Intravascular catheter with integrated guide structure

Abstract

Endovascular access is achieved by introducing a catheter with a guide element recess placed to receive the contoured distal end of a guide element. The guide element can be advanced along the outer surface of the access needle to form a loop over the distal end of the needle. Once over the distal end of the needle, the deployed guide element can form a partial or complete loop. After the catheter has been properly positioned, the access needle and guide element can be removed by automatic retraction, leaving the catheter in place within the blood vessel and available for use.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 088,979, entitled “INTRAVASCULAR CATHETER WITHINTEGRATED GUIDE STRUCTURE”, filed on October 7, 2020.

[0003] By incorporating references

[0004] All publications and patent applications mentioned in this specification are incorporated herein by reference to the same extent that each individual publication or patent application is specifically and individually indicated to be incorporated by reference.

[0005] Statement on Federally Funded Research

[0006] This invention did not receive government support.

[0007] field

[0008] This invention generally relates to methods and systems for performing vascular access. More specifically, the invention provides a catheter and needle assembly having an integrated guiding element or structure for percutaneous insertion of the catheter into a patient's arterial or venous vascular system.

[0009] background

[0010] A common method of blood vessel access is called venipuncture. Venipuncture generally refers to the procedure of obtaining access to a vein for any of a variety of purposes, including intravenous infusion, treatment, blood sampling, etc. For example, in hospitals, venipuncture is commonly used to place small venous catheters for the delivery of intravenous fluids, medications, blood sampling, etc.

[0011] While venipuncture and other forms of vascular access may be a simple matter in relatively healthy patients, they are often necessary in unhealthy patients who 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, especially for inexperienced venipuncturists, nurses, and other healthcare professionals.

[0012] Besides the difficulty in establishing access, many vascular catheter placement systems can lead to accidental punctures and / or accidental needle contamination during or after endovascular catheter placement. Furthermore, some conventional catheter placement devices employ relatively complex deployable handle movements, which increases cost and complexity. Additionally, conventional handle placement and movement can obscure the presence and status of the needle and tool's guiding structure or guiding element components, making the use of the insertion tool less intuitive.

[0013] For these reasons, there is a desire to provide improved methods, systems, and tools for deploying intravascular catheters using needles and guiding structures. In particular, there is a desire to provide simplified deployment systems and components with fewer parts, and even more so, components that are clearly visible to the user and configured for direct, intuitive use and manipulation. At least some of these objectives will be met by the following various embodiments.

[0014] Overview of this disclosure

[0015] In general, in one embodiment, the intravascular catheter assembly includes: a handle having a proximal end and a distal end, and a groove in the surface of the handle having both the distal and proximal ends; an actuation button located on the handle and coupled to a needle holder; a tubular catheter body having a distal end, a guiding element incision located in the distal end, a proximal end, and an inner lumen extending between the proximal and distal ends, the proximal end of the catheter body being coupled to the distal end of the handle; and an access needle disposed within the inner lumen of the tubular catheter body having a tissue-penetrating distal end extending distally beyond the distal end of the tubular catheter body. The needle tip and the proximal end of the needle holder are connected; a guide element having a proximal and a distal end, the guide element being positioned within the lumen of the tubular catheter body and adjacent to the outer wall of the entry needle, the distal portion of the guide element being shaped to provide a uniform transition when the distal portion is within the guide element incision, wherein the entry needle and the guide element can be withdrawn together from the tubular catheter body after the distal portion of the guide element has advanced along the outer wall of the entry needle from within the lumen of the tubular catheter body to a position distal to the tissue penetration distal end of the entry needle; and a slider connected to the proximal end of the guide element such that distal advancement of the slider causes the distal distal end portion of the guide element to advance distally along the outer wall of the entry needle from its position within the guide element incision.

[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 can bend 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 bend 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 can be disposed on the housing. The insertion needle can be securely fixed to the distal end of the housing, and the tubular catheter body can be detachably fixed to the distal end of the housing. A slider allows the guide element to advance beyond the distal end of the catheter, and wherein, after the catheter is in place, the housing, insertion needle, and guide element can be detached and removed from the catheter. A proximal region of the catheter can be disposed within the housing, and wherein the proximal ends of the catheter and the insertion needle are configured to engage via the slider to allow the catheter and needle, along with the guide element, to advance cooperatively relative to the housing after the guide element has extended distally beyond the distal end of the catheter. The insertion needle can have an inner lumen, and the guide element can be disposed outside the inner lumen of the insertion needle. The housing can have an axial groove, and the proximal end of the guide element can be connected to the slider, thereby allowing movement along the axial groove. The axial groove can be closed in both the distal and proximal regions of the insertion needle. A connection between the guide element and the slider can be disposed in the groove, wherein the travel length is defined by the closed end of the groove. The guide element can be slidably disposed within a guide structure or guide element within the lumen of the catheter body. The guide structure can hold the guide element in a position along the uppermost part of the insertion needle. A guiding structure may be a pair of features extending from the inner wall of the catheter body and protruding into the lumen of the catheter body. When the guiding element or guiding structure is positioned between the extending pair of features, the guiding structure may be positioned superiorly along the outer wall of the entry needle. The guiding structure may have a distal portion adjacent to the guiding element incision and a proximal portion greater than 1 cm from the guiding element incision. The guiding structure may have a distal portion adjacent to the guiding element incision and a proximal portion, wherein the guiding structure or guiding element is continuous from proximal to distal along the inner wall of the catheter body lumen. The tubular catheter body may have a proximal hub with a hemostatic valve, through which the entry needle can slide through the hemostatic valve.The slider may have a distal side that mates with a proximal side of the needle holder when the slider is fully advanced distally to extend the guiding element. When the distal side mates with the proximal side, the slider can be detachably locked to the proximal end of the needle holder. The intravascular catheter assembly may further include: a first configuration when the slider is in the proximal position, wherein the distal end of the guiding element is located in a guiding element incision, and the tissue-penetrating 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 guiding element extends beyond the guiding incision and bends beyond the tissue-penetrating distal end of the needle; and a third configuration when the slider is in a position close to the distal position and the needle and guiding element are at least partially retracted into the housing. In the first configuration, the distal end of the needle may extend beyond the distal end of the tubular catheter body by a distance ranging from 0.1 mm to 20 mm, and the proximal end of the slider is retracted from the proximal end of the tubular catheter body by a distance ranging from 10 mm to 100 mm. In the second configuration, the length of the guiding element extending beyond the guiding incision of the tubular catheter body can be from 5 mm to 100 mm. The guiding element can have a length greater than its width and a width greater than its thickness. The guiding element can be made wholly or partially of a polymeric material, PTFE, or nylon. The guiding element can be made wholly or partially of a metal, including nitinol, Elgiloy, or similar materials. The guiding element may also include an upper surface adapted to the curvature of the inner wall of the catheter body lumen and a lower surface adapted to the curvature of the outer wall of the needle. The catheter can be configured as a catheter component in 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, the intravascular catheter assembly includes: a tubular catheter body having a proximal hub, a guide element incision at its distal end, and a catheter body lumen extending from the proximal end to the distal end; an entry needle disposed within the catheter body lumen and having a distally extending tissue-penetrating distal end beyond the distal end of the tubular catheter body; and a guide element located within the catheter body lumen and outside the entry needle, the guide element having an upper surface adapted to the curvature of the catheter body inner wall and an outer wall adapted to the entry needle. The lower surface of the curvature and the distal end shaped to form a uniform transition with the guide element incision at the most distal end of the catheter body; and a slider coupled to the proximal end of the guide element such that distal advancement of the slider advances the distal end of the guide element from a first position at the guide element incision to a second position, in which the distal position of the guide element bends beyond the tissue penetration distal end of the needle, wherein the slider has a distal side that mates with the proximal side of the needle holder when the slider is fully advanced distally to extend the guide element.

[0018] This embodiment and other embodiments may include one or more of the following features: The slider can be detachably locked to the proximal hub when the distal side of the slider mates with the proximal side of the needle holder. The guide element can have a length greater than its width and a width greater than its thickness. The guide element can be a polymer.

[0019] In general, in one embodiment, a method of accessing a patient's blood vessel includes: advancing a tissue-penetrating distal end of an entry needle of an intravascular catheter assembly into the patient's blood vessel; advancing a guide structure from a first position to a second position, wherein in the first position, a distal portion of the guide structure forms a uniform transition within a guide incision in the distal portion of a catheter hub, and in the second position, a portion of the guide structure advances along the outer wall of the entry needle beyond the most distal portion of the catheter hub; advancing the guide structure along the patient's blood vessel to a third position beyond the tissue-penetrating distal end of the entry needle; advancing the distal portion of the catheter hub along the guide structure within the blood vessel; and automatically withdrawing the needle and guide structure into the intravascular catheter assembly.

[0020] This embodiment and other embodiments may include one or more of the following features. The method of entering a blood vessel may further include stopping the advance of the tissue-penetrating distal end of the entry needle of the intravascular catheter assembly when blood backflow is observed in the intravascular catheter assembly. The method of entering a blood vessel may further include stopping the advance of the tissue-penetrating distal end of the entry needle when the most distal portion of the catheter hub of the intravascular catheter assembly is within the patient's blood vessel. The method of entering a blood vessel may further include stopping the advance of the tissue-penetrating distal end of the entry needle when the most distal portion of the guiding structure of the intravascular catheter assembly is within the patient's blood vessel. After advancing the guiding structure beyond the tissue-penetrating distal end of the entry needle, the distal portion of the guiding element may bend beyond the tissue-penetrating distal end of the entry needle. After advancing the guiding structure beyond the tissue-penetrating distal end of the entry needle, the distal portion of the guiding element may bend from a position above the entry needle, beyond the position of the tissue-penetrating 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 guiding element relative to the tissue-penetrating distal end of the entry needle may be less than 360 degrees. The angle of curvature formed by the distal portion of the guide element relative to the distal tip of the needle penetrating the tissue can be greater than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the distal tip of the needle penetrating the tissue can be less than 270 degrees. The angle of curvature formed by the distal portion of the guide element relative to the distal tip of the needle penetrating the tissue can be greater than 180 degrees.

[0021] In general, in one embodiment, the 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 end, the tubular body having an outer wall and an inner wall; an inner lumen within the hub and the tubular body, the inner lumen being defined by the inner wall of the tubular body, the inner lumen having a proximal opening at the proximal end of the hub and a distal opening at the distal end of the tubular body; and a guide element incision in the distal end of the tubular body.

[0022] This embodiment and other embodiments may include one or more of the following features. The intravascular catheter may further include a guide element recess formed within at least a distal portion of the inner wall of the tubular body and extending along at least a distal portion of the inner wall of the tubular body. The intravascular catheter may further include a guide element recess formed within and extending along the inner wall of the tubular body. The intravascular catheter may further include a guide element recess formed within and extending along the inner wall of the tubular body from the hub distal end to the distal end of the tubular body. The guide element recess may be wider than the guide element incision. The intravascular catheter may further include a guide element rail longitudinally aligned with the guide element incision along the inner wall of the tubular body. The guide element rail, longitudinally aligned with the guide element cut along the inner wall of the tubular body, can be formed solely by a recessed portion of the inner wall of the tubular body, or by a combination of the recessed portion of the inner wall of the tubular body and one or more guide element rail features extending from or formed within the inner wall of the tubular body lumen. A portion of the guide element rail is adapted to at least a portion of the upper surface profile, lower surface profile, left side profile, or right side profile of the guide element. The intravascular catheter can be configured as a catheter component in an infusion device, a catheter component in a blood collection device, a catheter component in a safety wing-type blood collection device, or a catheter component in a venous catheter. Brief description of the attached diagram

[0024] In particular, the novel features of the invention are set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings, which illustrate illustrative embodiments utilizing the principles of the invention, in which:

[0025] Figure 1 This is a perspective view of an embodiment of an intravascular access device having a catheter, a guiding element, and a needle assembly.

[0026] Figure 2 yes Figure 1 A cross-sectional view of the intravascular access device shows the catheter, guiding element and needle assembly, actuation button, support rail and slider in the proximal position.

[0027] Figure 3 yes Figure 1 The top perspective view of the distal housing and catheter hub shows details of the needle, guide element, and needle holder inside the catheter hub.

[0028] Figure 4 yes Figure 3 An enlarged top perspective view of the distal housing and catheter hub shows details of the needle, guide element, needle holder, and needle holder groove inside the catheter hub.

[0029] Figure 5 yes Figure 3 A perspective view of a longitudinal section of the intravascular access device, showing additional details of the needle holder relative to the actuation button and the guide element relative to the support rail and the outer wall of the access needle.

[0030] Figure 6 It is closer to Figure 4 Watching Figure 1 A top view of a portion of an intravascular catheter, showing additional details of the distal end of the needle holder relative to the guide element and support track within the longitudinal groove of the needle holder.

[0031] Figure 7 It is similar to Figure 6 The upper view of a portion of the internal view shows the proximal end of the needle holder relative to the slider, guide element, and support rail.

[0032] Figure 8 yes Figure 1 and Figure 3 The upper perspective view of the distal portion of the intravascular access device shows the interior of the catheter hub, including the needle holder, needle, guide element, and support rail.

[0033] Figure 9 Is Figure 8 A perspective close-side view of the component seen in the image.

[0034] Figure 10 yes Figure 1 An enlarged view of the distal end of the endovascular device, showing the distal end of the insertion needle relative to the distal end of the catheter with the guide element incision and the distal end of the guide element within the guide element incision.

[0035] Figure 11 yes Figure 10 The distal view of the cross-sectional view of the vascular access device shows the relationship between the inner wall of the catheter, the guiding element, and the outer wall of the access needle.

[0036] Figure 12 yes Figure 11 An enlarged view of the central portion of the view shows the recessed portion of the catheter lumen wall, the upper surface of the guide element adjacent to the recessed portion of the lumen wall, and the lower surface of the guide element adjacent to and adapted to enter the outer wall of the needle.

[0037] Figure 13 It is similar to Figure 12 The view is Figure 11 The magnified view of the central portion of the view provides additional explanation of the various contours of the guide element between the outer wall of the needle, the inner wall of the catheter lumen, and these structures positioned within the vascular device.

[0038] Figure 14 The slider has already moved from... Figure 1 After the proximal position shown is moved to the distal position, Figure 10 and Figure 1 A perspective view of the catheter and the distal end of the inlet needle, wherein, in the distal position, the guiding element advances distally along the outer wall of the inlet needle to form a loop at the distal position of the inlet needle tip.

[0039] Figure 15 yes Figure 14 An enlarged view of the guide element ring.

[0040] Detailed description

[0041] Figure 1 This is a perspective view of an embodiment of an endovascular access device 100 having a catheter 110, a guiding element 120, and a needle assembly. In this configuration, an endovascular catheter with an integrated guiding structure or guiding element is prepared for positioning the catheter within a selected portion or lumen of the vascular system based on clinical needs. The catheter hub 110 is coupled to the distal end 103 of the handle 101, and the access needle 140 is positioned appropriately within the catheter lumen 116. In this view, the catheter hub 110 is transparent to show the positions of the needle holder 130 and the guiding element 120.

[0042] The handle or housing 101 has a proximal end 102 and a distal end 103. A groove 105 extends along the length, providing passage for a slider 150 to engage with a guide element 120 and to move along a support track 109 within the interior of the handle 101. The slider 150 includes a grip portion 152 and is shown in the proximal position used when the needle 140 is positioned in the catheter 110 and ready for insertion into the patient's vascular system. The catheter 110 has a distal end 114 and a proximal end 112, as well as an internal lumen 116 along its length. The proximal end 112 is adapted and configured to engage with the distal end 103 of the handle. The proximal end 112 is also configured to engage with a conventional medical conduit connection once inserted and the handle 101 is removed. For example, the proximal end 112 may include features for engagement with a Luer lock, fluid coupling, or other suitable medical connector or accessory.

[0043] Figure 2 yes Figure 1A cross-sectional view of the intravascular access device shows a catheter 110, a guide element 120, a needle holder 130, an actuation button 106, a support rail 109, and a slider 150 in a proximal position. This is the "ready to use" configuration. The proximal end 122 of the guide element is attached to the sliding tab 154. The guide element 120 extends along the support rail 109 beyond the distal end 132 of the needle holder, into the catheter lumen 116, and extends along the catheter lumen 116. The guide element 120 is located between the outer wall 148 of the needle and the inner wall 115 of the catheter lumen. As a result, as the slider 150 advances along the groove 105, the guide element advances along the support rail 109, along and beyond the distal ends of the catheter and needle, to form an atraumatic loop or partial loop or bend to cover the sharp distal end 144 of the needle (see [link to original text]). Figure 14 and Figure 15 ).

[0044] The catheter lumen 116 is also visible in this view. The needle 140 has a pointed distal end 144 for penetrating the skin and blood vessel walls. The proximal end 142 of the needle terminates within the needle holder 130. When the actuation button is released, the actuation element 108 moves the needle holder 130 toward the proximal end 102 of the housing. The movement of the needle holder 130 within the handle 101 is sufficient such that the pointed distal end 144 of the needle 140 is completely within the housing 101. The needle holder 130 also includes a support rail groove 138 along its length, which is sized to receive a support rail 109.

[0045] To see the details of the needle holder 130, an actuating element 108 is included but not shown in this view. The actuating element 108 may 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 distal recess 134 of the needle holder, which then allows the actuating element 108 to expand and push the needle holder 130, along with the needle 140, toward the proximal end 102 of the handle.

[0046] Figure 3 yes Figure 1 A top perspective view of the distal housing 103 and catheter hub 110, showing details of the needle 140, guide element 120, and needle holder 130 inside 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.

[0047] Figure 4 yes Figure 3An enlarged top perspective view of the distal housing 103 and catheter hub 110 shows details of the needle 140, guide element 120, needle holder 130, and needle holder support track groove 138 within the catheter hub 110. In this view, the needle 140 is shown exiting the catheter lumen 116 and entering the needle holder lumen 146. The proximal end of the needle 140 terminates within and is secured to the needle holder 130.

[0048] Figure 5 yes Figure 3 A perspective view of a longitudinal section of the intravascular access device 100 shows additional details of the needle holder 130 relative to the actuation button 106 and the guide element 120 relative to the support rail 109 and the outer wall 148 of the access needle. The proximal end 112 of the catheter hub is shown coupled to the distal end 103 of the housing or handle. Additional details of the guide element relative to other components are also understood. The guide element 120 extends along the support rail 109, the distal end of the groove 138, into the gap between the outer wall of the needle and the inner wall 115 of the catheter lumen. Additionally, the needle 140 is shown relative to the proximal end 116 of the catheter lumen and the inner lumen 146 of the needle holder. The proximal end 142 of the needle terminates in the blood return chamber 135 within the needle holder 130. All or part of the needle holder 130 or handle 101 may be transparent to allow visual detection of fluid or blood return or bleeding return once the distal end 144 of the needle has entered the target vessel.

[0049] Figure 5 The relationship between the actuation latch 107 and the associated needle holder recess 134 is also shown. When in a loaded or erect configuration, the latch 107 engages with the recess 134 to provide resistance against the recoil force of the actuating element 108. Pressing the actuation button 106 disengages the latch 107 from the needle holder recess 134, allowing the spring force or stored energy of the actuating element 108 to push the needle holder 130 toward the proximal end 102 of the handle. The view also shows the support rail 109 terminating within the distal end 103 of the housing.

[0050] Figure 6 It is closer to Figure 4 View of Figure 1 A top view of a portion of an intravascular catheter, showing additional details of the distal end 132 of the needle holder 130 relative to the guide element 120 and support rail 109 within the longitudinal groove 138 of the needle holder. The guide element 120 can be seen along the upper surface of the support rail 109, transitioning from the distal end of the support rail beyond the distal end 132 along the outer wall 148 of the needle into the catheter lumen 116. The arrangement of the support rail 109 to the needle holder support rail groove 138 allows the support rail to function as a monorail of the needle holder during retraction (i.e., when the stored energy of the actuating element 108 is released). The support rail 109 also supports the guide element 120 during the advance of the slider 150.

[0051] Figure 7 It is similar to Figure 6 This is a top view of a portion of the internal view, showing the proximal end of the needle holder 132 relative to the slider 150, guide element 120, and support rail 109. A sliding tab 154 of the slider 150 extends through a groove 105. The sliding tab includes a key plate 156 with a hole 158. The hole 158 is sized, shaped, and positioned to accommodate features of the guide element 120 and the support rail 109. Advantageously, the arrangement of the slider 150 and the support rail 109 allows the support rail 109 to allow the slider 150 to translate freely backward / forward. The guide element 120 has a proximal end 122, which is connected to the slider using the sliding tab 154 or other suitable structure. The support rail 109 extends through the sliding tab and connects to the proximal end 102 of the housing. Furthermore, this view also shows the relationship of the proximal end 132 of the needle holder, which is sized and positioned such that it engages with the sliding tab 154 during retraction. Rearward movement of the needle holder will cause the proximal end 132 of the needle holder to engage with the sliding tab 154 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 to simultaneously retract the needle and the guide element into the handle or housing.

[0052] Figure 8 yes Figure 1 and Figure 3 This is an upper perspective view of the distal portion 103 of the intravascular access device 100, showing the interior of the catheter hub 110, which includes a needle holder 130, a needle 140, a guide element 120, and a support rail 109. This is another view showing the placement of the guide element 120 along the support rail 109, extending beyond the needle holder and into the catheter lumen. The view also shows the support rail groove 138 along the length of the needle holder 130 relative to the proximal end 131 and distal recess 134 of the needle holder.

[0053] Figure 9 Is Figure 8 A perspective near-side view of the needle holder 130 and other components. The blood chamber 135 is visible within the proximal end 131 of the needle holder. The normally present cap for the chamber 135 has been removed to reveal the interior.

[0054] Figure 10 yes Figure 1 An enlarged view of the distal end of the endovascular device 100, showing the distal end 144 of the insertion needle 140 relative to the distal end 114 of the catheter with the guide element incision 115 and the distal end 123 of the guide element 120 within the guide element incision 115.

[0055] The distal end 123 of the guide element is molded / manufactured to mimic the geometry of the catheter tip 114. The guide element 120 is positioned in the space between the inner wall or inner diameter of the catheter lumen and the outer wall or outer diameter of the needle. In one embodiment, the guide element 120 is made of a polymeric material. The guide element 120 may also be pre-formed or shape-defined, or have shape memory properties, thereby forming a complete loop, partial loop, or multiple loops once extended beyond the distal end 144 of the needle (see...). Figure 14 and Figure 15 ).

[0056] In a similar manner, the distal end of the catheter includes a guide element incision 115. The guide element incision 115 is shaped to receive and fit the distal end of the guide element and to maintain the smoothness and finish of the distal end of the catheter. Figure 10 The view shown is an example of how the shaped distal end of the guide element fits into the guide element cutout at the catheter tip. It is also a view of the uniform transition between the catheter and the distal guide element contours, ensuring a smooth transition from the catheter tip to the needle and a smooth periphery of the catheter tip.

[0057] Figure 11 yes Figure 10 The distal view in a cross-sectional view of the vascular access device shows the relationship between 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 space within the catheter lumen along the outer wall of the access needle and the inner wall of the catheter lumen. Optional catheter designs include a groove 118 recessed into the inner wall of the catheter lumen, which corresponds to a portion of the upper surface shape 124 or profile of the guide element. The catheter groove 118 facilitates holding the guide element 120 in place along the catheter and translating it along the outer wall 148 of the needle.

[0058] Additionally or optionally, the guide element design of the upper surface profile 124 and the lower surface profile 125 may correspond to one or both of the inner wall of the catheter lumen and the outer wall of the needle, or to other alignment elements within the catheter lumen. Optionally, in other additional embodiments, the outer wall of the needle 148 may include a groove or recess for an embodiment in which the guide element 120 is shaped and configured to operate in a configuration opposite to that shown in this view. See [link to previous section] Figure 12 and Figure 13 The enlarged view shown illustrates additional details of an alternative embodiment of the catheter-guide element-needle.

[0059] Figure 12 yes Figure 11This is an enlarged view of the central portion of a cross-sectional view. The view shows the exemplary location and shape of the recessed portion 118 of the catheter inner 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 recessed portion 118 of the inner wall 115, and the lower surface 125 of the guide element is adjacent to and adapted to enter the outer wall 148 of the needle. The entry needle 140 and the needle lumen 146 are also shown within the catheter lumen 116.

[0060] Figure 13 yes Figure 11 An enlarged view of the central portion of the cross-sectional view, but similar to an alternative configuration. Figure 12 Those skilled in the art will understand that the guide element can have any of a variety of upper surface profiles 124, lower surface profiles 125, right side profiles 127, and left side profiles 126. Furthermore, variations in the cross-sectional shape 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 that space. Additionally or optionally, one or more guide element profiles may be complementary to an inner wall recess, guide element rail, or one or more guide element rail features on, within, or within a portion of the inner wall of the catheter lumen or the outer wall of the needle. In one aspect, the upper surface 124 of the guide element is profiled or shaped to at least partially fit the inner wall of the catheter lumen. Additionally or optionally, the lower surface 125 of the guide element may be shaped to at least partially fit into the outer wall 148 of the needle. Similarly, one or more guide element embodiments may employ variations of the right profile 127 and the left profile 126 to adapt for engagement or complementation with other features disposed along the needle or catheter lumen, allowing the guide element to smoothly translate along and beyond the distal end 144 of the needle. In some embodiments, the distance between the left profile 126 and the right profile 127 of the guide element is between 0.10 mm and 0.36 mm. This distance is considered the width of the guide element. Additionally, in other embodiments, the distance between the upper surface profile 124 and the lower surface profile 125 of the guide element is between 0.127 mm and 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.

[0061] Figure 14 The slider 150 has already moved from... Figure 1 After the proximal position is moved to the distal position as shown Figure 10 and Figure 1A perspective view of the distal end of the catheter and the entry needle, showing that in the distal position, the guide element 120 advances distally along the outer wall 148 of the entry needle to form a loop 128 distal to the end 144 of the entry needle 140. In this exemplary embodiment, the loop 128 is formed approximately one inch beyond the distal end 144 of the needle 140. The view also shows how the upper and lower contours of the guide element 120 mate with the catheter guide element cutout 115 and the outer wall 148 of the needle. Thus, the guide element 120 can advance along the outer surface of the entry needle to form a loop 128 beyond the distal end 144 of the needle 140. The deployed guide element 120 can form a partial loop, a complete loop, or more than one complete loop beyond 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 the case of one full rotation or more than one full rotation) in terms of the degree of revolution around the distal end of the needle. For example, Figure 14 and Figure 15 The ring 128 in the middle exceeds 270 degrees. In addition, the exemplary diameter of the ring 128 ranges from 1 mm to 3 mm.

[0062] Figure 15 yes Figure 14 An enlarged view of the guide element ring. When the guide element 120 is deployed beyond the distal end 144 of the insertion needle 140, the ring 128 is formed in the distal portion of the guide element 120. This view also shows additional exemplary shapes of the upper surface profile 124, lower surface profile 125, right side profile 127, and left side profile 126 of the guide element. The upper surface profile 124 and lower surface profile 125 of the guide element 120 are adapted to the space between the outer wall 148 of the needle 140 and the inner wall of the catheter lumen.

[0063] In some embodiments, the guide element 120 may be formed of 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, for example, but not limited to, titanium dioxide or barium. Furthermore, it should be understood that a wide variety of materials can be used to form the guide element, such as various polymer blends and all or part of 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 profiles illustrated in the various embodiments of the guide element may also vary along the length of the guide element. For example, the distal portion of the guide element may have a profile and dimensions tailored to breaking strength. The intermediate portion of the guide element 120 may be designed to transition from the housing to the catheter lumen without buckling. Moreover, not only are further transitions and variations in the profile of the guide element portion within the guiding catheter possible, but the internal lumen walls of the catheter may also be adapted to facilitate the use of various guide element embodiments. Thus, in yet 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 ease of catheter insertion. Furthermore, the guide element 120 may have varying thickness near the catheter hub to aid in fracture strength. In some embodiments, the distal side of the slider will mate with the proximal side of the needle holder located inside the housing. In some embodiments, a hemostatic valve is present within the proximal hub 110 of the tubular catheter.

[0064] As can be understood from the various views in the accompanying drawings, aspects of the invention provide improved methods, systems, and components for performing venous punctures, and in particular improved methods, systems, and components for placing an intravascular catheter at a target location in a patient's vein. While the methods, systems, and components are particularly useful for placing peripheral venous catheters, such as those placed in veins in the hand or arm, they can also be used for placing central venous catheters via insertion into a central vein, such as the internal jugular vein in the neck or the subclavian vein in the chest. Furthermore, aspects of the vascular access methods, systems, and components can be used for placing catheters in central arteries or other arteries.

[0065] More generally, the endovascular catheter assembly according to the principles of the present invention includes a tubular catheter body, an entry needle, a guiding element, and a slide for deploying the guiding element. The tubular catheter body has a distal end, a proximal end, at least one lumen between the distal and proximal ends, and a guiding element incision formed in the distal end. The entry needle has a distal end that penetrates tissue and a generally pervasive lumen through the entry needle. In a first embodiment, the guiding element is disposed in a space or lumen between the inner wall of the catheter lumen and the outer wall of the entry needle. In a second embodiment, the guiding element is disposed outside the entry needle and parallel to the entry needle, which travels along an axial groove, recess, or guiding structure or a structure or guiding element formed in the inner wall of the catheter lumen. In all embodiments, the guiding element has a distal end configured (a) to adapt to the shape and profile of the distal end of the catheter in a manner that forms a smooth transition (see...). Figure 10 (a) thereby maintaining the function of providing access to the needle-catheter combination; and (b) as it extends distally along the needle and distally along the catheter, it will form a partial or complete loop to facilitate the advancement of the catheter in the vascular system.

[0066] In one embodiment, a slider of the intravascular 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 way, the guide element can be guided along a path disposed on the housing ( Figure 1 The guide element is advanced distally by sliding the slider forward or distally within the groove. This movement moves the distal end of the guide element on the outer surface of the entry needle to position the distal end of the guide element beyond the distal end of the catheter (see...). Figure 14 Once in this configuration, the insertion needle can be fully or partially retracted, or left in place without retraction, and the catheter and the distally projecting guide element can advance collaboratively to position the distal end of the catheter body at a target location in a vein or other vascular system. By having the catheter and the projecting guide element advance collaboratively, the guide element acts as a “fixed” guide element tip, further simplifying catheter placement procedures. Furthermore, the protruding ring on the distal portion of the guide element helps prevent or substantially inhibits the distal end of the catheter from adhering to or becoming kinked to the inner wall of the vessel.

[0067] In another aspect, the intravascular access device includes a housing having a needle holder at its distal end that is attached to the proximal end of the access needle, such as... Figure 2 , Figure 3 , Figure 4 , Figure 8 and Figure 9Various views are shown in the diagram. The insertion needle 140 is securely attached to the needle holder 130, and the proximal end of the catheter is detachably attached to the distal end of the housing. In this way, the slider 150 can be used to advance the guide element beyond the distal end of the catheter and the insertion needle, and after the catheter is positioned in the desired location in the vascular system, the housing, the insertion needle, and the guide element can be detached and removed from the catheter.

[0068] The guide element 120 can be coupled to the slider 150 in any manner that allows the slider to advance or retract so that the guide element passes through the space between the catheter lumen and the outer wall of the entry needle in an equivalent advance or retraction. Advantageously, because the guide element is located outside the entry needle or along its outer wall, and positioned along the outer wall of the entry needle, the slider can be directly connected to the proximal end of the guide element with minimal interference from the entry needle.

[0069] In another aspect of the invention, a method for introducing an intravascular catheter into a target location within a patient's blood vessel includes penetrating the distal end of an entry needle carrying the catheter into the vein. A guiding element is located within a guiding element incision at the distal end of the catheter. As a result, introducing the distal end of the catheter into the blood vessel causes the distal end of the guiding element to also be positioned within the blood vessel. Therefore, once blood return is detected and the needle / catheter assembly advances to bring the distal end of the catheter within the blood vessel, the needle can remain stationary. While the needle remains stationary, a slider... Figure 1 and Figure 2 The proximal position shown advances to a distal position where the slider is located along the groove at the top of the housing. Proximal-to-distal movement of the slider moves the guide element from a position within a guide incision in the distal end of the conduit. Figure 10 Advance to a deployment state with a curved portion, which is a complete or partial loop on the distal side of the needle's penetrating end, as in Figure 14 and Figure 15 The guide element can be pre-shaped to form a ring 128 at a desired or selected distance from the distal end of the needle 144. In one embodiment, the ring 128 is formed at a minimum distance of approximately 1 inch or 25.4 mm. Additional specific spacing between the distal end of the needle and the ring may be provided based on application, clinical needs, and anatomical considerations of the target lumen.

[0070] After the guide element has advanced, the insertion needle can optionally retract proximally, leaving the guide element in place to aid catheter positioning. Alternatively, once the catheter is correctly positioned within the blood vessel, the insertion needle and guide element are completely withdrawn from the catheter, leaving the catheter in place for the desired medical protocol. In one embodiment, a spring-loaded retraction system or actuation element 108 is activated by pressing an actuation button 106. Once the actuation button 106 is pressed or otherwise moved to cause release of the needle holder 130, the actuation spring 108 automatically drives the needle holder 130, needle 140, slider 150, and guide element 120 proximally to withdraw the insertion needle 140 and guide element 120 from the patient and at least partially or completely back into the housing 101. The catheter hub 110 is then detached from the handle or distal end 103 of the housing 101, leaving the catheter 110 in place for the desired medical protocol as described above. The used housing 101 can then be disposed of using appropriate means.

[0071] Further aspects of the construction and operation of a catheter placement device 100 are described in U.S. Patent Publication US2008 / 0300574 and U.S. Patent 9,522,254 (each of which is incorporated herein by reference in its entirety), the catheter placement device 100 comprising: 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 from the catheter into both the needle and the guide structure or guide element after the placement process is completed; a push-button activated automatic needle; and a guide retraction assembly.

[0072] Further details of representative 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 US 2010 / 0094310, US 2010 / 0210934, and US 2012 / 0197200, the entire disclosure of each of the above patents and patent publications being incorporated herein by reference in its entirety.

[0073] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely by way of example. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. The scope of the invention is intended to be defined by the appended claims, and thereby covers the methods and structures within the scope of those claims and their equivalents.

[0074] When a feature or element is referred to herein as being “on” another feature or element, it may be directly on the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is referred to as being “directly on” another feature or element, no intermediate features or elements are present. It will also be understood that when a feature or element is referred to as being “connected,” “attached,” or “joined” to another feature or element, it may be directly connected, attached, or joined to the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is referred to as being “directly connected,” “directly attached,” or “directly joined” to another feature or element, no intermediate features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements thus described or illustrated may be applied to other embodiments. Those skilled in the art will also recognize that a structure or feature positioned with reference to “adjacent” to another feature may have portions overlapping with or below the adjacent feature.

[0075] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context otherwise 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 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 “ / ”.

[0076] For ease of description, spatially related terms such as “under,” “below,” “lower,” “over,” and “upper” are used herein to describe the relationship of an element or feature as illustrated in the accompanying drawings to other elements or features. It should be understood that spatially related terms are intended to encompass different orientations of the device in use or operation beyond those depicted in the drawings. For example, if the device in the drawings were inverted, an element described as “below” or “below” other elements or features would then be oriented “over” other elements or features. Thus, the exemplary term “under” can encompass both “above” and “below” orientations. The device may be otherwise oriented (rotated 90 degrees or otherwise), and the spatially related descriptive terms used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, the terms “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for illustrative purposes.

[0077] While 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 otherwise requires. These terms may be used to distinguish one feature / element from another. Therefore, without departing from the teachings of the 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.

[0078] In this specification and the appended claims, unless the context otherwise requires, the term "comprise" and its variations such as "comprises" and "comprising" mean that various components may be used together in methods and articles of manufacture (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any of the stated elements or steps, but does not exclude any other elements or steps.

[0079] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all figures may be treated as if preceded by the words “about” or “approximately”, even if the term is not explicitly stated. The phrase “about” or “approximately” may be used when describing magnitude and / or location to indicate that the described value and / or location is within a reasonably expected range of value and / or location. For example, numerical values ​​may have values ​​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 otherwise requires. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical ranges listed herein are intended to include all subranges contained therein. It should also be understood that when a value is disclosed, the terms "less than or equal to" that value, "greater than or equal to" that value, and the possible range between values ​​are also disclosed, as would be appropriately understood by a person 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" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and this data represents the endpoints and starting points, as well as the range, of any combination of data points. For example, if specific data point "10" and 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, as well as between 10 and 15, are considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0080] While various illustrative embodiments have been 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 typically be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of the various apparatus and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0081] The examples and illustrations included herein are shown by way of illustration, not limitation, of specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, such that structural and logical substitutions and changes can be made without departing from the scope of this 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 actually more than one is disclosed, it is not intended to actively limit the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement believed to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. After reading the above description, those skilled in the art will understand the combinations of the above embodiments and other embodiments not specifically described herein.

[0082] This invention also relates to the following aspects:

[0083] 1. An intravascular catheter assembly, comprising:

[0084] A handle having a proximal end and a distal end, and a groove having a distal end and a proximal end in the surface of the handle;

[0085] An actuation button is located on the handle and is connected to the needle holder;

[0086] A tubular catheter body having a distal end, a guide element incision in the distal end of the tubular catheter body, a proximal end, and a catheter body lumen extending between the proximal end and the distal end of the tubular catheter body, the proximal end of the tubular catheter body being coupled to the distal end of the handle;

[0087] An entry needle is disposed within the lumen of the catheter body, the entry needle having a distally extending tissue-penetrating distal end beyond the distal end of the tubular catheter body and a proximal end connected to the needle holder;

[0088] A guiding element having a proximal and a distal end, the guiding element being positioned within the lumen of the catheter body and adjacent to the outer wall of the entry needle, the distal portion of the guiding element being shaped to provide a uniform transition when the distal portion is within an incision in the guiding element, wherein, after the distal portion of the guiding element has advanced along the outer wall of the entry needle from the lumen of the catheter body to a position distal to the tissue penetration distal end of the entry needle, the entry needle and the guiding element are retractable together from the tubular catheter body; and

[0089] A slider is connected to the proximal end of the guide element such that distal advancement of the slider causes the distal end portion of the guide element to advance distally from a position within the guide element cutout along the outer wall of the entry needle.

[0090] 2. The intravascular catheter assembly according to aspect 1, wherein, when the slider is in its most distal position, the distal portion of the guiding element bends beyond the distal end of the tissue penetration of the insertion needle.

[0091] 3. The intravascular catheter assembly according to aspect 1, wherein, when the slider is in the most distal position, the distal portion of the guide element bends from a position above the entry needle, beyond the distal end of the tissue penetration of the entry needle, to a position below the entry needle.

[0092] 4. The intravascular catheter assembly according to aspect 3, wherein the bend formed by the distal portion of the guiding element has an angle of less than 360 degrees relative to the distal end of the tissue penetration of the insertion needle.

[0093] 5. The intravascular catheter assembly according to aspect 3, wherein the bend formed by the distal portion of the guiding element has an angle greater than 270 degrees relative to the distal end of the tissue penetration of the insertion needle.

[0094] 6. The intravascular catheter assembly according to aspect 3, wherein the bend formed by the distal portion of the guiding element has an angle of less than 270 degrees relative to the distal end of the tissue penetration of the insertion needle.

[0095] 7. The intravascular catheter assembly according to aspect 3, wherein the bend formed by the distal portion of the guiding element has an angle greater than 180 degrees relative to the distal end of the tissue penetration of the insertion needle.

[0096] 8. The intravascular catheter assembly according to aspect 1, wherein the slider is disposed on the proximal region of the insertion needle.

[0097] 9. The intravascular catheter assembly according to aspect 1 further includes a housing attached to the proximal end of the access needle, wherein the sliding element is disposed on the housing.

[0098] 10. The intravascular catheter assembly according to aspect 9, wherein the insertion needle is securely fixed to the distal end of the housing, and the tubular catheter body is detachably fixed to the distal end of the housing, wherein the slider allows the guiding element to advance beyond the distal end of the tubular catheter body, and wherein the housing, the insertion needle, and the guiding element are detachable and removable from the tubular catheter body after the tubular catheter body is in place.

[0099] 11. The intravascular catheter assembly according to aspect 10, wherein a proximal region of the tubular catheter body is disposed within the housing, and wherein the proximal end of the tubular catheter body and the proximal end of the entry needle are configured to engage via the slider to allow the tubular catheter body and the entry needle to advance cooperatively with the guide element relative to the housing after the guide element has extended distally beyond the distal end of the tubular catheter body.

[0100] 12. The intravascular catheter assembly according to aspect 1, wherein the access needle has an access needle lumen, and the guiding element is disposed outside the access needle lumen.

[0101] 13. The intravascular catheter assembly according to aspect 9, wherein the housing has an axial groove, and the proximal end of the guiding element is connected to the slide to allow movement along the axial groove.

[0102] 14. The intravascular catheter assembly according to aspect 13, wherein the axial groove is closed on the distal and proximal regions of the entry needle.

[0103] 15. The intravascular catheter assembly according to aspect 14, wherein the connection between the guiding element and the sliding element is disposed in the axial groove, wherein the travel length is defined by the closed end of the axial groove.

[0104] 16. The intravascular catheter assembly according to aspect 1, wherein the guiding element is slidably disposed within a guiding structure within the lumen of the catheter body.

[0105] 17. The intravascular catheter assembly according to aspect 16, wherein the guiding structure holds the guiding element in a position along the uppermost part of the entry needle.

[0106] 18. The intravascular catheter assembly according to aspect 16, wherein the guiding structure is a pair of features extending from the inner wall of the tubular catheter body and protruding into the lumen of the catheter body.

[0107] 19. The intravascular catheter assembly according to aspect 18, wherein when the guide structure is positioned between the extended pair of features, the guide structure is positioned superiorly along the outer wall of the insertion needle.

[0108] 20. The intravascular catheter assembly according to aspect 16, wherein the guiding structure has a distal portion adjacent to the incision of the guiding element and a proximal portion greater than 1 cm from the incision of the guiding element.

[0109] 21. The intravascular catheter assembly according to aspect 16, wherein the guiding structure has a distal portion adjacent to the incision of the guiding element and a proximal portion, wherein the guiding structure is continuous along the inner wall of the lumen of the catheter body from the proximal end of the tubular catheter body to the distal end of the tubular catheter body.

[0110] 22. The intravascular catheter assembly according to aspect 1, wherein the tubular catheter body has a proximal hub with a hemostatic valve, wherein the insertion needle extends slidably through the hemostatic valve.

[0111] 23. The intravascular catheter assembly according to aspect 22, wherein the slider has a distal side that engages with the proximal side of the needle holder when the slider is fully advanced distally to extend the guiding element.

[0112] 24. The intravascular catheter assembly according to aspect 23, wherein the slider is detachably locked to the proximal end of the needle holder when the distal side engages with the proximal side.

[0113] 25. The intravascular catheter assembly according to aspect 1 further includes:

[0114] In the first configuration when the slider is in the proximal position, the distal end of the guide element is located in the guide element incision, and the distal end of the tissue penetration of the entry needle is distal to the distal end of the tubular catheter body.

[0115] A second configuration when the slider is in its most distal position, wherein the distal end of the guide element extends beyond the guide element incision and bends beyond the tissue-penetrating distal end of the insertion needle; and

[0116] The third configuration is when the slider is in the proximal position of the farthest position and the entry needle and the guide element are at least partially retracted into the housing.

[0117] 26. The intravascular catheter assembly according to aspect 25, wherein, in the first configuration, the distal end of the tissue-penetrating insertion needle extends beyond the distal end of the tubular catheter body by a distance ranging from 0.1 mm to 20 mm, and the proximal end of the slider retracts from the proximal end of the tubular catheter body by a distance ranging from 10 mm to 100 mm.

[0118] 27. The intravascular catheter assembly according to aspect 25, wherein, in the second configuration, the length of the guide element extending beyond the guide element incision of the tubular catheter body is 5 mm to 100 mm.

[0119] 28. The intravascular catheter assembly according to any one of aspects 1-27, wherein the guiding element has a length greater than its width and a width greater than its thickness.

[0120] 29. The intravascular catheter assembly according to any one of aspects 1-27, wherein the guiding element is made wholly or partially of a polymeric material, PTFE, or nylon.

[0121] 30. The intravascular catheter assembly according to any one of aspects 1-27, wherein the guiding element is wholly or partially made of metal, including nitinol, Elgiloy, or similar materials.

[0122] 31. The intravascular catheter assembly according to any one of aspects 1-27, wherein the guiding element further comprises an upper surface adapted to the curvature of the inner wall of the lumen of the catheter body and a lower surface adapted to the curvature of the outer wall of the insertion needle.

[0123] 32. The intravascular catheter assembly according to any one of aspects 1-31, wherein the tubular catheter body is configured to serve as a catheter component of an infusion device, a catheter component of a blood collection device, a catheter component of a safety wing blood collection device, or a catheter component of a venous catheter.

[0124] 33. An intravascular catheter assembly, comprising:

[0125] A tubular catheter body having a proximal hub, a guide element incision at the distal end, and a catheter body lumen extending from the proximal end to the distal end;

[0126] An insertion needle is disposed within the lumen of the catheter body and has a distal end with tissue penetration extending distally beyond the distal end of the tubular catheter body;

[0127] A guiding element located within the lumen of the catheter body and outside the entry needle, the guiding element having an upper surface adapted to the curvature of the inner wall of the lumen of the catheter body, a lower surface adapted to the curvature of the outer wall of the entry needle, and a distal end shaped to form a uniform transition with the guide element cut in the distal end of the tubular catheter body.

[0128] A slider is coupled to the proximal end of the guide element such that distal advancement of the slider advances the distal end of the guide element from a first position at the guide element incision to a second position, in which the distal position of the guide element bends beyond the tissue-penetrating distal end of the insertion needle, wherein the slider has a distal side that mates with the proximal side of the needle holder when the slider is fully advanced distally to extend the guide element.

[0129] 34. The intravascular catheter assembly according to aspect 33, wherein the slider is detachably locked to the proximal hub when the distal side of the slider engages with the proximal side of the needle holder.

[0130] 35. The intravascular catheter assembly according to aspect 33, wherein the guiding element has a length greater than its width and a width greater than its thickness.

[0131] 36. The intravascular catheter assembly according to aspect 33, wherein the guiding element is a polymer.

[0132] 37. A method for accessing a patient's blood vessels, comprising:

[0133] The tissue of the entry needle of the intravascular catheter assembly is advanced through the distal end into the patient's blood vessel;

[0134] The guide element is advanced from a first position to a second position. In the first position, the distal portion of the guide element forms a uniform transition within a guide incision in the distal portion of the catheter hub. In the second position, a portion of the guide element advances along the outer wall of the insertion needle beyond the distal portion of the catheter hub.

[0135] The guiding element is advanced along the patient's blood vessel to a third position beyond the distal end of the tissue penetration needle;

[0136] The distal portion of the catheter hub is advanced along the guiding element within the blood vessel; and

[0137] The insertion needle and the guiding element are automatically retracted into the intravascular catheter assembly.

[0138] 38. The method of entering a blood vessel according to aspect 37 further includes stopping the step of advancing the tissue-penetrating distal end of the entry needle of the intravascular catheter assembly when blood backflow is observed in the intravascular catheter assembly.

[0139] 39. The method of accessing a blood vessel according to aspect 37 further includes stopping the step of advancing the tissue-penetrating distal end of the access needle when the distal portion of the catheter hub of the intravascular catheter assembly is within the patient's blood vessel.

[0140] 40. The method of accessing a blood vessel according to aspect 37 further includes stopping the step of advancing the tissue through the distal end of the access needle when the distal portion of the guiding element of the intravascular catheter assembly is within the patient's blood vessel.

[0141] 41. The method of entering a blood vessel according to aspect 37, wherein, after performing the step of advancing the guide element beyond the distal end of the tissue penetration of the entry needle, the distal portion of the guide element bends beyond the distal end of the tissue penetration of the entry needle.

[0142] 42. The method of entering a blood vessel according to aspect 37, wherein, after performing the step of advancing the guide element beyond the distal end of the tissue penetration of the entry needle, the distal portion of the guide element bends from a position above the entry needle, beyond the distal end of the tissue penetration of the entry needle, to a position below the entry needle.

[0143] 43. The method of accessing a blood vessel according to aspect 42, wherein the bend formed by the distal portion of the guiding element has an angle of less than 360 degrees relative to the distal end of the tissue-penetrating insertion needle.

[0144] 44. The method of accessing a blood vessel according to aspect 42, wherein the bend formed by the distal portion of the guiding element has an angle greater than 270 degrees relative to the distal end of the tissue-penetrating needle.

[0145] 45. The method of accessing a blood vessel according to aspect 42, wherein the bend formed by the distal portion of the guiding element has an angle of less than 270 degrees relative to the distal end of the tissue-penetrating needle.

[0146] 46. ​​The method of entering a blood vessel according to aspect 42, wherein the bend formed by the distal portion of the guiding element has an angle greater than 180 degrees relative to the distal end of the tissue-penetrating needle.

[0147] 47. An intravascular catheter, comprising:

[0148] A hub having a proximal end and a distal end;

[0149] A tubular body extending from the distal end of the hub to the distal end of the tubular body, the tubular body having an outer wall and an inner wall;

[0150] An inner cavity, located within the hub and the tubular body and defined by the inner wall of the tubular body, having a proximal opening at the proximal end of the hub and a distal opening at the distal end of the tubular body; and

[0151] A guide element cutout is located at the distal end of the tubular body.

[0152] 48. The intravascular catheter according to aspect 47 further includes a guiding element recess formed in at least a distal portion of the inner wall of the tubular body and extending along at least a distal portion of the inner wall of the tubular body.

[0153] 49. The intravascular catheter according to aspect 47 further includes a guiding element recess formed within and extending along the inner wall of the tubular body.

[0154] 50. The intravascular catheter according to aspect 47 further includes a guiding element recess formed within the inner wall of the tubular body and extending along the inner wall of the tubular body from the distal end of the hub to the distal end of the tubular body.

[0155] 51. The intravascular catheter according to aspect 48, 49 or 50, wherein the guide element recess is wider than the guide element incision.

[0156] 52. The intravascular catheter according to aspect 47 further includes a guide element rail, the guide element rail being longitudinally aligned with the guide element incision along the inner wall of the tubular body.

[0157] 53. The intravascular catheter according to aspect 52, wherein the guide element rail, longitudinally aligned with the guide element incision along the inner wall of the tubular body, is formed solely by a recessed portion of the inner wall of the tubular body, or by a combination of a recessed portion of the inner wall of the tubular body and one or more guide element rail features extending from or formed on the inner wall of the tubular body, wherein a portion of the guide element rail is adapted to at least a portion of the upper surface profile, lower surface profile, left side profile, or right side profile of the guide element.

[0158] 54. The intravascular catheter according to any one of aspects 47-53, wherein the intravascular catheter is configured to serve as a catheter component of an infusion device, a catheter component of a blood collection device, a catheter component of a safety wing blood collection device, or a catheter component of a venous catheter.

[0159] 55. The guide element or guide structure according to any one of the preceding aspects, wherein the distance between the left profile 126 of the guide element and the right profile 127 of the guide element is in the range of 0.10 mm to 0.36 mm, or wherein the distance between the upper surface profile 124 of the guide element and the lower surface profile 125 of the guide element is in the range of 0.127 mm to 0.203 mm.

Claims

1. An intravascular catheter assembly, comprising: A handle having a proximal end and a distal end, and a groove having a distal end and a proximal end in the surface of the handle; An actuation button is located on the handle and is connected to the needle holder; A tubular catheter body having a distal end, a guide element incision in the distal end of the tubular catheter body, a proximal end, and a catheter body lumen extending between the proximal end and the distal end of the tubular catheter body, the proximal end of the tubular catheter body being coupled to the distal end of the handle; An entry needle is disposed within the lumen of the catheter body, the entry needle having a distally extending tissue-penetrating distal end beyond the distal end of the tubular catheter body and a proximal end connected to the needle holder; A guiding element having a proximal and a distal end, the guiding element being positioned within the lumen of the catheter body and adjacent to the outer wall of the entry needle, the distal portion of the guiding element being shaped to provide a uniform transition when the distal portion is within the guiding element incision, wherein, after the distal portion of the guiding element has advanced along the outer wall of the entry needle from the lumen of the catheter body to a position distal to the tissue penetration distal end of the entry needle, the entry needle and the guiding element are retractable together from the tubular catheter body; as well as A slider is connected to the proximal end of the guide element such that distal advancement of the slider causes the distal end portion of the guide element to advance distally from a position within the guide element cutout along the outer wall of the entry needle.

2. The intravascular catheter assembly according to claim 1, wherein, When the slider is in its most distal position, the distal portion of the guide element bends beyond the distal end of the tissue penetration of the insertion needle.

3. The intravascular catheter assembly according to claim 1, wherein, When the slider is in the farthest position, the distal portion of the guide element bends from the position above the entry needle, beyond the distal end of the tissue penetration of the entry needle, and reaches the position below the entry needle.

4. The intravascular catheter assembly according to claim 3, wherein, The bend formed by the distal portion of the guiding element has an angle of less than 360 degrees relative to the distal end of the tissue penetration of the insertion needle.

5. The intravascular catheter assembly according to claim 3, wherein, The bend formed by the distal portion of the guiding element has an angle greater than 270 degrees relative to the distal end of the tissue penetration of the insertion needle.

6. The intravascular catheter assembly according to claim 3, wherein, The bend formed by the distal portion of the guiding element has an angle of less than 270 degrees relative to the distal end of the tissue penetration of the insertion needle.

7. The intravascular catheter assembly according to claim 3, wherein, The bend formed by the distal portion of the guiding element has an angle greater than 180 degrees relative to the distal end of the tissue penetration of the insertion needle.

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

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

10. The intravascular catheter assembly according to claim 9, wherein, The insertion needle is securely fixed to the distal end of the housing, and the tubular catheter body is detachably fixed to the distal end of the housing, wherein the slider allows the guide element to advance beyond the distal end of the tubular catheter body, and wherein the housing, the insertion needle, and the guide element are detachable and removable from the tubular catheter body after the tubular catheter body is in place.

11. The intravascular catheter assembly of claim 10, wherein, The proximal region of the tubular catheter body is disposed within the housing, and wherein the proximal end of the tubular catheter body and the proximal end of the insertion needle are configured to engage by the slider to allow the tubular catheter body and the insertion needle to advance cooperatively with the guidance element relative to the housing after the guiding element has extended distally beyond the distal end of the tubular catheter body.

12. The intravascular catheter assembly according to claim 1, wherein, The insertion needle has an insertion needle cavity, and the guiding element is disposed outside the insertion needle cavity.

13. The intravascular catheter assembly according to claim 9, wherein, The housing has an axial groove, and the proximal end of the guide element is connected to the slider, thereby allowing movement along the axial groove.

14. The intravascular catheter assembly of claim 13, wherein, The axial groove is closed on the distal and proximal regions of the entry needle.

15. The intravascular catheter assembly of claim 14, wherein, The connector between the guide element and the slider is disposed in the axial groove, wherein the stroke length is defined by the closed end of the axial groove.

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

17. The intravascular catheter assembly of claim 16, wherein, The guide structure holds the guide element in a position along the uppermost part of the entry needle.

18. The intravascular catheter assembly of claim 16, wherein, The guiding structure is a pair of features that extend from the inner wall of the tubular catheter body and protrude into the lumen of the catheter body.

19. The intravascular catheter assembly of claim 18, wherein, When the guide structure is positioned between the extended pair of features, the guide structure is positioned on the upper side along the outer wall of the entry needle.

20. The intravascular catheter assembly of claim 16, wherein, The guiding structure has a farthest portion adjacent to the incision of the guiding element and a proximal portion more than 1 cm away from the incision of the guiding element.

21. The intravascular catheter assembly of claim 16, wherein, The guiding structure has a distal portion adjacent to the incision of the guiding element and a proximal portion, wherein the guiding structure is continuous along the inner wall of the catheter body lumen from the proximal end of the tubular catheter body to the distal end of the tubular catheter body.

22. The intravascular catheter assembly according to claim 1, wherein, The tubular catheter body has a proximal hub with a hemostatic valve, wherein the insertion needle extends slidably through the hemostatic valve.

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

24. The intravascular catheter assembly of claim 23, wherein, When the distal side engages with the proximal side, the slider is detachably locked to the proximal end of the needle holder.

25. The intravascular catheter assembly according to claim 1, further comprising: In the first configuration when the slider is in the proximal position, the distal end of the guide element is located in the guide element incision, and the distal end of the tissue penetration of the entry needle is distal to the distal end of the tubular catheter body. The second configuration when the slider is in the farthest position, wherein the farthest end of the guide element extends beyond the guide element incision and bends beyond the tissue penetration distal end of the entry needle; as well as The third configuration is when the slider is in the proximal position of the farthest position and the entry needle and the guide element are at least partially retracted into the housing.

26. The intravascular catheter assembly of claim 25, wherein, In the first configuration, the distal end of the insertion needle extends beyond the distal end of the tubular catheter body by a distance ranging from 0.1 mm to 20 mm, and the proximal end of the slider retracts from the proximal end of the tubular catheter body by a distance ranging from 10 mm to 100 mm.

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

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

29. The intravascular catheter assembly according to any one of claims 1-27, wherein, The guiding element is made wholly or partially of a polymeric material, including PTFE or nylon.

30. The intravascular catheter assembly according to any one of claims 1-27, wherein, The guiding element is made wholly or partially of metal, including nitinol or Elgiloy.

31. The intravascular catheter assembly according to any one of claims 1-27, wherein the guiding element further comprises an upper surface adapted to the curvature of the inner wall of the lumen of the catheter body and a lower surface adapted to the curvature of the outer wall of the insertion needle.

32. The intravascular catheter assembly according to any one of claims 1-27, wherein, The tubular catheter body is configured as a catheter component in an infusion device or a catheter component in a blood collection device.

33. An intravascular catheter assembly, comprising: A tubular catheter body having a proximal hub, a guide element incision at the distal end, and a catheter body lumen extending from the proximal end to the distal end; An insertion needle is disposed within the lumen of the catheter body and has a distal end with tissue penetration extending distally beyond the distal end of the tubular catheter body; A guiding element located within the lumen of the catheter body and outside the entry needle, the guiding element having an upper surface adapted to the curvature of the inner wall of the lumen of the catheter body, a lower surface adapted to the curvature of the outer wall of the entry needle, and a distal end shaped to form a uniform transition with the guide element cut in the distal end of the tubular catheter body. A slider is coupled to the proximal end of the guide element such that distal advancement of the slider advances the distal end of the guide element from a first position at the guide element incision to a second position, in which the distal position of the guide element bends beyond the tissue-penetrating distal end of the insertion needle, wherein the slider has a distal side that mates with the proximal side of the needle holder when the slider is fully advanced distally to extend the guide element.

34. The intravascular catheter assembly of claim 33, wherein, When the distal side of the slider engages with the proximal side of the needle holder, the slider is detachably locked to the proximal hub.

35. The intravascular catheter assembly of claim 33, wherein the guiding element has a length greater than its width and a width greater than its thickness.

36. The intravascular catheter assembly of claim 33, wherein the guiding element is a polymer.

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