Vascular access device

Abstract

A vascular access device having a handle adapted to be releasably coupled to a proximal end of a catheter. A slot along the handle with a slider configured to translate along the slot A needle carrier disposed within the interior portion of the handle and coupled to an access needle with the proximal end of the needle carrier having a dock 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 and extending along the needle carrier, exiting the interior of the handle and extending along a needle channel in a catheter with a guide element at a distal end of the guide wire.

Description

VASCULAR ACCESS DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 666,635, titled “VASCULAR ACCESS DEVICE,” filed July 1, 2024, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

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

[0003] The present invention relates generally to methods and systems for performing vascular access. More particularly, the present invention provides a catheter and needle assembly with an integrated gu4ide element or structure for transcutaneous insertion of the catheter into a patient's arterial or venous vasculature.BACKGROUND

[0004] One common type of vascular access is called venipuncture. Venipuncture refers generally to the process of obtaining intravenous access for any one of a variety of purposes, including intravenous infusion, therapy, blood sampling, and the like. 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.

[0005] 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.

[0006] 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 canobscure 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.

[0007] Recent developments in intravascular access devices (IVADs) 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.

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

[0009] In general, a vascular access device can comprise a handle having a proximal end and a distal end, 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 carrier 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.

[0010] 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 clock 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 carrier dock. 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 guideelement 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 comprising an actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a proximal position within the handle. 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 distal end of a catheter hub to a notched catheter tip, and a valve positioned within the catheter hub, the valve configured to seal a distal portion of the catheter hub. The needle extends through the catheter lumen and the guide wire extending along the needle exterior within the catheter lumen.

[0011] This and any other embodiments described herein may further comprise one or more of the following. 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 cap releasably coupled to the distal end of the handle, the cap comprising an interior configured to receive the catheter assembly therein. The 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 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.

[0012] 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 therails are configured to contact the guide element to transition the guide element to a linear configuration in the stowed position.

[0013] 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.

[0014] 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 element 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.

[0015] In general, a method of placing a catheter assembly within a blood vessel may comprise the steps of inserting a tissue penetrating tip of a needle into a blood vessel, wherein the needle can be coupled to a vascular access device and extends through a catheter assembly releasably coupled to the distal end of the vascular access device, the vascular access device comprising a handle having a slider extending through a slot of the handle, a needle carrier coupled to a proximal end of the needle, a guide wire extending from the slider out of the handle to a longitudinal channel along the needle exterior surface to a guide element. The slider can be advanced distally along the slot to advance the guide element from a docked position in communication with a notch at the distal end of the catheter assembly to a deployed position beyond the tissue penetrating tip of the access needle. The needle carrier, access needle and guide element can be retracted into an interior of the handle. The catheter assembly can be detached from the distal end of the handle.

[0016] This and any other embodiments described herein may further comprise one or more of the following. The access needle may extend through a catheter lumen and the guide wire extends between an exterior surface of the access needle and an interior surface of the catheter assembly. The step of retracting the needle can comprise releasing a needle carrier coupled to the proximal end of the needle, wherein the needle carrier is spring biased to aproximal end of the handle interior. The step of retracting the needle can comprise docking the slider to a proximal end of the needle carrier and retracting the slider, needle carrier, and access needle proximally along the slot. The guide element can be configured to transition from a curled configuration to a linear configuration. A rail may extend along each side of the longitudinal channel of the access needle, and wherein each rail contacts the guide element to transition the guide element from the curled configuration to the linear configuration when the guide element is retracted. The step of advancing the slider can comprise transitioning the guide element from the linear configuration to the curled configuration beyond the tissue penetrating tip of the access needle. The method may further comprise the step of loading the vascular access device for use before inserting the tissue penetrating tip of the needle, wherein loading the vascular access device can comprise withdrawing a slider on the handle in a proximal direction to move a guide element proximally from the curled configuration into the linear configuration while the catheter assembly is within a cover. The guide element can be transitioned from a curled configuration beyond the tissue penetrating tip of the access needle to a linear configuration in the longitudinal channel of the access needle. The withdrawal of the slider may be stopped when the guide element is seated in communication with a notch at the distal end of the catheter.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] 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:

[0018] 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.

[0019] 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.

[0020] 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 andportion 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.

[0021] FIGS. 4 A 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.

[0022] 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 carrier 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.

[0023] 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 is also shown extending beyond the distal end of the needle carrier.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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 carrier lumen configured to receive the needle at the needle carrier distal end.

[0028] 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 inFIG. IOC. 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. IOC as it may be adapted to receive the bent leg of the slider in a distally most advanced position.

[0029] FIG. 11 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 intravascular 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.

[0030] 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.

[0031] 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.

[0032] FIGS. 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 overmolded to the guide wire. In some examples, the guide wire may comprise a braid or mesh at a distal end or segment that is overmolded with the guide elements described herein.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] FIGS. 21 A to 21D 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.DETAILED DESCRIPTION

[0040] An intravascular access device (IV AD) 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 IV AD and engaged by a user with positive feedback to indicate a position of the slider relative to an IV AD 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 IV AD 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 IVAD and / or the patient.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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 135 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.

[0045] FIG. 2 also shows an actuation button 125 that is configured to control a proximal release of the needle carrier when the needle 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 thehandle 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.

[0046] FIG. 3 shows the vascular access device 100 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 by 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.

[0047] 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 13 ©deployment or position.

[0048] 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 withinthe 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.

[0049] FIGS. 4 A 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 carrier 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 advancement 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.

[0050] 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 carrier, 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 carrier 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, overmolding, or other type of coupling support between the needle 135 and needle carrier 140.

[0051] 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 wire 131 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 tube 132 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 132 is positioned along an upper / exterior surface of the needle carrier 140. Then, the 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.

[0052] 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.

[0053] 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.

[0054] 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 carrier 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.

[0055] 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 to 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.

[0056] 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.

[0057] 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. FIG. 8B shows the same segment illustrated in FIG. 8 A 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.

[0058] 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. 8 A 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.

[0059] 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.

[0060] 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 refer 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 may be 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 the slider foot is positioned in the depression 174 and locked in a proximal position within the housing.

[0061] 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 needle channel 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 the needle channel 147. The intersection of opening 144 and needle channel 147 allow for the fixation of the needle to the needle carrier 140.

[0062] 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. 10A, the needle carrier 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 betweenthe actuation button 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.

[0063] Referring to FIGS. 10B and 10C, the needle lumen or channel 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 needle channel 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.

[0064] The cap 300 is illustrated in additional detail in FIG. 11 A and FIG. 1 IB. From the distal perspective in FIG. 11 A, 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.

[0065] 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 deployed 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 whereby the guide element can be adapted to curl the distal portion of segment of the guide element130 to provide the atraumatic tip during use. The curl 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 overmolding 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.

[0066] 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.

[0067] 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 / curl 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 otherwise 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.

[0068] 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 theneedle 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 / l 55b) 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.

[0069] 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 overmolded 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 overmolded 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.

[0070] 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 / l 55b 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.

[0071] 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 catheterhub 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 be 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.

[0072] 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, 21 A 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).

[0073] 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.

[0074] 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 actuationbutton 125, distal end of the handle slot 115, needle carrier 140, through to the hemostasis valve 220, catheter 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.

[0075] 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 carrier 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.

[0076] 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 retracted over the backstop 172, tapered section 173, and until the foot 163 engages the depression 174 to a locked or retained position. In someexamples, 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.

[0077] FIGS. 21 A 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.

[0078] Referring to FIG. 21 A, 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. 21 A 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.

[0079] FIG. 21B 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 the 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 310 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.

[0080] 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.

[0081] FIG. 2 ID then shows a close up view of the needle distal end from FIG. 21 C 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.

[0082] 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 130 of the guide element to a linear configuration as illustrated in FIG. 2 ID to be docked and seated in the needle channel through the catheter 210.

[0083] 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 guide 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 guideelement from the curled configuration to the linear configuration as it is retracted so as to avoid contact with the tissue penetrating tip.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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 statedvalue (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.

[0092] 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.The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intendedto cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A vascular access device, comprising: a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of a 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 move along the slot; a slider leg extending from the slider to a slider foot, the 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 of the handle, wherein the needle carrier distal end coupled to an access needle and a carrier dock at the needle carrier proximal end if sized and configured to receive the slider leg; and a guide wire coupled to a portion of the slider within the interior of the handle, the guide wire extending along the needle carrier and out of the distal end of the handle along an exterior of the access needle to a guide element positioned in a longitudinal channel along the access needle.

2. The vascular access device of claim 1, 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.

3. The vascular access device of claim 1 or claim 2, further comprising a slider lock positioned at the proximal end of the channel and configured retain the slider, needle carrier and access needle in a retracted configuration.

4. The vascular access device of claim 1, 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.

5. The vascular access device of claim 1, wherein the guide element configured to transition from a stowed position at a distal end of the catheter to a deployed position when the slider is distally advanced in the slot.

6. The vascular access device of claim 1, 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.

7. The vascular access device of claim 1, wherein the slider is configured to engage the needle carrier proximal end, and wherein the access needle is configured to retract into the housing when the slider retracts the needle carrier proximally in the interior of the handle.

8. The vascular access device of any of claims 1 to claim 7, further comprising an actuator in operable communication with a spring, wherein the actuator is configured to release the spring to bias the needle carrier to a proximal position within the handle.

9. The vascular access device of any of claims 1 to claim 8, the catheter comprising a lumen extending from a distal end of a catheter hub, a guide element notch at the distal end of the lumen, and a valve positioned within the catheter hub, the valve configured to seal a distal interior portion of the catheter hub.

10. The vascular access device of claim 9, wherein the needle extends through the catheter lumen and the guide element is in communication with the guide element notch.

11. The vascular access device of claim 9 or claim 10, further comprising a guide tube positioned on the needle carrier, wherein the guide wire extends from the slider through the guide tube to the catheter lumen.

12. The vascular access device of any of claims 9 to claim 11, wherein the guide element is shaped to complement the longitudinal channel of the access needle.

13. The vascular access device of claim 1, wherein the guide element is configured to transition from a deployed configuration wherein a distal segment of the guide element curls beyond a tissue penetrating tip of the access needle.

14. The vascular access device of claim 1, wherein a distal segment of the guide element is configured to form a curl when extended beyond a tissue penetrating tip of the access needle.

15. The vascular access device of claim 1, wherein the guide element is adapted to form a curl beyond a distal end of the access needle in a deployed configuration.

16. The vascular access device of claim 15, wherein the curl of the guide element is adapted to transition to a linear configuration as the guide element is retracted proximally along the longitudinal channel of the access needle17. The vascular access device of claim 15, wherein the slider is configured to move the guide element relative to a tissue penetrating tip of the access needle.

18. The vascular access device of claim 16, wherein the guide element is configured to form an atraumatic tip distal to the tissue penetrating tip when advanced distally beyond the tissue penetrating tip.

19. The vascular access device of any of claims 1 to claim 18, wherein the longitudinal channel of the access needle comprises a rail on each side of the longitudinal channel.

20. The vascular access device of claim 19, wherein the rails of the longitudinal channel are configured to contact a guide element and transition a distal end of the guide element from a curled configuration to a linear configuration.

21. The vascular access device of claim 19, wherein the rails of the longitudinal channel are configured to transition the guide element between a linear configuration and a curled configuration.

22. The vascular access device of any of claims 1 to claim 21, further comprising a cover releasably coupled to the distal end of the handle, the cover having an interior configured to receive the catheter therein.

23. A cover for a vascular access device, comprising: 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; and 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.

24. A method of loading a vascular access device for use, comprising; positioning a vascular access device having an indwelling catheter, access needle and guide element coupled to a handle into a cover of claim 22; withdrawing a slider on the handle in a proximal direction to move a guide element proximally within the interior of the cover along the exterior of the access needle; transitioning the guide element from a curled configuration beyond the tissue penetrating tip of the access needle to a linear configuration in the longitudinal channel of the access needle; andstopping the withdrawal of the slider when the guide element is seated in communication with a notch at the distal end of the catheter.

25. The method of claim 22, further comprising: removing the cover before use to place the indwelling catheter into a vessel of a patient.

26. A method of placing a catheter assembly within a blood vessel, the method comprising the steps of: inserting a tissue penetrating tip of a needle into a blood vessel, wherein the needle is coupled to a vascular access device and extends through a catheter assembly releasably coupled to the distal end of the vascular access device, the vascular access device comprising a handle having a slider extending through a slot of the handle, a needle carrier coupled to a proximal end of the needle, a guide wire extending from the slider out of the handle to a longitudinal channel along the needle exterior surface to a guide element; advancing the slider distally along the slot to advance the guide element from a docked position in communication with a notch at the distal end of the catheter assembly to a deployed position beyond the tissue penetrating tip of the access needle; retracting the needle carrier, access needle and guide element into an interior of the handle; and detaching the catheter assembly from the distal end of the handle.

27. The method of claim 26, wherein the access needle extends through a catheter lumen and the guide wire extends between an exterior surface of the access needle and an interior surface of the catheter assembly.

28. The method of claim 26, wherein the step of retracting the needle comprises releasing a needle carrier coupled to the proximal end of the needle, wherein the needle carrier is spring biased to a proximal end of the handle interior.

29. The method of claim 26, wherein the step of retracting the needle comprises docking the slider to a proximal end of the needle carrier and retracting the slider, needle carrier, and access needle proximally along the slot.

30. The method of claim 26, wherein the guide element is configured to transition from a curled configuration to a linear configuration.

31. The method of claim 30, wherein a rail extends along each side of the longitudinal channel of the access needle, and wherein each rail contacts the guide element to transition the guide element from the curled configuration to the linear configuration when the guide element is retracted.

32. The method of claim 30, wherein the step of advancing the slider comprises transitioning the guide element from the linear configuration to the curled configuration beyond the tissue penetrating tip of the access needle.

33. The method of any of claims 26 to 32, further comprising loading the vascular access device for use before inserting the tissue penetrating tip of the needle, wherein loading the vascular access device comprises withdrawing a slider on the handle in a proximal direction to move a guide element proximally from the curled configuration into the linear configuration while the catheter assembly is within a cover; transitioning the guide element from a curled configuration beyond the tissue penetrating tip of the access needle to a linear configuration in the longitudinal channel of the access needle; and stopping the withdrawal of the slider when the guide element is seated in communication with a notch at the distal end of the catheter.

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