Vascular access device

Abstract

A vascular access device having a handle adapted to be releasably coupled to a proximal end of a catheter assembly and a slider extending through and configured to translate along a handle slot to deploy a guide element positioned at the distal end of a guide wire extending from the handle through a needle carrier and along the exterior surface of a needle which comprises a linear segment of reduced cross section configured to be positioned through a slit of a valve within the catheter assembly hub as the needle and guide wire extend through the catheter to install the catheter into a blood vessel. The valve being adapted to reseal after the needle and guide wire are removed and configured to allow for vascular access through the proximal side of the catheter and valve.

Description

VASCULAR ACCESS DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 660,404, titled “VASCULAR ACCESS DEVICE,” filed June 14, 2024, which is incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] The present invention relates generally to methods and systems for performing vascular access. More particularly, the present invention provides a catheter and needle assembly with an integrated guide element or structure for transcutaneous insertion of the catheter into a patient's arterial or venous vasculature.BACKGROUND

[0004] One common type of vascular access is called venipuncture. Venipuncture refers generally to the process of obtaining intravenous access for any one of a variety of purposes, including intravenous infusion, therapy, blood sampling, and the like. Vascular access can be necessary for blood draws or administration of therapeutics to a patient. Indwelling catheters are often used to reduce the number of needle sticks when repeated vascular access is needed.

[0005] Generally, indwelling catheters have a catheter extending from a simple hub with a luer coupling for blood draws or therapeutic administration. These devices are limited in their capability to engage with different types or styles of medical devices as they have a standard luer connection requiring a corresponding connector of a peripheral device being coupled thereto. As the coupling mechanisms of medical devices have changed to include various coupling mechanisms, it is often required to use a matched pair catheter for the device being used. This creates a physical and financial burden on the patient and healthcare systems that are required to purchase and use the specific matched pair of devices and catheter for a given procedure.

[0006] Further, standard catheters and matched pair catheters are often open systems that rely on clamps between the portion of the catheter inserted into the patient and any accessibleport. While sterilization is vitally important for indwelling catheters, the additional sterilization process for standard catheters or open systems introduces risk of contamination.

[0007] Certain catheter systems attempting to address issues with open catheter systems introduce a tube for a vacutainer assembly that limits vascular access exclusively through the tube without any option or availability of access through the catheter after it has been placed. The inability to access the catheter in a more axially aligned manner fails to address the limited capabilities even in recent modified catheter systems.

[0008] For these reasons, it would be desirable to provide improved methods, systems, and tools for vascular access using needles and guide structures. It would be particularly desirable to provide vascular access deployment systems and assemblies having operational feedback mechanisms, step-processes for storage, deployment, and adjustment and, even more desirably, to provide components which increase efficacy and improve safety during use. At least some of these objectives will be met by the various embodiments that follow.SUMMARY OF THE DISCLOSURE

[0009] In general, a vascular access device can comprise a handle having a proximal end and a distal end with the distal end adapted to be releasably coupled to a proximal end of a vascular catheter. A slot may be positioned in a surface of the handle, the slot having a distal end and a proximal end. A slider in communication with the handle can be positioned through and configured to translate along the slot. A needle carrier having a distal end and a proximal end, can be disposed within the interior portion of the handle, the needle carrier distal end is coupled to a proximal end portion of an access needle, the access needle having an exterior wall including at least one flat section that separates two nearly circular sections.

[0010] In some aspects, there is provided a vascular access device having a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of a vascular catheter with a slot in a surface of the handle, the slot having a distal end and a proximal end. There is also a channel extending along an interior wall of the handle and a slider extending through and configured to translate along the slot along with a needle carrier having a distal end and a proximal end, the needle carrier disposed within the interior portion of the handle, the needle carrier distal end is coupled to a proximal end portion of an access needle wherein the needle carrier has a bleed back chamber in communication with a needle lumen. There is also a guide element coupled to the slider within the interior portion of the handle, the guide wire extending along the needle carrier, exiting the interior portion of the handle and extending beyond the distal end of the handle, wherein the guide element extends along an exterior wall of the needle including at least oneflat section that separates two nearly circular sections. Additionally or optionally, there is also a slider lock positioned on an interior of the handle adjacent to the proximal end configured to clock the slider in position when the needle is entirely retracted or a guide element positioned at a distal end of the guide wire, the guide element configured to transition from a stowed position within the distal end of the catheter to a deployed transition when the slider is distally advanced in the handle slot. In other embodiments, the slider is configured to engage the needle carrier proximal end, wherein the needle carrier is configured to retract the needle into the housing along with the bleed back chamber. There may also be an actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a proximal position within the handle or a catheter assembly releasably coupled to the distal end of the handle, the catheter assembly comprising a catheter having a lumen extending from a distal end of a catheter hub to a notched catheter tip, and a valve positioned within the catheter hub, the valve configured to seal a distal portion of the catheter hub. In still other aspects, the needle extends through the proximal end of a catheter assembly having a valve with a resealable slit and the guide wire is adapted to extend along the needle exterior. Additionally or optionally, there is a guide tube positioned along the needle carrier, wherein the guide wire extends beyond the distal end of the guide tube to the catheter lumen as well as a cap releasably coupled to the distal end of the handle, the cap comprising an interior configured to receive a catheter assembly therein or a guide element at the distal end of the guide wire, wherein the needle and the guide wire are configured to extend through a sealable slit in a valve positioned within a catheter assembly.

[0011] In still another alternative aspect, there is provided an indwelling catheter assembly having a hub having a proximal end and a distal end, the hub comprising an opening through the proximal end and one or more coupling bands positioned on an exterior of the hub along with a catheter extending from the hub distal end with a lumen in fluid communication with a distal interior of the hub. There is also a valve on a proximal end of the hub having a resealable slit, the valve configured to communicate with the needle and guide wire described herein and below. Optionally, there may also be an extension assembly comprising a tube extending between a luer and an extension port in fluid communication with an interior portion of the hub. In one variation there is also a stabilizing element coupled to the distal end of the hub additionally, the slit is configured to be traversed by a blood draw device coupled to the distal end of the hub. There may also be a proximal coupling region and a distal coupling region positioned around the hub exterior and configured to retain a blood draw device in communication with the hub. In another aspect, the indwelling catheter assembly is configured to direct a flow of blood from the catheter to a fluid container incommunication with the extension assembly. Still further, the indwelling catheter assembly may also be configured to receive a cannula through the slit for a blood draw through the catheter to a peripheral device coupled to the hub proximal end. In another alternative, there is a threaded coupler positioned on a proximal end of the hub, the threaded coupler configured to engage a peripheral device coupled to the proximal end of the hub. Additionally or optionally, the indwelling catheter assembly have also be configured to be placed within a vessel by a vascular access device comprising a handle with an access needle extending from the distal end of the handle and through the catheter, wherein a guide element at the distal end of a guide wire extending from the vascular access device may be positioned within the catheter lumen and the guide element can be in communication with a notch at the distal end of the catheter.

[0012] In yet another aspect, compatible with all of the above variations, there is a vascular access needle having a distal end with a tissue penetrating tip; a proximal end; a lumen extending from the proximal end to the distal penetrating tip, wherein an exterior wall of the needle has a proximal circular cross section and a distal circular cross section that are separated by a reduced diameter section. There may also be a configuration where the reduced diameter section of the exterior wall has a flat section on one side or two sides while maintaining fluid communication from the proximal end to the distal end. Additionally, there may be embodiments where the reduced diameter section of the exterior wall has a noncircular cross section profile adapted and configured for compatible placement within a valve of a closed vascular access system. Additionally or optionally, any of the needles described herein may also include a detent portion or a groove in an exterior wall portion of the needle adapted and configured to at least partially accommodate a guide element paired for use with the needle.

[0013] In some examples, methods described herein may generally comprise the steps of inserting a tissue penetrating tip of a needle into a blood vessel, extending through a valve within the catheter assembly, advancing a slider of the vascular access device distally to advance a guide element distally along the exterior of the needle and out from the a catheter lumen into the vessel, retracting the needle into an interior of the handle and detaching the catheter assembly from the distal end of the handle.

[0014] In this and any other example described herein, the method can further comprise one or more of the following. The distal end of the catheter may comprise a notch configured to engage the guide element. The step of retracting the needle can comprise releasing a needle carrier coupled to the proximal end of the needle, wherein the needle carrier is spring biased to a proximal end of the handle interior. The needle can be configured to slide proximallythrough a valve slit of the valve until the tissue penetrating tip is entirely within the handle interior. The method may further comprise a step of moving the slider distally along a slot of the handle to extend the guide element from a catheter notch and into the vessel. The catheter assembly can be coupled to a coupler at the distal end of the handle and the needle extends through the valve positioned in a catheter hub at a proximal end of the catheter lumen. The needle may comprise a guide wire channel extending along a length of the needle distal to the crimped portion. The guide wire may extend from the slider through the distal end of the handle to the distal end of the needle and between the needle exterior and catheter interior. The needle may be coupled to a vascular access device having a handle with a distal end releasably coupled to a proximal end of a catheter assembly, wherein the needle has a crimped portion.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0016] FIG. 1 A shows a distal perspective view of a blood collection device including an indwelling catheter coupled to a distal end of the device handle with a slider in a partially deployed position such that the guide element is extending beyond the catheter as it is routed through the catheter assembly through a valve along the exterior of a needle.

[0017] FIG. IB shows a side elevation view of the blood draw device from FIG. 1 A with the handle illustrated in a transparent manner to reveal the position of a needle carrier coupled to the proximal end of the needle extending through the catheter valve and catheter.

[0018] FIG. 2 is a top plan view showing zoomed into the distal segment of the device from FIG. 1 A with the catheter hub coupled to the handle distal end and the needle visible as it is positioned through the catheter hub.

[0019] FIGS. 3A and 3B are detailed distal perspective views of the device from FIG. 2A with the catheter hub removed to reveal the valve positioned within the hub and the needle / guide wire arrangement extending through the hub in alignment with the catheter lumen.

[0020] FIGS. 4 A and 4B are detailed cross section views of an exemplary arrangement of the linear needle segment passing through a slit in the proximal end of the valve positioned within the catheter hub.

[0021] FIGS. 5 A and 5B show another detailed cross section of a needle and guide wire extending through a valve in the catheter hub as an illustrative example of different cross- sectional geometries of the needle linear segment extending through the valve.

[0022] FIG. 6 is a side elevation view of a needle, described herein, showing different segments or regions including a crimped linear segment adapted to extend through the valve slit and channel segments pressed into the needle positioned distal to the crimped segment extending to a tissue penetrating tip.

[0023] FIG. 7 is a detailed side elevation view of the crimp linear segment of the needle from FIG. 6 highlighting examples of the crimped region adapted to extend through the catheter valve.

[0024] FIGS. 8 A and 8B show examples of a needle having a crimped linear segment with a flat contacting surface where a guide element can be configured to contact and extend along the flat surface through the valve slit.

[0025] FIGS. 9A-9C show examples of a needle having a crimped linear segment with a channel surface along the crimped segment where a guide element can be configured to contact and extend along the flat surface through the valve slit.

[0026] FIG. 10 is a detailed cross section of the crimped segment of the needle shown in FIG. 8A that reveals the needle lumen extending through the crimped needle segment.

[0027] FIG. 11 is another distal perspective of a needle, described herein including a cross-section view of a distal needle segment revealing an example of needle lumen geometry along a channel segment of the needle.

[0028] FIGS. 12A-12C are detailed cross section view of the distal end of the device coupled to the catheter assembly to highlight an exemplary arrangement of the needle, valve, and distal end of the device handle including the needle carrier and flashback chamber positioned proximal to the proximal needle lumen opening.

[0029] FIG. 13 is a side elevation view of the catheter valve alone illustrating features of the valve configured to align with the interior of the catheter hub, as described herein.

[0030] FIGS. 14A-14D are various detailed views of the distal end of the device first coupled with the catheter assembly and then with the catheter hub removed to highlight and exemplary arrangement of the valve and needle carrier distal end with the needle and guide wire extending through the valve slit.

[0031] FIG. 15 is a cross-section view of the device illustrated in FIG. 14D with the handle and catheter hub removed to reveal the needle carrier and the needle / guide wire extending through the valve positioned distal to the needle carrier.DETAILED DESCRIPTION

[0032] The vascular access device (VAD) as described herein can be a system including a catheter assembly (e.g., closed catheter system) and a device for installing the catheter system adapted to position a needle through the catheter with a guide element extending along the needle exterior surface from the distal end of the device handle. A valve positioned within the catheter hub can be adapted to receive a linear segment of the needle extending from a proximal side of the valve through a valve slit and on through the catheter. The device handle can be adapted to install the catheter assembly into a patient, subsequently remove the needle and guide wire through the valve, allow the valve to seal the slit and be available to subsequent engagement with a blood draw device configured to engage the catheter assembly from the proximal end and through the slit to draw blood using the installed catheter.

[0033] FIG. 1 A shows a distal perspective view of a blood collection system 100 including an indwelling catheter assembly 205 coupled to a distal end of the device handle 110 with a slider 115 in a partially deployed position such that the guide element 155 is extending beyond the catheter 202 as it is routed through a valve along the exterior of a needle 130. The slider 115 is positioned in a slot 120 and adapted to deploy and / or retract the guide element 155 as it is translated between the slot proximal end 120b and slit distal end 120a. The guide wire 150 can be seen at the distal end of the needle 130 and extends along the needle exterior through the catheter assembly 205. As shown here, the catheter assembly 205 is coupled to the distal end of the handle 110 as it may be in a ready -to-use configuration. The needle 130 and guide wire 150 are extending through a valve within the catheter assembly hub 210 with the proximal end of the needle coupled to the distal end of a needle carrier 140. An actuation button 125 is positioned at the distal end of the handle 110 near grip feature 11 and adapted to allow a user to press the button 125 to retract the needle 130 and guide element 155 after the catheter assembly 205 has been installed into a vessel.

[0034] In FIG. 1 A, an extension set 220 including a clamp 221 on an extension tube 223 extending from the catheter assembly 205 at extension port 224 can allow for a blood draw option via the luer 222 which can be coupled to a vacutainer assembly (not shown). Referring to the catheter assembly 205, a stabilizing feature 215 can be positioned adjacent to the hub 210 to stabilize the catheter assembly on the patient once installed.

[0035] FIG. IB shows a side elevation view of the blood draw device 100 with the handle 110 illustrated in a transparent manner to reveal the position of a needle carrier 140 coupled to the proximal end of the needle 130 extending through the catheter valve 300 of the catheter hub 210. The needle carrier 140 can be engaged by the slider 115 when it is in a distal most position of the handle 110. A proximal end of a guide tube 143 can be seen proximal to theneedle carrier 140 and can be configured to rout the guide wire 155 through the needle carrier 140 to the needle carrier distal end 140a and on to the surface of the needle 130 before extending through the valve 300. Also seen here is the actuation element 141. This actuation element can be triggered by the actuation button 125 such that when the button is depressed, the actuation element can bias the needle carrier proximally within the handle interior to retract (e.g., withdraw) the needle 130 and guide wire / guide element after the catheter assembly has been installed. In some examples, the slider 115 may be used to deploy the guide element 155 by moving the slider 115 in the handle slot 120. Then, when the catheter is positioned within the vessel the slider 115 may be docked at the proximal end of the needle carrier 140 and / or retracted proximally within the handle when the actuation button 125 is depressed to allow the actuation element 141 (e.g., spring) to force the needle carrier 140, needle 130, guide wire 150 and slider 115 into a retracted position with the needle distal end 130a safely within the handle interior.

[0036] The needles and guide wires described herein are configured to extend through the valve with minimal impact on the valve such that a valve slit can seal after the needle and guide wire are retracted when the catheter is placed in a patient. Accordingly, linear segments of the needle at the position where the needle is extending through the valve may be crimped or otherwise deformed compared to a standard cylindrical cannula to reduce the cross- sectional geometry and reduce the expansion of an opening through the valve. As described herein, crimped sections or segments of the needle may be dimpled, channeled, flat, or otherwise deformed on the needle exterior surface along a linear portion and adapted to be compatible with the valve slit such that the interaction between the needle / guide wire and the valve slit minimizes the impact through the valve, while also maintaining a fluid pathway through the needle lumen from the distal end (e.g., within a patient) to a flashback chamber within the needle carrier. In some examples, different geometries of the crimped linear portion of the needle extending can be configured to complement the guide wire that extends along the crimped segment and through the valve slit further reducing the overall cross- sectional geometry of the needle / guide wire that extends through the valve slit.

[0037] In some examples, reducing or preventing impact of the needle and guide wire positioned in the valve slit allows the valve slit to be resealable. The valve can therefore be used for subsequent blood draws with a blood draw device through the proximal end of the catheter assembly and through the valve (e.g., valve slit).

[0038] In FIG. 2, details of the handle distal end including a coupling feature 112 can be seen where the coupler 112 is configured to engage the catheter hub 201 and retain the catheter hub to the handle 110 while the system is being used and the catheter assembly isbeing installed. The distal end of the needle crimp section 131a can be seen just distal to the actuation trigger distal end, also configured to contact or otherwise engage the catheter hub 210. In the detailed distal view shown in FIG. 2, the alignment of the needle 130 from the handle 110 through the catheter hub 210 is visible as it is also aligned with the needle carrier 140 partially visible through the slot 120 and the handle distal end. The arrangement of these elements illustrates a coupled configuration with the handle 110 and the catheter assembly 205. Accordingly, after the catheter assembly 205 has been installed, the actuation button 125 may be depressed to retract the needle carrier 140 and the needle 130 from the catheter assembly 205 and the coupler 112 may be adapted to release or otherwise disengage with the catheter hub 210 allowing the valve to reseal and the catheter to be accessible for subsequent blood draws.

[0039] FIGS. 3A and 3B are detailed distal perspective views of the device from FIG. 2 with the catheter hub removed to reveal the valve 300 with the needle 130 and guide wire 150 arrangement extending through the valve 300. The crimped needle segment 131 can be seen in position through the valve 300 as it extends from the needle carrier 140. With the hub removed, the coupler 112 at the distal end of the handle 110 is still in position as it may be arranged relative to the valve 300 and the space between the valve and coupled is adapted to receive the proximal end of the catheter hub (e.g., threaded or luer engagement at the hub proximal side). Distal to the needle crimped portion 131, the guide element 150 can be seen extending along the needle 130 and, although not shown, the alignment of the needle 130 and guide wire 150 can be axially aligned with the catheter of the catheter assembly. Distal to the valve slit is an opening 301 into the valve interior that provides additional volume in the distal end of the catheter hub interior to support the optional flow path of a blood draw using the extension set 220 and extension port on the catheter hub. Referring to FIG. 3A, in this perspective, the tissue penetrating tip at the needle distal end 130a can be seen with the guide element 155 deployed to an atraumatic tip as it may be within a vessel when the catheter assembly is being installed.

[0040] In some examples, the distal end of the handle may be configured with a coupler that can be adapted to engage the catheter assembly including the proximal end of a valve within the catheter hub. For example, the distal end of the handle may have one or more features extending outward to engage with the catheter hub, valve, or other proximal elements of a catheter assembly, before the catheter is deployed from the distal end of the handle and installed in the patient.

[0041] FIGS. 4 A and 4B are detailed cross section views of an exemplary arrangement of the needle crimp segment 131 where it is positioned within the valve slit 305. In this crosssection, an example of the deformed cross-sectional geometry of the needle 130 can be appreciated with the lumen 134 still extending through the crimped segment 131. In this example, the upper surface of the crimped section 131 includes a channel 132a or recess configured to compliment the guide wire 155 to reduce the extent of opening or pressure applied against the valve 305 sufficiently allow for the needle 130 and guide wire 155 to be positioned therethrough. In some examples, the configuration of the needle crimped segment 131 reduces the impact to the valve slit 305 and allows for the slit to reseal after the needle and guide wire have been retracted. The slit, therefore, is available to seal the catheter until a blood draw device may be used to engage the proximal end of the installed catheter, penetrate through the valve slit, and establish a flow from the blood vessel through the catheter assembly. Also visible in FIG. 4A is the needle carrier distal end 140a and the valve 300.

[0042] In some examples, the length of the crimped segment of a needle can be adapted to the length of the needle passing through the valves. For example, the valve slit may have a length and width where the width is the distance between a proximal face and distal face of the valve slit. In this example, the length of the crimped segment of the needle may be equal to, greater than, or less than the width of the valve slit.

[0043] In FIG. 4B, the cross section is now taken distal to that shown in FIG. 4A and distal to the needle crimped section 131 now through the channel segment 133 of the needle 130. The lumen 134 is also visible with a different cross-sectional geometry that that at the crimped portion 131. However, the lumen 134 is configured to extend through the needle from the distal tissue penetrating tip to the proximal end open to the flashback chamber within the needle carrier 140. The channel 133c can also be adapted to accommodate the guide wire 150 extending along the needle exterior surface distal to the needle crimped portion 131.

[0044] As described herein, the irregular needle surface may be any geometry including any style of flat surface, recess, channel, or otherwise to accommodate the guide element extending along the needle exterior and through the valve slit to reduce the impact or opening of the valve slit where the needle and guide element pass therethrough. In FIGS. 5 A and 5B there is another detailed cross section of a needle 130 and guide wire 150 extending through a valve 300. In this example, the crimped portion 131 has a generally oval or oblong cross- sectional geometry and a flat surface 132b configured to contact the guide wire 150 along the length of the need that can be positionable through the valve slit 305. In any example described herein, the needle may extend from the needle carrier distal end 140 along with the guide element that may be routed along and / or through the needle carrier 140. The lumen 134 can be seen in these cross sections as still providing a flow path for blood from the vessel tothe flashback chamber within the needle carrier. FIG. 5B shows another cross-sectional view of the needle 130 distal to the crimped segment 131 and may be similar to that shown in FIG. 4B with the channel 133 complementing the guide wire 150 extending therethrough.

[0045] In some examples, the geometry of a valve slit may be linear such that it is adapted to conform to the exterior geometry of the needle and guide wire passing therethrough. In some examples, the valve slit may be sufficiently elastic to maintain a fluid seal around the exterior of the needle and / or guide wire passing therethrough.

[0046] The needles described herein may have different segments and features to facilitate tissue penetration, guide element routing, positioning within and through the catheter assembly, and flashback mechanisms with flashback openings or a proximal end configured to facilitate flashback that may be visible within the needle carrier 140 (e.g., flashback chamber).

[0047] FIG. 6 is a side elevation view of a needle 130 with an overall length from a proximal end 130b to a distal end 130a with a tissue penetrating tip and the distal end of the lumen 135a. Various segments of the needle may be adapted for the function of the needle described herein. For example, in FIG. 6, from the proximal side, segment 10 can be configured to couple with the needle carrier of the handle. Moving distally along the needle length, segment 10 can reflect the crimped portion 131 with a length between the crimped portion proximal end 131b and the crimped portion distal end 131a. The length of segment 10 (e.g., the crimped portion), may be any length that is sufficient to be positioned through the valve slit such that the geometry of the crimped portion is adapted to reduce any impact or opening of the valve slit and maintain the integrity of the valve while allowing for flashback and blood flow through the needle lumen 135. Segment 20 may reflect the first channel portion 133 along a length of the needle distal to the crimped portion. Transitions may be positioned between the segments of the needle to provide a complementary route for the guide wire that would extend along the needle surface. For example, segment 25 may be another channel section or distal channel section 134 extending from proximal channel section distal end 133a. The distal channel section 134 can then extend along any length until the distal lumen opening 135a. Accordingly, the needle can be adapted to route a guide element along the needle exterior through the catheter assembly, and into a vessel to position and install the catheter assembly, during use.

[0048] FIG. 7 is a detailed side elevation view of the crimp linear segment 131 (e.g., segment 15) of the needle 130 from FIG. 6 highlighting examples of the crimped region adapted to extend through the catheter valve. Again, the crimped section length 13 Id may be any length configured to extend through the catheter valve slit with a reduced diameter orcross section to complement the valve slit and reduce the impact or need for the slit to open. The crimped portion 131 extends from a proximal end 13 lb to a distal end 131a and a transition there to the channel section 133 moving distally along the length of the needle. Additional dimensions of the crimped section, such as the height 131c in this view, can be appreciated to complement the linear nature of the slit through the valve thereby reducing the amount the valve may need to open to accommodate the needle 130 therethrough.

[0049] FIGS. 8A and.8B show examples of the needle 130 including crimped section 131 configured with a flat exterior surface 132b along the length of the crimped section 131. In this perspective view, the proximal channel section 133 and distal channel section 134 can be seen extending along different planes relative to one another and a transition or decreasing taper at the proximal channel distal end 133a to the distal channel 134 that is depressed further into the needle 130. The lumen distal end 135a can be seen in FIG. 8A adjacent to the tissue penetrating tip at the needle distal end 130a. The needle proximal end 130b is generally cylindrical but also may have any geometry configured to support engagement between the needle 130 and the needle carrier of the device. From the needle proximal end 130b, there is a transition to the crimped section 131 which can facilitate the transition for the guide wire from the needle carrier (e.g., guide wire tube) onto the needle exterior surface starting at the crimped section 131. IN some examples, the guide wire is routed from the handle to the needle exterior surface proximal to the crimped portion 131 such that the guide element is aligned with the needle in a compact arrangement as the needle and guide element extend or are otherwise positioned through the valve slit. FIG. 8B shows a cross section of the needle in FIG. 8 A at the crimped section 131 to show an example of the crimp section geometry with a flat surface 132b and the lumen 135 still open and extending through the crimped portion to facilitate the flow of blood through the needle lumen to the proximal end 130b.

[0050] Similar to FIG. 8 A and 8B, FIGS. 9A-9C show another example of the needle 130 now having a crimped linear segment 131 including a channel surface 132a along the crimped segment 131 where a guide element can be configured to contact as the guide element and needle extend through the valve slit. Referring to FIG. 9A, the crimped section proximal end 131b has a portion of the channel 132a in the transition from the proximal portion of the needle 130 to the crimped section 131. Accordingly, the channel surface 132a can be configured to compliment the guide wire extending along the needle surface. In some examples, the channel surface 132a may then continue through the proximal channel section 133 then on through the distal channel section 134 where the guide element may be positioned at the distal end of the guide wire and seated adjacent, within, or otherwise at the distal end of the needle.

[0051] FIGS. 9B and 9C show detailed segment views of the crimped section 131 from FIG. 9A. In the perspective view in FIG. 9B, the channel surface 132a can be seen positioned along the entire length of the crimped section 131 of the needle. In some examples, the channel surface 132a may be coplanar with the proximal channel section 133. In some examples, there may be a transition between the channel surface 132a and channel section 133. In any example, the guide wire can be configured to extend along the needle exterior surface along the crimped section and to the distal end of the needle. Needle portion 20 may have a channel 133 that is different dimensions than the channel surface 132a of the crimped portion. In some example, needle portion 20 may have a channel 133 that is the same dimensions of the channel surface 132a. in any example, the crimped section 131 and any geometry associated therewith can be configured to be positioned within, through, across, or otherwise in contact with the valve slit to reduce the impact of the needle positioned through the valve and allow for the valve slit to be resealable for subsequent blood draws or access through the proximal end of the catheter assembly. In FIG. 9C, the cross section through the crimped section 131 including the channel surface 132a is shown again to highlight the lumen 135 still extending through the needle with any geometric configuration of the crimped portion such that the lumen is still capable of directing and facilitating a flow of blood through the needle to the needle proximal end 130b.

[0052] In some examples, the exterior geometry of the needle may be the same as the interior geometry of the lumen extending through the crimped needle portion. In some examples, the crimped needle portion may have a cross section that is circular, semicircular, or otherwise configured to reduce a diameter of the needle lumen through the crimped needle portion. For example, as illustrated in FIG. 10, the crimped needle portion has a rectangular cross section with rounded ends. In any example, the cross-sectional geometry of the crimped needle portion can be adapted to reduce the displacement of the valve slit around the needle exterior.

[0053] Regarding the needle lumen, FIG. 10 and FIG. 11 provide additional cross- sectional views to expose the needle lumen at different points of the needle. Referring to FIG. 10, the cross section is a detailed view from the distal end of the needle at the crimped section 131. The lumen dimensions, e.g., heigh 135c can be configured to allow a fluid to flow therethrough even with the crimped section 131 being more compressed than other sections of the needle. The exterior height 131c in any example of needles described herein can be optimized to reduce the impact and pressure on the valve slit allowing the valve slit to encircle or surround the needle crimped portion 131 and minimize the opening of the valve while maintain a seal against the needle and guide wire exterior positioned therethrough. Thecross section shown in FIG. 11 is taken across the distal channel section 134 and exposes a similarly deformed cross section geometry of the lumen. Here, a crescent shape of the lumen is illustrated such that is still configured to allow for a fluid to flow therethrough. Of note, in the view from FIG. 11, the crimped portion 131 is shown to be more compressed (e.g., decreased height) compared to the proximal needle portion or the channel section 133 and 134. In some examples, manufacturing the needles described herein may involve a process of applying pressure ethe a needle having an initially cylindrical or traditional circular cross section. The pressure supplied to the needle can be sufficient to deform the needle and provide for the different crimped or channel sections described herein. Accordingly, pressing the crimped section 131, the deformation may cause a reduction in the heigh of the needle cross section at the crimped section 131 accommodated by and increase in the lateral cross section as shown in FIG. 11 with the crimped section 131 being wider than other sections of the needle. The width of the crimped section can still be adapted to complement the catheter valve slit as the slit may be a linear feature through the valve.

[0054] The detailed cross section views in FIG. 12A to FIG. 12C highlight the arrangement of the catheter hub 210 with the valve 300 positioned therein at the distal end of the handle 110. These views also include a cap 400 that me be optionally associated with the vascular access system (e.g., vascular access device and catheter assembly) described herein. The cap 400 may be a protective cover configured to be positioned over the catheter assembly and coupled with the handle distal end to protect unwanted contact or displacement of the catheter assembly, needle, guide element, guide wire, etc. positionable therein. For example, the cap may be used when storing, shipping, prior to use, after use, etc. or any combination thereof.

[0055] Referring to FIG. 12A the handle 110 and catheter hub 210 are aligned with the needle 130 and is axially aligned with the needle carrier 140. The needle carrier distal end 140ais positioned adjacent to the valve proximal end 300b and the needle crimped portion 131 can be seen extending through the valve slit 305. The guide wire 150 is partially within the handle 110 and extends along and / or through the needle carrier initially through a guide wire tube 146. The guide wire 150 then exits the distal end of the guide wire tube 146 and extends through a sloped path 144 through the distal end of the needle carrier 140. The guide wire transition 146 through the needle carrier is adapted to route the guide wire from the guide wire tube extending along the needle carrier surface to become axially aligned with the needle 130 and positioned on the needle exterior before extending through the valve slit 305.

[0056] The cross-sectional views in FIGS. 12A-12C also show the flashback chamberto the catheter distal end thereby exposing the tip for insertion into a patient. During vascular access procedures, it may be beneficial to observe flashback or a visual indication that the needle is positioned within a blood vessel and the lumen now has access to the blood flowing through the vessel. Accordingly, flashback allows a user to see a flash or presence of blood from the needle in a sufficient volume to be visible, but a minimal volume for the purpose of confirming position of the needle tip in the vessel. The needle carrier described herein is coupled to the proximal portion or end of the needle such that the needle lumen is open and extend from the needle distal end (e.g., adjacent to the tissue penetrating tip) through the needle to the proximal end that can be open to a flashback chamber within the needle carrier 140. Referring to FIG. 12A, the flashback chamber is revealed in this cross section. However, the needle carrier described herein can be transparent or comprise one or more transparent sections or regions to allow visual access to the interior of the needle carrier and, in particular, the flashback chamber 143. The flashback chamber 143 can provide a volume of space adapted to receive flow from the blood vessel through the needle lumen and into the flashback chamber that can then be seen by a user to provide confirmation of the needle position and vascular access to the blood vessel. Still referring to FIG. 12 A, in some examples, flashback is facilitated by a flashback chamber 143. In some examples, flashback may be facilitated by a notch or opening at position along the needle of the needle configured to expose the needle lumen to the needle exterior. For example, the needle notch 130d indicates an optional, alternative, and / or additional flashback opening that can allow for flashback through the opening 13 Id and into the catheter that may be seen by the user. However, if the catheter is already inserted into the patient, flashback can be observed in the flashback chamber 143 of the needle carrier 140. At the flashback chamber proximal end 143a, there may be a cap or otherwise the chamber 143 can be sealed to retain any blood therein. In some examples, a notch through the needle to expose the needle lumen for flashback may be positioned at some area of the needle visible within the catheter hub (e.g., between the valve and catheter).

[0057] In FIG. 12B, further details of the arrangement including the valve 300, needle 130, guide wire 150, catheter hub 210, handle 110 and needle carrier 140 can be seen. As previously mentioned, the guide wire is extending through the guide wire tube 146 before transitioning through the guide wire transition 144 towards the needle surface before passing through the valve slit 305 with the needle crimped portion 131. The needle lumen 135 can be seen continuously extending from the distal side of the needle to the proximal end in the flashback chamber 143. The lumen 135 may be continuous but deformed based on the shape and configuration of the needle. For example, in FIG. 12B, the lumen is larger through thelength of the needle distal to the crimped portion 131, then reduced through the crimped portion 131 until the needle proximal end 130a through and within the needle carrier 140. Any configuration of the needle lumen can be configured to provide a flow of blood to indicate flashback and needle position within a vessel. Referring to FIG. 12C, the perspective here highlights the position of the valve 300 within the catheter hub 210 with the various areas of the valve configured to seat and align the valve 300 within the hub 210. The dimensions of the valve where the needle passes through the slit may be of any thickness to support the integrity of the valve 300 and the valve slit 305 with the needle / guide wire extending therethrough, as well as after the needle has been retracted to close and reseal the valve for subsequent blood draw or access to the vessel through the valve slit and catheter assembly proximal end.

[0058] FIG. 13 is a detailed view of the valve 300 alone to show the valve 300 may have regions or segments that can be used to describe the features and functions of the valve 300. Here, the distal region 306 may comprise a collar around the circumference of the valve 300 configured to contact or communicate with the interior of the catheter hub. For example, the collar at area 301b may be raised to insert into a complementary geometric area of the catheter hub interior. From the valve distal end 300a to the proximal end 300b, the circumference of the valve 300 may be the same, different, or a combination is concentric circumferential regions. Region 304 is shown to extend from the distal collar region 306 to the proximal end of the valve body at area 301a that again may be configured to engage a complementary geometric area within the hub interior. A tapered section 303 provides for a step down in the circumference between the body and the proximal region 302 with the valve slit 30 where the proximal end 300b may be configured to contact the distal end of the needle carrier.

[0059] FIGS. 14A-14D are select detailed vies of the distal end of select components of the system described herein with portions of the handle 110 and catheter hub 210 removed to expose the arrangement and interaction between the valve 300 and the needle carrier 140. Referring to FIG. 14A, the needle carrier is seen in a top plan view to show an example of an opening 140c to the guide wire transition through the needle carrier distal end 140a. Through opening 140c, the guide wire 150 continues from the guide element tube 146 to the needle130 and in particular to the needle crimped portion 131 before the needle crimped portion131 and guide wire 150 extend through the catheter hub 210. With the distal end of the handle removed, the threaded coupler 211 at the proximal end of the catheter hub is exposed and can be understood to be the area or region of the catheter hub that engages the handle coupler as shown in FIG. 2. In FIG. 14B, the catheter hub 210 is partially removed exposingthe valve 300 from the distal opening 301 to the proximal end adjacent to the needle carrier 140. The opening 140c is more exposed to illustrate an example of the guide wire 150 passing through the guide wire transition in the needle carrier 140 to the needle crimped portion 131 that then passes together through the valve 300. The guide wire tube 144 is positioned at the top of the needle carrier to direct the guide wire route along the needle carrier to the guide wire transition and needle exterior surface. FIG. 14C shows a similar view as FIG. 14B with the rest of the catheter hub removed and further detailing the guide wire 150 transition through the needle carrier 140 from the guide wire tube 144 and to the needle crimped portion 131. Here, the valve proximal end 300b is adjacent and potentially contacting the needle carrier distal end 140a as the needle crimped portion 131 passes through the valve slit 305 and then distally through the rest of the valve 300. In some examples, opening 140c may be provided in the needle carrier 140. In some examples, the guide wire tube may be integrated into the needle carrier. In some examples, the opening 140c is not present and the guide element may follow the guide element transition through the needle carrier distal end to the needle exterior enclosed in the routing including the guide element tube and the guide element transition. Finally, in FIG. 14D, the figure from 14C is rotated to show a side elevation view of the arrangement previously discussed with the crimped portion 131 extending through the valve slit 305 and the guide element 150 only partially exposed as it matches with the needle exterior and passes through the valve slit 305. The distal end of the guide tube 144 can be seen on top of the needle carrier 140 and the valve 300 still in position adjacent to the needle carrier 140. Needle segment 20 (e.g., with proximal channel portion 133) continues past the valve slit 305 through the remaining length of the valve 300 and the catheter (not shown).

[0060] FIG. 15 is a cross section of the device (e.g., system) from FIG. 14D zoomed out to expose the additional configuration of the needle carrier flashback chamber 143 extending through the needle carrier 140 proximal from the needle proximal end 130b. The flashback chamber has a closed proximal end 143. Other examples of needle carrier features that may be part of the system or may be optionally included are the recess 140e configured to facilitate fixing the needle to the needle carrier. For example, recess 140e may allow for an adhesive or other material or technique of coupling the needle to and in the needle carrier 140. In this cross section, the guide element transition 146 can be seen extending from the guide tube distal end 144a to provide routing for the guide wire 150 through the needle carrier 140 and to the needle 130. The guide wire 150 and needle crimped portion 131 are extending through the valve 300 at the valve slit 305 and then through the valve distal interior 310 where it can continue to extend through the catheter assembly and through the catheter.

[0061] Additional aspects of the construction and operation of a catheter placement device which includes a housing or handle having mechanism for advancing a guide structure or guide element which carries the catheter where the handle is adapted to automatically retract both the access needle and the guide structure or guide element from the catheter after the placement procedure is complete, a button activated automatic needle and guide withdrawal assembly are described in U.S. Patent Publication US 2008 / 0300574 and US Patent 9,522,254, each of which is incorporated herein by reference in their entirety. Still other details of representative vascular catheter insertion devices and methods are described in U.S. Pat. Nos. 5,704,914 and 5,800,395 and in U.S. Patent Publications US 2010 / 0094310; US 2010 / 0210934; and US 2012 / 0197200, the full disclosure of each of these are incorporated herein by reference in their entirety.

[0062] Additional aspects of the construction, configuration, and features of a needle or guide element used with the devices described herein are described in PCT Application Nos. PCT / US2023 / 084427, and PCT / US2024 / 014341, the full disclosure of each of these are incorporated herein by reference in their entirety.

[0063] Additional aspects of the construction and operation of a blood draw using the catheter assembly, as described herein, which includes a housing or handle having mechanism for advancing a cannula through the installed catheter assembly for a blood draw through the proximal end of the catheter hub and / or through the extension set of the catheter assembly are described in U.S. Provisional Patent Application Nos. 63 / 564,845 and 63 / 564,966, each of which is incorporated herein by reference in their entirety.

[0064] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0065] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directlyconnected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0066] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0067] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0068] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussedbelow could be termed a first feature / element without departing from the teachings of the present invention.

[0069] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0070] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0071] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various describedmethod steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A vascular access device, comprising: a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of a vascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider extending through and configured to translate along the slot; a needle carrier having a distal end and a proximal end, the needle carrier disposed within the interior portion of the handle, the needle carrier distal end is coupled to a proximal end portion of an access needle, the access needle having an exterior wall including at least one flat section that separates two nearly circular sections.

2. The vascular device of claim 1, further comprising a slider lock positioned on an interior of the handle adjacent to the proximal end configured to clock the slider in position when the needle is entirely retracted.

3. The vascular device of claim 1, further comprising a guide element positioned at a distal end of a guide wire, the guide element configured to transition from a stowed position within the distal end of the catheter to a deployed transition when the slider is distally advanced in the handle slot.

4. The vascular device of claim 1, wherein the slider is configured to engage the needle carrier proximal end, wherein the needle carrier is configured to retract the needle into the housing.

5. The vascular device of claim 1, further comprising an actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a proximal position within the handle.

6. The vascular device of claim 1, further comprising a catheter assembly releasably coupled to the distal end of the handle, the catheter assembly comprising a catheter having a lumen extending from a distal end of a catheter hub to a notched catheter tip, and a valve positioned within the catheter hub, the valve configured to seal a distal portion of the catheter hub.

7. The vascular device of claim 1, wherein the needle extends through a valve with a resealable slit, the valve positioned in the proximal end of a catheter assembly.

8. The vascular device of claim 1, further comprising a guide tube positioned along the needle carrier, wherein a guide wire extends from the slider through andbeyond the distal end of the guide tube and along the exterior surface of the access needle through a catheter lumen.

9. The vascular device of claim 1, further comprising a cap releasably coupled to the distal end of the handle, the cap comprising an interior configured to receive a catheter assembly therein.

10. The vascular device of claim 1, further comprising a guide element at the distal end of the guide wire, wherein the needle and the guide wire are configured to extend through a sealable slit in a valve positioned within a catheter assembly.

11. An indwelling catheter assembly comprising: a hub having a proximal end and a distal end, the hub comprising an opening through the proximal end and one or more coupling bands positioned on an exterior of the hub; a catheter extending from the hub distal end with a lumen in fluid communication with a distal interior of the hub; a valve on a proximal end of the hub having a resealable slit, the valve configured to communicate with the needle and guide wire of the device in claim 1; an extension assembly comprising a tube extending between a luer and an extension port in fluid communication with an interior portion of the hub.

12. The indwelling catheter assembly of claim 11, further comprising a stabilizing element coupled to the distal end of the hub.

13. The indwelling catheter assembly of claim 11, wherein the slit is configured to be traversed by a blood draw device coupled to the distal end of the hub.

14. The indwelling catheter assembly of claim 11, further comprising a proximal coupling region and a distal coupling region positioned around the hub exterior and configured to retain a blood draw device in communication with the hub.

15. The indwelling catheter assembly of claim 11, further configured to direct a flow of blood from the catheter to a fluid container in communication with the extension assembly.

16. The indwelling catheter assembly of claim 11, further configured to receive a cannula through the slit for a blood draw through the catheter to a peripheral device coupled to the hub proximal end.

17. The indwelling catheter assembly of claim 11, further comprising a threaded coupler positioned on a proximal end of the hub, the threaded coupler configured to engage a peripheral device coupled to the proximal end of the hub.

18. The indwelling catheter assembly of claim 11, further configured to be placed within a vessel by a vascular access device comprising a handle with an access needle extending from the distal end of the handle and through the catheter, wherein a guide element at the distal end of a guide wire extending from the vascular access device may be positioned within the catheter lumen and the guide element can be in communication with a notch at the distal end of the catheter.

19. A vascular access needle, comprising: a distal end with a tissue penetrating tip; a proximal end; a lumen extending from the proximal end to the distal penetrating tip, wherein an exterior wall of the needle has a proximal circular cross section and a distal circular cross section that are separated by a reduced diameter section.

20. The needle of claim 19, wherein the reduced diameter section of the exterior wall has a flat section on one side or two sides while maintaining fluid communication from the proximal end to the distal end.

21. The needle of claim 19, wherein the reduced diameter section of the exterior wall has a non-circular cross section profile adapted and configured for compatible placement within a valve of a closed vascular access system.

22. The needle of any of claims 19-21, further comprising a detent portion or a groove in an exterior wall portion of the needle adapted and configured to at least partially accommodate a guide element paired for use with the needle.

23. A method of placing a catheter assembly within a blood vessel, the method comprising the steps of: inserting a tissue penetrating tip of a needle into a blood vessel, wherein the needle is coupled to a vascular access device having a handle with a distal end releasably coupled to a proximal end of a catheter assembly, wherein the needle has a crimped portion extending through a valve within the catheter assembly; advancing a slider of the vascular access device distally to advance a guide element distally along the exterior of the needle and out from a catheter lumen into the vessel; retracting the needle into an interior of the handle; and detaching the catheter assembly from the distal end of the handle.

24. The method of claim 22, wherein the distal end of the catheter comprises a notch configured to engage the guide element.

25. The method of claim 22, wherein the step of retracting the needle comprises releasing a needle carrier coupled to the proximal end of the needle, wherein the needle carrier is spring biased to a proximal end of the handle interior.

26. The method of claim 25, wherein the needle is configured to slide proximally through a valve slit of the valve until the tissue penetrating tip is entirely within the handle interior.

27. The method of claim 22, further comprising the step of moving the slider distally along a slot of the handle to extend the guide element from a catheter notch and into the vessel.

28. The method of claim 22, wherein the catheter assembly is coupled to a coupler at the distal end of the handle and the needle extends through the valve positioned in a catheter hub at a proximal end of the catheter lumen.

29. The method of claim 22, wherein the needle comprises a guide wire channel extending along a length of the needle distal to the crimped portion.

30. The method of claim 29, wherein the guide wire extends from the slider through the distal end of the handle to the distal end of the needle and between the needle exterior and catheter interior.

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