Vascular access device

Abstract

A vascular access device comprising a handle and a slider in communication with a needle carrier in the handle. A needle extends from the needle carrier and a guide wire extends from the slider through the handle along and outside of the needle. A catheter assembly with a lumen extending from the proximal end to the distal end. The proximal end of the catheter assembly is releasably coupled to the handle such that the needle is within the lumen and the guide wire extends between the needle exterior surface and the interior surface of the catheter. A guide element coupled to the guide wire can be deployed from a stowed position such that tip of the guide element curls about a longitudinal axis of the needle or a side of the distal most end of the needle or curls off-axis compared to a guide element deployment direction.

Description

VASCULAR ACCESS DEVICECLAIM OF PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 723,585, filed November 21, 2024, titled “VASCULAR ACCESS DEVICE,” incorporated herein by reference.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.STATEMENT AS TO FEDERALLY SPONSORED RESEARCH

[0003] This invention was not made with Government support.FIELD

[0004] 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

[0005] 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. In the hospital, for example, venipuncture is commonly used to place a small intravenous catheter for delivering intravenous fluids, drug delivery, blood sampling and the like.

[0006] While venipuncture and other forms of vascular access in relatively healthy patients can be a simple matter, such access is often needed in patients who are not healthy and may have small, tortuous, collapsed, fragile, and / or difficult to locate arteries and / or veins. In such patients, venipuncture and other forms of vascular access can be very challenging, particularly to less experienced phlebotomists, paramedics, nurses, and other health care practitioners.- I of 56 -SG Docket No.: 14842-717.601

[0007] In addition to difficult access, many vascular catheter placement systems can result in accidental punctures and / or accidental needle contamination during or after placement of the intravascular catheter. Still further, some conventional catheter placement devices employ relatively complex deployment handle movements that lead to increases both cost and complexity. Additionally, conventional handle placement and movements can obscure the presence and status of the needle and guide structure or guide element components of the tool, thus making use of the insertion tool less intuitive.

[0008] Recent developments in vascular access devices (VADs) provide for dramatic improvement to previous devices and methods. However, the present invention provides novel solutions and substantial improvements to the operation, adaptability, safety, application, etc.

[0009] 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

[0010] In one aspect, there is a vascular access device having a handle having a proximal end and a distal end with a slot extending along a length of the handle in communication with an interior of the handle. There is also a needle having a distal end extending beyond the distal end of the handle and a proximal end within a needle carrier slidably arranged within the interior of the handle with a slider extending from the needle carrier and through the slot and a guide wire extending from the slider along and outside of the needle and beyond the handle distal end. There is also a catheter assembly having a proximal end. a distal end and an interior surface of the catheter defines a lumen extending from the proximal end to the distal end, wherein when the proximal end of the catheter assembly is releasably coupled to the handle distal end the needle is within the lumen and the guide wire is positioned between an exterior surface of the needle and the interior surface of the catheter. There is also a guide element coupled to a distal segment of the guide wire, wherein the guide element is adapted and configured to be deployed from a stowed position within the lumen and exterior to the needle and a deployed condition wherein a- 2 of 56 -SG Docket No.: 14842-717.601tip of the guide element is at least partially curled about a longitudinal axis of the needle or to one side of the distal most end of the needle or curls off-axis compared to a guide element deployment direction. In another aspect, there is a distal segment of the guide wire comprising a non-uniform distal segment having at least one region with a reduced diameter. Additionally or optionally, the distal segment of the guide wire further includes a guide element engagement feature. In still another aspect, the guide element is affixed onto the distal segment of the guide wire. In yet another aspect, the distal segment of the guide wire is positioned within the guide element or the guide element comprises a flexible distal portion configured to curl when the guide element is deployed from the catheter or the guide element comprises a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire or the guide element comprises a shape-set distal portion beyond the distal end of the guide wire positioned therein, wherein in use to position the catheter within a vessel the shape-set distal portion is adapted and configured to curl over a lateral edge of a beveled surface at the distal end of the needle.

[0011] In still other additional embodiments, there is a notch in a distal end of the catheter assembly a notch feature on the guide element adapted and configured for a complementary fit within the notch when the guide element is along the needle within the lumen in a stowed configuration. In some alternative embodiments, the flexible distal portion guide element comprises a notch feature and a distal end of the catheter comprises a notch adapted and configured to receive at least a portion of the notch feature. In another aspect, the slider is configured to be distally advanced within the handle slot to deploy the guide element from the distal end of the catheter. In one variation, the needle comprises one or more channels extending along a length of the needle, the one or more channels configured to accommodate the guide wire therethrough or a proximal needle channel and a distal needle channel, where in the distal needle channel is configured to accommodate the guide element between the distal needle channel and an interior surface of the catheter. In another variation there is a stabilizer positioned on a catheter hub of the catheter assembly, the stabilizer comprising at least one angled surface extending proximally from a distal end of the catheter hub at an acute angle configured to provide a position of a proximal end of the catheter hub after the catheter is positioned within a vessel.- 3 of 56 -SG Docket No.: 14842-717.601

[0012] In still another alternative embodiment, there is 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 catheter with a slot in a surface of the handle, the slot having a distal end within the handle distal end and a proximal end within the handle proximal end. There is a channel extending along an interior surface of the handle proximal end with a slider extending through and configured to translate along the slot. There is also a slider leg extending from the slider into an interior portion of the handle, the slider leg having a slider foot configured to engage the channel. There is also 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 an access needle and the needle carrier proximal end has a carrier dock sized and configured to receive a portion of the slider. There is a guide wire coupled to the slider, the guide wire extending along the needle carrier and beyond the distal end of the handle with a guide element engagement portion at a distal end of the guide wire adapted and configured to join with a guide element.

[0013] In one aspect, there is 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 when the slider is in the distal end of the slot a slider protrusion on the slider leg is engaged with a dock opening in the carrier dock or a slider knee on the slider leg configured to flex in response to the docking of the slider in the proximal end of the needle carrier. In one variation, the guide element engagement portion of the guide wire is positioned within the guide element, 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 still other alternatives, there is a slider lock recess at the proximal end of the channel, the slider lock recess configured to retain the slider in a retracted position within the handle. Additionally or optionally, the slider is configured to engage the needle carrier proximal end. wherein the needle carrier is configured to retract the needle into the housing. In one variation there may also be an actuator in the handle distal end, the actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a position within the handle proximal end. In yet another alternative, there is also a catheter assembly releasably coupled to a distal face of the handle distal end, the catheter assembly comprising a catheter having a lumen extending from a proximal end of a catheter hub to a catheter tip, and a valve- 4 of 56 -SG Docket No.: 14842-717.601positioned within the catheter hub, the valve configured to seal a proximal portion of the catheter hub. In another variation, the needle extends through the catheter lumen and the guide wire extends along the needle exterior within the catheter lumen. There may also be 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.

[0014] In yet another alternative configuration, there is a guide element configured to engage the notched catheter tip along with a notch in a distal end of the catheter assembly. There is also a notch feature on the guide element adapted and configured for a complementary fit within the notch when the guide element is along the needle within the lumen in a stowed configuration, in some configurations. In some configurations, the guide element comprises a flexible distal portion with a notch feature or a distal end of the catheter comprises a notch adapted and configured to receive at least a portion of a notch feature on a guide element. Additionally or optionally, the guide element comprises a flexible distal portion configured to curl when the guide element is deployed from the catheter or wherein the guide element comprises a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire or wherein the guide element comprises a shape-set distal portion beyond the distal end of the guide wire positioned therein, wherein in use to position the catheter within a vessel the shape-set distal portion is adapted and configured to curl over a lateral edge of a beveled surface at the distal end of the needle.

[0015] In another embodiment, there is a method of preparing a vascular access device for use, by moving a slider proximally along a handle to rotate a distal most portion of a guide element about a needle distal tip without contacting the needle distal tip. Next, there is a step of ceasing moving the slider proximally along the handle when the guide element is seated within a catheter lumen along an outer surface of the needle. Additionally, after the ceasing step a notch feature on the guide element is seated within a notch of the catheter.

[0016] In still another alternative aspect, there is a compound guide wire for placement of a catheter assembly having a guide wire with an elongate body and a distal segment having at least one region of a smaller diameter than a proximal end of the guide wire. There is also a guide element coupled to the distal segment of the guide wire, hi one variation, the guide element has a distal portion configured to transition from a linear configuration to a curled configuration,- 5 of 56 -SG Docket No.: 14842-717.601wherein the distal portion of the guide element extends beyond a position of a distal end of the guide wire.

[0017] In general, a vascular access device can comprise a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of a catheter. A slot in a surface of the handle, the slot having a distal end and a proximal end. A channel extending along an interior surface of the handle. A slider extending through and configured to translate along the slot. A slider leg extending from the slider into an interior portion of the handle, the slider leg having a slider foot configured to engage the channel extending along the interior surface of the handle. 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 an access needle and the needle earner proximal end has a carrier dock sized and configured to receive a portion of the slider. A guide wire coupled to a portion of 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.

[0018] This and any other embodiments described herein may further comprise one or more of the following. The device may further comprise a slider lock position on an interior of the handle adjacent to the proximal end configured to lock the slider in position when the needle is entirely retracted. The slider may be in the distal end of the slot a slider protrusion on the slider leg is engaged with a dock opening in the needle earner. The device may further comprise a slider knee on the slider leg configured to flex in response to the docking of the slider in the proximal end of the needle carrier. The device may further comprise 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. The device may further comprise a slider lock recess at the proximal end of the channel, the slider lock recess configured to retain the slider in a retracted position within the handle. The slider may be configured to engage the needle carrier proximal end, wherein the needle carrier is configured to retract the needle into the housing. The device may further comprise 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. The device may further comprise a catheter assembly releasably coupled to the distal end of the handle, the catheter assembly comprising a catheter having a lumen extending from a- 6 of 56 -SG Docket No.: 14842-717.601distal 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. The needle extends through the catheter lumen and the guide wire extending along the needle exterior within the catheter lumen. The device may further comprise 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. The guide element is configured to engage the notched catheter tip. The device may further comprise a needle protection cap releasably coupled to the distal end of the handle, the needle protection cap comprising an interior configured to receive the catheter assembly therein.. The device may further comprise a guide element at the distal end of the guide wire, wherein the needle and the guide wire may be configured to extend through a catheter lumen. The guide element may be configured to be advanced beyond a tissue penetrating tip of the needle when the slider is distally advanced in the slot.

[0019] The guide element may be configured to form an atraumatic tip distal to the tissue penetrating tip when distally advanced. The access needle further comprises a needle channel extending along a length of the needle with rails extending along each side of the needle channel. The rails may be configured to contact a guide element to transition an atraumatic tip of the guide element from a curled configuration to a linear configuration. The device may further comprise rails extending along lateral sides of a needle channel positioned on the needle surface from a distal end of the needle to a proximal region of the needle, wherein the rails are configured to contact the guide element to transition the guide element to a linear configuration in the stowed position.

[0020] In general, a cover for a vascular access device may comprise a body having a proximal end and a distal end and an interior portion accessible from the proximal end. One or more alignment features on a proximal face or region of the proximal end adapted and configured to releasably engage with a vascular access device. One or more alignment features along or within an interior wall of the body for accommodation of a portion of a vascular access hub. One or more alignment features along or within an interior wall of the body for facilitating the movement of a guide element into a loaded position when moved from a distal position to a proximal position along the interior of the body.

[0021] In general, a method of loading a vascular access device for use may comprise the steps of inserting a vascular access device having an indwelling catheter, access needle and guide- 7 of 56 -SG Docket No.: 14842-717.601element coupled to a handle into a cover described herein. Withdrawing a slider on the handle in a proximal direction to move a guide element proximally within the interior of the body along the one or more of the alignment features. Stopping the withdrawal of the slider when the guide element is seated between a needle exterior wall and a catheter interior wall. In some examples, the method may further comprise removing the cover before use to place the indwelling catheter into a vessel of a patient.

[0022] In general, a vascular access device can comprise a handle having a proximal end and a distal end with a slot extending along a length of the handle; a needle extending beyond the distal end of the handle with a proximal end coupled to a needle carrier positioned within the handle; a slider in communication with a guide wire, the guide wire extending from the slider through a tube positioned along the needle carrier and out of the handle distal end though a catheter assembly releasably coupled to the handle distal end, wherein the guide wire extends between an exterior surface of the needle and an interior surface of the catheter; a guide element positioned over a distal segment of the guide wire, wherein the guide element is configured to be deployed from the catheter along the needle exterior to form an atraumatic tip after a distal tip of the needle is inserted into a vessel.

[0023] This and any other embodiments described herein may further comprise one or more of the following. The guide wire can comprise a non-uniform distal segment having at least one region with a reduced diameter and a guide element engagement feature. The guide element can be affixed onto the distal segment of the guide wire. The distal segment of the guide wire can be positioned within the guide element.

[0024] The guide element may comprise a flexible distal portion that can be configured to curl when the guide element is deployed from the catheter. The guide element may comprise a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire. The guide element may comprise a shape-set distal portion beyond the distal end of the guide wire positioned therein, wherein the shape-set distal portion can be configured to curl over a lateral edge of a beveled surface at the distal end of the needle. The guide element may comprise a distal tip, and wherein a distal end of the catheter comprises a notch configured to receive at least a portion of the guide element distal tip. The slider is configured to be distally advanced within the handle slot to deploy the guide element from the distal end of the catheter. The needle comprises one or more channels extending along a length of the needle, the one or more channels- 8 of 56 -SG Docket No.: 14842-717.601configured to accommodate the guide wire therethrough. The vascular access device may further comprise a proximal needle channel and a distal needle channel, where in the distal needle channel can be configured to accommodate the guide element between the distal needle channel and an interior surface of the catheter.

[0025] The vascular access device may further comprise a stabilizer positioned on a catheter hub of the catheter assembly, the stabilizer comprising at least one angled surface extending proximally from a distal end of the catheter hub at an acute angle configured to provide a position of a proximal end of the catheter hub after the catheter can be positioned within a vessel.

[0026] In general, a vascular access device can comprise a handle with a proximal end and a distal end, the distal end can be adapted to be releasably coupled to a proximal end of a catheter; a slot in a surface of the handle, the slot may have a distal end and a proximal end; a channel extending along an interior surface of the handle; a slider extending through and configured to translate along the slot; a slider leg extending from the slider into an interior portion of the handle, the slider leg may have a slider foot configured to engage the channel extending along the interior surface of the handle; a needle carrier with a distal end and a proximal end, the needle carrier can be disposed within the interior portion of the handle, the needle carrier distal end can be coupled to an access needle and the needle carrier proximal end has a carrier dock sized and configured to receive a portion of the slider; and a guide wire coupled to a portion of the slider within the interior portion of the handle, the guide wire can extend along the needle carrier, exiting the interior portion of the handle and extending beyond the distal end of the handle with a guide element engagement portion at a distal end of the guide wire configured to communicate with a guide element.

[0027] This and any other embodiments described herein may further comprise one or more of the following. The vascular access device may comprise 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. When the slider is in the distal end of the slot a slider protrusion on the slider leg is engaged with a dock opening in the carrier dock. The vascular access device may further comprise a slider knee on the slider leg configured to flex in response to the docking of the slider in the proximal end of the needle carrier. The guide element engagement portion of the guide wire can be positioned within the guide element, the guide element configured to transition from a stowed position within the distal end of the catheter to a deployed transition when the- 9 of 56 -SG Docket No.: 14842-717.601slider is distally advanced in the handle slot. The vascular access device may further comprise a slider lock recess at the proximal end of the channel, the slider lock recess configured to retain the slider in a retracted position within the handle. The slider can be configured to engage the needle carrier proximal end, wherein the needle carrier is configured to retract the needle into the housing. The vascular access device may further comprise an actuator in operable communication with a spring, wherein the actuator can be configured to release the spring to bias the needle carrier to a proximal position within the handle. The vascular access device may further comprise 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 can be configured to seal a distal portion of the catheter hub. The needle extends through the catheter lumen and the guide wire extending along the needle exterior within the catheter lumen. The vascular access device may further comprise 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. The guide element can be configured to engage the notched catheter tip.

[0028] This and any other embodiments described herein may further comprise one or more of the following. The vascular access device may further comprise a cap releasably coupled to the distal end of the handle, the cap comprising an interior configured to receive the catheter assembly therein. The vascular access device may further comprise a cap releasably coupled to the distal end of the handle, the cap comprising an interior configured to receive a catheter assembly therein. The vascular access device may further comprise a guide element at the distal end of the guide wire, wherein the needle and the guide wire can be configured to extend trough a catheter lumen. The guide element is configured to be advanced beyond a tissue penetrating tip of the needle when the slider is distally advanced in the slot. The guide element can be configured to form an atraumatic tip distal to the tissue penetrating tip when distally advanced. The access needle further comprises a needle channel extending along a length of the needle with rails extending along each side of the needle channel. The rails are configured to contact a guide element to transition an atraumatic tip of the guide element from a curled configuration to a linear configuration. The vascular access device may further comprise rails extending along lateral sides of a needle channel positioned on the needle surface from a distal end of the needle- 10 of 56 -SG Docket No.: 14842-717.601to a proximal region of the needle, wherein the rails can be configured to contact the guide element to transition the guide element to a linear configuration in the stowed position.

[0029] In general, a cover for a vascular access device may comprise a body having a proximal end and a distal end and an interior portion accessible from the proximal end; one or more alignment features on a proximal face or region of the proximal end adapted and configured to releasably engage with a vascular access device; one or more alignment features along or within an interior wall of the body for accommodation of a portion of a vascular access hub; one or more alignment features along or within an interior wall of the body for facilitating the movement of a guide element into a loaded position when moved from a distal position to a proximal position along the interior of the body.

[0030] In general, a method of loading a vascular access device for use comprising the steps of inserting a vascular access device having an indwelling catheter, access needle and guide element coupled to a handle into a cover, as described herein; withdrawing a slider on the handle in a proximal direction to move a guide element proximally within the interior of the body along the one or more of the alignment features; stopping the withdrawal of the slider when the guide element is seated between a needle exterior wall and a catheter interior wall.

[0031] In some examples, the method may further comprise removing the cover before use to place the indwelling catheter into a vessel of a patient.

[0032] In general, a stabilizer for a catheter assembly may comprise a catheter hub with a catheter extending distally from the catheter hub; and a stabilizing element positioned at the distal end of the catheter hub with a surface extending proximally at an angle out from the stabilizing element, wherein the surface is configured to contact a patient and position a proximal opening of the catheter hub away from the patient.

[0033] This and any other embodiments described herein may further comprise one or more of the following. The surface of the stabilizing element may extend at an acute angle relative to a central axis of the catheter hub. The surface of the stabilizing element may extend an acute angle away from the catheter hub. The surface of the stabilizing element may extend at an angle between 10 degrees and 20 degrees.

[0034] In general, a compound guide wire for placement of a catheter assembly may comprise a guide wire having an elongate body and a distal segment having at least one region of a smaller diameter than a proximal end of the guide wire; and a guide element coupled to the- 11 of 56 -SG Docket No.: 14842-717.601distal segment of the guide wire, the guide element comprising a distal portion configured to transition from a linear configuration to a curled configuration, wherein the distal portion of the guide element extends beyond a position of a distal end of the guide wire.BRIEF DESCRIPTION OF THE DRAWINGS

[0035] 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:

[0036] FIG. 1 shows a perspective view of a vascular access device from a distal end with a cap covering a catheter assembly and coupled to the distal end of a handle. An example of a stabilizing element in communication with the catheter assembly is partially visible under the cap and the slider is shown in a stored configuration and position in the handle slot.

[0037] FIG. 2 shows the vascular access device in FIG. 1, again in a perspective view from the distal end now with the cap removed to expose the catheter assembly in communication with the distal end of the device and a guide element having an atraumatic tip curled beyond the tissue penetrating tip of the needle, both extending through an interior of a catheter lumen coupled to the distal end of the catheter hub.

[0038] FIG. 3 shows the vascular access device of FIG. 2 in a side elevation view with the handle illustrated in a transparent manner to expose the position of a needle carrier and portion of the slider extending into the handle through the handle slot. The atraumatic tip of the guide element is still curled beyond the tissue penetrating tip of the needle as the slider is in a distally advanced position relative to the handle slot. In this configuration, the vascular access device may be stored or otherwise ready to be loaded prior to insertion.

[0039] FIG. 4A and 4B show internal elements of the vascular access device of FIG. 2 in a side elevation view with the handle and catheter hub removed to expose the arrangement of the slider, needle carrier, guide tube, actuation button, hemostasis valve and guide element above the needle extending distally from the needle carrier.

[0040] FIG. 5 is a detailed view of internal elements of a vascular access device illustrated in FIG. 2 with the handle and catheter hub removed to expose the distal portion of the needle- 12 of 56 -SG Docket No.: 14842-717.601carrier proximal to the hemostasis valve with the guide tube transitioning from the needle carrier channel towards the surface of the needle. The needle is shown coupled to the needle carrier and extends through the catheter lumen with the guide element positioned between the needle car the catheter lumen interior surface.

[0041] FIG. 6 is a perspective view of the vascular access device illustrated in FIG. 1 from the distal end with the cap, catheter hub and assembly removed to expose the distal end of the needle carrier extending beyond the distal end of the handle. The guide element routing tube are also shown extending beyond the distal end of the needle carrier.

[0042] FIG. 7 is a perspective view of the vascular access device from the proximal end of the handle and the cap engaged to the handle distal end. Alignment elements of the catheter assembly are seen as accommodated by the cap.

[0043] FIG. 8A shows the vascular access device illustrated in FIG. 1 from a side elevation view close up to the proximal portion of the handle with the slider in an advanced position through the slider channel inside the handle interior.

[0044] FIG. 8B is a cross section of the view in FIG. 8A exposing details of the slider channel and arrangement of the operational elements at the proximal end of the slider channel within the handle. The slider is advanced and adjacent to the proximal end of the needle carrier, but has not yet advanced to a docked position within the needle carrier.

[0045] FIG. 9 is a cross section of a side elevation view of the vascular access device in FIG. 8A and 8B to expose the interior of the guide element. In this exposed view, the arrangement of the actuation button, needle carrier, guide tube, slider and distal handle portion can be appreciated with a dock at the proximal end of the needle carrier and needle earner lumen configured to receive the needle at the needle carrier distal end.

[0046] FIGS. 10A to 10C are various views of the needle carrier including a bottom plan view in FIG. 10A and perspective views from the distal end in FIG. 10B and proximal end in FIG. 10C. The guide tube channel extends along the needle carrier to accommodate the guide tube positioned therein from the guide tube lumen of the slider leg through the distal end of the handle towards the needle surface in the catheter hub. The dock at the proximal side of the needle carrier is shown in FIG. 10C as it may be adapted to receive the bent leg of the slider in a distally most advanced position.- 13 of 56 -SG Docket No.: 14842-717.601

[0047] FIG. 1 1 A and 1 IB are perspective views of the cap from FIG. 1 from the distal end and proximal end, respectively. The cap can be configured to removable couple to the distal end of the vascular access device. The interior of the cap in FIG. 1 IB shows several alignment features to support engagement with the catheter assembly and handle distal end including the actuation button.

[0048] FIGS. 12A and 12B are side elevation and distal end perspective views of the catheter, guide element and needle illustrated in FIG. 2. The guide element is shown with an atraumatic tip adapted to curl and straighten when it is advanced or retracted along the needle body, respectively. The needle comprises a curved channel pressed along a length of the needle body with a distal end of the channel adapted to contact the guide element curl and motivate the guide element to straighten out and avoid contact between the needle tissue penetrating tip and the guide element, as the guide element is retracted. Radiopaque elements are seen within the catheter and can identify the position of the catheter as well as the guide element and needle extending through the catheter lumen.

[0049] FIG. 13 is a detailed view for the distal perspective showing the guide element extended or in a deployed configuration beyond the tissue penetrating tip of the atraumatic tip of the guide element can be based on shape memory of the material or manufacturing processes of the guide element. The guide element channel of the needle can be seen including the distal end of the channel having raised rails configured to contact the guide element lateral edges when the guide element is retracted. Contact between the needle channel rails and the guide element can bias the guide element into a straight position uncurling the atraumatic tip in advance of the tissue penetrating tip of the needle to prevent inadvertent contact between the guide element and the tissue penetrating tip.

[0050] FIG. 14A and 14B are perspective views of the guide element from a distal perspective showing the atraumatic tip, guide element lateral edges and coupling features configured to support engagement between the guide element and the guide wire. In some examples, the guide element is over molded or otherwise affixed to the guide wire. In some examples, the guide wire may comprise a braid or mesh at a distal end or segment that is over molded with the guide elements described herein.

[0051] FIG. 15 is a side elevation view from the distal end of the needle and catheter distal end with a cross section of the guide element and guide wire as illustrated in FIG. 12A.- 14 of 56 -SG Docket No.: 14842-717.601

[0052] FIG. 16 is a cross section of a side elevation view of a distal segment of the device from FIG. 1 showing the arrangement of the catheter hub and handle distal end when the cap is coupled to the device.

[0053] FIG. 17 is a further detailed view of the device illustrated in FIG. 16 showing the guide element in a configuration as it may be when the cap is coupled to the distal end of the handle and the device is waiting to be primed or adjusted to a ready-to-deploy configuration.

[0054] FIG. 18 is another detailed view of the device illustrated in FIG. 16 showing a close up view of the distal end of the handle in the proximal end of the cap as it may be in a configuration when the cap is coupled to the handle.

[0055] FIG. 19 is a cross section view of the device handle as shown in FIG. 1 with the slider in a medial position within the handle such that the guide wire is ready to be retracted or primed to a ready-to-use configuration including the configuration of the proximal end of the needle carrier.

[0056] FIG. 20 is another detailed cross section view of the device illustrated in FIG. 1 showing the proximal end of the handle and highlighting examples of the proximal end of the slider channel and features of the handle interior near the proximal end configured to engage the slider leg.

[0057] FIG. 21 A to 2 ID show a transition of the device to an armed or ready-to-use configuration with the guide element being in a first partially deployed position in FIG. 21 A that then transitions to a ready-to-use configuration with the guide element docked in the needle channel within the catheter ready for insertion.

[0058] FIG. 22 is a top plan view of the distal end of a vascular access device with a lateral cross section of the guide element revealing a distal portion of the guide wire as it may be positioned in the guide element.

[0059] FIG. 23A is a detailed side elevation view of the needle with the catheter removed to expose an exemplary position of a guide element within the needle channel, as it may be prior to being deployed. FIG. 23B is a cross section view of the needle in FIG. 23A revealing additional details of the guide element and the distal guide wire segment within the guide element.

[0060] FIG. 24A to FIG. 24H show the needle in a perspective view with various cross sections taken along the needle length to reveal exemplary configurations of needle features with- 15 of 56 -SG Docket No.: 14842-717.601the position and arrangement of the guide wire and guide element in a nested configuration within the needle channel.

[0061] FIG. 25 shows the needle from FIG. 24 from the distal end.

[0062] FIG. 26 illustrates an exemplary configuration of a guide element distal segment having a curl or spiral configuration that can be offset from a linear axis of the distal end of the guide wire in a deployed configuration.

[0063] FIG. 27A and FIG. 27B illustrate the off-set guide element in an at least partially deployed configuration from a top plan view and bottom plan view, respectively.

[0064] FIG. 28A and FIG. 28B illustrate the guide element from FIG. 26 in a proximal perspective view to show an arrangement of the guide element offset curl relative to the needle distal end.

[0065] FIG. 29A and FIG. 29B illustrate the needle distal end from FIG. 28A and FIG. 28B now from the top of the needle and including a distal perspective view in FIG. 29A with the guide element at least partially deployed.

[0066] FIG. 30 to FIG. 32 illustrate a detailed cross section view the distal end of the needle having the guide element from FIG. 26 in an at least partially deployed configuration.

[0067] FIG. 33 illustrates detailed views of the guide wire distal end alone to highlight features including one or more non-uniform features along the guide wire distal segment that may be positioned or incorporated within the guide element.

[0068] FIG. 34A and FIG. 34B illustrate detailed views of various regions, segments, portions, or aspects of a needle alone to highlight features of the needle.

[0069] FIG. 35A to FIG. 36B illustrate an example of a handle of a vascular access device having at least two parts shown in perspective views including cross sections in FIG. 35C and FIG. 36B to expose additional interior handle details.

[0070] FIG. 37A and FIG. 37B are cross section views of the distal end of the vascular access device with the catheter hub coupled thereto and highlighting an exemplary arrangement of the guide tube distal end with the needle proximal end.

[0071] FIG. 38 shows the catheter assembly, as it may be coupled with the distal end of the handle and highlighting an exemplary configuration of the stabilizing features including an angular position of the stabilizing features to provide an improved presentation of the catheter hub after it has been installed in a vessel.- 16 of 56 -SG Docket No.: 14842-717.601DETAILED DESCRIPTION

[0072] A vascular access device (VAD) as described herein can comprise elements configured to access the vasculature of a patient in a safe, efficient and effective manner with intuitive manipulation of a needle controlled by a slider operably couples thereto. The slider can be operably coupled to the VAD and engaged by a user with positive feedback to indicate a position of the slider relative to an VAD handle (e.g., body) allowing the user to maintain constant focus on the placement and advancement of a needle, catheter, or other element into a blood vessel. The VAD may have one or more features to facilitate the static and / or dynamic positioning of the slider and elements operably couped thereto relative to the VAD and / or the patient.

[0073] FIG. 1 illustrates a vascular access device 100 from a distal end with a cap 300 covering a catheter assembly and coupled to the distal end of a handle 105. An example of a stabilizing element 205 in communication with the catheter assembly is partially visible under the cap 300 and the slider 110 is shown in a stored configuration and position in the handle slot 115. The handle 105 has a proximal end and a distal end. Although the distal end is obscured by the cap 300 in FIG. 1, it is configured to be inserted into the cap when the device is not in use. In this example, and near the distal end of the handle 105, engagement feature 120 is shown to support handling and manipulation of the device 100, in use. The slot 115 extends along a length of the handle 105 from the proximal end to the distal region of the handle 105.

[0074] In some examples, the length of the slot 115 is configured to define a length of travel of the slider 110 when in use. The slider 110 is configured to be advanced or retracted along the slot 115 and control a length of deployment or position of a guide element in communication with the slider 110. For example, the slider 110 is shown in a distal position within the slot 115 as an exemplary configuration of the device as it may be before it is loaded or adjusted to a ready-to-use configuration.

[0075] The cap 300 can have a proximal end and a distal end with an interior configured to receive the distal end of the handle 105, catheter hub, and needle therein. The stabilizing element 205 may be accommodated by the cap 300 with a channel or detent configured to allow the stabilizing element to seat in a position relative to the cap distal end.- 17 of 56 -SG Docket No.: 14842-717.601

[0076] FIG. 2 shows further detail of the vascular access device 100, now with the cap 300 removed to expose the catheter assembly in communication with the distal end of the device 107 and a guide element 130 having an atraumatic tip curled beyond the tissue penetrating tip of the needle 135, both extending through an interior of a catheter 210 (e.g., catheter lumen) coupled to the distal end of the catheter hub 200. The catheter assembly can include the catheter hub 200, stabilizing element 205 and catheter 210. The catheter hub 200 can be configured to couple to the handle distal end 107 with a hemostasis valve positioned therein adjacent to the needle carrier before being inserted and deployed into a patient. As seen in FIG. 2, the needle 135 and guide wire extend through catheter 210 with the guide element 130 positioned at a distal end of the catheter 210. The guide element 130 can be in communication with the slider 110 with a length of guide wire extending therebetween and through the catheter assembly, outside of the needle 135.

[0077] FIG. 2 also shows an actuation button 125 that is configured to control a proximal release of the needle carrier when the needle 135 is to be retracted after placement and insertion of the catheter 210 in the patient. As shown, the slider 110 is in the distal position of the handle slot 115 and in this position, the guide element 130 is extended or deployed beyond the needle 135. Although shown outside of a patient, it can be understood that deployment of the guide element 130 by the slider 110 can be appreciated to deploy beyond the needle 135 as it may be used to guide deployment of the catheter 210 through the vessel, protect the vessel against inadvertent puncture by the needle 135, and support position of the catheter assembly in pace within the patient. The length of deployment may relate to the position of the slider 110 in the handle slot 115 relative to the handle proximal end 106 and the distal end of the slot 115.

[0078] FIG. 3 shows the vascular access device 100 from FIG. 1 in a transparent manner to expose the handle interior and the position of a needle carrier 140 and slider leg 163 into the handle 105 through the handle slot 115. The guide element atraumatic tip 130a is still curled beyond the tissue penetrating tip of the needle 135 as the slider is in a distally advanced position relative to the handle slot 115. The device 100 is in the same position illustrated in FIG. 2 with the slider 110 in a distal position within the slot 115, but proximally positioned relative to the needle carrier 140. The slider foot 163 at the terminal end of the slider leg 162 is positioned within the slider channel at the bottom surface of the handle interior. The slider leg 162 is free to advance of retract within the slider channel. The needle carrier 140 is set in position and retained- 18 of 56 -SG Docket No.: 14842-717.601by the actuation button 125 against spring pressure from the actuation spring 145 in a compressed state ready to force the needle carrier 140 to a proximal position in the handle 105 when the actuation button is depressed. The catheter assembly including catheter hub 200, stabilizing element 205, catheter 210 are coupled to the distal end of the handle over the distal end of the needle carrier 140 that may be protruding from the handle distal end 107.

[0079] In the example illustrated in FIG. 3, the guide element 130 is in an advanced position relative to the needle 135 as it is extended through the interior of the catheter 210 between the catheter lumen interior surface and the needle exterior surface. The guide element 130 is at a distal end of a guide wire 131 seen extending proximally through and beyond the slider leg 162 that can be used to communicate with the guide wire 131. Accordingly, when the slider 110 is advanced or retracted in the slot 115. the slider position can be translated to the guide element 130deployment or position.

[0080] In some examples, the needle carrier 140 is coupled to the needle 135 at the needle proximal end. As described herein, the needle carrier 140 may be retained in a position within the handle 105 until the actuation button 125 is depressed causing the actuation spring 145 to force the needle carrier 140 proximally within the handle 105. The needle 135, coupled to the needle carrier 140, is correspondingly forced proximally within the handle 105 and maintained in a safe position with the tissue penetrating tip guarded inside of the handle thereby preventing inadvertent needle stick or contact.

[0081] FIG. 4A and 4B show internal elements of the vascular access device 100 from FIG.2. Here, the handle 105 has been removed from view to expose and highlight examples of internal component configuration including the needle carrier 140, slider 110, catheter 210, guide element 130, guide wire 131, and actuation button 125. Referring to FIG. 4A, the guide wire 131 can be seen extending through the slider leg 162, through the needle carrier 140, through the hemostasis valve 220. and through the catheter 210 to the guide element 130 at the guide wire distal end. When the guide wire 131 leaves the handle 105 through the distal end of the needle earner 140, it may be routed through the interior of the catheter 210, after passing through the hemostasis valve 220. The guide wire 131 can be configured to route through the catheter lumen along an exterior surface of the needle which may have a flat surface or channel to support additional space inside the catheter 210 allowing the guide element to pass therethrough. In some examples, the guide wire routing through the catheter and outside of the needle allow for- 19 of 56 -SG Docket No.: 14842-717.601advancement and function of the guide element during use, then allows for the retraction of the needle with the guide wire and guide element, in combination or independent of one another. In this example, a further feature of the guide element 130 is the guide element atraumatic tip 130a shown as a curled distal portion of the guide element 130 beyond the needle 135, as it may be when advanced to a deployed or partially deployed configuration.

[0082] FIG. 4B, is a detailed view exposing additional features of the needle carrier 140 including the needle carrier dock 150 at the needle carrier proximal end. The dock 150 can be configured to receive the slider 110 therein. The slider 110 may be distally advanced through the handle slot 115 to a distal most position where the slider leg 162, including the slider knee 161, and slider foot, can bend or conform to engage and seat in the needle carrier dock 150. In some examples, when the slider 110 is docked to the needle earner, the actuation spring 145 can then bias or force the needle carrier 140, needle 135, and slider proximally within the handle 105 when the actuation button 125 is pressed. In this detailed view, the proximal end of the needle 135 can be seen positioned within the needle earner 140. In some examples, the needle carrier 140 may have one or more features to facilitate communication between the needle 135 and the needle carrier 140. For example, openings, channels, grooves, apertures, or other features of the needle carrier 140 can allow for adhesive, over molding, or other type of coupling support between the needle 135 and needle carrier 140.

[0083] The hemostasis valve 220 is shown in a transparent manner in FIG. 4B to illustrate an example of routing or path for the guide wire 131 to extend from the handle, through the catheter assembly. Here, there is a guide element tube 132 that can be configured to route the guide wire131 therethrough. In the illustrated example, the guide element tube 132 may be a feature of the needle carrier 140, or may be a tube in communication with the needle carrier 140 with a lumen extending through the guide tube adapted for the guide wire to pass therethrough. The guide tube132 is shown with an angled segment near the distal end to support a directional transition of the guide wire from within the handle and along the upper surface of the needle carrier 140 in alignment with the slider leg 162 to transition down to the needle exterior surface. Here, the needle 135 may have an axis generally parallel with the guide tube 132, but separated by some distance as the needle 135 is coupled to or near the central axis of the needle carrier 140 while the guide wire 131 is positioned along an upper / exterior surface of the needle carrier 140. Then,- 20 of 56 -SG Docket No.: 14842-717.601the guide tube 132 is angled to direct or deflect the guide wire 131 towards the axis of the needle until the guide wire is positioned along an exterior surface of the needle and through the catheter.

[0084] FIG. 5 further details this arrangement of the needle carrier 140, guide tube 132, guide wire 131, and needle 135. The angled segment of the guide tube 132 tapers from the upper axis along the needle carrier 140 towards the needle 135 through the hemostasis valve 220 until the distal end of the guide tube 132 is generally aligned with the needle axis and in closer proximity to the needle 135 such that the guide wire 131 can extend from the guide tube 132 and be adjacent to the needle exterior surface through the catheter 210.

[0085] Also highlighted in FIG. 5 is the actuation button 125 configuration in communication with the distal end of the needle carrier 140. The actuation button 125 may retain the needle carrier 140 with arms extending between the button upper surface and a lower coupling mechanism 126 configured to engage the lower surface of the needle carrier 140 near its distal end 141. The needle 135 can be seen extending into the needle carrier interior and opening 144 provides a coupling feature or cavity where adhesive or other form of fixative may be introduced to retain the communication between the needle 135 and needle carrier 140.

[0086] FIG. 6 is another proximal view of the vascular access device 100 showing the distal end of the handle with the catheter assembly removed to expose the needle earner distal end 141 and the guide tube 132 extending distally out from the handle and out from the needle carrier distal end. In this example, the guide tube 132 is positioned within the guide tube channel 148 of the needle carrier. As described herein, the guide tube 132 may be used to support or facilitate guide element routing through the handle and catheter assembly. In some examples, the guide wire 131 may extend through the needle carrier 140. For example through the guide tube channel 148 and be deflected towards the needle exterior surface. Although other components are removed from this view, the slider 110 is also visible in the distal position within the handle slot 115 with a length of slot 115 proximal to the slider allowing for retraction of the slider to a proximal position for loading or adjustment of the guide element before or during use. The length of slot 115 distal to the slider 110 can allow for yet further deployment or advancement of the slider 110.

[0087] FIG. 7 is a perspective view of the vascular access device 100 from the proximal end of the handle 106 and the cap 300 engaged to the handle distal end. The proximal end of the cap 300 can be seen with a complementary geometry to the handle distal end and may be configured- 21 of 56 -SG Docket No.: 14842-717.601to receive the handle distal end. The cap 300 may also be configured to releasably retain or couple with the handle distal end based on the proximal geometry and interior features. In this perspective view from the bottom of the device 100, the stabilizing element 205 of the catheter assembly can be seen seated into the cap 300, as well as the engagement features of the handle exterior 120 that can support handling and manipulation of the device 100 during use. Details of the handle proximal end can include an opening 106a extending through the proximal end of the handle 105 and generally aligned with the handle axis. In some examples, the opening 106a may be configured to receive or allow a length of guide wire to extend therethrough. For example, the length of guide wire (e.g., guide wire 131) may extend proximally beyond the slider 110 and beyond the proximal length of the handle 105 such that excess length of the guide wire 131 may extend through the opening 106a. In some examples, the guide wire 131 may be a set length contained entirely within the handle 105. In some examples, the guide wire may be affixed to the slider 110 (e.g., slider leg). In some examples, the guide wire 131 may extend through the slider 110 such that the slider may selectively communicate with the guide wire to translate movement of the slider 110 with the deployment length of the guide wire 131. In some examples, the length of the guide wire may exceed the length of the handle 105 such that excess length of the guide wire may extend through the opening 106a and allow for repetitive advancement of the slider to introduce or deploy the guide element further distal from the handle.

[0088] The slider has been shown to have a portion of the slider on an exterior of the handle with a portion of the slider extending into the handle interior including a slider leg extending through the handle slot and through to the slider channel in a lower surface of the handle. The slider channel can be configured to facilitate movement of the slider in the handle. For example, the slider channel may be configured to restrict inadvertent rotation of the slider and maintain a linear path of the slider in use.

[0089] FIG. 8 A shows a proximal portion of the vascular access device 100 with the handle being transparent to expose details of the slider channel 171 and associated features. The slider 110 is in a distal position within the slot 115 and adjacent to the proximal end of the needle carrier 142. The slider foot 163 can be seen positioned in the slider channel 171 with the slider knee adjacent to the needle carrier dock 150. The guide wire 131 is extending through the slider 110 with a length of guide wire 131 extending proximally beyond the slider 110 within the handle 105. At the proximal end of the slider channel 171, there is a slider loading feature 170.- 22 of 56 -SG Docket No.: 14842-717.601FIG. 8B shows the same segment illustrated in FIG. 8A as a cross section to illustrate details of the slider loading feature 170. Here, the slider channel 171 extends proximally to the slider loading feature 170 with a backstop 172 at the terminal end of the slider channel 171. The slider foot 163 can be configured to contact the backstop 172 is a proximal most position during use. The backstop 172 may be configured to prevent excess retraction of the guide element 130 by limiting the proximal movement of the slider 110 in combination with the guide wire 131 when coupled therewith.

[0090] Also shown in FIG. 8A and 8B are the proximal features of the needle carrier 140 with the needle carrier proximal end 142 in FIG. 8A and the cross section in 8B further revealing the needle channel proximal portion extending through the interior of the needle carrier 140. In the cross-section view shown by FIG. 8B, the needle carrier proximal end 142 also shows the needle carrier dock 150 configured to receive the slider 110 (e.g., slider leg), when the slider 100 is advanced distally to engage the needle carrier dock 150.

[0091] Proximal to the backstop 172 is a tapered section 173 of the loading feature 170. The tapered section may have a slop or curve towards a raised proximal end of the tapered section 173 that can provide for a final adjustment region between a locked position of the slider 110 in a proximal most position within the handle 105 and the slider channel 171. The tapered section may have a slope or curve requiring additional or increasing amount of force to retract the slider 110 within the handle to indicate that the slider is approaching the locked position in the proximal most area of the handle 105. Distal to the tapered section 173 is a depression 174 that may be a depression into the handle 105 or may be an opening through the handle 105. The depression is configured to receive the slider foot 163 in a locked position and can be adapted to prevent or reduce subsequent distal advancement of the slider 110 and coupled guide wire 131.

[0092] In some examples, the slider channel is smooth allowing for selective, repetitive, and dynamic adjustment of the slider position, and therefore guide element deployment, when in use. In some examples, the device 100 may be described based on the current status or position of the slider that can relate to the position and status of the guide element. For example, some configurations may include the stowed configuration, ready-to-use configuration, locked configuration, docked configuration, in-use configuration. For example, the stowed configuration may refer to the device being stowed or coupled with the cap to cover or stow the distal components of the device including the catheter assembly. The stowed configuration may also- 23 of 56 -SG Docket No.: 14842-717.601refer to stowing the guide element within the distal end of the catheter. In some examples, the ready-to-use configuration may refer to the slider in a proximal position, possibly where the foot is contacting the backstop, or in any other configuration where the guide element is retracted to seat in the distal end of the catheter allowing the needle tissue penetrating tip to be exposed and ready to puncture tissue to access the vessel. In some examples, an in-use configuration may refer to the needle having made access to a vessel and the guide element being deployed or retracted as the user is placing the catheter assembly within the vessel. For example, the slider maybe advanced and retracted through the slot and along the slider channel until the guide element has supported position and placement of the catheter within the vessel. In some examples, a docked configuration may refer to the catheter assembly being positioned within the vessel and the needle set for retraction out of the vessel where the slider leg is positioned within the needle carrier dock and ready for actuation or proximal retraction of the needle to the handle interior. In some examples, the locked configuration may refer to the slider having been retracted against the slider loading feature such that he slider foot is positioned in the depression 174 and locked in a proximal position within the housing.

[0093] FIG. 9 is a cross section of a side elevation view of the vascular access device 100 in exposing the interior of the needle carrier 140 and the arrangement of the actuation button 125, guide tube 132, slider 110, handle distal end 107, actuation spring 145 and the needle carrier dock 150 adjacent to the slider knee 161 and slider foot 163 in the slider channel 171. In this view, the needle has been removed to highlight the lumen 147 through the center of the needle carrier 140. The distal end of the needle carrier 140 can be seen extending beyond the handle distal end 107. Although the needle is removed in this view, the openings 144 can be seen extending through the needle carrier 140 and to lumen 147. The intersection of opening 144 and lumen 147 allow for the fixation of the needle to the needle carrier 140.

[0094] FIGS. 10A to 10C are detailed views of the needle carrier 140 in a bottom plan, distal perspective, and proximal perspective respectively. Referring to FIG. 10 A, the needle earner 140 has a proximal end 142 and a distal end 141. Raised features 140a may be provided around the needle carrier exterior to support alignment and structural integrity of the needle carrier 140. Between the opening 144 and the distal end 141, a recess or collar 140b is shown where the actuation button may engage the needle carrier 140. The actuation button may hold the needle carrier in position until depressed and releasing communication between the actuation- 24 of 56 -SG Docket No.: 14842-717.601button and the needle carrier collar 140b. Near the proximal end 142 is a docking opening 149 configured to receive the slider 110 or a component of the slider leg 162 therein to lock or support communication between the needle carrier 140 and the slider 110.

[0095] Referring to FIGS. 10B and 10C, the lumen 147 can be seen extending through the needle carrier 140 from the proximal end 142 to the distal end 141. Although the lumen is shown here extending through the entire length of the needle carrier 140. there may be some examples, where the lumen 147 extends into the needle carrier 140 from the distal end 141, where the needle would then extend therefrom. On an upper surface of the needle carrier 140 is the guide tube channel 148. This channel is shown extending along an entire length of the needle carrier 140 and is configured to receive the guide element or guide tube with the guide element extending therethrough. The channel 148 can be configured to rout the guide element from the slider along the needle carrier 140 and through the catheter assembly. The channel 148 may be aligned with the slider such that the guide wire may have an axis extending from the slider through the needle carrier channel 148 until the transition or taper from the handle distal end towards the needle extending through the catheter lumen. The proximal perspective shown in FIG. 10C highlights the needle carrier dock 150 with the opening 149 and a geometry of the dock adapted to receive the slider leg when it is advanced to the distal most position within the handle and handle slot such that the slider may dock with the needle carrier 140 and the actuation button can trigger the proximal retraction of the combined needle carrier, needle, and slider.

[0096] The cap 300 is illustrated in additional detail in FIG. 11 A and FIG. 1 IB. From the distal perspective in FIG. 11A, the cap 300 has a body extending between a distal end 301 and proximal end 302. The vascular access device can be received within the cap 300 from the proximal end and opening 302. Referring to FIG. 1 IB, the interior of the cap can be seen including alignment features 310 positioned around an interior of the cap 300 and configured to guide or align the catheter assembly and / or handle distal end within the cap 300. Cap depressions 315 are provided around the proximal opening 302 and can be complementary to one or more features of the handle such as the engagement features 120. An opening 305 is disposed at the distal end of the cap 300 and can facilitate positioning of the guide element when the handle is inserted therein.

[0097] FIGS. 12A and 12B are side elevation and distal end perspective views of the catheter 210, guide element 130 and needle 135 with the guide element 130 in a partially- 25 of 56 -SG Docket No.: 14842-717.601deployed position as it may be during use or in a stowed configuration within the cap 300. The guide element 130 is shown with an atraumatic tip comprising a curled shape 130b whereby the guide element can be adapted to curl the distal portion of segment of the guide element 130 to provide the atraumatic tip during use. The curl 130b of the atraumatic distal end 130a may be straightened when the guide element 130 is retraced to a stowed position and seated in the catheter distal end 211. For example. FIG. 12B shows the catheter distal end notch 212 that may be adapted to receive the guide element 130 or a feature thereof, in a stowed configuration when the guide element is retracted prior to insertion of the needle tissue penetrating tip 136. In some examples, the guide element 130 may be coupled to the distal end of a guide wire 131. For example, the guide element 130 may have one or more openings 134a / 134b through the guide element body 130a that extend into or through the guide element 130 and at least intersect a guide wire channel or lumen through the guide element 130. The openings may support the additional of adhesive or other form of fixation or overholding to fix the guide element 130 to the distal end of the guide wire. In some examples, the guide wire may comprise a paddle feature insertable into the guide element such that the guide element body 130 may be compressed or affixed to the guide wire paddle portion. For example, the guide element 130 may comprise a compressed section 133 where the guide element body is affixed to the paddle portion of a guide wire.

[0098] FIG. 12A also includes additional features of the needle such as a flash back opening through the needle such that the flash back opening 137 is in fluid communication with the needle lumen and configured to allow blood to flow into the opening 137 to be visible through the catheter 210 to indicate a vessel has been accessed. In FIG. 12A, the side profile view of the needle 135 also includes the flat surface of channel through the catheter 210 that can allow for the guide wire to extend therethrough. In FIG. 12B, additional features such as radiopaque or other visible indicators of the catheter 213 are disposed in, on, and / or through the catheter 210 to support alignment or spatial positioning of the catheter when in use.

[0099] FIG. 12B also shows a side of the needle 135 including one of the needle rails 155 extending along the upper surface of a needle channel 154. Needle rails 155 can be configured to contact the lower surface of the guide element 130 and may contact the guide element atraumatic tip 130a before the guide element 130 may contact the tissue penetrating tip 136. The needle rails 155 can be configured to bias the guide element 130 into a straightened configuration or- 26 of 56 -SG Docket No.: 14842-717.601otherwise reduce the curl of the atraumatic distal end 130a as the guide element is retracted to prevent contact between the tissue penetrating tip 136 and the guide element 130.

[0100] Similar to FIG. 12A and FIG. 12B, FIG. 13 shows the distal portion of the needle 135 with the guide element 130 extended or deployed beyond the tissue penetrating tip 136. The guide element body 130a is coupled to the guide wire 131 that is extending through the needle channel 154 along the needle exterior surface while still within the catheter interior. From this distal perspective, the needle rails 155a and 155b can be seen. The rails 155 can be formed into the needle along the needle channel 154. In some examples, the rails 155 (e.g., 155a / 155b) may be raised near the distal end of the needle channel 154. As previously described, the needle rails can be configured to contact and engage the atraumatic tip of the guide element 130. Lateral guide element sides 156a and 156b may be adapted to contact the needle rails 155a and 155b such that the atraumatic tip 130a of the guide element 130 can be straightened or otherwise modified to straighten the guide element before contact between the guide element 130 and the needle tissue penetrating tip 136. In some examples, the guide element sides 156a and 156b may be conforming to the needle rails 155a and 155b to support consistent contact between the needle rails 155 and the guide element when the guide element 130 is retracted.

[0101] FIG. 14A and 14B are perspective view of the guide element 130 from a distal perspective showing the atraumatic tip 130a, guide element lateral edges 156a / 156b and coupling features 134a / 134b configured to support engagement between the guide element and the guide wire. In some examples, the guide element is over molded to the guide wire. In some examples, the guide wire 131 may comprise a braid or mesh at a distal end or segment that is over molded with the guide element such that the compressed region 133 reinforces coupling between the guide wire 131 and the guide element. Also shown in FIG. 14B is the guide wire channel 133a of the guide element where the guide wire may extend into for coupling with the guide element 130.

[0102] Referring to FIG. 14A, the curl 130b at the distal end of the guide element 130 can be configured to form after deployment of the distal tip 130a beyond the needle. As illustrated here, the distal tip 130a curls downward or otherwise in a curl towards the lower surface of the guide element 130 (e.g., the surface adjacent to the needle exterior). In some examples, the distal end or portion of the guide element 130 may be configured to transition from a linear configuration (e.g., when stowed along the needle exterior) to the curled configuration with a curl 130b- 27 of 56 -SG Docket No.: 14842-717.601forming in the distal portion of the guide element. In FIG. 14B, the curl 130b is shown transitioning around the guide element area 130b 1 and continuing the curl 130b to the distal tip 130a. In some examples, the distal portion of the guide element 130 may be sufficiently flexible to allow for the transition from the linear configuration to the curled configuration. The inferior perspective in FIG. 14B also reveals additional details of an exemplary geometry of the guide element distal end 138 being larger with additional features compared to the proximal portion of the guide element. Here, the distal end 138 extends from the guide element notch feature 138b to the guide element distal tip 130a. extending from the sides of the guide element notch feature 130b are raised edges 138a. In some examples, the guide element distal end 138 may have a generally triangular geometry distal to the notch feature 138b. This distal end geometry and dimensions may be configured to provide an atraumatic tip of the guide element, as well as, preventing the guide element distal end from entering the needle lumen when the guide element is retracted.

[0103] FIG. 15 shows a detailed view from the distal end of the needle 135 with the guide element 130 in a cross section to reveal the communication between the needle rails 155a and 155b with the guide element channels 156a and 156b. The guide wire 131 is shown as it may extend into the guide element 130 and the distal end of the catheter 210 can be seen with spatial markers 213 longitudinally disposed throughout the catheter 210. In some examples, the needle rails 155a / 155b can comprise a geometry accommodated by the guide element channels 156a and 156b such that when the guide element 130 is retracted to a seated position within the distal end of the catheter 210 a generally circular cross section is complete including the needle 135 with channel 154 and rails 155a / l 55b that are nested into guide element channels 156a and 156b with the guide wire 131 through the guide element 130 and all of which can extend through the interior of the catheter 210.

[0104] In some examples, the vascular access device 100 may be stored with the cap 300 coupled to the handle distal end over the catheter assembly, needle 135, guide element 130, and needle carrier distal end. As illustrated in the cross section view of FIG. 16, the catheter hub 200 is positioned within the cap 300 and hemostasis valve 220 and the needle carrier distal end are covered by the cap. At the distal end of the cap, the guide element 130 is partially extended with the atraumatic tip 130a curled beyond the needle tip 136 in the recess interior of the cap distal end. As described above, from the configuration shown in FIG. 16, the guide element 130 may- 28 of 56 -SG Docket No.: 14842-717.601be initially retracted from this stored position into a ready-to-use-configuration whereby the slider is retracted and the guide element 130 is drawn proximally back along the needle exterior through the catheter interior until the atraumatic tip 130a is straightened by the needle rails 155 and the guide element 130 is seated into the catheter distal end to expose the needle tissue penetrating tip 136 for insertion into a vessel.

[0105] Additionally or optionally, portions of the interior walls of the cap 300 may be modified to assist in the proper retraction and stowage for the distal tip. As described herein, the loading of the guide element is the process of transitioning the guide element from the extended and partially curved condition (i.e., FIGs. 12A, 12B, 16, 17, 21A and 21B) to the stowed and ready to use condition (FIG. 2 ID) may occur while the cover 300 is positioned over the indwelling catheter and needle. Advantageously, the interior walls of the cap may be adapted and configured to both protect the guide element, needle and catheter from damage or infection but also provide for easy storage. Still further, an interior portion of the cap may be modified to include rails, guides, detents or other features used to assist in the proper alignment and loading of the guide element onto the needle and access catheter. The shape, size and position of one or more features may take advantage of the relative movement of the guide element proximally along the interior of the guide as the slider is moved proximally (see e.g., FIGs, 21B-21D).

[0106] FIG. 17 is another cross section view of the distal end of the device 100 as it may be positioned in the cap 300. Here, additional details of the arrangement of the needle 135 and the guide element 130. Are shown. The guide wire 131 extends from the guide element 130 through the catheter 210 along the needle 135. The catheter 210 and needle 135 may be limited in position relative to the cap 300 interior while the guide element 130 may be capable of translation in the cap distal recess 305. In some examples, the interior of the cap has limited features allowing for translation of the guide element 130. For example, while the cap 300 is still engaged with the handle 105. the slider may be slightly advanced or retracted to confirm a freedom of movement of the guide element before the device 100 is transitioned from the stored configuration to the ready-to-use configuration with the guide element retracted to a seated positioned in the distal end of the catheter 210.

[0107] FIG. 18 shows another cross-section view of the cap 300 coupled to the device 100 as viewed proximal to the position shown in FIG. 17. Here, details of the actuation button 125, distal end of the handle slot 115, needle carrier 140, through to the hemostasis valve 220,- 29 of 56 -SG Docket No.: 14842-717.601catheter hub, and needle can be seen. In this example, the catheter hub has a tab 221 that may be configured to support manipulation of the catheter hub 220 in us. The cap recess 307 can be configured to accommodate various external features of the catheter hub and assembly. The needle lumen 135a can be seen in this cross section as the needle may extend from the needle carrier 140. The tapered section of the guide tube is also present with the guide wire 131 extending therethrough and into the catheter assembly through the catheter 210.

[0108] FIG. 19 is a cross section of a side elevation view of the vascular access device 100 including a medial segment of the handle 105 with the slider 110 proximally positioned relative to the needle earner 140. This detailed view exposes the smooth slider channel 171 with the slider leg 162 including the knee 161 biasing the distal leg including the foot 163 in communication with the slider channel 171. The slider dock element 162a can be seen on the leg 162 and is configured to engage the opening 149 of the needle carrier dock 150 at the needle carrier proximal end 142. In use, the slider 110 can be moved through the handle slot 115 proximally and distally to deploy, retract, or otherwise adjust the guide element. When the slider is advanced to a distal most position within the handle slot 115, the leg 162 can engage the needle carrier dock 150 and the slider dock element 162a can seat into the opening 149 to retain the slider 110 in a docked position in the needle carrier dock 150. The foot 163 will be raised off the slider channel 171 and when the needle carrier 140 is retracted proximally through the handle, the foot can be raised to travel over the backstop and tapered section at the proximal end of the handle interior to a locked position with the needle retained within the handle. In some examples, the guidewire 131 may be retracted with the needle carrier 140 and slider 110 when the actuation button 125 is pressed.

[0109] FIG. 20 is another cross section of a side elevation view from the device 100 showing a proximal segment to that shown in FIG. 19 including details of the proximal features of the slider channel 171 including the backstop 172, tapered section 173, and depression or opening 174. In some examples, the tapered section may be distal to a raised portion 171a between the backstop 172 and the loading features 173. In some examples, the tapered section 173 may include a tapered section extending proximally from the backstop 172 such that the tapered section 173 may extend at an angle from the backstop to the proximal end of the loading feature. When the slider is retracted after docking with the needle carrier, the slider leg can travel over these features on the interior proximal end of the handle. In some examples, the slider may be- 30 of 56 -SG Docket No.: 14842-717.601retracted over the backstop 172, tapered section 173, and until the foot 163 engages the depression 174 to a locked or retained position. In some examples, when the slider foot is retained in the depression 174, it may require a substantial amount of force to overcome the retained position and subsequently advance the slider 110 distally from that retained position. In some examples, the slider may be prevented from distal advancement after the leg and foot are positioned within the depression 174.

[0110] FIG. 21A to 21D show a transition of the device from to an armed or ready-to-use configuration. In some examples, the guide elements described herein comprise atraumatic tips or distal ends configurated to transition between a first shape or configuration to a second shape or configuration when the guide element is retracted or deployed. For example, when the slider is retracted in the handle slot correspondingly retract the guide wire and guide element proximally along the needle channel (e.g., needle channel 154 in FIG. 12B) the guide element may contact the rails (e.g., rails 155a and 155b in FIG. 15) and when the contact between the guide element and the rails continues along the retracting length of the guide element, the atraumatic tip or distal end may transition to a linear configuration as it is biased to the linear configuration by the needle rails. In some examples, the transition of the guide element from a curled configuration to a linear configuration can be adapted to prevent contact between the tissue penetrating tip of the needle and the guide element.

[0111] Referring to FIG. 21A, a detailed distal perspective of the device, for example from FIG. 17 with the cap removed, is shown including the guide element 130 at least partially advanced with the atraumatic tip 130a in a curled configuration beyond the needle tissue penetrating tip 136. In this perspective, one of the guide element rails 155b of the needle 135 is visible and in contact with the guide element along a length of the guide element proximal to the atraumatic tip 136a. In some examples, the guide element is shown in FIG. 21A as it may be in a shipped configuration (e.g.. also in FIG. 17 with the cap on) partially deployed with the atraumatic tip advanced distal to the tissue penetrating tip of the needle.

[0112] FIG. 2 IB illustrates the entire device from FIG. 21 A with the cap still removed and the guide element 130 in the same configuration detailed in FIG. 21 A. In this zoomed out view, the slider is shown in position distally within the handle slot with the guide element 130 at least partially advanced distally beyond the needle tip 136. The slider 110 is again configured to translate movement to the deployment length of the guide wire and guide element 130 through- 31 of 56 -SG Docket No.: 14842-717.601the handle 105, through the catheter hub 200 and the catheter 210 along the exterior surface of the needle 135 (e.g., along and through the needle channel). Arrow 322 shows a direction of proximal movement of the slider 110 from the depicted position to a proximal position adjacent to the slot proximal end 106 of the handle 105.

[0113] Then, in FIG. 21C, the slider 110 is now in the position proximal in the handle slot 115 adjacent to the slot proximal end 106 and the guide element 130 is shown in a docked position within the catheter 210 and the guide element atraumatic tip 130a is seated in the needle channel and can be docket at the distal end of the catheter 210 ready for deployment.Alternatively, the needle and guide element may be withdrawn proximally through the catheter 210 as they may be removed after the catheter 210 is in position within a vessel. In some examples, this view may also reflect the arrangement of the guide element and the needle tissue penetrating tip as it may be before, during, or after use to position the needle and catheter within a blood vessel.

[0114] FIG. 21D then shows a close up view of the needle distal end from FIG. 21C with the guide element 130 docked within the catheter 210 along the exterior surface of the needle 135 in the needle channel. The guide element atraumatic distal end 130a is shown here in an example of a docked configuration with the guide element distal tip 130a seated within the catheter notch 212 having complementary geometry to the guide element distal tip 130a such that when the guide element distal tip 130a is docked in the catheter notch 212, there is a smooth transition from the needle to the catheter exterior surface thereby reducing the physical impact to tissues and reducing or preventing coring or tissue or unnecessary dilation of tissue as the needle, guide element, and catheter are inserted through tissue in a vessel.

[0115] In FIG. 21D, both rails 155a and 155b are visible on either side of the needle channel. Here again, the rails can be aligned and in contact with the guide element lower surface such that when the guide element 130 is retracted to this docked or retracted position, the rails 155a / l 55b can bias the curled distal end of the guide element 130 to a linear configuration as illustrated in FIG. 21D to be docked and seated in the needle channel through the catheter 210.

[0116] In some examples, the guide element may be configured to avoid contact with the tissue penetrating tip a needle with or without support from the rails. For example, the guide element may comprise a shape-memory material configured to provide a curled distal end of the guide element (e.g., atraumatic distal tip) when the guide element is deployed. Then, when the- 32 of 56 -SG Docket No.: 14842-717.601guide element is retracted, the guide element atraumatic distal tip may transition to the linear configuration for retraction, docking, or otherwise positioning at the distal end of the catheter along the distal end of the needle exterior while avoiding inadvertent contact with the tissue penetrating tip. For example, an over-molded core of nitinol or braided configuration may provide for the curled configuration of the guide element when in a deployed position beyond the needle tip, then provide for a rising or alignment of the guide element from the curled configuration to the linear configuration as it is retracted so as to avoid contact with the tissue penetrating tip.

[0117] In some examples, the guide element may be configured to transition from the curled configuration to the linear configuration, as described herein, and any contact with the tissue penetrating tip may not negatively impact the guide element or the tissue penetrating tip.

[0118] FIG. 22 is a top plan view of the distal end of a vascular access device with a lateral cross section of the guide element 130 revealing a distal portion 231 of the guide wire 230 as it may be positioned in the guide element 130. As described herein, guide elements may be formed at the distal end of a guide wire or affixed, integrated, over molded, bonded, or otherwise coupled to a guide wire. As illustrated in this example, the guide wire 230 has a distal portion 231 that is deformed or otherwise not a uniform cross-section compared to other segments (e.g., proximal segment) of the guide wire 230. The deformation of the guide wire distal end can be configured to support the coupling between the guide wire and the guide element. In some examples, the position and configuration of the guide wire distal segment may provide additional function and support for the guide element. For example, the guide wire within the guide element may add structural integrity or rigidity to the length of the guide element overlapping the guide wire. Then, the distal portion of the guide element may have increased flexibility to support a transition from a linear configuration to a curled configuration.

[0119] In some examples, the distal guide element segment 139 extends distal to the guide wire distal end 230a. Accordingly, the curled section of the guide element curls along the guide element length beyond the guide wire distal tip 230a. Also visible in this view are the needle channel rails 155a and 155b. As described herein, the rails of a needle channel 157 may be configured to bias the guide element into a linear configuration during retraction where the rails 155a and 155b may contact the guide element as it is retracted and cause the curled flexible segment 139 to return to a straight configuration.- 33 of 56 -SG Docket No.: 14842-717.601

[0120] In some examples, the distal segment of the guide wire, at least along the length of the guide wire positioned within the guide element may have one or more features adapted to improve connection between the guide element and the guide wire, when the element is over molded or otherwise coupled to the distal end of the guide wire. For example, in FIG. 22 the length of guide wire within the guide element has various areas of different diameter that can provide a lock against the guide element from being removed or separated from the guide wire. Additionally, the length of the guide wire extending into the guide element may be further adapted to regulate flexibility of the guide element, at least along the length of the guide wire positioned therein. For example, the guide wire may provide additional stiffness for the guide element. In other examples, the features of the guide wire distal portion within the guide element may allow for additional functionality of the guide element. For example, segments or portions of the guide wire in the guide element may be more flexible or less flexible allowing for increased flexibility or decreased flexibility of the guide element at areas adjacent to the guide wire portion.

[0121] Further details of arrangement including guide elements, guide wire and the distal configuration of a needle are illustrated in FIG. 23 A and 23B. Here, a detailed side elevation view of a needle 250 are shown with the catheter removed to expose an exemplary position of a guide element 130 within the distal needle channel 265, as it may be prior to being deployed. In some examples described herein, the needle may have one or more channels along a length of the needle body. As shown in FIG. 22A, this needle example is a compound needle having a distal channel 265 and a proximal channel 260 with a transition 270 positioned between the needle channels. The guide element 130 can be seen extending through and along both proximal channel 260 and distal channel 265 with the guide element 230 positioned in the distal channel 265. In some examples, the distal needle channel may be configured to complement the guide element positioned therein such that both the needle and the guide element may be positionable within the catheter. The channels 260 and 265 can facilitate the deployment, retraction, and positioning of the guide element and guide wire during use. With the catheter removed, additional details of the guide element distal end 138 can be seen with the guide element notch feature 138b at a proximal end of the distal tip as it may be configured to communicate with a notch of a catheter tip forming a smooth transition (e.g., geometry) from the tissue penetrating tip 255 to the exterior of a catheter to reduce unnecessary harm to tissues during insertion. The- 34 of 56 -SG Docket No.: 14842-717.601guide element distal tip 130a is positioned adjacent to the needle lumen 251 as it may be arranged in a ready-to-use configuration.

[0122] The cross section of FIG. 23A illustrated in FIG. 23B further reveals the guide wire distal end 230a within the guide element 130. Proximal to the guide wire distal end 230a is a guide element engagement feature 235 formed in the guide wire distal segment between the guide wire distal end 230a and a tapered section 232 extending between the proximal guide wire and the distal segment 231. The guide element 130 is nested in the distal channel 265 of the needle 250. This cross-section view highlights the compact arrangement of the guide element 130 with the needle 250 allowing a catheter to be positioned around the needle and guide element.

[0123] In some examples, the distal end of a guide wire, over molded by a guide element may extend to any position between a proximal end and distal tip of the guide element. In some examples, the guide wire may provide additional stiffness to the guide element at least along the length to which the guide wire is over molded.

[0124] FIG. 24A to FIG. 25 show the needle 250 in a perspective view with various cross sections taken along the needle length to reveal exemplary configurations of needle features with the position and arrangement of the guide wire 230 and guide element 130 in a nested configuration within the needle channel 265. FIG. 24 includes indicators B, C, D, E, F, G, and H corresponding to areas where a cross section view is provided in the following figures.

[0125] FIG. 25A to FIG. 25C illustrate similar cross sections of the needle as shown in FIG. 24A to FIG. 24H, now with the catheter included as it may be positioned around the needle, guide wire and guide element. Referring to FIG. 24A, in this perspective view, the position of the guide element 130 provides an exemplary position of the guide element distal tip 130a with the needle lumen 251. In addition to the configuration of the guide element distal tip 130a and the needle channel 265 providing improved insertion requiring less force, the channel 265 pressed into the needle 250 also provide for an anti-coring impact to reduce or prevent any core of tissue being taken as the needle is inserted into a vessel.

[0126] FIG. 24B shows a proximal cross section taken at indicator B in FIG. 24. Here, the proximal needle channel 260 can be seen with the guide wire 230 extending distally through the channel 260 and then across the transition 270 to distal channel 265. With further details provided below, the transition 270 is illustrated as a transition between the plane of the proximal- 35 of 56 -SG Docket No.: 14842-717.601channel 260, down to the plane of the distal channel 265. Accordingly, the transition 270 may provide a slope between the needle channels. The proximal end of the channel 260 is shown with transition 270b with the needle segment being generally cylindrical along a length to the needle proximal end 250b. In some examples, the proximal channel 270b may be configured to facilitate the transition or routing of the guide wire from the guide tube to the proximal needle channel 260. The needle lumen 251 is shown in a compressed manner having a generally crescent cross section. In some examples, the needle channels are formed by pressing the channels into an initially cylindrical needle. Accordingly, the lumen may be deformed from an otherwise cylindrical lumen to the crescent shape illustrated here. However, providing the needle channels may also be done without modification to the needle lumen.

[0127] In FIG. 24C, the corresponding cross section is taken from FIG. 24 at indicator C and at this position, the cross section of the guide wire distal segment 231 can be seen inside of the guide element 130. The guide element 130 cross section has a generally almond shape with protruding sides 130d and 130e positioned over the needle rails 265a and 265b. Of note, with this cross-sectional geometry of the guide element and needle, it can be appreciated that he needle channel 265 is configured to complement the guide element therein forming a nearly complete circular cross section with the combination of the needle 250 and the guide element 130. FIG. 24D illustrates another cross section distal to that shown in FIG. 24C now with a different cross section of the guide wire distal segment 231. Here, the diameter of the guide wire is decreased compared to that shown in FIG. 24B. Accordingly, when the guide element 130 is over molded, the material may form around the guide wire distal segment 231 and be locked onto the guide wire distal segment 231. In FIG. 24D, the relative position of the guide element protruding regions 130d and 130e can be seen in additional detail. In some examples, the needle channel 265 may be less than a half circular channel with the guide element positioned on top of the channel. For example, the guide element may be considered on top of the channel, within the channel, through the channel. The cross section of FIG. 24E corresponds with the indicator E from FIG. 24 now with a cross section revealing an increase diameter of the guide wire distal end 231 in the guide element 130, as it may be where the guide element engagement feature 235 is positioned within the guide element distal segment 231. As the cross sections sequentially moved more distal long the needle, the position of the guide element exterior relative to the needle channel has remained generally constant such that he exterior geometry of the guide element- 36 of 56 -SG Docket No.: 14842-717.601may be constant along a length of the guide element while the interior dimensions of the guide element change according to the communication with the guide wire distal end 231. FIG. 24F shows yet another cross section at indicator F from FIG. 24 with the guide wire having again a reduce diameter within the guide element 130. The needle lumen 251 may be shown with a different cross section geometry compared to that of the needle cross sectional geometry of the needle proximal end. For example, the distal needle channel 265 may be pressed further into the needle surface providing for a deeper channel compared to the proximal channel 260. Accordingly, the needle lumen may be further compressed.

[0128] Now at FIG. 24G, 24H, and 25, the cross sections are near a distal end of the needle and provide additional details of the guide element distal end 138. Referring to FIG. 24G, the cross section of the guide element 130 does not reveal the guide wire as this cross section may be taken distal to the guide wire distal end (e.g., 230a) within the guide element 130. Accordingly, this cross section may be considered to be taken through the flexible segment of the guide element. FIG. 24H is distal still to the cross section shown in FIG. 24G and shows the guide element notch feature 138b raised above the guide element distal end 138 as it may be configured to protrude above the guide element and communicate with a notch in the tip of a catheter. In FIG. 25, the needle 250 and guide element 130 from FIG. 24A are fully visible from the distal end revealing the needle lumen 251, the guide element distal end 138 with the distal tip 130a and the guide element notch feature 138a arranged at the guide element distal end. The needle channel rails 265a and 265b are seen transitioning into the needle bevel surface to the tissue penetrating tip 155.

[0129] In some examples, and ash shown in FIG. 24G. the guide element has a major width (e.g., between 130d and 130e) that may be generally uniform or consistent at least along a length of the guide element middle region. For example, the guide element distal tip 130a may be geometrically configured to complement the distal end of the catheter, and the guide element body extending proximally from the distal tip 130a may have a generally uniform diameter.

[0130] Referring to FIG. 25, the dimensions of the guide element distal end may be configured to prevent or reduce the instance of the guide element entering the needle lumen 251 when the guide element is withdrawn. As illustrated and described throughout, the guide elements are deployed and may form a curl at the distal end of the guide element. The curl forms generally downward over the tissue penetrating top of the needle with the guide element tip- 37 of 56 -SG Docket No.: 14842-717.601curling down, then back forward the needle. When the guide element is retracted, the guide element curl is drawn proximally towards the needle. In some examples, the guide element distal tip may be sufficiently large to be physically prohibited from entering the needle lumen. For example, the needle may be of a gauge size less than the dimensions of the guide element distal tip. In some examples the needle lumen may be large and it may be beneficial to the overall dimensions of the VAD not to increase the guide element distal end dimensions. Accordingly, and as described further below, the deployment of the guide element may be offset such that a distal segment of the guide element may be deployed at an angle off of a central axis of the guide wire and begin to curl off set from the needle lumen such that when the guide element is retracted, it is withdrawn along the off-axis deployment path and does not enter the needle lumen based on the path or rout of the deployment and curling of the guide element. The view in FIG. 25 identifies the edges 256a and 256b on either side of the tissue penetrating tip 255. In some examples, the guide element may be deployed and the distal segment may curl off set as it may bend to curl off axis along the lateral edges 256a and 256b so not to interfere with the tissue penetrating tip or the needle lumen during deployment or retraction.

[0131] In some examples, the lateral edges may have a length from the tissue penetrating tip of the needle to the remaining beveled surface of the needle. For example, the length of the lateral edges (e.g., 256a and 256b) may be ,5mm, ,75mm, 1mm, 1.25mm, 1.5mm, 1.75mm, 2mm, 2.25mm, 2.5mm, 2.75mm, 3mm, or more or less or any length therebetween. For example, lateral edges may be between 1.2mm and 1.4mm.

[0132] Guide elements described herein may be deployed and provide an atraumatic tip beyond the needle tip. During deployment, the guide element may be deployed along an axis provided by the guide wire extending along the needle exterior. The curl formed at the distal segment of the guide element may curl downward over the tissue penetrating tip of the needle and the guide element distal end may be configured to prevent inadvertent positioning within a needle lumen. In any of the examples described herein, the guide element may be deployed and transition from a linear configuration within the catheter and along the needle exterior to having a curled distal end when the guide element is deployed at an angle off of the axis of the guide wire.

[0133] FIG. 26 illustrates an exemplary configuration of a guide element 300 with a distal segment having a curl or spiral 305 configuration that can be offset from a linear axis of the- 38 of 56 -SG Docket No.: 14842-717.601distal end of the guide wire 231 in a deployed configuration. In the top view of the distal end of the guide element 300 in FIG. 26, the guide element distal end 301 is visible at the terminal end of the curl 305 and being offset from the axis or plane of the guide element body and guide wire distal segment 231. The distance 306a indicates the extend that the curl 305 is off set from a plane of the needle penetrating tip (not visible) with additional dimensions including the length 306b from the guide element body to the guide element distal end 310 and the diameter of the curl 305 formed at the distal end of the guide element 300. In any example described herein, the guide element may form a curl, as illustrated and described, including a partial rotation (e.g., less than 360 degrees) of the guide element distal tip as it curls when deployed or extended beyond the needle tip. In some examples, the curl may be formed in-inline with (e.g., coplanar) to the longitudinal axis of the guide wire and / or other portion of the guide element. In some examples, the curl may be formed off-axis (e.g., off set) of the longitudinal axis of the guide wire and / or other portion of the guide element. In some examples, the curl may be less than a complete rotation. For example, the guide element distal tip may curl as it is extended beyond the needle tip to less than 360 degrees. In some examples, the curl may be more or less or equal to 360 degrees.

[0134] FIG. 27A and FIG. 27B illustrate the off-set guide element 300 in an at least partially deployed configuration. Referring to FIG. 27A, an axis including the guide wire 230, extends through needle channel 265 and through the guide element 300 until the guide element curl 305 where the guide element distal tip is shown offset from this axis. In this deployed configuration, the guide wire 230 has been distally advanced to deploy the guide element distal tip 300a out from the catheter 210 to a deployed configuration with at least the guide element proximal end 300b still positioned in the needle channel 265, but out of the catheter 210. The extent of the guide element curl 305 off set can be appreciated such that the guide element, when deployed, initially began to curl along a lateral edge of the needle beveled surface instead of curling directly over the tissue penetrating surface.

[0135] From the bottom view shown in FIG. 27B, the guide element distal tip 300a and guide element notch feature 303 are visible forming the end of the curl 305. In this view, the guide element notch feature 303 is illustrated off-axis from the guide wire 230 and the needle 250. Of note, this bottom view also reveals an example of an inferior guide element surface including the protruding regions 301 and 301 that can be adapted to communicate with the- 39 of 56 -SG Docket No.: 14842-717.601needle channel rails (e.g., 265a and 265b) when the guide element 300 is retracted such that the guide element is biased back into a linear configuration within the needle channel 265.

[0136] As described herein, and in any example of a vascular access device, a guide element may be adapted and configured to be deployed from a stowed position within the lumen and exterior to the needle and a deployed condition wherein a tip of the guide element is at least partially curled about a longitudinal axis of the needle (e.g., in a deployed or at least partially deployed configuration). As illustrated in FIG. 27 A, a curl may be to one side of the distal most end of the needle to form an atraumatic tip forming a curl such that a distal tip of the guide element curls off-axis compared to a guide element deployment direction.

[0137] In some examples, the guide element comprises a flexible distal portion configured to curl when the guide element is deployed from the catheter or wherein the guide element comprises a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire or wherein the guide element comprises a shape- set distal portion beyond the distal end of the guide wire positioned therein. For example, in use to position the catheter within a vessel, the shape-set distal portion is adapted and configured to curl over a lateral edge of a beveled surface at the distal end of the needle.

[0138] FIG. 28A and FIG. 28B reveal additional details of the off set guide element curl from FIG. 27A and 27B further illustrating the offset or off-axis nature of the guide element distal portion forming curl 305. In FIG. 28A, the guide element inferior surface 300c is generally curved to complement the needle channel (e.g., 265). However, in this view, the curve of surface 300c may be adjusted to a flat or substantially flat surface along a distal portion of the guide element 300 to facilitate the curl and off-set nature of the curl. In FIG. 28B, the guide element distal end 308 with distal tip 300a and notch feature 303 is positioned on a different plan than that of the needle tip 255. Accordingly, when the guide element 300 is retracted, the distal end 308 including distal tip 300a can be retracted along a lateral edge of the needle end rather than along the tissue penetrating tip. Accordingly, the off-set nature of the curl 305 can prevent or reduce any inadvertent contact or positioning of the guide element distal tip with the needle lumen.

[0139] FIG. 29A and FIG. 29B show similar arrangement of the guide element from FIG. 28A and FIG. 28B now with the guide element 300 only deployed such that the curl 305 is forming and the guide element body is substantially within the needle channel 265. In both- 40 of 56 -SG Docket No.: 14842-717.601views, the needle lumen 250 can be seen unobstructed by the guide element 300 as the off-axis deployment allows the guide element distal tip 300a to deploy and curl along a lateral edge of the needle dip. Referring to FIG. 29B, the tissue penetrating tip 255 is adjacent to point 305c of the guide element curl 305. However, as the guide element 300 is further retracted proximally, the tissue penetrating tip 255 may not contact the guide element 300 as the guide element un-curls to a linear configuration along the lateral edge of the needle tip and / or based on the communication between the needle channel rails 265a and 265b with the guide element.

[0140] In FIG. 29A, the guide element distal tip 300a is also illustrated in another exemplary position substantially separated a distance from the needle lumen 251 or the tissue penetrating tip 255 such that when the guide element 300 is retracted, the curl 305 can transition back to a linear configuration along an edge of the needle distal end.

[0141] FIG. 30 highlights an example of the different planar positions of the guide element 300 and the needle 250. The cross-section is taken along a single longitudinal plane of the needle 250 and reveals a coplanar relationship with the guide wire 230. guide wire distal end 230a. guide element engagement feature of the guide wire 235, and the tissue penetrating tip 255. However, the curl 305 is partially removed from view as the cross section serves to emphasize the off-axis or off-set aspect of the curl 305.

[0142] The cross section in FIG. 31 provides further details of an exemplary distal segment of a guide wire 230 in the guide element 200 having the guide element engagement feature 235, and varying diameters or other features along a length of the guide wire distal end. In any example, the guide wire distal segment may comprise one or more tapered regions as the diameter of the guide wire changes. For example, the length of tapered section 232a may refer to a proximal taper from the guide wire proximal body to the distal segment. In this example, guide wire region 234 then has a uniform diameter along a length between the tapered section 232 and the guide element engagement feature 235. IN any example, the guide element engagement features may be of any geometry to promote the coupling of the guide element 300 to the guide wire 230. A final length of guide element 234 extends distally from the guide element engagement feature to an end 230a. In this cross section, the length of guide element (e.g., 300) extending beyond the guide wire distal end 230a may allow the guide element to form the curl (e.g., curl 305) when deployed from the catheter 210.- 41 of 56 -SG Docket No.: 14842-717.601

[0143] In some examples, the guide element curl 305 can be formed based on the length of the guide element adapted to be more flexible and form the curl. Accordingly, and in some examples, the guide element may have one or more segments, regions, areas, etc. with increased flexibility allowing for the curl to form when the guide element is extended. When the guide element is withdrawn in the ready-to-use configuration as illustrated, for example, in FIG. 24, the guide element is generally linear an maintained in position along the needle exterior. In some examples, only when the guide element is distally advanced, with the curl form in the distal portion of the guide element. Otherwise, the guide element is configured to maintain the linear configuration adapting to the needle exterior surface.

[0144] In FIG. 32, additional details of a non-uniform guide wire 230 are provided. In some examples, the guide wires described herein may be considered compound guide wires with the guide element integrated to the guide wire. As described, the distal segment of the guide wire 230 includes the proximal portion 233 extending between the tapered region 232 and the guide element engagement feature 235. Then, a distal region 234 has yet a different dimension from the guide wire engagement feature 235 as it extends to the guide wire distal end 230a. This distal segment of guide wire 230 is positioned within the guide element 300 as it may be over molded or otherwise affixed (e.g., bonded, glued, etc.) to the guide elements described herein. Further, the segment of guide element extending beyond the guide wire distal end 230a may be flexible along an entire length of that segment, or less than an entire length, or a combination thereof with multiple guide element regions of different flexibility. In some examples, the guide element may comprise a shape memory or a composition capable of providing a shape memory to the guide element to form the curl (e.g., curl 305) when deployed from the catheter.

[0145] FIG. 33 shows a detailed perspective view of the guide wire distal segment 230 highlighting details of the various exemplary features including the proximal guide wire body 230 at the proximal end of the tapered section 232 transitioning to a small diameter segment 233 compared to the proximal guide wire 230. As described herein, the guide element engagement feature 235 then has a different diameter or geometry than segments 233 or 234 to support engagement with the guide element when it is coupled thereto. Finally, in this example, a distal portion 234 extends from the guide element engagement feature 235 to the guide wire distal end 230a. The configuration, arrangement, orientation and dimensions of the guide wire distal end may vary to support the coupling between the guide element and the guide wire. Ins some- 42 of 56 -SG Docket No.: 14842-717.601examples, the arrangement and configuration of the guide wire distal end features may also provide additional function of the soft-tip or flexible region of the guide element distal to the guide wire distal tip 230a.

[0146] In some examples, the distal segment of the guide wire may be 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, or more or less or any length therebetween. For example, the length between the tapered portion and the distal end of the guide wire may be 3 mm or more or less. In some examples, the guide element engagement feature at the distal segment of the guide wire may be ,1mm, ,2mm, ,3mm, ,4mm, ,5mm, ,6mm, ,7mm, ,8mm, ,9mm, 1mm, or more or less or any length therebetween. For example, the guide element engagement feature may be between ,5mm and .65mm.

[0147] FIG. 34A and FIG. 34B highlight details of the various features of a compound needle 250 having a proximal channel 260 and a distal channel 265 separated by a transition 270. The distal channel 265 can be configured to reduce or prevent a core taken by the needle as it reduces the dimensions of the needle lumen 251 opening adjacent to the tissue penetrating tip. In some examples, the length of the distal channel is configured to accommodate the length of the guide element positioned therein. For example, the channels 265 and 260 are provided to increase an interior volume of the space between the needle exterior and a catheter interior surface allowing the passage and positioning of a guide wire and guide element therein. In some examples the length of the proximal channel 260 may be configured to accommodate the guide wire extending therethrough. Referring to FIG. 35B, the proximal channel 260 transitions to the distal channel 265 across a sloped transition 270. In some examples, channels 265 and 260 are co-planar. In some examples, channels 265 and 260 extend along different planes. In some examples, channel 265 and channel 260 extend along parallel planes. In some examples, channel 265 may be angles from the proximal end adjacent to transition 270 and the channel distal end 265c adjacent to the needle lumen 251 such that the plane of channel 265 may intersect with the plane of channel 260.

[0148] The detailed view in FIG. 34B further highlights the edges 256a and 256b of the needle end where the guide element may be configured to deploy across to avoid curling directly over the needle tip 255 or the needle lumen 251. Similarly illustrated in FIG. 25, the lateral edges 256a and 256b of the needle can be configured to contact the guide element during deployment, advancement, or other use where the guide element distal tip is curled beyond the needle. In- 43 of 56 -SG Docket No.: 14842-717.601some examples, the lateral edges of the needle can allow for transition of the guide element from a linear configuration to a curled configuration without contact of the tissue penetrating tip with the guide element. Additionally, the ability of the guide element to curl off or along a lateral edge of the needle may also be configured to prevent the guide element distal tip from entering the needle lumen during withdraw or retraction. For example, when the guide element distal tip transitions from the curled configuration to the linear configuration the guide element distal tip can travel along the needle lateral edge such that the guide element distal tip retracts without the distal tip entering the open distal end of the needle lumen.

[0149] The needle channel rails can be configured to communicate with the guide element in some examples to support the deployment and retraction of the guide element. As described herein, the guide elements may be configured to complement the needle channels with protruding lateral sides that may communicate with an upper surface of the needle channel rails. For example, distal channel 265 has rails 265a and 265b. When the guide element is in a read-to- deploy configuration, the rails 265a and 265b may be in contact with the guide element. When the guide element is deployed, the curl may form as it is no longer restricted by the rails, needle, or catheter. Then, when the guide element is retracted and the guide element surface is again in contact with the needle channel rails 265a and 265b, the rails may bias the distal flexible segment of the guide element back to a linear configuration. In some the width of the proximal channel may be the same as the width of the distal channel. In some examples, the width of the proximal channel may be greater than the width of the distal channel. In some examples, the width of the proximal channel may be less than the width of the distal channel. For example, the width of a needle channel may be the distance between the lateral rails (e.g., 265a and 265b).

[0150] In some examples, the diameter (e.g., width) of a needle channel may be .1mm, ,2mm, ,3mm, ,4mm, ,5mm, ,6mm, ,7mm, ,8mm, .9mm, 1mm or more or less or any distance therebetween. For example, the width of a proximal needle channel may be between ,4mm and ,6mm. For example, the width of a distal needle channel may be between ,4mm and ,9mm. IN some examples, a needle channel may have the same width along the length of the channel. In some examples, a needle channel may have a first width at a proximal end of the needle channel and a second width at the distal end of the needle channel. In some examples, the first width and the second with may be the same. In some examples, the first width may be greater than the second width. In some examples, the first width may be less than the second width.- 44 of 56 -SG Docket No.: 14842-717.601

[0151] In some embodiments, the vascular access devices described herein may have a handle comprising a proximal portion and a distal portion. FIG. 35A to FIG. 36B illustrate an example of a handle of a vascular access device having at least two parts shown in perspective views including cross sections. Referring to FIG. 35A and 35B, the handle proximal portion 400 extends between a distal end 400a and a proximal end 410. The slot 410, as described herein, extends from adjacent to the proximal end 410 to the open distal end 400a as it may be arranged and configured to communicate with a portion of the slot in the handle distal segment. The bottom view shown in FIG. 35B of the proximal handle position 400 further reveals the position of the slider locking mechanism 470 similar to that previous described in relation to the proximal end of the slider channel (e.g., FIG. 20). The cross section of proximal handle portion 400 shown in FIG. 35C add additional details of the proximal end of the slider channel 470b with the channel 425 extending distally from the stop 470b and the ramp 470a. In some examples, the channel 425 of the handle proximal portion may be configured to align and communicate with the distal handle portion for a complete slider channel. The coupling region 415 at the distal end 400a can be configured to receive the proximal side of the handle distal portion. Along an interior of the slot 410 are detents 411 that may be provided at one or more positions along a length of the slot 410 to support positioning of the slider within the slot.

[0152] The distal handle portion 500 is shown in FIG. 36A and 26B with other features and elements removed. Here, the distal portion of the slot is shown extending along a length of the distal handle portion 500 at slot 510. Accordingly, when the proximal end 500b of the distal handle portion 500 is inserted into the proximal handle portion 400, the slot 510 can communicate with slot 410 to form a single slot along a length of the handle for the slider to move and deploy or retract the guide element. The distal end 500a of the distal handle portion 500 can be see and has been previously described as configured to communicate with the catheter hub. The cross section in FIG. 36B then provide additional details of the lumen 501 extending through the distal end 500a as it may be configured to allow for the position and translation of various elements of the VAD including the guide wire, guide wire tube, guide element, needle, needle carrier, etc.

[0153] In FIG. 37A and FIG. 37B, the cross section of the catheter hub 200 and VAD handle 105 reveals additional examples of the orientation and position of the guide tube 132 from the handle and into the catheter hub 200. In particular, the guide tube highlights a first segment- 45 of 56 -SG Docket No.: 14842-717.601within the handle, then a sloping portion 132b transitioning between this first segment and a distal end 132c at the end of a distal guide tube segment. The opening of the guide tube at distal end 132c is adjacent to the valve 220. In the proximal perspective shown in FIG. 37 A, the distal valve face 220b can be seen adjacent to the catheter proximal end in the catheter hub 200. The catheter 210 and the needle 250 are also seen extending from the catheter hub 200 and through the stabilizing feature 205.

[0154] The position of the guide tube distal end 132c is proximal to the valve proximal face 220 as seen in FIG. 37B. Accordingly, the distance between the guide tube distal end 132c and the valve proximal face 220a is reduced or eliminated as the guide tube can be configured to provide additional support for the routing of the guide wire through the valve. For example, the distance between the guide tube distal end 132a and the valve proximal face 220a may be minimal to reduce any unsupported distance traversed by the guide wire. In some examples, the distance between the guide tube distal opening and the valve may be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm, 4.5mm, or more or less or any distance therebetween. For example, the distance between the guide tube distal opening and the valve may be between 2.8mm and 3.25mm.

[0155] In some examples, the catheter assembly may comprise the stabilizing feature (e.g., 205) described herein with surfaces 206 extending at an angle 500 relative to the catheter hub 200 or a central axis of the catheter 210. The angle 500 may be configured to support the presentation and access of the catheter hub proximal end 200a such that it is easier for a user to access based on the increased angle of the catheter hub 200 relative to the surface of the patient’s skin. For example, angle 500 may be an angle between 5 degrees and 25 degrees or more or less configured to provide an outward angle of the catheter hub proximal end 200a relative to the patient’s skin allowing easier access to the catheter for subsequent vascular access via the indwelling catheter 210.

[0156] In any example of a guide element described herein, a guide wire may be coupleable to a guide element that is or can be linear, configured to transition between a linear to a curled configuration. In any of the examples described herein, the guide element may be configured to be linear and / or transition from a linear configuration to a curled configuration. Any of the guide elements that can be configured to curl may be configured to form a curl along its axis (e.g., axis of deployment, or generally an axis of the guide wire). Any of the guide elements that can be- 46 of 56 -SG Docket No.: 14842-717.601configured to curl may be configured to form a curl at an angle to, or generally off-axis (e.g., axis of deployment, or generally an axis of the guide wire).

[0157] In any of the examples described herein, various components, methods, aspects or other features of the VADs described herein may further include those previously described in International Application No. PCT / US 2024 / 01431, filed February 2, 2024, titled “GUIDE ELEMENT SYSTEM FOR INTRAVASCULAR ACCESS,” U.S. Provisional Patent Application No. 63 / 666,635, filed July 1, 2024, titled “VASCULAR ACCESS DEVICE,”, and U.S. Provisional Patent Application No. 63 / 723,585, filed November 21, 2025, titled “VASCULAR ACCESS DEVICE” all of which are incorporated by reference herein.

[0158] 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.

[0159] 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 directly connected, 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.

[0160] 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- 47 of 56 -SG Docket No.: 14842-717.601forms “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 “ / ”.

[0161] 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.

[0162] 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 discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0163] 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.- 48 of 56 -SG Docket No.: 14842-717.601

[0164] 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.

[0165] 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 described method 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.- 49 of 56 -SG Docket No.: 14842-717.601The 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.- 50 of 56 -SG Docket No.: 14842-717.601

Claims

CLAIMSWhat is claimed is:

1. A vascular access device comprising: a handle having a proximal end and a distal end with a slot extending along a length of the handle in communication with an interior of the handle; a needle having a distal end extending beyond the distal end of the handle and a proximal end within a needle carrier slidably arranged within the interior of the handle: a slider extending from the needle carrier and through the slot; a guide wire extending from the slider along and outside of the needle and beyond the handle distal end; a catheter assembly having a proximal end, a distal end and an interior surface of the catheter defines a lumen extending from the proximal end to the distal end, wherein when the proximal end of the catheter assembly is releasably coupled to the handle distal end the needle is within the lumen and the guide wire is positioned between an exterior surface of the needle and the interior surface of the catheter; and a guide element coupled to a distal segment of the guide wire, wherein the guide element is adapted and configured to be deployed from a stowed position within the lumen and exterior to the needle and a deployed condition wherein a tip of the guide element is at least partially curled about a longitudinal axis of the needle or to one side of the distal most end of the needle or curls off-axis compared to a guide element deployment direction.

2. The vascular access device of claim 1, the distal segment of the guide wire comprising a non-uniform distal segment having at least one region with a reduced diameter.

3. The vascular access device of claim 1 or claim 2, wherein the distal segment of the guide wire further includes a guide element engagement feature.

4. The vascular access device of claim 3, wherein the guide element is affixed onto the distal segment of the guide wire.- 51 of 56 -SG Docket No.: 14842-717.6015. The vascular access device of claim 3, wherein the distal segment of the guide wire is positioned within the guide element.

6. The vascular access device of claim 1, wherein the guide element comprises a flexible distal portion configured to curl when the guide element is deployed from the catheter.

7. The vascular access device of claim 1, wherein the guide element comprises a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire.

8. The vascular access device of claim 1, wherein the guide element comprises a shapeset distal portion beyond the distal end of the guide wire positioned therein, wherein in use to position the catheter within a vessel the shape-set distal portion is adapted and configured to curl over a lateral edge of a beveled surface at the distal end of the needle.

9. The vascular access device of claim 1, further comprising a notch in a distal end of the catheter assembly.

10. The vascular access device of claim 9, further comprising a notch feature on the guide element adapted and configured for a complementary fit within the notch when the guide element is along the needle within the lumen in a stowed configuration.

11. The vascular access device of claim 6 or claim 7, wherein the flexible distal portion guide element comprises a notch feature and a distal end of the catheter comprises a notch adapted and configured to receive at least a portion of the notch feature.

12. The vascular access device of claim 1, wherein the slider is configured to be distally advanced within the handle slot to deploy the guide element from the distal end of the catheter.

13. The vascular access device of claim 1, wherein the needle comprises one or more channels extending along a length of the needle, the one or more channels configured to accommodate the guide wire therethrough.

14. The vascular access device of claim 13, further comprising a proximal needle channel and a distal needle channel, where in the distal needle channel is configured to accommodate the guide element between the distal needle channel and an interior surface of the catheter.- 52 of 56 -SG Docket No.: 14842-717.60115. The vascular access device of claim 1 , further comprising a stabilizer positioned on a catheter hub of the catheter assembly, the stabilizer comprising at least one angled surface extending proximally from a distal end of the catheter hub at an acute angle configured to provide a position of a proximal end of the catheter hub after the catheter is positioned within a vessel.

16. 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 catheter; a slot in a surface of the handle, the slot having a distal end within the handle distal end and a proximal end within the handle proximal end; a channel extending along an interior surface of the handle proximal end; a slider extending through and configured to translate along the slot; a slider leg extending from the slider into an interior portion of the handle, the slider leg having a slider foot configured to engage the channel; 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 an access needle and the needle earner proximal end has a carrier dock sized and configured to receive a portion of the slider; a guide wire coupled to the slider, the guide wire extending along the needle carrier and beyond the distal end of the handle; and a guide element engagement portion at a distal end of the guide wire adapted and configured to join with a guide element.

17. The vascular device of claim 16, 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.

18. The vascular device of claim 16, wherein when the slider is in the distal end of the slot a slider protrusion on the slider leg is engaged with a dock opening in the carrier dock.

19. The vascular device of claim 16, further comprising a slider knee on the slider leg configured to flex in response to the docking of the slider in the proximal end of the needle carrier.- 53 of 56 -SG Docket No.: 14842-717.60120. The vascular device of claim 16, wherein the guide element engagement portion of the guide wire is positioned within the guide element, 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.

21. The vascular device of claim 16, further comprising a slider lock recess at the proximal end of the channel, the slider lock recess configured to retain the slider in a retracted position within the handle.

22. The vascular device of claim 16 or claim 21, 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.

23. The vascular device of any of claims 16 to 21 or claim 22, further comprising an actuator in the handle distal end, the actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a position within the handle proximal end.

24. The vascular device of claim 23, further comprising a catheter assembly releasably coupled to a distal face of the handle distal end, the catheter assembly comprising a catheter having a lumen extending from a proximal end of a catheter hub to a catheter tip, and a valve positioned within the catheter hub, the valve configured to seal a proximal portion of the catheter hub.

25. The vascular device of claim 24, wherein the needle extends through the catheter lumen and the guide wire extends along the needle exterior within the catheter lumen.

26. The vascular device of claim 24 or claim 25, further comprising 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.The vascular device of any of claims 21 to claim 23, wherein the guide element is configured to engage the notched catheter tip.

27. The vascular access device of claim 24 or claim 25, further comprising a notch in a distal end of the catheter assembly.

28. The vascular access device of claim 27, further comprising a notch feature on the guide element adapted and configured for a complementary fit within the notch when the guide element is along the needle within the lumen in a stowed configuration.- 54 of 56 -SG Docket No.: 14842-717.60129. The vascular access device of claim 20, wherein the guide element comprises a flexible distal portion with a notch feature.

30. The vascular access device of claim 24, wherein a distal end of the catheter comprises a notch adapted and configured to receive at least a portion of a notch feature on a guide element.

31. The vascular access device of any one of claim 27 or claim 28 or claim 29. or claim 30, wherein the guide element comprises a flexible distal portion configured to curl when the guide element is deployed from the catheter or wherein the guide element comprises a flexible distal portion configured to form an arc at an angle off set of an axis of the guide wire or wherein the guide element comprises a shape-set distal portion beyond the distal end of the guide wire positioned therein, wherein in use to position the catheter within a vessel the shape-set distal portion is adapted and configured to curl over a lateral edge of a beveled surface at the distal end of the needle.

32. A method of preparing a vascular access device for use, comprising:Moving a slider proximally along a handle to rotate a distal most portion of a guide element about a needle distal tip without contacting the needle distal tip; and Ceasing moving the slider proximally along the handle when the guide element is seated within a catheter lumen along an outer surface of the needle.

33. The method of claim 32, wherein after the ceasing step a notch feature on the guide element is seated within a notch of the catheter.

34. A compound guide wire for placement of a catheter assembly comprising: a guide wire having an elongate body and a distal segment having at least one region of a smaller diameter than a proximal end of the guide wire; and a guide element coupled to the distal segment of the guide wire, the guide element comprising a distal portion configured to transition from a linear configuration to a curled configuration, wherein the distal portion of the guide element extends beyond a position of a distal end of the guide wire.- 55 of 56 -SG Docket No.: 14842-717.601

Images