Intravascular catheter with integrated guide structure

Abstract

To provide an improved method, a system and a tool for deploying an intravascular catheter by using a needle and a guide structure.SOLUTION: Intravascular access is achieved by introducing a catheter 110 having a guide element recess placed to receive the contoured distal end of a guide element 120. The guide element may be advanced along an outer surface of an access needle to form a loop beyond the distal end of the needle. The deployed guide element may form a partial or complete loop once beyond the distal end of the needle. 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 a blood vessel and available for use.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 088,979, filed October 7, 2020, entitled "INTRAVASCULAR CATHETER WITH INTEGRATED GUIDE STRUCTURE."

[0002] Incorporation by Reference

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

[0003] Statement of Federally Funded Research

[0003] This invention was made without government support.

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

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

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

[0007] In addition to difficult access, many vascular catheter placement systems can result in accidental puncture and / or accidental needle contamination during or after placement of the intravascular catheter. Furthermore, some conventional catheter placement devices employ relatively complicated deployment handle movements that increase both cost and complexity. Additionally, conventional handle placement and movements can obscure the presence and status of the tool's needle and guide structure or element components, thus making use of the insertion tool less intuitive. Summary of the Invention [Problem to be solved by the invention]

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

[0009] In general, in one embodiment, an intravascular catheter assembly includes a handle having a proximal end and a distal end, wherein a slot in a surface of the handle has the distal and proximal ends; an actuation button on the handle coupled to a needle holder; a tubular catheter body having a distal end, a guide element notch at the distal end, a proximal end, and a lumen extending between the proximal and distal ends, wherein the proximal end of the catheter body is 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 tissue-piercing distal tip extending distally beyond the distal end of the tubular catheter body, and a proximal end coupled to the needle holder; and a guide element having a proximal end and a distal end. the guide element is positioned within the catheter body lumen and adjacent to the outer wall of the access needle, the distal end portion of the guide element is shaped to provide a uniform transition when the distal end portion is within the guide element notch, so that the access needle and guide element can be retracted together from the tubular catheter body after the distal-most portion of the guide element has been advanced along the outer wall of the access needle from the tubular catheter body lumen to a position distal to the tissue-penetrating distal tip of the access needle; and a slider coupled to the proximal end of the guide element such that distal advancement of the slider causes the distal tip end portion of the guide element to advance distally along the outer wall of the access needle from its position within the guide element notch.

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

[0011] In general, in one embodiment, an intravascular catheter assembly includes a tubular catheter body having a proximal hub, a guide element notch at its distal most end, and a catheter body lumen extending from its proximal end to its distal end; an access needle disposed in the catheter body lumen and having a tissue-penetrating distal tip extending distally beyond the distal end of the tubular catheter body; a guide element within the catheter body lumen and exterior to the access needle, the guide element having 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; a guide element having a distal tip shaped to form a uniform transition with the guide element notch at the distal-most end of the needle body; and a slider coupled to the proximal end of the guide element such that distal advancement of the slider advances the distal tip of the guide element from a first position at the guide element notch to a second position where the distal portion of the guide element curves beyond the tissue-penetrating distal tip of the access needle, the slider having a distal surface that mates with the proximal surface of the needle holder when the slider is fully advanced distally to extend the guide element.

[0012] This and other embodiments can include one or more of the following features: The slider can be releasably locked to the proximal hub when a distal surface of the slider mates with a proximal surface of the needle holder. The guide element has a length greater than its width and a thickness greater than its thickness. The guide element may be polymeric.

[0013]

[0013] Generally, in one embodiment, a method of accessing a patient's blood vessel includes the steps of advancing a tissue-penetrating distal tip of an access needle of an intravascular catheter assembly into the patient's blood vessel; advancing a guide structure from a first position in which a distal portion of the guide structure forms a uniform transition within a guide notch in the distal portion of the catheter hub to a second position in which a portion of the guide structure is advanced along the outer wall of the access needle beyond the distal-most portion of the catheter hub; advancing the guide structure along the patient's blood vessel to a third position beyond the tissue-penetrating distal tip of the access needle; advancing the distal portion of the catheter hub along the guide structure into the blood vessel; and automatically retracting the needle and guide structure into the intravascular catheter assembly.

[0014] This and other embodiments may include one or more of the following features. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly when backflow of blood is observed within the intravascular catheter assembly. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle when a distal-most portion of the catheter hub of the intravascular catheter assembly is within the patient's blood vessel. The method of accessing a blood vessel may further include ceasing to perform the step of advancing the tissue-penetrating distal tip of the access needle when a distal-most portion of the guiding structure of the intravascular catheter assembly is within the patient's blood vessel. After performing the step of advancing the guiding structure beyond the tissue-penetrating distal tip of the access needle, the distal portion of the guiding element may bend beyond the tissue-penetrating distal tip of the access needle. After performing the step of advancing the guiding structure beyond the tissue-penetrating distal tip of the access needle, the distal portion of the guiding element may bend from a position above the access needle to a position below the access needle, beyond the tissue-penetrating distal tip of the access needle. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be less than 360 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be greater than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be less than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the tissue-penetrating distal tip of the access needle may be greater than 180 degrees.

[0015]

[0015] Generally, in one embodiment, an intravascular catheter includes a hub having a proximal end and a distal end, a tubular body extending from the hub distal end to the distal tip, the tubular body having an outer wall and an inner wall, a lumen within the hub and tubular body bounded by the tubular body inner wall, the lumen having a proximal opening at the hub proximal end and a distal opening at the tubular body distal tip, and a guide element cutout portion at the tubular body distal tip.

[0016] This and other embodiments may include one or more of the following features. The intravascular catheter may further include a guide element recess formed in and extending along at least a distal portion of the tubular body inner wall. The intravascular catheter may further include a guide element recess formed in and extending along the tubular body inner wall. The intravascular catheter may further include a guide element recess formed in and extending along the tubular body inner wall from the hub distal end to the tubular body distal end. The guide element recess may be wider than the guide element cutout. The intravascular catheter may further include a guide element track along the tubular body inner wall longitudinally aligned with the guide element cutout. The guide element track along the tubular body inner wall longitudinally aligned with the guide element cutout may be formed by a concave portion of the tubular body inner wall alone or in combination with one or more guide element track features extending from or formed in the tubular body lumen inner wall. Further, a portion of the guide element track conforms to at least a portion of the guide element upper surface contour, the guide element lower surface contour, the guide element left side contour, or the guide element right side contour. The intravascular catheter may be configured for use as a catheter component of an infusion set, a catheter component of a blood collection set, a catheter component of a blood collection set with safety wing, or a catheter component of an intravenous catheter.

[0017] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief explanation of the drawings]

[0018] [Figure 1]

[0018] FIG. 1 is a perspective view of one embodiment of an intravascular access device having a catheter, a guide element, and a needle assembly. [Figure 2]

[0019] 2 is a cross-sectional view of the intravascular access device of FIG. 1 showing the catheter, guide element and needle assembly, actuation button, support rail, and proximal sliding device. [Figure 3]

[0020] 2 is a top perspective view of the distal housing and catheter hub of FIG. 1 showing details of the needle, guide element, and needle retainer inside the catheter hub. [Figure 4]

[0021] FIG. 4 is an enlarged top perspective view of the distal housing and catheter hub of FIG. 3 showing details of the needle, guide element, needle holder, and needle holder slot inside the catheter hub. [Figure 5]

[0022] 4 is a perspective view of a longitudinal section of the intravascular access device of FIG. 3 showing additional details of the needle holder in relation to the activation button, and showing additional details of the guide element in relation to the support rail and outer wall of the access needle. [Figure 6]

[0023] 5 is a top view of a portion of the intravascular catheter of FIG. 1, more proximal than the view of FIG. 4, showing additional detail of the distal end of the needle holder in relation to the guide elements and support rails within the needle holder longitudinal slot. [Figure 7]

[0024] 7 is a top view of a portion of an inner view similar to FIG. 6, showing the proximal end of the needle holder in relation to the sliding device, the guide element and the support rail. [Figure 8]

[0025] FIG. 4 is a top perspective view of the distal portion of the intravascular access device of FIGS. 1 and 3, showing the inside of the catheter hub, including the needle holder, needle, guide element, and support rail. [Figure 9]

[0026] FIG. 9 is a perspective proximal view of the components seen in FIG. 8. [Figure 10]

[0027] 2 is an enlarged view of the distal end of the intravascular device of FIG. 1 showing the distal tip of the catheter with the guide element notch and the distal end of the access needle in relation to the distal end of the guide element within the guide element notch. [Figure 11]

[0028] 11 shows the distal end of a cross-sectional view of the vascular access device of FIG. 10, illustrating the relationship of the inner catheter wall, the guide element, and the outer access needle wall. [Figure 12]

[0029] 12 is an enlarged view of the central portion of the view of FIG. 11 showing the concave portion of the catheter lumen wall, the upper surface of the guide element adjacent the concave portion of the lumen wall, and the lower surface of the guide element adjacent to and conforming to the outer wall of the access needle. [Figure 13]

[0030] 12 is an enlarged view of the central portion of the view of FIG. 11, similar to FIG. 12, providing additional explanation of the outer wall of the access needle, the catheter lumen wall, and the various geometries of the guide element positioned between these structures of the intravascular device. [Figure 14]

[0031] 10 and 1 after the slider has been moved from the proximal position shown in FIG. 1 to a distal position in which the guide element is advanced distally along the outer wall of the access needle to form a loop distal to the tip of the access needle. [Figure 15]

[0032] 15 is an enlarged view of the guide element loop of FIG. 14. DETAILED DESCRIPTION OF THE INVENTION

[0019]

[0033] 1 is a perspective view of one embodiment of an intravascular access device 100 having a catheter 110, a guide element 120, and a needle assembly. In this configuration, the intravascular catheter with an integrated guide structure or guide element is ready to be used to position the catheter within a selected portion of the vasculature or lumen based on clinical need. The catheter hub 110 is coupled to the distal end 103 of the handle 101 with the access needle 140 in place within the catheter lumen 116. The catheter hub 110 is transparent in this view to allow viewing of the position of the needle holder 130 and the guide element 120.

[0020]

[0034] The handle or housing 101 has a proximal end 102 and a distal end 103. A slot 105 runs along its length, providing access for a slider 150 to engage the guide element 120 and move along a support rail 109 inside the handle 101. The slider 150 includes a gripping portion 152 and is shown in its proximal-most position for use when a needle 140 is positioned within the catheter 110 and ready to be inserted into a patient's vasculature. The catheter 110 has a distal end 114 and a proximal end 112, as well as an inner lumen 116 along its entire length. The catheter proximal end 112 is adapted and configured to engage the handle distal end 103. The catheter proximal end 112 is also configured to engage a conventional medical tubing connection after insertion and removal of the handle 101. For example, the catheter proximal end 112 may include features for engaging a luer lock, a fluid coupling, or other suitable medical connector or fitting.

[0021]

[0035] FIG. 2 is a cross-sectional view of the intravascular access device of FIG. 1 , showing the catheter 110, guide element 120 and needle holder 130, actuator button 106, support rail 109, and slider 150 in a proximal position. This is the "ready to use" configuration. The guide element proximal end 122 is attached to slider tab 154. The guide element 120 extends along the support rail 109, past the needle holder distal end 132, and into and along the catheter lumen 116. The guide 120 resides between the needle outer wall 148 and the catheter lumen inner wall 115. As a result, as the slider 150 is advanced along the slot 105, the guide element advances along the support rail 109 and along and past the distal ends of the catheter and needle, forming an atraumatic or partial loop or curving over the sharp distal end 144 of the needle (see FIGS. 14 and 15 ).

[0022]

[0036] The catheter lumen 116 is also visible in this view. The needle 140 has a sharpened distal end 144 that is used to penetrate the skin and vessel wall. The access needle proximal end 142 terminates within the needle holder 130. When the activation button is released, the activation element 108 moves the needle holder 130 toward the housing proximal end 102. Movement of the needle holder 130 within the handle 101 is long enough for the sharpened distal end 144 of the needle 140 to be fully inserted into the housing 101. The needle holder 130 also includes a support rail slot 138 along its length that is sized to receive the support rail 109.

[0023]

[0037] An actuation element 108 is included but not shown in this view to allow for detailed visibility of the needle holder 130. The actuation element 108 may be a spring, such as a coil spring or wave spring, or other suitable compression element. When the actuation button 106 is depressed, the actuation button latch 107 disengages from the needle holder distal groove 134, which then allows the actuation element 108 to deploy and propel the needle holder 130, along with the needle 140, toward the handle proximal end 102.

[0024]

[0038] Figure 3 is a top perspective view of the distal housing 103 and catheter hub 110 of Figure 1, showing details of the needle 140, guide element 120, and needle holder 130 inside the catheter hub 110. The guide element 120 is shown exiting the distal end of the support rail and entering the space between the outer wall of the needle and the inner wall of the catheter lumen.

[0025]

[0039] 4 is an enlarged top perspective view of the distal housing 103 and catheter hub 110 of FIG. 3 showing details of the needle 140, guide element 120, needle holder 130, and needle holder support rail slot 138 inside the catheter hub 110. In this view, the needle 140 is shown exiting the catheter lumen 116 and entering the needle holder lumen 136. The proximal end of the needle 140 terminates within and is fastened to the needle holder 130.

[0026]

[0040] FIG. 5 is a perspective view of a longitudinal section of the intravascular access device 100 of FIG. 3 , showing additional detail of the needle holder 130 in relation to the activation button 106, and additional detail of the guide element 120 in relation to the support rail 109 and the access needle outer wall 148. The catheter hub proximal end 112 is shown coupled to the housing or handle distal end 103. Additional detail of the guide element relative to other components can also be seen. The guide element 120 extends along the support rail 109, the distal end of the slot 138, and into the gap between the needle outer wall and the catheter lumen wall 115. Additionally, the needle 140 is shown in relation to the catheter lumen proximal end 116 and the needle holder lumen 146. The needle proximal end 142 terminates at the needle holder 130 and leads to the blood return chamber 135. All or a portion of the needle holder 130 or handle 101 may be transparent to allow for visual detection of fluid or blood return or backflow after the needle distal end 144 enters the target vessel.

[0027]

[0041] 5 also shows the relationship between the activation latch 107 and the associated needle holder groove 134. When in a loaded or cocked configuration, the latch 107 engages the groove 134 to provide a restraining force on the activation element 108. Depressing the activation button 106 disengages the latch 107 from the needle holder slot 134, allowing the spring force or stored energy of the activation element 108 to propel the needle holder 130 toward the handle proximal end 102. This view also shows that the support rail 109 terminates within the housing distal end 103.

[0028]

[0042] Figure 6 is a top view of a portion of the intravascular catheter of Figure 1, more proximal than the view of Figure 4, showing additional detail of the guide element 120 within the needle holder longitudinal slot 138 and the distal end 132 of the needle holder 130 in relation to the support rail 109. The guide element 120 is visible along the upper surface of the support rail 109, transitioning from the support rail distal end, over the needle holder distal end 132, along the needle outer wall 148, and into the catheter lumen 116. The configuration of the support rail 109 relative to the needle holder support rail slot 138 allows the support rail to function like a monorail for the needle holder during retraction (i.e., when the stored energy of the actuation element 108 is released). The support rail 109 also supports the guide element 120 during advancement of the slider 150.

[0029]

[0043] FIG. 7 is a top view of a portion of an interior view similar to FIG. 6 showing the proximal end of needle holder 132 in relation to slide 150, guide element 120, and support rail 109. Slider tab 154 of slide 150 extends through slot 105. Slider tab 154 includes a key plate 156 having an aperture 158. Aperture 158 is sized, shaped, and positioned to accommodate features of guide element 120 and support rail 109. Advantageously, the configuration of slide 150 and support rail 109 allows for a more precise alignment of needle holder 132 with the guide element 120. This allows the support rail 109 to allow the slide 150 to translate freely rearward / forward. The guide element 120 has a proximal end 122 that is connected to the slide using a slider tab 154 or other suitable structure. The support rail 109 extends through the slider tab and is connected to the housing proximal end 102. Additionally, this view also shows the relationship of the needle holder proximal end 132, which is sized and positioned to engage the slider tab 154 during retraction. Rearward movement of the needle holder causes the needle holder proximal end 132 to engage and move the slider tab 154. Because the guide element 120 terminates in the slider 150, the guide element 120 also moves proximally within the housing. This movement (i.e., proximal movement of the needle holder 130) results in the needle and guide element being simultaneously retracted inside the handle or housing.

[0030]

[0044] 8 is a top perspective view of the distal portion 103 of the intravascular access device 100 of FIGS. 1 and 3, showing the inside of the catheter hub 110, including the needle holder 130, needle 140, guide element 120, and support rail 109. This is another view of the placement of the guide element 120 along the support rail 109, past the needle holder, and into the catheter lumen. This view also shows the support rail slot 138 along the length of the needle holder 130 in relation to the needle holder proximal end 131 and distal groove 134.

[0031]

[0045] Figure 9 is a perspective proximal view of the needle holder 130 and other components seen in Figure 8. A blood chamber 135 is visible within the needle holder proximal end 131. The cover for chamber 135 that is normally present has been removed to show the interior.

[0032]

[0046] FIG. 10 is an enlarged view of the distal end of the intravascular device 100 of FIG. 1 showing the distal tip 114 of the catheter with the guide element notch 115 and the distal end 144 of the access needle 140 in relationship to the distal end 123 of the guide element 120 within the guide element notch 115.

[0033]

[0047] The guide element distal end 123 is shaped / fabricated to mimic the geometry of the catheter tip 114. The location of the guide element 120 is the space between the inner wall or diameter of the catheter lumen and the outer wall or diameter of the needle. In one embodiment, the guide element 120 is constructed from a polymeric material. The guide element 120 may also be pre-shaped, shape-set, or have a shape-memory configuration to form a complete loop, partial loop, or multiple loops when extended beyond the needle distal end 144 (see FIGS. 14 and 15).

[0034]

[0048] Similarly, the catheter distal end includes a guide element notch 115. The guide element notch 115 is shaped to receive and conform to the guide element distal end, maintaining a smooth finish to the catheter's distal end. The illustration in Figure 10 is an example of how the shaped distal end of the guide element conforms to the catheter tip guide element notch. This also illustrates the uniform transition between the catheter and guide element distal end contours, so the transition from the catheter tip to the needle and the outer periphery of the catheter tip remain smooth.

[0035]

[0049] 11 is a distal end view of a cross-section of the vascular access device of FIG. 10 showing the relationship of the catheter inner wall 115, the guide element 120, and the access needle outer wall 148. The guide element is positioned in space within the catheter lumen along the outer wall of the access needle and the inner wall of the catheter lumen, and translates along the same. An optional catheter design includes a groove 118 recessed into the catheter lumen inner wall that corresponds to a portion of the upper surface shape 124 or contour of the guide element. The catheter groove 118 guides the guide element 120 along the catheter at a predetermined distance. It helps to hold it in position and translate it along the outer needle wall 148.

[0036]

[0050] Additionally or optionally, the guide element design of the upper surface contour 124 and lower surface contour 125 can correspond to one or both of the inner catheter lumen wall and the outer needle wall, or other alignment elements within the catheter lumen. Optionally, in other additional embodiments, the outer needle wall 148 may include grooves or concave portions for embodiments in which the guide element 120 is shaped and configured to operate in an inverted configuration from that shown in this figure. See the close-up views of Figures 12 and 13 for additional details of alternative catheter / guide element / needle embodiments.

[0037]

[0051] Figure 12 is an enlarged view of the central portion of the cross-sectional view of Figure 11. This view illustrates an exemplary location and shape of the concave portion 118 of the catheter lumen wall 115. This view also illustrates the guide element 120 in cross section, with the guide element upper surface 124 adjacent the concave portion 118 of the lumen wall 115 and the guide element lower surface 125 adjacent and conforming to the access needle outer wall 148. The access needle 140 and needle lumen 146 are also shown within the catheter lumen 116.

[0038]

[0052] FIG. 13 is an enlarged view of an alternative configuration of the central portion of FIG. 11 but in a cross-sectional view similar to FIG. 12. Those skilled in the art will understand that the guide element can have any of a variety of upper surface contours 124, lower surface contours 125, right side contours 127, and left side contours 126. Furthermore, variations in the cross-sectional profile or contour of the guide element 120 can enable the guide element to extend along and occupy various portions of the space between the inner catheter wall and the outer needle wall. Additionally or optionally, one or more guide element contours may be complementary to an inner wall recess, guide element track, or one or more guide element track features on, in, or within a portion of the inner catheter lumen wall or the outer needle wall. In one aspect, the guide element upper surface 124 may be contoured or shaped to at least partially conform to the inner catheter lumen wall. Additionally or optionally, the guide element lower surface 126 may be shaped to at least partially conform to the outer access needle wall 148. Similarly, one or more guide element embodiments may utilize variations in the right and left profiles 126, 127 to engage or complement other features provided along the needle or catheter lumen, allowing the guide element to smoothly translate along and beyond the access needle distal end 142. In some embodiments, the distance between the guide element left profile 126 and the guide element right profile 127 ranges from 0.10 mm to 0.36 mm. This distance is considered the width of the guide element. Additionally, in still other embodiments, the distance between the guide element upper surface profile 124 and the guide element lower surface profile 125 ranges from 0.127 mm to 0.203 mm. This distance is considered the thickness of the guide element. In some embodiments, the guide element has a length between 100 mm and 200 mm.

[0039]

[0053] FIG. 14 is a perspective view of the distal end of the catheter and access needle of FIGS. 10 and 1 after the slider 50 has been moved from the proximal position shown in FIG. 1 to a distal position where the guide element 120 has been advanced distally along the outer wall 148 of the access needle to form a loop 128 distal to the tip 144 of the access needle 140. In this exemplary embodiment, the loop 128 extends approximately 1 inch beyond the distal end 144 of the needle 140. This view also shows how the upper and lower profiles of the guide element 120 mate with the catheter guide element notch 115 and the needle outer wall 148. Thus, the guide element 120 can be advanced along the outer surface of the access needle to form the loop 128 beyond the distal end 144 of the needle 140. The deployed guide element 120 extends partially beyond the distal end of the needle. A single complete loop may be formed, or two or more complete loops may be formed. In terms of degrees of rotation about the distal end of the needle, the loop 128 may be greater than 90 degrees, greater than 180 degrees, greater than 270 degrees, or greater than 360 degrees, for one 360-degree rotation or two or more 360-degree rotations. By way of example, the loop 128 in Figures 14 and 15 is greater than 270 degrees. Furthermore, exemplary diameters of the loop 128 range from 1 mm to 3 mm.

[0040]

[0054] Figure 15 is an enlarged view of the guide element loop of Figure 14. Loop 128 is formed in the distal portion of guide element 120 when it is deployed over the distal-most end 144 of access needle 140. This view also shows additional exemplary shapes for guide element upper surface contour 124, lower surface contour 125, right side contour 127, and left side contour 126. Upper surface contour 124 and lower surface contour 125 of guide element 120 conform to the space between the inner wall of the catheter lumen and the outer wall 148 of needle 140.

[0041]

[0055] In some embodiments, the guide element 120 may be formed from PTFE, nylon, or another suitable polymer. Additionally, or optionally, the guide element 120 may include additives to enhance visibility under ultrasound guidance. Exemplary additives include, but are not limited to, titanium dioxide or barium, by way of example only. It should be understood that a variety of materials may be used to form the guide element, such as a mixture of polymers and metals, or metal alloys or shape memory materials, including metal and polymer-based shape memory materials, or Nitinol or Elgiloy, etc. Furthermore, the dimensions and geometries shown in the various guide element embodiments may vary along the length of the guide element. For example, the distal-most portion of the guide element may have a geometry and dimensions targeted toward column strength. The intermediate portion of the guide element 120 may be designed to accommodate a transition from the housing to the catheter lumen without buckling. Furthermore, geometry transitions and variations are not limited to the guide element portion within the guide catheter; the inner lumen wall of the catheter may also be adapted to facilitate the use of various guide element embodiments. Thus, in yet another embodiment, the guide element distal tip design creates a uniform transition with the distal end of the tubular catheter body, preserving ease of catheter insertion. Additionally, the guide element 120 may have a variable thickness proximally relative to the catheter hub to aid in column strength. In some embodiments, the distal surface of the slider will mate with the proximal surface of a needle retainer positioned inside the housing. In some embodiments, there is a hemostasis valve positioned inside the tubular catheter proximal hub 110.

[0042]

[0056] As can be seen through the various views of the figures, aspects of the present invention provide improved methods, systems, and assemblies for performing venipuncture, and particularly for placing an intravascular catheter at a desired site within a patient's veins. While the methods, systems, and assemblies are particularly useful for placing peripheral venous catheters, such as by placement in a vein in the hand or arm, they may also be useful for placing central venous catheters by insertion into a central vein, such as the internal jugular vein in the neck or the subclavian vein in the chest. Additionally, aspects of the vascular access methods, systems, and assemblies may also be useful for placing catheters in central or other arteries.

[0043]

[0057] More generally, an intravascular catheter assembly in accordance with the principles of the present invention includes a tubular catheter body, an access needle, a guide element, and a slider for deploying the guide element. The tubular catheter body has a distal end, a proximal end, at least one lumen therebetween, and a guide element notch formed in the distal end. The access needle has a tissue-penetrating distal tip and a lumen typically therethrough. In a first embodiment, the guide element is disposed in a space or lumen between the outer wall of the access needle and the inner wall of the catheter lumen. In a second embodiment, the guide element is disposed in a space or lumen between the outer wall of the access needle and the inner wall of the catheter lumen. In embodiments, the guide element is disposed outside of and parallel to the access needle, riding along an axial groove, recess, or one or more guide structures or guide elements formed in the inner wall of the catheter lumen. In all embodiments, the guide element (a) has a distal tip configured to conform to the shape and contour of the catheter distal tip in a manner to form a smooth transition (see FIG. 10), thereby maintaining the function of the needle-catheter combination to provide access, and (b) extends distally of the catheter along the needle, forming a partial or complete loop when distal to the needle to facilitate advancement of the catheter through the vasculature.

[0044]

[0058] In one embodiment, the slider of the intravascular vascular access assembly is slidably mounted on a support rail that houses a guide element. The proximal end of the guide element is attached to the slider. In this manner, the guide element can be advanced distally by sliding the slider forward or distally along a slot (FIG. 1) provided in the housing. This motion moves the distal end of the guide element over the outer surface of the access needle to position the distal tip of the guide element beyond the distal end of the catheter (FIG. 14). Once in this configuration, the access needle can be fully or partially retracted, or left in place without retraction, and the catheter and distally-extending guide element can be advanced side by side to position the distal end of the catheter body at the desired site in the vein or other vasculature. By advancing the catheter and protruding guide element side by side, the guide element acts as a "fixed" guide element tip, further simplifying the catheter placement protocol. Additionally, the protruding loops on the distal portion of the guide element help prevent or substantially inhibit the distal tip of the catheter from piercing or kinking the interior wall of the blood vessel.

[0045]

[0059] As shown in various views of Figures 2, 3, 4, 8, and 9, in an additional embodiment, an intravascular access device includes a housing having a needle holder at its distal end attached to the proximal end of an access needle. An access needle 140 is fixedly fastened to the needle holder 130, and the proximal end of the catheter is removably fastened to the distal end of the housing. Thus, a slider 150 can be used to advance a guide element over the distal end of the catheter and access needle, and the housing, access needle, and guide element can be disengaged and removed from the catheter after the catheter is in position at a desired site in the vasculature.

[0046]

[0060] The coupling between the slider 150 and the guide element 120 may be accomplished in any manner that allows the slider to be advanced or retracted to equivalently advance or retract the guide element through the space between the catheter lumen and the outer wall of the access needle. Advantageously, the guide element is positioned on or outside of and along the outer wall of the access needle so that the slider can be directly coupled to the proximal end of the guide element with minimal interference from the access needle.

[0047]

[0061] In yet another aspect of the invention, a method for introducing an intravascular catheter to a target site within a patient's blood vessel includes penetrating the distal tip of an access needle carrying the catheter into a vein. A guide element resides within a guide element notch in the distal tip of the catheter. As a result, introducing the most distal end of the catheter into the blood vessel also positions the distal end of the guide element within the blood vessel. Thus, the needle can be held stationary when reflux of blood is detected and the needle / catheter combination is advanced so that the distal end of the catheter is intravascular. With the needle position held stationary, the slider is advanced from a proximal position shown in FIGS. 1 and 2 to a distal position where the slider resides in a distal portion of a slot along the top of the housing. Proximal-to-distal movement of the slider moves the slider from a position within the guide notch in the catheter distal tip (FIG. 10) to a curved position distal to the penetrating tip of the needle, as best seen in FIGS. 14 and 15. The guide element advances to a deployed state having a closed, complete, or partial loop. It should be understood that the guide element may be pre-shaped 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 approximately 1 inch or 25.4 mm. Other specific spacings between the needle distal tip and the loop may be provided based on the application, clinical needs, and anatomical considerations of the intended lumen.

[0048]

[0062] After the guide element has been advanced, the access needle may optionally be retracted proximally, leaving the guide element in place to aid in positioning the catheter. Optionally, once the catheter is properly positioned within the blood vessel, the access needle and guide element are fully retracted from the catheter, leaving the catheter in place for the desired medical protocol. In one embodiment, depressing the activation button 106 activates a spring-loaded retraction system or activation element 108. When the activation button 106 is depressed or otherwise moved to release the needle holder 130, the activation spring 108 automatically drives the needle holder 130, needle 140, slider 150, and guide element 120 proximally, retracting the access needle 140 and guide element 120 from the patient and at least partially or completely into the housing 101. The catheter hub 110 is then detached from the distal end 103 of the handle or housing 101, leaving the catheter 110 in place for the desired medical protocol, as previously described. The used housing 101 can then be disposed of using appropriate means.

[0049]

[0063] Additional aspects of the structure and operation of catheter placement device 100, including a housing or handle 101 having a mechanism for advancing a catheter-carrying guide structure or element, where the handle is adapted to automatically retract both the access needle and the guide structure or element from the catheter after the placement procedure is complete, a button-activated automatic needle and guide retraction assembly are described in U.S. Patent Publication US2008 / 0300574 and U.S. Patent No. 9,522,254, each of which is incorporated herein by reference in its entirety.

[0050]

[0064] Further details of exemplary intravascular catheter insertion devices and methods are described in U.S. Patent Nos. 5,704,914 and 5,800,395, and U.S. Patent Publications US2010 / 0094310, US2010 / 0210934, and US2012 / 0197200, the entire disclosures of each of which are incorporated herein by reference.

[0051]

[0065] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The appended claims define the scope of the invention, and it is therefore intended to cover methods and structures that fall within the scope of these claims and their equivalents.

[0052]

[0066] As used herein, when a feature or element is referred to as being "on" another feature or element, the feature or element may be directly on the other feature or element, and there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements. When a feature or element is referred to as being "coupled," "attached," or "bonded" to another feature or element, the feature or element may be directly coupled, attached, or bonded to the other feature or element, and there may be intervening features and / or elements. It will also be understood that additional features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may also apply to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being "adjacent" to another feature may have an overlapping or underlying portion of the adjacent feature.

[0053]

[0067] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0054]

[0068] Spatially related terms such as "below," "lower," "below," "above," "upper," and the like may be used herein to describe the relationship of one element or feature to another element or feature shown in the figures for ease of description. It will be understood that spatially related terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if a device in a figure were inverted, an element described as being "below" or "directly below" another element or feature would be oriented "above" the other element or feature. Thus, the exemplary term "below" may encompass both an above and below orientation. A device may be oriented in other ways (rotated 90 degrees or at other orientations), and the spatially related descriptors used herein will be interpreted accordingly. Similarly, unless specifically indicated otherwise, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only.

[0055]

[0069] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context clearly indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0056]

[0070] Unless the context requires otherwise, throughout this specification and the claims that follow, the word "comprise," as well as variations such as "comprises" and "comprising," mean that various components may be employed together in methods and articles (e.g., compositions and apparatuses, including apparatus and methods). For example, the term "comprising" is understood to imply the inclusion of any stated element or step, but not the exclusion of any other element or step.

[0057]

[0071] As used herein in the specification and claims, including when used in the examples, and unless expressly specified otherwise, the term is intended to be unambiguous. All numbers may be read as if preceded by the word "approximately" or "about," even if they do not appear in the specification. The phrase "approximately" or "about" may be used when describing a size and / or location to indicate that the stated value and / or location falls within an expected reasonable range of values ​​and / or locations. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Unless the context clearly indicates otherwise, any numerical value given herein should also be understood to include approximately that value or approximately that value. For example, if the value "10" is disclosed, then "approximately 10" is also disclosed. Any numerical range stated herein is intended to include all subranges subsumed therein. As will be appreciated by those of skill in the art, when a value is disclosed, it is understood that "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between the values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. It is also understood that throughout this application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only between 10 and 15, but also greater than or equal to 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are considered to be disclosed. It is also understood that each unit amount between two specific unit amounts is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0058]

[0072] While various exemplary embodiments have been described above, any of a number of changes may be made to the various embodiments without departing from the scope of the present invention, as set forth by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the present invention, as set forth in the claims. The examples and examples included herein indicate specific embodiments in which the subject matter may be practiced, for purposes of illustration, not limitation. As mentioned, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention," merely for convenience and without any intention to intentionally limit the scope of this application to any single invention or inventive concept where more than one is actually disclosed. Thus, although specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to include any and all modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. a handle having a proximal end and a distal end, wherein a slot in a surface of the handle has a distal end and a proximal end; an actuation button on the handle coupled to a needle holder; a tubular catheter body having a distal end, a guide element cutout at the distal end, a proximal end, and a lumen extending between the proximal end and the distal end, the proximal end being coupled to the distal end of the handle; an access needle disposed within the tubular catheter body lumen, the access needle having a tissue-piercing distal tip extending distally beyond the distal end of the tubular catheter body and a proximal end coupled to the needle holder; a guide element having a proximal end and a distal end, the guide element positioned within the catheter body lumen and adjacent an outer wall of the access needle, the distal end portion of the guide element being shaped to provide a uniform transition when the distal end portion is within the guide element notch, such that the access needle and the guide element can be retracted together from the tubular catheter body after the distal-most portion of the guide element has been advanced along the outer wall of the access needle from the tubular catheter body lumen to a position distal to the tissue-penetrating distal tip of the access needle; a slider coupled to the proximal end of the guide element, wherein distal advancement of the slider causes a distal tip portion of the guide element to advance distally from a position within the guide element notch along the outer wall of the access needle; Equipped with Intravascular catheter assembly.

2. When the slider is in its distal-most position, a distal portion of the guide element bends beyond the tissue-piercing distal tip of the access needle.

10. The intravascular catheter assembly of claim 1.

3. When the slider is in its distal-most position, the distal portion of the guide element curves from a position above the access needle, past the tissue-piercing distal tip of the access needle, to a position below the access needle.

10. The intravascular catheter assembly of claim 1.

4. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is less than 360 degrees; 4. The intravascular catheter assembly of claim 3.

5. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is greater than 270 degrees; 4. The intravascular catheter assembly of claim 3.

6. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is less than 270 degrees; 4. The intravascular catheter assembly of claim 3.

7. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is greater than 180 degrees; 4. The intravascular catheter assembly of claim 3.

8. the slider is disposed on a proximal region of the access needle; 10. The intravascular catheter assembly of claim 1.

9. a housing attached to the proximal end of the access needle; The sliding portion is provided on the housing.

10. The intravascular catheter assembly of claim 1.

10. the access needle is fixedly fastened to the distal end of the housing; the tubular catheter body is removably fastened to the distal end of the housing; the slider advances the guide element over the distal end of the catheter; The housing, the access needle, and the guide element may be detached and removed from the catheter after the catheter is in place.

10. The intravascular catheter assembly of claim 9.

11. a proximal region of the catheter disposed within the housing; the proximal end of the catheter and the proximal end of the access needle are configured to be engaged by the slider after the guide element is extended distally beyond the distal end of the catheter to advance the catheter and the needle relative to the housing alongside the guide element.

11. The intravascular catheter assembly of claim 10.

12. the access needle having a lumen; the guide element is disposed outside the access needle lumen; 10. The intravascular catheter assembly of claim 1.

13. the housing having an axial slot; the proximal end of the guide element is coupled to the slider to allow movement along the axial slot; 10. The intravascular catheter assembly of claim 9.

14. the axial slot is closed on the distal and proximal regions of the access needle; 14. The intravascular catheter assembly of claim 13.

15. a link between the guide element and the slider is provided within the slot with a travel length defined by both closed ends of the slot; 15. The intravascular catheter assembly of claim 14.

16. the guide element is slidably mounted within a guide structure within the catheter body lumen; 10. The intravascular catheter assembly of claim 1.

17. the guide structure holds the guide element in position along the uppermost portion of the access needle.

17. The intravascular catheter assembly of claim 16.

18. the guiding structure being a pair of features extending from the inner wall of the catheter body and projecting into the catheter body lumen; 17. The intravascular catheter assembly of claim 16.

19. When the guide structure is positioned between the pair of extending features, the guide structure is positioned along an upper surface of an outer wall of the access needle.

20. The intravascular catheter assembly of claim 18.

20. The guide structure is a distal-most portion adjacent the guide element cutout; a proximal portion more than 1 cm from the guide element notch; having 17. The intravascular catheter assembly of claim 16.

21. the guide structure having a distal-most portion adjacent the guide element notch and a proximal portion; the guiding structure is continuous along the inner wall of the catheter body lumen from the proximal end to the distal end.

17. The intravascular catheter assembly of claim 16.

22. the tubular catheter body having a proximal hub with a hemostatic valve; the access needle slidably extends through the hemostasis valve; 10. The intravascular catheter assembly of claim 1.

23. the slider having a distal surface that mates with a proximal surface of the needle holder when the slider is fully advanced distally to extend the guide element.

23. The intravascular catheter assembly of claim 22.

24. the slider releasably locks onto the proximal end of the needle holder when the distal surface mates with the proximal surface.

24. The intravascular catheter assembly of claim 23.

25. a first configuration when the slider is in a proximal-most position, the distal end of the guide element residing within the guide element notch and the tissue-penetrating distal tip of the needle being distal to the distal-most end of the tubular catheter body; a second configuration when the slider is in a distal-most position, the distal-most end of the guide element extending beyond the guide notch and bending beyond the tissue-piercing distal tip of the needle; a third configuration when the slider is in a position proximal to the distal-most position and the needle and guide element are at least partially retracted into the housing; and Further provided with 10. The intravascular catheter assembly of claim 1.

26. 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; the proximal end of the slider is recessed from the proximal end of the tubular catheter body by a distance in the range of 10 mm to 100 mm; 26. The intravascular catheter assembly of claim 25.

27. In the second configuration, the length of the guide element extending beyond the guide cutout in the tubular catheter body is between 5 mm and 100 mm.

26. The intravascular catheter assembly of claim 25.

28. the guide element has a length greater than its width and a width greater than its thickness; 28. An assembly according to any preceding claim.

29. the guide element is made entirely or partly of a polymer material, PTFE, nylon; 28. An assembly according to any preceding claim.

30. the guide element being made entirely or partly of metal, including Nitinol, Elgiloy or similar materials; 28. An assembly according to any preceding claim.

31. The guide element is an upper surface conforming to the curvature of the inner wall of the catheter body lumen; a lower surface conforming to the curvature of the outer wall of the access needle; Further provided with 28. An assembly according to any preceding claim.

32. The catheter the catheter component of the infusion set; catheter components of blood collection sets; Catheter component of blood collection set with safety wing, or a catheter component of an intravenous catheter is configured to be used as, 32. An assembly according to any one of claims 1 to 31.

33. a tubular catheter body having a proximal hub, a guide element cutout at a distal-most end, and a catheter body lumen extending from the proximal end to the distal end; an access needle disposed within the catheter body lumen and having a tissue-piercing distal tip extending distally beyond the distal end of the tubular catheter body; a guide element within the catheter body lumen and exterior to the access needle, the guide element having an upper surface that conforms to the curvature of the inner wall of the catheter body lumen, a lower surface that conforms to the curvature of the outer wall of the access needle, and a distal tip shaped to form a uniform transition with the guide element notch at the distal-most end of the catheter body; a slider coupled to the proximal end of the guide element, wherein distal advancement of the slider advances the distal tip of the guide element from a first position at the guide element notch to a second position where the distal portion of the guide element curves beyond the tissue-piercing distal tip of the access needle, the slider having a distal surface that mates with a proximal surface of the needle holder when the slider is fully advanced distally to extend the guide element; Equipped with Intravascular catheter assembly.

34. the slider releasably locks to the proximal hub when the distal surface of the slider mates with the proximal surface of the needle holder.

34. The assembly of claim 33.

35. the guide element has a length greater than its width and a width greater than its thickness; 34. The assembly of claim 33.

36. the guide element is a polymer; 34. The assembly of claim 33.

37. advancing a tissue-penetrating distal tip of an access needle of an intravascular catheter assembly into a blood vessel of a patient; advancing a guide structure from a first position in which a distal portion of the guide structure forms a uniform transition within a guide notch in the distal portion of the catheter hub to a second position in which a portion of the guide structure is advanced along an outer wall of the access needle beyond the distal-most portion of the catheter hub; advancing the guide structure along the patient's blood vessel to a third location beyond the tissue-piercing distal tip of the access needle; advancing a distal portion of the catheter hub along the guide structure and into the blood vessel; automatically retracting the needle and the guide structure into the intravascular catheter assembly; Including, A method of accessing a patient's blood vessels.

38. and ceasing to advance the tissue-penetrating distal tip of the access needle of the intravascular catheter assembly when backflow of blood is observed within the intravascular catheter assembly.

38. The method of claim 37.

39. and ceasing to advance the tissue-penetrating distal tip of the access needle when a distal-most portion of the catheter hub of the intravascular catheter assembly is within the blood vessel of the patient.

38. The method of claim 37.

40. and ceasing to advance the tissue-penetrating distal tip of the access needle when a distal-most portion of the guide structure of the intravascular catheter assembly is within the blood vessel of the patient.

38. The method of claim 37.

41. and after performing the advancing of the guide structure beyond the tissue-penetrating distal tip of the access needle, a distal portion of the guide element is curved beyond the tissue-penetrating distal tip of the access needle.

38. The method of claim 37.

42. after performing the advancing of the guide structure past the tissue-piercing distal tip of the access needle, the distal portion of the guide element curves from a position above the access needle, past the tissue-piercing distal tip of the access needle, to a position below the access needle.

38. The method of claim 37.

43. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is less than 360 degrees; 43. The method of claim 42.

44. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is greater than 270 degrees; 43. The method of claim 42.

45. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is less than 270 degrees; 43. The method of claim 42.

46. the angle of curvature formed by the distal portion of the guide element relative to the tissue-piercing distal tip of the access needle is greater than 180 degrees; 43. The method of claim 42.

47. 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; a lumen within the hub and the tubular body, bounded by an inner wall of the tubular body, the lumen having a proximal opening at the hub proximal end and a distal opening at the tubular body distal tip; a guide element notch at the distal tip of the tubular body; Equipped with Intravascular catheter.

48. a guide element recess formed within and extending therealong at least a distal portion of the tubular body inner wall; 48. The intravascular catheter of claim 47.

49. a guide element recess formed in and extending therealong the tubular body inner wall; 48. The intravascular catheter of claim 47.

50. a guide element recess formed in and extending along the tubular body inner wall from the hub distal end to the tubular body distal end; 48. The intravascular catheter of claim 47.

51. the guide element recess is wider than the guide element cutout; The intravascular catheter according to any one of claims 48 to 50.

52. a guide element track along the tubular body inner wall longitudinally aligned with the guide element notch.

48. The intravascular catheter of claim 47.

53. the guide element track along the tubular body inner wall longitudinally aligned with the guide element cutout is formed by a concave portion of the tubular body inner wall alone or in combination with one or more guide element track features extending from or formed in the tubular body lumen inner wall; a portion of the guide element track conforms to at least a portion of a guide element upper surface contour, a guide element lower surface contour, a guide element left side contour, or a guide element right side contour; 53. The intravascular catheter of claim 52.

54. the intravascular catheter the catheter component of the infusion set; catheter components of blood collection sets; Catheter component of blood collection set with safety wing, or a catheter component of an intravenous catheter is configured to be used as An intravascular catheter according to any one of claims 47 to 53.

55. the distance between the guide element left contour 126 and the guide element right contour 127 is in the range of 0.10 mm to 0.36 mm; or the distance between the guide element upper surface contour 124 and the guide element lower surface contour 125 is in the range of between 0.127 mm and 0.203 mm; A guiding element or structure according to any one of the preceding claims.

Images