Intravascular catheter with integrated guidance structure - Patents.com

Abstract

Intravascular access is achieved by introducing a catheter having a guide element recess positioned to receive a contoured distal end of the guide element. The guide element may be advanced along the outer surface of the access needle to form a loop beyond the distal end of the needle. The deployed guide element may form a partial or complete loop beyond the distal end of the needle. After the catheter is properly positioned, the access needle and guide element may be removed by automatic retraction, leaving the catheter in place within the vessel and ready for use.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 328,732, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE," filed April 7, 2022, and 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. STATEMENT REGARDING FEDERALLY FUNDED RESEARCH

[0003] This invention was made without government support.

[0002]

[0004] The present invention relates generally to methods and systems for achieving vascular access, and more particularly to a catheter and needle assembly with an integrated guiding element or structure for percutaneously inserting a catheter into a patient's arterial or venous vascular system. [Background technology]

[0003]

[0005] One common type of vascular access is called venipuncture. Venipuncture generally refers to the process of gaining intravenous access for any one of a variety of purposes including intravenous infusions, medical treatments, blood sample collection, etc. In hospitals, for example, venipuncture is commonly used to place thin venous catheters for intravenous fluid delivery, medication delivery, blood sample collection, etc.

[0004]

[0006] While venipuncture and other forms of vascular access can be straightforward in relatively healthy patients, such access is often required in less healthy patients who may have arteries and / or veins that are thin, tortuous, collapsed, fragile, and / or difficult to locate. In these patients, venipuncture and other forms of vascular access can be particularly challenging for inexperienced phlebotomists, emergency medical technicians, nurses, and other medical personnel.

[0005]

[0007] 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 that increase both cost and complexity. Additionally, conventional handle placement and movements can obscure the presence and state of the tool's needle and guiding structure or element components, thus making use of the insertion tool less intuitive. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0008] For these reasons, it would be desirable to provide improved methods, systems, and tools for deploying intravascular catheters using needles and guiding structures. It would be particularly desirable to provide simplified deployment systems and assemblies having fewer components, and even more desirable to provide components that are clearly visible to the user and configured to be utilized and operated in a straightforward, intuitive manner. At least some of these objectives will be achieved by the various embodiments that follow. [Means for solving the problem]

[0007]

[0009] In general, in one embodiment, an intravascular catheter assembly includes a handle having a proximal end and a distal end, a slot in a surface of the handle having the distal and proximal ends; an actuator button on the handle coupled to a needle holder; a tubular catheter body having a distal end, a guide element notch at the distal end, a proximal hub, and a lumen extending between the proximal and distal ends, the proximal hub of the catheter body being coupled to the distal end of the handle; a blood control valve in the proximal hub, the blood control valve configured to be selectively advanced within the proximal hub; and an access lumen disposed in the tubular catheter body lumen, having a tissue piercing distal tip extending distally beyond the distal end of the tubular catheter body, and a proximal end coupled to the needle holder. the distal end of the guide element is configured to conform to a guide element notch of the catheter, such that a distal-most portion of the guide element is advanced along the outer wall of the access needle from the tubular catheter body lumen to a position distal to the tissue-penetrating distal tip of the access needle after which the access needle and the guide element may be retracted together from the tubular catheter body; and a slider coupled to the proximal end of the guide element, wherein distal advancement of the slider causes a distal tip portion of the guide element to advance distally along the outer wall of the access needle from a position within the guide element notch.

[0008]

[0010] This and other embodiments may include one or more of the following features: When the slider is in a distal-most position, the distal portion of the guide element may be curved past the tissue-penetrating distal tip of the access needle. When the slider is in a distal-most position, the distal portion of the guide element may be curved from a position above the access needle to a position below the access needle, past the tissue-penetrating distal tip of the access needle. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be less than 360 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be greater than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be less than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be greater than 180 degrees. The slider may be provided over a proximal region of the access needle. The intravascular catheter assembly may further include a housing attached to the proximal end of the access needle, and a slider is provided on the housing. The access needle may be fixedly fastened to the distal end of the housing, and the tubular catheter body may be removably fastened to the distal end of the housing, and the slider advances the guide element beyond the distal end of the catheter, and the housing, access needle, and guide element may be disengaged and removed from the catheter after the catheter is in place. The proximal region of the catheter may be provided within the housing, and the proximal end of the catheter and the proximal end of the access needle may be configured to be engaged by the slider to advance the catheter and needle relative to the housing alongside the guide element after the guide element is extended distally beyond the distal end of the catheter. The access needle may have a lumen, and the guide element may be provided outside the access needle lumen. The housing may have an axial slot, and the proximal end of the guide element may be coupled to the slider that allows movement along the axial slot. The axial slot may be closed on the distal and proximal regions of the access needle.A link between the guide element and the slider may be provided in a slot having a travel length defined by both closed ends of the slot. The guide element may be slidably provided in a guide structure within the catheter body lumen. The guide structure may hold the guide element in position along the uppermost portion of the access needle. The guide structure may be a pair of features extending from the inner wall of the catheter body and projecting into the catheter body lumen. When the guide structure is positioned between the extending pair of features, the guide structure may be positioned along the upper surface of the outer wall of the access needle. The guide structure may have a distal-most portion adjacent the guide element notch and a proximal portion more than 1 cm from the guide element notch. The guide structure may have a distal-most portion adjacent the guide element notch and a proximal portion, and the guide structure may be continuous along the inner wall of the catheter body lumen from the proximal end to the distal end. The tubular catheter body may have a proximal hub with a blood control valve, and the access needle may slidably extend through the blood control valve. The slider can have a distal surface that mates with the proximal surface of the needle holder when the slider is fully advanced distally to extend the guide element. The slider can releasably lock to the proximal end of the needle holder when the distal surface mates with the proximal surface. The intravascular catheter can further include a first configuration, a second configuration, and a third configuration. In the first configuration when the slider is in a proximal-most position, the distal end of the guide element can be within the guide element notch and the tissue-penetrating distal tip of the needle can be distal to the distal-most end of the tubular catheter body. In the second configuration when the slider is in a distal-most position, the distal-most end of the guide element can be beyond the guide notch and can be curved beyond the tissue-penetrating distal tip of the needle. In the third configuration, the slider can be in a position proximal to the distal-most position and the needle and guide element can be at least partially retracted into the housing.In the first configuration, the distal tip of the access needle may extend beyond the distal end of the tubular catheter body by a distance ranging from 0.1 mm to 20 mm, and the proximal end of the slider may be set back from the proximal end of the tubular catheter body by a distance ranging from 10 mm to 100 mm. In the second configuration, the length of the guide element that extends beyond the guide cutout of the tubular catheter body may be 5 mm to 100 mm. The guide element may have a length that is greater than its width and a width that is greater than its thickness. The guide element may be made entirely or partially of a polymeric material, PTFE, nylon. The guide element may be made entirely or partially of a metal, including Nitinol, including Elgiloy or similar materials. The guide element may further include an upper surface that conforms to the curvature of the inner wall of the catheter body lumen and a lower surface that conforms to the curvature of the outer wall of the access needle. The catheter may be configured for use as the catheter component of an infusion set, the catheter component of a blood collection set, the catheter component of a blood collection set with safety wing, or the catheter component of a venous catheter.

[0009]

[0011] In general, in one embodiment, a method of accessing a patient's blood vessel includes the steps of advancing a tissue-penetrating distal tip of an access needle of an intravascular catheter assembly into the patient's blood vessel, the access needle having a flat surface along an upper portion, a lower portion, a right portion, or a left portion; advancing a guide element distal tip from a first position within a guide notch in a distal portion of a catheter hub to a second position where a portion of the guide element elongate body is advanced along the flat surface of the access needle to a position beyond a distal-most portion of the catheter hub; advancing a guide structure along the patient's blood vessel to a third position where the distal tip of the guide element is positioned beyond the tissue-penetrating distal tip of the access needle; and advancing a distal portion of the catheter hub along the guide structure and into the blood vessel.

[0012] and automatically retracting the needle and guiding structure into the intravascular catheter assembly.

[0010]

[0013] This and other embodiments may include one or more of the following features. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly when backflow of blood is observed within the intravascular catheter assembly. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle when a distal-most portion of the catheter hub of the intravascular catheter assembly is within the patient's blood vessel. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle when a distal-most portion of the guiding structure of the intravascular catheter assembly is within the patient's blood vessel. After performing the step of advancing the guiding structure beyond the tissue-penetrating distal tip of the access needle, a distal portion of the guiding element may bend beyond the tissue-penetrating distal tip of the access needle. After performing the step of advancing the guiding structure beyond the tissue-penetrating distal tip of the access needle, a distal portion of the guiding element may bend from a position above the access needle to a position below the access needle beyond the tissue-penetrating distal tip of the access needle. An angle of curvature formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle may be less than 360 degrees. An angle of curvature formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle may be greater than 270 degrees. An angle of curvature formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle may be less than 270 degrees. An angle of curvature formed by the distal portion of the guide element relative to the tissue penetrating distal tip of the access needle may be greater than 180 degrees. Advancing the guide element from the first position may include advancing a proximal guide tube into a lumen of a distal guide tube in communication with the needle holder, where a proximal end of the guide element may be coupled to the proximal guide tube.

[0011]

[0014] In general, in one embodiment, an intravascular access device includes a handle having a proximal end and a distal end, a slot extending from the proximal end to the distal end, a catheter having a proximal catheter hub and a distal catheter lumen, the proximal catheter hub being releasably engaged to the distal end of the handle, an access needle extending proximally from within the needle holder through the catheter lumen, the access needle having at least one flat surface extending longitudinally along a circumference of the access needle and a tissue penetrating tip extending distally beyond the catheter lumen, and at least one guide tube in the handle, the guide tube having a lumen therethrough and extending through a distal section of the needle holder. the catheter includes at least one guide tube having a distal end in communication with a lumen extending from the proximal end of the handle, through the at least one guide tube and the needle holder, a guide element having at least one longitudinal flat surface, the guide element extending from the proximal end of the handle, through the at least one guide tube and the needle holder, a distal portion of the guide tube being disposed within the catheter lumen, the longitudinal flat surface of the guide element contacting the at least one flat surface of the access needle; and a slider extending through the slot, the slider communicating with the proximal end of the guide element such that distal advancement of the slider advances a distal tip portion of the guide element from a position adjacent the distal end of the catheter lumen along the at least one flat surface of the access needle.

[0012]

[0015] This and other embodiments may include one or more of the following features: At least one flat surface of the access needle may extend longitudinally along an outer surface of the access needle. A guide element may be provided through a path defined by the at least one flat surface of the access needle, a distal guide tube coupled to the needle, and a proximal guide tube axially aligned with the at least one flat surface of the access needle. The at least one guide tube may be aligned parallel to a plane of the at least one flat surface of the access needle. When the slider is in a distal-most position, a distal portion of the guide element may be curved beyond the tissue-penetrating distal tip of the access needle. When the slider is in a distal-most position, a distal portion of the guide element may be curved beyond the tissue-penetrating distal tip of the access needle from a position defined by the plane of the at least one flat surface of the access needle. The intravascular access device may further include an access needle lumen, where the plane of the at least one flat surface of the access needle may be perpendicular to a radius of the access needle lumen. The intravascular access device may further include a blood control valve disposed within the proximal catheter hub, the blood control valve having a body including a distal end and a proximal end, and a lumen within the body that may extend from the proximal end to the distal end. The distal end of the blood control valve may include a surface that extends across the lumen and may include a plurality of slots. The proximal end of the blood control valve body may include a perimeter surface on the proximal end configured to be engaged with a portion of a luer to advance the blood control valve distally within the catheter hub to displace the plurality of slots. The proximal end perimeter may be continuous on a single plane. The proximal end perimeter may include a recess that enters the outer surface of the valve body. The recess may be configured to accommodate the distal end of the distal guide tube, a section of the guide element body, or the distal end of the needle holder. In use, when the needle holder is in a distal-most position, the needle holder may be proximal to the proximal end of the blood control valve without contacting the blood control valve. The tissue penetrating tip can define the distal end of the beveled surface of the access needle.The at least one flat surface may be offset on the circumference of the access needle at an angle relative to the location of the tissue-piercing tip. The intravascular access device may further include an activation button coupled to the needle holder and an activation element that exerts a force on the needle holder toward the proximal end of the handle, such that when the activation button is depressed, the activation element may displace the needle holder and the access needle toward the proximal end of the handle. The plane of the at least one flat surface of the access needle may be perpendicular to any radial extension outward from the center of the access needle. The catheter may be configured for use as 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 a venous catheter. The venous access device may further include a spool of guide element in communication with the proximal end of the intravascular device, and a length of the guide element may be housed within the spool. The guide element may be made completely or partially of a metallic material, a polymeric material, or a combination thereof.

[0013]

[0016] In general, in one embodiment, an intravascular catheter assembly includes a handle having a proximal end and a distal end, a slot in a surface of the handle having the distal and proximal ends, a spring loaded activation button on the handle coupled to a needle holder, a tubular catheter body having a distal end, a guide element notch at the distal end, a proximal end, and a lumen extending between the proximal and distal ends, the proximal end of the catheter body being coupled to the distal end of the handle, a multi-faceted tissue penetrating distal tip extending distally beyond the distal end of the tubular catheter body, and a proximal end coupled to the needle holder in the handle. the access needle having a guide element configured to operably couple with the guide element notch, a guide element including an elongate body extending distally from a guide element tip configured to operably couple with the guide element notch, the guide element being positioned within the catheter body lumen and adjacent an outer surface of the access needle, such that the guide element tip is advanced from the tubular catheter body lumen along the outer wall of the access needle to a position distal to the tissue penetrating distal tip of the access needle after which the access needle may be retracted from the tubular catheter body, and a slider coupled to a proximal end of the guide element, wherein distal advancement of the slider causes the tip of the guide element to advance distally from a position within the guide element notch.

[0014]

[0017] This and other embodiments may include one or more of the following features: When the slider is in a distal-most position, the distal portion of the guide element may be curved past the tissue-penetrating distal tip of the access needle. When the slider is in a distal-most position, the distal portion of the guide element may be curved from a position above the access needle to a position below the access needle past the tissue-penetrating distal tip of the access needle. The proximal side of the guide element tip may be configured to contact the guide element notch. The access needle may include a flat surface axially positioned along the length of the access needle outer surface. The guide element elongate body may extend proximally within the catheter body lumen adjacent the axial flat surface along the access needle outer surface. The guide element tip may include a geometry configured to complement the guide element notch. The guide element tip may be affixed to a distal end of the guide element elongate body. The intravascular catheter assembly may further include a housing attached to the proximal end of the access needle, and the slider may be provided on the housing. The access needle can be fixedly secured to the distal end of the housing, and the tubular catheter body can be removably secured to the distal end of the housing. The slider can advance the guide element over the distal end of the catheter, and the housing, access needle, and guide element can be disengaged and removed from the catheter after the catheter is in place. The intravascular catheter assembly can further include a blood control valve positioned in a hub at the proximal end of the tubular catheter body, the blood control valve can include a valve body and a lumen, the surface covering the distal end of the lumen, the surface having a plurality of slits. The intravascular catheter assembly can further include a proximal guide tube axially aligned with the distal guide tube, and the guide element elongate body can extend through the proximal guide tube, the distal guide tube, and the catheter body lumen. The proximal end of the guide element can be coupled to the inside of the proximal guide tube. The proximal guide tube can be axially aligned with the distal guide tube coupled to the needle holder. The guide element may be slidably disposed within the catheter body lumen along the flat surface of the access needle.The tubular catheter body can have a proximal hub including a blood control valve, and the access needle can slidably extend through the blood control valve. The slider can have a distal surface that mates with the proximal surface of the needle holder when the slider is fully advanced distally to extend the guide element. The intravascular catheter assembly can further include a first configuration, a second configuration, and a third configuration. In the first configuration, when the slider is in a proximal-most position, the guide element distal tip can be within the guide element notch, and the tissue-penetrating distal tip of the needle is distal to the distal-most end of the tubular catheter body. In the second configuration, when the slider is in a distal-most position, the guide element distal tip can be curved past the guide notch and past the tissue-penetrating distal tip of the needle. In the third configuration, when the slider is in a position proximal to the distal-most position, the needle can be at least partially retracted into the housing. The catheter may be configured for use as the catheter component of an infusion set, the catheter component of a blood collection set, the catheter component of a safety winged blood collection set, or the catheter component of a venous catheter.

[0015]

[0018] In general, in one embodiment, an intravascular catheter assembly includes a catheter lumen extending distally from a proximal hub, the catheter lumen including a guide element notch at a distal end of the catheter lumen, an access needle disposed within the catheter lumen, the access needle having a flat surface positioned axially along a length of the access needle, a guide element disposed between the flat surface of the needle and the inside of the catheter lumen, and a slider coupled to a proximal section of the guide element, where distal advancement of the slider advances a shaped distal tip of the guide element from a first position in the guide element notch to a second position, the distal section of the guide element curves past the tissue penetrating distal tip of the access needle, the slider having a distal face that mates with a proximal face of the needle holder when the slider is fully advanced distally to extend the guide element.

[0016]

[0019] This and other embodiments can include one or more of the following features: The slider can be releasably locked to the proximal hub when the distal surface of the slider mates with the proximal surface of the needle holder. The guide can have an elongate body extending distally from a molded tip, the elongate body including a flat surface in communication with the flat surface of the access needle. The guide element can be polymeric.

[0017]

[0020] In general, in one embodiment, a method of accessing a patient's blood vessel includes advancing a tissue-penetrating tip of an access needle of an intravascular catheter assembly into the patient's blood vessel; advancing a formed distal tip of a guide element from a first position within a guide element notch in a distal portion of the catheter lumen, where a distal portion of the guide structure forms a uniform transition outside the catheter lumen, to a second position where a portion of the guide structure is advanced past the tissue-penetrating tip along a flat surface of the access needle, the flat surface being positioned axially along an outer wall of the access needle; advancing a distal portion of a catheter hub along the guide element into the blood vessel; and retracting the needle into the intravascular catheter assembly.

[0018]

[0021] This and other embodiments may include one or more of the following features: The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly when backflow of blood is observed within the intravascular catheter assembly. The method of accessing a blood vessel may further include advancing a blood control valve positioned within the catheter hub. The shaped distal tip of the guide element and the distal-most portion of the guide element may form an atraumatic tip after being advanced beyond the tissue-penetrating tip. Advancing the shaped distal tip of the guide element may include distally advancing a sliding device within a slot of the handle, the sliding device may couple to a proximal guide tube and the guide element may extend through a lumen of the proximal guide tube.

[0019]

[0022] In general, in one embodiment, an intravascular catheter includes a hub having a proximal end and a distal end, a tubular body extending from the hub distal end to a distal tip, the tubular body having an outer wall and an inner wall, a lumen within the hub and tubular body bounded by the tubular body inner wall, the lumen having a guide element notch at its distal end, a guide element having a formed distal tip configured to mate with the guide element notch, and an access needle having a longitudinal flat along the length of an outer surface of the needle, the guide element including a flat surface adjacent to the flat surface of the needle.

[0020]

[0023] This and other embodiments may include one or more of the following features: The intravascular catheter may further include a needle holder in the handle, the needle holder coupled to the proximal end of the access needle. The intravascular catheter may further include a proximal guide tube slidably coupled to the distal guide tube, and the guide element elongate body may extend proximally from the formed distal tip through a lumen formed by the distal and proximal guide tubes. The intravascular catheter may further include a slider operably coupled to the proximal guide tube, and the slider may be configured to advance the formed distal tip by advancing the proximal guide tube.

[0021]

[0024] In general, in one embodiment, an intravascular access device includes a handle having proximal and distal ends and a slot extending from the proximal end to the distal end; a catheter having a catheter lumen extending distally from a catheter hub, the catheter hub releasably engaged to the distal end of the handle; an access needle extending distally through the catheter lumen from a needle holder, the access needle having at least one flat surface extending axially along an access needle body and a tissue penetrating tip; a guide element configured to extend through a lumen including the catheter lumen and through a guide tube positioned within the handle proximal to the needle holder, the guide element including a formed distal tip configured to engage a guide element notch at a distal end of the catheter lumen; and a slider extending through the slot and in communication with a proximal section of the guide element, the slider configured to advance the guide element distally along the at least one flat surface of the access needle.

[0022]

[0025] This and other embodiments may include one or more of the following features: The guide element may include an elongate body extending proximally from the formed distal tip. The guide element may include an elongate body extending proximally from the formed distal tip through a lumen including the catheter lumen and through a guide tube proximal to the needle holder. The guide element may include a distal section having a flat surface adjacent to at least one flat surface of the access needle. The guide element distal end may be configured to curve upon advancement beyond the tissue penetrating tip. The at least one flat surface of the access needle may include a lateral edge proximal to the tissue penetrating tip. The intravascular access device may further include a blood control valve positioned within the catheter hub. The blood control valve may include a distal section having one or more grooves configured to increase the volume of the catheter hub. The proximal section of the blood control valve may be configured to accommodate the distal end of the needle holder. The at least one flat surface of the access needle may extend along an outer surface of the access needle at an angle relative to the location of the tissue penetrating tip. The intravascular access device may further include an activation button coupled to the needle holder.

[0023]

[0026] Generally, in one embodiment, an intravascular catheter assembly includes a hub having a proximal end and a distal end, a tubular body extending from the hub distal end to a distal tip, and a blood control valve positioned within the hub, the blood control valve including a distal surface configured to accommodate fluid flow therethrough when the blood control valve is advanced distally within the hub.

[0024]

[0027] This and other embodiments can include one or more of the following features: The blood control valve can include a recess in the proximal periphery configured to accommodate the needle retainer. The guide element notch at the distal tip of the tubular body can be configured to mate with the guide element distal tip. The catheter hub can include an actuation element configured to open a distal surface of the blood control valve.

[0025]

[0028] The novel features of the invention are set forth with particularity in the claims which follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0026] [Figure 1A]

[0029] FIG. 1 is a perspective view of one embodiment of an intravascular access device having a catheter, a guide element, and a needle assembly. [Figure 1B]

[0030] 1 is a perspective view of an embodiment of an intravascular access device having a catheter, a guide element and a needle assembly. [Figure 2A]

[0031] 1B is a cross-sectional view of the intravascular access device of FIG. 1A showing the catheter, guide element and needle assembly, actuation button, support rail, and sliding device in a proximal position. [Figure 2B]

[0032] 1C is a cross-sectional view of the intravascular access device of FIG. 1B showing the catheter, the guide element and needle assembly, the actuator button, the support rail, the first guide tube, and the second guide tube. [Figure 2C]

[0033] FIG. 2 is a cross-sectional view of an intravascular access device with the catheter hub removed to show details of the blood control valve, distal guide tube, and needle holder near the distal end of the handle. [Diagram 3]

[0034] FIG. 1B is a top perspective view of the distal housing and catheter hub of FIG. 1A showing details of the needle, guide element, and needle holder inside the catheter hub. [Figure 4]

[0035] FIG. 4 is an enlarged top perspective view of the distal housing and catheter hub of FIG. 3 showing details of the needle, guide element, needle holder, and needle holder slot inside the catheter hub. [Figure 5A]

[0036] 4 is a perspective view of a longitudinal section of the intravascular access device of FIG. 3 showing additional detail of the needle holder in relation to the actuation button, and showing additional detail of the guide element in relation to the support rail and the outer wall of the access needle. [Figure 5B]

[0037] 1C is a perspective view of a longitudinal section of the intravascular access device of FIG. 1B showing further details of the needle holder associated with the activation button and the guiding element through the needle holder to the needle flat. [Figure 6]

[0038] 1B is a top view of a portion of the intravascular catheter of FIG. 1A, more proximal than the view of FIG. 4, showing additional detail of the distal end of the needle holder in relationship to the guide elements and support rails within the needle holder longitudinal slot. [Figure 7]

[0039] FIG. 7 is a top view of a portion of an inner view similar to FIG. 6, showing the proximal end of the needle holder in relation to the sliding device, the guide element and the support rail. [Figure 8]

[0040] 1A and 3, showing the inside of the catheter hub, including the needle holder, needle, guide elements, and support rails. [Figure 9]

[0041] FIG. 9 is a perspective proximal view of the components seen in FIG. [Figure 10A]

[0042] 1B is a close-up view of the distal end of the intravascular device of FIG. 1A showing the distal tip of the catheter with the guide element notch and the distal end of the access needle in relationship to the distal end of the guide element within the guide element notch. [Figure 10B]

[0043] 1C is a close-up view of the distal end of the intravascular device of FIG. 1B showing the distal end of the access needle in relation to the distal tip of the catheter, including the guide element engagement feature and the transition from the needle flat surface to the needle bevel surface. [Figure 11]

[0044] 10B illustrates a distal end view of a cross-sectional view of the vascular access device of FIG. 10A showing the relationship of the inner catheter wall, the guide element, and the outer access needle wall. [Figure 12]

[0045] FIG. 10C illustrates the distal end of the vascular access device of FIG. 10B in cross section, showing the alignment of the guide element root through the guide tube and on top of the needle flat. [Figure 13]

[0046] 1 is a perspective view of the needle holder, the first guide tube, the second guide tube, and the orientation of the guide element root. FIG. [Figure 14]

[0047] 12 is an enlarged view of the central portion of the view of FIG. 11 showing the concave portion of the catheter lumen wall, the upper surface of the guide element adjacent the concave portion of the lumen wall, and the lower surface of the guide element adjacent and conforming to the outer wall of the access needle. [Figure 15]

[0048] 14 is an enlarged view of the central portion of the view of FIG. 11 , similar to FIG. 14 , providing additional explanation of the outer wall of the access needle, the catheter lumen wall, and the various geometries of the guiding element positioned between these structures of the intravascular device. [Figure 16A]

[0049] FIG. 16A is an enlarged view of a central portion of the intravascular device of FIG. 1B providing further illustration of the orientation and configuration of the guide elements relative to the needle. [Figure 16B] 1C is an enlarged view of a central portion of the intravascular device of FIG. 1B providing further illustration of the orientation and configuration of the guide elements relative to the needle. [Figure 16C] 1C is an enlarged view of a central portion of the intravascular device of FIG. 1B providing further illustration of the orientation and configuration of the guide elements relative to the needle. [Figure 16D] 1C is an enlarged view of a central portion of the intravascular device of FIG. 1B providing further illustration of the orientation and configuration of the guide elements relative to the needle. [Figure 17A]

[0050] FIG. 13 is a close-up view of the distal tip of the catheter, the distal tip of the needle, and the distal tip of the guide element oriented in a lateral position relative to the needle. [Figure 17B] FIG. 13 is a close-up view of the distal tip of the catheter, the distal tip of the needle, and the distal tip of the guide element oriented in a lateral position relative to the needle. [Figure 17C]

[0051] A perspective view of a configuration for alignment of the needle flat surface, the needle holder, and the guide tube forming the guide element route in a timing position other than on top of the needle surface. [Figure 17D]

[0052] FIG. 17D is an enlarged view of FIG. 17C illustrating the transition of the guidewire through the distal end of the needle holder and into the second guide tube. [Figure 18]

[0053] 10A and 1A , after the sliding device has been moved from the proximal position shown in FIG. 1A to a distal position where the guide element is advanced distally along the outer wall of the access needle to form a loop distal to the tip of the access needle. [Figure 19A]

[0054] FIG. [Figure 19B] FIG. 2 is a close-up view of the guide element and the distal end of the catheter lumen. [Figure 19C] FIG. 2 is a close-up view of the guide element and the distal end of the catheter lumen. [Figure 20]

[0055] FIG. 13 is an enlarged perspective view of a guide element flat surface extending through the distal end of the catheter tip and beyond the tissue-piercing tip of the needle. [Figure 21]

[0056] FIG. 13 is a perspective view of a guide element oriented laterally relative to the needle in an expanded configuration. [Figure 22]

[0057] FIG. [Figure 23A]

[0058] FIG. 2 is an expanded view of a homeostasis valve, according to an embodiment of the present invention. [Figure 23B] FIG. 2 is an expanded view of a homeostasis valve, according to an embodiment of the present invention. [Figure 23C] FIG. 2 is an expanded view of a homeostasis valve, according to an embodiment of the present invention. [Figure 24A]

[0059] FIG. 2 is a close-up view of a catheter hub and the distal end of an intravascular access device handle as described herein. [Figure 24B] FIG. 2 is a close-up view of a catheter hub and the distal end of an intravascular access device handle as described herein. [Figure 25A]

[0060] FIG. 25A is a close-up view of the catheter hub, distal guide tube, and distal end of an intravascular access device handle described herein. [Figure 25B] FIG. 2 is a close-up view of the catheter hub, distal guide tube, and distal end of an intravascular access device handle as described herein. [Figure 26A]

[0061] FIG. 2 is a close-up view of a peripheral medical device and catheter hub connection as described herein. [Figure 26B] FIG. 2 is a close-up view of a peripheral medical device and catheter hub connection as described herein. [Figure 27]

[0062] FIG. 2 is an enlarged view of a catheter assembly as described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027]

[0063] 1A is a perspective view of one embodiment of an intravascular access device 100 having a catheter hub 110, a guide element 120, and a needle assembly. In this configuration, an intravascular catheter with an integrated guide structure or guide element is prepared to be used to position the catheter within a vessel. The catheter hub 110 may be coupled to the distal end 103 of a handle 101, and an access needle 140 extends from a needle holder 130, through the catheter lumen 116, and distally from the catheter hub 110. The catheter hub 110 is transparent in this view to allow viewing of the position of the needle holder 130 and the guide element 120.

[0028]

[0064] The handle or housing 101 has a proximal end 102 and a distal end 103. A slot 105 runs along its length where a slider 150 engages the guide element 120 and provides access for advancing the guide element tip distally from within the guide element notch at the distal end of the catheter lumen 116. The slider 150 includes a gripping portion 152 and is shown in its proximal-most position for use when a needle 140 is positioned within the catheter 110 and ready to be inserted into the patient's vasculature. In some examples, the catheter hub 110 has a distal end 114 and a proximal end 112, as well as an inner lumen 116 along its entire length. The catheter proximal end 112 is adapted and configured to engage the handle distal end 103. The catheter proximal end 112 is also configured to engage surrounding elements, such as conventional medical tubing connections, after insertion and removal of the handle 101. For example, the catheter proximal end 112 may include features that engage a Luer lock, a fluid coupling, or other suitable medical connector or fitting.

[0029]

[0065] FIG. 1B is a perspective view of an example of an intravascular access device 200 including several elements shown as semi-transparent to allow visualization of the internal components. In this view, the intravascular access device has a catheter assembly 219 in communication with a distal end 207 of a handle 201, a guide element 210 that moves back and forth through a needle holder 240. An actuation element 206 is visible through the semi-transparent handle 201 of this example. The actuation element may be configured to selectively displace the needle holder 240 when an actuation button 205 is engaged. For example, the actuation element 206 may be a spring wrapped around the needle holder 240 and positioned between an inner wall of the distal portion of the handle and a needle holder collar 243, as shown here. A slider 202 extends through a slot 207 in an upper portion of the handle 201. The slide 202 includes a grip 203 accessible on the outer surface of the handle 201 and an arm 204 that extends through a slot 207 in the handle to the proximal end of the first guide tube 230 .

[0030]

[0066] The intravascular access device depicted in FIG. 1B is shown in a ready-to-use configuration. The slider 202 is positioned near the proximal end of the handle 201, and the arm 204 is in communication with the guide element 210 near the proximal end of the handle. The slider may be in operative communication with a proximal end or proximal section of the guide element 210 such that the slider 202 can advance the guide element 210 distally. For example, as depicted in more detail in FIG. 2B, the guide element 210 may have an elongate body 233 extending proximally from a distal tip into the handle.

[0031]

[0067] In some examples, the catheter assembly 219 may be deployed after the access needle 250 and the distal end of the guide element 210 are deployed to facilitate catheter placement within the blood vessel. Once the catheter 220 is deployed, an actuation button 205 shown near the distal end of the handle 201 may be depressed to release the actuation element 206 and displace the needle holder 240 and the needle 250 into the handle 201. In some examples, the actuation button is configured to release the actuation element and retract (e.g., proximally displace) the needle holder 240, the access needle 250, and the guide element. In any of the examples described herein, retraction of the access needle 250 and the guide element 210 (e.g., the distal end of the guide element) occurs simultaneously. For example, when the actuation button 205 is depressed and the actuation element 206 displaces the needle holder 240 proximally, the access needle is retracted into the handle 201 and the guide element distal end may also be retracted proximally into the handle 201. In some examples, the needle 250 is retracted completely into the handle 201. In some examples, the guide element 210 is retracted completely into the handle 201.

[0032]

[0068] 1B, a blood control valve 279 may be positioned in the catheter hub 222 and configured to control the flow of fluid (e.g., blood) through the catheter assembly. The blood control valve 279 may prevent blood flow from the blood vessel through the catheter assembly 219 until a valve is opened at the distal end. For example, the catheter assembly may be deployed or removed from the handle after access to the blood vessel is established, and the blood control valve 279 may prevent blood from exiting the catheter assembly until a peripheral element (e.g., a male portion of a luer lock) is attached to the catheter hub and the blood control valve 279 is advanced distally within the catheter hub 222.

[0033]

[0069] 2A-2C are cross-sectional views of an example intravascular access device. FIG. 2A is a cross-sectional view of an intravascular access device showing the catheter hub 110, guide element 120 and needle holder 130, actuator button 106, support rail 109, and slider 150 in a proximal position. This is the "ready to use" configuration. The guide element proximal end 122 is attached to the slider tab 154. The guide element 120 extends along the support rail 109, past the needle holder distal end 132, and into and along the catheter lumen 116. The guide 120 resides between the needle outer wall 148 and the catheter lumen inner wall 115. As a result, as the slider 150 is advanced along the slot 105, the guide element advances along the support rail 109 and along and past the distal end of the catheter and needle to form an atraumatic loop or partial loop or curve over the sharp distal end 144 of the needle (see Figures 14 and 15).

[0034]

[0070] In this view, the catheter lumen 116 can also be seen. The needle 140 has a sharp distal end 144 that is used to penetrate the skin and the vessel wall. The access needle proximal end 142 terminates in the needle holder 130. When the activation button is released, the activation element 108 moves the needle holder 130 towards the housing proximal end 102. Movement of the needle holder 130 within the handle 101 is long enough for the sharp distal end 144 of the needle 140 to be completely within the housing 101. The needle holder 130 also includes a support rail slot 138 along its length that is sized to receive the support rail 109.

[0035]

[0071] An actuation element 108 is included but not shown in this view in order to allow for detail of the needle holder 130. The actuation element 108 may be a spring, such as a coil spring or wave spring, or other suitable compression element. When the actuation button 106 is depressed, the actuation button latch 107 disengages from the needle holder distal groove 134, which then allows the actuation element 108 to deploy and propel the needle holder 130 along with the needle 140 towards the handle proximal end 102.

[0036]

[0072] 2B is a cross-sectional view of the intravascular access device 200 shown in FIG. 1B. The guide element 210 includes a distal end, not shown, and an elongate body that extends proximally through the catheter and catheter hub 222, then continues through the distal guide tube 235 and then through the concentric lumen of the proximal guide tube 230. The proximal and distal guide tubes 230 are generally positioned within the handle to provide additional support to the guide element extending therethrough. For example, the guide element elongate body may extend through the lumen formed by the proximal and distal guide tubes 235 and 230, so that the guide tubes may be configured to prevent buckling of the guide element elongate body extending therethrough or to otherwise support the guide element elongate body to increase column strength thereof as the sliding device advances the guide element distally. In some examples, the guide element 210 is further routed through the catheter proximal hub 222 and the catheter lumen 221 after passing through the needle holder lumen 221 within the distal portion of the needle holder 240. The needle holder lumen 221 has a slope that facilitates the transition of the guide element 210 from the distal end of the second guide tube 235, through the distal end of the needle holder 240, and into contact with the outer surface of the needle 250. The guide element 210 extends through the catheter between the outer surface of the needle 250 and the inner surface of the catheter lumen 221.

[0037]

[0073] The distal end of the proximal guide tube 230 can be partially and slidably inserted into the distal guide tube 235 to provide concentric lumens that define the route of the guide element within the handle. In one embodiment, the distal end of the first guide tube and the proximal end of the second guide tube can interdigitate with each other (see FIG. 13). For example, a groove around the inner circumference of the second guide tube can correspond to a toroidal ridge around the outer surface of the first guide tube, so that the first and second guide tubes can be constrained in a position relative to each other once the ridge is fully within the groove. The interdigitated configuration of the first and second guide tubes can provide retention of the needle holder 240 after the actuator button 205 is depressed to allow the actuator element 206 to urge the needle holder 240 towards the proximal end of the handle 201. For example, when the needle retainer is biased toward the proximal end of the handle, the second guide tube will slide over the first guide tube toward the proximal end of the handle until the distal end of the first guide tube interlocks with the distal end of the second guide tube. Alternatively, the proximal end of the second guide tube can continue to slide over the first guide tube and engage with an interlocking element positioned near the proximal end of the first guide tube.

[0038]

[0074] In some examples, the guide element elongate body may be coupled to the proximal guide tube 235. For example, the guide element elongate body may be attached, crimped, or otherwise connected to the proximal end of the proximal guide tube 235 such that a sliding device engages the proximal guide tube 235 to advance the guide tube-catheter combination and, in response, cause the guide element distal tip to advance distally out of the guide element cutout of the catheter.

[0039]

[0075] FIG. 2C is another example of an intravascular device, showing the distal end of the handle and details of elements positioned distally from or extending through the handle. The catheter hub has been removed from this view to highlight the blood control valve 279 and the routing through the distal guide tube 235 as the guide element elongated body 233 transitions from the handle to the flat surface of the access needle 250. The distal guide tube 235 is shown to have a tapered distal section. For example, the distal section of the distal guide tube 235 is angled toward the needle to route the guide element elongated body 233 through the inside of the blood control valve 279. Also visible in FIG. 2C is the space or gap between the proximal end of the blood control valve 279 and the distal end of the needle holder 240. In some examples, the needle holder 240 may have a length or configuration to support the space between the distal end of the needle holder 240 and the blood control valve 279. Therefore, in use, the needle holder cannot come into contact with the blood control valve 279 .

[0040]

[0076] In some examples, the distal guide tube (e.g., element 235 in FIG. 2C) may have a lumen extending therethrough from the proximal end to the distal end. The guide tube may have a tubular lumen with a linear axis. In some examples, the guide tube lumen may have a lumen with a substantially linear axis. In some examples, the guide tube may have a lumen with a segment defined by the linear axis of the lumen, which may extend distally to another segment with a different axis (e.g., tilted). The configuration of the guide tube may be based on routing by the guide element elongate body transitioning from inside the handle to the flat surface of the access needle in the catheter lumen. In some examples, the guide tube (e.g., the distal guide tube) may be in communication with or adjacent to the needle holder.

[0041]

[0077] In either example, the distal guide tube may be adjacent to the needle holder, for example, the distal guide tube may be coupled to the needle holder, integrated within the needle holder, attached to the needle holder, mounted within or along the needle holder, or combinations thereof.

[0042]

[0078] 3 is a top perspective view of the distal housing 103 and catheter hub 110 of FIG. 1A showing details of the needle 140, guide element 120, and needle holder 130 within the interior of the catheter hub 110. The guide element 120 is shown exiting the distal end of the support rail and entering the space between the outer needle wall and the inner wall of the catheter lumen. In some examples, the guide element elongate body may be routed through one or more guide tubes described herein. In some examples, the guide tube elongate body may be routed through a groove in the needle holder.

[0043]

[0079] 4 is an enlarged top perspective view of the exemplary distal housing 103 and catheter hub 110 of FIG. 3 showing details of the needle 140, guide element 120, needle holder 130, and needle holder support rail slot 138 inside the catheter hub 110. In this view, the needle 140 is shown exiting the catheter lumen 116 and entering the needle holder lumen 136. The proximal end of the needle 140 terminates within and is fastened to the needle holder 130.

[0044]

[0080] FIG. 5A is a perspective view of a longitudinal section of the intravascular access device 100 of FIG. 3 showing additional detail of the needle holder 130 in relation to the activation button 106, and additional detail of the guide element 120 in relation to the support rail 109 and the access needle outer wall 148. The catheter hub proximal end 112 is shown coupled to the housing or handle distal end 103. Additional detail of the guide element relative to other components can also be seen. The guide element 120 extends along the support rail 109, the distal end of the slot 138, and into the gap between the needle outer wall and the catheter lumen wall 115. Additionally, the needle 140 is shown in relation to the catheter lumen proximal end 116 and the needle holder lumen 146. The needle proximal end 142 terminates at the needle holder 130 into the blood return chamber 135. All or a portion of the needle holder 130 or handle 101 may be transparent to allow for visual detection of fluid or blood return or backflow of blood after the needle distal end 144 enters the target vessel.

[0045]

[0081] 5A also shows the relationship of the activation latch 107 to the associated needle holder groove 134. When in a loaded or cocked configuration, the latch 107 engages the groove 134 to provide a restraining force to the activation element 108. Depressing the activation button 106 disengages the latch 107 from the needle holder slot 134, allowing the spring force or stored energy of the activation element 108 to propel the needle holder 130 toward the handle proximal end 102. Also shown in this view is the termination of the support rail 109 within the housing distal end 103.

[0046]

[0082] 5B is a perspective view of a longitudinal section of the intravascular access device 200 of FIG. 1B showing the route that the guide element 210 takes as it is angled from the second guide tube 235, through the distal portion of the needle holder 240, and onto the outer surface of the needle 250. The proximal section of the needle 250 held within the needle holder 240 is visible in detail and is generally parallel to the first and second guide tubes.

[0047]

[0083] Here, the relationship of the actuator button 205 to an associated needle holder groove 245. When in a loaded or cocked configuration, the latch 227 engages the groove 245 to provide a restraining force on the actuation element 205. Depressing the actuation button 205 disengages the latch 227 from the needle holder slot 207, allowing the spring force or stored energy of the actuation element 206 to propel the needle holder 240 towards the proximal end of the handle.

[0048]

[0084] FIG. 5B further illustrates the relationship of the components that define the route of the guide element through the interior of the intravascular access device 200. In particular, the route of the guide element is defined by the concentric and collinear lumens of the first guide tube 230 and the second guide tube 235. The first and second guide tubes are parallel and coplanar with the surface of the needle contacted by the guide element 210. The outer surface of the distal portion of the needle holder is shown to have a slope corresponding to the slope of the lumen therethrough. The cross-sectional view of FIG. 5B highlights an embodiment in which each of the components that define the route of the guide element are aligned with one another, whereby the guide element 210 has a deviation from an otherwise straight route through the interior of the intravascular access device 200 in the ready-to-use configuration. A hemostasis valve 281 (e.g., a blood control valve) may be positioned adjacent to the needle holder distal end 246. 5B, blood control valve 281 may be within catheter proximal hub 222 and may be configured to minimize, prevent, or reduce backflow of fluid (e.g., blood) from proximal catheter hub 222. In some examples, guide element 220 and needle 250 may pass through a distal end of blood control valve 281.

[0049]

[0085] 6 is a top view of a portion of the intravascular catheter of FIG. 1A, more proximal than the view of FIG. 4, showing additional detail of the guide element 120 within the needle holder longitudinal slot 138 and the distal end 132 of the needle holder 130 in relation to the support rail 109. The guide element 120 can be seen along the upper surface of the support rail 109, transitioning from the support rail distal end, over the needle holder distal end 132, along the needle outer wall 148 and into the catheter lumen 116. The configuration of the support rail 109 relative to the needle holder support rail slot 138 allows the support rail to function like a monorail for the needle holder during retraction (i.e., when the stored energy of the actuation element 108 is being released). The support rail 109 also supports the guide element 120 during advancement of the slider 150.

[0050]

[0086] FIG. 7 is a top view of a portion of an inner view similar to FIG. 6 showing the proximal end of the needle holder 132 in relation to the slider 150, the guide element 120, and the support rail 109. The slider tab 154 of the slider 150 extends through the slot 105. The slider tab includes a key plate 156 having an aperture 158. The aperture 158 is sized, shaped, and positioned to accommodate features of the guide element 120 and the support rail 109. Advantageously, the configuration of the slider 150 and the support rail 109 allows the support rail 109 to allow the slider 150 to translate freely rearward / forward. The guide element 120 has a proximal end 122 coupled to the slider using the slider tab 154 or other suitable structure. The support rail 109 extends through the slider tab and is coupled to the housing proximal end 102. Additionally, this view illustrates the relationship of needle holder proximal end 132, which is sized and positioned to engage slider tab 154 during retraction. Rearward movement of the needle holder causes needle holder proximal end 132 to engage and move slider tab 154. Because guide element 120 terminates in slider 150, guide element 120 also moves proximally within the housing. This movement (i.e., proximal movement of needle holder 130) results in the needle and guide element being simultaneously retracted inside the handle or housing.

[0051]

[0087] FIG. 8 is a top perspective view of the distal portion 103 of the intravascular access device 100 (e.g., as shown in FIG. 1A and FIG. 3), showing the inside of the catheter hub 110, including the needle holder 130, needle 140, guide element 120, and support rail 109. This is another view of the placement of the guide element 120 along the support rail 109, over the needle holder, and into the catheter lumen. This view also shows the support rail slot 138 along the entire length of the needle holder 130, in relationship to the needle holder proximal end 131 and distal groove 134. FIG. 9 is a perspective proximal view of the needle holder 130 and other components seen in FIG. 8. A blood chamber 135 is visible within the needle holder proximal end 131. The normally present cover for the chamber 135 has been removed to show the inside.

[0052]

[0088] FIG. 10A is a close-up view of the distal end of an intravascular device (e.g., 100 in FIG. 1A ) showing the distal tip 114 of the catheter with the guide element notch 115, and the distal end 144 of the access needle 140 in relation to the guide element distal end 123 of the guide element 120 within the guide element notch 115. The guide element distal end 123 can be shaped / fabricated to mimic the geometry of the catheter tip 114. The guide element (e.g., the guide element elongated body) can extend over the needle within the catheter lumen along a flat surface that extends along the needle body. For example, the guide element 120 can be positioned between the catheter lumen inner wall or inner diameter and the needle outer wall or needle outer diameter. In some examples, the guide element positioned within the needle lumen does not require additional space or expanded catheter volume because the needle flat surface provides a route or pathway for the guide element elongated body. In some examples, the guide element 120 can be made of a polymeric material. The guide element 120 may also be pre-shaped, shape-set, or have a shape-memory configuration to form a complete loop, partial loop, or multiple loops when extended beyond the needle distal end 144 (see Figures 18 and 19).

[0053]

[0089] In some examples, the catheter distal end includes a guide element notch 115 configured to mate with the guide element distal tip 123. The guide element notch 115 can have a geometry that corresponds to the guide element distal tip 123 to promote a smooth or continuous outer surface from the outside of the needle to the outside of the catheter. The diagram in FIG. 10A is an example of how the shaped distal end of the guide element conforms to the catheter tip guide element notch. This is also an illustration of a uniform transition between the catheter and the contours of the guide element distal end, so that the transition from the catheter tip to the needle and the circumference of the catheter tip remain smooth.

[0054]

[0090] In FIG. 10B, an example of a guide element distal end 212 (e.g., a formed distal tip) is shown molded / fabricated to mimic the geometry of the guide element notch of the catheter tip 224 at the distal end of the catheter. The distal end of the catheter is shown to have a guide element engagement feature 226 (e.g., a guide element notch) having a shape configured to receive a portion of the guide element distal end 212. The geometry of the catheter tip 224 is shown to be angled or sloped toward the outer surface of the needle 250. The guide element distal end 212, when in communication with the guide element notch 226, has a slope that corresponds to the slope of the catheter tip 224, thereby providing a smooth transition from the outer surface of the needle 250 to the outer surface of the catheter 220. Also shown in FIG. 10B is the needle flat surface 251 and the transition to the needle beveled surface 256 that terminates in the tissue penetrating tip 254. In one embodiment, and in the ready-to-use configuration, the tissue penetrating tip 254, the guide element distal end 212, and the catheter tip 224 may be referred to as a distal tip assembly.

[0055]

[0091] In use, the geometry of the distal end assembly provides a smooth transition through one or more layers of tissue guided by the tissue-piercing tip 254. As the distal end assembly is advanced through one or more layers of tissue, the tissue-piercing tip 254 can enter the patient's vasculature without unnecessary damage or restriction within the tissue or vasculature.

[0056]

[0092] The guide element distal tip 212 (e.g., a formed tip of the guide element) may be molded into the distal end of the guide element elongate body 223. In some examples, the guide element distal tip 212 may be coupled to the guide element elongate body 223. For example, the guide element distal tip 212 may be affixed or otherwise attached to the distal end of the guide element elongate body 223. The geometry of the guide element distal tip 212 may be configured to complement or otherwise engage with the guide element notch 226. The distal end of the catheter may have a non-uniform distal circumference that includes a distal surface configured to couple with (e.g., seat to, receive, engage with, etc.) the guide element distal tip 212. Thus, the guide element distal tip may be formed to engage with the notch or may include an element configured to otherwise engage with the notch. For example, the guide element distal tip 212 may include a proximal surface configured to contact or otherwise be positioned adjacent to a distal surface of the catheter at the guide element notch.

[0057]

[0093] In some examples, the guide element can have a flexible distal section configured to facilitate a change from a straight state to a curled state when advanced and retracted distally. For example, the guide element distal section can be configured to curl beyond the tissue-piercing tip after the formed guide element tip is advanced from the guide element notch. When an attempt is made to retract the guide element and needle, the flexible distal section of the guide element can be configured to straighten or straighten sufficiently so that the guide element distal tip can be retracted through the catheter distal end and into the catheter lumen. In some examples, the guide element distal section or distal end is sufficiently flexible so that retraction of the guide element can be accomplished without displacement or impact to the position of the catheter (e.g., within the blood vessel).

[0058]

[0094] In one embodiment, needle flat 251 transitions into needle bevel 256. The guide element distal end may be shaped to match the slope of needle bevel 256 and provide a smooth continuation of the needle bevel slope onto the outer surface of catheter 220.

[0059]

[0095] 11 is a cross-sectional, distal end view of the vascular access device of FIG. 10A showing the relationship of the catheter inner wall 115, the guide element 120, and the access needle outer wall 148. The guide element is positioned in space within the catheter lumen along the outer wall of the access needle and the inner wall of the catheter lumen and translates along it. An optional catheter design includes a groove 118 recessed into the catheter lumen inner wall that corresponds to a portion of the upper surface shape 124 or profile of the guide element. The catheter groove 118 helps hold the guide element 120 in place along the catheter and translate along the needle outer wall 148.

[0060]

[0096] Additionally or optionally, the guide element design of the upper surface contour 124 and lower surface contour 125 can correspond to one or both of the catheter lumen inner wall and the needle outer wall, or other alignment elements within the catheter lumen. Optionally, in other additional embodiments, the needle outer wall 148 may include a groove or concave portion for embodiments where the guide element 120 is shaped and configured to operate in an inverted configuration from that shown in this figure. See Figures 12 and 13 for additional details of alternative catheter / guide element / needle embodiments.

[0061]

[0097] FIG. 12 is a close-up view of an embodiment of an intravascular access device 200 showing the components that define the route of the guide element. As shown in FIG. 5B, the guide element 210 is provided through a lumen initially defined by the proximal guide tube 230 and the distal guide tube 235. The guide element 210 (e.g., the guide element elongate body) extends through the distal portion of the needle holder 240 and contacts the needle flat surface 251. The alignment of the lumen through the proximal guide tube 230, the distal guide tube 235, and the distal portion of the needle holder 240 is based on the surface of the needle that is contacted by the guide element 210. In this embodiment, the needle has a semicircular cross-sectional geometry, whereby a section of the needle circumference is substantially flat. The flat section of the outer surface of the needle is a plane in communication with the guide element. FIG. 12 shows that the guide element 210 further has a flat surface that is in contact with the needle flat surface 251.

[0062]

[0098] In one embodiment, the needle flat surface 251 and the guide element flat surface 211 are in contact with one another. Thus, the outer surface of the guide element 210 may have an arc that corresponds to the curvature of the outer surface of the needle 250. The guide element flat surface 211 may have a width that corresponds to the chord line that defines the needle flat surface 251, such that when they are in contact, their outer surfaces form a substantially continuous circumference.

[0063]

[0099] 13 is a perspective view of selected components associated with the route of the guide element 210. In particular, the needle holder 240 is shown transparent to allow the second guide tube 235 to be viewed within the needle holder 240. The proximal guide tube distal end 230 is obscured within the distal guide tube proximal end 235. The needle proximal end 252 held within the needle holder 240 is visible below the distal guide tube 235. The guide element 210 is shown transitioning from the distal guide tube distal end 235 through the angled needle holder lumen 241. The guide element 210 is shown adjacent the needle flat 251 as the needle 250 and guide element 210 move back and forth through the catheter 220. The route of the guide element 210 above and on top of the needle flat 251 is aligned with the orientation of the needle flat 251 such that the slope of the needle holder lumen 241 is positive and upward toward the collinear second and first guide tubes. The needle 250 appears generally parallel to the first and second guide tubes on the same plane of the needle holder lumen 241 and the guide element 210. FIG. 13 shows an example of a guide tube with concentric lumens that extend generally along a single axis. The guide element elongate body then transitions out of the distal guide tube 235 and finishes transitioning to the needle flat. In some examples, the transition of the guide element elongate body from the distal guide tube may be through the distal guide tube, through a distal portion of the needle holder, or angled through a space within the catheter hub, or a combination thereof.

[0064]

[0100] Figure 14 is an enlarged view of the central portion of the cross-sectional view of Figure 11. This view illustrates an exemplary location and shape of the concave portion 118 of the catheter lumen wall 115. This view also illustrates the guide element 120 in cross section, with the guide element upper surface 124 adjacent the concave portion 118 of the lumen wall 115 and the guide element lower surface 125 adjacent and conforming to the access needle outer wall 148. The access needle 140 and needle lumen 146 are also shown within the catheter lumen 116.

[0065]

[0101] FIG. 15 is a close-up view of an alternative configuration of the central portion of FIG. 11, but in a cross-sectional view similar to FIG. 14. One skilled in the art will appreciate that the guide element may have any of a variety of upper surface contours 124, lower surface contours 125, right side contours 127, and left side contours 126. Furthermore, variations in the cross-sectional profile or contours of the guide element 120 may enable the guide element to extend along and occupy various portions of the space between the inner catheter wall and the outer needle wall. Additionally or optionally, one or more guide element contours may be complementary to an inner wall recess, guide element track, or one or more guide element track features on, in, or within a portion of the inner catheter lumen wall or the outer needle wall. In one aspect, the guide element upper surface 124 may be contoured or shaped to at least partially conform to the inner catheter lumen wall. Additionally or optionally, the guide element lower surface 126 may be shaped to at least partially conform to the outer access needle wall 148. Similarly, one or more guide element embodiments may utilize variations in the right and left contours 126, 127 to be adapted to engage or be complementary to other features provided along the needle or catheter lumen to allow smooth translation of the guide elements along and beyond the access needle distal end 142. In some embodiments, the distance between the guide element left contour 126 and the guide element right contour 127 ranges between 0.10 mm and 0.36 mm. This distance is considered to be the width of the guide element. Additionally, in still other embodiments, the distance between the guide element upper surface contour 124 and the guide element lower surface contour 125 ranges between 0.127 mm and 0.203 mm. This distance is considered to be the thickness of the guide element. In some embodiments, the guide element has a length between 100 mm and 200 mm.

[0066]

[0102] 16A-16D are close-up views of a central portion of an alternative configuration of the cross-sectional view of the needle 250 of the intravascular access device 200 shown in FIG. 12. Detailing herein are examples of different embodiments regarding the location of the guide element 210 about the outer surface of the needle 250. The guide element 210 is above the needle in FIG. 16A and as shown in FIG. 1B and FIG. 12. FIG. 16B shows the guide element 210 positioned below the needle 250. FIGS. 16C and 16D respectively show the guide element 210 in contact with a needle flat 251 on either side of the needle 250. The needle flat 251 is in contact with a corresponding guide element flat 211, and when each of these flats are in contact with each other, a circumference is generally formed that includes the remaining outer surface of the needle and the remaining outer surface of the guide element. The location of the needle flat 251 on the circumference of the needle defines the location of the guide element 210 relative to the needle 250 and therefore defines the guide element route through the first guide tube 230, the second guide tube 235, the needle holder 240 and the catheter lumen 221.

[0067]

[0103] In one embodiment, the needle 250 has a cross-sectional geometry that is substantially a semicircle that is greater than a 180 degree arc, but that terminates in a flat surface. The needle flat surface 251 may be perpendicular to any possible radial extension outward from the center of the needle lumen 253. The tissue-piercing tip 254 provides a fixed reference point in describing the location of the needle flat surface 251. For example, the location of the tissue-piercing tip may be set in a 180° radial direction around the central axis of the needle. The radial location of the needle flat surface 251 may be described relative to the fixed location of the tissue-piercing tip 254. For example, in FIG. 16A where the guide element 210 is above the needle flat surface 251, the needle flat surface 251 may be perpendicular to the 360° radial direction. In this example, a line drawn from the tissue-piercing tip across the needle to the midpoint of the needle flat surface may be the diameter of the needle.

[0068]

[0104] In some examples, the location of the needle flat 251 is described relative to a clock position. When the needle flat 251 is clocked and resides longitudinally on the circumference of the needle 250, the clocked position may be described relative to the terminal end of the needle. For example, the tissue-piercing tip 245 may be a fixed reference at 6 o'clock, and when describing the location of the needle flat 254 on the circumference of the needle, the clocked position is described considering the tissue-piercing tip 254 as a fixed reference relative to the clocked location of the needle flat. For example, FIG. 16A shows an example of the needle flat 251 at the 12 o'clock position, FIG. 16B shows an example of the needle flat 251 at the 6 o'clock position, FIG. 16C shows an example of the needle flat 251 at the 3 o'clock position, and FIG. 16D shows an example of the needle flat 251 at the 9 o'clock position. The figures shown provide examples of positions of needle flat 251, however, needle flat 251 can be in any position in or between the given examples.

[0069]

[0105] In some examples, the needle flat surface 251 and the guide element flat surface are adjacent to each other. As seen in Figures 16A-16D, the adjacent flat surfaces result in a circular or substantially circular cross section. For example, the guide element 210 has an outer surface facing the guide element flat surface 211 with an arc corresponding to the arc of the outer surface of the needle. Thus, the space or gap between the outer surface of the needle guide element assembly and the inside of the catheter lumen is reduced or substantially eliminated, which can increase the chances of using a standard sized catheter lumen. Reducing or eliminating the gap between the needle guide element assembly and the inside of the catheter lumen improves insertion into a blood vessel by reducing distension or physical injury to tissue caused by a larger volume catheter. In some examples, reducing the gap or spacing between the needle guide element assemblies can improve the flow of blood through the needle lumen 253, thereby reducing the amount of blood flowing along the outside of the needle when the catheter is inserted into a blood vessel.

[0070]

[0106] In some instances, the location of the needle's flat surface can establish a route or path for the guide element elongate body. For example, if the flat surface is generally at the 12 o'clock position, the guide element elongate body can extend proximally along the top of the needle and then into a distal guide tube and through the inside of the handle. If the flat surface is at the 6 o'clock position, the guide element elongate body can extend proximally along the side of the needle and into a guide tube positioned along a path corresponding to the side of the needle's flat surface to define the route of the guide element elongate body within the handle.

[0071]

[0107] 17A and 17B are detailed images of the distal portion of needle 250. The needle has a tissue-piercing tip 254 at a distal point of needle bevel 256. The distal end of catheter lumen 221 is shown to have a bevel extending between the tissue-piercing tip 254. In one embodiment, two or more bevels may extend from the tissue-piercing tip angled away from the center of needle 250 to improve control and tissue penetration. The distal end of needle flat 251 is shown partially exposed and extending distally from the tip of guide element 212. As illustrated here, needle flat 251 may be lateral or generally perpendicular to needle bevel 256 and generally oriented perpendicular to the 3 o'clock or 90° radial direction.

[0072]

[0108] The geometry of the guide element's shaped distal end 212 provides a smooth transition from the outer surface of the needle 250 to the outer surface of the catheter 220. FIG. 10B provided an example of this, where the needle flat 251 was at the 12 o'clock position and the distal end of the guide element 210 provided a transition between the needle bevel 256 and the outer surface of the catheter lumen 221. FIGS. 17A and 17B show a properly aligned needle flat 251 and guide element distal end 212 in a 3 o'clock orientation. Here, the needle flat 251 does not extend to the tissue-piercing tip 254, but rather terminates generally at the circumferential outer surface of the needle proximal to the transition of the needle bevel 256. Additionally, the guide element distal end communicates with the guide element notch 226 at the catheter lumen distal end.

[0073]

[0109] 17A and 17B, the plane of the needle flat 251 will extend along the length of the needle. In one embodiment, the needle flat 251 may extend to the proximal end of the needle held in the needle holder 240. In other embodiments, the needle flat 251 may extend a length of the needle that is less than the entire length of the needle defined from the tissue penetrating tip 254 to the proximal end of the needle. For example, the needle flat 251 may have a length from the needle holder distal end 246 to the distal portion of the needle. The needle flat 251 may have a length defined by the proximal contact point of the guide element to the needle flat, yet extend sufficiently to the distal end of the needle to provide a smooth transition of the intravascular access device distal end assembly.

[0074]

[0110] 17A and 17B, the shaped distal tip 212 of the guide element has a geometry confirmed to mate with the guide element notch 226. For example, the guide element notch may have a recess in the catheter tip into which the guide element may be configured to seat or mate when the guide element is in a ready-to-use configuration (e.g., prior to distal advancement).

[0075]

[0111] 17C and 17D are further details of the embodiment regarding the alignment of the needle flat 251, the needle holder 240, the second guide tube 235 (e.g., distal guide tube), the first guide tube 230 (e.g., proximal guide tube), and the arm 204 of the proximally positioned slider 202 as in a ready-to-use configuration. The handle 201 has been removed from the figure to illustrate the components therein. The slope of the needle holder distal end 246 may be negative since the guidewire route continues from the needle flat at the 6 o'clock position (or alternatively 180° radial). The needle proximal end 252 is shown within the needle holder and is positioned above the second guide tube 235 within the needle holder 240. The route of the guide element 210 runs along the needle flat surface 251, then through the catheter 220 and needle holder lumen 241, and transitions along and into the distal guide tube 235 aligned near the lower portion of the handle.

[0076]

[0112] The slider 202 shown near the proximal end of the intravascular device has an arm 204 coupled to the proximal end of the proximal guide tube 230. The length and orientation of the arm 204 may depend on the alignment of the guide element 210 root and the proximal guide tube 230. For example, in FIG. 17C, when the needle flat 251 is at the 6 o'clock position, the arm 204 extends further from the rest of the slider to contact the proximal guide tube 230. The guide tube is below the needle 250 in the needle holder 240 and is therefore located lower in the handle relative to the slot 207. The guide element tip 217 is shown between the tissue penetrating tip 254 and the catheter tip 224. FIG. 17D is an enlarged view of FIG. 17C, showing the relationship and details of the guide element root with respect to the needle flat 251, the needle holder 240, and the orientation of the distal guide tube 235.

[0077]

[0113] In some examples, the proximal guide tube 230 is configured to slidably engage the distal guide tube 235 when the slider 202 is advanced. The guide element 210 may extend proximally through a lumen including the catheter assembly (e.g., from the catheter lumen), the needle holder 240, the distal guide tube 235, and the proximal guide tube 230. The proximal end of the guide element elongate body may be within the proximal guide tube 230 inside the handle. The proximal end or proximal section of the guide element may be coupled to the proximal guide tube 230 such that advancing, retracting the proximal guide tube 230, or a combination thereof, advances the guide element (e.g., accordingly, with the proximal guide tube). For example, the slider 202 can engage the proximal guide tube 230 and advance distally within the handle, thereby advancing the proximal guide tube 230 into the lumen of the distal guide tube 235, and in response, the guide element 210 advances with the proximal guide tube 230, such that the guide element distal tip is advanced out of the guide element notch of the catheter.

[0078]

[0114] According to any of the embodiments disclosed herein, the orientation of the slot 207 in the handle 201 will remain through the top of the handle 201, and therefore the slot 207 may be considered to be above all components contained within or substantially within the handle. In some examples, the orientation and alignment of any of the elements described herein may be described relative to the top location of the slot 207.

[0079]

[0115] 17D, the distal guide tube 235 is positioned lower within the handle, and the guide element 210 extends from the distal guide tube 235 to the flat surface of the needle. In some examples, as shown in FIG. 2C, the distal guide tube can include a length or segment that extends beyond the distal end of the needle holder 240 and / or handle, such that the guide element elongate body extends distally from the distal guide tube 235 along the plane of the flat surface of the needle.

[0080]

[0116] 18 is a perspective view of the distal end of the catheter and access needle of FIGS. 10A and 1A after the slider 50 has been moved from the proximal position shown in FIG. 1A to a distal position when the guide element 120 has been advanced distally along the outer wall 148 of the access needle to form a loop 128 distal to the tip 144 of the access needle 140. In this exemplary embodiment, the loop 128 is formed approximately 1 inch beyond the distal end 144 of the needle 140. This view also shows how the upper and lower profiles of the guide element 120 mate with the catheter guide element notch 115 and the needle outer wall 148. Thus, the guide element 120 can be advanced along the outer surface of the access needle to form the loop 128 beyond the distal end 144 of the needle 140. The deployed guide element 120 may form a partial, complete loop once, or may form two or more complete loops over the distal end of the needle. In terms of degrees of rotation about the distal end of the needle, the loop 128 may be greater than 90 degrees, greater than 180 degrees, greater than 270 degrees, or greater than 360 degrees, for one 360 ​​degree rotation or two or more 360 ​​degree rotations. As an example, the loop 128 of Figures 18 and 19 is greater than 270 degrees. Moreover, exemplary diameters of the loop 128 range from 1 mm to 3 mm.

[0081]

[0117] In some examples, loop 128 may be a distal section of the guide element that is configured to be flexible and to form a loop upon advancing guide element 120 distally beyond tissue-piercing tip 144. As described herein, when attempting to retract the guide element, loop 128 (e.g., the distal section of the guide element) is sufficiently flexible that it can be retracted into the catheter lumen and the transition can assume a sufficiently straight configuration without displacement or inadvertent impact to the position of the catheter within the blood vessel.

[0082]

[0118] FIG. 19A is an enlarged view of the guide element loop of FIG. 18. The loop 128 is formed in the distal portion of the guide element 120 as it is deployed beyond the distal-most end 144 of the access needle 140. This view further illustrates additional exemplary shapes for the guide element upper surface contour 124, lower surface contour 125, right side contour 127, and left side contour 126. The upper surface contour 124 and lower surface contour 125 of the guide element 120 conform to the space between the inner wall of the catheter lumen and the outer wall 148 of the needle 140. In FIGS. 19B and 19C, further details of an exemplary guide element engagement with the guide element notch of the catheter distal end are shown. As described herein, the guide element can have a formed distal tip 217 that includes an elongate body 233 extending distally from the formed distal tip 217. In Figure 19B, the formed distal tip 217 is attached to, molded with, or otherwise coupled to the elongate body 233 at 237. In some examples, the guide element formed distal tip 217 may be molded with, manufactured with, or otherwise integral to the guide element elongate body 233. Figure 19B further shows details of the corroborating geometry of the guide element distal tip 217. In this example, the guide element distal tip 217 includes a proximal engagement feature 234 configured to seat or couple to a guide element notch in a catheter tip.

[0083]

[0119] 19C, the guide element has been advanced distally from the guide element notch 226 such that the formed distal tip 217 of the guide element is curled to form an atraumatic tip (e.g., when within a blood vessel) distal to the tissue-piercing tip 254. The guide element flat surface 211 is shown inside the curl of the loop formed by the guide element distal section.

[0084]

[0120] 20 is a close-up view of the guide element distal end 212 deployed beyond the tissue-piercing tip 254 after the slider 202 has been advanced toward the distal end of the handle 201, as shown in FIG. 1B. The guide element flat 211 is visible above the needle bevel 256 after sliding longitudinally over the needle flat 251. During guide element advancement, the notch 226 at the catheter tip is no longer in contact with the guide element distal end. As seen here, the guide element 210 and needle flat 251 are oriented near the 12 o'clock position.

[0085]

[0121] 21 is a close-up perspective view of the needle distal end 246 including the guide element distal end 212 deployed beyond the tissue-piercing tip 254. This embodiment shows the 3 o'clock orientation of the needle flat 251 and guide element 210. In this orientation, the guide element distal end 212 extends beyond the tissue-piercing tip 254 on the 3 o'clock side as shown in FIGS. 17A and 17B. Although not shown, the guide element distal end curves to form a loop after it is deployed beyond the tissue-piercing tip 254.

[0086]

[0122] In some embodiments, the curvature of the guide element distal end 212 is formed when the guide element tip 217 curls toward the tissue-piercing tip 254. For example, as shown in FIG. 18 , the guide element 120 is oriented in the 12 o'clock position, with the tissue-piercing tip 144 inferior to the guide element 120. Thus, the guide element tip 123 curls downward toward the tissue-piercing tip 144. As another illustrative example, when the guide element 210 is oriented in the 3 o'clock position, the guide element tip curls laterally toward the tissue-piercing element. In general, the guide element curls toward the needle.

[0087]

[0123] The deployed guide element 210 can form a partial loop, one complete loop, or more than one complete loop over the distal end of the needle. Figure 22 shows an embodiment where the guide element flat surface 211 is an inner guide element loop. In terms of the angle of rotation around the distal end of the needle, the loop may be greater than 90 degrees, greater than 180 degrees, greater than 270 degrees, or greater than 360 degrees, either one complete rotation or more than one complete rotation. Example guide element tip 217 geometries are shown optimized for a smooth transition between the needle 250 and the catheter exterior surface.

[0088]

[0124] In some embodiments, the guide element 120 may be formed from PTFE, nylon, or another suitable polymer. Additionally or optionally, the guide element 120 may include additives to enhance visibility under ultrasound guidance. Exemplary additives include, but are not limited to, titanium dioxide or barium, by way of example. Additionally, it should be understood that a variety of materials may be used to form the guide element, such as a mixture of polymers and metals, or shape memory materials, including metal alloys or metal and polymer-based shape memory materials, in whole or in part, or Nitinol or Elgiloy, and the like. Additionally, the dimensions and geometries shown in the various guide element embodiments may vary along the length of the guide element. For example, the most distal portion of the guide element may have a geometry and dimensions that target column strength. The middle portion of the guide element 120 may be designed to fit the transition from the housing to the catheter lumen without buckling. Additionally, geometry transitions and variations are not only possible for the guide element portion within the guide catheter, but the inner lumen wall of the catheter may also be adapted to aid in the use of the various guide element embodiments. Thus, in yet another embodiment, the guide element distal tip design creates a uniform transition with the distal end of the tubular catheter body to maintain ease of catheter insertion. Additionally, the guide element 120 may have a variable thickness proximally relative to the catheter hub to aid in column strength. In some embodiments, the distal face of the slider will mate with the proximal face of the needle retainer located inside the housing.

[0089]

[0125] In some embodiments, the guide element 210 may be formed from PTFE, nylon, or another suitable polymer. Additionally or optionally, the guide element 210 may include additives to enhance visibility under ultrasound guidance. Exemplary additives include, but are not limited to, titanium oxide or barium, by way of example. Additionally, it should be understood that a variety of materials may be used to form the guide element, such as a mixture of polymers and metals, or shape memory materials, including metal alloys or metal and polymer-based shape memory materials, in whole or in part, or Nitinol or Elgiloy, and the like. Additionally, the dimensions and geometries shown in the various guide element embodiments may vary along the length of the guide element. For example, the most distal portion of the guide element may have a geometry and dimensions targeted to column strength. The middle portion of the guide element 210 may be designed to fit the transition from the housing to the catheter lumen without buckling. Additionally, geometry transitions and variations are not only possible for the guide element portion within the guide catheter, but the inner lumen wall of the catheter may also be adapted to aid in the use of the various guide element embodiments. Thus, in further embodiments, the guide element distal tip design creates a uniform transition with the distal end of the tubular catheter body to maintain ease of catheter insertion. Additionally, the guide element 210 may have a variable thickness proximally relative to the catheter hub to aid in column strength. In some embodiments, the distal face of the slider will mate with the proximal face of the needle retainer located inside the housing.

[0090]

[0126] In any of the embodiments described herein, the guide element may be made of a metallic material, a polymeric material, or a combination thereof. For example, the composition of the guide element material may relate to the properties and usefulness of the guide element's function. The size and geometry of the guide element may further be determined based on the optimal function of the guide element in an intravascular access device or the function of the guide element in the patient's vasculature. The cross-sectional geometry of the guide element may range from substantially circular or substantially elliptical to semicircular. For example, a guide element having a semicircular cross-sectional geometry may be semicircular. Another example of a semicircular cross-sectional geometry of the guide element may be larger than a semicircular, but smaller than a continuous complete circle or ellipse. In some embodiments, the shape and geometry of the guide element is based on the optimal moment of inertia of the guide element geometry. The outer surface of the guide element may have an arc based on the inner surface of the catheter lumen. The surface of the guide element most proximal to the outer surface of the needle may be considered the inner surface of the guide element. The inner surface of the guide element may be flat or substantially flat corresponding to the area of ​​the guide element that the outer needle surface contacts.

[0091]

[0127] In some embodiments, the blood control valve is positioned inside a tubular catheter proximal hub. Figures 23A-23C are close-up views of a blood control valve inside a tubular catheter proximal hub, according to some embodiments. Figure 23A has multiple segments 271 on a distal surface 272. The multiple segments can converge to the center of the distal face and are displaced as the catheter is advanced into the patient's vasculature. The valve body circumferential outer side 271 corresponds to the catheter proximal hub 222 circumferential inner side. A groove 274 around the circumference of the valve body 274 engages a corresponding element (e.g., a toroidal ridge) on the inner surface of the catheter proximal hub 222 to hold the valve in place until deployment. Figure 23B is a close-up perspective view of another homeostasis valve embodiment having a non-uniform outer surface. In particular, the distal portion of the valve body can have a series of longitudinal grooves or indentations around the outer surface. The grooves 271 can be configured to increase the volume inside the catheter proximal hub 222.

[0092]

[0128] In some examples, the blood control valve may include one or more features to accommodate one or more elements of the intravascular access device. For example, as shown in Figures 23A and 23B, the proximal end of the blood control valve body may include a recess configured to accommodate or receive the distal end of the needle holder, which may extend beyond the distal end of the handle. In some examples, the proximal end of the blood control valve may be continuous, as shown at 284 in Figure 23C and shown in Figure 2C. In this configuration, the needle holder may include a different distal configuration, a shortened length, or a combination thereof, in which case the needle holder is positioned some distance proximally from the blood control valve 283. For example, the needle holder does not contact the blood control valve. Figure 23C further shows an example of a distal end opening including a section 271 that is biased inwardly into the valve, thereby opening the valve to allow blood flow through the inner lumen of the valve. For example, in this configuration, the valve can be opened or actuated by a peripheral element, such as a male section of a Luer lock that is coupled to the catheter hub, urging the valve distally against a feature in the catheter hub, thereby opening section 271.

[0093]

[0129] In some examples, a blood control valve (e.g., 279, 281, 283) is positioned within the catheter hub and configured to prevent, reduce, inhibit, or otherwise control blood flow from inside the blood vessel through the catheter lumen to further peripheral elements (e.g., a male luer lock). Thus, the distal end of the blood control valve may be configured to contact or be contacted by a peripheral medical device, or may be coupled to advance the blood control valve to open the valve or initiate blood flow through the valve.

[0094]

[0130] According to some embodiments, when the intravascular access device is used, the tissue-piercing tip 254 enters the patient's vasculature and fluid from within the vasculature flows through the needle lumen and into the catheter proximal hub, signaling the location of the tissue-piercing tip 254 within the vasculature. The volume of fluid may increase within the catheter proximal hub, and the pressure therein may increase accordingly. If fluid pressure increases within the catheter proximal hub and needle lumen, deployment of the catheter may require additional force to advance the catheter lumen into the vasculature. The grooves in the valve body increase the volume of the catheter proximal hub and reduce the need for additional pressure to allow the catheter to be smoothly deployed within the patient's vasculature, thereby reducing the possibility of damage or injury associated with forcibly deploying the catheter against fluid pressure therein.

[0095]

[0131] 24A and 24B show examples of catheter hub configurations at the distal end of an intravascular access device. With reference to FIG. 24A, catheter hub 222 is shown separated from the intravascular access device. Details of catheter hub 222 are shown to include valve control feature 229 configured to contact section 271 of the blood control valve (e.g., 279, 281, 283) when the blood control valve is advanced distally within catheter hub 222. Blood control valve engagement feature 286 is visible and configured to engage the blood control valve, e.g., at 275, to hold the blood control valve in an open position when the blood control valve is fully advanced within catheter hub 222. In some examples, blood control valve engagement feature 286 may be configured to hold the blood control valve in a closed position, and distal advancement of the blood control valve may require distal displacement of the blood control valve from the coupling of blood control valve engagement feature 286 with corresponding engagement feature 275 of the blood control valve.

[0096]

[0132] As can be seen by the various views of the figures, aspects of the present invention provide improved methods, systems, and assemblies for performing venipuncture, and in particular for placing an intravascular catheter at a desired site within a patient's veins. While the methods, systems, and assemblies are particularly useful for placing peripheral venous catheters, such as by placement in a vein in the hand or arm, they may also be useful for placing central venous catheters by insertion into a central vein, such as the internal jugular vein in the neck or the subclavian vein in the chest. Additionally, aspects of the vascular access methods, systems, and assemblies may also be useful for placing catheters in central or other arteries.

[0097]

[0133] In Figure 24B, catheter hub 222 is aligned or coupled with the distal end of the handle and is shown as semi-transparent to reveal the exemplary configuration of elements therein. For example, blood control valve 281 is positioned within catheter hub 222 and proximally adjacent valve control feature 229. Guide elements can be seen transitioning through the handle and through blood control valve 281.

[0098]

[0134] Further details and examples of configurations within the catheter hub 222 at the distal end of the handle are shown in Figures 25A and 25B, where a distal guide tube 235 is shown routing a guide element elongate body 233 from the handle to the blood control valve 283, as previously shown in Figure 2C, where the guide element elongate body 233 extends within the catheter lumen along the needle flat.

[0099]

[0135] 26A and 26B illustrate an example engagement or coupling of a peripheral medical device with a catheter hub 222. For example, a male luer lock 300 having an engagement feature 305 may be configured to engage or contact a blood control valve 283 to advance the valve distally to the engagement feature 229, thereby opening the valve and allowing blood to flow therethrough. With reference to FIG. 26A, the male luer lock 300 is not yet in contact with the blood control valve 283 or with the catheter hub 222, but is aligned or registered with a proximal opening 310 of the catheter hub 222. The catheter lumen 221 is shown distally through the translucent catheter hub 222 to highlight an example pathway for blood flow from a blood vessel. In FIG. 26B, the valve is opened or transitioned from the closed state as shown by FIG. 26A, where the engagement feature 305 of the male luer lock 300 is shown engaging the proximal end of the blood control valve 283 and advancing the valve distally against the engagement feature 229 which opens the distal surface of the valve, completing a pathway or lumen for blood to flow from the catheter lumen 221, through the valve and to an associated peripheral medical device.

[0100]

[0136] In some examples, the catheter assembly shown in FIG. 27 can include a catheter lumen 320 having an inner wall and an outer wall. The distal tip of the catheter includes a guide element notch 325 configured to receive or couple with a guide element (e.g., a formed tip of the guide element). The catheter lumen 320 can extend proximally from the distal tip with the guide element notch 325 to a catheter hub 330, and the blood control valve 283 can be positioned and configured to selectively control (e.g., prevent or allow) the flow of blood from a blood vessel through the catheter lumen 320 and out the distal opening 340 when the catheter hub is coupled to a peripheral medical device. The blood control valve 283 can be configured to advance within the catheter hub when biased distally. For example, a male luer lock can be coupled to the distal end of the catheter hub 320 and configured to advance the blood control valve distally to abut an engagement feature 335 of the catheter hub 330. The engagement feature may be adjacent to a distal surface of the blood control valve and may be configured to cause the distal surface of the valve to open when the valve is urged distally within the hub.

[0101]

[0137] In use, the intravascular access device may be configured to access and position (e.g., insert) a catheter into a patient's blood vessel. A catheter assembly having a catheter lumen extending between a distal tip with a guide element notch and a catheter hub may be coupled to a distal end of the handle. A guide element with a formed distal tip may be configured to seat or be coupled to the guide element notch, and an elongate body of the guide element may extend along an outer surface of an access needle provided through the catheter lumen. In some examples, the entire guide element adjacent the access needle is positioned outwardly relative to the needle within the catheter lumen. A proximal end of the needle may be coupled to a needle holder coupled to an engagement element configured to proximally retract the needle, needle holder, and guide element proximally into the handle when an activation button is depressed. The proximal and distal guide tubes include lumens through which the guide element elongate body extends proximally into the handle, and a sliding device may be coupled to the proximal guide tube and configured to advance the guide element distally. When the tissue-penetrating tip of the needle is inserted into the blood vessel, a flashback may be observed. For example, a flashback may be observed within the catheter lumen, catheter assembly, or the like to indicate proper position within the blood vessel. The sliding device may be advanced distally, thereby advancing the proximal guide tube and the guide element distal tip from within the guide element notch. The guide element distal tip may be advanced past the tissue-penetrating tip, where the distal section of the guide element may form an atraumatic tip (e.g., a loop). The catheter may then be advanced into the blood vessel along the guide element. Once the catheter is positioned within the blood vessel, an actuation button may be depressed, causing the actuation element to urge (e.g., force) the needle holder proximally within the handle, thereby retracting the needle and guide element. In some instances, the distal guide tube is appropriately biased proximally such that the distal guide tube slides proximally over the proximal guide tube.

[0102]

[0138] In some examples, actuation of the actuation element may be configured to simultaneously retract the needle and guide element when attempting to retract the needle and guide element. In some examples, the needle and guide element may be selectively retracted such that when the actuation element is engaged, the needle may be retracted and the needle holder is forced to the proximal end of the handle. The guide element may then be selectively retracted thereafter. In some examples, the needle may first retract when the actuation element pushes the needle holder proximally within the handle, and then the guide element may be automatically retracted by the needle holder or guide tube being retracted. For example, when the actuation button is depressed and the actuation element urges the needle holder proximally, the needle may retract with the needle holder, which may cause the distal guide tube, the proximal guide tube, or a combination thereof to retract proximally within the handle, thereby causing the guide element distal tip to retract proximally. In some examples, the guide element may straighten out when retracted. For example, the distal section of the guide element may be sufficiently flexible so that it can transition from a loop (e.g., when advanced distally into the blood vessel) to a straight configuration at the distal end of the catheter lumen so as to avoid inadvertent displacement of the catheter once it is placed or positioned within the blood vessel.

[0103]

[0139] The catheter hub may be removed from the handle and blood flow may be restricted by the blood control valve in the catheter hub until a peripheral medical device or tubing is coupled to the catheter hub and the blood control valve is advanced distally within the catheter hub to activate or open the valve and initiate blood flow through the catheter assembly.

[0104]

[0140] More generally, an intravascular catheter assembly according to the principles of the present invention includes a tubular catheter body, an access needle, a guide element, and a slider for deploying the guide element. The tubular catheter body has a distal end, a proximal end, at least one lumen therebetween, and a guide element notch formed in the distal end. The access needle has a tissue penetrating distal tip and a lumen usually therethrough. In a first embodiment, the guide element is disposed in a space or lumen between the outer wall of the access needle and the inner wall of the catheter lumen. In a second embodiment, the guide element is disposed outside and parallel to the access needle, riding along an axial groove, recess, or one or more guide structures or guide elements formed in the inner wall of the catheter lumen. In all embodiments, the guide element (a) has a distal tip configured to conform to the shape and contour of the catheter distal tip in a manner that forms a smooth transition (see FIG. 10A ), thereby maintaining the functionality of the needle-catheter combination to provide access, and (b) extends distally of the catheter along the needle, and when distal to the needle, forms a partial or complete loop to facilitate advancement of the catheter through the vasculature.

[0105]

[0141] In one embodiment, the slide of the intravascular vascular access assembly is slidably mounted on a support rail that houses a guide element. The proximal end of the guide element is attached to the slide. Thus, the guide element can be advanced distally by sliding the slide forward or distally along a slot (FIG. 1) provided in the housing. This motion moves the distal end of the guide element over the outer surface of the access needle to position the distal tip of the guide element beyond the distal end of the catheter (FIG. 18). Once in this configuration, the access needle can be fully or partially retracted or left in place without being retracted, and the catheter and distally protruding guide element can be advanced side by side to position the distal end of the catheter body at the desired site in the vein or other vasculature. By advancing the catheter and protruding guide element side by side, the guide element acts as a "fixed" guide element tip, further simplifying the catheter placement protocol. Additionally, the protruding loops on the distal portion of the guide element help prevent or substantially inhibit the distal tip of the catheter from piercing or kinking the inner wall of the blood vessel.

[0106]

[0142] As shown in various views of Figures 2A, 3, 4, 8, and 9, in an additional embodiment, an intravascular access device includes a housing having a needle holder at its distal end attached to the proximal end of an access needle. An access needle 140 is fixedly fastened to the needle holder 130, and a proximal end of a catheter is releasably fastened to the distal end of the housing. Thus, a slider 150 can be used to advance a guide element over the distal end of the catheter and access needle, and the housing, access needle, and guide element can be disengaged and removed from the catheter after the catheter is in position at a desired site in the vasculature.

[0107]

[0143] The coupling between the slider 150 and the guide element 120 may be accomplished in any manner that allows the slider to be advanced or retracted to equally advance or retract the guide element through the space between the catheter lumen and the outer wall of the access needle. Advantageously, since the guide element is positioned on or outside of and along the outer wall of the access needle, the slider may be directly coupled to the proximal end of the guide element with minimal interference from the access needle.

[0108]

[0144] In some embodiments, the slider is coupled to a proximal end of a first guide tube having a proximal end in which the guide element is retained, and the slider can advance the first guide tube into the second guide tube, thereby effecting simultaneous advancement of the guide elements through the intravascular access device.

[0109]

[0145] In another aspect of the invention, the needles described herein are selectively manufactured with a specific orientation of the needle flat on the outer surface of the needle. Considerations for the selection of the intravascular access devices described herein may take into account the patient's demographics and the condition of the patient's subject vasculature. For example, depending on the intravascular access point, blood vessels may have non-linear paths, which makes it advantageous to select an intravascular access device with a needle flat and guide element orientation other than the 12 o'clock position to optimize the chances of safe and successful deployment of the guide element and catheter into the patient's vasculature. Another example may include defining the patient's anatomy or anatomical structure that facilitates the selection of a needle flat and guide element orientation that allows the least obstructed path for the deployment of the guide element into the vasculature. Given the common orientation of needles with tissue-penetrating elements, insertion generally proceeds with the tissue-penetrating tip closest to the outside of the patient. Some embodiments of the invention described herein achieve optimal tissue-penetrating tip orientation with selectable guide element positioning that is not limited to a specific location around the needle outer surface.

[0110]

[0146] In yet another aspect of the invention, a method for introducing an intravascular catheter to a desired site within a patient's blood vessel includes passing a distal tip of an access needle carrying the catheter through a vein. A guide element resides within a guide element notch at the distal tip of the catheter. As a result, introducing the most distal end of the catheter into the vessel also positions the distal end of the guide element into the vessel. Thus, the needle can be held stationary when blood reflux is detected and the needle / catheter combination is advanced such that the distal end of the catheter is intravascular. With the needle position held stationary, the slider is advanced from the proximal position shown in Figures 1A and 2A to a distal position where the slider resides in a distal portion of a slot along the top of the housing. Proximal to distal movement of the slider advances the guide element from a position in the guide notch of the catheter distal tip (FIG. 10A) to a deployed state having a curved portion, complete loop or partial loop, distal to the piercing tip of the needle, as best seen in FIGS. 18 and 19A. It should be appreciated that the guide element may be pre-shaped to form a loop 128 at a desired or selected distance from the needle distal end 144. In one embodiment, the loop 128 is formed to a minimum distance that is approximately 1 inch or 25.4 mm. Other specific spacings between the needle distal tip and the loop may be provided based on the application, clinical needs, and anatomical considerations of the intended lumen.

[0111]

[0147] After the guide element has been advanced, the access needle may optionally be retracted proximally, leaving the guide element in place to aid in positioning the catheter. Optionally, once the catheter is properly positioned within the vessel, the access needle and guide element are fully retracted from the catheter, leaving the catheter in place for the desired medical protocol. In one embodiment, a spring-loaded retraction system or activation element 108 is activated by depressing the activation button 106. When the activation button 106 is depressed or otherwise moved to release the needle holder 130, the activation spring 108 automatically drives the needle holder 130, needle 140, slider 150, and guide element 120 proximally to retract the access needle 140 and guide element 120 from the patient and at least partially or completely into the housing 101. The catheter hub 110 is then detached from the distal end 103 of the handle or housing 101, leaving the catheter hub 110 in place for the desired medical protocol as previously described. The used housing 101 may then be disposed of using appropriate means.

[0112]

[0148] A spool to accommodate excess length of guide element may provide for an increase in the length of the guide element. The spool may be coupled to the handle or may be separately in communication with the handle such that a sufficient portion of the excess guide element may be available for advancement into the patient's vasculature after the tissue-penetrating tip is successfully inserted. For example, the tissue-penetrating tip may be inserted at an anatomical location away from the desired target deployment location of the catheter. In such an instance, the guide element may require a sufficient length to advance through a wide range of sections of the patient's vasculature to the desired catheter deployment location. When the slider is pushed near the proximal end of the handle to engage the guide element, the guide element may be repeatedly advanced by the slider. The slider is then continually pushed and advanced toward the distal end of the handle until it reaches the distal-most portion of the slot. The slider may be released and slid back into the proximal end of the slot and pushed and advanced distally. This process may be repeated until a sufficient amount of the guidewire is deployed. In some embodiments, the handle may be removed proximally while the guidewire is held partially inserted within the patient's vasculature, and an additional catheter or length of catheter is slid over the guide element and further into the vasculature to reach the desired catheter deployment site.

[0113]

[0149] A needle holder retention mechanism may be positioned within the body of the handle and may assist in retaining the needle holder after it has been retracted toward the proximal end of the handle. The needle holder retention mechanism may engage the proximal end of the needle holder, or a corresponding element thereon, to retain the needle holder toward the proximal end of the handle, thereby preventing vibration of the actuation spring and needle holder assembly.

[0114]

[0150] Additional aspects of the structure and operation of catheter placement device 100, including a housing or handle 101 having a mechanism for advancing a catheter-carrying guiding structure or element, where the handle is adapted to automatically retract both the access needle and the guiding 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.

[0115]

[0151] Further details of representative intravascular catheter insertion devices and methods are described in U.S. Patent Nos. 5,704,914 and 5,800,395, as well as U.S. Patent Publications US2010 / 0094310, US2010 / 0210934, and US2012 / 0197200, the entire disclosures of each of which are hereby incorporated by reference in their entirety.

[0116]

[0152] 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 is understood that various alternatives to the embodiments of the present invention described herein may be employed in carrying out the present invention. The appended claims define the scope of the present invention, and therefore it is intended to cover methods and structures that fall within the scope of these claims and their equivalents.

[0117]

[0153] In this specification, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly on the other feature or element, and there may be intervening features and / or elements 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 will also be understood that the feature or element may be directly coupled, attached, or coupled to the other feature or element, and there may 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 also apply to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0118]

[0154] The terminology used herein is merely for the purpose of describing particular embodiments and is not intended to limit the invention. For example, 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 "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0119]

[0155] Spatially related terms such as "below," "lower," "below," "above," and the like may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures for ease of description. It will be understood that the spatially related 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 flipped, an element described as being "below" or "directly below" another element or feature would be oriented "above" the other element or feature. Thus, the exemplary term "below" may encompass both an above and below orientation. The device may be oriented in other ways (rotated 90 degrees or in other orientations) and the spatially related 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 illustrative purposes only.

[0120]

[0156] 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.

[0121]

[0157] Unless the context requires otherwise, throughout this specification and the claims that follow, the word "comprise," as well as variations such as "comprises" and "comprising," mean that various components may be employed together in methods and articles (e.g., compositions and apparatuses that include devices 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.

[0122]

[0158] 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 the 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 is 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. Any numerical value given herein should also be understood to include approximately that value, or approximately that value, unless the context clearly indicates otherwise. For example, if the value "10" is disclosed, then "approximately 10" is also disclosed. Any numerical ranges stated 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 also 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, when a value "X" is disclosed, "less than or equal to" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is also understood that throughout this application, data is provided in a number of different formats, and this data represents endpoints and starting points, as well as ranges for any combination of the data points. For example, when a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only between 10 and 15, 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 are considered to be disclosed. It is also understood that each unit amount between two specific unit amounts is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0123]

[0159] Although 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 by 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 altogether. Optional features of the various apparatus and system embodiments may be included in some embodiments and not included in other embodiments. Thus, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims. The examples and illustrations contained herein indicate specific embodiments in which the subject matter may be practiced, for purposes of illustration and not limitation. As mentioned, other embodiments may be utilized or derived therefrom, and thus structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein by the term "invention," either individually or collectively, for mere convenience and without any intention of willfully limiting the scope of the present application to any single invention or inventive concept where more than one is actually disclosed. Thus, although specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiment 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 of skill in the art upon consideration of the above description.

Claims

1. A handle having a proximal end and a distal end, wherein the slots on the surface of the handle have a distal end and a proximal end, The operating button on the handle is connected to the needle holder, A tubular catheter body having a distal end, a guide element notch within the distal end, a proximal hub, and a lumen extending between the proximal end and the distal end, wherein the proximal hub is connected to the distal end of the handle, A blood control valve in the proximal hub, configured to be selectively advanced within the proximal hub, An access needle provided in the lumen of the tubular catheter body, having a tissue-penetrating distal end that extends distally beyond the distal end of the tubular catheter body and a proximal end connected to the needle holding portion, A guide element having a proximal end and a distal end, The guide element is positioned within the lumen of the catheter body and adjacent to the outer wall of the access needle. The distal end portion of the guide element is shaped to match the shape of the notch portion of the guide element of the catheter. After the distal portion of the guide element is advanced along the outer wall of the access needle from the lumen of the tubular catheter body to a position distal to the distal tip of the access needle that penetrates the tissue, the access needle and the guide element can be retracted together from the tubular catheter body. Guidance elements and, A sliding portion coupled to the proximal end of the guide element, wherein as the sliding portion advances distally, the distal tip end portion of the guide element advances distally from its position within the notch of the guide element along the outer wall of the access needle. Equipped with, Intravascular catheter assembly.

2. When the sliding portion is in its most distal position, the distal portion of the guide element curves beyond the distal tip of the access needle that penetrates the tissue. The intravascular catheter assembly according to claim 1.

3. When the sliding portion is in its most distal position, the distal portion of the guide element curves from a position above the access needle, past the tissue-penetrating distal tip of the access needle, to a position below the access needle. The intravascular catheter assembly according to claim 1.

4. The angle of curvature formed by the distal portion of the guide element with respect to the distal tip of the access needle that penetrates the tissue is less than 360 degrees, or The angle of curvature formed by the distal portion of the guide element with respect to the distal tip of the access needle that penetrates the tissue is greater than 270 degrees, or The angle of curvature formed by the distal portion of the guide element with respect to the distal tip of the access needle that penetrates the tissue is less than 270 degrees, or The angle of curvature formed by the distal portion of the guide element with respect to the distal tip of the access needle that penetrates the tissue is greater than 180 degrees. The intravascular catheter assembly according to claim 3.

5. The access needle further comprises a housing attached to its proximal end, The sliding portion is provided on the housing, The housing has an axial slot, The proximal end of the guide element is connected to the sliding portion that enables movement along the axial slot. The intravascular catheter assembly according to claim 1.

6. The tubular catheter body has a proximal hub equipped with a blood control valve, The access needle extends slidably through the blood control valve, The intravascular catheter assembly according to claim 1.

7. The sliding portion has a distal surface that faces the proximal surface of the needle holder when the sliding portion is fully advanced distally to extend the guide element. The intravascular catheter assembly according to claim 1.

8. A first configuration in which the sliding portion is in its nearest position, wherein the distal end of the guide element is located within the notch of the guide element, and the tissue-penetrating distal tip of the needle is distal to the most distal end of the tubular catheter body, A second configuration in which the sliding portion is in its most distal position, wherein the most distal end of the guide element extends beyond the guide notch and curves beyond the distal tip of the needle that penetrates the tissue, A third configuration in which the sliding portion is located proximal to the furthest distal position, and the needle and the guide element are at least partially retracted toward the housing. Furthermore, The intravascular catheter assembly according to claim 1.

9. In the first configuration described above, The distal tip of the access needle extends beyond the distal end of the tubular catheter body by a distance ranging from 0.1 mm to 20 mm. The proximal end of the sliding portion is retracted from the proximal end of the tubular catheter body by a distance ranging from 10 mm to 100 mm. The intravascular catheter assembly according to claim 8.

10. In the second configuration described above, the length of the guide element extending beyond the guide notch of the tubular catheter body is 5 mm to 100 mm. The intravascular catheter assembly according to claim 8.

11. The access needle includes a flat surface positioned axially along the length of the outer surface of the access needle, The intravascular catheter assembly according to claim 1.

12. The elongated guide element body extends proximal within the lumen of the catheter body, adjacent to the axially flat surface along the outer surface of the access needle. The intravascular catheter assembly according to claim 1.

13. The guide element is provided so as to be slidable within the lumen of the catheter body along the flat surface of the access needle. The intravascular catheter assembly according to claim 1.

14. The distal portion of the guide element has a length longer than its width and a width greater than its thickness. The assembly according to any one of claims 1 to 13.

15. The guide element is made entirely or partially of a polymer material, PTFE, nylon, nitinol, or a metal including Elgiloy. The assembly according to any one of claims 1 to 13.

Images