Extension retention, midline catheter, and related method

Abstract

To provide an IV catheter assembly with one-handed operation for work, in particular, having an IV catheter related to a needle device and an IV (intravenous) injection device.SOLUTION: An extension retention catheter assembly includes a housing having an inner side in which a catheter assembly that can include a catheter tube and a needle is arranged. The catheter tube of the catheter assembly can be arranged intravenously of a patient even with and without a guide wire. Then, the extension retention catheter assembly can be operated such as to be divided into two or more housing components, or by opening a gate which allows the division of the catheter assembly from the housing. A needle guard can be included to cover a tip end part of the needle to prevent any unwanted needle pricking.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Technology field The disclosed invention relates generally to needle devices and intravenous (IV) infusion devices, including IV catheters. In particular, an IV catheter assembly with one-handed operation for actuation is disclosed. [Background technology]

[0002] IV catheters are commonly used for various infusion therapies, including infusing fluids into a patient, withdrawing blood from a patient, or monitoring various parameters of a patient's vascular system. Catheters are typically connected to a catheter adapter, which houses the IV tubing attached to the catheter. Blood control catheters include an internal blood control valve that is opened by inserting a male luer or another 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 placing the catheter in the patient's vascular system, an IV fluid source can be connected to the catheter adapter or catheter hub to open the blood control valve. Once connected in this manner, fluid from the IV source can begin to flow through the catheter and into the patient.

[0003] As is well known in the art, typical blood pressure is 10 to 20 centimeters of water. The infusion bag is usually placed approximately 100 cm above the patient's heart and directs the flow to 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 and therefore 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). An extended dwell catheter is a midline catheter, which can be thought of as a peripherally inserted catheter. However, typical midline catheters are configured for insertion into veins larger than those used for standard IV therapy. The recommended insertion site for a midline catheter is the basilic, cephalic, or midline vein in the antecubital fossa. For patients with DIVA, physicians can use visualization equipment to assist in identifying deep veins for catheter access. In this case, an extended dwell catheter provides a longer and more flexible catheter for insertion into the patient. The addition of a guidewire can help reduce the chance of the catheter kinking. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0003] Described are extended-indwelling catheter assemblies. Each extended-indwelling catheter assembly includes a housing having an interior within which the catheter assembly is disposed, which may include a needle, a needle hub, a catheter, and a catheter tube. The catheter tube of the catheter assembly may be placed into a patient's vein, with or without a guidewire, and the extended-indwelling catheter assembly may then be actuated to separate the housing into two or more housing components, allowing for separation of the catheter assembly from the housing. A needle guard may be included in the catheter assembly to protect the needle tip from an unintentional needlestick injury. [Means for solving the problem]

[0006] An indwelling extension catheter assembly according to an embodiment of the present invention can include a housing including a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly including a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing, the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; an upper seam located between the first and second frames along a first surface and a lower seam located between the first and second frames along a second surface; the first and second frames being separable from each other along the upper and lower seams, the upper seam being located above the lower seam in terms of height.

[0007] The catheter hub may include an interior cavity, and the needle guard may be disposed within the interior cavity of the catheter hub.

[0008] The needle guard can include a proximal arm and two arms that can cross each other in the ready-to-use position and the activated or guarding position when the needle guard is viewed from the side.

[0009] The valve and valve opener may be located internally within the catheter hub.

[0010] The second frame can include a plurality of male detents, each including a tip that points distally.

[0011] The second frame can include a plurality of male detents, and each detent can include a tip that points in a proximal direction.

[0012] The first and second frames may have bottom wall structures that engage each other along their respective joining edges.

[0013] The first and second frames may be of non-jointed wall construction to define a longitudinal housing opening.

[0014] The distal opening of the housing may be round and may be formed from two partial cutouts, one cutout formed from the first frame and one cutout formed from the second frame.

[0015] The needle hub can have a flange extension that lies in the opening in the housing, and the edge of the opening can limit distal movement of the needle hub.

[0016] The needle hub can have a flange defining a plane that lies perpendicular to the needle, the flange being located in a channel in the housing.

[0017] The housing can have a base end, and the base end can have a plurality of faces, which can define a square or rectangular shape when viewed along an end view.

[0018] The housing can be separated into a first frame and a second frame, which can be separated by separating the male detents from the female receiving or engaging slots.

[0019] The first and second frames can be separated from each other by applying a compressive force and a proximal force to the first or top lever while simultaneously applying a compressive force and a distal force to the bottom lever.

[0020] The first frame and the second frame can be separated from each other, or at least the proximal ends of the first frame and the second frame can be separated from each other, by sliding the catheter hub distally within the interior space of the housing and pressing it against one or two activation ramps (inclined surfaces) located within the interior space.

[0021] The first frame may include a plurality of engagement slots sized and shaped to receive a plurality of male detents.

[0022] The first and second levers may be provided on the housing, and the first and second levers may protrude from different surfaces of the housing.

[0023] The first lever can be attached to a three-sided notch in the second frame.

[0024] The second lever may include a curved proximally facing surface.

[0025] The second frame may include a plurality of slots and the first frame may include a plurality of tabs.

[0026] The tabs can engage with the slots. The engagement can be a friction fit or an interference fit. The engagement can include a positive engagement.

[0027] The first frame can include an end cap component including a tab, and the second frame can include a recess, and the tab of the end cap component can engage the recess.

[0028] The end cap component located at the distal end of the first frame can be understood as a gate that can be closed to hold the catheter hub within the housing and can be swung open to allow the catheter hub to separate from the housing. Similarly, the end cap component located at the distal end of the second frame can be understood as a gate that can be closed to hold the catheter hub inside the housing and can be swung open to allow the catheter hub to separate from the housing. Together, the two gates on the two frames can both be opened to crease a large access opening to allow the catheter hub to separate from the housing. The two gates are rotatable or pivotable around living hinges.

[0029] The recess in the second frame may be disposed on the end cap component.

[0030] The end cap components of the first frame may be attached to the walls of the first frame by living hinges.

[0031] The end cap components of the second frame may be attached to the walls of the second frame by living hinges.

[0032] The housing can have two living hinges including a first living hinge and a second living hinge, and the first frame can swing about the first living hinge and the second frame can swing about the second living hinge.

[0033] A further aspect of the present invention includes an extended indwelling catheter assembly comprising: a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; and a first lever protruding in a first radial direction of the housing and a second lever protruding in a second radial direction of the housing, the second radial direction being opposite the first radial direction.

[0034] A plurality of male detents may be mounted to the plurality of mating sockets to secure the first frame to the second frame.

[0035] Yet a further aspect of the present invention is an extended indwelling catheter assembly comprising: a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; a first end cap component attached to the wall of the first frame by a first living hinge; and a second end cap component attached to the wall of the second frame by a second living hinge.

[0036] The plurality of tabs are engageable with the plurality of slots to secure the first frame to the second frame.

[0037] A tab adapter having a body, a channel, a first opening, and a second opening can be provided for use with a catheter hub. The tab adapter can be attached to the exterior of the catheter hub.

[0038] The push tab of the catheter hub can be positioned inside the body of the tab adapter.

[0039] An extended-length indwelling catheter assembly comprising: a housing including a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly including a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; an upper seam located between the first and second frames along a first surface and a lower seam located between the first and second frames along a second surface; the first and second frames being separable from each other along the upper and lower seams, the upper seam being located above the lower seam in terms of height.

[0040] 1. An extended indwelling catheter assembly comprising: a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; and a first lever protruding in a first radial direction of the housing and a second lever protruding in a second radial direction of the housing, the second radial direction being opposite to the first radial direction.

[0041] an extended indwelling catheter assembly comprising: a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; a first end cap component attached to the wall of the first frame by a first living hinge; and a second end cap component attached to the wall of the second frame by a second living hinge.

[0042] A still further aspect of the present invention is an extended indwelling catheter assembly comprising: a housing having an interior space, the housing including a first frame and a second frame, the housing having a distal opening and a proximal opening; and a catheter assembly disposed within the interior space of the housing, the catheter assembly including a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter tube protruding from the distal opening of the housing, and the needle hub protruding from the proximal opening of the housing in a read-use position.

[0043] The catheter hub is slidable within the interior space of the housing from a proximal position to a distal position within the interior space.

[0044] A gate assembly comprising a first gate and a second gate, the first gate having a key fitted into an opening in a first frame, and the second gate having a key fitted into an opening in a second frame.

[0045] The first gate can be pivotable or rotatable about a hinge, and the second gate can be pivotable or rotatable about a hinge. The hinge can be a living hinge. Both hinges can be living hinges.

[0046] The key that fits into the opening in the first frame can have a gate sidewall and a flange. There can be two or more flanges extending from the plane of the gate sidewall to define the gate.

[0047] The two keys may be located on opposite sides of the nose end having the bore, where opposite sides can be understood to be on different sides of the axis defined by the bore.

[0048] The opening in the frame into which the key fits can be formed by a first wall slab and a second wall slab. Each of the two wall slabs can have an edge. The two wall slabs can be connected along one or more edges. At least one edge on one wall slab can be directly connected to the other edge of the other wall slab. The two edges, one on each wall slab, can be connected via a rib. One of the first and second wall slabs can be shaped to have angles, curves, contours, etc., rather than just a flat wall.

[0049] A tab adapter includes a body having a first opening, a second opening, and a channel, the tab adapter being connectable to a catheter hub. For example, the tab adapter can straddle the exterior of the catheter hub. The catheter hub can be at least partially disposed within the channel of the tab adapter. A push tab on the catheter hub can protrude into the interior of the tab adapter. The tab adapter can have a shaped proximally-facing surface. The shaped proximally-facing surface can resemble a curved ramp. Optionally, it can resemble a linear ramp. The shaped surface can provide a convenient contact point for a user or practitioner to press against to move the catheter hub from a proximal position within the interior of the housing to a distal position. A protrusion or gripping mechanism can be provided on the proximally-facing surface.

[0050] The distally facing surface of the tab adapter can have a curved or contoured surface. The shaped distally facing surface can resemble a curved ramp. Optionally, it can resemble a straight ramp. Optionally, the surface can include protrusions or gripping features.

[0051] The top and two side surfaces of the distally facing surface can converge to a tip. The tip can be a narrow tip. The tip can have an end tip. The end tip can have an arrow shape. The end tip can be used to push against a gate assembly. The end tip can push against an abutting edge of the gate assembly. The abutting edge of the gate assembly can have two adjacent edges with a seam between them. The two adjacent edges can separate at the seam, such as when pushed by the end tip.

[0052] An extension having a narrow tip can be provided for use with the distally facing surface end tip of the tab adapter. The extension and the distally facing surface end tip can be referred to as the working end. The extension end tip can have an arrow shape. The extension end tip can be distal to the distally facing surface end tip. The extension can be positioned below the distally facing surface in terms of height.

[0053] The tab adapter can have side portions. The two side portions can define a width of the tab adapter. The width can be considered perpendicular to the longitudinal direction of the tab adapter. A protrusion can extend from a surface of each of the two side portions. Each protrusion can further push the gate assembly after the two gates of the gate assembly are opened by the actuation end.

[0054] The body of the tab adapter can include an actuation end that includes a tip.

[0055] The tip can be located at a distal end of the distally facing surface, and the tab adapter can further include an extension having a tip located below the tip of the distally facing surface in terms of height.

[0056] The gate assembly can include two adjacent edge sections bisected by a seam and defining an abutting edge. The two adjacent edge sections can be separated by the seam.

[0057] The gate assembly includes a hook arm that engages with a female detent. The hook arm can be located on the first gate and the female detent can be located on the second gate. The locations can be reversed. The hook arm can have a stem, rod, or stub-like structure with a notch or curvature at the end that forms the hook arm.

[0058] The first gate may be attached to the second gate by a tie strip. The tie strip may be omitted.

[0059] Each gate may have a male detent or stab for frictionally engaging a receiving slot on the opposing gate. Each gate may have both a male detent or stub and a receiving slot.

[0060] A cylindrical nose section may be provided on the gate assembly that defines the bore.

[0061] The gate assembly can have a base wall with a guide opening, which can have a diameter smaller than the diameter of the bore, and which can support a catheter tube with a needle positioned within the lumen of the catheter tube.

[0062] Yet a further aspect of the present invention is an extended-length indwelling catheter assembly comprising: a housing including a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly including a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter hub protruding from the distal opening of the housing and the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; an upper seam located between the first and second frames along a first surface and a lower seam located between the first and second frames along a second surface, the upper seam being located above the lower seam in terms of height; and the first and second frames being separable from each other along the upper and lower seams.

[0063] The catheter hub can include an internal cavity, and a needle guard including a proximal wall and two arms can be disposed within the internal cavity of the catheter hub.

[0064] The first frame or the second frame may include a plurality of tabs, and the other of the first frame or the second frame may include a plurality of receiving slots that engage the plurality of tabs.

[0065] The housing can have a base end with multiple side walls. There can be four side walls defining a square or rectangular cross section. In other examples, the base end can have a circular or oval cross section.

[0066] A first lever and a second lever may be provided on the housing, and the first lever and the second lever may protrude from different surfaces of the base end of the housing. The protrusions of the first lever and the second lever may be radial to the longitudinal axis of the housing.

[0067] The first lever can be attached to the three-sided notch of the second frame.

[0068] The second lever may include a curved proximally facing surface.

[0069] The housing can include a body opening, and the push tab on the catheter hub can be positioned in the body opening.

[0070] The push tab is slidable within the body opening from a proximal position to a distal position.

[0071] The first and second levers are movable relative to one another to separate the first and second frames.

[0072] The first frame can include a gate with a living hinge, and the second frame can include a gate with a living hinge.

[0073] The tabs can engage the recesses to engage the two end cap components together.

[0074] The first frame can have an actuation structure, and the second frame can have an actuation structure, and a gap defined by the two actuation structures can be sized and shaped to be pressed by the catheter hub to separate the first frame from the second frame.

[0075] The tab adapter can be attached around the catheter hub.

[0076] The tab adapter can mate with a push tab on the catheter hub.

[0077] A guidewire assembly having a guidewire can extend through the needle.

[0078] Aspects of the invention can further include a method of manufacturing an extended indwelling catheter assembly. The method can include forming a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening, forming an upper seam disposed between the first and second frames along a first side of the housing and a lower seam disposed between the first and second frames along a second side of the housing, the upper seam being disposed above the lower seam in height; and disposing a catheter assembly within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter tube protruding from the distal opening of the housing, the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; the first frame and the second frame being separable from each other along the upper seam and the lower seam.

[0079] The first and second frames are separable by moving the first frame in a first direction and the second frame in a second direction.

[0080] The first and second frames may be separable by distally advancing the catheter hub to push apart two actuation structures located inside the interior space of the housing.

[0081] The catheter hub is separable from the housing by moving two end cap components about two living hinges.

[0082] Yet a further aspect of the present invention is an extended indwelling catheter assembly comprising: a housing comprising a first frame attached to a second frame and having an interior space, the housing having a distal opening and a proximal opening; a catheter assembly disposed within the interior space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, the needle and catheter tube protruding from the distal opening of the housing, the needle hub protruding from the proximal opening of the housing, the catheter hub being slidable within the interior space of the housing from a proximal position to a distal position within the interior space; and a gate assembly attached to the housing, the gate assembly comprising a first gate attached to a living hinge and a second gate attached to the living hinge; the two gates being rotatable about the two living hinges to open the two gates to separate the catheter assembly from the housing.

[0083] A tie strip can connect two gates together.

[0084] The gate assembly may include a key with a flange for mounting in a slot on the housing.

[0085] Unless an element or feature is described as critical or essential, it may be practiced as optional or with alternatives.

[0086] Broadly speaking, each extended-indwelling ("ExD") catheter assembly described herein comprises a housing and a catheter assembly. The housing is configured to accommodate the catheter assembly by advancement of the catheter to separate the catheter hub from the needle hub during initial puncture, and by subsequent actuation to allow separation of the catheter hub from the housing to allow the catheter to remain with the patient. Thus, in the ready-to-use position, the needle tip and catheter tubing of the catheter assembly can protrude from the distal end of the housing and needle hub, or at least a vent connected to the needle hub can extend from a proximal opening in the housing.

[0087] The housing and catheter hub can be separated via a variety of different mechanisms. For example, the housing can split into two or more housing portions to release the catheter hub, the housing can have portions that swing, rotate, or pivot, the housing can have an end cap component that swings open to open a gated opening at the distal end of the housing to allow the catheter hub to exit the housing, the housing can have a gate assembly attached to the distal end of the housing, and the gate assembly can have one or more gates that swing open about a hinge, among other options.

[0088] The gate assembly can have two gates positioned in two joinable gate housing bodies, each of which swings open via a living hinge. The two gates can be engaged with each other during initial assembly with the housing via a male detent and receiving slot. The two gates can be engaged via a hook arm and female detent. The hook arm and female detent can be in addition to or as an alternative to the male detent and receiving slot.

[0089] The unique housing design allows for use with standard or existing catheter assemblies, optionally without the need for specially designed catheters. Therefore, standard catheters with extended catheter lengths and midline catheters with catheter lengths of approximately 8-10 cm can be easily used with the housing of the present disclosure, with or without a guidewire. The guide openings allow the catheter to be supported during cannulation and vascular access. Once the catheter hub is moved distally to position the catheter tube within the patient, one or more structures defining the guide openings can be separated to allow the catheter hub to pass through, as described further below. The guide openings can be separated by separating the housing into two or more frames or frame sections. The guide openings can be separated by opening two gates in a gate assembly disposed with the housing. The gate assembly can be integrally formed with the housing or formed separately and then attached to the housing.

[0090] In examples, an extended indwelling or ExD catheter assembly according to embodiments of the present invention includes a housing having a receiving space or interior space within which a catheter assembly is disposed, the receiving space or interior space having a catheter tube extending from a distal end or distal opening of the housing and a needle disposed within the lumen of the catheter tube. The catheter hub can be a standard or midline catheter with an extended length of catheter.

[0091] The needle tip of the needle may extend from a distal opening of the catheter tube, which may be attached to a catheter hub, such as with a bushing or ferrule, and the needle may be attached to the needle hub.

[0092] A needle hub may extend from the proximal end of the housing. The needle hub may include a vent plug that may engage the proximal opening of the needle hub with a luer fitting or the like. The vent plug may have a vent filter that allows air but not blood to be purged.

[0093] Optionally, as discussed further below, a guidewire may be incorporated to assist in the insertion, positioning, and movement of the catheter tube of an ExD catheter assembly according to embodiments of the present invention.

[0094] In an example, a catheter assembly may include a first hub or catheter hub having an over-needle tube or catheter tube attached thereto and a second hub or needle hub having a needle attached thereto. The first hub or catheter hub may be a one-hub structure having a distal opening attached to the catheter tube and a proximal opening having a female luer. Optionally, the catheter hub may be formed from two hub bodies attached together, one of which has a female luer.

[0095] The catheter tube has a lumen or bore for receiving a needle and has a distal opening or distal end opening, the needle tip of the needle extending distally of the distal opening when the assembly is in a ready-to-use position ready for venipuncture. The catheter assembly used with the housing may also be referred to as a needle assembly, since it incorporates a needle having a needle tip.

[0096] The needle can include a change in profile located proximal to the needle tip for use with a needle guard. In the ready-to-use position, the needle tip extends distally of the distal end opening of the catheter tube or tubing and, when incorporated for use with a needle guard, has a change in profile located proximal to the distal end opening of the catheter tube. The change in profile can be a crimp, bump, or accumulation of material having a different profile than other diameter sections 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 opposite end or side.

[0097] The change in profile can be used to interact with the needle guard during needle retraction after successful venipuncture, as described further below. A 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, which is conventional. The catheter tube is attached to the first hub or catheter hub by a ferrule or bushing.

[0098] A needle guard can be provided in the internal cavity of the first hub or catheter hub to cover the needle tip in a protected position. When incorporated, the needle guard can be one of the needle guards disclosed in U.S. Patent No. 6,616,630, the contents of which are expressly incorporated herein by reference. In some instances, the needle guard can be omitted. If so, the profile change on the needle can also be omitted.

[0099] In yet another example, a needle guard can be included without also including a change in profile on the needle. In yet another example, the needle guard can be disposed in a third housing between the first and second hubs. An exemplary needle guard disposed in a third housing is disclosed in U.S. Patent No. 8,597,249, the contents of which are expressly incorporated herein by reference. In yet another example, a needle guard is disclosed in U.S. Patent No. 9,387,307, the contents of which are expressly incorporated herein by reference, including multiple arms or fingers extending in both a first direction and an opposite second direction. For example, the needle guard can include a first protector body surrounded by a second protector body.

[0100] In an example, 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 be disposed on the side of the needle and include a wall that can move distally of the needle tip to guard the needle tip from accidental contact with the needle tip. The wall can be a needle trap and can move directly in front of or distal to the tip of the needle tip.

[0101] The needle guard can include a proximal wall and two arms extending distally from the proximal wall. The two arms can cross each other in a ready-to-use position and in a protective position where the needle guard covers the needle tip when viewed from the side. In some examples, the two arms of the needle guard can extend distally without crossing each other.

[0102] Two distal walls, one on each arm, can be incorporated to block the needle tip. The two distal walls can be biased outward by the needle in the ready-to-use position and can be positioned distal to the internal change in the inner profile of the first hub in the ready-to-use position. The internal change in the catheter hub inner profile can be a reduced diameter section positioned adjacent to a larger inner diameter section. Elbows on the two arms of the needle guard can have a dimension larger than the inner diameter at the internal change in the profile, limiting proximal movement of the needle guard from the catheter hub until the two arms are no longer biased outward or until the dimension at the two elbows is reduced.

[0103] 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, the dimension measured between the two joints or elbows at the intersection between each arm and its respective distal wall may be larger than the inner diameter of the profile's internal transition, which can prevent the needle guard from moving proximally due to the relative dimensions. As the needle tip moves proximally between the two distal walls, the two arms may move radially inward, and one or both distal walls may close over the needle tip, blocking it in the protective position. At this point, the dimension between the two joints or elbows may decrease and become smaller than the dimension inside the profile's internal transition inside the catheter hub, which then allows 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 or elbows may be equal to or slightly larger than the dimension inside the profile's internal transition, and the needle can still move proximally by bending or squeezing the two joints to pass through the profile's internal transition.

[0104] The first or catheter hub can have a proximal opening with the nose section of the second or needle hub disposed therein. The proximal opening of the first hub can have a female luer for receiving a male luer tip of a syringe, IV tubing connector, luer extension set, etc. Male threads can be provided on the exterior surface of the proximal end of the catheter hub for threaded engagement with a threaded collar of a male-threaded luer tip.

[0105] A pair of stabilizing wings can extend radially from the first hub to facilitate securing the first hub to the patient after successful venipuncture. Optionally, the wings can be omitted. The first hub can embody a standard IV catheter hub without an injection port. In other examples, the first hub can include an injection port or an integrated extension set. If wings are not present on the first hub or catheter hub, the bottom of the first hub can have a flat surface sloped at an angle between 2 and 15 degrees from the penetration axis of the first hub.

[0106] The first hub can be removably secured to the second hub by receiving the nose section of the second hub in the proximal opening thereof. A flange or extension can be provided on the second hub and, together with the nose section, define a gap within which a portion of the first hub is located.

[0107] Optionally, the flange or extension can be omitted and a stub or other surface-fitting mechanism can be provided. The stub can be a male keyed portion that passes through the luer thread or resides in a gap partially within the luer thread to inhibit rotation of the second hub relative to the first hub. The proximal end face of the first hub abuts the distally facing surface of a step on the outer surface of the second hub at the proximal end of the nose section inside the first hub. This abutment can set the extent to which the needle tip protrudes from the catheter tubing. The stub can be an optional structural feature.

[0108] The second hub can have a body with an optional internal cavity with the proximal end of the needle protruding therein. The internal cavity can function as a primary blood flashback chamber. The proximal opening of the body can have a female luer for receiving a vent plug or syringe tip therein, and the exterior can be threaded or unthreaded. In an example, the exterior of the second hub body is generally cylindrical without threads. The first and second hubs can be made from a plastic material, such as by a plastic injection process.

[0109] The push tab can be provided on the first hub or the catheter hub. The push tab can be located on the outer surface of the first hub at a location distal to the external threads so as to avoid interference with the external threads. For example, the push tab should be located sufficiently distal to the external threads and approximately at the 12 o'clock position on the catheter hub so that when a threaded male connector, such as a syringe-type connector with a threaded collar, is connected to the threads of the first hub, the push tab does not interfere with the connection. In some examples, the push tab should be located sufficiently distal to the external threads so that when the push tab is folded, the push tab does not interfere with the connection.

[0110] In some examples, the catheter assembly can incorporate a valve and a valve opener. For example, both the valve and the valve opener can be disposed within the catheter hub. In use, the valve opener can be pushed distally into the valve to open one or more slits formed with the valve and open a fluid passageway through the valve for fluid flow. An exemplary valved catheter assembly having 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.

[0111] The valve opener can have a nose section having a bore and a plunger section disposed proximal to the nose section. The nose section can be pressed into the valve to open one or more slits in the valve, such as three slits defining three flaps. The plunger section can include two or more plunger components with a gap therebetween. The gap can allow fluid to flow through the plunger components and through the bore in the nose section.

[0112] The housing of the ExD catheter assembly includes a left or first frame and a second or right frame attached to each other. Each frame includes 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.

[0113] In examples, the nose end or nose section is provided with a nose tip having an elongated cylindrical structure with a bore for accommodating the catheter tube and needle, which is disposed within the catheter tube. The nose end or nose section can further include a nose base having an enlarged portion formed at the tip and a tapered distal portion.

[0114] A plurality of support ribs or fins may be provided at the intersection between the tip and the nose base of the housing. Alternatively, the nose end may be a spherical or rounded dome with openings to accommodate the catheter tube and needle.

[0115] The housing body may have an interior space for accommodating a catheter assembly, which may be the catheter assembly described with reference to FIG. 2. A body opening or a first opening opens into the interior space. The body opening may extend from the nose end to the base end. The body opening may be located between two upper edges of the first and second frames.

[0116] In some examples, the body may be provided with a second opening opposite the first opening, providing access to the interior space through two body openings. Thus, the body may have a through passage defined by two body openings between the distal and proximal ends of the housing. In other examples, the body may have only a single opening leading to the interior space, with the opposite side being closed or enclosed by the walls of the first and second frames.

[0117] If the housing incorporates a single body opening, the opening may be located at the top of the housing in terms of height to allow a user to see when the ExD catheter assembly is in use. Optionally, the enclosed surface may have a small window or opening for access or ventilation rather than a complete opening as with a single body opening.

[0118] The base or base end of the housing can extend from the body and have multiple sides. The multiple sides can define a base with polygonal sections. In an example, there can be four sides defining an interior space that opens to the interior space of the body. In another example, the base or base end can be embodied as a generally elongated cylinder or non-cylindrical shape. The four sides can be referred to as a first side, a second side, a third side, and a fourth side. The four sides can also be referred to as a top side, a bottom side, a left side, and a right side. These specific nomenclatures are provided to allow for the inclusion of certain sides only relative to other sides, but are not structurally limiting unless the context dictates otherwise.

[0119] The base or base end can have an open proximal end to allow a needle hub to extend proximally therethrough in the ready-to-use position. As shown, the first and second faces of the base end can each have an opening to allow viewing and access to the interior space of the base end to facilitate or assist in assembly of the catheter assembly therein.

[0120] The base end can have a first or top lever on its top surface and a second or bottom lever on its bottom surface. When a user simultaneously applies a compressive and distal force to the top lever and a compressive and proximal force to the bottom lever, the user can move the left and right housing frames relative to each other, separating the detents of the first and second frames. This, in turn, allows the housing to separate into separate housing components, e.g., the left and right frames.

[0121] A user can separate the housing into two or more housing components by operating the first or top and bottom levers. Separation of the housing into housing components can then expose 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, for example, by using tape or a securement dressing.

[0122] In another example, 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 top lever and a compressive and distal force to the second or bottom lever to move the two housing sections relative to each other and separate the detents of the first and second frames.

[0123] The housing exterior can have multiple surface decorations, such as on the outer surface of the left or first frame. A similar set of surface decorations can be provided on the right or second frame. A generally flat top edge can be provided on both body frames. Furthermore, the distal-most edge of the top lever can be located proximal to the distal-most edge of the bottom lever. This arrangement can be utilized to separate the housing into housing components, allowing the thumb to easily grasp the top lever and the outer edge of the index finger to easily grasp the bottom lever to separate the housing components. For example, the index finger can press against the curved, proximally facing surface of the bottom lever and push in a distal or distal direction. In other examples, the relative arrangement between the top and bottom levers can be changed or arranged differently depending on the detent-type or snap connection incorporated to hold the first and second frames together.

[0124] The housing may include a wall along the top surface of the housing that faces the body opening. A seam may extend longitudinally of the housing and may define an interface between the left and right frames of the housing along the body and nose end of the housing. The seam may extend from the nose end to and include the base end of the housing. However, the seam may be nonlinear or may not extend in a straight line. For example, the seam may be off-axis relative to a line defined by the seam along the body and nose end.

[0125] The base end seam may be near a portion or intersection of surfaces, such as the right and lower surfaces. Multiple pairs of detents may be incorporated between the left and right frames to secure the two frames together. For example, the catheter assembly may be placed inside the housing before engaging the left frame with the right frame, or vice versa. After use, such as after successful venipuncture, the top and second or bottom levers may be actuated to separate the detents, and the housing may then be separated into its components, such as separating the left frame from the right frame, to separate the catheter assembly from the housing.

[0126] In an example, the right frame can have a second surface and a top or third surface at the base portion, which are generally perpendicular to each other, and a first surface and a bottom or fourth surface can be provided on the left frame.

[0127] To secure the catheter assembly to the right frame, and in particular the needle hub, against movement, a lower wall structure or portion of the right frame can terminate in a proximal edge disposed along an axial position on the right frame to accommodate a flange or extension of the needle hub, such that the distal edge of the flange can be restricted from shifting or moving distally by the proximal edge on the lower wall structure.

[0128] To prevent proximal movement of the needle hub, the second surface includes a channel and a shoulder on the proximal edge of the channel for retaining the flange on the needle hub. The channel on the second surface and the corresponding channel on the first surface define a gap or width to accommodate the width of the luer thread on the catheter hub and the flange on the needle hub.

[0129] A non-circular structure for joining the flange and groove channel, such as using a multi-sided structure, can prevent the needle hub from rotating while within the space defined by the faces of the base end, thereby holding the needle hub in an assembled position so that the needle bevel can be oriented in a desired location without premature rotation prior to sequential venipuncture.

[0130] The second surface of the base portion can have a channel and a shoulder. A plurality of tabs or male detents can be provided on a lower edge of the second surface. The tabs can be embodied as hook-like structures for engaging with female detents disposed on the left or first frame. Optionally, there can be three or more detents or only one detent. Each of the male detents can have a distally facing tip for moving or sliding from a proximal position to a distal position to engage and engage the female detent.

[0131] In certain configurations, the right frame and detents must move proximally relative to the left frame to separate the male detents from the female detents on the left frame. In other instances, the male detents on the right frame can be oriented proximally, and separation of the male and female frames requires movement of the right frame distally relative to the left frame to separate the male detents or tabs from the female detents on the left frame.

[0132] A notch may be provided along the top surface to form a top lever. The notch may have three sides, with a fourth side connected to the base of the top lever. The top lever may be formed to protrude outward from the bottom edge. The top lever may have a tapered or ramped portion and a contact portion. The contact portion may provide a surface for a user to touch or manipulate.

[0133] Ribs or protrusions may be provided on the underside of the top surface and may be recessed from the side edges of the top surface. The recessed space between the side edges and the protrusions may be sized to accommodate the thickness of the first surface of the left frame when the left frame is assembled to the right frame. The ribs may be thought of as alignment tabs for use in aligning the first surface with the side edges, thereby providing a generally flush surface between the side edges and the exterior of the first surface upon assembly with the first surface.

[0134] A second rib or protrusion spaced from the first rib can be provided on the underside of the upper surface. In examples, the second rib can be at or aligned with the side edge and configured to engage a corresponding slot or recess on the left side or first surface of the left frame to align the two frames at their base ends along the axial direction of the housing.

[0135] In an example, the second rib has an arrowhead-like structure with two tapered edges and an apex therebetween. The arrowhead-like structure can be configured to seat in a corresponding seat on a left side surface of the left frame, and the two tapered surfaces can allow the protrusion to deviate from the corresponding seat by sliding the corresponding tapered surfaces against each other when the top lever and the bottom lever are gripped and slid against each other.

[0136] A shoulder may be formed on the lower surface of the upper wall just distal to the notch. The shoulder on the lower surface may be configured to support a flange on the needle hub, similar to the function of the shoulder on the second surface.

[0137] Tabs or detents having distally pointing free ends may be shown located on the side edges of the lower wall structure. The tabs may engage with corresponding female detents formed with the left frame. In other examples, additional tabs may be provided along the side edges of the lower wall structure.

[0138] Two protrusions may be provided at the tip of the right frame. As shown, a lower protrusion may be provided at the side edge of the lower wall structure to engage with a slot in the left frame to provide additional rigidity along the seam. An upper protrusion may be provided at the side edge of the base to engage with a slot in the left frame to provide additional rigidity along the upper seam of the nose end of the housing. The upper seam is located above the lower seam in terms of height.

[0139] In an example, the right frame has a bottom wall structure, a top wall structure or section, and a side wall structure or section, each having a surface. In an example, the top wall or section may have a length extending in the same longitudinal direction as the needle and a width perpendicular or radial to the length. The width of the top wall structure may be smaller than the width of the bottom wall structure. These different widths between the top and bottom wall structures, for example, the top wall structure does not protrude as far toward the needle as the bottom wall, allowing for a gap along the top of the housing and allowing the bottom to close when the first frame is attached to the second frame.

[0140] A shoulder may be provided between the upper wall structure and the top wall, and a raised stub may be provided distal to the top lever. The shoulder step may provide a relatively large interior space at the base end of the housing to accommodate a flange on the needle hub and a luer thread on the catheter hub. The raised stub may not be connected to the contact portion of the top lever, but may be provided with a tapered surface to mimic the ramps at the base of the top lever for a more symmetrical appearance. A gap may be provided between the top lever and the raised stub, which may incorporate spaced apart gripping bumps. The top lever may also incorporate similar spaced apart gripping bumps.

[0141] The left frame can be configured to couple to the right frame to form a housing according to aspects of the invention shown and described elsewhere. In an embodiment, the first frame can include a nose portion, a body portion, and a base portion. The left and right frames can join to form a nose end, a body, and a base end. In an exemplary embodiment, the lower wall structure can be provided with an engagement slot for engaging a tab or detent and a receiving slot for receiving a protrusion on the right frame. As described further below, the engagement slot can have a detent for receiving a corresponding detent on the right frame. However, the receiving slot can be embodied as a simple channel without an engagement surface for receiving a lower protrusion on the right frame.

[0142] 9, proximal to body portion 188a is base portion 190a having a left or first side 200 and a bottom or fourth side 206 with a bottom lever 216 formed thereon. First side 200 and bottom side 206 resemble two wall structures positioned at right angles to one another with bottom lever 216 on one of the walls. One or more gripping mechanisms 284 may be provided on the exterior of bottom lever 216.

[0143] The engagement slot can have an opening for the tab to enter, a tapered surface, and a tab. The tab on the right frame can enter the opening of the engagement slot and then move distally to engage the tab of the engagement slot to complete the engagement between the tab and the engagement slot.

[0144] To disengage the left and right frames, the tabs can move in opposite directions. The tabs can move proximally relative to the engagement slots. The proximal movement can move the tapered surface of the engagement slot against the tapered surface on the tabs, applying a pair of forces including radially directed forces that move the left and right frames away from each other to separate the tabs from the engagement slots. Simultaneously, the lower protrusion of the right frame can separate from the receiving slot of the left frame. A similar engagement mechanism can be provided at the base end of the housing to allow separation of the two frames at the base end.

[0145] The bottom or fourth surface of the base end includes two engagement slots formed in an edge of the bottom surface. Each of the engagement slots may include an opening for receiving a corresponding tab on the lower edge of the second surface of the right frame. Each engagement slot may be provided with a lip having a recessed pocket for receiving and engaging a finger of a corresponding tab. A gap between the finger and the lower edge of the tab may be configured to receive the lip therebetween and engage the tab with the engagement slot.

[0146] The engagement slots toward the distal end of the base section can be bounded by at least three sides and can have openings that can be relatively longer than the length of the corresponding tabs to allow axial movement of the tabs out of the engagement slots. Optionally, the engagement slots at the proximal end of the base section can be bounded by only two sides without a third side to restrain the corresponding tabs.

[0147] The first face of the base portion may be provided with an opening and two receiving slots for mating with or aligning with a rib and protrusion on the top wall of the base section of the right frame. The more distal receiving slot may have a recess formed in the inner surface of the first face, while the more proximal receiving slot may have a recess formed in the outer surface of the first face. This arrangement may allow the wall structure of the first face to straddle or pass between the rib and protrusion.

[0148] Like the right frame, the base portion may be provided with a channel for interacting with a flange on the needle hub, and the barrier wall distal to the channel may be provided with a shaped contour for accommodating the catheter hub when the left frame is attached to the right frame with the catheter hub positioned therebetween or inside the interior space of the housing.

[0149] During use, the ExD catheter assembly can be advanced into a patient to a selected catheter location, such as a deep or superficial vein. The user can puncture the target vein with guidance from a visualization device, such as an ultrasound monitor with an ultrasound probe. A primary blood flashback can be observed entering the needle hub. The insertion angle of the ExD catheter assembly can then be reduced before further advancing the ExD catheter assembly to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser with a housing can be positioned in the proximal opening of the catheter hub after protruding through the vent plug and needle lumen and removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to the desired treatment location within the body.

[0150] The needle and catheter tube can be advanced over the guidewire, stopping just before the nose end of the catheter hub contacts the skin. If the ExD catheter assembly is used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the top lever and their index finger on the bottom lever, as described above, to separate the housing into two or more housing components, such as separating the left frame from the right frame. Once the housing has been separated into smaller components, such as separate first and second housing frames, the catheter assembly can be released from the housing and separated from the housing. The user can then retract the needle and needle hub from the catheter hub.

[0151] With respect to the ExD catheter assemblies and components thereof disclosed below, where a feature is shown but not explicitly described, and is otherwise the same or similar to one or more features described elsewhere, such as those described above with reference to FIGS. 1-14, it is understood that one or more disclosed portions that are shown in all drawings but not explicitly described, for redundancy and because knowledge is building on the foundation laid by prior disclosures, can still be understood to be described or taught by the same or similar features explicitly described in the text for the embodiment in which the one or more features are described. In other words, subsequent disclosures in this application build on the foundation of prior disclosures unless the context dictates otherwise. Thus, the present disclosure is understood to teach the disclosed embodiments and features of the disclosed embodiments to those skilled in the art without the need to repeat similar components and features in every embodiment, as one skilled in the art would not ignore similar structural features that he or she has read about in several previous paragraphs, nor would it disregard knowledge gained from prior descriptions in the same specification. Thus, the same or similar features shown in the following ExD catheter assemblies incorporate the teachings of the previous embodiments unless the context dictates otherwise. Accordingly, it is contemplated that the later-disclosed embodiments will enjoy the benefit of the previously explicitly described embodiments, such as the features and structures of the previously described embodiments, unless the context dictates otherwise.

[0152] The alternative ExD catheter assembly shares similar aspects with the ExD catheter assemblies of Figures 1-14. In particular, they share a similar housing configuration in which a first or left frame and a second or right frame are attached to form a housing that can be separated to release the catheter hub from the housing. The housing can include a nose end, a body, and a base end. The housing has a body opening that opens to the interior space. The catheter assembly can be disposed within the interior space of the housing.

[0153] At the distal end, a portion of the needle attached to the needle hub and a catheter tube attached to the catheter hub can protrude from the distal opening of the housing at the nose end. Optionally, after removal of the vent plug, a guidewire dispenser, such as a SonoStik® guidewire dispenser, can be connected to the proximal opening of the needle hub.

[0154] Each of the two first and second frames may include a wall structure including a lower wall section, an upper wall section, and a side wall section. The outer surfaces of the side wall sections may be provided with a plurality of protrusions or decorations, which may be embodied as circular, elongated, polygonal, or irregularly shaped protrusions. The protrusions may be spaced apart from one another and may be provided for aesthetic purposes and to facilitate gripping of the housing on its two side walls.

[0155] The proximal base end of the housing can have a plurality of sidewalls, including a first or left sidewall, a second or right sidewall opposite the first sidewall, a third or upper sidewall, and a fourth or lower sidewall opposite the third sidewall. The sidewalls at the base end define a generally square or rectangular structure having a hollow interior for accommodating the catheter assembly. In other examples, the sidewalls can define a cross-section of a different shape, such as oval or circular. A seam can pass through both the upper and lower sidewalls and through the nose end of the housing.

[0156] The first and second side walls can define a width of the housing at the base end. In some examples, the width of the base end can be greater than the width of the body immediately distal to the base end. In other examples, the width of the base end and the width of the body immediately distal to the base end can be approximately the same or equal. The width of the body, measured as the distance between the two side wall sections of the first and second frames, can be approximately constant distally from either their respective outer or inner surfaces to near the beginning of the body's activation area or region, where the body expands distally to a maximum width at the body's distal end. From there, the width can rapidly decrease to a peak or apex where the distal opening is located.

[0157] The activation area of ​​the body can be extended to allow each of the two frames, or at least one of the two frames, to incorporate an activation structure. The activation ramp can be sized and shaped to interact with the catheter hub to allow separation of the housing into two or more housing components.

[0158] The proximal end of the housing is provided with a notch for receiving the flange extension of the needle hub, which is defined by a partial notch in the bottom surface of the base end and a partial notch in the proximal end of the two frames.

[0159] An opening can be provided in the lower wall of the housing near the distal end of the housing. The opening can be elongated and can have a proximal edge, a distal edge, and a side edge. In other examples, the opening can have a different shape as long as the shape does not interfere with an activation lamp disposed inside the housing.

[0160] The seam may be provided longitudinally of the housing, extending from the distal end to the proximal end, and may be discontinuous at the rear and front openings. The distal edges of the front openings may be provided with end cap components or gates at the distal ends of each of the left and right frames. The description of the end cap components of the second frame applies equally to the end cap components of the first frame, and the end cap components may have a lower section, an upper section, and a side section. In an example, the side sections may have semicircular notches, so that two side sections with two notches from two adjacent end cap components can form through-holes or openings for accommodating needles and catheter tubes. The through-holes formed by the two notches can provide support and guidance for the needle and catheter, allowing for venipuncture of extended-length catheters with or without a guidewire, as well as short midline catheters approximately 8-10 cm long without an integrated guidewire.

[0161] The lower section of the end cap component can be separated from the lower wall of the housing wall by a gap, and the upper or top section of the end cap component can be separated from the upper wall of the housing wall by a gap. Thus, each end cap component can be attached to the remainder of its respective left and right frame by a material strip or layer having a thickness. In an example, the material strip can have a thickness equal to the thickness of the walls of the side and front sections. In another example, the material strip can include recesses to reduce the thickness of the material strip so that it is thinner than the thickness of the side and front sections.

[0162] In an example, the strip of material connecting the left end cap component to the left frame and the strip of material connecting the right end cap component to the right frame can function as hinges, such as living hinges. The living hinges can allow the end cap components and their respective frames, i.e., front end walls, to pivot, rotate, or swing relative to one another. For example, when the assembly is activated by pressing the catheter hub against one or more activation ramps, if the first and second frames separate from one another starting from the proximal end, the first and second frames can swing or rotate outward from one another and pivot about their respective strips of material or living hinges. As described further below, the two end cap components can remain attached to one another as the two frames pivot or rotate about the two living hinges until the two frames also separate to release the catheter hub from the two frames.

[0163] The second frame can have a joining edge where a seam is formed with the joining edge of the first frame. The left or first frame and the right or second frame can be connected to each other along their respective joining edges. Engagement slots, tabs, and / or detents can be used to removably secure the two frames, as further described below. The right frame can have a notch in the bottom or underside of the housing that forms a portion of the opening.

[0164] In the figure, the catheter assembly can be disposed in an interior space of the housing, which can have a needle and catheter tubing passing through a notch and a catheter hub, or at least a push tab on the catheter hub, disposed distally of the base end. The needle hub and vent plug can protrude from a proximal opening of the housing, with a flange on the needle hub engaging the housing.

[0165] The flange extending from the needle hub, which may have a generally square or rectangular profile, may be positioned so that the plane defined by the flange is generally perpendicular to the longitudinal axis of the housing. The portion of the flange that protrudes outside the outer profile of the needle hub may engage with grooves formed in multiple sides of the base end, such as the first, second, third, and fourth sides. The grooves may be recessed channels formed in the wall thickness of the multiple sides of the base end. The grooves may be formed continuously across the surfaces, except for the fourth side, which may have a notch cut out to accommodate the flange extension of the needle hub. The grooves may be structured to receive, accommodate, or accommodate a flange on the needle hub, including where the flange transitions between various sides, such as at the intersection of the flange surfaces.

[0166] In the ready-to-use position, in which the ExD catheter assembly is ready to be used to perform venipuncture, the needle hub can be held stationary from axial movement by restricting distal movement of the needle hub's flange extension via the bottom housing edge in the two bottom wall structure cutouts. To restrict proximal movement of the needle hub, the flange extending from the needle hub can be positioned against the proximal lip of the groove in the base end. Furthermore, a non-circular structure for coupling the flange and groove, such as using a multi-sided structure, can prevent the needle hub from rotating while in the space defined by the face of the base end. This allows the needle hub to be held in the assembled position during assembly so that the needle bevel can be oriented in the desired position without premature rotation before sequentially performing venipuncture.

[0167] The external threads of the catheter hub can include a slot for receiving a tab protruding from the upper inner surface of the base end. In other examples, the arrangement can be reversed, with the upper surface incorporating a slot and the catheter hub incorporating a tab. In still other examples, a detent can be provided between the catheter hub and the housing at another location along their respective structures to engage the two. The engagement ensures proper alignment between the catheter hub and the housing in the ready-to-use position and prevents the catheter hub from rotating while engaged with the housing.

[0168] The catheter hub can be configured to slide axially distally within the interior space of the housing after successfully placing the needle and catheter hub in the patient's vein, with the needle hub remaining engaged with the base end of the housing. In an example, the external threads are configured to ride or slide against the inner surfaces of the two lower walls of the housing. For example, a user can push the push tab to advance the needle hub distally. The push tab can be disposed between the two upper wall sections of the two frames. As shown, the upper edge of the push tab can protrude above the outer surfaces of the two upper wall sections, exposing itself for contact and pressure by the practitioner. In some examples, the push tab can be structured so that the upper edge of the push tab protrudes further above the two upper wall sections, exposing itself as a larger target for the practitioner to press against.

[0169] When the practitioner pushes the push tab distally after placing the catheter tube in the vein, and optionally after advancing a guidewire into the vein to guide the catheter tube, the body of the catheter hub abuts one or more activation ramps on one of the left frame, the right frame, or each of the two frames, separating the two frames starting from the proximal end of the housing. The push tab can be molded with a length or height sufficient to extend above the housing to allow pushing by the practitioner. Optionally, a tab extender can snap onto a standard push tab to increase the height of the push tab for the practitioner to push, as described further below.

[0170] The second frame can have a base portion having a second surface, a top surface, and a bottom surface. The top and bottom surfaces can be relatively shorter in length than the second surface. The top and bottom surfaces of the right frame can be referred to as partial surfaces because they form the top and bottom surfaces of the base end when similar top and bottom sections are supported by the first or left frame, with the two partial top sections joined at their respective joining edges and the two partial bottom sections joined at their respective joining edges.

[0171] At the joining edge, the partial top section can incorporate a slot, and the partial bottom section can incorporate a slot. The slot can be generally rectangular in shape with sharp or rounded corners, but can alternatively be embodied as a circle, square, star, oval, polygon, or irregular shape. The slot in the partial top section and the slot in the partial bottom section can be positioned along the same axial position of the longitudinal axis of the right frame. In other examples, they can be axially offset from the same axial position. In an example, both slots are positioned approximately along the proximal ends of the two joining edges.

[0172] The body portion can be located distal to the base portion, and the base portion can have a wall with a top wall portion, a bottom wall portion, or a lower wall portion, and a side wall portion. In an example, two slots similar to the slots in the base portion are provided at the joining edge of the lower wall structure or compartment. The two slots can have the same shape as the two slots on the base portion or can be different. In an example, one of the two slots in the lower wall compartment can be located adjacent to the housing edge of the bottom notch, and the second slot can be located distal thereto. In other examples, there can be only one slot or three or more slots in the lower wall compartment, which can be located elsewhere along the joining edge.

[0173] The activation ramp may be disposed on an inner surface of a sidewall section of the housing wall closer to the distal end than the proximal end in the activation region of the frame. The activation ramp has a proximal ramp section, a distal ramp section, and a central ramp section located between the proximal and distal ramp sections. In an example, the proximal ramp section can be viewed as a structure having a surface that includes an increasing slope from the inner surface of the right frame and extends radially away from the inner surface.

[0174] When assembled with the left frame and assembled housing with the catheter assembly disposed therein, the proximal ramp section can extend away from the inner surface toward the needle or toward a longitudinal axis passing through the housing. The longitudinal axis passing through the housing can be considered a reference line, and the proximal ramp section can be understood to have a surface that is furthest from the reference line and that gradually approaches the reference line as the ramp approaches the central ramp section.

[0175] The central ramp portion has a surface closer to the reference line than the proximal ramp portion and may include a generally flat area or surface area having a larger radius.

[0176] The distal ramp section, in examples, can include a slope that decreases from a central ramp section, which can have a surface that moves away from the reference line. If the proximal ramp section has a positive slope, the distal ramp section can have a negative slope. Thus, the actuation ramp can be considered a sloped structure that increases to a peak or apex at the central ramp section and then has a negative slope. In other examples, the distal ramp section can be constant or flat with the central ramp section, without slope. In yet other examples, the distal ramp section can have a positive slope that continues toward the reference line. Preferably, the distal ramp section has a negative slope.

[0177] When the left and right frames are assembled together to form the housing, the gap between two adjacent activation ramps, which may be referred to as an activation gap if two activation ramps are incorporated, or the gap between the activation ramp and the inner surface of the adjacent frame if only one activation ramp is incorporated, may vary. The activation gap may extend and narrow from the proximal ramp section to a narrower point in the central ramp section, or from the two proximal ramp sections to a narrower point in the two central ramp sections. As described further below, the activation gap may be incorporated as a means by which the catheter hub can advance and apply a force to a pair of components that can then separate the housing into two or more housing components.

[0178] The recess can be provided in the second or right frame end cap component. The recess can have three sides and an open fourth side. Optionally, the recess can be embodied as a four-sided slot similar to one of the slots in the body section or base section. The recess in the end cap component can be sized and shaped to receive a corresponding tab on an adjacent end cap component in an interference fit or snap fit arrangement. In some examples, the location of the recess and the location of the tab for mating with the recess can be reversed so that the recess can be located in the first or left frame end cap component.

[0179] The activation ramp can be implemented as two separate activation ramp sections, each having a proximal ramp portion, a distal ramp portion, and a central ramp portion. The two separate activation ramp sections can operate or function as previously described. A gap or void can be provided in the distal ramp section of the two ramp sections and formed by a negative slope of the two distal ramp sections. A small gap can be located between the two ramp sections. In other examples, the activation ramp can be formed as a single ramp structure without a gap. The surface of the activation ramp can be substantially flat or have a large radius to form a slight curvature to accommodate the contours of the catheter hub.

[0180] As can be visualized, when the second or right frame is coupled to the first or left frame and the catheter hub is advanced distally to abut against the two separate activation ramp sections, the nose section of the catheter hub first abuts against the two proximal ramp sections of the two separate activation ramp sections and then moves into the gap or void as the nose section continues to move distally. The middle section of the catheter hub, which is larger in diameter or size than the nose section of the catheter hub, then moves over the two proximal ramp sections, further expanding the two frames apart. At this point, the two frames are completely separated from each other at the distal end of the housing, except for their engagement at the two end cap components. If they are not completely separated proximally of the two end cap components, further movement of the catheter hub's external threads relative to the two proximal ramp sections can further expand the two frames apart, resulting in the tabs and slots of the two frames completely separating from each other, except for their engagement at the two end cap components. Finally, the final engagement between the recess and the tab on the left frame can be separated by physically grasping one or both of the frames and pulling them apart. The catheter hub can then be completed by connecting it to an IV line, taping it to the patient, etc.

[0181] In an example, the recess in the end cap component can have two side walls, a bottom wall, and a central wall. In an example, each of the two side walls can include a surface, and the two surfaces of the two side walls can taper or converge toward the bottom wall. Thus, the surface of the central wall can be trapezoidal in shape. The recess can be tapered, and the width or gap at the opening of the recess can be greater than the width or gap at the bottom of the recess. This configuration can allow a corresponding tab on the end cap component of the first frame to engage with the recess and easily disengage, facilitating separation of the two frames at the two end cap components and subsequently separating the catheter hub from the housing of the ExD catheter assembly.

[0182] The outer surface of the second frame can have a plurality of spaced apart protrusions or decorations, similar to those of the left frame. In some examples, the two different sets of protrusions on the two frames can be the same and have the same spacing. In other examples, the protrusions can have different shapes and / or different spacing between two adjacent protrusions.

[0183] In an example, tabs or male detents can be provided on the third surface of the base portion of the joining edge and on the fourth surface of the base portion of the joining edge for engaging with two slots in the base portion of the second frame. Tabs or male detents can also be provided on the joining edge on the lower wall structure or section for engaging with two slots on the lower wall structure of the second frame. Optionally, the two frames can be joined together along adjacent seams via welding or adhesive. If welding or adhesive is used, the upper and lower seams of the distal end of the housing are attached to each other via detents, so that the detents can be disengaged to open the distal gate opening, subsequently allowing separation of the catheter hub from the housing, as described further below.

[0184] A tab or male detent may be provided on the mating edge of the end cap component of the first frame. The tab may be positioned on the end cap component in a position that matingly engages with a slot on the right frame when the left and right frames are assembled to form a housing according to this aspect of the invention. The tab may be sized and shaped to engage with a recess in the end cap component of the second frame. In an example, the engagement between the tab and the recess is slight interference.

[0185] In examples, the engagement between the tabs or male detents and recesses of the two end cap components can grip or engage more tightly than the engagement between the tabs on the base portion and the tabs on the lower wall structure that engage with corresponding slots on the second frame 194. This relative engaging force between the mating pairs of tabs and slots ensures that when the catheter hub advances distally within the interior space of the housing after initial catheter tube placement, and after guidewire advancement when installed, when the catheter hub contacts the activation ramp, the housing will first separate at the proximal end of the housing and then at the two end cap components. In other examples, the various pairs of tabs and slots can generally open approximately simultaneously when the catheter hub contacts the activation ramp.

[0186] The tabs on the base portion of the first frame can be longer than the tabs on the lower wall structure of the body section. The tabs on the base portion can also be longer than the tabs on the end cap components. The different lengths of the various tabs can mate or engage with slots having different corresponding depths to ensure a generally tight seam when the two housing frames are joined to form the housing. In some examples, each of the left and right frames can have both slots and tabs that mate with corresponding tabs and slots, or rather have an arrangement where all slots are located on one frame and all tabs are located on another frame.

[0187] The outer surface of the first frame may have a plurality of spaced apart projections or ornamentations similar to those of the second frame. In some examples, the projections of two different sets of the frames of the two housings may be the same and have the same spacing. In other examples, the projections may have different shapes and / or different spacing between two adjacent projections.

[0188] In use, a user can use an ExD catheter assembly according to an embodiment of the present invention to puncture a target vein with guidance from a visualization device, such as an ultrasound monitor, using an ultrasound probe. A primary blood flashback can be observed entering the needle hub. The insertion angle of the ExD catheter assembly can then be reduced before further advancing the ExD catheter assembly to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser having a housing protruding through the vent plug and needle lumen can be placed in the proximal opening of the catheter hub after removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to a desired treatment location within the body.

[0189] The needle and catheter tube can be advanced over the guidewire, stopping just before the nose end of the housing contacts the skin. If the ExD catheter assembly is to be used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the push tab on the catheter hub and advance the catheter hub against one or more activation ramps on one or both of the first and second housing frames.

[0190] When the catheter hub is pushed distally until the nose end of the catheter hub presses against the two activation ramps, a pair of component forces can be generated in each of the two frames. This can separate the two frames from the base end of the housing. As the catheter hub continues to move distally, the two frames can further separate until the tabs and slots on the base end and the body completely separate from each other. At this point, the tabs and recesses on the two end cap components remain engaged, allowing the two frames to pivot on their respective living hinges. Next, while maintaining a grip on the catheter hub, the user can use their free hand to pull on one of the two frames, separating them from their respective end cap components. At this point, the catheter hub and housing can be freed from each other. The user can then complete preparation of the catheter hub, such as connecting an IV line to the catheter hub and taping it to the patient to secure the puncture site.

[0191] In an alternative embodiment of an ExD catheter assembly according to aspects of the present invention, the left and right frames, or the first and second frames, can be secured together with tabs or male detents that engage corresponding slots or female detents. In this embodiment, the engagement between the tabs or male detents on the body and base and the slots or female detents can prevent separation when the catheter hub is advanced distally within the housing. For example, the engagement between the tabs and slots can be by interference and / or adhesive, bonding, or welding. Additionally, the activation ramps can be omitted from the first and second frames to prevent radial forces generated by the advancing catheter hub from separating the two housing frames. Thus, when the catheter hub is advanced distally to further position the catheter tube within the vein, the catheter hub can reach the void space at the distal end of the body section without the activation ramp and without exerting any radial force on the two frames to separate them. Instead, distal abutment of the catheter hub against the distal gate opens the distal gate opening, which then allows separation of the catheter hub from the housing.

[0192] When pushed distally by the advancing catheter hub, the male detents or tabs of the first frame can disengage or separate from the recesses of the second frame. The recesses can have an open slot. This structure allows the tabs to pass through a side opening of the recess without a sidewall, rather than through an opening adjacent to the joining edge, thereby allowing separation between the tabs and the recesses of the two end cap components of the left and right frames. Thus, separation of the two end components can be achieved by simply applying an axial force when the catheter hub is pressed distally against the two end cap components, without the need to generate a radial force.

[0193] Thus, after cannulation, optionally guidewire placement, and catheter placement, as described above in the first or prior embodiment of the ExD catheter assembly, the catheter hub can be advanced against the proximally facing surfaces of the two end cap components of the left and right frames. The force of the catheter hub's advancement pulls the tab away from the recess. This separation can be facilitated by the open side between the two side walls of the recess in the end cap component of the second or right frame. That is, the tab on the first or left frame can simply slide out through the gap provided by the missing side of the recess between the two side walls.

[0194] When the tabs and female detents on the two end components separate and the two frames are held fixed by the tabs and slots on the body and base portions of the two frames, the two end components are swung distally about the two living hinges.

[0195] In an example, the space or distance between the two living hinges is greater than the horizontal or cross-sectional dimension of the catheter hub. Therefore, when the two end cap components swing distally around the two living hinges, a gate having a gap defined by the space provided by the distally swinging end components, referred to as a gate opening or distal gate opening, opens to provide a gap for the catheter hub to pass through. The swinging end cap component may also be referred to as a gate that can swing open to open the distal gate opening. In effect, opening the gate to open the gate opening at the distal end allows the catheter hub to be separated from the needle hub and housing through the gate opening or distal gate opening, separating the catheter hub from the needle, needle hub, housing, and, if used, guidewire and guidewire dispenser. The catheter hub can then be secured to a patient for fluid administration. The needle, needle hub, housing, and, if used, guidewire and guidewire dispenser can be discarded or disposed of according to approved protocols.

[0196] Thus, one aspect of the present invention can be understood to include an ExD catheter assembly including a multi-part housing having an interior space with a catheter assembly disposed therein. The catheter assembly includes a catheter tube attached to a catheter hub and a needle attached to a needle hub and extending through the catheter tube with the needle tip extending distally of the distal opening of the catheter tube. The needle and catheter tube protrude through an opening at the distal end of the housing. The distal end can include two end cap components removably attached to each other, for example, by engaging a male detent with a female detent. The female detent can be a recess having three side walls, at least one open face, and an open entrance to the recess. Each end cap component can include a gate that is pivotable or rotatable about a living hinge. When the two gates of the two end cap components pivot or rotate open to open the gate opening at the distal end of the housing, the needle hub can move distally beyond the gate opening and separate from the housing.

[0197] A multi-part housing for forming the housing of an ExD catheter assembly can include a first frame attached to a second frame. The two frames can have a seam between them. The two frames can be attached along a joining edge. One of the two frames can include a tab or male detent, and the other frame can include a corresponding slot or female detent for receiving the male detent to removably secure the two frames to each other. The distal end of the housing can include a seam. The distal end opening through which the needle and catheter tube protrude can be formed by two notches in the two walls, which, when joined together, form a substantially cylindrical guide opening. The distal end of the housing can include a living hinge. Preferably, there are two living hinges at the distal end of the housing. A gap gate can be defined by the distance between the two living hinges. With at least one opening surface separated from the other by a tab and female detent, the two end cap components can swing distally about two living hinges to open a gate opening or distal gate opening at the distal end of the housing. The catheter hub can exit the gate opening or distal gate opening and separate from the remaining components of the ExD catheter assembly, which can include the needle, needle hub, housing, and, if used, guidewire and guidewire dispenser.

[0198] According to a further aspect of the present invention, an ExD catheter assembly may include a tab extender or tab adapter attached to the catheter hub, extending through the housing opening perpendicular to the longitudinal axis of the housing so that an upper portion of the tab adapter rises above the upper wall structure of the housing to expose a surface for pushing or gripping by the practitioner. In an example, the tab adapter is provided to extend the profile of the catheter hub's integrally formed push tab sufficiently above the upper wall structure to facilitate manipulation of the ExD catheter assembly. Alternatively, the push tab can be formed in an extended configuration, extending above the upper wall structure of the housing to expose itself for pushing by the practitioner without a separately formed tab adapter.

[0199] The tab adapter can be formed from a plastic material, such as by plastic injection molding. The tab adapter can include a body having a first end and a second end. The first end can be positioned above the second end in terms of height. In an example, the body can be partially formed as a solid structure above an imaginary line, with a tunnel or channel below the imaginary line having a first arcuate opening and a second arcuate opening communicating with each other via a channel. In another embodiment, the body is hollow and formed with a wall structure having an outer surface and an inner surface defining an interior space or cavity. The wall thickness between the outer surface and the inner surface can be thick enough to provide structural rigidity to support a finger load applied by a user to advance the catheter hub.

[0200] The tab adapter can be sized and shaped to fit onto a catheter hub. In an example, the tab adapter is configured to seat on a hub body that is positioned within a channel in the catheter hub and body. The first and second openings of the tab adapter can be sized to fit snugly around the curved body of the catheter hub. Depending on how the tab adapter is positioned on the catheter hub, such as by its axial position or location along the catheter hub, the first and second openings of the tab adapter can have the same or different sizes to accommodate the particular contour of the catheter hub. In an example, the first and second openings can have a hemispherical, semi-elliptical or elliptical shape, or an arc shape. Preferably, the two openings are sized and shaped to fit snugly over the catheter hub body and exert a gripping force around the hub body. The two openings can have different shapes, which can be selected based on the size and contour of the catheter hub body.

[0201] When the tab adapter is attached to the catheter hub, the push tab is configured to fit within the interior space of the body of the tab adapter. Two gripping bars may be provided at the second end of the body, one on each side of the two openings, to prevent slippage, sliding, or movement relative to the catheter hub when finger pressure is applied to the body. The gripping bars may resemble ribs and may have contoured surfaces for a snug fit with the catheter hub. The gripping bars on the body of the tab adapter should be positioned relative to the tops of the two openings so that, when attached to the catheter hub, the two gripping bars are below the centerline of the catheter hub body. The size and shape of the first and second openings and the position of the two gripping bars ensure that the tab adapter grips the catheter hub body with a snug fit. The adapter can be used by sliding the channel and the two openings over the catheter hub body, ensuring that the push tab on the catheter hub is positioned inside the tab adapter. The channel may have an open side for placing the tab adapter on the catheter hub.

[0202] The push tab of the catheter hub can contact the inner proximal surface of the body. Thus, when the tab adapter is pushed distally by the practitioner, the inner surface of the tab adapter presses against the proximally facing surface of the push tab, advancing the push tab, and therefore the catheter hub, distally. In examples, the interior space of the tab adapter is provided with a socket that receives the push tab with a size match or slight interference to resist separation from the catheter hub body during distal advancement of the catheter hub.

[0203] In a further example, the first and second frames can be attached to each other along the seam by corresponding tabs or male detents and engagement slots. Optionally, the first and second frames can be attached to each other along the top-bottom seam via adhesive or welding. The catheter hub of the catheter assembly can be separated from the housing by incorporating a gate assembly at the distal end of the housing that opens to allow the catheter hubs to separate through a gate opening formed by pivoting two gates distally. The housing of this embodiment can remain attached together, with only the gate assembly at the distal opening being operable to separate the catheter hubs.

[0204] The ExD catheter assembly includes a removable protective cap configured to be placed over the needle to cover the needle and needle tip prior to use, the proximal opening of the protective cap being capable of frictionally engaging the nose section or nose end of the housing.

[0205] A tab adapter or tab extender can be placed over the catheter hub and secured thereto by a fitting. The needle hub extends outside the housing, proximal to the base end. A vent plug can be attached to the needle hub, which can allow air to escape but trap any blood that may flow inside the needle hub and vent plug.

[0206] The housing of the extension catheter assembly can include a nose end or nose section terminating in two nose pieces with an upper seam extending between them. The upper seam can extend through the upper portion of the nose end. A similar corresponding lower seam can extend through the lower portion of the nose end. Each nose piece can be joined to an end cap component of each respective first or second frame. Each nose piece and each end cap component can be referred to as a gate or a rotating gate. The two gates from the two end cap components can be part of a gate assembly. The two gates can swing open to allow the catheter hub to be separated from the housing without having to separate the first and second frames from each other.

[0207] In one example, each of the two first and second frames includes a wall structure including a lower wall section, an upper wall section, and a side wall section. The outer surfaces of the side wall sections may be provided with a plurality of protrusions or decorations, which may be embodied as circular, elongated, polygonal, or irregularly shaped protrusions. The protrusions may be spaced apart from one another and may be provided for aesthetic purposes and to facilitate gripping of the housing on its two side walls. The two housing frames may have an interior for accommodating the inner catheter assembly.

[0208] In this example, unlike the opening in FIG. 16 , a lower elongated opening is not incorporated. The lower walls of both housing frames may be solid and may be joined together along a seam up to a gap separating the two end cap components from the rest of the two frames. This arrangement allows the two frames to remain attached to each other while the two end cap components, along with the two nose portions of the nose ends, swing open about their respective living hinges to open the distal gate opening. In other embodiments, the two housing frames may be joined together up to a longitudinal gap. The longitudinal gap may extend, flow, or blend into a forward gap that allows the two end cap components to swing open the distal gate opening, as described further below. The proximal end of the longitudinal gap may serve as an injection point for a plastic injection gate or inlet.

[0209] Optional scorelines can be incorporated into the walls of each frame. The scorelines can be straight, curved, or both for aesthetic appeal. Scorelines are understood to be groove lines formed in the lower walls of the two frame walls. In other instances, scorelines can be omitted.

[0210] The two end cap components may be attached to the two front end walls via two living hinges. Each of the two end cap components may be attached to the nose piece, and this combination may be referred to as a gate or a rotating gate. The two gates of the gate assembly may swing open when pushed distally by distal movement of the catheter hub, opening a distal gate opening that may be moved when finger pressure is applied to a tab adapter attached to the catheter hub.

[0211] A front base wall may be provided proximal and inward of the boundary defined by the hollow partial cylinder of each nose portion. Each front base wall may have a notch sized and shaped to accommodate a needle and a portion of the catheter tube. When the first and second frames are joined, the two notches from the two front base walls form a perimeter defining an opening sized and shaped to receive the perimeter of the combined catheter tube with the needle of the catheter assembly disposed within the housing. In an example, the perimeter of the two notches may be referred to as a guide opening that guides the combined needle and catheter tube as the combination advances distally during cannulation and vascular access. The two base walls may have varying thicknesses measured along the length of the first and / or second frames. Male detents may protrude from the sides of the thicker base walls. In another example, the base walls may have a uniform thickness.

[0212] The male detents may alternatively be stubs or studs having elongated bodies with rounded ends and may be provided on each of the first and second frames. The male detents on the first frame may be positioned above the needle and / or catheter tube in height and extend approximately perpendicular to the axis defined by the needle. The male detents on the second frame may be positioned below the needle in height and extend approximately perpendicular to the axis defined by the needle.

[0213] The arrangement of the two male detents on the two frames can be reversed. In an example, the two male detents can protrude radially relative to the longitudinal axis of the needle by a sufficient amount so that the tip of each male detent extends beyond the midpoint of the needle diameter, preferably beyond the edge of the needle opposite to which the male detent extends. In another example, the male detents can extend a shorter length or distance from the respective surface from which they extend. The length of the male detents can be selected to vary the amount of engagement with the corresponding receiving slot, as further described below.

[0214] The receiving slots can include a first frame below the male detents. Similarly, the receiving slots can include a second frame above the male detents. Again, the arrangement can be reversed. Each receiving slot can include wall structure configured to frictionally engage a corresponding male detent disposed on the opposing frame. Thus, the receiving slots of the first frame can be configured to frictionally engage the male detents of the second frame, and the receiving slots of the second frame can be configured to frictionally engage the male detents of the first frame.

[0215] In an example, the receiving slot can have a first wall and a second wall configured to frictionally engage two surface sections of a mating male detent. In an example, the first wall and the second wall can be disposed substantially perpendicular to one another. Preferably, each receiving slot does not have a wall opposite the second wall, which provides a gap or wall absence for the male detent to separate from the receiving slot when a catheter hub body, such as the nose end of the catheter hub, abuts and presses against the two base walls in a distal direction. When so pressed, the two gates of the gate assembly rotate about two living hinges to open the distal gate opening, which can then separate the catheter hub from the housing. In an embodiment, each receiving slot can further include a wall opposite the respective first wall, such that each receiving slot can have a three-sided wall structure. The rigidity of each receiving slot and end cap component can be sized to grip a corresponding male detent with a slight interference fit.

[0216] In use, after removing the protective cap, the user can use the ExD catheter assembly to puncture the target vein with guidance from a visualization device, such as an ultrasound monitor, using an ultrasound probe. A primary blood flashback can be observed entering the needle hub. The insertion angle of the ExD catheter assembly is then reduced before further advancing the ExD catheter assembly to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser with a housing protruding through the vent plug and needle lumen can be placed in the proximal opening of the catheter hub after removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to the desired treatment location within the body.

[0217] The needle and catheter tube can be advanced over the guidewire, stopping just before the nose end of the housing contacts the skin. If the ExD catheter assembly is used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the tab adapter that engages the catheter hub to advance the catheter hub relative to the gate assembly.

[0218] When the catheter hub is pushed distally, with its nose end pressing against the two gates of the two end components, a distal force is transmitted to the gate assembly, overcoming or exceeding the interference and / or frictional forces created by the engagement between the two male detents, stubs, or studs and the two receiving slots. As the catheter hub continues to move distally, the two gates can swing distally around the living hinges. The user can continue to move the catheter hub distally while applying a proximal force or a stable holding force to the housing, until the needle hub is completely moved through the gate openings created by the two rotated gates. At this time, the catheter hub and the housing can be free from each other. The user can then complete preparation of the catheter hub, including connecting an IV line to the catheter hub, taping it to the patient to secure the puncture site, and optionally removing the tab adapter from the catheter hub.

[0219] A tab adapter according to an embodiment can be formed from a plastic material, such as by plastic injection molding. The tab adapter can include a body having a first end and a second end. The first end can be positioned above the second end in terms of height. In examples, the body can be formed as a solid structure having a slot to accommodate a push tab extending from the catheter hub and a hollow tunnel for mounting onto the catheter hub body, as further described below.

[0220] The body can have an outer surface and an inner surface, a first or distal opening, and a second opening on the body opposite the first opening. A channel can be provided between the two openings. The channel can have an open side for placement over the catheter hub. A wall thickness between the outer surface and the inner surface can be thick enough to provide structural rigidity to support a finger load applied by a user to advance the catheter hub.

[0221] The body can have a distally facing outer surface including one or more protrusions or surface features for aesthetic appeal. The distally facing outer surface can be curved or arcuate. The protrusions or surface features can optionally be omitted. In other examples, the protrusions can be embodied as other shapes, such as dimples, rounded bumps, contoured protrusions, random protrusions, etc. The distally facing outer surface can be located between two side surfaces. In examples, each of the two side surfaces can have flat or planar walls without varying surface features. In embodiments, each side surface has a first surface portion, a tapered side portion, and a second surface portion. The second surface portion, like the first surface portion, can have flat or planar walls. The two second surface portions on the two side surfaces can define a width greater than the width defined by the two first surface portions. Thus, the width of the first end of the tab adapter can be greater than the width of the second end of the tab adapter.

[0222] The distal opening of the tab adapter can have a perimeter defined by multiple edge sections or segments. The shape of the perimeter can vary depending on the shape of the catheter hub to which the tab adapter is configured to attach. For example, the shape of the perimeter can have only four edge sections, or can be semicircular or partially circular.

[0223] In examples, the proximally-facing surface of the tab adapter has a first surface segment and a second surface segment. The first surface segment can be generally planar but sloped from the plane of the second surface segment at an inflection or transition line. The first surface segment can incorporate one or more surface features or protrusions.

[0224] The proximal or second opening can have a perimeter defined by a semicircular or partial circular edge. The shape of the perimeter can vary depending on the shape of the catheter hub to which the tab adapter is configured to be attached. For example, the shape of the perimeter can be defined by multiple edge segments or sections and can vary depending on the shape of the catheter hub to which the tab adapter is configured to be attached. The first and second openings should extend more than halfway or down the midline of the catheter hub body to ensure a secure grip across more than half the diameter of the catheter hub body. Multiple ribs can be incorporated into the internal cavity of the tab adapter to provide rigidity.

[0225] A catheter hub according to an embodiment of the present invention has a nose section at its distal end and a proximal body section. The nose section can have a generally square shape with rounded corners connecting its four sides. In other examples, the nose section can have other cross-sectional shapes, including generally cylindrical, elliptical, oval, polygonal, etc. The proximal body section can be generally circular and have a relatively larger girth or outer contour than the nose section. Thus, a step-up or stepped section can be provided between the nose section and the proximal body section. The opening of the tab adapter can be sized and shaped accordingly to fit the contour of the catheter hub body.

[0226] The tab adapter can be sized and shaped to fit onto a catheter hub. In an example, the tab adapter is configured to seat onto the catheter hub and the hub body, which is positioned within a channel in the body of the tab adapter. The first and second openings of the tab adapter are sized to fit snugly around the curved body of the catheter hub. Depending on how the tab adapter is positioned on the catheter hub, such as by its placement or location along the axial position of the catheter hub, the first and second openings of the tab adapter can have the same size or different sizes to fit the particular contours of the catheter hub.

[0227] In examples, the first opening can have a shape that fits snugly around the generally square cross-section of the nose section, and the second opening can have a hemispherical, semi-elliptical, or oval shape, or an arc shape to fit around the proximal body section. Preferably, the two openings are sized and shaped to fit snugly over the catheter hub body and exert a gripping force around the hub body. A channel located between the two openings has an open side for placing the tab adapter onto the catheter hub.

[0228] When mounted onto the catheter hub, the push tab of the catheter hub is configured to fit within the interior space of the body. The push tab of the catheter hub can contact the inner proximal surface of the body or can protrude into an internal female detent, recess, or socket to improve fixation between the tab adapter and the catheter hub. Thus, in use, when the tab adapter is pushed distally by the practitioner, the inner surface of the tab adapter, or the recess or female detent in the adapter, presses against the proximally facing surface of the push tab, advancing the push tab, and therefore the catheter hub, distally. In other examples, the grip provided by the opening of the tab adapter against the catheter hub body can also transmit a distal force to the catheter hub to advance the catheter hub when the tab adapter is pushed.

[0229] In accordance with yet a further aspect of the present invention, an extended indwelling catheter assembly is provided having a first or left frame and a second or right frame attached to form a housing having an interior for receiving the catheter assembly, the housing allowing the catheter hub to move from a proximal position to a distal position within the housing and thereafter separate from the housing.

[0230] The ExD catheter assembly further includes a catheter assembly, which may be similar to other catheter assemblies described herein. The catheter assembly is shown at least partially disposed within the housing. The catheter assembly includes a catheter hub, a needle hub, and a protective cap that covers the needle at the needle tip.

[0231] The first and second frames forming the housing can be separated to release the catheter hub of the catheter assembly from the housing. The first and second frames can be attached to one another along a seam by corresponding tabs or male detents and engaging slots, as described above, which can be disengaged.

[0232] Optionally, the first and second frames can be attached to one another along top and bottom seams via adhesive or welding in addition to or as an alternative to using tabs and detents. If the two housing frames are not separable or the housing can be separated into smaller housing components, the housing can be provided with a gate assembly that allows separation of the catheter hub from the housing after cannulation and vascular access.

[0233] In an alternative embodiment, the housing can be assembled from two housing frames, representing an upper frame and a lower frame, instead of the left and right frames described herein. For example, the upper frame can have a body opening similar to opening 196 in FIG. 1, and the lower frame can have a closed bottom wall similar to the closed bottom wall in FIG. 4, which can optionally have one or more small vents or openings. Thus, the seam between the two alternative frames is rotated from the seam shown and described elsewhere.

[0234] In yet another example, the housing can be assembled from two housing frames representing a front frame and a rear frame, instead of a left-right frame or a top-bottom frame. In other words, the housing can be assembled along a seam located anywhere between the distal and proximal ends of the housing.

[0235] In yet another alternative embodiment, the housing for positioning the catheter hub therein can be integrally formed and include a distal opening and a proximal opening. The gate assembly described herein can be attached to the distal opening, and the needle hub and / or vent plug can extend from the proximal opening in the ready-to-use position.

[0236] In yet another embodiment, the tab adapter can include a body having a first end and a second end. The first end can be positioned above the second end in terms of height. In examples, the body can be formed as a solid structure having a slot to accommodate a push tab extending from the catheter hub and a hollow tunnel for mounting onto the catheter hub body, as further described below.

[0237] The body can have an outer surface and an inner surface, a first or distal opening, and a second opening at an end of the body opposite the first opening. A channel can be provided between the two openings. The channel can have an open side for attachment to a catheter hub. The wall thickness between the outer and inner surfaces is sufficient to provide structural rigidity to support a finger load applied by a user to advance the catheter hub.

[0238] The body of the tab adapter can have a distally facing outer surface that includes one or more protrusions or surface features for aesthetic appeal. The distally facing outer surface can be arcuate or curved. The protrusions or surface features can optionally be omitted. In other examples, the protrusions can be embodied as other shapes, such as dimples, rounded bumps, molded protrusions, random protrusions, etc.

[0239] The distally facing outer surface can be located between two sides. In an example, each of the two sides can have a flat or planar wall without varying surface features. However, the two sides can be curved to provide a curved end cross-section.

[0240] A recessed groove or race can be located between the first and second surface portions of each of the two sides of the tab adapter. The two second surface portions of the two sides can be substantially planar and parallel to each other, thereby defining a generally constant outer dimension along at least a portion of the two sides. The two first surface portions can be substantially parallel to each other. In an example, the two first surface portions of the two sides taper inward in a direction from the second end toward the first end.

[0241] The protrusion can be incorporated into at least one of the two sides of the tab adapter and extend radially from the longitudinal axis of the tab adapter. The protrusion can include an inclined surface and a flat end surface intersecting the inclined surface. In another example, the protrusion can be formed from a hemispherical dome or a non-spherical dome with straight sides and a flat end surface. In use, the protrusion can be positioned to abut or contact the gate assembly at the distal end of the housing to open the gate more widely and allow separation between the housing and the catheter hub. In an example, a protrusion is provided on each of the two sides of the tab adapter so that the gate assembly can be abutted by both protrusions.

[0242] The distal opening of the tab adapter can have a perimeter defined by multiple edge sections or segments. The shape of the perimeter can vary depending on the shape of the catheter hub to which the tab adapter is attached or configured to be attached. For example, the shape of the perimeter can have only four edge sections, or can be semicircular or partial circular, or any shape corresponding to the outer contour of the catheter hub. However, the shape of the perimeter does not need to exactly match the contour of the catheter hub in order for the tab adapter to be used with the catheter hub and secured thereto by a fitting.

[0243] In an example, the proximally-facing surface of the tab adapter has a first surface segment and a second surface segment. The first surface segment may be generally curved, arcuate, or sloped, such as a ramp with approximately vertical or upwardly extending walls. The second surface segment may be curved or arcuate, and may be mostly horizontal or flat. The first surface segment and the second surface segment are connected or joined to one another, and together resemble a jump or ramp, as does the arcuate outer surface of the distally-facing surface. The first surface segment of the proximally-facing surface may incorporate one or more surface features or protrusions.

[0244] In examples, the proximal or second opening of the tab adapter can have a perimeter defined by a semicircular or partial circular edge. The shape of the perimeter of the second opening can vary depending on the shape of the catheter hub to which the tab adapter is attached or configured to be mounted. For example, the shape of the perimeter can be defined by multiple edge segments or sections and can vary depending on the shape of the catheter hub to which the tab adapter is attached or configured to be mounted.

[0245] In some instances, the shape of the perimeter of the second opening does not need to exactly match the contours of the catheter hub because the tab adapter is used with the catheter hub and secured thereto by a fitting. The perimeters of the first and second openings may be the same or different from each other. The first and second openings should extend more than halfway or down the midline of the catheter hub body to ensure a secure grip over more than half the diameter of the catheter hub body.

[0246] In embodiments, the distally facing outer surface of the tab adapter is provided with a narrowed tip that narrows to a smaller tip with a tip resembling a spear or arrow. Thus, the distally facing surface and two sides of the tab adapter can converge to define a slightly pointed but sharp tip resembling a wide arrow. An extension is provided directly below the height of the tip of the distally facing outer surface. In examples, the extension can be shaped as an elongated stem or bar formed with the body of the tab adapter. The extension can have side edges and a bottom edge with an elongated shape with the narrowed tip. The narrowed tip or tip of the extension can be located distal to the tip of the distally facing outer surface. In alternative embodiments, the extension can be omitted. The extension can be integrally formed with the tab adapter and share one of its side edges with the underside of the tab adapter.

[0247] The actuation end of the tab adapter can include one or both of the narrowed tip or tip of the extension and the narrowed tip or tip of the distally facing surface. The actuation end can be located at the distal end of the tab adapter. The actuation end can be configured to separate two gates of a gate assembly located at the distal end of the housing and provide clearance for a catheter hub attached to the tab adapter to separate from the housing after successful venipuncture.

[0248] In an example, the gate assembly can include a nose end having a tip. The nose end can be hollow and define a bore. The gate assembly further includes an upper joint and a lower joint, which allows the gate assembly to separate at the upper and lower joints and swing distally about two pivotable or rotatable hinges, as further described below. The upper joint extends through an upper portion of the nose end. A similar corresponding lower joint can extend through a lower portion of the nose end. The upper joint is disposed above the lower joint in terms of height.

[0249] The gate assembly may be clam-shaped or clamshell-shaped and includes a body having a first gate and a second gate that can be combined to form an assembled gate assembly according to an embodiment of the present invention. In an example, the two gates may be formed by molding, such as plastic injection molding, and may include tie strips to hold the pair together during manufacturing and assembly. Optionally, the tie strips may be omitted, and other tracking and monitoring may be used to associate corresponding pairs of gates.

[0250] Both the first and second gates can have a body section with a barrier wall having a proximally extending wall section and a distally extending wall section. Each gate can further include a male detent, or a stem or stud, and a receiving slot for engaging a corresponding receiving slot and male detent in the opposing gate. Each receiving slot can have at least one open or missing side so that a mating male detent can swing through the missing side. For example, each receiving slot can have three sides and be sized and shaped to interferingly receive a male detent. Thus, when a load is applied to the gate, each male detent can slide past the missing wall of the corresponding receiving slot, allowing the gate to swing open, as described further below. The first and second gates can swing distally about their respective living hinges.

[0251] Each gate includes a front base wall within a boundary defined by the hollow partial cylinder of each nose portion or distal wall. Each front base wall can have a notch sized and shaped to accommodate a needle and a portion of the catheter tube. When the first and second frames are joined, the two notches from the two front base walls form a perimeter that defines an opening sized and shaped to accommodate the combined catheter tube and needle. The opening can be considered a guide opening for guiding the catheter tube and needle during advancement of the catheter tube and needle during cannulation and vascular access.

[0252] In some examples, the perimeter of the two notches in the gate assembly may be referred to as a guide opening that guides the combination needle and catheter tube as the combination advances distally during cannulation and vascular access. The two base walls may have varying thicknesses measured along the length of the first frame and / or second frame. A male detent may protrude from the side of the thicker base wall. In other examples, the base walls may have a uniform thickness.

[0253] A male detent may be provided on each of the first and second gates. The male detent on each of the first and second gates may be located on the side of the notch opposite the receiving slot. In an example, the two male detents may protrude radially relative to the longitudinal axis of the needle by a sufficient amount so that the tip of each male detent extends beyond the midpoint of the needle diameter, preferably beyond the edge of the needle opposite from which the male detent extends. In another example, the male detents may extend a shorter length or distance from the respective surface from which the male detent extends. The length of the male detents may be selected to vary the amount of engagement with the corresponding receiving slot.

[0254] Each receiving slot of the gates may include a wall structure configured to frictionally engage a corresponding male detent disposed on the opposing gate, wherein the receiving slot of a first gate located with the first frame or the left frame may be configured to frictionally engage a male detent of a second gate located with the second frame, and the receiving slot on the second gate is configured to frictionally engage a male detent on the first gate.

[0255] In an example, the receiving slot can have a first wall and a second wall configured to frictionally engage two surface segments of the male detent. In an example, the first wall and the second wall are disposed substantially perpendicular to one another. Preferably, each receiving slot does not have a wall opposite the second wall, or has a missing wall segment to define an open slot or channel, which then provides clearance for the male detent to separate from the receiving slot when the tip of the tab adapter abuts and presses distally against the two base walls. When so pressed, the two gates rotate about two living hinges to open the gates and separate the catheter hub from the housing. In an embodiment, each receiving slot can further include a wall opposite the respective first wall, such that each receiving slot has a three-sided wall structure. The rigidity of each receiving slot can be sized to grip a corresponding male detent with a slight interference fit.

[0256] Assembly of the two gates of a gate assembly can be facilitated by a hook arm located on the first gate hooking or locking into a corresponding female detent on the second gate housing. In other examples, the positions of the hook arm and female detent can be reversed. Thus, in addition to the frictional force provided by the immediately preceding male detent and receiving slot combination, the clamshell or clam-shaped structure of the gate assembly can be held together via the hook arm and female detent. In some examples, the hook arm and female detent can be omitted, and interference between the pair of male detents and the receiving slot can be increased to provide the necessary engagement to hold the first and second gates together. In still other examples, the pair of male detents and the receiving slot can incorporate positive engagement means, such as barbs, to provide additional engagement force.

[0257] The combination of the hook arm and female detent can provide a radial holding force against a shaft passing through the hole in the nose end. However, when pushed distally against an actuation end of the tab adapter, such as the tip of an extension on the tab adapter, such as when the tab adapter is moved distally to advance the catheter tubing into a patient's vein, as described above, the hook arm deforms and separates from the female detent. At approximately the same time that the hook arm flexes and separates from the female detent, the male detent separates from the corresponding receiving slots on the two gates.

[0258] Two of the proximal wall sections extending proximally of the barrier wall can be referred to as gate side walls. In an example, the two gate side walls can be pivotally connected to corresponding barrier walls of the first and second gates. In an example, each pivotable or rotatable connection is a living hinge, which is understood to mean an integrally formed thin section or thin plastic strip formed during molding that joins two adjacent sections, such as joining a gate side wall and a barrier wall. The thin plastic strip allows the two joined adjacent sections to pivot or rotate about the living hinge.

[0259] Each gate sidewall can have a flange, and multiple flanges are contemplated, such as two or three spaced flanges. Each set of two flanges, or at least one flange, and the gate sidewall can define a key for engaging a slot in the distal end of the housing to retain the gate assembly therein. The key can extend from the body section of each gate via a living hinge, and the key can be attached to the housing to allow the body section to rotate about the living hinge.

[0260] The first and second gates can have a seam passing between them. Separation occurs at the seam when the two gates are pushed distally apart, such as by the actuation end of a tab adapter. The seam extends between two adjacent proximal wall segments. The wall segments can be referred to as deflection walls. Each deflection wall has a proximal edge 638. The proximal edges can have different edge segments. The different edge segments of the proximal edges can have straight or curved edges. The two relatively straight edges are joined by an elbow, a radius, or an angle, which can be an acute or obtuse angle. The two adjacent straight edge segments of the two deflection walls converge at the seam. The two adjacent edge segments at or bisected by the seam 232 define abutting edges. The abutting edge is configured to be abutted or pressed by the working end of the tab adapter, such as by the tip of the distally facing outer wall surface, when the tab adapter is advanced distally during use of the ExD catheter assembly.

[0261] An extension indwelling catheter assembly according to an embodiment of the present invention is understood to include a tab adapter having an actuating end, such as a narrowed tip or tip, for pressing against the abutment edge or mating hook arm and female detent of a gate assembly. In an example, the tab adapter has both a tip disposed on the distally facing outer surface and a tip disposed on the extension that is positioned below the distally facing outer surface in height. The two tips can be part of the actuating end of the tab adapter. In some examples, the tip of the distally facing outer surface is positioned proximal to the tip of the extension so that the two tips contact two different surfaces along two different planes. In an example, the tip of the extension is configured to abut a surface distal to the surface abutted by the tip of the distally facing outer surface.

[0262] Movement of the two gates in a closing direction causes the hook arm to engage the female detent and the two male detents to engage the two receiving slots, creating a clamshell-shaped structure. The two engaged housing sections can be mated without the use of adhesive or bonding materials.

[0263] In an example, the housing can have two receiving slots at its distal end, one in the first or left frame and one in the second or right frame. In an example, each receiving slot can be formed by a first wall slab and a second wall slab. The first and second wall slabs of each receiving slot define a hollow space therebetween for receiving a key.

[0264] The gate assembly can have a key formed on each of the two gates. In an example, each gate can include a gate sidewall with one or more flanges or protrusions extending outward from the surface of the gate sidewall. The combined gate sidewall and one or more flanges can define a profile or outline, referred to as a key 633, sized and shaped to fit within the hollow space of a receiving slot in the distal end of the housing. Thus, when the gate assembly is assembled to the housing, the two keys 6 on the first and second gates slide into the two receiving slots and are held there by friction, interference, and / or mechanical engagement. Once assembled, the gate assembly is secured to the distal end of the housing, and the two gates can swing open about their respective living hinges, allowing a catheter hub assembled to the housing to separate from the housing.

[0265] A gap may be provided between the first wall slab and the second wall slab. The gap may be provided to accommodate a wall structure of the gate sidewall adjacent the living hinge. The gap may be bounded at an end opposite the opening to the hollow space by a rib that may join the first wall slab and the second wall slab to one another. The first wall slab may have a contoured wall structure that may be sized and shaped to accommodate a contour defined by at least one flange on the gate sidewall of the gate assembly.

[0266] An indwelling extension catheter assembly according to aspects of the present invention is understood to have a housing molded as a single piece. The housing may be partially cylindrical and partially rectangular. The rectangular portion of the housing may be the base. In some embodiments, the housing may be completely cylindrical. A gate opening at the top of the housing may bisect the housing longitudinally. Opening the housing by widening the gate opening may allow the catheter hub to be removed from the interior space of the housing through the body opening.

[0267] In some embodiments, the gate opening may be a living hinge. The living hinge may separate when the gate opening is pulled apart by a radial force. In some embodiments, the gate opening may be a frangible living hinge. The frangible living hinge may have perforations that facilitate separation of the living hinge and the gate opening when the gate opening is pulled apart.

[0268] The lock can act as additional reinforcement to keep the gate opening intact. The lock can be located in the nose section of the housing between the nose end and the body opening. In some embodiments, the gate opening may have multiple locks along its length. The lock can be a two-sided detent engagement formed by bisecting the housing by the gate opening. The detent engagement can be released by applying additional radial force to the housing to pull the gate opening apart. The male and female detents of the detent engagement can be on alternate sides of the gate opening.

[0269] The base of the housing can have an upper opening extending from a skirt of the base to the proximal end of the housing. The skirt can be rectangular. The skirt can have rounded edges. Other skirt shapes, such as circular and triangular, are also contemplated.

[0270] A movable bridge or bridges may extend over the opening. The movable bridge may have a splitting or moving edge that may be collinear with the gate opening. In some embodiments, the edges may be connected to each other with a living hinge. In some embodiments, the edges may be connected to each other with a frangible living hinge. The edges may be split by applying a radial force to the base facing outward from the edge.

[0271] The base can have wings extending from its sides. Once the skin is punctured, the wings can be held to advance the catheter assembly toward the patient. The wings can have protruding grips for improved handling. The wings can also be pressed downward, away from the base opening, to apply a radial force to the housing. In some embodiments, pressing down on the wings can apply enough force to split the movable bridge. In some embodiments, pressing down on the wings can split one or more components, including the movable bridge, the gate opening, and the lock, and unlock the lock. In such embodiments, the ability to split one or more components can depend on the length and / or material properties of the housing. For example, a shorter housing reduces the distance that force must travel along the length of the housing, resulting in less force dissipation between the wings and the nose end. In another example, a housing constructed from a material with lower ductility or hardness can allow one or more of the movable bridge, the gate opening, and the lock to split more easily.

[0272] An extension indwelling catheter assembly according to aspects of the present invention is understood to have a housing with a base. The base can have an upper opening for monitoring flashback from the needle hub. The housing may further have a body opening providing access to an interior space housing the catheter hub. The catheter hub can be pushed to a distal position via a push tab extending from the catheter hub and exiting the body opening to fully advance the catheter tube once inside the body. The body opening may extend between the skirt of the base and the proximal section cover. The proximal section cover may allow the catheter assembly to be held from a more proximal position relative to the patient, thus accommodating larger hands and providing more holding positions for improved control. The base may be rectangular up to the proximal section cover, which may also be cylindrical. In some embodiments, the base may be fully rectangular or fully cylindrical.

[0273] The gate opening at the top of the housing can longitudinally bisect the housing between the nose end and the proximal end. Having a proximal compartment cover, and therefore a gate opening, can provide additional structural reinforcement to the housing by bisecting the housing all the way from the nose end to the proximal end. Therefore, additional force may be required to widen the gate opening to remove the catheter hub from the interior space of the housing than in a catheter assembly without a proximal compartment cover. In some embodiments, the gate opening can be a living hinge. In some embodiments, the gate opening can be a frangible living hinge.

[0274] The proximal compartment cover can have wings. When the wings are pushed downward, meaning away from the base opening, to remove the catheter hub, more force may be required than in a shorter catheter assembly without a proximal compartment cover because the wings and nose end are farther apart than in such a catheter assembly and the gate opening, unlike in such an assembly, continues to bisect the housing proximal to the base opening. In some embodiments, if additional reinforcement is not desired, the housing can be constructed of a material with lower ductility or hardness than a catheter assembly without a proximal compartment cover to allow easier removal of the catheter hub from the housing despite the aforementioned constraints.

[0275] An indwelling extension catheter assembly according to aspects of the present invention is understood to have a housing constructed from separate parts. The housing may have a first frame and a second frame. The first and second frames may be held together by a hinge or multiple hinges. The hinge may be located at the bottom of the housing. The first frame may have a male hinge portion and the second frame may have a female hinge portion. In other embodiments, the first frame may have a female hinge portion and the second frame may have a male hinge portion. A pin can pass through both the male and female portions. In some embodiments, the male portion may be insertable into the female portion instead of using a pin.

[0276] In some embodiments, the housing may be constructed as a single piece. In such embodiments, the hinge may be a living hinge. In some such embodiments, the hinge may resemble a conventional hinge, such as a hinge commonly used to open and close a door. The hinge may allow the first frame to open and hang from the second frame in the open position.

[0277] The first and second frames may have a top seam at the top of the housing and a bottom seam at the bottom of the housing. The top and bottom seams may bisect the housing. The top and bottom seams may be living hinges, frangible living hinges, or spaced apart. In some embodiments, only the top seam may be a living hinge or a frangible living hinge. In some such embodiments, only the bottom seam may be a living hinge or a frangible living hinge. In some embodiments, one of the top seam and the bottom seam may be a living hinge while another of the top seam and the bottom seam may be a frangible living hinge. In some embodiments, one of the top and bottom seams may be a frangible living hinge while the other of the top and bottom seams may be a living hinge. In some embodiments, some portions of the top and bottom seams may be living hinges and some portions may be frangible living hinges. The living hinges and / or frangible living hinges of the upper and / or lower joints can be separated by applying a radial force directed away from the upper and lower joints to the housing to pull the first frame down from the closed state to the open state. The radial force can be applied by depressing wings located on the proximal compartment cover of the base. The upper joint is positioned above the lower joint in terms of height.

[0278] The base of the housing may be separated from the remainder of the housing by a skirt. In some embodiments, the proximal compartment cover may be removed and wings may extend from the face of the base. In some embodiments, the face may have protrusions to provide improved grip.

[0279] In addition to or instead of wings, the radial force can be applied by depressing a rail extending from the housing. The rail can extend from the skirt to the nose section. The rail can extend widthwise from a body opening that provides access to the interior space of the housing. The rail can be supported by one or more rail legs extending between the bottom of the rail and the housing.

[0280] The lock can act as additional reinforcement to keep the top and bottom seams intact. The lock can interrupt the top seam. The lock can be located in the nose section of the housing between the nose end and the body opening. In some embodiments, there can be multiple locks. In some embodiments, the lock can be a detent engagement of the first and second frames. In some embodiments, the detent engagement can be released by pushing the tab out of engagement to lift the male detent and release it from the female detent. The tab can be located on the same frame as the male detent. In some embodiments, the male detent can be on the second frame and the female detent can be on the first frame. In some embodiments, the male detent can be on the first frame and the female detent can be on the second frame.

[0281] The tabs may have a curved shape resembling a fin. The inner curve of the tabs may have a roughened surface. The roughened surface may provide an improved grip. In some embodiments, the tabs may be eliminated. In such embodiments, the detent engagement may be released by applying an additional radial force to the housing when pulling the first frame down from the closed state to the open state.

[0282] The catheter hub of the catheter assembly can be pushed to a distal position via a push tab extending from the catheter hub and exiting the body opening to fully advance the catheter tube once inside the body. In the distal position, the catheter hub can be partially covered by the nose section. Also, in the distal position, the push tab can abut against the nose section to stop further movement of the catheter hub into the nose section.

[0283] The first frame may hang open from the second frame by a hinge. The first frame may not contact the second frame at the bottom seam except at the hinge. In embodiments having a top seam that is a living hinge and / or a frangible living hinge, the top seam can be torn open by applying a radial force to the housing.

[0284] The needle hub may be tightly fitted to the second frame to prevent the needle hub from falling out of the interior space after the housing is opened from the first frame. In other embodiments, the location of one, some, or all features and / or components of the housing may be switched to the opposing frame to allow the housing to be opened from the second frame.

[0285] The catheter hub can be removed from the housing by moving the nose section laterally while holding the catheter hub in place. The catheter hub may then remain attached to the patient. When the catheter hub is removed from the assembly, the needle may be exposed. The needle can engage a needle guard (not shown) located inside the catheter hub as the needle is withdrawn from the catheter hub. The needle guard can prevent needle sticks. The needle, needle hub, and housing can then be safely discarded.

[0286] An indwelling extension catheter assembly according to aspects of the present invention is understood to have a housing constructed from a single piece. The housing may have a hinge. The hinge may be a living hinge. The hinge may not have a pin. The housing may have a lock or locks to hold the housing closed. The lock may not feature a tab. The housing may be retained from the proximal base of the housing. Wings or a proximal compartment cover may be omitted. Thus, the base may be open at the proximal end. A needle hub may extend proximally from the base.

[0287] An indwelling extension catheter assembly according to aspects of the present invention is understood to have a housing constructed from separate parts. The housing may have a first frame and a second frame. The first and second frames may be held together by a detent engagement between the first and second frames. The detent engagement may be located in the nose section of the housing between the nose end and the body opening. In some embodiments, there may be multiple detent engagements between the first and second frames. In some embodiments, the detent engagement may be released by pressing a button on the housing, which separates the first and second frames. Once the first and second frames are disconnected, the catheter hub may be released from the interior space of the housing.

[0288] The button can have one or more angled sides that apply a radial force to the housing to release the detent engagement when the button is depressed. The button can be housed within a button housing. The button can have a top surface. The top surface can be directly contacted to depress the button. The top surface can be circular. Other shapes for the top surface, such as oval, square, and rectangular, are also contemplated. The button can be located proximal to the body opening on the base of the housing. The needle hub can extend from within the interior space out of the base. The base can be sized so that more than half of the needle hub is exposed. In some embodiments, the button can be replaced with a latch that is unlatched by applying a radial force to the housing to release the detent engagement.

[0289] In some embodiments, the male detent of the detent engagement may be on the second frame and the female detent of the detent engagement may be on the first frame. In some embodiments, the male detent may be on the first frame and the female detent may be on the second frame. Once the detent engagement is fully disengaged and the first and second frames are completely removed from each other, the catheter hub can be pulled from the housing. In some embodiments, the partially disengaged state may be the result of the button being only partially depressed. In some embodiments, the partially disengaged state may be the result of the button being fully depressed, and the frames may require additional radial force to complete removal from each other. For example, each frame may be grasped with one hand and pulled away from the partially disengaged state.

[0290] When the button is in a depressed state, the button housing may separate, with a first half of the button housing on the first frame and a second half of the button housing on the second frame. The button housing may have one or more sloped sidewalls. Each sloped sidewall may slidably receive a corresponding side surface. When the button is pressed, the sidewalls and side ramps may align, so that unless the button housing separates, no space is left for the button to move downward, and each side surface may apply force to each sloped sidewall.

[0291] One or more male tabs and one or more female tabs that can mate with the one or more male tabs may extend from the first and second halves of the button housing. A male tab may extend from each side of the first half and a female tab may extend from each side of the second half. In other embodiments, a male tab may extend from each side of the second half and a female tab may extend from each side of the first half. In other embodiments, one of the sides may have a male tab and the other side may have a female tab, or one of the sides may have a female tab and the other side may have a male tab.

[0292] One of the female tabs may be slidably engageable with a recess on the button. When the button is pressed, the male tab may disengage from the female tab by radial force applied to the button housing and the recess roof depressing the female tab, thereby releasing it from the complementary male tab. In other embodiments, there may be multiple recesses that may be slidably engageable with multiple female tabs and multiple recess roofs that may release multiple female tabs from the male tabs.

[0293] The angled side of the button can have a pin extending therefrom. The button can be attached to the catheter assembly by coupling the pin to a seat located inside the button housing. When the button is pressed, the pin can move up and down within the seat until the first and second frames separate along with the button and can be safely discarded. In some embodiments, the button can be coupled to one of the first and second frames such that the button remains with that frame after the frames separate from one another. By way of example and not limitation, such a coupling that allows the button to remain with one of the frames can require one of the pins to fit tightly within its complementary seat.

[0294] The button may have a sloped rear surface in addition to the sloped sides. In some embodiments, the sloped rear surface can facilitate sliding of the button when pressed. In some embodiments, the sloped rear surface can exert a radial force on the button housing because the bulk of the button within the housing changes when pressed. The pin can have legs that extend below and connect from the bottom of the button. The legs can allow the button to move evenly downward when pressed.

[0295] An indwelling extension catheter assembly according to an embodiment of the present invention is understood to have a housing constructed from separate parts. The housing may have a first frame and a second frame. The first and second frames may be held together by a clamp-shaft coupling. The first and second frames can pivot or rotate relative to one another at the clamp-shaft coupling to open the housing. The clamp-shaft coupling may be disposed between the upper and lower body openings of the housing and the base of the housing. The base may have ends on each of the first and second frames that curve outward in the proximal direction. The curved ends can be pressed together and used as leverage to open the housing. Once the housing is opened, a catheter hub disposed within the interior space of the housing can be removed.

[0296] Prior to removal, the catheter hub can be pushed distally to advance the catheter tube into the patient. The catheter hub can be pushed with a pusher. The pusher can have a T-shape. The pusher can be initially proximal to the push tab on the catheter hub. The pusher can be pushed distally to engage the push tab and push the catheter hub into the nose section of the housing. Once the catheter hub is fully advanced, the base can be squeezed from the base end to open the housing and remove it from the catheter hub.

[0297] The clamp-shaft coupling can have pairs of upper clamps and upper shafts, and lower clamps and lower shafts. The upper and lower clamps can be on alternating frames. Similarly, the upper and lower shafts can be on alternating frames. In some embodiments, the upper and lower clamps can be on the same frame, and thus the upper and lower shafts. In some embodiments, the clamp-shaft coupling can be replaced with another connection that allows the first and second frames to pivot. By way of example and not limitation, such a connection can be a hinge, such as a traditional hinge used to open and close doors.

[0298] The base can have a plurality of grips protruding from each of the first and second frames. The grips can provide an improved grip when holding the catheter assembly from the base. The grips can be pleated in shape and arrangement. The base can also have a second type of grip protruding from each of the first and second frames. The grips can be positioned more proximal to the housing relative to the grips. The grips can be circular in shape. The grips can have curved surfaces that complement the user's fingertips. The grips can provide an improved grip when the user grasps the base end to open the housing.

[0299] The pusher can have a pair of legs, one at each end of the T-shaped cap. The legs can have a hook shape. The hook shapes of the legs can each slidably engage with a track on the housing. The tracks can extend along each side of the upper body opening. The pusher can first engage with a push tab on the catheter hub and then slide distally on the track to push the catheter hub toward the nose section.

[0300] In the fully advanced or distal position, the push tab may be sandwiched between the nose section and the pusher. The pusher can be slid to this position by holding and guiding it from the handle. The handle may be horizontal above the legs. Having the handle further out from the housing makes it easier to grip the pusher and allows the handle of the pusher to rest above the base when in the proximal position. The handle may have a protrusion to improve grip.

[0301] In the distal position, each leg of the legs may be above the track end of the track. The track end may be a recess between the nose section and the track on each side of the upper body opening. The track end may be dimensioned to provide space for the hooked legs of the pusher to not grip the housing but to be removed from the housing. The first and second frames may each have a grip extending across the nose section and base. The grip may be used to push or remove the pusher with one hand while holding the catheter assembly with the other.

[0302] When the housing is opened, the opening between the first and second frames can be reduced proximally because the pivot point clamp-shaft coupling is located within the proximal section of the housing. The pusher and housing can be discarded, and the catheter hub can remain attached to the patient.

[0303] At the distal end of the housing, a tip can extend from the nose end. The tip can have two separable sections, one for each of the first and second frames. The sections can form a double butt lap joint when the housing is closed. The tip sections can be on top of the sections when joined together. In other embodiments, the sections can be on top of the sections when joined together.

[0304] The lock can serve as additional reinforcement to join the sections and generally keep the first and second frames intact. The lock can interrupt the upper seam. The lock can be located in the nose section of the housing between the nose end and the upper body opening. In some embodiments, there can be multiple locks. In such embodiments, one of the locks can be located between the nose end and the lower body opening.

[0305] In some embodiments, the lock may be a detent engagement of the first and second frames. In some embodiments, the detent engagement can be disengaged by squeezing the curved base ends together. A radial force on the housing can lift the male detent and release it from the female detent. In some embodiments, the male detent may be on the second frame and the female detent may be on the first frame. In some embodiments, the male detent may be on the first frame and the female detent may be on the second frame. In embodiments with multiple locks, the male and female detents may alternate between the first and second frames, respectively.

[0306] There may be other embodiments of the pusher having distal and proximal handles. The distal and proximal handles can provide multiple options for holding the pusher. Depending on the size of the user's hand or the position of the catheter assembly relative to the patient, it may be easier to hold the pusher from the distal or proximal handle. The proximal handle may be elevated relative to the distal handle. The elevated position of the proximal handle may allow the proximal handle to seat on the base of the housing when the pusher is in the proximal position. The distal and proximal handles may be the same size or different sizes. The distal and proximal handles may each have one or more grips protruding therefrom. The distal handle may have a tip extending distally therefrom. The tip may be curved upward. The curvature of the tip may allow the user's fingers to engage the distal handle without slipping and utilize the tip when sliding the pusher distally.

[0307] It is understood that an indwelling extension catheter assembly according to an embodiment of the present invention has a housing that may be constructed from separate parts. The housing may have a first frame and a second frame. The first and second frames may be held together by a clamp-shaft coupling. The first and second arms may be pivotally or rotatably attached to the clamp-shaft coupling. The first and second arms may overlap one another. Due to the overlap, the first and second arms may resemble scissors. The first and second arms may have a distal section and a proximal section. The distal section may be within the interior space of the housing, and the proximal section may extend from the interior space. The distal section may push the first and second frames apart when the first and second arms pivot away from each other at the clamp-shaft coupling to open the housing when the ends of the housing are squeezed. The first and second arms may provide additional leverage, making it easier to open the housing. A lock or locks holding the first and second frames together may be easier to unlock due to the radial force applied to the housing by the first and second arms.

[0308] The clamp-shaft coupling may be larger in size than a catheter assembly without the first and second arms. The larger size may allow the first and second arms to pivot with less force. Multiple locks are shown, one located in the nose section of the housing between the nose end and the upper body opening and another located between the nose end and the lower body opening.

[0309] An indwelling extension catheter assembly according to aspects of the present invention is understood to have a housing constructed from separate parts. The housing may have a first frame and a second frame. The first and second frames may have an upper seam and a lower seam. The upper seam may be located in the nose section of the housing. The upper seam may curve and expand into the body opening.

[0310] At the distal end of the housing, a tip can extend from the nose end. The tip can have two separable sections, one for each of the first and second frames. The sections can form two finger joints, one extending from the top joint and the other extending from the bottom joint, when the first and second frames are together.

[0311] The first and second frames may be held together by a bottom plate. The bottom plate may have long tabs engageable with slots in the first frame and short tabs engageable with slots in the second frame. A latch pivotally attachable to the bottom plate and the first frame may, when actuated, pull the bottom plate proximally, thereby releasing the short tabs from their slots. At the same time, the long tabs may still engage the slots, thereby allowing the second frame to separate from the first frame, which remains attached to the bottom plate and the latch. The latch may extend beyond the base of the housing. When the needle hub is pushed to a distal position, the catheter hub may be ejected proximally from the base.

[0312] The long and short tabs may be distal to the long and short tabs. The long and short tabs may extend from their respective slots to the first and second frame distal slot recesses when engaged with the first and second frames, respectively. The first and second frame distal slot recesses may have the same dimensions. The first and second frame distal slot recesses may have a trapezoidal shape. Other shapes, such as rectangular, square, and triangular, are also contemplated.

[0313] The long and short tabs may extend from their respective slots to the first and second frame proximal slot recesses when engaged with the first and second frames, respectively. The first frame proximal slot recess may be larger in size than the second frame proximal slot recess. The larger size of the first frame proximal slot recess allows it to accommodate the long tab. The first and second frame proximal slot recesses may provide a snug fit for the tabs. In other embodiments, the first and second frame proximal slot recesses may have the same size. In such embodiments, the fit of the tabs may not be snug.

[0314] The tabs may have chamfered distal ends. The tabs may have rounded distal ends. In other embodiments, all distal ends may be rounded, chamfered, or angular. The slots may be just wide enough to accommodate each tab. The tabs may be directly adjacent to the base.

[0315] The bottom plate may be positioned inside the interior space of the housing below the catheter hub. The tabs engageable with the first frame and the tabs engageable with the second frame may be separated by a groove. The groove may extend along the entire length of the bottom plate on the upwardly facing surface or toward the catheter hub when assembled. The latch may be pivotally or rotatably connected to the first frame from below the bottom plate. The connection may be facilitated by a connecting pin. The connecting pin may extend inward from a distal bottom corner of the first face of the latch or toward the interior space. The connecting pin may have a generally cylindrical shape with a protrusion on its outer surface extending along its length. The protrusion may engage a slot inside the base of the first frame that limits rotation of the connecting pin to allow the latch to pivot proximally only a certain amount.

[0316] The latch can have a top and a second surface. The top can have teeth extending downward from an inner surface facing the base when assembled. The teeth can form finger joints with opposing teeth that fit between them. A first half of the teeth can be on the first frame and a second half can be on the second frame. In some embodiments, there can be multiple teeth that can be received by multiple sets of teeth. The top and first surface can extend across the entire height and width of the base. The second surface can extend partially across the height of the base. The first surface can have a proximal bottom corner. An edge can extend across the bottom corner. The edge can be beveled, with the proximal bottom corner being higher in height than the distal bottom corner.

[0317] The latch may be movably connected to the base plate using a shaft that extends inward or toward the base. The shaft may be cylindrical. The shaft may move laterally in a proximal direction when the latch is pulled in the same direction. The lateral movement of the shaft may be limited by limited rotation of the connecting pin. The first and second faces of the latch may form a filleted corner with the top of the latch. In other embodiments, the corner may be straight.

[0318] The bottom plate may have a proximal hook attached to the shaft of the latch. When the latch is pulled proximally, the shaft can pull the bottom plate proximally from the proximal hook. When the bottom plate is pulled proximally, the short tabs disengage from their respective slots, while the long tabs remain engaged with their respective slots. As a result, the second frame is detached from the first frame, which remains attached to the latch and bottom plate. The first and second frames may be separated from the catheter hub, which may remain attached to the patient. The first and second frames can then be discarded.

[0319] Methods of making and using the indwelling extension catheter assembly and its components are within the scope of the present invention. [Brief explanation of the drawings]

[0320] These and other features and advantages of the present devices, systems, and methods will become better understood as they become better understood with reference to the specification, claims, and accompanying drawings.

[0321] [Figure 1] 1 is a schematic perspective view of an indwelling extension catheter assembly in accordance with an aspect of the present invention;

[0322] [Figure 2] 1 is a side cross-sectional view of a catheter assembly provided in accordance with an aspect of the present invention for use with a multi-part housing.

[0323] [Figure 3] FIG. 2 is a side view of the assembly of FIG. 1.

[0324] [Figure 4] 2 is a perspective view of the indwelling extension catheter assembly of FIG. 1 taken from a different perspective.

[0325] [Figure 5] 2 is a partial perspective view of the extension indwelling catheter assembly of FIG. 1 taken from a different perspective and shown without one of the housing components.

[0326] [Figure 6] FIG. 2 is a partial perspective view of one of the housing components of the extension indwelling catheter assembly of FIG. 1.

[0327] [Figure 7] 7 is a perspective view of the housing component of FIG. 6 from a different perspective.

[0328] [Figure 8] 2 is a partial perspective view of the extension indwelling catheter assembly of FIG. 1 taken from a different perspective and shown without one of the housing components. FIG.

[0329] [Figure 9] FIG. 2 is a perspective view of one of the housing components of the extension indwelling catheter assembly of FIG. 1.

[0330] [Figure 10] 2 is a partial perspective view of the indwelling extension catheter assembly of FIG. 1 taken from a different perspective.

[0331] [Figure 11] 10 is a perspective view of the housing component of FIG. 9 from a different perspective.

[0332] [Figure 12] 10 is a perspective view of the housing component of FIG. 9 from a different perspective.

[0333] [Figure 13] 10 is a perspective view of the housing component of FIG. 9 from a different perspective.

[0334] [Figure 14] 2 is a perspective view of the extension indwelling catheter assembly of FIG. 1 taken from a different perspective and shown without one of the housing components.

[0335] [Figure 15] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0336] [Figure 16] FIG. 16 is a perspective view of the indwelling extension catheter assembly of FIG. 15 taken from another perspective.

[0337] [Figure 17] 16 is a perspective view of the extension indwelling catheter assembly of FIG. 15 taken from a different perspective and shown without one of the housing components.

[0338] [Figure 18A]16 is a partial perspective view of the extension indwelling catheter assembly of FIG. 15 taken from a different perspective and shown without one of the housing components. [Figure 18B] 16 is a partial perspective view of the extension indwelling catheter assembly of FIG. 15 taken from a different perspective and shown without one of the housing components.

[0339] [Figure 19] FIG. 19 is a perspective view of one of the housing components of FIG. 18.

[0340] [Figure 20] FIG. 19 is a perspective view of one of the housing components of FIG. 18.

[0341] [Figure 21] FIG. 19 is a perspective view of one of the housing components of FIG. 18.

[0342] [Figure 22] FIG. 19 is a perspective view of one of the housing components of FIG. 18.

[0343] [Figure 23] FIG. 19 is a perspective view of one of the housing components of FIG. 18.

[0344] [Figure 24] 16 is a perspective view of the extension indwelling catheter assembly of FIG. 15 taken from a different perspective and shown without one of the housing components.

[0345] [Figure 25] FIG. 25 is a perspective view of one of the housing components of FIG. 24.

[0346] [Figure 26] FIG. 26 is a perspective view of one of the housing components of FIG. 25.

[0347] [Figure 27] FIG. 26 is a perspective view of one of the housing components of FIG. 25.

[0348] [Figure 28] FIG. 16 is a schematic diagram of the extension indwelling catheter assembly of FIG. 15 showing a pair of force components when the catheter hub contacts the activation ramp.

[0349] [Figure 29] 1A-1C are different views and cross-sectional views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly. [Figure 30] 1A-1C are different views and cross-sectional views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly. [Figure 31] 1A-1C are different views and cross-sectional views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly.

[0350] [Figure 32] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly provided in accordance with a further aspect of the present invention.

[0351] [Figure 33] FIG. 33 is a top view of the ExD catheter assembly of FIG. 32.

[0352] [Figure 34] FIG. 33 is a bottom view of the ExD catheter assembly of FIG. 32.

[0353] [Figure 35] 33A and 33B are enlarged top and bottom views of the distal end of the housing of the ExD catheter assembly of FIG. 32. [Figure 36] 33A and 33B are enlarged top and bottom views of the distal end of the housing of the ExD catheter assembly of FIG. 32.

[0354] [Figure 37] FIG. 33 is an enlarged perspective view of a cross section of the ExD catheter assembly of FIG. 32, showing only the first frame.

[0355] [Figure 38] FIG. 33 is an enlarged perspective view of a cross section of the ExD catheter assembly of FIG. 32, showing only the second frame.

[0356] [Figure 39] 10A-10C are different views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly, according to a further embodiment of the present invention. [Figure 40] 10A-10C are different views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly, according to a further embodiment of the present invention. [Figure 41] 10A-10C are different views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly, according to a further embodiment of the present invention. [Figure 42] 10A-10C are different views of a tab adapter for use with a catheter hub to facilitate manipulation of an ExD catheter assembly, according to a further embodiment of the present invention.

[0357] [Figure 43] FIG. 43 is a perspective view of the ExD catheter assembly of FIG. 32 shown with the tab adapter of FIGS. 39-42 attached to a catheter hub.

[0358] [Figure 44] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0359] [Figure 45A] 1 shows different views of a tab adapter. [Figure 45B] 1 shows different views of a tab adapter. [Figure 45C] 1 shows different views of a tab adapter.

[0360] [Figure 46]FIG. 1 is a perspective view of a housing having a gate assembly.

[0361] [Figure 47A] 1A-1C show different views of the gate assembly in an open state. [Figure 47B] 1A-1C show different views of the gate assembly in an open state.

[0362] [Figure 48A] 1A-1C show different views of the gate assembly in an assembled state. [Figure 48B] 1A-1C show different views of the gate assembly in an assembled state. [Figure 48C] 1A-1C show different views of the gate assembly in an assembled state.

[0363] [Figure 49] 1 shows the direction of movement for assembling the gate assembly.

[0364] [Figure 50] 10 shows the direction of movement for attaching the assembled gate assembly to the housing.

[0365] [Figure 51] FIG. 10 is a partial bottom perspective view showing the open distal end of the housing.

[0366] [Figure 52] FIG. 10 is a partial rear perspective view of the housing showing the open proximal end.

[0367] [Figure 53] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly provided in accordance with a further aspect of the present invention.

[0368] [Figure 54] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0369] [Figure 55] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0370] [Figure 56] FIG. 56 is a different perspective view of the extension indwelling catheter assembly of FIG. 55 with the catheter hub in a distal position.

[0371] [Figure 57] FIG. 56 is a perspective view of the extension indwelling catheter assembly of FIG. 55 with the catheter hub in a distal position and the housing components in an open position.

[0372] [Figure 58] FIG. 56 is a perspective view of the extension indwelling catheter assembly of FIG. 55 with the catheter hub removed from the housing component.

[0373] [Figure 59] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0374] [Figure 60] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0375] [Figure 61] FIG. 61 is an enlarged perspective view of the proximal end of the extension indwelling catheter assembly of FIG. 60.

[0376] [Figure 62] FIG. 61 is an enlarged perspective view of the distal end of the extension indwelling catheter assembly of FIG. 60.

[0377] [Figure 63] FIG. 61 is an enlarged perspective view of the housing component separation button of the extension indwelling catheter assembly of FIG. 60.

[0378] [Figure 64]FIG. 61 is a partial perspective view of the extension indwelling catheter assembly of FIG. 60 without the housing components.

[0379] [Figure 65] FIG. 61 is an enlarged view of the housing component separation button of the extension indwelling catheter assembly of FIG. 60 without the housing component.

[0380] [Figure 66] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0381] [Figure 67] FIG. 67 is an enlarged perspective view of the clamp-shaft connection of the housing component of the extension indwelling catheter assembly of FIG. 66.

[0382] [Figure 68] FIG. 67 is an enlarged view of the catheter hub pusher and clamp of the catheter hub with push tab of the extended indwelling catheter assembly of FIG.

[0383] [Figure 69] FIG. 67 is a partial perspective view of the extended indwelling catheter assembly of FIG. 66 with the catheter hub pusher and catheter hub in a distal position.

[0384] [Figure 70] FIG. 67 is a partial perspective view of the extension indwelling catheter assembly of FIG. 66 with the housing component in an open position and the catheter hub pusher removed from the housing component.

[0385] [Figure 71] FIG. 67 is an enlarged perspective view of the distal end of the housing component of the dwell catheter assembly of FIG. 66.

[0386] [Figure 72]FIG. 67 is an enlarged perspective view of the proximal end of the housing component of the dwell catheter assembly of FIG. 66, featuring another embodiment of the catheter hub pusher.

[0387] [Figure 73] 1 is a schematic top view of an indwelling extension catheter assembly according to a further aspect of the present invention; FIG.

[0388] [Figure 74] FIG. 74 is a side view of the indwelling extension catheter assembly of FIG. 73.

[0389] [Figure 75] FIG. 10 is a schematic perspective view of an indwelling extension catheter assembly according to a further aspect of the present invention.

[0390] [Figure 76] FIG. 76 is a perspective view of the bottom of the indwelling extension catheter assembly of FIG. 75.

[0391] [Figure 77] FIG. 76 is an enlarged perspective view of the bottom of the indwelling extension catheter assembly of FIG. 75.

[0392] [Figure 78] FIG. 76 is a perspective view of the extension indwelling catheter assembly of FIG. 75 without the first housing component frame.

[0393] [Figure 79] FIG. 76 is an isolated perspective view of the latch and bottom plate of the extension indwelling catheter assembly of FIG. 75.

[0394] [Figure 80] FIG. 76 is an isolated side view of the latch and bottom plate of the extension indwelling catheter assembly of FIG. 75. DETAILED DESCRIPTION OF THE INVENTION

[0395] The detailed description set forth below in connection with the accompanying drawing figures 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. The description explains features and steps for constructing and using embodiments of the present device, system, and method in connection with the illustrated embodiment. However, it should be understood that the same or equivalent functions and structures may be achieved by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As shown elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

[0396] Broadly speaking, each of the extended-dwelling ("ExD") catheter assemblies described herein includes a housing and a catheter assembly. The housing is configured to accommodate the catheter assembly by separating the catheter hub from the needle hub upon advancement of the catheter during initial puncture, and by subsequently actuating to separate the catheter hub from the housing, allowing the catheter to remain with the patient. The housing and catheter hub can be separated via a variety of different mechanisms. For example, the housing can be split into two or more housing sections to release the catheter hub; the housing can have sections that swing, rotate, or pivot; the housing can have an end cap component that swings to open a gate opening to allow the catheter hub to exit the housing; and the housing can have a gate assembly attached to the distal end of the housing, among other options. The gate assembly can have two gates disposed in a two-gate housing body that can be joined, each of which can swing open via a living hinge. The two gates can engage via a male detent and a receiving slot; or the two gates can engage via a hook arm and a female detent. The unique housing design allows for use with standard or existing catheter assemblies, optionally without the need for specially designed catheters. Thus, standard catheters with extended lengths and midline catheters with catheter lengths of approximately 8-10 cm can be readily used with the disclosed housing, with or without a guidewire.

[0397] Referring now to FIG. 1 , a perspective view of an exemplary embodiment of an extended indwelling catheter assembly 100 according to an aspect of the present invention is shown. In the illustrated example, the extended indwelling or ExD catheter assembly 100 comprises a housing 102 having a receiving space or interior space 104 within which is disposed a catheter assembly 108 having a catheter tube 110 extending from a distal end 120 of the housing 102 and a needle 112 disposed within the lumen of the catheter tube. 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 a proximal opening of the needle hub 122, such as with a luer fitting.

[0398] 2, 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 may be used with the housing 102 to form an ExD catheter assembly according to embodiments of the present invention. Optionally, a guidewire may be incorporated to aid in the insertion, positioning, and movement of the catheter, as described further below.

[0399] In the example, the catheter assembly 108 includes a first hub or catheter hub 130 having an over-needle tube or catheter tube 110 attached thereto, and a second hub or needle hub 122 having a needle 112 attached thereto. 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 assembly is in a ready-to-use position, ready for venipuncture. The catheter assembly 108 is sometimes referred to as a needle assembly.

[0400] The needle 112 can include a change in profile 136 located proximal to the needle tip 114 for use with a needle guard. In the ready-to-use position, the needle tip 114 extends distally of the distal end opening of the tube or tubing 110 and, when incorporated for use with a needle guard, has a change in profile 136 located proximal to the distal end opening 110a. The change in profile 136 can be a crimp, bump, or accumulation of material having a different profile than other diameter sections 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 opposite end or side.

[0401] The change in profile 136 can be used to interact with a needle guard 140 during retraction of the needle 112 after successful venipuncture, as described further below. A vent plug 124 is disposed at a proximal open end 138 of the second hub or needle hub 122. The vent 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.

[0402] A needle guard 140 can be provided in the internal cavity 148 of the first hub or catheter hub 130 to cover the needle tip 114 in a protected position. When 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 examples, the needle guard 140 can be omitted. If so, the change in profile on the needle 136 can also be omitted. In still other examples, the needle guard can be included without also including a change in profile on the needle. In still 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 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. For example, the needle guard can include a first protector body surrounded by a second protector body, the contents of which are expressly incorporated herein by reference.

[0403] In an example, 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 be disposed on the side of the needle and include a wall that can move distally of the needle tip to guard the needle tip from accidental contact with the needle tip. The wall can be a needle trap and can move directly in front of or distal to the tip of the needle tip.

[0404] 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 in the ready-to-use position in FIG. 1 and when viewed from the side of FIG. 1, and in a protective position in which the needle guard covers the needle tip, also when viewed from the side. In some examples, 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 are biased outward by the needle 112 in the ready-to-use position in FIG. 1 and can be positioned distal to an internal change 152 in the inner profile of the first hub 130 in the ready-to-use position. The internal change 152 in the profile can be a reduced diameter section positioned adjacent to a larger inner diameter section. The elbows on the two arms of the needle guard can have a dimension larger than the inner diameter at the internal change in profile 152, limiting proximal movement of the needle guard from the catheter hub until the two arms are no longer biased outward or the dimension at the two elbows decreases.

[0405] 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, the dimension measured between the two joints or elbows at the intersection between each arm and its respective distal wall is greater than the inner diameter of the profile's internal transition 152, which prevents the needle guard 140 from moving proximally due to the relative dimensions. As the needle tip 114 moves proximally between the two distal walls, the two arms can move radially inward, causing one or both distal walls to close over the needle tip, blocking it in the protective position. At this point, the dimension between the two joints or elbows decreases and becomes smaller than the inner dimension of the profile's internal transition 152, which then allows 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 change 152 of the profile, and the needle can still be moved proximally by bending or squeezing the two joints to pass through the internal change 152 of the profile.

[0406] The first hub 130 has a proximal opening 156 with a nose section 158 of the second hub 122 disposed therein. The proximal opening 156 of the first hub has a female luer for receiving a male luer tip of a syringe, IV tubing connector, luer extension set, or the like. Male threads 154 can be provided on the exterior surface of the proximal end for threaded engagement with a threaded collar of the male luer tip. A pair of stabilizing wings 162 can extend radially from the first hub 130 to facilitate fixation of the first hub 130 to the patient after successful venipuncture. Optionally, the wings can be omitted. The first hub 130 can be embodied as a standard IV catheter hub without an injection port. In other examples, the first hub can include an injection port or an integrated extension set. If wings are not present on the first hub or catheter hub 130, the bottom of the first hub can have a flat surface sloped at an angle between 2 and 15 degrees from the through axis of the first hub.

[0407] The first hub 130 is removably secured to the second hub 122 by receiving the nose section 158 of the second hub in its proximal opening 156. A flange or extension 160 can be provided on the second hub 122, which, together with the nose section 158, defines a gap 166 within which a portion of the first hub is located. Optionally, the flange or extension 160 can be omitted, and a stub 164 or other surface-fitting feature can be provided. The stub 164 can be a keyed male portion within the gap that extends through or is partially within the Luer threads to inhibit rotation of the second hub 122 relative to the first hub 130. The proximal end face of the first hub abuts the distally facing surface of a step on the outer surface of the second hub at the proximal end of the nose section 158 inside the first hub. This abutment sets the extent to which the needle tip 114 protrudes from the catheter tubing 110a. The stub 164 may be an optional structural feature.

[0408] The second hub 122 has a body 168 with an optional internal cavity 170 with the proximal end 172 of the needle 112 protruding therein. The internal cavity 170 can function as a primary blood flashback chamber. The proximal opening 138 of the body 168 can have a female luer therein for receiving the vent plug 124 or a syringe tip, and the exterior can be threaded or unthreaded. In an example, the exterior of the body 168 of the second hub 122 is generally cylindrical without threads. The first and second hubs can be fabricated from a plastic material, such as by a plastic injection process.

[0409] A push tab 176 can be provided on the first hub or catheter hub 130. The push tab 176 can be positioned on an outer surface 178 of the first hub 130 distal to the outer threads 154 so as to avoid interference with the outer threads. For example, the push tab 176 should be positioned sufficiently distal to the male threads 154 so that when a threaded male connector, such as a syringe-type connector having a threaded collar, is connected to the threads of the first hub, the push tab 176 does not interfere with the connection. In some examples, the push tab 176 should be positioned sufficiently distal to the outer threads 154 so that when the push tab 176 is folded, the push tab does not interfere with the connection.

[0410] In some examples, the catheter assembly 108 can incorporate a valve and a valve opener. For example, both the valve and the valve opener can be disposed within the catheter hub 130. In use, the valve opener can be pushed distally into the valve to open one or more slits formed with the valve and open a fluid passageway through the valve for fluid flow. An exemplary valved catheter assembly having 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 section having a bore and a plunger section disposed proximal to the nose section. The nose section can be pushed into the valve to open one or more slits in the valve, such as three slits defining three flaps. The plunger section can include two or more plunger components with a gap between them. The gap can allow fluid to flow through the plunger components and through the bore of the nose section.

[0411] Referring again to FIG. 1 in addition to FIG. 2, the housing 102 of the present ExD catheter assembly 100 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 the nose end 184, the two body portions 188a can be joined to form the body 188, and the two base ends 190a can be joined to form the base end 190. In the example, the nose end or nose portion 184 is provided with a nose tip 186 having an elongated cylindrical structure with a bore for accommodating the catheter tube 110 and needle 112, which is disposed within the catheter tube. The nose end or nose portion 184 can further include a nose base 192 having an enlarged portion formed by the tip portion 186 and a tapered distal portion. A plurality of support ribs or fins may be provided at the intersection between the tip 186 and the nose base 192. In another example, the nose end 184 may be a sphere or rounded dome with openings for accommodating the catheter tube and needle. In another example, the nose end 184 may have a different shape, such as resembling a multi-sided structure connected to form a closed end with a central opening for accommodating the needle and catheter tube.

[0412] The body 188 has an interior space 104 for receiving a catheter assembly, which may be the catheter assembly 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 end 190.

[0413] In an example, the body 188 is provided with a second opening opposite the first opening 196, allowing access to the interior space 104 through both body openings. Thus, the body can have a through passage defined by the two body openings 196. In other examples, the body 188 has only a single opening 196 leading to the interior space 104, as shown with the opposite sides being solid or surrounded by first and second frame walls. Optionally, the surrounded surface can have a small window or opening for access or ventilation, rather than a complete opening like the body opening 196.

[0414] The base or base end 190 extends from the body 188 and has multiple sides. In an example, there may be four sides 200, 202, 204, and 206 that define the interior space 104 that opens into the interior space 208 of the body 188. In other examples, the base 190 may be embodied as a generally elongated cylinder or non-cylindrical shape. For purposes of explanation, the sides 204 and 206 may be identified as the top and bottom sides, respectively. The sides 200 and 202 may be identified as the left and right sides, respectively. The sides may also be understood as the first side 200, the second side 202, the third side 204, and the fourth side 206. These specific nomenclature is provided solely to enable the designation of certain sides relative to other sides and is not limiting unless the context indicates otherwise.

[0415] 1, the base 190 can have an open proximal end to allow the needle hub 122 to extend proximally proximal of the end face 126a. As shown, the first and second faces 200, 202 of the base end 190 can each have an opening 210 that allows viewing and access to an interior space 208 of the base end 190, as described further below, to facilitate or assist in assembly of the catheter assembly 108 therein.

[0416] The top surface 204 of the base end 190 may include a first or top lever 214, and the bottom surface 206 may include a bottom lever 216 (FIG. 3). As described further below, when a user simultaneously applies a compressive and distal force to the top lever 214 and a compressive and proximal force to the bottom lever 216, the user can move the left and right housing frames 193, 194 relative to one another, separating the detents of the first and second frames 193, 194, and then separating the housing into separate housing components, i.e., the left and right frames 193, 194. In other words, by manipulating the top and bottom levers 214, 216, the user can separate the housing 102 into two or more housing components. Separation of the housing 102 into housing components can then expose the catheter assembly 108 to separate from the housing 102 after successful venipuncture, so that the catheter hub 130 (FIG. 2) can be secured to an IV line and secured to a patient, for example, by using tape or a securement dressing. In another example, by repositioning the detents or engagement tabs between the left and right housing frames 193, 194, a user can simultaneously apply a compressive and proximal force to the first or top lever 214 and a compressive and distal force to the second or bottom lever 216 to move the two housing sections relative to each other and separate the detents of the first and second frames 193, 194.

[0417] FIG. 3 is a side view of the ExD catheter assembly 100 of FIG. 1. In the illustrated orientation, a plurality of surface decorations 220 can be seen on or near the exterior of the left or first frame 193, specifically the left body 188. A similar set of surface decorations can be provided on the right or second frame 194. A generally flat top edge 224 is provided on both body frames 193, 194. Additionally, the distal-most edge of the top lever 214 is located proximal to the distal-most edge of the second or bottom lever 216. This arrangement allows for easy grasping of the top lever 214 by the thumb and the bottom lever 216 by the outer edge of the index finger to separate the housing 102 into housing components, as described further below. For example, the index finger can press against the curved, proximally-facing surface 216a of the bottom lever 216 and push in a distal or distal direction.

[0418] In other examples, the relative positioning between the top lever 214 and the bottom lever 216 can be changed or positioned differently depending on the detent type or snap connection incorporated to hold the first frame 193 and the second frame 194 together, as further described below.

[0419] Referring now to FIG. 4, a bottom perspective view of the ExD catheter assembly 100 of FIG. 1 is shown. As shown, the housing 102 includes a wall 230 facing the body opening 196 (FIG. 1) along the top surface of the housing, as previously described. A seam 232 extends longitudinally through the housing 102 and marks the interface between the left and right frames 193, 194 of the housing along the body 188 and nose end 184 of the housing. The seam 232 extends from the nose end 184 to and includes the base end 190 of the housing. However, the seam may be nonlinear or non-linear. For example, the seam 232 may be off-axis relative to the line defined by the seam 232 along the body and nose end. The seam at the base end 190 may be near an edge or intersection of a surface, such as the right side surface 202 or the bottom surface 206. Multiple pairs of detents can be incorporated between the left frame 193 and the right frame 194 to secure the two frames together, as shown in FIG. 4. In an example, the catheter assembly can be placed inside the housing 102 before engaging the left frame 193 with the right frame 194, or vice versa. After use, such as after successful venipuncture, the top lever 214 (FIG. 1) and second or bottom lever 216 can be actuated to separate the detents, which then separates the housing into components, such as separating the left frame 193 from the right frame, to separate the catheter assembly from the housing.

[0420] 5, the ExD catheter assembly 100 of FIG. 1 is shown with the first or left frame 193 separated from the right frame 194 and the catheter assembly 108 held by the right or second frame 194. In the example, the right frame 194 includes a second surface 202 and a top or third surface 204 on the base portion 190a, which are generally perpendicular to each other. The first surface 200 and the bottom or fourth surface 206 are provided with the left frame 193, which is separated from the right frame 194 in the separated view shown.

[0421] To secure the catheter assembly 108 to the right frame 194, and particularly to secure the needle hub against movement, the lower wall structure or portion 230a of the right frame 194 terminates in a proximal edge 240 disposed along an axial position on the right frame to accommodate the flange or extension 160 on the needle hub 122. The distal edge of the flange 160 is therefore restricted from shifting or moving distally by the proximal edge 240 on the lower wall structure 230a. To prevent proximal movement of the needle hub 122, the second surface 202 includes a channel 244 and a shoulder 246 (FIG. 6) on the proximal edge of the channel for retaining the flange 161 to the needle hub. The channel 244 located on the second surface 202 and the corresponding channel (FIG. 1) in the first surface 200 define a gap or width to accommodate the luer thread 154 on the catheter hub and the width of the flange 161 on the needle hub. Additionally, the non-circular structure for coupling flange 161 and groove channel 244, such as by using a multi-sided structure, prevents the needle hub from rotating while within the space defined by the faces of base end 190. This holds the needle hub in the assembled position so that the needle bevel can be oriented in a desired location without premature rotation prior to sequential venipuncture.

[0422] FIG. 6 is an enlarged view of the right or second frame 194, showing the body 188 of the right frame 194 and the base portion 190a of the right frame without the catheter assembly. With continued reference to FIG. 6 and further reference to FIG. 5, the second surface 202 of the base portion 190a is shown along with the channel 244 and shoulder 246. A plurality of tabs or male detents 250 are provided on the lower edge 252 of the second surface 202. In the illustrated example, the tabs 250 may embody hook-like structures for engaging with female detents disposed on the left or first frame 193, as described further below. Optionally, there may be three or more detents or only one detent 250. Each of the male detents 250 is shown with a distally facing tip for moving or sliding from a proximal position to a distal position to engage and engage the female detent. Thus, as explained further below, the right frame 194 and detents 250 must move proximally relative to the left frame 193 to separate the male detents or tabs 250 from the female detents on the left frame. In other examples, the male detents 250 on the right frame can face proximally, such that separation of the male and female frames requires movement of the right frame distally relative to the left frame 193 to separate the male detents or tabs 250 from the female detents on the left frame.

[0423] Along the top surface 204, a notch 254 is provided to form the top lever 214. The notch 254 has three sides, with a fourth side connecting to the base of the top lever 214. The top lever 214 may be formed to project outward from the bottom edge 252. As shown, the top lever 214 has a tapered or ramped portion 214a and a contact portion 214b. The contact portion 214b provides a surface for a user to contact or manipulate.

[0424] A rib or protrusion 260 is provided on an underside 264 of top surface 204 and is recessed from a side edge 262 of the top surface. The recessed space between side edge 262 and protrusion 260 is sized to accommodate the thickness of first surface 200 of left frame 193 when the left frame is assembled to right frame 194. Rib 260 can function as an alignment tab for use in aligning first surface 200 with side edge 262, thereby providing a generally flush surface between side edge 262 and the exterior of first surface 200 upon assembly with first surface 200. Optionally, rib 260 can be omitted.

[0425] A second rib or protrusion 268 spaced from the first rib 260 may also be provided on the lower surface 264 of the top surface 204. In an example, the second rib 268 is aligned with or at the side edge 262 and is configured to engage with a corresponding slot or recess in the left face or first face 200 of the left frame 193 to align the two frames 193, 194 at the base end 190 along the axial direction of the housing 102. In an example, the second rib 268 has an arrowhead-like structure with two tapered edges and an apex therebetween. The arrowhead-like structure is configured to seat in a corresponding seat on the left face 200 of the left frame 193, and the two tapered surfaces allow the protrusion 268 to disengage from the corresponding seat by sliding the corresponding tapered surfaces relative to each other when the top lever 214 and the bottom lever 214 ( FIG. 3 ) are gripped and slid relative to each other.

[0426] Also shown is a shoulder 245 formed on the underside 264 of the top wall 204 just distal to the notch 254. The underside shoulder 245 is configured to support a flange on the needle hub, similar to the function of the shoulder 246 on the second face 202.

[0427] 7 shows the front or distal portion of the right frame 194, with the catheter tube extending from the distal opening 342 in the nose portion 184a. A tab or detent 250 having a free end pointing distally is shown located on a side edge 270 of the lower wall structure 230a. The tab or male detent 250 can engage with a corresponding female detent formed with the left frame 193. In other examples, additional tabs 250 can be provided along the side edge 270 of the lower wall structure.

[0428] The tip of the right frame 194 is provided with two protrusions 268. As shown, a side edge 270 of the bottom wall structure 230a is provided with a lower protrusion 268 for engaging a slot in the left frame to provide additional rigidity along seam 232 (FIG. 4). An upper protrusion 268 is provided on the side edge 272 of the base 192 for engaging a slot in the left frame to provide additional rigidity along top seam 276 (FIG. 1) of the nose end 184 of the housing 102. Element 232 may be generally referred to as a seam, which may be either a top seam or a bottom seam. However, to more easily distinguish between the top and bottom seams by using different reference numbers, the top seam may be referred to as 276 and the bottom seam as 232.

[0429] FIG. 8, similar to FIG. 5, is an enlarged view of the right frame 194 with the catheter assembly 108 attached. In the illustrated orientation, the right frame 194 is clearly shown having a bottom wall structure 230a, a top wall structure or section 230b, and a side wall structure or section 230c, each having a surface. In the example, the top wall or section 230b has a length extending longitudinally along the needle and a width perpendicular or radial to the length. The width of the top wall structure 230b is smaller than the width of the bottom wall structure 203a. These different widths between the top and bottom wall structures—for example, the top wall structure 230b not projecting as far toward the needle as the bottom wall—allows for a gap along the top of the housing, as shown in FIG. 4, allowing for the bottom to close when the first frame is attached to the second frame.

[0430] A shoulder 278 is provided between the upper wall structure 230b and the upper surface 204, and a raised stub 280 is provided distal to the top lever 214. The step in the shoulder 278 provides a relatively large interior space at the base end of the housing to accommodate the flange on the needle hub 122 and the luer threads on the catheter hub 130. The raised stub 280 is not connected to the contact portion 214b of the top lever 214 and is provided with a tapered surface to mimic the ramps 214a at the base of the top lever 214 for a more symmetrical appearance. A gap 282 is provided between the top lever 214 and the raised stub 280, which may incorporate spaced apart gripping bumps 284. The top lever 214 may also incorporate similar spaced apart gripping bumps 284.

[0431] Referring now to FIG. 9, a perspective view of a left or first frame 193 is shown, which resembles the right frame 194 with a few exceptions. The left frame 193 is configured to couple to the right frame 194 to form the housing shown in FIG. 1 and elsewhere. In this embodiment, the first frame 193 includes a nose portion 184a, a body portion 188a, and a base portion 190a. The left frame 193 and right frame 194 may join to form the nose end 184, the body 188, and the base end 190. In this embodiment, the lower wall structure 230a is provided with an engagement slot 288 for engaging a tab or detent 250 ( FIG. 7 ) and a receiving slot 290 for receiving a protrusion 268 on the right frame 194. As described further below, the engagement slot 288 may have a detent for receiving a corresponding detent on the right frame 194. However, the receiving slot 290 may be embodied as a simple channel without an engagement surface for receiving the lower protrusion 268 on the right frame 194, as will be further explained below.

[0432] 9, proximal to body portion 188a is base portion 190a having a left or first side 200 and a bottom or fourth side 206 with a second or bottom lever 216 formed thereon. First side 200 and bottom side 206 resemble two wall structures positioned at right angles to one another with bottom lever 216 on one of the walls. One or more gripping mechanisms 284 may be provided on the exterior of bottom lever 216.

[0433] 10 , there is shown a detailed view of the distal portion of the housing 102 showing the left frame 193 attached to the right frame 194. As shown, the engagement slot 288 has an opening for the tab 250 to enter, having a tapered surface 294 and a tab 296. The tab 250 on the right frame 194 can enter the opening of the engagement slot 288 and then move distally to engage the tab 296 of the engagement slot 288 to complete the engagement between the tab 250 and the engagement slot 288.

[0434] To disengage the left and right frames, the tabs 250 are removed in the reverse order. The tabs 250 can move proximally relative to the engagement slots 288. The proximal movement causes the tapered surface 294 of the engagement slots 288 to move against the tapered surface 298 on the tabs 296, applying a pair of radially directed force components that move the left and right frames away from each other to separate the tabs 250 from the engagement slots 288. Simultaneously, the lower protrusions 268 of the right frame 294 disengage from the receiving slots 290 of the left frame 193. A similar engagement mechanism is provided at the base end 190 of the housing (FIG. 1) to allow separation of the two frames 193, 194 at the base end.

[0435] FIG. 11 shows an enlarged view of the left frame 193 at the base portion 190a. As shown, the bottom or fourth surface 206 of the base end 206 includes two engagement slots 288 formed in the bottom edge 262. Each of the engagement slots 288 includes an opening for receiving a corresponding tab 250 on the lower edge 252 of the second surface 202 of the right frame 194 (FIG. 6). A lip 300 having a recessed pocket for receiving and engaging a finger of the corresponding tab 250 is provided in each engagement slot. The gap between the finger of the tab 250 and the lower edge 252 is configured to receive the lip 300 therebetween to engage the tab 250 in the engagement slot. Note that the engagement slot 288 toward the distal end of the base section is bounded by at least three sides and has an opening that is relatively longer than the length of the corresponding tab 250 to allow axial movement of the tab out of the engagement slot. The engagement slot 288 at the proximal end of the base section is bounded by only two sides, with no third side to restrain the corresponding tab.

[0436] The first surface 200 of the base portion 190a is provided with an opening 210 as described above and two receiving slots 290 for mating with or aligning with the ribs 260 and protrusions 268 on the top wall of the base section of the right frame 194. As shown, the more distal receiving slot 290 has a recess formed in an inner surface 304 of the first surface 200, while the more proximal receiving slot 290 has a recess formed in an outer surface of the first surface 200. This arrangement allows the wall structure 306 of the first surface 200 to straddle or pass between the ribs 260 and protrusions 268, as shown with reference to FIG.

[0437] Similar to right frame 194, base portion 190a is provided with a channel 244 for interacting with a flange on a needle hub. Barrier wall 308 distal to channel 244 is provided with a shaped contour 310 for receiving a catheter hub when left frame 193 is attached to right frame 194 with the catheter hub positioned therebetween.

[0438] FIG. 12 is a perspective view similar to FIG. 11 but showing the left frame 193 of the base portion 190a from a different perspective.

[0439] Figure 13 is a perspective view of the left frame 193 at the body portion 188a and nose portion 184a. This view is similar to the view shown with reference to Figure 9, but from a different perspective. In this embodiment, the receiving slot 290 in the nose portion 184a for coupling to the upper protrusion 268 of the right frame 194 (Figure 7) is more clearly shown.

[0440] FIG. 14 is a perspective view showing the left frame 193 separated from the right frame 194 with the catheter assembly 108 held by the left frame 193 to show how the catheter assembly 108 seats within the molded contours of the left frame, similar to that described with reference to FIG. 5, but with the left frame 193 replacing the right frame 194.

[0441] Referring again to FIGS. 1, 5, and 14, during use, the ExD catheter assembly 100 is advanced into a patient to a selected catheter location, such as a deep or superficial vein. The user can puncture the target vein with guidance from a visualization device, such as an ultrasound monitor with an ultrasound probe. A primary blood flashback can be observed entering the needle hub 122. The insertion angle of the ExD catheter assembly 100 is then reduced before further advancing the ExD catheter assembly 100 to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser having a housing extending through the vent plug 124 and needle lumen can be placed in the proximal opening of the catheter hub after removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to the desired treatment location within the body. In some instances, the guidewire dispenser may be attached to the ExD catheter assembly prior to initial needle insertion, and the assembly does not have a removable vent plug 124.

[0442] The needle and catheter tube are advanced over the guidewire, stopping just before the nose end 184 contacts the skin. If the ExD catheter assembly is to be used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the first or top lever 214 and their index finger on the bottom lever (FIG. 3) as described above to separate the housing 102 (FIG. 1) into two or more housing components, such as separating the left frame 193 from the right frame 194. Once the housing 102 has been separated into smaller components, the catheter assembly 108 is free from the housing. The user can then retract the needle 122 and needle hub 122 from the catheter hub, as described above with reference to FIG. 2.

[0443] With respect to the ExD catheter assemblies and components thereof disclosed below, where a feature is shown but not explicitly described, and is otherwise the same or similar to one or more features described elsewhere, such as those described above with reference to FIGS. 1-14, it is understood that one or more disclosed portions that are shown in all drawings but not explicitly described, for redundancy and because knowledge is building on the foundation laid by prior disclosures, can still be understood to be described or taught by the same or similar features explicitly described in the text for the embodiment in which the one or more features are described. In other words, subsequent disclosures in this application build on the foundation of prior disclosures unless the context dictates otherwise. Thus, the present disclosure is understood to teach the disclosed embodiments and features of the disclosed embodiments to those skilled in the art without the need to repeat similar components and features in every embodiment, as one skilled in the art would not ignore similar structural features that he or she has read about in several previous paragraphs, nor would it disregard knowledge gained from prior descriptions in the same specification. Thus, the same or similar features shown in the following ExD catheter assemblies incorporate the teachings of the previous embodiments unless the context dictates otherwise. Accordingly, it is contemplated that the later-disclosed embodiments will enjoy the benefit of the previously explicitly described embodiments, such as the features and structures of the previously described embodiments, unless the context dictates otherwise.

[0444] Referring now to FIG. 15, an extended indwelling catheter assembly 100 is provided in accordance with a further aspect of the present invention. This ExD catheter assembly 100 shares similar aspects with the ExD catheter assemblies of FIGS. 1-14. In particular, it shares a similar housing 102 configuration, in which a first or left frame 193 and a second or right frame 194 are attached to form the housing and can be separated to release the catheter hub from the housing. As shown, the housing 102 includes a nose end 184, a body 188, and a base end 190. The housing 102 has a body opening 196 that opens to the interior space 104. A catheter assembly 108 is disposed in the interior space 104. The catheter assembly 108 can be similar to the catheter assembly 108 described elsewhere herein, such as with reference to FIG. 2, and includes a needle guard located inside the catheter hub 130 and a needle hub 122 having a vent plug 124 protruding proximally from an end face 126a of the housing 102.

[0445] At the distal end 120, a portion of the needle 112 attached to the needle hub 122 and the catheter tube 110 attached to the catheter hub 130 protrude from the housing's distal end opening 342 at the nose end 184. Optionally, after removal of the vent plug 124, a guidewire dispenser, such as a SonoStik® guidewire dispenser, can be connected to the proximal opening of the needle hub.

[0446] Each of the two first and second frames 193, 194 includes a wall structure 230 having a lower wall section 230a (FIG. 16), an upper wall section 230b, and a side wall section 230c. The outer surface of the side wall section 230 is provided with a plurality of protrusions or decorations 220, which may be embodied as circular, elongated, polygonal, or irregularly shaped protrusions. The protrusions 220 may be spaced apart from one another and may be provided for aesthetic purposes and to facilitate gripping of the housing 102 on the two side walls 230c of the housing.

[0447] The base end 190 of the proximal end 126 of the housing is provided with a plurality of side walls, including a first or left side wall 200, a second or right side wall 202 ( FIG. 19 ) opposite the first side wall, a third or top side wall 204, and a fourth or bottom side wall 206 ( FIG. 16 ) opposite the third side wall. The side walls of the base end 190 define a generally square or rectangular cross-sectional configuration having a hollow interior for accommodating the catheter assembly 108. In other examples, the side walls can define different shapes, such as oval or circular. A seam 232 passes through both the top and bottom side walls 204, 206 and through the nose end 184 of the housing 102.

[0448] The first side wall 200 and the second side wall 202 ( FIG. 19 ) define the width of the housing at the base end 190. In some examples, the width of the base end 190 is greater than the width of the body 188 immediately distal to the base end 190. In other examples, the width of the base end 190 and the width of the body 188 immediately distal to the base end 190 can be approximately the same or equal. The width of the body 188, measured as the distance between the two side wall sections 230 c of the first and second frames, can be approximately constant distally from either their respective outer or inner surfaces to near the beginning of the body's activation area or region 320, where the body expands distally to a maximum width at the body distal end 322. From there, the width rapidly decreases to a peak or apex 324 where the distal opening 342 is located. As described further below, activation region 320 of body 188 extends so that each of the two frames 193, 194, or at least one of the two frames, can incorporate an activation ramp or structure 328. Activation ramp 328 is sized and shaped to interact with catheter hub 130 to allow separation of housing 102 into two or more housing components.

[0449] Figure 16 is a perspective view showing the ExD catheter assembly 100 of Figure 15 from a different perspective. The two lower wall sections 230a of the first frame 193 and the right frame 194 are visible. The proximal end 126 of the housing 102 is provided with a notch 330 for receiving the flange extension 160 of the needle hub 122, which is defined by a partial notch in the bottom surface 206 of the base end 190 and partial notches in the proximal ends of the two frames 193, 194.

[0450] An opening 334 is provided in the lower wall of the housing near the distal end 120 of the housing 102. The opening 334 can be elongated and can have a proximal edge 334a, a distal edge 334b, and a side edge 334c. In other examples, the opening 334 can have a different shape so long as the shape does not interfere with the activation ramp 328 located inside the housing 102.

[0451] A seam 232 runs the length of the housing, extending from the distal end 120 to the proximal end 126, and is discontinuous at the rear opening 330 and the front opening 334. An end cap element or gate 340 is provided at the distal edge 334b ​​of the front opening 334 at the distal end of each of the left and right frames 193, 194. Thus, the housing has two gates or end cap elements 340. With particular reference to the end cap element 340 of the second frame 194, the description of which applies equally to the end cap element of the first frame 193, the end cap element 340 has a lower section or side wall 340a, an upper section or side wall 340b (FIG. 17), and a side section 340c. In the example, side section 340c has a semicircular-like cutout 342a, so that the two side sections 340c with the two cutouts 342a from two adjacent end cap components 340 form a through passage or opening 342 for accommodating the needle 112 and catheter tube 110. The through passage 342 formed by the two cutouts 342a provides support and guidance for the needle and catheter, allowing for venipuncture of extended length IV catheters with or without a guidewire, and short midline catheters approximately 8-10 cm in length without an integrated guidewire.

[0452] 16 and 17 , a lower section 340a of the end cap component 340 is separated from the lower wall 230a of the housing wall 230 by a gap 344, and an upper or top section 340b of the end cap component is separated from the upper wall 230b of the housing wall by a gap 344. Thus, each end cap component 340 is attached to the remainder of its respective left and right frames 193, 194 by a strip or layer 346 of material having a thickness. In an example, the strip of material 346 can have a thickness equal to the thickness of the walls of the side sections 230c and the front section 340c. In another example, the strip of material 346 can include a recess 348 to reduce the thickness of the strip of material 346 to be less than the thickness of the side sections 230c and the front section 340c.

[0453] In an example, the strip of material 346 connecting the left end cap component 340 to the left frame 193 ( FIG. 15 ) and the strip of material 346 connecting the right end cap component 340 to the right frame 194 can function as hinges, such as living hinges. Thus, the housing 102 in this embodiment has two gates or end cap components 340, each of which is pivotable or rotatable by a living hinge 346. The living hinges allow the end cap components or gates 340 and their respective frames, i.e., front end walls 347, to pivot, rotate, or swing relative to one another. For example, as described further below, when the assembly is activated by the catheter hub 130 pressing on one or more activation ramps 328, if the first and second frames 193, 194 separate from one another starting at the proximal end 126, the first and second frames can swing outward from one another and pivot about their respective strips of material or living hinges 346. As described further below, the two end cap components 340 can remain attached to one another as they pivot about the two living hinges 346 until the two frames are also separated to release the catheter hub 130 from the two frames. In other examples, the two frames remain attached while the two end cap components 340 pivot or rotate about the two living hinges 346, similar to opening a double gate to access an opening at the distal end of the housing 102, as described below.

[0454] Referring now to FIG. 17 , the ExD catheter assembly of FIG. 15 is shown without the first frame 193 so as to more clearly show the interior space 104 of the housing 102, now separated. The second frame 194 is shown with a joining edge 350 where the seam 232 is formed with the joining edge 350 of the first frame 193. The left or first frame 193 and the right or second frame 194 can be connected to each other along their respective joining edges 350. Engagement slots, tabs, and / or detents 354 can be used to removably secure the two frames, as described further below. The right frame 194 is shown with a notch 334 m in the bottom or underside of the housing 102 that forms a portion of the opening 334 shown in FIG. 16 .

[0455] In the figures, the catheter assembly 108 is shown disposed in the interior space 104 of the housing 102 with the needle and catheter tubing passing through the notch 342 and the catheter hub 130, or at least the catheter hub push tab 176, disposed distally of the base end 190. The needle hub 122 and vent plug 124 protrude from the proximal opening 101 of the housing 102, and the flange 161 of the needle hub 122 engages with the housing 102 as further described below with reference to Figures 18A and 18B.

[0456] 18A and 18B, enlarged, partial perspective views of the assembly of FIG. 17 are shown, respectively, showing a further enlarged view of the catheter assembly positioned inside the right frame 194. As shown, a flange 161 extending from a needle hub 122 having a generally square or rectangular outline is positioned so that the plane defined by the flange is generally perpendicular to the longitudinal axis of the housing 102 (FIGS. 15 and 16). The portion of the flange 161 that projects outside the outer outline of the needle hub 122 engages with grooves 358 (FIG. 18B) formed on multiple sides of the base end 190, including the first side 200, the second side 202, the third side 204, and the fourth side 206. The grooves 358 may be recessed channels formed in the wall thickness of the multiple sides of the base end. The grooves 358 may be formed continuously across the surfaces except for the notch 330 (FIG. 16) in the fourth side 206 to accommodate the flange extension 160 of the needle hub 122. The groove 358 can be structured to receive, accommodate, or accommodate the flange 161 on the needle hub, including where the flange transitions between various surfaces, such as at the intersection of the surfaces of the flange 161.

[0457] In the ready-to-use position, in which the ExD catheter assembly 100 is ready to be used to perform venipuncture, the needle hub 122 can be held stationary from axial movement by restricting the needle hub's flange extension 160 from distal movement via the bottom housing edge 330a in the two bottom wall structures 330. To restrict the needle hub 122 from moving proximally, the flange 161 extending from the exterior of the needle hub 122 is positioned against the proximal lip of the groove 358 in the base end 190. Furthermore, a non-circular structure for coupling the flange 161 and groove 358, such as using a multi-faceted structure, prevents the needle hub from rotating while within the space defined by the faces of the base end 190. This holds the needle hub in the assembled position so that, upon assembly, the needle bevel can be oriented in a desired position without premature rotation prior to sequentially performing venipuncture.

[0458] 18A and 18B, particularly FIG. 18B, the external threads 154 of the catheter hub 130 include a slot 362 for receiving a tab 364 protruding from the inner surface of the top surface 204 of the base end 190. In other examples, the arrangement can be reversed, with the top surface 204 incorporating the slot and the catheter hub incorporating the tab. In yet other examples, a detent can be provided between the catheter hub and the housing at other locations along their respective structures to engage the two. The engagement ensures proper alignment between the catheter hub 130 and the housing 102 in the ready-to-use position and prevents the catheter hub from rotating while engaged with the housing.

[0459] The catheter hub 130 is configured to slide axially distally after successfully placing the needle and catheter hub within a patient's vein, with the needle hub remaining engaged with the base end 190 of the housing. In an example, the external threads 154 are configured to ride or slide against the inner surfaces of the two lower walls 230a of the housing 102. For example, with further reference to FIG. 15 , a user can push the push tab 176 to advance the needle hub 130 distally. The push tab 176 is shown positioned between the two upper wall sections 230b of the two frames 193, 194. As shown, the upper edge of the push tab 176 protrudes above the outer surfaces of the two upper wall sections 230b, exposing itself for contact and pressure by the practitioner. In some examples, the push tab 176 can be structured so that the upper edge of the push tab protrudes further above the two upper wall sections 230b, exposing itself as a larger target for the practitioner to press against. As discussed further below, when the practitioner pushes the push tab 176 distally after placing the catheter tube in the vein, and optionally after advancing a guidewire into the vein to guide the catheter tube, the body of the catheter hub 130 abuts one or more activation ramps 328 on one of the left frame 193, the right frame 194, or each of the two frames 193, 184, separating the two frames starting from the proximal end 126 of the housing 102. The push tab 176 can be molded with a length or height sufficient to extend above the housing to allow pushing by the practitioner. Optionally, a tab extender can snap onto a standard push tab to increase the height of the push tab for the practitioner to push, as described further below.

[0460] 19 is a perspective view of the right or second frame 194, shown without the left frame 193 and catheter assembly 108. The second frame 194 is shown with a base portion 190a having a second side 202, a top side 204, and a bottom side 206. The top and bottom sides are relatively shorter in length than the second side 202. The top side 204 and bottom side 206 of the right frame 194 can be referred to as partial sides because, when similar top and bottom sections are supported by the first or left frame 193, with two partial top sections joined at their respective joining edges 350 and two partial bottom sections joined at their respective joining edges 350, they form the top side 204 and bottom side 206 of the base end 190 (FIG. 16).

[0461] As shown, at the joining edge 350, the partial top section 204 incorporates a slot 368, and the partial bottom section 206 incorporates a slot 368. The slot can be generally rectangular in shape with sharp or rounded corners, but can alternatively be embodied as a circle, square, star, oval, polygon, or irregular shape. The slot 368 of the partial top section 204 and the slot 368 of the partial bottom section 206 can be positioned along the same axial position of the longitudinal axis of the right frame. In other examples, they can be axially offset from the same axial position. As shown, both slots 368 are positioned approximately along the proximal ends of the two joining edges 350.

[0462] Body portion 188a is located distally of base portion 190a and has a wall 230 having an upper wall section 230b, a bottom or lower wall section 230a, or a side wall section 230c, as described above. In an example, two slots 370 similar to slot 368 of base portion 190a are provided in a joining edge 350 of lower wall structure or section 230a. The two slots 370 may have the same shape as the two slots 368 on base portion 190a, or they may be different. In an example, one of the two slots 370 in lower wall section 230a can be positioned adjacent to housing edge 330a of bottom cutout 330 ( FIG. 18B ), and the second slot 370 can be positioned distal thereto. In other examples, there can be only one slot or more than two slots in lower wall section 230a, which can be positioned elsewhere along joining edge 350.

[0463] 19 , activation ramp 328 is located on an inner surface 374 of side wall section 230c of housing wall 230, closer to distal end 120 than proximal end 126, in activation region 320 ( FIG. 15 ) of frame 194. Activation ramp 328 includes proximal ramp section 328a, distal ramp section 328b, and central ramp section 328c located between the proximal and distal ramp sections. In the example, proximal ramp section 328a includes an increasing slope from inner surface 374 of right frame 194 and can be viewed as a structure having a surface extending radially away from the inner surface. When assembled with left frame 193 and the assembled housing with the catheter assembly disposed therein, proximal ramp section 328a extends away from the inner surface toward the needle or toward the longitudinal axis passing through the housing. The longitudinal axis passing through the housing can be considered a reference line, and the proximal ramp section 328 can be understood to have a surface that is furthest from the reference line and gradually approaches the reference line as the ramp approaches the central ramp section 328c.

[0464] The central ramp portion 328c has a surface closer to the reference line than the proximal ramp portion 328a and may include a generally flat area or surface area with a larger radius.

[0465] The distal ramp portion 328b, in an example, includes a slope that decreases from the central ramp portion 328c, which has a surface that moves away from the reference line. If the proximal ramp portion 328a has a positive slope, the distal ramp portion 328b has a negative slope. Therefore, the actuation ramp 328 shown in FIG. 8 can be considered a sloped structure that increases to a peak or apex at the central ramp section and then has a negative slope. In other examples, the distal ramp portion 328b can be constant or flat with the central ramp portion 328c without any slope. In yet other examples, the distal ramp portion 328b can have a positive slope that continues toward the reference line. Preferably, the distal ramp portion 328c has a negative slope.

[0466] When the left and right frames 193, 194 are assembled together to form the housing 102, the gap between two adjacent activation ramps 328, which may be referred to as an activation gap 400 ( FIG. 28 ), if two activation ramps are incorporated, or the gap between the activation ramp 328 and the inner surface 374 of the adjacent frame, if only one activation ramp is incorporated, may vary. The activation gap may extend and narrow from the proximal ramp portion 328 a to a narrower point at the central ramp portion 328 c, or from the two proximal ramp portions to a narrower point at the two central ramp portions. As described further below, the activation gap 400 may be incorporated as a means by which the catheter hub 130 ( FIG. 2 ) can advance and apply a force to a pair of components that can then separate the housing 102 into two or more housing components.

[0467] 19 , a recess 378 is provided in the end cap component 340 of the second or right frame 194. The recess 378 may have three sides and an open fourth side. Optionally, the recess 378 may be embodied as a four-sided slot similar to one of the slots 368, 370 in the body or base sections. The recess 378 in the end cap component 340 may be sized and shaped to receive a corresponding tab on an adjacent end cap component in an interference or snap-fit ​​arrangement. In some examples, the location of the recess 378 and the location of the tab for mating with the recess may be reversed so that the recess can be located in the end cap component of the first or left frame 193.

[0468] 20 and 21 are different perspective views of the right frame 194 showing various details.

[0469] FIG. 22 is another perspective view of the right or second frame 194. In the illustrated view, the activation ramp 328 is implemented as two separate activation ramp segments 328x, 328y, each having a proximal ramp portion 328a, a distal ramp portion 328b, and a central ramp portion 328c. The two separate activation ramp segments 328x, 328y can operate or function as previously described. A gap or void 380 is provided in the distal ramp segment of the two ramp segments 328x, 328y and is formed by the negative slope of the two distal ramp segments. There is a small gap between the two ramp segments 328x, 328y. In other examples, the activation ramp 328 is formed as a single ramp structure without a gap. The surface of the activation ramp 328 may be substantially flat or have a large radius to form a slight curvature to accommodate the contours of the catheter hub.

[0470] As can be visualized, when the second or right frame 194 is coupled to the first or left frame 193 and the catheter hub 130 is advanced distally to abut against the two separate actuation ramp segments 328x, 328y, the nose section of the catheter hub 130 (FIG. 2) first abuts against the two proximal ramp portions 328a of the two separate actuation ramp segments 328x, 328y and then moves into the gap or void 380 as the nose section continues to move distally. Then, a middle section of the catheter hub, which is larger in diameter or size than the nose section of the catheter hub, moves over the two proximal ramp portions 328a, further expanding the two frames 193, 194 away from each other. At this point, the two frames 193, 194 are completely separated from each other except for their engagement at the two end cap components 340 at the distal ends of the housings. If the two end cap components are not fully separated proximally, further movement of the male threads 154 of the catheter hub 130 relative to the two proximal ramp portions 328a will further expand the two frames 193, 194 away from each other, resulting in the tabs and slots of the two frames fully separating from each other except for the engagement at the two end cap components 340. Finally, the final engagement between the recess 378 and the tab 398 on the left frame 193 (FIG. 26) can be separated by physically grasping one or both of the frames and pulling one or both frames away from each other. The catheter hub can then be completed by connecting an IV line and taping it to the patient, etc.

[0471] In the example, the recess 378 in the end cap component 340 has two side walls 340a, 340b, a bottom wall 340c, and a central wall 340d. In the example, the two side walls 340a, 340b each include a surface, and the two surfaces of the two side walls taper or converge toward the bottom wall 340c. This results in a trapezoidal surface for the central wall 340d. Therefore, the recess 378 is tapered, and the width or gap at the opening of the recess 378 is greater than the width or gap at the bottom of the recess. This configuration allows corresponding tabs on the end cap component 340 of the first frame 193 to engage with the recess 378 and easily disengage, facilitating separation of the two frames 193, 194 of the two end cap components and subsequently separating the catheter hub from the housing of the ExD catheter assembly.

[0472] Figure 23 is a perspective view of the second frame 194 of Figure 22, shown in an inverted view to show the outer surface 374a of the right frame. As shown, the outer surface is provided with a plurality of spaced apart protrusions or ornamentations 220, similar to those shown on the left frame of Figure 15. In examples, the two different sets of protrusions 220 on the two frames can be the same and have the same spacing. In other examples, the protrusions can have different shapes and / or different spacing between two adjacent protrusions.

[0473] Figure 24 is a side view of the ExD catheter assembly 100 of Figure 15 with the catheter assembly 108 attached to the first or left frame 193 and the second frame 194 removed to more clearly show an arrangement similar to that of Figure 17 but with the first frame 193 instead of the second frame 194. This combination is similar to the previous combination except that in this combination, tabs or male detents 392 are provided on the third surface 204 of the base portion 190a at the joining edge 350 and on the fourth surface 206 of the base portion 190a at the joining edge 350 (Figure 19) for engaging two slots 368 on the base portion 190a of the second frame 194 (e.g., Figure 17). Tabs or male detents 394 are also provided on the joining edge 350 on the lower wall structure or section 230a for engaging two slots 370 on the lower wall structure 230a of the second frame 194 (Figure 19). Optionally, the two frames 193, 194 can be joined together along adjacent seams via welding or adhesive. If welding or adhesive is used, the top and bottom seams of the distal end of the housing are attached to one another via detents so that the detents can be disengaged to open the distal gate opening, subsequently allowing separation of the catheter hub from the housing, as described further below.

[0474] Figure 25 is a perspective view of the first frame 193 of Figure 24 without the catheter assembly 108. Tabs or male detents 392 on the base portion 190a and tabs or male detents 394 on the lower wall structure or section 230a are shown. Also shown are two activation ramp segments 328x, 328y located on the side wall structure or section 230c of the frame, which are similar in shape and function to the two activation ramp segments 328x, 328y described above with reference to Figure 22. Like the other activation ramp segments 328x, 328y, each activation ramp segment includes a proximal ramp portion 328a, a distal ramp portion 328b, and a central ramp portion 328c located between the proximal and distal ramp portions.

[0475] A tab or male detent 398 is provided on the mating edge 350 of the end cap component 340 of the first frame 193. The tab 398 is positioned on the end cap component 340 in a position that will matingly engage with a slot on the right frame 194 when the left and right frames are assembled to form the housing of FIG. 15. The tab 398 is sized and shaped to engage with a recess 378 in the end cap component 340 of the second frame 194. In the example, there is slight interference engagement between the tab 398 and the recess 378.

[0476] In examples, the engagement between the tabs or male detents 398 and the recesses 378 of the two end cap components 340 provides a stronger grip or engagement retention than the engagement between the tabs 392 on the base portion 190a and the tabs 394 on the lower wall structure 230a, which engage with corresponding slots 368, 370 on the second frame 194. This relative engagement force between the mating tab and slot pairs ensures that when the catheter hub 130 is advanced distally within the housing interior space 104 after initial catheter tube placement, and after guidewire advancement when installed, when the catheter hub contacts the activation ramp, the housing will separate first at the proximal end of the housing, and then at the two end cap components 340. In other examples, the various tab and slot pairs generally open approximately simultaneously when the catheter hub contacts the activation ramp.

[0477] FIG. 26 is a perspective view of the first frame 193 of FIG. 25 from a different perspective. In the orientation shown, the tabs 392 on the base portion 190a are longer than the tabs 392 on the lower wall structure 230a of the body section. The tabs on the base portion 190a are also longer than the tabs 398 on the end cap component 340. The different lengths of the various tabs mate or engage with slots having different corresponding depths to ensure a generally tight seam 232 ( FIG. 16 ) when the two housing frames 193, 194 are joined to form the housing 102. In some examples, instead of having an arrangement where all slots are located on one frame and all tabs are located on another frame, the left and right frames can each have both slots and tabs that mate with corresponding tabs and slots.

[0478] 27 is a perspective view of the first frame 193 inverted to show the outer surface 374a of the first frame. As shown, the outer surface 374a is provided with a plurality of spaced apart protrusions or ornamentations 220, similar to those shown on the second frame. In an example, two different sets of protrusions 220 on two frames can be the same and have the same spacing. In other examples, the protrusions can have different shapes and / or different spacing between two adjacent protrusions.

[0479] Referring again to Figures 15-17, 24, and 28, an illustration of the ExD catheter assembly 100 in use is provided. A user can use the ExD catheter assembly to puncture a target vein with guidance from a visualization device, such as an ultrasound monitor, using an ultrasound probe. A primary blood flashback can be observed entering the needle hub 122. The insertion angle of the ExD catheter assembly 100 is then reduced before further advancing the ExD catheter assembly 100 to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser having a housing extending through the vent plug 124 and needle lumen can be placed in the proximal opening of the catheter hub after removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to a desired treatment location within the body.

[0480] The needle and catheter tube are advanced over the guidewire, stopping just before the nose end 184 of the housing 102 contacts the skin. If the ExD catheter assembly is to be used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the push tab 176 of the catheter hub 130 and advance the catheter hub against one or more activation ramps 328 on one or both of the first and second housing frames 193, 194.

[0481] With further reference to the schematic diagram of the ExD catheter assembly 100 in FIG. 28, when the catheter hub 130 is pushed distally until the nose end of the catheter hub presses against the two activation ramps 328, a pair of component forces is generated in each of the two frames 193, 194. This separates the two frames from the base end of the housing. As the catheter hub continues to move distally, the two frames further separate until the tabs and slots on the base end and the body completely separate from each other. At this point, the tabs 398 (FIG. 26) and the recesses 378 (FIG. 19) on the two end cap components 340 remain engaged, and the two frames pivot at their respective living hinges 346. Next, while maintaining a grip on the catheter hub, the user can use their free hand to pull on one of the two frames 193, 194, separating them at their respective end cap components 340. At this point, the catheter hub 130 and the housing 102 are separated from each other. The user can then complete preparation of the catheter hub, such as connecting an IV line to the catheter hub and taping it to the patient to secure the puncture site.

[0482] Referring again to Figures 15-27, particularly Figures 15, 17, 22, and 26, an alternative embodiment of the device or assembly is contemplated. In this alternative embodiment, the left and right frames, or first and second frames 193, 194, are secured with tabs or male detents 392, 394, 398 that engage corresponding slots or female detents 354, 378. In this embodiment, the engagement between the tabs or male detents 392, 394 on the body 188 and base 190 and the slots or female detents 354 prevents separation as the catheter hub 130 is advanced distally within the housing 102. For example, the engagement between the tabs and slots can be by interference and / or adhesive, bonding, or welding. Additionally, the activation ramps 328 (Figure 28) can be omitted from the first and second frames 193, 194 to prevent radial forces generated by the advancing catheter hub from separating the two housing frames. Thus, when the catheter hub 130 is advanced distally to further position the catheter tube within the vein, the catheter hub can reach the space in the void 380 ( FIG. 22 ) at the distal end of the body section without exerting any radial force on the two frames to separate them. Instead, distal abutment of the catheter hub 130 against the distal gate opens the distal gate opening, allowing separation of the catheter hub 130 from the housing 102.

[0483] 22 and 26, the tab 398 on the end cap component 340 of the first frame 193 engages with the recess 378 on the second frame 194 in a frictional, loose, or releasable engagement. That is, when pushed distally by the advancing catheter hub 130, the male detent or tab 398 on the first frame 193 can disengage or separate from the recess 378 on the second frame 194. In the detailed view of FIG. 22, the recess 378 is shown as an open slot or recess. This configuration allows the tab 398 to pass through a side opening in the recess without a sidewall, rather than through an opening adjacent the joining edge 350, thereby allowing the tab and the recess on the two end cap components 340 of the left and right frames 193, 194 to separate. Thus, separation of the two end components 340 can be achieved simply by applying an axial force when the catheter hub 130 is pressed distally against the two end cap components, without the need to generate a radial force as described with reference to FIG. 28.

[0484] Thus, after cannulation, optionally guidewire placement, and catheter placement, as previously described for the first embodiment of the ExD catheter assembly 100 of FIGS. 15-28, the catheter hub 130 can be advanced against the proximally facing surfaces 340Z of the two end cap components 340 of the left and right frames (FIGS. 22 and 26). The force of the catheter hub 130 advancing pulls the tab 398 away from the recess 378. This separation is facilitated by the open side between the two side walls 340a, 340b of the recess in the end cap component 340 of the second or right frame 194 (FIG. 22). That is, the tab 398 on the first or left frame 194 can simply slide off through the gap provided by the missing side of the recess 378 between the two side walls 340a, 340b.

[0485] 15 and 16, once the tabs 398 and female detents 378 of the two end components 340 separate and the two frames are held fixed by the tabs 392, 394 and slots 354 (FIGS. 22 and 26) of the body portions 188a and base portions 190a of the two frames 193, 194, the two end components 340 are swung distally about the two living hinges 346. In the example, the space or distance between the two living hinges 346 is greater than the horizontal or cross-sectional dimension of the catheter hub 130. Thus, as the two end cap components 340 swing distally about the two living hinges, a gate having a gap defined by the space provided by the distally swinging end components, referred to as a gate opening or distal gate opening, opens to provide clearance for the catheter hub 130 to pass through. The swinging end cap component 340 may be referred to as a gate that can swing open to open the distal gate opening. In effect, this allows the catheter hub 130 to be separated from the needle hub 122 and housing 102 via the gate opening or distal gate opening, and separated from the needle 112, needle hub 122, housing 102, and, if used, a guidewire and guidewire dispenser. The catheter hub can then be secured to a patient for fluid administration. The needle 112, needle hub 122, housing 102, and, if used, a guidewire and guidewire dispenser can be discarded or disposed of according to approved protocols.

[0486] Accordingly, aspects of the present invention are understood to include an ExD catheter assembly including a multi-part housing having an interior space with a catheter assembly disposed therein. The catheter assembly includes a catheter tube attached to a catheter hub and a needle attached to a needle hub and extending through the catheter tube with the needle tip extending distally of the distal opening of the catheter tube. The needle and catheter tube protrude through an opening in the distal end of the housing. The distal end may include two end cap components removably attached to one another, for example, by engaging a male detent with a female detent. The female detent may be a recess having three sidewalls, at least one open face, and an open entrance to the recess.

[0487] The multi-part housing may include a first frame attached to a second frame. The two frames may have a seam between them. The two frames may be attached along a joining edge. One of the two frames may include a tab or male detent, and the other frame may include a corresponding slot or female detent for receiving the male detent to removably secure the two frames to one another. The distal end of the housing may include a seam. The distal end opening through which the needle and catheter tube protrude may be formed by two notches. The distal end of the housing may include a living hinge. Preferably, there are two living hinges at the distal end of the housing. A gap gate may be defined by the distance between the two living hinges. In the case of a tab and female detent where at least one opening surface is separated from each other, the two end cap components may swing distally about the two living hinges to open a gate opening or a distal gate opening at the distal end of the housing. The catheter hub can exit the gate opening or distal gate opening and be separated from the remaining components of the ExD catheter assembly, which can include the needle, needle hub, housing, and, if used, guidewire and guidewire dispenser.

[0488] Referring now to FIG. 29, a partial perspective view of an ExD catheter assembly 100 including a housing 102 and a catheter assembly 108 is shown. The ExD catheter assembly 100 may be similar to one of the ExD catheter assemblies disclosed elsewhere herein, such as the assembly 100 of FIGS. 15-16. The ExD catheter assembly of this embodiment is shown with a tab extender or tab adapter 404 attached to the catheter hub 130, extending perpendicular to the longitudinal axis of the housing through the housing opening 196 so that an upper portion of the tab adapter 404 rises above the housing's upper wall structure 230b to expose a surface for the practitioner to push or grip. In the example, the tab adapter 404 is provided to extend the profile of the catheter hub 130's integrally formed push tab 176 (FIG. 2) sufficiently above the upper wall structure 230b to facilitate manipulation of the ExD catheter assembly. Alternatively, the push tab 176 can be formed in an expanded configuration, extending above the upper wall structure 230b of the housing to expose itself to be pushed by a practitioner without a separately formed tab adapter 404.

[0489] FIG. 30 shows the tab adapter 404 spaced apart from the catheter hub 130, and FIG. 31 shows a side cross-sectional view of the tab adapter 404. With reference to FIGS. 29-31, and with continued reference to FIG. 29, the tab adapter 404 can be formed from a plastic material, such as by plastic injection molding. The tab adapter 404 can include a body 406 having a first end 408 and a second end 410. The first end 408 can be positioned above the second end 410 in terms of height. In an example, the body 406 can be formed as a solid structure above an imaginary line 412, with a tunnel or channel 414 below the imaginary line 412 having an arcuate first opening 420 and an arcuate second opening 422 that communicate with each other via the channel 414. In another embodiment, the body 406 is hollow and formed of a wall structure having an outer surface 426 and an inner surface 428 that define an interior space or cavity 429. The wall thickness between the outer surface 426 and the inner surface 428 is sufficient to provide structural rigidity to support the digital load applied by the user to advance the catheter hub 130 .

[0490] The tab adapter 404 is sized and shaped to fit onto the catheter hub 130. In an example, the tab adapter 404 is configured to seat onto the catheter hub 130 and the hub body, which is located within the channel 414 of the body 406. The first opening 420 and the second opening 422 of the tab adapter 404 are sized to fit snugly around the curved body of the catheter hub 130. Depending on how the tab adapter 404 is positioned on the catheter hub 130, such as by its placement or location along the axial position of the catheter hub, the first and second openings 420, 422 of the tab adapter 404 can have the same size or different sizes to accommodate the particular contours of the catheter hub. In an example, as shown in FIG. 30 , the first and second openings 420, 422 can have a hemispherical, semi-elliptical or elliptical shape, or an arc shape. Preferably, the two openings 420, 422 are sized and shaped to fit snugly over the catheter hub body and exert a gripping force around the hub body. The two openings can have different shapes, which can be selected based on the size and contour of the catheter hub body.

[0491] When mounted on the catheter hub 130, the push tab 176 (FIG. 30) is configured to fit within the interior space 429 of the body 406. To prevent slippage, sliding, or movement relative to the catheter hub 130 when finger pressure is applied to the body 406, two gripping bars 432 are provided on the second end 410 of the body 406, one on each side of the two openings 420, 422. The gripping bars 432 may resemble ribs and may be provided with contoured surfaces for a snug fit with the catheter hub. The position of the gripping bars 432 on the body of the tab adapter 404 relative to the tops of the two openings 420, 422 should be positioned so that the two gripping bars 432 are below the centerline of the catheter hub body when mounted on the catheter hub. The size and shape of the first and second openings 420, 422 and the position of the two gripping bars 432 allow the tab adapter 404 to grip the catheter hub body with a snug fit. The adapter 404 can be used by sliding the channel and two openings over the catheter hub body, ensuring that the push tab on the catheter hub is located inside the tab adapter.

[0492] The push tab 176 of the catheter hub 130 can contact the proximal inner surface 428 of the body 406. Thus, when the tab adapter 404 is pushed distally by the practitioner, the inner surface 428 of the tab adapter 404 presses against the proximally facing surface of the push tab 176, distally advancing the push tab 176, and thus the catheter hub 130. In examples, the interior space 429 of the tab adapter 404 is provided with a socket that receives the push tab 176 with a size fit or slight interference to resist separation from the catheter hub body during distal advancement of the catheter hub.

[0493] Referring now to FIG. 32, an extended indwelling catheter assembly 100 is provided in accordance with a further embodiment of the present invention. This ExD catheter assembly 100 shares similar aspects with the catheter assemblies of FIGS. 1-14 and 15-28. In particular, it shares a similar housing 102 configuration, in which a first or left frame 193 and a second or right frame 194 are attached to form a housing 102 that can be separated to release a catheter hub 130 of the catheter assembly 108 from the housing. The first and second frames 193, 194 can be attached to each other along a seam by corresponding tabs or male detents and engagement slots. Optionally, the first and second frames 193, 194 can be attached to each other along a top-bottom seam via adhesive or welding. The catheter hub 130 of the catheter assembly 108 can alternatively be separated from the housing 102 by incorporating a gate assembly at the distal end of the housing 102 that opens to allow the catheter hub to be separated.

[0494] As shown, the ExD catheter assembly 100 includes a removable protective cap 500 configured to be placed over the needle to cover the needle and needle tip prior to use. The proximal opening of the protective cap 500 can frictionally engage the nose section or nose end 184 of the housing 102.

[0495] A tab adapter or tab extender 404, similar to the tab extender of Figures 29-31, may be placed over the catheter hub 130 and secured thereto by a fitting. The needle hub 122 extends outside the housing 102, proximal to the base end 190. A vent plug 124 is attached to the needle hub 122, which may allow air to escape but capture any blood that may flow inside the needle hub and vent plug.

[0496] FIG. 33 is a top view of the ExD catheter assembly 100 of FIG. 32, shown without the protective cap 500. The housing 102 is shown with a nose end or nose section 184 having tips 186 at the ends of two nose portions 184a with an upper seam 276 extending therebetween. The upper seam 276 extends through the upper portion of the nose end 184. A similar corresponding lower seam extends through the lower portion of the nose end 184. Each nose portion 184a is joined to an end cap component 340 of each respective first or second frame 193, 194, similar to those of FIGS. 15 and 16. Each nose portion 184a and each end cap component 340 can be referred to as a gate or rotating gate 339 (FIG. 36). The two gates 339 from the two end cap components 340 are part of a gate assembly 600. The two gates 339 are capable of swinging open to allow the catheter hub 130 to be separated from the housing 102 without the need to separate the first and second frames 193, 194 from each other.

[0497] FIG. 34 is a bottom view of the ExD catheter assembly 100 of FIG. 33, which is similar to the housing of FIG. 16. In this embodiment, two first and second frames 193, 194 each include a wall structure 230, including a lower wall section, an upper wall section, and a side wall section. The outer surfaces of the side wall sections are provided with a plurality of protrusions or decorations, which can be embodied as circular, elongated, polygonal, or irregularly shaped protrusions. The protrusions can be spaced apart from one another and can be provided for aesthetic purposes and to facilitate gripping of the housing 102 on the two side walls of the housing. The two housing frames have interiors for accommodating the inner catheter assembly 108 (FIG. 32).

[0498] In this embodiment, unlike the opening 334 in FIG. 16 , a lower elongated opening is not incorporated. The lower walls 230a of both housing frames 193, 194 may be solid and may be joined together along seam 232 up to a gap 344 separating the two end cap components 340 from the rest of the two frames. This allows the two frames to remain attached to each other while the two end cap components 340, along with the two nose portions 184a of the nose end 184, swing open about their respective living hinges to open the distal gate opening, as described further below. In other embodiments, the two housing frames 193, 194 are joined together up to a longitudinal gap 506 ( FIG. 34 ). The longitudinal gap 506 extends to the forward gap 344, which allows the two end cap components 340 to swing open the distal gate opening, as described further below, to flow in or blend. The proximal end of the longitudinal gap 506 can function as an injection point for a plastic injection gate or entrance.

[0499] Optional scorelines 502 may be incorporated into the walls of each frame. The scorelines 502 may be straight, curved, or both for aesthetic appeal. Scorelines are understood to be groove lines formed in the lower walls of the wall thickness 230a of the two frames 193, 194. In other examples, scorelines may be omitted.

[0500] 35 and 36 are enlarged top and bottom views, respectively, of the distal end of the housing and nose portion 184a of nose end 184, showing end cap component 340 similar to FIGS. 15-17. Distal gap 344, longitudinal gap 506, and seam 232 between the two upper and lower side walls 340b, 340a of the two end cap components 340 are also shown.

[0501] The two end cap components 340 are attached to two front end walls 347 via two living hinges 346. Each of the two end cap components 340 is attached to the nose portion 184a, and this combination may be referred to as a gate or rotating gate 339. As with the embodiment of Figures 15-27, the two gates 339 of the gate assembly 600 can swing open when pushed distally by distal movement of the catheter hub 130, thereby opening the distal gate opening.

[0502] Figure 37 is a side view of the first or left frame 193 of the housing, shown with a needle and catheter tube, but without the second or right frame 194. Figure 38 is a side view of the second or right frame 194 of the housing, shown with a needle and catheter tube, but without the first or left frame 193. The two views, Figures 37 and 38, will now be described to illustrate the mechanical engagement between the two at the distal end and how they separate when pushed distally by the catheter hub to open the distal gate opening. As shown, each of the two nose portions 184a represents a hollow partial cylinder that, when combined, forms the generally cylindrical cylinder of the nose section or nose end 184 of the housing 102.

[0503] Proximal and inward of the boundary defined by the hollow partial cylinder of each nose portion 184a is a front base wall 510. Each front base wall 510 has a notch 512 sized and shaped to accommodate a needle 112 and a portion of the catheter tube 110. When the first and second frames 193, 194 are joined, the two notches 512 from the two front base walls 510 form a perimeter defining an opening sized and shaped to accommodate the perimeter of a combined catheter tube with a needle of a catheter assembly disposed within the housing 102. In an example, the perimeter of the two notches 512 may be referred to as a guide opening that guides the combined needle and catheter tube as the combination is advanced distally during cannulation and vascular access. The two base walls 510 may have varying thicknesses measured along the length of the first and / or second frames. Male detents may protrude from the sides of the thicker base walls 510. In another example, the base walls 510 may have a uniform thickness.

[0504] The male detents 520 may alternatively be stubs or studs having elongated bodies with rounded ends, and are provided on each of the first and second frames 193, 194. As shown in FIG. 37 , the male detents 520 on the first frame 193 are positioned above the needle 112 and / or catheter tube 110 in height and extend approximately perpendicular to the axis defined by the needle. The male detents 520 on the second frame 194 are positioned below the needle 112 in height and extend approximately perpendicular to the axis defined by the needle, as shown in FIG. 38 . The arrangement of the two male detents 520 on the two frames 193, 194 can be reversed. In an example, the two male detents protrude radially a sufficient amount relative to the longitudinal axis of the needle so that the tip of each male detent extends beyond the midpoint of the needle diameter, preferably beyond the edge of the needle opposite to which the male detent extends. In other examples, the male detents 520 can extend a shorter length or distance from each surface from which they extend. The length of the male detents 520 can be selected to vary the amount of engagement with the corresponding receiving slots, as described further below.

[0505] The receiving slots 524 are provided with the first frame 193 below the male detents 520. Similarly, the receiving slots 524 are provided with the second frame 194 above the male detents 520. Again, the arrangement may be reversed. Each receiving slot 524 includes a wall structure configured to frictionally engage a corresponding male detent 520 disposed on the opposing frame. Thus, the receiving slots 524 of the first frame are configured to frictionally engage the male detents of the second frame, and the receiving slots 524 of the second frame are configured to frictionally engage the male detents of the first frame. In the example, the receiving slots have a first wall surface 524a and a second wall surface 524b configured to frictionally engage two surface sections of a mating male detent. In the example, the first wall surface 524a and the second wall surface 524b are disposed substantially perpendicular to each other. Preferably, each receiving slot 524 does not have a wall opposite the second wall 524b, which then provides a gap or missing wall for the male detent 520 to separate from the receiving slot 524 when the catheter hub body 130, such as the nose end of the catheter hub, abuts and presses distally against the two base walls 510. Upon such pressing, the two gates 339 of the gate assembly 600 rotate about two living hinges 346 (FIG. 36) to open the distal gate opening and separate the catheter hub 130 from the housing 102, as discussed above. In an embodiment, each receiving slot 524 further includes a wall opposite the respective first wall 524, such that each receiving slot 524 has a three-sided wall configuration. The rigidity of each receiving slot 524 and end cap component 340 can be sized to grip a corresponding male detent 520 with a slight interference fit.

[0506] After removing the protective cap 500, a user can use the ExD catheter assembly 100 of FIG. 32 to puncture a target vein with guidance from a visualization device, such as an ultrasound monitor, using an ultrasound probe. A primary blood flashback can be observed entering the needle hub 122. The insertion angle of the ExD catheter assembly 100 is then reduced before further advancing the ExD catheter assembly 100 to position the catheter tube deeper into the vein. In some instances, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a SonoStik® guidewire dispenser having a housing protruding through the vent plug 124 and needle lumen can be placed in the proximal opening of the catheter hub after removing the advanced guidewire in a manner known in the art. The guidewire can be used to guide the catheter tube to a desired treatment location within the body.

[0507] The needle 112 and catheter tube 110 (FIG. 33) are advanced over the guidewire and stop at or just before the nose end 184 of the housing 102 where they contact the skin. If the ExD catheter assembly is to be used without a guidewire, the ExD catheter assembly can be advanced without first advancing the guidewire. The practitioner can then place their thumb on the tab adapter 404 that engages with the catheter hub 130 to advance the catheter hub 130 relative to the gate assembly 600.

[0508] 37 and 38 of the ExD catheter assembly 100 of FIG. 32 , when the catheter hub 130 is pushed distally so that the nose end of the catheter hub 130 presses against the two gates 339 of the two end components 340, a distal force is transmitted to the gate assembly 600, overcoming or exceeding the interference and / or frictional forces caused by the engagement between the two male detents 520 or stubs or studs and the two receiving slots 524. As the catheter hub continues to move distally, the two gates 339 swing distally about the living hinges 346 ( FIG. 36 ). The user can continue to move the catheter hub 130 distally while applying a proximal force or a steady holding force to the housing 102, until the needle hub 130 moves completely through the gate openings provided by the two rotated gates 339. At this point, the catheter hub 130 and the housing 102 are free from each other. The user can then complete preparation of the catheter hub 130, such as connecting an IV line to the catheter hub, taping it to the patient to secure the puncture site, and optionally removing the tab adapter 404 from the catheter hub 130.

[0509] Referring now to Figure 39, a tab adapter 404 according to a further aspect of the present invention is shown, similar to the tab adapter 404 of Figures 29-31. The tab adapter 404 of this embodiment may be formed from a plastic material, such as by plastic injection molding. The tab adapter 404 may include a body 406 having a first end 408 and a second end 410. The first end 408 may be positioned above the second end 410 in terms of height. In examples, the body 406 may be formed as a solid structure having a slot to accommodate a push tab extending from a catheter hub and a hollow tunnel for mounting onto a catheter hub body, as described further below.

[0510] The body 406 can have an outer surface 426 and an inner surface 428 (FIG. 42), a first or distal opening 420, and a second opening 422 (FIG. 41) on the side of the body opposite the first opening. A channel 414 is provided between the two openings 420, 422. The wall thickness between the outer surface 426 and the inner surface 428 is sufficient to provide structural rigidity to support a finger load applied by a user to advance the catheter hub 130.

[0511] The body 406 has a distally facing outer surface 540 that includes one or more protrusions or surface features 542 for aesthetic appeal. The distally facing outer surface may be curved or arcuate. The protrusions or surface features may optionally be omitted. In other examples, the protrusions may be embodied as other shapes, such as dimples, rounded bumps, contoured protrusions, or random protrusions. The distally facing outer surface 540 is located between two side surfaces 546. In examples, each of the two side surfaces 546 has flat or planar walls without varying surface features. In embodiments, each side surface 546 has a first surface portion 546a, a tapered side portion 546b, and a second surface portion 546c. The second surface portion 546c, like the first surface portion, has flat or planar walls. The two second surface portions 546c of the two side surfaces 546 define a width that is greater than the width defined by the two first surface portions 546a. Thus, the width of the first end 408 of the tab adapter 404 is greater than the width of the second end 410 of the tab adapter.

[0512] 40 is a front view of the tab adapter 404, facing the first or distal opening 420 and distally facing outer surface 540. As shown, the distal opening 420 can have a perimeter 550 defined by multiple edge sections or segments. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the tab adapter is configured to attach. For example, the shape of the perimeter 550 can have only four side edge sections, or can be semicircular or partially circular.

[0513] 41 is a rear view of tab adapter 404 looking at proximally-facing outer wall surface 560. In one example, proximally-facing surface 560 has a first surface segment 560a and a second surface segment 560b. First surface segment 560a can be generally planar but is sloped from the plane of second surface segment 560b at an inflection or transition line 562. First surface segment 560a can incorporate one or more surface features or protrusions 542.

[0514] As shown, the proximal or second opening 422 can have a perimeter 550 defined by a semicircular or partial circular edge. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the tab adapter is configured to attach. For example, the shape of the perimeter 550 can be defined by multiple edge segments or sections and can vary depending on the shape of the catheter hub 130 to which the tab adapter is configured to attach. The first and second openings 420, 422 should extend more than halfway or down the midline of the catheter hub body to ensure a grip across more than half the diameter of the catheter hub body.

[0515] 42 is a bottom view of tab adapter 404, showing inner surface 428 and an internal cavity 564 defined by inner surface 428. A number of ribs 566 may be incorporated into the internal cavity to provide rigidity.

[0516] FIG. 43 is a front perspective view of the tab adapter 404 attached to the catheter hub 130 of the catheter assembly 108, along with the needle hub 122, vent plug 123, and the catheter tube 110 and needle 112 extending from the distal end of the catheter hub. As shown, the catheter hub 130 has a nose section 570 at its distal end and a proximal body section 572. The nose section 570 has a generally square shape with rounded corners connecting its four sides. In other examples, the nose section 570 can have other cross-sectional shapes, including generally cylindrical, elliptical, oval, polygonal, etc. The proximal body section 572 can be generally circular and have a relatively larger girth or outer contour than the nose section 570. Accordingly, a step-up or stepped section 574 can be provided between the nose section 270 and the proximal body section 572. The opening of the tab adapter can be sized and shaped accordingly to fit the contour of the catheter hub body.

[0517] In this embodiment, the tab adapter 404 is sized and shaped to fit onto the catheter hub 130. In an example, the tab adapter 404 is configured to seat onto the catheter hub 130 and the hub body, which is located within the channel 414 of the body 406. The first opening 420 and the second opening 422 of the tab adapter 404 are sized to fit snugly around the curved body of the catheter hub 130. Depending on how the tab adapter 404 is positioned on the catheter hub 130, such as by its placement or location along the axial position of the catheter hub, the first and second openings 420, 422 of the tab adapter 404 can have the same size or different sizes to accommodate the particular contours of the catheter hub. In an example, as shown in FIGS. 40 and 41 , the first opening 420 can have a shape that fits snugly around the approximately square cross-section of the nose section 570, and the second opening 422 can have a hemispherical, semi-elliptical or oval shape, or an arc shape to fit around the proximal body section 572. Preferably, the two openings 420, 422 are sized and shaped to fit snugly over the catheter hub body and provide a gripping force around the hub body.

[0518] When mounted on the catheter hub 130, the push tab 176 of the catheter hub is configured to fit within the interior space 429 of the body 406. The push tab 176 of the catheter hub 130 can contact the proximal inner surface 428 of the body 406 or can protrude into an internal female detent, recess, or socket to improve securement between the tab adapter and the catheter hub. Thus, when the tab adapter 404 is pushed distally by the practitioner, the inner surface 428 of the tab adapter 404, or the recess or female detent within the adapter, presses against the proximally facing surface of the push tab 176, advancing the push tab 176, and thus the catheter hub 130, distally. In other examples, the grip provided by the openings 420, 422 on the catheter hub body can also transmit a distal force to the catheter hub to advance the catheter hub when the tab adapter is pushed.

[0519] Referring now to FIG. 44, an extended indwelling catheter assembly 100 is provided in accordance with a further embodiment of the present invention. The present ExD catheter assembly 100 shares similar aspects with the catheter assemblies of FIGS. 1-14, 15-28, and 32-43. As shown, the present ExD catheter assembly 100 includes a housing 102 having a first or left frame 193 and a second or right frame 194 attached to form the housing 102. The assembly further includes a catheter assembly 108, which may be similar to other catheter assemblies described herein. The catheter assembly 108 is shown at least partially disposed within the housing 102. The catheter assembly includes a catheter hub, a needle hub 122, and a protective cap 500 that covers the needle at the needle tip. The first and second frames are separable to release the catheter hub of the catheter assembly 108 from the housing. The first and second frames 193, 194 may be attached to one another along a seam by corresponding tabs or male detents and engagement slots, as previously described, thereby allowing for disengagement. Optionally, the first and second frames 193, 194 can be attached to one another along top and bottom seams via adhesive or welding, in addition to or as an alternative to tabs and detents. If the two housing frames 193, 194 are not separable, the housing 102 can be provided with a gate assembly that allows separation of the catheter hub from the housing 102 after cannulation and vascular access, as described further below. However, the housing still has top and bottom seams to separate the housing into left and right housing frames, as opposed to horizontal frames that separate the housing into upper and lower frames.

[0520] Similar to the embodiment of Figures 32-43, a tab adapter or tab extender 404 can be placed over the catheter hub 130 and secured thereto by a fitting. The needle hub 122 is shown extending proximally from the base end 190 having a vent plug (Figure 32) attached thereto. When using the ExD catheter assembly 100, the protective cap 500 is first removed to expose the needle.

[0521] 45A-45C, top perspective and bottom views of a tab adapter 404 according to a further aspect of the present invention are shown. The present tab adapter 404 shares many similarities with the tab adapter 404 of FIGS. 39-43, with some differences. The tab adapter 404 of this embodiment may be formed from a plastic material, such as by plastic injection molding. The tab adapter 404 may include a body 406 having a first end 408 and a second end 410. The first end 408 may be positioned above the second end 410 in height. In an example, the body 406 may be formed as a solid structure having a slot to accommodate a push tab extending from a catheter hub and a hollow tunnel for mounting onto a catheter hub body, as described further below.

[0522] The adapter body 406 can have an outer surface 426 and an inner surface 428 (FIG. 45C), a first or distal opening 420, and a second opening 422 (FIG. 45C) at an end of the body opposite the first opening 420. A channel 414 is provided between the two openings 420, 422. The wall thickness between the outer surface 426 and the inner surface 428 is sufficient to provide structural rigidity to support finger loads applied by a user to advance the catheter hub 130.

[0523] The body 406 has a distally facing outer surface 540 that includes one or more protrusions or surface features 542 for aesthetic appeal. The distally facing outer surface 540 may be arcuate or curved. The protrusions or surface features 542 may optionally be omitted. In other examples, the protrusions may be embodied as other shapes, such as dimples, rounded bumps, contoured protrusions, random protrusions, etc. The distally facing outer surface 540 is positioned between two side surfaces 546. In examples, each of the two side surfaces 546 may have flat or planar walls without varying surface features. As shown, a recessed groove or race 580 is positioned between a first surface portion 546a and a second surface portion 546c of each of the two side surfaces 546 of the tab adapter 404. The two second surface portions 546c of the two side surfaces may be generally planar and parallel to one another, thereby defining a generally constant outer dimension along at least a portion of the two side surfaces. The two first surface portions 546a may be generally parallel to one another. However, as shown, the two first surface portions 546a of the two side surfaces 546 taper inward in a direction from the second end 410 toward the first end 408.

[0524] The protrusion 582 can be incorporated into at least one of the two side surfaces 546 of the tab adapter 404 and can extend radially from the longitudinal axis of the tab adapter 404. The protrusion 582 can include an inclined surface 582a and a flat end surface 582b intersecting the inclined surface. In other examples, the protrusion can be formed from the straight sides and flat end surface of a hemispherical dome or a non-spherical dome. In use, the protrusion 582 can be positioned to abut or contact the gate assembly 600 (FIG. 46) at the distal end of the housing, as described above with reference to FIGS. 32-43 and further described below, to open the gate more widely and allow separation between the housing and the catheter hub. In an example, a protrusion 582 is provided on each of the two side surfaces 546 of the tab adapter 404 so that the gate assembly can be abutted by both protrusions 582.

[0525] The adapter distal opening 420 can have a perimeter 550 defined by multiple edge sections or segments. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the tab adapter 404 is configured to attach. For example, the shape of the perimeter 550 can have only four side edge sections, or can be semicircular or partial circular, or any corresponding shape of the outer contour of the catheter hub. However, the shape of the perimeter 550 does not need to exactly match the contour of the catheter hub in order for the tab adapter 404 to be used with the catheter hub and secured thereto by a fitting.

[0526] In one example, the proximally-facing surface 560 has a first surface segment 560a and a second surface segment 560b. The first surface segment 560a may be generally curved, arcuate, or sloped, such as a ramp with approximately vertical or upwardly extending walls. The second surface segment 560b may be curved or arcuate, and may be mostly horizontal or flat. The first surface segment 560a and the second surface segment 560b are connected or joined to one another, and together resemble a jump or ramp, as does the arcuate outer surface of the distally-facing surface. The first surface segment 560a of the proximally-facing surface 560 can incorporate one or more surface features or protrusions 542.

[0527] In an example, the proximal or second opening 422 can have a perimeter 550 defined by a semicircular or partial circular edge. The shape of the perimeter 550 of the second opening 422 can vary depending on the shape of the catheter hub 130 to which the tab adapter 404 is configured to attach. For example, the shape of the perimeter 550 can be defined by multiple edge segments or sections and can vary depending on the shape of the catheter hub 130 to which the tab adapter 404 is configured to attach. However, the shape of the perimeter 550 of the second opening 422 does not need to exactly match the contours of the catheter hub in order for the tab adapter 404 to be used with the catheter hub and secured thereto by a fitting. The perimeters of the first and second openings 420, 422 can be the same or different from one another. The first and second openings 420, 422 should extend more than halfway or down the midline of the catheter hub body to ensure a grip across more than half the diameter of the catheter hub body.

[0528] 45C is a bottom view of tab adapter 404, showing inner surface 428 and an internal cavity 564 defined by inner surface 428. A plurality of ribs 566 may be incorporated into the internal cavity to provide rigidity.

[0529] In an embodiment, the distally facing outer surface 540 is provided with a narrowed tip 590 having a tip 591 resembling a spear or arrow. Thus, the distally facing surface 540 and the two side surfaces 546 may converge to define a slightly pointed but sharp tip resembling a wide arrow. An extension 592 is provided in height on the distally facing outer surface 540 directly below the tip 590. In an example, the extension 592 may be shaped as an elongated stem or bar formed with the body 406 of the tab adapter 404. The extension 592 may have side edges 592a and a bottom edge 592b having an elongated shape with a narrowed tip 594. The narrowed tip or tip 594 of the extension 592 may be located distal to the tip 591 of the distally facing outer surface 540. In an alternative embodiment, the extension 592 may be omitted. The extension can be integrally formed with the tab adapter and can share one of its side edges with the lower surface 555 of the tab adapter 404 .

[0530] 45A and 45B, an actuation end 598 including both a narrowed tip or tip 594 of extension 592 and a narrowed tip or tip 591 of distally facing surface 540 is provided at the distal end of tab adapter 404. As described further below, actuation end 598 is configured to separate two gates of gate assembly 600 (FIG. 46) located at distal end 120 of housing 102 and to provide clearance for a catheter hub attached to tab adapter 404 to separate from the housing after successful venipuncture.

[0531] FIG. 46 is a front perspective view of the housing 102 of the ExD catheter assembly 100 of FIG. 44, shown without the catheter assembly 108 and tab adapter 404. The housing 102 is shown with the first or left frame 193 attached to the second or right frame 194, as previously described. A gate assembly 600, which can be attached to the distal end of the housing 102, is also shown attached to the housing 102. In the example, the gate assembly 600 includes a nose end 184 having a tip 186. The nose end 184 is hollow and defines a bore 602. The gate assembly 600 further includes an upper seam 276 and a lower seam, which allow the gate assembly 600 to separate at the upper and lower seams and swing distally about two pivotable hinges, as described further below. The upper seam 276 extends through the top of the nose end 184. A similar corresponding lower seam extends through the lower portion of nose end 184 .

[0532] 47A and 47B show a pre-assembled front view and a pre-assembled front perspective view of the gate assembly 600 of FIG. 46. As shown, the gate assembly 100 may be clam-shaped or clamshell-shaped and includes a body 604 having a first gate 606a and a second gate 606b that can be combined to form the assembled gate assembly 600 shown in FIG. 46. In an example, the two gates 606a, 606b may be formed by molding, such as plastic injection molding, and may include tie strips 610 to hold the pair together during manufacturing and assembly. Optionally, the tie strips 610 may be omitted, and other tracking and monitoring may be used to associate corresponding pairs of gates.

[0533] As shown, both the first and second gates 606a, 606b have a body section 611 having a barrier wall 612 with its proximally extending wall section 614 and its distally extending wall section 646. Each gate further includes a male detent 520, or stem or stud, and a receiving slot 524 for engaging a corresponding receiving slot 524 and male detent 520 in the opposing gate. Each receiving slot 524 can have at least one open or missing side to allow a mating male detent 520 to swing through the missing side, similar to the arrangement of the receiving slots 524 and male detents 520 in FIGS. 37 and 38 . For example, each receiving slot 524 can have three sides and can be sized and shaped to interference-receive a male detent 520. 45A-45C, each male detent 520 can slide past the missing wall of a corresponding receiving slot 524, swinging the gate open, as described further below. More specifically, the first and second gates 606a, 606b swing distally about their respective living hinges 618.

[0534] Each gate includes a front base wall 510 within the boundary defined by the hollow partial cylinder of each nose portion 184a or each distal wall 616. Each front base wall 510 has a notch 512 sized and shaped to accommodate a needle 112 and a portion of the catheter tube 110. When the first and second frames 193, 194 are joined, the two notches 512 from the two front base walls 510 form a perimeter that defines an opening 620 ( FIG. 48A ) sized and shaped to receive the perimeter of the combined catheter tube and needle. The opening 620 can be considered a guide opening for guiding the catheter tube and needle during advancement of the catheter tube and needle during cannulation and vascular access. In an example, the perimeter of the two notches 512 may be referred to as a guide opening that guides the combined needle and catheter tube as the combination advances distally during cannulation and vascular access. The two base walls 510 can have varying thicknesses measured along the length of the first frame and / or second frame. The male detents can protrude from the sides of the thicker base wall 510. In other examples, the base walls 510 can have a uniform thickness.

[0535] A male detent 520 is provided on each of the first and second gates 606a, 606b. As shown, the male detent 520 on each of the first and second gates 606a, 606b is located on the side of the notch 512 opposite the receiving sl...

Claims

1. An indwelling extension catheter assembly (100), comprising: a housing (102) comprising a first frame (193) attached to a second frame (194) and having an interior space (104), the housing (102) having a distal opening (342) and a proximal opening (101); a catheter assembly (108) disposed within the interior space (104) of the housing (102), the catheter assembly (108) comprising a catheter tube (110) attached to a catheter hub (130) and a needle (112) attached to a needle hub (122), the needle (112) and the catheter tube (110) projecting from the distal opening (342) of the housing (102), the needle hub (122) projecting from the proximal opening (101) of the housing (102), the catheter hub (130) being slidable within the interior space (104) of the housing (102) from a proximal position to a distal position within the interior space (104); an upper seam (276) located between the first frame (193) and the second frame (194) along a first surface of the housing (102); a lower joint (232) located between the first frame (193) and the second frame (194) along a second surface of the housing; the upper seam (276) is located above the lower seam (232) in terms of height; An extension indwelling catheter assembly, wherein the first frame (193) and the second frame (194) are separable from each other along the upper seam (276) and the lower seam (232).

2. 2. The indwelling extension catheter assembly (100) of claim 1, wherein the catheter hub (130) has an internal cavity (148), and a needle guard (140) having a proximal wall and two arms is disposed within the internal cavity (148) of the catheter hub (130).

3. 3. The indwelling extension catheter assembly (100) of claim 1 or 2, wherein the first frame (193) or the second frame (194) comprises a plurality of tabs (250, 394), and the other of the first frame (193) or the second frame (194) comprises a plurality of receiving slots (288, 354) that engage with the plurality of tabs (250, 394).

4. The indwelling extension catheter assembly (100) of any one of claims 1 to 3, wherein the housing (102) comprises a base end (190) comprising a plurality of side walls (200, 202, 204, 206).

5. 5. The indwelling extension catheter assembly (100) of claim 4, further comprising a first lever (214) and a second lever (216), the first lever and the second lever (214, 216) protruding from different surfaces of the base end (190) of the housing (102).

6. 6. The indwelling extension catheter assembly (100) of claim 5, wherein the first lever (214) is attached to a three-sided notch (254) in the second frame (194).

7. 7. The indwelling extension catheter assembly (100) of claim 6, wherein the second lever (216) comprises a curved proximally facing surface (216a).

8. 8. The indwelling extension catheter assembly (100) of claim 1, wherein the housing (102) has a body opening (196) and the push tab (176) of the catheter hub (130) is disposed within the body opening (196).

9. 6. The indwelling extension catheter assembly (100) of claim 5, wherein the first lever (214) and the second lever (216) move relative to each other to separate the first frame (193) and the second frame (194).

10. 2. The indwelling extension catheter assembly (100) of claim 1, wherein the first frame (193) comprises a gate (340, 606a) having a living hinge (346, 618), and the second frame (194) comprises a gate (340, 606b) having a living hinge (346, 618).

11. 11. The indwelling extension catheter assembly (100) of claim 10, wherein the tabs (398) engage the recesses (378) to engage the two end cap components (340).

12. 2. The indwelling extension catheter assembly (100) of claim 1, wherein the first frame (193) has an actuation structure (328), the second frame (194) has an actuation structure (328), and the gap defined by the two actuation structures (328, 328) is sized and shaped to be pressed by the catheter hub (130) to separate the first frame (193) from the second frame (194).

13. The indwelling extension catheter assembly (100) of any one of claims 1 to 12, further comprising a tab adapter (404) mounted about the catheter hub (130).

14. The indwelling extension catheter assembly (100) of any one of claims 1 to 13, further comprising a guidewire extending through said needle (112).

15. A method of manufacturing an indwelling extension catheter assembly (100), comprising: The method comprises: forming a housing (102), the housing (102) comprising a first frame (193) attached to a second frame (194) and having an interior space (104), the housing having a distal opening (342) and a proximal opening (101), an upper seam (276) disposed between the first frame (193) and the second frame (194) along a first side of the housing (102), and a lower seam (232) disposed between the first frame (193) and the second frame (194) along a second side of the housing; the upper seam (276) is located above the lower seam (232) in terms of height; The method also includes: disposing a catheter assembly (108) within the interior space (104) of the housing (102), the catheter assembly (108) comprising a catheter tube (110) attached to a catheter hub (130) and a needle (112) attached to a needle hub (122), the needle (112) and the catheter tube (110) projecting from the distal opening (342) of the housing (102), the needle hub (122) projecting from the proximal opening (102) of the housing (102), and the catheter hub (130) being slidable within the interior space (104) of the housing (102) from a proximal position to a distal position within the interior space (104); The method, wherein the first frame (193) and the second frame (194) are separable from each other along the upper seam (276) and the lower seam (232).

16. 16. The method of claim 15, wherein the first frame (193) and the second frame (194) are separable by moving the first frame (193) in a first direction and the second frame (194) in a second direction.

17. 16. The method of claim 15, wherein the first frame (193) and the second frame (194) are separable by advancing the catheter hub (130) distally to push apart two actuation structures (328) located inside the interior space (104) of the housing (102).

18. 16. The method of claim 15, wherein the catheter hub (130) is separable from the housing (102) by moving two end cap components (340) about two living hinges (346).

19. An indwelling extension catheter assembly (100), comprising: a housing (102) comprising a first frame (193) attached to a second frame (194) and having an interior space (104), the housing (102) having a distal opening (342) and a proximal opening (101); a catheter assembly (108) disposed within the interior space (104) of the housing (102), the catheter assembly (108) comprising a catheter tube (110) attached to a catheter hub (130) and a needle (112) attached to a needle hub (122), the needle (112) and the catheter tube (110) projecting from the distal opening (342) of the housing (102), the needle hub (122) projecting from the proximal opening (101) of the housing (102), the catheter hub (130) being slidable within the interior space (104) of the housing (102) from a proximal position to a distal position within the interior space (104); a gate assembly (600) attached to the housing (102), the gate assembly (600) comprising a first gate (606a) attached to a living hinge (618) and a second gate (606b) attached to the living hinge (618); An extension indwelling catheter assembly, wherein the two gates (606a, 606b) are rotatable about the two living hinges (618) to open the two gates (606a, 606b) to separate the catheter assembly (108) from the housing (102).

20. 20. The indwelling extension catheter assembly (100) of claim 19, further comprising a tie strip (610) connecting the two gates (606a, 606b) together.

21. 21. The indwelling extension catheter assembly (100) of claim 20, wherein the gate assembly (600) comprises a key (633) having a flange (632) for mounting in a slot (644) in the housing (102).

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