and the bushing 50 to prevent fluid flow between the layers or components. The diameter of the elongated distal sheet 70 can be the same as or larger than the diameter of the lumen 141 of the catheter tube 140 and the inner diameter of the inner capillary 60a. Thus, the catheter tube 140 and the inner capillary 60a can be stretched over the elongated distal sheet 70 to form a tight and secure fit. Adhesive or other fastening means can be provided to further secure the inner capillary 60a to the elongated distal sheet 70 and / or the tapered sheet 55.

[0095] Referring to FIG. 6 , the catheter tube 140 and the reinforcing capillary tube 60, or the inner capillary tube 60a as shown, can be bent together or integrally to form an n-shape, or any other term or description that can be used to describe the shape shown. This bending can exert compressive stress on the portion of the catheter tube 140 that forms the inner surface or radius 72 of the n-shaped bend and tensile stress on the portion of the catheter tube 140 that forms the outer surface or radius 74 of the n-shaped bend. The inner capillary tube 60a, which lines or supports the inner surface 72 and outer surface 74 of the catheter tube, can provide structural support against compression of the catheter tube 140 due to bending, reducing the likelihood of or eliminating kinking. In one example, the n-shape can be characterized as a large radius bend or a tight radius bend. The reinforcing capillary tube 60, which can be the outer capillary tube 60b, can similarly support the catheter tube 140 to prevent unwanted kinking.

[0096] 7, a partial cross-sectional view of the catheter hub assembly 108 of FIG. 2 is shown, with some hidden components shown in dashed lines for purposes of discussion. In the shown view, the distal end 91 of the catheter hub 101 can have a rounded opening to form a recess 109 to accommodate bending of the catheter tube 140 and the reinforcing capillary tube 60, or, as examples, the inner capillary tube 60a or the outer capillary tube 60b. The shape of the recess 109 is not limited, and can embody any shape, as long as sufficient clearance is provided to accommodate movement of the catheter tube 140 and the reinforcing capillary tube 60, such as the distal end 91 shown in FIG. 7.

[0097] FIG. 8 shows an embodiment of a catheter assembly 127 including a catheter hub 101 and a catheter tube 140 attached to a bushing 50 described elsewhere herein, with at least a portion of the stiffening capillary tube 60, or inner capillary tube 60a as shown, or alternatively, outer capillary tube 60b as shown in FIG. 1B or 5, extending from the distal end of the catheter hub 101. The assembly 127 further includes a needle hub 102 having a needle 110 extending through the catheter tube 140, a side fluid port 184, and a fluid adapter (not shown) attached to the side fluid port 184 by tubing 188 attached to the side fluid port 184 by a second bushing 52. The tubing 188 may have an internal lumen for fluid flow between the side fluid port 184 and the fluid adapter, which may be a needleless valve with a female Luer inlet. This catheter assembly is sometimes referred to as an integrated catheter assembly. To prevent the second bushing 52 from being pulled out of the catheter hub 101, the second bushing 52 may be secured to the catheter hub 101 with an adhesive, an interference fit, or a combination thereof.

[0098] The interior of the catheter hub 101 may include a septum, seal, or valve to prevent fluid from flowing out the proximal opening of the hub body after removal of the needle 110 and needle hub 102. A needle guard 103, as described above, may be incorporated into a third housing between the needle hub 102 and the catheter hub 101. The catheter hub 101 is shown with a pair of wings. Instead of wings on its sides, the needle hub 102 may alternatively have wings extending distally along the side of the catheter hub 101 opposite the side fluid port 184.

[0099] The needle tip 112 of the needle 110 can extend distally beyond the distal opening of the catheter tube 140. Once inserted into a patient, blood flow can be monitored from primary flashback through the needle hub and from secondary flashback in the annular space between the needle and the catheter tube 140. After successful venipuncture, the needle 110 can be removed from the patient, such as by withdrawing the needle hub 102 proximally. A seal or septum at the proximal end of the catheter hub can prevent fluid from exiting the proximal opening. Fluid can be injected through a fluid adapter (not shown) via tubing 188 into the side port 184, then through the catheter hub 101, and then out the catheter tube 140. Alternatively, if the proximal end of the catheter hub 101 has a valve instead of a septum or seal, fluid can be injected through the valve, via the proximal opening in the hub body, and then through the catheter tube. A clamp (not shown) can be used to clamp the extension line between the side fluid port 184 and the fluid adapter.

[0100] Referring to FIG. 9, catheter assembly 100 is similar to the catheter assemblies of FIGS. 1A and 1B, respectively, and includes either an inner sleeve or an outer sleeve, but the catheter assembly may further include a valve activator or actuator 104 for opening valve 122, which may have one or more slits defining multiple flaps, such as three, four, or more, that can be opened when valve activator 104 is advanced by a male medical instrument, such as the tip of a syringe, a male luer connector, or a luer adapter. Actuator 104 may have a nose portion for physically opening valve 122 and a plunger end including at least one plunger element or leg 90 configured to be pushed by a male medical instrument. As shown, valve actuator 104 has two plunger elements, with needle guard 103 positioned therebetween in the ready-to-use position. Optionally, valve 122, valve actuator 104, and needle guard 103 may be omitted. The valve 122 is housed within the internal cavity 92 of the catheter hub 101 and, when assembled, has the needle 110 protruding therethrough in the ready-to-use position as shown in FIG.

[0101] In some examples, three slits are provided in the valve 122, forming three flaps. In other examples, four slits in the shape of an "X" are provided, forming four flaps. A different number of slits and flaps are contemplated. The valve 122 can be seated on a valve seat formed in the interior cavity 92 of the catheter hub. For example, an undercut can be formed inside the catheter hub 101 to hold the valve 122 proximal to the vale within the interior cavity. A shoulder can be provided inside the catheter hub distal to the valve to support the valve from distal displacement. In some examples, a bump or protrusion can be provided around the exterior of the valve 122 to form a pathway between the valve 122 and the interior of the catheter hub 101 for venting during blood flashback. After the flexible tubing 14 is positioned in the patient's vasculature, the needle 110 is withdrawn from the catheter hub 101, causing the one or more slits to close and the valve 122 to seal itself, thereby restricting flow across the valve 122. Thus, valve 122 limits the backflow of blood through catheter hub 101. Valve 122 can be constructed of a material that forms a seal or restriction at its interface with needle 110 and reseals after needle 110 is withdrawn. For example, without limitation, valve 122 may include silicone, silicone rubber, polypropylene, or other suitable material. Unless otherwise indicated, the various components discussed elsewhere herein may be made from conventional materials.

[0102] The activator 104 can be configured to protrude through the slit and press against the valve 122 to open or deflect a flap when moved distally by a medical instrument to open the valve 122 and allow fluid or solution to pass through the valve 122. The activator 104 has a passageway formed through the nose 94 to receive the needle 110 in the ready position and to allow fluid flow when the catheter hub is connected to an IV line. The activator can have a surface profile to allow mixing of the fluids as they enter the catheter hub.

[0103] After the needle 110 and needle hub 102 are removed, a male medical instrument, such as a luer tip of a syringe, a male luer connector or adapter such as those used in connection with IV lines, a luer access connector, or a vent plug, can be inserted to push the activator 104 distally to open the seal 122. For example, the activator 104 can be advanced distally by the tip of a syringe, which presses the activator 104 against the proximally facing surface of the valve disc 80, advancing the nose 94 of the activator 104 distally and pushing it into the valve 122 within the skirt 82, opening one or more slits. In one example, the activator 104 can have a wedge-shaped nose 94 for pushing open the valve 122 and an extension, plunger, or leg 90 extending proximally from the nose 94 to be pressed by the male medical instrument.

[0104] While a single extension or leg can be used to push the activator 104, two or more leg extensions are preferred, as shown in FIG. 9. The extension 90 can embody one or more separate sections that can be pressed against by a male medical instrument to advance the activator 104 against the valve 122. Two spaced apart extensions 90 can be provided to house the needle guard 103 therebetween. Examples of activators can be found in U.S. Patent Application No. 14 / 062,081, published as US2014 / 0052065 A1, the contents of which are expressly incorporated herein by reference.

[0105] The valve 122 can be modified or a different valve embodiment can be used in the catheter assembly. For example, only the disk 80, rather than the skirt 82, can be located at the joint 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, as shown in FIG. 10. The intermediate hub can be removably coupled to the catheter hub 101 and is sometimes referred to as a third hub or needle shield or needle guard housing.

[0106] In yet another example, the catheter hub 101 includes a valve that can be actuated solely by fluid pressure, such that an actuator can be omitted from within the interior cavity of the catheter hub. For example, head pressure from an IV bag hanging from an IV pole can deflect the valve, pushing it up and opening one or more flow paths or channels for fluid flow. In yet another example, the valve is positioned in a closed position relative to the proximal open end of the catheter hub such that it is opened by a male luer connected to the proximal open end of the catheter hub without the use of an actuator or activator 104.

[0107] Referring now to Figure 10, an exemplary catheter assembly 162 is shown, similar to the catheter device of Figure 9, except that a needle safety shield or guard 103, including a biasing or resilient member such as a resilient arm, is completely or substantially outside of the catheter hub 101. Thus, the catheter assembly 162 includes a catheter tube 140 supported by a reinforcing capillary tube or sleeve, which may be an inner or outer sleeve as described elsewhere. As shown, an intermediate hub, needle shield hub, or third hub 105 is at least partially disposed between the catheter hub 101 and the needle hub 102. The needle 110 has a varying profile 113, similar to other embodiments described elsewhere herein.

[0108] The needle shield 103 is disposed on or within the intermediate hub 105. The intermediate hub 105 can be enclosed as shown, have a single wall, or have an opening in the wall. The needle shield 103 can be supported by a support flange 106 on the intermediate hub 105, or the distal arm can directly contact the needle 110. The support flange 106 extends from the distal wall of the intermediate hub 105 such that the resilient arm of the needle safety shield or guard 103 is supported on the flange 106.

[0109] In use, when the needle 110 is retracted as shown and the needle hub is no longer visible, the change in contour or profile 113 engages the proximal opening on the proximal wall of the needle shield 103, pulling the needle shield 103 proximally so that the two resilient arms are pulled away from the support flange 106 and then move closer together to block the needle tip 112.

[0110] Methods of making and using the needle device and its components as discussed elsewhere herein are contemplated.

[0111] While specific embodiments of various catheter assemblies with bushings and reinforcing sleeves have been specifically described and illustrated herein, numerous modifications and variations will be apparent to those skilled in the art. For example, any over-the-needle catheter may benefit from the use of the inner or outer capillaries disclosed herein, reducing the likelihood of kinking, increasing flexibility, and allowing patient movement without causing additional discomfort at or near the insertion point. Furthermore, it is understood and contemplated that features specifically discussed for one catheter assembly with bushings and reinforcing sleeves may be adopted for inclusion in another catheter device, provided that functionality is compatible. Accordingly, it is understood that catheter devices and components thereof with bushings and reinforcing sleeves constructed according to the principles of the disclosed devices, systems, and methods may be embodied in ways other than those specifically described herein. The present disclosure is also defined by the following claims.

Claims

1. A catheter assembly (100, 127, 162) comprising: The catheter assembly comprises: a catheter hub (101) having a hub body (88) with exterior and interior surfaces defining an interior cavity (92); a bushing (50) having a distal section (70) and a proximal section (55) disposed within an internal cavity (92); a catheter tube (140) having a first length, a lumen (141), and a distal opening (142) overlying a bushing; a reinforcing sleeve (60) made of a non-metallic material and having a second length that is fitted over the bushing (50); the reinforcing sleeve (60) overlaps at least a portion of the catheter tube (140) at the distal end of the catheter hub (101) to resist or prevent kinking of the catheter tube (140); The catheter assembly further comprises: a needle hub (102) with a needle (110) extending out from a distal end of the needle hub (102); The needle (110) includes a needle shaft (111) having a needle lumen and a needle tip (112); In the ready-to-use position, the needle shaft (111) protrudes through the bushing (50), the catheter tube (140), and the reinforcing sleeve (60); The catheter assembly further comprises: a needle guard (103) having a proximal wall with a proximal opening and two resilient arms slidably attached to the needle shaft (111); A catheter assembly (100, 127, 162).

2. The first length is greater than the second length; 10. The catheter assembly (100, 127, 162) of claim 1.

3. The catheter tube (140) or the reinforcing sleeve (60) is in direct contact with the bushing (50); 10. The catheter assembly (100, 127, 162) of claim 1.

4. The reinforcing sleeve (60) is placed over or within the catheter tube (140); 10. The catheter assembly (100, 127, 162) of claim 1.

5. The reinforcing sleeve (60) is a heat shrink tube.

10. The catheter assembly (100, 127, 162) of claim 1.

6. The heat shrink tubing surrounds at least a portion of the outer casing of the catheter hub (101).

6. The catheter assembly (100, 127, 162) of claim 5.

7. Between 20% and 70% of the second length extends distal to the catheter hub (101); 10. The catheter assembly (100, 127, 162) of claim 1.

8. The catheter system of claim 1, further comprising a valve (122) for restricting fluid flow through the catheter hub (101); The valve (122) includes at least one slit that defines at least two flaps; 10. The catheter assembly (100, 127, 162) of claim 1.

9. The catheter system of claim 8, further comprising a valve actuator (104) located within the catheter hub (101) proximal to the valve (122); The valve actuator (104) includes a nose (94) having a fluid passageway and at least one plunger element (90) for being pushed by a male luer tip; 9. A catheter assembly (100, 127, 162) according to claim 8.

10. The hub assembly further includes a side fluid port (184) extending radially from the hub body (88); The side fluid port (184) has a bushing (52) that secures the tube (188) to the lumen of the side fluid port (184).

10. The catheter assembly (100, 127, 162) of claim 1.

11. A method of manufacturing a catheter assembly (100, 127, 162), comprising: The method is: forming a catheter hub (101) having a body (88) with an interior surface defining an interior cavity (92); placing a catheter tube (140) having a first length over the bushing (50); placing a non-metallic reinforcing sleeve (60) having a second length over the bushing (50); Securing the bushing (50) in the internal cavity (92) of the catheter hub (101); forming a needle hub (102) having a needle (110) including a needle shaft (111) having a needle lumen and a needle tip (112), with the needle shaft (111) protruding through a bushing (50) and a catheter tube (140) in a ready-to-use position; Slidably disposing a needle guard (103) having a proximal wall with a proximal opening and two resilient arms on the needle shaft (111); A method comprising:

12. The method further comprises the steps of: disposing a valve (122) in the internal cavity (92) of the catheter hub (101) for restricting fluid flow through the catheter hub (101); and disposing a valve actuator (104) proximal to the valve (122). The method of claim 11.

13. A catheter assembly (100, 127, 162), comprising: a catheter hub (101) having a hub body (88) with exterior and interior surfaces defining an interior cavity (92); a bushing (50) having an elongated distal seat (70) and a tapered seat (55) disposed within an internal cavity (92); a catheter tube (140) having a first length fitted over the bushing (50); a non-metallic reinforcing sleeve (60) over the bushing (50) and having a second length that is shorter than the first length; a needle hub (102) having a needle (110) extending from a distal end of the needle hub (102); The needle (110) includes a needle shaft (111) having a needle lumen and a needle tip (112); In the ready-to-use position, the needle shaft (111) protrudes through the bushing (50), the catheter tube (140) and the reinforcing sleeve (60); a reinforcing sleeve (60) disposed over or within the catheter tube (140); The catheter assembly (100, 127, 162) further comprises: a needle guard (103) having a proximal wall with a proximal opening and two resilient arms slidably attached to the needle shaft (111); A catheter assembly (100, 127, 162).

14. The catheter hub of claim 10, wherein 20% to 70% of the second length of the reinforcing sleeve extends distally from the nose portion of the catheter hub.

14. A catheter assembly (100, 127, 162) according to claim 13.

15. The catheter tube (140) or the reinforcing sleeve (60) is in direct contact with the bushing (50); 14. The catheter assembly of claim 13.

16. The reinforcing sleeve (60) is a heat shrink tube.

14. A catheter assembly (100, 127, 162) according to claim 13.

17. The tapered seat (55) is conical and has an opening at its proximal end (56) that is larger than the opening at its distal end (57).

14. A catheter assembly (100, 127, 162) according to claim 13.

18. The reinforcing sleeve (60) is provided with markings.

14. A catheter assembly (100, 127, 162) according to claim 13.

19. The reinforcing sleeve (60) is provided with an antibacterial agent.

14. A catheter assembly (100, 127, 162) according to claim 13.

20. At least a portion of the catheter hub (101) is covered with a heat shrink material.

14. A catheter assembly (100, 127, 162) according to claim 13.

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