Extended indwelling and midline catheters and related methods

Abstract

The invention relates to extended indwelling and midline catheters and related methods. An extended indwelling catheter assembly (100) each having a housing (102) with an interior (104) having a catheter assembly (108) therein, the catheter assembly (108) may include a catheter tube (110) and a needle (112). The catheter tube (110) of the catheter assembly (108) may be placed into a patient's vein with or without the use of a guidewire, and then the extended indwelling catheter assembly (100) may be activated to separate into two or more housing members (193, 194), or by opening a door (340, 606a, 606b) to enable the catheter assembly (108) to be separated from the housing (102). A needle guard (140) may be included to cover a needle tip (114) of the needle (112), preventing accidental needling.

Description

Technical Field

[0001] This application is a divisional application, the parent application number of which is 202080075730.1, the application date is August 28, 2020, and the invention name is "Extended Indwelling and Midline Catheters and Related Methods". The disclosed invention generally relates to needle devices and intravenous (IV) infusion devices, including IV catheters. In particular, an IV catheter assembly with a single-handed operation for actuation is disclosed. Background Art

[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. The catheter is typically connected to a catheter adapter that accommodates the attachment of IV tubing to the catheter. The blood control catheter includes an internal blood control valve that is opened by inserting a male Luer interface or another object into the proximal end of the catheter adapter. A non-limiting example of a blood control valve is disclosed in U.S. Patent Application Publication No. 2011 / 0046570, entitled "System and Method for Providing a Flushable Catheter Assembly," filed on August 20, 2009. After the catheter is placed in the patient's vascular system, an IV fluid source can be connected to a catheter adapter or catheter hub to open the blood control valve. Thus connected, fluid from an IV source can begin to flow into the patient through the catheter.

[0003] As is well known in the art, typical blood pressure is 10 to 20 cm H2O. The infusion bag is usually placed about 100 cm above the patient's heart to direct the blood into the patient. At approximately that height, the pressure exerted by the fluid from the infusion bag is much greater than the patient's blood pressure, and therefore can flow into the patient.

[0004] For patients with different venous access, an extended indwelling catheter can be used to assist with difficult venous access (DIVA). An extended indwelling catheter is a midline catheter that can be considered a peripherally inserted catheter. However, a typical midline catheter is configured to be inserted into a larger vein than that used for standard IV therapy. The recommended insertion site for a midline catheter is the basilar, cephalic, or median vein in the antecubital fossa. For DIVA patients, the physician can use a visualization device to assist in identifying the deep vein for catheter access. In this case, an extended indwelling catheter will provide a longer length and a more flexible catheter for insertion into the patient. With the addition of a guidewire, this can help reduce the chance of catheter kinking. Summary of the invention

[0005] An extended indwelling catheter assembly is described. Each extended indwelling catheter assembly includes a housing having an interior with a catheter assembly located therein, which can include a needle, a needle hub, a catheter, and a catheter tube. The catheter tube of the catheter assembly can be placed in a patient's vein with or without a guidewire, and the extended indwelling catheter assembly can then be activated to separate the housing into two or more housing components, thereby enabling the catheter assembly to be separated from the housing. The catheter assembly can include a needle guard to cover the needle tip to prevent accidental needle sticks.

[0006] An extended indwelling catheter assembly according to aspects of the present invention may 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 located in 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, wherein the needle and the catheter hub protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub is slidable within the interior space of the housing from a proximal position within the interior space to a distal position; an upper seam located between the first frame and the second frame along a first side and a lower seam located between the first frame and the second frame along a second side; and wherein the first frame and the second frame are separable from each other along the upper seam and the lower seam. The upper seam is located above the lower seam in the height direction.

[0007] The catheter hub may include an interior cavity, and wherein the needle guard may be located in the interior cavity of the catheter hub.

[0008] The needle guard may include a proximal side and two arms. When the needle guard is viewed from one side, the two arms may intersect each other in the ready-to-use position and the activated position or the protection position.

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

[0010] The second frame may include a plurality of male detents, and wherein each detent includes a tip pointing in a distal direction.

[0011] The second frame may include a plurality of male detents, and wherein each detent may include a distal end pointing in a proximal direction.

[0012] The first frame and the second frame may have lower wall structures joined to each other along respective joining edges.

[0013] The first frame and the second frame may be connected to a wall structure that is not joined to define a longitudinal housing opening.

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

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

[0016] The needle hub may have a flange defining a plane normal to a plane in which the needle lies, and wherein the flange is located in the channel of the housing.

[0017] The housing may include a base end, and wherein the base end may include a plurality of sides. When viewed along an end view, the plurality of sides may define a square or rectangular shape.

[0018] The housing can be divided into a first frame and a second frame. The first frame and the second frame can be separated by separating the male pawl from the female receiving groove or the female engaging groove.

[0019] The first frame and the second frame may be separated from each other by applying a compressive force on the first or top bar while applying a proximally directed force and applying a compressive force on the bottom bar while applying a distally directed force.

[0020] The first and second frames may be separated from each other, or at least their proximal ends may be separated from each other, by sliding the catheter hub in a distal direction within the interior space of the housing to push against one or two activation ramps located within the interior space.

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

[0022] The housing may be provided with a first rod and a second rod, and the first rod and the second rod may protrude from different surfaces of the housing.

[0023] The first bar may be attached to the three-sided cutout on the second frame.

[0024] The second rod 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 protrusions.

[0026] The plurality of protrusions may engage the plurality of grooves. The engagement may be a friction fit or an interference fit. The engagement may include a positive engagement.

[0027] The first frame may include an end cap component having a protrusion, and the second frame may include a recess, and wherein the protrusion of the end cap component may engage the recess.

[0028] The end cap component located at the distal end of the first frame can be understood as a door that can be closed to retain the catheter hub within the housing and can be swung open to allow the catheter hub to be separated from the housing. Similarly, the end cap component can be located at the distal end of the second frame and can be understood as a door that can be closed to retain the catheter hub within the housing and can be swung open to allow the catheter hub to be separated from the housing. The two doors on the two frames can be opened together to form a large access opening, thereby enabling the catheter hub to be separated from the housing. The two doors can rotate or pivot about a living hinge.

[0029] The recess of the second frame may be located on the end cap component.

[0030] The end cap member of the first frame may be attached to the wall of the first frame by a living hinge.

[0031] The end cap member of the second frame may be connected to the wall of the second frame by a living hinge.

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

[0033] Another 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 located in 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, wherein the needle and the catheter hub protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub can slide within the interior space of the housing from a proximal position within the interior space to a distal position; and a first rod protruding in a first radial direction of the housing, and a second rod protruding in a second radial direction of the housing, the second radial direction being opposite to the first radial direction.

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

[0035] Yet another 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 located in 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, wherein the needle and the catheter hub protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub can slide within the interior space of the housing from a proximal position within the interior space to a distal position; a first end cap component attached to a wall of the first frame by a first movable hinge; and a second end cap component connected to the wall of the second frame by a second movable hinge.

[0036] The plurality of protrusions may engage the plurality of slots to secure the first frame to the second frame.

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

[0038] The push tab of the catheter hub may be located within the body interior of the tab adapter.

[0039] An extended indwelling catheter assembly includes: 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 located in 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, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub is slidable within the interior space of the housing from a proximal position within the interior space to a distal position; an upper seam located between the first frame and the second frame along a first side of the housing, and a lower seam located between the first frame and the second frame along a second side of the housing; and wherein the first frame and the second frame are separable from each other along the upper seam and the lower seam. The upper seam is located above the lower seam in the height direction.

[0040] An extended indwelling catheter assembly comprises: 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 located in 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, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub can slide within the interior space of the housing from a proximal position within the interior space to a distal position; and a first rod member protruding along a first radial direction of the housing and a second rod member protruding along a second radial direction of the housing, the second radial direction being opposite to the first radial direction.

[0041] An extended indwelling catheter assembly comprises: 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 located in 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, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub is slidable within the interior space of the housing from a proximal position within the interior space to a distal position; a first end cap component attached to a wall of the first frame by a first movable hinge; and a second end cap component connected to the wall of the second frame by a second movable hinge.

[0042] Yet another aspect of the present invention is an extended indwelling catheter assembly, comprising: a housing comprising a first frame and a second frame and having an internal space, the housing having a distal opening and a proximal opening; a catheter assembly located in the internal space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing in a ready-to-use position.

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

[0044] A door assembly includes a first door and a second door, wherein the first door has a key that fits into an opening of a first frame and the second door has a key that fits into an opening of a second frame.

[0045] The first door may be pivotable or rotatable about a hinge and the second door may be pivotable or rotatable about a hinge. The hinge may be a living hinge. Both hinges may be living hinges.

[0046] The key that fits into the opening of the first frame may have a door sidewall and a flange. There may be more than one flange extending from the planar surface of the door sidewall to define the door.

[0047] The two keys may be located on opposite sides of the nose end having the hole. Opposite sides may be understood as being located on different sides of the axis defined by the hole.

[0048] The opening on the frame into which the key fits can be formed by a first wall panel and a second wall panel. Each of the two wall panels can have an edge. The two wall panels can be connected along one or more edges. At least one edge on one wall panel can be directly connected to another edge of the other wall panel. The two edges (one on each wall panel, two in total) can be connected via a rib. One of the first and second wall panels can be shaped such as to have an angle, a curve, a profile, etc., and not just a flat wall.

[0049] A tab adapter comprises a body having a first opening, a second opening and a channel, and wherein the tab adapter can be connected 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 located 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 straight ramp. The shaped surface can provide a convenient contact point for a user or physician to push against to move the catheter hub from a proximal position to a distal position within the housing interior. A protrusion or gripping feature can be provided on the proximally facing surface.

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

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

[0052] An extension having a narrow tip may be provided for use with the end tip of the distal facing surface of the nose adapter. The extension and the end tip of the distal facing surface may be referred to as an actuation tip. The end tip of the extension may have an arrow shape. The end tip of the extension may be distal to the end tip of the distal facing surface. The extension may be located below the distal facing surface in height.

[0053] The tab adapter may have side surface portions. The two side surface portions may define a width of the tab adapter. The width may be considered to be orthogonal to the longitudinal direction of the tab adapter. A protrusion may extend from a surface of each of the two side surface portions. After the two doors of the door assembly are opened by the actuation end, each protrusion may further push against the door assembly.

[0054] The body of the nose adapter may include an actuation end including a terminal end.

[0055] The terminal end may be located at a distal end of the distally facing surface, and wherein the nose adapter may further include an extension having a terminal end located height-wise below the terminal end of the distally facing surface.

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

[0057] The door assembly includes a hook arm that engages the female pawl. The hook arm can be located on the first door and the female pawl can be located on the second door. This arrangement can be reversed. The hook arm can have a rod, bar or short columnar structure with a notch or bend at one end forming the hook arm.

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

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

[0060] A cylindrical nose section may be disposed on the door assembly defining the aperture.

[0061] The door assembly may have a base wall with a guide opening. The guide opening may have a diameter smaller than the diameter of the hole. The guide opening may support a catheter tube having a needle located within the lumen of the catheter tube.

[0062] Yet another 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 internal space, the housing having a distal opening and a proximal opening; a catheter assembly located in the internal space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub is slidable within the internal space of the housing from a proximal position within the internal space to a distal position; an upper seam between the first frame and the second frame along a first side of the housing and a lower seam between the first frame and the second frame along a second side of the housing, the upper seam being located above the lower seam in a height direction; and wherein the first frame and the second frame are separable from each other along the upper seam and the lower seam.

[0063] The catheter hub may include an interior cavity, and wherein a needle guard including a proximal wall and two arms may be located in the interior cavity of the catheter hub.

[0064] The first frame or the second frame may include a plurality of protrusions, and the other of the first frame or the second frame may include a plurality of receiving grooves engaging the plurality of protrusions.

[0065] The housing may include a base end including a plurality of side walls. There may be four side walls defining a square or rectangular cross section. In other examples, the base end may have a circular or oval cross section.

[0066] The housing may be provided with a first rod and a second rod, and the first rod and the second rod may protrude from different surfaces of the base end of the housing. The protrusions of the first and second rods may be in a radial direction of the longitudinal axis of the housing.

[0067] The first bar may be attached to the three-sided cutout on the second frame.

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

[0069] The housing may include a body opening, and wherein the push tab on the catheter hub may be located 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 rod and the second rod may be movable relative to each other to separate the first frame and the second frame.

[0072] The first frame may include a door having a living hinge, and the second frame may include a door having a living hinge.

[0073] The protrusion may engage the recess to join the two end cap components together.

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

[0075] The tab adapter may fit around the catheter hub.

[0076] The tab adapter may fit over the push tab on the catheter hub.

[0077] A guidewire assembly with a guidewire may be extended through the needle.

[0078] Aspects of the present invention may further include a method for manufacturing an extended indwelling catheter assembly. The method may include: forming 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, an upper seam between the first frame and the second frame along a first side of the housing, and a lower seam between the first frame and the second frame along a second side of the housing, the upper seam being located above the lower seam in height direction; placing a catheter assembly in 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, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub can slide from a proximal position in the interior space to a distal position in the interior space of the housing; and wherein the first frame and the second frame are separable from each other along the upper seam and the lower seam.

[0079] The first frame and the second frame may be separated by moving the first frame in a first direction and moving the second frame in a second direction.

[0080] The first frame and the second frame can be separated by advancing the catheter hub in a distal direction to push apart two activation structures located within the interior space of the housing.

[0081] The catheter hub can be separated from the housing by displacing the two end cap components about the two living hinges.

[0082] Another 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 internal space, the housing having a distal opening and a proximal opening; a catheter assembly located in the internal space of the housing, the catheter assembly comprising a catheter tube attached to a catheter hub and a needle attached to a needle hub, wherein the needle and the catheter tube protrude from the distal opening of the housing, and the needle hub protrudes from the proximal opening of the housing, and wherein the catheter hub can slide within the internal space of the housing from a proximal position within the internal space to a distal position; and a door assembly attached to the housing, the door assembly comprising a first door attached to a movable hinge and a second door attached to the movable hinge; wherein the two doors can rotate around two movable hinges to open the two doors for separating the catheter assembly from the housing.

[0083] Tie strips can connect two doors together.

[0084] The door assembly may include a key including a flange for attachment to a slot on the housing.

[0085] Unless a component or structure is described as critical or essential, it can be implemented as optional or with alternatives.

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

[0087] The housing and the catheter hub can be separated by a variety of different mechanisms. For example, the housing can be separated 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 door opening at the distal end of the housing to allow the catheter hub to exit the housing, and the housing can have a door assembly attached to the distal end of the housing, and the door assembly can have one or more doors that swing open about hinges, among other options.

[0088] The door assembly may have two doors on two door housing bodies that may be coupled and wherein each door may swing open via a living hinge. The two doors may engage with each other via a male detent and a receiving slot during initial assembly with the housing. The two doors may engage via a hook arm and a female detent. The hook arm and the female detent may be in addition to, or in lieu of, the male detent and the receiving slot.

[0089] The unique housing design allows for use with standard or existing catheter assemblies without the need for a specially designed catheter, although this is optional. Therefore, a standard catheter with an extended catheter length and a midline catheter with an approximate 8-10 cm catheter length can be easily used with the housing of the present disclosure with or without a guidewire. The catheter can be supported by the guide opening during intubation and vascular access. When the catheter hub moves distally to place the catheter tube into the patient, one or more structures defining the guide opening can be separated to allow the catheter hub to pass, as discussed further below. The guide opening can be separated by dividing the housing into two or more frames or frame segments. The guide opening can be separated by opening two doors of a door assembly located in the housing. The door assembly can be formed integrally with the housing, or can be formed separately and subsequently attached to the housing.

[0090] In one example, an extended indwelling or ExD catheter assembly according to aspects of the present invention includes a housing having a receiving space or interior space having a catheter assembly located therein, the catheter assembly having a catheter tube and a needle located within the catheter lumen and extending out of a distal end or distal opening of the housing. The catheter hub can be a standard catheter or a midline catheter with an extended catheter length.

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

[0092] The needle hub may extend beyond the proximal end of the housing. The needle hub may include a vent plug that may engage a proximal opening of the needle hub, such as in a Luer fit. The vent plug may have a vent filter that allows air to be purged but does not allow blood to be purged.

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

[0094] In one example, the catheter assembly can include a first hub or catheter hub to which a needle tube or catheter tube is attached, and a second hub or needle hub to which a needle is attached. The first needle hub or catheter hub can be a single hub structure having a distal opening attached to the catheter tube and a proximal opening having a female Luer interface. Optionally, the catheter hub can be formed by two hub bodies attached together, one of the two hub bodies having a female Luer interface.

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

[0096] The needle may include a change in profile proximal to the needle tip for use with a needle guard. The needle tip extends distally from a distal opening of a catheter tube or tubing in a ready-to-use position, and if used in conjunction with a needle guard, the change in profile is proximal to the distal opening of the catheter tube. The change in profile may be a curl, a bulge, or a buildup 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 physician, and the term "distal" is the opposite end or side.

[0097] The change in profile can be used to interact with the needle guard during needle retraction after a successful venipuncture, as discussed further below. The vent plug is disposed at the proximal open end of the second hub or needle hub. The vent may 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 sleeve.

[0098] A needle guard may be disposed in the interior cavity of the first hub or the catheter hub for covering the needle tip in a protected position. When incorporated, the needle guard may 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 may be omitted. If so, the change in contour on the needle may also be omitted.

[0099] In other examples, a needle guard may be included without including a profile change on the needle. In other examples, the needle guard may be located in a third housing between the first hub and the second hub. An exemplary needle guard located 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 other examples, the needle guard may include a plurality of arms or fingers extending both in a first direction and in an opposite second direction, as disclosed in U.S. Patent No. 9,387,307, the contents of which are expressly incorporated herein by reference. For example, the needle guard may include a first protector body surrounded by a second protector body.

[0100] In one example, the needle guard may be made of a metal material and may have an elastic portion capable of generating a biasing force. The needle guard may include a wall surface positioned to one side of the needle and movable distally of the needle tip to protect the needle tip from accidental contact therewith. The wall surface may be a needle catcher and movable directly in front of or distally of the needle tip.

[0101] The needle guard may include a proximal wall and two arms extending distally from the proximal wall. When viewed from one side, the two arms may intersect each other in a ready-to-use position and in a protective position in which the needle guard covers the needle tip. In some examples, the two arms of the needle guard may extend in a distal direction without intersecting each other.

[0102] Two distal walls (one on each arm) may be combined to block the needle tip. The two distal walls may be biased outwardly by the needle in the ready-to-use position and disposed distally of an internal change in the first hub internal profile in the ready-to-use position. The internal change in the catheter hub internal profile may be a reduced diameter section located next to a larger sized internal diameter section. The elbows on the two arms of the needle guard may have a size larger than the internal diameter at the internal change in profile to limit the proximal movement of the needle guard from the catheter hub until the two arms are no longer biased outwardly or until the size 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 corresponding distal wall, may be greater than the inner diameter of the internal change in profile, which may prevent the needle guard from moving proximally due to the relative size. Once the needle tip moves proximally of the two distal walls, the two arms may be allowed to move radially inward, and one or both distal walls may close over the needle tip to block the needle tip in a protective position. At this point, the dimension between the two joints or elbows may be reduced and less than the inner dimension of the internal change in profile 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 greater than the inner dimension of the internal change in profile, and the needle may still be moved proximally by bending or squeezing the two joints to pass through the internal change in profile.

[0104] The first hub or catheter hub may have a proximal opening with a nose section of a second hub or needle hub disposed therein. The proximal opening of the first hub may have a female Luer interface for receiving a male Luer interface end (such as a syringe, IV tubing connector, Luer interface extension assembly, etc.). External threads may be provided on an outer surface at the proximal end of the catheter hub for threaded engagement with a threaded collar of the male threaded Luer interface end.

[0105] A pair of stabilizing wings can extend radially from the first needle hub to facilitate securing or anchoring the first needle hub to the patient after a successful venipuncture. Optionally, the wings can be omitted. The first hub 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 assembly. If the wings are not present on the first hub or catheter hub, the bottom of the first hub can have a flat surface at an angle of 2 to 15 degrees to the through axis of the first needle hub.

[0106] The first hub may be removably secured to the second hub by receiving the nose segment of the second hub in the proximal opening of the second hub.A flange or extension may be provided on the second hub and together with the nose segment define a gap having a portion of the first hub located therein.

[0107] Optionally, the flange or extension can be omitted and a stub or other surface matching feature is provided. The stub can be the male portion of the key fitting that passes through the Luer interface thread or partially enters the gap of the Luer interface thread to prevent the second hub from rotating relative to the first hub. The proximal facing end surface of the first hub abuts the distal facing surface of the step in the outer surface of the second hub, which is located at the proximal end of the nose section inside the first hub. This abutment can set the amount that the needle tip protrudes from the catheter tube. The stub can be an optional structural feature.

[0108] The second hub can have a body with an optional internal cavity into which the proximal end of the needle protrudes. The internal cavity can function as an initial blood flashback chamber. The proximal opening of the body can have a female Luer structure for receiving a vent plug or a syringe end therein, and the exterior can be threaded or unthreaded. In one example, the exterior of the body of the second hub is generally cylindrical and unthreaded. The first and second hubs can be made of a plastic material, such as by plastic injection.

[0109] The first hub or the catheter hub may be provided with a push protrusion. The push protrusion may be located on the outer surface of the first hub, at a position distal to the external thread, so as to avoid interference with the external thread. For example, the push protrusion should be positioned sufficiently distal to the external thread, and approximately at the 12 o'clock position of the catheter hub, so that when a threaded male connector (such as a syringe type with a threaded collar) is connected to the thread of the first hub, the push protrusion does not interfere with the connection. In some examples, the push protrusion should be positioned sufficiently distal to the external thread, so that when the push protrusion is folded, the push protrusion 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 located 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, thereby opening a fluid passage for fluid flow through the valve. U.S. Patent No. 8,333,735 discloses an exemplary valved catheter assembly having a valve and a valve opener, the contents of which are expressly incorporated herein by reference.

[0111] The valve opener can have a nose section having an aperture and a plunger section located proximal to the nose. The nose section can be pushed into the valve to open one or more slits of 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 the aperture in the nose section.

[0112] The housing of various aspects of the ExD catheter assembly according to the present invention includes a left frame or first frame and a second frame 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 connected to form a nose end, the two body portions can be connected to form a body, and the two base portions can be connected to form a base end.

[0113] In one example, the nose tip or nose portion is provided with a nose end having an elongated cylindrical structure having a hole for receiving a catheter tube and a needle, the hole being located within the catheter tube. The nose tip or nose portion may also include a nose base and a tapered distal portion, the nose base having an expanded portion formed by the tip.

[0114] A plurality of support ribs or fins may be provided at the intersection between the distal end of the housing and the nose base. In other examples, the nose tip may be a spherical or rounded dome having an opening to accommodate a catheter tube and a needle.

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

[0116] In one example, the body may be provided with a second opening opposite to the first opening, such that the interior space is accessible from both body openings. Thus, the body may thus have a through passage defined by the two body openings between the distal and proximal ends of the housing. In other examples, the body has only a single opening leading to the interior space, and the opposite sides of the body are solid or enclosed by the wall surfaces of the first frame and the second frame.

[0117] When the housing includes a single body opening, the opening can be located at the top of the housing in height direction to allow the user to see when using the ExD catheter assembly. Optionally, the enclosed side can have a small window or opening for entry or ventilation but not a complete opening like the single body opening.

[0118] The base or base end of the housing can extend from the body and can have multiple sides. The multiple sides can define a base with a polygonal cross-section. In one example, the base can have four sides that define an interior space that is open to the interior space of the body. In other examples, the base or base end can be embodied as a generally elongated cylinder or a non-circular cylinder. These four sides can be referred to as the first, second, third, and fourth sides. These four sides can also be referred to as the top, bottom, left, and right sides. These specific terms are given to enable specific sides to be called only relative to other sides, but unless the context indicates otherwise, these terms are not restrictive in structure.

[0119] The base or base end may have an open proximal end to allow the needle hub to extend proximally thereof, proximally of the end face, in a ready-to-use position. The first side and the second side of the base end may each have an opening to allow viewing and access to the interior space of the base end, such as to facilitate or assist in the assembly of a catheter assembly therein.

[0120] The top side of the base end may be provided with a first or top rod, and the bottom side may be provided with a second or bottom rod. When a user simultaneously applies a compressive force and a distally directed force on the top rod and a compressive force and a proximally directed force on the bottom rod, the user may move the left and right housing frames relative to each other and the detents on the first and second frames disengage. This in turn will allow the housing to be separated into separate housing components, for example, into a left frame and a right frame.

[0121] By manipulating the first or top and bottom rods, the user can cause the housing to separate into two or more housing components. After successful venipuncture, separating the housing into the housing components can then expose the catheter assembly to be separated from the housing so that the catheter hub can be secured to the IV line and to the patient, such as by using tape or a fixation dressing.

[0122] In other examples, by rearranging the detents or engagement protrusions between the left and right housing frames, a user can simultaneously apply a compressive force and a proximally directed force on the top rod and a compressive force and a distally directed force on the second or bottom rod to move the two housing segments relative to each other and disengage the detents on the first and second frames.

[0123] The housing exterior may have a plurality of surface decorations, such as on the outer surface of the left or first frame. The right frame or the second frame may be provided with a set of similar surface decorations. The two main body frames may be provided with upper edges of substantially planes. In addition, the distal edge of the top rod may be located proximal to the distal edge of the bottom rod. This arrangement may be used to allow the thumb to easily grasp the top rod and the outer edge of the index finger to easily grasp the bottom rod, thereby dividing the housing into housing components. For example, the index finger may push against the curved proximal-facing surface of the bottom rod and push distally or in a distal direction. In other examples, the relative arrangement between the top and bottom rods may be changed or arranged differently depending on the type of pawl or snap connection that is combined to hold the first frame and the second frame together.

[0124] The shell can include a wall along the top side of the shell opposite the main body opening. The seam can extend in the longitudinal direction of the shell, which can mark the interface between the left frame and the right frame of the shell along the main body and the nose of the shell. The seam can extend from the nose to and include the base end through the shell. However, the seam can be non-linear or not extend in a straight line. For example, the seam can be off-axis compared to the straight line defined by the seam along the main body and the nose.

[0125] The seam at the base end can be near the intersection of the edge or each side, such as the right side and the bottom side. Multiple pairs of ratchets can be incorporated between the left frame and the right frame to fix the two frames together. In one example, before the left frame is engaged to the right frame, the catheter assembly can be located inside the shell, or vice versa. After use, such as after successful venipuncture, the top rod and the second or bottom rod can be actuated to separate the ratchets, and then the shell is divided into parts, such as separating the left frame from the right frame, so that the catheter assembly can be separated from the shell.

[0126] In one example, the right frame may be provided at the base portion with a second side and a top side or a third side, which are substantially at right angles to each other. The left frame may be provided with a first side and a bottom side or a fourth side.

[0127] In order to fix the catheter assembly to the right frame, and in particular to prevent the needle hub from moving, the lower wall structure or section of the right frame can terminate at a proximal edge, which is located along the axial position on the right frame to accommodate the flange or extension on the needle hub. Therefore, the distal edge of the flange can be limited by the proximal edge on the lower wall structure and not displaced or moved in the distal direction.

[0128] To secure the needle hub from moving in the proximal direction, the second side may be provided with a channel and a shoulder on the proximal edge of the channel for retaining the flange on the needle hub. The channel may be on the second side, and the corresponding channel on the first side defines a gap or width for accommodating the width of the Luer thread on the catheter hub and the flange on the needle hub.

[0129] The non-circular structure for coupling the flange and the groove channel, such as by using a multi-faceted structure, can prevent the needle hub from rotating simultaneously within the space defined by the sides of the base end. This in turn can retain the needle hub in the assembled position so that the needle bevel can be oriented in the desired position without premature rotation before performing a venipuncture.

[0130] The second side of the base portion may have a channel and a shoulder. A plurality of protrusions or male pawls may be provided at the lower edge of the second side. The protrusions may be embodied as hook-like structures for engaging a female pawl located on the left side or the first frame. Optionally, there may be more than two pawls or only one pawl. Each male pawl may have a distal end pointing in a distal direction for engaging the female pawl from a proximal position of the female pawl and moving or sliding to a distal position for engagement.

[0131] For a particular arrangement, the right frame and pawl must travel or move in a proximal direction relative to the left frame to disengage the male pawl from the female pawl on the left frame. In other examples, the male pawl on the right frame may be directed in a proximal direction such that separation of the male and female frames will require movement of the right frame in a distal direction relative to the left frame to disengage the male pawl from the female pawl on the left frame.

[0132] Along the top side, a cutout may be provided to form a top bar. The cutout may be provided with three sides, wherein a fourth side is connected to a base of the top bar. The top bar may be formed to protrude outwardly in a direction away from the lower edge. The top bar 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] A rib or protrusion may be provided on the underside surface of the top side and may be recessed from the side edge of the top side. When the left frame is assembled to the right frame, the recessed space between the side edge and the protrusion may be sized to accommodate the thickness of the first side of the left frame. The rib may be considered an alignment tab for aligning the first side with the side edge, such that when assembled with the first side, a substantially flush surface is provided between the side edge and the exterior of the first side.

[0134] The second rib or protrusion can be spaced apart from the first rib and disposed on the underside surface of the top side. In one example, the second rib can be aligned to or with the side edge and can be configured to engage a corresponding groove or recess on the left side or first side of the left frame to align the two frames at the base end along the axial direction of the housing.

[0135] In one example, the second rib can have an arrow-shaped structure having two tapered edges and an apex therebetween. The arrow-shaped structure can be configured to be seated in a corresponding seat on the left side of the left frame, and when the top bar and the bottom bar are grasped and caused to slide relative to each other, the two tapered surfaces can allow the protrusion to disengage from the corresponding seat by allowing the corresponding tapered surfaces to slide relative to each other.

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

[0137] A protrusion or pawl with a free end pointing in the distal direction may be located on the side edge of the lower wall structure. The protrusion may engage a corresponding female pawl formed with the left frame. In other examples, additional protrusions may be provided along the side edge of the lower wall structure.

[0138] The distal portion of the right frame may be provided with two protrusions. As shown, a lower protrusion may be provided on the side edge of the lower wall structure for engaging a groove on the left frame to provide additional rigidity along the seam. An upper protrusion may be provided on the side edge of the base for engaging a groove on the left frame to provide additional rigidity along the upper seam at the nose end of the housing. The upper seam is located above the lower seam in the height direction.

[0139] In one 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 one example, the upper wall or top wall structure can have a length extending in the same longitudinal direction as the needle and a width perpendicular to or radial to the length. The width of the top wall structure can be smaller in size than the width of the bottom wall structure. These different widths between the top wall and the bottom wall structure (e.g., the top wall structure does not protrude much toward the needle as much as the bottom wall) allow for clearance along the upper portion of the housing, and when the first frame is attached to the second frame, the bottom is closed.

[0140] A shoulder may be provided between the upper wall structure and the top wall, and a raised stud may be provided on the distal side of the top rod. The step at the shoulder may provide a relatively large internal space at the base end of the housing to accommodate the flange on the needle hub and the Luer interface threads on the catheter hub. The raised stud may not be connected to the contact portion of the top rod, but may be provided with a tapered surface to mimic the slope at the base of the top rod, thereby appearing more symmetrical. A gap may be provided between the top rod and the raised stud, which gap may be combined with spaced apart gripping projections. The top rod may also be combined with similar spaced apart gripping projections.

[0141] According to aspects of the present invention, the left frame can be configured to be coupled to the right frame to form a housing, as shown and described elsewhere. In one embodiment, the first frame can be provided with a nose portion, a main body portion, and a base portion. The left frame and the right frame can be connected to form a nose end, a main body, and a base end. In an exemplary embodiment, the lower wall structure can be provided with an engagement groove for engaging a protrusion or a pawl and a receiving groove for receiving a protrusion on the right frame. As further discussed below, the engagement groove can have a pawl for receiving a corresponding pawl on the right frame. However, the receiving groove can be embodied as a simple channel without an engagement surface for receiving the lower protrusion on the right frame.

[0142] Likewise Fig. 9 As shown, proximal to the body portion 188a is the base portion 190a having a left side or first side 200 and a bottom side or fourth side 206 having a bottom bar 216 formed thereon. The first side 200 and the bottom side 206 are similar to two wall structures placed at right angles to each other, with the bottom bar 216 located on one of the walls. One or more gripping features 284 may be disposed on the exterior of the bottom bar 216.

[0143] The engagement groove may have an opening for the protrusion to enter, a tapered surface and a protrusion. The protrusion on the right frame may enter the opening of the engagement groove and then advance distally to engage the protrusion of the engagement groove, thereby completing the engagement between the protrusion and the engagement groove.

[0144] To separate the left and right frames, the protrusions can move in the opposite direction. The protrusions can move proximally relative to the engagement slot. The proximally moving can cause the tapered surface of the engagement slot to move against the tapered surface on the protrusion to impart a pair of force components, which include radially directed forces to cause the left and right frames to move away from each other, thereby separating the protrusions from the engagement slot. At the same time, the lower protrusion on the right frame can be separated from the receiving slot on the left frame. A similar engagement mechanism can be provided at the base end of the housing to enable separation of the two frames at the base end.

[0145] The bottom side or fourth side of the base end may include two engagement slots formed at the bottom side edge. Each engagement slot may include an opening for receiving a corresponding protrusion on the lower edge of the second side of the right frame. A lip may be provided at each engagement slot with a recess for receiving and engaging a finger on the corresponding protrusion. The gap between the finger and the lower edge of the protrusion may be configured to receive the lip therebetween to engage the protrusion to the engagement slot.

[0146] The engagement slot towards the distal end of the base segment may have an opening defined by at least three sides and may be relatively longer than the length of the corresponding protrusion to allow axial movement of the protrusion out of the engagement slot. Optionally, the engagement slot at the proximal end of the base segment may be defined by only two sides without a third side to constrain the corresponding protrusion.

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

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

[0149] In use, the ExD catheter assembly can be advanced against the patient to a selected catheter location, such as a deep vein or a superficial vein. The user can puncture the target vein under guidance from a visualization machine (such as an ultrasound monitor with an ultrasound probe). Initial blood reflux into the needle hub can be observed. Next, the insertion angle of the ExD catheter assembly can be lowered before further advancing the ExD catheter assembly to position the catheter deeper into the vein. In some examples, a guidewire dispenser having a guidewire extending through the lumen of the needle can be used with the ExD catheter assembly. For example, a guidewire dispenser having a housing The guidewire dispenser can be placed into the proximal opening of the catheter hub after removing the vent plug and the guidewire protruding through the lumen of the needle and advanced in a manner known in the industry.The guidewire can be used to guide the catheter tube to the desired treatment location in the body.

[0150] The needle and catheter tube can be advanced over the guidewire and stopped when or just before the nose 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 physician can then place his or her thumb on the top bar and the index finger against the bottom bar to separate the housing into two or more housing components, such as separating the left frame from the right frame as described above. Once the housing is separated into smaller components, such as into separate first and second housing frames, the catheter assembly is disengaged from the housing and can be 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 hereinafter, it should be understood that where features are shown but not explicitly described, and are otherwise the same or similar to one or more features described elsewhere, such as those described above with reference to Figure 1-14 As described, one or more portions of the disclosure that are shown in all figures but are not explicitly described due to redundancy and because the knowledge is built on the foundation laid by the previous disclosure can still be understood to be described or taught by the same or similar features explicitly set forth in the text of the embodiment describing the one or more features. In other words, the subsequent disclosure of the present application is based on the previous disclosure, unless the context indicates otherwise. Therefore, the present disclosure is understood to teach the disclosed embodiments and features of the disclosed embodiments to those of ordinary skill in the art without having to repeat similar components and features in all embodiments, because the skilled person will not ignore similar structural features that have just been read in the previous paragraphs, nor will he ignore the knowledge gained from the previous description set forth in the same specification. Therefore, unless the context indicates otherwise, the same or similar features shown in the following ExD catheter assembly are combined with the teachings of the previous embodiments. Therefore, it is expected that the embodiments disclosed later will enjoy the benefits of the previously explicitly described embodiments, such as the features and structures of the previously described embodiments, unless the context indicates otherwise.

[0152] Replacement ExD catheter assembly with Figure 1-14 The ExD catheter assembly of has similar aspects, and in particular a similar housing construction, wherein a first frame or left frame and a second frame or right frame are attached to form a housing and 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 to an interior space. The catheter assembly can be positioned in the interior space of the housing.

[0153] At the distal end, a portion of the needle attached to the needle hub and the catheter tube attached to the catheter hub may protrude from the distal opening of the housing at the nose end. Optionally, after removing the vent plug, a guidewire dispenser (such as A 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. A plurality of protrusions or decorations may be provided on the outer surface of the side wall section, which may be embodied as protrusions of circular, elongated, polygonal or irregular shapes. The protrusions may be spaced apart from each other and provided on the two side walls of the housing for aesthetics and convenience in holding the housing.

[0155] The base end at the proximal end of the shell can be provided with a plurality of sidewalls, which can include a first or left sidewall, a second or right sidewall relative to the first sidewall, a third or top sidewall, and a fourth or bottom sidewall relative to the third sidewall. The sidewall at the base end defines a generally square or rectangular structure having a hollow interior for accommodating the catheter assembly. In other examples, the sidewall can define a cross section of different shapes, such as an oval or circular shape. The seam can pass through both the top sidewall and the bottom sidewall, and through the nose of the shell.

[0156] The first sidewall and the second sidewall can define a width of the housing at the base end. In one example, 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 at 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 sidewall segments of the first and second frames from their respective outer or inner surfaces, can be approximately constant in the distal direction until approximately at the beginning of the activation area or zone of the body, where the body widens in the distal direction to a maximum width at the distal end of the body. From there, the width can rapidly decrease to a peak or apex at which the distal opening is located.

[0157] The activation area of ​​the body may be widened so that each or at least one of the two frames may incorporate an activation structure. The activation ramp may be sized and shaped to interact with the catheter hub to enable the housing to separate into two or more housing components.

[0158] A cutout for receiving the needle hub flange extension may be provided at the proximal end of the housing, the cutout being defined by a partial cutout on the bottom side of the base end and partial cutouts at the proximal ends of the two frames.

[0159] An opening may be provided near the distal end of the housing, at a lower wall of the housing. The opening may be elongated, may have a proximal edge, may have a distal edge, and may have a side edge. In other examples, the opening may have a different shape, as long as the shape does not interfere with the activation ramp located in the interior of the housing.

[0160] The seam can be arranged along the longitudinal direction of the shell, and extends from the distal end to the proximal end, and can be discontinuous at the rear opening and the front opening. At the distal edge of the front opening, the end cap component can be arranged at the distal end of each of the left frame and the right frame. About the end cap component of the second frame, its discussion is equally applicable to the end cap component of the first frame, and the end cap component can have a lower section, a top section and a side section. In one example, the side section can have a cutout similar to a semicircle, so that the two side sections with two cutouts from two adjacent end cap components can form a through channel or opening to accommodate a needle and a catheter tube. The through channel formed by the two cutouts can provide support and guidance for the needle and the catheter, so that it is possible to puncture a catheter of an extended length with or without a guide wire, and to puncture a short midline catheter of about 8-10 cm in length without an integrated guide wire.

[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. Therefore, each end cap component can be attached to the remaining portion of the corresponding left frame and right frame by a strip or layer of material having a certain thickness. In one example, the strip of material can have the same thickness as the wall thickness of the side section and the front section. In other examples, the strip of material can include indentations to thin the thickness of the strip of material so that it is thinner than the thickness of the side section and the front section.

[0162] In one 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 act as a hinge, such as a living hinge. The living hinge can allow the end cap component and the corresponding frame (i.e., the front end wall) to which it is attached to pivot, rotate, or swing relative to each other. For example, if the first and second frames are separated from each other starting from the proximal end, when the assembly is activated due to the catheter hub pushing against one or more activation ramps, the first and second frames can swing outward away from each other and pivot or rotate around their corresponding strips of material or living hinges. When the two frames pivot or rotate around the two living hinges, the two end cap components can remain attached to each other until they are also separated to release the catheter hub from the two frames, as discussed further below.

[0163] The second frame can have a joining edge, wherein the seam is formed together with the joining edge of the first frame. The left frame or the first frame and the right frame or the second frame can be connected to each other along their respective joining edges. Engagement grooves, protrusions and / or pawls can be used for removable fixing of the two frames, as discussed further below. The right frame can have a notch, which forms a part of the opening at the bottom or lower side of the shell.

[0164] In this figure, the catheter assembly can be located in the interior space of the housing, the housing can have a needle and catheter tube passing through the incision, and the catheter hub or at least the push projection of the catheter hub is located distal to the base end. The needle hub and vent plug can protrude from the proximal opening of the housing, wherein the flange of the needle hub engages the housing.

[0165] The flange extending from the needle hub that can have a generally square or rectangular shape can be arranged so that the plane defined by the flange is generally orthogonal to the longitudinal axis of the housing. The portion of the flange protruding outward from the outer contour of the needle hub can engage the groove formed by multiple sides (such as the first side, the second side, the third side and the fourth side) of the base end. The groove can be a recessed channel formed into the wall thickness of multiple sides of the base end. In addition to the place where the incision is set at the fourth side to accommodate the flange extension of the needle hub, the groove can be continuously formed across the side. The groove can be configured to receive, receive or accommodate the flange on the needle hub, including the place where the flange transitions between various sides, such as the intersection of the flange side.

[0166] In the ready-to-use position, i.e., the position in which the ExD catheter assembly is ready for performing a venipuncture, the needle hub can remain stationary without axial movement by limiting the flange extension of the needle hub from distal movement via the bottom housing edge at the cutouts of the two bottom wall structures. In order to limit the needle hub from moving in the proximal direction, a flange extending from the exterior of the needle hub can be positioned against the proximal lip of the base end groove. In addition, the non-circular structure for coupling the flange and the groove (such as by using a multi-faceted structure) can prevent the needle hub from rotating within the space defined by the sides of the base end. This in turn can hold the needle hub in the assembled position so that the needle bevel can be oriented in the desired position when assembled without rotating prematurely before performing a venipuncture.

[0167] The external threads of the catheter hub may include grooves for receiving protrusions protruding from the inner surface of the top side of the base end. In other examples, the arrangement may be reversed and the top side may include grooves and the catheter hub may incorporate protrusions. In other examples, detents may be provided at other locations between the catheter hub and the housing along their respective structures to engage the two. This engagement ensures proper alignment between the catheter hub and the housing in the ready-to-use position and prevents the catheter hub from rotating when engaged to the housing.

[0168] The catheter hub can be configured to slide axially in a distal direction within the interior space of the housing after the needle and catheter hub are successfully placed in the patient's vein while the needle hub remains engaged with the base end of the housing. In one example, the external thread is configured to ride on or slide on the inner surface of the two lower walls of the housing. For example, a user can push the push protrusion to advance the needle hub in a distal direction. The push protrusion can be located between the two upper wall sections of the two frames. As shown, the upper edge of the push protrusion can protrude above the outer surface of the two upper wall sections so as to present itself for contact and pushing by a physician. In some examples, the push protrusion can be configured so that the upper edge of the push protrusion protrudes further upward from the two upper wall sections to present itself as a larger target for being pushed by a physician.

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

[0170] The second frame can have a base portion having a second side, a top side and a bottom side. The length of the top side and the bottom side can be relatively shorter than the second side. The top side and the bottom side of the right frame can be referred to as partial sides, because similar top side and bottom side sections are carried by the first frame or the left frame, so that when two partial top sections are connected at their respective connection edges and two partial bottom sections are connected at their respective connection edges, they form the top side and the bottom side of the base end.

[0171] Part of the top side section can be joined with a groove at the joining edge, and part of the bottom side section can be joined with a groove at the joining edge. The groove can be a generally rectangular shape with sharp or rounded corners, but can also be specifically embodied as a circular shape, a square shape, a star shape, an oval shape, a polygonal shape or an irregular shape. The groove on the part of the top side section and the groove on the part of the bottom side section can be positioned at the same axial position along the longitudinal axis of the right frame. In other examples, they can be axially offset from the same axial position. In one example, both grooves are positioned roughly along the proximal ends of the two joining edges.

[0172] The body portion can be located distally of a base portion, which can have a wall with a top wall segment, a bottom wall segment or a lower wall segment and a side wall segment. In one example, similar to the grooves of the base portion, two grooves can be provided at the joining edge of the lower wall structure or segment. The two grooves can have the same shape as the two grooves on the base portion, or can be different. In one example, one of the two grooves on the lower wall segment can be located near the edge of the shell of the bottom cutout, and the second groove can be located distally thereof. In other examples, there can be only one groove on the lower wall segment, or more than two grooves, and they can be located elsewhere along the joining edge.

[0173] At the activation area of ​​the frame, the activation ramp can be located on the inner surface of the side wall segment of the housing wall closer to the distal end than the proximal end. The activation ramp can have a proximal ramp segment, a distal ramp segment, and a central ramp segment, which can be located between the proximal ramp segment and the distal ramp segment. In one example, the proximal ramp segment can include a slope that increases from the inner surface of the right frame, which can be regarded as a structure having a surface that extends radially away from the inner surface.

[0174] When assembled with the left frame and the assembled housing with the catheter assembly located therein, the proximal ramp segment can extend away from the inner surface toward the needle, or toward the longitudinal axis through the housing. The longitudinal axis through the housing can be considered a reference line, and the proximal ramp segment can be understood as having a surface farthest from the reference line, and as the ramp approaches the central proximal ramp segment, the surface gradually moves closer to the reference line.

[0175] The central ramp portion may have a surface that is closer to the reference line than the proximal ramp portion and may include a substantially flat region or a surface region having a large radius.

[0176] In one example, the distal ramp portion may include a slope that decreases from the central ramp portion, which may have a surface that is away from the reference line. If the proximal ramp portion has a positive slope, then the distal ramp portion may have a negative slope. Thus, the activation ramp may be considered to be an inclined structure that increases to a peak or crest at the central ramp section and then has a negative slope. In other examples, the distal ramp portion may be constant or flat at the central ramp portion without any slope. In other examples, the distal ramp portion may have a positive slope that continues to extend toward the reference line. Preferably, the distal ramp portion has a negative slope.

[0177] When the left frame and the right frame are assembled together to form the housing, if two activation ramps are incorporated, the gap between two adjacent activation ramps can be referred to as an activation gap, or if only one activation ramp is incorporated, the gap between the activation ramp and the inner surface of the adjacent frame can vary. The activation gap can narrow as the activation gap extends from the proximal ramp portion to a narrower point at the central ramp portion, or from two proximal ramp portions to narrower points at two central ramp portions. As discussed further below, the activation gap can be incorporated as a device that the catheter hub can be pushed against to impart a pair of component forces so as to then separate the housing into two or more housing components.

[0178] The end cap component of the second or right frame can be provided with a recess. The recess can have three sides and an open fourth side. Optionally, the recess can be embodied as a four-sided groove, similar to one of the grooves of the main body section or the base section. The size and shape of the recess at the end cap component can be configured to receive a corresponding protrusion on an adjacent end cap component in an interference fit or snap fit arrangement. In some examples, the position of the recess and the protrusion for coupling with the recess can be reversed so that the recess can be located on the end cap component of the first or left frame.

[0179] The activation ramp can be implemented as two separate activation ramp sections, each section 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 explained above. A gap or void can be provided at the distal ramp section of the two ramp sections, which is formed by the 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 generally flat, or can have a large radius to form a slight bend for accommodating the catheter hub profile.

[0180] As can be seen, when the second or right frame is coupled to the first or left frame and the catheter hub is advanced distally to abut against two separate activation ramp segments, the nose segment of the catheter hub initially abuts against two proximal ramp portions of the two separate activation ramp segments and then moves into the gap or void as the nose segment continues to move in the distal direction. Then, the middle portion of the catheter hub, which has a diameter or size greater than the nose segment of the catheter hub, moves on the two proximal ramp portions to further expand the two frames away from each other. At this point, the two frames are completely separated from each other except for the engagement at the two end cap components at the distal end of the housing. If there is no complete separation at the proximal side of the two end cap components, the further movement of the external thread of the catheter hub against the two proximal ramp portions can further expand the two frames away from each other, so that the protrusions and grooves of the two frames are completely separated from each other, except for the engagement at the two end cap components. Finally, the final engagement between the recess and the protrusion on the left frame can be separated by physically grabbing one or both frames and pulling one or both frames apart from each other. The catheter hub can then be completed, such as connected to a drip line, and taped to the patient.

[0181] In one example, the recess at the end cap component can have two side walls, a bottom wall and a center wall. In one example, the two side walls can each include a surface, and wherein the two surfaces of the two side walls can be tapered or can converge in the direction of the bottom wall. Thus, the shape of the surface of the center wall can be trapezoidal. The recess can be tapered, and the width or gap at the recess opening can be greater than the width or gap at the bottom of the recess. This configuration can allow the corresponding protrusion on the end cap component of the first frame to engage the recess, and the engagement is easily separated, so as to facilitate the separation of the two frames at the two end cap components, so as to then separate the catheter hub from the housing of the ExD catheter assembly.

[0182] Similar to the left frame, the outer surface of the second frame can be provided with a plurality of spaced apart protrusions or decorations. In one example, the two sets of different protrusions of the two frames can be identical and can have the same spacing. In other examples, the protrusions can have different shapes and / or different spacings between two adjacent protrusions.

[0183] In one example, a protrusion or male detent can be provided on a third side of the base portion at the joining edge and on a fourth side of the base portion at the joining edge to engage two grooves on the base portion of the second frame. A protrusion or male detent can also be provided at the joining edge on the lower wall structure or segment to engage two grooves on the lower wall structure of the second frame. Optionally, the two frames can be connected to each other along adjacent seams via welding or adhesive. If welding or adhesive is used, the upper seam and the lower seam at the distal end of the housing are attached to each other via detents so that the detents can be disengaged to open the distal door opening, thereby enabling the catheter hub to be separated from the housing, as further discussed below.

[0184] A protrusion or male detent may be provided at the joining edge of the end cap component of the first frame. According to aspects of the invention, when the left and right frames are assembled to form the housing, the protrusion may be located at a position on the end cap component that matches and engages with a groove on the right frame. The protrusion may be sized and shaped to engage a recess on the end cap component of the second frame. In one example, the engagement between the protrusion and the recess is a slight interference.

[0185] In one example, the engagement between the protrusions or male detents and the recesses at the two end cap components can have a stronger grip or engagement retention force than the engagement between the protrusions on the base portion and the protrusions on the lower wall structure that engage the corresponding grooves on the second frame 194. This relative engagement force between the paired protrusions and grooves can ensure that when the catheter hub is advanced in the distal direction within the interior space of the housing after initial catheter tube placement, and when combined, after the guidewire is advanced, when the catheter hub contacts against the activation ramp, the housing can be separated first at the proximal separation of the housing and then at the two end cap components. In other examples, each pair of protrusions and grooves can open approximately simultaneously when the catheter hub contacts against the activation ramp.

[0186] The protrusions on the base portion of the first frame can be longer than the protrusions on the lower wall structure of the body section. The protrusions on the base portion can also be longer than the protrusions on the end cap components. The different lengths of the various protrusions can be matched or engaged with grooves having different and corresponding depths to ensure a substantially tight seam when the two housing frames are coupled to form the housing. In some examples, each of the left and right frames can have both grooves and protrusions to match the corresponding protrusions and grooves, rather than having an arrangement where all the grooves are in one frame and all the protrusions are in the other frame.

[0187] Similar to the outer surface of the second frame, the outer surface of this frame can be provided with a plurality of spaced apart protrusions or decorations. In one example, the two different sets of protrusions for the two housing frames can be identical and can have the same spacing. In other examples, the protrusions can have different shapes and / or different spacings between two adjacent protrusions.

[0188] In use, a user can use an ExD catheter assembly according to aspects of the present invention to puncture a target vein under guidance from a visualization device (such as an ultrasound monitor using an ultrasound probe). Initial blood flashback into the needle hub can be observed. Next, the insertion angle of the ExD catheter assembly can be lowered before further advancing the ExD catheter assembly to position the catheter deeper into the vein. In some examples, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a guidewire dispenser having a housing The guidewire dispenser can be placed into the proximal opening of the catheter hub after removing the vent plug and the guidewire protruding through the lumen of the needle and advanced in a manner known in the industry.The guidewire can be used to guide the catheter to the desired treatment location in the body.

[0189] The needle and catheter tube can be advanced over the guidewire and stopped when or just before the front 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 physician can then place his or her thumb on the push tab of the catheter hub to 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 in the distal direction until the nose end of the catheter hub pushes against the two activation ramps, a pair of component forces can be generated on each of the two frames. This will then cause the two frames to separate from the base end of the shell. As the catheter hub continues to move in the distal direction, the two frames can be further separated until the protrusions and grooves on the base end and the main body are completely separated from each other. At this point, as the protrusions and recesses on the two end cap components continue to engage, the two frames can pivot at their corresponding living hinges. The user can then use a free hand while maintaining a grip on the catheter hub to pull one of the two frames to separate them at their corresponding end cap components. The catheter hub and the shell can then be separated from each other. The user can then complete the preparation of the catheter hub, such as connecting a drip line to the catheter hub and taping it to the patient to secure the puncture site.

[0191] In an alternative embodiment of the ExD catheter assembly according to various aspects of the present invention, the left frame and the right frame or the first frame and the second frame can be fixed together by the projection or male pawl engaging the corresponding groove or female pawl. In the present embodiment, the engagement between the projection or male pawl and the groove or female pawl at the body and the base can be such that when the catheter hub is advanced in the distal direction inside the shell, they will not separate. For example, the engagement between the projection and the groove can be achieved by interference and / or adhesive, bonding or welding. In addition, the activation ramp can be omitted from the first and second frames so that the advancing catheter hub does not generate radial force to separate the two shell frames. Therefore, when the catheter hub is advanced distally to further place the catheter into the vein, the catheter hub can reach the void space at the distal end of the body section without imparting any radial force on the two frames to separate them without activating the ramp. Instead, the catheter hub opens the distal door opening against the distal abutment of the door at the distal end, thereby then allowing the catheter hub to separate from the shell.

[0192] When the catheter hub being advanced is pushed distally, the male detent or protrusion on the first frame can be released or separated from the recess on the second frame. The recess can have an open slot. This structure allows the protrusion and the recess to separate at the two end cap components of the left and right frames by allowing the protrusion to pass through the side opening of the recess without a side wall instead of the opening near the connecting edge. Therefore, when the catheter hub is pushed against the two end cap components in the distal direction, the separation at the two end components can be achieved by simply providing an axial force without generating a radial force.

[0193] Thus, after cannulation, optionally after guidewire placement and after catheter insertion, as described above with respect to the first or previously discussed embodiment of the ExD catheter assembly, the catheter hub can be advanced against the proximal-facing surfaces of the two end cap components of the left and right frames. The advancing force of the catheter hub forces the protrusion to separate from the recess. This separation can be facilitated by the open side between the two side walls of the recess at the end cap component of the second or right frame. That is, the protrusion 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] The two end pieces are forced to swing in the distal direction about the two living hinges when the protrusions and female detents at the two end pieces are disengaged and the two frames are held fixed by the protrusions and slots at the body and base portions of the two frames.

[0195] In one example, the space or distance between the two movable hinges is greater than the horizontal dimension or cross-sectional dimension of the catheter hub. Therefore, when the two end cap components swing in the distal direction around the two movable hinges, the door with a gap opens to provide a gap for the catheter hub to pass therethrough, which is referred to as a door opening or a distal door opening, which is defined by the space provided by the end component that swings to the distal end. The swinging end cap component can be referred to as a door, which can be swung open to open the distal door opening. In practice, opening the door to open the door opening at the distal end allows the catheter hub to be separated from the needle hub and the housing through the door opening or the distal door opening, thereby separating from the needle, the needle hub, the housing, and the guide wire and the guide wire dispenser (if used). Then, the catheter hub can be fixed to the patient for fluid administration. The needle, the needle hub, the housing, and the guide wire and the guide wire dispenser (if used) can be discarded or processed according to the approved scheme.

[0196] Therefore, one aspect of the present invention is understood to include an ExD catheter assembly, which includes a multi-part housing having an interior space with a catheter assembly located 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 from the distal opening of the catheter tube. The needle and the catheter tube protrude through the opening at the distal end of the housing. The distal end may include two end cap components that are removably attached to each other (such as by engaging a male pawl and a female pawl). The female pawl can be a recess with three side walls and has at least one open side and an open entrance to the recess. Each end cap component may include a door that can be pivoted or rotated around a living hinge. When the two doors of the two end cap components are pivoted or rotated open to open the door opening at the distal end of the housing, the needle hub can move distally through the door opening to separate from the housing.

[0197] A multi-part housing for forming a housing of an ExD catheter assembly 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 protrusion or a male pawl, and the other frame may include a corresponding groove or a female pawl for receiving the male pawl to removably fix the two frames together. The distal end of the housing may include a seam. The opening at the distal end of the needle and catheter protruding therefrom may be formed by two cutouts on two wall surfaces so that when the two wall surfaces are brought together, a substantially cylindrical guide opening is formed by the two cutouts. 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 door with a gap may be defined by the distance between the two living hinges. When the protrusion and the female pawl having at least one open side are separated from each other, the two end cap components may swing distally around the two living hinges to open a door opening or a distal door opening at the distal end of the housing. The catheter hub may be removed from the door opening or distal door opening and separated from the remaining components of the ExD catheter assembly, which may include the needle, needle hub, housing, guidewire, and guidewire dispenser (if used).

[0198] According to an additional aspect of the invention, an ExD catheter assembly may include a tab extender or tab adapter attached to the catheter hub and extending through the housing opening orthogonally to the longitudinal axis of the housing so that an upper portion of the tab adapter rises above the top wall structure of the housing to present a surface for a physician to push or grasp. In one example, the tab adapter is configured to extend the profile of an integrally formed push tab of the catheter hub above the top wall structure to facilitate operation of the ExD catheter assembly. Alternatively, the push tab may be formed as an extended configuration and extend above the top wall structure of the housing to present itself to be pushed by a physician without the need for 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 located above the second end in a height direction. In one example, the body can be partially formed as a solid structure above the imaginary line and have a tunnel or channel below the imaginary line, the tunnel or channel having an arcuate first opening and an arcuate second opening connected to each other via the channel. In an alternative embodiment, the body is hollow and is 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 of sufficient thickness to provide structural rigidity for carrying a digital load applied by a user to advance the catheter hub.

[0200] The tab adapter can be sized and shaped to be mounted on a catheter hub. In one example, the tab adapter is configured to be placed on the catheter hub and the hub body located in the body channel. The first opening and the second opening of the tab adapter can be sized to fit tightly around the curved body of the catheter hub. Depending on how the tab adapter is located on the catheter hub, such as by placement or positioning 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 match the specific shape of the catheter hub. In one example, the first and second openings can have a hemispherical shape, a semi-oval shape, an elliptical shape, or an arcuate shape. Preferably, the two openings are sized and shaped to fit tightly on the catheter hub body and have a grip around the hub body. The two openings can have different shapes from each other and can be selected based on the size and shape of the catheter hub body.

[0201] When the tab adapter is mounted on the catheter hub, the push tab is configured to fit within the interior space of the tab adapter body. In order to secure against sliding, sliding or moving relative to the catheter hub when digital pressure is applied to the body, two gripping bars can be provided at the second end of the body, on either side of each of the two openings. The gripping bars can be similar to ribs and can be provided with a surface with a certain profile to fit tightly against the catheter hub. The position of the gripping bars on the tab adapter body relative to the upper portion of the two openings should be positioned so that when mounted 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 allow the tab adapter to fit tightly and grip the catheter hub body. The adapter can be used by sliding the channel and the two openings on the catheter hub body and ensuring that the push tab on the catheter hub is located within the interior of the tab adapter. The channel can have an open side for placing the tab adapter on the catheter hub.

[0202] The push protrusion of the catheter hub can contact the inner surface on the proximal side of the body. Therefore, when the physician pushes the protrusion adapter in the distal direction, the inner surface of the protrusion adapter pushes against the proximal-facing surface of the push protrusion to advance the push protrusion in the distal direction and thus advance the catheter hub. In one example, the inner space of the protrusion adapter is provided with a socket that receives the push protrusion in a size-to-size fit or slight interference manner to prevent separation from the catheter hub body when the catheter hub is advanced distally.

[0203] In another example, the first and second frames can be attached to each other along the seam by corresponding protrusions or male pawls and engagement grooves. Optionally, the first and second frames can be attached to each other along the upper seam and the lower seam via adhesive or welding. The catheter hub of the catheter assembly can be separated from the shell by combining a door assembly at the distal end of the shell, and the door assembly is opened to allow the catheter hub to be separated via a door opening formed by two doors pivoting in the distal direction. The shell in this embodiment can remain attached together, and only the door assembly at the distal opening can be actuated to allow the catheter hub to separate.

[0204] The ExD catheter assembly may include 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 may frictionally engage with a nose section or nose tip of the housing.

[0205] A tab adapter or tab extender may be positioned on the catheter hub and secured thereto by a fitting. The needle hub may extend proximal to the base end and outside of the housing. A vent plug may be attached to the needle hub, which may allow air to vent but capture any blood that may flow inside the needle hub and vent plug.

[0206] The housing of the extension indwelling catheter assembly of the present invention may include a nose tip or nose segment having a terminal end at the end of two nose portions, which has an upper seam extending between the two nose portions. The upper seam may extend through the upper portion of the nose tip. A similar corresponding lower seam may extend through the lower portion of the nose tip. Each nose portion may be attached to the end cap components of each corresponding first or second frame. Each nose portion and each end cap component may be referred to as a door or rotatable door. Two doors from the two end cap components may be a part of a door assembly. The two doors may swing open to allow the catheter hub to separate from the housing without the need for the first frame and the second frame to separate 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. A plurality of protrusions or decorations can be provided on the outer surface of the side wall section, which can be embodied as circular, elongated, polygonal or irregularly shaped protrusions. The protrusions can be spaced apart from each other and are provided for aesthetics and convenience in holding the housing on the two side walls of the housing. The two housing frames can have an interior for accommodating a catheter assembly having a catheter hub therein.

[0208] In one example, with Fig.16The lower walls of the two housing frames can be solid and can be connected to each other along the seam until a gap separates 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, together with the two nose portions of the nose end, swing open about corresponding movable hinges to open the distal door opening. In other embodiments, the two housing frames can be connected to each other until a longitudinal gap. The longitudinal gap can extend upward and flow or blend into the front gap, which allows the two end cap components to swing open to open the distal door opening, as further discussed below. The proximal end of the longitudinal gap can be used as an injection point for a plastic injection door or inlet.

[0209] Each frame may have an optional scoreline incorporated into the wall surface. For aesthetic purposes, the scoreline may be straight, may have a curve, or may have both. The scoreline is understood to be a groove line formed into the wall thickness of the lower wall of the two frames. In other examples, the scoreline may be omitted.

[0210] The two end cap components can be attached to the two front end walls via two living hinges. Each of the two end cap components can be attached to the nose portion, and the combination can be referred to as a door or a rotatable door. When pushed in the distal direction by the distal movement of the catheter hub, the two doors of the door assembly can swing open to open a distal door opening that can move when digital pressure is applied to a nose adapter attached to the catheter hub.

[0211] The front base wall can be arranged on the near side and the inside of the boundary defined by the hollow part cylinder of each nose part. Each front base wall can have an incision, the size and shape of which are arranged to accommodate a part of a needle and a catheter tube. When the first and second frames are connected, two incisions from the two front base walls form a perimeter, which defines an opening, the size and shape of which are arranged to receive the circumference of the combined catheter tube, which has the needle of the catheter assembly in the shell. In one example, the perimeter of the two incisions can be referred to as a guide opening, which guides the combination when the combined needle and the catheter tube are advanced in the distal direction during cannulation and vascular access. Along the length measurement of the first frame and / or the second frame, the two base walls can have different thicknesses. The male ratchet can protrude from the side portion of the thicker base wall. In other examples, the base wall can have a uniform thickness.

[0212] A male detent may be provided on each of the first and second frames, which may alternatively be a short post or stud having an elongated body with rounded ends. The male detent of the first frame may be located above the needle and / or catheter tube in the height direction and extend generally orthogonal to the axis defined by the needle. The male detent of the second frame may be located below the needle in the height direction and extend generally orthogonal to the axis defined by the needle.

[0213] The arrangement of the two male pawls on the two frames can be reversed. In one example, the two male pawls can protrude radially relative to the longitudinal axis of the needle by a sufficient amount so that the tip of each male pawl extends beyond the half-diameter mark of the needle and preferably beyond the edge of the needle on the opposite side from which the male pawl extends. In other examples, the male pawls can extend a shorter length or distance from the respective side from which the male pawls extend. The length of the male pawls can be selected to vary the amount of engagement with the corresponding receiving slots, as discussed further below.

[0214] The first frame may be provided with a receiving slot below the male pawl. Similarly, the second frame may be provided with a receiving slot above the male pawl. Likewise, this arrangement may be reversed. Each receiving slot may include a wall structure configured to frictionally engage a corresponding male pawl located on the opposing frame. Thus, the receiving slot on the first frame may be configured to frictionally engage the male pawl on the second frame, and the receiving slot on the second frame may be configured to frictionally engage the male pawl on the first frame.

[0215] In one example, the receiving slot can have a first wall surface and a second wall surface, and the first wall surface and the second wall surface are configured to frictionally engage two surface segments of the male pawl to match it. In one example, the first wall surface and the second wall surface can be arranged approximately orthogonally to each other. Preferably, each receiving slot does not have a wall surface opposite to the second wall surface, and when the catheter hub body (such as the nose end of the catheter hub) abuts and pushes against the two base walls in the distal direction, the second wall surface provides a gap or missing wall for the male pawl to separate from the receiving slot. When so pushed, the two doors of the door assembly can rotate around two movable hinges to open the distal door opening, and then allow the catheter hub to separate from the shell. In one embodiment, each receiving slot can also include a wall surface opposite to the corresponding first wall surface, so that each receiving slot can have a three-sided wall structure. The size of the rigidity of each receiving slot and the end cap component can be set to hold the corresponding male pawl with a slight interference fit.

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

[0217] The needle and catheter tube can be advanced over the guidewire and stopped when or just before the front 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 physician can then place his or her thumb on the tab adapter that engages the catheter hub to advance the catheter hub against the door assembly.

[0218] When the catheter hub is pushed in the distal direction so that the nose of the catheter hub pushes against the two doors of the two end components, the force directed distally is transmitted to the door assembly and overcomes or exceeds the interference and / or friction provided by the engagement between the two male pawls or short columns or studs and the two receiving grooves. As the catheter hub continues to move in the distal direction, the two doors can swing in the distal direction around the movable hinge. The user can continue to move the catheter hub in the distal direction while applying a force directed proximally to the housing or a stable retaining force to the housing at the same time so that the needle hub moves completely through the door opening provided by the two rotating doors. The catheter hub and the housing can then be separated from each other. The user can then complete the preparation of the catheter hub, such as connecting the drip line to the catheter hub and taping it to the patient to fix the puncture site, and optionally removing the protrusion adapter from the catheter hub.

[0219] The tab adapter according to various aspects can be formed of 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 located above the second end in a height direction. In one example, the body can be formed as a solid structure having a slot to accommodate a push tab extending from a catheter hub and having a hollow passage for mounting on the catheter hub body, as discussed further below.

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

[0221] The body may have an outer surface facing the distal side, which includes one or more protrusions or surface features for aesthetics. The outer surface facing the distal side may be curved or arched. The protrusions or surface features may be optionally omitted. In other examples, the protrusions may be embodied in other shapes, such as pits, rounded protrusions, shaped protrusions, random protrusions, etc. The outer surface facing the distal side may be located between the two side surfaces. In one example, each of the two side surfaces may have a flat or planar wall without changing the surface features. In one embodiment, each side surface has a first surface portion, a tapered side surface portion, and a second surface portion. Like the first surface portion, the second surface portion may have a flat or planar wall. The two second surface portions on the two side surfaces may define a width greater than the width defined by the two first surface portions. Therefore, the width at the first end of the protrusion adapter may be wider than the width at the second end of the protrusion adapter.

[0222] The distal opening of the nose adapter may have a perimeter defined by a plurality of edge segments or segments. The shape of the perimeter may vary depending on the shape of the catheter hub to which the nose adapter is configured to be mounted. For example, the shape of the perimeter may have only four side edge segments, or may be semicircular or partially circular.

[0223] In one example, the proximal-facing surface of the protrusion adapter has a first surface segment and a second surface segment. The first surface segment can be generally planar, but slopes from the planar surface of the second surface segment at an inflection line 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 partially circular edge. The shape of the perimeter can vary depending on the shape of the catheter hub to which the protrusion adapter is 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 protrusion adapter is configured to be mounted. The first and second openings should extend beyond half or the midline of the catheter hub body to ensure grip to more than half of the diameter of the catheter hub body. Multiple ribs can be incorporated into the interior cavity of the protrusion adapter to provide rigidity.

[0225] The catheter hub according to various aspects of the present invention has a nose segment and a proximal body segment located at the distal end. The nose segment can have a generally square shape with rounded corners connecting the four sides. In other examples, the nose segment can have other cross-sectional shapes, including generally cylindrical, oval, elliptical, polygonal, etc. The proximal body segment is generally circular and can be relatively larger in circumference or outer shape than the nose segment. Therefore, a step or step segment can be provided between the nose segment and the proximal body segment. The size and shape of the opening on the protrusion adapter can be correspondingly set to match the outer shape of the catheter hub body.

[0226] The tab adapter can be sized and shaped to be mounted on a catheter hub. In one example, the tab adapter is configured to be seated on a catheter hub and a hub body, the hub body being located in a channel of the tab adapter body. The first opening and the second opening of the tab adapter are sized to fit tightly around the curved body of the catheter hub. Depending on how the tab adapter is located on the catheter hub, such as by placement or positioning along an axial position of the catheter hub, the first and second openings of the tab adapter can have the same size or different sizes to match a specific shape of the catheter hub.

[0227] In one example, the first opening can have a shape that fits tightly around the generally square cross-section of the nose segment, and the second opening can have a hemispherical shape, a semi-oval shape, or an elliptical shape, or an arcuate shape to fit around the proximal body segment. Preferably, the two openings are sized and shaped to fit tightly on the catheter hub body and have a grip around the hub body. The passageway between the two openings has an open side for placing the nose adapter on the catheter hub.

[0228] When mounted on the catheter hub, the push protrusion of the catheter hub is configured to fit within the interior space of the body. The push protrusion of the catheter hub may contact an inner surface on the proximal side of the body, or may protrude into a female detent, recess, or socket within the interior to increase the fixation between the protrusion adapter and the catheter hub. Thus, in use, when the physician pushes the protrusion adapter in a distal direction, the inner surface of the protrusion adapter or the recess or female detent within the adapter pushes against the proximal-facing surface of the push protrusion to advance the push protrusion in a distal direction, and thereby advance the catheter hub. In other examples, the grip against the catheter hub body provided by the opening of the protrusion adapter may also transmit a distally directed force to the catheter hub to advance the catheter hub when the protrusion adapter is pushed.

[0229] According to another aspect of the present invention, an extended indwelling catheter assembly is provided, comprising a housing having a first or left frame and a second or right frame attached to form the housing, the housing having an interior for accommodating the catheter assembly and allowing the catheter hub to move from a proximal position within the interior to a distal position and then subsequently detached from the housing.

[0230] The ExD catheter assembly also includes a catheter assembly, which may be similar to other catheter assemblies described herein. The catheter assembly is shown as being at least partially located within the housing. The catheter assembly includes a catheter hub, a needle hub, and a protective cover for covering a needle with a 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.As previously described, the first and second frames can be attached to each other along the seam by corresponding protrusions or male detents and engagement grooves, and the engagement can be separated thereby.

[0232] Optionally, in addition to or as an alternative to using tabs and detents, the first and second frames can be attached to each other along upper and lower seams via adhesive or welding. In cases where the two housing frames are not separated, or in cases where the housing can be separated into smaller housing components, the housing can be provided with a door assembly to allow the catheter hub to be separated from the housing after cannulation and vascular access.

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

[0234] In yet another example, the shell can be assembled from two shell frames representing the front frame and the rear frame, rather than being assembled from the left frame and the right frame or the upper frame and the lower frame. In other words, the shell can be assembled along a seam located elsewhere between the distal end and the proximal end of the shell.

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

[0236] In yet another embodiment, the protrusion adapter may include a body having a first end and a second end. The first end may be located above the second end in a height direction. In one example, the body may be formed as a solid structure having a slot to accommodate a push protrusion extending from a catheter hub and having a hollow passage for mounting on the catheter hub body, as discussed further below.

[0237] The body of the adapter may have an outer surface and an inner surface, a first opening or a distal opening, and a second opening on an end of the body opposite the first opening. A channel may be provided between the two openings. The channel may have an open side for mounting on a catheter hub. The wall thickness between the outer surface and the inner surface has sufficient thickness to provide structural rigidity for carrying a digital load applied by a user to advance the catheter hub.

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

[0239] The outer surface facing the distal side can be located between the two side surfaces. In one example, each of the two side surfaces can have a flat or planar wall without changing the surface characteristics. However, the two side surfaces can be curved to provide an end cross-section with a curve.

[0240] The concave groove or seat ring can be located between the first surface portion and the second surface portion on each of the two side surfaces of the protrusion adapter. The two second surface portions of the two side surfaces can be generally planar and parallel to each other, thereby defining a generally constant outer dimension at least along a portion of the two side surfaces. The two first surface portions can also be generally parallel to each other. In one example, the two first surface portions of the two side surfaces taper inwardly in a direction from the second end toward the first end.

[0241] The protrusion can be incorporated on at least one of the two side surfaces of the protrusion adapter and extend radially along the longitudinal axis of the protrusion adapter. The protrusion may include a ramp surface and a planar end surface intersecting the ramp surface. In other examples, the protrusion may be formed by a straight edge and a planar end surface of a hemispherical dome or a non-spherical dome. In use, the protrusion can be arranged to abut or contact the door assembly at the distal end of the housing to open the door wider and allow separation between the housing and the catheter hub. In one example, a protrusion is provided on each of the two side surfaces of the protrusion adapter so that the door assembly can be abutted by two protrusions.

[0242] The distal opening of the tab adapter can have a perimeter defined by a plurality of edge segments 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 be mounted or mounted. For example, the shape of the perimeter can have only four side edge segments, or can be semicircular or partially circular, or any corresponding shape of the outer contour of the catheter hub. However, the shape of the perimeter does not have to precisely conform to 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 one example, the proximal-facing surface of the protrusion adapter has a first surface segment and a second surface segment. The first surface segment can be generally curved, arcuate, or inclined, such as a ramp with a generally vertical or upwardly extending wall. The second surface segment can be curved or arcuate and is generally horizontal or flat. The first surface segment and the second surface segment are connected or linked to each other and together resemble a jump or ramp, similar to the arcuate outer surface of the distal-facing surface. The first surface segment of the proximal-facing surface may include one or more surface features or protrusions.

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

[0245] In some examples, the perimeter shape of the second opening does not have to precisely conform to the outer shape of the catheter hub in order for the tab adapter to be used with the catheter hub. The perimeters of the first and second openings may be the same or may be different from each other. The first and second openings should extend beyond half or the midline of the catheter hub body to ensure a grip to more than half of the catheter hub body diameter.

[0246] In one embodiment, the distally facing outer surface of the protrusion adapter is provided with a narrowed end that narrows to a smaller end having an end similar to that of a spear or arrow. Thus, the distally facing surface and two side surfaces of the protrusion adapter may converge to define a sharp end that is a little pointed but flares outward to resemble a broad arrow. Just below the end of the distally facing outer surface in the height direction, an extension is provided. In one example, the extension may be molded as an elongated rod or bar formed with the body of the protrusion adapter. The extension may have side edges and a bottom edge having an elongated shape with a narrowed end. The narrowed end or terminal end of the extension may be located distal to the end of the distally facing outer surface. In an alternative embodiment, the extension may be omitted. The extension may be integrally formed with the protrusion adapter and may share a side edge with the lower side surface of the protrusion adapter.

[0247] The actuation end of the nose adapter may include one or the other or both of the narrowed end or terminal end of the extension and the narrowed end or terminal end facing the distal surface. The actuation end may be disposed at the distal end of the nose adapter. The actuation end may be configured to separate two doors of a door assembly located at the distal end of the housing, thereby then providing clearance for a catheter hub attached to the nose adapter to be separated from the housing after a successful venipuncture.

[0248] In one example, the door assembly can include a nose having a distal end. The nose can be hollow and define an aperture. The door assembly can also include an upper seam and a lower seam, which allow the door assembly to be separated at the upper seam and the lower seam and swing distally about two pivotable or rotatable hinges, as discussed further below. The upper seam extends through an upper portion of the nose. A similar corresponding lower seam can extend through a lower portion of the nose. The upper seam is located above the lower seam in a height direction.

[0249] The door assembly may be clam-shaped or clamshell-shaped and include a body having a first door and a second door that may be combined to form an assembled door assembly according to aspects of the invention. In one example, the two doors may be formed by molding, such as plastic injection molding, and may include a tie bar for holding the pair of doors together during manufacturing and assembly. Optionally, the tie bar may be omitted and other tracking and monitoring may be used to associate a corresponding pair of doors.

[0250] The first and second doors can both have a body section having a blocking wall having a wall section extending proximally and distally thereof. Each door can also include a male pawl or a short column or a stud, and a receiving slot for engaging a corresponding receiving slot of the relative door and the male pawl. Each receiving slot can have at least one open side or a missing side so that the matching male pawl can swing outward through the missing side. For example, each receiving slot can have three sides, and its size and shape can be configured to receive the male pawl in an interference manner. Therefore, when a load is applied to the door, each male pawl can slide over the missing wall of the corresponding receiving slot and allow the door to swing open, as further discussed below. The first and second doors can swing distally around corresponding living hinges.

[0251] Each door is provided with a front base wall within the boundaries defined by the hollow portion cylinder of each nose portion or each distal wall. Each front base wall may have an incision, the size and shape of which are arranged to accommodate a portion of a needle and a catheter tube. When the first and second frames are coupled, two incisions from the two front base walls form a perimeter defining an opening, the size and shape of which are arranged to receive the perimeter of the combined catheter tube and needle. The opening may be considered as a guide opening for guiding the catheter and needle during cannulation and vascular access, during advancement of the catheter tube and needle.

[0252] In one example, the perimeter of the two cutouts of the door assembly can be referred to as a guide opening that guides the combination needle and catheter tube as it is advanced in a distal direction during cannulation and vascular access. The two base walls can have different thicknesses measured along the length of the first frame and / or the second frame. The male detents can protrude from the side portions of the thicker base wall. In other examples, the base wall can have a uniform thickness.

[0253] A male pawl may be provided on each of the first and second doors. The male pawl of each of the first and second doors may be located on a side of the cutout opposite the receiving slot. In one example, the two male pawls may protrude radially relative to the longitudinal axis of the needle by a sufficient amount so that the tip of each male pawl extends beyond the half-diameter mark of the needle and preferably beyond the edge of the needle on the opposite side from which the male pawl extends. In other examples, the male pawl may extend a shorter length or distance from the respective side from which the male pawl extends. The length of the male pawl may be selected to vary the amount of engagement with the corresponding receiving slot.

[0254] Each receiving slot of the door may include a wall structure configured to frictionally engage a corresponding male detent located on an opposing door. The receiving slot on a first door positionable with the first frame or the left frame may be configured to frictionally engage a male detent on a second door positionable with the second frame, and the receiving slot on the second door may be configured to frictionally engage a male detent on the first door.

[0255] In one example, the receiving slot can have a first wall surface and a second wall surface, which are configured to frictionally engage two surface segments of the male pawl. In one example, the first wall surface and the second wall surface are arranged approximately orthogonally to each other. Preferably, each receiving slot does not have a wall surface opposite to the second wall surface, or has a missing wall segment so as to define an open slot or channel, which then provides a gap for the male pawl to separate from the receiving slot when the terminal end of the protrusion adapter abuts and pushes against the two base walls in the distal direction. When so pushed, the two doors can rotate around two living hinges to open the doors, and then allow the catheter hub to separate from the housing. In one embodiment, each receiving slot can also include a wall surface opposite to the corresponding first wall surface, so that each receiving slot has a three-sided wall structure. The size of each receiving slot can be set to hold the corresponding male pawl with a slight interference fit.

[0256] A hook arm located on the first door that hooks or latches to a corresponding female pawl on the second door shell can facilitate the assembly of the two doors of the door assembly. In other examples, the positions of the hook arm and the female pawl can be reversed. Thus, in addition to the friction provided by the combination of the male pawl and the receiving slot just discussed above, the clamshell or clam-shaped structure of the door assembly can be held together via the hook arm and the female pawl. In some examples, the hook arm and the female pawl can be omitted, and the interference between a pair of male pawls and the receiving slot can be increased to provide the engagement required to hold the first and second doors together. In other examples, a secure engagement device (such as a barb) can be combined with the pair of male pawls and the receiving slot to provide additional engagement force.

[0257] The combined hook arm and female detent can provide a radial retention force relative to the axis of the hole through the nose tip. However, when abutted and pushed in the distal direction by an actuating end of the nose adapter (such as the terminal end of the extension on the nose adapter), such as when the nose adapter is moved in the distal direction to advance the catheter into the patient's vein, as described above, the hook arm deforms and separates from the female detent. At about the same time as the hook arm deflects to separate from the female detent, the male detents on the two doors separate from the corresponding receiving slots.

[0258] The two proximal wall sections extending proximally to the barrier wall may be referred to as door side walls. In one example, the two door side walls may be pivotally connected to the corresponding barrier walls of the first and second doors. In one example, each pivotable or rotatable connection may be a living hinge, which is understood to mean an integrally formed thin section or thin plastic strip formed during molding to connect two adjacent sections, such as linking the door side wall and the barrier wall. The thin plastic strip allows the two linked adjacent sections to pivot or rotate about a living hinge.

[0259] Each door sidewall may be provided with a flange, more than one flange is contemplated, such as two or three spaced apart flanges. Each set of two flanges or at least one flange and door sidewall may define a key for fitting into a slot at a distal end of the housing to retain the door assembly to the housing. The key may extend from the body section of each door via a living hinge, and the key may be attached to the housing to allow the body section to rotate about the living hinge.

[0260] The first and second doors may have a seam between them. When the two doors are pushed apart in the distal direction, such as by the actuation end of the protrusion adapter, the separation occurs at the seam. The seam may extend between two adjacent proximal wall segments. These wall segments may be referred to as deflection walls. Each deflection wall may have a proximal edge 638. The proximal edge may have different edge segments. The different edge segments of the proximal edge may have straight edges or curved edges. The two relatively straight edges are connected by an elbow, a radius or an angle, which may be an acute angle or an obtuse angle. Two adjacent straight edge segments of the two deflection walls converge at the seam. Two adjacent edge segments at the seam 232 or two adjacent edge segments bisected by the seam define an abutment edge. When the protrusion adapter is advanced in the distal direction during use of the ExD catheter assembly, the abutment edge is configured to be abutted or pushed by the actuation or actuation end of the protrusion adapter, such as by the terminal end of the distally facing outer wall surface.

[0261] The extension indwelling catheter assembly according to various aspects of the present invention is understood to include a protrusion adapter having an actuation end (such as a narrowed end or terminal end) for pushing against an adjacent edge or a combined hook arm and a female pawl of a door assembly. In one example, the protrusion adapter has both a terminal end and a terminal end located on an extension, the terminal end having a terminal end located on a distally facing outer surface, the extension being located below the outer surface of the distally facing outer surface in a height direction. The two terminal ends can be part of the actuation end of the protrusion adapter. In some examples, the terminal end of the distally facing outer surface is located proximal to the terminal end of the extension, so that the two terminal ends contact two different surfaces along two different planes. In one example, the terminal end of the extension is configured to abut a surface distal to the surface abutted by the terminal end of the distally facing outer surface.

[0262] Movement of the two doors in the closing direction may cause the hook arm to engage the female detent, and the two male detents to engage the two receiving slots to close the clamshell structure. The two engaged housing sections may be engaged without the addition of adhesive glue or bonding.

[0263] In one example, the housing can be provided with two receiving slots at the distal end, one on the first or left frame and one on the second or right frame. In one example, each receiving slot can be formed by a first wall and a second wall. The first and second walls of each receiving slot define a hollow space therebetween for receiving a key.

[0264] The door assembly can have a key formed by each of the two doors. In one example, each door can include a door sidewall having one or more flanges or protrusions protruding outwardly from the surface of the door sidewall. The combined door sidewall and the one or more flanges can define a profile or shape referred to as a key 633, the size and shape of which are configured to fit within the hollow space of a receiving slot at the distal end of the housing. Thus, when the door assembly is assembled to the housing, the two keys 633 on the first and second doors slide into the two receiving slots and are held there by friction, interference and / or mechanical engagement. Once assembled, the door assembly is secured to the distal end of the housing, wherein the two doors can pivot about corresponding movable hinges to swing open, such as allowing a catheter hub assembled to the housing to be separated from the housing.

[0265] A gap may be provided between the first wall panel and the second wall panel. The gap may be provided to accommodate a wall structure of the door sidewall adjacent the living hinge. The gap may be limited by a rib at an end opposite the opening to the hollow space, which rib may connect the first wall panel and the second wall panel together. The first wall panel may have a wall structure with a certain profile, which may be sized and shaped to receive the profile defined by the at least one flange on the door sidewall of the door assembly.

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

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

[0268] The lock may serve as an additional reinforcement to maintain the door opening intact. The lock may be located on the nose section of the housing between the nose end and the body opening. In some embodiments, there may be multiple locks on the door opening along its length. The lock may be a pawl engagement on both sides formed by the door opening bisecting the housing. The pawl engagement may be disengaged by applying additional radial force on the housing to pull the door opening open. The male and female pawls of the pawl engagement may alternate relative to the door opening.

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

[0270] One or more movable bridges may extend over the opening. The movable bridge may have edges that separate or move, and these edges may be co-linear with the door 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 separate when a radial force is applied to the base away from the edges.

[0271] The base can have wings extending from its side. Once the skin is pierced, the wings can be held to advance the catheter assembly toward the patient. The wings can have protruding grips for improved manipulation. The wings can also be pushed downward, which means in the direction opposite to the base opening to apply radial force on the housing. In some embodiments, pushing the wings downward can only apply enough force to separate the movable bridge. In some embodiments, pushing the wings downward can separate one or more components, including the movable bridge, the door opening, and the unlocking lock. In such embodiments, the ability to separate one or more components can depend on the length and / or material properties of the housing. For example, a shorter housing provides a shorter distance for the force to pass through the length of the housing, in which case the force dissipation occurring between the wing and the nose tip is less. In another example, a housing constructed of a material with lower ductility or hardness can allow one or more movable bridges, the door opening, and the lock to be separated more easily.

[0272] The extended indwelling catheter assembly according to various aspects of the present invention is understood to have a housing with a base. The base can have a top opening to observe the backflow from the needle hub. The housing can also have a body opening that provides access to the interior space that accommodates the catheter hub. The catheter hub can be pushed to a distal position via a push protrusion extending from the catheter hub and extending out of the body opening to fully advance the catheter tube once it is located in the body. The body opening can extend between the skirt and the proximal section cover of the base. The proximal section cover can allow the catheter assembly to be held from a position closer to the patient. Therefore, larger hands can be accommodated, and the availability of more holding positions can provide improved control. The base can be rectangular until the proximal section cover, which can be cylindrical. In some embodiments, the base can be completely rectangular or completely cylindrical.

[0273] The door opening on the top of the housing can bisect the housing longitudinally between the nose and the proximal end. Having a proximal section cover and thus having a door opening that bisects the housing all the way from the nose to the proximal end can provide additional structural reinforcement for the housing. Therefore, additional force may be required to open the door opening to remove the catheter hub from the interior space of the housing compared to a catheter assembly without a proximal section cover. In some embodiments, the door opening can be a living hinge. In some embodiments, the door opening can be a frangible living hinge.

[0274] The proximal section cover can have wings. When the wings are pushed downward (meaning in the direction opposite to the base opening) to remove the catheter hub, greater force may be required than for a shorter catheter assembly without a proximal section cover because the wings and nose are further apart than for such a catheter assembly, and unlike such an assembly, the door opening continues to bisect the housing proximal to the base opening. In some embodiments, if additional reinforcement is not desired, the housing can be made of a material having a lower ductility or hardness than for a catheter assembly without a proximal section cover to allow for easier removal of the catheter hub from the housing despite the above limitations.

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

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

[0277] The first and second frames may have an upper seam on the top of the housing and a lower seam on the bottom of the housing. The upper seam and the lower seam may bisect the housing. The upper seam and the lower seam may be living hinges, fragile living hinges, or spaced apart. In some embodiments, only the upper seam may be a living hinge or a fragile living hinge. In some such embodiments, only the lower seam may be a living hinge or a fragile living hinge. In some embodiments, one of the upper seam and the lower seam may be a living hinge, and the other of the upper seam and the lower seam may be a fragile living hinge. In some embodiments, one of the upper seam and the lower seam may be a fragile living hinge, and the other of the upper seam and the lower seam may be a living hinge. In some embodiments, some parts of the upper seam and the lower seam may be living hinges, and some parts may be fragile living hinges. The living hinges and / or fragile living hinges of the upper seam and / or the lower seam may be separated by applying a radial force directed away from the upper seam and the lower seam on the housing to pull the first frame from the closed state to the open state. The radial force may be applied by pushing downwardly on a wing located on the proximal section cover of the base.The upper seam is located above the lower seam in height direction.

[0278] The base of the housing can be separated from the rest of the housing by a skirt. In some embodiments, the proximal section cover can be deleted and the wings can extend from the sides of the base. In some embodiments, the sides can have protrusions to provide an improved grip.

[0279] In addition to the wings, or in lieu of the wings, the radial force may be applied by pushing downwardly on a track extending out of the housing. The track may extend from the skirt to the nose section. The track may extend laterally outward from the body opening, thereby providing access to the interior space of the housing. The track may be supported by one or more track legs extending below the track and between the housing.

[0280] The lock can be used as an additional reinforcement to keep the upper and lower seams intact. The lock can interrupt the upper seam. The lock can be located on the nose section of the shell between the nose end and the body opening. In some embodiments, there can be multiple locks. In some embodiments, the lock can be a pawl engagement of the first and second frames. In some embodiments, the pawl engagement can be disengaged by pushing the protrusion away from the engagement to lift and release the male pawl from the female pawl. The protrusion can be on the same frame as the male pawl. In some embodiments, the male pawl can be on the second frame and the female pawl can be on the first frame. In some embodiments, the male pawl can be on the first frame and the female pawl can be on the second frame.

[0281] The protrusion may have a fin-like curved shape. The inner curve of the protrusion may have a rough surface. The rough surface may provide an improved grip. In some embodiments, the protrusion may be deleted. In such embodiments, the pawl engagement may be disengaged by applying additional radial force on the housing when the first frame is pulled 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 protrusion extending from the catheter hub out of the main body opening to fully advance the catheter tube once located in the main body. In the distal position, the catheter hub can be covered by the nose segment. In addition, in the distal position, the push protrusion can abut the nose segment to prevent the catheter hub from moving further into the nose segment.

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

[0284] The needle hub can be tightly fitted to the second frame so that once the housing is opened from the first frame, the needle hub will not fall out of the interior space. In other embodiments, the position of one, some or all features and / or components of the housing can be switched to the relative frame so that the housing can 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 can then remain attached to the patient. When the catheter hub is separated from the assembly, the needle can be exposed. When the needle is withdrawn from the catheter hub, the needle can engage with a needle guard (not shown) located inside the catheter hub. The needle guard can prevent needle sticks. The needle, needle hub, and housing can then be safely discarded.

[0286] The extended indwelling 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 multiple locks to hold the housing closed. The lock may not have a protrusion. The housing may be held from a base proximal to the housing. The wing or proximal section cover may be omitted. Therefore, the base may be open at the proximal end. The needle hub may extend proximally from the base.

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

[0288] The button may have one or more ramped side surfaces that, when pressed, exert a radial force on the housing to disengage the pawl. The button may be housed in a button housing. The button may have a top surface. The top surface may be directly contacted to press the button. The top surface may be circular. Other shapes of the top surface, such as oval, square, and rectangular, are also contemplated. The button may be located proximal to the body opening on the housing base. The needle hub may extend out of the base from within the interior space. The base may be sized so that more than half of the needle hub is exposed. In some embodiments, the button may be replaced by a latch that is unlocked by exerting a radial force on the housing to disengage the pawl.

[0289] In some embodiments, the male pawl of the pawl engagement can be on the second frame and the female pawl of the pawl engagement can be on the first frame. In some embodiments, the male pawl can be on the first frame and the female pawl can be on the second frame. Once the pawl engagement is fully disengaged and the first and second frames are completely separated from each other, the catheter hub can be withdrawn 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 separation from each other. For example, each frame can be held with one hand and pulled apart from the partially disengaged state.

[0290] When the button is pressed, the button housing can be separated, with the first half of the button housing on the first frame and the second half of the button housing on the second frame. The button housing can have one or more sloped side walls. Each sloped side wall can slidably receive each side surface. When the button is pressed, the slopes of the side walls and the side surfaces can be aligned so that there is no room for the button to move downward unless the button housing is separated, so that each side surface can exert a force on each sloped side wall.

[0291] One or more male protrusions and one or more female protrusions that can engage with the one or more male protrusions can extend from the first and second halves of the button housing. The male protrusions can extend from each side surface of the first half, and the female protrusions can extend from each side surface of the second half. In other embodiments, the male protrusions can extend from each side surface of the second half, and the female protrusions can extend from each side surface of the first half. In other embodiments, one of the side surfaces can have a male protrusion and the other side surface can have a female protrusion, and one of the side surfaces can have a female protrusion and the other side surface can have a male protrusion.

[0292] One of the female protrusions may be slidably engageable with the recess of the button. When the button is pressed, the male protrusion may disengage from the female protrusion due to the radial force exerted on the button housing and the top plate of the recess pressing down on the female protrusion, which then disengages from its complementary male protrusion. In other embodiments, there may be multiple recesses that may be slidably engageable with multiple female protrusions and multiple recess top plates that may release multiple female protrusions from the male protrusions.

[0293] The sloped side surface 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 in the button housing. When the button is pressed, the pin can move up and down in the seat until the first and second frames are separated from the button to be safely discarded. In some embodiments, the button can be coupled to one of the first and second frames in such a way that the button remains with the frame after the frames are separated from each other. As an example and not limitation, this connection that allows the button to remain with one of the frames may require one of the pins to be tightly fitted into its complementary seat.

[0294] In addition to the sloped side surfaces, the button may also have a sloped rear surface. In some embodiments, the sloped rear surface may facilitate sliding of the button when pressed. In some embodiments, the sloped rear surface may exert a radial force on the button housing due to the change in volume of the button within the housing when pressed. The pin may have legs extending below and connected from below the button. The legs may allow the button to move downward evenly when pressed.

[0295] The extended indwelling catheter assembly according to aspects of the present invention is understood to have a housing composed of separate parts. The housing can have a first frame and a second frame. The first and second frames can be held together by a clamp-shaft coupling. The first and second frames can be pivoted or rotated away from each other at the clamp-shaft coupling to open the housing. The clamp-shaft coupling can be located between the upper and lower body openings of the housing and the base of the housing. The base can have an end that is bent proximally outward on each of the first and second frames. The bent end can be used as a lever to be pushed together and open the housing. Once the housing is opened, the catheter hub located in the interior space of the housing can be removed.

[0296] Prior to removal, the catheter hub can be pushed in a distal direction to advance the catheter into the patient. The catheter hub can be pushed with a pusher. The pusher can have a T-shape. The pusher can initially be proximal to the push protrusion of the catheter hub. The pusher can be pushed in a distal direction to engage with the push protrusion and push the catheter hub to 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 separate from the catheter hub.

[0297] The fixture-shaft coupling can have an upper fixture and an upper shaft and a lower fixture and a lower shaft pair. The upper fixture and lower fixture can be on alternating frames. Similarly, the upper shaft and lower shaft can be on alternating frames. In some embodiments, the upper fixture and lower fixture can be on the same frame, and therefore the upper shaft and lower shaft can also be on the same frame. In some embodiments, the fixture-shaft coupling can be replaced with another connection from which the first and second frames can pivot. By way of example and not limitation, such a connection can be a hinge similar to a traditional hinge used to open and close a door.

[0298] The base can have a plurality of grips protruding from each of the first and second frames. The grips can improve the grip when holding the catheter assembly from the base. The shape and arrangement of the grips can be like cheeks. The base can also have a second type of grip protruding from each of the first and second frames. The grips can be located more proximal on the housing relative to the grips. The grips can have a circular shape. The grips can have a curved surface complementary to a user's fingertips. The grips can allow the user to have an improved grip when squeezing the base end to open the housing.

[0299] The pusher may have a pair of legs, one at each end of the cap's T-shape. The legs may have a hook-like shape. The hook-like shapes of the legs may be slidably engaged with guide rails of the housing, respectively. The guide rails may extend along each side of the upper body opening. The pusher may slide in a distal direction on the guide rails to first engage with a push protrusion of the catheter hub and then push the catheter hub toward the nose segment.

[0300] In the fully advanced or distal position, the pusher protrusion may be sandwiched between the nose segment and the pusher. The pusher may be slid into this position by holding and guiding the pusher from the handle. The handle may be horizontal above the legs. The handle being further away from the housing may make it easier to grip the pusher and allow the handle of the pusher to rest above the base when in the proximal position. The handle may have a protrusion for increased grip.

[0301] In the distal position, each leg of the legs can be above the end of the rail at the end of the rail. The end of the rail can be a recess between the nose section and the rails on each side of the upper body opening. The size of the rail end can be designed so that the hooked legs of the pusher do not catch on the housing and have space to separate from the housing. The first and second frames can each have a grip extending through the nose section and the base. The grip can be used to hold the catheter assembly with one hand while pushing or removing the pusher with the other hand.

[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 in 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 farthest end of the housing, the tip may extend beyond the nose. The tip may have two separable sections, one at each of the first and second frames. When the housing is closed, the sections may form a double butt lap joint. The sections of the tip may be on top of the sections when joined together. In other embodiments, the sections may be on top of the sections when joined together.

[0304] The lock may serve as an additional reinforcement to keep the segments joined and to keep the first and second frames substantially intact. The lock may interrupt the upper seam. The lock may be located on the nose segment of the housing between the nose end and the upper body opening. In some embodiments, there may be multiple locks. In such an embodiment, one of the locks may be between the nose end and the lower body opening.

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

[0306] There can be another embodiment of a pusher with a distal handle and a proximal handle. The distal and proximal handles can provide a variety of options for holding the pusher. Depending on the size of the user's hand or the position of the catheter assembly relative to the user or patient, it may be easier to hold the pusher from the distal handle or the proximal handle. The proximal handle can be raised relative to the distal handle. When the pusher is in the proximal position, the raised position of the proximal handle can allow it to be placed on the base of the housing. The distal and proximal handles can be the same size or different sizes. The distal handle and the proximal handle can each have one or more grips protruding therefrom. The distal handle can have a distally extending end from it. The end can be bent upward. The curvature of the end can allow the user's fingers to engage with the distal handle without slipping, and leverage the end when sliding the pusher in the distal direction.

[0307] The extended indwelling catheter assembly according to various aspects of the present invention is understood to have a housing that can be composed of separate parts. The housing can have a first frame and a second frame. The first and second frames can be held together by a clamp-shaft coupling. The first arm and the second arm are pivotally or rotatably attached to the clamp-shaft coupling. The first and second arms can overlap each other. Due to the overlap, the first and second arms can be similar to a pair of scissors. The first and second arms can have a distal segment and a proximal segment. The distal segment can be within the interior space of the housing, and the proximal segment can extend out of the interior space. When the ends of the housing are squeezed, the distal segment can push the first and second frames apart when the first and second arms are pivoted away from each other at the clamp-shaft coupling to open the housing. The first and second arms can make it easier to open the housing by providing additional levers. Due to the radial force applied by the first and second arms on the housing, one or more locks that keep the first and second frames intact can be unlocked more easily.

[0308] The size of the clamp-shaft coupling can be larger than the size of the catheter assembly without the first and second arms. The larger size can allow the first and second arms to pivot with less applied force. Multiple locks are shown, one located on 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] The extended indwelling catheter assembly according to aspects of the present invention is understood to have a housing composed of separate parts. The housing can have a first frame and a second frame. The first and second frames can have an upper seam and a lower seam. The upper seam can be at the nose section of the housing. The upper seam can bend outward and widen into a main body opening.

[0310] At the farthest end of the housing, the tip may extend out of the nose. The tip may have two separable sections, one at each of the first and second frames. When the first and second frames are complete, the sections may form two finger joints, one extending from the upper seam and one extending from the lower seam.

[0311] The first and second frames can be held together by a base plate. The base plate can have a long protrusion that can engage with the slots of the first frame and a short protrusion that can engage with the slots of the second frame, respectively. The latches that are pivotally attached to the base plate and the first frame can pull the base plate in a proximal direction when activated, thereby releasing the short protrusions from their slots. At the same time, the long protrusions can still engage with the slots, and thus the second frame can be separated from the first frame, which remains attached to the base plate and the latches. The latches can pass over the base of the housing. Once the catheter hub is pushed to the distal position, the needle hub can pop out proximally from the base.

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

[0313] The long protrusion and the short protrusion can extend from their corresponding grooves to the first frame proximal groove recess and the second frame proximal groove recess when engaging with the first and second frames respectively. The size of the first frame proximal groove recess can be set to be larger than the size of the second frame proximal groove recess. The larger size of the first frame proximal groove recess can accommodate the long protrusion. The first and second frame proximal groove recesses can provide a tight fit for the protrusion. In other embodiments, the first and second frame proximal groove recesses can have the same size. In such an embodiment, the fit of the protrusion may not be tight.

[0314] The protrusions may have chamfered distal ends. The protrusions may have rounded distal ends. In other embodiments, all distal ends may be rounded, chamfered, or square. The width of the slots is just enough to accommodate their corresponding protrusions. The protrusions may be directly adjacent to the base.

[0315] The base plate can be located within the interior space of the housing below the catheter hub. The protrusion engageable with the first frame and the protrusion engageable with the second frame can be separated by a groove. The groove can extend along the entire length of the base plate on its upward-facing surface, or extend toward the catheter hub when assembled. The latch can be pivotally or rotatably connected to the first frame from below the base plate. The connection can be facilitated by a connecting pin. The connecting pin can extend inwardly or toward the interior space from the distal bottom corner of the first side of the latch. The connecting pin can have a generally cylindrical shape with a protrusion extending along its length on its outer surface. The protrusion can engage with a groove in the base of the first frame that limits the rotation of the connecting pin to allow the latch to pivot only a certain amount in the proximal direction.

[0316] The latch may have a top and a second side. The top may have teeth that extend downward from an inner surface facing the base when assembled. The teeth may form a finger joint with an opposing tooth that enters between the teeth. The first half of the teeth may be on the first frame and the second half may be on the second frame. In some embodiments, there may be multiple teeth that can be received by multiple sets of teeth. The top and first side may extend across the entire height and width of the base. The second side may extend partially across the height of the base. The first side may have a proximal bottom angle. The edge may extend across the bottom angle. The edge may be inclined, with the proximal bottom angle being higher in height than the distal bottom angle.

[0317] The latch may be movably connected to the base plate by a shaft extending inwardly 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 side and the second side of the latch may form a rounded corner with the top of the latch. In other embodiments, the corner may be straight.

[0318] The base plate can have a proximal hook attached to the shaft of the latch. When the latch is pulled in the proximal direction, the shaft can pull the base plate proximally from the proximal hook. When the base plate is pulled in the proximal direction, the short protrusions will disengage from their corresponding slots, while the long protrusions remain engaged with their corresponding slots. As a result, the second frame will be separated from the first frame, and the first frame will remain attached to the latch and the base plate. The first and second frames can be separated from the catheter hub, and the catheter hub can remain attached to the patient. The first and second frames can then be discarded.

[0319] Methods of making and using extended indwelling catheter assemblies and components thereof are within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0320] These and other features and advantages of the apparatus, systems and methods of the present invention will become apparent and better understood with reference to the specification, claims and drawings, in which: Figure 1is a perspective view of an extended indwelling catheter assembly provided in accordance with aspects of the present invention.

[0321] Figure 2 is a cross-sectional side view of a catheter assembly provided in accordance with aspects of the present invention for use with a multi-part housing.

[0322] Figure 3 yes Figure 1 Side view of the assembly.

[0323] Figure 4 From different perspectives Figure 1 Perspective view of an extended indwelling catheter assembly.

[0324] Figure 5 From different perspectives Figure 1 A partial perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0325] Figure 6 yes Figure 1 A partial perspective view of one of the housing components of an extended indwelling catheter assembly.

[0326] Figure 7 From different perspectives Figure 6 A partial perspective view of the housing components.

[0327] Figure 8 From different perspectives Figure 1 A partial perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0328] Fig. 9 yes Figure 1 A perspective view of one of the housing components of an extended indwelling catheter assembly.

[0329] Fig.10 From different perspectives Figure 1 A partial perspective view of an extended indwelling catheter assembly.

[0330] Fig.11 From different perspectives Fig. 9 A partial perspective view of the housing components.

[0331] Fig.12 From different perspectives Fig. 9 A partial perspective view of the housing components.

[0332] Fig.13 From different perspectives Fig. 9 A partial perspective view of the housing components.

[0333] Fig.14 From different perspectives Figure 1A partial perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0334] Fig.15 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0335] Fig.16 From another perspective Fig.15 Perspective view of an extended indwelling catheter assembly.

[0336] Fig.17 From different perspectives Fig.15 A perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0337] Fig.18A and 18B From different perspectives Fig.15 A partial perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0338] Fig.19 is a perspective view of one of the housing components of FIG. 18 .

[0339] Fig. 20 is a perspective view of one of the housing components of FIG. 18 .

[0340] Fig.21 is a perspective view of one of the housing components of FIG. 18 .

[0341] Fig. 22 is a perspective view of one of the housing components of FIG. 18 .

[0342] Fig.23 is a perspective view of one of the housing components of FIG. 18 .

[0343] Fig.24 From different perspectives Fig.15 A perspective view of an extended indwelling catheter assembly and which is shown without a housing component.

[0344] Fig.25 yes Fig.24 A perspective view of the housing components.

[0345] Fig.26 yes Fig.25 A perspective view of one of the housing components.

[0346] Fig. 27 yes Fig.25 A perspective view of one of the housing components.

[0347] Fig.28 yes Fig.15Schematic diagram of an extended indwelling catheter assembly showing a pair of force components when the catheter hub contacts the activation ramp.

[0348] Figure 29-31 are various views and cross-sections of a nose adapter used with a catheter hub to facilitate operation of an ExD catheter assembly.

[0349] Fig.32 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0350] Fig.33 yes Fig.32 Top view of the ExD catheter assembly.

[0351] Fig.34 yes Fig.32 Bottom view of the ExD catheter assembly.

[0352] Fig.35 and 36 yes Fig.32 Magnified top and bottom views of the housing distal end of the ExD catheter assembly.

[0353] Fig.37 Only the first frame is shown Fig.32 An enlarged cross-sectional perspective view of the ExD catheter assembly.

[0354] Fig.38 yes Fig.32 An enlarged cross-sectional perspective view of the ExD catheter assembly showing only the second frame.

[0355] Figure 39-42 are different views of a nose adapter for use with a catheter hub to facilitate operation of an ExD catheter assembly according to further aspects of the present invention.

[0356] Fig.43 yes Fig.32 A perspective view of an ExD catheter assembly showing the Figure 39-42 protrusion adapter.

[0357] Fig.44 is a perspective view of an extended indwelling catheter assembly according to further aspects of the present invention.

[0358] Figures 45A-45C Different views of the nose adapter are shown.

[0359] Fig.46 is a perspective view of the housing with the door assembly.

[0360] Fig.47A and 47B Different views of the door assembly are shown in an open position.

[0361] Figures 48A-48C Different views of the door assembly are shown in an assembled state.

[0362] Fig.49 The direction of movement for assembling the door assembly is shown.

[0363] Fig.50 The direction of movement for mounting the assembled door assembly to the housing is shown.

[0364] Fig.51 is a partial bottom perspective view showing the open distal end of the housing.

[0365] Fig.52 is a partial rear perspective view of the housing showing the open proximal end.

[0366] Fig.53 is a perspective view of a housing component of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0367] Fig.54 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0368] Fig.55 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0369] Fig.56 yes Fig.55 Different perspective views of an extended indwelling catheter assembly with the catheter hub in a distal position.

[0370] Fig.57 yes Fig.55 A perspective view of an extended indwelling catheter assembly with the catheter hub in a distal position and the housing components in an open position.

[0371] Fig.58 yes Fig.55 A perspective view of an extended indwelling catheter assembly with the catheter hub removed from the housing component.

[0372] Fig.59 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0373] Fig.60 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0374] Fig.61 yes Fig.60 An enlarged perspective view of the proximal end of an extended indwelling catheter assembly.

[0375] Fig.62 yes Fig.60An enlarged perspective view of the distal end of an extended indwelling catheter assembly.

[0376] Fig.63 yes Fig.60 An enlarged perspective view of a detachment button of a housing component of an extended indwelling catheter assembly.

[0377] Fig.64 There is no outer shell Fig.60 A partial perspective view of an extended indwelling catheter assembly.

[0378] Fig.65 There is no outer shell Fig.60 An enlarged view of the detachment button of the housing component of the extended indwelling catheter assembly.

[0379] Fig.66 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0380] Fig.67 yes Fig.66 An enlarged exploded view of the clamp-shaft connection of the housing component of the extended indwelling catheter assembly.

[0381] Fig.68 yes Fig.66 An enlarged view of a catheter hub pusher of an extended indwelling catheter assembly and a clamp of a catheter hub having a pushing protrusion.

[0382] Fig.69 yes Fig.66 A partial perspective view of an extended indwelling catheter assembly with the catheter hub pusher and the catheter hub in a distal position.

[0383] Fig.70 yes Fig.66 A partial perspective view of an extended indwelling catheter assembly with the housing component in an open position and the catheter hub pusher removed from the housing component.

[0384] Fig.71 yes Fig.66 An enlarged perspective view of the distal end of a housing component of an indwelling catheter assembly.

[0385] Fig.72 yes Fig.66 An enlarged perspective view of the proximal end of a housing component of an indwelling catheter assembly featuring another embodiment of a catheter hub pusher.

[0386] Fig.73 is a top view of an extended indwelling catheter assembly provided according to another aspect of the present invention.

[0387] Fig.74 yes Fig.73 Side view of an extended indwelling catheter assembly.

[0388] Fig.75 is a perspective view of an extended indwelling catheter assembly provided according to further aspects of the present invention.

[0389] Fig.76 yes Fig.75 A bottom perspective view of an extended indwelling catheter assembly.

[0390] Fig.77 yes Fig.75 An enlarged bottom perspective view of an extended indwelling catheter assembly.

[0391] Fig.78 There is no first housing component frame Fig.75 Cross-sectional view of an extended indwelling catheter assembly.

[0392] Fig.79 yes Fig.75 Isolated perspective view of the latch and base plate of an extended indwelling catheter assembly.

[0393] Fig.80 yes Fig.75 Isolated side view of the latch and base plate of an extended indwelling catheter assembly. DETAILED DESCRIPTION

[0394] The detailed description set forth below in conjunction with the accompanying drawings is intended to be the description of the current preferred embodiment of the conduit assembly and parts thereof that provide as the aspect of the device, system and method according to the present invention, and is not intended to represent that the device, system and method of the present invention can be constructed or the only form utilized. This description sets forth the features and steps of the embodiments for constructing and using the present device, system and method in conjunction with the illustrated embodiments. However, it should be understood that identical or equivalent functions and structures can be realized by different embodiments, and these embodiments are also intended to be included in the spirit and scope of the present disclosure. As shown elsewhere herein, similar element numbers are intended to represent identical or similar elements or features.

[0395] In a broad sense, the extended indwelling ("ExD") catheter assembly described herein each includes a housing and a catheter assembly. The housing is configured to be separated from the housing and allow the catheter to remain with the patient during initial puncture, by catheter advancement, by the separation of the catheter hub and the needle hub, and then activated so that the catheter hub can be separated from the housing and allow the catheter to remain with the patient, accommodating the catheter assembly. The housing and the catheter hub can be separated by various mechanisms. For example, the housing can be divided into two or more housing parts to release the catheter hub, the housing can have a swinging, rotating or pivoting part, the housing can have an end cap component, the end cap component swings open to open a door opening to allow the catheter hub to leave the housing, and the housing can have a door assembly attached to the housing distal end, and other options. The door assembly can have two doors located on two door housing bodies, the two door housings can be connected, and each door can be swung open via a living hinge. The two doors can be engaged via a male ratchet and a receiving slot. The two doors can be engaged via a hook arm and a female ratchet. The unique housing design allows use with a standard or existing catheter assembly without the need for a specially designed catheter, although this is optional. Thus, standard catheters with extended lengths and midline catheters with approximately 8-10 cm catheter lengths may be readily used with the housing of the present disclosure, with or without a guidewire.

[0396] Reference now Figure 1 , shows a perspective view of an exemplary embodiment of an extended indwelling catheter assembly 100 according to aspects of the present invention. In the example shown, the extended indwelling or ExD catheter assembly 100 includes a housing 102 having a receiving space or interior space 104 having a catheter assembly 108 located therein, the catheter assembly 108 having a catheter tube 110 and a needle 112 located within a catheter lumen protruding from a distal end 120 of the housing 102. A needle tip 114 of the needle extends out of 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 out of a proximal end 126 of the housing 102. The needle hub 122 may include a vent plug 124, which may engage a proximal opening of the needle hub 122, such as in a luer fit.

[0397] Reference now Figure 2 , outside of the housing 102 or away from the housing 102 shows Figure 1 108. According to various aspects of the present invention, the catheter assembly 108 and similar catheter assemblies shown herein can be used with the housing 102 to form an ExD catheter assembly. Optionally, a guidewire can be incorporated to assist in inserting, positioning, and moving the catheter, as discussed further below.

[0398] In one example, the catheter assembly 108 includes a first hub or catheter hub 130 having a 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 hole for receiving the needle 112 and has a distal opening or distal end opening 110a, and the needle tip 114 of the needle 112 extends distally to the distal opening 110a in a ready-to-use position in which the assembly is ready for venipuncture. The catheter assembly 108 may also be referred to as a needle assembly.

[0399] Needle 112 may include a change in profile 136 located proximal to needle tip 114 for use with a needle guard. Needle tip 114 extends distally from the distal opening of tube or tubing 110 in a ready-to-use position with a change in profile 136, which, if used in conjunction with a needle guard, is located proximal to distal opening 110a. The change in profile 136 may be a curl, bulge, 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 physician, and the term "distal" is the opposite end or side.

[0400] The change in profile 136 can be used to interact with the needle guard 140 during retraction of the needle 112 after a successful venipuncture, as discussed further below. The vent plug 124 is disposed at the proximal open end 138 of the second needle hub or needle hub 122. The vent may have a conventional vent filter 142 at its proximal end. As shown, the catheter tube 110 is attached to the first hub or catheter hub 130 by a ferrule or sleeve 144.

[0401] The needle guard 140 can be disposed in the interior cavity 148 of the first hub or catheter hub 130 for covering the needle tip 114 in the protected position. When combined, 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 the contour 136 on the needle can also be omitted. In other examples, the needle guard can be included without including the change in the contour on the needle. In yet another example, the needle guard 140 can be located in a third housing between the first hub 130 and the second hub 122. An exemplary needle guard located 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 other examples, the needle guard can include a plurality of arms or fingers extending both in a first direction and in an opposite second direction, as disclosed in U.S. Pat. No. 9,387,307, the contents of which are expressly incorporated herein by reference. For example, the needle guard device may include a first protector body surrounded by a second protector body.

[0402] In one example, the needle guard may be made of a metal material and may have an elastic portion capable of generating a biasing force. The needle guard may include a wall surface positioned to one side of the needle and movable distally of the needle tip to protect the needle tip from accidental contact therewith. The wall surface may be a needle catcher and movable directly in front of or distally of the needle tip point.

[0403] As shown, the needle guard 140 may include a proximal wall and two arms extending distally from the proximal wall. Figure 1 When viewed from the side, the two arms can be Figure 1 In the ready-to-use position, the needle guard 140 intersects each other, and in the protected position, when viewed from a side view, the needle guard covers the needle tip. In some examples, the two arms of the needle guard 140 may extend in the distal direction without intersecting each other. Two distal walls (one on each arm) may be combined to block the needle tip. Figure 1 In the ready-to-use position of the catheter, the two distal walls may be biased outwardly by the needle 112 and are disposed distally of an internal change in profile 152 within the first hub 130 in the ready-to-use position. The internal change in profile 152 may be a section of reduced diameter located next to a section of larger sized inner diameter. The elbows on the two arms of the needle guard may have a larger dimension than the inner diameter at the internal change in profile 152 to limit the movement of the needle guard proximally from the catheter hub until the two arms are no longer biased outwardly or until the dimensions at the two elbows are reduced.

[0404] 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 is greater than the inner diameter of the internal variation of the profile 152 at the intersection between each arm and its corresponding distal wall, which prevents the needle guard 140 from moving proximally thereof due to the relative dimensions. Once the needle tip 114 moves proximally of the two distal walls, the two arms are allowed to move radially inwardly and one or both distal walls close over the needle tip to block the needle tip in the protected position. At this point, the dimension between the two joints or elbows is reduced and is less than the inner dimension of the internal variation of the profile 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 may be equal to or slightly greater than the inner dimension of the internal variation of the profile 152, and the needle may still be moved proximally by bending or squeezing the two joints to pass through the internal variation of the profile 152.

[0405] The first hub 130 has a proximal opening 156, which has a nose section 158 of the second hub 122 disposed therein. The proximal opening 156 of the first hub has a female Luer interface for receiving a male Luer interface end (such as a syringe, an IV tubing connector, a Luer interface extension assembly, etc.). The external thread 154 can be disposed on the outer surface at the proximal end for threaded engagement with the threaded collar of the male threaded Luer interface end. A pair of stabilizing wings 162 can extend radially from the first hub 130 to facilitate fixing or anchoring 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 assembly. If the wings are not present on the first hub or catheter hub 130, the bottom of the first hub can have a flat surface at an angle between 2 and 15 degrees to the through axis of the first hub.

[0406] The first hub 130 is removably secured to the second hub 122 by receiving the nose segment 158 ​​of the second hub in its proximal opening 156. A flange or extension 160 may be provided on the second hub 122 and together with the nose segment 158 ​​define a gap 166 having a portion of the first hub located therein. Optionally, the flange or extension 160 may be omitted and a stud 164 or other surface matching feature may be provided. The stud 164 may be the male portion of a key that fits in a gap through or partially into the Luer interface threads to prevent the second hub 122 from rotating relative to the first hub 130. The proximally facing end surface of the first needle hub abuts the distally facing surface of the step in the outer surface of the second hub, which is located at the proximal end of the nose segment 158 ​​inside the first hub. This abutment may set the amount by which the needle tip 114 protrudes from the catheter tube 110a. The stud 164 may be an optional structural feature.

[0407] The second hub 122 has a body 168 with an optional internal cavity 170 into which the proximal end 172 of the needle 112 protrudes. The internal cavity 170 can function as an initial blood flashback chamber. The proximal opening 138 of the body 168 can have a female Luer interface for receiving a vent plug 124 or a syringe end therein, and the exterior can be threaded or unthreaded. In one example, the exterior of the body 168 of the second hub 122 is generally cylindrical and unthreaded. The first and second hubs can be made of a plastic material, such as by plastic injection.

[0408] The first hub or catheter hub 130 can be provided with a push tab 176. The push tab 176 can be located on the outer surface 178 of the first hub 130 at a position distal to the external threads 154 so as to avoid interference with the external threads. For example, the push tab 176 should be located far enough from the external threads 154 so that when a threaded male connector (such as a syringe type with a threaded collar) is connected to the threads of the first hub, the push tab 176 does not interfere with the connection. In some examples, the push tab 176 should be located far enough from the external threads 154 so that when the push tab 176 is folded, the push tab does not interfere with the connection.

[0409] In some examples, the catheter assembly 108 can combine a valve and a valve opener. For example, the valve and the valve opener can both be located in 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, thereby opening a fluid passage for fluid flow through the valve. An exemplary valved catheter assembly with a valve opener is disclosed in U.S. Patent No. 8,333,735, the contents of which are expressly incorporated herein by reference. The valve opener can have a nose segment having a hole and a plunger segment located proximal to the nose segment. The nose segment can be pushed into the valve to open one or more slits of the valve, such as three slits defining three flaps. The plunger segment can include two or more plunger components with a gap therebetween. The gap can allow fluid to flow through the holes in the plunger component and the nose segment.

[0410] Apart from Figure 2 In addition, refer to Figure 1 , the housing 102 of the ExD catheter assembly 100 of the present invention includes a left frame or a first frame 193 and a second frame or a right frame 194 attached to each other. Each frame includes a nose portion 184a, a main body portion 188a and a base portion 190a. The two nose portions 184a can be connected to form a nose end 184, the two main body portions 188a can be connected to form a main body 188, and the two base portions 190a can be connected to form a base end 190. In one example, the nose end or nose portion 184 is provided with a nose tip 186, which has an elongated cylindrical structure having a hole for accommodating a catheter tube 110 and a needle 112 located in the catheter tube. The nose end or nose portion 184 may also include a nose base 192 and a tapered distal portion, and the nose base 192 has an expanded portion formed with the end 186. A plurality of support ribs or fins may be provided at the intersection between the end 186 and the nose base 192. In other examples, nose end 184 can be a spherical or rounded dome with an opening to accommodate a catheter tube and a needle. In other examples, nose end 184 can have a different shape, such as a multi-faceted structure similar to a connection to form an enclosed end with a central opening to accommodate a needle and a catheter tube.

[0411] The body 188 has an interior space 104 for accommodating a catheter assembly, which may be a reference Figure 2 The catheter assembly described herein. The body opening or first opening 196 leads to the interior space 104. As shown, the body opening 196 extends from the nose end 184 to the base end 190.

[0412] In one example, the body 188 is provided with a second opening opposite to the first opening 196, so that the interior space 104 can be entered from both body openings. Therefore, 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, and the opposite side is solid or enclosed by the wall surfaces of the first frame and the second frame. Optionally, the enclosed side can have a small window or opening for entry or ventilation, but not a complete opening like the body opening 196.

[0413] The base or base end 190 extends from the body 188 and has multiple sides. In one example, there can be four sides 200, 202, 204, 206 that define an interior space 208, which opens into the interior space 104 of the body 188. In other examples, the base 190 can be embodied as a generally elongated cylinder or a non-circular cylinder. For the purpose of discussion, the side 204 and the side 206 can be identified as the top side and the bottom side, respectively. The side 200 and the side 202 can be identified as the left side and the right side, respectively. The side can also be understood as a first side 200, a second side 202, a third side 204, and a fourth side 206. These specific terms are given to enable specific sides to be called only relative to other sides, but unless the context indicates otherwise, these terms are not restrictive.

[0414] exist Figure 1 In the ready-to-use position, the base 190 can have an open proximal end to allow the needle hub 122 to extend proximally thereof proximal to the end surface 126a. As shown, the first side 200 and the second side 202 of the base end 190 can each have an opening 210 to allow viewing and access to the interior space 208 of the base end 190, such as to facilitate or assist in the assembly of the catheter assembly 108 therein, as discussed further below.

[0415] The top side 204 of the base end 190 may be provided with a first rod or top rod 214 and the bottom side 206 may be provided with a bottom rod 216 ( Figure 3). As discussed further below, when the user simultaneously applies a compressive force and a distally directed force on the top rod 214 and a compressive force and a proximally directed force on the bottom rod 216, the user can move the left housing frame 193 and the right housing frame 194 relative to each other and disengage the detents on the first frame 193 and the second frame 194, and then separate the housing into separate housing components, namely the left frame 193 and the right frame 194. In other words, by manipulating the top rod 214 and the bottom rod 216, the user can separate the housing 102 into two or more housing components. The separation of the housing 102 into the housing components can then expose the catheter assembly 108 to be separated from the housing 102 after a successful venipuncture, so that the catheter hub 130 ( Figure 2 ) can then be secured to the IV line and to the patient, such as by using tape or a securing dressing. In other examples, by rearranging the detents or engagement protrusions between the left and right housing frames 193, 194, a user can simultaneously apply a compressive force and a proximally directed force on the first or top bar 214 and a compressive force and a distally directed force on the second or bottom bar 216 to move the two housing portions relative to each other and disengage the detents on the first and second frames 193, 194.

[0416] Figure 3 yes Figure 1 18 is a side view of the ExD catheter assembly 100. In the orientation shown, a plurality of surface decorations 220 can be seen on the outer surface of the left or first frame 193, particularly at or on the left body 188. The right or second frame 194 can be provided with a similar set of surface decorations. A generally planar upper edge 224 is provided with two body frames 193, 194. In addition, the distal edge of the top rod 214 is located proximal to the distal edge of the second or bottom rod 216. As discussed further below, this arrangement is used to enable the top rod 214 to be easily grasped with the thumb, and the bottom rod 216 to be easily grasped with the outer edge of the index finger to separate the housing 102 into housing components. For example, the index finger can push against the curved proximal-facing surface 216a of the bottom rod 216 and push distally or in a distal direction.

[0417] In other examples, the relative arrangement between the top and bottom bars 214, 216 may be altered or arranged differently depending on the detent-type or snap-fit ​​connection incorporated to hold the first and second frames 193, 194 together, as discussed further below.

[0418] Reference now Figure 4 , showing Figure 1100. As shown in the figure, as previously described, the housing 102 includes a housing top side and a main body opening 196 ( Figure 1 ) opposite wall 230. A seam 232 extends longitudinally along the housing 102, marking the interface between the left frame 193 and the right frame 194 of the housing along the body 188 and the nose 184 of the housing. The seam 232 extends from the nose 184 to and through the base end 190 of the housing. However, the seam can be non-linear or not a straight line. For example, the seam 232 can be offset from the axis compared to the straight line defined by the seam 232 along the body and the nose. The seam at the base end 190 can be near the edge or intersection of the side (such as the right side 202 and the bottom side 206). Multiple pairs of pawls can be incorporated between the left frame 193 and the right frame 194 to secure the two frames together, such as Figure 4 In one example, the catheter assembly can be located inside the housing 102 before the left frame 193 is joined to the right frame 194, or vice versa. After use, such as after a successful venipuncture, the top rod 214 ( Figure 1 ) and the second or bottom rod 216 can be actuated to disengage the pawl and then separate the housing into components, such as separating the left frame 193 from the right frame, so that the catheter assembly can be separated from the housing.

[0419] Reference now Figure 5 , showing Figure 1 ExD catheter assembly 100, wherein the first or left frame 193 is separated from the right frame 194, and the catheter assembly 108 is fixed to the right or second frame 194. In one example, the right frame 194 is provided with a second side 202 and a top side or third side 204 at the base portion 190a, which are generally at right angles to each other. The first side 200 and the bottom side or fourth side 206 are provided with the left frame 193, and in the separated view shown, the left frame 193 has been separated from the right frame 194.

[0420] In order to fix the catheter assembly 108 to the right frame 194, and in particular to prevent the needle hub from moving, the lower wall structure or section 230a of the right frame 194 terminates at a proximal edge 240, which is positioned along the axial position on the right frame to accommodate the flange or extension 160 on the needle hub 122. Therefore, the distal edge of the flange 160 is limited by the proximal edge 240 on the lower wall structure 230a and does not shift or move in the distal direction. In order to fix the needle hub 122 to prevent it from moving in the proximal direction, the second side 202 is provided with a channel 244 and a shoulder 246 ( Figure 6 ) for retaining the flange 161 on the needle hub. The channel 244 on the second side 202 and the corresponding channel ( Figure 1) defines a gap or width for accommodating the width of the Luer interface threads 154 on the catheter hub and the flange 161 on the needle hub. In addition, the non-circular structure for coupling the flange 161 and the groove channel 244 (such as by using a multi-faceted structure) prevents the needle hub from rotating within the space defined by the sides of the base end 190. This in turn holds the needle hub in the assembled position so that the needle bevel can be oriented in the desired position without rotating prematurely before performing a venipuncture.

[0421] Figure 6 1 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. Figure 6 And further reference Figure 5 , the second side 202 of the base portion 190a is shown as having a channel 244 and a shoulder 246. A plurality of protrusions or male detents 250 are provided at the lower edge 252 of the second side 202. In the example shown, the protrusions 250 can be embodied as hook-like structures for engaging the female detents located on the left or first frame 193, as further discussed below. Optionally, there can be more than two detents or only one detent 250. Each male detent 250 is shown as having a distal end pointing in a distal direction for engaging the female detent from a proximal position of the female detent and moving or sliding to a distal position to engage. Therefore, the right frame 194 and the detents 250 must travel or move in a proximal direction relative to the left frame 193 to separate the male detents or protrusions 250 from the female detents on the left frame, as further discussed below. In other examples, the male detent 250 on the right frame may be pointed in a proximal direction such that separation of the male and female frames will require movement of the right frame in a distal direction relative to the left frame 193 to separate the male detent or protrusion 250 from the female detent on the left frame.

[0422] Along the top side 204, a cutout 254 is provided for forming the top bar 214. The cutout 254 is provided with three sides, with the fourth side connected to the base of the top bar 214. The top bar 214 can be formed to protrude outwardly in a direction away from the lower edge 252. As shown, the top bar 214 has a tapered or ramped portion 214a and a contact portion 214b. The contact portion 214b provides a surface for a user to touch or manipulate.

[0423] The rib or protrusion 260 is provided on the lower side surface 264 of the top side 204 and is recessed from the side edge 262 of the top side. The size of the recessed space between the side edge 262 and the protrusion 260 is set to accommodate the thickness of the first side 200 of the left frame 193 when the left frame is assembled to the right frame 194. The rib 260 can function as an alignment protrusion for aligning the first side 200 to the side edge 262 so that when assembled with the first side 200, a substantially flush surface is provided between the side edge 262 and the exterior of the first side 200. Optionally, the rib 260 can be omitted.

[0424] A second rib or protrusion 268 spaced apart from the first rib 260 may also be provided on the underside surface 264 of the top side 204. In one example, the second rib 268 is aligned with or aligned with the side edge 262 and is configured to engage a corresponding groove or recess on the left side or first side 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 one example, the second rib 268 has an arrow tip shaped structure having two tapered edges and an apex therebetween. The arrow tip shaped structure is configured to be seated in a corresponding seat on the left side 200 of the left frame 193 and when the top bar 214 and the bottom bar 214 ( Figure 3 ) are grasped and caused to slide relative to each other, the two tapered surfaces allow the protrusion 268 to disengage from the corresponding seat by allowing the corresponding tapered surfaces to slide relative to each other.

[0425] Also shown is a shoulder 245 formed on the underside surface 264 of the top wall 204, just distal to the cutout 254. Similar in function to the shoulder 246 on the second side 202, the shoulder 245 on the underside surface is configured to support a flange on the needle hub.

[0426] Figure 7 The front or distal portion of the right frame 194 is shown with a conduit extending out of the distal opening 342 of the nose portion 184a. A projection or detent 250 having a free end pointing in the distal direction is shown located on the side edge 270 of the lower wall structure 230a. The projection or male detent 250 can engage a corresponding female detent formed on the left frame 193. In other examples, additional projections 250 can be provided along the side edge 270 of the lower wall structure.

[0427] Two protrusions 268 are provided on the distal portion of the right frame 194. As shown, the lower protrusion 268 is provided on the side edge 270 of the lower wall structure 230a for engaging the groove on the left frame to provide additional rigidity along the seam 232 ( Figure 4 ). An upper protrusion 268 is provided on the side edge 272 of the base 192 for engaging a groove on the left frame to extend along an upper seam 276 ( Figure 1 ) provides additional rigidity. Element 232 may generally be referred to as a seam, which may be an upper seam or a lower seam. However, in order to provide different reference numerals to more easily distinguish between the upper and lower seams, the upper seam may be referred to as 276, and the lower seam may be referred to as 232.

[0428] Figure 8 is a close-up view of the right frame 194 with the catheter assembly 108 attached to the right frame 194, similar to Figure 5 In the orientation shown, the right frame 194 is clearly shown as having a bottom wall structure 230a, a top wall structure or segment 230b, and a side wall structure or segment 230c, each having a surface. In one example, the upper or top wall structure 230b has a length extending in the same length direction as the needle and a width perpendicular or radial to the length. The width of the top wall structure 230b is smaller in size than the width of the bottom wall structure 203a. As shown in FIG. Figure 4 As shown, these different widths between the top and bottom wall structures, such as the top wall structure 230b not protruding as much toward the needle as the bottom wall, allow for clearance along the upper portion of the housing and the bottom to be closed when the first frame is attached to the second frame.

[0429] A shoulder 278 is disposed between the upper wall structure 230b and the top side 204, and a raised stud 280 is disposed distally of the top rod 214. The step at the shoulder 278 provides a relatively large internal space at the base end of the housing to accommodate the flange on the needle hub 122 and the Luer interface threads on the catheter hub 130. The raised stud 280 is not connected to the contact portion 214b of the top rod 214, but is provided with a tapered surface to mimic the ramp 214a at the base of the top rod 214, thereby appearing more symmetrical. A gap 282 is provided between the top rod 214 and the raised stud 280, which may include spaced apart gripping protrusions 284. The top rod 214 may also include similar spaced apart gripping protrusions 284.

[0430] Reference now Fig. 9 , shows a perspective view of a left or first frame 193, which is similar to the right frame 194 with some exceptions. The left frame 193 is configured to be coupled to the right frame 194 to form Figure 1 and housings shown elsewhere. In this embodiment, the first frame 193 is provided with a nose portion 184a, a body portion 188a, and a base portion 190a. The left frame 193 and the right frame 194 can be connected 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 groove 288 and a receiving groove 290, and the engagement groove 288 is used to engage the protrusion or pawl 250 ( Figure 7), the receiving groove 290 is used to receive the protrusion 268 on the right frame 194. As discussed further below, the engagement groove 288 can have a detent for receiving a corresponding detent on the right frame 194. However, the receiving groove 290 can be embodied as a simple channel without an engagement surface for receiving the lower protrusion 268 on the right frame 194, as discussed further below.

[0431] Likewise Fig. 9 As shown, proximal to the main body portion 188a is the base portion 190a having a left side or first side 200 and a bottom side or fourth side 206 on which a second or bottom bar 216 is formed. The first side 200 and the bottom side 206 are similar to two wall structures disposed at right angles to each other, with the bottom bar 216 located on one of the walls. One or more gripping features 284 may be disposed on the exterior of the bottom bar 216.

[0432] Reference now Fig.10 , shows 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 protrusion 250 to enter, the opening having a tapered surface 294 and a protrusion 296. The protrusion 250 on the right frame 194 can enter the opening of the engagement slot 288 and then travel distally to engage the protrusion 296 of the engagement slot 288, thereby completing the engagement between the protrusion 250 and the engagement slot 288.

[0433] To separate the left and right frames, the protrusion 250 is removed in the reverse direction. The protrusion 250 can be moved proximally relative to the engagement slot 288. The proximal movement causes the tapered surface 294 of the engagement slot 288 to move against the tapered surface 298 on the protrusion 296 to impart a pair of force components, which include radially directed forces to cause the left and right frames to move away from each other, thereby separating the protrusion 250 from the engagement slot 288. At the same time, the lower protrusion 268 on the right frame 294 is separated from the receiving slot 290 on the left frame 193. A similar engagement mechanism is provided at the base end 190 ( Figure 1 ) so that the two frames 193, 194 can be separated at the base end.

[0434] Fig.11 190a. As shown, the bottom side or fourth side 206 of the base end 206 includes two engagement slots 288 formed at the bottom side edge 262. Each engagement slot 288 includes an opening for receiving the right frame 194 ( Figure 6). The lip 300 is provided with a recess at each engagement slot for receiving and engaging a finger on the corresponding projection 250. The gap between the finger and the lower edge 252 of the projection 250 is configured to receive the lip 300 therebetween to engage the projection 250 to the engagement slot. Note that the engagement slot 288 toward the distal end of the base segment has an opening that is defined by at least three sides and is longer than the length of the corresponding projection 250 to allow axial movement of the projection out of the engagement slot. The engagement slot 288 at the proximal end of the base segment is defined by only two sides, with no third side to constrain the corresponding projection.

[0435] The first side 200 of the base portion 190a is provided with an opening 210 and two receiving slots 290 as previously described for mating 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 on the inner surface 304 of the first side 200, while the more proximal receiving slot 290 has a recess formed on the outer surface of the first side 200. This arrangement allows the wall structure 306 of the first side 200 to span or straddle between the ribs 260 and protrusions 268, as shown in the figure. Figure 6 shown.

[0436] Like the right frame 194, the base portion 190a is provided with a channel 244 for interacting with a flange on a needle hub. When the left frame 193 is attached to the right frame 194 and the catheter hub is located therebetween, the barrier wall 308 at the distal end of the channel 244 is provided with a shaped profile 310 for accommodating the catheter hub.

[0437] Fig.12 is a perspective view showing the left frame 193 at the base portion 190a, similar to Fig.11 perspective, but from a different angle of view.

[0438] Fig.13 188a and the left frame 193 and the nose portion 184a. Fig. 9 In this embodiment, the receiving slot 290 on the nose portion 184a is more clearly shown for connecting to the upper protrusion 268 ( Figure 7 ).

[0439] Fig.14 1 is a perspective view showing the left frame 193 separated from the right frame 194 and having the catheter assembly 108 secured to the left frame 193 to illustrate how the catheter assembly 108 is positioned within the shaped contour of the left frame, similar to reference Figure 5 As discussed, but with the left frame substituted for the right frame 194.

[0440] Reference again Figure 1 , 5 and 14, and in use, the ExD catheter assembly 100 is advanced against the patient to a selected catheter location, such as a deep vein or a superficial vein. The user can puncture the target vein under guidance from a visualization machine (such as an ultrasound monitor with an ultrasound probe). Initial blood reflux can be observed to flow into the needle hub 122. Next, the insertion angle of the ExD catheter assembly 100 is lowered before further advancing the ExD catheter assembly 100 to position the catheter deeper into the vein. In some examples, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a guidewire dispenser having a housing The guidewire dispenser can be placed into the proximal opening of the catheter hub after removing the vent plug 124 and the guidewire protruding through the needle lumen, and advanced in a manner known in the industry. The guidewire can be used to guide the catheter to the desired treatment location in the body. In some examples, the guidewire dispenser can be installed to the ExD catheter assembly before the initial needle insertion, and the assembly does not have a removable vent plug 124.

[0441] The needle and catheter tube are advanced over the guidewire and stop when or just before the nose tip 184 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 physician can then place his or her thumb on the first or top bar 214 and place the index finger against the bottom bar ( Figure 3 ) to replace the housing 102 ( Figure 1 ) into two or more housing components, such as separating the left frame 193 from the right frame 194, as described above. Once the housing 102 is divided into smaller components, the catheter assembly 108 is separated from the housing. Figure 2 As described, the user may then retract the needle 122 and the needle hub 122 from the catheter hub.

[0442] With respect to the ExD catheter assemblies and components thereof disclosed hereinafter, it should be understood that where features are shown but not explicitly described, and are otherwise the same or similar to one or more features described elsewhere, such as those described above with reference to Figure 1-14As described, one or more portions of the disclosure that are shown in all figures but are not explicitly described due to redundancy and because the knowledge is built on the foundation laid by the previous disclosure can still be understood to be described or taught by the same or similar features explicitly set forth in the text of the embodiment describing the one or more features. In other words, the subsequent disclosure of the present application is based on the previous disclosure, unless the context indicates otherwise. Therefore, the present disclosure is understood to teach the disclosed embodiments and features of the disclosed embodiments to those of ordinary skill in the art without having to repeat similar components and features in all embodiments, because those skilled in the art will not ignore similar structural features that have just been read in the previous paragraphs, nor will they ignore the knowledge gained from the previous description set forth in the same specification. Therefore, unless the context indicates otherwise, the same or similar features shown in the following ExD catheter assembly are combined with the teachings of the previous embodiments. Therefore, it is expected that the embodiments disclosed later will enjoy the benefits of the previously explicitly described embodiments, such as the features and structures of the previously described embodiments, unless the context indicates otherwise.

[0443] Reference now Fig.15 , shows an extended indwelling catheter assembly 100 provided according to another aspect of the present invention. The ExD catheter assembly 100 of the present invention is Figure 1-14 The ExD catheter assemblies of the present invention share similar aspects, and in particular, a similar housing 102 construction, wherein a first frame or left frame 193 and a second frame 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 leading to the interior space 104. A catheter assembly 108 is positioned in the interior space 104. The catheter assembly 108 can be similar to the catheter assembly 108 described elsewhere herein, such as reference 108. Figure 2 , and has a needle guard device and a needle hub 122 located inside the catheter hub 130, and the needle hub 122 has a vent plug 124 protruding proximally from the end surface 126a of the housing 102.

[0444] 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 distal opening 342 of the housing at the nose end 184. Optionally, after removing the vent plug 124, a guidewire dispenser (such as A guidewire dispenser) can be connected to the proximal opening of the needle hub.

[0445] Each of the two first and second frames 193, 194 includes a wall structure 230 including a lower wall section 230a ( Fig.16), upper wall section 230b and side wall section 230c. A plurality of protrusions or decorations 220 are provided on the outer surface of the side wall section 230, which can be embodied as protrusions of circular, elongated, polygonal or irregular shapes. The protrusions 220 can be spaced apart from each other and are provided on the two side walls 230c of the housing for aesthetics and convenience in holding the housing 102.

[0446] A plurality of side walls are disposed at the base end 190 of the housing proximal end 126, including a first or left side wall 200, a second or right side wall 202 ( Fig.19 ), a third or top side wall 204 and a fourth or bottom side wall 206 opposite the third side wall ( Fig.16 ). The sidewalls at the base end 190 define a generally square or rectangular shaped cross-sectional structure having a hollow interior for accommodating the catheter assembly 108. In other examples, the sidewalls may define different shapes, such as oval or circular. The seam 232 passes through both the top sidewall 204 and the bottom sidewall 206 and through the nose end 184 of the housing 102.

[0447] The first side wall 200 and the second side wall 202 ( Fig.19 ) defines the width of the housing at the base end 190. In one example, the width at 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 at 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 from their respective outer or inner surfaces (measured as the distance between the two side wall segments 230c of the first and second frames) can be approximately constant in the distal direction until the beginning of the activation area or region 320 of the body, where the body widens in the distal direction to a maximum width at the distal end 322 of the body. From there, the width rapidly decreases to a peak or apex 324 where the distal opening 342 is located. As discussed further below, the activation area 320 of the body 188 widens 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. The activation ramp 328 is sized and shaped to interact with the catheter hub 130 to enable the housing 102 to separate into two or more housing components.

[0448] Fig.16 Shown from different perspectives Fig.15 100. The two lower wall sections 230a on the first frame 193 and the right frame 194 can be seen. A cutout 330 for receiving the flange extension 160 of the needle hub 122 is provided at the proximal end 126 of the housing 102, which is defined by a partial cutout on the bottom side 206 of the base end 190 and a partial cutout at the proximal ends of the two frames 193, 194.

[0449] The opening 334 is disposed near the distal end 120 of the housing 102, at the lower wall of the housing. The opening 334 may be elongated, may have a proximal edge 334a, may have a distal edge 334b, and may have a side edge 334c. In other examples, the opening 334 may have a different shape, as long as the shape does not interfere with the activation ramp 328 located inside the housing 102.

[0450] The seam 232 is disposed longitudinally along the housing and extends from the distal end 120 to the proximal end 126 and is discontinuous at the rear opening 330 and the front opening 334. At the distal edge 334b ​​of the front opening 334, an end cap member or door 340 is disposed at the distal end of each of the left frame 193 and the right frame 194. Thus, the housing has two doors or end cap members 340. With specific reference to the end cap member 340 of the second frame 194, the discussion of which is equally applicable to the end cap member of the first frame 193, the end cap member 340 has a lower section or side wall 340a, a top section or side wall 340b ( Fig.17 ) and side segments 340c. In one example, the side segments 340c have a semicircular-like cutout 342a such that the two side segments 340c with two cutouts 342a from two adjacent end cap components 340 form a through-channel or opening 342 to accommodate the needle 112 and the catheter tube 110. The through-channel 342 formed by the two cutouts 342a provides support and guidance for the needle and catheter to enable intravenous puncture of an extended length IV catheter with or without a guidewire, as well as puncture of a short midline catheter of approximately 8-10 cm in length without an integrated guidewire.

[0451] Continue to refer Fig.16 and 17 , the 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 the upper section or top section 340b of the end cap component is separated from the upper wall 230b of the housing wall by a gap 344. Therefore, each end cap component 340 is attached to the remaining portion of the corresponding left frame 193 and right frame 194 by a material strip or layer 346 having a certain thickness. In one example, the material strip 346 can have the same thickness as the wall thickness of the side segment 230c and the front segment 340c. In other examples, the material strip 346 can include a notch 348 to thin the thickness of the material strip 346 so that it is thinner than the thickness of the side segment 230c and the front segment 340c.

[0452] In one example, the strip of material 346 ( Fig.15) and the strip of material 346 connecting the right end cap component 340 to the right frame 194 can act as a hinge, such as a living hinge. Thus, the housing 102 of this embodiment has two doors or end cap components 340, each of which can be pivoted or rotated by a living hinge 346. The living hinge allows the end cap component or door 340 and the corresponding frame (i.e., the front end wall 347) to which it is attached to pivot, rotate, or swing relative to each other. For example, if the first and second frames 193, 194 are separated from each other starting from the proximal end 126, when the assembly is activated due to the catheter hub 130 pushing against the one or more activation ramps 328, as further discussed below, the first and second frames can swing outward away from each other and pivot about their corresponding strips of material or living hinges 346. When the two frames pivot about the two living hinges 346, the two end cap components 340 can remain attached to each other until they are also separated to release the catheter hub 130 from the two frames, as further discussed below. In other examples, as described below, the two frames remain attached as the two end cap components 340 pivot or rotate about the two living hinges 346 , similar to opening a double door to provide access to an opening at the distal end of the housing 102 .

[0453] Reference now Fig.17 , Fig.15 The ExD catheter assembly of FIG. 1 is shown without the first frame 193 so that the interior space 104 of the now separated housing 102 is more clearly shown. The second frame 194 is shown having a joining edge 350, wherein the seam 232 is formed together 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 grooves, protrusions and / or detents 354 can be used for removable fixation of the two frames, as further discussed below. The right frame 194 is shown having a cutout 334m at the bottom or underside of the housing 102, the cutout 334m forming Fig.16 A portion of opening 334 is shown.

[0454] In this figure, the catheter assembly 108 is shown as being located in the interior space 104 of the housing 102, the housing 102 having the needle and catheter passing through the cutout 342, and the catheter hub 130 or at least the push tab 176 of the catheter hub positioned distally of the base end 190. The needle hub 122 and the vent plug 124 protrude from the proximal opening 101 of the housing 102, with the flange 161 of the needle hub 122 engaging the housing 102, as described below with reference to Fig.18A and 18B Further discussion.

[0455] Reference now Fig.18A and 18B , respectively showing Fig.17194 and a further enlarged view of the catheter assembly located inside the right frame 194. As shown, the flange 161 extending from the needle hub 122 has a generally square or rectangular profile, and the flange 161 is arranged so that the plane defined by the flange is generally orthogonal to the longitudinal axis ( Fig.15 and 16 The portion of flange 161 that protrudes outward from the outer contour of needle hub 122 engages groove 358 ( Fig.18B ), the groove 358 is formed with multiple sides of the base end 190, such as the first side 200, the second side 202, the third side 204, and the fourth side 206. The groove 358 can be a recessed channel formed into the wall thickness of multiple sides of the base end. In addition to the cutout 330 ( Fig.16 ) is disposed at the fourth side 206 for receiving the flange extension 160 of the needle hub 122, the groove 358 can be formed continuously across both sides. The groove 358 can be configured to receive, accommodate or accommodate the flange 161 on the needle hub, including where the flange transitions between various sides, such as the intersection of the sides of the flange 161.

[0456] In the ready-to-use position, in which the ExD catheter assembly 100 is ready for performing a venipuncture, the needle hub 122 can remain stationary without axial movement by restraining the flange extension 160 of the needle hub at the cutouts 330 of the two bottom wall structures 330 from moving distally via the bottom housing edge 330a. To limit the needle hub 122 from moving in the proximal direction, a flange 161 extending from the exterior of the needle hub 122 is positioned against the proximal lip of the groove 358 of the base end 190. In addition, the non-circular structure for coupling the flange 161 and the groove 358 (such as by using a multi-faceted structure) prevents the needle hub from rotating when located within the space defined by the sides of the base end 190. This in turn holds the needle hub in the assembled position so that the needle bevel can be oriented in the desired position upon assembly without premature rotation prior to performing a venipuncture.

[0457] Continue to refer Fig.18A and 18B , and especially Fig.18B , the external threads 154 of the catheter hub 130 include grooves 362 for receiving protrusions 364 protruding from the inner surface of the top side 204 of the base end 190. In other examples, the arrangement can be reversed, and the top side 204 can incorporate the grooves, and the catheter hub can incorporate the protrusions. In other examples, detents can be provided at other locations between the catheter hub and the housing along their respective structures to engage the two. This 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 when engaged to the housing.

[0458] The catheter hub 130 is configured to slide axially in the distal direction after the needle and catheter hub are successfully placed in the patient's vein while the needle hub remains engaged to the base end 190 of the housing. In one example, the external threads 154 are configured to ride on or slide on the inner surfaces of the two lower walls 230a of the housing 102. For example, and with further reference to Fig.15 , the user can push the push protrusion 176 to advance the needle hub 130 in the distal direction. The push protrusion 176 shown is located between the two upper wall sections 230b of the two frames 193, 194. As shown, the upper edge of the push protrusion 176 protrudes above the outer surface of the two upper wall sections 230b to present itself for contact and pushing by the doctor. In some examples, the push protrusion 176 can be configured so that the upper edge of the push protrusion protrudes further upward from the two upper wall sections 230b to present itself as a larger target for being pushed by the physician. As further discussed below, when the doctor pushes the push protrusion 176 in the distal direction after placing the catheter in the vein, and optionally after advancing the guidewire into the vein to guide the catheter tube, the body of the catheter hub 130 abuts against one or more activation ramps 328 on each of the left frame 193, the right frame 194, or the two frames 193, 184 to separate the two frames from the proximal end 126 of the housing 102. Pushing projection 176 can be molded with enough length or height to extend above the housing so as to be pushed by a doctor. Optionally, a projection extender can be snapped onto a standard pushing projection to increase the height of the pushing projection for the doctor to push, as discussed further below.

[0459] Fig.19 1 is a perspective view of the right or second frame 194, shown without the left frame 193 and the 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 side and the bottom side are relatively shorter in length than the second side 202. The top side 204 and the bottom side 206 of the right frame 194 can be referred to as partial sides because similar top side segments and bottom side segments are carried by the first or left frame 193 so that when two partial top segments are joined at their respective joining edges 350 and two partial bottom segments are joined at their respective joining edges 350, they form the top side 204 and the bottom side 206 of the base end 190 ( Fig.16 ).

[0460] As shown, part of the top side section 204 is combined with a groove 368 at the joint edge 350, and part of the bottom side section 206 is combined with a groove 368. The groove can be a generally rectangular shape with sharp corners or rounded corners, but can also be embodied as a circular shape, a square shape, a star shape, an oval shape, a polygonal shape or an irregular shape alternatively. The groove 368 on the part of the top side section 204 and the groove 368 on the part of the bottom side 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 grooves 368 are roughly positioned along the proximal ends of the two joint edges 350.

[0461] The body portion 188a is located distally of the base portion 190a, which has a wall 230 having a top wall section 230b, a bottom wall or lower wall section 230a, and a side wall section 230c, as previously discussed. In one example, similar to the groove 368 at the base portion 190a, two grooves 370 are provided at the joining edge 350 of the lower wall structure or section 230a. The two grooves 370 can have the same shape as the two grooves 368 on the base portion 190a, or can be different. In one example, one of the two grooves 370 on the lower wall section 230a can be located at the housing edge 330a (proximate to the bottom cutout 330) Fig.18B ), and the second groove 370 can be located at its far side. In other examples, there can be only one groove or more than two grooves on the lower wall segment 230a, and they can be located elsewhere along the connecting edge 350.

[0462] Continue to refer Fig.19 , in the activation area 320 ( Fig.15 ) place, activation ramp 328 is located on the inner surface 374 of the side wall section 230c of the shell wall 230, closer to the distal end 120 than the proximal end 126.Activation ramp 328 has a proximal ramp section 328a, a distal ramp section 328b and a central ramp section 328c located between the proximal and distal ramp sections.In one example, the proximal ramp section 328a comprises an inclined plane increased from the inner surface 374 of the right frame 194, which can be regarded as a structure with a surface extending radially away from the inner surface.When assembled with the left frame 193 and the assembled shell with the catheter assembly therein, the proximal ramp section 328a extends away from the inner surface toward the needle, or extends toward the longitudinal axis passing through the shell. The longitudinal axis through the housing can be considered a reference line, and the proximal ramp segment 328 can be understood as having a surface farthest from the reference line and gradually moving closer to the reference line as the ramp approaches the central ramp segment 328c.

[0463] The central ramp portion 328c has a surface that is closer to the reference line than the proximal ramp segment 328a and may include a substantially flat area or a surface area having a large radius.

[0464] In one example, the distal ramp segment 328b includes a slope that decreases from the central ramp segment 328c, which has a surface that is away from the reference line. If the proximal ramp segment 328a has a positive slope, then the distal ramp segment 328b has a negative slope. Therefore, Figure 8 The activation ramp 328 shown in can be considered as an inclined structure, which increases to a peak or crest 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 other examples, the distal ramp portion 328b can have a positive slope that continues to extend toward the reference line. Preferably, the distal ramp portion 328c has a negative slope.

[0465] When the left frame 193 and the right frame 194 are assembled together to form the housing 102, if two activation ramps are combined, the gap between two adjacent activation ramps 328 may be referred to as an activation gap 400 ( Fig.28 ), or if only one activation ramp is incorporated, the gap between two adjacent activation ramps 328 and the inner surface 374 of the adjacent frame can vary. The activation gap can narrow as it extends from the proximal ramp portion 328a to a narrower point at the central ramp portion 328c, or from the two proximal ramp portions to a narrower point at the two central ramp portions. As discussed further below, the activation gap 400 can be incorporated as a catheter hub 130 ( Figure 2 ) can abut against the propelling device to impart a pair of component forces, thereby then separating the housing 102 into two or more housing components.

[0466] Further references Fig.19 , the end cap component 340 of the second or right frame 194 is provided with a recess 378. The recess 378 can have three sides and an open fourth side. Optionally, the recess 378 can be embodied as a four-sided groove, similar to one of the grooves 368, 370 of the main body section or the base section. The size and shape of the recess 378 at the end cap component 340 can be configured to receive a corresponding protrusion on an adjacent end cap component in an interference fit or snap fit arrangement. In some examples, the positions of the recess 378 and the protrusion for coupling with the recess can be reversed so that the recess can be located on the end cap component of the first or left frame 193.

[0467] Fig. 20 and 21 is a different perspective view of the right frame 194 showing various details.

[0468] Fig. 22 328 . It is another perspective view of the right frame or second frame 194. In the view shown, the activation ramp 328 is implemented as two separate activation ramp sections 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 sections 328x, 328y can operate or function as described above. A gap or void 380 is provided at the distal ramp sections of the two ramp sections 328x, 328y, formed by the negative slope of the two distal ramp sections. A small gap is located between the two ramp sections 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 can be substantially flat, or can have a large radius to form a slight bend for accommodating the catheter hub profile.

[0469] As can be seen, 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 the two separate activation ramp sections 328x, 328y, the nose section ( Figure 2 ) initially abuts the two proximal ramp segments 328a of the two separate activation ramp segments 328x, 328y, and then moves into the gap or void 380 as the nose segment continues to move in the distal direction. Then, the middle portion of the catheter hub, which has a larger diameter or size than the nose segment of the catheter hub, moves over the two proximal ramp segments 328a to further expand 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 the engagement at the two end cap components 340 at the distal end of the housing. If complete separation is not complete proximal to the two end cap components, further movement of the external threads 154 of the catheter hub 130 against the two proximal ramp portions 328a further expands the two frames 193, 194 away from each other, such that the protrusions and grooves of the two frames are completely separated from each other except for the engagement at the two end cap components 340. Finally, the recess 378 and the protrusion 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, such as connected to a drip line, and taped to the patient.

[0470] In one example, the recess 378 at the end cap component 340 has two side walls 340a, 340b, a bottom wall 340c and a center wall 340d. In one example, the two side walls 340a, 340b each include a surface, and wherein the two surfaces of the two side walls taper or converge in the direction of the bottom wall 340c. Thus, the surface shape of the center wall 340d is a trapezoid. The recess 378 is thus 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 the corresponding protrusion on the end cap component 340 of the first frame 193 to engage the recess 378, and the engagement is easily separated, so as to facilitate the separation of the two frames 193, 194 at the two end cap components, thereby separating the catheter hub from the housing of the ExD catheter assembly.

[0471] Fig.23 yes Fig. 22 A perspective view of the second frame 194 is shown from an opposite angle to show the outer surface 374a of the right frame. As shown, the outer surface is provided with a plurality of spaced protrusions or decorations 220, similar to Fig.15 In one example, the two different sets of protrusions 220 for the two frames can be the same and can have the same spacing. In other examples, the protrusions can have different shapes and / or different spacings between two adjacent protrusions.

[0472] Fig.24 yes Fig.15 1 is a side view of an ExD catheter assembly 100 in which the catheter assembly 108 is installed with the first or left frame 193 and in which the second frame 194 has been removed to more clearly illustrate the arrangement, similar to Fig.17 The arrangement is similar to that of FIG. 1 , but the second frame 194 is replaced by the first frame 193. This combination is different from the previous combination (such as Fig.17 ), except that in the present combination, a protrusion or male detent 392 is provided on the third side 204 of the base portion 190a at the joining edge 350 and on the fourth side 206 of the base portion 190a at the joining edge 350 to engage the two grooves 368 ( Fig.19 A protrusion or male detent 394 is also provided at the connecting edge 350 on the lower wall structure or section 230a for engaging the two grooves 370 ( Fig.19 ). Optionally, the two frames 193, 194 can be attached to each other along the adjacent seams via welding or adhesive. If welding or adhesive is used, the upper and lower seams at the distal end of the housing are attached to each other via detents so that the detents can be disengaged to open the distal door opening, which then enables the catheter hub to be separated from the housing, as discussed further below.

[0473] Fig.25 yes Fig.24 108. A perspective view of the first frame 193 is shown without the catheter assembly 108. A protrusion or male detent 392 on the base portion 190a and a protrusion or male detent 394 on the lower wall structure or section 230a are shown. Also shown are two activation ramp sections 328x, 328y located on the side wall structure or section 230c of the frame, which are similar in shape and function to those described above with reference to Fig. 22 Two activation ramp segments 328x, 328y are discussed. 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.

[0474] A protrusion or male detent 398 is provided at the connecting edge 350 of the end cap part 340 of the first frame 193. When the left frame and the right frame are assembled to form Fig.15 When the housing is assembled, the protrusion 398 is located on the end cap component 340 and is matingly engaged with the groove on the right frame 194. The protrusion 398 is sized and shaped to engage the recess 378 on the end cap component 340 of the second frame 194. In one example, the engagement between the protrusion 398 and the recess 378 is a slight interference.

[0475] In one example, the engagement between the protrusions or male detents 398 and the recesses 378 at the two end cap components 340 provides a stronger grip or engagement retention force than the engagement between the protrusions 392 on the base portion 190a and the protrusions 394 on the lower wall structure 230a engaging the corresponding grooves 368, 370 on the second frame 194. The relative engagement forces between the pairs of engaging protrusions and grooves ensure that when the catheter hub 130 is advanced in the distal direction within the interior space 104 of the housing after initial catheter tube placement, and after the guidewire is advanced when engaged, the housing will separate first at the proximal end of the housing and then at the two end cap components 340 when the ramps are activated against the contact by the catheter hub. In other examples, each pair of protrusions and grooves opens substantially simultaneously when the ramps are activated against the contact by the catheter hub.

[0476] Fig.26 Observed from different perspectives Fig.25193 of the first frame 190a. In the orientation shown, the protrusion 392 on the base portion 190a is longer than the protrusion 392 on the lower wall structure 230a of the body section. The protrusion on the base portion 190a is also longer than the protrusion 398 on the end cap component 340. When the two housing frames 193, 194 are coupled to form the housing 102, the various protrusions of different lengths match or engage with the grooves having different and corresponding depths to engage, thereby ensuring a substantially tight seam 232 ( Fig.16 ). In some examples, each of the left and right frames may have both slots and protrusions to mate with corresponding protrusions and slots, rather than having an arrangement where all slots are in one frame and all protrusions are in the other frame.

[0477] Fig. 27 1 is a perspective view of the first frame 193, shown from an opposite perspective to show the outer surface 374a of the first frame. As shown, the outer surface 374a is provided with a plurality of spaced protrusions or decorations 220, similar to those shown in the second frame. In one example, the two different sets of protrusions 220 for the two frames can be the same and can have the same spacing. In other examples, the protrusions can have different shapes and / or different spacings between two adjacent protrusions.

[0478] Reference again Figure 15-17 , 24 and 28 to discuss the ExD catheter assembly 100 that is about to be put into use. A user can use the ExD catheter assembly to puncture a target vein under guidance from a visualization device (such as an ultrasound monitor using an ultrasound probe). Initial blood flashback into the needle hub 122 can be observed. Next, the insertion angle of the ExD catheter assembly 100 is lowered before further advancing the ExD catheter assembly 100 to position the catheter tube deeper into the vein. In some examples, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a guidewire dispenser having a housing The guidewire dispenser can be placed into the proximal opening of the catheter hub after removing the vent plug 124 and the guidewire protruding through the needle lumen, and advanced in a manner known in the industry.The guidewire can be used to guide the catheter tube to the desired treatment location in the body.

[0479] The needle and catheter tube are advanced over the guidewire and stop when or just before the nose 184 of the housing 102 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 physician can then place his or her thumb on the push tab 176 of the catheter hub 130 to advance the catheter hub against one or more activation ramps 328 on one or both of the first and second housing frames 193, 194.

[0480] Further references Fig.28 Schematic diagram of ExD catheter assembly 100, when the catheter hub 130 is pushed in the distal direction until the nose end of the catheter hub pushes against the two activation ramps 328, a pair of component forces are generated on each of the two frames 193, 194. This causes the two frames to begin to separate from the base end of the housing. As the catheter hub continues to move in the distal direction, the two frames separate further until the protrusions and grooves on the base end and the body are completely separated from each other. At this time, as the protrusions 398 ( Fig.26 ) and recess 378 ( Fig.19 ) continue to engage, the two frames pivoting at their respective living hinges 346. The user can then use a free hand, while maintaining a grip on the catheter hub, to pull one of the two frames 193, 194, thereby separating them at their respective end cap components 340. The catheter hub 130 and the housing 102 are then separated from each other. The user can then complete preparation of the catheter hub, such as connecting a drip line to the catheter hub and taping it to the patient to secure the puncture site.

[0481] Reference again Figure 15-27 The ExD catheter assembly 100, and in particular with reference to Fig.15 , 17 , 22 and 26, alternative embodiments of the device or assembly are contemplated. In alternative embodiments, the left frame and the right frame, or the first and second frames 193, 194 are fixed together, wherein the protrusions or male detents 392, 394, 398 engage corresponding grooves or female detents 354, 378. In this embodiment, the engagement between the protrusions or male detents 392, 394 and the grooves or female detents 354 at the body 188 and the base portion 190 is such that they do not separate when the catheter hub 130 is advanced in the distal direction within the housing 102. For example, the engagement between the protrusions and the grooves can be achieved by interference and / or with an adhesive, bonding or welding. In addition, the activation ramp 328 ( Fig.28 ) can be omitted from the first and second frames 193, 194 so that the advancing catheter hub does not generate radial forces to separate the two housing frames. Therefore, when the catheter hub 130 is advanced distally to further place the catheter into the vein, the catheter hub can reach the gap 380 space ( Fig. 22 ), without imparting any radial force on the two frames to separate them. Instead, the distal abutment of the catheter hub 130 against the distal door opens the distal door opening, then allows the catheter hub 130 to separate from the housing 102.

[0482] Now specific reference Fig. 22 and 26, the protrusions 398 at the end cap component 340 of the first frame 193 engage the recesses 378 on the second frame 194 in a frictional, loose or releasable engagement. That is, when the catheter hub 130 being advanced is pushed distally, the male detents or protrusions 398 on the first frame 193 can be released or separated from the recesses 378 on the second frame 194. Fig. 22 In the detailed view of FIG. 1 , the recess 378 is shown as having an open slot or recess. This structure allows the protrusions and recesses at the two end cap components 340 of the left frame 193 and the right frame 194 to separate by allowing the protrusions 398 to pass through the side openings without side walls of the recesses rather than the openings near the connecting edge 350. Therefore, separation at the two end components 340 can be achieved by simply providing an axial force when the catheter hub 130 is pushed against the two end cap components in the distal direction, without having to generate a force as described in reference to FIG. Fig.28 The radial force in question.

[0483] Thus, after cannulation, optionally after guidewire placement and after catheter insertion, as previously described in Figure 15-28 As described in the first embodiment of the ExD catheter assembly 100, the catheter hub 130 can be pushed against the proximally facing surfaces 340Z of the two end cap components 340 of the left and right frames ( Fig. 22 and 26 ). The thrust of the catheter hub 130 forces the protrusion 398 to separate from the recess 378. The open side between the two side walls 340a, 340b of the recess at the end cap component 340 of the second or right frame 194 facilitates this separation ( Fig. 22 ). That is, the protrusion 398 on the first or left frame 193 can simply slide out through the gap provided by the missing side of the recess 378 between the two side walls 340a, 340b.

[0484] Reference now Fig.15 and 16 , as the protrusions 398 and female pawls 378 at the two end members 340 separate, and the two frames are formed by the protrusions 392, 394 and grooves 354 ( Fig. 22 and 26) remain fixed, the two end parts 340 are forced to swing in the distal direction around the two movable hinges 346. In one example, the space or distance between the two movable hinges 346 is greater than the horizontal dimension or cross-sectional dimension of the catheter hub 130. Therefore, when the two end cover parts 340 swing in the distal direction around the two movable hinges, a door with a gap (the gap is called a door opening or a distal door opening, which is defined by the space provided by the end parts swinging distally) opens to provide a gap for the catheter hub 130 to pass through. The swinging end cover parts 340 can be referred to as a door that can be swung open to open the distal door opening. In practice, this allows the catheter hub 130 to be separated from the needle hub 122 and the housing 102 through the door opening or the distal door opening to separate from the needle 112, the needle hub 122, the housing 102, and the guidewire and the guidewire dispenser (if used). The catheter hub can then be fixed to the patient for fluid administration. Needle 112, needle hub 122, housing 102, and guidewire and guidewire dispenser (if used) may be discarded or disposed of in accordance with approved protocols.

[0485] Therefore, one aspect of the present invention is understood to include an ExD catheter assembly, which includes a multi-part housing having an interior space with a catheter assembly located 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 from the distal opening of the catheter tube. The needle and catheter tube protrude through the opening at the distal end of the housing. The distal end may include two end cap components that are removably attached to each other, such as by engaging a male pawl and a female pawl. The female pawl can be a recess having three sidewalls and having at least one open side and an open entrance to the recess.

[0486] The multi-part housing may include a first frame attached to a second frame. There may be a seam between the two frames. The two frames may be attached along a joining edge. One of the two frames may include a protrusion or a male detent, and the other frame may include a corresponding groove or a female detent for receiving the male detent to removably fix the two frames together. The distal end of the housing may include a seam. The opening at the distal end with a needle and a catheter tube protruding therein may be formed by two cutouts. The distal end of the housing may include a living hinge. Preferably, there are two living hinges at the distal end of the housing. The door with a gap may be defined by the distance between the two living hinges. When the protrusion and the female detent with at least one open side are separated from each other, the two end cap components may be swung distally around the two living hinges to open the door opening or the distal door opening at the distal end of the housing. The catheter hub may leave the door opening or the distal door opening and be separated from the remaining components of the ExD catheter assembly, which may include a needle, a needle hub, a housing, a guidewire, and a guidewire dispenser (if used).

[0487] Reference now Fig.29 , showing a partial perspective view of an ExD catheter assembly 100 including a housing 102 and a catheter assembly 108. The ExD catheter assembly 100 may be similar to one of the ExD catheter assemblies disclosed elsewhere herein, such as Figure 15-16 The ExD catheter assembly of this embodiment is shown as having a tab extender or tab adapter 404 attached to the catheter hub 130 and extending through the housing opening 196 orthogonally to the longitudinal axis of the housing so that the upper portion of the tab adapter 404 rises above the top wall structure 230b of the housing to present a surface for the physician to push or grasp. In one example, the tab adapter 404 is configured to extend the integrally formed push tab 176 ( Figure 2 ) extends above the top wall structure 230b to facilitate the operation of the ExD catheter assembly. Alternatively, the push protrusion 176 can be formed as an extended structure and extend above the top wall structure 230b of the housing to present itself to be pushed by the physician without the need for a separately formed protrusion adapter 404.

[0488] Fig.30 The nose adapter 404 is shown spaced apart from the catheter hub 130, and Fig.31 A cross-sectional side view of the nose adapter 404 is shown. Figure 29-31 , and continue to refer to Fig.29 , the protrusion adapter 404 can be formed of a plastic material, such as by plastic injection molding. The protrusion adapter 404 can include a body 406 having a first end 408 and a second end 410. The first end 408 can be located above the second end 410 in terms of height. In one example, the body 406 can be formed as a solid structure above the imaginary line 412 and have a tunnel or channel 414 below the imaginary line 412, the tunnel or channel 414 having an arcuate first opening 420 and an arcuate second opening 422 communicating with each other via the channel 414. In an alternative embodiment, the body 406 is hollow and is formed with a wall structure having an outer surface 426 and an inner surface 428 defining an interior space or cavity 429. The wall thickness between the outer surface 426 and the inner surface 428 has a sufficient thickness to provide structural rigidity for carrying a digital load applied by a user to advance the catheter hub 130.

[0489] The tab adapter 404 is sized and shaped to be mounted on the catheter hub 130. In one example, the tab adapter 404 is configured to be seated on the catheter hub 130 and the hub body located in 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 tightly around the curved body of the catheter hub 130. Depending on how the tab adapter 404 is located on the catheter hub 130, such as by placement or positioning 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 fit the specific shape of the catheter hub. In one example, as shown in FIG. Fig.30 As shown, the first opening 420 and the second opening 422 can have a hemispherical shape, a semi-oval or elliptical shape, or an arcuate shape. Preferably, the size and shape of the two openings 420, 422 are set to fit tightly on the catheter hub body and have a grip around the hub body. The two openings can have different shapes from each other and can be selected based on the size and shape of the catheter hub body.

[0490] When installed on the catheter hub 130, the protrusion 176 ( Fig.30 ) is configured to fit within the interior space 429 of the body 406. When digital pressure is applied to the body 406, in order to secure against slipping, sliding or movement relative to the catheter hub 130, two gripping bars 432 are provided at the second end 410 of the body 406 on either side of each of the two openings 420, 422. The gripping bars 432 may be similar to ribs and may be provided with a surface having a certain profile to fit tightly against the catheter hub. The position of the gripping bars 432 on the body of the protrusion adapter 404 relative to the upper portion of the two openings 420, 422 should be positioned so that when mounted to the catheter hub, the two gripping bars 432 are located below the centerline of the catheter hub body. The size and shape of the first and second openings 420, 422 and the position of the two gripping bars 432 enable the protrusion adapter 404 to fit tightly and grip the catheter hub body. The adapter 404 can be used by sliding the channel and the two openings on the catheter hub body and ensuring that the push protrusion on the catheter hub is located within the interior of the protrusion adapter.

[0491] The push protrusion 176 of the catheter hub 130 may contact the inner surface 428 on the proximal side of the body 406. Therefore, when the physician pushes the protrusion adapter 404 in the distal direction, the inner surface 428 of the protrusion adapter 404 pushes against the proximal-facing surface of the push protrusion 176 to push the push protrusion 176 in the distal direction and thus push the catheter hub 130. In one example, the inner space 429 of the protrusion adapter 404 is provided with a socket that receives the push protrusion 176 in a size-to-size fit or slight interference manner to prevent separation from the catheter hub body when the catheter hub is pushed distally.

[0492] Reference now Fig.32 , shows an extended indwelling catheter assembly 100 according to another aspect of the present invention. The ExD catheter assembly 100 of the present invention is Figure 1-14 and Figure 15-28 The catheter assembly of the present invention shares similar aspects, and in particular, a similar housing 102 configuration, wherein a first frame or left frame 193 and a second frame or right frame 194 are attached to form the housing 102, and can be separated to release the 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 the seam by corresponding protrusions or male detents and engagement grooves. Optionally, the first and second frames 193, 194 can be attached to each other along the upper and lower seams via adhesives or welding. In contrast, the catheter hub 130 of the catheter assembly 108 can be separated from the housing 102 by combining a door assembly at the distal end of the housing 102, which opens to allow the catheter hub to be separated.

[0493] As shown, the ExD catheter assembly 100 includes a removable protective cover 500 configured to be placed over the needle to cover the needle and needle tip between uses. The proximal opening of the protective cover 500 can frictionally engage the nose section or nose tip 184 of the housing 102.

[0494] Similar to Figure 29-31 The nose extender, nose adapter or nose extender 404 can be positioned on the catheter hub 130 and secured thereto by a fitting. The needle hub 122 extends proximally of the base end 190 and is exterior to the housing 102. Attached to the needle hub 122 is a vent plug 124 which can allow air to escape but capture any blood that may flow inside the needle hub and vent plug.

[0495] Fig.33 yes Fig.32500. The housing 102 is shown having a nose or nose section 184 having a tip 186 at the end of two nose sections 184a with an upper seam 276 extending therebetween. The upper seam 276 extends through an upper portion of the nose 184. A similar corresponding lower seam extends through a lower portion of the nose 184. Similar to Fig.15 and 16 Each nose portion 184a is connected to the end cover member 340 of each corresponding first or second frame 193, 194. Each nose portion 184a and each end cover member 340 can be referred to as a door or a rotatable door 339 ( Fig.36 ). The two doors 339 from the two end cap components 340 are part of the door assembly 600. The two doors 339 can be swung open to allow the catheter hub 130 to be separated from the housing 102 without requiring the first frame 193 and the second frame 194 to be separated from each other.

[0496] Fig.34 yes Fig.33 A bottom view of the ExD catheter assembly 100 is similar to Fig.16 In the present embodiment, each of the two first and second frames 193, 194 includes a wall structure 230, which includes a lower wall section, an upper wall section and a side wall section. A plurality of protrusions or decorations are provided on the outer surface of the side wall section, which can be specifically implemented as protrusions of circular, elongated, polygonal or irregular shapes. The protrusions can be spaced apart from each other and are provided on the two side walls of the housing for the sake of aesthetics and convenience in holding the housing 102. The two housing frames have a plurality of protrusions or decorations for accommodating the catheter assembly 108 ( Fig.32 ) inside of which the catheter assembly 108 has a catheter hub.

[0497] In this embodiment, Fig.16 Unlike the opening 334 of the nose end 184, there is no combined lower elongated opening. The lower walls 230a of the two housing frames 193, 194 can be solid and can be connected to each other along the seam 232 until a gap 344 separates 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, together with the two nose portions 184a of the nose end 184, swing open about corresponding living hinges to open the distal door opening, as further discussed below. In other embodiments, the two housing frames 193, 194 are connected to each other until the longitudinal gap 506 ( Fig.34). The longitudinal gap 506 extends upward and flows or blends into the front gap 344, which allows the two end cap components 340 to swing open the distal door opening, as discussed further below. The proximal end of the longitudinal gap 506 can be used as an injection point for the plastic injection door or inlet.

[0498] Optional score lines 502 may be incorporated into the wall surface of each frame. For aesthetic purposes, score lines 502 may be straight, may have a curve, or may have both. Score lines are understood to be groove lines formed into the wall thickness of the lower wall 230a of the two frames 193, 194. In other examples, score lines may be omitted.

[0499] Fig.35 and 36 Close-up top and bottom views of the far end of the housing, showing a structure similar to Figure 15-17 The end cap component 340 and the nose portion 184a of the nose end 184. The distal gap 344, the longitudinal gap 506 and the seam 232 between the two upper side walls 340b and the lower side walls 340a of the two end cap components 340 are also shown.

[0500] Two end cap members 340 are attached to two front end walls 347 via two living hinges 346. Each of the two end cap members 340 is attached to the nose portion 184a, and the combination can be referred to as a door or rotatable door 339. Figure 15-27 In the embodiment of the present invention, the two doors 339 of the door assembly 600 can swing open when pushed in the distal direction by the distal movement of the catheter hub 130 to open the distal door opening.

[0501] Fig.37 It is a side view of the first or left frame 193 of the housing, shown with the needle and catheter tube, and without the second or right frame 194. Fig.38 is a side view of the second or right frame 194 of the housing, showing the needle and catheter tube, and without the first or left frame 193. Fig.37 and 38 184a to explain the mechanical engagement between the two at the distal end and how they separate when pushed in the distal direction by the catheter hub to open the distal door opening. As shown, each of the two nose portions 184a represents a hollow partial cylinder that, when combined, forms the generally cylindrical body of the nose or nose end 184 of the housing 102.

[0502] Front base wall 510 is arranged on the near side and the inner side of the boundary defined by the hollow part cylinder of each nose part 184a.Each front base wall 510 has an incision 512, the size and shape of which are arranged to accommodate a part of needle 112 and catheter tube 110.When the first and second frames 193, 194 are connected, two incisions 512 from two front base walls 510 form the perimeter of the defined opening, the size and shape of which are arranged to receive the circumference of the combined catheter tube, wherein the needle of the catheter assembly is located in the shell 102.In one example, the perimeter of the two incisions 512 can be referred to as a guide opening, which guides the combination when the combined needle and catheter are advanced in the distal direction during cannulation and blood vessel access.Measured along the length of the first frame and / or the second frame, the two base walls 510 can have different thicknesses.The male ratchet can protrude from the side portion of the thicker base wall 510.In other examples, the base wall 510 can have a uniform thickness.

[0503] A male detent 520 is provided on each of the first and second frames 193, 194, which male detent 520 may alternatively be a stud or a threaded post having an elongated body with rounded ends. Fig.37 As shown, the male detent 520 of the first frame 193 is located above the needle 112 and / or the catheter tube 110 in the height direction and extends generally orthogonally to the axis defined by the needle. Fig.38 As shown, the male pawl 520 of the second frame 194 is located below the needle 112 in the height direction and extends approximately orthogonal to the axis defined by the needle. The arrangement of the two male pawls 520 on the two frames 193, 194 can be reversed. In one example, the two male pawls protrude radially relative to the longitudinal axis of the needle by a sufficient amount so that the end of each male pawl extends beyond the half mark of the needle diameter and preferably beyond the edge of the needle on the opposite side from which the male pawl extends. In other examples, the male pawl 520 can extend a shorter length or distance from the corresponding side from which the male pawl extends. The length of the male pawl 520 can be selected to change the amount of engagement with the corresponding receiving groove, as discussed further below.

[0504] The first frame 193 is provided with a receiving groove 524 below the male pawl 520. Similarly, the second frame 194 is provided with a receiving groove 524 above the male pawl 520. Likewise, this arrangement can be reversed. Each receiving groove 524 includes a wall structure that is configured to frictionally engage the corresponding male pawl 520 located on the opposite frame. Therefore, the receiving groove 524 on the first frame is configured to frictionally engage the male pawl on the second frame, and the receiving groove 524 on the second frame is configured to frictionally engage the male pawl on the first frame. In one example, the receiving groove has a first wall surface 524a and a second wall surface 524b, which are configured to frictionally engage two surface sections of the male pawl to match therewith. In one example, the first wall surface 524a and the second wall surface 524b are arranged approximately orthogonally to each other. Preferably, each receiving groove 524 does not have a wall surface opposite to the second wall surface 524b, which provides a gap or missing wall for the male pawl 520 to separate from the receiving groove 524 when the catheter hub body 130 (such as the nose end of the catheter hub) abuts and pushes against the two base walls 510 in the distal direction. When pushed in this way, the two doors 339 of the door assembly 600 rotate around the two living hinges 346 ( Fig.36 ) to open the distal door opening and then allow the catheter hub 130 to be separated from the housing 102, as previously discussed. In an embodiment, each receiving groove 524 also includes a wall surface opposite to the corresponding first wall surface 524, so that each receiving groove 524 has a three-wall structure. The rigid dimensions of each receiving groove 524 and the end cap component 340 can be set to hold the corresponding male pawl 520 with a slight interference fit.

[0505] After removing the protective cover 500, the user can use Fig.32 The ExD catheter assembly 100 is inserted into the target vein under guidance from a visualization device, such as an ultrasound monitor using an ultrasound probe. Initial blood reflux into the needle hub 122 can be observed. Next, the insertion angle of the ExD catheter assembly 100 is lowered before the ExD catheter assembly 100 is further advanced to position the catheter deeper into the vein. In some examples, a guidewire dispenser having a guidewire extending through the needle lumen can be used with the ExD catheter assembly. For example, a guidewire dispenser having a housing The guidewire dispenser can be placed into the proximal opening of the catheter hub after removal of the vent plug 124 and protrusion of the guidewire through the lumen of the needle and advanced in a manner known in the art. The guidewire can be used to guide the catheter tube to the desired treatment location in the body.

[0506] Needle 112 and catheter tube 110 ( Fig.33) is advanced over the guidewire and stops when or just before the nose 184 of the housing 102 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 physician can then place his or her thumb on the nose adapter 404 that engages the catheter hub 130 to advance the catheter hub 130 against the door assembly 600.

[0507] Further references Fig.32 ExD Catheter Assembly 100 Fig.37 and 38 , when the catheter hub 130 is pushed in the distal direction so that the nose of the catheter hub 130 pushes against the two doors 339 of the two end components 340, a force directed distally is transmitted to the door assembly 600 and overcomes or exceeds the interference and / or friction force provided by the engagement between the two male pawls 520 or short posts or studs and the two receiving grooves 524. As the catheter hub continues to move in the distal direction, the two doors 339 swing in the distal direction about the living hinge 346 ( Fig.36 ). The user can continue to move the catheter hub 130 in the distal direction while applying a proximally directed force to the housing 102 or while applying a steady holding force to the housing 102 to completely move the needle hub 130 through the door opening provided by the two rotating doors 339. The catheter hub 130 and the housing 102 are then separated from each other. The user can then complete preparation of the catheter hub 130, such as connecting a drip line to the catheter hub and taping it to the patient to secure the puncture site, and optionally remove the nose adapter 404 from the catheter hub 130.

[0508] Reference now Fig.39 , shows a protrusion adapter 404 according to another aspect of the present invention, which is similar to Figure 29-31 The protrusion adapter 404 of the present embodiment can be formed of a plastic material, such as by plastic injection molding. The protrusion adapter 404 can include a body 406 having a first end 408 and a second end 410. The first end 408 can be located above the second end 410 in the height direction. In one example, the body 406 can be formed as a solid structure having a slot to accommodate a push protrusion extending from a catheter hub and having a hollow channel for mounting on the catheter hub body, as discussed further below.

[0509] The body 406 may have an outer surface 426 and an inner surface 428 ( Fig.42 ), a first or distal opening 420 and a second opening 422 on a side of the body opposite the first opening ( Fig.41). The channel 414 is disposed between the two openings 420, 422. The wall thickness between the outer surface 426 and the inner surface 428 has sufficient thickness to provide structural rigidity for carrying the digital load applied by the user to advance the catheter hub 130.

[0510] The body 406 has an outer surface 540 facing the distal side, which includes one or more protrusions or surface features 542 for aesthetics. The outer surface facing the distal side can be curved or arched. The protrusions or surface features can be optionally omitted. In other examples, the protrusions can be embodied as other shapes, such as pits, rounded protrusions, shaped protrusions, random protrusions, etc. The outer surface 540 facing the distal side is located between two side surfaces 546. In one example, each of the two side surfaces 546 has a flat or planar wall without varying surface features. In an embodiment, each side surface 546 has a first surface portion 546a, a tapered side surface portion 546b, and a second surface portion 546c. Like the first surface portion, the second surface portion 546c has a flat or planar wall. The width defined by the two second surface portions 546c on the two side surfaces 546 is greater than the width defined by the two first surface portions 546a. Thus, the width of the nose adapter 404 at the first end 408 is wider than the width of the nose adapter at the second end 410 .

[0511] Fig.40 4 is a front view of the nose adapter 404 viewing the first or distal opening 420 and the distally facing outer surface 540. As shown, the distal opening 420 can have a perimeter 550 defined by a plurality of edge segments or segments. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the nose adapter is configured to be mounted. For example, the shape of the perimeter 550 can have only four side edge segments, or can be semicircular or partially circular.

[0512] Fig.41 560a. FIG. 560b is a rear view of the protrusion adapter 404 viewing the proximal facing outer wall surface 560. In one example, the proximal facing surface 560 has a first surface segment 560a and a second surface segment 560b. The first surface segment 560a can be generally planar, but is angled from the planar surface of the second surface segment 560b at an inflection line or transition line 562. The first surface segment 560a can incorporate one or more surface features or protrusions 542.

[0513] As shown, the proximal or second opening 422 can have a perimeter 550 defined by a semicircular or partially circular edge. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the nose adapter is configured to be mounted. 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 nose adapter is configured to be mounted. The first and second openings 420, 422 should extend beyond half or the midline of the catheter hub body to ensure that more than half of the diameter of the catheter hub body is gripped.

[0514] Fig.42 is a bottom view of the nose adapter 404 illustrating the inner surface 428 and the interior cavity 564 defined by the inner surface 428. A plurality of ribs 566 may be incorporated into the interior cavity to provide rigidity.

[0515] Fig.43 1 is a front perspective view of a nose adapter 404 mounted on a catheter hub 130 of a catheter assembly 108, which also shows a needle hub 122, a vent plug 123, and a catheter tube 110 and a needle 112 extending from the distal end of the catheter hub. As shown, the catheter hub 130 has a nose section 570 at the distal end and a proximal body section 572. The nose section 570 has a generally square shape with rounded corners connecting the four sides. In other examples, the nose section 570 can have other cross-sectional shapes, including generally cylindrical, oval, elliptical, polygonal, etc. The proximal body section 572 is generally circular and can be relatively larger in circumference or outer shape than the nose section 570. Therefore, a step or step section 574 can be provided between the nose section 270 and the proximal body section 572. The size and shape of the opening on the nose adapter can be correspondingly set to match the outer shape of the catheter hub body.

[0516] In this embodiment, the tab adapter 404 is sized and shaped to be mounted on the catheter hub 130. In one example, the tab adapter 404 is configured to be seated on the catheter hub 130 and the hub body located in 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 tightly around the curved body of the catheter hub 130. Depending on how the tab adapter 404 is located on the catheter hub 130, such as by placement or positioning 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 fit the specific shape of the catheter hub. In one example, as Fig.40 and 41As shown, the first opening 420 can have a shape that fits tightly around the generally square cross-section of the nose segment 570, and the second opening 422 can have a hemispherical shape, a semi-oval shape, or an elliptical shape, or an arcuate shape to fit around the proximal body segment 572. Preferably, the two openings 420, 422 are sized and shaped to fit tightly on the catheter hub body and have a grip around the hub body.

[0517] 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 may contact the interior surface 428 on the proximal side of the body 406, or may protrude into a female detent, recess, or socket within the interior to increase the fixation between the tab adapter and the catheter hub. Thus, when the physician pushes the tab adapter 404 in the distal direction, the interior surface 428 of the tab adapter 404 or the recess or female detent within the adapter pushes against the proximal facing surface of the tab 176 to advance the push tab 176 in the distal direction, and thus advance the catheter hub 130. In other examples, the grip against the catheter hub body provided by the openings 420, 422 may also transmit a distally directed force to the catheter hub to advance the catheter hub when the tab adapter is pushed.

[0518] Reference now Fig.44 , shows an extended indwelling catheter assembly 100 according to another aspect of the present invention. Figure 1-14 , Figure 15-28 and Figure 32-43The catheter assembly of ExD has similar aspects. As shown, the present ExD catheter assembly 100 includes a housing 102, wherein a first frame or left frame 193 and a second frame or right frame 194 are attached to form the housing 102. The assembly also includes a catheter assembly 108, which may be similar to other catheter assemblies described herein. The catheter assembly 108 is shown as being at least partially located within the housing 102. The catheter assembly includes a catheter hub, a needle hub 122, and a protective cover 500 covering a needle with a needle tip. The first and second frames can be separated to release the catheter hub of the catheter assembly 108 from the housing. As previously described, the first and second frames 193, 194 can be attached to each other along the seam by corresponding protrusions or male pawls and engagement grooves, and the engagement can be separated thereby. Optionally, the first and second frames 193, 194 can be attached to each other along the upper seam and the lower seam via adhesive or welding, in addition to the protrusions and pawls, or as an alternative. In the case where the two housing frames 193, 194 are not separated, the housing 102 can be provided with a door assembly to allow the catheter hub to be separated from the housing 102 after cannulation and vascular access, as discussed further below. However, the housing still has upper and lower seams that separate the housing into left and right housing frames, as opposed to a horizontal frame that separates the housing into upper and lower frames.

[0519] Similar to Figure 32-43 In the embodiment of the present invention, the nose adapter or nose extender 404 can be positioned on the catheter hub 130 and secured thereto by a fitting. The needle hub 122 is shown extending proximally of the base end 190 and having a vent plug ( Fig.32 ). When using the ExD catheter assembly 100, first remove the protective cover 500 to expose the needle.

[0520] Reference now Figures 45A-45C , showing a top perspective view and a bottom view of a nose adapter 404 according to another aspect of the present invention. Figure 39-43 The tab adapter 404 of the present embodiment shares many similarities, but has some differences. The tab adapter 404 of the present embodiment 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 located above the second end 410 in a height direction. In one example, the body 406 can be formed as a solid structure having a slot to accommodate a push tab extending from a catheter hub and having a hollow passage for mounting on the catheter hub body, as discussed further below.

[0521] The body 406 of the adapter may 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 ). The channel 414 is disposed between the two openings 420, 422. The wall thickness between the outer surface 426 and the inner surface 428 has sufficient thickness to provide structural rigidity for carrying the digital load applied by the user to advance the catheter hub 130.

[0522] The body 406 has an outer surface 540 facing the distal side, which includes one or more protrusions or surface features 542 for aesthetics. The outer surface 540 facing the distal side can be arched or curved. The protrusion or surface feature 542 can be optionally omitted. In other examples, the protrusion can be embodied as other shapes, such as pits, rounded protrusions, shaped protrusions, random protrusions, etc. The outer surface 540 facing the distal side is located between two side surfaces 546. In one example, each of the two side surfaces 546 can have a flat or planar wall without changing the surface features. As shown, the concave groove or seat ring 580 is located between the first surface portion 546a and the second surface portion 546c on each of the two side surfaces 546 of the protrusion adapter 404. The two second surface portions 546c of the two side surfaces can be substantially planar and parallel to each other, thereby defining a substantially constant outer dimension at least along the portion of the two side surfaces. The two first surface portions 546a can also be substantially parallel to each other. However, as shown, the two first surface portions 546 a of the two side surfaces 546 taper inwardly in a direction from the second end 410 toward the first end 408 .

[0523] The protrusion 582 can be coupled to at least one of the two side surfaces 546 of the nose adapter 404 and extend radially along the longitudinal axis of the nose adapter 404. The protrusion 582 may include a ramp surface 582a and a planar end surface 582b intersecting the ramp surface. In other examples, the protrusion may be formed by a straight side and a planar end surface of a hemispherical dome or a non-spherical dome. In use, the protrusion 582 may be arranged to abut or contact the door assembly 600 ( Fig.46 ) to open the door wider and allow separation between the housing and the conduit hub, as referenced above Figure 32-43 In one example, a protrusion 582 is provided on each of the two side surfaces 546 of the nose adapter 404 , such that a door assembly can be abutted by the two protrusions 582 .

[0524] The distal opening 420 of the adapter can have a perimeter 550 defined by a plurality of edge segments or sections. The shape of the perimeter 550 can vary depending on the shape of the catheter hub 130 to which the nose adapter 404 is configured to be mounted or mounted. For example, the shape of the perimeter 550 can have only fou...

Claims

1. An extended indwelling 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) located in 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), wherein the needle (112) and the catheter tube (110) protrude from a distal opening (342) of the housing (102), and the needle hub (122) protrudes from a proximal opening (101) of the housing (102), and wherein the catheter hub (130) is slidable within the interior space (104) of the housing (102) from a proximal position within the interior space (104) to a distal position; an upper seam (276) located between the first frame (193) and the second frame (194) along a first side of the housing (102) and a lower seam (232) located between the first frame (193) and the second frame (194) along a second side of the housing, the upper seam (276) being located above the lower seam (232) in a height direction; and 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. The extended indwelling catheter assembly (100) according to claim 1, wherein: The catheter hub (130) includes an interior cavity (148), and wherein a needle guard (140) including a proximal wall and two arms is located in the interior cavity (148) of the catheter hub (130).

3. The extended indwelling catheter assembly (100) according to claim 1 or claim 2, wherein: The first frame (193) or the second frame (194) includes a plurality of protrusions (250, 394), and the other of the first frame (193) or the second frame (194) includes a plurality of receiving grooves (288, 354) engaging the plurality of protrusions (250, 394).

4. An extended indwelling catheter assembly (100) according to any one of the preceding claims, wherein: The housing (102) includes a base end (190) including a plurality of side walls (200, 202, 204, 206).

5. The extended indwelling catheter assembly (100) according to claim 4 further includes a first rod member (214) and a second rod member (216), and the first and second rod members (214, 216) protrude from different surfaces of the base end (190) of the housing (102).

6. The extended indwelling catheter assembly (100) according to claim 5, wherein: The first rod (214) is attached to a three-sided cutout (254) on the second frame (194).

7. The extended indwelling catheter assembly (100) according to claim 6, wherein: The second rod (216) includes a curved proximally facing surface (216a).

8. An extended indwelling catheter assembly (100) according to any one of the preceding claims, wherein: The housing (102) includes a body opening (196), and wherein the push tab (176) on the catheter hub (130) is located in the body opening (196).

9. The extended indwelling catheter assembly (100) according to claim 5, wherein: The first rod (214) and the second rod (216) move relative to each other to separate the first frame (193) and the second frame (194).

10. The extended indwelling catheter assembly (100) according to claim 1, wherein: The first frame (193) includes a door (340, 606a) having a living hinge (346, 618), and the second frame (194) includes a door (340, 606b) having a living hinge (346, 618).

11. The extended indwelling catheter assembly (100) according to claim 10, wherein: The protrusion (398) engages the recess (378) to engage the two end cap components (340).

12. The extended indwelling catheter assembly (100) according to claim 1, wherein: The first frame (193) has an activation structure (328), and the second frame (194) has an activation structure (328), and wherein a gap defined by the two activation structures (328, 328) is sized and shaped to be pushed by the catheter hub (130) to separate the first frame (193) from the second frame (194).

13. The extended indwelling catheter assembly (100) according to any one of the preceding claims, further comprising a nose adapter (404) that fits around the catheter hub (130).

14. The extended indwelling catheter assembly (100) according to any one of the preceding claims, further comprising a guidewire extending through the needle (112).

15. A method of manufacturing an extended indwelling catheter assembly (100), comprising: A housing (102) is formed, the 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), an upper seam (276) located between the first frame (193) and the second frame (194) along a first side of the housing (102), and a lower seam (232) located between the first frame (193) and the second frame (194) along a second side of the housing, the upper seam (276) being located above the lower seam (232) in a height direction, placing a catheter assembly (108) in 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), wherein the needle (112) and the catheter tube (110) protrude from a distal opening (342) of the housing (102), and the needle hub (122) protrudes from a proximal opening (102) of the housing (102), and wherein the catheter hub (130) is slidable within the interior space (104) of the housing (102) from a proximal position within the interior space (104) to a distal position; and 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. The method according to claim 15, wherein: The first frame (193) and the second frame (194) can be separated by moving the first frame (193) in a first direction and moving the second frame (194) in a second direction.

17. The method according to claim 15, wherein: The first frame (193) and the second frame (194) are separable by advancing the catheter hub (130) in a distal direction to push apart two activation structures (328) located within the interior space (104) of the housing (102).

18. The method according to claim 15, wherein: The catheter hub (130) can be separated from the housing (102) by displacing the two end cap components (340) about two living hinges (346).

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