阅读说明：本技术 具有改进的推送翼片和尖端保护器组件的导管插入装置 (Catheter insertion device with improved push tab and tip protector assembly ) 是由 蒂莫西·D·埃布纳 凯瑟琳·费利西托 沃尔顿·诺弗利特 格雷格·奥科涅夫斯基 于 2020-04-22 设计创作，主要内容包括：提供了改进的尖端保护器组件(TPA)和导管接头用于与I.V.导管一起使用。改进的TPA包括被配置为促进导管的单手放置的直立推送翼片。本公开还提供可用于一旦导管被放置并且TPA被移除时流体密封或至少盖住导管接头的近侧配件的铰接推送翼片。公开了减轻离轴负载和从导管接头意外过早脱离的改进的TPA。(An improved Tip Protector Assembly (TPA) and catheter adapter are provided for use with an i.v. catheter. The improved TPA includes an upright push tab configured to facilitate one-handed placement of the conduit. The present disclosure also provides a hinged push tab that can be used to fluidly seal or at least cover the proximal fitting of the catheter adapter once the catheter is placed and the TPA is removed. An improved TPA that mitigates off-axis loading and accidental premature disengagement from a conduit fitting is disclosed.)

1. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

a tubular housing having an outer surface, a proximal end portion having a proximal circumferential opening, a distal end portion having a distal circumferential opening, and an interior space defining a central axis therethrough;

a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle, the distal tip axially slidable through the tubular housing and through the needle guard along the central axis; and

a push tab connected to the distal end portion of the tubular housing and including a distal face and a proximal face, the push tab extending radially from an outer surface of the tubular housing at an angle to the central axis.

2. The tip protector assembly of claim 1, wherein the angle is about 90 °, and wherein the distal face of the push tab is flush with the distal circumferential opening of the tubular housing.

3. The tip protector assembly of claim 1, wherein said angle is about 20 ° to about 90 °.

4. The tip protector assembly of claim 1, further comprising an alignment feature extending distally from the distal circumferential opening of the tubular housing, the alignment feature being dimensionally configured to rotationally index the tip protector assembly to the catheter hub.

5. The tip protector assembly of claim 1, wherein said push tab further comprises a rolled edge along an edge of said push tab opposite said tubular housing, said rolled edge disposed substantially orthogonal to said central axis.

6. The tip protector assembly of claim 1, wherein the push tab further comprises a curved or angled portion opposite the tubular housing, the curved or angled portion extending proximally from the proximal face of the push tab.

7. The tip protector assembly of claim 1, wherein the push tab radially narrows from the tubular housing to an edge opposite the tubular housing, the push tab being connected to the tubular housing at two locations such that the push tab includes an open window between the two locations.

8. The tip protector assembly of claim 1, further comprising at least one bracket connected to an outer surface of the tubular housing and at least one of the distal face or the proximal face of the push tab.

9. The tip protector assembly of claim 1, wherein the push tab further comprises a distally extending portion configured to be parallel to the outer surface of the tubular housing between the tubular housing and the radially extending push tab such that the entire push tab comprises a stepped structure projecting distally beyond the distal circumferential opening of the tubular housing.

10. The tip protector assembly of claim 1, wherein said push tab further comprises two non-parallel surfaces such that said push tab forms a distally directed arrow configuration.

11. The tip protector assembly of claim 1, further comprising a radially configured aperture through the tubular housing, the aperture being dimensionally arranged to expose the needle guard to visual inspection from an external environment of the tip protector assembly.

12. A catheter adapter for an i.v. catheter, the catheter adapter comprising:

a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen; and

a hinged push flap connected to the outer surface of the housing at the proximal end portion, the hinged push flap including a radially protruding portion connecting a proximally extending portion of the hinged push flap to the outer surface of the housing, the hinged push flap including an elastic portion disposed on the proximally extending portion and a hinge on the radially protruding portion,

wherein the hinged push tab is rotatable through the hinge between a ready to use position and a safe position,

wherein in the ready-to-use position, the hinged push tab is rotatable toward the proximal fitting of the housing, and

wherein, in the safe position, the hinged push tab is coupled to the proximal fitting of the housing to reduce an overall height of the catheter hub.

13. The catheter adapter of claim 12, further comprising a sealing element that prevents fluid from flowing out of the proximal open end.

14. The catheter adapter of claim 12, wherein, in the safe position, the coupling between the hinged push tab and the proximal fitting of the housing comprises a fluid-tight seal between the resilient portion of the hinged push tab and the proximal fitting of the housing.

15. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

a tubular housing having an outer surface, a proximal end portion having a proximal circumferential opening, a distal end portion having a distal circumferential opening, and an interior space defining a central axis therethrough; wherein the proximal portion and the distal portion are connected by a coaxially aligned and continuous flexible tube segment; and

a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle, the distal tip axially slidable through the tubular housing and through the needle guard along the central axis,

wherein the flexible tube segment is configured to allow off-axis pivoting between the proximal portion and the distal portion of the tubular housing when the proximal portion is fixedly coupled to a proximal fitting of a catheter hub.

16. The tip protector assembly of claim 15, further comprising a push tab connected to said distal end portion of said tubular housing and including a distal face and a proximal face, said push tab extending radially from an outer surface of said tubular housing at an angle to said central axis.

17. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

an outer tubular sleeve comprising a proximal end portion having a proximal circumferential opening and a distal end portion having a distal circumferential opening and a central axis therethrough;

an inner tubular sleeve nested within and axially slidable within the outer tubular sleeve relative to the outer tubular sleeve between a first position and a second position, the inner tubular sleeve comprising an outer surface, a proximal end portion having a proximal wall, a distal end portion having a distal circumferential opening, and an inner surface defining an interior space therein;

a needle guard contained within the interior space of the inner tubular sleeve, the needle guard configured to capture a sharp distal tip of a needle that is axially slidable along the central axis through the nested inner and outer tubular sleeves and through the needle guard; and

at least one marking disposed on the outer surface of the inner tubular sleeve,

wherein in the first position the marker is obscured by the outer tubular sleeve, and wherein in the second position the marker is unobstructed by the outer tubular sleeve and observable by an observer.

18. The tip protector assembly of claim 17, further comprising a hole in the outer tubular sleeve configured to pass radially in the outer surface to the inner tubular sleeve such that the indicia is viewable through the hole when the inner tubular sleeve is in the second position.

19. A catheter adapter for an i.v. catheter, the catheter adapter comprising:

a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen;

two cylindrical posts extending radially in opposite directions from the proximal portion of the housing, the cylindrical posts being positioned 180 ° apart from each other; and

a detachable push tab comprising an upstanding portion having a proximal face and a distal face and two parallel arms, each arm reversibly joined to each of the two posts, the upstanding portion bridging the proximal portion of the housing and projecting radially therefrom,

wherein the catheter hub is transitionable from a placed configuration in which the arm of the detachable push tab is engaged on the post to a placed configuration in which the arm of the detachable push tab is disengaged from the post.

20. The catheter adapter of claim 19, wherein the detachable push tab further comprises a space configured between the proximal and distal faces such that the upright portion includes a proximal portion and a distal portion that are movable toward each other to disengage the two arms from the two posts.

Technical Field

The present disclosure relates generally to medical devices, and more particularly to peripheral intravenous catheters configured for one-handed operation.

Background

Peripheral Intravenous (IV) catheters (PIVCs) are one of the most widely used medical devices for hospitalized patients. They are primarily used to provide a port into the cardiovascular system of a patient so that they can be used to administer fluids or to extract blood samples. A central feature of the PIVC is the hollow plastic catheter tube that is threaded over an introducer needle (introducer needle) in response to the PIVC being in a ready-to-use configuration. Placing the PIVC into the vasculature of a patient includes inserting an introducer needle into a blood vessel, inserting a catheter tube into the blood vessel, and removing the introducer needle.

However, such seemingly simple processes are often fraught with difficulties. For example, accidental needle sticks may occur when the introducer needle is withdrawn. Further, medical practitioners often can only use one hand when placing a PIVC. Some PIVCs are not configured to address these and other issues related to PIVC placement and fixation. Accordingly, there is a continuing need for improvements to address the common challenges associated with IV insertion.

Disclosure of Invention

In various embodiments, features are configured on the PIVC to better facilitate one-handed placement. These features include a more robust upright tab configuration, hinged tabs, a flexible interface between the catheter hub and the Tip Protector Assembly (TPA), a viewing window in the TPA to provide confirmation of needle protection, and/or color indicators.

In various embodiments, a tip protector assembly for an i.v. catheter comprises: a tubular housing having an outer surface, a proximal end portion having a proximal circumferential opening, a distal end portion having a distal circumferential opening, and an interior space defining a central axis therethrough; a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle, the distal tip axially slidable through the tubular housing and through the needle guard along the central axis; and a push tab connected to the distal end portion of the tubular housing and including a distal face and a proximal face, the push tab extending radially from an outer surface of the tubular housing at an angle to the central axis.

In various embodiments, the angle is about 90 ° such that the distal face of the pusher tab is flush with the distal circumferential opening of the tubular housing.

In various embodiments, the angle is about 20 ° to about 90 °. As the angle decreases (i.e., the flat push tab becomes closer to parallel with the tubular housing of the TPA), the operator may engage the edge of the push tab rather than the proximal face of the push tab when placing the catheter assembly into the patient. Exemplary angles of the pusher tabs are illustrated in fig. 3A and 3B, recognizing that the noted angles are with respect to the distal circumferential opening of the tubular housing.

In various embodiments, the tip protector assembly may further include an alignment feature extending distally from the distal circumferential opening of the tubular housing, the alignment feature being dimensionally configured to rotationally index the tip protector assembly to the catheter hub, such as illustrated in fig. 2A-2C. In various embodiments, the tip protector housing may include only the alignment feature without the push tab, such as shown in fig. 2D. For such a configuration, a push tab may instead be provided on the catheter hub.

In various embodiments, the pusher tab further comprises a rolled edge along an edge of the pusher tab opposite the tubular housing, the rolled edge disposed substantially orthogonal to the central axis, such as illustrated in fig. 5A.

In various embodiments, the pusher tab further comprises a curved or angled portion opposite the tubular shell extending proximally from the proximal face of the pusher tab, such as illustrated in fig. 5B and 5C.

In various embodiments, the push tab narrows radially from the tubular housing to an edge opposite the tubular housing, the push tab being connected to the tubular housing at two locations such that the push tab includes an open window between the two locations, such as illustrated in fig. 5D.

In various embodiments, the push tab further comprises at least one bracket connected to an outer surface of the tubular shell and at least one of the distal face or the proximal face of the push tab, such as illustrated in fig. 4A-4E.

In various embodiments, the pusher tab further comprises a distally extending portion configured to be parallel to the outer surface of the tubular housing, between the tubular housing and the radially extending pusher tab, such that the entire pusher tab comprises a stepped structure that projects distally beyond the distal circumferential opening of the tubular housing. An exemplary embodiment is illustrated in fig. 5E.

In various embodiments, the pusher flap further comprises two non-parallel surfaces such that the pusher flap forms a distally directed arrow configuration, such as illustrated in fig. 6.

In various embodiments, the tip protector assembly further comprises a radially configured aperture through the tubular housing, the aperture being sized to expose the needle guard to visual inspection from an external environment of the tip protector assembly.

In various embodiments, a catheter adapter for an i.v. catheter comprises: a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen; and an articulated push flap connected to the outer surface of the housing at the proximal end portion, the articulated push flap including a radially protruding portion connecting a proximally extending portion of the articulated push flap to the outer surface of the housing, the articulated push flap including a resilient portion disposed on the proximally extending portion and a hinge on the radially protruding portion, wherein the articulated push flap is rotatable through the hinge between a ready-to-use position and a safe position, wherein in the ready-to-use position the articulated push flap is rotatable towards the proximal fitting of the housing, and wherein in the safe position the articulated push flap is coupled to the proximal fitting of the housing to reduce the overall height of the catheter hub.

In various embodiments, the catheter adapter may further comprise a sealing element that prevents fluid from flowing out of the proximal open end. In various embodiments, the sealing element comprises an elastomeric septum that forms a seal after the introducer needle is fully withdrawn therefrom.

In various embodiments, the coupling between the hinged push tab and the proximal fitting of the housing comprises a fluid-tight seal between the resilient portion of the hinged push tab and the proximal fitting of the housing in the safe position.

In various embodiments, a tip protector assembly for an i.v. catheter comprises: a tubular housing having an outer surface, a proximal end portion having a proximal circumferential opening, a distal end portion having a distal circumferential opening, and an interior space defining a central axis therethrough; wherein the proximal portion and the distal portion are connected by a coaxially aligned and continuous flexible tube segment; and a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle that is axially slidable along the central axis through the tubular housing and through the needle guard, wherein the flexible tube segment is configured to allow off-axis pivoting between the proximal portion and the distal portion of the tubular housing when the proximal end portion is fixedly coupled to a proximal fitting of a catheter hub.

In various embodiments, the tip protector assembly further comprises a push tab connected to the distal end portion of the tubular housing and comprising a distal face and a proximal face, the push tab extending radially from an outer surface of the tubular housing at an angle to the central axis.

In various embodiments, a tip protector assembly for an i.v. catheter includes an outer tubular sleeve including a proximal end portion having a proximal circumferential opening and a distal end portion having a distal circumferential opening and a central axis therethrough; an inner tubular sleeve nested within and axially slidable within the outer tubular sleeve relative to the outer tubular sleeve between a first position and a second position, the inner tubular sleeve comprising an outer surface, a proximal end portion having a proximal wall, a distal end portion having a distal circumferential opening, and an inner surface defining an interior space therein; a needle guard contained within the interior space of the inner tubular sleeve, the needle guard configured to capture a sharp distal tip of a needle that is axially slidable along the central axis through the nested inner and outer tubular sleeves and through the needle guard; and at least one indicia disposed on the outer surface of the inner tubular sleeve, wherein in the first position the indicia is obscured by the outer tubular sleeve, and wherein in the second position the indicia is unobstructed by the outer tubular sleeve and observable by an observer. Various non-limiting embodiments are illustrated in fig. 10A-10B.

In various embodiments, the tip protector assembly may further comprise a hole in the outer tubular sleeve configured radially through to the outer surface of the inner tubular sleeve such that the indicia is viewable through the hole when the inner tubular sleeve is in the second position, as illustrated in fig. 11A-11B.

In various embodiments, a catheter adapter for an i.v. catheter comprises: a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen; two cylindrical posts extending radially in opposite directions from the proximal portion of the housing, the cylindrical posts being positioned 180 ° apart from each other; and a detachable push tab comprising an upstanding portion having a proximal face and a distal face and two parallel arms, each arm reversibly engageable to each of the two posts, the upstanding portion spanning the proximal portion of the housing and projecting radially therefrom, wherein the conduit fitting is transitionable from a deployed configuration in which the arms of the detachable push tab are engaged on the posts to a deployed configuration in which the arms of the detachable push tab are disengaged from the posts.

In various embodiments, the detachable pusher tab further comprises a space configured between the proximal and distal faces such that the upright portion comprises a proximal portion and a distal portion movable toward each other to disengage the two arms from the two posts. An exemplary embodiment is illustrated in fig. 12D.

Drawings

The subject matter is particularly pointed out and distinctly claimed in the concluding portion of the specification. A more complete understanding, however, may be best obtained by referring to the detailed description and claims when considered in connection with the following figures:

1A-1C illustrate various embodiments of a push tab configuration on a TPA housing that facilitates one-handed PIVC operation, according to various embodiments;

fig. 2A-2D illustrate various embodiments of a TPA housing arrangement including alignment features for rotationally indexing the TPA housing to a conduit fitting, according to various embodiments;

fig. 3A and 3B illustrate various embodiments of a proximally angled push tab configuration on a TPA housing that facilitates one-handed PIVC operation, in accordance with various embodiments;

4A-4E illustrate various embodiments of a TPA housing configuration in which a push tab configured on the TPA housing is structurally reinforced by the presence of at least one bracket connecting the body of the TPA housing to the proximal and/or distal side of the push tab, according to various embodiments;

5A-5C illustrate various embodiments of push tab functional designs, according to various embodiments;

fig. 5D illustrates an embodiment of an outwardly flared push tab functional design in which a larger portion of the push tab is connected to the TPA housing by two narrower portions, according to various embodiments;

fig. 5E illustrates an embodiment of a stepped push tab that provides a push tab positioned above a catheter hub when the PIVC is in a ready-to-use configuration, in accordance with various embodiments;

fig. 6 illustrates two rotated perspective views of an embodiment of a push tab functional design that provides for rotationally indexing a TPA to both an orientation mark and an alignment feature of a conduit fitting, in accordance with various embodiments;

FIGS. 7A and 7B illustrate a hinged push tab and method of use thereof according to various embodiments, beginning in an upright position for cannulation (FIG. 7A) and ending in a down-turned position after the introducer needle has been fully withdrawn from the catheter hub (FIG. 7B);

fig. 8A illustrates a flexible and segmented TPA housing pivotable about a proximal-distal axis at an end of a catheter hub, according to various embodiments;

8B-8D illustrate that the flexible TPA housing of FIG. 8A can pivot at an angle to a proximal-distal axis running through the catheter adapter, in accordance with various embodiments;

fig. 9 illustrates that the TPA housing further includes a visual locking indicator in the form of a transparent viewing window or open fenestration that allows visualization of the needle guard within the TPA housing, in accordance with various embodiments;

fig. 10A and 10B illustrate an embodiment of a TPA housing that includes an axially slidable visual marker for signal capture by a needle guard configured within the TPA housing, according to various embodiments;

fig. 11A and 11B illustrate an embodiment of a TPA housing that includes an axially slidable visual marker for signal capture by a needle guard configured within the TPA housing, according to various embodiments; and

figures 12A-12D illustrate various embodiments of a detachable pusher tab configured on a catheter hub and methods of use thereof.

Detailed Description

The detailed description of various embodiments herein makes reference to the accompanying drawings, which show, by way of illustration, various embodiments. While these various embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, it is to be understood that other embodiments may be realized and that logical, chemical, mechanical and structural changes may be made without departing from the spirit of the disclosure. Accordingly, the detailed description herein is presented for purposes of illustration only and not of limitation.

Definition and contract

As used herein, the term "proximal" refers to the location or device end of the device portion closest to the user. Thus, the term "distal" refers to the position of the device or the end of the device that is the portion of the device that is furthest from the user. For example, a hypodermic syringe has a sharpened needle tip at its distal end and a plunger at its proximal end. These terms are also associated with direction, movement, and relative positioning, whereby "proximal" generally refers to movement or relative positioning closer to the user, and "distal" generally refers to movement or relative positioning further from the user.

As used herein, the term "catheter assembly" refers to a medical device that includes: a catheter hub having a fluid central bore therethrough from a proximal end to a distal end, a catheter tube extending distally from the distal end of the catheter hub, a resealable elastomeric septum located within the central bore, and optionally a side port in fluid communication with the central bore; and a needle hub having an introducer needle extending distally from a distal end of the needle hub and being movable coaxially within the catheter tube through the septum, the introducer needle providing a fluid cannula from a distal sharp tip to the needle hub, the needle hub optionally having a proximal end configured with a flashback chamber (flash chamber) to observe flashback of blood. The "safety catheter" further comprises a "tip protector assembly" defined below, which is configured to capture the sharp distal tip of the introducer needle upon withdrawal of the needle from the catheter tube and catheter hub. Without the tip protector assembly, the sharp distal tip of the introducer needle would be fully exposed once the needle tip emerges from the proximal end of the catheter hub upon withdrawal of the needle. The catheter assembly is used to provide a port into the vascular system of a patient, wherein the catheter tube provides a fluid connection of the patient's blood vessel to the catheter hub in the event that the introducer needle is completely withdrawn from the assembly. Upon withdrawal of the introducer needle, the septum in the catheter adapter forms a seal, leaving only the side port of the catheter adapter for access to the vasculature of the patient.

As used herein, a TPA (tip protector assembly) is a "safety mechanism" configured in the catheter assembly for preventing accidental needle sticks when the introducer needle is fully withdrawn from the catheter assembly at the end of PIVC placement. In various embodiments herein, the TPA comprises an outer housing having a tubular shape and a hollow interior. The housing is sized to properly enclose a mechanical needle guard that further includes at least one movable arm or other movable member that moves to cover the sharp tip of the introducer needle as the needle is withdrawn through the TPA. In various embodiments, the needle guard may provide an audible "click" sound when the mechanism captures the sharp distal tip of the introducer needle, although the audible features are typically dependent on the occurrence of a metal-on-metal event within the TPA. The TPA can also be configured to prevent the introducer needle from moving in any direction once the sharp tip is captured by the needle guard portion of the TPA.

A tubular housing portion of the TPA encloses the needle guard mechanism. In various embodiments, a tubular housing of the TPA ("TPA housing") is configured (such as on an exterior surface) with one or more structural features that facilitate one-handed operation and/or improve safety of the PIVC when placed into the vasculature of a patient. In various embodiments, the TPA housing can be made of molded plastic, and these features according to various embodiments can be disposed on an outer surface, such as protruding therefrom, or through a wall of the tubular structure, such as in the case of a viewing window into an interior space of the TPA housing. To aid in orienting and referencing the relative positioning of various features on the TPA housing, the TPA housing is typically shaped as a straight cylinder including an outer surface and an inner surface defining a hollow interior in which the needle guard mechanism is located. In use, the TPA housing is oriented along a proximal-distal axis in the PIVC through the catheter hub, the catheter tube, and the introducer needle, with the introducer needle of the PIVC disposed on and axially movable on the axis. In various embodiments, the tubular housing is about 10-15mm in length and about 5-7mm in diameter, although these dimensions are not meant to be limiting. While the TPA housing may be cylindrical in appearance, there may be one or more step changes in its outer and/or inner diameter to accommodate mating to the proximal end of the catheter adapter or to accommodate some of the structural features disclosed herein. In a general embodiment, the distal end of the TPA housing is configured with a collar portion providing a larger inner diameter that can be reversibly snap-fit onto the proximal end of the catheter hub of the PIVC. In various embodiments, certain structural features may be disposed on an outer surface of the collar. In various embodiments, certain structural features may be configured to pass through the TPA housing wall thickness, such as to facilitate viewing of the interior of the TPA housing, and particularly to view the state of the guard mechanism contained therein.

As used herein, the term "push tab" refers to an upstanding feature disposed on the TPA housing or on the conduit fitting to facilitate one-handed operation of the PIVC. The push wings can be of various sizes and shapes, such as to fit the size and shape of a physician's thumb or finger, and the upright push wings can be hinged or fixed, permanently attached or detachable, or have other functional attributes according to various embodiments. Generally, the push tabs are configured to project radially outward from the TPA housing or conduit fitting, meaning that the push tabs herein will include a generally planar portion that is orthogonal to the proximal-distal axis of the PIVC.

The terms "insertion," "placement," and "cannulation" refer to the steps involved in connecting a catheter to a patient's vasculature. Insertion generally refers to opening a blood vessel of a patient with an introducer needle portion of a catheter assembly, and the term placement is generally used to refer to the entire process of attaching a catheter to a patient. By cannulation is meant the insertion of the catheter tube into a patient's blood vessel once the blood vessel has been located and fenestrated using an introducer needle. The term cannulation is used because of the relative movement of the introducer needle and the catheter tube, which are axially nested by the introducer needle being "cannulated" into the catheter tube as described above. Generally, the tube threading is a combination of distal movement of the catheter tube into the blood vessel and proximal movement of the introducer needle out of the blood vessel, i.e. in exchange for each other, involving axial displacement of the catheter tube and the introducer needle relative to each other. To move the catheter tube distally, the operator pushes the catheter hub because the catheter tube is fixed to the distal end of the catheter hub and the two do not move apart from each other. Further, to move the introducer needle proximally, it is common to grasp and withdraw the needle hub proximally, as the introducer needle and the needle hub are fixed to each other and cannot move independently. Ideally, catheterization is a two-handed procedure, but for various practical reasons, this is often not the case, such as the use of a single hand by a practitioner during tourniquet operation.

The embodiments described herein address three major jump hazards associated with IV catheters and their placement in the vasculature of patients, for example:

1. facilitating one-handed techniques during catheter insertion and threading;

2. enhance the usability and confidence of the TPA's safety mechanism in noisy and/or stressed environments where audible markings are not applicable or equipped; and

3. the height of the catheter hub is minimized to prevent dressing material that may be used over the assembly, such as to adhere the catheter hub to the patient's body, from being obscured or torn off.

Various embodiments may provide functional design options for safety catheters that can be manufactured without a latch or locking mechanism to release the catheter hub, which reduces cost and complexity. Various embodiments maximize ease of use by: providing a large push tab during insertion and cannulation but minimizing catheter height after placement to facilitate the dressing, prevent damage to the dressing, and minimize dead space under the dressing that could lead to contamination. Various embodiments also describe visual indicia related to the relative positioning between the sharpened tip of the introducer needle and the internal safety mechanism of the TPA to enhance the safety of the product and the confidence that the clinician has engaged the safety feature of the TPA.

The various embodiments described herein are intended for use with catheters of closed systems, but may be applied to any IV catheter that includes a catheter adapter that interfaces with a needle stick safety mechanism, also referred to as a Tip Protector Assembly (TPA). Various embodiments may be divided into 5 categories: (1) TPA push tabs functional design, (2) hinged push tabs, (3) staged TPA, (4) TPA with various visual locking indicators, and (5) removable push tabs.

According to various embodiments, a Tip Protector Assembly (TPA) further includes a needle guard, and may include an arm that moves radially to be proximate over a sharpened tip of a needle as the tip of the needle is drawn into the TPA. As noted, the TPA includes a housing that may further include an elongated circumferential alignment feature or collar configured to extend over the proximal end of the catheter adapter. This feature maintains axial alignment between the conduit fitting and the TPA during insertion, resists bending or buckling at the interface between the TPA and the conduit fitting, and prevents premature disengagement of the TPA assembly from the conduit fitting due to off-axis loading. The TPA with a collar snap-fit over or in the proximal end of the catheter hub can maximize the strength of the interface between the hub and the TPA without requiring a dedicated locking mechanism, and thereby reduce the manufacturing cost of the PIVC. Such a collar may further include a flat relief or other key feature to provide rotational alignment with the conduit fitting.

Fig. 1-6 provide top view embodiments of TPA housings with various push tab functional designs. Such an embodiment with an upright push tab generally optimizes the grip and ease of use of the PIVC. In these examples, the upstanding tab portions are disposed on an outer surface of the TPA housing radiating orthogonally from the tubular housing from the distal collar portion of the TPA housing.

In each of the illustrated embodiments, the top circular opening in which the push tab may be positioned is a distal opening of a TPA housing (i.e., the recess of the snap-fit arrangement described above) that is configured to fit onto the proximal end (i.e., the protrusion) of the catheter hub of the PIVC. In various embodiments, the distal female end of the TPA housing can include a collar portion having a diameter greater than the diameter of the remainder of the tubular housing to accommodate a fit on a catheter fitting, although in some embodiments, the outer diameter of the TPA housing can be constant. In various embodiments, the parts are reversed, as the proximal end of the conduit fitting may include a connected recess, and the distal end of the TPA housing may include a protrusion.

Referring now specifically to fig. 1A-1C, TPA housings 100a, 100b, and 100C each include a push tab 101A, 101b, and 101C, respectively, extending radially from TPA housings 102a, 102b, 102C, respectively, and specifically attached to distal collars 106a, 106b, 106C, respectively.

Fig. 1A illustrates an embodiment of the TPA housing 100a in which the push tab 101A is located on the distal collar 106a and is positioned directly on the distal edge of the TPA housing 102a such that the distal face of the push tab 101A is coplanar and flush with the distal circumferential opening 109a of the TPA housing 102 a. In various embodiments, the upstanding push tab 101a may be at any radial position around the circumference of the TPA housing 102a, recognizing that the TPA housing 100a may be indexed to a conduit fitting having various tab and notch configurations such that it is locked in a particular rotational configuration and prevented from rotating on the proximal end of the conduit fitting. The pusher tab 101a may be positioned at the 12 o ' clock position, or may be positioned off-center, such as between 9-3 o ' clock or 10-2 o ' clock, to facilitate various hand-held positions by the user. These clock directions can be viewed with reference to a plane defined by wings that radiate in opposite directions, typically from a catheter hub that can be used to secure the PIVC to the arm of the patient after placement. Thus, the "12 o 'clock position" means orthogonal to the plane defined by the wings of the conduit fitting, and thus in use, the push tab at 12 o' clock should be cocked perpendicular to the plane defined by the wings. In various embodiments, the push tab 101a may be narrow or wide relative to the outer diameter of the TPA housing. Further, there may be more than one push tab 101a positioned radially around the outer circumference of the TPA housing. One or more push tabs may be positioned on collar 106a as shown, or on a narrower diameter portion of TPA housing 102 a.

Referring now to fig. 1B and 1C, the push tabs 101B and 101C, respectively, may be spaced closely away from the distal circumferential opening of the TPA housing, rather than being flush with the opening. Fig. 1B illustrates an embodiment 100B in which the push tab 101B is closely spaced from the distal circumferential opening 109B of the TPA housing 102B, but still attached to the collar 106B portion of the housing 102B. Fig. 1C illustrates an example 100C in which the push tab 101C is spaced closely even further away from the distal circumferential opening 109C of the TPA housing 102C, such as to the proximal end of the collar 106C of the TPA housing 102, as shown. In various embodiments, the push tab may be attached at any location axially along the exterior of the TPA housing, such as at the distal half of the housing length rather than the proximal half.

Fig. 2A-2D illustrate four functional design embodiments in which the TPA housings 202A, 202b, 202c, and 202D may further include alignment features. The alignment features are denoted as 203a, 203b, 203c, and 203d, respectively, and each of these alignment features is shown as a continuous portion molded into the collar portions 206a, 206b, 206c, and 206d of the TPA housing. The alignment features provide additional resistance against off-axis loading during insertion and threading to provide rotational alignment with the conduit fitting and reduce bowing at the interface between the conduit fitting and the TPA housing. As shown, the first three functional designs 200a, 200b, and 200c further include radially extending pusher tabs 201a, 201b, and 201c, respectively. In various embodiments, alignment features such as 203a, 203b, 203c, and 203d may be dimensionally configured to fit within complementary recesses configured at the proximal end of the catheter hub. In this manner, the alignment feature may interface in a recess in the conduit fitting. In addition to the same type of tab/notch arrangement, an alignment feature may be provided on the TPA housing that can be used to index the distal end of the needle hub into the proximal end of the catheter hub, such as illustrated in fig. 2A-2D. In other words, indexing the TPA housing to the conduit fitting may be independent of indexing the needle fitting to the conduit fitting, recognizing that in various embodiments, a portion of the needle fitting may completely cover the TPA housing when both the needle fitting and the TPA housing are docked on the proximal end of the conduit fitting.

Fig. 3A and 3B illustrate that the push tab or segment thereof may be extended or angled closely to enhance user control when using one hand to perform cannulation. For example, fig. 3A illustrates a perspective view and a side plan view of a TPA housing embodiment 300a, wherein the push tabs 301a radiate from the collar 306a of the TPA housing 302a at an angle of about 35 ° from the plane defined by the circumferential distal edge 309a, rather than being flush with this opening. Fig. 3B illustrates a perspective view and a side plan view of TPA housing embodiment 300B, wherein the push tabs 301B radiate from the collar 306B of TPA housing 302B at an angle of about 45 ° from the plane defined by the circumferential distal edge 309B, rather than being flush with this opening. In various embodiments, the angle between the push tab and the plane defined by the circumferential distal edge 309 of the TPA housing 302 can be between about 0 ° to about 70 °. Viewed another way, the angle between the push tab and the central axis through the cylindrical TPA housing can be about 20 ° to about 90 °. At 90 ° to the cylinder central axis, the pusher tabs project radially, such as in fig. 1-2. At various angles, the user's finger may engage the proximal edge of the angled push tab, rather than the proximal face of the push tab. Both embodiments 300a and 300b further include optional alignment features 303a and 303b, respectively, that can be used to index the TPA housing to the conduit fitting in a fixed rotational position.

Fig. 4A and 4B illustrate that the push tab may further include one or more standoffs or "standoffs" that contact both the outer surface of the TPA housing (or the collar portion of the TPA housing) and the push tab. In various embodiments, one or more stents may be configured on both the proximal and distal sides (or both) of the pusher flap. In various embodiments, the bracket may take the physical form of a smooth "rounded corner" or may be configured at a greater angle, even triangular, as in architectural brackets. In various embodiments, the bracket may be connected with other surfaces because the entire TPA housing, including the push tab and bracket structure, may be molded as a single plastic part, such as by injection molding.

Fig. 4A illustrates an embodiment of TPA housing 400a in which upstanding push tab 401a is supported by a single triangular bracket 404A disposed on the distal face of push tab 401a near the center of the width of push tab 401a and contacting push tab 401a and collar 406a of TPA housing 402 a. This particular configuration is not intended to be limiting. For example, the bracket 404a need not extend distally as shown to end distally at precisely the distal circumferential edge 409a of the TPA housing 402 a. Fig. 4B illustrates an embodiment of TPA housing 400B wherein upstanding push tab 401B is supported by a single triangular seat 404B disposed on a proximal face of push tab 401B. In various embodiments, one or more brackets on the distal and/or proximal side of the pusher tab may be used to reinforce the pusher tab and prevent the pusher tab from bending under stress. In various embodiments, one or more legs located proximally of the pushing tab may be sized and/or contoured in a manner to conform the one or more legs to the shape of a human finger and/or to be comfortably pushed by a thumb or other finger of a medical practitioner. In various embodiments, the shelf on the distal side of the push tab can be configured to be at a greater angle, such as to resist engagement on the distal side of the push tab, while the shelf on the proximal side of the push tab can be configured with a profile that can be engaged by a user's fingers.

Fig. 4C, 4D, and 4E illustrate variations in the geometry of one or more stents 404. These functional designs are not intended to be limited to the specific examples illustrated. One or more of the supports may be triangular or curved/angled to provide finger rest. The brace, particularly when disposed on a proximal side of the push tab, may include ridges, grooves, steps, bumps, or textured surfaces to enhance the grip between the push tab and the user's fingers, with or without the user wearing medical gloves. As illustrated by the TPA housing embodiment 400C in fig. 4C, there may be two triangular brackets 404C configured on the proximal face of the push tab 401C. As illustrated by the TPA housing embodiment 400D in fig. 4D, two contoured brackets 404D can be disposed on the proximal side of the push tab 401D, where the contour provides engagement with the user's fingers. As illustrated by TPA housing embodiment 400E in fig. 4E, the bracket 404E may comprise a single wider profile in the shape of a ramp or slide. In fig. 4E, the bracket 404E is formed with the slats, collectively forming an angled surface that connects the push tab to the TPA housing 402E. In various embodiments, the functional design may be varied to accommodate a particular manufacturing method, such as injection molding.

5A-5E illustrate additional push tab configurations according to various embodiments. For each of these configurations, the attachment of the push tab on the outer surface of the TPA housing can be anywhere along the distal portion of the TPA housing, such as on the distal collar portion of the TPA housing. As discussed above, the push tab may be flush with a plane defined by the distal circumferential opening of the TPA housing, or spaced from the opening such that the push tab is attached adjacent to the distal opening of the TPA, rather than flush with the opening. Generally, these and other variations of the push tab shaped functional design enhance traction with the user's fingers and improve control when threading the PIVC.

As illustrated in fig. 5A, TPA housing 500a includes push tab 501a disposed flush with a distal circumferential opening at distal collar 506a of TPA housing 502a, and further includes a rolled edge 517a to enhance secure engagement with a user's fingers.

Fig. 5B illustrates TPA housing 500B comprising push tabs 501B that are disposed flush with the distal circumferential opening at distal collar 506B of TPA cylindrical body 502B, and further comprising curved portions 517B that curve in a proximal direction. The proximal edge of the curvilinear feature 517b may engage with a user's finger.

Fig. 5C illustrates TPA housing 500C comprising push tabs 501C that are disposed flush with the distal circumferential opening at the distal collar 506C of TPA cylindrical body 502C, and further comprising bent/folded portions 517C extending in a proximal direction. The proximal edge of bend feature 517c may engage with a user's finger.

These push tab configurations aid in traction and control during threading. In other embodiments not shown, the features for enhancing traction and control may include ridges, grooves, bumps, or chamfered edges or surfaces, or combinations thereof.

Fig. 5D illustrates a bottom perspective view and a top view of the push tab 501D, which includes an outwardly flared shape, wherein the base of the tab is narrower than the top. In such an embodiment, the push tab 501d includes a larger flared portion 518d and two smaller portions 519d that form a connecting section that attaches the push tab 501d to the collar 506d of the TPA housing 502 d. In various embodiments, the push tab 501d may be connected to the outer surface of the TPA housing 502d at more than one section, such as two or three connected sections. In the embodiment illustrated in fig. 5D, the two connecting segments 519D and the larger flared portion 518D of the pusher tab 501D surround and define a space 521D. Such a configuration allows for less material to manufacture and a way to control the feel of the flap when in use. In this particular embodiment, the two connecting segments 519d merge into the collar 506d flush with the distal circumferential opening 509d of the collar 506d of the TPA housing 502 d. In other embodiments, the pusher tab may comprise a tapered shape, wherein the base of the tab is thinner than the top or vice versa, or a vertical rib aligned with a long edge of the pusher tab.

Crush figure 5E illustrates an embodiment of TPA housing 500E that includes push tabs 501E configured in a stepped configuration to extend over a conduit fitting when the conduit assembly is in a ready-to-use configuration. As illustrated, the push tab 501e includes both a distally extending axial portion 558e and a radially extending portion 538e that is connected together with and orthogonal to the axial portion 558 e. In use, when the collar portion 506e is attached to the proximal end of the catheter adapter, the push tab will extend partially over the proximal end of the catheter adapter when the TPA housing is attached to the catheter adapter, such as in a ready to use configuration. As illustrated, the push tab 501e may further include a fenestration 521e to adjust flexion and provide comfort. In other embodiments, these features 521e may include texture to assist with finger engagement.

Fig. 6 illustrates two rotated views of an embodiment of a TPA housing 600 that includes a push tab 601 that has an angle or "V-shape. In various embodiments, the pusher flap may include at least two non-parallel surfaces. In the illustrated embodiment, the push tab 601 is shaped like an arrow and can be used as an indication of the direction in which the conduit fitting and attached TPA housing should be pushed by the user during threading. The V-shape of the push tab 601 provides a finger rest for pushing against the push tab and indicia showing the direction of push for the catheterization assembly. The shape of the push tab 601 may enhance control when threading with a single hand. The push tab 601 may extend onto a distal alignment feature 603, which, as discussed above, may be used to rotationally index the TPA housing to the proximal end of the catheter hub. In embodiment 600, the apex of arrow shaped pusher tab 601 may extend distally beyond the distal circumferential opening 609 of collar portion 606 of the housing. The alignment feature 603 extends distally beyond the opening so that it may be incorporated into a tab/notch that indexes the TPA housing into the conduit fitting.

Fig. 7A and 7B illustrate embodiments of an articulated push tab and methods of use thereof, wherein in various configurations, the articulated push tab provides both a surface for an operator to engage while threading a catheter assembly and a feature that can be used to fluidly seal or at least cover and obscure a proximal opening of a catheter hub after a catheter has been placed. In various embodiments, the hinged pusher flap provides the following two positions of the catheter hub: (1) a ready-to-use position in which the hinged push flap is held rotatable by the hinge toward a proximal fitting provided on the catheter hub, and (2) a safe position in which the hinged push flap couples with the proximal fitting of the catheter hub to reduce the overall height of the catheter hub.

Referring to configuration (a) in fig. 7A, hinged push tab 701 is configured on proximal portion 786 of catheter adapter 785, rather than on a TPA connected to catheter adapter 785. In the ready-to-use configuration as shown, and as explained above, the catheter assembly further includes a needle hub 730 engaged with the proximal end of the catheter hub 785. Catheter adapter 785 will typically include a side port and a septum, neither of which are illustrated in fig. 7A for purposes of clarity. As shown in (a), TPA housing 702 may be located below an outer housing of the needle connector, such as referred to as a "finger grip portion". The introducer needle extending distally from the needle hub is not visible because the needle is disposed axially through the catheter hub and through the catheter tube attached to the distal end of the catheter hub. The hinged push flap 701 includes both an axially extending portion and a proximally extending portion, although the hinged push flap 701 in configuration (a) may be fully radially extending, i.e., an upstanding push flap. In such an embodiment, the hinged push flap 701 further includes a hinge 765, which may include a living hinge (thinner section) or notch that provides a demarcation where the hinged push flap 701 may bend or fold. The hinge 765 may be configured to operate in only one direction, e.g., to allow folding of a portion of the hinged push flap 701 in a proximal direction, blocking folding in a distal direction, so that a user can push the hinged push flap without inadvertently hinging under stress. In various embodiments, the hinged push tab 701 may include more than one hinge or notch, or may include a resilient "rubber-like" portion that is capable of flexing. As illustrated in configuration (a), hinged pushing tab 701 further includes an elastic portion 723, as explained below.

When the catheter assembly is in the ready-to-use configuration (a) in fig. 7A, the distal end of TPA housing 702 is attached to a fitting 787 provided on the proximal end 786 of catheter adapter 785. The shape of the various portions of catheter adapter 785 are not meant to be precise or limiting as the catheter adapter will typically include side ports, wings, and other features not shown. As discussed above, the proximal fitting 787 may be one component of a male/female snap fitting coupled between the TPA housing 702 and the catheter hub 785. As also explained above, once the introducer needle is placed into the patient's blood vessel, the needle hub 730 is withdrawn (shown in the direction of the bold arrow, typically proximally) while the catheter hub is pushed distally in order to remove the introducer needle from the blood vessel and replace it with the catheter tube. For such placement, the user may engage and push against hinged push flap 701, such as against the proximal edge when it is in the partially rolled back folded position.

Referring now to configuration (B) in fig. 7A, once the needle connector 730 is fully withdrawn, the sharp distal tip of the introducer needle is captured within the needle guard mechanism of the TPA and the entire TPA assembly is disengaged from the catheter connector. Remaining in fluid attachment with the vasculature of the patient is a catheter hub 785, as shown in side plan view and proximal perspective view. Positioned inside the proximal collar portion 786 of the catheter hub 785 is a generally resilient membrane (not shown) configured to block blood outflow of the proximal fitting 787 of the catheter hub 785. Access to the patient's vasculature is typically only through a side port fluidly configured to access the catheter adapter. However, the user may erroneously attempt to inject or extract fluid through a septum configured in the proximal end of the catheter hub, especially since the septum is still accessible and may be visible to some extent. Hinged flap 701 may now be used to block any attempted access through the proximal end of the catheter hub and, in various embodiments, to fluidly seal it.

Referring to both fig. 7A and 7B and the transition from configuration (B) to configuration (C), hinged flap 701 may now be folded around to fluidly seal or otherwise shield or obscure proximal end 787 of catheter hub 785. In various embodiments, hinged flap 701 may be configured to close automatically rather than manually. To configure the flaps in this manner, a catheter hub 785 including integral hinged push flap 701 may be molded with hinged push flap 701 in the folded position so that the plastic retains the shape memory of this configuration. For the shape memory embodiment, the hinged push tab 701 may be biased to a straight position in the ready-to-use configuration using the pin joint 730 (same as (a) in fig. 7A). Once the needle connector and TPA containing the captured needle tip are withdrawn and completely detached from the catheter connector, hinged flap 701 automatically returns to its molded position by virtue of the shape memory characteristics of the material from which it is molded. In various embodiments, the shape memory feature may be sufficient to automatically move the hinged push tab in all around and at least proximate to the proximal opening 787 of the catheter hub 785, in which case the final snap-fit or plugging of the resilient portion 723 may be at least manually accomplished.

In various embodiments, and as illustrated by the transition from the configuration of (B) to (C), the hinged push flap 701 is folded all around and physically snapped into the proximal end of the catheter hub, completely manually, as guided by the living hinge 765. In various embodiments, portions of the push flap may be elastic to also assist in the rewind folding process. The curved arrow in diagram (B) shows how the hinged pushing tab moves to cover the proximal opening 787 of the catheter hub 785. As illustrated, hinged push tab 701 includes a resilient portion 723 that is sized to fit into the same snap fitting 787 that was previously used to secure the TPA to conduit fitting 785 when the conduit assembly was in the ready-to-use configuration. In various embodiments, resilient portion 723 may comprise a circular female collar sized to accommodate male fitting 787 of catheter adapter 785. The snap-fit male and female components can be reversed depending on the fit between the distal end of the TPA housing and the proximal end of the catheter adapter, and in this case, the resilient portion 723 of the hinged push tab and the proximal fitting 787 on the catheter adapter would be reversed. In various embodiments, the resilient portion 723 may comprise a silicone rubber or other elastomeric polymer plug sized to fit within the proximal end of the catheter hub (e.g., cork), and the fit between the resilient portion 723 and the proximal fitting 787 of the catheter hub 785 need not be fluid-tight, given that a septum within the catheter hub is sufficient to seal fluid flowing from the proximal end of the catheter hub. In various embodiments, the back side of the hinged push flap may carry a marker (e.g., a large size "X" to indicate the proximal end of the catheter hub), now occluded by the resilient portion 723, and not a suitable pathway into the patient's vasculature, forcing the practitioner to use the side port of the catheter hub.

Referring now to configuration (C) in fig. 7B, the resilient portion 723 of the articulating push flap 701 now fits into or over the proximal fitting 787 provided on the proximal end 786 of the catheter hub 785. In this way, the proximal end of the catheter hub may be fluid-tight or may simply be closed or blocked from view with an arrangement that indicates at least "inaccessible" but not fluid-tight.

The hinged push tab configuration, such as illustrated in the operations in fig. 7A and 7B, enables inclusion of a large push tab without negatively affecting the dressing on top of the catheter assembly placed thereby. In such embodiments, the push tab may be coupled with other functions when in the closed or down position. In the down position, the flap may be configured to also cover the proximal opening of the catheter hub, which may be desirable in a closed system where the proximal opening of the catheter hub should not be accessed. With conventional catheters, the push tab 701 may act as a stopper to selectively block or access the lumen of the catheter hub 785, which may prevent blood leakage and potential contamination, and improve ease of use.

While the large push tab makes it easier to thread the catheter, it may prevent proper application of the dressing to the catheter. According to various embodiments, and as illustrated by example in fig. 7A and 7B, hinged push tab 701 is attached to conduit fitting 785 instead of TPA housing 702. In this concept, the hinged push tab 701 may pivot or hinge about its fixed point from a vertical position, but after removal of the needle and TPA, the hinged push tab 701 is flipped down or may be manually flipped, axially aligned with the flow path through the conduit. In this manner, hinged push tab 701 may be large enough to facilitate one-handed cannulation, but after insertion, it may be flipped down or manually flipped down to minimize the overall height of the catheter assembly and enable proper dressing above.

According to various embodiments, hinged push flap 701 is secured to catheter hub 785 and is configured to pivot between an upward and downward position. Various embodiments may include living hinges, pins, fasteners, or flexible materials at the base of the push flap 701 near the catheter hub 785 that allow the rotational position of the push flap 201. In various embodiments, the push tab 701 remains upright when the device is assembled, such as in a configuration in which the needle hub is pushed up against the push tab 701. In various embodiments, the starting position of the needle assembly, or finger grip, maintains the hinged push tab 701 in an upright position as illustrated in fig. 7A, (a) and (B).

In various embodiments, hinged push flap 701 does not include elastic portion 723. After threading the catheter and removing the needle from the catheter hub 785, the hinged push tab 701 may be flipped down to simply lay flat against the catheter hub 785. In these embodiments, once down, the push tab 701 is removed, improving the ability to apply the catheter dressing.

According to various embodiments, the hinged push tabs 701 may be curved or curvilinear, such as to improve control in threading, but the angular shape may further be such that: (i) the push tab 701 can cover the proximal end of the catheter hub and close the internal septum when flipped down, and/or (ii) the push tab 701 can include a plug or protrusion to occlude the catheter hub 785. In this regard, various embodiments may (i) prevent access through the lumen of the catheter hub 785 for closed system catheters, and/or (ii) prevent blood leakage in systems without blood control catheters.

When placing the PIVC, there may be an off-axis torque at the interface (e.g., snap fit) between the catheter adapter 305 and the TPA as the insertion device cannulates the catheter, when withdrawing the needle into the TPA, and when continuously withdrawing the TPA from the catheter adapter by pulling on the needle adapter. This off-axis torque can cause difficulty in threading, accidental premature release of the TPA from the catheter hub, and angular discomfort when removing the needle. Premature or "premature release" of the TPA from the catheter hub is quite dangerous because the sharp distal tip of the needle has not been captured in the needle guard mechanism within the TPA housing. To overcome these and other problems, TPA with a segmented flexible and pivoting design allows the TPA to flex and bend relative to the catheter adapter without withdrawing the TPA from the hub. The segmented and flexible TPA allows for angular disconnection when the TPA is withdrawn from the conduit fitting.

Fig. 8A illustrates a TPA housing 800 that is segmented and flexible. TPA housing 800 comprises a distal collar portion 806 attached to a smaller diameter cylindrical body 802 by a flexible "accordion" portion 890 such that the three portions are coaxially aligned and may comprise a single molded plastic piece. The flexible portion 890 of the housing may comprise a relatively thin-walled plastic or metal segment in a corrugated and undulating configuration such as may be found in pipe connections and venting configurations (e.g., referred to as "accordion pipes"). Such a flexible housing as illustrated in fig. 8A may reduce torque on the interface with the conduit, which may help eliminate the need for a more expensive locking/latching interface.

The TPA housing collar 806 and TPA cylindrical body portion 802 can flex and bend relative to each other. The TPA collar 806 is still removed from the catheter hub by withdrawing the finger grip/needle hub removal and the needle along with the TPA, but the segmented portion 890 allows flexing and prevents premature release of the TPA due to off-axis loading.

Fig. 8B-8D illustrate the flexing and flexibility between the TPA housing and the conduit fitting provided by the flexible section 890. Fig. 8B-8D illustrate that the interface 890 configured between the TPA collar 806 and the cylindrical body 802 is flexible, allowing the proximal portion 802 of the TPA to pivot and move off-axis while the distal collar portion 806 remains securely attached to and securely positioned on the proximal end of the catheter adapter 885. Fig. 8B illustrates the axial alignment between the proximal portion 802 of the TPA housing and the conduit coupler 885. Fig. 8C and 8D illustrate how the flexible interface 890 accommodates off-axis removal needles, isolating off-axis loads from the conduit fitting/TPA interface. Additionally, the flexible TPA housing can reduce needle stick injuries when the needle is removed at high angles. Further, such a flexible TPA housing can ensure that the TPA is removed only due to axial tension and not due to off-axis loading. Further, the flexible TPA housing can improve ease of use at various insertion angles.

In some cases, a PIVC will be placed inside a patient in a noisy environment where audible signals emitted by various components of the PIVC cannot be heard while moving. The following embodiments illustrated in fig. 9-11 describe a TPA with a visual lock indicator for providing a visual cue to confirm that the needle guard portion of the TPA has been properly engaged over the sharpened needle tip before the TPA is removed from the catheter adapter.

In various embodiments, the TPA includes one or more indicia that provide confirmation that the needle guard portion of the TPA has been captured and secured to the sharpened distal tip of the introducer needle. In various embodiments, the indicia includes a viewing access, e.g., a clear plastic "clear" portion or open window, through which the user can view whether a needle guard within the TPA housing has been secured around the sharp tip of the needle, informing the user that it is otherwise safe to disengage the TPA from the catheter adapter. In other embodiments, the TPA includes axially nested portions that are slidable relative to each other, and withdrawing the needle guard and the needle tip captured therein causes indicia (e.g., letters and/or colors) to slide into the user's field of view, informing the user that it is safe to continue pulling back to disengage the TPA from the catheter adapter.

Referring now specifically to fig. 9, TPA housing 902 includes holes 927 as indicia members. The entire TPA housing 902, or only a portion thereof, can be made of clear plastic, or the TPA housing 902 can include a clear plastic window, or the proximally located insert can be elongated and made clear. In other embodiments, the marker feature 927 can be an open window, i.e., a hole. As the needle 950 is withdrawn, a tab 952 on the needle shaft engages a rear wall 952 of the clip 936 and pulls it proximally into view through the window 927. In other embodiments, the sharpened tip 951 is captured by the action of the distal flanges 939a and 939b of the clip near the front of the sharpened tip 951, causing the clip to change shape. In various embodiments, the shape of the clip 936 changes, specifically the movement of the cross arms and/or the clip closure changes the shape of the clip in a visually observable manner. The transparent portion or opening 927 enables a user to view the position of the clip 936 as an indicator that the security mechanism is activated, or the clip closes an element that changes the shape and visibility of the clip 936 or the clip through the window 936. Alternatively, the clip 936 or a portion thereof may be colored in a bright color or configured with a brightly colored indicator such that the location of the clip 936 within the TPA housing 902 is readily observable by a user. In various embodiments, the TPA housing 902 can be elongated proximally. The TPA, a section of the TPA body, or the TPA window may be transparent. The locking action may change the clip position or clip shape, which can be observed by the TPA locator. Embodiments may include a color or secondary visible element on the locking clip to improve visibility through the retainer window.

Referring now specifically to fig. 10A and 10B, an embodiment of a TPA housing configured with a slidable indicia is illustrated. In various embodiments, the TPA includes an outer tubular sleeve and an inner tubular sleeve (also referred to as a TPA locator or a needle guard locator) that are slidable within the outer tubular sleeve along the same central axis. I.e. the outer tubular sleeve and the inner tubular sleeve are nested. The clip positioning housing 1007 of the TPA assembly can be configured as a proximal piece of TPA that is slidably disposed within the fixed outer sleeve 1002. The length and undercut (undercut) of the TPA setter 1007 may be elongated to accommodate the slidable length and indicia. The TPA locator 1007 can be transparent or opaque, but has at least one visual marker 1094 at a plurality of discrete longitudinal positions. The elongated portion may include multiple depths, retention forces, or multiple undercuts of the elongated slot. When the needle 1050 is removed, a protrusion 1052 disposed on the needle shaft engages the rear wall 1038 of the clip 1036, withdrawing the clip 1036 against the proximal wall of the TPA locator 1007. TPA locator 1007 can be partially withdrawn from TPA exterior housing 1002 to expose indicia 1094, as shown in fig. 10B, indicating that the needle guard has captured needle tip 1051 and has been withdrawn. Due to the secondary undercut provided, the TPA locator 1007, i.e., the inner sleeve portion, can still remain partially nested within the TPA outer housing 1002. The undercut prevents the TPA housing from being completely withdrawn from the entire TPA and enables a user to disengage the TPA from the duct housing by continued withdrawal.

Referring now specifically to fig. 11A and 11B, examples of distal and/or proximal movement markers visible through one or more apertures are illustrated. The outer TPA tubular sleeve 1102, or a portion thereof, can be transparent or translucent. As illustrated in fig. 11A, a proximal hole 1127a and/or a distal hole 1127b may be provided in the outer tubular sleeve 1102 of the TPA. The TPA is configured with axially nested inner and outer tubular sleeve portions, with the inner portion, TPA retainer 1107, slidably engaged within the TPA housing 1102 configured with a larger diameter. The configuration of the inner and outer sleeves may be substantially similar to the arrangement illustrated in figures 10A-10B. Internal markers, such as "check markers" or colors 1199a and/or 1199b, are moved proximally to enter the field of view through the windows 1127a and/or 1127 b. In various embodiments, the internal markers 1199a and/or 1199B may be withdrawn by the action of locking the safety clip, as described above in the context of fig. 10A-10B. The movement of the marker may be visible through one or more windows to provide some contrasting visual perception. In various embodiments, the indicia may begin to be visible in red and the green indicia may become visible as the TPA locator is withdrawn. In various embodiments, the indicia may be green and start out of view (e.g., as illustrated in the examples of fig. 11A-11B), then pull the green segment (e.g., "check mark") into the window to display the green indicia, notably with the sharp distal tip of the needle safely captured in the needle guard of the TPA.

In various embodiments, once the PIVC is placed into the vasculature of a patient, the large push tab configured on the catheter hub can be withdrawn and discarded. As illustrated in fig. 12B-12D, the detachable push tab 1201 may be a detachable feature for the conduit fitting that is not permanently affixed to TPA1202 or conduit fitting 1285. In various embodiments, the catheter hub with these posts and the detachable tab with the connecting arm can transition from a "placed" configuration in which the arm of the detachable push tab is engaged on the post to a "placed" configuration in which the arm of the detachable push tab is disengaged from the post and the tab is completely removed from the catheter hub such that the height is substantially reduced.

As shown in fig. 12A, the detachable pusher tab 1201 includes an upstanding portion having a proximal face and a distal face and two parallel arms depending therefrom. Each arm includes a forked end 1281a and 1281b configured to reversibly engage each of two posts on a catheter adapter. As illustrated in fig. 12B, the detachable pusher tab 1201 snaps over posts 1279 (only one of which is visible in this side plan view) disposed on opposite sides (180 apart) on the proximal portion 1286 of the catheter hub 1285. The prongs 1281a and 1281b are configured to snap fit via a circular cut-out portion onto a cylindrical post provided on the catheter hub. In this placement configuration, the detachable push tab 1201 bridges the catheter connector 1285 and provides a surface for pushing the catheter connector 1285 distally to cannulate/advance the catheter.

As illustrated in fig. 12C, the detachable push tab 1201 may be detached from the post 1279 by simply pulling radially upward to change the catheter hub to the placed configuration. By thus removing the detachable push tab 1201, the height of the catheter hub 1285 is substantially reduced, allowing for dressing on the placed catheter. In various embodiments, the detachable push tab 1201 may be detached and discarded before or after the needle is removed and the TPA1202 is detached from the catheter adapter 1285. An advantage of this embodiment is that a large push tab 1201 is provided to ease threading, but the profile of the catheter hub 1285 is minimized to ease dressing/securing.

In various embodiments, the detachable push tab 1201 may further include an operable feature that provides "assisted removal" of the tab from the post, such as illustrated in fig. 12D. In various embodiments, the upstanding tab portion of the detachable tab (1201 in fig. 12A) is modified to have a space between the proximal and distal faces such that the upstanding tab portion is divided into a distal portion 1211 and a proximal portion 1212. The forked structure of the end of each arm is elongated such that the detachable tab with the secondary removal feature comprises an H-shaped cross-section. Generally, the secondary removal feature operates by squeezing the distal 1211 and proximal 1212 portions of the upstanding tab portion together, which concomitantly opens each prong. That is, 1281a moves away from 1281b while 1281c moves away from 1281 d. Pinching the movable distal portion 1211 and the proximal portion 1212 at the top of the tab together will open the fork-like structure provided at the bottom of the arms of the detachable push tab 1201, similar to the action of a clothes peg. In various embodiments, the detachable push tab of fig. 12D is an extruded part such that it is made of more than one material. For example, the thinner elastomer portion 1213 provides a pivot point, much like a spring in a clothes peg, such that squeezing the portions 1211 and 1212 together opens the prong structures 1281a/1281b and 1281c/1281 d. In various embodiments, the stiffener is embedded in the long portion of the H structure, making translation through the hinge portion 1213 more efficient. In various embodiments, the metal stem component is overmolded with a plastic or elastomeric polymer. In various embodiments, the thinner hinge portion 1213 is configured to bend easily, such as when a soft elastomeric polymer is included. Dissimilar plastics may be used to ensure bending at the hinge portion 1213, such as by extrusion similar to a striped tube (still tube) process.

In the detailed description, references to "various embodiments," "one embodiment," "an example embodiment," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will become apparent to a person skilled in the relevant art how to implement the disclosure in alternative embodiments.

The steps recited in any method or process description may be performed in any order and are not necessarily limited to the order presented. Furthermore, any reference to the singular includes plural embodiments and any reference to more than one component or step may include a single embodiment or step. Likewise, any reference to being attached, secured, connected, coupled, etc., may include permanent (e.g., integrated), removable, temporary, partial, full, and/or any other possible attachment option. Any of the components may be coupled to each other by friction, snaps, sleeves, brackets, clips, or other means currently known in the art. Additionally, any reference to no contact (or similar phrases) may also include reduced contact or minimal contact.

Benefits, other advantages, and solutions to problems have been described herein with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element of the disclosure. Accordingly, the scope of the disclosure is limited only by the appended claims, in which reference to an element in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more. Further, where a phrase similar to "A, B and C" or "A, B or at least one of C" is used in the claims or specification, that phrase is intended to mean that a may be present in an embodiment alone, B may be present in an embodiment alone, C may be present in an embodiment alone, or any combination of elements A, B and C may be present in an embodiment; for example, a and B, A and C, B and C or a and B and C.

All structural and functional equivalents to the elements of the various embodiments described above that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or device component or method of using a device to address each and every problem sought to be solved by the present disclosure, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. Unless the phrase "means for. As used herein, the terms "comprises," "comprising," "includes" or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

The claims (modification according to treaty clause 19)

1. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

a tubular housing having an outer surface, a proximal end portion having a proximal circumferential opening, a distal end portion having a distal circumferential opening, a radially configured bore through the tubular housing, and an interior space defining a central axis therethrough; and

a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle, the distal tip axially slidable through the tubular housing and through the needle guard along the central axis;

wherein the radially configured aperture through the tubular housing is sized to expose the needle guard to visual inspection in an external environment from the tip protector assembly.

2. The tip protector assembly of claim 11, wherein the angle is about 90 °, and wherein the distal face of the push tab is flush with the distal circumferential opening of the tubular housing.

3. The tip protector assembly of claim 11, wherein said angle is about 20 ° to about 90 °.

4. The tip protector assembly of claim 1, further comprising an alignment feature extending distally from the distal circumferential opening of the tubular housing, the alignment feature being dimensionally configured to rotationally index the tip protector assembly to the catheter hub.

5. The tip protector assembly of claim 11, wherein said push tab further comprises a rolled edge along an edge of said push tab opposite said tubular housing, said rolled edge disposed substantially orthogonal to said central axis.

6. The tip protector assembly of claim 11, wherein the push tab further comprises a curved or angled portion opposite the tubular housing, the curved or angled portion extending proximally from the proximal face of the push tab.

7. The tip protector assembly of claim 11, wherein the push tab radially narrows from the tubular housing to an edge opposite the tubular housing, the push tab being connected to the tubular housing at two locations such that the push tab includes an open window between the two locations.

8. The tip protector assembly of claim 11, further comprising at least one bracket connected to an outer surface of the tubular housing and at least one of the distal face or the proximal face of the push tab.

9. The tip protector assembly of claim 11, wherein the push tab further comprises a distally extending portion configured to be parallel to the outer surface of the tubular housing between the tubular housing and the radially extending push tab such that the entire push tab comprises a stepped structure projecting distally beyond the distal circumferential opening of the tubular housing.

10. The tip protector assembly of claim 11, wherein said push tab further comprises two non-parallel surfaces such that said push tab forms a distally directed arrow configuration.

11. The tip protector assembly of claim 1, further comprising a push tab connected to said distal end portion of said tubular housing and including a distal face and a proximal face, said push tab extending radially from an outer surface of said tubular housing at an angle to said central axis.

12. A catheter adapter for an i.v. catheter, the catheter adapter comprising:

a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen; and

a hinged push flap connected to the outer surface of the housing at the proximal end portion, the hinged push flap including a radially protruding portion connecting a proximally extending portion of the hinged push flap to the outer surface of the housing, the hinged push flap including an elastic portion disposed on the proximally extending portion and a hinge on the radially protruding portion,

wherein the hinged push tab is rotatable through the hinge between a ready to use position and a safe position,

wherein in the ready-to-use position, the hinged push tab is rotatable toward the proximal fitting of the housing, and

wherein, in the safety position, the hinged pusher flap is coupled to the proximal fitting of the housing by a fluid-tight seal formed between the resilient portion of the hinged pusher flap and the proximal fitting of the housing.

13. The catheter adapter of claim 12, further comprising a sealing element that prevents fluid from flowing out of the proximal open end.

14. The catheter adapter of claim 12, wherein, in the safe position, the coupling between the hinged push tab and the proximal fitting of the housing reduces the overall height of the catheter adapter.

15. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

a tubular housing having an outer surface, a proximal cylindrical body portion having a proximal circumferential opening, a distal end portion having a distal collar end in a distal circumferential opening, and an interior space defining a central axis therethrough; wherein the proximal end portion and the distal collar are connected by a coaxially aligned and continuous flexible tube segment; and

a needle guard contained within the tubular housing, the needle guard configured to capture a sharp distal tip of a needle, the distal tip axially slidable through the tubular housing and through the needle guard along the central axis,

wherein the flexible tube segment is configured to allow the proximal cylindrical body portion of the tubular housing and the distal collar to flex and bend relative to one another when the distal collar is fixedly coupled to a proximal fitting of a catheter hub.

16. The tip protector assembly of claim 15, further comprising a push tab connected to said distal end portion of said tubular housing and including a distal face and a proximal face, said push tab extending radially from an outer surface of said tubular housing at an angle to said central axis.

17. A tip protector assembly for an i.v. catheter, the tip protector assembly comprising:

an outer tubular sleeve comprising a proximal end portion having a proximal circumferential opening and a distal end portion having a distal circumferential opening and a central axis therethrough;

an inner tubular sleeve nested within and axially slidable within the outer tubular sleeve relative to the outer tubular sleeve between a first position and a second position, the inner tubular sleeve comprising an outer surface, a proximal end portion having a proximal wall, a distal end portion having a distal circumferential opening, and an inner surface defining an interior space therein;

a needle guard contained within the interior space of the inner tubular sleeve, the needle guard configured to capture a sharp distal tip of a needle that is axially slidable along the central axis through the nested inner and outer tubular sleeves and through the needle guard; and

at least one marking disposed on the outer surface of the inner tubular sleeve,

wherein in the first position the marker is obscured by the outer tubular sleeve, and wherein in the second position the marker is unobstructed by the outer tubular sleeve and observable by an observer.

18. The tip protector assembly of claim 17, further comprising a hole in the outer tubular sleeve configured to pass radially in the outer surface to the inner tubular sleeve such that the indicia is viewable through the hole when the inner tubular sleeve is in the second position.

19. A catheter adapter for an i.v. catheter, the catheter adapter comprising:

a housing having an outer surface and an interior space defining an axial cavity extending therethrough; a proximal end portion comprising a proximal fitting at a proximal open end; and a distal portion comprising a catheter tube extending distally from the distal portion of the housing, wherein the proximal open end and the catheter tube are fluidly connected by the axial lumen;

two cylindrical posts extending radially in opposite directions from the proximal portion of the housing, the cylindrical posts being positioned 180 ° apart from each other; and

a detachable push tab comprising an upstanding portion having a proximal face and a distal face and two parallel arms, each arm reversibly joined to each of the two posts, the upstanding portion bridging the proximal portion of the housing and projecting radially therefrom,

wherein the catheter hub is transitionable from a placed configuration in which the arm of the detachable push tab is engaged on the post to a placed configuration in which the arm of the detachable push tab is disengaged from the post.

20. The catheter adapter of claim 19, wherein the detachable push tab further comprises a space configured between the proximal and distal faces such that the upright portion includes a proximal portion and a distal portion that are movable toward each other to disengage the two arms from the two posts.