Needle devices with wings and related methods

Abstract

A catheter assembly having a needle hub, a needle with a needle tip, and a catheter hub removably connected to the needle hub. The catheter hub has a first body with a first nose section and a second body connected to the first body and which has a pair of laterally extending wing members. The catheter hub also has at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section, and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle.

Description

NEEDLE DEVICES WITH WINGS AND RELATED METHODSFIELD OF ART

[0001] The present disclosure is generally related to needle devices with specific discussions on needle devices, such as catheter assemblies, with intuitive and ergonomically shaped hub bodies and related methods.BACKGROUND

[0002] The insertion procedure for an IV catheter assembly contains four basic steps: (1) the healthcare worker inserts the needle and catheter together into the patient's vein; (2) after insertion into the vein with the needle point, the catheter is forwarded into the vein of the patient by the healthcare worker pushing the catheter with his or her finger; (3) the healthcare worker withdraws the needle by grasping the hub end (opposite the point end) while at the same time applying pressure to the patient's skin at the insertion site with his or her free hand to slow down or stop the flow of blood through the catheter; and (4) the healthcare worker then tapes the exposed end of the catheter (the catheter hub) to the patient's skin and connects it to the source of the fluid to be administered into the patient's vein.

[0003] The problem is that immediately after the withdrawal of the needle from the patient's vein, the healthcare worker, who is at this time involved in at least two urgent procedures, must place the exposed needle tip at a nearby location and address the tasks required to accomplish the needle withdrawal. It is at this juncture that the exposed needle tip creates a danger of an accidental needle stick, which, under the circumstances, leaves the healthcare worker vulnerable to the transmission of various dangerous blood-borne pathogens, including AIDS and hepatitis.

[0004] Other needle types similarly expose healthcare workers to risks of accidental needle sticks. For example, a doctor administering an injection, using a straight needle, a Huber needle, an epidural needle, etc., may place the used needle on a tray for subsequent disposal by a nurse. During the period between placing the used needle on a tray or a workstation to the time it is discarded, the used needle is a potential source for disease transmissions for those that work near or around the needle.

[0005] Accordingly, exposed needle tips should be covered immediately following use to ensure greater worker safety. Ideally, the procedure for covering the needle tip should be passive, self-activating, or at least simple to perform. In addition, the device for covering the needle should be reliable and robust.

[0006] Needle devices often include safety systems that cover the tip of the needle to prevent accidental sticks after placement of the catheter tube into the vasculature of a patient. These systems can be either passive or active. In some systems, the safety features are located inside the catheter hub in the ready position while in other systems they are external of the catheter hub. In either location, the safety features serve the same function, to cover the needle tip in order to prevent accidental needle sticks after venipuncture.

[0007] Needle devices may additionally include securement platforms with wings. The wings extend laterally from the annular body of the catheter hub. The wings provide additional support to better secure and immobilize the catheter hub after it has been attached to a patient with adhesive dressing. The wings are typically unitarily formed with the catheter hub, and thus are made of the same rigid material as the catheter hub. Such wings decrease patient comfort as they cause pressure ulcers and pressure markings. Other wings are separate components and are made of a soft and flexible material. Such wings help to increase patient comfort; however, soft wings can cause the catheter hub to be difficult to grip or maneuver, especially during needle insertion.SUMMARY

[0008] Aspects of the present invention comprises a catheter assembly comprising a catheter unit and a needle hub with a needle.

[0009] Aspects of the invention further can include a catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub. The catheter hub comprising: a first body having a first nose section; a second body connected to the first body and having a pair of laterally extending wing members; at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section; and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle.

[0010] The first body can comprise a pair of laterally extending wing support members configured for supporting the wing members of the second body.

[0011] The wing support members of the first body and the wing members of the second body can collectively define a reinforced pair of wings of the catheter hub.

[0012] The wing members of the second body can extend rearwardly of the wing support members of the first body.

[0013] The first body can comprise a pair of secondary support members connected to the wing support members.

[0014] The at least one finger cradle and the at least one finger guiding feature can be integrally formed as part of at least one of the wing support members of the first body.

[0015] Each wing support member of the first body can comprise at least one notch configured for allowing each wing support member to flex.

[0016] The at least one finger cradle can be integrally formed as part of both of the first body and the second body.

[0017] The at least one finger guiding feature can be integrally formed as part of both of the first body and the second body.

[0018] The first body can comprise one or more gripping features.

[0019] The second body can comprise one or more gripping features located on the wing members.

[0020] The at least one finger cradle and the at least one finger guiding feature can be integrally formed as part of at least one of the wing members of the second body.

[0021] The second body can connect to and cover at least a portion of the underside of the first body.

[0022] The first body can be made from a first material and the second body can be made from a second material which is softer and more flexible than the first material.

[0023] The relative softness and hardness can be measured in durometers for plastic and elastomeric materials.

[0024] The second material of the second body can be a transparent material.

[0025] The second body can comprise a second nose section connected to and covering at least a portion of the first nose section of the first body.

[0026] The at least one finger cradle can be a groove and / or a curved surface profile.

[0027] The at least one finger guiding feature can be a surface profile which slopes toward the at least one finger cradle.

[0028] The catheter hub can comprise at least one finger guard integrally formed as part of the first body and / or the second body.

[0029] The at least one finger guard can be configured for preventing the finger of the user from moving laterally inward toward the first nose section.

[0030] The catheter hub can comprise at least one gripping feature located within the at least one finger cradle.

[0031] The second body can be monolithically formed with a gap between two wings and the first body is located in the gap.

[0032] Each of the laterally extending wings of the first body can comprise a first section extending radially a first distance and a second base portion extending radially a second distance less than the first distance and defining a wing space, and wherein one of the laterally extending wing members of the second body is located in the wing space.

[0033] Each of the second base portion can extend in a proximal direction and has a tapered upper surface to define a smooth transition with one of the laterally extending wing members of the second body.

[0034] Each of the second base portion can extend in radially outward direction as it extends in a proximal direction.

[0035] The pair of laterally extending wing members of the second body can be unitarily formed with a nose section, which is located subjacent the first nose section of the first body.

[0036] The at least one finger cradle and the at least one finger guiding feature can be located on a leading edge of a wing of the first body and at least one finger cradle and at least one finger guiding feature can be located on a leading edge of one of the pair of the laterally extending wing members of the second body.

[0037] The at least one finger cradle and the at least one finger guiding feature on the leading edge of one of the pair of the laterally extending wing members of the second body can be located below, elevation-wise, the at least one finger cradle and the at least one finger guiding feature on the leading edge of the wing of the first body.

[0038] The second body can have a base section having a planar surface located between the pair of laterally extending wing members and located distal of the pair of laterally extending wing members.

[0039] At least one finger cradle can be located between two triangular shape projections or can have a concave surface.

[0040] Each of the pair of secondary support members has a proximally extending member and a laterally extending member forming a T-shape structure.

[0041] Each of the pair of laterally extending wing members of the second body can comprise an inner edge that extends in a proximal to distal direction and that directly contacts an exterior of the first body.

[0042] The first body can have a wing comprising a fixation feature located on a proximal surface that engages a fixation on a distal surface of one of the pair of laterally extending wing members of the second body.

[0043] The first body can have a fixation feature located on a lower surface that engages a fixation feature on a base section of the second body, the base second can be located between the pair of laterally extending wing members.

[0044] Each of the pair of laterally extending wing members of the second body can be located distally of a leading edge of each of two wings of the first body.

[0045] Aspects of the invention further can include a catheter hub comprising: a first body having a first nose section; a second body connected to the first body and having a pair of laterally extending wing members; at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section; and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle.

[0046] Aspects of the invention further can include a method of manufacturing a catheter assembly comprising the steps: forming a catheter hub comprising a first body having a first nose section, a second body connected to the first body and having a pair of laterally extending wing members, at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section, and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle; attaching a catheter tube having a length and a lumen to the first nose section of the first body of the catheter hub; and extending a needle attached to a needle hub and having a needle tip through the first body and the lumen of the catheter tube in a ready to use position.

[0047] The catheter hub can comprise a multipart body having a main body and a wing body. The catheter hub can also include wings, one or more finger cradles, and one or more finger guiding features.

[0048] The wings, the finger cradles, and the finger guiding features can be multipart members respectively composed of one or more portions of the main and wing bodies.

[0049] The catheter hub can further comprise at least one multipart gripping feature composed of one or more portions of the main and wing bodies.

[0050] The main body comprises a nose section, a middle section which is substantially conical, and a proximal end. The main body also comprises a base section and a pair of wing support members. The main body has a lengthwise axis extending from the distal end to the proximal end. The main body may have chamfered or rounded edges to eliminate sharp edges and augment patient comfort.

[0051] The main body can be made from a polypropylene (PP) material. Alternatively, the main body may be made from a polyurethane, low density polyethylene (LDPE), polyethylene terephthalate (PET), or polyvinyl chloride (PVC) material, or equivalent materials. Other non-limiting examples include polycarbonate (PC), glass filled nylon, high density polyethylene (HDPE), polystyrene, and acrylonitrile butadiene styrene (ABS).

[0052] The base section may provide additional structural support to the wing body and may extend the physical cross-sectional girth of the main body. The base section may extend downwardly and outwardly away from the nose section and / or middle section. The base section may extend on either lateral side of the middle section.

[0053] The base section may define a substantially flat bottom surface which is angled downwardly relative to the lengthwise axis of the main body. The base section has two upwardly extending sidewalls that are angled to one another and define an apex therebetween. Measurement at the two apexes on either side of the main body constitutes the widest width of the base section. The base section may be alternatively configured to have a different shape, such as a differing angle or no angle or a smaller or larger lateral profile. In other examples, the main body may not comprise a base section.

[0054] Each wing support member is configured for providing additional structural support to the wing body. Each wing support member extends from the nose section, the middle section, and / or the base section. In an example, the wing support members extend from each lateral side of the base section. The wing support members can be co-molded, insert-molded, or unitarily molded with the rest of the main body. In other examples, the wing support members can be separately formed and subsequently attached to one or more sections of the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof.

[0055] Each wing support member can extend laterally away from the nose section, the middle section, and the base section. Each wing support member also slopes downwardly, away from the nose section. Each wing support member also tapers in thickness. In other words, the thickness profile of each wing support member varies in the radial direction, from its base to tip or end. The inner or proximal end of each wing support member may extend up and around about half of the circumference of the middle section.

[0056] Each wing support member can comprise a finger cradle, a finger guiding feature, and / or at least one gripping feature. The finger cradle, the finger guiding feature, and the at least one gripping feature are located at the leading or distal side of each wing support member. The finger cradle, the finger guiding feature, and / or the at least one gripping feature can be integrally formed with, or separately formed and subsequently attached to, each wing support member. In an alternative example, only one wing support member comprises a finger cradle, a finger guiding feature, and one or more gripping features.

[0057] The finger cradle is configured for receiving and retaining a finger of a user laterally and rearwardly, or proximally, away from the nose section. The finger cradle is located on each wingsupport member at a lateral distance away from the main body. In an example, the finger cradle is at least a portion of the profile of each wing support member. For instance, the finger cradle can be formed by a groove and / or a concave surface. Additionally, for instance, the finger cradle can be located in between a rearwardly sloping surface and a forwardly sloping surface of each wing support member. The finger cradle can be formed as a recessed section between two axially extending gripping features.

[0058] The finger guiding features are configured for guiding the finger of the user toward the finger cradle. Hence, the finger guiding features may slope and / or be angled toward the finger cradles. Each finger guiding feature may guide the finger of the user in any desired direction or directions. One or more finger guiding features can be located on each wing support member at a specific location or locations. The finger guiding feature can also encompass at least a portion or the entirety of the profile of each wing support member.

[0059] The finger guiding feature can comprise multiple surface profiles, such as a rearwardly slanted surface laterally inward of the finger cradle and a forwardly slanted surface laterally outward of the finger cradle. In some embodiments, the finger guiding feature may comprise an indented curve or groove. In some embodiments, the finger guiding feature may comprise a structure with a convex shape or slip, for the fingers to slip or fall therearound and into the finger cradle. Optionally, surface roughness or projections can be provided on each wing support member at the finger cradle to provide tactile feedback.

[0060] Each gripping feature is configured for enhancing the grip of the user. The gripping features can be located within and / or next to the finger cradle. The gripping features can be in the form of protrusions, recesses, pins, slots, dimples, waves, or other textured features. In an example, the gripping features are in the form of triangular protrusions.

[0061] Each wing support member can include two gripping features. One gripping feature can be located within the finger cradle, and another gripping feature can be located adjacent to the finger cradle. The finger cradle can also be located between two gripping features.

[0062] The main body may or may not comprise fixation features to help attach the wing body to the main body. The fixation features can be in the form of rods, pins, fins, and / or hole and rivet structures to create a simple mechanical interlock in between the main body and the wing body 174. Optionally, once the main body is coupled to the wing body, adhesive or welding may be used to more permanently secure the two together.

[0063] The wing body can comprise a nose section at a distal end of the wing body, a base section, and a pair of extended wing members. The wing body may have chamfered or rounded edges to augment patient comfort. The profile of the wing body generally coincides, matches, or aligns with the corresponding slanted and curved profiles of the main body.

[0064] The wing body can be made from a soft thermoplastic material or a soft thermoplastic elastomer (TPE) material, having a softer feel than the material used to form the main body. The soft thermoplastic material or the soft TPE material may be soft and flexible. The soft thermoplastic material or the soft TPE material may be flexible, and at least the bottom surface, be smooth for improved patient comfort. The material of the wing body may also be transparent.

[0065] The wing body may be over-molded onto the main body. Alternatively, the wing body can be co-molded, insert-molded, or unitarily molded with the main body. In other examples, the wing body can be separately formed and subsequently attached to the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof.

[0066] The wing body may or may not extend above and / or around the main body. In an example, the wing body does not extend above and around the main body. The wing body only covers the bottom or underside of the main body. Therein, the wing body does not obstruct the view of the various other components. For instance, the wing body will not obstruct the view of blood flashback during insertion and infusion of medication fluid through the catheter assembly.

[0067] The nose section of the wing body may extend distally or forwardly of the base section and the wing members. The nose section may have a profile which is complimentary to the nose section of the main body. Thereby, the nose section may connect to and at least partially cover the underside of the nose section and / or base section of the main body. In an example, the nose section of the wing body may extend almost to the end of the nose section of the main body. In an alternative embodiment, the wing body may not include a nose section.

[0068] The base section of the wing body may serve as a platform or base for the wing members. The leading edge of the base section defines the finger cradles, the finger guiding features, and the gripping features of the wing body. The finger cradles, the finger guiding features, and the gripping features of the wing body are complimentary in form and function to their corresponding counterparts of the main body, and therein collectively define the multipart finger cradles, the finger guiding features, and the gripping features. In an alternative example, the wing body may comprise a finger cradle and finger guiding feature(s) on only one wing member.

[0069] The base section and the nose section may be substantially flush with one another. In an example, a flat bottom surface, composed of the undersides of the nose section and the base section, stretches from the tip of the nose section all the way to the trailing edge of the base section, i.e., rear or proximal end of the wing members. Therein, the flat bottom surface spans a distance from a majority of the nose section to a little over mid-length of the main body.

[0070] In use, the base section of the wing body directly contacts the patient; and thus, the main body may not contact the patient. The base section provides a stable base to prevent rotation of the catheter hub, such as during use, during patient movement, and during connector change out, whichin turn improves patient comfort. The enlarged and generally flat bottom surface distributes forces from being concentrated at any uneven point on the catheter assembly. With this, the pressure is equally distributed to prevent discomfort, pressure ulcers, and pressure markings. In some examples, one or more recessed channels can be provided at the base section to provide ventilations.

[0071] The pair of wing members of the wing body extend above the base section. That is, each of the wing members has surfaces that are elevated above the surface of the base section. The surfaces of the wing members preferably form smooth transitions with the surfaces of the base section to form smooth curving surfaces that appear as if unitarily formed. The wing members also extend laterally from the middle and / or base sections of the main body. Additionally, the wing members extend below and proximally, or rearwardly, of the wing support members.

[0072] Each wing member may be relatively thick. For instance, each wing member may be the same thickness or have a greater thickness than that of each wing support member. Each wing member has a top surface which tapers downwardly, an inner side edge which is complimentary to the base section, a leading edge which is complimentary to the trailing edge of the wing support member, an outer or distal side edge, and a trailing edge which is complimentary the trailing edge of the base section. Given the downwardly tapering top surfaces of the wing members, there exists a smooth transition between the main body and the wing body. In other words, the wing members have a thickness profile that varies in the radial direction, from the tip to the base of each wing member. As such, the base of each wing member can be thicker than the radial outmost part of each wing member. Hence, the tapering profile of the multipart wings creates an overall mound-like structure. The resulting smooth contour facilitates securement of the adhesive dressing. The trailing edges of the wing members, and base section therewith, are generally straight with a slight angle which bow outwardly such that they form an apex where they meet to increase the overall bottom surface area. In alternative embodiments, the trailing edges may comprise straight, non-linear, and / or curved sections.

[0073] Together, the bodies of the multipart body of the catheter hub provide enlarged and sturdy surfaces for a practitioner to grip and push, and / or pull, especially when performing vascular access. The multipart body also provides additional overall stability, improves access to gripping in general, and makes the entire assembly less prone to rotation during use. Additionally, the ergonomically shaped fronts of the multipart wings guide the user’s finger(s) to the finger cradle(s). In essence, the user’s fingers are biased to remain in a designated location so that the catheter assembly may be more easily manipulated and further that the user does not undesirably contact other portions of the catheter assembly. For instance, the finger cradles also help to prevent touch contamination. Due to the finger cradles and finger guiding features of the multipart wings, thefinger(s) of the user can be held away from the nose section of the main body, the capillary tube area, and the insertion site.

[0074] Additionally, the size, shape, softness, and flexibility of the multipart wings help to augment patient comfort. The thicker wing members which contact the patient, and the overall size and rounded edges thereof, help to more evenly distribute forces that act upon the edges of wing body. Also, the increased flat and soft surface area of the wing body helps to reduce movement, e.g., rocking, and improve patient comfort. Furthermore, the profile on the top of the catheter hub is made to gradually decrease in thickness from the middle to its side edges, thus creating a small moundlike structure or overall profile. This small mound-like structure in turn minimizes air pockets and increases surface contact between the dressing, catheter hub, and the skin of the patient. Thereby, the small mound-like structure reduces tenting, improves fixation and stability, and increases patient comfort.

[0075] In another embodiment, the main body can comprise flexing wing support members that are configured for bending or flexing. Each wing support member has one or more notches in its underside surface. Therein, each wing support member can have an inward or proximal portion, extending from the main body and being radially inward of the notch, and an outward or distal portion, radially outward of the notch. Therein, the distal portions of the wing support members may flex relative to the proximal portions. Since a given notch extends into the underside and partially into the side surfaces of each wing support member, the distal portions of each wing support member may bend sideways and / or up and down. The movement of the support members may help the user grip the catheter hub and may also improve securement of the catheter hub onto contoured surfaces. For instance, an insertion site may be curved or otherwise uneven, and the flexing wing support members may allow the main body and the wing body to flex to conform to the profile of the insertion site, thereby improving stabilization and securement.

[0076] In another embodiment, the catheter hub can comprise a push tab on the main body, a reduced profile main body with a smaller base section, and one or more fixation features on the underside of the main body. The base section can have two substantially parallel extending sidewalls. The base section may not radially extend beyond the circumference of the middle section of the main body. The catheter hub may also comprise wing support members with uniform thickness and angled side portions that wrap around the outside of the wing members. The wing support members protect the distal and side surfaces of the wing members.

[0077] The catheter hub can also comprise a wing body with a reduced profile and a substantially uniform thickness. The fixation features help to secure the wing body to the main body. The fixation features can be in the form of rods, pins, fins, and / or hole and rivet structures.

[0078] The wing body may not include a nose section. Therein, the wing body may not cover the nose section of the main body. The wing body may only extend over and cover a portion of the middle section of the main body. The wing body may extend up and around to about a little less than half of the circumference of the middle section. The wing body may or may not cover the undersides of the wing support members. The surfaces of the wing members of the wing body form a smooth transition with the complimentary surfaces of the wing support members.

[0079] Additionally, the finger cradles and the finger guiding features are not multipart components. Therein, only the wing support members comprise the finger cradles and the finger guiding features. The finger cradles can be in the form of grooves and / or cutouts. Each finger guiding feature can be in the form of the curved profile of its respective wing support member.

[0080] In another embodiment, the catheter hub can comprise a main body with primary support members and secondary support members.

[0081] The secondary support members are configured for supporting the primary support members and / or the wing body. The secondary support members can be connected to the primary support members and / or other sections of the main body. In an example, each secondary support member extends from a respective trailing surface of a primary support member. Therein, the secondary support member may extend rearwardly or proximally of the primary support members. Each secondary support member may also extend downwardly or upwardly to reside above or below the top or bottom surface of its respective primary support member. For instance, each secondary support member may extend behind or proximally and beneath the primary support members. Each secondary support member can be in the form of one or more protrusions, pins, fins, and / or fins with rivet holes. Each secondary support member can comprise one or more sections, such as a rod section and a pad section.

[0082] The secondary support members may be flush, shorter, or longer than the wing body. For instance, the secondary support members may be slightly longer than the wing body such that they extend through the rear or proximal surface of the wing members, whereby the user may directly contact the secondary support member(s) with his finger. Therein, the user may securely grab and manipulate the catheter hub when pushing, pulling, and / or rotating via engaging with the primary and secondary support members instead of the wing body.

[0083] In another embodiment, the catheter hub can comprise a main body with rearwardly or proximally bent wing support members and a larger wing body which at least partially covers the nose section and the wing support members of the main body. Also, the wing support members of the main body may include fixation features in addition to the fixation features on the middle section. The main body may not include a base section.

[0084] The wing body may be thicker and may substantially cover the wing support members such that only the upper surfaces of the wing support members are uncovered and visible. The surfaces of the wing body preferably form smooth transitions with the surfaces of the nose section, the middle section, and the wing support members of the main body.

[0085] The leading surfaces of the multipart wings of the catheter hub are defined by the wing body. Thereby, the finger cradles and the finger guiding features can be mostly or entirely formed by the wing members of the wing body.

[0086] The finger cradle can be in the form of a concave surface in the leading edge of a respective wing member. The finger guiding feature can be in the form of the sloping profile of a respective wing member. The wing body may also have a trailing edge which is curved. Therein, each wing member may gradually curve rearwardly or proximally as it extends laterally. Each wing member may also include a concaved indent which defines the finger cradle. Each wing member may also form a rounded apex. Measurement at the two apexes of the wing members constitutes the widest width of the wing body. After the apex, each wing member may also curve rearwardly or proximally again as it extends inwardly toward the main body.

[0087] In another example, the catheter hub can comprise a main body with shorter wing support members that have a greater thickness and which have blunt edges. The wing support members comprise the finger cradles. The finger cradles are at least partially exposed or uncovered by the wing body so that the user may fit his fingers therein.

[0088] In another example, the catheter hub can comprise a main body with substantially “U”- shaped wing support members. The “U”-shaped wing support members are aligned such that the “U” opens toward the nose section. The majority, or all, of the leading edges of the wing support members are exposed or uncovered by the wing body. The prominent curvature of each wing support member dually defines the finger cradle and the finger guiding feature. Said differently, each leading surface profile of each wing support member is defined by a parabola. The vertex of the parabola of each wing support member defines the finger cradle, and the inwardly sloping side surfaces thereof define the two adjacent finger guiding features which guide the user’s fingers into the finger cradle. Each finger cradle comprises an enlarged concave surface, for instance the base of the “U” shape. The finger guiding features comprise the inwardly sloping surfaces abutting the finger cradle, for instance the sides of the “U” shape.

[0089] In another example, the catheter hub can comprise a main body with thicker wing support members and a wing body with thicker wing members. The wing support members and the wing members extend around a majority of the circumference of the middle section of the main body.

[0090] In another example, the catheter hub can comprise a main body with wider wing support members and a smaller wing body. The finger cradles, due to the shallower curvatures of the wingsupport members, are located more rearwardly or distally. The finger cradles may be approximately in line with the push tab.

[0091] In another example, the catheter hub comprises an additional finger guard. The finger guard may be integrally formed as part of the wing support members of the first body and / or the wing members of the wing body. The wing body can comprise wing support members with unitary finger guards.

[0092] The finger guards are configured for preventing the finger of the user from moving laterally inward toward the nose section or catheter tube. Each finger guard comprises a distally curved portion, an apex, and a proximally curved portion which transitions into the radially innermost finger guiding feature 180 of each wing support member. Each finger guard may extend distally such that is extends distal of the middle section. Hence, the apexes of the finger guards define the leasing edges of the wing support members. In another example, the finger guards may be separate components that are connected to the wing support members by adhesive or welding. The wing body may or may not at least partially cover the wing support members, including the finger cradles, the finger guiding features, and the finger guards thereof.

[0093] In another example, the catheter hub can comprise inverted multipart wings, wherein the wing members of the wing body are positioned distally of the wing support members of the main body.

[0094] In another example, the catheter hub can comprise unitary or monolithic wings. The main body does not comprise wing support members. The wing body can comprise the monolithic wings.

[0095] Any of the catheter units described herein are understood to include a catheter tube, a needle, a needle hub, and optionally one or more of a needle guard, a valve, a valve opener, and a third housing for housing the needle guard, as described elsewhere herein.

[0096] Methods of making and methods of using catheter assemblies and catheter units and components thereof as described elsewhere herein are within the scope of the present invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0097] These and other features and advantages of the present devices, systems, and methods will become appreciated as the same becomes better understood with reference to the specification, claims and appended drawings wherein:

[0098] FIG. 1 is a cross-sectional side view of a catheter assembly comprising a catheter hub and a needle hub and wherein a needle guard is located inside the catheter hub.

[0099] FIG. 2 shows a side view and partial cross-sectional view of an alternative catheter assembly, in accordance with aspects of the invention.

[0100] FIGs. 3A, 3B, 3C, and 3D are different views of a multibody catheter hub which includes a catheter tube (not shown), a first body with wing support members, and a second body with wing members, in accordance with aspects of the invention.

[0101] FIG. 4 is a front perspective view of an alternative first body of the catheter hub, which has flexing wing support members, in accordance with aspects of the invention.

[0102] FIGs. 5A, 5B, and 5C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0103] FIGs. 6A, 6B, 6C, and 6D are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0104] FIGs. 7A, 7B, and 7C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0105] FIGs. 8A, 8B, and 8C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0106] FIGs. 9A, 9B, and 9C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0107] FIG. 10 is a front perspective view of an alternative catheter hub, in accordance with aspects of the invention.

[0108] FIGs. 11 A, 11B, and 11C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0109] FIGs. 12A, 12B, and 12C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0110] FIG. 13 is a front perspective view of an alternative catheter hub, in accordance with aspects of the invention.

[0111] FIGs. 14A, 14B, and 14C are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0112] FIGs. 15A and 15B are different views of an alternative catheter hub, in accordance with further aspects of the invention.

[0113] FIGs. 16A and 16B are different views of an alternative catheter hub, in accordance with aspects of the invention.

[0114] FIGs. 17A-17D alternative catheter hubs in accordance with still further aspects of the invention.

[0115] FIGs. 18A and 18B are different views of an alternative catheter hub, in accordance with further aspects of the invention.

[0116] FIGs. 19A and 19B are different views of an alternative catheter hub, in accordance with further aspects of the invention.DETAILED DESCRIPTION

[0117] The detailed description set forth below in connection with the appended drawings is intended as a description of some embodiments of needle devices, such as catheter assemblies and peripheral type catheter assemblies, in accordance with aspects of the present devices, systems, and methods and is not intended to represent the only forms in which the present devices, systems, and methods may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present devices, systems, and methods in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

[0118] Descriptions of technical features or aspects of an exemplary configuration of the disclosure should typically be considered as available and applicable to other similar features or aspects in another exemplary configuration of the disclosure. Accordingly, technical features described herein according to one exemplary configuration of the disclosure may be applicable to other exemplary configurations of the disclosure, and thus duplicative descriptions may be omitted herein. As used herein, the term proximal is understood to mean an end or side closer to the practitioner and the term distal is the opposite end or side.

[0119] FIG. 1 shows a cross-sectional side view of a needle assembly or needle device 100 in accordance with aspects of the present disclosure. The needle assembly 100 comprises a first hub 102 having an over-the-needle tube or tubing 105 attached thereto and a second hub 104 having a needle 106 attached thereto. The tubing 105 has a lumen or bore for receiving the needle and has a distal opening or distal end opening 107. The needle assembly 100 can be called a catheter assembly or a catheter device. The needle device or assembly 100 is configured for peripheral access but components used therein can apply to other or different applications. The needle 106 has a needle tip 108 and can include a change in profile 110 located proximal of the tip 108 for use with a needle guard. The needle tip 108 extends distally of the distal end opening 107 of the tube or tubing 105 in the ready to use position with the change in profile 110, if incorporated for use with a needle guard, located proximally of the distal tube opening. The change in profile 110 can be a crimp, a bump, or a material build-up having different profile than other diameter sections of the needle shaft. The change in profile 110 can be used to interact with a needle guard during retraction of the needle, as further discussed below.

[0120] The first hub 102 may alternatively be referred to as a catheter hub, and the second hub 104 may alternatively be referred to as a needle hub. A vent plug 112 is disposed at the proximal open end 148 of the second hub 104 and has a vent filter 114 at a proximal end thereof, which is conventional. As shown, the tube 105 is attached to the first hub 102 by a ferrule or metal bushing 116 and may be referred to as a catheter tube.

[0121] A needle guard 120 can optionally be provided in the interior cavity 118 of the first hub 102 for covering the needle tip 108 in the protective position, such as following successful venipuncture. When incorporated, the needle guard 120 can be one of the needle guards disclosed in US Pat. No. 6,616,630, the contents of which are expressly incorporated herein by reference. In some examples, the needle guard 120 can be omitted. If so, the change in profile can also be omitted. In still other examples, a needle guard can be included without also including a change in profile on the needle. In yet other examples, the needle guard 120 can 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 US Pat. No. 8,597,249, the contents of which are expressly incorporated herein by reference.

[0122] The needle guard 120 can include a proximal wall and two arms extending distally of the proximal wall. The two arms can intersect one another in the ready to use position of FIG.1 and in the protective position in which the needle guard covers the needle tip, and as viewed from a side. In some examples, the two arms of the needle guard 120 can extend in a distal direction without intersecting one another. Two distal walls, one on each arm, can be incorporated to block the needle tip. The two distal walls are biased outwardly by the needle 106 in the ready to use position of FIG. 1 and disposed distally of an internal change in profile 122 inside the first hub 102 in the ready to use position. The internal change in profile 122 can be a reduced diameter section located next to an inside diameter section of a larger dimension. Each distal wall can include a curved lip to facilitate relative movement between the needle guard and the needle. The two distal walls can also each have a curved lip at an end thereof to improve sliding movement along the needle shaft.

[0123] The first hub 102 has a proximal opening 124 having a nose section 126 of the second hub 104 disposed therein. The proximal opening 124 has a female Luer for receiving a male Luer tip, such as a syringe, an IV tubing adaptor, a Luer extension, etc. External threads 130 can be provided on the exterior surface at the proximal end for thread. A pair of stabilizing wings 132 can extend radially of the first hub to facilitate securement or anchoring of the first hub 102 to a patient following successful venipuncture. The first hub 102 can embody a standard IV catheter hub without a tubing port. In other examples, the first hub can include a tubing port and a tubing connected thereto, with a needleless valve connector connected on the opposite end of the tubing, which is also known as an integrated catheter. In still other examples, the first hub 102 can include a side fluid port, also known as a ported catheter. Externally, a push tab 133 can be unitarily formed with thehub body. The push tab 133 can be used by a practitioner to grip and advance the needle device 100, such as to gain peripheral access.

[0124] The first hub 102 is removably secured to the second hub 104 by receiving the nose section 126 of the second hub in the proximal opening 124 of the first hub. A flange or extension 134 is provided on the second hub 104 and together with the nose section 126 define a gap 136 having part of the first hub located therein. Optionally the flange or extension 134 can be omitted and a stub 138 or other surface mating features provided. The stub 138 can limit the extent of insertion of the second hub 104 into the first hub 102. A rib or annular flange can also extend from the nose section 126 of the second hub 104 to limit the extent of insertion of the nose section into the first hub.

[0125] The second hub 104 has a body 140 having an interior cavity 144 having the proximal end 142 of the needle 106 projecting there-into. The interior cavity 144 can function as a primary blood flashback chamber. The proximal opening 148 of the body 140 can have a female Luer for receiving a vent plug 112 therein and the exterior can have threads or be without threads. The first and second hubs 102, 104 can be made from plastic materials, such as by plastic injection.

[0126] With reference now to FIG. 2, a side view of an alternative needle assembly or needle device 100 in accordance with further aspects of the invention is shown, which is similar to the needle device of FIG. 1 with several changes. The present embodiment comprises a catheter hub 102 having a catheter tube 105 extending therefrom and a needle hub 104 with a needle 106 projecting through the catheter hub 102. The needle tip 108 extends out of a distal end of the catheter tube 105. A vent filter 114 is connected to the needle hub and can be similar to that of FIG. 1. Internally of the catheter hub 102, the assembly may optionally include a needle guard like that of FIG. 1. In still yet other examples, the catheter hub 102 may further include a valve and a valve opener located in the interior of the catheter hub 102. The valve can comprise a plurality of slits defining a plurality of flaps and the valve opener can comprise a nose section and one or more actuating elements extending in the proximal direction from the nose section. The valve opener can be pushed in a distal direction by a male Luer tip, such as a syringe tip, to open the valve flaps. Catheter assemblies with a needle guard, a valve, and a valve opener that are usable with catheter assemblies of the present application are disclosed in U.S. Publication No. 2018 / 0214682 Al to Woehr et al. and in U.S. Publication No. 2020 / 0188634 Al to Woehr et al., the contents of which are expressly incorporated herein by reference.

[0127] The catheter hub 102 comprises a catheter hub body 156 having an interior, which can accommodate at least one of a needle guard, a valve, and a valve opener. The catheter tube 105 can attach to the distal end of the hub body 156 with a metal bushing or ferrule, which is standard or traditional. The catheter hub 102 also comprises a hub extension 158 and a push tab adaptor 160.The hub extension 158 can include a body 164 having a receiving space that is sized and shaped to receive the catheter hub body 156. The hub body 156 typically has a body that is rounded or not substantially flat, which can shift or rotate during use. The hub extension 158 provides an enlarged surface area so that when the hub extension 158 is secured to the patient following successful venipuncture, the enlarged surface area provides comfort and stability from rotating, such as during connector change.

[0128] In an example, the push tab adaptor 160 is removably attached to the hub body 156, such as by interference, tapered fit, friction fit, snap fit, detents, or equivalent attachment means or connection means. In other examples, the tab adaptor 160 is removably attached to the hub extension 158. A typical unitarily formed push tab has a first size that is configured for pushing or manipulating when using the catheter assembly.

[0129] FIGs. 3A, 3B, 3C, and 3D show different views of another embodiment of a catheter hub 102 of a needle assembly or needle device 100, as discussed above, in accordance with further aspects of the invention. FIGs. 3A, 3B, 3C, and 3D respectively show a front perspective view, a side view, a bottom view, and an exploded view of the catheter hub 102. For simplicity, the catheter tube 105, the needle hub 104, and the needle 106 have been omitted from the drawings but are understood to be usable with the catheter hub 102, and may be referred to collectively as a catheter assembly or unit 100. The catheter hub 102 is removably connected to the needle hub 104.

[0130] The catheter hub 102 of FIGs. 3A, 3B, 3C, and 3D comprises a multipart body 170, which in the present embodiment includes a first body 172 connected to a second body 174. The first body 172 may be referred to as a catheter or main body 172, and the second body 174 may be referred to as a securement or wing body 174. The catheter hub 102, and more particularly the wing body 174, further comprises wings 176, one or more finger cradles 178 located on at least one of the wings 176, and one or more finger guiding features 180 located on at least one of the wings 176. In the present example, the wings 176, the finger cradles 178, and the finger guiding features 180 are multipart members respectively composed of one or more portions 176M, 176W, 178M, 178W, 180M, 180W of the main and wing bodies 172, 174, as discussed in more detail below. The catheter hub 102 further comprises at least one multipart gripping feature 182 composed of one or more portions 182M, 182W of the main and wing bodies 172, 174.

[0131] The first or main body 172 comprises a nose section 184 at a distal end of the main body 172, a middle section 186 which is substantially conical, and a proximal end 188. The main body 172 also comprises a bottom or base section 190 and a pair of wing support members 176M. The main body 172 has a lengthwise axis extending from the distal end 184 to the proximal end 188. The main body 172 also has distal and proximal openings and a lumen extending between the openings(unnumbered). In an example, the main body 172 does not include a push tab. The main body 172 may have chamfered or rounded edges to eliminate sharp edges and augment patient comfort.

[0132] The main body 172 can be made from a polypropylene (PP) material. Alternatively, the main body 172 may be made from a polyurethane, low density polyethylene (LDPE), polyethylene terephthalate (PET), or polyvinyl chloride (PVC) material, or equivalent materials. Other nonlimiting examples include polycarbonate (PC), glass filled nylon, high density polyethylene (HDPE), polystyrene, and acrylonitrile butadiene styrene (ABS).

[0133] The base section 190 is configured for providing additional structural support to the wing body 174 and extends the physical cross-sectional girth of the main body 172. The base section 190 may be unitarily molded with the main body 172. Alternatively, the base section 190 may also be connected to the undersides of at least portions of the nose section 184 and middle section 186. The base section 190 may extend downwardly and outwardly away from the nose section 184 and / or middle section 186. The base section 190 may extend on either lateral side of the middle section 186. The base section 190 may define a substantially flat bottom surface which is angled downwardly relative to the lengthwise axis of the main body 172. The base section 190 has two upwardly extending sidewalls that are angled to one another and define an apex therebetween. Measurement at the two apexes on either side of the main body 172 constitutes the widest width of the base section 190. The base section 190 may be alternatively configured to have a different shape, such as a differing angle or no angle or a smaller or larger lateral profile. In other examples, the main body 172 may not comprise a base section 190.

[0134] Each wing support member 176M is configured for providing additional structural support to the wing body 174. Each wing support member 176M extends from the nose section 184, the middle section 186, and / or the base section 190. In an example, the wing support members 176M extend from each lateral side of the base section 190. The wing support members 176M can be comolded, insert-molded, or unitarily molded with the rest of the main body 172. In other examples, the wing support members 176M can be separately formed and subsequently attached to one or more sections of the main body 172, such as by welding, adhesive, snap fit, detents, or combinations thereof. Each wing support member 176M extends laterally away from the nose section 184, the middle section 186, and the base section 190 (FIG. 3A). Each wing support member 176M also slopes downwardly, away from the nose section 184 (FIG. 3B). Each wing support member 176M also tapers in thickness. In other words, the thickness profile of each wing support member 176M varies in the radial direction, from its base to tip or end. The inner or proximal end of each wing support member 176M may extend up and around about half of the circumference of the middle section 186.

[0135] Each wing support member 176M comprises a finger cradle 178M, a finger guiding feature 180M, and / or at least one gripping feature 182M. The finger cradle 178M, the finger guiding feature 180M, and the at least one gripping feature 182M are located at the leading or distal side of each wing support member 176M. The finger cradle 178M, the finger guiding feature 180M, and / or the at least one gripping feature 182M can be integrally formed with, or separately formed and subsequently attached to, each wing support member 176M. In an alternative example, only one wing support member 176M comprises a finger cradle 178M, a finger guiding feature 180M, and one or more gripping features 182M.

[0136] The finger cradle 178M is configured for receiving and retaining a finger of a user laterally and rearwardly, or proximally, away from the nose section 184. The finger cradle 178M is located on each wing support member 176M at a lateral distance away from the main body 172. In an example, the finger cradle 178M is at least a portion of the profile of each wing support member 176M. For instance, the finger cradle 178M can be formed by a groove and / or a concave surface. Additionally, for instance, the finger cradle 178M can be located in between a rearwardly sloping surface and a forwardly sloping surface of each wing support member 176M. As shown, the finger cradle 178M is formed as a recessed section between two axially extending gripping features 182M.

[0137] The finger guiding features 180M are configured for guiding the finger of the user toward the finger cradle 178M. Hence, the finger guiding features 180M may slope and / or be angled toward the finger cradles 178M. Each finger guiding feature 180M may guide the finger of the user in any desired direction or directions. One or more finger guiding features 180M can be located on each wing support member 176M at a specific location or locations. The finger guiding feature 180M can also encompass at least a portion or the entirety of the profile of each wing support member 176M. In an example, the finger guiding feature 180M comprises multiple surface profiles, such as a rearwardly slanted surface laterally inward of the finger cradle 178M and a forwardly slanted surface laterally outward of the finger cradle 178M. In some embodiments, the finger guiding feature 180M may comprise an indented curve or groove. In some embodiments, the finger guiding feature 180M may comprise a structure with a convex shape or slip, for the fingers to slip or fall therearound and into the finger cradle 178M. Optionally, surface roughness or projections can be provided on each wing support member 176M at the finger cradle 178M to provide tactile feedback.

[0138] Each gripping feature 182M is configured for enhancing the grip of the user. The gripping features 182M can be located within and / or next to the finger cradle 178M. The gripping features 182M can be in the form of protrusions, recesses, pins, slots, dimples, waves, or other textured features. In an example, the gripping features 182M are in the form of triangular protrusions. Each wing support member 176M can include two gripping features 182M. One gripping feature 182M can be located within the finger cradle 178M, and another gripping feature 182M can belocated adjacent to the finger cradle 178M. The finger cradle 178M can also be located between two gripping features 182M.

[0139] The main body 172 may or may not comprise fixation features to help attach the wing body 174 to the main body 172. The fixation features can be in the form of rods, pins, fins, and / or hole and rivet structures to create a simple mechanical interlock in between the main body 172 and the wing body 174. Optionally, once the main body 172 is coupled to the wing body 174, adhesive or welding may be used to more permanently secure the two together.

[0140] The wing body 174 comprises a nose section 184W at a distal end of the wing body 174, a base section 190W, and a pair of extended wing members 176W (FIG. 3D). The wing body 174 may have chamfered or rounded edges to augment patient comfort. The profile of the wing body 174 generally coincides, matches, or aligns with the corresponding slanted and curved profiles of the main body 172.

[0141] The wing body 174 can be made from a soft thermoplastic material or a soft thermoplastic elastomer (TPE) material, having a softer feel than the material used to form the main body 172. The soft thermoplastic material or the soft TPE material may be soft and flexible. The soft thermoplastic material or the soft TPE material may be flexible, and at least the bottom surface, be smooth for improved patient comfort. The material of the wing body 174 may also be transparent.

[0142] The wing body 174 may be over-molded onto the hub body 156 of the main body 172. Alternatively, the wing body 174 can be co-molded, insert-molded, or unitarily molded with the main body 172. In other examples, the wing body 174 can be separately formed and subsequently attached to the main body 172, such as by welding, adhesive, snap fit, detents, or combinations thereof.

[0143] The wing body 174 may or may not extend above and / or around the main body 172. In an example, the wing body 174 does not extend above and around the main body 172. The wing body 174 only covers the bottom or underside of the main body 172. Therein, the wing body 174 does not obstruct the view of the various other components. For instance, the wing body 174 will not obstruct the view of blood flashback during insertion and infusion of medication fluid through the catheter assembly 100.

[0144] The nose section 184W of the wing body 174 may extend distally or forwardly of the base section 190W and the wing members 176W. The nose section 184W may have a profile which is complimentary to the nose section 184 of the main body 172. Thereby, the nose section 184W may connect to and at least partially cover the underside of the nose section 184 and / or base section 190 of the main body 172. In an example, the nose section 184W of the wing body 174 may extend almost to the end of the nose section 184 of the main body 172. In an alternative embodiment, the wing body 174 may not include a nose section 184W.

[0145] The base section 190W of the wing body 174 may serve as a platform or base for the wing members 176W. The leading edge of the base section 190W defines the finger cradles 178W, the finger guiding features 180W, and the gripping features 182 of the wing body 174. The finger cradles 178W, the finger guiding features 180W, and the gripping features 182 of the wing body 174 are complimentary in form and function to their corresponding counterparts 178M, 180M, 182M of the main body 172, and therein collectively define the multipart finger cradles 178, the finger guiding features 180, and the gripping features 182. In an alternative example, the wing body 174 may comprise a finger cradle 178W and finger guiding feature(s) 180W on only one wing member 176W.

[0146] The base section 190W and the nose section 184W may be substantially flush with one another. In an example, a flat bottom surface, composed of the undersides of the nose section 184W and the base section 190W, stretches from the tip of the nose section 184W all the way to the trailing edge of the base section 190W, i.e., rear or proximal end of the wing members 176W. Therein, the flat bottom surface spans a distance from a majority of the nose section 184 to a little over midlength of the main body 172. In use, the base section 190W of the wing body 174 directly contacts the patient; and thus, the main body 172 may not contact the patient. The base section 190W provides a stable base to prevent rotation of the catheter hub 102, such as during use, during patient movement, and during connector change out, which in turn improves patient comfort. The enlarged and generally flat bottom surface distributes forces from being concentrated at any uneven point on the catheter assembly 100. With this, the pressure is equally distributed to prevent discomfort, pressure ulcers, and pressure markings. In some examples, one or more recessed channels can be provided at the base section 190W to provide ventilations.

[0147] The pair of wing members 176W of the wing body 174 extend above the base section 190W. That is, each of the wing members 176W has surfaces that are elevated above the surface of the base section 190W. As shown in FIG. 3 A, the surfaces of the wing members 176W preferably form smooth transitions with the surfaces of the base section 190 to form smooth curving surfaces that appear as if unitarily formed. The wing members 176W also extend laterally from the middle and / or base sections 186, 190 of the main body 172. Additionally, the wing members 176W extend below and proximally, or rearwardly, of the wing support members 176M. Each wing member 176W may be relatively thick. For instance, each wing member 176W may be the same thickness or have a greater thickness than that of each wing support member 176M. Each wing member 176W has a top surface which tapers downwardly, an inner side edge which is complimentary to the base section 190, a leading edge which is complimentary to the trailing edge of the wing support member 176M, an outer or distal side edge, and a trailing edge which is complimentary the trailing edge of the base section 190W. Given the downwardly tapering top surfaces of the wing members 176W, there exists a smooth transition between the main body 172 and the wing body 174. In other words, the wingmembers 176W have a thickness profile that varies in the radial direction, from the tip to the base of each wing member 176W. As such, the base of each wing member 176W can be thicker than the radial outmost part of each wing member 176W. Hence, the tapering profile of the multipart wings 176 creates an overall mound-like structure. The resulting smooth contour facilitates securement of the adhesive dressing. The trailing edges of the wing members 176W, and base section 190W therewith, are generally straight with a slight angle which bow outwardly such that they form an apex where they meet to increase the overall bottom surface area. In alternative embodiments, the trailing edges may comprise straight, non-linear, and / or curved sections.

[0148] Together, the bodies 172, 174 of the multipart body 170 of the catheter hub 102 provide enlarged and sturdy surfaces for a practitioner to grip and push, and / or pull, especially when performing vascular access. The multipart body 170 also provides additional overall stability, improves access to gripping in general, and makes the entire assembly less prone to rotation during use. Additionally, the ergonomically shaped fronts of the multipart wings 176 guide the user’s finger(s) to the finger cradle(s) 178. In essence, the user’s fingers are biased to remain in a designated location so that the catheter assembly 100 may be more easily manipulated and further that the user does not undesirably contact other portions of the catheter assembly 100. For instance, the finger cradles 178 also help to prevent touch contamination. Due to the finger cradles 178 and finger guiding features 180 of the multipart wings 176, the finger(s) of the user can be held away from the nose section 184 of the main body 172, the capillary tube area, and the insertion site.

[0149] Additionally, the size, shape, softness, and flexibility of the multipart wings 176 help to augment patient comfort. The thicker wing members 176W which contact the patient, and the overall size and rounded edges thereof, help to more evenly distribute forces that act upon the edges of wing body 174. Also, the increased flat and soft surface area of the wing body 174 helps to reduce movement, e.g., rocking, and improve patient comfort. Furthermore, the profile on the top of the catheter hub 102 is made to gradually decrease in thickness from the middle to its side edges, thus creating a small mound-like structure or overall profile. This small mound-like structure in turn minimizes air pockets and increases surface contact between the dressing, catheter hub 102, and the skin of the patient. Thereby, the small mound-like structure reduces tenting, improves fixation and stability, and increases patient comfort.

[0150] FIG. 4 shows a perspective view of another main body 172 of a catheter hub 102 in accordance with further aspects of the invention. The present main body 172 ha a hub body 156 and resembles the main body of FIGs. 3A-3D, with a few exceptions. As shown, the main body 172 comprises flexing wing support members 176M that are configured for bending or flexing. Each wing support member 176M has one or more notches 192 in its underside surface. Therein, each wing support member 176M can have an inward or proximal portion, extending from the main body172 and being radially inward of the notch 192, and an outward or distal portion, radially outward of the notch 192. Thereby, the distal portions of the wing support members 176M may flex relative to the proximal portions. Since a given notch 192 extends into the underside and partially into the side surfaces of each wing support member 176M, the distal portions of each wing support member 176M may bend sideways and / or up and down. The movement of the support members 176M may help the user grip the catheter hub 102 and may also improve securement of the catheter hub 102 onto contoured surfaces. For instance, an insertion site may be curved or otherwise uneven, and the flexing wing support members 176M may allow the main body 172 and the wing body 174 to flex to conform to the profile of the insertion site, thereby improving stabilization and securement.

[0151] FIGs. 5A, 5B, and 5C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 3A-3D, with a few exceptions. As shown, the catheter hub 102 comprises a push tab 133 on the main body 172, a reduced profile main body 172 with a smaller base section 190, and one or more fixation features 194 on the underside of the main body 172. The base section 190 has two substantially parallel extending sidewalls. The base section 190 may not radially extend beyond the circumference of the middle section 186 of the main body 172. The catheter hub 102 also comprises wing support members 176M with uniform thickness and angled side portions that wrap around the outside of the wing members 176W. The wing support members 176M protect the distal and side surfaces of the wing members 176W. The catheter hub 102 also comprises a wing body 174 with a reduced profile and a substantially uniform thickness. The fixation features 194 help to secure the wing body 174 to the main body 172 (FIG. 5C). The fixation features 194 can be in the form of rods, pins, fins, and / or hole and rivet structures.

[0152] The wing body 174 may not include a nose section 184W, as discussed above. Therein, the wing body 174 may not cover the nose section 184 of the main body 172. The wing body 174 may only extend over and cover a portion of the middle section 186 of the main body 172. The wing body 174 may extend up and around to about a little less than half of the circumference of the middle section. The wing body 174 may or may not cover the undersides of the wing support members 176M. The surfaces of the wing members 176M of the wing body 174 form a smooth transition with the complimentary surfaces of the wing support members 176M (FIG. 5C).

[0153] Additionally, the finger cradles 178 and the finger guiding features 180 are not multipart components. Therein, only the wing support members 176M comprise the finger cradles 178 and the finger guiding features 180. The finger cradles 178 can be in the form of grooves and / or cutouts. Each finger guiding feature 180 can be in the form of the curved profile of its respective wing support member 176M.

[0154] FIGs. 6A, 6B, 6C, and 6D show a front perspective view, a rear perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 5A-5C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with primary support members 176M and secondary support members 196.

[0155] The secondary support members 196 are configured for supporting the primary support members 176M and / or the wing body 174. The secondary support members 196 can be connected to the primary support members 176M and / or other sections of the main body 172. In an example, each secondary support member 196 extends from a respective trailing surface of a primary support member 176M. Therein, the secondary support member 196 may extend rearwardly or proximally of the primary support members 176M. Each secondary support member 196 may also extend downwardly or upwardly to reside above or below the top or bottom surface of its respective primary support member 176M. For instance, each secondary support member 196 may extend behind or proximally and beneath the primary support members 176M (FIG. 6D). Each secondary support member 196 can be in the form of one or more protrusions, pins, fins, and / or fins with rivet holes. Each secondary support member 196 can comprise one or more sections, such as a rod section and a pad section.

[0156] The secondary support members 196 may be flush, shorter, or longer than the wing body 174. For instance, the secondary support members 196 may be slightly longer than the wing body 174 such that they extend through the rear or proximal surface of the wing members 176W, whereby the user may directly contact the secondary support member(s) 196 with his finger. Therein, the user may securely grab and manipulate the catheter hub 102 when pushing, pulling, and / or rotating via engaging with the primary and secondary support members 176M, 196 instead of the wing body 174.

[0157] FIGs. 7A, 7B, and 7C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 5A-5C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with rearwardly or proximally bent wing support members 176M and a larger wing body 174 which at least partially covers the nose section 184 and the wing support members 176M of the main body 172. Also, the wing support members 176M of the main body 172 may include fixation features 194 in addition to the fixation features on the middle section 186 (FIG. 7B). The main body 172 may not include a base section 190.

[0158] The wing body 174 may be thicker and cover more surface area of the nose section 184, the middle section 186, and the wing support members 176M of the main body 172. In an example, the wing body 174 may substantially cover the wing support members 176M such that only the upper surfaces of the wing support members 176M are uncovered and visible (FIG. 7C). The surfaces ofthe wing body 174 preferably form smooth transitions with the surfaces of the nose section 184, the middle section 186, and the wing support members 176M of the main body 172.

[0159] The leading surfaces of the multipart wings 176 of the catheter hub 102 are defined by the wing body 174. Thereby, the finger cradles 178 and the finger guiding features 178 can be mostly or entirely formed by the wing members 176W of the wing body 174. The finger cradle 178 is in the form of a concave surface in the leading edge of a respective wing member 176W. The finger guiding feature 180 is in the form of the sloping profile of a respective wing member 176W. The wing body 174 may also have a trailing edge which is curved. Therein, each wing member 176W may gradually curve rearwardly or proximally as it extends laterally. Each wing member 176W may also include a concaved indent which defines the finger cradle 178. Each wing member 176W may also form a rounded apex. Measurement at the two apexes of the wing members 176W constitutes the widest width of the wing body 174. After the apex, each wing member 176W may also curve rearwardly or proximally again as it extends inwardly toward the main body 172.

[0160] FIGs. 8A, 8B, and 8C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 7A-7C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with shorter wing support members 176M that have a greater thickness and which have blunt edges. The wing support members 176M comprise the finger cradles 178. The finger cradles 178 are at least partially exposed or uncovered by the wing body 174 so that the user may fit his fingers therein. The wing body 174 may be substantially similar to the wing body 174 of FIGs. 7A-7C except that the wing body 174 does not cover a majority, or all, of the leading surfaces of the wing support members 176M.

[0161] FIGs. 9A, 9B, and 9C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 8A-8C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with substantially “U”-shaped wing support members 176M. The “U”-shaped wing support members 176M are aligned such that the “U” opens toward the nose section 184. The majority, or all, of the leading edges of the wing support members 176M are exposed or uncovered by the wing body 174. The prominent curvature of each wing support member 176M dually defines the finger cradle 178 and the finger guiding feature 180. Said differently, each leading surface profile of each wing support member 176M is defined by a parabola. The vertex of the parabola of each wing support member 176M defines the finger cradle 178, and the inwardly sloping side surfaces thereof define the two adjacent finger guiding features 180 which guide the user’s fingers into the finger cradle 178. Each finger cradle 178 comprises an enlarged concavesurface, for instance the base of the “U” shape. The finger guiding features 180 comprise the inwardly sloping surfaces abutting the finger cradle 178, for instance the sides of the “U” shape.

[0162] FIG. 10 shows a perspective view of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 9A- 9C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with thicker wing support members 176M and a wing body 174 with thicker wing members 176W. The wing support members 176M and the wing members 176W extend around a majority of the circumference of the middle section 186 of the main body 172.

[0163] FIGs. 11 A, 11B, and 11C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 9A-9C, with a few exceptions. As shown, the catheter hub 102 comprises a main body 172 with wider or more open “U”-shaped wing support members 176M and a smaller wing body 174. The finger cradles 178, due to the shallower curvatures of the wing support members 176M, are located more rearwardly or distally. The finger cradles 178 may be approximately in line with the push tab 133.

[0164] FIGs. 12A, 12B, and 12C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 has a hub body 156 and resembles the catheter hub 102 of FIGs. 9A-9C, with a few exceptions. As shown, the catheter hub 102 comprises an additional finger guard 198. The finger guard 198 may be integrally formed as part of the wing support members 176M of the first body and / or the wing members of the wing body 174. In an example, the wing body 174 comprises wing support members 176M with unitary finger guards 198. The finger guards 198 are configured for preventing the finger of the user from moving laterally inward toward the nose section 184 or catheter tube 105. Each finger guard 198 comprises a distally curved portion, an apex, and a proximally curved portion which transitions into the radially innermost finger guiding feature 180 of each wing support member 176M. Each finger guard 198 may extend distally such that is extends distal of the middle section 186 (FIG. 12C). Hence, the apexes of the finger guards 198 define the leading edges of the wing support members 176M. In another example, the finger guards 198 may be separate components that are connected to the wing support members 176M by adhesive or welding. The wing body 174 may or may not at least partially cover the wing support members 176M, including the finger cradles 178, the finger guiding features 180, and the finger guards 198 thereof.

[0165] FIG. 13 shows a perspective view of a catheter hub 102 in accordance with further aspects of the invention. The present catheter hub 102 resembles the catheter hub 102 of FIGs. 8A- 8C, with a few exceptions. As shown, the catheter hub 102 comprises inverted multipart wings 176,wherein the wing members 176W of the wing body 174 are positioned distally of the wing support members 176M of the main body 172.

[0166] FIGs. 14A, 14B, and 14C show a perspective view, a top view, and a side view, respectively, of a catheter hub 102 in accordance with further aspects of the invention. As shown, the catheter hub is assembled onto a unitary or monolithically formed wings 200. The wing body 174 of the unitary formed wings 200 can have a space or gap between two wings for receiving the main body 172 of the catheter hub. The main body 172 does not comprise wing support members 176M. The wing body 174 may be substantially similar to the wing body 174 of FIGs. 7A-7C. The wing body 174 comprises the monolithic wings 200.

[0167] With reference now to FIGs. 15A and 15B, a schematic plan view and side view of another embodiment of a catheter hub 102 of a needle assembly or needle device 100 are shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102, and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0168] The catheter body 172 has a hub body 156 comprising an interior cavity with a Luer proximal opening and a nose section, similar to other catheter hub bodies discussed elsewhere herein. In the present embodiment, a pair of wing support members 176M extend laterally of the lengthwise axis of the hub body. The pair of wing support members 176M can be unitarily formed with the hub body and can resemble wing support members of other catheter hubs described herein, including that of FIGs. 3A, 4, 5A, 6A, 7A, 8A, 9A, 10, 11A, 12A, and 13. For example, each wing support member 176M can have at least one finger cradle 178 and at least one guiding feature 180.

[0169] Each wing support member 176M can have an elongated arm 210 extending radially of the lengthwise axis of the hub body 156. The elongated arm 210 can have a base 190 and a remote end or free end 214. In an example, the base 190 has a width that is approximately the width of the elongate arm 210. In the present embodiment, the base 190 is widened so that the width of the base is at least two times the width of the elongated arm. In a particular example, the widened base 190 is about three or more times the width of the elongated arm. The widened base 212 is directly attached to the elongated hub body, such as being unitarily formed to the hub body.

[0170] The widened base 190 can have a constant radial width, as measured relative to the lengthwise axis of the hub body 156. As shown, the radial width of the base 190 varies from a smallest value adjacent the elongated arm 210 to a widest or largest value at a remoted end 216 away from the elongated arm. The widened base 190 and the elongated arm 210 share an attachment interface 218 for attaching or coupling with the second body or wing body 174. The wing body 174may be over-molded onto the main body 172, and specifically attached to the attachment interface 218. Alternatively, the wing body can be co-molded, insert -molded, or unitarily molded with the main body. In other examples, the wing body can be separately formed and subsequently attached to the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof. As described elsewhere herein, the wing body 174 is preferably formed with a relatively softer material than the material used to form the main body 172.

[0171] In the embodiment shown, the wing body 174 is formed around the free end 214 of the wing support member 176M. In particular, parts of the wing body 174 can be located both distally and proximally of the elongated arm 210, as well as around the free end 214 of the elongated arm. This configuration ensures that the relatively softer material of the wing body 174 covers sharp edges of the free end to thereby aid in patient comfort.

[0172] FIG. 15B is a cross-sectional side view of the assembly of FIG. 15 A, taken along lines 15B-15B. As shown, the second body or wing body 174 has a thickness that increases in the proximal directly. It is believed that when the wing body thickness increases in the proximal direction, the wings provide improved support and improved gripping during venipuncture. In an example, the configuration can also orient the hub body 156 so that the nose section 184 is angled relative to the patient to improve insertion and minimize catheter tube kinking.

[0173] With reference now to FIGs. 16A and 16B, a schematic plan view and side view of another embodiment of a catheter hub 102 of a needle assembly or needle device 100 are shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102, and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0174] The catheter body 172 has a hub body 156 comprising an interior cavity with a Luer proximal opening and a nose section, similar to other catheter hub bodies discussed elsewhere herein. In the present embodiment, a pair of wing support members 176M extend laterally of the lengthwise axis of the hub body. The pair of wing support members 176M can be unitarily formed with the hub body and can resemble wing support members of other catheter hubs described herein.

[0175] Each wing support member 176M can have an elongated arm 210 extending radially of the lengthwise axis of the hub body 156. The elongated arm 210 can have a base 190 and a remote end or free end 214. In an example, the base 190 has a width that is approximately the width of the elongate arm 210. In the example shown, the width at the base 190 is about the same as the width at the free end 214, and a mid-section between the base and the free end can be smaller or narrower.

[0176] Each elongated arm 210 has a perimeter 217 with a leading edge 197, a trailing edge 220, and an end edge 222 at the free end 214. The trailing edge 220 can be generally straight or linear, and either orthogonal to the lengthwise axis or angled at other than 90-degrees to the lengthwise axis of the hub body 156. The leading edge 197 can have a complex edge. As shown, the leading edge has a shallow concave shape. Each arm 210 is also curved and / or slopes in the radial direction as it extends away from the hub body 156, as shown in end view of FIG. 16B. For example, the arm can slope downwardly from the attachment point with the hub body and then slopes as it extends radially outwardly away from the hub body.

[0177] The wing body 174 may be over-molded onto the main body 172, and specifically attached to the perimeter 217 of each elongated arm and to the underside surface 226 (FIG. 16B) of each arm. Alternatively, the wing body can be co-molded, insert-molded, or unitarily molded with the main body. In other examples, the wing body can be separately formed and subsequently attached to the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof. As described elsewhere herein, the wing body 174 is preferably formed with a relatively softer material than the material used to form the main body 172. Preferably, the wing body 174 is continuously formed so that the wing body is located under both the two elongated arms and the hub body. Placement of the second body 174 under the first body or main body 172 provides a comfortable layer between the catheter and a patient’s skin, similar to that shown in FIG. 3C. As described elsewhere herein, the wing body 174 is preferably formed with a relatively softer material than the material used to form the main body 172.

[0178] With continued reference to FIG. 16A in addition to FIG. 16B, the second body or wing body 174 has a pair of wing perimeters 230, with each of the pair of wing perimeters 230 encompassing the perimeter 217 of a corresponding elongated arm 210. Each wing perimeter 230 extends further outwardly than the corresponding perimeter 217 of the elongated arm 210 so that the perimeter 217 of the corresponding elongated arm is recessed within the wing perimeter 230. As configured, the relatively thin elongated arms 210, which are made from a harder material than the material of the wing body, provide the rigidity to grip and operate the catheter assembly while the second body 174provides the softness for interacting with the patient’s skin.

[0179] With reference again to FIG. 16A, the hub body 156 has a nose section 184 with an mating point 232. The mating point 232 can be an undercut, such as a recess, or a recess for mating engagement with the mating point 234 on a horn section 236, which can be the other one of a bump or an undercut. The horn section 236 can be separately formed from a relatively softer material than the material of the hub body and then attached to the nose section 184 of the hub body. The two mating points 232, 234 provide for a positive mechanical engagement rather than just friction or interference fit. In an example, the horn section 236 may be over-molded onto the nose section 184of the main body 172. Alternatively, the horn section 236 can be co-molded, insert-molded, or unitarily molded with the nose section of the main body. In other examples, the horn section can be separately formed and subsequently attached to the nose section, such as by welding, adhesive, snap fit, detents, or combinations thereof.

[0180] With reference now to FIG. 17A, a schematic perspective view of another embodiment of a catheter hub 102 of a needle assembly or needle device 100 is shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102, and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0181] The catheter body 172 has a hub body 156 comprising an interior cavity with a Luer proximal opening and a nose section, similar to other catheter hub bodies discussed elsewhere herein. In the present embodiment, a pair of wing support members 176M extend laterally of the lengthwise axis of the hub body. The pair of wing support members 176M can be unitarily formed with the hub body and can resemble wing support members of other catheter hubs described herein.

[0182] Each wing support member 176M can have an elongated arm 210 extending radially of the lengthwise axis of the hub body 156, similar to other elongated arms discussed elsewhere herein. The elongated arm 210 can have a base 190 and a remote end or free end 214. The base of the elongated arm can have the widest dimension and tapers inwardly to terminate with the relatively smaller free end 214 than at the base. A notch 234 is provided through the elongated arm 210, notched in a way that allows the free end 214 to bend or fold downwardly towards the hub body. The notch 234 allows each elongated arm 210 to flex in the down-up direction but not the proximal- distal direction to ensure grip firmness when performing venipuncture by advancing the catheter assembly in the distal direction.

[0183] In the present embodiment, the wing body 174 comprises two spaced apart wing body parts 174a, 174b. The two wing body parts 174a 174b of the wing body 174 may be over-molded onto the main body 172, and specifically attached to each elongated arm 210. Alternatively, the wing body can be co-molded, insert-molded, or unitarily molded with the main body. In other examples, the wing body can be separately formed and subsequently attached to the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof. As shown, each wing body part is attached to a corresponding elongated arm. In an example, each wing body part is molded over and around the free end 214 of the elongated arm 210, and extend under at least part of the elongated arm. However, part of the elongated arm 210, including the part with the notch 234, is exposed and not covered by the wing body part. This allows the elongated arm to flex in down-up direction. The two elongated arms 210 and the two wing body parts 174a, 174b are preferably similar or identical.

[0184] With reference now to FIG. 17B, a schematic perspective view of another embodiment of a catheter hub 102 of a needle assembly or needle device 100 is shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102, and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0185] The present catheter hub 102 is particularly similar to the catheter hub of FIG. 17A. However, in the present embodiment, one or more ribs 240 are incorporated on one of the two elongated arms 210. The one or more ribs 210 can be closely spaced or provided in contact with one another along a proximal edge of the left elongated arm 210, when looking in the distal direction from the proximal end of the hub body 156. In an alternative embodiment, a single planar rib can be provided instead of a plurality of smaller ribs. The wing body part 174a should be sized and shaped to obscure or to overlie the one or more ribs 240. The one or more fins can be added to the elongated arm to increase sturdiness for catheter advancement.

[0186] With reference now to FIG. 17C, a schematic perspective view of yet another embodiment of a catheter hub 102 of a needle assembly or needle device 100 is shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102 and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0187] The present catheter hub 102 is particularly similar to the catheter hub of FIG. 17A. However, in the present embodiment, the left wing body part 174a is thickened, or has increased girth or mass compared to the right wing body part 174B. For example, the distance between the bottom 244 and the top 246 of the left wing body part 174a is thicker than the corresponding dimension of the right wing body part 174b. In an example, the far end or free left wing body part 174a can be generally flat or planar, or optionally can be convex or dome shape.

[0188] With reference now to FIG. 17D, a schematic perspective view of yet another embodiment of a catheter hub 102 of a needle assembly or needle device 100 is shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102 and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0189] In the present embodiment, the first body 172 has a pair of wing support members 176M extending radially outwardly of the hub body 156. However, the wing support members 176M are shortened compared to other wing support members discussed elsewhere herein. For example, each wing support member is in the order of about 0.1 to 0.7 of an inch long in the radial direction and has a base 190 and a free end 214.

[0190] The second body 174 can comprise a left wing body part 174a and a right wing body part 174b, each attached to a respective free end 214 of the wing support member 176M. In the present embodiment, the two wing body parts are substantially mirror images of one another. As shown, each wing body part has a first rolled section 250 that is generally C-shaped and a second extended section 252, and a bend or a kink 254 between the two sections. The two second extended sections 252, 252 of the two wing body parts 174a, 174b can removably connect to one another along the split line 258 therebetween. For example, the two second extended sections 252, 252 can connect using detents, repositionable adhesive, snap fittings, frangible lines, removable adhesive sheet, an adhesive sheet for connecting the two extended sections and wherein perforations are provided on the adhesive sheet for tearing, or combinations thereof.

[0191] In the connected position of the two wing body parts 174a, 174b shown, which are made from a relatively softer material than the material used for forming the main body 172, a user can grip the second body 174 to advance the catheter assembly during insertion. Once successful venipuncture is achieved, the two wing body parts 174a, 174b can separate at the split line 258 and extended for dressing against the patient’s skin, such as with adhesive tape or adhesive dressing.

[0192] With reference now to FIGs. 18A and 18B, a schematic top plan view and a front end view, respectively, of yet another embodiment of a catheter hub 102 of a needle assembly or needle device 100 are shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102 and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similar to other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0193] The present catheter hub 102 is similar to other catheter hubs described elsewhere herein, and particularly similar to the catheter hub of FIGs. 9A-9C. However, in the present embodiment, the pair of wing support members 176M are arranged to form a generally U-shaped structure. As shown, each wing support member 176M has a base 190 and a free end 214 and the elongated arm 210 is curved so that the free end 214 is located distally of the base.

[0194] In the present embodiment, the wing body 174 comprises three spaced apart wing body parts 174d, 174e. As shown with reference to FIG. 18B, the wing body parts include a central wing body part 174d and two end body parts 174e. As shown, the central wing body part 174d formsaround the lower part of the hub body 156 and is continuous along the bottom of the hub body but not at the top of the hub body where the hub body is exposed, as shown in FIG. 18 A. The central wing part 174d is attached to the attachment interface 218 of both wing support members 176M. Similarly, the two end body parts 174e are attached to the attachment interface of both wing support members 176M, but are spaced from one another and spaced from the central wing body part 174d. In particular, the central wing body part 174d is attached the inner attachment interface 218d of the two elongated arms and the two end body parts 174e are attached to the outer attachment interface 218b. The wing body parts 174d 174e of the wing body 174 may be over-molded onto the main body 172, and specifically attached to each elongated arm 210. Alternatively, the wing body can be co-molded, insert-molded, or unitarily molded with the main body. In other examples, the wing body can be separately formed and subsequently attached to the main body, such as by welding, adhesive, snap fit, detents, or combinations thereof.

[0195] In an example, the central wing part 174d and the two end body parts 174e form a generally straight distal edge or leading edge 260, a generally straight proximal edge or trailing edge 262, and each of the two end body parts 174e have generally straight side edges 264. Together, each of the two wings is formed by the combination wing support member and wing body and has a generally rectangular shape and the two rectangular shaped wings defined a stretched generally rectangular shaped structure having the hub body bisecting the stretched generally rectangular shaped structure.

[0196] In an example, the free ends 214 of the two wing support members 176M are exposed and are recessed from the leading edge 260, which limits direct contact therewith by the user and / or the patient. The two wing support members 176M also have upper surfaces (FIG. 18A), lower surfaces (FIG. 18B) and, at the trailing edge 262, bases 190 that are exposed. This configuration informs the user that the wings are made from at least two different materials. In alternative examples, at least one of the upper surfaces, the lower surfaces, the free ends, and the bases of the wing support members are covered by the wing body.

[0197] The two wing support members 176M, the central wing body part 174d, and two end body parts 174e define a generally planar lower contact surface 266. The lower contact surface 266 is relatively large and pliable for comfort when secured to the patient.

[0198] With reference now to FIGs. 19A and 19B, a schematic bottom plan view and a combination end cross-sectional view of the wings and front elevation view, respectively, of yet another embodiment of a catheter hub 102 of a needle assembly or needle device 100 are shown, without a needle hub and needle and catheter tube for clarity but are understood to be usable with the catheter hub 102 and may be referred to collectively as a catheter assembly or unit. The present catheter hub 102 has a multi-part body and comprises a first body 172 and a second body 174, similarto other catheter hubs discussed elsewhere herein. The catheter hub 102 is removably connected to the needle hub.

[0199] In the present embodiment, the pair of wing support members 176M are arranged to form a generally U-shaped structure. As shown, each wing support member 176M has a base 190 and a free end 214 and the elongated arm 210 is curved so that the free end 214 is located distally of the base, similar to the wing support members 176M of FIGs. 18A and 18B.

[0200] In the present embodiment, the wing body 174 comprises a single body part 174, unlike the configuration of FIGs. 18A and 18B. While the two wings extending laterally of the hub body are each generally rectangular in shape and the combined wings defines a stretched generally rectangular shaped structure, the single body part envelopes the upper surfaces of the two elongated arms as well as the distal ends of the two free ends. Thus, in the present embodiment, only the bottom surfaces of the two elongated arms and the base are exposed and not covered by the single body part.

[0201] Any of the catheter assemblies described herein are understood to include a catheter tube, a needle, a needle hub, and optionally one or more of a needle guard, a valve, a valve opener, and a third housing for housing the needle guard, as described elsewhere herein.

[0202] Methods of making and methods of using catheter assemblies and components thereof, as described elsewhere herein, are within the scope of the present invention.

[0203] Although limited embodiments of needle assemblies and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Accordingly, it is to be understood that the needle assemblies and their components constructed according to principles of the disclosed device, system, and method may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.

Claims

CLAIMS1. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section; a second body connected to the first body and having a pair of laterally extending wing members; at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section; and at least one finger guiding feature sized and shaped for guiding the finger of the user toward the finger cradle.

2. The catheter assembly of claim 1 , wherein the first body comprises a pair of laterally extending wing support members configured for supporting the wing members of the second body.

3. The catheter assembly of claim 2, wherein each of the pair of laterally extending member is unitarily formed with the first body and has a length, a width, and a surface for attaching to one of the wing members.

4. The catheter assembly of claim 2, wherein the wing support members of the first body and the wing members of the second body collectively define a reinforced pair of wings of the catheter hub.

5. The catheter assembly of claim 2, wherein the wing members of the second body extend rearwardly of the wing support members of the first body.

6. The catheter assembly of claim 2, wherein the first body comprises a pair of secondary support members connected to the wing support members.

7. The catheter assembly of claim 2, wherein each of the pair of secondary support members comprises an elongated body extending in a proximal direction from a corresponding wing support member.

8. The catheter assembly of claim 2, wherein the at least one finger cradle and the at least one finger guiding feature are integrally formed as part of at least one of the wing support members of the first body.

9. The catheter assembly of claim 2, wherein each wing support member of the first body comprises at least one notch configured for allowing each wing support member to flex.

10. The catheter assembly of claim 1, wherein the at least one finger cradle is integrally formed as part of both of the first body and the second body, and wherein the at least one finger guiding feature is integrally formed as part of both of the first body and the second body.

11. The catheter assembly of claim 10, wherein the first body comprises one or more gripping features, and wherein the second body comprises one or more gripping features located on the wing members.

12. The catheter assembly of claim 1, wherein the at least one finger cradle and the at least one finger guiding feature are integrally formed as part of at least one of the wing members of the second body.

13. The catheter assembly of claim 1, wherein the at least one guiding feature has a length that is about 4% to 30% of a length of a wing support member.

14. The catheter assembly of claim 1, wherein the at least one guiding feature has a length that is about 50%-85% of a length of a wing support member.

15. The catheter assembly of claim 1, wherein the at least one guiding feature is located closer to a free end of a wing support member than at a base of the wing support member.

16. The catheter assembly of claim 1, wherein the at least one guiding feature is located closer to at a base of the wing support member than a free end of the wing support member.

17. The catheter assembly of claim 1, wherein the first body has an underside, and wherein the second body connects to and covers at least a portion of the underside of the first body.

18. The catheter assembly of claim 1 , wherein the first body is made from a first material and the second body is made from a second material which is softer and more flexible than the first material.

19. The catheter assembly of claim 18, wherein the second material of the second body is a transparent material.

20. The catheter assembly of claim 1 , wherein a wing member has a surface that extends both proximally and distally of a wing support member.

21. The catheter assembly of claim 1 , wherein the second body comprises a second nose section connected to and covering at least a portion of the first nose section of the first body.

22. The catheter assembly of claim 1, wherein the at least one finger cradle is a groove and / or a curved surface profile.

23. The catheter assembly of claim 1, wherein the at least one finger guiding feature is a surface profile which slopes toward the at least one finger cradle.

24. The catheter assembly of claim 1 , wherein the catheter hub further comprises at least one finger guard integrally formed as part of the first body and / or the second body, and wherein the at least one finger guard is configured for preventing the finger of the user from moving laterally inward toward the first nose section.

25. The catheter assembly of claim 1 , wherein the catheter hub further comprises at least one gripping feature located within the at least one finger cradle.

26. The catheter assembly of claim 1 , wherein the second body is monolithically formed has a gap between two wings and the first body is located in the gap.

27. The catheter assembly of claim 2, wherein each of the laterally extending wings of the first body comprises a first section extending radially a first distance and a second base portion extending radially a second distance less than the first distance and defining a wing space, and wherein one of the laterally extending wing members of the second body is located in the wing space.

28. The catheter assembly of claim 27, wherein each of the second base portion extends in a proximal direction and has a tapered upper surface to define a smooth transition with one of the laterally extending wing members of the second body.

29. The catheter assembly of claim 27, wherein each of the second base portion extends in radially outward direction as it extends in a proximal direction.

30. The catheter assembly of claim 1, wherein the pair of laterally extending wing members of the second body are unitarily formed with a nose section, which is located subjacent the first nose section of the first body.

31. The catheter assembly of claim 1 , wherein the at least one finger cradle and the at least one finger guiding feature are located on a leading edge of a wing of the first body and further comprising at least one finger cradle and at least one finger guiding feature on a leading edge of one of the pair of the laterally extending wing members of the second body.

32. The catheter assembly of claim 1, wherein the at least one finger cradle and the at least one finger guiding feature on the leading edge of one of the pair of the laterally extending wing members of the second body are located below, elevation-wise, the at least one finger cradle and the at least one finger guiding feature on the leading edge of the wing of the first body.

33. The catheter assembly of claim 1 , wherein the second body has a base section having a planar surface located between the pair of laterally extending wing members and located distal of the pair of laterally extending wing members.

34. The catheter assembly of claim 1 , wherein the at least one finger cradle is located between two triangular shape projections or has a concave surface.

35. The catheter assembly of claim 7, wherein each of the pair of secondary support members has a proximally extending member and a laterally extending member forming a T-shape structure.

36. The catheter assembly of claim 1, wherein each of the pair of laterally extending wing members of the second body comprises an inner edge that extends in a proximal to distal direction and that directly contacts an exterior of the first body.

37. The catheter assembly of claim 1, wherein the first body has a wing comprising a fixation feature located on a proximal surface that engages a fixation on a distal surface of one of the pair of laterally extending wing members of the second body.

38. The catheter assembly of claim 1, wherein the first body has fixation feature located on a lower surface that engages a fixation feature on a base section of the second body, the base second located between the pair of laterally extending wing members.

39. The catheter assembly of 1, further comprising a plurality of fixation features extending from the first body or from a wing support member that is unitarily formed with the first body, and wherein each of the plurality of fixation feature comprises a stub or a knob for projecting into a wing member.

40. The catheter assembly of claim 1 , wherein each of the pair of laterally extending wing members of the second body is located distally of a leading edge of each of two wings of the first body.

41. The catheter assembly of claim 1, wherein the at least one finger guiding feature is at least one of an indented curve, an indented groove, a convex shaped structure, and an array of surface projections.

42. The catheter assembly of claim 1, wherein the at least one finger guiding feature is an array of projections of different sizes, and wherein the different sizes are arranged to direct a user’s finger towards the at least one cradle.

43. The catheter assembly of claim 1, wherein the at least one finger guiding feature is one or more arrow tip oriented to direct a user’s finger towards the at least one cradle.

44. A catheter hub comprising: a first body having a first nose section; a second body connected to the first body and having a pair of laterally extending wing members; at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section; and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle.

45. A method of manufacturing a catheter assembly comprising the steps: forming a catheter hub comprising a first body having a first nose section, a second body connected to the first body and having a pair of laterally extending wing members, at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section, and at least one finger guiding feature configured for guiding the finger of the user toward the finger cradle;attaching a catheter tube having a length and a lumen to the first nose section of the first body of the catheter hub; and extending a needle attached to a needle hub and having a needle tip through the first body and the lumen of the catheter tube in a ready to use position.

46. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein each elongated arm has a free end; a second body connected to the first body and having a pair of laterally extending wing members surrounding the free end of each of the pair of elongated arms; at least one finger cradle configured for receiving and retaining a finger of a user laterally and rearwardly away from the first nose section; and at least one finger guiding feature sized and shaped for guiding the finger of the user toward the finger cradle.

47. The catheter assembly of claim 46, wherein each of the elongated arm has a length and a width and wherein a base is located at an end opposite the free end.

48. The catheter assembly of claim 47, wherein the base has a width and wherein the width of the base is at least two times the width of the elongated arm.

49. The catheter assembly of claim 47, wherein the base and the elongated arm define an attachment interface, and wherein at least part of the second body is attached to the attachment interface and extends around the free rend.

50. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein each elongated arm has a perimeter; a second body connected to the first body and having a pair of laterally extending wing members surrounding the perimeter of each of the pair of elongated arms; and wherein each elongated arm is recessed into the second body and upper surfaces of each elongated arm are exposed.

51. A catheter assembly comprising: a needle hub;a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein each elongated arm has a notch; a second body connected to the first body and having a pair of laterally extending wing members surrounding at least part each of the pair of elongated arms but not the notch.

52. The catheter assembly of claim 51, wherein one or more fins are incorporated on an edge of at least one of the two elongated arms.

53. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein each elongated arm has a notch; a second body connected to the first body and having a pair of laterally extending wing members surrounding at least part each of the pair of elongated arms but not the notch.

54. The catheter assembly of claim 53, wherein each elongated arm has an upper surface and a lower surface, and wherein the notch is located at the lower surface.

55. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising: a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein each elongated arm has a free end; a second body connected to the first body and having a pair of laterally extending wing members, wherein each laterally extending wing member is connected to the free end of a corresponding elongated arm, and wherein each laterally extending wing member has a free end and the free ends of the pair of laterally extending wing members are removably connected to one another.

56. A catheter assembly comprising: a needle hub; a needle attached to the needle hub and having a needle tip; and a catheter hub removably connected to the needle hub, the catheter hub comprising:a first body having a first nose section and a pair of elongated arms extending laterally of a lengthwise axis and wherein the pair of elongated arms define a generally U-shape structure; a second body connected to the first body and having a pair of laterally extending wing members, wherein each of the pair of laterally extending wing members has a leading edge, a trailing edge, and a side edge and wherein the leading edge, the trailing edge, the side edge, and the first body define a generally rectangular shape wing to define two generally rectangular shape wings that are separated from one another by the first body.

57. The catheter assembly of claim 56, wherein the two generally rectangular shape wings are separated from one another by the first body.

58. The catheter assembly of claim 57, wherein the two generally rectangular shape wings define a stretched generally rectangular shaped structure having the hub body bisecting the stretched generally rectangular shaped structure.

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