Intravascular catheter with integrated guide structure

Abstract

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

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 328,732, filed on April 7, 2022, entitled “INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE,” which is incorporated herein by reference in its entirety. Incorporated 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 received no government support. field

[0004] The present invention generally relates to methods and systems for performing vascular access. More specifically, the present invention provides a catheter and needle assembly having an integrated introducing element or structure for percutaneously inserting a catheter into the arterial or venous vasculature of a patient. background

[0005] One common type of vascular access is called venipuncture. Venipuncture generally refers to the process of gaining access to a vein for any of a variety of purposes, including IV infusions, treatments, blood sampling, etc. For example, in hospitals, venipuncture is often used to place small intravenous catheters for delivery of intravenous fluids, medication delivery, blood sampling, etc.

[0006] While venipuncture and other forms of vascular access may be a simple matter in a relatively healthy patient, such access is often required in patients who are unhealthy and may have small, tortuous, collapsed, fragile, and / or difficult to locate arteries and / or veins. In such patients, venipuncture and other forms of vascular access can be very challenging, particularly for inexperienced phlebotomists, paramedics, nurses, and other health care practitioners.

[0007] In addition to the difficulty in establishing access, many vascular catheter placement systems may result in accidental punctures and / or accidental needle contamination during or after placement of an intravascular catheter. In addition, some conventional catheter placement devices employ relatively complex deployment handle movements, which results in increased cost and complexity. Furthermore, conventional handle placement and movement may obscure the presence and status of the needle and guide structure or guide element components of the tool, thereby making the use of the insertion tool less intuitive.

[0008] For these reasons, it is desirable to provide improved methods, systems and tools for deploying intravascular catheters using needles and guide structures. It is particularly desirable to provide simplified deployment systems and assemblies with fewer components, and even more desirable to provide components that are clearly visible to the user and configured to be used and manipulated in a direct, intuitive manner. At least some of these goals will be met by the following various embodiments. Overview of the Disclosure

[0009] In general, in one embodiment, an intravascular catheter assembly includes: a handle having a proximal end and a distal end, a groove in a surface of the handle having a distal end and a proximal end; an actuation button on the handle, the actuation button coupled to a needle holder; a tubular catheter body having a distal end, a guide element cutout in the distal end, a proximal hub, and a lumen extending between the proximal and distal ends, the proximal hub of the catheter body coupled to the distal end of the handle; a blood control valve within the proximal hub, the blood control valve being configured to selectively advance within the proximal hub; an access needle disposed in the lumen of the tubular catheter body, the access needle having a tissue penetrating distal tip extending distally beyond the distal end of the tubular catheter body and a guide element having a proximal end and a distal end, the guide element being positioned within the lumen of the catheter body and adjacent to the outer wall of the access needle, the distal portion of the guide element being shaped to fit within the guide element cutout of the catheter, wherein the access needle and guide element can be withdrawn together from the tubular catheter body after the distal-most portion of the guide element has been advanced from the tubular catheter body along the outer wall of the access needle to a position distal to the tissue-penetrating distal end of the access needle; and a slider coupled to the proximal end of the guide element such that distal advancement of the slider advances the distal terminal end portion of the guide element distally along the outer wall of the access needle from a position within the guide element cutout.

[0010] This embodiment and other embodiments may include one or more of the following features. When the slider is in the most distal position, the distal portion of the guide element can be bent beyond the tissue penetration distal end of the entry needle. When the slider is in the most distal position, the distal portion of the guide element can be bent from a position above the entry needle, beyond the tissue penetration distal end of the entry needle, to a position below the entry needle. The angle of the bend formed by the distal portion of the guide element relative to the tissue penetration distal end of the entry needle can be less than 360 degrees. The angle of the bend formed by the distal portion of the guide element relative to the tissue penetration distal end of the entry needle can be greater than 270 degrees. The angle of the bend formed by the distal portion of the guide element relative to the tissue penetration distal end of the entry needle can be less than 270 degrees. The angle of the bend formed by the distal portion of the guide element relative to the tissue penetration distal end of the entry needle can be greater than 180 degrees. The slider can be disposed on the proximal region of the entry needle. The intravascular catheter assembly also includes a housing attached to the proximal end of the entry needle, wherein the slider is disposed on the housing. The access needle can be fixedly fixed to the distal end of the housing, and the tubular catheter body can be removably fixed to the distal end of the housing, wherein the slider advances the guide element beyond the distal end of the catheter, and wherein after the catheter is in place, the housing, the access needle and the guide element can be disassembled and removed from the catheter. The proximal region of the catheter can be arranged in the housing, and wherein the proximal end of the catheter and the proximal end of the access needle can be configured to engage by the slider to advance the catheter and the needle in cooperation with the guide element relative to the housing after the guide element has extended distally beyond the distal end of the catheter. The access needle can have an inner cavity, and the guide element can be arranged outside the inner cavity of the access needle. The housing can have an axial groove, and the proximal end of the guide element can be connected to the slider to allow movement along the axial groove. The axial groove can be closed on the distal region and the proximal region of the access needle. The connector between the guide element and the slider can be arranged in the groove, wherein the stroke length is defined by the closed end of the groove. The guide element can be slidably arranged in a guide structure in the inner cavity of the catheter body. The guide structure can keep the guide element in a position along the uppermost portion of the access needle. The guide structure can be a pair of features extending from the inner wall of the catheter body and protruding into the inner cavity of the catheter body. When the guide structure is positioned between the extended pair of features, the guide structure can be positioned along the top side of the outer wall of the access needle. The guide structure can have a distal-most portion adjacent to the guide element cutout and a proximal portion greater than 1 cm from the guide element cutout. The guide structure can have a distal-most portion adjacent to the guide element cutout and have a proximal portion in which the guide structure is continuous along the inner wall of the inner cavity of the catheter body from the proximal end to the distal end. The tubular catheter body can have a proximal hub with a blood control valve, wherein the access needle can be slidably extended through the blood control valve. The slider can have a distal side that cooperates with the proximal side of the needle holder when the slider is fully advanced distally to extend the guide element.When the distal side is engaged with the proximal side, the slider can be removably locked to the proximal end of the needle holder. The intravascular catheter can also include a first configuration, a second configuration, and a third configuration. In the first configuration when the slider is in the most proximal position, the distal end of the guide element can be located in the guide element cutout, and the tissue penetration distal end of the needle is distal to the most distal end of the tubular catheter body; in the second configuration when the slider is in the most distal position, the most distal end of the guide element can exceed the guide cutout and can be bent at the tissue penetration distal end of the needle. In the third configuration, the slider can be in a position proximal to the most distal position, and the needle and the guide element can be at least partially retracted into the housing. In the first configuration, the distal end of the entry needle can extend beyond the distal end of the tubular catheter body by a distance in the range of 0.1 mm to 20 mm, and the proximal end of the slider can be retracted from the proximal end of the tubular catheter body by a distance in the range of 10 mm to 100 mm. In the second configuration, the length of the guide element extending beyond the guide cutout of the tubular catheter body can be 5 mm to 100 mm. The guide element can have a length greater than the width and a width greater than the thickness. The guide element can be made of a polymeric material, PTFE, nylon in whole or in part. The guide element can be made of a metal, including Nitinol, including Elgiloy or similar materials. The guide element can also include an upper surface adapted to the curvature of the inner wall of the inner cavity of the catheter body and a lower surface adapted to the curvature of the outer wall of the entry needle. The catheter can be configured to be used as a catheter component of an infusion device, a catheter component in a blood collection device, a catheter component in a safety wing blood collection device, or a catheter component in an intravenous catheter.

[0011] In general, in one embodiment, a method of accessing a patient's blood vessel includes: 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 distal tip of a guide element from a first position within a guide notch in a distal portion of a catheter hub to a second position in which a portion of an elongated body of the guide element 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 to a third position in which the distal tip of the guide element is positioned beyond the tissue-penetrating distal tip of the access needle and along the patient's blood vessel; advancing the distal portion of the catheter hub in the blood vessel along the guide structure; and The needle and guide structure are automatically retracted into the intravascular catheter assembly.

[0012] This embodiment and other embodiments may include one or more of the following features. The method for entering a blood vessel may also include stopping the step of advancing the tissue penetration distal end of the entry needle of the intravascular catheter assembly when blood reflux is observed in the intravascular catheter assembly. The method for entering a blood vessel may also include stopping the step of advancing the tissue penetration distal end of the entry needle when the most distal part of the catheter hub of the intravascular catheter assembly is in the patient's blood vessel. The method for entering a blood vessel may also include stopping the step of advancing the tissue penetration distal end of the entry needle when the most distal part of the guide structure of the intravascular catheter assembly is in the patient's blood vessel. After executing the step of advancing the guide structure beyond the tissue penetration distal end of the entry needle, the distal portion of the guide element may be bent at the tissue penetration distal end exceeding the entry needle. After executing the step of advancing the guide structure beyond the tissue penetration distal end of the entry needle, the distal portion of the guide element may be bent from the position above the entry needle, exceeding the tissue penetration distal end of the entry needle, and reaching the position below the entry needle. The angle of the bend formed by the distal portion of the guide element relative to the tissue penetration distal end of the entry needle can be less than 360 degrees. The bend formed by the distal portion of the guide element may be at an angle greater than 270 degrees relative to the tissue penetration distal tip of the access needle. The bend formed by the distal portion of the guide element may be at an angle less than 270 degrees relative to the tissue penetration distal tip of the access needle. The bend formed by the distal portion of the guide element may be at an angle greater than 180 degrees relative to the tissue penetration distal tip of the access needle. Advancing the guide element from the first position may include advancing the proximal guide tube into a lumen of a distal guide tube in communication with the needle holder, wherein the proximal end of the guide element may be coupled to the proximal guide tube.

[0013] 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 releasably engaged to the distal end of the handle; an access needle extending proximally through the catheter lumen from within a needle holder, the access needle having at least one flat surface extending longitudinally along the periphery of the access needle and a tissue penetrating tip extending distally beyond the catheter lumen; at least one guide tube within the handle, the guide tube having a lumen extending therethrough and a distal end communicating with a lumen extending through a distal section of 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 element disposed within the catheter lumen, wherein the longitudinal flat surface of the guide element contacts at least one flat panel 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.

[0014] This embodiment 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 the outer surface of the access needle. The guide element may be arranged to pass 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. At least one catheter may be aligned parallel to the plane of the at least one flat surface of the access needle. When the slider is in the most distal position, the distal portion of the guide element may be bent beyond the tissue penetrating distal end of the access needle. When the slider is in the most distal position, the distal portion of the guide element may be bent beyond the tissue penetrating distal end 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 also include an access needle lumen, wherein the plane of the at least one flat surface of the access needle may be perpendicular to the radius of the access needle lumen. The intravascular access device may also include a blood control valve disposed in the proximal catheter hub, the blood control valve having a body having a distal end and a proximal end, and the lumen in the body may extend from the proximal end to the distal end. The distal end of the blood control valve may include a surface extending across the inner cavity, which may include a plurality of grooves. The proximal end of the blood control valve body may include a peripheral surface on the proximal end, which is configured to engage with a portion of the Luer connector to advance the blood control valve distally in the catheter hub, thereby displacing the plurality of grooves. The proximal periphery may be continuous on a single plane. The proximal periphery may include a recess into the exterior of the valve body. The recess may be configured to accommodate the distal end of a distal guide tube, a section of a guide element body, or the distal end of a needle holder. In use, when the needle holder is in the most distal position, the needle holder may be proximal to the proximal end of the blood control valve without contacting the blood control valve. The tissue penetration end may define the distal terminal end of the inclined surface of the entry needle. At least one flat surface may be offset to a certain degree relative to the position of the tissue penetration end on the periphery of the entry needle. The intravascular access device may further include an actuation button coupled to the needle holder, and an actuation element that applies a force on the needle holder toward the proximal end of the handle, wherein when the actuation button is pressed, the actuation element may displace the needle holder and the access needle toward the proximal end of the handle. The plane of at least one flat surface of the access needle may be perpendicular to any radius extending outward from the center of the access needle. The catheter may be configured to be used as a catheter component of an infusion device, a catheter component in a blood collection device, a catheter component in a safety wing blood collection device, or a catheter component in an intravenous catheter. The intravenous access device may further include a spool of a guide element connected to the proximal end of the intravascular device, wherein a certain length of the guide element may be contained within the spool. The guide element may be made of a metallic material, a polymeric material, or a combination thereof in whole or in part.

[0015] In general, in one embodiment, an intravascular catheter assembly includes: a handle having a proximal end and a distal end, a groove in a surface of the handle having the distal end and the proximal end; a spring-loaded actuation button coupled to a needle holder on the handle; a tubular catheter body having a distal end, a guide element cutout in the distal end, a proximal end, and a lumen extending between the proximal and distal ends, the proximal end of the catheter body coupled to the distal end of the handle; an access needle disposed in the lumen of the tubular catheter body, the access needle having a multi-faceted tissue penetrating distal tip extending distally beyond the tubular catheter body and coupled to the needle holder in the handle a proximal end; a guide element including an elongated body extending distally from a guide element end adapted to be operably coupled to a guide element cutout, the guide element being positioned within the lumen of the catheter body and adjacent an outer surface of an access needle, wherein the access needle can be withdrawn from the tubular catheter body after the guide element end has been advanced from the lumen of the tubular catheter body along an outer wall of the access needle to a position distal to a tissue-penetrating distal end of the access needle; and a slider coupled to the proximal end of the guide element such that distal advancement of the slider advances the guide element end distally from a position within the guide element cutout.

[0016] This embodiment and other embodiments may include one or more of the following features. When the slider is in the most distal position, the distal portion of the guide element may be bent at the tissue penetration distal end beyond the entry needle. When the slider is in the most distal position, the distal portion of the guide element may be bent from a position above the entry needle, beyond the tissue penetration distal end of the entry needle, to a position below the entry needle. The proximal side of the guide element end may be configured to contact the guide element incision. The entry needle may include a flat surface axially positioned along the length of the entry needle outer surface. The guide element elongated body may extend proximally along the adjacent axial flat surface outside the entry needle within the catheter body lumen. The guide element end may include a geometric shape configured to complement the guide element incision. The guide element end may be attached to the distal end of the guide element elongated body. The intravascular catheter assembly may also include a housing attached to the proximal end of the entry needle, wherein the slider may be disposed on the housing. The entry needle may be securely fixed to the distal end of the housing, and the tubular catheter body may be removably fixed to the distal end of the housing. The slide can advance the guide element beyond the distal end of the catheter, and wherein after the catheter is in place, the housing, the entry needle and the guide element can be disassembled and removed from the catheter. The intravascular catheter assembly can also include a blood control valve, which is positioned in a hub at the proximal end of the tubular catheter body, and the blood control valve can include a valve body and an inner cavity, wherein the surface covering the distal end of the inner cavity has a plurality of slits. The intravascular catheter assembly can also include a proximal guide tube axially aligned with the distal guide tube, wherein the guide element elongated body can extend through the proximal guide tube, the distal guide tube and the catheter body inner cavity. The proximal end of the guide element can be connected to the inside of the proximal guide tube. The proximal guide tube can be axially aligned with the distal guide tube connected to the needle holder. The guide element can be slidably arranged in the catheter body inner cavity along the flat surface of the entry needle. The tubular catheter body can have a proximal hub, and the proximal hub has a blood control valve, wherein the entry needle can slidably extend through the blood control valve. The slider may have a distal side that cooperates with the proximal side of the needle holder when the slider is fully advanced distally to extend the guide element. The intravascular catheter assembly may also include a first configuration, a second configuration, and a third configuration. A first configuration when the slider is in a proximal position, wherein the distal end of the guide element is located in the guide element cutout, and the tissue penetration distal end of the needle is distal to the distal end of the tubular catheter body; a second configuration when the slider is in the distal position, wherein the distal end of the guide element can exceed the guide cutout and bend at a position beyond the tissue penetration distal end of the needle. A third configuration when the slider is in a proximal position of the distal position and the needle can be at least partially retracted into the housing. The catheter can be configured to be used as a catheter component of an infusion device, a catheter component in a blood collection device, a catheter component in a safety wing blood collection device, or a catheter component in an intravenous catheter.

[0017] 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 cutout in a distal end of the catheter lumen; an access needle disposed in the catheter lumen and having a flat surface positioned axially along the length of the access needle; a guide element disposed between the flat surface of the needle and the interior of the catheter lumen; a slide coupled to a proximal segment of the guide element such that distal advancement of the slide advances a molded distal tip of the guide element from a first position at the guide element cutout to a second position in which the distal segment of the guide element bends beyond the tissue penetrating distal tip of the access needle, wherein the slide has a distal side that mates with a proximal side of the needle holder when the slide is fully advanced distally to extend the guide element.

[0018] This and other embodiments may include one or more of the following features. The slider may be removably locked to the proximal hub when the distal face of the slider mates with the proximal face of the needle holder. The guide may have an elongated body extending distally from the molded tip, the elongated body including a flat surface that communicates with the flat surface of the access needle. The guide element may be a polymer.

[0019] In general, in one embodiment, a method for accessing a patient's blood vessel includes: advancing the tissue penetrating end of an access needle of an intravascular catheter assembly into the patient's blood vessel; advancing a contoured distal end of a guide element from a first position within a guide element cutout in a distal portion of a catheter lumen to a second position, wherein the distal portion of the guide structure forms a uniform transition to the exterior of the catheter lumen, and wherein a portion of the guide structure is advanced beyond the tissue penetrating end along a flat surface of the access needle, the flat surface being axially positioned along an outer wall of the access needle; advancing a distal portion of a catheter hub along the guide element in the blood vessel; and withdrawing the needle into the intravascular catheter assembly.

[0020] This embodiment and other embodiments may include one or more of the following features. The method for entering a blood vessel may also include stopping the step of advancing the tissue penetration distal end of the entry needle of the intravascular catheter assembly when blood reflux is observed in the intravascular catheter assembly. The method for entering a blood vessel may also include advancing a blood control valve positioned in the catheter hub. The molded distal end of the guide element and the distal-most portion of the guide element may form an atraumatic end after advancing beyond the tissue penetration end. Advancing the molded distal end of the guide element may include advancing a slider distally in a groove of a handle, wherein the slider may be coupled to a proximal guide tube, wherein the guide element may extend through the lumen of the proximal guide tube.

[0021] 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 distal end of the hub to a distal tip, the tubular body having an outer wall and an inner wall; an inner lumen within the hub and the tubular body defined by the inner wall of the tubular body, the inner lumen having a guide element cutout in the distal end; a guide element having a molded distal tip configured to couple with the guide element cutout; and an access needle having a longitudinal flat surface along the length of the exterior of the needle, wherein the guide element includes a flat surface adjacent to the flat surface of the needle.

[0022] This embodiment and other embodiments may include one or more of the following features. The intravascular catheter may also include: a needle holder, the needle holder is within the handle, and the needle holder is connected to the proximal end of the access needle. The intravascular catheter may also include a proximal guide tube slidably connected to the distal guide tube, wherein the elongated body of the guide element can extend proximally from the molded distal end through the inner cavity formed by the distal guide tube and the proximal guide tube. The intravascular catheter may also include a sliding member operably connected to the proximal guide tube, wherein the sliding member can be configured to advance the molded distal end by advancing the proximal guide tube.

[0023] 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 catheter lumen extending distally from a catheter hub, the catheter hub being releasably engaged to the distal end of the handle; an access needle extending distally from a needle holder through the catheter lumen, the access needle having at least one flat surface extending axially along the access needle body and a tissue penetrating tip; a guide element configured to extend through such a lumen: the lumen includes the catheter lumen and a guide tube positioned proximal to the needle holder within the handle, the guide element including a molded distal tip configured to engage a guide element cutout at the distal end of the catheter lumen; and a sliding member extending through the slot, the sliding member communicating with a proximal segment of the guide element, wherein the sliding member is configured to advance the guide element distally along at least one flat surface of the access needle.

[0024] This embodiment and other embodiments may include one or more of the following features. The guide element may include an elongated body extending proximally from the shaped distal end. The guide element may include an elongated body extending proximally from the shaped distal end through such an inner cavity, the inner cavity including the catheter lumen and the 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 distal end of the guide element may be configured to bend when advancing beyond the tissue penetration end. The at least one flat surface of the access needle may include a lateral edge proximal to the tissue penetration end. The intravascular access device may also include a blood control valve positioned within the catheter hub. The blood control valve may include a distal section having one or more channels, the one or more channels 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 to a certain extent along the exterior of the access needle relative to the position of the tissue penetration end. The intravascular access device may also include an actuation button coupled to the needle holder.

[0025] In general, in one embodiment, an intravascular catheter assembly includes: a hub having a proximal end and a distal end; a tubular body extending from the distal end of the hub 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 as the blood control valve is advanced distally within the hub.

[0026] This and other embodiments may include one or more of the following features. The blood control valve may include a notch in the proximal periphery configured to accommodate a needle holder. The guide element cutout at the distal end of the tubular body may be configured to couple with the guide element distal end. The catheter hub may include an actuation element configured to open a distal surface of the blood control valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In particular, the novel features of the present invention are set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and the accompanying drawings, which set forth illustrative embodiments utilizing the principles of the present invention, wherein: Figure 1A is a perspective view of an embodiment of an intravascular access device having a catheter, an introducing element, and a needle assembly.

[0028] Figure 1B is a perspective view of an embodiment of an intravascular access device having a catheter, an introducing element, and a needle assembly.

[0029] Figure 2A yes Figure 1ACross-sectional view of an intravascular access device of FIG. 1 , showing a catheter, an introducing element and a needle assembly, an actuation button, a support track, and a slider in a proximal position.

[0030] Figure 2B yes Figure 1B A cross-sectional view of an intravascular access device showing a catheter, an introducing element and a needle assembly, an actuation button, a support track, a first guide tube, and a second guide tube.

[0031] Figure 2C 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.

[0032] Figure 3 yes Figure 1A A top perspective view of the distal housing and catheter hub of FIG. 1 , showing details of the needle, introducing element and needle holder within the interior of the catheter hub.

[0033] Figure 4 yes Figure 3 An enlarged top perspective view of the distal housing and catheter hub of FIG. 1 , showing details of the needle, introducing element, needle holder and needle holder slot within the interior of the catheter hub.

[0034] Figure 5A yes Figure 3 A perspective view of a longitudinal section of an intravascular access device showing additional details of the needle holder and activation button and the guide element in relation to the support track and outer wall of the access needle.

[0035] Figure 5B yes Figure 1B A perspective view of a longitudinal section of an intravascular access device showing additional details of a needle holder with an actuation button and an introducing element passing through the needle holder associated with a flat surface of the needle.

[0036] Figure 6 yes Figure 1A Intravascular catheters Figure 4 A top view of a portion of the proximal side of the view showing additional details of the distal end of the needle holder relative to the guide element and support track within the longitudinal slot of the needle holder.

[0037] Figure 7 is similar to Figure 6 FIG. 1 is an upper view of a portion of an interior view of FIG. 1 showing the proximal end of the needle holder relative to the slide, the guide element and the support track.

[0038] Figure 8 yes Figure 1A and Figure 3 An upper perspective view of the distal portion of an intravascular access device of FIG. 1 , showing the interior of a catheter hub including a needle holder, needle, introducing element, and support track.

[0039] Fig. 9 is Figure 8 A perspective, close-up view of the components as seen in FIG.

[0040] Fig. 10A yes Figure 1A An enlarged view of the distal end of an intravascular device showing the relationship of the distal end of an access needle to the distal tip of a catheter having an introducer element cutout with the distal end of the introducer element positioned within the introducer element cutout.

[0041] Fig. 10B yes Figure 1B An enlarged view of the distal end of an intravascular device showing the relationship of the distal end of the access needle relative to the distal tip of a catheter having an introducing element engagement feature and the transition from a flat surface to an angled surface of the needle.

[0042] Fig.11 yes Fig. 10A A cross-sectional view of the distal end of a vascular access device showing the relationship of the catheter inner wall, the introducing element, and the outer wall of the access needle.

[0043] Fig.12 yes Fig. 10B A cross-sectional view of the distal end of a vascular access device showing the alignment of the guide element path through the guide tube and on top of the needle flat surface.

[0044] Fig.13 is a perspective view of the orientation of the needle holder, first guide tube, second guide tube, and guide element path.

[0045] Fig.14 yes Fig.11 An enlarged view of the central portion of the view of the catheter, showing the recessed portion of the inner cavity wall of the catheter, the upper surface of the guide element adjacent to the recessed portion of the inner cavity wall, and the lower surface of the guide element adjacent to and suitable for entering the outer wall of the needle.

[0046] Fig.15 is similar to Fig.14 of Fig.11 An enlarged view of the central portion of the view of FIG. 1 provides additional explanation of the correlation of the various contours of the access needle outer wall, the catheter lumen wall, and the introducing element positioned between these structures of the intravascular device.

[0047] Figures 16A-16D yes Figure 1B An enlarged view of a central portion of an intravascular device providing additional illustration of the orientation and placement of the introducing element relative to the needle.

[0048] Fig.17A and Fig. 17Bis an enlarged view of the distal tip of the catheter, the distal tip of the needle, and the distal tip of the introducing element oriented in a lateral position relative to the needle.

[0049] Fig. 17C is a perspective view of a configuration for aligning a flat surface of a needle, a needle holder, and guide tubes that form a guide element path at a clocked location other than the top of the needle surface.

[0050] Fig.17D yes Fig. 17C , showing the guidewire transition through the distal end of the needle holder and into the second guide tube.

[0051] Fig.18 Is the slider has been Figure 1A After the proximal position shown in FIG. 1 is moved to a distal position where the guide element is advanced distally along the outer wall of the access needle to form a loop at a position distal to the tip of the access needle, Fig. 10A and Figure 1A Perspective view of the distal end of the catheter and the access needle.

[0052] FIG. 19A to FIG. 19C is an enlarged view of the introducing element and distal end of the catheter lumen.

[0053] Fig. 20 is an enlarged perspective view of the flat surface of the introducing element extending through the distal end of the catheter tip and beyond the tissue penetrating end of the needle Fig.21 is a perspective view of a guide element in an extended configuration oriented transversely to the needle.

[0054] Fig. 22 is an enlarged view of the guide element ring.

[0055] FIG. 23A to FIG. 23C is an enlarged view of a body balancing valve according to an embodiment of the present invention.

[0056] Fig.24A and Fig. 24B is an enlarged view of the distal end of a catheter hub and intravascular access device handle as described herein.

[0057] Fig.25A and Fig.25B is an enlarged view of the distal end of a catheter hub, distal guide tube, and intravascular access device handle as described herein.

[0058] Fig.26A and Fig.26B is an enlarged view of the coupling of a peripheral medical device to a catheter hub as described herein.

[0059] Fig. 27 is an enlarged view of a catheter assembly as described herein. Detailed Description

[0060] Figure 1A 1 is a perspective view of an 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 having an integrated guide structure or guide element is ready for positioning the catheter within a blood vessel. The catheter hub 110 can be coupled to the distal end 103 of the handle 101 and an access needle 140 extending from a needle holder 130 through a catheter lumen 116 extending distally from the catheter hub 110. In this view, the catheter hub 110 is transparent so that the position of the needle holder 130 and the guide element 120 can be seen.

[0061] The handle or housing 101 has a proximal end 102 and a distal end 103. A slot 105 extends along the length, providing a path for a slider 150 to engage with the guide element 120 and advance the guide element tip distally from within the guide element cutout in the distal end of the catheter lumen 116. The slider 150 includes a grip 152, and the slider 150 is shown in a proximal position used when the needle 140 is positioned in the catheter 110 and is 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 and a lumen 116 along the length. The catheter proximal end 112 is adapted and configured to engage with the handle distal end 103. The catheter proximal end 112 is also configured to engage with peripheral elements such as conventional medical tube connectors after being inserted and the handle 101 is removed. For example, the catheter proximal end 112 may include features that engage with a Luer lock, a fluid coupling, or other suitable medical connector or accessory.

[0062] Figure 1B 2 is a perspective view of an example of an intravascular access device 200, in which certain elements are shown as translucent to allow internal components to be visible. In this view, the intravascular access device has a catheter assembly 219 and a guide element 210, the catheter assembly 219 is in communication with the distal end 207 of the handle 201, and the guide element 210 passes through the needle holder 240. The actuation element 206 can be seen through this example of the translucent handle 201. The actuation element can be configured to selectively displace the needle holder 240 when the actuation button 205 is engaged. For example, the actuation element 206 can be a spring coiled around the needle holder 240 and positioned between the inner wall of the distal portion of the handle and the needle holder collar 243, as shown herein. The slider 202 extends through the slot 207 in the top portion of the handle 201. The slider 202 includes a grip 203 accessible on the outer surface of the handle 201 and an arm 204 extending through the slot 207 of the handle to the proximal end of the first guide tube 230.

[0063] Figure 1BThe illustrated intravascular access device is shown in a ready-to-use configuration. Slider 202 is positioned near the proximal end of handle 201, and arm 204 is in communication with guide element 210 near the proximal end of the handle. Because the slider can be in operative communication with the proximal end or proximal segment of guide element 210, slider 202 can advance guide element 210 distally. Guide element 210 can have an elongated body 233 that extends proximally from the distal end into the handle, with additional details such as in Figure 2B Described in.

[0064] In some examples, the catheter assembly 219 can be deployed after the distal end of the access needle 250 and the guide element 210 assists in placing the catheter in the blood vessel. When the catheter 220 is deployed, the actuation button 205 shown near the distal end of the handle 201 can be pressed to release the actuation element 206, thereby displacing 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 withdraw (e.g., displace proximally) the needle holder 240, the access needle 250, and the guide element proximally. In any example described herein, the withdrawal 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 pressed and the actuation element 206 displaces the needle holder 240 proximally, the access needle is withdrawn into the handle 201, and the distal end of the guide element can also be withdrawn proximally into the handle 201. In some examples, the needle 250 is completely withdrawn into the handle 201. In some examples, guide element 210 is fully withdrawn into handle 201 .

[0065] Still Figure 1B , a blood control valve 279 can be positioned within the catheter hub 222 and can be configured to control the flow of a fluid (e.g., blood) through the catheter assembly. The blood control valve 279 can prevent the flow of blood from the blood vessel through the catheter assembly 219 until the valve is opened at the distal end. For example, after establishing access to the blood vessel, the catheter assembly can be deployed or separated from the handle, and the blood control valve 279 can prevent blood from flowing out of the catheter assembly until a peripheral element (e.g., a male portion of a Luer lock) has been attached to the catheter hub and the blood control valve 279 has been advanced distally within the catheter hub 222.

[0066] FIG. 2A to FIG. 2C is a cross-sectional view of an example of an intravascular access device. Figure 2A1 is a cross-sectional view of an intravascular access device showing the catheter hub 110, the guide element 120 and the needle holder 130, the actuation button 106, the support track 109, and the slider 150 in the proximal position. This is the "ready to use" configuration. The guide element proximal end 122 is attached to the sliding tab 154. The guide element 120 extends along the support track 109 beyond the needle holder distal end 132, into the catheter lumen 116 and extends along the catheter lumen 116. The guide 120 is located between the needle outer wall 148 and the catheter lumen inner wall 115. As a result, as the slider 150 advances along the slot 105, the guide element advances along the support track 109, along and beyond the distal end of the catheter and needle to form an atraumatic ring or partial ring or bend to cover the sharp distal end 144 of the needle. (See Fig.14 and Fig.15 ).

[0067] The catheter lumen 116 is also visible in this view. The needle 140 has a sharp distal end 144 for penetrating 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 toward the proximal end 102 of the housing. The needle holder 130 moves within the handle 101 long enough so that the sharp distal end 144 of the needle 140 is completely within the housing 101. The needle holder 130 also includes a support track slot 138 along its length that is sized to receive the support track 109.

[0068] An actuation element 108 is included, but is not shown in this view in order to see the details of the needle holder 130. The actuation element 108 can be a spring, such as a coil spring or a wave spring or other suitable compression element. When the actuation button 106 is pressed, the actuation button latch 107 disengages from the needle holder distal groove 134, which then allows the actuation element 108 to expand and push the needle holder 130 together with the needle 140 toward the handle proximal end 102.

[0069] Figure 2B yes Figure 1B2 is a cross-sectional view of an intravascular access device 200 shown. The guide element 210 includes a distal end (not shown) and an elongated body, and the elongated body extends proximally through the catheter and the catheter hub 222, then continues to extend through the distal guide tube 235, and then through the concentric lumen of the proximal guide tube 230. The proximal guide tube 230 and the distal guide tube 235 are generally positioned within the handle and provide additional support for the guide element extending therethrough. For example, the guide element elongated body can extend through the lumen formed by the proximal guide tube 235 and the distal guide tube 230, so that when the slider advances the guide element distally, the guide tube can be configured to prevent buckling or otherwise support to increase the column strength of the guide element elongated body extending therethrough. In some examples, the guide element 210 is further guided through the catheter proximal hub 222 and the catheter lumen 221 after passing through the catheter lumen 221 within the distal portion of the needle holder 240. The catheter lumen 221 has an inclination to facilitate 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 to contact the outer surface of the needle 250. The guide element 210 passes through the catheter continuously between the outer surface of the needle 250 and the inner surface of the catheter lumen 221.

[0070] The distal end of the proximal guide tube 230 can be partially and slidably inserted into the distal guide tube 235, thereby providing a concentric lumen that defines the path 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 interlock with each other (see Fig.13 ). For example, a channel around the inner circumference of the second guide tube can correspond to an annular ridge around the outer surface of the first guide tube, so that when the ridge fully enters the channel, the first guide tube and the second guide tube can be restrained in position relative to each other. The interlocking configuration of the first guide tube and the second guide tube can provide retention of the needle holder 240 after the actuator button 205 is pressed, thereby allowing the actuator element 206 to push the needle holder 240 toward the proximal end of the handle 201. For example, when the needle holder is biased toward the proximal end of the handle, the second guide tube will slide on 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 on the first guide tube to engage the interlocking element positioned near the proximal end of the first guide tube.

[0071] In some examples, the introducer element elongate body can be coupled to the proximal guide tube 235. For example, the introducer element elongate body can be attached, crimped, or otherwise connected to the proximal end of the proximal guide tube 235 such that the slider can engage the proximal guide tube 235 to advance the guide tube-catheter combination, thereby providing corresponding distal advancement of the introducer element distal tip from the introducer element cutout of the catheter.

[0072] Figure 2C is another example of an intravascular device and shows the distal end of a handle and details of elements located distal to or extending through the handle. The catheter hub has been removed from this view to highlight the blood control valve 279 and the path of the guide element elongated body 233 through the distal guide tube 235 as the guide element elongated body 233 transitions from the handle to the flat surface of the entry needle 250. The distal guide tube 235 is shown as having a tapered distal section. For example, the distal section of the distal guide tube 235 is angled toward the needle to guide the guide element elongated body 233 through the interior of the blood control valve 279. It is also possible to Figure 2C 279 and the distal end of needle holder 240. In some examples, needle holder 240 may have a length or configuration that supports the space between the distal end of needle holder 240 and blood control valve 279. Thus, the needle holder may not contact blood control valve 279 during use.

[0073] In some examples, a distal guide tube (e.g., Figure 2C Element 235 in (235) may include a lumen extending through the catheter from the proximal end to the distal end. The guide tube may have a tubular lumen with a linear axis. In some examples, the catheter lumen may have a lumen with a substantially linear axis. In some examples, the guide tube may have a lumen having a segment defined by the linear axis of the lumen, wherein the lumen continues distally to another segment having a different axis (e.g., inclined). The configuration of the guide tube may be based on the guidance of the elongated body of the guide element from the interior of the handle through the transition to the flat surface of the entry needle within the catheter lumen. In some examples, the guide tube (e.g., a distal guide tube) may be in communication with or adjacent to the needle holder.

[0074] In any example, the distal guide tube can be adjacent to the needle holder. For example, the distal guide tube can be coupled to the needle holder, integrated in the needle holder, attached to the needle holder, attached to the needle holder, located within the needle holder or along the needle holder, or a combination thereof.

[0075] Figure 3 yes Figure 1A 1 and 10. A top perspective view of the distal housing 103 and catheter hub 110 of the present invention is shown, 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 as exiting the distal end of the support rail and entering the space between the outer wall of the needle and the inner wall of the catheter lumen. In some examples, the guide element elongated body can be guided through one or more catheters, as described herein. In some examples, the catheter elongated body can be guided through a passage in the needle holder.

[0076] Figure 4 yes Figure 310 and 110, showing details of the needle 140, guide element 120, needle holder 130, and needle holder support track groove 138 within the interior of 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 the needle holder 130 and is secured to the needle holder 130.

[0077] Figure 5A yes Figure 3 1 is a perspective view of a longitudinal section of an intravascular access device 100 showing additional details of the needle holder 130 relative to the actuation button 106 and the guide element 120 relative to the support track 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 details of the guide element relative to other components can also be appreciated. The guide element 120 extends along the support track 109, the distal end of the slot 138 into the gap between the needle outer wall and the catheter lumen wall 115. In addition, the needle 140 is shown relative to the catheter lumen proximal end 116 and the needle holder lumen 146. The needle proximal end 142 terminates in the needle holder 130 into the blood flashback chamber 135. All or part of the needle holder 130 or handle 101 can be transparent to allow visual detection of fluid or blood flashback or bleeding flashback once the needle distal end 144 has entered the target vessel.

[0078] Figure 5A Also shown is the relationship of the activation latch 107 to the associated needle holder recess 134. When in the loaded or cocked configuration, the latch 107 will engage the recess 134 to provide a restraining force against the activation element 108. Depressing the activation button 106 will disengage the latch 107 from the needle holder recess 134, allowing the spring force or stored energy of the activation element 108 to push the needle holder 130 toward the handle proximal end 102. This view also shows that the support track 109 terminates within the housing distal end 103.

[0079] Figure 5B yes Figure 1B 2 is a perspective view of a longitudinal section of an intravascular access device 200 illustrating the path of the guide element 210 obliquely from the second guide tube 235, through the distal portion of the needle holder 240 to the outer surface of the needle 250. Details of the proximal segment of the needle 250 retained within the needle holder 240 are visible and are generally parallel to the first and second guide tubes.

[0080] Here, the actuator button 205 is associated with an associated needle holder recess 245. When in the loaded or cocked configuration, the latch 227 will engage the recess 245 to provide a restraining force against the activation element 205. Depressing the activation button 205 will disengage the latch 227 from the needle holder recess 207, allowing the spring force or stored energy of the activation element 206 to push the needle holder 240 toward the proximal end of the handle.

[0081] Figure 5B Also illustrated are the relationships of the components that define the path of the introducing element through the interior of the intravascular access device 200. In particular, the path of the introducing element is defined by the concentric and co-linear lumens of the first and second guide tubes 230, 235. The first and second guide tubes are parallel and co-planar with the surface of the needle that is contacted by the introducing element 210. The outer surface of the distal portion of the needle holder is shown to have an inclination that corresponds to the inclination of the lumen passing therethrough. Figure 5B The cross-sectional view of highlights an embodiment in which each component defining the path of the guide element is aligned with each other, whereby the guide element 210 has a deviation from other linear paths 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) can be positioned adjacent to the distal end 246 of the needle holder. Figure 5B As shown, blood control valve 281 can be within proximal catheter hub 222 and can be configured to minimize, prevent, or reduce backflow of fluid (e.g., blood) from proximal catheter hub 222. In some examples, introducing element 220 and needle 250 can pass through the distal end of blood control valve 281.

[0082] Figure 6 yes Figure 1A Intravascular catheters Figure 4 1, showing additional details of the distal end 132 of the needle holder 130 relative to the guide element 120 and the support track 109 within the longitudinal slot 138 of the needle holder. The guide element 120 can be seen along the upper surface of the support track 109, where the guide element 120 transitions from the support track distal end, beyond the needle holder distal end 132, along the needle outer wall 148 and into the catheter lumen 116. The arrangement of the support track 109 to the needle holder support track slot 138 allows the support track to function like a monorail of the needle holder during retraction (i.e., when the stored energy of the actuation element 108 is released). The support track 109 also supports the guide element 120 during advancement of the slide 150.

[0083] Figure 7 is similar to Figure 61, showing the proximal end of the needle holder 132 relative to the slider 150, the guide element 120 and the support track 109. The slide tab 154 of the slider 150 extends through the slot 105. The slide tab includes a key plate 156 having a hole 158. The hole 158 is sized, shaped and positioned to accommodate the features of the guide element 120 and the support track 109. Advantageously, the arrangement of the slider 150 and the support track 109 allows the support track 109 to allow the slider 150 to freely translate backward / forward. The guide element 120 has a proximal end 122 that is connected to the slider using the slide tab 154 or other suitable structure. The support track 109 extends through the slide tab and is connected to the housing proximal end 102. In addition, this view also shows the relationship of the needle holder proximal end 132, which is sized and positioned so as to engage with the slide tab 154 during retraction. The rearward movement of the needle holder will cause the needle holder proximal end 132 to engage with and move the sliding tab 154. Since the guide element 120 terminates in the slider 150, the guide element 120 will also move proximally within the housing. The result of this movement (i.e., the proximal movement of the needle holder 130) is the simultaneous withdrawal of the needle and the guide element into the interior of the handle or housing.

[0084] Figure 8 is an intravascular access device 100 (e.g., Figure 1A and Figure 3 109, showing the interior of the catheter hub 110 including the needle holder 130, the needle 140, the guide element 120, and the support track 109. This is another view of the placement of the guide element 120 along the support track 109, beyond the needle holder and into the catheter lumen. This view also shows the support track groove 138 along the length of the needle holder 130 relative to the needle holder proximal end 131 and the distal groove 134. Fig. 9 is Figure 8 1. A perspective proximal side view of the needle holder 130 and other components as seen in FIG. The blood chamber 135 is visible within the needle holder proximal end 131. To show the interior, the cover for the chamber 135 that would normally be present is removed.

[0085] Fig. 10A is an intravascular device (e.g. Figure 1A100 ), showing the relationship of the distal end 144 of the access needle 140 to the distal end 114 of the catheter, the distal end 114 of the catheter having a guide element cutout 115, and the guide element distal end 123 of the guide element 120 is located within the guide element cutout 115. The guide element distal end 123 can be molded / manufactured to mimic the geometry of the catheter end 114. The guide element (e.g., the guide element elongated body) can extend over the needle within the catheter lumen along a flat surface extending along the needle body. For example, the guide element 120 can be positioned between the inner wall or inner diameter of the catheter lumen and the outer wall or outer diameter of the needle. In some examples, the guide element positioned within the needle lumen does not require additional space or expanded catheter specifications because the needle flat surface provides a path or route for the guide element elongated body. In some examples, the guide element 120 can be composed of a polymer material. The introducing element 120 may also be pre-formed or shape-set, or have a shape memory form, so that once extended beyond the needle distal end 144, it forms a complete loop, a partial loop, or multiple loops (see Fig.18 and Figure 19).

[0086] In some examples, the catheter distal end includes an introducer element cutout 115 configured to couple with an introducer element distal tip 123. Introducing element cutout 115 can have a geometry corresponding to introducer element distal tip 123 to promote a smooth or continuous outer surface from the exterior of the needle to the exterior of the catheter. Fig. 10A The view of FIG. 1 is an example of how the shaped distal end of the introducer element conforms to the introducer element cutout at the catheter tip. This is also a view of the uniform transition between the catheter and introducer element distal end contours, allowing the catheter tip to needle transition and the outer periphery of the catheter tip to remain smooth.

[0087] exist Fig. 10B , an example of a guide element distal end 212 (e.g., a molded distal tip) is shown as being molded / manufactured to mimic the geometry of a guide element cutout at a catheter tip 224 at the distal end of the catheter. The distal end of the catheter is shown as having a guide element engagement feature 226 (e.g., a guide element cutout) having a shape configured to receive a portion of the guide element distal end 212. The geometry of the catheter tip 224 is shown as being angled or having an inclination toward the outer surface of the needle 250. When in communication with the guide element cutout 226, the guide element distal end 212 has an inclination that corresponds to the inclination of the catheter tip 224, resulting in a smooth transition from the outer surface of the needle 250 to the outer surface of the catheter 220. Also shown in FIG. Fig. 10B25 and 26. The transition of needle flat surface 251 and needle angled surface 256 terminating at tissue penetrating tip 254 is illustrated in FIG. In one embodiment and in a ready-to-use configuration, tissue penetrating tip 254, introducing element distal end 212, and catheter tip 224 may be referred to as a distal assembly.

[0088] In use, the geometry of the distal assembly provides a smooth transition through one or more tissue layers led by the tissue penetrating tip 254. As the distal assembly is advanced through the one or more tissue layers, the tissue penetrating tip 254 can enter the patient's vasculature without causing unnecessary damage or restriction within the tissue or vasculature.

[0089] The guide element distal end 212 (e.g., the end of the guide element molding) can be molded to the distal end of the guide element elongated body 223. In some examples, the guide element distal end 212 can be coupled to the guide element elongated body 223. For example, the guide element distal end 212 can be attached or otherwise attached to the distal end of the guide element elongated body 223. The geometry of the guide element distal end 212 can be configured to complement or otherwise engage the guide element cutout 226. The distal end of the catheter can have a non-uniform distal periphery having a distal surface configured to couple (e.g., seat, receive, engage, etc.) with the guide element distal end 212. Therefore, the guide element distal end can form or otherwise include an element configured to engage the cutout. For example, the guide element distal end 212 can include a proximal surface configured to contact the distal surface of the catheter at the guide element cutout or otherwise be positioned adjacent to the distal surface of the catheter.

[0090] In some examples, the guide element can include a flexible distal segment that is configured to facilitate a change from a linear state to a curled state as the guide element is advanced and retracted distally. For example, the guide element distal segment can be configured to curl beyond the tissue penetration end after the formed guide element end has advanced from the guide element incision. When the guide element and needle are to be retracted, the flexible distal segment of the guide element can be configured to straighten or fully straighten when the guide element distal end is retracted through the catheter distal end and enters the catheter lumen. In some examples, the guide element distal segment or distal end is flexible enough to provide retraction of the guide element without displacing or impacting the position of the catheter (e.g., within a vessel).

[0091] In one embodiment, needle flat surface 251 transitions to needle bevel surface 256. The introducer element distal end may be molded to match the beveled surface of needle bevel surface 256 and provide a smooth continuation of the bevel of the needle bevel surface to the outer surface of catheter 220.

[0092] Fig.11 yes Fig. 10A FIG. 1 is a cross-sectional view of a distal end of a vascular access device of FIG. 1, showing the relationship of the catheter inner wall 115, the guide element 120, and the outer wall 148 of the access needle. The guide element is positioned within the catheter lumen and translates along the outer wall of the access needle and the inner wall of the catheter lumen along the space within the catheter lumen. An optional catheter design includes a groove 118 recessed into the inner wall of the catheter lumen, which groove 118 corresponds to a portion of the upper surface shape 124 or contour of the guide element. The catheter groove 118 helps to keep the guide element 120 in place along the catheter and translate along the outer wall 148 of the needle.

[0093] Additionally or alternatively, the guide element design of the upper surface profile 124 and the lower surface profile 125 may correspond to one or both of the catheter lumen inner wall and the needle outer wall, or to other alignment elements within the catheter lumen. Optionally, in other additional embodiments, the needle outer wall 148 may include a groove or notch portion for embodiments in which the guide element 120 is shaped and configured to operate in a configuration opposite to that shown in this view. See Fig.12 and Fig.13 An enlarged view of FIG. 1 is shown showing additional details of an alternative embodiment of a catheter-introducing element-needle.

[0094] Fig.12 FIG. 2 is an enlarged view of an embodiment of an intravascular access device 200 illustrating components defining a path for an introducing element. Figure 5B As shown, the guide element 210 is disposed 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 elongated body) continues through the distal portion of the needle holder 240 to contact the needle flat surface 251. The alignment of the proximal guide tube 230, the distal guide tube 235, and the lumen through the distal portion of the needle holder 240 is based on the surface of the needle contacted by the guide element 210. In this embodiment, the needle has a semicircular cross-sectional geometry, whereby a segment of the needle circumference is substantially flat. The flat segment of the outer surface of the needle is the surface that communicates with the guide element. Fig.12 The guide element 210 is shown also having a flat surface that contacts the needle flat surface 251 .

[0095] In one embodiment, the needle flat surface 251 and the guide element flat surface 211 are in contact with each other. Therefore, the outer surface of the guide element 210 may have an arc shape corresponding to the curvature of the outer surface of the needle 250. The guide element flat surface 211 may have a width corresponding to the chord defining the needle flat surface 251, so that when the needle flat surface 251 and the guide element flat surface 211 are in contact, their outer surfaces form a substantially continuous circumference.

[0096] Fig.132 is a perspective view of selected components associated with the path of guide element 210. In particular, needle holder 240 is shown and is transparent so that second guide tube 235 within needle holder 240 is visible. Proximal guide tube distal end 230 is obscured within distal guide tube proximal end 235. Needle proximal end 252 retained within needle holder 240 can be seen beneath distal guide tube 235. Guide element 210 is shown coming from distal guide tube distal end 235 and transitioning through angled needle holder lumen 241. Guide element 210 is shown adjacent needle flat surface 251 as needle 250 and guide element 210 traverse catheter 220. The path of guide element 210 over and on top of needle flat surface 251 is aligned with the orientation of needle flat surface 251 so that the inclination of needle holder lumen 241 is positive and upward toward the collinear second and first guide tubes. Needle 250 is generally parallel to the first and second guide tubes in the same plane of needle holder lumen 241 and guide element 210 . Fig.13 An example of a guide tube having concentric lumens extending generally along a single axis is shown. The guide element elongated body then transitions out of the distal guide tube 235 and transitions through the needle flat surface. In some examples, the transition of the guide element elongated body from the distal guide tube can be through the distal guide tube, through the distal portion of the needle holder, or obliquely through a space within the catheter hub, or a combination thereof.

[0097] Fig.14 yes Fig.11 1. The view shows an exemplary location and shape of the notched portion 118 of the catheter lumen wall 115. The view also shows a cross section of the guide element 120, wherein the upper surface 124 of the guide element is adjacent to the notched portion 118 of the lumen wall 115, and the lower surface 125 of the guide element is adjacent to and fits into the entry needle outer wall 148. The entry needle 140 and the needle lumen 146 are also shown within the catheter lumen 116.

[0098] Fig.15 yes Fig.11 An enlarged view of an alternative configuration of the central portion of the cross-sectional view of Fig.14. A person of ordinary skill will appreciate that the guide element can have any of a variety of upper surface profiles 124, lower surface profiles 125, right profiles 127, and left profiles 126. In addition, changes in the cross-sectional profile or profile of the guide element 120 can allow the guide element to extend along the space between the inner wall of the catheter and the outer wall of the needle and occupy different portions of the space between the inner wall of the catheter and the outer wall of the needle. Additionally or alternatively, one or more guide element profiles can be complementary to an inner wall recess, a guide element guide rail, or one or more guide element guide rail features on, in, or within a portion of the inner wall of the catheter lumen or the outer wall of the needle. In one aspect, the guide element upper surface 124 is contoured or shaped to at least partially fit within the inner wall of the catheter lumen. Additionally or alternatively, the guide element lower surface 126 can be shaped to at least partially fit within the outer wall 148 of the needle. In the same manner, one or more guide element embodiments may employ variations of the right profile 127 and the left profile 126 so as to be adapted to engage or complement other features disposed along the lumen of the needle or catheter, thereby allowing the guide element to smoothly translate along and beyond the distal end 142 of the entry needle. In some embodiments, the distance between the guide element left profile 126 and the guide element right profile 127 is in the range of between 0.10 mm and 0.36 mm. This distance is considered to be the guide element width. Additionally, in other embodiments, the distance between the guide element upper surface profile 124 and the guide element lower surface profile 125 is in the range of between 0.127 mm and 0.203 mm. This distance is considered to be the guide element thickness. In some embodiments, the guide element has a length between 100 mm and 200 mm.

[0099] Figures 16A-16D yes Fig.12 FIG. 2 is an enlarged view of an alternative configuration of a central portion of a cross-sectional view of a needle 250 of an intravascular access device 200. Detailed herein are examples of various embodiments regarding the location of an introducing element 210 around the outer surface of the needle 250. Fig.16A In and as Figure 1B and Fig.12 As shown, the guide element 210 is higher than the needle. Fig. 16B The guide element 210 is shown positioned downwardly relative to the needle 250 . Fig. 16C and Fig.16DThe guide element 210 is shown contacting the needle flat surface 251 on either lateral side of the needle 250. The needle flat surface 251 contacts the corresponding guide element flat surface 211, and when each of these flat surfaces contacts each other, generally forms a circumference that includes the remaining outer surface of the needle and the remaining outer surface of the guide element. The position of the needle flat surface 251 on the outer circumference of the needle defines the position of the guide element 210 relative to the needle 250, and therefore defines the path of the guide element through the first guide tube 230, the second guide tube 235, the needle holder 240 and the catheter lumen 221.

[0100] In one embodiment, the needle 250 has a substantially semicircular cross-sectional geometry in which an arc greater than 180 degrees terminates in a flat surface. The needle flat surface 251 can be perpendicular to any imaginary radius extending outward from the center of the needle lumen 253. The tissue penetration tip 254 provides a static reference point when describing the position of the needle flat surface 251. For example, the position of the tissue penetration tip can be set at a 180° radius around the central axis of the needle. The radial position of the needle flat surface 251 can be described relative to the static position of the tissue penetration tip 254. For example, Fig.16A , where the guide element 210 is higher than the needle flat surface 251, the needle flat surface 251 can be perpendicular to the 360° radius. In this example, a line drawn across the needle from the tissue penetrating tip to the midpoint of the needle flat surface can be the diameter of the needle.

[0101] In some examples, the position of needle flat surface 251 is described relative to a clock position. When needle flat surface 251 is positioned in a clock position and exists longitudinally on the periphery of needle 250, the clock position can be described relative to the terminal end of the needle. For example, tissue penetration end 245 can be a static reference of 6 o'clock, and when describing the position of needle flat surface 254 on the periphery of the needle, the clock position is described by treating tissue penetration end 254 as a static reference relative to the clock position of the needle flat surface. For example, Fig.16A An example of the needle flat surface 251 at the 12 o'clock position is illustrated. Fig. 16B An example of the needle flat surface 251 at the 6 o'clock position is illustrated. Fig. 16C An example of the needle flat surface 251 at the 3 o'clock position is illustrated. Fig.16D An example of needle flat surface 251 at the 9 o'clock position is illustrated. Although the illustrated figures provide examples of positions of needle flat surface 251, needle flat surface 251 may be at any position or between any positions of the provided examples.

[0102] In some examples, the needle flat surface 251 and the guide element flat surface are adjacent to each other. Figures 16A-16DAs seen in , adjacent flat surfaces provide a circular or substantially circular cross-section. For example, guide element 210 has an outer surface opposite guide element flat surface 211, the outer surface of guide element 210 having an arc shape corresponding to the arc shape of the outer surface of the needle. Therefore, the space or gap between the outer surface of the needle guide element assembly and the interior of the catheter lumen is reduced or substantially eliminated, thereby allowing for increased opportunities to use standard sized catheter lumens. Reducing or eliminating the gap between the needle guide element assembly and the interior of the catheter lumen and improving insertion into a blood vessel by reducing expansion or physical damage to tissue caused by larger gauge catheters. In some examples, reducing the gap or spacing between the needle guide element assemblies can reduce the amount of blood that flows along the outside of the needle when the catheter is inserted into a blood vessel by improving blood flow through the needle lumen 253.

[0103] In some examples, the position of the flat surface of the needle can establish a path or route for the elongated body of the introducer element. For example, if the flat surface is approximately at the 12 o'clock position, the elongated body of the introducer element can extend proximally along the top of the needle and then extend up to the distal guide tube and through the interior of the handle. With the flat surface at the 6 o'clock position, the elongated body of the introducer element can extend proximally along one side of the needle to the guide tube, which is positioned along a path corresponding to one side of the flat surface of the needle to guide the elongated body of the introducer element within the handle.

[0104] Fig.17A and Fig. 17B 256. The needle has a tissue penetrating tip 254 at a point distal to the needle beveled surface 256. The distal end of the catheter lumen 221 is shown as having a beveled surface extending between the tissue penetrating tips 254. In an embodiment, more than one beveled surface may extend from the tissue penetrating tip at an angle away from the center of the needle 250 to increase control and tissue penetration. The distal end of the needle flat surface 251 is partially exposed and is shown extending distally from the end of the guide element 212. As illustrated here, the needle flat surface 251 is transverse to or generally perpendicular to the needle beveled surface 256 and can be generally described as being at the 3 o'clock position or perpendicular to the 90° radius position.

[0105] The geometry of distal end 212 formed by the introducing element enables a smooth transition from the outer surface of needle 250 to the outer surface of catheter 220 . Fig. 10B An example is provided in which the needle flat surface 251 is at the 12 o'clock position and the distal end of the introducing element 210 facilitates the transition between the needle angled surface 256 and the outer surface of the catheter lumen 221 . Fig.17A and Fig. 17BThe 3 o'clock orientation of the needle flat surface 251 and the corresponding aligned introducing element distal end 212 is illustrated. Here, the needle flat surface 251 does not extend to the tissue penetrating tip 254, and terminates generally in the circumferential outer surface of the needle proximal to the transition of the needle beveled surface 256. In addition, the introducing element distal end communicates with the introducing element cutout 226 at the distal end of the catheter lumen.

[0106] consider Fig.17A and Fig. 17B As shown, the plane of the needle flat surface 251 will continue along the length of the needle. In one embodiment, the needle flat surface 251 can continue to the proximal end of the needle held in the needle holder 240. In other embodiments, the needle flat surface 251 can extend the length of the needle less than the entire length of the needle (the entire length of the needle is defined from the tissue penetration end 254 to the proximal end of the needle). For example, the needle flat surface 251 can have a length from the needle holder distal end 246 to the distal portion of the needle. The needle flat surface 251 can have a length that is defined by the proximal contact point of the guide element with the needle flat surface and extends to a sufficient length to the distal portion of the needle to achieve a smooth transition of the distal end assembly of the intravascular access device.

[0107] Also refer to Fig.17A and Fig. 17B , the guide element contoured distal tip 212 has a geometry identified for coupling with the guide element cutout 226. For example, the guide element cutout can include a notch in the catheter tip in which the guide element can be configured to seat in or couple with the notch when the guide element is in a ready-to-use configuration (e.g., prior to distal advancement).

[0108] Fig. 17C and Fig.17D 2 is an embodiment of the alignment of the needle flat surface 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 in a ready-to-use configuration. The handle 201 has been removed from view to illustrate the components therein. The inclination of the needle holder distal end 246 can be negative because the path of the guidewire begins at the needle plane at the 6 o'clock position (or alternatively a 180° radius). The needle proximal end 252 is shown within the needle holder and is located above the second guide tube 235 within the needle holder 240. The path of the guide element 210 travels along the needle flat surface 251, then transitions through the catheter 220 and the needle holder lumen 241 and into the distal guide tube 235 aligned along and near the lower portion of the handle.

[0109] Slider 202 is shown near the proximal end of the intravascular device having an arm 204 coupled to the proximal end of proximal guide tube 230. The length and orientation of arm 204 may depend on the path of guide element 210 and the alignment of proximal guide tube 230. For example, in Fig. 17C 2, when the needle flat surface 251 is in the 6 o'clock position, the arm 204 extends further from the rest of the slider to contact the proximal guide tube 230. The catheter is below the needle 250 in the needle holder 240 and is therefore disposed below in the handle relative to the slot 207. The guide element end 217 is shown between the tissue penetrating end 254 and the catheter end 224. Fig.17D yes Fig. 17C 25. An enlarged view of FIG. 25 shows the relationship and details of the guide element path relative to the orientation of the needle flat surface 251, the needle holder 240, and the distal guide tube 235.

[0110] 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 can extend proximally through the 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 elongated body can be inside the handle within the proximal guide tube 230. The proximal end or proximal segment of the guide element can be coupled to the proximal guide tube 230 so that when the proximal guide tube 230 is advanced, retracted, or a combination thereof, the guide element advances (e.g., corresponding to the proximal guide tube). For example, the slider 202 can engage the proximal guide tube 230 and advance distally within the handle so that the proximal guide tube 230 advances into the lumen of the distal guide tube 235, and the guide element 210 can be advanced corresponding to the proximal guide tube 230 so that the guide element distal tip advances from the guide element cutout of the catheter.

[0111] According to any embodiments disclosed herein, the orientation of the slot 207 of the handle 201 will remain through the top of the handle 201, so that the slot 207 can be considered to be above all components contained or substantially contained within the handle. In some examples, the orientation and alignment of any elements described herein can be described relative to the upper position of the slot 207.

[0112] like Fig.17D As shown, the distal guide tube 235 is positioned below the handle, and the guide element 210 extends from the distal guide tube 235 to the flat surface of the needle. Figure 2C As shown, the distal guide tube may include a length or segment that extends beyond the distal end of the needle holder 240 and / or handle such that the guiding element elongate body extends distally from the distal guide tube 235 along the plane of the planar surface of the needle.

[0113] Fig.18The slide 50 has been Figure 1A After the proximal position shown is moved to the distal position, Fig. 10A and Figure 1A 144 , the guide element 120 is shown in FIG. 146 , which is a perspective view of the distal end of a catheter and an access needle in which the guide element 120 is advanced distally along the outer wall 148 of the access needle to form a loop 128 at a location distal to the tip 144 of the access needle 140. In this exemplary embodiment, the loop 128 is formed approximately one inch beyond the distal end 144 of the needle 140. This view also shows how the upper and lower contours of the guide element 120 cooperate with the catheter guide element cutout 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 can form a partial loop, a full loop, or more than one full loop beyond the distal end of the needle. In terms of the degree of revolution around the distal end of the needle, the loop 128 can be greater than 90 degrees, greater than 180 degrees, greater than 270 degrees, or greater than 360 degrees (in one full revolution or more than one full revolution). For example, Fig.18 19 is greater than 270 degrees. In addition, an exemplary diameter range for the ring 128 is from 1 mm to 3 mm.

[0114] In some examples, loop 128 can be a distal segment of an introducer element that is configured to be flexible and provide a loop when introducer element 120 is advanced distally beyond tissue penetrating tip 144. As described herein, when the introducer element is to be retracted, loop 128 (e.g., a distal segment of the introducer element) can be sufficiently flexible to be withdrawn into the catheter lumen and can transition to a sufficiently straight configuration without dislodging or inadvertently impacting the position of the catheter within the vessel.

[0115] Fig.19A yes Fig.18 14. An enlarged view of the guide element loop of FIG. 14. When the guide element 120 is deployed beyond the distal-most end 144 of the access needle 140, a loop 128 is formed in the distal portion of the guide element 120. The view also shows additional exemplary shapes of the guide element upper surface profile 124, lower surface profile 125, right profile 127, and left profile 126. The upper surface profile 124 and lower surface profile 125 of the guide element 120 fit into the space between the outer wall 148 of the needle 140 and the inner wall of the catheter lumen. Fig.19B and Fig.19C , showing additional details of an exemplary guide element engaging a guide element cutout at the distal end of a catheter. As described herein, the guide element can include a shaped distal tip 217 with an elongated body 233 extending distally from the shaped distal tip 217. Fig.19BIn some examples, the contoured distal tip 217 is attached, molded, or otherwise coupled to the elongated body 233 at 237. In some examples, the guide element contoured distal tip 217 can be molded, manufactured, or otherwise integrated with the guide element elongated body 233. Fig.19B Also shown are details of the confirmed geometry of the introducing element distal tip 217. In this example, the introducing element distal tip 217 includes a proximal engagement feature 234 configured to seat at or couple with an introducing element cutout of a catheter tip.

[0116] exist Fig.19C 2, the introducer element has been advanced distally from the introducer element cutout 226 so that the introducer element shaped distal tip 217 is distal to the tissue penetrating tip 254 and has been curled to form an atraumatic tip (e.g., when intravascular). The introducer element flat surface 211 is shown inside the curl of the loop formed by the introducer element distal segment.

[0117] Fig. 20 Yes Figure 1B An enlarged view of the guide element distal end 212 deployed beyond the tissue penetration tip 254 after the slider 202 has been advanced toward the distal end of the handle 201 is shown. After longitudinally sliding across the needle flat surface 251, the guide element flat surface 211 is visible above the needle inclined surface 256. As the guide element is advanced, the cutout 226 at the catheter tip no longer contacts the guide element distal end. As seen here, the guide element 210 and the needle flat surface 251 are oriented near the 12 o'clock position.

[0118] Fig.21 2 is an enlarged perspective view of the needle distal end 246 with the introducing element distal end 212 deployed beyond the tissue penetrating end 254. This embodiment illustrates a 3 o'clock orientation of the needle flat surface 251 and the introducing element 210. In this orientation, the introducing element distal end 212 is positioned at Fig.17A and Fig. 17B The illustrated 3 o'clock lateral side extends beyond tissue penetrating tip 254. Although not shown, the introducer element distal end bends beyond tissue penetrating tip 254 after deployment, forming a loop.

[0119] In some embodiments, the bend in the distal end 212 of the introducing element is formed when the introducing element end 217 is curled in the direction of the tissue penetrating end 254. For example, as shown in FIG. Fig.18As shown, guide element 120 is oriented at the 12 o'clock position and tissue penetration tip 144 is below guide element 120. Therefore, guide element tip 123 is curled downward toward tissue penetration tip 144. As another illustrative example, with guide element 210 oriented at the 3 o'clock position, the guide element tip is curled laterally toward the tissue penetration element. In general, the guide element is curled toward the needle.

[0120] The deployed introducing element 210 may form a partial loop, a full loop, or more than one full loop beyond the distal end of the needle. Fig. 22 An embodiment is illustrated in which the introducing element flat surface 211 is an inner introducing element ring. In terms of degree of revolution around the distal end of the needle, the ring can be greater than 90 degrees, greater than 180 degrees, greater than 270 degrees, or greater than 360 degrees (in one full revolution or more than one full revolution). Examples of introducing element tip 217 geometries are shown that are optimized for a smooth transition between the needle 250 and the catheter outer surface.

[0121] In some embodiments, the guide element 120 can be formed of PTFE, nylon or another suitable polymer. Additionally or optionally, the guide element 120 can include additives to enhance visibility under ultrasound guidance. Exemplary additives include, for example, but not limited to titanium oxide or barium. In addition, it should be understood that a variety of materials can be used to form the guide element, such as a variety of polymer blends and all or part of the metal, or metal alloys or shape memory materials (including metal and polymer-based shape memory materials, or Nitinol or Elgiloy, etc.). In addition, the dimensions and profiles illustrated in the various embodiments of the guide element can also vary along the length of the guide element. For example, the most distal portion of the guide element can have a profile and size for the breaking strength. The middle portion of the guide element 120 can be designed to be suitable for transition from the housing to the catheter lumen without buckling. In addition, not only is the transition and change of the profile of the guide element portion within the guide catheter possible, but the inner lumen wall of the catheter can also be adapted to help use various guide element embodiments. Therefore, in another embodiment, the distal end of the guide element is designed to form a uniform transition with the distal end of the tubular catheter body to maintain the ease of catheter insertion. Additionally, the guide element 120 may have a varying thickness near the catheter hub to aid in breaking strength. In some embodiments, the distal face of the slider will mate with the proximal face of a needle holder located inside the housing.

[0122] In some embodiments, the guide element 210 can be formed of PTFE, nylon or another suitable polymer. Additionally or optionally, the guide element 210 can include additives to enhance visibility under ultrasound guidance. Exemplary additives include, for example, but not limited to titanium oxide or barium. In addition, it should be understood that a variety of materials can be used to form the guide element, such as a variety of polymer blends and all or part of the metal, or metal alloys or shape memory materials (including metal and polymer-based shape memory materials, or Nitinol or Elgiloy, etc.). In addition, the dimensions and profiles illustrated in the various embodiments of the guide element can also vary along the length of the guide element. For example, the most distal portion of the guide element can have a profile and size for the breaking strength. The middle portion of the guide element 210 can be designed to be suitable for transition from the housing to the catheter lumen without buckling. In addition, not only is the transition and change of the profile of the guide element portion within the guide catheter possible, but the inner lumen wall of the catheter can also be adapted to help use various guide element embodiments. Therefore, in another embodiment, the distal end of the guide element is designed to form a uniform transition with the distal end of the tubular catheter body to maintain the ease of catheter insertion. Additionally, the guide element 210 may have a varying thickness near the catheter hub to aid in breaking strength. In some embodiments, the distal face of the slider will mate with the proximal face of a needle holder located inside the housing.

[0123] In any embodiment described herein, the guide element can be made of a metallic material, a polymer material, or a combination thereof. For example, the composition of the guide element material can be related to the characteristics and utility of the guide element function. The size and geometry of the guide element can also be determined based on the optimal function of the guide element in the intravascular access device or the function of the guide element in the patient's vascular system. The cross-sectional geometry of the guide element can range from substantially circular or substantially elliptical to semicircular. For example, a guide element with a semicircular cross-sectional geometry can be semicircular. Another example of a semicircular cross-sectional geometry of the guide element can be larger than or larger than a semicircle, but smaller than a continuous and complete circle or ellipse. In some embodiments, the shape and geometry of the guide element are based on the optimal moment of inertia of the guide element geometry. The outer surface of the guide element can have an arc based on the inner surface of the catheter lumen. The surface of the guide element closest to the outer surface of the needle can be considered to be the inner surface of the guide element. The inner surface of the guide element can be flat or substantially flat, corresponding to the area of ​​the guide element that contacts the outer needle surface.

[0124] In some embodiments, the blood control valve is positioned within the proximal hub of the tubular catheter. FIG. 23A to FIG. 23C is an enlarged view of a blood control valve inside a proximal hub of a tubular catheter according to some embodiments. Fig.23AThere are multiple segments 271 on the distal surface 272. The multiple segments can converge on the center of the distal surface and shift as the catheter is advanced into the patient's vasculature. The circumferential valve body exterior 271 corresponds to the circumferential interior of the catheter proximal hub 222. The channel 274 around the circumference of the valve body 274 engages a corresponding element (e.g., annular ridge) on the inner surface of the catheter proximal hub 222 to hold the valve in place until deployment. Fig. 23B 271 is an enlarged perspective view of another embodiment of an intracorporeal balancing valve having a non-uniform outer surface. In particular, the distal portion of the valve body can have a series of longitudinal channels or recesses around the outer surface. Channels 271 can be configured to increase the volume of the interior of the catheter proximal hub 222.

[0125] In some examples, the blood control valve may include one or more features to accommodate one or more components of an intravascular access device. Fig.23A and Fig. 23B As shown, the proximal end of the blood control valve body can include a recess configured to accommodate or receive a distal end of a needle holder, which can extend beyond the distal end of the handle. In some examples, the proximal transmission of the blood control valve can be continuous, such as Fig.23C In 284 and Figure 2C In this configuration, the needle holder can include a different distal configuration, a shortened length, or a combination thereof, wherein the needle holder is positioned at a distance proximal to the blood control valve 283. For example, the needle holder does not contact the blood control valve. Fig.23C An example of a distal opening is also shown, wherein segment 271 is biased inwardly to the interior of the valve, thereby opening the valve to allow blood to flow through the interior lumen of the valve. For example, in this configuration, the valve can be opened or actuated by a peripheral element such as a male segment of a Luer lock that is coupled to the catheter hub and biases the valve distally against a feature of the catheter hub, thereby causing segment 271 to open.

[0126] In some examples, a blood control valve (e.g., 279, 281, 283) is positioned within the catheter hub and is configured to prevent, reduce, inhibit, or otherwise control the flow of blood from within the vessel through the catheter lumen and to another peripheral component (e.g., a male Luer lock). Thus, the distal end of the blood control valve can be configured to contact or be contacted by a peripheral medical device or coupling to advance the blood control valve and open or initiate blood flow through the valve.

[0127] According to some embodiments, when the intravascular access device is used, the tissue penetration end 254 enters the patient's vasculature, and fluid from within the vasculature can flow through the needle lumen into the catheter proximal hub to indicate the position of the tissue penetration end 254 in the vasculature. The volume of fluid within the catheter proximal hub can increase, and the pressure therein can increase accordingly. In the event of increased fluid pressure within the catheter proximal hub and the needle lumen, deployment of the catheter may require additional force to advance the catheter lumen into the vasculature. The passage of the valve body increases the capacity of the catheter proximal hub and reduces the need for increased pressure, thereby allowing the catheter to be smoothly deployed into the patient's vasculature and reducing the possibility of damage or injury associated with the catheter being forced to deploy against the fluid pressure therein.

[0128] Fig.24A and Fig. 24B An example of a catheter hub configuration at the distal end of an intravascular access device is illustrated. Fig.24A , the catheter hub 222 is shown separated from the intravascular access device. Details of the catheter hub 222 are shown to include a valve control feature 229 configured to contact a segment 271 of the blood control valve (e.g., 279, 281, 283) as the blood control valve is advanced distally within the catheter hub 222. A blood control valve engagement feature 286 is visible and can be configured to engage the blood control valve, for example, at 275, to hold the blood control valve in an open position when the blood control valve has been sufficiently advanced within the catheter hub 222. In some examples, the blood control valve engagement feature 286 can be configured to hold the blood control valve in a closed position, and distal advancement of the blood control valve can require the blood control valve to be displaced distally from the coupling between the blood control valve engagement feature 286 and a corresponding engagement feature 275 of the blood control valve.

[0129] As will be understood by the various views of the accompanying drawings, aspects of the present invention provide improved methods, systems and assemblies for performing venipuncture, particularly for placing an intravascular catheter at a target location in a patient's vein. Although the methods, systems and assemblies are particularly useful for the placement of peripheral intravenous catheters, such as for placement in a vein on the hand or arm, they can also be used to place a central venous catheter by inserting a central vein (such as the internal jugular vein in the neck or the subclavian vein in the chest). In addition, aspects of the vascular access methods, systems and assemblies can be used to place a catheter in a central artery or other artery.

[0130] exist Fig. 24B, the catheter hub 222 is positioned at or coupled to the distal end of the handle and is shown as translucent to reveal an example configuration of elements therein. For example, the blood control valve 281 is positioned within the catheter 222 and proximally adjacent to the valve control feature 229. The guide element can be seen transitioning through the handle and through the blood control valve 281.

[0131] Additional details and examples of the configuration within the catheter hub 222 at the distal end of the handle are provided in Fig.25A and Fig.25B Here, as previously shown in Figure 2C As illustrated in FIG. 2 , the distal guide tube 235 is shown guiding the guide element elongate body 233 from the handle to the blood control valve 283 , wherein the guide element elongate body 233 continues within the catheter lumen along the needle flat surface.

[0132] Fig.26A and Fig.26B An exemplary engagement or coupling of a peripheral medical device to the catheter hub 222 is shown. For example, a male Luer lock 300 having an engagement feature 305 can be configured to engage or contact a blood control valve 283 and advance the valve distally to the engagement feature 229 such that the valve opens to allow blood to flow therethrough. Fig.26A , the male Luer lock 300 has not yet contacted the blood control valve 283 or the catheter hub 222, but is positioned or aligned relative to the proximal opening 310 of the catheter hub 222. Distally, the catheter lumen 221 is shown passing through the translucent catheter hub 222 to highlight an example of a route for blood to flow from a blood vessel. Fig.26B The valve is already open or Fig.26A The illustrated closed state becomes open, wherein the engagement feature 305 of the male Luer lock 300 has engaged the proximal end of the blood control valve 283 and abuts against the engagement feature 229 to advance the valve distally, wherein the engagement feature 229 is shown as opening the distal surface of the valve, completing the route or lumen for blood to flow from the catheter lumen 221 through the valve and to the connected peripheral medical device.

[0133] In some examples, such as Fig. 27The illustrated catheter assembly may include a catheter lumen 320 having an inner wall and an outer wall. The distal end of the catheter includes a guide element cutout 325, which is configured to receive a guide element (e.g., a guide element molded end) or is coupled to a guide element. The catheter lumen 320 may extend proximally from the distal end having the guide element cutout 325 to a catheter hub 330, wherein the blood control valve 283 may be positioned and configured to selectively control (e.g., prevent or allow) blood from flowing through the catheter lumen 320 and out of the distal opening 340 from a blood vessel when the catheter hub is coupled to a peripheral medical device. The blood control valve 283 may be configured to advance within the catheter hub when biased distally. For example, a male Luer lock may be coupled to the distal end of the catheter hub 320 and configured to advance the blood control valve distally against 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 open the distal surface of the valve when the valve is biased distally within the hub.

[0134] In use, the intravascular access device can be configured to access and position (e.g., insert) a catheter into a patient's blood vessel. A catheter assembly having a catheter lumen can be coupled to the distal end of the handle, the catheter lumen extending between the distal end with a guide element cutout and the catheter hub. A guide element with a molded distal end can be configured to be placed in or coupled to the guide element cutout, and the elongated body of the guide element can extend along the outer surface of an entry needle arranged to pass through the catheter lumen. In some examples, the entire guide element adjacent to the entry needle is positioned outside the needle in the catheter lumen. The proximal end of the needle can be coupled to a needle holder, which is coupled to an engagement element, which is configured to retract the needle, the needle holder, and the guide element proximally into the handle when an actuation button is pressed. The proximal guide tube and the distal guide tube include a lumen through which the elongated body of the guide element extends proximally into the handle, and a slider can be coupled to the proximal guide tube and configured to advance the guide element distally. When the tissue penetration end of the needle is inserted into the blood vessel, a flashback can be observed. For example, a flashback can be observed in the catheter lumen, catheter assembly, etc. to indicate the correct position in the vessel. The slider can be advanced distally, thereby advancing the proximal guide tube and the distal end of the guide element from the guide element incision. The distal end of the guide element can be advanced beyond the tissue penetration end, wherein the distal segment of the guide element can form an atraumatic end (e.g., a loop). The catheter can then be advanced into the blood vessel along the guide element. When the catheter is positioned in the blood vessel, the actuation button can be pressed, and the actuation element can bias (e.g., push) the needle holder proximally in the handle, thereby retracting the needle and the guide element. In some examples, the distal guide tube is accordingly biased proximally, whereby the distal guide tube slides proximally on the proximal guide tube.

[0135] In some examples, when the needle and guide element are to be retracted, the actuation of the actuator can be configured to withdraw the needle and guide element simultaneously. In some examples, the needle and guide element can be selectively withdrawn so that the needle can be withdrawn when the actuator is engaged and the needle holder is pushed to the proximal end of the handle. The guide element can then be selectively withdrawn afterwards. In some examples, when the actuator pushes the needle holder proximally in the handle, the needle can be withdrawn first, and then the guide element can be automatically withdrawn by the needle holder or catheter being withdrawn. For example, when the actuator button is pressed and the actuator biases the needle holder proximally, the needle can be withdrawn together with the needle holder, and the needle holder can withdraw the distal guide tube, the proximal guide tube, or a combination thereof proximally in the handle, thereby withdrawing the distal end of the guide element proximally. In some examples, the guide element can be straightened when it is withdrawn. For example, the distal segment of the introducing element can be sufficiently flexible to change from a loop to a straightened configuration at the distal end of the catheter lumen (eg, when advanced distally into a vessel) so as not to inadvertently dislodge the catheter once it is placed or positioned in the vessel.

[0136] The catheter hub can be separated from the handle and the flow of blood can be restricted by the blood control valve within the catheter hub until a peripheral medical device or tube 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.

[0137] 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 between the distal end and the proximal end, and a guide element cutout formed in the distal end. The access needle has a tissue penetrating distal tip and a lumen that generally passes through the access needle. In a first embodiment, the guide element is disposed in a gap or lumen between an inner wall of the catheter lumen and an outer wall of the access needle. In a second embodiment, the guide element is disposed outside the access needle and parallel to the access needle, and the access needle travels along an axial groove, notch or guide structure or structure or guide element formed in the inner wall of the catheter lumen. In all embodiments, the guide element has a distal tip that is configured to (a) conform to the shape and contour of the distal tip of the catheter 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) forming a partial or complete loop as the catheter extends distally along the needle and when distal to the needle to facilitate advancement of the catheter in the vasculature.

[0138] In one embodiment, a slider of an intravascular vascular access assembly is slidably disposed on a support track containing a guide element. The proximal end of the guide element is attached to the slider. In this manner, the guide element can be advanced distally by sliding the slider forwardly or distally along a slot disposed in the housing (FIG. 1). This movement causes the distal end of the guide element to move over the outer surface of the access needle so as to position the distal tip of the guide element beyond the distal end of the catheter (see FIG. 1). Fig.18 ). Once in this configuration, the access needle can be fully or partially retracted, or left in place without retraction, and the catheter and distally protruding guide element can be advanced in concert to position the distal end of the catheter body at a target location in a vein or other vasculature. By advancing the catheter and protruding guide element in concert, the guide element acts as a "fixed" guide element tip, further simplifying catheter placement protocols. In addition, the protruding ring on the distal portion of the guide element will help prevent or substantially inhibit the distal tip of the catheter from adhering or kinking to the inner wall of the vessel.

[0139] In another aspect, an intravascular access device includes a housing having a needle holder at a distal end thereof attached to a proximal end of an access needle, such as Figure 2A , Figure 3 , Figure 4 , Figure 8 and Fig. 9 1. The access needle 140 is securely secured to the needle holder 130, and the proximal end of the catheter is removably secured to the distal end of the housing. In this manner, the slider 150 can be used to advance the guide element beyond the distal end of the catheter and access needle, and after the catheter is in place at the desired location in the vascular system, the housing, access needle and guide element can be disassembled and removed from the catheter.

[0140] Coupling the guide element 120 to the slider 150 can be accomplished in any manner that allows advancement or retraction of the slider to result in equivalent advancement or retraction of the guide element through the space between the lumen of the catheter and the outer wall of the access needle. Advantageously, because the guide element is located outside of and along the exterior or outer wall of the access needle, the slider can be directly coupled to the proximal end of the guide element with minimal interference from the access needle.

[0141] In some embodiments, a slider is connected to a proximal end of a first guide tube having a proximal end of an introducing element retained therein. The slider can advance the first guide tube into the second guide tube, thereby causing the introducing element to be simultaneously advanced through the intravascular access device.

[0142] In another aspect of the invention, a needle as described herein is selectively manufactured to have a needle flat surface in a specific orientation on the outer surface of the needle. Considerations for the selection of the intravascular access device described herein can take into account the attributes of the patient and the condition of their target vasculature. For example, depending on the intravascular access point, the vessel can have a non-linear path, whereby it would be advantageous to select an intravascular access device having a needle flat surface and a guide element orientation different from the 12 o'clock position to optimize the chances of the guide element and catheter being safely and successfully deployed into the patient's vasculature. Another example can include limiting the patient's anatomical structure or anatomical structure to facilitate the selection of the needle flat surface and guide element orientation, which will allow for the least obstructed path for deploying the guide element into the vasculature. Given the common orientation of needles with tissue penetration elements, insertion is typically performed with the tissue penetration tip closest to the outside of the patient. Certain embodiments of the invention described herein provide optimal tissue penetration tip orientation, wherein the selectable guide element positioning is not limited to a specific position around the outer surface of the needle.

[0143] In yet another aspect of the invention, a method for introducing an intravascular catheter to a target location in a patient's blood vessel includes penetrating the distal end of an access needle carrying the catheter into a vein. A guide element is positioned within a guide element notch at the distal end of the catheter. As a result, introduction of the distal-most end of the catheter into the vessel causes the distal end of the guide element to also be positioned in the vessel. Thus, once blood flashback is detected and the needle / catheter combination is advanced so that the distal end of the catheter is within the vessel, the needle can remain stationary. With the needle position remaining stationary, the slider is moved from Figure 1A and Figure 2A The proximal position shown is advanced to a distal position in which the slider is located in the distal portion of the slot along the top of the housing. Movement of the slider from proximal to distal causes the guide element to move from a position within the guide cutout in the distal tip of the catheter ( Fig. 10A ) to a deployed state having a curved portion, a full or partial loop distal to the penetrating tip of the needle (e.g. Fig.18 and Fig.19A It should be understood that the guide element can be preformed to form the loop 128 at a desired or selected distance from the needle distal end 144. In one embodiment, the loop 128 is formed at a minimum distance of about 1 inch or 25.4 mm. Other specific spacings between the needle distal end and the loop can be provided based on the application, clinical needs, and anatomical considerations of the target lumen.

[0144] After the guide element has been advanced, the access needle can optionally be retracted proximally, leaving the guide element in place to assist in catheter positioning. Optionally, once the catheter is properly located within the blood vessel, the access needle and guide element are completely withdrawn from the catheter, leaving the catheter in place for the desired medical regimen. In one embodiment, the spring-loaded retraction system or activation element 108 is activated by pressing the actuation button 106. Once the actuation button 106 is pressed or otherwise moved to cause the release of the needle holder 130, the actuation spring 108 automatically drives the needle holder 130, the needle 140, the slider 150 and the guide element 120 proximally to withdraw the access needle 140 and the guide element 120 from the patient and at least partially or completely withdrawn into the housing 101. Thereafter, the catheter hub 110 is disassembled from the handle or distal end 103 of the housing 101, leaving the catheter hub 110 in place for the desired medical regimen as described above. The used housing 101 can then be disposed of using an appropriate device.

[0145] The bobbin containing the remaining length of the guiding element can provide an extension of the length of the guiding element. The bobbin can be connected to the handle or communicated with the handle separately, so as to allow sufficient parts of the redundant guiding element to be used to advance into the patient's vascular system after the tissue penetration end has been successfully inserted. For example, the tissue penetration end can be inserted at an anatomical position away from the desired target deployment position of the catheter. In such an example, the guiding element may need to be sufficient to pass through the extension section of the patient's vascular system to the desired catheter deployment position. The guiding element can be repeatedly advanced by a slider, wherein the slider is pressed near the proximal end of the handle to engage the guiding element. The slider then advances toward the distal end of the handle, continuously pressing until the slider reaches the most distal part of the groove. The slider can be released and slide back to the proximal end of the groove to be pressed and advance distally. The process can be repeated until a sufficient amount of guide wire is deployed. In some embodiments, the handle can be removed proximally while the guide wire remains partially inserted into the patient's vascular system, and the additional catheter or catheter length can be further slid into the vascular system on the guiding element to reach the desired catheter deployment position.

[0146] The needle holder retention mechanism can be positioned within the body of the handle and support retention of the needle holder after the needle holder has been retracted toward the proximal end of the handle. The needle holder retention mechanism can engage the proximal end of the needle holder or a corresponding element disposed thereon to retain the needle holder toward the proximal end of the handle and prevent oscillation of the actuation spring and needle holder assembly.

[0147] Other aspects of the construction and operation of the catheter placement device 100 are described in U.S. Patent Publication No. US 2008 / 0300574 and U.S. Patent No. 9,522,254 (each of which is incorporated herein by reference in its entirety), which includes: a housing or handle 101 having a mechanism for advancing a guide structure or guide element carrying the catheter, wherein the handle is adapted to automatically retract both the entry needle and the guide structure or guide element from the catheter after the placement procedure is completed; a button-activated automatic needle; and a guide member withdrawal assembly.

[0148] Further details of representative intravascular catheterization devices and methods are described in U.S. Patent Nos. 5,704,914 and 5,800,395 and U.S. Patent Publications US 2010 / 0094310; US 2010 / 0210934 and US 2012 / 0197200, the entire disclosure of each of which is incorporated herein by reference in its entirety.

[0149] Although 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. Without departing from the present invention, those skilled in the art will now appreciate many variations, changes and substitutions. It should be understood that various alternatives to the embodiments of the present invention described herein may be adopted in the process of practicing the present invention. It is intended that the scope of the present invention be limited by the appended claims, and methods and structures and their equivalents within the scope of these claims are thus covered.

[0150] When a feature or element is referred to herein as being "on" another feature or element, it may be directly on other features or elements, or there may also be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly on another feature or element", there is no intermediate feature or element. It will also be understood that when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to other features or elements, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intermediate feature or element. Although described or shown with respect to one embodiment, the features and elements described or shown in this way may be applied to other embodiments. Those skilled in the art will also recognize that the structure or feature set with reference to "adjacent" another feature may have a portion overlapping or below an adjacent feature.

[0151] The terms used herein are used only for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises" and / or "comprising" when used in this specification specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, 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 " / ".

[0152] For ease of description, spatially related terms such as "under", "below", "lower", "over", "upper", etc. may be used herein to describe the relationship of one element or feature to other elements or features as illustrated in the accompanying drawings. It should be understood that spatially related terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is reversed, the elements described as "below other elements or features" or "below other elements or features" will then be oriented to "above other elements or features". Therefore, the exemplary term "below" may include both "above" and "below". The device can be oriented otherwise (rotated 90 degrees or in other orientations), and the spatially related descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms "upwardly", "downwardly", "vertical", "horizontal", etc. are used herein for illustrative purposes.

[0153] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0154] In this specification and the appended claims, unless the context requires otherwise, the term "comprise" and variations thereof such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and apparatus, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0155] As used herein in the specification and claims, including in the examples and unless otherwise expressly stated, all numbers may be treated as being preceded by the word "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing the magnitude and / or position to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -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 about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range listed herein is intended to include all sub-ranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0156] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted as limiting the scope of the invention as set forth in the claims. The examples and descriptions included herein illustrate specific embodiments in which the subject matter may be practiced by way of illustration and not limitation. As mentioned, other embodiments may be utilized and derived therefrom, so that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention", and if more than one is actually disclosed, it is not intended to actively limit the scope of the present application to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement that is considered to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of the various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reading the above description.

Claims

1. An intravascular catheter assembly, comprising: a handle having a proximal end and a distal end, a groove in a surface of the handle having a distal end and a proximal end; an actuation button located on the handle, the actuation button coupled to the needle holder; a tubular catheter body having a distal end, an introducing element cutout in 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 located within the proximal hub, the blood control valve being configured to selectively advance within the proximal hub; an access needle disposed within the lumen of the tubular catheter body, the access needle having a tissue penetrating distal tip extending distally beyond the distal end of the tubular catheter body and a proximal end coupled to the needle holder; an introducer element having a proximal end and a distal end, the introducer element being positioned within the lumen of the catheter body and adjacent an outer wall of the access needle, the distal portion of the introducer element being shaped to fit within the introducer element cutout of the catheter, wherein the access needle and introducer element are retractable together from the tubular catheter body after the distal-most portion of the introducer element has been advanced along the outer wall of the access needle from the lumen of the tubular catheter body to a position distal to the tissue penetrating distal tip of the access needle; as well as A slider is coupled to the proximal end of the introducing element such that distal advancement of the slider advances a distal terminal end portion of the introducing element distally from a position within the introducing element cutout along the outer wall of the access needle.

2. The intravascular catheter assembly according to claim 1, wherein: When the slider is in the distal-most position, the distal portion of the guide element bends beyond the tissue penetrating distal tip of the access needle.

3. The intravascular catheter assembly according to claim 1, wherein: When the slider is in the distal-most 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.

4. The intravascular catheter assembly according to claim 3, wherein: The angle of the bend formed by the distal portion of the introducing element relative to the tissue penetrating distal tip of the access needle is less than 360 degrees.

5. The intravascular catheter assembly according to claim 3, wherein: The angle of the bend formed by the distal portion of the introducing element relative to the tissue penetrating distal tip of the access needle is greater than 270 degrees.

6. The intravascular catheter assembly according to claim 3, wherein: The bend formed by the distal portion of the introducing element is at an angle of less than 270 degrees relative to the tissue penetrating distal tip of the access needle.

7. The intravascular catheter assembly according to claim 3, wherein: The bend formed by the distal portion of the introducing element is at an angle greater than 180 degrees relative to the tissue penetrating distal tip of the access needle.

8. The intravascular catheter assembly according to claim 1, wherein: The slider is disposed on a proximal region of the access needle.

9. The intravascular catheter assembly of claim 1, further comprising a housing attached to the proximal end of the access needle, wherein the slider is disposed on the housing.

10. The intravascular catheter assembly according to claim 9, wherein: The access needle is securely secured to the distal end of the housing and the tubular catheter body is removably secured to the distal end of the housing, wherein the slider advances the guide element beyond the distal end of the catheter, and wherein the housing, access needle and guide element are capable of being disassembled and removed from the catheter after the catheter is in place.

11. The intravascular catheter assembly according to claim 10, wherein: A proximal region of the catheter is disposed within the housing, and wherein the proximal end of the catheter and the proximal end of the access needle are configured to be engaged by the slider to advance the catheter and the needle in coordination with the guide element relative to the housing after the guide element has been extended distally beyond the distal end of the catheter.

12. The intravascular catheter assembly of claim 1, wherein: The access needle has a lumen, and the guide element is disposed outside the lumen of the access needle.

13. The intravascular catheter assembly according to claim 9, wherein: The housing has an axial slot, and the proximal end of the guide element is connected to the slider so as to be allowed to move along the axial slot.

14. The intravascular catheter assembly according to claim 13, wherein: The axial slot is closed at a distal region and a proximal region of the access needle.

15. The intravascular catheter assembly of claim 14, wherein: The connection between the guide element and the slide is arranged in the slot, wherein the stroke length is defined by the closed end of the slot.

16. The intravascular catheter assembly of claim 1, wherein: The guide element is slidably disposed within a guide structure within the lumen of the catheter body.

17. The intravascular catheter assembly of claim 16, wherein: The guide structure maintains the guide element in an uppermost position along the access needle.

18. The intravascular catheter assembly of claim 16, wherein: The guide structure is a pair of features extending from the inner wall of the catheter body and protruding into the lumen of the catheter body.

19. The intravascular catheter assembly of claim 18, wherein: When the guide structure is positioned between the extending pair of features, the guide structure is positioned along an upper side of an outer wall of the access needle.

20. The intravascular catheter assembly of claim 16, wherein: The guide structure has a distal-most portion adjacent to the guide element cutout and a proximal portion greater than 1 cm from the guide element cutout.

21. The intravascular catheter assembly of claim 16, wherein: The guide structure has a distal-most portion adjacent the guide element cutout and has a proximal portion in which the guide structure is continuous along an inner wall of the catheter body lumen from the proximal end to the distal end.

22. The intravascular catheter assembly of claim 1, wherein: The tubular catheter body has a proximal hub with a blood control valve, wherein the access needle slidably extends through the blood control valve.

23. The intravascular catheter assembly of claim 22, wherein: The slider has a distal side that cooperates with the proximal side of the needle holder when the slider is fully advanced distally to extend the introducing element.

24. The intravascular catheter assembly of claim 23, wherein: The slider is removably locked to the proximal end of the needle holder when the distal side is mated with the proximal side.

25. The intravascular catheter assembly of claim 1, further comprising: a first configuration when the slider is in a proximal-most position wherein the distal end of the introducing element is located in the introducing element notch and the tissue penetrating distal tip of the needle is distal to a distal-most end of the tubular catheter body; a second configuration when the slider is in a distal-most position, wherein the distal-most end of the guide element extends beyond the guide cutout and curves beyond the tissue-penetrating distal tip of the needle; as well as A third configuration is provided when the slider is in a position proximal to the distal-most position and the needle and the introducing element are at least partially retracted into the housing.

26. The intravascular catheter assembly of claim 25, wherein: In the first configuration, the distal tip of the access needle extends beyond the distal end of the tubular catheter body a distance in the range of 0.1 mm to 20 mm, and the proximal end of the slider is retracted from the proximal end of the tubular catheter body a distance in the range of 10 mm to 100 mm.

27. The intravascular catheter assembly of claim 25, wherein: In the second configuration, the length of the introducing element extending beyond the introducing cutout of the tubular catheter body is 5 mm to 100 mm.

28. An assembly according to any one of claims 1 to 27, wherein The guide element has a length greater than its width and a width greater than its thickness.

29. The assembly according to any one of claims 1 to 27, wherein: The guide element is made entirely or partially of polymer material, PTFE, nylon.

30. The assembly according to any one of claims 1 to 27, wherein: The guide element is made entirely or partially of metal, including Nitinol, including Elgiloy or similar materials.

31. The assembly of any one of claims 1-27, the introducing element further comprising an upper surface conforming to the curvature of the inner wall of the catheter body lumen and a lower surface conforming to the curvature of the outer wall of the access needle.

32. An assembly according to any one of claims 1 to 31, wherein The catheter is configured to be used as a catheter component in an infusion set, a catheter component in a blood collection set, a catheter component in a safety-wing blood collection set, or a catheter component in an intravenous catheter.

33. A method of accessing a patient's blood vessel, comprising: advancing a tissue penetrating distal tip of an access needle of an intravascular catheter assembly into a blood vessel of the patient, the access needle having a flat surface along an upper portion, a lower portion, a right portion, or a left portion; advancing an introducer element distal tip from a first position within an introducer notch in a distal portion of a catheter hub to a second position in which a portion of the introducer element elongate body is advanced along the flat surface of an access needle to a position beyond the distal-most portion of the catheter hub; advancing the guide structure to a third position in which the distal tip of the guide element is positioned beyond the tissue penetrating distal tip of the access needle and along a blood vessel of a patient; advancing a distal portion of the catheter hub along the guide structure in a blood vessel; and The needle and the guide structure are automatically retracted into the intravascular catheter assembly.

34. The blood vessel access method of claim 33, further comprising stopping the step of advancing the tissue penetrating distal tip of the access needle of the intravascular catheter assembly when blood flashback is observed in the intravascular catheter assembly.

35. The method of accessing a blood vessel of claim 33, further comprising ceasing to advance a tissue penetrating distal tip of an access needle when a distal-most portion of a catheter hub of the intravascular catheter assembly is within the patient's blood vessel.

36. The method of accessing a blood vessel of claim 33, further comprising ceasing to advance the tissue penetrating distal tip of the access needle when the distal-most portion of the guide structure of the intravascular catheter assembly is within the patient's blood vessel.

37. The method for accessing a blood vessel according to claim 33, wherein: After the step of advancing the guide structure beyond the tissue penetrating distal tip of the access needle is performed, the distal portion of the guide element bends beyond the tissue penetrating distal tip of the access needle.

38. The method for accessing a blood vessel according to claim 33, wherein: After performing the step of advancing the guide structure beyond the tissue penetrating distal tip of the access needle, the distal portion of the guide element bends from a position above the access needle, beyond the tissue penetrating distal tip of the access needle, to a position below the access needle.

39. The method of claim 38, wherein the bend formed by the distal portion of the introducing element is less than 360 degrees relative to the tissue penetrating distal tip of the access needle.

40. The method of claim 38, wherein the bend formed by the distal portion of the introducing element is at an angle greater than 270 degrees relative to the tissue penetrating distal tip of the access needle.

41. The method of claim 38, wherein the bend formed by the distal portion of the introducing element is less than 270 degrees relative to the tissue penetrating distal tip of the access needle.

42. The method of claim 38, wherein the bend formed by the distal portion of the introducing element is at an angle greater than 180 degrees relative to the tissue penetrating distal tip of the access needle.

43. The method of accessing a blood vessel of claim 33, wherein advancing the guide element from a first position comprises advancing a proximal guide tube into a lumen of a distal guide tube in communication with a needle holder, wherein a proximal end of the guide element is coupled to the proximal guide tube.

44. An intravascular access device comprising: 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 periphery of the access needle and a tissue penetrating tip extending distally beyond the catheter lumen; at least one guide tube positioned within the handle, the guide tube having a lumen extending therethrough and a distal end in communication with a lumen extending through a distal section of the needle holder; an introducing element having at least one longitudinal planar surface, the introducing element extending from the proximal end of the handle through the at least one introducing tube and the needle holder, the distal portion of the introducing tube being disposed within the lumen of the catheter, wherein the longitudinal planar surface of the introducing element contacts the at least one planar surface of the access needle; and A slider extends through the slot and is in communication with the proximal end of the guide element such that distal advancement of the slider advances the 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.

45. The intravascular access device of claim 44, wherein: The at least one flat surface of the access needle extends longitudinally along an outer surface of the access needle.

46. ​​The intravascular access device of claim 45, wherein: The guide element is disposed through a path defined by the at least one planar 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 planar surface of the access needle.

47. The intravascular access device according to any one of claims 45-46, wherein: The at least one guide tube is aligned parallel to a plane of the at least one planar surface of the access needle.

48. The intravascular access device according to any one of claims 44-47, wherein: When the slider is in the distal-most position, the distal portion of the guide element bends beyond the tissue penetrating distal tip of the access needle.

49. The intravascular access device according to any one of claims 44-47, wherein: When the slider is in the distal-most position, the distal portion of the guide element bends from a position defined by the plane of the at least one planar surface of the access needle beyond the tissue penetrating distal tip of the access needle.

50. The intravascular access device of any one of claims 44-49, further comprising an access needle lumen, wherein a plane of the at least one planar surface of the access needle is perpendicular to a radius of the access needle lumen.

51. The intravascular access device according to any one of claims 44-50, further comprising a blood control valve disposed in the proximal catheter hub, the blood control valve having a body and an inner cavity, the body having a distal end and a proximal end, the inner cavity of the blood control valve extending from the proximal end to the distal end in the body.

52. The intravascular access device of claim 51, the distal end of the blood control valve comprising a surface extending across the lumen, the surface comprising a plurality of grooves.

53. The intravascular access device of claim 51, the proximal end of the blood control valve body comprising an outer peripheral surface on the proximal end, the outer peripheral surface being configured to engage with a portion of a Luer connector to advance the blood control valve distally within the catheter hub to displace the plurality of grooves.

54. The intravascular access device of claim 53, wherein: The proximal periphery is continuous in a single plane.

55. The intravascular access device of claim 53, wherein: The proximal periphery includes a recess into the exterior of the valve body.

56. The intravascular access device of claim 55, wherein: The recess is configured to receive a distal end of a distal guide tube, a segment of the introducing element body, or a distal end of the needle holder.

57. The intravascular access device of claim 55, wherein: In use, when the needle holder is in the distal-most position, the needle holder is located proximal to the proximal end of the blood control valve without contacting the blood control valve.

58. The intravascular access device of claim 44, wherein: The tissue penetrating tip defines a distal terminus of the angled surface of the access needle.

59. The intravascular access device according to any one of claims 44-49, wherein: The at least one planar surface is offset to a degree on the periphery of the access needle relative to the location of the tissue penetrating tip.

60. The intravascular access device of any one of claims 44-59, further comprising an actuation button coupled to the needle holder, and an actuation element that applies a force on the needle holder toward the proximal end of the handle, wherein when the actuation button is depressed, the actuation element displaces the needle holder and the access needle toward the proximal end of the handle.

61. The intravascular access device according to any one of claims 44-60, wherein: The plane of the at least one flat surface of the access needle is perpendicular to any radius extending outward from the center of the access needle.

62. The intravascular access device according to any one of claims 44-61, wherein: The catheter is configured to be used as a catheter component in an infusion set, a catheter component in a blood collection set, a catheter component in a safety-wing blood collection set, or a catheter component in an intravenous catheter.

63. The intravenous access device of any one of claims 44-62, further comprising a spool of an introducing element in communication with the proximal end of the intravascular device, wherein a length of the introducing element is contained within the spool.

64. The device according to any of the preceding claims, wherein: The guide element is made completely or partially of a metallic material, a polymer material or a combination thereof.

65. An intravascular catheter assembly comprising: a handle having a proximal end and a distal end, a groove in a surface of the handle having a distal end and a proximal end; a spring loaded actuation button on the handle and coupled to the needle holder; a tubular catheter body having a distal end, an introducing element cutout in 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; an access needle disposed within the lumen of the tubular catheter body, the access needle having a multi-faceted tissue penetrating distal tip extending distally beyond the distal end of the tubular catheter body and a proximal end coupled to a needle holder within the handle; an introducer element including an elongated body extending distally from an introducer element tip adapted to operably couple with the introducer element cutout, the introducer element being positioned within the catheter body lumen and adjacent an outer surface of the access needle, wherein the access needle may be withdrawn from the tubular catheter body after the introducer element tip has been passed 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; and A slider is coupled to the proximal end of the introducing element such that distal advancement of the slider advances the introducing element tip distally from a position within the introducing element cutout.

66. An intravascular catheter assembly according to claim 65, wherein: When the slider is in the distal-most position, the distal portion of the guide element bends beyond the tissue penetrating distal tip of the access needle.

67. An intravascular catheter assembly according to claim 65, wherein: When the slider is in the distal-most 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.

68. An intravascular catheter assembly according to claim 65, wherein: The proximal side of the introducing element tip is configured to contact the introducing element cutout.

69. An intravascular catheter assembly according to claim 65, wherein: The access needle includes a flat surface positioned axially along a length of the access needle outer surface.

70. An intravascular catheter assembly according to claim 65, wherein: The introducing element elongated body extends proximally within the catheter body lumen along the exterior of the access needle adjacent to the axially planar surface.

71. An intravascular catheter assembly according to claim 65, wherein: The introducing element tip includes a geometry configured to be complementary to the introducing element cutout.

72. An intravascular catheter assembly according to claim 65, wherein: The introducing element tip is attached to the distal end of the introducing element elongated body.

73. The intravascular catheter assembly of claim 65, further comprising a housing attached to the proximal end of the access needle, wherein the sliding member is disposed on the housing.

74. An intravascular catheter assembly according to claim 65, wherein: The access needle is securely secured to the distal end of the housing and the tubular catheter body is removably secured to the distal end of the housing, wherein the slider advances the guide element beyond the distal end of the catheter, and wherein the housing, access needle and guide element are capable of being disassembled and removed from the catheter after the catheter is in place.

75. The intravascular catheter assembly of claim 65, further comprising a blood control valve positioned within a hub at the proximal end of the tubular catheter body, the blood control valve comprising a valve body and an inner cavity, wherein a surface covering a distal end of the inner cavity has a plurality of slits.

76. The intravascular catheter assembly of claim 65, further comprising a proximal guide tube axially aligned with the distal guide tube, wherein the elongated body of the guide element extends through the proximal guide tube, the distal guide tube, and the catheter body lumen.

77. An intravascular catheter assembly according to claim 65, wherein: The proximal end of the guide element is coupled to an interior of a proximal guide tube, wherein the proximal guide tube is axially aligned with a distal guide tube coupled to the needle holder.

78. An intravascular catheter assembly according to claim 65, wherein: The guide element is slidably disposed within the catheter body lumen along the planar surface of the access needle.

79. An intravascular catheter assembly according to claim 65, wherein: The tubular catheter body has a proximal hub with a blood control valve, wherein the access needle slidably extends through the blood control valve.

80. An intravascular catheter assembly according to claim 79, wherein: The slider has a distal side that cooperates with the proximal side of the needle holder when the slider is fully advanced distally to extend the introducing element.

81. The intravascular catheter assembly of claim 65, further comprising: a first configuration when the slider is in a proximal-most position, wherein the introducing element distal tip is located in the introducing element notch and the tissue penetrating distal tip of the needle is distal to a distal-most end of the tubular catheter body; a second configuration when the slider is in a distal-most position, wherein the guide element distal tip extends beyond the guide cutout and curves beyond the tissue-penetrating distal tip of the needle; and and a third configuration when the slider is in a proximal position of the distal-most position and the needle is at least partially retracted into the housing.

82. The assembly of claim 65, wherein: The catheter is configured to be used as a catheter component in an infusion set, a catheter component in a blood collection set, a catheter component in a safety-wing blood collection set, or a catheter component in an intravenous catheter.

83. An intravascular catheter assembly comprising: a catheter lumen extending distally from the proximal hub, the catheter lumen including an introducer element cutout in a distal end of the catheter lumen; an access needle disposed within the catheter lumen and having a flat surface axially positioned along the length of the access needle; a guide element disposed between the flat surface of the needle and an interior of the catheter lumen; a slider coupled to the proximal section of the guide element such that distal advancement of the slider advances the molded distal tip of the guide element from a first position at the guide element cutout to a second position in which the distal section of the guide element bends beyond the tissue penetrating distal tip of the access needle, wherein the slider has a distal side that mates with a proximal side of the needle holder when the slider is fully distally advanced to extend the guide element.

84. The assembly of claim 84, wherein: The slider is removably locked to the proximal hub when the distal side of the slider is mated with the proximal side of the needle holder.

85. The assembly of claim 84, wherein: The guide has an elongated body extending distally from the molded tip, the elongated body including a planar surface in communication with the planar surface of the access needle.

86. The assembly of claim 84, wherein: The guide element is a polymer.

87. A method of accessing a patient's blood vessel, comprising: advancing a tissue penetrating tip of an access needle of an intravascular catheter assembly into a blood vessel of the patient; advancing a contoured distal tip of an introducer element from a first position within an introducer element cutout in a distal portion of a catheter lumen, wherein a distal portion of the introducer structure forms a uniform transition to an exterior of the catheter lumen, to a second position wherein a portion of the introducer structure is advanced beyond the tissue penetrating tip along a planar surface of the access needle, the planar surface being axially located along an outer wall of the access needle; advancing a distal portion of the catheter hub along the introducing element in the blood vessel; and The needle is withdrawn into the intravascular catheter assembly.

88. The blood vessel access method of claim 88, further comprising stopping the step of advancing the tissue penetrating distal tip of the access needle of the intravascular catheter assembly when blood reflux is observed in the intravascular catheter assembly.

89. The method of accessing a blood vessel of claim 88, further comprising a blood control valve positioned within the catheter hub.

90. The method for accessing a blood vessel according to claim 88, wherein: The contoured distal tip of the introducing element and the distal-most portion of the introducing element form an atraumatic tip after advancement beyond the tissue penetrating tip.

91. The method for accessing a blood vessel according to claim 88, wherein: Advancing the contoured distal tip of the guide element includes distally advancing a slider within a slot of a handle, wherein the slider is coupled to a proximal guide tube, wherein the guide element extends through a lumen of the proximal guide tube.

92. An intravascular catheter, comprising: a hub having a proximal end and a distal end; a tubular body extending from the distal end of the hub to the distal tip, the tubular body having an outer wall and an inner wall; a lumen within the hub and the tubular body, the lumen being defined by an inner wall of the tubular body, the lumen having a guide element cutout in a distal end; an introducer element having a shaped distal tip configured to couple with the introducer element cutout; and An access needle having a longitudinal planar surface along a length of an exterior of the needle, wherein the guide element includes a planar surface adjacent to the planar surface of the needle.

93. The intravascular catheter of claim 93, further comprising a needle holder located within the handle, the needle holder coupled to the proximal end of the access needle.

94. The intravascular catheter of claim 93, further comprising a proximal guide tube slidably coupled to the distal guide tube, wherein an elongated body of the guide element extends proximally from the molded distal end through a lumen formed by the distal guide tube and the proximal guide tube.

95. The intravascular catheter of claim 93, further comprising a sliding member operably coupled to the proximal guide tube, wherein the sliding member is configured to advance the shaped distal tip by advancing the proximal guide tube.

96. An intravascular access device comprising: 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 catheter lumen extending distally from a catheter hub, the catheter hub being releasably engaged to the distal end of the handle; an access needle extending distally from the needle holder through the catheter lumen, the access needle having a tissue penetrating tip and at least one flat surface extending axially along the access needle body; an introducer element configured to extend through a lumen including the catheter lumen and a guide tube positioned within the handle proximal to the needle holder, the introducer element including a shaped distal tip configured to engage an introducer element cutout at a distal end of the catheter lumen; and A slider extends through the slot, the slider communicating with the proximal section of the guide element, wherein the slider is configured to advance the guide element distally along the at least one flat surface of the access needle.

97. The intravascular access device of claim 97, wherein: The introducing element includes an elongated body extending proximally from the contoured distal tip.

98. The intravascular access device of claim 97, wherein: The introducing element includes an elongated body extending proximally from the contoured distal tip through a lumen including the catheter lumen and a guide tube proximal to the needle holder.

99. The intravascular access device of claim 97, wherein: The introducing element includes a distal segment having a planar surface adjacent to the at least one planar surface of the access needle.

100. The intravascular access device of claim 97, wherein: The introducing element distal end is configured to bend when advanced beyond the tissue penetrating tip.

101. The intravascular access device of claim 97, wherein: The at least one flat surface of the access needle includes a lateral edge proximal to the tissue penetrating tip.

102. The intravascular access device of claim 97, further comprising a blood control valve positioned within the catheter hub.

103. The intravascular access device of claim 103, wherein: The blood control valve includes a distal section having one or more channels configured to increase the volume of the catheter hub.

104. The intravascular access device of claim 103, wherein: The proximal section of the blood control valve is configured to receive the distal end of the needle holder.

105. The intravascular access device of claim 103, wherein: The at least one planar surface of the access needle extends to an extent along an exterior of the access needle relative to a location of the tissue penetrating tip.

106. The intravascular access device of claim 103, further comprising an actuation button coupled to the needle holder.

107. An intravascular catheter assembly comprising: 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 is positioned within the hub, the blood control valve including a distal surface configured to accommodate fluid flow therethrough as the blood control valve is advanced distally within the hub.

108. An intravascular catheter according to claim 108, wherein The blood control valve includes a recess in a proximal periphery configured to receive a needle holder.

109. An intravascular catheter according to claim 108, wherein An introducing element cutout at the distal end of the tubular body is configured to couple with an introducing element distal tip.

110. The intravascular catheter of claim 110, wherein: The catheter hub includes an actuation element configured to open the distal surface of the blood control valve.

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