CATHETER WITH INTEGRATED DELIVERY DEVICE AND ASSOCIATED METHODS - Patent application

Abstract

A catheter assembly (100) includes a catheter unit (102) having a catheter hub (106) having a hub body (120) and a catheter tube (108), and an integral needle unit (104) having a needle hub (110) with a body (134), with a needle lumen, and with a needle (112) extending from a distal end of the needle hub (110). The needle hub (110) includes a distal passageway (140) having a distal passageway opening (140a) and with the needle (112) attached to an end of the distal passageway (140), a proximal passageway (144) having a proximal passageway opening (144a) and a rearmost opening (144b), and a work surface (138) on a workbench (136) located between the distal passageway opening (140a) and the proximal passageway opening (144a). A guidewire (148) optionally passes between the distal passageway (140) and the proximal passageway (144) and functions as a dispenser when pressed against the working surface (138).

Description

[Technical field]

[0001] The disclosed invention relates generally to needle devices and intravenous (IV) infusion devices, including intravenous catheters, peripheral catheters, and midline catheters. In particular, an IV catheter assembly having one-handed operation for dispensing a guidewire is disclosed. [Background technology]

[0002] Intravenous catheters are commonly used for various infusion therapies, such as infusing fluids into a patient, withdrawing blood from a patient, and monitoring various parameters of the patient's vascular system. Catheters are typically connected to a catheter adapter to which an intravenous tube can be attached. Blood management catheters include an internal blood management valve that is opened by inserting a male Luer or other object into the proximal end of the catheter adapter. Non-limiting examples of blood management valves are disclosed in U.S. Patent Application Publication No. 2011 / 0046570, filed August 20, 2009, entitled "Systems and Methods for Providing a Flushable Catheter Assembly." After the catheter is placed in the patient's vascular system, an IV fluid source can be connected to the catheter adapter or catheter hub and the blood management valve can be opened. Once connected, fluid from the IV source begins to flow through the catheter and into the patient.

[0003] As is well known in the art, a typical blood pressure is 10-20 centimeters of water. The infusion bag is usually placed approximately 100 cm above the patient's heart to induce flow into the patient. At approximately that height, the pressure exerted by the fluid from the infusion bag is significantly greater than the patient's blood pressure, and so it can flow into the patient.

[0004] For patients with difficult venous access, extended dwell catheters can be used to aid in difficult intravenous access (DIVA) conditions. Extended dwell catheters are midline catheters that can be considered peripherally inserted catheters. The recommended insertion site for midline catheters is in the upper arm, with the tip located just below the axilla. For DIVA patients, the physician can use visualization devices to identify deep veins for catheter placement. In this case, extended dwell catheters provide additional length and more flexibility for insertion into the patient. The addition of a guidewire can reduce the chance of the catheter kinking. Summary of the Invention

[0005] Various embodiments of the catheter assembly have several features, none of which alone satisfies all of their desirable attributes. An embodiment of the catheter assembly of the present invention includes a catheter hub attached to an integrated needle hub for carrying a hollow needle and guidewire. Without limiting the scope of the present embodiments as expressed by the claims that follow, we will briefly discuss their salient features. After considering this discussion, and particularly after reading the section entitled Detailed Description, one will appreciate how the features of the present embodiments provide advantages including, among other things, an integrated design that enables peripheral vascular access using conventional IVC procedures.

[0006] A catheter assembly is described. In one embodiment, the catheter assembly comprises: a catheter unit including a catheter hub having a hub body with a proximal opening and having a catheter tube extending from a distal end of the catheter hub, the catheter tube having a catheter tube opening; Also, an integrated needle unit including a needle hub having a body and having a needle with a needle lumen extending from a distal end of the needle hub; Needle hub is a distal passageway having a distal passageway opening and a needle attached to an end of the distal passageway; a proximal passageway having a proximal passageway opening and a rearmost opening; a work surface on the working platform located between the distal pathway opening and the proximal pathway opening; The working surface is exposed on one side of the body. A catheter assembly is disclosed.

[0007] The catheter assembly may further include a nose portion disposed on the end of the needle hub and projecting into a proximal opening of the catheter hub in the ready-to-use position.

[0008] The catheter assembly can be used with or without a guidewire, like a standard peripheral intravenous catheter (PIVC).

[0009] A guidewire can extend through both the distal passageway, the proximal passageway, and through at least a portion of the needle lumen in the ready-to-use position.

[0010] A tube having a first end may be directly coupled to the needle hub.

[0011] The needle hub may have a socket and a second end of the tube coupled to the socket.

[0012] A first end of the tube may protrude into the rearmost opening of the needle hub.

[0013] The guidewire can be partially disposed inside the tube, for example, the proximal end of the guidewire can extend into the hollow interior of the tube.

[0014] The tube may have a first end attached to the needle hub and a second end that is either unsupported or coupled to a socket disposed in the needle hub.

[0015] The guidewire can have a proximal or second end, and the proximal end can be sized and shaped to abut the rearmost opening of the needle hub to stop distal movement of the guidewire. The proximal end of the guidewire can have an enlarged element, such as a sleeve, a buildup of material or a crimp, or can have a J-loop or a coiled loop.

[0016] The guidewire can have an enlarged portion sized and shaped to abut a crimp on the needle from inside the needle to stop distal movement of the guidewire.

[0017] The needle hub can have a first proximal pathway section, a guide stub extending from a proximal end face of the needle hub, and a second proximal pathway section aligned with the first proximal pathway section.

[0018] The needle hub can have a receiving cavity that bisects the distal pathway, or the distal pathway can pass through or begin at the receiving cavity.

[0019] A flow restrictor may be located within the receiving cavity.

[0020] The flow restrictor can be a septum, a valve, or a hydrophobic filter.

[0021] The needle hub may be sized and shaped to be grasped in one hand and the work surface of the workbench may be accessible by at least one finger of one hand.

[0022] The working surface can have an arc shape between the proximal and distal paths.

[0023] The needle hub can have a base surface and a thickness defined by the working surface and the base surface.

[0024] The needle hub can have a channel with a worktable, with a sidewall extending upwardly from a working surface of the worktable.

[0025] A needle guard can be positioned inside the catheter hub, and the needle guard can include two arms biased outwardly with the needle in the ready-to-use position.

[0026] A valve and a valve opener can be located within the catheter hub.

[0027] The valve may include multiple flaps, and the needle guard is disposed between two plunger elements of the valve opener.

[0028] A tube may be attached to the needle hub and a guidewire may be disposed partially within the tube and partially within the needle.

[0029] The guidewire can pass through both the distal and proximal pathways.

[0030] Aspects of the invention further include a method of manufacturing a catheter assembly, comprising the steps of forming a catheter unit including a catheter hub having a hub body with a proximal opening and a catheter tube extending from a distal end of the catheter hub, the catheter tube having a catheter tube opening, and forming an integral needle unit including a needle hub having a body and a needle having a needle lumen extending from a distal end of the needle hub, the needle hub having a distal pathway opening, a distal pathway having a needle attached to an end of the distal pathway, a proximal pathway having a proximal pathway opening and a rearmost end opening, and a work surface on a work bench located between the distal pathway opening and the proximal pathway opening, the work surface being exposed on one side of the body.

[0031] The method may further include causing a nose on the end of the catheter hub to project into a proximal opening of the catheter hub in the ready-to-use position.

[0032] The method may further include passing a guidewire through the proximal passageway, through the distal passageway and at least partially through the needle lumen.

[0033] The method may further include exposing a guidewire for pushing by a user in a working plane between the proximal and distal pathways.

[0034] The method may further include attaching a tube to the needle hub prior to passing the guidewire through the proximal passage.

[0035] The method may further include disposing a flow restrictor in a receiving cavity formed in the distal end of the needle hub.

[0036] Aspects of the invention further include a method of using the catheter assembly, the method of using comprising the steps of grasping the catheter assembly in one hand as a holding hand; The catheter assembly comprises: a catheter unit including a catheter hub having a hub body with a proximal opening and having a catheter tube extending from a distal end of the catheter hub, the catheter tube having a catheter tube opening; The catheter assembly also includes an integrated needle unit including a needle hub having a body and having a needle with a needle lumen extending from a distal end of the needle hub; Needle hub is a distal passageway having a distal passageway opening and a needle attached to an end of the distal passageway; a proximal passageway having a proximal passageway opening and a rearmost opening; a work surface on the workbench located between the distal pathway opening and the proximal pathway opening; A work surface is exposed on one side of the body, with the fingers of the holding hand directed above the work surface.

[0037] The method may further include pressing down on the guidewire with a finger to wed the guidewire between the finger and the working surface.

[0038] Aspects of the present invention include a catheter assembly including a catheter unit and a needle unit. The catheter unit may include a catheter hub and a catheter tube extending from the catheter hub.

[0039] The needle unit may include a needle hub having a needle attached thereto, the needle extending distally through the catheter hub and the lumen of the catheter tube, the needle tip protruding distally from a distal opening of the catheter tube in the ready-to-use position.

[0040] The catheter hub can have a hub body with a proximal opening with a female luer that receives the distal end of the needle hub. The hub body can have multiple sides connected together along interlocking corners, or can have a traditional frusto-conical body, as described further below. A push tab can be located on the top of the hub body for the practitioner to press to separate the catheter hub from the needle hub after successful venipuncture.

[0041] The nose can be located at the distal end of the hub body and can have a smaller cross-sectional dimension than the proximal portion of the hub body, such as by providing one or more tapered surfaces between the proximal and distal ends of the hub body. Optionally, the nose can be omitted. For example, a flange, tab, or arm can extend from the needle hub and secure to the catheter hub without the use of a nose. The hub body can be made from a conventional plastic material used for catheter hubs that has a translucent appearance.

[0042] The needle hub may include a body having a length and a width, the body can have a generally polygonal shaped cross-section having multiple sides including a work surface, an irregular shaped cross-section having a work surface, or a generally circular shaped cross-section having a work surface.

[0043] The work surface may be defined by a top or work surface against which a user or practitioner of the catheter assembly can press at least one finger, such as an index finger, to eject the guidewire, as described below. The needle hub may have a nose that protrudes into the interior of the catheter hub in the ready-to-use position. The catheter hub may have a female luer at a proximal end for receiving the nose of the needle hub. The catheter hub may also optionally incorporate a needle guard, a valve and / or a valve opener.

[0044] In one embodiment, the needle hub body includes a distal passageway and a proximal passageway. The two passageways may be sealed, each may include a passageway or bore, or may include an open channel. The two passageways may be positioned or aligned to pass a guidewire therethrough or between them. From the worktable, the guidewire may have a length that extends distally, through the distal passageway, and through the lumen of the needle, with the guidewire distal end terminating proximal to the needle tip opening.

[0045] From the working platform, the guidewire can have a length that extends proximally and exits through a proximal passage in the needle hub. The needle hub can incorporate a guide stub that extends from a proximal end face of the body to extend the length of the proximal passage. When incorporated, the guide stub has a bore that is aligned with and communicates with the proximal passage originating from the working platform. The guide stub can be omitted from the body, and the proximal end face of the body can be provided with an opening for the guidewire to exit proximally.

[0046] A length of tube with a first or distal end can be engaged, such as with an interference fit, into an opening or bore of a guide stub located at the proximal end of the catheter hub. Optionally, an adhesive or glue can be used to more permanently secure the distal end of the tube within the bore of the guide stub. The tube can be flexible and made from a variety of prior art tubing materials. The tube can be hollow or have a lumen and can be adapted to house or accommodate a proximal portion of a guidewire (the portion extending proximally through the proximal passage). The proximal end of the tube can be supported. For example, the proximal end can be connected to a socket on the needle hub body, which can be an open socket with a gap or a closed socket without a gap.

[0047] By engaging the socket, the tube is wound into a loop or partial loop, and the tube and guidewire disposed therein can be designed such that the tube and guidewire do not hang down from the proximal end of the needle hub. In other examples, the tube may not be supported at its proximal end. For example, the tube may extend from the needle hub without engaging the needle hub at the second end of the tube.

[0048] As shown, the guidewire has a length, with a proximal end located within the lumen of the tube. How far the guidewire extends within the tube depends on how far the guidewire is allowed to be expelled from the tip of the needle, as described below. In one embodiment, the overall length of the guidewire is selected such that, when expelled by the user, the proximal end of the guidewire terminates within the bench, representing the end of the guidewire length and therefore the guidewire cannot physically be expelled any further.

[0049] In other examples, the guidewire can include an enlargement such as an integrated notch, bump, build-up, J-loop proximal end, or sleeve, and upon ejection of the guidewire, the enlargement is physically stopped by a relatively small opening formed with the needle hub, such as the guide stub, body, distal passage, or proximal passage. In yet another example, the needle can have a crimp, and distal advancement of the guidewire is stopped when the enlargement of the guidewire contacts the crimp from within the needle lumen.

[0050] As used herein, a guidewire is slidable or movable within a tube, and a finger, such as an index finger, can be used to press the guidewire against a surface of a work surface while simultaneously sliding the guidewire distally against the surface to expel the distal end of the guidewire from the needle tip.

[0051] Because the needle unit holds both the needle and the guidewire without a separate guidewire dispenser with a guidewire dispenser housing, the needle unit can be referred to as an integral needle guidewire hub and the catheter assembly can be referred to as a catheter assembly with an integral needle guidewire hub.

[0052] In one embodiment, one or more sides of the needle hub may include a plurality of spaced apart surface features. The spaced apart surface features may embody bumps, depressions, or combinations of bumps and depressions of any number of shapes. As illustrated, the spaced apart surface features are bumps having an oval or elliptical shape, although other shapes such as circles, squares, stars, irregular shapes, etc. are also contemplated. The surface features may enhance grip or simply function as an aesthetic feature.

[0053] The catheter assembly of the present invention with guidewire can be operated using a one-handed technique. In one embodiment, the index finger is positioned on or above the work surface and the hand grasps the needle unit in a supinated position to advance the guidewire after the needle tip has accessed the vessel. Although the illustration shows the right hand, this is by way of example only, as the catheter assembly can also be used with the left hand.

[0054] The tube can be coiled under the hand with a first or distal end coupled to the guide stub and a second or proximal end of the tube supported in the socket, and a portion of the guidewire, including the proximal end of the guidewire, can be disposed within the lumen of the tube and can slide freely within the tube as it is advanced by the user.

[0055] In alternative embodiments, a first end of the tube is attached to the needle unit while a second end is spaced apart or unsupported etc. The tube may be generally straight as shown by incorporating a thicker, harder or relatively high durometer tubing material, or it may incorporate a thinner, softer or relatively low durometer tubing material allowing the tube to bend or curve as it extends from the needle unit.

[0056] The guidewire can extend into the lumen of the tube, and the second or proximal end of the guidewire can be located within the lumen of the tube, but extend short of the proximal opening of the second end of the tube. The guidewire can be of a peripheral type, typically having a core diameter of about 0.014 inches, 0.018 inches, or 0.035 inches, to name a few non-limiting examples, and can be made from a variety of prior art materials, such as stainless steel, nitinol, or hybrid types.

[0057] A catheter unit provided in accordance with the present invention may have a catheter hub and a catheter tube extending therefrom. The catheter hub of the present invention may embody a more traditional elongated generally circular generally frustoconical hub body. The catheter hub may include a nose portion having a catheter tube extending therefrom and a proximal opening for receiving the nose portion of the needle hub in a ready-to-use position. Disposed within the catheter hub may be a needle guard for covering the needle tip and / or a combination valve and valve opener for controlling fluid flow through the catheter hub, as described below.

[0058] The catheter unit can have a body with a proximal opening having a female luer with the nose of the needle hub disposed therein. An optional tab or flange can be provided adjacent the nose to sandwich a portion of the catheter hub therebetween. The proximal opening of the catheter hub has external threads and is sometimes referred to as a female threaded luer.

[0059] The catheter hub has a body defining an internal cavity. The catheter tube extends distally to a nose of the catheter hub and may be retained in the catheter hub by a metal bushing or ferrule. A valve or septum may be disposed in the internal cavity between a distal shoulder and a proximal shoulder formed on the interior surface of the catheter hub to retain the valve therebetween.

[0060] The valve can have a number of slits defining a number of flaps. The flaps can be open to allow flow through the catheter hub or closed to inhibit or restrict flow through the catheter hub. A valve opener or septum opener having a nose, also called an actuator, can be positioned proximal to the valve and within the space defined by the skirt of the valve. The nose of the valve opener can be generally cylindrical and have a bore with a needle therethrough, the bore having a guidewire disposed within its lumen. One or more openings can be provided through the body of the nose for fluid flushing.

[0061] The valve opener can have a plunger element extending proximally from the nose. In one embodiment, two plunger elements can extend from the nose with a gap therebetween for accommodating a needle guard that can be disposed in the gap between the two plunger elements. A pair of bands or stabilizers can be provided on the valve opener. In one embodiment, each band or stabilizer is connected to both of the two plunger elements such that a continuous ring or loop is formed with the two bands and the two plunger elements. The ring or loop is spaced apart from the nose. A through hole or aperture can be provided on the valve opener between the nose and the ring. In one example, there are at least two through holes between the nose and the ring.

[0062] The needle guard provided herein can include a proximal wall having an outer periphery defining an opening for accommodating a needle passing through the proximal wall. A pair of arms can extend distally of the proximal wall, each arm having a distal wall and a curved lip at its end. An elbow is defined between the arm and the distal wall of each arm, the two elbows defining a maximum guard dimension when the two arms are biased outwardly by a needle in the ready-to-use position. The needle guard can be disposed in two through openings of the valve opener in a gap between two plunger elements, the proximal wall located proximal to the ring and the two elbows located distal to the ring. In one embodiment, in the ready-to-use position, the two elbows can contact an interior of the catheter hub, be spaced apart from an interior of the catheter hub, contact one or both of the two bands or the stabilizer, be spaced apart from the two bands, or a combination thereof.

[0063] In use, after successful venipuncture, the needle is retracted proximally and the needle tip moves proximal to the two distal walls of the needle guard, and when the two arms are no longer biased outward by the needle, the two arms recoil or move inward such that the profile of the two elbows becomes smaller than the inner diameter of the continuous ring of the actuator and the crimp on the needle abuts or contacts the outer periphery defining the opening in the proximal wall, allowing the needle guard to be withdrawn from the catheter hub along with the needle.

[0064] The valve and valve opener can remain in the catheter hub and control the flow of fluid through the catheter hub. For example, a male luer tip, such as the tip of a syringe, can be inserted into the female luer and the valve opener advanced distally to open the valve with the nose of the valve opener. The valve can have multiple slits defining multiple flaps that are deflected by the nose of the valve opener as the valve opener is advanced distally. In one example, the valve has three slits defining three flaps. The needle guard and combination of valves and valve openers, or both, can be incorporated into other catheter hubs described elsewhere herein.

[0065] The catheter assemblies described herein can be used with a guidewire using a one-handed technique in which the puncture and guidewire ejection are performed with the same gripping or operating hand. The process can begin with one hand gripping the catheter assembly in a cambered position. The hand used to grip and hold the catheter assembly is called the holding hand and can be the left or right hand. The user can then poke the patient to access the vein with the needle tip of the catheter tube and the catheter tube opening. Proper needle puncture can be confirmed by a temporary blood flashback. Alternatively or additionally, an ultrasound probe or gauge, such as a 2D or 3D ultrasound probe, can be used to confirm proper needle puncture. If used, the ultrasound probe can be held in the free hand not holding the catheter assembly. In certain embodiments, the needle used can be selected to have a desired stiffness to minimize bending, especially if the needle is longer than a standard peripheral intravenous catheter (PIVC). A large enough gauge needle, a ribbed needle, a dual diameter needle, or a multi-diameter needle can be used.

[0066] The user can then advance the guidewire while steadily holding the catheter assembly in approximately the same position with the same holding hand to limit or avoid the needle tip moving from the target area within the vein. The user can advance the guidewire by using one finger, such as the index finger, of the same hand holding the catheter assembly to press the guidewire against a surface of the bench and, using friction between the fingertip and the surface, incrementally advancing the wire by moving the finger between a proximal and distal position on the bench, then repeatedly lifting the finger back to the proximal position on the bench.

[0067] The guidewire can be advanced until a physical stop is activated, felt, or triggered, such as when a crimp, bump, or enlarged portion on the guidewire hits the crimp on the needle from inside the needle, until the end of the guidewire is reached and the guidewire cannot be advanced any further, until the enlarged portion on the guidewire hits the hub of the needle, a narrow opening in the tube, or a combination thereof.

[0068] After the guidewire is advanced into the vein, the catheter tube can be slid or advanced over the guidewire, which serves to support and guide the catheter tube into the vein. As an example, the catheter tube can be advanced over the guidewire by pushing a push tab on the catheter hub in a distal direction with one finger of the holding hand. This action can cause the catheter hub to separate from the needle hub. This separation can continue until the needle, guidewire, and needle hub are completely separated from the catheter hub, and the tip of the catheter tube remains in the vein for vascular access. In this way, the user can operate the catheter assembly with the same handle without having to switch hands or use both hands when using the catheter assembly of the present invention through various stages.

[0069] The catheter unit of the present invention may optionally include a needle guard to cover the needle tip in the needle protection position. Additionally or alternatively, the catheter unit may include a valve or septum and a valve opener or actuator. When incorporated, the distal walls of the needle guard may each have a vertical slit sized to accommodate the diameter of the guidewire but not the needle. This slit allows the distal wall to move distal to the needle tip in the protection position to accommodate the guidewire extending from the needle as it is withdrawn after successful venipuncture. The valve or septum and valve or septum opener remain with the catheter hub to control flow through the catheter hub.

[0070] The catheter assembly of the present invention can be used in the same manner as a standard peripheral intravenous catheter (PIVC) assembly; that is, initial puncture of the patient and separation of the needle and needle hub from the catheter hub after successful venipuncture essentially involve the same techniques and can be performed using a one-handed technique. Furthermore, the guidewire advancement step does not require shifting the holding hand to the other hand, using two hands, or moving the holding hand away from the needle hub. Minimizing shifting and handling of the catheter assembly reduces undesirable needle movement as the needle enters the vein and / or as the guidewire is advanced into the vein to guide the catheter tube. These advantages provide for easy practitioner adaptation and acceptance of the disclosed catheter assembly.

[0071] The catheter assembly with integrated guidewire ejection needle hub of the present invention can eliminate at least one attachment point typically found between the needle hub and the guidewire ejector housing. Thus, the needle hub and guidewire ejector housing of the prior art can be provided in separate packages, and the catheter assembly of the present invention can eliminate at least one pre-procedure assembly step since there is no separate guidewire ejector to attach to the needle hub. The catheter assembly with integrated guidewire ejection needle hub can also be implemented without a removable or separable outer housing used to guide the catheter hub during separation from the needle hub typically found on midline catheters.

[0072] Additionally, the present catheter assembly design including the disclosed needle unit with integrated guidewire and needle hub can be used without a guidewire and used as a standard peripheral intravenous catheter (PIVC) assembly, for example, a catheter assembly as shown and described can be used without a guidewire.

[0073] The catheter assembly of the present invention can have a length of tubing extending from the needle hub and unsupported at the unattached end of the tube. This application can be used to indicate guidewire movement, especially when the tube is transparent or semi-opaque. The same concept applies when the proximal end of the tube is supported. The same concept applies equally when the catheter unit has a generally cylindrical, generally frusto-conical body.

[0074] The guidewire proximal end may be coiled to increase the overall size or profile of the guidewire at the proximal end and define an enlarged end. The enlarged end, having an enlarged profile relative to the guidewire diameter at the proximal end, may be used to engage or be captured by the needle hub, either through a small opening in the guide stub if one is incorporated, or through a small opening in the needle hub body or tube. As an example, the enlarged tip may be a J-shaped tip or a coiled tip. The needle hub, such as the guide stub or proximal passage, may have an inner diameter to accommodate the diameter of the guidewire, but is too small for the enlarged end of the guidewire to pass therethrough. Thus, when the guidewire is ejected during use, the engagement between the enlarged end and the structure defining the bore may stop further distal advancement of the guidewire, which correspondingly stops further distal advancement of the guidewire tip relative to the needle tip, thus defining the ejection length of the guidewire.

[0075] In an alternative embodiment, the guidewire can have an enlargement, such as a bump or a raised portion of material near the tip of the needle at the needle crimp that is larger than the internal path through the needle lumen. When expelled, the bump or raised portion on the guidewire can engage the needle crimp to stop distal advancement of the guidewire. Thus, the needle crimp can be used to both engage and retract the needle guard and to stop further distal advancement of the guidewire.

[0076] In use, a user can grasp the catheter assembly in one hand in an upturned position. The user can hold the catheter assembly in the holding hand, which can be the left or right hand, and the ultrasound probe in the other hand, called the probe hand, for holding the ultrasound probe. The user can then pierce the patient using the holding hand to access the vein with the tip of the needle and the opening of the catheter tube. The user can use the ultrasound probe in the probe hand to monitor the puncture site for proper needle tip placement. Optionally, proper needle puncture can be confirmed by a temporary blood flashback in addition to confirmation by the ultrasound probe.

[0077] The user can then advance the guidewire out of the needle while holding the catheter assembly steadily in approximately the same position with the same holding hand to limit or avoid movement of the needle tip in the vein from the target area. The user can advance the guidewire by using one finger, such as the index finger, of the same holding hand holding the catheter assembly to press the guidewire against the surface of the bench and, using friction between the fingertip and the surface, incrementally advancing the wire by moving the finger from a proximal position to a distal position on the bench, then lifting the finger back to the proximal position on the bench, and repeating this process. The guidewire can be advanced under the confirmation or supervision of the ultrasound probe held in the probe hand until it is physically stopped by the engagement between the guidewire and the needle hub or the engagement between the guidewire and the crimp of the needle, as previously described.

[0078] After the guidewire is advanced into the vein, the catheter tube slides over the guidewire, which serves to support and guide the catheter tube into the vein. As an example, to advance the catheter tube over the guidewire, one finger of the holding hand is used to push the push tab of the catheter hub distally. This action separates the catheter hub from the needle hub. Further advancement of the catheter tube can be monitored by the probe hand or an ultrasound probe, such as a 2D or 3D ultrasound, held in the non-holding hand. In this way, the user can use the same holding hand to manipulate the catheter assembly without having to switch hands or use two hands as they move through the various stages of gaining vascular access.

[0079] The user can continue to separate the needle, guidewire and needle hub by moving the needle hub and catheter hub away from each other until the needle hub, needle and guidewire are completely separated from the catheter hub. After complete separation, the tip of the catheter tube remains in the patient's vein for vascular access. Separation of the catheter hub and needle hub can be accomplished without the use of the ultrasound probe. Separation can also be accomplished with just the holding hand. Optionally, after releasing the ultrasound probe and successfully advancing the catheter tube further into the vein, the non-holding hand can be used to hold the catheter hub steady against the patient's skin or the like as the user retracts the needle hub with the holding hand.

[0080] As described, the catheter assembly of the present invention can be used similarly to a standard peripheral intravenous catheter (PIVC) assembly. Furthermore, the steps of puncturing the patient, advancing the guidewire, advancing the catheter tube over the guidewire, and retracting the needle can be performed using a one-handed procedure. This process does not require shifting of the holding hand or the use of two hands used to hold the catheter assembly at the beginning of the procedure. Minimizing shifting of hands and handling of the catheter assembly can reduce undesired needle movement as the needle enters the vein and / or as the guidewire is advanced into the vein to guide the catheter tube.

[0081] In another aspect of the invention, the needle hub can have a body having a nose at a distal end and a tube guide at a proximal end. A worktable having a top or working surface is provided between the distal and proximal ends. A distal or first pathway can be provided from the distal portion of the worktable through the nose, and a proximal or second pathway can be provided from the proximal portion of the worktable through the tube guide at the proximal end of the catheter hub. In some embodiments, the worktable can embody shapes other than those shown. For example, the worktable's working surface can be narrower, wider, longer, curved, have side edges, etc.

[0082] The distal pathway opening can be a pathway opening, or an outer periphery defining a distal pathway opening, and the proximal pathway opening can be a pathway opening, or an outer periphery defining a proximal pathway opening, both provided in a work platform. The two openings can be spaced apart from one another. A surface of the work platform can be located between the two openings, where the surface can be exposed to the environment or atmosphere. The exposed surface between the two openings can allow a guidewire passing between the two openings to be accessible by a user or practitioner.

[0083] Exposed means that the work surface is not covered by a structure and that access to the work surface is permitted or available from the side of the needle hub body for a user's finger to press against. In some examples, the distance between the two openings is at least 1 inch, preferably at least 1.25 inches, more preferably at least 1.5 inches, at least 2 inches, at least 2.5 inches, or at least 3 inches. The width of the needle hub is about 0.5 inches or more, for example, from about 0.75 inches to about 1.25 inches.

[0084] In an alternative embodiment, the work surface can be covered, such as with a clear, flexible plastic sheet or plastic tube, to cover the guidewire from blood splashes and exposure. The clear plastic sheet can cover the work surface, but is flexible or soft enough so that the user can press both the plastic sheet and the guidewire against the work surface to advance the guidewire. If a plastic tube is used, the plastic tube can provide a protective cover surrounding the guidewire and hide it. Both the clear plastic sheet and the plastic tube are stretchy and flexible, so they do not impede the advancement and retraction of the guidewire during application.

[0085] In one embodiment, both the distal pathway opening and the proximal pathway opening are generally circular and generally the same size. In other embodiments, the size may be different and / or the shape of the two openings may be different. For example, the proximal pathway opening, which is the exit point for the guidewire, may be smaller in size than the distal pathway opening, which is the entrance point for the guidewire to pass from the proximal end through the needle hub and into the needle lumen.

[0086] The body of the needle hub can be considered to have three distinct sections, including a first section, a second section, and a third section. The first section can include a nose portion having a needle well for receiving and securing a proximal end of a needle. The needle well can be located at an end of the distal passageway, and the needle can be attached to the needle well.

[0087] Externally, the nose can be sized and shaped to project into the proximal end of the catheter hub in the ready-to-use position. The nose can have a luer taper or be a male stub sized to fit into the catheter hub. The distal side of the nose can incorporate a flange or extension. The extension can be sized and shaped to press the needle guard into the catheter hub during assembly. However, the extension can be omitted if other tools or options are used to assemble the needle guard.

[0088] The first section may further include a transition or neck connecting the nose to the second section. The neck may have a three-dimensional trapezoidal shaped structure having multiple sides and a distal passageway extending therethrough. The neck may expand from a smaller distal end to a larger proximal end to bridge the size difference between the nose and the second section. In other examples, the neck may embody a different shape, such as having a frusto-conical shape. Additionally, although a nose is shown at the distal end of the first section, the nose need not be designed. For example, the first section may incorporate a structure that can grip or set an assembly position with the catheter hub at an external location, such as an arm, hood, saddle, etc. that grips the catheter hub on the outside of the catheter hub.

[0089] In one embodiment, a receiving cavity is formed in the neck portion. The receiving cavity can resemble a channel or slot and is sized and shaped to accommodate a flow restrictor for restricting flow from the needle lumen through the distal path. As an example, the flow restrictor can embody a septum, a valve, or a hydrophobic filter or membrane. In use, when the patient's vasculature is accessed, blood pressure causes blood to flow proximally through the needle lumen. When a flow restrictor is incorporated, proximal blood flow can be stopped or restricted at the flow restrictor, thereby eliminating or limiting blood leakage into the second section and onto the work surface.

[0090] In one embodiment, the receiving cavity is sized and shaped to frictionally grip the flow restrictor or hold the flow restrictor in an interference fit. The receiving cavity can be a slot, a portion of the receiving cavity can bisect the distal pathway, or the distal pathway can pass through or originate from the receiving cavity. In other embodiments, a retainer clip can be provided that fits over an opening of the receiving cavity to secure the flow restrictor therein. Preferably, the flow restrictor is sized and shaped to allow penetration by a guidewire and to allow movement of the guidewire therethrough during advancement of the guidewire.

[0091] The second section may be generally arcuate in side view, where the work surface and the opposing bottom surface of the work platform have matching arcuate shapes. The two surfaces are separated from each other by a thickness that defines the thickness of the needle hub. This thickness may be constant, may vary along the length of the work platform, or may not be constant. In other examples, the two surfaces may have different arcuate shapes. In still other examples, the bottom surface may be flat or generally planar, or may have a combination of planar and contoured surfaces.

[0092] The surface of the worktable is preferably arc-shaped. The arc-shaped surface helps to bring the worktable's working surface closer to the practitioner's fingers when the practitioner uses the fingers to slide the guidewire against the surface from a proximal position to a distal position. However, the surface is not limited to an arc shape. For example, the worktable's working surface can be generally flat or have different degrees of arc shape. Thus, if the second section can have two upper reference points that define a plane, the worktable's surface can be located below the plane or adjacent to the plane and can have an arc shape.

[0093] In addition to the top and bottom surfaces, the second section has two opposing side surfaces. The sides can be smooth or flat or have a surface texture, as previously described. The sides can alternatively have grooves for receiving the fingers of a holding hand.

[0094] The third section of the needle hub may optionally include a guide stub. The guide stub may be integrally formed with the first and second sections, such as by a single plastic injection molding, or may be formed separately and secured to the first and second sections. For example, the guide stub may be molded separately with a bore or passageway and then secured to the proximal end face of the second section with an adhesive, a snap fit, or a weld. If molded separately, the portion of the proximal pathway formed by the second section is aligned with the portion of the proximal pathway formed by the guide stub.

[0095] In one embodiment, the guide stub is generally cylindrical. In other embodiments, the guide stub can be multi-sided, such as having a polygonal shape. The guide stub can extend the entire length of the proximal pathway and provide an anchor or attachment point for the tube, as previously described. However, the guide stub can be omitted and the second section can be provided with sufficient pathway length to act as an attachment point for the tube. For example, from the end of the second section, the second section can be extended proximally such that the proximal end face extends further proximally instead of coinciding with the end point. This allows the pathway to be longer and the tube can be directly coupled to its end opening.

[0096] In yet another aspect of the invention, the needle hub has a body with a neck portion modified to have a generally cylindrical shape, and the receiving cavity is modified to receive a relatively small flow restrictor. The flow restrictor is disposed at the distal pathway opening of the distal pathway and may be gripped along at least two sides, and preferably at least three sides, by the structure of the receiving cavity. Optionally, the flow restrictor may be retained in the receiving cavity, such as with a clip, a detent engagement, an adhesive, or a combination thereof.

[0097] The second section of the needle hub includes a worktable having a top surface and a bottom surface, both of which may be arcuate. In this embodiment, the worktable is like a bowl-shaped channel, and the top surface or work surface of the worktable may be located at the bottom of the channel. The worktable may have two upwardly extending side surfaces extending from the work surface. Along a cross section of the end, the bowl-shaped channel resembles the letter "U," but with a shorter lower extending side wall. Additionally, the channel arcs or curves as the surface extends from the proximal end to the distal end. For example, the top edges of the work surface and both side walls are arcuate. The channel aids in positioning the practitioner's fingers between the two side walls when advancing a guidewire using the catheter assembly.

[0098] In one example, the guide stub of the third section can be a separately formed part that is attached to the second section of the body, such as by adhesive or welding. However, the guide stub can be integrally formed with the second section or omitted entirely. If separately formed, the first proximal path section of the proximal path can be aligned with the second proximal path section of the proximal path to define an overall proximal path. As shown, the top contour of the guide stub can be generally flat or flush with the top proximal point of the second section. In other examples, the top contour of the guide stub can be located above or below the top proximal point of the second section.

[0099] The rearmost opening of the proximal passageway is preferably enlarged or made larger than the diameter of the passageway itself. The rearmost opening can be enlarged to facilitate insertion of a guidewire. The rearmost opening can be enlarged to accommodate a tube. The tube can be attached to the rearmost opening by a friction fit, an interference fit, a weld, an adhesive, or a combination thereof.

[0100] In use, a user can grasp the catheter assembly in an upturned position in one hand. The catheter assembly can include a catheter unit and a needle unit. The catheter unit can embody any of the catheter units described elsewhere herein. The user can hold the catheter assembly in a holding hand, which can be the left or right hand. The user can puncture the patient at the puncture site, allowing the tip of the needle and the opening of the catheter tube to enter the vein, thereby allowing blood to flow upward through the lumen of the needle.

[0101] In one example, proximal blood flow through the needle is stopped or restricted by a flow restrictor. The flow restrictor can be disposed within a receiving cavity formed with the needle hub. The flow restrictor, which can be a septum, valve, or hydrophobic filter, can limit the flow of blood from flowing onto and wetting the surface of the work surface.

[0102] A user can advance the guidewire distally from the needle tip into the patient's vasculature. As the guidewire is advanced distally, it moves through at least a flow restrictor. The flow restrictor can be integrated into the guidewire and needle hub to limit or prevent blood flowing through the needle lumen from flowing out onto the benchtop.

[0103] Methods of making and using the catheter assembly and its components are within the scope of the present invention. [Brief description of the drawings]

[0104] These and other features and advantages of the present devices, systems and methods will become better understood with reference to the following specification, claims and accompanying drawings.

[0105] [Figure 1] FIG. 1 is a perspective view of a catheter assembly provided in an embodiment of the present invention, the catheter assembly including a catheter unit and a needle unit having a needle and a guidewire. [Diagram 2] FIG. 2 is a schematic perspective view of a practitioner holding a catheter assembly with a supported tube. [Diagram 3] FIG. 3 is a schematic perspective view of a practitioner holding a catheter assembly with an unsupported tube. [Figure 4A] FIG. 4A is a perspective view of a catheter assembly including a catheter unit and a needle unit having a needle and a guidewire, as provided in a further embodiment of the present invention. [Figure 4B] FIG. 4B is a partial cross-sectional side view of the catheter unit of FIG. 4A. [Diagram 5] 5(A)-5(C) are diagrams illustrating a sequence in which a user uses the catheter assembly of the present invention to eject a guidewire with the same holding hand. [Figure 6] FIG. 6 is a perspective view of a catheter assembly with an unsupported tube. [Figure 6A] FIG. 6A is a close-up view of the proximal end of the guidewire. [Figure 7] 7(A)-7(D) are diagrams illustrating a sequence in which a user uses the catheter assembly of the present invention to eject a guidewire with the same holding hand while holding an ultrasound probe with the other hand. [Figure 8A] FIG. 8A is a perspective view of a needle unit having a flow restrictor. [Figure 8B] FIG. 8B is a side view of a needle unit having a flow restrictor. [Figure 9]FIG. 9 is a cross-sectional side view of a needle unit having a flow restrictor according to a further embodiment of the invention. [Figure 10] FIG. 10 is a schematic diagram of a practitioner holding a catheter assembly having a flow restrictor. [Figure 11] FIG. 11 is a schematic diagram of a practitioner holding a catheter assembly having a flow restrictor while ejecting a guidewire with the same holding hand. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0106] The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of presently preferred embodiments of catheter assemblies and components thereof provided in accordance with aspects of the present device, system, and method, and is not intended to represent the only manner in which the present device, system, and method may be constructed or utilized. This specification defines features and steps for constructing and using the present device, system, and method embodiments in conjunction with the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures may be accomplished by different embodiments that are intended to be encompassed within the spirit and scope of the present disclosure. As shown elsewhere in this specification, like element numbers are intended to indicate similar or similar elements or features.

[0107] The description of technical features or aspects of an exemplary configuration of the present disclosure should be considered as typically applicable and applicable to other similar features or aspects in another exemplary configuration of the present disclosure. Therefore, the technical features described in this specification according to one exemplary configuration of the present disclosure may be applicable to other exemplary configurations of the present disclosure, and therefore, the overlapping description may be omitted in this specification.

[0108] 1, there is shown a catheter assembly 100 according to an aspect of the present invention, including a catheter unit 102 and a needle unit 104. In one embodiment, the catheter unit 102 includes a catheter hub 106 and a catheter tube 108 extending from the catheter hub 106. The needle unit 104 includes a needle hub 110 having a needle 112 attached thereto, the needle extending distally through the lumen of the catheter hub 106 and the catheter tube 108, with a needle tip 114 projecting distally from a distal opening 116 of the catheter tube in a ready-to-use position.

[0109] The catheter hub 106 can have a hub body 120 with a proximal opening with a female luer that receives the distal end of the needle hub 110. The hub body 120 can have multiple sides 122 connected together along connecting corners 124, or can have a conventional frusto-conical body, as described further below. A push tab 126 can be located on the top of the hub body 120 and is used by the practitioner to push to separate the catheter hub from the needle hub after successful venipuncture. A nose 130 is located at the distal end of the hub body 120 and can have a smaller cross-sectional dimension than the proximal portion of the hub body 120, such as by providing one or more tapered surfaces between the proximal and distal ends of the hub body 120. The hub body can be made from a conventional plastic material used for catheter hubs that has a translucent appearance.

[0110] In one embodiment, the needle hub 110 may include a body 134 having a length and a width. The body 134 may have a generally polygonal shaped cross-section having multiple sides including a work surface 136, an irregular shaped cross-section having a work surface 136, or a generally circular shaped cross-section having a work surface 136. The work surface 136 may be defined by a top or work surface 138 against which a user or practitioner of the catheter assembly 100 may press with at least one finger, such as an index finger, to eject the guidewire, as described further below. The needle hub 110 may have a nose that protrudes into the interior of the catheter hub 106 in the ready-to-use position. The catheter hub 106 may have a female luer at a proximal end for receiving the nose of the needle hub. The catheter hub 106 may also optionally incorporate a needle guard, a valve and / or a valve opener within the hub body 120, as shown in FIG. 4B.

[0111] In one embodiment, the body 134 of the needle hub 110 includes a distal passageway 140 and a proximal passageway 144. The two passageways 140, 144 can be positioned or aligned to pass a guidewire 148 therethrough or between. From the working platform 136, the guidewire 148 can have a length that extends distally, through the distal passageway 140, through the lumen of the needle 112, with the guidewire distal end terminating proximal to the needle tip opening. From the working platform 136, the guidewire 148 can have a length that extends proximally and exits through the proximal passageway 144 of the needle hub 110. The needle hub 110 can incorporate a guide stub 150 extending from a proximal end face 152 of the body 134 to extend the length of the proximal passageway. When incorporated, the guide stub 150 has a bore 154 that is aligned and in communication with the proximal passageway 144 originating from the working platform 136. The guide stub 150 may be omitted from the body 134, and an opening may be provided in the proximal end face 152 of the body 134 for the guidewire to exit proximally.

[0112] As shown, a tube 158 having a length with a first or distal end 160 engages an opening or bore 154 in the guide stub 150, such as by an interference fit. Optionally, the distal end 160 can be more permanently secured to the bore 154 using an adhesive or glue. The tube 158 is flexible and can be manufactured from any number of conventional tubing materials. The tube 158 can be hollow or have a lumen and can be adapted to house or accommodate a proximal portion of the guidewire 148 (the portion extending proximally through the proximal passageway 144) therein. A proximal end 162 of the tube 158 can be supported. For example, the proximal end 162 can be connected to a socket 164 on the needle hub body 134, which can be an open socket or a closed socket. By engaging the socket 164, the tube 158 can be wound into a loop or partial loop to organize the tube and a guidewire disposed therein, e.g., to prevent the tube and guidewire from dangling from the proximal end of the needle hub 110. In other examples, the tube 158 can be unsupported at the proximal end of the tube. For example, the tube can extend from the needle hub 110 without engaging the needle hub at the second end of the tube.

[0113] As shown, the guidewire 148 has a length and a proximal end that is located within the lumen of the tube 158. How far the guidewire 148 extends into the tube 158 may depend on how far the guidewire is allowed to be ejected from the needle tip 114, as described further below. In some embodiments, the overall length of the guidewire 148 is selected such that, upon ejection by the user, the proximal end of the guidewire terminates within the worktable 136, signifying the end of the guidewire length and thus preventing the guidewire from being physically ejected any further. In other embodiments, the guidewire may include an enlargement, such as an integrated notch, bump, ridge, J-loop proximal end, or sleeve, and upon ejection of the guidewire, the enlargement is physically stopped by a relatively small opening formed in the needle hub 110, such as the guide stub 150, the body 134, the distal passageway 140, or the proximal passageway 144. In yet another example, needle 112 can have a crimp such that distal advancement of the guidewire is stopped when the upset of the guidewire contacts the crimp from within the needle lumen.

[0114] As described further below, the guidewire 148 is slidable or movable within the tube 158 when a finger, such as an index finger, is used to press the guidewire against the surface 138 of the work surface 136 and simultaneously slide the guidewire distally against the surface 138 to eject the distal end of the guidewire 148 from the needle tip. Because the needle unit 104 carries both the needle 112 and the guidewire 148 without a separate guidewire ejector with a guidewire ejector housing, the needle unit 104 may be referred to as an integrated needle and guidewire hub, and the catheter assembly 100 may be referred to as a catheter assembly having an integrated needle and guidewire hub.

[0115] In one embodiment, a plurality of spaced apart surface features 170 may be provided on one or more sides of the needle hub 110. The spaced apart surface features 170 may embody any number of shapes of bumps, indentations, or combinations of bumps and indentations. As shown, the spaced apart surface features 170 are bumps having an oval or elliptical shape, with other shapes contemplated, such as round, square, star, irregular, etc. The surface features 170 may enhance grip or simply function as an aesthetic feature.

[0116] 2 is a schematic diagram illustrating how a practitioner or user 174, such as a doctor or nurse, holds the catheter assembly 100 using a one-handed technique. In particular, the hand 176 grasps the needle unit 104 in an upturned position with the index finger 178 positioned above or above the work surface 136 for advancing the guidewire 148 following vascular access by the needle tip 114. Although the hand is shown to be right-handed, this is merely exemplary as the user can optionally use the catheter assembly 100 with the left hand.

[0117] 1, is coiled under hand 176 with a first or distal end 160 coupled to guide stub 150 and a second or proximal end 162 of the tube supported by socket 164. A portion of guidewire 148, including the proximal end of the guidewire, is positioned within the lumen of tube 158 and is freely slidable within the tube when advanced by user 174.

[0118] Figure 3 is a schematic diagram showing a user 174 holding the catheter assembly 100 using a one-handed technique similar to that of Figure 2. In this embodiment, a first end of the tube 158 is shown attached to the needle unit 104 while a second end 162 is spaced apart, unsupported, or otherwise not attached to the needle unit 104. The tube 148 may be generally straight as shown by incorporating a thicker, harder, or relatively high rubber durometer tubing material, or may bend or curve as it extends from the needle unit 104 by incorporating a thinner, softer, or relatively low rubber durometer tubing material.

[0119] 3 also shows guidewire 148 extending within the lumen of tube 158, with a second or proximal end 180 of the guidewire located within the lumen, but extending below the proximal opening of tube second end 162. The guidewire may be of a peripheral type, typically having a core diameter of about 0.014 inches, 0.018 inches, or 0.035 inches, to name a few non-limiting examples, and may be made from any number of prior art materials, such as stainless steel, nitinol, or hybrid types.

[0120] FIG. 4A illustrates a catheter assembly 100 provided in accordance with a further aspect of the present invention. The catheter assembly 100 of the present invention includes a catheter unit 102 and a needle unit 104, similar to the catheter assembly of FIG. 1. The needle unit 104 can be similar to the needle unit 104 of FIG. 1. The catheter unit 102 can include a catheter hub 106 and a catheter tube 108 extending therefrom. The present catheter hub 106 embodies a more traditional elongated generally circular generally cone-shaped hub body 120. As shown, the catheter hub 106 includes a nose portion 130 having the catheter tube 108 extending therefrom in a ready-to-use position, and a proximal opening for receiving the nose portion of the needle hub 110. Disposed within the catheter hub 106 can be a needle guard for covering the needle tip 114 and / or a combination of a valve and valve opener for controlling fluid flow through the catheter hub, as will be further described below with reference to FIG. 4B.

[0121] Figure 4B is a partial cross-sectional side view of the catheter unit 102 of Figure 4A having a body 120 with a proximal opening 184 with a female luer disposed therein, and a nose 186 of the needle hub 110. An optional tab or flange 188 may be provided adjacent the nose 186 for gripping a portion of the catheter hub 106 therebetween. The proximal opening 184 of the catheter hub 106 is externally threaded and is sometimes referred to as a female threaded luer.

[0122] The catheter hub 106 has a body 120 that defines an internal cavity 190. The catheter tube 108 extends distally to a nose 130 of the catheter hub and is retained in the catheter hub by a metal bushing or ferrule 132. A valve or septum 192 is disposed within the internal cavity 190 between distal and proximal shoulders formed on the inner surface of the catheter hub to retain the valve 192 therebetween. The valve may have multiple slits that define multiple flaps. The flaps may be open to permit flow through the catheter hub or closed to restrict flow through the catheter hub. A valve or septum opener 194 (also referred to as an actuator) having a nose 198 is disposed proximal of the valve 192 in the space defined by a skirt 196 of the valve. The nose piece 198 of the valve opener 194 is generally cylindrical and has a bore with the needle 112 therethrough, which has a guidewire 148 disposed within its lumen. The body of the nose piece 198 may have one or more openings for fluid irrigation.

[0123] The valve opener 194 has a plunger element 206 extending proximally from the nose 198. In one embodiment, two plunger elements 206 extend from the nose 198 with a gap therebetween for accommodating a needle guard 200 that may be disposed in the gap between the two plunger elements 206. A pair of bands or stabilizers 202 may be provided with the valve opener 194. In one embodiment, each band or stabilizer 202 is connected to both of the two plunger elements 152 such that a continuous ring or loop 204 is formed in the two bands 202 and the two plunger elements 206. The ring or loop 204 is spaced apart from the nose 198. Thus, a through hole or opening 208 is provided in the valve opener 194 between the nose 198 and the ring 204. In one embodiment, there are at least two through holes between the nose and the ring 204 .

[0124] In one embodiment, the needle guard 200 has a proximal wall with an outer periphery defining an opening for accommodating the needle 112 passing through the proximal wall. A pair of arms extend distally of the proximal wall, each arm having a distal wall and a curved lip at its end. An elbow is defined between each arm and the distal wall, the two elbows defining a maximum guard dimension when the two arms are biased outwardly by a needle in a ready-to-use position, as shown in FIG. 4B. The needle guard 200 is disposed within two through openings 208, 208 of the valve opener in the gap between two plunger elements 206, 206, with the proximal wall located proximal to the ring 204 and the two elbows located distal to the ring. In one embodiment, the two elbows can contact the interior of the catheter hub 106, can be spaced apart from the interior of the catheter hub, can contact one or both of the two bands or stabilizers 202, 202, can be spaced apart from the two bands, or a combination thereof in the ready-to-use position.

[0125] In use, after successful venipuncture, the needle 112 is retracted proximally, the needle tip moves to the proximal side of the two distal walls of the needle guard 200, and when the two arms are no longer biased outward by the needle, the two arms recoil or move inward such that the profile of the two elbows becomes smaller than the inner diameter of the ring 204, allowing the crimp (not shown) of the needle to abut or contact the inner diameter of the ring 204, and the needle guard 200 along with the needle 112 can be withdrawn from the catheter hub 106.

[0126] The valve 192 and valve opener 194 can remain with the catheter hub 106 to control the flow of fluid through the catheter hub. For example, a male luer tip, such as the tip of a syringe, can be inserted into the female luer to advance the valve opener 194 distally, causing the valve to open at the nose 198 of the valve opener. The valve 192 can have multiple slits that define multiple flaps that are deflected by the nose of the valve opener as the valve opener is advanced distally. In one example, the valve has three slits that define three flaps. The needle guard and combination of valves and valve openers, or both, can be incorporated into other catheter hubs, such as the catheter hub 106 of FIGS. 1-3.

[0127] Further aspects of the catheter unit 102, such as the valve 192, the valve opener 194, and the needle guard 200, are disclosed in U.S. Publication No. 2018 / 0214682, the contents of which are expressly incorporated by reference into this specification for all that it discloses.

[0128] FIG. 5 is a series of diagrams illustrating the one-handed use capability of the catheter assembly 100 of the present invention. Starting with FIG. 5(A), a user can grasp the catheter assembly 100 in one hand in a cambered position as previously described. The hand used to grasp and hold the catheter assembly may be referred to as the holding hand 175, which may be the left or right hand. The user can then pierce the patient 210 to access the vein 212 using the needle tip 114 and catheter tube opening 116 of the catheter tube 108. Proper needle penetration may be confirmed by a temporary flashback of blood. Alternatively or additionally, an ultrasound probe or meter, such as a 2D or 3D ultrasound probe, may be used to confirm proper needle penetration. If used, the ultrasound probe may be held in the free hand not holding the catheter assembly. In some embodiments, the needle 112 used may be selected to have a desired stiffness to minimize bending, especially if the needle is longer than a standard peripheral intravenous catheter (PIVC). A large enough gauge needle, a ribbed needle, a dual diameter needle, or a multi-diameter needle may be used.

[0129] 5(B) shows a user steadily holding the catheter assembly 100 in approximately the same position with the same holding hand 175 while advancing the guidewire 148 to limit or avoid moving the needle tip from the target area within the vein 212. The user can advance the guidewire 148 by using one of the fingers, such as the index finger, of the same hand holding the catheter assembly 100 to press the guidewire against the surface 138 of the work table 136 (FIG. 1) and using the friction between the fingertip and the surface 138 to incrementally advance the wire by moving the finger between a proximal and distal position on the work table 136, then lifting the finger back to the proximal position on the work table, and repeating the process. The guidewire 148 can be advanced until a physical stop is actuated, sensed, or triggered, such as when a crimp, bump, or enlarged portion on the guidewire hits the crimp on the needle from inside the needle, until the end of the guidewire is reached and the guidewire cannot be advanced any further, until the enlarged portion on the guidewire hits a narrow opening on the needle hub, or a combination thereof.

[0130] After the guidewire 148 enters the vein 212, the catheter tube 108 is slid or advanced over the guidewire, which serves to support and guide the catheter tube into the vein 212. In one embodiment, as shown in FIG. 5C, the catheter tube 108 can be advanced over the guidewire 148 by pushing the push tab 126 on the catheter hub 106 in a distal direction with one finger of the holding hand. This action separates the catheter hub 106 from the needle hub 110. This separation can continue until the needle 112, guidewire 148, and needle hub 110 are completely separated from the catheter hub 106 and the tip of the catheter tube 108 remains in the vein for vascular access. Thus, when moving from FIG. 5A to FIG. 5C, the user can operate the catheter assembly with the same holding hand without having to switch hands or use two hands.

[0131] Referring again to FIG. 4B in combination with FIG. 5(C), the catheter unit 102 may optionally include a needle guard 200 for covering the needle tip 114 in the needle protection position. Additionally or alternatively, the catheter unit 104 may have a valve or septum 192 and a valve opener 194. If incorporated, the distal walls of the needle guard 200 may each have a vertical slit sized to accommodate the diameter of the guidewire 148 but not the needle. The slit allows the distal wall to move distal to the needle tip in the protection position to accommodate the guidewire 148 extending from the needle as it is withdrawn after successful venipuncture. The valve or septum 192 and valve or septum opener 194 remain with the catheter hub 106 to control flow through the catheter hub.

[0132] As described, the catheter assembly 100 of the present invention can be used in the same manner as a standard peripheral intravenous catheter (PIVC) assembly. That is, the initial puncture of the patient and the separation of the needle and needle hub from the catheter hub after successful venipuncture essentially involve the same techniques and can be performed using a one-handed technique. Furthermore, the step of advancing the guidewire does not require transferring the holding hand to the other hand, using two hands, or removing the holding hand from the needle hub. Minimizing hand-holding and handling locations of the catheter assembly can reduce undesirable needle movement as the needle enters the vein and / or as the guidewire is advanced into the vein to guide the catheter tube. These advantages provide for easy adaptation and acceptance by practitioners of the disclosed catheter assembly.

[0133] As shown and described, the catheter assembly with integrated guidewire ejection needle hub of the present invention can eliminate at least one attachment point typically found between the needle hub and the guidewire ejector housing. Thus, the catheter assembly of the present invention can eliminate at least one pre-procedure assembly step since the needle hub and guidewire ejector housing of the prior art can be provided in separate packages. The catheter assembly with integrated guidewire ejection needle hub can also be implemented without a removable or separable outer housing used to guide the catheter hub during separation from the needle hub typically found on midline catheters.

[0134] Furthermore, the present catheter assembly design, including the disclosed needle unit with integrated guidewire and needle hub, can be used without a guidewire and can be used as a standard peripheral intravenous catheter (PIVC) assembly, for example, a catheter assembly as shown and described can be used without a guidewire.

[0135] Figure 6 is a schematic diagram of the catheter assembly 100 of the present invention, showing a length of tubing 158 extending unsupported from the needle hub 110 to illustrate movement of the guidewire 148 during use. The same concepts apply when the tubing 158 is supported at its proximal end 180. The same concepts apply equally when the catheter unit 104 has a generally cylindrical, generally frusto-conical shaped body, as shown in Figures 4A and 4B.

[0136] The guidewire in the ready-to-use position is represented by line 220, which indicates that the distal tip or guidewire tip 218 of the guidewire is recessed proximally from the needle tip 114 of the needle and the proximal end 180 of the guidewire 148 is distal from the proximal end opening 162 of the tube 158. The guidewire tip 218 is located at a point T1 within the needle 112 and the proximal end 180 of the guidewire 148 is located at a point R1 within the tube 158. Stated another way, the guidewire distal tip 218 is recessed proximally from the needle tip 114 at point T1 and the trailing end 180 of the guidewire 148 is recessed from the proximal end opening 162 of the tube 158 at point R1.

[0137] In use, the guidewire 148 may be ejected and pushed distally through the needle tip 114 as previously discussed. In one embodiment, and referring again to line 222, the guidewire distal tip 218 may be ejected distal to the needle tip 114 to point T2 and the proximal end 180 of the guidewire 148 may move distally to point R2. The distance between the needle tip 114 and point R2, i.e., the guidewire ejection length, may be selected to provide appropriate guidance and support for the catheter tube 108 for advancing the catheter tube 108 into the target vein for vascular access.

[0138] Referring to FIG. 6A, which is an enlarged view of point AA in FIG. 6, the guidewire proximal end 180 can be coiled to increase the overall size or profile of the guidewire at the proximal end and define an enlarged end 181. The enlarged end 181, having an enlarged profile relative to the diameter of the guidewire at the proximal end 180, can be used to engage or capture a needle hub, such as by a small opening in the guide stub 150, if incorporated, or by a small opening in the body 134 of the needle hub 110. In one example, the enlarged end 181 can be a J-shaped tip or a coiled tip. The guide stub 150 or needle hub 110, such as the proximal passage 144, can have an inner diameter to accommodate the diameter of the guidewire 148, but is too small for the enlarged end 181 of the guidewire to pass therethrough. Thus, during use, when guidewire 148 is ejected, engagement between enlarged end 181 and the structure defining the bore can stop further distal advancement of guidewire 148, which correspondingly stops further distal advancement of guidewire tip 218 relative to needle tip 114, thus defining the ejection length of the guidewire.

[0139] In an alternative embodiment, the guidewire 148 can have an enlargement, such as a bump or a raised portion of material, at the needle crimp near the needle tip 114 that is larger than the internal path through the lumen of the needle 112. When expelled, the bump or raised portion on the guidewire can engage the needle crimp to stop distal advancement of the guidewire. Thus, the needle crimp can be used to both engage and retract the needle guard and to stop further distal advancement of the guidewire.

[0140] FIG. 7 is a series of diagrams illustrating the one-handed use capability of the catheter assembly of the present invention used in combination with an ultrasound probe, such as a 2D or 3D ultrasound probe. Starting with FIG. 7(A), a user 174 can grasp the catheter assembly 100 in one hand in a lean-back position as previously described. The user can hold the catheter assembly 100 with a holding hand 175, which can be the left or right hand, and the ultrasound probe in the other hand, referred to as a probe hand 177 for holding an ultrasound probe 226. The user can then pierce the patient 210 with the holding hand 175 to access the vein 212 with the needle tip 114 and the catheter tube opening 116. The user can use the ultrasound probe 226 in conjunction with the probe hand 177 to monitor the puncture site for proper placement of the needle tip 114. Optionally, proper needle puncture can be confirmed by a temporary blood flashback in addition to confirmation by the ultrasound probe 226.

[0141] FIG. 7(B) shows the user advancing the guidewire 148 from the needle while holding the catheter assembly 100 steadily with the same holding hand 175 and in approximately the same position to limit or avoid moving the needle tip in the vein 212 from the target area. The user can advance the guidewire 148 by using one of the fingers, such as the index finger, of the same holding hand 175 holding the catheter assembly 100 to press the guidewire against the surface 138 of the worktable 136 (FIG. 1) and using the friction between the fingertip and the surface 138 to advance the guidewire 148 incrementally by moving the finger between a proximal position on the worktable 136 and a distal position, then lifting the finger back to the proximal position on the worktable, and repeating this process. The guidewire 148 can be advanced under the observation or supervision of the ultrasound probe 226 held in the probe hand 177 until it is physically stopped by the engagement between the guidewire 148 and the needle hub 110 or the engagement between the guidewire and the crimp of the needle, as previously described.

[0142] After the guidewire 148 has entered the vein 212, the catheter tube 108 slides over the guidewire, which serves to support and guide the catheter tube into the vein, as shown in FIG. 7C. In one embodiment, the catheter tube 108 can be advanced over the guidewire 148 by pushing the push tab 126 of the catheter hub 106 distally with one finger of the holding hand 175. This action separates the catheter hub 106 from the needle hub 110. Further advancement of the catheter tube can be monitored by the ultrasound probe 116 held by the probe hand 177. In this way, when moving from FIG. 7A to FIG. 7C, the user can operate the catheter assembly with the same handle without having to switch hands or use both hands.

[0143] The user can continue to separate the needle 112, guidewire 148, and needle hub 110 by moving the needle hub and catheter hub away from each other until the needle hub, needle, and guidewire are fully separated from the catheter hub 106, as shown in FIG. 7D. After full separation, the tip of the catheter tube 108 remains in the patient's vein for vascular access. The separation shown in FIG. 7D can be performed without the use of the ultrasound probe 226. Separation can also be performed with the holding hand 175 alone. Optionally, the non-holding hand 177 can be used to hold the catheter hub 106 steady, such as against the patient's skin, as the user retracts the needle hub 110 with the holding hand 175 after releasing the ultrasound probe and after further advancing the catheter tube into the vein.

[0144] As described, the catheter assembly 100 of the present invention can be used similarly to a standard peripheral intravenous catheter (PIVC) assembly. Additionally, the steps of puncturing the patient, advancing the guidewire, advancing the catheter tube over the guidewire, and retracting the needle can be performed using a one-handed procedure. This process does not require shifting or using two hands to hold the holding hand 175 used to hold the catheter assembly at the beginning of the procedure. Minimizing shifting and handling of the catheter assembly can reduce undesired needle movement as the needle enters the vein and / or as the guidewire is advanced into the vein to guide the catheter tube.

[0145] FIG. 8A is a perspective view of the needle hub 110 shown without a needle. FIG. 8B is a side view of the needle hub 110 of FIG. 8A. FIG. 9 is a cross-sectional side view of the needle hub 110 according to a further embodiment of the present invention, slightly modified from the needle hub of FIG. 8B. Referring initially to FIG. 8A, the needle hub 110 is similar to the needle hubs described elsewhere herein, such as in FIGS. 1, 2 and 3, with some differences. This embodiment includes a hub body 134 having a nose 186 at its distal end and a tube guide 150 at its proximal end. A worktable 136 having an upper or working surface 138 is provided between the distal and proximal ends. A distal or first pathway 140 is provided from the distal portion of the worktable 136 through the nose 186, and a proximal or second pathway 144 is provided from the proximal portion of the worktable through the tube guide 150 at the proximal end of the catheter hub 110. In some embodiments, the work surface 136 may embody shapes other than those shown in the drawings. For example, the work surface of the work surface may be narrower, wider, longer, curved, have sides, etc.

[0146] The distal pathway 140 has an opening or periphery defining a distal pathway opening 140a, and the proximal pathway 144 has an opening or periphery defining a proximal pathway opening 144a, both of which are provided on the work platform. The two openings 140a, 144a are spaced apart from each other. The surface 138 of the work platform 134 is located between the two openings 140a, 144a, and the surface 138 is exposed to the environment or atmosphere. The exposed surface 138 between the two openings 140a, 144a can be accessible by a user or practitioner to a guidewire 148 passing between the two openings, as previously described. Thus, by being exposed, the work surface 138 is not covered by any structure, and the surface is accessible or available from the side of the needle hub body for pressing by the user's finger. In some instances, the distance between the two openings is at least 1 inch, preferably at least 1.25 inches, more preferably at least 1.5 inches, at least 2 inches, at least 2.5 inches, or at least 3 inches. The width of the needle hub is about 0.5 inches or more, for example, about 0.75 inches to about 1.25 inches. In an alternative embodiment, the work surface can be covered, such as overlaid, by a clear, flexible plastic sheet or plastic tube to cover the guidewire from blood splash or exposure. The clear plastic sheet can cover the work surface, but be flexible or soft enough so that the user can press both the plastic sheet and the guidewire against the work surface to advance the guidewire. If a plastic tube is used, the plastic tube can provide a protective cover surrounding the guidewire and hide the guidewire. Both the clear plastic sheet and the plastic tube are stretchable and flexible, so they do not impede the advancement and retraction of the guidewire during application.

[0147] In one embodiment, both the distal pathway opening 140a and the proximal pathway opening 144a are generally circular and generally the same size. In other examples, the size may differ and / or the shape of the two openings may differ. For example, the proximal pathway opening 144a, which is the exit point for the guidewire, may be sized smaller than the distal pathway opening 140a, which is the entrance point for passing the guidewire 148 from the proximal end through the needle hub 110 and into the lumen of the needle 112.

[0148] With further reference to FIG. 8B, the body 134 of the needle hub 110 can be considered to have three distinct sections including a first section 230, a second section 232, and a third section 234. The first section 230 includes a nose 186 having a needle well 236 (FIG. 9) for receiving and securing the proximal end of a needle therein. The needle well 236 can be located at the end of the distal passageway 140, and the needle can be attached to the needle well. Externally, the nose 186 can be sized and shaped to protrude into the catheter hub proximal end in the ready-to-use position, as shown in FIGS. 1, 2, 3, and 4. The nose 186 can have a luer taper or be a male stub sized to fit into the catheter hub. A flange or extension 240 can be incorporated distally of the nose 186. The extension 240 can be sized and shaped to press the needle guard into the catheter hub during assembly, as shown in FIG. 4B. However, extension 240 may be omitted if other tools or options are used to install the needle guard.

[0149] The first section 230 may further include a transition or neck 242 connecting the nose 186 to the second section 232. The neck 242 may have a three-dimensional trapezoidal shaped structure having multiple sides 244 and the distal passageway 140 extending therethrough. The neck 242 expands from a smaller distal end to a larger proximal end to bridge the size difference between the nose 186 and the second section 232. In other embodiments, the neck 242 may embody a different shape, such as having a frusto-conical shape. Additionally, although the nose 186 is shown at the distal end of the first section 230, the nose may be omitted from the design. For example, the first section 230 may incorporate structures that can grip or set an assembly position with the catheter hub for an external position on the catheter hub, as well as arms, hoods, saddles, etc. that grip the catheter hub on the outside of the catheter hub.

[0150] In one embodiment, a receiving cavity 246 is formed in the neck portion 242. The receiving cavity 246 may resemble a channel or slot and is sized and shaped to accommodate a flow restrictor 250 for restricting flow from the needle lumen through the distal pathway 140. In one embodiment, the flow restrictor 250 may embody a septum, a valve, or a hydrophobic filter or membrane. In use, and upon accessing the patient's vasculature, blood pressure causes blood to flow proximally through the needle lumen. When the flow restrictor 250 is incorporated, proximal blood flow can be stopped or restricted by the flow restrictor, thereby eliminating or limiting blood leakage onto the second section 232 and the work platform 136.

[0151] In one embodiment, the receiving cavity 246 is sized and shaped to frictionally grip the flow restrictor 250 or hold the flow restrictor with an interference fit. The receiving cavity may be a slot, a portion of the receiving cavity may bisect the distal passageway 140, or the distal passageway may pass through or originate at the receiving cavity. In other embodiments, a retainer clip may be provided that fits over the opening of the receiving cavity 246 to secure the flow restrictor 250 therein. Preferably, the flow restrictor is sized and shaped to allow penetration by a guidewire and to allow movement of the guidewire therethrough during advancement of the guidewire.

[0152] 8B, the second section 232 is generally arcuate along a side view, and the bottom surface 254, which faces the work surface 138 of the work platform 136, has a matching arcuate shape. The two surfaces 138, 254 are separated from one another by a thickness that defines the thickness of the needle hub. This thickness may be constant, may vary along the length of the work platform, or may not be constant. In other embodiments, the two surfaces 138, 254 may have different arcs. In yet other embodiments, the bottom surface 254 may be flat or generally planar, or may have a combination of planar and contoured surfaces.

[0153] The surface 138 of the worktable 136 is preferably arc-shaped. The arc-shaped surface helps bring the working surface 138 of the worktable 136 closer to the practitioner's fingers as the practitioner uses the fingers to slide the guidewire from a proximal position to a distal position relative to the surface 138. However, the surface 138 is not limited to an arc shape. For example, the working surface 138 of the worktable 136 can be generally flat or can have different degrees of arc shape. Thus, if the second section 232 can have two upper reference points 259, 261 that define a plane, the surface 138 of the worktable 232 can be below the plane or adjacent to the plane and have an arc shape.

[0154] In addition to the top surface 138 and bottom surface 254, the second section has two opposing side surfaces 122. The sides can be smooth or flat, or have a surface structure 170, as previously described. The sides can alternatively have grooves for receiving the fingers of a holding hand.

[0155] The third section 234 of the needle hub 110 may optionally include a guide stub 150. The guide stub 150 may be integrally formed with the first and second sections 230, 232, such as by a single plastic injection molding, or may be formed separately and secured to the first and second sections. For example, the guide stub 150 may be molded separately to have a bore or passageway and then glued, snap-fitted, or welded to the proximal end face 152 of the second section 232. If molded separately, the portion of the proximal pathway 144 formed in the second section 232 and the portion of the proximal pathway formed in the guide stub 150 should be aligned.

[0156] In one embodiment, the guide stub 150 is generally cylindrical. In other embodiments, the guide stub can be multi-sided, such as having a polygonal shape. The guide stub can extend the entire length of the proximal passageway 144 and provide an anchor or attachment point for the tube as previously described. However, the guide stub 150 can be omitted and the second section 232 can be provided with sufficient passageway length to act as an attachment point for the tube. For example, the second section can be extended proximally from the end point 260 of the second section 232 such that the proximal end face 152 extends further proximally instead of coinciding with the end point 260. This allows the passageway 144 to be longer and the tube can be directly coupled to its end opening.

[0157] 9, a cross-sectional side view of a needle hub 100 provided in accordance with a further aspect of the present invention is shown. The needle hub 100 is similar to the needle hub 100 of FIGS. 8A and 8B, with some exceptions. In this embodiment, the neck portion 242 has been modified to have a generally cylindrical shape, and the receiving cavity 246 has been modified to receive a relatively small flow restrictor 250. The flow restrictor 250 is disposed at the distal passageway opening 140a of the distal passageway 140 and is gripped along at least two sides, and preferably at least three sides, by the structure of the receiving cavity 246. Optionally, the flow restrictor 250 can be retained in the receiving cavity 246, such as by a clip, a detent engagement, an adhesive, or a combination thereof.

[0158] The second section 232 of the needle hub 110 includes a worktable 136 having a surface 138 and a bottom surface 254, both of which may be arcuate as in FIG. 8B. However, in this embodiment, the worktable 136 resembles a bowl-shaped channel, with the top or work surface 138 of the worktable 136 located at the bottom of the channel. The worktable 136 has two upwardly extending side surfaces 264 (only one shown) extending from the work surface 138. Along a cross-section of the end, the bowl-shaped channel resembles the letter "U," but with a shorter lower extending side wall. Additionally, as the surface 138 extends from the proximal end to the distal end, the channel arcs or curves. For example, the upper edges 268 of the work surface 138 and both side walls 264 have an arcuate shape. The channel aids in positioning the practitioner's fingers between the two side walls 264 when advancing a guidewire using the catheter assembly.

[0159] FIG. 9 illustrates the guide stub 150 of the third section 234 as a separately formed piece that is attached to the second section 232, such as by adhesive or welding. However, as previously discussed, the guide stub 150 can be integrally formed with the second section 232 or omitted entirely. If separately formed, the first proximal passage section 144(1) of the proximal passage 144 aligns with the second proximal passage section 144(2) of the proximal passage 144 to define the overall proximal passage 144. As shown, the top profile of the guide stub 150 is generally flat or flush with the top proximal point 260 of the second section 232. In other examples, the top profile of the guide stub 150 can be located above or below the top proximal point of the second section.

[0160] The rearmost opening 144b of the proximal passageway 144 is preferably enlarged or made larger than the diameter of the passageway itself. The rearmost opening 144b may be enlarged to facilitate insertion of a guidewire 148. The rearmost opening 144b may be enlarged to receive a tube 158, as shown with reference to FIG. 1. The tube 158 may be attached to the rearmost opening 144b via a friction fit, an interference fit, a weld, an adhesive, or a combination thereof.

[0161] The needle hub 100 of Figures 8A and 8B or Figure 9 can be used as described elsewhere in this specification, such as with reference to Figures 1, 4A, 5(A)-5(C), and 7(A)-7(D).

[0162] FIG. 10 shows a user 174 holding the catheter assembly 100 in a cambered position with one hand, as previously described. The catheter assembly 100 includes a catheter unit 102 and a needle unit 104. The catheter unit 102 can embody any of the catheter units described elsewhere herein, such as the catheter unit of FIG. 4B. The needle unit 104 can embody any of the needle units described elsewhere herein, such as the needle units of FIGS. 1, 4A, 8A, and 8B. The user 174 can hold the catheter assembly 100 in a holding hand 175, which can be the left or right hand. The user 174 punctures the patient 210 at the puncture site, causing the needle tip 114 and catheter tube opening 116 to enter the vein 212, which causes blood 272 to flow upward through the lumen of the needle 112, which is shown diagrammatically for purposes of illustration. In some embodiments, needle unit 104 may have a different ergonomic shape than that shown to assist the user as to where to grip the needle unit.

[0163] In one embodiment, proximal blood flow through the needle is stopped or restricted by a flow restrictor 250. The flow restrictor 250 may be located within a receiving cavity formed in the needle hub 110 as described with reference to Figures 8A, 8B, and 9. The flow restrictor 250, which may be a septum, valve, or hydrophobic filter, may restrict the flow of blood from flowing onto and wetting the surface of the work surface 136. Figure 10 is similar to the positions of Figures 5(A) and 7(A) and may be used in combination with an ultrasound probe.

[0164] 11 , the catheter assembly 100 is shown with the guidewire 148 advanced distally from the needle tip 114 and into the vasculature of the patient 210. In this embodiment, in order to advance the guidewire 148 distally, at least a portion of the guidewire must move through a flow restrictor 250 as the user advances it. The flow restrictor 250 is incorporated into an integrated guidewire and needle hub so that blood flowing through the needle lumen is restricted or blocked from spilling onto the work surface 136.

[0165] FIG. 11 is similar to the positions of FIG. 5(B) and FIG. 7(B) and can be used in combination with an ultrasound probe.

[0166] Methods of making and using the catheter assembly and its components are within the scope of the present invention.

[0167] While certain limited embodiments of the catheter assembly and its components have been specifically described and illustrated herein, numerous modifications and variations will be apparent to those skilled in the art. It is therefore to be understood that the catheter assembly and its components constructed in accordance with the principles of the disclosed devices, systems, and methods may be embodied in ways other than as specifically described herein. The disclosure is also defined in the following claims.

Claims

1. A catheter assembly (100), comprising a catheter unit (102) including a hub body (120) having a proximal opening (184) and a catheter hub (106) having a catheter tube (108) extending from a distal end of the catheter hub (106), the catheter tube (108) having a catheter tube opening (116), the catheter assembly (100) also including a needle hub (110) having a body (134) and an integral needle unit (104) having a needle (112) with a needle lumen extending from a distal end of the needle hub (110), the needle hub (110) having a distal path opening (140a) and a distal path (140) having a needle (112) attached to an end of the distal path (140), a proximal path (144) having a proximal path opening (144a) and a rearmost opening (144b), a working surface (138) on a workbench (136) located between the distal path opening (140a) and the proximal path opening (144a), the working surface (138) being exposed on one side of the body (134), a guide wire (148) extending through at least a portion of both the distal path (140), the proximal path (144), and the needle lumen, the assembly being configured such that after advancement of the guide wire (148), the catheter tube (108) advances over the guide wire (148), thereby separating the catheter hub (146) from the needle hub (110), such that when the needle hub (110) and the catheter hub (106) move apart from each other, the needle hub (110), the needle (112), and the catheter hub (106) are configured to completely separate, the catheter assembly (100).

2. The catheter assembly (100) according to claim 1, wherein the proximal opening of the hub body (120) of the catheter hub (106) includes a female Luer for receiving the distal end of the needle hub (110). The catheter assembly (100) according to claim 1.

3. A tube (158) having a first end (160) is directly coupled to the needle hub (110). The catheter assembly (100) according to claim 1.

4. The first end (160) projects into the rearmost opening (144b) of the needle hub (110). The catheter assembly (100) according to claim 3.

5. The guide wire (148) is partially disposed inside the tube (158). The catheter assembly (100) according to claim 3.

6. The tube (158) has a second end (162), wherein the second end (162) is unsupported or the second end (162) is supported by a socket (164) disposed in the needle hub (110), The catheter assembly (100) according to claim 3.

7. The guide wire (148) has a proximal end (180), wherein the proximal end (180) has a size and shape such that it abuts against the rearmost opening (144b) of the needle hub (110) to stop the distal movement of the guide wire (148), or The guide wire (148) has an enlarged portion, wherein the enlarged portion has a size and shape such that it abuts against a crimp on the needle (112) from inside the needle (112) to stop the distal movement of the guide wire (148), The catheter assembly (100) according to claim 1.

8. The needle hub (110) has a first proximal path section (144(1)), a guide stub (150) extending from the proximal end face (152) of the needle hub (110), and a second proximal path section (144(2)) aligned with the first proximal path section (144(1)), The catheter assembly (100) according to claim 1.

9. The needle hub (110) has a receiving cavity (246) in the distal path (140), The catheter assembly (100) according to claim 1.

10. Further comprising a flow limiter (250) located in the receiving cavity (246), wherein the flow limiter (250) includes one of a septum, a valve, or a hydrophobic filter, The catheter assembly (100) according to claim 1.

11. The needle hub (110) has a channel, the workbench (136) is part of the channel, and the channel has side walls (264, 264) extending from the work surface (138), The catheter assembly (100) according to claim 1.

12. Further comprising a needle guard (200) disposed inside the catheter hub (106), wherein the needle guard (200) includes two arms biased outwardly by the needle (112), The catheter assembly (100) according to claim 1.

13. Further comprising a valve (192) and a valve opener (194) disposed inside the catheter hub (106), The catheter assembly (100) according to claim 12.

14. The tube (158) is attached to the needle hub (110), and the guide wire (148) is partially disposed within the tube (158) and partially within the needle (112). The catheter assembly (100) according to claim 1.

15. The guide wire (148) passes through both the distal path (140) and the proximal path (144). The catheter assembly (100) according to claim 14.

16. A method of manufacturing the catheter assembly (100) according to any one of claims 1 to 15, the method comprising: The method includes: forming a catheter unit (102) including a hub body (110) having a proximal opening (184) and a catheter hub (106) having a catheter tube (108) extending from the distal end of the catheter hub (106), the catheter tube (108) having a catheter tube opening (116); forming an integrated needle unit (104) including a needle hub (110) having a body (134) and a needle (112) having a needle lumen extending from the distal end of the needle hub (110); including The needle hub (110) has a distal path (140) having a distal path opening (140a) and a needle (112) attached to the end of the distal path (140), a proximal path (144) having a proximal path opening (144a) and a rearmost opening (144b), and a working surface (138) on a workbench (136) located between the distal path opening (140a) and the proximal path opening (144a), the working surface (138) being exposed on one side of the body (134), The method also includes passing a guide wire (148) through the proximal path (144), through the distal path (140), and at least partially through the needle lumen. The method

17. further comprising exposing the guide wire (148) for a user to push at a working surface between the proximal path (144) and the distal path (140). The method according to claim 16.

18. further comprising disposing a flow restrictor (250) within a receiving cavity (246) formed at the distal end of the needle hub (110). The method according to claim 16.

19. A method of using the catheter assembly (100) according to any one of claims 1 to 15, comprising the step of gripping the catheter assembly (100) with one hand holding the catheter assembly (100), The catheter assembly (100) comprises a catheter unit (102) including a hub body (110) having a proximal opening (184) and a catheter hub (106) having a catheter tube (108) extending from the distal end of the catheter hub (106), the catheter tube (108) having a catheter tube opening (116), The catheter assembly (100) also comprises a one-piece needle unit (104) including a needle hub (110) having a body (134) and a needle (112) having a needle lumen extending from the distal end of the needle hub (110), The needle hub (110) has a distal path (140) having a distal path opening (140a) and a needle (112) attached to the end of the distal path (140), a proximal path (144) having a proximal path opening (144a) and a rearmost opening (144b), a working surface (138) on a workbench (136) located between the distal path opening (140a) and the proximal path opening (144a), wherein the working surface (138) is exposed on one side of the body (134), and the fingers of the holding hand are directed onto the workbench (136), Method.

20. A guide wire (148) passes between the distal path (140) and the proximal path (144), The method according to claim 19, further comprising the step of pressing down the guide wire (148) with a finger between the finger and the working surface (138). The method according to claim 19.

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