Intravascular Access Devices

Abstract

The intravascular access device includes a handle having a slot through its surface and a plurality of ratchet teeth aligned within the handle. A slider is positioned within the slot with slider legs extending to engage the ratchet teeth. A needle carrier is positioned on the handle, with a proximal dock configured to receive the slider legs, and a needle coupled to its distal end. The needle has a longitudinal flat surface clocked along the length of the needle body and extends through a catheter and catheter hub releasably coupled to the distal end of the handle. A guide element extends through the slider legs, through the needle carrier channel, and along the flat surface of the needle within the catheter. The slider is configured to advance the guide element distally from the catheter distal end when the slider is advanced distally within the handle slot along the ratchet teeth.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 477,378, filed December 27, 2022, entitled "INTRAVASCULAR ACCESS DEVICE," which is incorporated by reference in its entirety. Incorporation by Reference

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

[0002]

[0003] The present invention relates generally to methods and systems for providing vascular access, and more particularly to a catheter and needle assembly with an integrated guide element or structure for percutaneous insertion of the catheter into a patient's arterial or venous vasculature. [Background technology]

[0003]

[0004] One common type of vascular access is called venipuncture. Venipuncture generally refers to the process of securing intravenous access for any one of a variety of purposes, including intravenous infusions, medical treatments, blood draws, etc. In hospitals, for example, venipuncture is commonly used to place small intravenous catheters for intravenous fluid delivery, medication delivery, blood draws, etc.

[0004]

[0005] While venipuncture and other forms of vascular access in relatively healthy patients can be a straightforward matter, such access is often required in less healthy patients with small, tortuous, collapsed, fragile, and / or difficult-to-find arteries and / or veins, in which venipuncture and other forms of vascular access can be extremely difficult, especially for inexperienced phlebotomists, paramedics, nurses, and other healthcare professionals.

[0005]

[0006] In addition to difficult access, many vascular catheter placement systems can result in accidental puncture and / or accidental needle contamination during or after placement of the intravascular catheter. Furthermore, some conventional catheter placement devices employ relatively complicated deployment handle movements, thereby increasing both cost and complexity. Additionally, conventional handle placement and movement can obscure the presence and status of the needle and guiding structure or element components of the device, resulting in a non-intuitive use of the insertion device.

[0006]

[0007] Recent developments in intravascular access devices (IVADs) have significantly improved upon previous devices and methods. However, the present invention offers substantial improvements by providing novel solutions to issues such as ease of use, adaptability, safety, and applicability.

[0007]

[0008] For these reasons, it would be desirable to provide improved methods, systems, and devices for intravascular access using needles and guiding structures. In particular, it would be desirable to provide intravascular access deployment systems and assemblies having operational feedback mechanisms, step processes for storage, deployment, and adjustment, and even more desirable to provide components that enhance effectiveness and improve safety during use. At least some of these objectives will be achieved by the various embodiments described below. Summary of the Invention

[0008]

[0009] In one aspect, a device includes a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of an intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a plurality of ratchets along an inner wall of the handle; a slider extending through and configured to translate along the slot; and slider legs extending from the slider to an inner portion of the handle, the slider configured to engage and advance along the plurality of ratchets as the slider advances along the slot. An intravascular access device is provided, the needle carrier having a slider leg having a slider foot configured to be slidably supported by the slider leg; a needle carrier having a distal end and a proximal end and disposed within an interior portion of the handle, the needle carrier distal end being coupled to the access needle and the needle carrier proximal end having a carrier dock sized and configured to receive a portion of the slider; and a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along the needle carrier, exiting the interior portion of the handle, and extending beyond the distal end of the handle. In one aspect, a slider protrusion is provided on the slider leg, adapted and configured to engage with a dock opening of the carrier dock. Additionally, the slider protrusion on the slider leg is engaged with the dock opening of the carrier dock when the slider is at the distal end of the slot. A slider knee may also be provided on the slider leg, configured to bend in response to movement of the slider foot along the plurality of ratchets. Additionally or optionally, there may be a proximal ratchet valley within the interior of the handle and proximal to the most proximal ratchet of the plurality of ratchets. An example may be where the slider foot is in the proximal ratchet valley when the slider is in the proximal end portion of the slot, or optionally the plurality of ratchets are equally spaced along the interior wall of the handle. In another version, proximal and distal spaces are within the plurality of ratchets, dividing the plurality of ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth.There may also be visual or tactile or combination markings on the handle surface corresponding to the position of the slider relative to the proximal and distal spaces within the plurality of ratchets, the proximal set of ratchet teeth, the intermediate set of ratchet teeth, and the distal set of ratchet teeth.

[0009]

[0010] In some configurations, when the slider is positioned with the slider foot in the proximal ratchet valley, the guide element is adjacent to the needle and the guide element tip is seated in the notched catheter tip, in some embodiments, when the slider is positioned with the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip, or when the slider is positioned with the slider foot in the distal space, the guide element tip is spaced from the distal-most end of the needle.

[0010]

[0011] In an alternative embodiment, a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to the proximal end of an intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider extending through the slot and configured to translate along the slot; slider legs extending from the slider to an interior portion of the handle; and a needle carrier having a distal end and a proximal end and disposed within the interior portion of the handle, the needle carrier distal end being coupled to the access needle and the needle carrier proximal end being coupled to the needle. An intravascular access device is provided, comprising: a needle carrier having a carrier dock sized and configured to receive a portion of the slider; and a guide element coupled to a portion of the slider within an interior portion of the handle, the guide element extending along a channel in the needle carrier, exiting the interior portion of the handle and extending beyond the distal end of the handle, the guide element including a flat side that corresponds to and is positioned along the flat side of the access needle, the guide element coupled to a portion of the slider that directly aligns with a location of the flat side of the needle.

[0011]

[0012] In a further variation, a plurality of ratchets may be provided along the inner wall of the handle, and a slider foot on the slider leg may be configured to engage and advance along the plurality of ratchets as the slider advances along the slot, or a slider protrusion on the slider leg may be adapted and configured to engage with a dock opening of the carrier dock when the slider is at the distal end of the slot. A further variation may include a slider knee on the slider leg configured to bend in response to movement of the slider foot along the plurality of ratchets. A proximal ratchet valley may also be provided within the interior of the handle and proximal to the most proximal ratchet of the plurality of ratchets. Optionally, the slider foot is within the proximal ratchet valley when the slider is at the proximal end portion of the slot. In some variations, the ratchets are evenly spaced along the interior wall of the handle, or proximal and distal spaces are within the ratchets, dividing the ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth. In yet other embodiments, visual or tactile markings or combination markings on the handle surface corresponding to any of the slider positions relative to the proximal and distal spaces within the ratchets, the proximal set of ratchet teeth, the intermediate set of ratchet teeth, and the distal set of ratchet teeth may further be provided. Furthermore, when the slider is positioned so that the slider foot rests in the proximal ratchet valley, the guide element is adjacent to the needle and the guide element tip rests in the notched catheter tip; and When the slider is positioned to place the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip, or when the slider is positioned to place the slider foot in the distal space, the guide element tip is spaced from the distal-most end of the needle.

[0012]

[0013] In another alternative embodiment, a catheter includes a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of an intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider configured to extend through and translate along the slot; slider legs extending from the slider to an interior portion of the handle; and a needle carrier having a distal end and a proximal end and disposed within the interior portion of the handle, the needle carrier distal end being coupled to an access needle, the needle carrier An intravascular access device is provided, comprising: a needle carrier having a proximal end with a carrier dock sized and configured to receive a portion of the slider; and a guide element coupled to a portion of the slider within an interior portion of the handle, the guide element extending along a channel in the needle carrier, exiting the interior portion of the handle and extending beyond the distal end of the handle, the guide element including a flat side that corresponds to and is positioned along the flat side of the access needle, the guide element including a transition section from the top portion of the slider to where the flat side of the needle is located.

[0013]

[0014] In some variations, the guide element transition section couples the slider to a needle flat side located on the right portion of the handle, a needle flat side located on the left portion of the handle, or a needle flat side located on the bottom portion of the handle. Another aspect includes a plurality of ratchets along the inner wall of the handle and a slider foot on the slider leg configured to engage and advance along the plurality of ratchets as the slider advances along the slot. Optionally, a slider protrusion on the slider leg may be further provided, adapted and configured to engage with a dock opening of the carrier dock. In one variation, the slider protrusion on the slider leg engages with the dock opening of the carrier dock when the slider is at the distal end of the slot. Also, a slider knee on the slider leg, or a proximal ratchet valley within the interior of the handle and proximal to the proximal-most ratchet of the plurality of ratchets, may be further provided, configured to flex in response to movement of the slider foot along the plurality of ratchets. In one variation, when the slider is in the proximal end portion of the slot, the slider foot is in the proximal ratchet valley. In some embodiments, multiple ratchets are evenly spaced along the interior wall of the handle. In one aspect, proximal and distal spaces are within the multiple ratchets, dividing the multiple ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth. In some embodiments, visual, tactile, or combination markings are provided on the handle surface corresponding to the position of the slider relative to the proximal and distal spaces within the multiple ratchets, the proximal set of ratchet teeth, the intermediate set of ratchet teeth, and the distal set of ratchet teeth. Optionally, when the slider is positioned to place the slider foot in the proximal ratchet valley, the guide element is adjacent to the needle, and the guide element tip is seated in the notched catheter tip, or when the slider is positioned to place the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip, or when the slider is positioned to place the slider foot in the distal space, the guide element tip is spaced from the distal-most end of the needle.

[0014]

[0015] In one variation, there is further provided an intravascular device over the intravascular catheter having a lumen configured to accommodate an access needle extending therethrough and a notched distal end portion sized and configured to receive the guide element tip.

[0015]

[0016] In yet another variation, a cover for a vascular access device is provided having a body having a closed distal end and an open proximal end defining an interior portion, the open proximal end sized and configured to releasably couple to a distal end of a handle of a vascular access device, a pair of alignment features in the interior portion defining a lumen extending from the open proximal end to an indentation in a distal-most portion of the interior portion, and a beveled surface along the interior portion proximal to the indentation. In one configuration, an intravascular access device is provided coupled to the open proximal end of the cover. Additionally, the cover may be adapted and configured for use with an intravascular access device, the intravascular access device including a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to a proximal end of an intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider configured to extend through and translate along the slot; and a needle carrier having a distal end and a proximal end and disposed within an interior portion of the handle, the needle carrier distal end being coupled to the access needle and the needle carrier proximal end being coupled to the access needle. The handle includes a needle carrier having a carrier dock at its end sized and configured to receive a portion of the slider, and a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along the needle carrier, exiting the interior portion of the handle, and extending beyond the distal end of the handle, wherein the access needle extends along and between the alignment features, the tissue-penetrating tip of the needle is proximal to the beveled surface, and the slider is positioned along the slot such that the distal tip of the guide element is distal to the beveled surface and within the recess. In one variation, proximal movement of the slider moves the distal end of the guide element over the beveled surface and into the notched distal end portion of the catheter lumen. The handle further includes visual or tactile markings to indicate the position of the distal end of the guide element relative to the notched distal end of the catheter or the tissue-penetrating tip of the needle. In a further variation, the cover is adapted and configured for use with any of the vascular access devices described herein.

[0016]

[0017] In yet another embodiment, a method of accessing a patient's blood vessel is provided by advancing a tissue-penetrating distal tip of an access needle of an armed intravascular access device into the patient's blood vessel, engaging a guide element with legs of a slider, the guide element extending through the distal tip of a catheter and through the proximal end of the intravascular access device, advancing the slider distally within a slot extending longitudinally along the intravascular access device, the slider legs being advanced across a ratchet system on an inner surface of the intravascular access device, advancing the distal tip of the guide element from within a notch in the distal tip of the catheter into the blood vessel distal to the tissue-penetrating tip of the access needle, advancing a distal portion of a catheter hub in the blood vessel along the guide structure, and retracting a needle carrier coupled to the proximal end of the access needle into the intravascular access device. Another step includes applying a force to the slider before advancing the slider, the force increasing frictional engagement between the legs of the slider and the guide element. Optionally, there is a step of confirming access to the blood vessel when blood is observed at the catheter hub coupled to the distal end of the intravascular access handle. Additionally, there is a step of uncoupling the catheter hub from the distal end of the intravascular access device handle after the catheter is positioned within the blood vessel. In another variation, there is a step of withdrawing the intravascular access device handle proximally along the guide element after the slider is advanced to the distal end of the slot. In one aspect, there is a step of determining the length of the guidewire advanced into the blood vessel based on the distance the slider is advanced over the ratchet system. Optionally, the slider is advanced from a neutral configuration in which the slider legs contact the proximal valleys of the ratchet system. In another variation, after the slider is advanced, the ratchet system prevents proximal translation of the slider or advances the slider legs to contact the proximal end of the needle carrier. In some embodiments, there is a process for ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly if reflux is observed in the intravascular catheter assembly.

[0017]

[0018] In yet another configuration, there is provided an intravascular access device as described above, wherein the intravascular access device is adapted for use with a needle cover having a proximal opening sized to engage a portion of a handle, a lumen communicating with the proximal opening, the lumen sized to receive a needle and a catheter, and a beveled surface distal to the lumen adjacent an indentation in a distal-most portion of the lumen, wherein, when used with an IVAD within the needle cover, the distal tip of the needle is separated from the guide element by a portion of the beveled surface, and the guide element is in a rolled state within the indentation. In some configurations, the needle cover and the intravascular device are adapted and configured to interact with one or more of a neutral state, an armed state, a ready-to-use state, and a discarded state. There may also be versions of the above method having one or more steps of interaction between the vascular access device and the needle cover to place the vascular access device in one or more of a neutral state, an armed state, a ready-to-use state, and a discarded state.

[0018]

[0019] In yet another variation, an intravascular access device is provided having: a handle including a proximal and distal end, a slot in a surface of the handle having distal and proximal ends, and a plurality of ratchet teeth along an interior of the handle; a slider positioned in the slot, the slider including slider legs extending toward the plurality of ratchet teeth; a needle carrier having a distal end coupled to the access needle and a proximal end positioned within the handle; a catheter having a proximal end coupled to a catheter hub, the catheter hub configured to engage the distal end of the handle and including a lumen configured to accommodate the access needle extending therethrough; and a guide element extending from the slider through the catheter lumen, the guide element including a distal tip configured to engage a notched distal tip of the catheter, the guide element configured to be advanced distally from the notched distal tip of the catheter by the slider legs. In some variations, a dock at the proximal end of the needle carrier adapted to receive the slider leg therein, or a channel along the needle carrier adapted to receive a guide element, or a channel extending along the needle carrier adapted to receive a guide element therethrough, may be provided. In still other variations, the access needle includes a flat surface along the needle exterior, or the needle carrier includes a channel along the needle carrier adapted to receive a guide element therethrough, or the channel is positioned on the needle carrier at the same clock position as the needle flat surface. In still other variations, one or more ratchet systems configured to prevent retraction of the slider after it has been advanced distally along the ratchet system may be provided, or the slider further includes one or more support elements configured to engage the periphery of the slot to prevent rotational displacement of the slider, or the ratchet system includes a plurality of ratchet teeth positioned distal to a valley near the proximal end of the handle.In some other variations, there is provided an aperture positionable on the slider leg, configured against the exterior of the guide element when the slider is advanced along the slot, through which the guide element extends, or a guide element channel extending longitudinally along the exterior of the needle carrier and configured for routing the guide element therethrough. In some aspects, there may also be provided a guide element extending through the catheter lumen along the exterior of the needle, or a configuration in which a distal portion of the guide element transitions beyond the distal tip of the needle to the atraumatic tip when the slider is in its distal-most position.

[0019]

[0020] In yet another additional configuration of the vascular access device, the slider is configured to transition from the neutral configuration to the advanced configuration when the slider is advanced distally from the proximal valley region of the ratchet system or the slider legs are spring biased toward the ratchet system or the distal end of the needle, and the distal tip of the guide element and the distal end of the catheter are configured to expand the opening into the blood vessel. A guide element notch and a guide element distal tip having a proximal end and a distal end may further be provided, wherein the proximal end of the guide element distal tip is configured to engage the guide element notch or the bevel of the needle distal end is flush with the guide element distal tip and the catheter distal end. In other aspects, an actuation element operably coupled to the needle carrier configured to displace the needle carrier proximally within the handle when an actuation trigger is engaged, or a slider leg dock at the proximal end of the needle carrier configured to receive a portion of the slider leg therein, is provided. In some embodiments, the slider is configured to engage the proximal end of the needle carrier. Other embodiments provide a ratchet-type system configured to provide feedback to a user of the position of the guide element distal tip within the vessel.

[0020]

[0021] In yet another variation of the vascular access device, the device is configured to transition from a deployed configuration, in which the slider leg is positioned adjacent a proximal stop of the ratchet system, to an advanced configuration, in which the slider leg is advanced distally against one or more ratchet teeth of the ratchet system. In one aspect, the distal tip of the guide element nests with the guide element notch in the deployed position. In another variation, the ratchet-type system includes a plurality of ratchet teeth that are parallel to the slots along the length of the ratchet system. In some embodiments, the guide element is made entirely or partially of a polymeric material, PTFE, or nylon. In some configurations, the guide element is made entirely or partially of a metal, including Nitinol, Elgiloy, or similar materials. In an additional aspect, the catheter is configured for use as an introducer, a dilator, a catheter component of an infusion set, a catheter component of a blood collection set, a catheter component of a safety winged blood collection set, or a catheter component of an intravenous catheter.

[0021]

[0022] The novel features of the invention are set forth with particularity in the following claims. 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. [Brief explanation of the drawings]

[0022] [Figure 1]

[0023] 1 is a perspective view of an exemplary intravascular access device in a deployed configuration with a guide element advanced beyond a needle tip. [Figure 2]

[0024] 2 is a perspective view of the intravascular access device shown in FIG. 1 with internal elements visible through the transparent handle. [Figure 3A]

[0025] 2 is a side elevational view of the intravascular access device shown in FIG. 1 with the handle and catheter hub removed to reveal the needle carrying, slider and guide element positioning arrangement. [Figure 3B]

[0026] FIG. 2 is a side elevational view of the intravascular access device shown in FIG. 1 with the handle and catheter hub omitted to show the routing configuration of the needle carrier, slider, and guide element through alternate clock positions along the needle carrier and needle. [Figure 3C]

[0027] FIG. 2 is a side elevational view of the intravascular access device shown in FIG. 1 with the handle and catheter hub omitted to show the routing configuration of the needle carrier, slider, and guide element through alternate clock positions along the needle carrier and needle. [Figure 4]

[0028] 3 is a side elevational view detailing the intermediate region of the intravascular access device shown in FIG. 2 including an example of a ratchet system as described herein. [Figure 5A]

[0029] 3 is a cross-sectional view from a distal perspective of the intravascular access device shown in FIG. 2 showing details of the slider engagement with the ratchet teeth. [Figure 5B]

[0030] 3 is a cross-sectional view of the intravascular access device shown in FIG. 2 from a proximal perspective showing additional details of the slider engagement with the ratchet teeth. [Figure 6A]

[0031] 3 is a top view of the distal portion of the intravascular access device shown in FIG. 2 with the slider in an advanced position distal to the handle. [Figure 6B]

[0032] 6B is a close-up view of the intravascular access device in FIG. 6A showing additional details of the catheter hub configuration, including the guide element path from the needle carrier through the hemostatic valve in the catheter hub. [Figure 7]

[0033] 2 is a perspective view of the intravascular access device shown in FIG. 1 with the handle and catheter hub omitted to reveal the needle carrier, activation button, and hemostasis valve positioned at the proximal end of the catheter. [Figure 8]

[0034] 2 is a top, distal perspective view of the intravascular access device shown in FIG. 1 with the handle, catheter hub, and actuation button omitted to reveal details of the guide element path from the slider to the catheter. [Figure 9]

[0035] 2 is a distal perspective view of the intravascular access device shown in FIG. 1 with the catheter hub omitted to reveal details of the distal end of the handle and guide element extending from the needle carrier to the space between the flat surface of the needle and the interior of the catheter. [Figure 10]

[0036] Figures 10A, 10B, 10C, and 10D are cross-sectional views of an exemplary needle configuration including a flat surface along the needle body that may be positioned around the needle exterior. [Figure 11]

[0037] 2 is a perspective view of a distal section of a catheter, needle, and guide element that can be coupled to the handle of an intravascular access device such as the device shown in FIG. 1. [Figure 12A]

[0038] 2 is a perspective view from the distal end of a slider from the intravascular access device shown in FIG. 1. [Figure 12B]

[0039] FIG. 12B is a perspective view from the proximal end of the slider of FIG. 12A. [Figure 12C]

[0040] FIG. 12B is a perspective view from the distal end of the slider showing the alternative guide element lumen position of FIG. 12A. [Figure 13]

[0041] 12B is a view of the proximal region of the slider shown in FIG. 12A showing additional details of the alignment features and guide element lumens positioned on the slider extension. FIG. [Figure 14]

[0042] 3 is a cross-sectional side view from a distal region of the intravascular access device shown in FIG. 2. [Figure 15]

[0043] 3 is a proximal perspective view of the intravascular access device shown in FIG. 2, showing additional details of the slider extension engaging the ratchet teeth in a proximal-most position when in a usable configuration. [Figure 16]

[0044] 3 is a proximal perspective view of the intravascular access device shown in FIG. 2 zoomed in on the proximal end of the needle carrier with the slider adjacent the needle carrier dock as the slider is advanced distally along the handle. [Figure 17]

[0045] 17A-17C show subsequent positions of the slider extension advanced distally beyond the position shown in FIG. 16, where the slider extension engages the needle carrier dock. [Figure 18]

[0046] 18 is a further view in the series of views of FIGS. 16 and 17 in cross section of a side elevation showing details of the engagement between the slider extension and the needle carrier dock in the docking configuration when the slider is advanced to its distal-most position on the handle. [Figure 19A]

[0047] 1 is a flowchart of an exemplary method of placing a neutral state intravascular access device (e.g., the device shown in FIG. 1) into a needle cover and a process of transitioning the neutral state intravascular access device to an armed and ready state. [Figure 19B]

[0048] 1 is a flowchart of an exemplary method of a process for entering a blood vessel using an intravascular access device (e.g., the device shown in FIG. 1) in a ready-to-use state, then advancing a guide element by advancing a slider along a series of ratchet points, and then guiding a needle and catheter hub into a desired location within the blood vessel. [Figure 20]

[0049] FIG. [Figure 21]

[0050] 21 is a rear isometric view of the needle cover of FIG. 20 showing the distal end of an intravascular access device (eg, the device shown in FIG. 1) adjacent the cover opening. [Figure 22A]

[0051] FIG. 10 is an enlarged cross-sectional view of a guide element moving up an inclined surface. [Figure 22B] The guide element then travels down the ramp, which separates the guide element from the needle tip and guides the guide element into the recess in the needle cover as shown in the enlarged cross-sectional view of the guide element. [Figure 23]

[0052] 22C is an enlarged cross-sectional view of the intravascular access device of FIG. 22B showing the relative position of the perforation needle tip to the beveled surface, with the guide element omitted for clarity. [Figure 24A]

[0053] FIG. 22C is an isometric detailed internal view of the intravascular access device configured in the stowed state of FIG. 22B. [Figure 24B] 1 is an isometric transparent view of an intravascular access device of the above configuration. [Figure 25]

[0054] 10A-10C are cross-sectional views illustrating the movement of the guide element along the ramp into position relative to the catheter tip during transition to the armed state. [Figure 26A]

[0055] 26 is an isometric detailed internal view of the intravascular access device in an deployed state with the guide element moved into position as shown in FIG. 25. [Figure 26B] 26 is an isometric transparent view of the intravascular access device showing the orientation of the slider to achieve the movement of the guide element shown in FIG. 25. [Figure 27]

[0056] 26A and 26B, with the needle cover as shown in FIG. 21 removed to transition the intravascular access device to a usable state. [Figure 28]

[0057] 24A and 24B are isometric views of an intravascular access device in a neutral state with pictograms affixed to the needle cover and slider indicating the sequence of movements to transition the intravascular access device from a neutral or stowed state to an operational state. [Figure 29]

[0058] FIG. 10 is a detailed view of a distal region of an intravascular access device with an alternative ratchet teeth configuration including a deployed length identification feature. [Figure 30A]

[0059] FIG. 10 is a perspective view of an intravascular access device handle including an external feature adapted to indicate a length of guide element deployment corresponding to a slider position within a handle slot. [Figure 30B] 1 is a perspective view of the intravascular access device handle. [Figure 30C] 1 is a perspective view of the intravascular access device handle. DETAILED DESCRIPTION OF THE INVENTION

[0023]

[0060] An intravascular access device (IVAD) as described herein can include elements configured to access a patient's vasculature in a safe, efficient, and effective manner with intuitive needle manipulation controlled by a slider operably coupled to the device. The slider can be operably coupled to the IVAD and engageable by a user with positive feedback to indicate the position of the slider relative to the IVAD handle (e.g., body), allowing the user to maintain constant attention to the placement and advancement of a needle, catheter, or other element into a blood vessel. The IVAD can have one or more features to facilitate static and / or dynamic positioning of the operably coupled slider and elements relative to the IVAD and / or the patient.

[0024]

[0061] 1 is a perspective view of an embodiment of an IVAD 100 having a catheter 110, a guide element (e.g., guidewire) 120, and a needle 125 operably coupled to the distal end of the IVAD 100. As shown here, the guide element 120 extends beyond the tissue-piercing tip of the needle 125 with an atraumatic tip configuration that may be established when the guidewire 120 is advanced within a patient's vasculature. A catheter hub 130 is coupled to the distal end of a handle (e.g., body, housing, etc.) 140 with the access needle 125 in place within a catheter lumen (not shown).

[0025]

[0062] The handle or housing 140 has a proximal end and a distal end. In some examples, the IVAD may have one or more engagement elements 145 coupled to or integrated with the handle 140. Example engagement elements 145 provide surfaces and geometries configured to promote a positive interaction between the user and the housing 140 during use. For example, the engagement elements 145 taper proximally along the length of the housing 140, allowing the user to handle the IVAD during use without increasing the grip strength of the handle 140. A slot 150 extends along the length of the housing 140 and provides access for the slider 160 to engage with the guide element 120 extending through the interior of the handle 140. The slider 160 can be positionable along the length of the slot 150. Positioning of the slider 160 within the slot 150 can be facilitated by a ratchet system involving corresponding elements on the slider and the IVAD housing 140. The catheter 110 has a distal end, a proximal end, and an internal lumen along the length of the catheter 110. The catheter proximal end can be adapted and configured to engage with the distal end of the handle 140. The catheter proximal end may also be configured to engage with one or more connections, hubs, peripheral devices, etc. upon insertion into a blood vessel and removal of the handle 140. For example, the catheter proximal end may include features that engage with a luer lock, fluid coupling, or other suitable medical connector or fitting.

[0026]

[0063] FIG. 2 is a perspective view of an IVAD 100 configured similarly to the example shown in FIG. 1 , where the housing 140 is transparent. The slider 160 includes slider legs 165 extending from the slider 160 into the housing 140. The slider legs 165 may extend to contact the inner surface of the housing 140. A ratchet system may include one or more elements of the slider 160 and corresponding elements positionable within the handle 140. As shown in FIG. 2 , the ratchet system may include the slider legs 165 and one or more elements on the uneven inner surface of the handle. For example, ratchet teeth 170 are positioned on the inner surface of the handle and oriented in the same direction as the slot 150 and / or in the direction of translation of the slider 160 from a proximal position to a distal position within the slot 150.

[0027]

[0064] The actuation element 210, seen in FIG. 2 , can be located near the distal end of the IVAD housing. An illustrated example of the actuation element 210 is a spring wrapped around the needle carrier 200 and positioned around the outer surface of the needle carrier 200 within the handle. The actuation element 210 can be configured to bias the needle carrier 200 to a proximal position and can be selectively actuated (e.g., released by an actuation trigger 215). In some examples, the needle carrier may be held in operable communication with the actuation trigger 215 by one or more grooves, channels, or any style of retention mechanism so that the trigger can be selectively engaged to release the needle carrier 200 and the actuation element 210 can initially push the needle carrier 200 within the handle. In some examples, the needle carrier 200 is operably coupled to the proximal end of the needle and configured to retract, pull, or otherwise translate the needle within the handle.

[0028]

[0065] In some examples, the IVADs described herein may be described in different configurations based on the stage of use (e.g., the position of one or more elements of the IVAD). Some example IVAD configurations may include a usable configuration, a stowed configuration, an armed configuration, a locked configuration, a deployed configuration, etc. For example, in the usable configuration, the slider can be positioned near the proximal end of the handle and in operable communication with the guide element near the proximal end of the handle. From that configuration, the IVAD may transition to a deployed configuration in which the slider can be advanced distally within the slot, thereby advancing the guide element along a route through the intravascular access device as the guide element is advanced through the needle carrier such that the distal tip (e.g., the atraumatic tip) of the guide element is advanced beyond the tissue-piercing tip of the needle. Another transition may be from the deployed configuration to a retracted configuration, whereby, after the catheter is deployed, the actuation trigger can be depressed to release the actuation element and displace the needle carrier and needle into the handle.

[0029]

[0066] FIG. 3A is a side elevation view of an IVAD with the handle omitted from the view, revealing details of the internal arrangement of elements. In particular, a slider leg 165 is positioned at the proximal end of the slider 160. The slider leg 165 may extend from the slider 160 and may include a slider knee 168, a slider protrusion 166, and a slider foot 169. The slider knee may be configured to flex or bend like a spring so that the slider leg 165 can move across ratchet teeth in the handle. The slider protrusion 166 may be configured to engage the proximal end of the needle carrier 200 at the dock opening 212. The slider foot 169 at the end of the slider leg 165 is adapted to engage multiple ratchet teeth as the slider is advanced through the handle. For example, the slider foot 169 may sequentially engage the ratchet teeth during distal advancement. The foot 169 may be configured to prevent retraction of the slider 160 until the slider leg 165 engages the needle carrier dock 211 and the foot 169 is lifted off the ratchet system, as shown in FIG. 17 . The guide element 120 is routed through the IVAD, including the slider 160 and the needle carrier 200. The needle carrier can have a dock 211 near the proximal end of the needle carrier 200 that includes an opening 212 configured to receive the slider protrusion 166 therein when the slider 160 is in an advanced position within the IVAD. With the handle omitted from the figures, the actuation element 210 and actuation trigger 215 are clearly visible. The actuation trigger 215 is shown here as a button that can be selectively depressed to unlock the needle carrier 200 and allow the needle carrier to be propelled proximally within the handle by the actuation element 210. At the distal end or region of the IVAD, the catheter hub is omitted to reveal the distal end of the needle carrier 200 extending distally beyond the actuation trigger 215. A valve 300 may be positioned distally from the distal end of the handle (e.g., distal to the actuation trigger). The catheter 110 may extend through the valve 300, which may be configured to accommodate pressure changes as the catheter is advanced and one or more fluids (e.g., gas / liquid) are displaced from the catheter, the catheter hub, within the vasculature, etc.

[0030]

[0067] 3A, FIGS. 3B and 3C show alternative routings of guide element 120 from slider 160 through needle carrier channel 204. In FIG. 3B, guide element 120 is routed through needle carrier 200 in channel 204 clocked to correspond to needle flat 127 in an orientation as shown in FIG. 10B. In this arrangement, guide element 120 can be described as moving to the 3 o'clock position as supported by the positions of needle carrier channel 204 and needle flat 127 aligned at the same 3 o'clock position along needle carrier 200 and needle 125, respectively. FIG. 3C shows another example of a different guide element routing at the 9 o'clock position, where needle carrier channel 204 is aligned along the side of the needle carrier with the needle flat in the same orientation as shown in FIG. 10D. An additional illustrative example shown in Figure 3C is a guide element that is straight or substantially straight in linear or coaxial alignment from the slider leg 165 (e.g., slider lumen 163) to the needle carrier channel 204. As shown in further detail in Figure 12C, the slider leg 165 may include one or more openings positioned on the slider leg 165 to receive the guide element therethrough in a similar orientation relative to the clock position of the needle carrier channel 204 and the needle flat surface 127.

[0031]

[0068] FIG. 4 shows a detailed view of a section of an IVAD described herein. In particular, this section shows an example of an IVAD ratchet system, including a slider leg 165, a slider leg protrusion 166, a ratchet tooth 170, a ratchet proximal valley 171, and a ratchet proximal hard stop 172. The arrangement, orientation, and function of the ratchet system elements are clearly visible from this view. The slider leg protrusion 166 is shown contacting the peak or upper area of ​​one of the ratchet teeth 170, with the end of the ratchet leg positioned at the ratchet proximal valley 171. The slider may be considered to be in a neutral configuration. For example, the slider 160 may be positioned proximally relative to the central portion of the handle, so that the end of the slider leg 165 is in the neutral zone (e.g., the ratchet proximal valley 171).

[0032]

[0069] 4, the position of the slider leg 165 at the proximal valley 171 holds the guide element 120 in a position such that the distal tip of the guide element is aligned proximal or close enough to the tissue-penetrating top of the needle to prevent damage to the guide element during storage or transport of the IVAD. In this neutral position, the slider 165 can be displaced (e.g., advanced distally) with sufficient force to overcome the engagement of the slider leg end with the ratchet proximal valley 171.

[0033]

[0070] 4, the slider 160 can be advanced distally from the neutral position, and the slider legs 165 can engage the ratchet teeth 170. Distal advancement of the slider 160 through the slot 150 and along the ratchet teeth 170 can be sequential, such that contact between the slider legs 165 and the ratchet teeth maintains the slider in the distally advanced position until the slider 160 is advanced further along the ratchet system, or until the needle, guide element, needle carrier, and slider 160 (e.g., slider legs 165) engage the proximal end of the dock 211 at the proximal end of the needle carrier 200 as the needle, guide element, needle carrier, and slider are retracted proximally by the actuation element. The engagement of the slider 160 with the needle carrier dock 211 can be supported by a slider protrusion 166 seated within an opening 212 in the slider dock 211 to create a positive engagement between the slider and the needle carrier.

[0034]

[0071] In some examples, the IVAD may transition from the neutral configuration to the armed configuration when the slider 160 is retracted proximally from a neutral position, where the slider legs 165 contact the ratchet proximal valleys 171, to an armed position, where the slider legs 165 contact the ratchet proximal hard stops 172. The guide element distal end is retracted from the neutral configuration to the armed configuration in response to the slider 160. The guide element distal end may be retracted to engage a guide element slot (e.g., a catheter notch). For example, the distal end of the catheter may include a notch 128 having a shape or geometry corresponding to the guide element distal tip, and the notch 128 can be configured to receive the guide element distal tip therein. Some examples of guide elements may be those described in co-pending U.S. Provisional Patent Application No. 63 / 408,419, filed September 20, 2022, entitled "GUIDE ELEMENT FOR INTRAVASCULAR ACCESS DEVICE," the contents of which are incorporated herein by reference in their entirety. From an outfitted configuration, slider 160 may be advanced distally (e.g., as needed) to advance guide element 120 within the vasculature after venipuncture is complete (e.g., after the needle penetrates the blood vessel).

[0035]

[0072] The slider leg 165 may act as a spring or other resilient element configured to be biased toward the extended position. The slider leg may be configured to apply a force (e.g., a resilient force) to the slider leg end along the length of the slider leg 165, such that contact between the slider leg (e.g., the slider leg end) and the interior of the handle (e.g., a ratchet system) can be increased based on the spring force applied by the slider leg 165.

[0036]

[0073] In some examples, the slider leg 165 may be configured to apply sufficient force to the slider leg end to provide audible or tactile feedback to a user engaging the handle as the slider is advanced over, across, through, etc., the ratchet system. For example, as the slider 160 is advanced distally and the slider leg 165 passes over the ratchet teeth 170, an audible click may occur as the slider leg end contacts the valley surface after passing over the ratchet teeth. In some examples, the audible click may be the result of physical contact between the slider leg end and the interior surface of the handle and may include or be accompanied by a vibration noticeable by a user engaging the handle. The click and / or vibration may provide feedback to the user that the slider has advanced to a position and may or may not be able to be retracted proximally from its current locked position. This feedback system can be calibrated or configured to provide a quantifiable distance of slider 160 movement, allowing a user to understand the current position or change in position (displacement) of the slider during use. For example, each click can represent or correspond to a distance, such that one click can represent one centimeter of advancement of slider 160 and guide element 120. In some examples, the distance between each ratchet tooth can be any predetermined distance from one another, and a measurement can be provided, predetermined, or otherwise established to indicate the distance the slider has traveled, and therefore the corresponding distance the guide element distal tip has traveled. In some examples, the distance between ratchet teeth can be less than, equal to, or greater than 1 mm. In some examples, the distance between each ratchet tooth can be the same, different, or a combination of the same distance between ratchet teeth and different distances between ratchet teeth.

[0037]

[0074] 5A and 5B show perspective views of a cross section of the slider 160 in a neutral configuration, with the slider legs 165 contacting the ratchet proximal valleys 171. The cross section of the guide element 120 is shown as an example of a routing arrangement from the slider 165 through the interior of the handle. The elements of the ratchet system may be more clearly visible when the ratchet teeth 170 are shown aligned with each other and distal to the slider legs 165. In some examples, the slider 160 is advanced distally from this position, and the slider legs 165 can slide over the peaks of the ratchet teeth 170 and, as advanced, fit within the valleys between each of the ratchet teeth 170.

[0038]

[0075] The geometry of the ratchet teeth 170 can be any geometric shape. For example, any uneven inner surface of the housing can be considered a ratchet tooth, where the uneven surface promotes retention of the slider as it passes over, through, or traverses the ratchet teeth. For example, the ratchet teeth can refer to an uneven surface having one or more raised portions, so that in the absence of force, the slider legs 165 can be held or guided in a stationary position between the one or more raised portions. Referring to FIG. 4 , the ratchet teeth 170 are shown with a generally triangular geometry having a negative slope on one side adjacent to another side that is generally perpendicular to the inner surface of the handle. In this example, the slider 165 can be advanced distally such that the slider legs 165 slide over the slope and down the vertical side, preventing the slider from being pulled back or withdrawn proximally.

[0039]

[0076] 6A and 6B, details of the IVAD are shown in a zoomed-in top view of the distal end of the handle 140, illustrating the arrangement and configuration of the handle 140, catheter hub 130, actuation element 210, actuation trigger 215, and needle carrier 200. From this view, an exemplary arrangement of the guide element 120 is shown routed generally along the interior of the handle body and through a channel 204 in the needle carrier 200. The channel may be configured to provide stability for the guide element 120 while it moves within and through the handle 140.

[0040]

[0077] FIG. 6B is a more detailed view of the catheter hub 130 having a valve 300 with a catheter 110 and a guide element 120 generally coaxial therewith. For example, in this configuration, the guide element 120 can be advanced distally into the patient's vasculature via the slider 160. The guide element 120 can be advanced through the needle-carrying channel 204, through the distal end of the handle, and into the catheter hub 130, where it may be further advanced through the valve 300 and the internal lumen of the catheter 110. In some examples, the guide element may be advanced through a catheter lumen from the distal end of the catheter (not shown) into the vasculature. In some examples, the guide element may pass through a catheter lumen having a needle extending therethrough, such that the guide element can pass between the outer surface of the needle and the inner surface of the catheter. In some examples, the guide element may pass through the needle lumen, the catheter lumen, both, or a combination thereof, depending on the guide element's placement, configuration, and type of use.

[0041]

[0078] 7 shows an example of further details of the arrangement and configuration of the valve 300, guide element 120, needle carrier 200, and actuation trigger. Here, actuation trigger 215 is shown operably engaged to needle carrier 200 such that needle carrier 200 has a channel 201 or other element near its distal end configured to facilitate engagement with the actuation trigger. In some examples, as shown in FIG. 7, the actuation element may be a depressible button that can be configured to move independently from the needle carrier, and the actuation trigger can be depressed to release the needle carrier via the actuation element (not shown).

[0042]

[0079] FIG. 8 shows a perspective view of the IVAD components with the handle, actuation element, actuation trigger, and catheter hub omitted or hidden from view to reveal the alignment of the needle carrier 200, guide element 120, valve 300, and slider 160. In some examples, the needle carrier channel 204 may be an open channel or a closed lumen configured to route or guide the guide element through the IVAD during use. As shown in FIG. 8, the needle carrier channel 204 can be configured to receive the guide element 120 extending therethrough. In some examples, the guide element may be exposed when positioned in the needle carrier channel 204. In some examples, a lumen for tubing or a guide element may be provided within the needle carrier channel 204 configured to facilitate advancement of the guide element as the guide element may be advanced therethrough. With the actuation trigger omitted, engagement feature 202 is shown in an exemplary location near the distal end of needle carrier 200 and is configured to engage with an actuation trigger (not shown) for operation of the needle carrier when the IVAD is in use. Engagement feature 202 is shown here as a detent or channel that can receive a portion of the actuation trigger to lock or hold needle carrier 200 in place until the trigger is actuated or depressed to release the needle carrier from a distal position in the handle to a proximal position in the handle as the needle is retracted.

[0043]

[0080] The guide element route or pathway through the IVAD can be supported by the arrangement and configuration of various components, such as the needle carrier (e.g., the needle carrier channel), the guide element coupling on the slider, and the location of the flat outer surface of the needle. In some examples, the needle carrier distal end may be configured to facilitate the transition of the guide element distally from the IVAD handle through the catheter hub, hemostasis valve, and catheter lumen. FIG. 9 shows an exemplary configuration and arrangement of a guide element transitioning from the distal end of the handle (e.g., within the handle body) to the catheter lumen. In this example, the valve has been omitted to show an exemplary transition from the needle carrier distal end 203 of the guide element 120 to the catheter 110 (e.g., the catheter lumen). The needle 125 is shown extending into the catheter lumen generally along the axis of the needle carrier. The guide element 120 is shown to have a slight downward slope entering the catheter 110 from the top portion of the needle carrier 200 (e.g., from the needle carrier channel) toward the needle 125. In some instances, as the slider advances distally, the guide element may advance accordingly, with the length of the guide element 120 traversed along this passage path, including the angled transition through the distal end of the handle and into the catheter 110.

[0044]

[0081] The needle carrier distal end 203 may be configured such that the channel 204 can be positioned anywhere around its periphery. For example, the channel 204 may be positioned near the 12 o'clock position oriented longitudinally along the length of the needle carrier, as shown in FIG. 9 . However, the channel 204 can also be positioned longitudinally along the needle carrier body at any location along the longitudinal periphery of the needle carrier 200. In some examples, the location of the needle carrier channel 204 may be based on the location of the needle flat 127. For example, FIG. 9 illustrates the needle carrier channel 204 at the 12 o'clock position, and correspondingly, FIG. 10A illustrates the needle flat position at the 12 o'clock position as well. Considering this example, the guide element can extend through the slider lumen 163 and curve downward within the handle through the lumen 163 to accommodate routing of the guide element to the 12 o'clock and needle flat positions of the needle carrier channel 204.

[0045]

[0082] FIGS. 10A through 10D show cross-sectional views of the needle, catheter, and guide element from the distal end of the IVAD. In particular, FIG. 10A shows the needle lumen 131 generally in a central axial position with a generally concentric circle that includes the catheter 110. The guide element 120 is shown above the needle 125 and within the catheter 110. In this example, the guide element 120 has a surface that corresponds to the outer shape of the needle 125, and the guide element 120 and the needle 125 contact this surface. For example, the guide element may be advanced or retracted along the outer surface of the needle 125 so that the guide element 120 and the needle 125 contact each other along their contact surface. FIGS. 10B, 10C, and 10D show examples of different placements and orientations of the guide element 120 centered around the needle 125. Dotted lines are shown as markers to illustrate the positioning of the guide element within the catheter lumen. For example, dotted lines distinguish the four quadrants of each image (e.g., FIGS. 10A-10D), depicted clockwise from the first quadrant in the upper left to the fourth quadrant in the lower left. As an example, FIG. 10B shows guide elements positioned in the second and third quadrants, FIG. 10C shows guide elements 120 in the third and fourth quadrants, and FIG. 10D shows guide elements 120 in the first and third quadrants. The guide elements may be longitudinally positionable along the surface of the needle at any location.

[0046]

[0083] Flat surfaces 127 are provided along the length of the needle body to correspond to the position and orientation of guide element 120 on the needle exterior. Flat surfaces 127 may contact corresponding surfaces of guide element 120. Referring to the examples shown in Figures 10A-10D, each example of needle 125 is shown in the same rotational position with tissue-piercing tip 126 shown down lumen 131, while guide element 120 is shown in different positions around the needle exterior.

[0047]

[0084] The guide element, catheter, and needle relationship allows for unprecedented flexibility in guide element deployment and use. Given existing technology, guide element locations are limited. However, having a needle configured to communicate with the guide element as described herein provides improved opportunities for guide element function when advanced through the vasculature. FIG. 11 shows a perspective view from the distal end of an IVAD. In particular, the tissue-piercing tip 126 of the needle 125 may depict the distal tip of the IVAD with the guide element 120 nested in a notch 128 at the distal top of the catheter 110 and pulled back (e.g., in a usable configuration). In this example, the tissue-piercing tip 126, guide element 120, and distal end of the catheter 110 form a taper that can be configured to reduce the amount of physical impact during insertion (e.g., venipuncture). The guide element may be advanced beyond the needle tip 126 to form an atraumatic tip. In the example shown in FIG. 11, the guide element would be advanced past the tip 126, up the needle lumen along the needle flat surface 127.

[0048]

[0085] 12A and 12B show detailed perspective views of a slider 160 as described herein. In some examples, the slider may include one or more supports to interface with an IVAD and facilitate manipulation. In some examples, the slider supports may be a rail system 162 configured to engage with an IVAD handle (e.g., a handle slot). FIG. 12A shows an example of a rail system having rails 162 (e.g., dovetail / c-shaped rails) positionable along the length of the slider body. A corresponding rail may be positioned on the opposite side of the slider body, and together the rails may comprise a rail system. Although not shown in FIG. 12A , it can be understood that the slider 160 may be positioned within a handle (e.g., a slot) such that the periphery of the slot engages the rail to hold the slider in place relative to the handle and slot. For example, the slider feet may exert some force on the slider against the slot, which may include torque due to the slider around the slot. The rails can be configured to hold the slider in a relatively stable position within the slot while the slider is in use (e.g., while moving within the slot). The rails 162 can be configured to facilitate stable communication of the slider 160 within the slot and reduce the amount of deviation or displacement of the slider from a consistent path as it moves within the slot. For example, the rails 162 can be configured to allow translation of the slider while preventing it from moving up or down, taking into account the moment created by the stop legs when engaged with the housing.

[0049]

[0086] In FIG. 12B , a slider support is shown that includes a slider recess 164. In some examples, slider legs contacting the interior surface of the handle (e.g., a ratchet system) can introduce a force or moment that can cause the slider to pitch within the handle. Pitching may be undesirable during use. Therefore, in some examples, a slider recess may be incorporated into the slider to prevent instability of the slider within the handle and promote overall stability of the slider before, during, or after use. The slider recess may work in conjunction with the proximal housing. In some examples, the slider support may be configured or aligned with the handle such that the slider is configured to have one or more supports with corresponding structural elements of the handle to promote sufficient engagement between the slider and the handle to promote stability without inhibiting function or translation of the slider within the handle slot.

[0050]

[0087] In some examples, the guide element 120 may be in communication with the slider 160. An opening or lumen 163 in the slider leg shown in FIGS. 12A and 12B may be adapted to receive a guide element (e.g., a guidewire) extending therethrough. In some examples, the guidewire may be coupled to the slider 160 at the opening 163. In some examples, the guidewire may extend from the slider through the needle carrier channel 204 to the needle flat 127, as described herein. In some examples, the lumen 163 may have a smaller diameter distal opening, as shown in FIG. 12A, compared to the distal portion of the lumen visible in FIG. 12B. The configuration of the lumen 163 can accommodate and support the clocking of the guide element's path, or routing, from the slider through the needle carrier to the needle flat. In some examples, the guide element extending through lumen 163 can bend through a larger diameter portion of lumen 163 to accommodate the direction of guide element 120 along the path of the guide element through needle carrier channel 204 to the needle flat. In some examples, needle carrier channel 204 (e.g., as shown in FIG. 8 ) may be positioned along the exterior length of the needle carrier in the same orientation as the location of the needle flat. For example, needle carrier channel 204 may be clocked around the needle carrier body to correspond to the clocked location of the needle flat, as described herein.

[0051]

[0088] 12C shows an alternative example of the location of the lumen 163 on the slider 160. In this perspective view, additional or alternative examples of openings 163a, 163b, 163c, 163d are shown to illustrate the location of the lumens, but are shown to be substantially aligned with the needle carrier channel 204 for routing the guide element 120 through the interior of the handle 140 to the needle flat 127. Thus, the routing of the guide element may be clocked and directed toward the inside of the handle starting from the location of the lumens 163 (e.g., 163a, 163b, 163c, 163d) on the slider, the location of the needle carrier channel 204 on the needle carrier, and the location of the flat 127 on the needle exterior.

[0052]

[0089] In some instances, the smaller diameter distal opening of lumen 163 may be adapted to facilitate bonding between the guide element or guide element tube and the slider. For example, the smaller diameter opening may be adapted to receive the guide element extending therethrough, and the distal section of the opening may be filled with a bonding material to secure the guide element in place coupled with the slider.

[0053]

[0090] FIG. 13 shows a more detailed perspective view from below of slider 160. The rails shown herein include rail 162 and a secondary set of rails that can mate with the handle or another component of the IVAD (e.g., a needle carrier). The secondary rails may provide additional stability to support rail 162 or may form a stop mechanism as a safety element to prevent over-rotation of slider 160 within the handle. In some examples, secondary rail 167 may act as a stop mechanism to prevent slider 160 from being displaced beyond an acceptable position. For example, secondary rail 167 may be configured to prevent slider 160 from advancing past a point within the handle (e.g., a slot) by contacting a block or structural element that prevents slider 160 from advancing beyond that contact point.

[0054]

[0091] Another view of the slider 160, handle 140, and slider support is shown in the cross-sectional view of FIG. 14. In particular, the slider legs 165 are shown here from their proximal ends, with the housing 140 forming an incomplete cylinder due to the slot included in this cross-sectional view. The legs extend from the slider 160 into the slot 150 so that the slot perimeter 151 engages the rails 126 of the slider 160. The slider reliefs 164 are shown above the handle 140 in general alignment with one another to promote stability and prevent rotational forces from inadvertently displacing the slider 160 within the slot 150.

[0055]

[0092] As described herein, an IVAD may be configured or accountable for the orientation, positioning, and configuration of one or more components. For example, FIG. 15 illustrates how an IVAD may be configured in a “deployed” configuration. In some examples, the IVAD may be deliverable or in an initial deployed position when the guide element tip is engaged with the catheter tip / notch 128 and the slider legs 165 are engaged with ratchet teeth near the proximal end of the handle. Visible in FIG. 15 is the proximal portion of the ratchet feature, including a proximal stop 177 configured to prevent or inhibit further proximal translation of the slider 160. The distal slider legs 165 can contact the proximal stop 177 at a set point 178, at which point the legs act to lock the slider in place to prevent further proximal translation within the slot. The proximal stop 177 may thus provide feedback to the user about the location of the slider within the slot (e.g., the handle). For example, the proximal stop 177 may be engaged and identifiable when further proximal translation of the slider is prevented. In some examples, the proximal stop 177 may not prevent forward translation (e.g., distal advancement) of the slider because the legs may be configured to advance distally from the proximal stop. In some examples, the proximal slot may initially be configured to have a position relative to the length of the guide element needed to position the guide element distal tip within the distal catheter end (e.g., catheter notch). In such examples, both the guide element and the proximal stop may be configured to prevent continued proximal translation of the slider within the slot.

[0056]

[0093] As described herein, during use, the needle carrier may be displaced to withdraw the needle from within the blood vessel after accessing the blood vessel. For example, the needle may no longer be needed for the procedure beyond initially accessing and introducing the catheter into the blood vessel. Thus, the needle carrier may be configured to translate or slide proximally within the handle to withdraw the needle coupled thereto.

[0057]

[0094] 16-18 are detailed views showing the engagement of the slider leg 165 with the proximal end of the needle carrier 200. In FIG. 16, the slider 165 is in a distal position relative to its initial position within the handle. For example, the slider may be advanced distally because a procedure may require the guide element 120 to be advanced by the slider 160. The perspective view is also a longitudinal cross-section showing the dock 211 of the needle carrier 200 at its proximal end. The dock 211 may be a concave or cylindrical recess extending from the proximal end into the needle carrier and may be configured to couple with the slider leg 165 when the slider leg 165 is advanced sufficiently into the dock 211 so that the slider protrusion 166 engages the opening 212. The slider leg 165 is shown engaging the ratchet teeth 170 as it is advanced distally within the handle. The distal end of the needle carrier may be generally held by the handle 140, as previously shown, and may be prevented from moving distally even when the slider 165 makes contact. The slider knee 168 has encouraged the extension of the leg 165 toward the ratchet teeth so that the slider foot 169 of the slider leg 165 is in contact with the ratchet teeth 170. The slider knee 168 is adjacent to the needle carrier dock 211, but the slider leg has not yet made contact to bend the knee 168.

[0058]

[0095] Continuing with FIG. 17 , the slider leg 165 has been advanced further toward the needle carrier dock 211. Now, referring to the slider knee 168, as the slider knee 168 enters the dock 211, the slider leg engages with the dock 211. As the slider 160 and slider leg 165 are advanced into the needle carrier dock 211, the knee 168 is bent. At this point in the sequence, the leg 165 has entered the dock, but the slider protrusion 165 has not yet entered the dock opening 212 for positive or locked engagement between the slider and needle carrier 200. In this view, the slider foot 169 has been lifted away from the ratchet teeth and is no longer in contact with the ratchet teeth 170. Thus, the slider 165 may be in a position to be retracted into the housing 140.

[0059]

[0096] Finally, FIG. 18 shows an example of a slider leg 165 nested within the needle carrier 200. The slider knee 168 is at a distal location within the dock 211, and the slider leg protrusion 166 has engaged with the dock opening 212 so that the slider 160 can be retained within the dock 211. In some examples, when the slider leg protrusion 166 engages the dock as shown, the slider can be prevented from further translation without correspondingly moving the needle carrier. In some examples, when the slider 160 engages the needle carrier dock 211, the needle carrier may be configured to hold the slider and needle carrier in place within the handle. In some examples, when the needle carrier 200 is engaged by the slider legs 165, the slider legs can be bent or otherwise biased onto or away from the ratchet teeth so that the slider can be pulled proximally over the ratchet teeth, allowing proximal retraction without interference from the ratchet teeth. In some examples, the slider can be used to pull or withdraw the needle and needle carrier proximally into the handle. In this manner, a user can determine the amount, speed, and other characteristics of force with which the needle is withdrawn from the vessel when manually retracting the needle carrier into the handle. In some examples, the actuation element may be actuated or actuable by engagement of the slider legs 165 engaging the proximal end of the needle carrier. For example, the slider legs can act as an actuation trigger that initiates displacement of the needle carrier 200 by the actuation element when the slider legs 165 engage the needle carrier dock 211.

[0060]

[0097] In some examples, the slider legs 165 and the plurality of teeth 170 on the inner wall are adapted and configured to act like a ratchet system, ensuring only unidirectional, irreversible movement of the slider to a more distal position. This ratchet system is engaged until distal advancement of the slider 160 causes the slider legs 165 to seat and nest in the needle carrier dock 211. Once the slider legs are fully seated in the needle carrier dock 211, the slider protrusions 166 seat within the dock openings 212, mechanically locking the slider to the carrier dock. At this point, the slider legs are withdrawn, and the needle carrier is above and clear of the ratchet teeth 175, allowing the slider to be freely advanced proximally and distally. In some instances, the actuation button is thus depressed to retract the needle carrier and slider combination proximally within the handle after the slider 160 has been placed into the needle carrier 200, thereby allowing the needle and guide element to be withdrawn while leaving the catheter in place within the blood vessel.

[0061]

[0098] In use, an IVAD as described herein can enhance the safety and effectiveness of vascular access procedures. Through easy and intuitive use of the slider to operate the guide element and ratchet system, where the user receives real-time feedback during use to determine the position and placement of the guide element and other characteristics, the integrated guide element and associated deployment system can increase the success rate of first-pass placement of a catheter within a blood vessel.

[0062]

[0099] Generally, an IVAD as described herein can be used by inserting a needle (e.g., a tissue-piercing tip) into a patient's blood vessel. The guide element and distal catheter tip can act as a dilator to introduce the catheter into the blood vessel corresponding to the entrance created by the needle. In some examples, the guide element and distal catheter tip can have a tapered geometry to gently expand the opening into the blood vessel sufficient for the catheter to enter without unnecessary trauma to the patient's tissue. The user can then engage the slider and advance it distally within the slot, which correspondingly advances the guide element distally from the catheter tip along the needle. The guide element can be configured to form an atraumatic distal end after passing the needle tip, thereby preventing further trauma within the blood vessel. Once the user has advanced the guide element sufficiently into the tip, the catheter can be deployed and the needle can be easily and concisely withdrawn.

[0063]

[0100] It should be understood that various different IVAD embodiments and configurations may undergo different forms of preparation and use. By way of example, a user may prepare an IVAD by establishing a configuration for the IVAD. Different IVAD configurations may include an armed configuration, a ready-to-use configuration, a neutral configuration, a stowed configuration, etc. In any configuration, the user may orient the guide element distal tip, needle distal tip, catheter distal tip, slider, handle, needle carrier, etc. relative to one another to prepare the IVAD in a configuration for vascular access. The user then inserts the needle into the patient's vein. In some instances, the catheter hub may exhibit sufficient vascular penetration with visible flush or blood or other fluid within the catheter hub. After the needle accesses the vein, the guide element distal tip and catheter distal tip also have vascular access because the needle is generally positioned within the catheter lumen and the guide element is generally positioned between the exterior of the needle and the interior of the catheter lumen. The user may then advance the slider distally within the handle slot. To advance the slider, the user applies pressure to the slider as it is advanced within the slot, allowing the slider to fully engage the length of the guide element so that the guide element is advanced in correspondence with the slider.

[0064]

[0101] In some embodiments, as the slider is advanced, the slider feet contact the ratchet teeth and may provide feedback including an indication that is audible, tactile, visual, or a combination thereof For example, a user may advance the slider and feel the click of the slider feet sliding over the ratchet teeth.

[0065]

[0102] In an alternative method of use, the user may determine that the guide element is sufficiently positioned or advanced within the blood vessel and then retract the needle from within the blood vessel. The user may activate the actuation element by engaging the actuation trigger and releasing the needle carrier, which may then urge the needle carrier and needle proximally within the handle. In some examples, the slider legs may be advanced to engage the needle carrier dock, and the slider may then be retracted within the handle to manually retract or withdraw the needle into the handle. The catheter hub may then be engaged or disengaged from the handle and used in conjunction with any other medical device or in conjunction with continuing the medical procedure utilizing vascular access.

[0066]

[0103] 19A is a flowchart of an exemplary method 1900 of the process of placing an IVAD in a neutral state within a needle cover and transitioning the IVAD from a neutral state to an armed and enabled state. Initially, in step 1905, with the guide elements extended and the IVAD in a neutral state, the needle, catheter hub, and guide elements are advanced into the needle cover 400.

[0067]

[0104] Next, step 1910 involves continuing to advance the IVAD until the guide element coil is seated within the recess 410 of the needle cover. At the recess, the end of the guide element is separated from the needle by the beveled surface 415. With the guide element in the recess and the needle cover secured to the handle, as in Figures 24A and 24B, the IVAD is in a stored or neutral state. This is a suitable condition for long-term storage of the IVAD, as the coiled, curved, or shaped characteristics of the distal-most end of the guide element are maintained within the recess.

[0068]

[0105] Next, when the user wishes to use the IVAD, the IVAD is transitioned to an armed state by moving the slider proximally to pull the guide element up the ramp, onto the needle flat, and into the catheter notch (step 1915).

[0069]

[0106] Next, in step 1920, after verifying that the guide element is seated, the slider is in the correct position, or the IVAD is armed, the IVAD is transitioned from the armed state to the ready state by separating the needle cover from the handle to expose the penetrating needle tip.

[0070]

[0107] 19B is a flow chart of an exemplary method 1950 of the process of using an IVAD that is ready to enter a blood vessel. In step 1955, the IVAD is ready to enter a blood vessel and the needle is inserted until flashback is observed.

[0071]

[0108] Next, in step 1960, while holding the handle steady against the blood vessel, the slider is advanced distally through successive ratchet points to disengage the guide element from the catheter tip and move it along the needle flat and beyond the needle tip into the blood vessel.

[0072]

[0109] Next, in step 1965, the needle and catheter hub are advanced along the guide element to the desired location within the blood vessel.

[0110] Next, in step 1970, once the user is satisfied with the catheter placement, the IVAD is transitioned to a used or discarded state by retracting the needle and guide element into the handle, after which the used IVAD is disposed of using appropriate medical waste procedures (step 1975).

[0073]

[0111] Figure 20 is a cross-sectional view of needle cover 400. Needle cover 400 has a proximal opening 420 and lumen 405 adapted and configured to receive a needle, guide element, and catheter hub. Additionally, opening 420 can be sized for a friction fit or may have corresponding mating elements for releasable attachment to a handle. Figure 21 is a rear isometric view of the needle cover of Figure 20 adjacent the perforated needle tip at the distal end of needle 125.

[0074]

[0112] Lumen 405 includes features such as a beveled surface 415 and an indentation 410. Beveled surface 415 is used to guide and protect the guide element from potential damage from contact with the perforating needle tip. The shape of beveled surface 415 interacts with the guide element, as can be better understood by reference to FIGS. 22A and 22B. Also visible on cap 400 in this view are alignment features extending along the interior of lumen 405. Alignment feature 407 can be configured to align the distal end of the IVAD when the cap is attached or detached from the distal end of the IVAD.

[0075]

[0113] 22A and 22B are enlarged cross-sectional views of the guide element advancing up the ramp 415 (FIG. 22A) and then down the ramp 415 (FIG. 22B), thereby separating the guide element from the needle tip and guiding the guide element into the recess 410 in the needle cover, as shown in FIG. 22B. In some instances, the transition of the guide element over the ramp 415 allows for loading or transitioning of the IVAD into a deployment configuration, with the guide element 120 retracted into a position above the needle flat and seated in the notched distal end of the catheter. The tissue-piercing tip 126 of the needle 125 can be restricted from advancing over the ramp 415 to prevent contact between the tissue-piercing tip 126 and the ramp 415.

[0076]

[0114] Figure 23 is an enlarged cross-sectional view of the IVAD of Figure 22B showing the relative position of the perforating needle tip to the beveled surface. The guide element has been omitted for clarity. In use, the needle tip does not contact the needle cover, beveled surface 415, or the interior of the guide element.

[0077]

[0115] Figures 24A and 24B are isometric detailed internal and isometric transparent views, respectively, of the IVAD as configured in the stowed state of Figure 22B, which is the state of the IVAD at the end of the guide element travel shown in Figures 22A and 22B. A cap 400 is coupled to the distal end of the handle 140 in a manner that prevents contact with or damage to the catheter hub 130, needle 125, guide element 120, or other features that extend beyond the distal end of the handle 140.

[0078]

[0116] FIG. 25 is a cross-sectional view showing the movement of the guide element along the ramp into position relative to the catheter tip during transition to the armed state.

[0117] Figures 26A and 26B are isometric detailed internal and isometric transparent views of the IVAD in the installed state with the guide elements moved into position as shown in Figures 24 and 25. Figure 26B shows the orientation of the slider that achieves the movement of the guide elements shown in Figure 25.

[0079]

[0118] FIG. 27 is a perspective view of the distal end of an equipped IVAD as shown in FIGS. 26A and 26B with the needle cover as shown in FIG. 21 removed to transition the IVAD to a usable state.

[0080]

[0119] 28 is an isometric view of an IVAD in the neutral state as in FIGS. 24A and 24B with pictograms affixed to the needle cover and slider indicating the sequence of movements to transition the IVAD from the neutral or stowed state to the ready state. The pictogram indicates that the first movement of the slider is in the proximal direction, as indicated by arrow 1. The second movement, which separates the needle cover from the handle, is indicated by arrow 2.

[0081]

[0120] In some examples, the ratchet system (e.g., teeth 170, valleys 171, proximal stops 177, etc.) and other features of the IVAD may be adapted to indicate the deployment length of the guide element. As the slider is advanced distally, the position of the guide element distal end can be identified by the length of slider travel through the handle slot after the needle enters the blood vessel. FIG. 29 shows an example of an alternative ratchet tooth configuration having proximal spaces 173a and distal spaces 173b in a line or row of multiple ratchet teeth 170. In this example, the ratchet teeth may be described relative to their proximal or distal location within the handle. For example, a first set of proximal ratchet teeth 170a may be positioned proximally relative to spaces 173a. The middle section of ratchet teeth 170b and the distal section of ratchet teeth 170c can indicate the extent of deployment of the guide element based on the engagement of the slider legs with the corresponding sections of the ratchet teeth.

[0082]

[0121] 30A, 30B, and 30C are perspective views of a vascular access device handle with features on the exterior surface and along the length of the slot. The features can be tactile, visual, or both. The segments may correspond to segments of a ratchet as described herein, such as having intermittent intervals (FIG. 29) or regular intervals (FIG. 5B) or proximal ratchet valleys (FIG. 5B), corresponding to the state of the vascular access device or the relative positions of the access device components. For example, markings may be used to indicate whether the distal end of the guide element is distal to the distal end of the needle (as in the case of the needle cover in FIG. 22B), seated at the notched end of the catheter (FIG. 11, 23, or 27), or beyond the most distal end of the needle (see, e.g., FIGS. 1 and 2). As a result, the position or placement of the guide element tip relative to the needle or catheter can be included in the feedback provided about the slider position. Advantageously, this allows the slider position to be used as an indicator of the guide element position relative to the needle tip and the progress of advancing the guide element to its final deployed length. For example, as best seen in FIG. 30A, there may be a segment with a series of evenly spaced markers. The markers may be grouped into proximal deployment markers 180a, mid-deployment markers 180b, and distal markers 180c. In one variation, some of the markers are only along the bottom of the handle, as in segment 180a. This differs from the markers in segments 180b, 180c, which almost completely surround the handle. In contrast to FIG. 30A, FIG. 30B shows a pair of markers at different points on each of the segments. In another variation, FIG. 30C shows a point marker 184a at the proximal end, a single band marker 184b at the mid-segment, and a pair of markers marking the distal segment 184c. The placement and type of markers used, and their placement along the handle, can be used to provide a tactile or visual indication to the user as to whether the access device is loaded, deployed, or in the fully extended guide element configuration, among other things.

[0083]

[0122] Additional aspects of the construction and operation of catheter placement devices including a housing or handle having a mechanism for advancing a catheter-carrying guide structure or element, where the handle is adapted to automatically retract both the access needle and the guide structure or element from the catheter after the placement procedure is completed, a button-activated automatic needle and guide retraction assembly are described in U.S. Patent Publication US2008 / 0300574 and U.S. Patent No. 9,522,254, each of which is incorporated herein by reference in its entirety.

[0084]

[0123] Further details of exemplary intravascular catheter insertion devices and methods are described in U.S. Patent Nos. 5,704,914 and 5,800,395, and U.S. Patent Publications US2010 / 0094310, US2010 / 0210934, and US2012 / 0197200, the entire disclosures of each of which are incorporated herein by reference.

[0085]

[0124] There may be one or more variations, alternatives, constructions, compositions, and / or components described herein that can be used to modify the elements, components, devices, systems, processes, etc. of the guide element, intravascular access device, and / or related structures or processes. Accordingly, any variations, descriptions, examples, elements, components, processes, methods, method steps, etc. described herein can be used as a modification, variation, and / or replacement for any element, device, system, composition, example, component, process, method, method step, etc. described in co-pending U.S. Provisional Patent Application No. 63 / 328,732, filed April 7, 2022, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," and / or PCT Application No. PCT / US2021 / 54046, filed October 7, 2021, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," which are incorporated herein by reference in their entirety.

[0086]

[0125] While preferred embodiments of the present invention have been shown and described herein, it will be apparent 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. The appended claims define the scope of the invention, and it is therefore intended to cover methods and structures within the scope of these claims and their equivalents.

[0087]

[0126] As used herein, when a feature or element is referred to as being "on" another feature or element, the feature or element can be directly on the other feature or element, and intervening features and / or elements may 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. When a feature or element is referred to as being "coupled," "attached," or "coupled" to another feature or element, it is understood that the feature or element can be directly coupled, attached, or coupled to the other feature or element, and there may also be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly coupled," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being disposed "adjacent" another feature may have a portion that overlaps or underlies the adjacent feature.

[0088]

[0127] The 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 unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprise" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude 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 " / ."

[0089]

[0128] Spatially relative terms such as "below," "lower," "below," "above," "upper," and the like may be used herein to describe the relationship of one element or feature to another element or feature shown in the figures for ease of description. It is understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, an element described as being "below" or "directly below" another element or feature would then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an above and below orientation. The device may be oriented in other ways (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, unless specifically indicated otherwise, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only.

[0090]

[0129] 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 clearly indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0091]

[0130] Unless the context requires otherwise, throughout this specification and the claims that follow, the word "comprise," and variations such as "comprises" and "comprising," mean that various elements can be employed together in methods and articles (e.g., compositions and apparatuses, including apparatus and methods). For example, the term "comprising" is understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0092]

[0131] As used herein in the specification and claims, including when used in the examples, and unless expressly specified otherwise, all numbers may be read as if preceded by the word "approximately" or "about," even if that term does not explicitly appear. The phrase "approximately" or "about" may be used when describing a size and / or location to indicate that the stated value and / or location falls within an expected reasonable range of values ​​and / or locations. For example, a numerical 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. Unless the context clearly indicates otherwise, any numerical value given herein should also be understood to include approximately that value or approximately that value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical ranges set forth herein are intended to include all subranges subsumed therein. As will be appreciated by those skilled in the art, when a value is disclosed, it is understood that "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between the values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is understood that throughout this application, data is provided in several different formats, and this data represents endpoints and starting points, as well as ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only the range between 10 and 15 is considered to be disclosed, but also greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15. It is also understood that each unit amount between two specific unit amounts is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0093]

[0132] While various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments and not in other embodiments. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0094]

[0133] The examples and illustrations contained herein indicate, for purposes of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As noted, other embodiments may be utilized or derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein by the term "invention," either individually or collectively, for mere convenience and without intending to intentionally limit the scope of this application to any single invention or inventive concept if multiple are actually disclosed. Thus, while specific embodiments have been illustrated and described herein, any configurations calculated to achieve the same purpose may be substituted for the specific embodiments shown. The present disclosure is intended to include any and all modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. 1. An intravascular access device comprising: a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to the proximal end of the intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a plurality of ratchets along an inner wall of the handle; a slider configured to extend through and translate along the slot; a slider leg extending from the slider to an interior portion of the handle, the slider leg having a slider foot configured to engage and advance along the plurality of ratchets as the slider advances along the slot; a needle carrier having a distal end and a proximal end and disposed within the interior portion of the handle, the needle carrier distal end being coupled to an access needle and the needle carrier proximal end having a carrier dock sized and configured to receive a portion of the slider; a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along the needle carrying portion, exiting the interior portion of the handle and extending beyond the distal end of the handle; 1. An intravascular access device comprising:

2. further comprising a slider protrusion on the slider leg adapted and configured to engage a dock opening of the carrier dock. The intravascular device of claim 1 .

3. when the slider is at the distal end of the slot, a slider protrusion on the slider leg engages with a dock opening of the carrier dock; The intravascular device of claim 1 .

4. a slider knee on the slider leg configured to flex in response to movement of the slider foot along the plurality of ratchets. The intravascular device of claim 1 .

5. further comprising a proximal ratchet valley within the interior of the handle and proximal to a proximal-most ratchet of the plurality of ratchets; The intravascular device of claim 1 .

6. When the slider is in the proximal end portion of the slot, the slider foot is in the proximal ratchet valley.

6. The intravascular device of claim 5.

7. The ratchets are evenly spaced along the inner wall of the handle.

7. An intravascular device according to any one of claims 1 to 6.

8. a proximal space and a distal space are within the plurality of ratchets, dividing the plurality of ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth; 7. An intravascular device according to any one of claims 1 to 6.

9. a visual, tactile, or combination marking on the handle surface corresponding to one of the positions of the slider relative to proximal and distal spaces within the plurality of ratchets; and a proximal set of ratchet teeth; an intermediate set of ratchet teeth; Distal set of ratchet teeth and The intravascular device of claim 8 , further comprising:

10. When the slider is positioned with the slider foot in the proximal ratchet valley, the guide element is adjacent to the needle and the guide element tip rests in the notched catheter tip.

9. The intravascular device of claim 8.

11. When the slider is positioned with the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip.

9. The intravascular device of claim 8.

12. When the slider is positioned so that the slider foot is in the distal space, the guide element tip is spaced from the distal-most end of the needle.

9. The intravascular device of claim 8.

13. 1. An intravascular access device comprising: a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to the proximal end of the intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider configured to extend through and translate along the slot; a slider leg extending from the slider to an inner portion of the handle; a needle carrier having a distal end and a proximal end and disposed within the interior portion of the handle, the needle carrier distal end being coupled to an access needle and the needle carrier proximal end having a carrier dock sized and configured to receive a portion of the slider; a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along a channel in the needle carrier, exiting the interior portion of the handle, and extending beyond the distal end of the handle, the guide element including a flat side positioned along and corresponding to the flat side of the access needle; Equipped with the guide element is coupled to a portion of the slider that directly aligns with a location of the flat side of the needle; Intravascular access devices.

14. a plurality of ratchets along an inner wall of the handle; a slider foot on the slider leg configured to engage and advance along the plurality of ratchets as the slider advances along the slot; and 14. The intravascular access device of claim 13, further comprising:

15. further comprising a slider protrusion on the slider leg adapted and configured to engage a dock opening of the carrier dock.

15. The intravascular device of claim 14.

16. when the slider is at the distal end of the slot, a slider protrusion on the slider leg engages with a dock opening of the carrier dock; 15. The intravascular device of claim 14.

17. a slider knee on the slider leg configured to flex in response to movement of the slider foot along the plurality of ratchets.

15. The intravascular device of claim 14, further comprising:

18. a proximal ratchet valley within the interior of the handle and proximal to a proximal-most ratchet of the plurality of ratchets; 15. The intravascular device of claim 14, further comprising:

19. When the slider is in the proximal end portion of the slot, the slider foot is in the proximal ratchet valley.

20. The intravascular device of claim 18.

20. The ratchets are evenly spaced along the inner wall of the handle.

20. An intravascular device according to any one of claims 15 to 19.

21. a proximal space and a distal space are within the plurality of ratchets, dividing the plurality of ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth; 20. An intravascular device according to any one of claims 15 to 19.

22. a visual, tactile, or combination marking on the handle surface corresponding to one of the positions of the slider relative to proximal and distal spaces within the plurality of ratchets; and a proximal set of ratchet teeth; an intermediate set of ratchet teeth; Distal set of ratchet teeth and 22. The intravascular device of claim 21, further comprising:

23. When the slider is positioned with the slider foot in the proximal ratchet valley, the guide element is adjacent to the needle and the guide element tip rests in the notched catheter tip.

22. The intravascular device of claim 21.

24. When the slider is positioned with the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip.

22. The intravascular device of claim 21.

25. When the slider is positioned with the slider foot in the distal space, the guide element tip is spaced from the distal-most end of the needle.

22. The intravascular device of claim 21.

26. 1. An intravascular access device comprising: a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to the proximal end of the intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider configured to extend through and translate along the slot; a slider leg extending from the slider to an inner portion of the handle; a needle carrier having a distal end and a proximal end and disposed within the interior portion of the handle, the needle carrier distal end being coupled to an access needle and the needle carrier proximal end having a carrier dock sized and configured to receive a portion of the slider; a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along a channel in the needle carrier, exiting the interior portion of the handle and extending beyond the distal end of the handle, the guide element including a flat side that corresponds to and is positioned along the flat side of the access needle; Equipped with the guide element includes a transition section from the top portion of the slider to the flat side of the needle; Intravascular access devices.

27. the guide element transition section couples the slider to a needle flat side located on the right portion of the handle, a needle flat side located on the left portion of the handle, or a needle flat side located on the bottom portion of the handle; 27. The intravascular access device of claim 26.

28. a plurality of ratchets along an inner wall of the handle; a slider foot on the slider leg configured to engage and advance along the plurality of ratchets as the slider advances along the slot; and 27. The intravascular access device of claim 26, further comprising:

29. a slider protrusion on the slider leg adapted and configured to engage with a dock opening of the carrier dock; 27. The intravascular device of claim 26, further comprising:

30. when the slider is at the distal end of the slot, a slider protrusion on the slider leg engages with a dock opening of the carrier dock; 27. The intravascular device of claim 26.

31. a slider knee on the slider leg configured to flex in response to movement of the slider foot along the plurality of ratchets.

27. The intravascular device of claim 26, further comprising:

32. a proximal ratchet valley within the interior of the handle and proximal to a proximal-most ratchet of the plurality of ratchets; 27. The intravascular device of claim 26, further comprising:

33. When the slider is in the proximal end portion of the slot, the slider foot is in the proximal ratchet valley.

27. The intravascular device of claim 26.

34. The plurality of ratchets are equally spaced along the inner wall of the handle.

34. An intravascular device according to any one of claims 28 to 33.

35. a proximal space and a distal space are within the plurality of ratchets, dividing the plurality of ratchets into a proximal set of ratchet teeth, an intermediate set of ratchet teeth, and a distal set of ratchet teeth; 34. An intravascular device according to any one of claims 28 to 33.

36. a visual, tactile, or combination marking on the handle surface corresponding to one of the positions of the slider relative to proximal and distal spaces within the plurality of ratchets; and a proximal set of ratchet teeth; an intermediate set of ratchet teeth; Distal set of ratchet teeth and 36. The intravascular device of claim 35, further comprising:

37. When the slider is positioned with the slider foot in the proximal ratchet valley, the guide element is adjacent to the needle and the guide element tip rests in the notched catheter tip.

36. The intravascular device of claim 35.

38. When the slider is positioned with the slider foot in the proximal space, the guide element tip is spaced from the notched catheter tip.

36. The intravascular device of claim 35.

39. When the slider is positioned so that the slider foot is in the distal space, the guide element tip is spaced from the distal-most end of the needle.

36. The intravascular device of claim 35.

40. a lumen configured to accommodate the access needle extending therethrough; a notched distal end portion sized and configured to receive the guide element tip; and further comprising an intravascular catheter having 40. An intravascular device according to any one of claims 26 to 39.

41. 1. A cover for a vascular access device, comprising: a body having a closed distal end and an open proximal end defining an interior portion, the open proximal end sized and configured to releasably couple to a distal end of a handle of the vascular access device; a pair of alignment features within the inner portion defining a lumen extending from the open proximal end to a recess in the distal-most portion of the inner portion; a sloped surface along the inner portion proximal to the recess; Provided with a cover.

42. an intravascular access device coupled to the open proximal end of the cover; 42. The cover of claim 41, further comprising:

43. the intravascular access device, a handle having a proximal end and a distal end, the distal end adapted to be releasably coupled to the proximal end of the intravascular catheter; a slot in a surface of the handle, the slot having a distal end and a proximal end; a slider configured to extend through and translate along the slot; a needle carrier having a distal end and a proximal end and disposed within an interior portion of the handle, the needle carrier distal end being coupled to an access needle and the needle carrier proximal end having a carrier dock sized and configured to receive a portion of the slider; a guide element coupled to a portion of the slider within the interior portion of the handle, the guide element extending along the needle carrying portion, exiting the interior portion of the handle and extending beyond the distal end of the handle; Furthermore, the access needle extends along and between the alignment features; the tissue-piercing tip of the needle is proximal to the beveled surface; Further, the slider is positioned along the slot such that a distal tip of the guide element is distal to the inclined surface and within the recess.

43. The cover of claim 42.

44. Proximal movement of the slider moves the distal end of the guide element over the beveled surface and into the notched distal end portion of the catheter lumen.

44. The cover of claim 43.

45. The handle may include visual or tactile markings to indicate the location of the distal end of the guide element relative to the notched distal end of the catheter or the tissue-piercing tip of the needle.

45. The cover of claim 43 or 44, further comprising:

46. 41. Further comprising the vascular access device of any of claims 1-40.

46. ​​A cover according to any one of claims 41 to 45.

47. 1. A method of accessing a blood vessel in a patient, comprising: advancing a tissue-piercing distal tip of an access needle of the armed intravascular access device into the patient's blood vessel; engaging a guide element with legs of a slider, the guide element extending through the distal tip of the catheter and through the proximal end of the intravascular access device; advancing the slider distally within a slot extending longitudinally along the intravascular access device, the slider legs being advanced across a ratchet system on an interior surface of the intravascular access device; advancing the distal tip of the guide element from within a notch in the distal tip of the catheter into a blood vessel distal to the tissue-piercing tip of the access needle; advancing a distal portion of the catheter hub in the blood vessel along a guide structure; retracting a needle carrier coupled to a proximal end of the access needle into the intravascular access device; A method comprising:

48. further comprising applying a force to the slider before advancing the slider; the force increases the frictional engagement between the legs of the slider and the guide elements; 48. The method of claim 47.

49. and further comprising the step of confirming vascular access when blood is observed at a catheter hub coupled to the distal end of the intravascular access handle.

48. The method of claim 47.

50. and after the catheter is positioned within the blood vessel, further comprising the step of uncoupling the catheter hub from the distal end of the intravascular access device handle.

48. The method of claim 47.

51. and after the slider is advanced to the distal end of the slot, further comprising the step of withdrawing the intravascular access device handle proximally along the guide element.

48. The method of claim 47.

52. determining a length of guidewire advanced into the vessel based on the distance the slider is advanced over the ratchet system.

48. The method of claim 47.

53. the slider is advanced from a neutral configuration in which the foot of the slider contacts a proximal valley of the ratchet system; 48. The method of claim 47.

54. the ratchet system preventing proximal translation of the slider after the slider is advanced.

48. The method of claim 47.

55. 48. The method of claim 47, further comprising advancing the slider leg into contact with the proximal end of the needle carrier.

56. and if reflux is observed in the intravascular catheter assembly, ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly.

56. The method of any one of claims 47 to 55.

57. a needle cover having a proximal opening sized to engage a portion of the handle; a lumen in communication with the proximal opening, the lumen sized to receive the needle and catheter; a beveled surface at a distal location of the lumen adjacent a recess in the distal-most portion of the lumen; Furthermore, When used with an IVAD in the needle cover, the distal tip of the needle is separated from the guide element by a portion of the beveled surface, and the guide element is in a coiled state within the recess.

41. The intravascular access device of any one of claims 1 to 40.

58. the needle cover and the intravascular device are adapted and configured to interact in one or more of a neutral state, an armed state, a ready-to-use state, and a discarded state; 58. The intravascular access device of claim 57.

59. further comprising one or more steps of interaction between the vascular access device and a needle cover to place the vascular access device in one or more of a neutral state, an armed state, a usable state, and a discarded state.

57. A method of accessing a blood vessel according to any one of claims 47 to 56.

60. a handle including a proximal end and a distal end, a slot in a surface of the handle having a distal end and a proximal end, and a plurality of ratchet teeth along an interior of the handle; a slider positioned in the slot, the slider including slider legs extending toward the plurality of ratchet teeth; a needle carrier having a distal end coupled to an access needle and a proximal end positioned within the handle; a catheter having a proximal end coupled to a catheter hub configured to engage the distal end of the handle and including a lumen configured to accommodate the access needle extending therethrough; a guide element extending from the slider through the catheter lumen, the guide element including a distal tip configured to engage a notched distal tip of the catheter; Equipped with the guide element is configured to be advanced distally from the notched distal tip of the catheter by the slider leg. Intravascular access devices.

61. a dock at the proximal end of the needle carrier adapted to receive the slider leg therein; 61. The apparatus of claim 60, further comprising:

62. a channel along the needle carrier adapted to receive the guide element therein; 61. The apparatus of claim 60, further comprising:

63. a channel extending along the needle carrier adapted to receive the guide element therethrough; 61. The apparatus of claim 60.

64. the access needle includes a flat surface along the exterior of the needle; 61. The apparatus of claim 60.

65. the needle carrier includes a channel along the needle carrier adapted to receive the guide element therethrough; 65. The apparatus of claim 64.

66. the channel is positioned on the needle carrier at the same clock position as the needle flat surface; 66. The apparatus of claim 65.

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