CATHETER WITH GUIDEWIRE ADAPTER AND ASSOCIATED METHODS - Patent application

Abstract

A catheter assembly (108) having a catheter hub (130), a needle hub (122) having an interior, an adapter (290) disposed within the needle hub (122), and a guidewire dispenser (292) having a connecting tip located within the bore of the adapter (290). A guidewire (302) may extend through the dispenser (292) into the adapter (290) to guide the catheter tube (110). The adapter (290) may have a valve (386) for restricting or restricting blood flow in a proximal direction. A gas channel (450) may be provided on the exterior of the adapter (290) to facilitate air evacuation and blood flashback.

Description

[Technical field]

[0001] The disclosed invention relates generally to needle devices, including intravenous catheters, and intravenous (IV) drip devices. A specific embodiment of an IV catheter assembly having an adapter for use with a guidewire dispenser 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 a patient's vascular system. Catheters are typically connected to a catheter adapter to which an infusion tube can be attached. Blood control catheters incorporate a blood control 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 control 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 control 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 cm of water. The infusion bag is usually placed about 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 much greater than the patient's blood pressure, 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). Extended dwell catheters can be considered peripherally inserted catheters. Extended dwell catheters can be configured for insertion into larger veins than those used for standard intravenous therapy and can have a relatively longer catheter length than typical peripheral access catheters. For DIVA patients, physicians can use visualization devices to assist in identifying deep veins for catheter access. In this case, the extended dwell catheter has a longer length, allowing for greater flexibility in the catheter to be inserted into the patient. The addition of a guidewire can reduce the chance of the catheter kinking. Summary of the Invention

[0005] Aspects of the present invention are directed broadly to a catheter assembly. In one embodiment, the catheter assembly includes a catheter hub and a needle hub having an interior with a needle protruding through the catheter tube. An adapter having a tip can be disposed inside the needle hub, and a guidewire dispenser having a connecting tip can be disposed in the bore of the adapter. A guidewire can extend through the dispenser and into the adapter to guide the catheter tube. The adapter can have a valve to limit or restrict proximal blood flow or a no clearance or narrow guidewire passage to limit or restrict proximal blood flow. In some examples, a guidewire dispenser and a guidewire can be used with the adapter, as described below.

[0006] Aspects of the invention further include a catheter assembly, The catheter assembly comprises: a catheter tube attached to a catheter hub and a needle attached to a needle hub; a needle positioned within the lumen of the catheter tube, the needle tip protruding from a distal opening of the catheter tube; The catheter assembly also includes an adapter having a body including a base, a tip, and a bore, the bore extending through the body, the base having a base bore section, the tip having a tip bore section having a cone shape, the tip located at a proximal opening of the needle hub; The catheter assembly also includes a guidewire dispenser having a frame having a plurality of branches and a connecting tip of a first branch of the plurality of branches located inside a proximal bore of an adapter; A guidewire extends through a second branch of the multiple branches, through the connecting tip, and into the bore of the adapter. However, the tip can have other bore shapes and still be encompassed by the aspects of the present invention.

[0007] The housing can be used with the catheter assembly. The housing can include a first frame attached to a second frame, the two frames defining an interior space, the housing having a distal opening and a proximal opening, and the catheter hub is at least partially disposed in the interior space of the housing. The housing can have the catheter assembly disposed therein, and the guidewire adapter can be attached to a needle hub of the catheter assembly. In some embodiments, the catheter assembly can be used without the housing.

[0008] The guidewire dispenser can include a duct having a first end, the first end of the duct can be attached to a socket of the second branch, and the guidewire can extend at least partially within the duct.

[0009] The duct can have a second end that is attached to a socket of a third branch of the multiple branches of the guidewire dispenser.

[0010] The duct and frame of the guidewire dispenser form an enclosed loop. The closed loop may be generally circular. The duct may be a length of tubing.

[0011] A valve can be disposed within the bore of the adapter. The valve can have a valve disc having at least one slit and at least two valve flaps. In some examples, there can be three slits defining three valve flaps.

[0012] The bulb may include a bulb and a skirt extending therefrom. The bulb may have portions of different thicknesses.

[0013] The needle guard can be disposed within the catheter hub. The needle guard can have a proximal wall and at least one arm extending distally from the proximal wall. The arm can have a movable surface that is laterally adjacent to the needle in the ready-to-use position and distal to the needle tip in the guarded position.

[0014] The needle can have a crimp for engaging the needle guard during retraction of the needle. The needle can have a lumen. The guidewire can abut the needle at the crimp to limit distal movement of the guidewire.

[0015] The guidewire can have at least two guidewire sections having at least two different diameters.

[0016] The guidewire can have a distal guidewire portion of a first diameter and a proximal guidewire portion of a second diameter, the second diameter being larger than the first diameter.

[0017] The guidewire may include a shoulder or gradual taper located at a point between the distal and proximal guidewire portions.

[0018] At least one of the shoulder, the gradual taper, and the second diameter can engage the needle at the crimp portion.

[0019] The location of the shoulder or gradual taper on the guidewire defines the length of the distal guidewire portion that extends from the needle tip when the guidewire engages the needle with a crimp.

[0020] The distal guidewire section can pass through the needle at the crimp and extend from an opening in the needle tip.

[0021] The guidewire may be provided with a marker or indicator that shows how far the distal guidewire portion extends distally beyond the tip of the needle.

[0022] A marker or indicator on the guidewire can indicate at least one of when the first end of the distal guidewire portion reaches the needle tip, passes the needle tip, and is fully advanced from the distal tip.

[0023] The guidewire may have multiple markers or guidewires to indicate when the first end of the distal guidewire portion has reached, passed the needle tip, and been fully advanced out of the distal tip.

[0024] The guidewire may have a code, the guidewire dispenser may have a code, or both the guidewire and the guidewire dispenser may have a code indicating the guidewire gauge size.

[0025] The code or symbol may include a color, an alphabetic symbol, a numeric symbol, an alphanumeric symbol, or a combination thereof.

[0026] The tip of the adapter may include a cannula channel having an inner diameter and a guidewire passageway having an inner diameter, the diameter of the cannula channel being larger than the diameter of the guidewire passageway.

[0027] The cannula channel is located distal to the guidewire passage.

[0028] The base of the adapter can have a body having a profile with a number of slats.

[0029] Two or more flanges may extend from two or more slats on the base of the adapter.

[0030] One of the male and female detents may be formed on each of the two or more flanges.

[0031] The body at the distal end of the adapter can have a cannula channel having an inner surface that defines a non-circular cross-sectional opening.

[0032] The proximal end of the needle can contact the inner surface of the cannula channel when the catheter assembly is in the ready-to-use position.

[0033] The non-circular cross-sectional opening of the cannula channel may have a plurality of straight sides and a plurality of arcuate connectors.

[0034] The needle can contact the straight sides of the cannula channel.

[0035] A bypass gap may be formed between the plurality of arcuate connectors and the needle.

[0036] The body at the end of the adapter may have a number of bore sections with different inside diameters.

[0037] The multiple branches of the guidewire dispenser may include at least three branches including a first branch, a second branch, and a third branch.

[0038] A tube having a first end, a second end, and a lumen, wherein a guidewire may be disposed at least partially within the lumen of the tube.

[0039] A first end of the tube can be disposed in a socket of the second branch and a second end of the tube can be disposed in a socket of the third branch or can be disposed away from the third branch.

[0040] The intermediate retaining clip can grip different portions of the tube. The intermediate retaining clip can have two slots. Optionally, the intermediate retaining clip can be omitted.

[0041] The valve may be located in the catheter hub.

[0042] The valve opener can be located in the catheter hub.

[0043] The adapter embodiments described herein can be packaged or provided separately from the catheter assembly. After successful access to the vessel, the vent plug can be removed from the needle hub, the adapter can be connected to the needle hub, and a guidewire dispenser can be connected to the adapter.

[0044] In some embodiments, the adapter is prepackaged with the catheter assembly, such as by being attached to a catheter hub. For example, a valve can be disposed within the adapter to restrict flow out of the proximal end of the adapter so that the catheter assembly can be used to access a blood vessel while the adapter is connected to the needle hub.

[0045] A further aspect of the invention includes an adapter used to guide a guidewire through a needle lumen, The adapter includes a body including a base, a tip, and a bore extending through the body, the base having a base bore portion and the tip having a tip bore portion having a cone-shaped configuration; The adapter also includes at least one of a cannula channel at the distal end having a plurality of generally linear sides with two adjacent plurality of linear sides connected to one another by an arcuate connecting portion and sized to receive the needle shaft, and a valve including a wall having at least one slit disposed within the base bore at the base; The base includes a proximal opening sized and shaped to receive the male tip of the guidewire dispenser and a plurality of first engagement structures for engaging with a corresponding plurality of second engagement structures on the male tip of the guidewire dispenser.

[0046] The base of the adapter may have a non-circular cross-section with multiple slats or side walls.

[0047] Each of the plurality of first engagement structures on the adapter can extend from one of the plurality of slats or side walls. The first engagement structures can engage with second engagement structures on the guidewire dispenser.

[0048] The cannula channel may have a first inner cross-sectional dimension and the guidewire passage may have a second inner cross-sectional dimension located proximal to the cannula channel, and the first inner cross-sectional dimension may be larger than the second inner cross-sectional dimension.

[0049] The cannula channel may have three generally straight sides and three arcuate connecting portions.

[0050] The valve can have a skirt extending from the wall, and the wall can have at least one slit defining at least two flaps.

[0051] The wall of the valve can have a first portion having a first thickness and a second portion having a second thickness, the first thickness being greater than the second thickness, measured orthogonal to a medial plane passing through the wall.

[0052] The valve may be disposed between two interior shoulders of the base.

[0053] Yet another aspect of the present invention is an adapter for use in guiding a guidewire through a needle lumen, comprising: a body including a base, a tip, and a bore extending through the body; the base has a base bore portion and the tip has a tip bore portion; The adapter also a plurality of gas channels disposed on an exterior of the tip; The base is an adapter including a proximal opening sized and shaped to receive the male tip of the guidewire dispenser, and each of the gas channels includes a first channel end disposed adjacent a shoulder between the tip and the base.

[0054] The adapter may further include a protective cap having an end disposed over the tip of the adapter and a connecting tip of a guidewire dispenser disposed within the base bore, and the duct may include a lumen attached to the guidewire dispenser.

[0055] A further aspect of the present invention includes a guidewire dispenser comprising: The guidewire dispenser is a frame having a plurality of branches including a first branch and a second branch; a connecting tip provided on the first branch, the connecting tip including a lumen and a tapered nose; a guide bracket on the second branch, the guide bracket including a socket, the guide bracket having a lumen formed therethrough; a tube having a first free end and a second free end, the first free end located in the socket and the second free end being retained by a retaining clip or by a socket located on the third branch; a guidewire having a length with a first free end and a second free end, the guidewire located within the tube and extending through a socket of the second branch into a lumen of the connection tip; The guidewire is exposed between the first branch and the second branch.

[0056] The third branch of the guidewire dispenser can have a wall that is enclosed by an end of the socket. The third branch can be free of a penetration. Alternatively, the third branch can have a C-channel.

[0057] The second branch may be positioned higher than the first branch.

[0058] The tube or duct and the frame may form a closed loop.

[0059] The guidewire can have a first portion having a first diameter and a second portion having a second diameter larger than the first diameter.

[0060] The frame of the guidewire dispenser may be configured in a Y-shape.

[0061] Two or more retaining clips may be used to hold different sections of a tube or duct.

[0062] A further aspect of the present invention is a catheter assembly comprising: The catheter assembly comprises: a catheter tube attached to a catheter hub and a needle having a needle tip attached to the needle hub, the needle extending through the catheter tube and the needle tip disposed distal to a distal opening of the catheter tube; The catheter assembly also includes the adapter having a body having an outer surface and an inner surface defining a bore, the body further having a base having a plurality of slats interconnected along respective edges, and a tip having a cone having a guidewire passage and a cannula channel distal to the guidewire passage, the tip being disposed in the proximal opening of the needle hub; The catheter assembly also includes a guidewire dispenser having a tip disposed within the bore of the adapter and a guidewire having a first end disposed within the guidewire passage; The proximal end of the needle is disposed within the cannula channel of the adapter. However, the tip can have other bore shapes and still encompass aspects of the present invention.

[0063] Yet another aspect of the present invention is a catheter assembly comprising: The catheter assembly comprises: a catheter tube attached to a catheter hub and a needle having a needle tip attached to the needle hub, the needle extending through the catheter tube and the needle tip disposed distal to a distal opening of the catheter tube; The catheter assembly also includes The adapter includes a body having an outer surface and an inner surface defining a bore, the body further having a base and a tip. A shoulder may be provided between the base and the tip. Optionally, a gradual tapered transition may be located between the base and the tip. A bore may extend through the adapter and through the base to define a valve chamber. A valve including at least one slit and two flaps may be disposed within the valve chamber of the adapter. The tip may have a cone portion having a guidewire passage, the tip being located at the proximal opening of the needle hub. A guidewire dispenser having a tip may be disposed within the bore of the adapter, and a guidewire having a first end may be disposed within the bore of the adapter. A guidewire passage and a cannula channel may be disposed at a distal end of the tip of the adapter.

[0064] Yet another embodiment of the present invention may include a catheter assembly, The catheter assembly comprises: a catheter tube attached to a catheter hub and a needle attached to the needle hub, the needle being positioned within the lumen of the catheter tube and the tip of the needle projecting from a distal opening of the catheter tube; The catheter assembly also includes an adapter having a body including a base, a tip, and a bore extending through the body, the base having a base bore portion and the tip having a tip bore portion, the tip located at the proximal opening of the needle hub; The catheter assembly also includes a guidewire dispenser having a frame with a plurality of branches, a connecting tip of a first branch of the plurality of branches being located inside a base bore portion of the adapter; A guidewire extends through a second branch of the multiple branches and extends inwardly through the connecting tip of the first branch.

[0065] The present invention further includes a method of assembling a catheter assembly, comprising: The method is: providing a catheter hub comprising a catheter tube extending from a distal end of the catheter hub, the catheter hub having a body with an internal cavity, the catheter tube comprising a lumen and a distal opening; The method also providing a needle hub comprising a needle having a shaft with a lumen and a needle tip, the needle hub having a body with an internal cavity, the needle protruding through the lumen of the catheter tube with the needle tip protruding distally of a distal opening of the catheter tube; The method also providing an adapter having a body having an outer surface and an inner surface defining a bore, the body further having a base having a base bore and a tip, the tip of the adapter being positioned within an internal cavity of the proximal opening of the needle hub; The method also Providing a guidewire dispenser having a connecting tip disposed within a proximal bore of the adapter and a guidewire extending across an advancement platform of the guidewire dispenser is included.

[0066] Yet another aspect of the present invention is an adapter for use in guiding a guidewire through a needle lumen, comprising: a body including a base, a tip, and a bore extending through the body, the base having a base bore portion and the tip having a tip bore portion; The adapter also a plurality of gas channels disposed outside the tip, the base including a proximal opening sized and shaped to receive a male tip of a guidewire dispenser; Each of the gas channels includes a first channel end disposed proximate a shoulder between the tip and the base.

[0067] A plurality of elongated ribs can be provided on the first and second tip portions of the tip, and each rib can have a length extending axially of the adapter, a width measured perpendicular to the length, and a height measured from an outer surface of the tip to a top surface of the rib.

[0068] In one embodiment, the collective upper surface of the plurality of ribs defines an effective diameter. In some embodiments, the height of each rib can vary from the distal end of the tip to the second end of the transition section. Thus, the effective diameter of the tip at the third tip portion can vary due to the varying height of the ribs.

[0069] If incorporated, the effective diameter of the tip of the third tip section may be tapered or untapered so that the tip fits inside and matches the tapered profile of the needle hub bore. The effective diameter of the tip of the second tip section may likewise be selected to fit inside and match the tapered profile of the needle hub bore.

[0070] Preferably, the effective diameter defined by the plurality of ribs and the outer shape of the first tip portion form a continuous outer diameter profile capable of fitting into the bore of the needle hub upon insertion of the tip into the proximal opening of the needle hub. The effective diameter at the distal end of the tip is preferably smaller than other portions of the effective diameter so as to form a reduced tip shape to facilitate insertion of the tip into the needle hub.

[0071] A ravine is defined between two adjacent elongated ribs. Each groove has a width and a length. Each groove also has a depth measured relative to the top surface of the adjacent rib relative to the effective diameter of the tip. Thus, the tip of this embodiment includes a plurality of ribs and a plurality of grooves. In one example, the tip of the adapter is provided with four elongated ribs defining four grooves. In some embodiments, there may be fewer than four ribs or more than four ribs, such as three ribs, five ribs, or six ribs, each defining three, five, or six grooves.

[0072] The ribs are preferably spaced around the circumference of the tip to define four generally equally sized grooves. However, even if different sized, unequally spaced ribs and grooves are incorporated, the tip of the adapter of the present invention can still be inserted into the proximal opening of the needle hub and coupled to the needle hub. A gas channel can be provided in the tip. The gas channel can be sized and shaped to allow gas, such as air, to travel therethrough and escape the interior space of the needle hub, but not so large as to allow viscous fluids, such as blood, to flow freely therethrough.

[0073] In one embodiment, each gas channel is axially aligned with respect to a longitudinal axis of the adapter. Each gas channel can have a first channel end located near the shoulder, such as distal to the shoulder, and a second channel end located distal to the first end of the second tip portion. In one example, the second channel end can begin or end anywhere in the third tip portion, depending on the viewing point.

[0074] The second channel end of each gas channel is preferably located somewhere between the first and second ends of the second tip portion. The first and second channel ends may be understood to form two ends of each gas channel. More preferably, different second channel ends of the plurality of gas channels are disposed along different portions of the tip, for example, some disposed at the second tip portion and others disposed at the third tip portion.

[0075] As discussed above, the first channel end of each gas channel can begin or end at the shoulder between the tip and the base, in some embodiments, the first channel ends of some or all of the gas channels can be located distal to the shoulder, i.e., anywhere along the first distal portion of the gap when the adapter is coupled to the needle hub and guidewire dispenser.

[0076] The gas channels allow air to escape by entering at the second channel end and flowing proximally through the respective gas channels. Without the gas channels, the first tip section may form a continuous tapered fit with the interior of the needle hub. Thus, air trapped within the needle hub during blood flashback may not have sufficient vent openings in the system. The gas channels incorporated in the present adapter provide air passage through an otherwise continuous seal between the interior of the needle hub and the exterior of the tip, e.g., the exterior of the first tip section.

[0077] When the present adapter with gas channels is used as part of a PG unit with a catheter assembly, initial puncture of the vein allows blood to enter the needle lumen and into the needle hub interior space. By incorporating multiple gas channels, air can be evacuated from the needle hub interior space as blood travels to the needle hub flashback chamber, thereby facilitating blood flashback flow and minimizing vapor lock in the absence or absence of air. In one example, four or more gas channels can be incorporated into the tip. Preferably, six evenly spaced gas channels are incorporated into the tip. More preferably, eight gas channels are incorporated into the tip.

[0078] The present adapter with gas channels can be packaged and used as a guide unit along with a protective sleeve and a guidewire dispenser.

[0079] The present invention further includes a guidewire dispenser, The guidewire dispenser is a frame having a plurality of branches including a first branch and a second branch; a connection tip provided on the first branch and including a lumen; a guide bracket provided on the second branch and a lumen formed through the guide bracket; The guide bracket is A socket; a tube having a first free end and a second free end, the first free end being located in the socket and the second free end being retained by a retaining clip or by a socket located on the third branch; The guidewire dispenser also includes a guidewire having a length with a first free end and a second free end, the guidewire being positioned within the tube and extending through the socket at the second branch into a lumen of the connection tip; The guidewire is exposed between the first branch and the second branch.

[0080] Yet another aspect of the present invention is a method of assembling a catheter assembly, comprising the steps of: The method is: providing a catheter hub comprising a catheter tube extending from a distal end of the catheter hub, the catheter hub having a body with an internal cavity, the catheter tube comprising a lumen and a distal opening; The method also providing a needle hub comprising a needle having a shaft with a lumen and a needle tip, the needle hub having a body with an internal cavity, the needle protruding through the lumen of the catheter tube with the needle tip protruding distally of a distal opening of the catheter tube; The method also The method includes providing an adapter having a body having an outer surface and an inner surface defining a bore, the body further having a base with a base bore and a tip having a conical cross-section. The bore extends through the base and the tip can have a guidewire passage. The bore of the base and the guidewire passage can be in fluid communication. The tip of the adapter can be located within the internal cavity at the proximal opening of the needle hub. The method can further include providing a guidewire dispenser having a tip disposed within the base bore of the adapter and a guidewire having a first end disposed within the base bore of the adapter.

[0081] The distal tip of the needle can have a needle bevel, and since the needle is hollow, the bevel tip can have an opening.

[0082] 1. A method of using a catheter assembly having a guidewire, comprising: The method is: puncturing a vein with a needle tip having a needle crimp; advancing a guidewire through an adapter connected to a needle hub having a needle attached thereto; and advancing the guidewire further so that a distal guidewire portion extends from the needle tip and the guidewire engages the needle at the needle crimp.

[0083] The guidewire can be advanced through the needle without a guidewire dispenser.

[0084] The method can include dispensing a guidewire from a guidewire dispenser, which can have a tip connected to a base of the adapter.

[0085] In one embodiment, the catheter assembly can be embodied as an extended dwell catheter assembly. The extended dwell catheter assembly can include a housing having a receiving or interior space with the catheter assembly disposed therein.

[0086] The catheter assembly can have a vent plug that engages the proximal opening of the needle hub. In an alternative embodiment, the vent plug can be replaced with an adapter and a guidewire dispenser that is coupled or engaged to the adapter. The catheter assembly with the adapter and guidewire dispenser can optionally be used with or without a housing. In other examples, a guidewire can be projected through the adapter without using a guidewire dispenser to connect the guidewire to the adapter.

[0087] In some instances, the needle may incorporate a crimp for engaging an opening on the needle guard when the needle is withdrawn after successful venipuncture. If a crimp is used, the crimp may define an internal opening in the needle lumen that is relatively smaller than the nominal inner diameter of the needle lumen. The relatively small internal opening in the crimp may be used as a limiter, physical barrier, or restrictive means to restrict distal advancement of the guidewire. For example, the guidewire may include a bead or enlargement at a predetermined location along the guidewire between the ends, i.e., between a first end at the distal end and a second end at the proximal end.

[0088] As the bead or enlarged portion on the guidewire passes through the needle, after the distal end of the guidewire exits through the needle tip, the bead or enlarged portion is physically restricted from passing distally through the relatively small internal opening of the crimp, thereby preventing further advancement of the first end of the guidewire past the needle tip. The location of the bead or enlarged portion relative to the first end of the guidewire can be selected to control the length of the first end that moves from the needle tip and thus enters the patient's vasculature when the guidewire is in use.

[0089] In some embodiments, the guidewire comprises at least two different guidewire sections having two different outer diameter dimensions. The distal guidewire section has a first outer diameter and the proximal guidewire section has a second outer diameter, the second outer diameter being larger than the first outer diameter. The first outer diameter can be small enough to pass through the lumen of the needle at the crimp, but the second outer diameter cannot. The length of the distal guidewire section can be selected to indicate the length of the guidewire that will pass through the patient's vasculature or vein when the guidewire stops at the crimp. A shoulder can be provided at the interface between the two guidewire sections. In other embodiments, a gradual transition can be provided between the two guidewire sections. The shoulder, gradual transition, or second outer diameter of the guidewire can be sized to abut against the crimp of the needle upon ejection of the guidewire through the needle tip. Thus, the assembly can comprise a safety stop that prevents further advancement of the guidewire into the vein. In some embodiments, rather than a crimp, a gradual transition or the second outer diameter of the guidewire can be sized to abut the reduced needle portion at a needle notch to stop distal advancement of the guidewire.

[0090] The catheter assembly has a catheter tube and a needle disposed within the lumen of the catheter tube, both extending from the distal end of the housing. The tip of the needle can extend from a distal opening of the catheter tube. The catheter tube can be attached to a catheter hub, and the needle can be attached to the needle hub. The needle hub can extend from a proximal end of the housing of the extended residence catheter assembly. The needle hub can include a vent plug, which can engage the proximal opening of the needle hub, such as by a Luer fit. For longer catheter tubes and needles, an adapter and guidewire dispenser can replace the vent plug.

[0091] In one embodiment, the catheter assembly includes a first hub or catheter hub having an over-the-needle tube or catheter tube attached thereto, and a second hub or needle hub having a needle attached thereto. The catheter tube may have a lumen or bore for receiving the needle and has a distal opening or distal end opening, with the needle tip extending distally of the distal opening when the assembly is in a ready-to-use position ready for venipuncture or access to a patient's vascular system. The catheter assembly may also be referred to as a needle assembly.

[0092] The needle may include a change in profile located proximal to the needle tip for use with a needle guard. The needle tip may extend distal to the distal end opening of the tube or tube in a ready-to-use position with the change in profile, and when assembled for use with a needle guard, is located proximal to the distal end opening. The change in profile may be a crimp, bump, or a rise in material having a different profile than other diameter portions of the needle shaft. As used herein, the term proximal is understood to mean the end or side closest to the practitioner and the term distal is understood to mean the opposite end or side.

[0093] The profile deviation can be used to interact with the needle guard during retraction of the needle after successful venipuncture, as described further below. The vent plug is disposed at the proximal open end of the second hub or needle hub. The vent can have a vent filter at its proximal end, as is known in the art. The catheter tube can be attached to the first hub or catheter hub by a ferrule or bushing.

[0094] A needle guard can be provided in the interior cavity of the first hub or the catheter hub to cover the needle tip in the protected position. If incorporated, the needle guard can be one of the needle guards disclosed in U.S. Patent No. 6,616,630, the disclosure of which is expressly incorporated herein by reference.

[0095] In some examples, the needle guard can be omitted. In that case, the needle profile transition point can also be omitted. However, the needle profile transition point can be utilized even if the needle guard is omitted if the profile transition point is used as a stop mechanism to stop the distal advancement of the guidewire. In still other examples, the needle guard can be included without including the needle profile transition point. In still other examples, the needle guard can be disposed in a third housing between the first hub and the second hub. An exemplary needle guard disposed in a third housing is disclosed in U.S. Pat. No. 8,597,249, the contents of which are expressly incorporated herein by reference. In still other examples, the needle guard can include multiple arms or fingers extending in both a first direction and an opposite second direction, as disclosed in U.S. Pat. No. 9,387,307, the contents of which are expressly incorporated herein by reference. For example, the needle guard can include a first protector body surrounded by a second protector body.

[0096] In one embodiment, the needle guard can be made of a metallic material and can have a resilient portion capable of generating a biasing force. The needle guard can have a wall disposed to the side of the needle and movable distal to the needle tip to prevent accidental contact with the needle tip. The wall can be a needle trap and can be moved directly in front of or distal to the point of the needle tip.

[0097] The needle guard may include a proximal wall and two arms extending distally from the proximal wall. The two arms may cross each other when viewed from the side in a ready-to-use position and in a protective position where the needle guard covers the needle tip. In some examples, the two arms of the needle guard may extend distally without crossing each other. Two distal walls, one on each arm, may be incorporated to block the needle tip.

[0098] The two distal walls may be biased outwardly by the needle in the ready-to-use position and may be located distal to an internal transition point of the profile inside the first hub in the ready-to-use position. The internal transition point of the profile may be a reduced diameter portion located next to an internal diameter portion of a larger dimension. The elbows of the two arms of the needle guard may have a larger dimension than the internal diameter at the internal transition point of the profile to limit proximal movement of the needle guard from the catheter hub until the two arms are no longer biased outwardly or the dimension at the two elbows is reduced.

[0099] Each distal wall of each arm may include a curved lip to facilitate relative movement between the needle guard and the needle. When in the ready-to-use position, at the intersection between each arm and its respective distal wall, a dimension measured between the two joints or elbows is greater than the inner diameter of the internal transition point of the profile, thereby preventing the needle guard from moving proximally due to the relative dimensions.

[0100] As the needle tip moves proximally of the two distal walls, the two arms are allowed to move radially inward, causing one or both distal walls to close over the needle tip, blocking the needle tip in a protected position. At this point, the dimension between the two joints or elbows decreases and becomes smaller than the internal dimension of the internal deviation point of the profile, allowing the needle guard to move proximally and be removed from the catheter hub along with the needle. In an alternative embodiment, the dimension between the two joints can be equal to or slightly larger than the internal dimension of the internal deviation point of the profile, and the needle can still be moved proximally by bending or squeezing the two joints to pass the internal deviation point of the profile.

[0101] The first hub can have a proximal opening with a nose of the second hub disposed therein. The proximal opening of the first hub has a female luer for receiving a male luer tip, such as a syringe, an IV tubing connector, a luer extension set, etc. External threads can be provided on an exterior surface of the proximal end for threaded engagement with a threaded collar of a male threaded luer tip.

[0102] A pair of stabilizing wings may extend radially from the first hub to facilitate fixation or anchoring of the first hub to the patient after successful venipuncture. Optionally, the wings may be omitted. The first hub may embody a standard IV catheter hub without an injection port. In other examples, the first hub may include an injection port or an integral extension set. If no wings are present on the first hub or catheter hub, the bottom surface of the first hub may have a flat surface angled between 2 degrees and 15 degrees from the penetration axis of the first hub.

[0103] The first hub can be removably secured to the second hub by receiving a nose of the second hub in a proximal opening of the first hub. The second hub can include a flange or extension that, together with the nose, defines a gap in which a portion of the first hub resides.

[0104] Optionally, the flange or extension can be omitted and a stub or other surface mating feature can be provided. The stub can be a male portion of a key that fits into a gap that penetrates or partially penetrates the luer thread to inhibit rotation of the second hub relative to the first hub. The proximal end face of the first hub can abut against the distal end face of a step on the exterior surface of the second hub at the proximal end of the nose on the inside of the first hub. This abutment can set the amount of needle tip protrusion from the catheter tube. The stub can be an optional structural feature.

[0105] The second hub can have a body with an optional internal cavity into which the proximal end of the needle projects. The internal cavity can function as a primary blood flashback chamber. The proximal opening of the body can have a vent plug, syringe tip, or female luer for receiving an adapter therein, and the exterior can be threaded or non-threaded. In one embodiment, the exterior of the body of the second hub is generally cylindrical and non-threaded. The first and second hubs, i.e., the catheter hub and the needle hub, respectively, can be made from a plastic material, such as plastic injection molding.

[0106] The first hub or catheter hub may be provided with a push tab. The push tab may be located on the exterior surface of the first hub at a location distal to the exterior threads so as not to interfere with the exterior threads. For example, the push tab should be located sufficiently distal from the exterior threads so that when a threaded male connector, such as a syringe type with a threaded collar, is connected to the threads of the first hub, the push tab will not interfere with the connection. In some embodiments, the push tab should be located sufficiently distal from the exterior threads so that when the push tab is folded back, the push tab will not interfere with the connection.

[0107] In some examples, a catheter assembly can incorporate a valve and a valve opener. For example, the valve and the valve opener can both be disposed within a catheter hub. In use, the valve opener can be depressed distal to the valve to open one or more slits formed in the valve and open a fluid passageway through the valve for fluid flow. An exemplary catheter assembly with a valve and a valve opener is disclosed in U.S. Patent No. 8,333,735, the contents of which are expressly incorporated herein by reference.

[0108] The valve opener can have a nose portion having a bore and a plunger portion located proximal to the nose portion. The nose portion can be pressed into the valve to open one or more slits in the valve, such as three slits defining three flaps, to open the valve for fluid flow. The plunger portion of the valve opener can be comprised of two or more plunger parts with a gap therebetween. The gap allows fluid to flow through the plunger parts and through the bore in the nose portion.

[0109] In one embodiment, a housing for use in an extended residence catheter assembly of the present invention can include a left or first frame and a second or right frame attached to each other. Each frame can be comprised of a nose portion, a body portion, and a base portion. The two nose portions can be joined to form a nose end, the two body portions can be joined to form a body, and the two base portions can be joined to form a base end.

[0110] In one example, the nose end or nose section includes a nose tip having an elongated cylindrical like configuration with a bore for accommodating the catheter tube and needle that is placed within the catheter tube. The nose end or nose section may further include a nose base having an enlarged portion formed with the tip and a tapered distal portion. A number of support ribs or fins may be provided at the intersection between the tip and the nose base. In another example, the nose end may be spherical or rounded dome shaped with an opening for accommodating the catheter tube and needle.

[0111] The body of the housing can have an interior space for receiving a catheter assembly, which can be a catheter assembly described elsewhere herein. The body opening or the first opening can open into the interior space. The body opening can extend from the nose end to the base end.

[0112] In one embodiment, the body may have a second opening opposite the first opening such that the interior space is accessible from both body openings. Thus, the body may have a through passage defined by the two body openings. In another embodiment, the body may have only a single opening leading to the interior space as shown, and the opposing sides may be solid or enclosed by the walls of the first and second frames. Optionally, the enclosed sides may have small windows or openings for access or ventilation, but may not be completely open like the body openings.

[0113] The base can extend from the body, and the base can have multiple sides. In one example, there can be four sides defining an interior space, and the sides can open to the interior space of the body. In other examples, the base can embody a generally elongated cylindrical or non-cylindrical shape. For example, the sides can include an upper side, a lower side, a left side, and a right side. The sides can also be understood as a first side, a second side, a third side, and a fourth side. These particular designations are provided to allow for designation of certain sides relative to other sides, and are not intended to be limiting unless the context indicates otherwise.

[0114] The base can have an open proximal end to allow the needle hub to extend proximally of the end face in the ready-to-use position. As shown, the first and second sides of the base end can each have an opening to allow viewing or access to the interior space of the base end to facilitate or aid in assembly of the catheter assembly, as described below.

[0115] An upper lever may be provided on the upper side of the base end, and a lower lever may be provided on the lower side. When a user simultaneously applies a compressive force and a distally directed force to the top lever and a compressive force and a proximally directed force to the bottom lever, the user can move the left and right housing frames relative to each other, causing the detents on the first and second frames to move apart, separating the housing into separate housing components, i.e., the left and right frames. In other words, by manipulating the upper and lower levers, the user can separate the housing into two or more housing components along a separation line.

[0116] Separating the housing into housing components exposes the catheter assembly for separation from the housing after successful venipuncture so that the catheter hub can be secured to the IV line and secured to the patient, such as by using tape or a securement dressing. In other embodiments, by repositioning the detents or engagement tabs between the left and right housing frames, a user can simultaneously apply a compressive and proximal force to the upper lever and a compressive and distal force to the lower lever to move the two housing portions relative to one another and separate the detents of the first and second frames.

[0117] In some embodiments, rather than having two housing portions separate to allow separation of the catheter hub from the housing after successful venipuncture, one or more gates can be provided at the nose end of the housing. For example, as the catheter hub advances against the two gates, the detents or engagements that secure the two gates together can separate so that the two gates swing outward to open an outlet or passageway at the distal end of the housing to allow separation of the catheter hub from the housing. The two gates can be molded directly into the frame of the housing and each can be provided with a living hinge to swing open. Alternatively, the gates can be molded into a carrier and the carrier can be attached to the housing.

[0118] The needle with the needle tip and the needle hub with the adapter and dispenser can be referred to as a piercing and guiding unit (PG unit). The PG unit can be used in relatively long catheter assemblies with catheter tubes and needles having lengths of about 7.5 cm to 20 cm. Such relatively long catheters and needles are typically found in midline catheters. However, the PG unit of the present invention is not so limited and may be used in short catheters and needles or long catheters typically found in peripheral access catheters.

[0119] Typically, once venipuncture is successful, the entire PG unit is removed as a single unit from the catheter tube and catheter hub. If necessary, components of the PG unit can be removed piecemeal from the catheter hub, first from the dispenser, then from the adapter, then from the needle hub together with the needle, or a combination thereof. Preferably, the guidewire and needle are removed together as a unit.

[0120] When used with a catheter assembly, the PG unit is used as an extended dwell catheter assembly, with or without an outer housing, with a catheter hub having a catheter tube extending therefrom. The PG unit is used to access a blood vessel and is removed from the catheter upon successful venipuncture. For example, a user can first grasp the catheter assembly with the PG unit and guide the tip of the needle through the skin at a suitable insertion site to access a vein or blood vessel.

[0121] Verification of adequate vascular access can be made by a primary blood flush, i.e., the presence of blood in the needle hub. The user can then retract the tip of the needle proximal to the opening of the catheter tube and observe for a secondary blood flashback, i.e., blood between the outer diameter of the needle and the inner diameter of the catheter tube. In some embodiments, the needle can have a through notch formed through the wall of the needle shaft, a longitudinal groove near the needle tip, or a longitudinal groove formed by forming a longitudinal indentation along the needle shaft. In these alternatives, a flashback can be observed between the interior of the catheter tube and the exterior of the needle shaft, which can be detected relatively sooner than blood flashback at the needle hub. At the notch, the notch formation process can cause the needle to have a reduced inner diameter or a reduced lumen. Thus, the notch can also be used as a stop to stop the distal advancement of the guidewire, such as to capture a change in guidewire diameter, as described further below.

[0122] After successful venipuncture is confirmed, the guidewire dispenser is actuated by applying manual pressure to the guidewire at the advancement or advancement platform of the dispenser to slide or advance the guidewire distally. The guidewire, such as the tip of the guidewire, may be initially disposed within the hollow needle, may be initially disposed only within the adapter, or may be initially disposed only within the catheter hub.

[0123] Distal advancement of the guidewire continues until the guidewire is fully extended within the patient's vessel. In one embodiment, the amount of extension of the guidewire into the vessel can be controlled by fixing the overall length of the extendable guidewire at the advancement platform. For example, the guidewire can have two ends, a first end at the distal end of the guidewire and a second end at the proximal end. The length of the guidewire can be selected to indicate a fully extended position of the guidewire when the second end of the guidewire moves to the advancement platform. The user can stop advancing the guidewire at that point. Optionally, there can be a physical stop as described above, or a marker that indicates how far the first end of the guidewire has extended distal to the needle tip as the guidewire is advanced. Of course, when using a catheter assembly with a PG unit of the present invention, the user need not fully extend the guidewire. In some embodiments, one or more markers or indicators can be used to indicate when the guidewire reaches the bevel tip of the needle tip, passes the bevel tip, when the guidewire is fully advanced from the bevel tip, or all of the above.

[0124] The catheter tube is further inserted into the vessel and guided by the guidewire. As the catheter tube and catheter hub are advanced distally and the catheter tube is guided into the vessel by the guidewire, the catheter hub separates or further separates from the needle hub. The catheter tube and catheter hub may be advanced over the guidewire a sufficient amount to ensure successful placement within the vessel. The PG unit may then be removed or separated from the catheter tube and catheter hub. After removal, the PG unit is separated from the catheter hub and catheter tube.

[0125] When the PG unit is used with or as part of an extended dwell catheter assembly, the method of using the assembly is similar to the process described immediately above, except that as the catheter hub advances and the catheter tube travels over the guidewire, the catheter hub or attachment to the catheter hub opens a gate at the distal end of the housing to allow the catheter hub to be separated from the housing, or the user activates a lever, tab, or button to split the housing into two or more housing components and allow the catheter hub to be separated from the housing. The PG unit can be separated from the catheter hub at the same time as, before, or after the housing separates from the catheter hub.

[0126] A dispenser according to an embodiment of the invention has a frame or body, a duct engaged to the body, and a guidewire. The frame has a generally transverse Y-shaped configuration having a first branch, a second branch, and a third branch.

[0127] The three branches can be connected to one another at a focal or connecting portion of the frame or body, and each branch can have a respective free end extending away from the focal or connecting portion. The free ends can be spaced apart from one another, and the frame having the three branches can be integrally formed.

[0128] As shown, the first branch has a free end pointing generally in a distal direction, the second branch has a free end pointing generally in a proximal direction, and the third branch has a free end pointing radially of a longitudinal axis defined by the first and second free ends, the free end of the third branch optionally pointing proximally in addition to pointing radially. In one embodiment, each branch of the frame can be elongated and have a surface contour and / or an arcuate bend. For example, the first branch can have a portion of reduced thickness extending distally from the connecting portion and defining the guide platform. The reduced portion can be formed by providing a surface resembling a cross section of an arc with portions of greater width or thickness on either side of the reduced portion.

[0129] The first branch can have a connecting tip at its distal end. The connecting tip resembles a reducer and reduces to function as a slip-on tip or nipple for connecting to the open proximal end of the adapter. The connecting tip of the dispenser can reduce in diameter to a first tip and then to a second tip of smaller diameter. The size and shape of the connecting tip, including the first and second tip portions, are configured to mate with a matching female bore of the adapter.

[0130] In some embodiments, the engagement between the two is a taper interference fit similar to a Luer fit, but not necessarily formed according to the Luer ISO standard. In yet other examples, the connecting tips of the adapter and dispenser can be provided with a detent or detent-like engagement. As shown, the connecting tip and the receiving bore of the adapter can include a raised lip or shoulder and a corresponding recess to form a snap fit. In yet other embodiments, rather than a connecting tip having different tip portions, such as different tip diameters, the connecting tip can embody a single taper to engage a corresponding taper of the adapter similar to a Luer taper, but having a non-ISO standard size.

[0131] The first branch can have a guide passageway extending axially through the first branch and through the connecting tip. The guide passageway is provided for passing a guidewire through the adapter and into and out of the needle during use to guide the catheter tube, as previously described. For example, the guidewire has an end referred to as a first or distal end and an end referred to as a second or proximal end.

[0132] In the ready-to-use position, the first end can extend from the connecting tip through the guide passageway into the interior of the adapter. In one embodiment, the first or distal end of the guidewire does not enter the needle lumen in the ready-to-use position of the catheter assembly to provide flow path space for primary blood flashback during needle puncture, as discussed further below.

[0133] The dispenser can have a slope that slopes in a distal to proximal direction toward the second branch. The guide bracket can be disposed at the proximal end of the second branch. The guide bracket can have a generally cuboid shape, such as resembling a rectangular prism, and have a body with a sloped distal end or a sloped tapered distal side. In some examples, the guide bracket can have a different cross-sectional shape, such as circular or polygonal, and the distal side can be more vertically aligned.

[0134] A guide passage may be provided axially through the body of the guide bracket to accommodate the guide wire. In height, the distal end or side of the guide bracket may be seated higher than the inlet of the connecting tip at the end of the first branch. This height difference allows the dispenser to be gripped while sliding the guide wire distally with the thumb, as described below, facilitating the dispensing of the guide wire. However, the angle of the guide wire extending between the guide bracket of the second branch and the guide tip of the first branch may be varied while still providing an ergonomic shape to the dispenser.

[0135] The guide bracket of the second branch may include a socket for receiving the first end of the duct. The guide bracket may have a plurality of walls defining a circular socket therein. As an example, the duct may embody a round tube section, the first end of the tube may engage the round socket of the guide bracket in a manner such as a friction fit, an interference fit, a snap fit, or the like. While the use of a duct with the frame is preferred, it is not required, as the guide wire may simply extend and hang down from the second branch if no duct is used. The incorporated duct receives a portion of the guide wire therein to prevent kinking or bending of the guide wire. In yet another embodiment, a duct having a length shorter than shown may be incorporated, with the second end of the duct hanging down in the air.

[0136] In one embodiment, the second end of the duct and the guide wire hang down from the second branch with the second end unsupported. Alternatively, the duct has a curved body that is curved such that the second end of the duct projects into a socket in the support bracket of the third branch with a friction fit, an interference fit, or a snap fit. The socket can be circular and formed by the walls of the support bracket. Thus, the duct in the illustrated embodiment is supported at both the first end and the second end by the guide bracket and the support bracket, respectively. If the length of the guide wire is short enough that it does not extend beyond the opening in the second end of the duct, the support bracket can be implemented without a guide wire passage. However, if necessary to accommodate the length of the guide wire, a guide wire passage can be incorporated axially in the support bracket.

[0137] In yet another embodiment, the socket of the third branch has a pass-through such that the second end of the tube passes through the socket of the third branch and extends beyond the socket toward a central portion of the length of the tube. This second end may be held at the central portion of the length of the tube by one or more clips, as described below. This third branch pass-through socket version allows the tube to be looped in a relatively smaller loop than a closed end socket version. As a result, the overall profile of the guidewire dispenser may be reduced.

[0138] The support brackets in the third branch are generally cubic shaped, resembling a rectangular prism, with a sloping or tapered far end or distal side, In some embodiments, the support brackets have a different cross-sectional shape, such as circular or polygonal, and the distal side may be more vertically aligned.

[0139] The third branch and the first branch may include a curved or arcuate edge or surface. Similarly, the body may include a curved or arcuate edge or surface between the third branch and the second branch. The curved edge and the curved duct between the third branch and the second branch of the frame may form a generally circular structure with a hollow space or opening for receiving or housing and gripping the guidewire. For example, the curved edge between the third branch and the first branch provides a gripping surface for the user. As shown, the duct and the frame may form a closed loop. In a particular example, the curved edge surface of the duct and the frame may define a generally circular structure.

[0140] In use, when used with one hand, a user can grip the dispenser with their middle finger, ring finger, and pinky finger inside the hollow interior of the dispenser against the curved edge. The index finger can grip around the curved edge between the third and first branches and against the inner curved edge. The thumb can then be placed on the top side of the dispenser, over the ramp, guide wire and guide platform.

[0141] To dispense or actuate the guidewire, the user uses their thumb to press the guidewire against the surface at the guide platform with both a downward force and a distal force that moves the guidewire distally, which moves a first end of the guidewire through the needle to the distal end, which helps guide the catheter tube.

[0142] The movement of the guidewire from the needle tip can be controlled by controlling or sizing the overall length of the guidewire so that when the second end of the guidewire is pushed into the connecting tip at the first branch, no more guidewire can be expelled. In other embodiments, the second end of the guidewire, or a portion of the guidewire, can be provided with a catch, such as a hook, an enlarged portion such as a larger diameter, a knot, etc., that catches on the frame of the dispenser after the guidewire has been expelled a finite amount, or against the reduced lumen opening of the crimp of the needle, to prevent the guidewire from moving further distally from the connecting tip and / or the needle tip. Obviously, curved edges of the frame are preferred for the reasons discussed above, but modifications such as less curvature or having straight sections can still provide the general functionality described.

[0143] In one embodiment, the tip of the adapter projects into the interior space of the needle hub, and the distal opening of the tip is positioned over the proximal end of the needle having a blunt tip. In one example, the bore or cannula channel of the distal opening of the tip is sized to fit the proximal end of the needle in a size-on-size manner, optionally with a loose fit with slight clearance between the two. The distal opening of the tip can be provided with a flared inlet or entry. The flared entry allows the tip to easily slide over the needle to receive the proximal end into the bore of the tip and helps compensate for potential slight misalignment.

[0144] The tip can include a modified luer taper for luer-fitting engagement with the needle hub at the proximal opening of the needle hub. The tip can be elongated such that the distal end of the tip reaches and projects above the proximal end of the needle to receive the needle within the bore of the tip.

[0145] An adapter is provided according to an aspect of the invention having a body including a base and a tip having a shoulder therebetween. Externally, the base may include a plurality of interconnected and angled slats or side walls. The walls or slats may be interconnected along their respective edges. At least one end of the slats is provided with a flange or tab. The flange or tab may be formed continuous with the slat from which it extends.

[0146] The flange or tab may have at least three unobstructed side edges. In other examples, the flange or tab may be rounded, such as partially circular, or may have more than two edges. There may be one or more flanges or tabs incorporated into the base. In a preferred embodiment, at least two spaced flanges or tabs are incorporated into the base. When two spaced flanges are incorporated, the tip of the dispenser is disposed therebetween.

[0147] The tip of the adapter can be generally cone-shaped with one or more reduced tips. For example, the tip can have a first tip having a first size, a second tip having a second size, a third tip having a third size, and a fourth tip having a fourth size. However, the tip can have other bore shapes and still encompass aspects of the invention. In other embodiments, there can be fewer or more sections depending on the desired compatibility with the interior of the needle hub and the reach of the tip within the needle hub surrounding or adjacent the needle proximal end. In other embodiments, the tip comprises a single tapered profile.

[0148] Two flanges or tabs extending from the base of the adapter can be opposed along the longitudinal axis and each can include an inner surface having a lip or surface-engaging feature. The gap distance between the two tabs can be relatively smaller than the inner diameter of the base. The relatively small dimension between the two flanges or tabs can be selected to engage a lip or corresponding surface on the connecting tip of the guidewire dispenser.

[0149] Internally, the adapter can have a bore with a proximal end open to fluid communication with the distal end of the adapter. In one example, the bore has different bore sections with different bore diameters. The different bore diameter sections can be selected or sized to fit a selected connection tip of the guidewire dispenser. The bore can have a first bore section with a first diameter for coupling to a first tip section of the dispenser and a second bore section with a second diameter for coupling to a second tip section of the dispenser. Distal to the second bore section, a third bore section can be provided.

[0150] The third bore portion, when assembled, may have a cone shape that narrows to the guidewire passage and then expands in diameter to the cannula channel, which may have a larger cross-sectional space than the guidewire passage since the needle has a larger outer diameter than the guidewire diameter. The distal end of the adapter is provided with a flared entrance having tapered edges to facilitate placement of the cannula channel over the blunt proximal end of the needle, as previously described.

[0151] The cannula channel can have a non-circular space defined by three generally straight sides connected to each other by arcuate connections. When the proximal end of the needle is placed in the cannula channel, the proximal end of the needle becomes disc-shaped and contacts the three generally straight sides of the cannula channel. The bore of the needle is centered in the disc-shaped structure and aligned with the illustrated guidewire passage. The contact of the exterior of the needle with the three generally straight sides can create a slight interference fit to ensure a tight connection between the cannula channel and the needle. Each arcuate connection and the exterior of the needle defines a bypass gap in the cannula channel. The tip of the adapter at the cannula channel and the needle define three bypass gaps. In other examples, there can be more than two straight sides and a corresponding number of arcuate connections.

[0152] In use during initial needle puncture, the guidewire occupies the guidewire passage at the distal end of the adapter, but the guidewire first end does not protrude into the needle lumen at the proximal end of the needle. Thus, when the primary blood flashback flows proximally out of the needle proximal end, blood first flows into the cannula channel but cannot flow proximally into the proximal bore or does not substantially flow into the proximal bore due to the restriction. This is because the guidewire occupies the guidewire passage and the clearance between the guidewire and the bore diameter in the guidewire passage is too restrictive for blood to flow across or freely flow therethrough.

[0153] However, the bypass gaps can be sized for blood flow, such as by providing sufficient flow paths or clearances in each bypass for a given fluid viscosity, so that blood entering the cannula channels can exit through the bypass gaps into the interior space of the needle hub. Thus, the practitioner can detect a primary blood flashback in the interior space of the needle hub after blood flashback enters the cannula channels of the adapter and then backflows and exits through the bypass gaps into the interior space of the needle hub, and can be detected visually through the walls of the needle hub, for example, by perceiving a blood-red color within the interior space. In some examples, the adapter can be made of at least partially transparent translucent material, allowing blood flashback to be observed through the walls of the adapter.

[0154] In another embodiment, the adapter has a body including a base and a tip. The base may also have a number of slats or sidewalls joined along their respective edges. One or more flanges or tabs may extend proximally of the base, and each flange or optionally may incorporate an engagement feature for engaging a guidewire dispenser as previously described. In an alternative embodiment, the exterior of the base may be one continuous generally circular cylinder instead of separate slats.

[0155] The tip of the adapter can have a different outer tip and a different inner tip. In one embodiment, the most distal end of the tip has a bore with an internal bore shaped similar to a cone shape. However, the tip can have other bore shapes and still be within the scope of the invention. The internal bore shaped is distal to the first and second bore portions and has a reduced tip defining a guidewire passage. The guidewire passage is sized and shaped to accommodate a guidewire passing therethrough, but is too small to accommodate the proximal end of a needle.

[0156] Thus, in an exemplary embodiment, the adapter does not incorporate a cannula channel distal to the guidewire passageway for receiving the proximal end of the needle. In use, the distal-most tip of the adapter can be spaced from the proximal end of the needle, and any primary blood flashback flowing through the needle lumen can simply flow directly into the interior space of the needle hub. In some examples, the adapter can have a valve and a tip with a cannula channel that receives the proximal end of the needle.

[0157] In an alternative embodiment, the present adapter can be lengthened and incorporate structure distal to the guidewire passageway to define a cannula channel, in which the adapter can receive the proximal end of the needle when the adapter is engaged to the needle hub. Thus, blood flashback into the cannula channel of an improved adapter with a cannula channel can flow back and out of the bypass gap of the improved tip.

[0158] The base of the adapter can include a valve chamber having a valve disposed therein. In one embodiment, the base includes internal shoulders for forming various internal chamber sizes or sections including a first bore portion or chamber, a valve chamber, and a reduced chamber located between the first bore portion and the valve chamber.

[0159] In some embodiments, the first bore chamber is configured to receive a connecting tip of a guidewire dispenser and the reduction chamber is configured to accommodate a reducing tip of the connecting tip, as described further below. In some embodiments, the base can be continuous or have a generally cylindrical structure without distinct slats and edges formed between the slats.

[0160] The valve may be disposed within the valve chamber and retained therein by a distal shoulder and a proximal shoulder. In one embodiment, the valve may have a valve disc and a valve skirt extending from the valve disc. A distal face of the valve disc may press or contact the distal shoulder and a proximal end of the valve skirt may press or contact the proximal shoulder to position the valve therebetween. In some embodiments, the valve may include a valve disc without a skirt extending therefrom, and the internal bore of the adapter is appropriately modified to retain the valve without a skirt.

[0161] In one embodiment, a valve usable with the adapter can have a valve disc and a skirt integral therewith. In the illustrated example, the valve and skirt are integrally formed. The skirt can be considered as a generally cylindrical length with an open proximal end and has a proximal extreme end.

[0162] The valve disc may have multiple slits or valve disc slit portions that define multiple valve flaps. For example, the valve may have three slits that define three flaps. However, the valve may be implemented with one slit that defines two flap portions, or more than two slits and three flap portions. The three slits may meet at a focal or central point. The lengths of the slits are preferably, but not necessarily, equal, and the slits stop at the short of the outer diameter of the valve. In this embodiment, the wall thickness of the valve in the axial direction is generally constant and the surface shape does not change. However, it is also possible to incorporate noticeable surface features.

[0163] In some examples, the valve skirt can have a generally constant outside diameter (OD). The valve skirt can have a generally constant thickness such that the inner diameter of the skirt is generally constant. In alternative embodiments, the thickness can vary such that the outer diameter of the skirt is constant and the inner diameter varies.

[0164] In another embodiment, the valve has a valve disc and a valve skirt extending therefrom. The valve disc can have a plurality of slits or valve disc slits that define a plurality of valve flaps. In this embodiment, the wall thickness of the valve disc in the axial direction has distinct first and second portions. The first portion can have a first thickness and the second portion can have a second thickness, the first thickness being greater than the second thickness, measured perpendicular to an inner plane passing through a diameter of the valve. The second portion having the second thickness can have a substantially constant thickness, but can optionally include a thickness that varies along a cross section of the valve in the second portion.

[0165] In one embodiment, the second portion can be formed by recessing a distal facing surface of the valve, a proximal facing surface of the valve opposite the distal facing surface, or both the distal and proximal facing surfaces of the valve, while the first portion retains substantially the full width or thickness of the valve between the proximal and distal facing surfaces. In one embodiment, the recess in the second portion can embody an undercut formed in the valve.

[0166] The surface appearance between the first and second portions can resemble a three-leaf clover. The three-leaf clover can be present on the distally facing surface, the proximally facing surface, or both surfaces of the valve. In other examples, the contours of the proximal and / or distally facing surfaces can have a variety of contours, such as a three-leaf clover can have a variety of curves, lines, and edge contours. The surface features can facilitate bending and sealing of the valve at the slit.

[0167] A PG unit having a dispenser, an adapter, and a needle hub with a needle extending therefrom can be implemented with the adapter having a valve. The valve can have a valve disk and a valve skirt. The distal-most tip of the dispenser in which the valve is disposed can be spaced from the proximal end of the needle. However, the tip of the adapter can include a cannula channel and the proximal end of the needle can be located within the cannula channel.

[0168] Another guidewire dispenser can have a frame or body modified so that the guidewire extends generally horizontally through the guide platform of the frame and generally coaxial with the needle. The frame can have a guide passage with a sloped section that slopes toward the guide bracket of the second branch. This arrangement causes the guidewire to extend toward the connecting tip of the dispenser, reducing the insertion angle of the guidewire as it is inserted into the adapter.

[0169] The connecting tip of the dispenser can protrude into a receiving space or hole in the base of the adapter, with one or more tabs engaging corresponding detent faces on the dispenser to maintain a tight engagement between the adapter and the dispenser. Optionally, an interference fit can be provided without the use of flanges or tabs.

[0170] As shown, the distal tip portion of the dispenser does not push through the valve disc to deflect the valve flap and can be located in the interior space defined by the skirt of the valve. In one embodiment, the distal tip portion of the dispenser is spaced from the proximally facing surface of the valve disc. The guidewire extends through a slit in the valve disc such that a first end of the guidewire is located within the bore of the adapter and recessed from the distal-most tip of the adapter. The location of the first end of the guidewire can be implemented in a ready-to-use position of the catheter assembly.

[0171] The adapter tip can be disposed in the interior space of the needle hub, with the dispenser connection tip disposed within the proximal bore of the adapter. The adapter's distal-most end is spaced from the needle proximal end with a gap therebetween. A first end of the guidewire is located within the bore of the adapter and recessed from the adapter's distal-most tip. The adapter can have a valve disposed therein.

[0172] After initial vascular access, blood flows proximally through the needle lumen and out of the proximal opening of the needle. Because there is a gap between the needle and the tip of the adapter, some of the blood will escape into the interior space of the needle hub and can be visually detected as a temporary blood flashback through the wall of the needle hub. Some of the blood may also flow through the distal opening of the adapter tip, which can be a guidewire passage. In that case, blood flow through the inner diameter of the adapter can be restricted or stopped by a valve inside the adapter. In this way, the practitioner can take the appropriate time to place the guidewire into the vein and then slide the catheter tube over the guidewire to place the catheter tube deep into the vein without feeling rushed due to blood escaping through the openings of the adapter and / or dispenser in the case of an adapter without a seal. After successful venipuncture, the PG unit including the needle hub, adapter, and guidewire dispenser can be removed from the catheter hub and catheter tube. These parts can be removed as an integrated unit or individually.

[0173] A protective cap can be placed on the tip of the adapter, and the assembly including the protective cap, adapter, and guidewire dispenser with the guidewire and duct or tube can be marketed as a unit in a shipping package such as a blister pack or thermoplastic pouch.

[0174] The protective cap may have a first end and a second end and may be formed as a thermoplastic protective sleeve. The first end may have a bore sized and shaped to snap-fit ​​onto the tip of the adapter. Optionally, a detent engagement and / or a friction fit between the two may be implemented. The second end of the protective cap may be a closed end or may have an opening. The protective cap may be removed from the adapter and discarded prior to using the adapter and the guidewire dispenser unit.

[0175] Another guidewire dispenser may have a frame or body modified such that the third branch has a C-channel rather than a socket. The C-channel of the modified third branch may be a through clip with a slot. That is, the duct does not end at the third branch, but is routed through the clip or C-channel of the third branch such that the second end of the duct is routed away from or away from the C-channel.

[0176] The duct can be snapped into the clip by placing it over the slot and pushing it through the slot so that the duct fits into the C-channel. The second end of the duct can be threaded through the C-channel by inserting the duct into the end opening and pushing the second end through, but this is not optimal.

[0177] An intermediate retaining clip may be provided to hold together a portion of the intermediate portion of the duct. In the example shown, the intermediate retaining clip has a unitary or single formed body with two slots for receiving two different sections of the duct. The intermediate retaining clip may be considered as two C-channels formed side by side with a common center side. Both C-channels may be throughs where the tube does not terminate in either C-channel.

[0178] The second intermediate clip can be used to support an additional portion of the tube or duct, for example, the second intermediate clip can be adjacent to the first intermediate clip, contacting the first intermediate clip, or spaced apart from the first intermediate clip to support the duct near the second end, with the second end passing through the second intermediate clip.

[0179] Alternatively or additionally, an end clip may be provided to support the second end of the duct or tube, particularly the duct. The end clip may be considered as a C-channel and a modified C-channel formed side-by-side with a common center side. The end clip has a C-channel with a through slot and a closed slot with an end wall. The end wall may prevent the second end from passing through the modified C-channel.

[0180] By using one or more intermediate clips, and optionally an end clip in combination with a through C-channel on the third branch, the tubing can be wrapped with overlapping sections, i.e., the tubing can be wrapped in more than one full loop. This allows the duct and frame to form a smaller closed loop than a similar size dispenser and duct without a C-channel. This allows for reduced packaging size and storage space.

[0181] Methods of making and using catheter assemblies and components thereof, such as including one or more of the outer housing, guidewire, guidewire dispenser, and adapter, are within the scope of the present invention. [Brief description of the drawings]

[0182] These and other features and advantages of the present devices, systems, and methods will become apparent as the same becomes better understood with reference to the specification, claims, and accompanying drawings.

[0183] [Figure 1]FIG. 1 is a perspective view of a catheter assembly located within a housing, the catheter assembly including a catheter with a catheter tube and a needle hub with a needle. [Diagram 2] FIG. 2 is a partial cross-sectional side view of a catheter that can be used with the housing of FIG. [Diagram 3] Figure 3 is a puncture and guide unit, or PG unit, which includes a needle, needle hub, adapter, and a guidewire dispenser having a guidewire. [Figure 3A] FIG. 3A is an enlarged view of a portion of the dispenser 292 and adapter 290 of FIG. [Figure 4A] FIG. 4A is a partial cross-sectional side view of a PG unit engaged with a catheter hub. [Figure 4B] FIG. 4B is a partial enlarged cross-sectional view of the adapter of FIG. 4A positioned within the interior cavity of the needle hub. [Diagram 5] FIG. 5 is a perspective view of the adapter. [Figure 6A] FIG. 6A is a longitudinal side cross-sectional view of the adapter 290 of FIG. [Figure 6B] FIG. 6B is an end cross-sectional view taken along line DD in FIG. 6A. [Figure 6C] FIG. 6C is an enlarged view of part E in FIG. 6B. [Figure 7A] FIG. 7A is a side elevation view. [Figure 7B] FIG. 7B is a side cross-sectional view. [Figure 8] FIG. 8 is a side elevational view of the PG unit. [Figure 9] FIG. 9 is a side cross-sectional view of an adapter with a valve located therein. [Figure 10] FIG. 10 is a valve that can be used with the adapter of FIG. [Figure 11] FIG. 11 is a valve that can be used with the adapter of FIG. [Figure 12A] FIG. 12A is a PG unit that has an adapter with a valve located within it. [Figure 12B] FIG. 12B is an enlarged view of the guidewire dispenser and adapter of FIG. 12A. [Figure 13] FIG. 13 is a close-up of the PG unit with the adapter showing the valves and blood flow direction. [Figure 14] FIG. 14 is a side view of the adapter and guidewire dispenser with a protective cap placed over the tip of the adapter. [Figure 15] FIG. 15 is a partial perspective view of the puncture and guide unit or PG unit. [Figure 16] FIG. 16 is a rear perspective view of the adapter of FIG. 15 separated from the other components. [Figure 17] 17 is a front perspective view of the adapter of FIG. 16. FIG. [Figure 18] FIG. 18 is an end view of the adapter of FIG. [Figure 19] 19 is an enlarged end view of the cannula channel of the adapter of FIG. 18. FIG. [Figure 20] FIG. 20 is a front perspective view of an adapter with multiple gas channels. [Figure 21] FIG. 21 is a front end view of the adapter of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0184] 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.

[0185] The description of technical features or aspects of an exemplary configuration of the present disclosure should typically be considered as 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 duplicated description may be omitted in this specification.

[0186] General identifying terms such as first and second are understood to merely identify different components by their general name for the purpose of tracing their existence, but are not structurally limiting. Furthermore, while one component may be referred to as first and another as second, the specific references to the different components may be reversed or changed and are not structurally limiting. The terms "can" or "may" are intended to convey features that may be included, but are not required.

[0187] Generally speaking, each of the extended residence catheter assemblies described herein includes a housing and a catheter assembly configured to house the catheter assembly during initial puncture, during advancement of the catheter, during separation of the needle hub from the catheter hub, and thereafter actuated to permit separation of the catheter hub from the housing, allowing the catheter to remain in the patient.

[0188] The housing and catheter hub can be separated by a variety of different mechanisms: for example, the housing can be split into two or more housing parts to release or separate from the catheter hub, the housing can have parts that swing or pivot to open a path for the catheter hub to separate, the housing can have end cap parts that swing to open a gated opening to allow the catheter hub to exit the housing, or the housing can have a gate assembly attached to the distal end of the housing that can be actuated to open as the catheter hub is advanced distally within the housing to allow the catheter tube to slide deeper into the vein, among other options.

[0189] When the gate assembly is used with a housing, the gate assembly can have two gates, each gate disposed in each of two gate housing bodies or housing sections, which can be joined together and each gate can swing open via a living hinge. The two gates can be engaged via a male detent and a receiving slot. The two gates can be engaged via a hook arm and a female detent. The unique housing design for use with the catheter hub allows for use with standard or existing catheter assemblies and does not require a specially designed catheter, although that is an option. Thus, standard catheters with extended lengths or midline catheters with catheter lengths of about 8-10 cm can be easily used with the housing of the present disclosure, with or without a guidewire. Exemplary extended retention catheter assemblies and housings described hereinabove are disclosed in Provisional Application Serial No. 62 / 893,382, filed August 29, 2019, entitled "EXTENDED RETENTION AND MIDLINE CATHETERS AND RELATED METHODS," the contents of which are expressly incorporated herein by reference.

[0190] 1, a perspective view of an exemplary embodiment of an extended retention catheter assembly 100 in accordance with aspects of the present invention. In the illustrated example, the extended retention catheter assembly 100 includes a housing 102 having a receiving or interior space 104 having a catheter assembly 108 disposed therein. As shown, the catheter assembly 108 has a vent plug 124 that engages a proximal opening of a needle hub 122. In an alternative embodiment, as described further below, the vent plug 124 is replaced with an adapter and a guidewire dispenser that is coupled or engaged to the adapter. The catheter assembly 108 with the adapter and guidewire dispenser can optionally be used with or without the housing 102.

[0191] The catheter assembly 108 has a catheter tube 110 and a needle 112 located within a lumen of the catheter tube extending from a distal end 120 of the housing 102. A needle tip 114 of the needle extends from a distal opening 110a of the catheter tube 110. The catheter tube 110 is attached to a catheter hub 130, and the needle 112 is attached to a needle hub 122. The needle hub 122 is shown extending from a proximal end 126 of the housing 102. The needle hub 122 can include a vent plug 124 that can engage the proximal opening of the needle hub 122 in a luer-like manner.

[0192] 2 in addition to FIG 1, a cross-sectional side view of the catheter assembly 108 of FIG 1 is shown outside or away from the housing 102. The presently shown catheter assembly 108 and similar catheter assemblies can be used in conjunction with the housing 102 to form an extended residence catheter assembly according to embodiments of the present invention. Optionally, as described above and further below, a guidewire can be incorporated to aid in the insertion, positioning and navigation of the catheter into the patient's vasculature.

[0193] In one embodiment, the catheter assembly 108 includes a first hub or catheter hub 130 to which an over-the-needle tube or catheter tube 110 is attached, and a second hub or needle hub 122 to which a needle 112 is attached. The catheter tube 110 has a lumen or bore for receiving the needle 112 and has a distal opening or distal end opening 110a, with the needle tip 114 of the needle 112 extending distally of the distal opening 110a when the catheter assembly is in a ready-to-use position, where the catheter assembly is ready for venipuncture or access to a patient's vascular system. The catheter assembly 108 may also be referred to as a needle assembly.

[0194] The needle 112 may include a profile change point 136 located proximal to the needle tip 114 for use with a needle guard 140. The needle tip 114, when incorporated for use with a needle guard, extends distal to the distal opening 110a (which may be referred to as the distal end opening) of the tube or tube 110 in the ready-to-use position, with the profile change point 136 located proximal to the distal end opening 110a. The profile change point 136 may be a crimp, bump, or a rise in material having a different profile than other diameter portions of the needle shaft. As used herein, the term proximal is understood to mean the end or side closer to the practitioner, and the term distal is understood to mean the end or side opposite.

[0195] The profile transition point 136 can be used to interact with a needle guard 140 during retraction of the needle 112 after successful venipuncture, as described further below. The vent plug 124 is disposed in a proximal open end or proximal opening 138 of the second hub or needle hub 122. The vent plug 124 can have a vent filter 142 at its proximal end, which is conventional. As shown, the catheter tube 110 is attached to the first hub or catheter hub 130 by a ferrule or bushing 144.

[0196] A needle guard 140 can be provided in an internal cavity 148 of the first hub or catheter hub 130 to cover the needle tip 114 in a protected position. If incorporated, the needle guard 140 can be one of the needle guards disclosed in U.S. Pat. No. 6,616,630, the contents of which are expressly incorporated herein by reference. In some embodiments, the needle guard 140 can be omitted. In that case, the needle profile transition point 136 can optionally be omitted. In some embodiments, the profile transition point 136 can interact with the guidewire to limit distal movement of the guidewire, as further described below. In still other embodiments, a needle guard can be included without including a profile transition point on the needle. In yet other examples, the needle guard 140 can be disposed in a third housing between the first hub 130 and the second hub 122. An exemplary needle guard disposed in a third housing is disclosed in U.S. Pat. No. 8,597,249, the contents of which are expressly incorporated herein by reference. In yet another example, the needle guard can include multiple arms or fingers extending in both a first direction and an opposite second direction, as disclosed in U.S. Patent No. 9,387,307, the contents of which are expressly incorporated herein by reference. For example, the needle guard can include a first protector body surrounded by a second protector body.

[0197] In one embodiment, the needle guard can be made of a metallic material and can have a resilient portion capable of generating a biasing force. The needle guard can include a wall disposed on the side of the needle and movable distal to the needle tip to protect the needle tip from accidental contact. The wall can be a needle trap and can be moved directly in front of or distal to the point of the needle tip. The wall can alternatively be a second protector body surrounding the first protector body.

[0198] As shown, the needle guard 140 can include a proximal wall and two arms extending distally from the proximal wall. The two arms can cross each other when viewed from the side in FIG. 2 in the ready-to-use position of FIG. 1 and FIG. 2, and when viewed from the side in the protective position where the needle guard covers the needle tip. In some embodiments, the two arms of the needle guard 140 can extend distally without crossing each other. Two distal walls, one on each arm, can be incorporated to block the needle tip. The two distal walls can be deflected outward by the needle 112 in the ready-to-use position of FIG. 2 and can be located distal to an internal transition point 152 of the profile inside the first hub 130 in the ready-to-use position. The internal transition point 152 of the profile can be a reduced diameter located next to an inner diameter of a larger dimension. The elbows on the two arms of the needle guard can have a dimension larger than the inner diameter at the internal transition point 152 of the profile to limit proximal movement of the needle guard from the catheter hub until the two arms are no longer biased outward by the needle 112 or until the dimensions at the two elbows are smaller.

[0199] Each distal wall of each arm may include a curved lip to facilitate relative movement between the needle guard 140 and the needle 112. When in the ready-to-use position, at the intersection between each arm and its respective distal wall, the dimension measured between the two joints or elbows is greater than the inner diameter of the internal transition point 152 of the profile, which prevents the needle guard 140 from moving proximally thereto due to the relative dimensions. Once the needle tip 114 moves proximally of the two distal walls and is therefore no longer biased by the needle, the two arms are permitted to move radially inward, causing one or both distal walls to close over the needle tip, blocking it in a protected position. At this point, the dimension between the two joints or elbows decreases and becomes smaller than the inner dimension of the internal transition point 152 of the profile, which allows the needle guard 140 to move proximally and be removed from the catheter hub along with the needle. In an alternative embodiment, the dimension between the two joints can be equal to or slightly larger than the internal dimension of the internal transition point 152 of the profile, and the needle can still move proximally by bending or slipping through the two joints and passing through the internal transition point 152 of the profile.

[0200] The first hub 130 has a proximal opening 156 having a nose 158 of the second hub 122 disposed therein. The first hub proximal opening 156 has a female luer for receiving a male luer tip, such as a syringe, IV tubing connector, Luer extension set, and the like. An external thread 154 can be provided on the exterior surface of the proximal end for threaded engagement with a threaded collar of a male threaded luer tip. A pair of stabilizing wings 162 can extend radially of the first hub 130 to facilitate fixation or anchoring of the first hub 130 to a patient after successful venipuncture. Optionally, the wings can be omitted. The first hub 130 can embody a standard IV catheter hub without an injection port. In other examples, the first hub can include an injection port or an integral extension set. If there are no wings on the first hub or catheter hub 130, the bottom surface of the first hub can have a flat surface angled between 2 degrees and 15 degrees from the through axis of the first hub.

[0201] The first hub 130 is removably secured to the second hub 122 by receiving the nose 158 of the second hub in its proximal opening 156. A flange or extension 160 may be provided on the second hub 122, which together with the nose 158 defines a gap 166 in which a portion of the first hub is located. Optionally, the flange or extension 160 may be omitted and a stub 164 or other surface mating configuration may be provided. The stub 164 may be a male portion of a key that penetrates the luer thread or partially fits into the gap to inhibit rotation of the second hub 122 relative to the first hub 130. The proximal end face of the first hub abuts the distal end face of a step on the exterior surface of the second hub at the proximal end of the nose 158 inside the first hub. This abutment may set the amount of projection of the needle tip 114 from the catheter tube 110a. The stub 164 may be an optional structural feature.

[0202] The second hub 122 has a body 168 with an optional internal cavity 170 into which the proximal end 172 of the needle 112 projects. The internal cavity 170 may function as a primary blood flashback chamber. The proximal opening 138 of the body 168 may have a female luer therein for receiving the vent plug 124, a syringe tip, or an adapter, and the exterior may be threaded or unthreaded. In one embodiment, the exterior of the body 168 of the second hub 122 is generally cylindrical and unthreaded. The first and second hubs, i.e., the catheter hub and the needle hub, respectively, may be manufactured from a plastic material, such as by plastic injection molding.

[0203] The first hub or catheter hub 130 can be provided with a push tab 176. The push tab 176 can be located on an exterior surface 178 of the first hub 130 distal to the exterior threads 154 so as not to interfere with the exterior threads. For example, the push tab 176 should be located sufficiently distal to the exterior threads 154 so that when a threaded male connector, such as a syringe type having a threaded collar, is connected to the threads of the first hub, the push tab 176 will not interfere with the connection. In some embodiments, the push tab 176 should be located sufficiently distal to the exterior threads 154 so that when the push tab 176 is folded back, the push tab will not interfere with the connection.

[0204] In some examples, the catheter assembly 108 can incorporate a valve and a valve opener. For example, the valve and valve opener can both be disposed within the catheter hub 130. In use, the valve opener can be pressed distally of the valve to open one or more slits formed in the valve and deflect the flaps of the valve to open a fluid passageway through the valve for fluid flow. An exemplary catheter assembly with a valve and a valve opener is disclosed in U.S. Pat. No. 8,333,735, the contents of which are expressly incorporated herein by reference. The valve opener can have a nose portion having a bore and a plunger portion located proximal to the nose portion. The nose portion can be pressed into the valve to open one or more slits in the valve, such as three slits defining three flaps, to open the valve for fluid flow. The plunger portion of the valve opener can be comprised of two or more plunger parts having a gap therebetween. The gap allows fluid to flow through the plunger parts and through the bore of the nose portion.

[0205] 1 in addition to FIG. 2, the housing 102 of the extended residence catheter assembly 100 of the present invention includes a left or first frame 193 and a second or right frame 194 attached to each other. Each frame includes a nose portion 184a, a body portion 188a, and a base portion 190a. The two nose portions 184a can be joined to form a nose end 184, the two body portions 188a can be joined to form a body 188, and the two base portions 190a can be joined to form a base end 190. In one embodiment, the nose end or nose portion 184 includes a nose tip 186 having an elongated cylindrical like configuration having a bore for receiving the catheter tube 110 and the needle 112, the nose tip 186 being disposed within the catheter tube. The nose end or nose portion 184 may further include a nose base 192 having an enlarged portion formed integrally with the tip 186 and a tapered distal portion. A number of support ribs or fins may be provided at the intersection between the tip 186 and the nose base 192. In other embodiments, the nose end 184 may be spherical or rounded dome-shaped with openings to accommodate the catheter tube and needle.

[0206] The body 188 has an interior space 104 for receiving a catheter assembly, which may be the catheter assembly 108 described with reference to Figure 2. A body opening or first opening 196 opens into the interior space 104. As shown, the body opening 196 extends from the nose end 184 to the base 190.

[0207] In one embodiment, a second opening opposite the first opening 196 is provided in the body 188 such that the interior space 104 is accessible from two body openings. Thus, the body can have a through passage defined by two body openings 196. In other embodiments, the body 188 has only a single opening 196 leading to the interior space 104 as shown, with the opposing sides being solid or enclosed by first and second frame walls. Optionally, the enclosed sides can have a small window or opening for access or ventilation, but are not a complete opening like the body opening 196.

[0208] The base portion or end 190 extends from the body 188 and has a number of sides. In one embodiment, the base portion or end 190 may have four sides 200, 202, 204, 206 that define an interior space 208 that is open to the interior space 104 of the body 188. In other embodiments, the base portion or end 190 may embody a generally elongated cylindrical or non-cylindrical shape. For purposes of discussion, the sides 204 and 206 may be identified as upper and lower sides, respectively. The sides 200 and 202 may be identified as left and right sides, respectively. The sides may also be understood as a first side 200, a second side 202, a third side 204, and a fourth side 206. These particular designations are provided to allow for designation of certain sides relative to other sides, but are not intended to be limiting unless the context indicates otherwise.

[0209] The base portion or end 190 can have an open proximal end to allow the needle hub 122 to extend proximally therefrom, proximal to the end face 126a in the ready-to-use position of FIG. 1. As shown, a first side 200 and a second side 202 of the base end 190 can each have an opening 210 to provide visibility or access to an interior space 208 of the base end 190 to facilitate or aid in assembling the catheter assembly 108 therein, as discussed further below.

[0210] An upper side 204 of the base portion or end 190 may include an upper lever 214, and a lower side 206 may include a lower lever (not shown). When a user simultaneously applies a compressive and distally directed force to the top lever 214 and a compressive and proximally directed force to the bottom lever, the user may move the left and right housing frames 193, 194 relative to one another, causing the detents on the first and second frames 193, 194 to separate such that the housings may then separate into separate housing components, i.e., the left and right frames 193, 194. In other words, by manipulating the upper and lower levers, the user may cause the housing 102 to separate into two or more housing components along the separation line 276. Separation of the housing 102 into housing components can then expose the catheter assembly 108 to be separated from the housing 102 after successful venipuncture so that the catheter hub 130 (FIG. 2) can be secured to the IV line and secured to the patient, such as by using tape or a securement dressing. In other embodiments, by repositioning the detents or engagement tabs between the left housing frame 193 and the right housing frame 194, a user can simultaneously apply a compressive and proximal force to the upper lever 214 and a compressive and distal force to the lower lever 216 to move the two housing portions relative to one another and separate the detents of the first frame 193 and second frame 194.

[0211] In some embodiments, rather than having two housing portions of the housing 102 separate to allow for separation of the catheter hub 130 from the housing 102 after successful venipuncture, one or more gates can be provided at the nose end 184 of the housing. For example, as the catheter hub 130 is advanced against the two gates, the detents or engagements that caused the two gates to lock together can separate, causing the two gates to swing outward to open an exit or passageway at the distal end of the housing, allowing for separation of the catheter hub from the housing. The two gates can be molded directly into the frame of the housing, each with a hinge to swing open. Alternatively, the gates can be molded into a carrier, and the carrier can be attached to the housing.

[0212] Referring now to FIG. 3, the needle hub 122 having the needle 112 with the needle tip 114 is shown together with an adapter 290 and a dispenser 292. The adapter 290 may also be referred to as an adapter. The combination of the needle, needle hub, adapter, and dispenser shown in FIG. 3 may also be referred to as a puncture and guide unit 300, or PG unit 300. The PG unit 300 may be used with any catheter assembly, such as any catheter in which the catheter tube and needle have a relatively long length of about 6.0 cm to 20 cm. Such relatively long catheters and needles are typically found in midline catheters. However, the PG unit 300 of the present invention is not so limited and may in some cases be used with shorter catheters and needles, typically found in peripheral access catheters. Typically, after successful venipuncture, the entire PG unit 300 is removed together as a single unit, and the catheter hub and catheter tube remain with the patient. If necessary, the components of the PG unit 300 can be removed piecemeal from the catheter hub, first from the dispenser 292, then from the adapter 290, then from the needle hub 122 with the needle 112, or any combination thereof. Preferably, the PG unit 300 is removed together as a unit, not in parts.

[0213] The PG unit 300 of FIG. 3 replaces the needle 112, needle hub 122 and vent plug 124 shown in FIG. 2 when used with a catheter assembly with or without the outer housing 102 (FIG. 1). As shown, the PG unit 300 does not utilize a vent plug, which is removed from the needle hub 122 prior to coupling the dispenser 292 to the needle hub 122 via the adapter 290. In other embodiments, the adapter 290 may be omitted and the dispenser 292 may be directly coupled to the needle hub. The PG unit 300 shown in FIG. 3 represents a removed state of the PG unit after successful venipuncture. For example, a user may first grasp the catheter assembly 108 of FIG. 2 with the PG unit 300 of FIG. 3 and guide the tip of the needle 112 through the skin at the appropriate insertion site to access the vein. Confirmation that access to the vessel is adequate may be confirmed via a temporary blood flush, i.e., the presence of blood in the needle hub 122 and / or the adapter 290. The user can then retract the needle tip proximal to the catheter tube opening to observe secondary blood flashback, i.e., blood between the outer diameter of the needle 112 and the inner diameter of the catheter tube 110. In some embodiments, the needle can have a penetration notch formed through the wall of the needle shaft, a longitudinal groove near the needle tip, or by forming a longitudinal indentation along the needle shaft. These alternative methods allow for flashback to be observed between the interior of the catheter tube and the exterior of the needle shaft, which can be detected relatively quickly compared to blood flashback at the needle hub.

[0214] After successful venous access is confirmed, the dispenser 292 is actuated by applying finger pressure to the guidewire 302 with the advancement or advancement platform 322 of the dispenser 292, sliding or advancing the guidewire 302 distally. The guidewire 302, such as the tip of the guidewire, may be initially disposed within the hollow needle 112, may be initially disposed only within the adapter 290, or may be initially disposed only within the catheter hub 122. In some examples, the guidewire 302 may have a length with at least two different guidewire portions. For example, the guidewire 302 may have a distal guidewire portion of a first diameter and a proximal guidewire portion of a second diameter that may be larger than the first diameter. The first diameter and the second diameter may be understood as outer diameters. A shoulder or gradual taper may be located between the first guidewire portion and the second guidewire portion.

[0215] Distal advancement of the guidewire 302 may continue until the guidewire 302 is fully extended within the patient's vessel. In one embodiment, the amount of extension of the guidewire into the vessel may be controlled by fixing the overall length of the extendable guidewire 302 at the advancement platform 322. For example, the guidewire 302 may have two ends, a first end at the distal end of the guidewire and a second end at the proximal end. The length of the guidewire may be selected to indicate a fully extended position of the guidewire when the second end of the guidewire moves to the advancement platform 322. At that point, the user may stop further advancement of the guidewire. Optionally, a physical stop or marker may be provided as the guidewire is advanced to indicate how far the first end of the guidewire has extended distally beyond the needle tip 114, as described below. Of course, when using a catheter assembly with the PG300 unit of the present invention, the user need not fully extend the guidewire.

[0216] In some examples, the relative lengths of the first and second guidewire portions can be selected to ensure proper ejection of the first guidewire portion from the needle tip to support the catheter during catheter insertion. In one example, as the guidewire is ejected and the first diameter of the guidewire exits the distal tip opening, a shoulder, gradual taper, or second diameter of the guidewire 302 can engage the needle at the crimp to stop the distal advancement of the guidewire. In this embodiment, the engagement between the transition point of the needle profile and the shoulder of the guidewire ensures a physical stop and prevents overextension of the guidewire into the vein. The ejection length of the guidewire is defined from the point where the guidewire engages the crimp to the distal end of the guidewire. The ejection length of the guidewire can be selected to adequately support the catheter tube during catheter insertion into the vein. In one example, the length of the guidewire from the distal end to where the guidewire exits the needle tip (referred to as the support length) is approximately 50% of the length of the catheter tube. In some embodiments, the support length is greater than 50% of the catheter length.

[0217] The catheter tube 110 (FIGS. 1 and 2) can be further inserted into the blood vessel and guided by the guidewire 302. As the catheter tube 110 and catheter hub 130 advance distally and the catheter tube is guided into the blood vessel by the guidewire, the catheter hub 130 separates or further separates from the needle hub 122. The catheter tube 110 and catheter hub 130 can be advanced over the guidewire 302 a sufficient amount to ensure successful placement in the blood vessel. The PG unit 300 can then be removed or separated from the catheter tube and catheter hub. After removal, the PG unit 300 resembles the PG unit of FIG. 3 separated from the catheter hub and catheter tube.

[0218] When the PG unit 300 of Figure 3 is used with or as part of an extended dwell catheter assembly, such as the assembly 100 of Figure 1, the method of using the assembly is similar to the process described immediately above, except that as the catheter hub 130 is advanced to move the catheter tube 110 over the guidewire 302 (Figure 3), the catheter hub or attachment to the catheter hub can open a gate at the distal end of the housing 102 (Figure 1) to allow separation of the catheter hub from the housing 102, or the user can actuate a lever, tab, or button to split the housing into two or more housing subcomponents to allow separation of the catheter hub from the housing 102. The PG unit 300 can be separated from the catheter hub at the same time as, before, or after the housing is separated from the catheter hub.

[0219] FIG. 3A is an enlarged view of a portion of the dispenser 292 and adapter 290 of FIG. 3. As shown, the dispenser 292 has a frame or body 306, a duct 308 engaged to the body 306, and a guidewire 302. The duct 308 may be a length of tube having two free ends and a lumen. The frame 306 has a generally transverse Y-shaped configuration having a first branch 312, a second branch 314, and a third branch 316. The three branches 312, 314, 316 connect to one another at a focal or connecting portion 318 of the frame or body 306, and each branch may have a respective free end 312a, 314a, 316a extending away from the focal or connecting portion 318. The free ends are spaced apart from one another, and the frame 306 with the three branches 312, 314, 316 may be integrally formed. In some examples, the third branch 316 can be omitted and the second end of the tube can be looped around and held to itself via one or more tube clips, as further described below. The embodiment in which the third branch 316 is omitted can be used with any of the adapters and any of the PG units described herein.

[0220] As shown, the first branch 312 has a free end 312a that generally points in a distal direction, the second branch 314 has a free end 314a that generally points in a proximal direction, and the third branch 316 has a free end 316a that generally points in a radial direction of a longitudinal axis defined by the first and second free ends 312a, 314a, with the free end of the third branch optionally pointing in a proximal direction in addition to pointing radially. In one embodiment, each branch of the frame 306 can be elongated and have a surface contour and / or an arcuate bend. For example, the first branch 312 can extend distally from the connecting portion 318 and have a portion of reduced thickness that defines a guide platform 322, also referred to as an advancement or advancement platform. The reduced section can be formed by providing a surface 322a that resembles a portion of an arc with a relatively larger width or thickness portion on either side of the reduced section.

[0221] The first branch 312 can have a connecting tip 326 at its distal end. The connecting tip 326 resembles a reducer and is reduced to function as a slip-on tip or nipple for connecting to the open proximal end 290a of the adapter 290. With further reference to FIG. 4A, which shows the dispenser 292, the adapter 290, and a portion of the catheter assembly 108 in cross section, the connecting tip 326 has a first tip 326a and a second tip 326b of a smaller diameter. The size and shape of the connecting tip 326, including the first and second tip portions 326a, 326b, are configured to mate with the female bore of the adapter 290. In one embodiment, the engagement between the two is a tapered interference fit similar to a luer fit, but not necessarily formed to the luer ISO standard. In yet another example, the connecting tips 326 of the adapter 290 and the dispenser 292 can be provided with a detent or detent-like engagement portion 330. As shown, the connection tip 326 and the receiving bore of the adapter can include a raised lip or shoulder and a corresponding recess to form a snap fit. As shown, the lip 330 can grip a flange or shoulder on the tip of the dispenser 292. In yet other examples, rather than the connection tip 326 having different tip portions, such as different tip diameters, the connection tip can embody a single taper to engage a corresponding taper on the adapter, similar to a luer taper, but having a non-standard ISO size. In yet other examples, the tip 360 of the adapter 290 engages with an opening of the needle hub 122 with a luer fit. The connection tip 326 of the dispenser 292 can also engage with a proximal opening of the adapter 290 with a luer fit. In some examples, the connection tip 326 of the dispenser is sized and shaped to engage directly with the needle hub without an adapter. That is, in some embodiments, the guidewire dispenser can have a connection tip that connects directly to the needle hub and the dispenser body can have two or three prongs. For dispenser embodiments 292 without adapter 290, connection tip 326 may be elongated to ensure alignment with the proximal opening of the needle to facilitate guiding a guidewire into the needle lumen.In other examples, the body of the dispenser 292 can be integrally formed with the adapter 290 .

[0222] The first branch 312 can have a guide passage 332 extending axially through the first branch and through the connecting tip 326. The guide passage 332 is provided for passing the guide wire 302 through the adapter 290 and into and out of the needle 112 during use to guide the catheter tube, as described above. For example, the guide wire 302 has two ends, referred to as a first or distal end and a second or proximal end. In a ready-to-use position, the first end can extend through the guide passage 332, out of the connecting tip 326, and into the interior of the adapter 290. In an embodiment, the first or distal end of the guide wire 302 does not enter the needle lumen in the ready-to-use position of the catheter assembly to provide flow path space for temporary blood flashback during needle penetration, as described further below.

[0223] 3A in addition to FIG. 12A, dispenser 292 has a sloped portion 328 that slopes in a distal to proximal direction toward second branch 314. Disposed at the proximal end of second branch 314 is a guide bracket 334. Guide bracket 334 has a body 338 that is generally cubic shaped, such as resembling a rectangular prism, and has a sloped or tapered distal end or side 336. In some embodiments, guide bracket 334 has a different cross-sectional shape, such as circular or polygonal, and the distal side may be more vertically aligned.

[0224] A guide passageway is provided axially through the body 338 of the guide bracket 334 to accommodate the guide wire 302. A portion of the guide wire 302 resides in a duct attached to the guide bracket 334. In height, the distal end or side 336 of the guide bracket 334 is higher than the entrance of the connecting tip 326 at the end of the first branch 312. This height difference allows the dispenser 292 to be grasped while sliding the guide wire 302 distally with the thumb, as described below, facilitating dispensing of the guide wire. However, the angle of the guide wire extending between the guide bracket 334 of the second branch and the guide tip 326 of the first branch can be varied while still providing an ergonomically shaped dispenser, such as the dispenser of FIG. 12B. For example, the distal end or side 336 can be at the same height as the entrance of the connecting tip 326.

[0225] The guide bracket 334 in the second branch 314 can include a socket 340 for receiving the first end 308a of the duct 308. In one embodiment, the guide bracket 334 can have a plurality of walls defining a circular socket 340 therein. In one embodiment, the duct 308 can embody a round tube section, and the first end 308a of the tube can engage the round socket 340 in the guide bracket 334 in a manner such as a friction fit, an interference fit, a snap fit, or the like. While the use of the duct 308 with the frame 306 of the dispenser 292 is preferred, it is not required as the guidewire 302 can simply extend from the second branch 314 and hang proximally therefrom if the duct 308 is not used. As incorporated, the duct 308 receives a portion of the guidewire 302 therein to prevent kinking or bending of the guidewire. Yet another embodiment may incorporate a duct having a shorter length than shown, and the second end of the duct may hang in the air and not be attached to the socket 342 at the third branch 316. The two sockets 340, 342 may be of any internal diameter shape capable of gripping or joining the ends of tubing.

[0226] In one embodiment, the second end 308b of the duct 308 and the guidewire 302 both hang from the second branch 314, with the second end 308b of the tube unsupported. In other words, the guidewire dispenser can be without a third branch, i.e., the third branch can be omitted. Alternatively, as shown, the duct 308 has a curved body such that the second end 308b of the duct 308 protrudes into a socket 342 in the support bracket 349 of the third branch 316 with a friction fit, interference fit, or snap fit. The socket 342 can be circular and formed by the walls of the support bracket. Thus, the duct 308 in the illustrated embodiment is supported at both the first end 308a and the second end 308b by the guide bracket 334 and the support bracket 349, respectively, with a middle portion 308c suspended between the ends. The support bracket 349 may be implemented without a guidewire passage through the third branch 316 if the length of the guidewire is short enough that it does not extend beyond the opening in the second end 308b of the duct. However, a guidewire passage through the support bracket 349 in the third branch 316 may be incorporated as needed to accommodate the length of the guidewire.

[0227] The support bracket 349 on the third branch 316 is generally cubic in shape, similar to a rectangular prism, with a sloped or tapered remote end or distal side 346. In some embodiments, the support bracket 349 has a different cross-sectional shape, such as circular or polygonal, and the distal side may be more vertically aligned.

[0228] The body 306 of the dispenser includes a curved or arcuate edge or surface 350 between the third branch 316 and the first branch 312. Similarly, the body 306 includes a curved or arcuate edge or surface 352 between the third branch 316 and the second branch 314. The curved edge 352 between the third branch 316 and the second branch 314 of the frame 306 and the curved duct 308 form a generally circular structure with a hollow space 356 or opening for receiving or housing and gripping the guidewire 302. For example, the curved edge 350 between the third branch 316 and the first branch 312 provides a gripping surface for the user. As shown, the duct 308 and the frame 306 form a closed loop. In particular, the curved edge surface 352 of the duct 308 and the frame 306 define a generally circular structure. Clearly, the curved edges 350, 352 of the frame 306 are preferred for the reasons discussed above, but may be modified to be less curved or to have straight sections, and may provide the general functionality described without defining a circular structure.

[0229] In use, a user can grip the dispenser in a one-handed procedure with their middle, ring and pinky fingers in the hollow interior 356 of the dispenser against the curved edge 352. The index finger can grip around the curved edge 350 between the third branch 316 and the first branch 312, facing the inner curved edge 352. The thumb can then be placed on the top side of the dispenser 292, over the ramp 328, and over the guidewire 302 and guide platform 322. To dispense or actuate the guidewire 302, the user uses the thumb to press the guidewire 302 against the surface 322a of the guide platform 322 with both a downward force against the surface 322a and a distal force that moves the guidewire 302 in a distal direction. This moves the first end of the guidewire out its distal end through the needle, aiding in guiding the catheter tube. By controlling or sizing the overall length of the guidewire so that when the second end of the guidewire is pushed into the connection tip 326 of the first branch 312, the total movement of the guidewire from the needle tip can be controlled. In other embodiments, the second end of the guidewire 302, or a portion of the guidewire, can be provided with a hook, an enlarged section such as a hook at the proximal guidewire section, a knot, or the like, that hooks into the frame 306 of the dispenser 292 or into the crimp of the needle after the guidewire 302 has dispensed a finite amount to prevent the guidewire from moving further distally from the connection tip. For example, as previously described, the guidewire can have at least two wire diameters with a shoulder or transition between the two diameters that can be configured to engage a transition point in the crimp or profile of the needle to prevent distal advancement of the guidewire.

[0230] In some instances, the needle may incorporate a crimp for engaging an opening on the needle guard when the needle is withdrawn after successful venipuncture. When a crimp is used, the crimp may define a lumen opening that is relatively smaller than the nominal inner diameter of the needle lumen, since the needle is actually crimped to form the crimp. The relatively small internal opening or lumen at the crimp may be used as a limiter, physical barrier, or restrictive means to restrict distal advancement of the guidewire. For example, the guidewire may include a bead or enlargement at a predetermined location along the guidewire between the ends, i.e., between a first end at the distal end and a second end at the proximal end.

[0231] As the bead or enlarged portion on the guidewire passes through the needle, after the distal end of the guidewire exits through the needle tip, the bead or enlarged portion is physically restricted from passing distally through the relatively small internal opening of the crimp, thereby preventing further advancement of the first end of the guidewire from the needle tip. The location of the bead or enlarged portion relative to the first end of the guidewire can be selected to control the length of the first end that travels away from the needle tip and thus into the patient's vasculature when the guidewire is in use. In one example, the first end travels outside the needle tip by a length of approximately 50% of the length of the catheter. The length of travel can be greater than 50% of the length of the catheter. However, the length can also be less than 50% of the length of the catheter, for example, 20%-50% of the length of the catheter.

[0232] In some embodiments, the guidewire comprises at least two different guidewire portions having two different outer diameter dimensions. For example, the distal guidewire portion has a first outer diameter and the proximal guidewire portion has a second outer diameter, the second outer diameter being larger than the first outer diameter. The first outer diameter can be small enough to pass through the lumen of the needle at the crimp, but not through a second outer diameter having a cross section larger than the penetration dimension of the lumen at the crimp. The length of the distal guidewire portion can be selected to represent the length of the guidewire passing through the patient's vasculature or vein when the guidewire stops at the crimp. The interface between the two guidewire portions can include a shoulder, which can abut the crimp to act as a stop. In other embodiments, a gradual transition can be provided between the two guidewire portions. The shoulder, gradual transition, or second outer diameter of the guidewire can be sized to abut the crimp of the needle upon ejection of the guidewire through the needle tip to act as a stop. Thus, the assembly can include a safety stop that stops further advancement of the guidewire into the vein.

[0233] In one embodiment, a guidewire having at least two guidewire portions with two different guidewire outer diameter sizes can be used without a guidewire dispenser housing. In this variation, an adapter, such as one of the adapters featured herein, can be connected to the needle hub. The user can hold the guidewire directly without the guidewire dispenser housing and advance the guidewire through the adapter and into the lumen of the needle. Advancement of the guidewire stops when a shoulder, a gradual transition, or the second outer diameter portion of the guidewire catches on the needle at the crimp. In an embodiment, the guidewire, the guidewire dispenser, or both the guidewire and the guidewire dispenser can incorporate a code or coding indicative of the gauge size of the guidewire. The code or coding can be a color, a numeric code, an alphabetic code, an alphabetic and numeric code, or a combination thereof.

[0234] The use and assembly of the various components will now be described with reference to Figures 4A and 4B, which are close-up views of the connection between the adapter 290 and the needle hub 122 of Figure 3A. As shown, the tip 360 of the adapter 290 projects into the interior space 362 of the needle hub 122, and the distal opening 366 at the distal end 367 of the tip 360 is located over the proximal end 112a of the blunt needle 112. In one embodiment, the bore or cannula channel 363 at the distal opening 366 of the tip 360 (Figure 4B) is sized to have a close fit with the needle proximal end 112a, although a loose fit with a small clearance therebetween can optionally be employed. The distal opening 366 of the tip 360 can be provided with a flared entrance or entrance. The flared entrance of the distal opening 366 allows the tip 360 to easily slide over the needle to receive the proximal end 112a within the bore of the tip 360, and helps compensate for potential slight misalignment.

[0235] The tip 360 may include a modified luer taper to engage the needle hub 122 with a tapered fit at the proximal opening of the needle hub. The tip 360 may be elongated such that the distal end of the tip 360 can reach and protrude over the needle proximal end 112a to receive the needle within a bore 363 of the tip 360.

[0236] FIG. 5 is a perspective view of an adapter 290 provided in accordance with an embodiment of the present invention, similar to the adapters discussed elsewhere herein. The adapter 290 in this embodiment has a body 368 including a base 370 and a tip 360 with a shoulder 372 located therebetween. The exterior of the base 370 is provided with a plurality of interconnected and angled slats or side walls 370a. At least one end of the slats 370a is provided with a flange or tab 374. The flange or tab 374 may be formed contiguous with the slat 370a from which it extends. The flange or tab 374 may have at least three unobstructed side edges. In other examples, the flange or tab 374 may be rounded, such as partially circular, or may have three or more edges. There may be one or more flanges or tabs 374 incorporated into the base 370. In a preferred embodiment, at least two spaced apart flanges or tabs 374 are incorporated into the base 370. When the two spaced flanges are assembled, the tip of the dispenser located between them deflects the two flanges into detent engagement. For example, the tip of the dispenser 292 can have a shoulder or lip 377 (FIG. 12B) and two or more flanges or tabs 374 can grip the shoulder or lip to help engage the dispenser to the adapter. Thus, broadly speaking, the dispenser can include a first structure 374 that engages a second structure 377 on the dispenser.

[0237] The tip 360 may be generally cone-shaped with one or more reduced tip sections. For example, the tip 360 may have a first tip 360a having a first size, a second tip 360b having a second size, a third tip 360c having a third size, and a fourth tip 360d having a fourth size. In other embodiments, the number of sections may be fewer or more than those shown, depending on the desired compatibility with the interior of the catheter hub 122 and the reach of the tip within the needle hub surrounding or adjacent the needle proximal end. In other embodiments, the tip 360 may have a continuous cone shape without a distinct reduced section such as section 360b. However, the tip 360 of the present adapter 290, as well as other adapters discussed herein, may have other bore shapes other than cone-shaped and still encompass aspects of the invention.

[0238] FIG 6A is a longitudinal cross-sectional side view of the adapter 290 of FIG 5. FIG 6B is an end view of the adapter 290 taken along line DD, and FIG 6C is an enlarged view of the center E of FIG 6B. Referring initially to FIG 6A, two flanges or tabs 374 are opposed along the longitudinal axis and each define an inner surface having a lip or surface engaging feature. The gap distance between the two tabs 374 can be relatively smaller than the inner diameter of the base 370. The relatively small dimension between the two flanges or tabs 374 can be selected to engage a lip or corresponding surface of the connecting tip of a guidewire dispenser, as shown in FIG 4A.

[0239] Internally, the adapter 290 can have a bore 376 with a proximal end open to fluid communication with the distal end of the adapter. In one embodiment, the bore 376 has different bore sections with different bore diameters. The bore 376 extends through the length of the adapter 290 including the base 370 and defines a base bore. The different bore diameter sections can be selected or sized to fit a selected connection tip of a guidewire dispenser. Referring again to FIG. 4A in addition to FIG. 6A, the bore 376 can have a first bore section 376a with a first diameter for coupling to a first tip 326a of the dispenser and a second bore section 376b with a second diameter for coupling to a second tip 326b of the dispenser. The various sections of the bore 376 can also be tapered to match a corresponding taper of the tip of the dispenser. Distal to the second bore section 376b is a third bore section 376c. The third bore portion 376c may have a cone shape that narrows to a guidewire passage 376d and then expands in diameter to a cannula channel 363 that has a larger cross-sectional space than the guidewire passage because the needle has a larger outer diameter than the guidewire diameter. The distal end of the adapter 290 is provided with a flared entrance at the distal opening 366. The tapered edge of the flared entrance is provided to facilitate placement of the cannula channel 363 over the blunt proximal end of the needle, as previously described. In one embodiment, the first bore portion 376a has an inner diameter larger than the inner diameter of the second bore portion 376b, which has an inner diameter larger than the third bore portion 376c, which has an inner diameter larger than the guidewire passage 376d, which has an inner diameter smaller than the cannula channel 363. Thus, the tip has a smaller inner diameter at guidewire passage 376d than the two adjacent bore portions, namely third bore portion 376c and cannula channel 363.

[0240] Figure 6B is a cross-sectional end view of adapter 290 taken along line DD in Figure 6A. From the outermost to the innermost components of adapter 290 in Figure 6B, it can be seen that base 370 has six slats or side walls 370a, shoulder 372, tip 360, a cross section of fourth tip portion 360d, i.e., a wall of the fourth tip portion, cannula channel 363, and guidewire passage 376d.

[0241] 6B, and further referring to FIG. 6C, the cannula channel 363 has a non-circular interior space defined by three generally straight sides 363a connected to each other by arcuate connectors 363b. When the proximal end 112a of the needle 112 is placed in the cannula channel 363, the proximal end 112a of the needle should resemble a ring-like structure shown in dashed lines in FIG. 6C and should contact or be in close contact with the three generally straight sides 363a of the cannula channel 363. The needle bore is centrally aligned with the illustrated guidewire passage 376d. The contact between the exterior of the needle 112 and the three generally straight sides 363a may create a slight interference fit to ensure a tight connection between the cannula channel 363 and the needle 112. Each arcuate connector 363b and the exterior of the needle define a bypass gap 380 in the cannula channel 363. As shown, the tip 360 of the adapter 290 and the needle of the cannula channel 363 define three bypass gaps 380. In other embodiments, there may be more than two straight sides and a corresponding number of arcuate connectors. For example, there may be four straight sides 363a connected by four arcuate connectors 363b. In still other examples, the contour of the cannula channel 363 may have a different shape than that shown. For example, the three straight lines that contact the needle may be slightly arcuate with a different curvature than the arc of the outer diameter of the needle.

[0242] 4B in addition to FIG. 6C, during initial needle puncture use, guidewire 302 (FIG. 3A) occupies guidewire passage 376d at distal end 360 of adapter 290, but the guidewire first end does not protrude into the needle lumen at the needle proximal end. Thus, when a primary blood flashback flows proximally out of the needle proximal end, blood first flows into cannula channel 363, but cannot flow proximally into bore 376 of base 370. This is because guidewire 302 (FIG. 3A) occupies guidewire passage 376d, and the clearance between guidewire 302 and the bore diameter in guidewire passage 376d may be too restrictive for blood to flow across it.

[0243] However, the bypass gaps 380 can be sized appropriately for blood flow, such as by providing sufficient flow paths or clearances at each bypass for a given fluid viscosity, so that blood entering the cannula channel 363 can flow out through the bypass gaps 380 and into the interior space 362 (FIG. 4B) of the needle hub 122. Thus, a practitioner can detect a primary blood flashback in the interior space 362 of the needle hub 122 after the blood flashback flows into the cannula channel 363 of the adapter 290 and then back out and out through the bypass gaps 380 into the interior space 362 of the needle hub 122, and can be visually detected through the walls of the needle hub, such as by perceiving a blood-red color within the interior space 362.

[0244] 7A is a side elevational view of the adapter 290 of FIG. 5, and FIG. 7B is a side cross-sectional view thereof taken along line DD of FIG. 7A, which is the same as the cross-sectional view of FIG. 6A.

[0245] Figure 8 is a side elevational view of the PG unit 300 of Figure 3, showing the needle hub 122 with the needle 112, the adapter 290, and the guidewire dispenser 292 with the guidewire 302. In the example shown, the proximal edge 139 of the needle hub 122 is spaced from a shoulder 372 on the adapter 290 by a gap 289. The shoulder 372 is located between the distal and proximal ends of the adapter (Figure 6A). The gap 289 exposes the distal end between the needle hub and the base to the atmosphere.

[0246] FIGURE 9 is a side cross-sectional view of an adapter 290 provided in accordance with a further embodiment of the present invention, which is similar to, but includes minor variations on, the adapter 290 of FIGURES 5 and 6A-6C. Like the adapter 290 previously described, the adapter has a body 368 including a base 370 and a tip 360. The base 370 may similarly have a number of slats or sidewalls 370a joined along respective edges. One or more flanges or tabs 374 may extend proximally of the base 370, each of which may optionally incorporate an engagement feature for engaging a guidewire dispenser 292, as previously described.

[0247] The tip 360 of the present adapter 290 can include different internal tips as well as different external tips as previously described. In this embodiment, the most distal end of the tip 360 has a bore with an internal bore 376m shaped like a cone shape. The internal bore 376m is distal to the first bore portion 376a and the second bore portion 376b and has a reduced tip defining a guidewire passage 376d. The guidewire passage 376d is sized and shaped to accommodate a guidewire passing therethrough, but is too small to accommodate the proximal end of a needle. Thus, compared to the adapter 290 of FIG. 6A, the adapter 290 of FIG. 9 does not incorporate a cannula channel 363 (FIG. 6A) distal to the guidewire passage 376d for receiving the proximal end of a needle. In use, similar to the configuration shown in FIG. 4B, and as further described below, the distal-most tip 376n of the adapter 290 can be spaced from the proximal end of the needle, such that any primary blood flashback flowing through the needle lumen can simply flow directly into the interior space 362 of the needle hub 122 (FIG. 4B).

[0248] In an alternative embodiment, the present adapter 290 can be lengthened and incorporate structure distal to the guidewire passage 376d to define a cannula channel, similar to the adapter 290 of FIG. 6A and the cannula channel 363 incorporated therein. When incorporated, the adapter 290 of FIG. 9 can receive the proximal end of the needle within the cannula channel when the adapter 290 is engaged to a needle hub, similar to that shown in FIG. 4B. Thus, blood flashback into the cannula channel of the modified adapter 290 of FIG. 9 having a cannula channel can conversely flow out of the bypass gap of the modified tip, as described with reference to FIG. 6C.

[0249] The base 370 of the present adapter 290 includes a valve chamber 384 having a valve 386 disposed therein. In one example, the base 370 includes internal shoulders 386a, 386b, 386c to form various internal chamber sizes or sections including a first bore portion or chamber 376a, a valve chamber 384, and a reduced chamber 376r located between the first bore portion 376a and the valve chamber 384. In one example, the first bore chamber 376a is configured to receive a connecting tip of a guidewire dispenser, similar to the embodiment of FIG. 4A, and the reduced chamber 376r is configured to receive a reduced tip of the connecting tip of the dispenser, as described further below. In some examples, the base 370 can have a continuous or generally cylindrical structure without distinct slats and edges formed between the slats.

[0250] The valve 386 can be disposed within the valve chamber 384 and held therein by distal and proximal shoulders 386c, 386b. In one embodiment, the valve 386 can have a valve disc 388 and a valve skirt 390 extending from the valve disc. The valve disc 388 can have a wall, a distal face 392 of the wall can press or contact the distal shoulder 386c and a proximal end 394 of the valve skirt 390 can press or contact the proximal shoulder 386b to dispose the valve therebetween. In some embodiments, the valve 386 can include a valve disc without a skirt depending therefrom and the valve chamber 384 can be modified to accommodate the modified valve.

[0251] In one embodiment, the valve 386 shown in FIG. 9 may be similar to the valve 386 shown in FIG. 10, which is shown in a front perspective view. Stated differently, the valve 386 of FIG. 10 may be implemented using the adapter 290 of FIG. 9. Referring to FIG. 10, the valve 386 of this embodiment may include a valve disc 388 and an integral skirt 390. In the illustrated example, the valve 388 and skirt 390 are integrally formed. The skirt 390 may be viewed as a generally cylindrical length having an open proximal end and a proximal-most end 394. In some embodiments, the skirt 390 may be omitted and only the valve 388 may be disposed within the adapter. The valve disc 388 is shown with a plurality of slits or valve disc slit portions 396 that define a plurality of valve flaps 398. For example, the valve may have three slits that define three flaps. However, the valve can be implemented with one slit defining two flap portions, or more than two slits and three flaps. The three slits can meet at a focal point or center point. The lengths of the slits are preferably, but not necessarily, equal, and the slits stop at the short of the outer diameter of the valve disc. In this embodiment, the axial wall thickness of the valve 388 is generally constant without changing the surface profile. However, distinct surface features can be incorporated, as shown in FIG. 11. In some examples, a pierceable septum is used in place of the valve.

[0252] In some examples, the valve skirt 390 can have a generally constant outside diameter (OD). The valve skirt 390 can have a generally constant thickness such that the inner diameter of the skirt is generally constant. In alternative embodiments, the thickness can vary such that the outer diameter of the skirt is constant while the inner diameter can vary.

[0253] FIG. 11 illustrates an alternative valve 386 that can be used with the adapter 290 of FIG. 9. As shown, and similar to the valve 386 of FIG. 10, the valve 386 of FIG. 11 includes a valve disc 388 and a valve skirt 390 extending therefrom. The valve disc 388 is shown with a plurality of slits or valve disc slits 396 that define a plurality of valve flaps 398. In this embodiment, the wall thickness of the valve disc 388 has distinct first and second portions 400 and 402 in an axial direction. The first portion 400 can have a first thickness and the second portion 402 can have a second thickness, the first thickness being greater than the second thickness, measured orthogonally to an inner plane passing through a diameter of the valve. The second portion 402 having the second thickness can have a substantially constant thickness, but can optionally include a thickness that varies along a cross section of the valve in the second portion 402.

[0254] In one embodiment, the second portion 402 may be formed by recessing the distal facing surface 392 of the valve disc 388, the proximal facing surface of the valve opposite the distal facing surface, or both the distal and proximal facing surfaces of the valve disc 388, while the first portion retains substantially the entire width or thickness of the valve between the proximal and distal sides. In one embodiment, the recess in the second portion may embody an undercut formed in the valve.

[0255] The surface appearance between the first and second portions 400, 402 can resemble a three-leaf clover. The three-leaf clover can be present on the distally facing surface, the proximally facing surface, or both surfaces of the valve disc. In other embodiments, the proximal and / or distally facing surface appearance can have various contours, such as a three-leaf clover can have various curves, lines, and edge contours. The surface features can facilitate the deflection and sealing of the valve at the slits. The valve 386 can alternatively embody different shapes. For example, the skirt length can be shorter than that shown. The number of slits can be more or less than three. The skirt can optionally incorporate vents across the outside of the skirt to allow for air venting, but not large enough to allow blood to flow across it.

[0256] FIG. 12A shows a PG unit 300 having a dispenser 292, an adapter 290, and a needle hub 122 having a needle 112 extending therefrom, with the needle only partially shown. The PG unit 300 of this embodiment is similar to the PG unit 300 of FIG. 3 with some exceptions. In this embodiment, the dispenser 292 can embody the dispenser of FIG. 9, which can have a valve 386 disposed therein. The valve can have a valve disk and a valve skirt. For example, the valve 386 of FIG. 12A can embody the valve 386 of FIG. 10 or FIG. 11. Additionally, the distal-most tip 376n of the dispenser is spaced from the proximal end 112a of the needle 112, but the tip 360 can include a cannula channel 363, and the proximal end 112a of the needle can be located within the cannula channel, similar to the embodiment of FIG. 4B.

[0257] The dispenser 292 of FIG. 12A is similar to the dispenser of FIGS. 3 and 3A and includes three branches 312, 314, 316. However, in this embodiment, the frame or body 306 has been modified so that the guidewire 302 extends generally horizontally through the guide platform 302 of the frame and generally coaxial with the needle. The frame 306 may include a guide passageway that slopes at the angled portion 328 toward the guide bracket 334 at the second branch 334. This arrangement results in a low insertion angle of the guidewire 302 as it extends toward the connecting tip 326 of the dispenser and is inserted into the adapter 290.

[0258] 12B is an enlarged view of the PG unit 300 with the needle hub 122 removed for clarity. As shown, the connecting tip 326 of the dispenser 292 projects into a receiving space or bore 326 in the base 370 of the adapter 290, with one or more tabs 374 engaging a corresponding detent surface on the dispenser 292, such as a shoulder, lip, flange, etc., to maintain a firm engagement between the adapter and the dispenser. Optionally, an interference fit can be provided without the use of a flange or tab.

[0259] As shown, the distal tip portion 326b of the dispenser 292 is positioned in the interior space defined by the skirt 390 of the valve 386, but does not push through the valve disc so as to deflect the valve flap. In one embodiment, the distal tip 326 of the dispenser 292 is spaced from the proximally facing surface of the valve disc 388. The guidewire 302 extends through a slit in the valve disc such that a first end 406 of the guidewire 302 is positioned within the bore 376 of the adapter and is recessed from the distal-most tip 376n of the adapter. The position of the first end 406 as shown can be implemented in a ready-to-use position of the catheter assembly, as further described below with reference to FIG. 13.

[0260] FIG. 13 is an enlarged view of a catheter or needle assembly having an adapter 290 and a dispenser 292 according to an embodiment of the present invention, shown without the catheter hub 130 (FIG. 2) for clarity. Optionally, an outer housing 102 (FIG. 1) may be used, but is not shown for clarity. As shown, the tip 386 of the adapter 290 is disposed in the interior space 362 of the needle hub 122, and the connecting tip 326 of the dispenser 292 is disposed within the bore 376 at the base of the adapter 290. The distal-most tip 376n of the adapter 290 is spaced from the needle proximal end 112a such that a gap 410 is provided therebetween. The first end 406 of the guidewire 302 is located within the bore of the adapter 290 and is recessed from the distal end 376n of the adapter. The adapter 290 has a valve 386 disposed therein, as shown and described with reference to FIGS. 12A and 12B.

[0261] After initial vascular access, blood flows proximally through the lumen of the needle 112 and out of the proximal opening of the needle. Because of the gap 410 between the needle and the tip 360 of the adapter 290, some of the blood may escape into the interior space 362 of the needle hub 122 and may be visually detected as a temporary blood flashback through the wall of the needle hub. Some of the blood may also flow through the distal opening 366 of the tip of the adapter 290 having the guidewire passage 376d (FIG. 9). Blood flow 414 through the bore 376 of the adapter 290 may be restricted or stopped by a valve 386 disposed in a valve chamber inside the adapter 290. In this way, the practitioner may take the appropriate time to place the guidewire into the vein and then slide the catheter tube over the guidewire to place the catheter tube deep into the vein without feeling rushed by blood escaping through the adapter opening and / or the dispenser opening if a seal 386 is not incorporated inside the adapter. After successful venipuncture, the PG unit 300, including the needle hub 122, adapter 290, and dispenser 292, is removed from the catheter hub and catheter tube. These components can be removed as a single integrated unit or can be removed individually.

[0262] Referring now to FIG. 14, there is shown a guide unit 301 including an adapter 290 and a guidewire dispenser 292. The guide unit 301 does not include a needle and a needle hub. In this embodiment, the guidewire dispenser 292 is similar to the guidewire dispensers described elsewhere, but with some modifications. The dispenser 292 includes a guidewire 302 and a duct 308 and is shown connected to an adapter 290, which can be one of the adapters described elsewhere herein. The adapter 290 is provided with a protective cap 420 at its tip. The assembly shown in FIG. 14 can be provided in a shipping package, such as a blister pack or a thermoplastic pouch, and can be sold commercially as a unit, as shown. Alternatively, the dispenser can be one of the dispensers discussed elsewhere herein.

[0263] The protective cap 420 may be formed as a thermoplastic protective sleeve having a first end 420a and a second end 420b. The first end 420a may have a bore sized and shaped to snap-fit ​​onto the tip of the adapter 290. An optional detent engagement and / or friction fit between the two may be implemented. The second end 420b may be a closed end or may have an opening. The protective cap 420 may be removed from the adapter 290 and discarded prior to using the adapter and dispenser unit.

[0264] The dispenser 292 of FIG. 14 is similar to the dispenser of FIGS. 3, 3A, 12A, 12B and includes three branches 312, 314, 316. However, in this embodiment, the frame or body 306 is modified such that the third branch 316 has a C-channel 424 rather than a socket 342 (FIG. 3A). Additionally, the third branch 316 can face away from the second branch 314. The C-channel 424, which can be referred to as a retaining clip, can be a through clip in the third branch 316 with a slot 426. That is, the duct 308 does not terminate at the third branch 316, but is routed through the clip such that the second end 308b is away from or away from the C-channel. The duct 308 can be snap-fitted into the clip 424 by placing the duct over the slot 426 and pushing the duct through the slot to fit within the C-channel. Although less optimal, the second end 308b of the duct 308 can be threaded through the C-channel 424 by inserting it through the end opening 428 and then forcing the second end 308b through.

[0265] An intermediate retaining clip 430 is provided to hold the portions of the intermediate section 308c of the duct together. In the example shown, the intermediate retaining clip 430 has an integral or unitarily formed body with two slots 426, 426 for receiving the two different sections of the duct 308. The intermediate retaining clip 430 can be considered as two C-channels formed side by side with a common center side. Both C-channels are pass-through in that the tube does not terminate in either C-channel.

[0266] A second intermediate clip 430 (not shown) may be used to support an additional portion of the tube or duct 308. For example, the second intermediate clip 430 may be positioned adjacent to the first intermediate clip 430, either in contact with the first intermediate clip 430 or spaced apart from the first intermediate clip 430, and may support the duct near the second end 308b such that the second end 308b passes through the second intermediate clip 430.

[0267] Alternatively or additionally, an end clip 434, which may be broadly referred to as a retaining clip, may be provided to support the duct or tube 308, and in particular the second end 308b of the duct. The end clip 434 may be considered a side-by-side C-channel and modified C-channel with a common center side. The end clip 434 has a C-channel with a through slot 426 and a closed slot 426b in which an end wall 436 is provided. The end wall 436 prevents the second end 308b from passing through the modified C-channel 426a.

[0268] By using one or more intermediate clips 430, and optionally an end clip 434 in combination with the through C-channel 424 of the third branch 316, the tube 308 can be wrapped to have an overlapping section or sections 440. That is, the tube 308 can be wrapped to have one or more loops. This allows the duct 308 and frame 306 to form a smaller closed loop than a similar size dispenser and duct without a C-channel. This allows for a reduced packaging size and storage space for the illustrated assembly. If the end clip 434 is instead an intermediate clip 430 with two through slots 426, the second end 308b of the tube can be capped to cover the open second end.

[0269] The guidewire 302 can have a distal end located at the tip of the first branch 312 and can optionally protrude into the adapter in the assembled state shown. The guidewire can extend into the duct or tube 308 and be coiled with the tube. The second end of the guidewire 302 can extend to the duct second end 308b, or can terminate shorter than the second end 308b, depending on the overall guidewire length desired for a particular catheter assembly.

[0270] Similar to the guidewires previously described, guidewire 302 usable with guidewire dispenser 292 can include at least two different guidewire sections having two different guidewire diameters. The smaller diameter distal guidewire section can pass through the tip of a needle into the vein to guide the catheter tube, while a proximal section of a second larger diameter can be stopped at a shoulder, gradual taper, and / or crimp on the needle to limit further distal movement of the guidewire.

[0271] 15, there is shown a partial perspective view of a puncture and guide unit 300 or PG unit according to a further aspect of the present invention. Similar to other PG units discussed elsewhere herein, the PG unit 300 of this embodiment includes a needle hub 122 with a needle (not shown), an adapter 290, and a guidewire dispenser 292 with a guidewire 302. The components of the PG unit 300 of this embodiment can be similar to the components described elsewhere, with some differences, as will be further described below. Furthermore, the needle hub 122 with needle can be omitted, and the present PG unit can be converted into a guide unit similar to that of FIG. 14, which can include a protective cap located on the tip of the adapter 290, and then packaged and shipped as a combined guide unit.

[0272] In this embodiment, multiple gas channels 450 are incorporated into the adapter 290. As shown, the multiple gas channels 450 are located at the tip portion of the adapter distal to the base 370. Each of the multiple gas channels 450 may be axially positioned relative to the longitudinal axis of the adapter 290. The multiple gas channels 450 may be spaced apart from one another. In a preferred embodiment, the multiple gas channels 450 are equally spaced around the circumference of the tip of the adapter. Most preferably, the gas channels 450 are exposed to the atmosphere at the gap 289 between the proximal edge 139 of the needle hub 122 and the shoulder 372 on the adapter 290.

[0273] FIG. 16 is a rear perspective view of the adapter 290 of FIG. 15 separated from the other components. Similar to the other adapters discussed elsewhere, the adapter 290 includes a base 370, a tip 360, and a shoulder 372 located therebetween. In this embodiment, the tip 360 has a first tip 360a, a second tip 360b, and a third tip 360c. The second tip 360b can be a reducer or transition section to transition the outer diameter dimension of the first tip 360a to the outer diameter dimension of the third tip 360c. The second tip 360b has a first end 454 that connects or couples to the first tip 360a and a second end 456 that connects or couples to the third tip 360c, with the first end 454 of the transition section having a larger outer diameter than the second end 456.

[0274] In one embodiment, the first tip portion 360a is generally cylindrical. In some embodiments, the first tip portion has a taper or draft angle in a proximal to distal direction. The third portion 360c can be generally cylindrical as well. In some examples, the third tip portion has a taper or draft angle in a proximal to distal direction.

[0275] A plurality of elongated ribs 460 are provided on the first and second tip portions 360b, 360c. Each rib 460 has a length extending axially of the adapter, a width measured perpendicular to the length, and a height measured from the outer surface 462 of the tip to the top surface 464 of the rib. In one example, the collective top surface 464 of the plurality of ribs 460 defines an effective diameter. In some embodiments, the height of each rib may vary from the distal end of the tip to the second end 456 of the transition section. Thus, the effective diameter of the tip at the third tip 360c may vary due to the varying height of the ribs. When incorporated, the effective diameter of the tip at the third tip 360c may be tapered or untapered to allow the tip 360 to fit within the bore of the needle hub and match the tapered contour of the bore of the needle hub. The effective diameter of the tip at the second tip 360b may be selected to fit within the bore of the needle hub and match the tapered contour of the bore.

[0276] Preferably, the effective diameter defined by the plurality of ribs and the exterior of first tip 360a form a continuous outer diameter profile capable of mating with the inner diameter of a needle hub upon insertion of the tip into the proximal opening of the needle hub. The effective diameter at the distal end of tip 360 is preferably smaller than other portions of the effective diameter to allow the tip to shrink to facilitate insertion of the tip into the needle hub.

[0277] A groove 470 is defined between two adjacent elongated ribs 460. Each groove 470 has a width and a length. Each groove also has a depth measured relative to the top surface 464 of the adjacent rib 460, relative to the effective diameter of the tip. Thus, the tip 360 of this embodiment includes a plurality of ribs 460 and a plurality of grooves 470. In one embodiment, the tip of the present adapter 290 is provided with four elongated ribs 460 defining four grooves 470. In some embodiments, there may be fewer than four ribs or more than four ribs, such as three ribs, five ribs, or six ribs, each defining three, five, or six grooves.

[0278] With reference to FIG. 17 and further with reference to FIG. 16, the ribs 460 are preferably spaced about the circumference of the tip 360 to define four generally equally sized grooves 470. However, the present adapter tips may be inserted into the proximal opening of the needle hub and coupled to the needle hub even if they incorporate different sized, unequally spaced ribs and grooves. Also shown in both FIG. 16 and FIG. 17 are a number of gas channels 450. As will be further described below, the gas channels are sized and shaped to allow gases, such as air, to travel therethrough and escape the interior space of the needle hub, but are not sized to allow viscous fluids, such as blood, to flow freely therethrough.

[0279] FIG. 17 is a front perspective view of the adapter 290 of FIG. 16 , showing the plurality of ribs 460, grooves 470, and distal opening 366 of the distal end 367. FIG. 17 also clearly shows the plurality of gas channels 450. In the illustrated example, each gas channel 450 is axially aligned with respect to the longitudinal axis of the adapter 290. Each gas channel can have a first channel end 478 located approximately at the shoulder 372 and a second channel end 480 located distal to the first end 454 of the second tip 360b. In one embodiment, the second channel end 480 can begin or end anywhere in the third tip portion 360c, depending on the viewing point.

[0280] The second channel end 480 of each gas channel 450 is preferably located somewhere between the first end 454 and the second end 456 of the second tip portion 360b. The first and second channel ends 478, 480 are understood to form the two ends of each gas channel 450. More preferably, the different second channel ends 480 of the multiple gas channels 450 are disposed along different portions of the tip 360, for example, some disposed at the second tip portion 360b and others disposed at the third tip portion 360c.

[0281] As discussed above, the first channel end 478 of each gas channel 374 can originate or terminate at the shoulder 372 between the tip 360 and the base 370. In some embodiments, the first channel ends 478 of some or all of the gas channels 374 can be located distal to the shoulder 372, i.e., somewhere along the first tip 360a in the gap 289 when the adapter 290 is coupled to the needle hub 122 and the guidewire dispenser 292 (FIGS. 8 and 15).

[0282] The gas channels 450 allow air to enter at the second channel end 480 and escape by flowing proximally within the respective gas channels 450. Without the gas channels, the first tip portion 360a may form a continuous tapered fit with the interior of the needle hub. Thus, air trapped within the needle hub upon blood flashback may not have sufficient vent openings within the system. The gas channels 450 incorporated in the present adapter provide a passage for air through an otherwise continuous seal between the interior of the needle hub and the exterior of the tip 360, e.g., the exterior of the first tip 360a.

[0283] When the present adapter 290 with gas channels is used as part of a PG unit with a catheter assembly, the initial puncture of the vein allows blood to enter the needle lumen and into the interior space of the needle hub, known as the primary blood flashback. By incorporating multiple gas channels 450, air can be evacuated from the interior space of the needle hub as blood travels to the flashback chamber of the needle hub, thereby facilitating blood flashback flow and minimizing vapor lock when little or no air is evacuated. In one embodiment, four or more gas channels 450 can be incorporated into the tip 360. Preferably, six evenly spaced gas channels 450 are incorporated with the tip 360. More preferably, eight gas channels 450 are incorporated into the tip 360. However, more than eight gas channels 450 can be incorporated to increase the channels available for gas venting.

[0284] 18, an end view of the adapter 290 of FIG. 17 is shown revealing the distal end 367 of the tip 360 and the distal opening 366. The end view of FIG. 18 clearly shows four elongated ribs 460, four grooves 470, and eight gas channels 450 at the tip 360 of the adapter 290. As previously mentioned, the number of ribs, grooves, and gas channels can be variables that can be selected to ensure sufficient blood flashback and air flow or venting during vascular access, and the number of each can vary.

[0285] 18, each gas channel 450 has two side walls and a bottom wall, forming a generally U-shaped surface feature at the tip 360 of the adapter 290. The length and width of each U-shaped surface should be selected to allow for the flow of gas or air, but not the free flow of blood. The cross-sectional shape of the gas channels can also vary, such as generally circular, generally C-shaped, etc.

[0286] The walls of the cannula channel 363 of the adapter 290 are shown in FIG. 18 through the distal opening 366 of the tip 360. The cannula channel 363 of the present adapter 290 is similar to the cannula channel 363 of the adapter 290 of FIG. 6A. The cannula channel 363 is also shown in an enlarged view in FIG. 19. As shown, the cannula channel 363 has a non-circular interior space defined by five generally straight sides 363a connected to one another by arcuate connectors 363b. Thus, this embodiment has five generally straight sides 363a connected to one another by five arcuate connectors 363b to define a non-circular cannula channel or passageway 363.

[0287] When the proximal end of the needle is placed into the cannula channel 363 of this embodiment, it should contact, fit, or have some play with the five generally straight sides 363a of the cannula channel 363, similar to the ring-like structure shown in dashed lines in FIG. 19. The needle bore is centrally aligned with the illustrated guidewire passage 376d. The contact between the outside of the needle and the five generally straight sides 363a can create a slight interference fit for a solid connection between the cannula channel 363 and the needle. However, an interference fit is not required, and some play can be practiced to limit physical contact between the needle and the relatively soft material of the adapter. Additionally, play can facilitate assembly without perfect concentricity. Each arcuate connection 363b and the exterior of the needle define a bypass gap 380 in the cannula channel 363.

[0288] As shown, the dashed lines representing the tip 360 of the adapter 290 and the needle of the cannula channel 363 define five bypass gaps 380. In other embodiments, there may be more than five straight sides and a corresponding number of arcuate connections, or fewer than five connections, such as four. In still other examples, the contour of the cannula channel 363 may have a different shape than that shown. For example, the five straight lines that contact the needle may be slightly arcuate, with a different curvature than the arc of the outer diameter of the needle. In still other embodiments, the present cannula channel 363 may be similar to the cannula channel of FIG. 6C.

[0289] As previously described with reference to Figure 6C, the bypass gaps 380 can be sized for blood flow, such as by providing sufficient flow paths or clearances at each bypass for a given fluid viscosity, so that blood entering the cannula channel 363 can flow out through the bypass gaps 380 and into the interior space of the needle hub (362 in Figure 4B). Thus, a practitioner can detect a primary blood flashback in the interior space of the needle hub after the blood flashback flows into the cannula channel 363 of the adapter 290 and then back out and out through the bypass gaps 380 into the interior space of the needle hub, e.g., visually through the walls of the needle hub by perceiving a blood-red color within the interior space.

[0290] As can be seen from the immediately preceding paragraph, the bore of the present adapter 290 can have multiple bore sections, guidewire passages, and cannula channels, similar to the adapter of FIG. 6A. In some embodiments, the bore of the present adapter can incorporate a valve chamber for housing one of the valves described elsewhere herein, such as the valves of FIGS. 10 and 11, similar to the bore of the adapter of FIG. 9. In yet another embodiment, the tip of the present adapter is spaced from the proximal end of the cannula, similar to that shown in FIGS. 12A and 12B.

[0291] Figure 20 is a front perspective view of an adapter 290 similar to the adapter 290 of Figures 16-19, but with some modifications. In this adapter 290, the gas channels 450 are more closely spaced as compared to the gas channels of Figures 16-19. In one embodiment, additional gas channels 450 are incorporated into the more closely spaced gas channels 450.

[0292] With further reference to FIG. 21, which shows a front end view of the adapter of FIG. 20, twelve gas channels 450 are incorporated to increase the number of venting channels. However, as previously discussed, more or less than twelve gas channels can be incorporated. For example, at least three gas channels 450, at least four gas channels, at least eight gas channels, and twelve gas channels can be incorporated in the venting tip. By way of example, four to twelve gas channels 450 can be incorporated. In the illustrated example, the twelve gas channels 450 are generally equally spaced about the first tip portion 360a. However, the gas channels 450 can be unevenly spaced to direct more exhaust to certain areas of the tip than others.

[0293] In one embodiment, four of the gas channels 450 are axially aligned with four elongated ribs 460 on the first and second tip portions 360b, 360c. The four aligned gas channels 450 with the four elongated ribs 460 allow air to be evacuated at a location where the four ribs 460 are closely spaced from the interior of the needle hub when the adapter 290 is connected to the needle hub. However, alignment is not required and air can be evacuated by incorporating any suitable number of gas channels 450, e.g., 6-14, 8-12, etc.

[0294] Methods of making and using the catheter assembly, as well as components for use with the catheter assembly, are within the scope of the present invention.

[0295] The present disclosure is also described by the following embodiments.

[0296] Embodiment 1: A catheter assembly comprising: a catheter tube attached to a catheter hub and a needle attached to a needle hub; a needle positioned within the lumen of the catheter tube, the needle tip protruding from a distal opening of the catheter tube; The catheter assembly also includes an adapter having a body including a base, a tip, and a bore extending therethrough; the base has a base bore portion and the tip has a cone-shaped tip bore portion, the tip being located at the proximal opening of the needle hub; The catheter assembly also includes A guidewire dispenser having a frame with a plurality of branches, a connecting tip of a first branch of the plurality of branches is located inside a base bore portion of the adapter; A catheter assembly, wherein a guidewire extends through a second branch of the multiple branches, through the connecting tip, and into the bore of the adapter.

[0297] Embodiment 2: A method for manufacturing a semiconductor device comprising: a first frame attached to a second frame, the method further comprising: The housing has a distal opening and a proximal opening, and the catheter hub is at least partially disposed within the interior space of the housing. 2. A catheter assembly as described in embodiment 1.

[0298] Embodiment 3: The method further includes a duct having a first end attached to the socket of the second branch; A guidewire extends at least partially into the duct; 2. A catheter assembly as described in embodiment 1.

[0299] Embodiment 4: A duct has a second end attached to a socket of a third branch of the plurality of branches. 4. A catheter assembly as described in embodiment 3.

[0300] Embodiment 5: the duct and the frame define a closed loop; 5. A catheter assembly as described in embodiment 4.

[0301] Embodiment 6: The method further includes the step of: 2. A catheter assembly as described in embodiment 1.

[0302] Embodiment 7: A valve includes a valve disc and a skirt extending therefrom. 7. A catheter assembly as described in embodiment 6.

[0303] Embodiment 8: Further comprising a needle guard disposed within the catheter hub. 2. A catheter assembly as described in embodiment 1.

[0304] Embodiment 9: The needle has a crimp, The guidewire abuts the needle at a crimp to limit distal movement of the guidewire. 2. A catheter assembly as described in embodiment 1.

[0305] Embodiment 10: The guidewire has at least two guidewire sections having at least two different diameters. 2. A catheter assembly as described in embodiment 1.

[0306] Embodiment 11: A guidewire having a distal guidewire portion of a first diameter and a proximal guidewire portion of a second diameter; The second diameter is greater than the first diameter. 11. A catheter assembly as described in embodiment 10.

[0307] Embodiment 12: The guidewire includes a shoulder or gradual taper located at a point between the distal and proximal guidewire portions. 12. A catheter assembly as described in embodiment 11.

[0308] Embodiment 13: At least one of the shoulder, the gradual taper, and the second diameter is engageable with the needle at the crimp of the needle. 13. A catheter assembly as described in embodiment 12.

[0309] Embodiment 14: The location of the shoulder or gradual taper defines the length of the distal guidewire portion that extends from the needle tip when the guidewire engages the needle at the crimp. 14. A catheter assembly as described in embodiment 13.

[0310] Embodiment 15: The distal guidewire portion passes through the needle at the crimp and extends out through an opening at the needle tip. 13. A catheter assembly as described in embodiment 12.

[0311] Embodiment 16: The guidewire has a marker or indicator that shows how far the distal guidewire portion has extended distally beyond the needle tip. 13. A catheter assembly as described in embodiment 12.

[0312] Embodiment 17: A marker or indicator indicates at least one of when the first end of the distal guidewire portion reaches the needle tip, passes the needle tip, and is fully advanced from the distal tip. 17. A catheter assembly as described in embodiment 16.

[0313] Embodiment 18: The guidewire has a plurality of markers or guidewires for indicating when the first end of the distal guidewire portion reaches the needle tip, passes the needle tip, and is fully advanced from the distal tip. 17. A catheter assembly as described in embodiment 16.

[0314] Embodiment 19: The guidewire has a code, the guidewire dispenser has a code, or both the guidewire and the guidewire dispenser have a code to indicate gauge size. 2. A catheter assembly as described in embodiment 1.

[0315] Embodiment 20: The code comprises a color, an alphabetic code, a numeric code, an alphanumeric code, or a combination thereof. 20. A catheter assembly as described in embodiment 19.

[0316] Embodiment 21: The tip of the adapter includes a cannula channel having an inner diameter and a guidewire passageway having an inner diameter, the diameter of the cannula channel being larger than the diameter of the guidewire passageway. 2. A catheter assembly as described in embodiment 1.

[0317] Embodiment 22: The cannula channel is located distal to the guidewire passage. 22. A catheter assembly as described in embodiment 21.

[0318] Embodiment 23: The adapter base has a body having an exterior with a plurality of slats. 2. A catheter assembly as described in embodiment 1.

[0319] Embodiment 24: Further comprising two or more flanges extending from two or more of the slats. 24. A catheter assembly as described in embodiment 23.

[0320] Embodiment 25: Further comprising one of a male detent and a female detent formed with each of the two or more flanges. 25. A catheter assembly as described in embodiment 24.

[0321] Embodiment 26: A body at the tip of the adapter has a cannula channel having an inner surface defining an opening of a non-circular cross section. 2. A catheter assembly as described in embodiment 1.

[0322] Embodiment 27: The proximal end of the needle contacts the inner surface at the cannula channel. 27. A catheter assembly as described in embodiment 26.

[0323] Embodiment 28: The opening of the non-circular cross section has a plurality of straight side surfaces and a plurality of arc-shaped connectors. 28. A catheter assembly as described in embodiment 27.

[0324] Embodiment 29: A bypass gap is formed between the plurality of arcuate connectors and the needle. 29. A catheter assembly as described in embodiment 28.

[0325] Embodiment 30: The body of the tip of the adapter has a plurality of bore portions with different inner diameters. 27. A catheter assembly as described in embodiment 26.

[0326] Embodiment 31: The plurality of branches includes at least three branches, including a first branch, a second branch, and a third branch. 2. A catheter assembly as described in embodiment 1.

[0327] Embodiment 32: A method for treating a vascular endovascular disease, further comprising the steps of: a guidewire disposed at least partially within the lumen of the tube; 32. A catheter assembly as described in embodiment 31.

[0328] Embodiment 33: A first end of the tube is placed in a socket of the second branch, and a second end of the tube is placed in a socket of the third branch or is remote from the third branch. 33. A catheter assembly as described in embodiment 32.

[0329] Embodiment 34: Further comprising intermediate retaining clips that grip different portions of the tube. 34. A catheter assembly as described in embodiment 33.

[0330] Embodiment 35: The valve is disposed in the catheter hub. 2. A catheter assembly as described in embodiment 1.

[0331] Embodiment 36: A catheter assembly comprising: a catheter tube attached to a catheter hub; and a needle having a needle tip attached to the needle hub; the needle extends through the catheter tube with the needle tip positioned distal to the distal opening of the catheter tube; The catheter assembly also includes an adapter having a body with an outer surface and an inner surface defining a bore; The body further has a base having a plurality of slats interconnected along respective edges, and a tip having a cone having a guidewire passage and a cannula channel distal to the guidewire passage, the tip being disposed in the proximal opening of the needle hub; The catheter assembly also includes a guidewire dispenser having a guidewire with a tip disposed within the bore of the adapter and a first end disposed within the guidewire passage; The proximal end of the needle is disposed within the cannula channel of the adapter. Catheter assembly.

[0332] Embodiment 37: A catheter assembly comprising: a catheter tube attached to a catheter hub; and a needle having a needle tip attached to the needle hub; the needle extends through the catheter tube with the needle tip positioned distal to the distal opening of the catheter tube; The catheter assembly also includes an adapter having a body with an outer surface and an inner surface defining a bore; The body further includes a base having a valve including a base bore having a valve chamber and at least one slit and two flaps disposed within the valve chamber, and a tip having a cone having a guidewire passage, the tip being disposed at the proximal opening of the needle hub; The catheter assembly also includes a guidewire dispenser having a tip disposed within the bore of the adapter and a guidewire having a first end disposed within the bore of the adapter; Catheter assembly.

[0333] Embodiment 38: A method of assembling a catheter assembly, comprising: The method is: providing a catheter hub comprising a catheter tube extending from a distal end of the catheter hub; The catheter hub has a body with an internal cavity, and the catheter tube includes a lumen and a distal opening; The method also providing a needle hub having a shaft with a lumen and a needle having a distal tip; The needle hub includes a body having an internal cavity and a shaft that projects through the lumen of the catheter tube, with a distal tip that projects distally of the distal opening of the catheter tube; The method also providing an adapter having a body with an outer surface and an inner surface defining a bore; The body further has a base having a base bore and a tip having a cone having a guidewire passage, the tip of the adapter being positioned within the interior cavity of the proximal opening of the needle hub; The method also Providing a guidewire dispenser; The guidewire dispenser has a tip disposed within the proximal bore of the adapter and a guidewire having a first end disposed within the proximal bore of the adapter. method.

[0334] Embodiment 39: A method of using a catheter assembly with a guidewire, comprising: The method is: puncturing a vein with a needle tip having a needle crimp; advancing a guidewire through an adapter connected to a needle hub having a needle attached thereto; further advancing the guidewire so that a distal guidewire portion extends from the needle tip and the guidewire engages the needle at the needle crimp; The method includes:

[0335] Embodiment 40: Advancing a guidewire without a guidewire dispenser. 40. The method of embodiment 39.

[0336] Embodiment 41: A guidewire is at least partially disposed within a guidewire dispenser; a guidewire dispenser having a tip connected to a base of the adapter; 41. The method of embodiment 40.

[0337] Embodiment 42: An adapter for use in guiding a guidewire through a needle lumen, comprising: a body including a base, a tip, and a bore extending through the body; The base portion has a base bore portion, and the tip portion has a tip bore portion having a cone shape, The adapter also at least one of a cannula channel having a plurality of generally straight sides at a distal end, two adjacent plurality of straight sides being connected to one another by an arcuate connecting portion, the cannula channel having a size to receive the needle shaft, and a valve including a wall having at least one slit disposed within a base bore at a base; the base includes a proximal opening sized and shaped to receive a male tip of a guidewire dispenser and a plurality of first engagement structures for engaging a corresponding plurality of second engagement structures of the male tip of the guidewire dispenser; adapter.

[0338] Embodiment 43: The base has a non-circular cross-section with multiple slats or side walls. An adapter as described in embodiment 42.

[0339] Embodiment 44: Each of the plurality of first engagement structures extends from one of the plurality of slats or sidewalls. An adapter as described in embodiment 43.

[0340] Embodiment 45: A catheter comprising a cannula channel having a first inner cross-sectional dimension and a guidewire passageway proximal to the cannula channel and having a second inner cross-sectional dimension; The first inner cross-sectional dimension is greater than the second inner cross-sectional dimension; An adapter as described in embodiment 42.

[0341] Embodiment 46: The cannula channel has three generally straight sides and three arcuate connecting portions. An adapter as described in embodiment 42.

[0342] Embodiment 47: The valve has a skirt extending from the wall. An adapter as described in embodiment 42.

[0343] Embodiment 48: A wall of a valve having a first portion having a first thickness and a second portion having a second thickness, the first thickness is greater than the second thickness measured perpendicular to an interior plane passing through the wall; An adapter as described in embodiment 47.

[0344] Embodiment 49: The valve is located between two internal shoulders of the base. An adapter as described in embodiment 42.

[0345] Embodiment 50: A guidewire dispenser comprising: a frame having a plurality of branches including a first branch and a second branch; a connecting tip of the first branch including a lumen and a tapered nose; a guide bracket provided on the second branch, the guide bracket having a socket, and a lumen formed through the guide bracket; a tube having a first free end and a second free end; the first free end is located within the socket and the second free end is retained by a retaining clip or a socket located on the third branch; The guidewire dispenser also includes a guidewire having a length with a first free end and a second free end; a guidewire is positioned within the tube and extends through the socket at the second branch into the lumen of the connecting tip; The guidewire is exposed between the first branch and the second branch. Guidewire dispenser.

[0346] Embodiment 51: The third branch has a wall bounded by the end of the socket. A guidewire dispenser as described in embodiment 50.

[0347] Embodiment 52: The second branch is located higher in the height direction than the first branch. A guidewire dispenser as described in embodiment 50.

[0348] Embodiment 53: The tube and the frame form a closed loop. A guidewire dispenser as described in embodiment 50.

[0349] Embodiment 54: A guidewire having a first portion having a first diameter and a second portion having a second diameter larger than the first diameter. A guidewire dispenser as described in embodiment 50.

[0350] Embodiment 55: The frame has a Y-shaped configuration. A guidewire dispenser of embodiment 50.

[0351] Embodiment 56: The retention clip is a first retention clip; a second retaining clip having two through slots; 56. A guidewire dispenser as described in embodiment 55.

[0352] Although limited embodiments of the extended retention catheter assembly and its components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. For example, the location and arrangement of the male and female detents can be reversed at the mating edges, the gripping surfaces can be asymmetric, and materials can be changed, such as insert molding or co-molding. Thus, it should be understood that the extended retention catheter assembly and its components constructed according to the principles of the disclosed devices, systems, and methods can be embodied in ways other than those specifically described herein. The present disclosure is also defined in the following claims.

Claims

1. A catheter assembly (108) comprising: a catheter tube (110) attached to a catheter hub (130) and a needle (112) attached to a needle hub (122); a needle (112) positioned within the lumen of the catheter tube (110), with the needle tip (114) of the needle (112) protruding from the distal opening (110a) of the catheter tube (110); The catheter assembly also includes: an adapter (290) having a body (368) including a base (370), a tip (360), and a bore (376) extending therethrough; the base (370) having a base bore portion and the tip (360) having a tip bore portion, the tip (360) being located in the proximal opening (138) of the needle hub (122); The catheter assembly also includes: A guidewire dispenser (292) having a frame (306) with multiple branches, a connecting tip (326) of a first branch (312) of the plurality of branches is located inside the base bore portion of the adapter (290); A guidewire (302) extends through the second branch (314) of the multiple branches, through the connecting tip, and through the connecting tip (326) at the first branch (312); A catheter assembly (108).

2. a housing (102) including a first frame (193) attached to a second frame (194) and having an interior space (104); The housing (102) has a distal opening and a proximal opening, and the catheter hub (108) is at least partially disposed within the interior space (104) of the housing (102). The catheter assembly (108) of claim 1.

3. further comprising a duct (308) having a first end (308a) attached to a socket (340) of the second branch (314); The guidewire (302) extends at least partially into the duct (308); The catheter assembly (108) of claim 1.

4. The duct (308) has a second end (308b) attached to a socket (342) of a third branch (316) of the plurality of branches; The catheter assembly (108) of claim 3.

5. The duct (308) and the frame (306) define a closed loop. The catheter assembly (108) of claim 4.

6. further comprising a valve (386) disposed within the bore (376) of the adapter (290); The catheter assembly (108) of claim 1.

7. The valve (386) includes a valve disc (388) and a skirt (390) extending therefrom; The catheter assembly (108) of claim 6.

8. further comprising a needle guard (140) disposed in the interior cavity (148) of the catheter hub (130); The catheter assembly (108) of claim 1.

9. The needle (112) has a crimp (136); The guidewire (302) abuts the needle at a crimp (136) to limit distal movement of the guidewire; The catheter assembly (108) of claim 1.

10. The guidewire (302) has at least two guidewire portions having at least two different diameters; The catheter assembly (108) of claim 1.

11. a guidewire (302) having a distal guidewire portion of a first diameter and a proximal guidewire portion of a second diameter; The second diameter is greater than the first diameter; The catheter assembly (108) of claim 10.

12. The tip (360) of the adapter (290) includes a plurality of spaced gas channels (450); The catheter assembly (108) of claim 1.

13. further comprising a plurality of spaced apart elongated ribs (460) located on the exterior of the tip (360); A groove (470) including a width and a length is defined between two adjacent elongated ribs (460); The catheter assembly (108) of claim 12.

14. a plurality of spaced gas channels (450) exposed in a gap (289) between the proximal edge (139) of the needle hub (122) and the shoulder (372) of the adapter (290); The catheter assembly (108) of claim 13.

15. The guidewire (302) includes a shoulder or gradual taper located at a point between the distal and proximal guidewire portions; The catheter assembly (108) of claim 11.

16. a shoulder, gradual taper, or second diameter engageable with the needle (112) at the crimp (136) of the needle (112); 16. The catheter assembly (108) of claim 15.

17. The location of the shoulder or gradual taper defines the length of the distal guidewire portion that extends from the needle tip (114) when the guidewire (302) engages the needle (112) at the crimp (136); 17. The catheter assembly (108) of claim 16.

18. A distal guidewire portion passes through the needle (112) at the crimp (136) and extends out through an opening in the needle tip (114); 16. The catheter assembly (108) of claim 15.

19. the guidewire (302) has a marker or indicator that shows how far the distal guidewire portion extends distally beyond the needle tip (114); 16. The catheter assembly (108) of claim 15.

20. a marker or indicator indicating at least one of when the first end of the distal guidewire portion reaches the needle tip, passes the needle tip, and is fully advanced from the distal tip; 17. The catheter assembly of claim 16.

21. the guidewire having a plurality of markers or guidewires for indicating when the first end of the distal guidewire portion reaches the needle tip, passes the needle tip, and is fully advanced from the distal tip; 17. The catheter assembly of claim 16.

22. The guidewire has a code, the guidewire dispenser has a code, or both the guidewire and the guidewire dispenser have a code to indicate the gauge size. The catheter assembly of claim 1 .

23. The code includes a color, an alphabetic code, a numeric code, an alphanumeric code, or a combination thereof; 20. The catheter assembly of claim 19.

24. the distal end (360) of the adapter (290) includes a cannula channel (363) having an inner dimension and a guidewire passage (376d) having an inner dimension, the inner dimension of the cannula channel (363) being larger than the inner dimension of the guidewire passage (376d); The catheter assembly (108) of claim 1.

25. A cannula channel (363) is located distal to the guidewire passage (376d).

25. The catheter assembly (108) of claim 24.

26. The base (370) of the adapter (290) is formed with a plurality of slats (370a); The catheter assembly (108) of claim 1.

27. further comprising two or more flanges (374) extending from two or more of the slats (370a); 27. The catheter assembly (108) of claim 26.

28. further comprising one of a male detent and a female detent formed with each of the two or more flanges (374); 28. The catheter assembly (108) of claim 27.

29. the body (368) of the tip (360) of the adapter (290) has a cannula channel (363) with an inner surface defining an opening of a non-circular cross section; The catheter assembly (108) of claim 1.

30. The proximal end (112a) of the needle (112) contacts the inner surface at the cannula channel (363); 30. The catheter assembly (108) of claim 29.

31. The opening of the non-circular cross section has a plurality of linear side surfaces (363a) and a plurality of arc-shaped connecting portions (363b).

31. The catheter assembly (108) of claim 30.

32. A bypass gap (380) is formed between the plurality of arcuate connectors (363b) and the needle (112).

32. The catheter assembly of claim 31.

33. The body (368) of the tip (360) of the adapter (290) has a plurality of bore sections with different inner diameters.

30. The catheter assembly (108) of claim 29.

34. the plurality of branches includes at least three branches including a first branch (312), a second branch (314), and a third branch (316); The catheter assembly (108) of claim 1.

35. further comprising a tube (308) having a first end (308a), a second end (308b), and a lumen; A guidewire (302) is at least partially disposed within the lumen of the tube (308); 35. The catheter assembly (108) of claim 34.

36. a first end (308a) of the tube (380) disposed within the socket (340) of the second branch (314) and a second end (308b) of the tube (380) disposed within the socket (342) of the third branch (316) or away from the third branch (316); 36. The catheter assembly (108) of claim 35.

37. further comprising an intermediate retaining clip (430) having two through slots; Intermediate retaining clips (430) grip different portions of the tube (308); 37. The catheter assembly (108) of claim 36.

38. A valve (386) is disposed within the catheter hub (130). The catheter assembly (108) of claim 1.

39. The tip (360) has a cone-shaped tip bore. The catheter assembly (108) of claim 1.

40. the plurality of gas channels (450) includes 4 to 12 gas channels 450; The catheter assembly (108) of claim 12.

41. A catheter assembly (108) comprising: a catheter tube (110) attached to a catheter hub (130), and a needle (112) having a needle tip (114) attached to a needle hub (122); The needle (112) protrudes through the catheter tube (110) with the needle tip (114) positioned distal to the distal opening (110a) of the catheter tube (110); The catheter assembly also includes: an adapter (290) having a body (368) with an outer surface and an inner surface defining a bore (376); The body (368) further has a base (370) having a plurality of slats (370a) connected to one another along respective edges thereof, and a tip (360) having a guidewire passage (376d) and a cannula channel (363) distal to the guidewire passage (376d), the tip (360) being disposed in a proximal opening of the needle hub (122); The catheter assembly also includes: a guidewire dispenser (292) having a tip (326) disposed within the bore (376) of the adapter (290) and a guidewire (302) having a first end disposed within the guidewire passage (376d); The proximal end (112a) of the needle (112) is disposed within the cannula channel (363) of the adapter (290); A catheter assembly (108).

42. further comprising a plurality of spaced gas channels (450) disposed on an outer surface of the body (368) of the adapter (290); 42. The catheter assembly (108) of claim 41.

43. further comprising a plurality of elongated ribs (460) disposed on an outer surface of the body (368) of the adapter (290); A catheter assembly (108) according to claim 41 or 42.

44. The tip (360) has a cone-shaped portion.

42. The catheter assembly (108) of claim 41.

45. A catheter assembly (108) comprising: a catheter tube (110) attached to a catheter hub (130), and a needle (112) having a needle tip (114) attached to a needle hub (122); The needle (112) protrudes through the catheter tube (110) with the needle tip (114) positioned distal to the distal opening (110a) of the catheter tube (110); The catheter assembly also includes: an adapter (290) having a body (368) with an outer surface and an inner surface defining a bore (376); The body (368) further includes a base (370) having a base bore with a valve chamber (384), a valve (386) including at least one slit (396) and two flaps (398) disposed within the valve chamber (384), and a tip (360) having a guidewire passage (376d); The tip (360) is disposed in the proximal opening of the needle hub (122); The catheter assembly also includes: a guidewire dispenser (292) having a tip (326) disposed within the bore (376) of the adapter (290), and a guidewire (302) having a first end disposed within the bore (376) of the adapter (290); A catheter assembly (108).

46. further comprising a plurality of spaced gas channels (450) disposed on an outer surface of the body (368) of the adapter (290); 46. ​​A catheter assembly (108) according to claim 45.

47. further comprising a plurality of elongated ribs (460) disposed on an outer surface of the body (368) of the adapter (290); A catheter assembly (108) according to claim 45 or 46.

48. A method of assembling a catheter assembly (108), comprising: The method is: providing a catheter hub (130) comprising a catheter tube (110) extending from a distal end of the catheter hub (130); The catheter hub (130) has a body with an internal cavity (148), and the catheter tube (110) includes a lumen and a distal opening (110a); The method also providing a needle hub (122) having a shaft with a lumen and a needle (112) having a needle tip (114); The needle hub (122) includes a body (168) having an internal cavity (170) and a needle (112) that protrudes through the lumen of the catheter tube (110), with a needle tip (114) protruding distally from a distal opening (110a) of the catheter tube (110); The method also providing an adapter (290) having a body (368) with an outer surface and an inner surface defining a bore (376); The body (368) further has a base (370) with a base bore and a tip (360), the tip (360) of the adapter (290) being positioned within the internal cavity (170) of the proximal opening of the needle hub (122); The method also providing a guidewire dispenser (292); The guidewire dispenser (292) has a connecting tip (326) disposed within the proximal bore of the adapter (290) and a guidewire (302) extending across an advancement platform (322) of the guidewire dispenser (292). method.

49. A method of using a catheter assembly (108) with a guidewire (302), comprising: The method is: puncturing a vein with a needle tip (114) of a needle (112) having a needle crimp (136); advancing a guidewire (302) through an adapter (290) connected to a needle hub (122) having a needle (112) attached thereto; further advancing the guidewire (302) so that a distal guidewire portion extends from the needle tip (114) and the guidewire (302) engages the needle (112) at the needle crimp (136); A method comprising:

50. advancing the guidewire (302) without a guidewire dispenser; 50. The method of claim 49.

51. a guidewire (302) disposed at least partially within the guidewire dispenser (292); The guidewire dispenser (292) has a tip (326) connected to the base (370) of the adapter (290).

50. The method of claim 49.

52. 1. An adapter for use in guiding a guidewire (302) through a needle lumen, comprising: a body (368) including a base (370), a tip (360), and a bore (376) extending through the body (376); The base (370) has a base bore portion, and the tip (360) has a tip bore portion; The adapter also a cannula channel (363) having a plurality of generally straight sides (363a) at the distal end (360) where two adjacent straight sides (363a) are connected to one another by an arcuate connector (363b), the cannula channel (363) being sized to receive a needle shaft; and a valve (386) including a wall (392) having at least one slit (396) disposed within a base bore of the base (370); the base (370) comprising a proximal opening sized and shaped to receive the tip (326) of the guidewire dispenser (292) and a first engagement structure (374) for engaging with a second engagement structure (377) of the tip (326) of the guidewire dispenser (292); Adapter (290).

53. The base (370) has a non-circular cross section with a plurality of slats or side walls (370a); 53. The adapter (290) of claim 52.

54. A first engagement structure (374) extends from one of the plurality of slats or side walls (370a); 54. The adapter (290) of claim 53.

55. a cannula channel (363) having a first inner cross-sectional dimension and a guidewire passage (376d) located proximal to the cannula channel (363) and having a second inner cross-sectional dimension; the first inner cross-sectional dimension is greater than the second inner cross-sectional dimension; 53. The adapter (290) of claim 52.

56. The cannula channel (363) has a plurality of generally straight sides (363a), and two of the generally straight sides (363) are connected by an arc-shaped connector (363b).

53. The adapter (290) of claim 52.

57. The valve (386) has a skirt (390) extending from the wall; 53. The adapter (290) of claim 52.

58. the wall of the valve (386) having a first portion (400) having a first thickness and a second portion (402) having a second thickness; the first thickness is greater than the second thickness measured perpendicular to an interior plane passing through the wall; 58. The adapter (290) of claim 57.

59. A valve (386) is located between two internal shoulders (386b, 386c) of the base (370); 53. The adapter (290) of claim 52.

60. The tip (360) has a cone-shaped tip bore.

53. The adapter (290) of claim 52.

61. 1. A guidewire dispenser comprising: a frame (306) with a plurality of branches, including a first branch (312) and a second branch (314); a connecting tip (326) of the first branch (312) including a lumen; a guide bracket (334) of the second branch (314) having a socket (340) and a lumen formed through the guide bracket (334); a tube (308) having a first free end (308a) and a second free end (308b); The first free end (308a) is located in a socket (340) and the second free end (308b) is held by a retaining clip (434) or a socket (342) located on the third branch (316); The guidewire dispenser also a guidewire (302) having a length with a first free end and a second free end; The guidewire (302) is located within the tube (308) and extends through a socket (340) at the second branch (314) into the lumen of the connecting tip (326); The guidewire (302) is exposed between the first branch (312) and the second branch (314). A guidewire dispenser (292).

62. The third branch (316) has a wall that is enclosed at the end of the socket (342).

62. A guidewire dispenser (292) according to claim 61.

63. The second branch (314) is located at a higher position in the vertical direction than the first branch (312).

62. A guidewire dispenser (292) according to claim 61.

64. The tube (308) and the frame (306) form a closed loop.

62. A guidewire dispenser (292) according to claim 61.

65. The guidewire (302) has a first portion having a first diameter and a second portion having a second diameter greater than the first diameter; 62. A guidewire dispenser (292) according to claim 61.

66. The frame (306) has a Y-shaped configuration; 62. A guidewire dispenser (292) according to claim 61.

67. The retention clip (434) is the first retention clip; further comprising a second retaining clip (430) having two through slots; 62. A guidewire dispenser (292) according to claim 61.

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