Guidewire and assembly for automatic removal of a stylet from a catheter - Patents.com

Abstract

A guidewire (110) for automatically removing a stylet (108) from a catheter assembly (100). The stylet assembly (104) includes a guidewire (106) disposed within a stylet (108). The guidewire (108) includes a proximal portion having a first outer diameter, a distal portion including an expanded section having a second outer diameter greater than the first outer diameter, and a guidewire tip at the distal portion of the guidewire. The stylet includes a stylet tip and a stylet lumen passing therethrough having a stylet inner diameter corresponding to the first outer diameter of the guidewire. At least a proximal portion of the guidewire can be disposed within the stylet lumen of the stylet in a corresponding orientation. The expanded section of the guidewire is configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter.

Description

[Background technology]

[0001] Insertion of a central venous catheter (CVC) into a patient is a multi-step process that is prone to multiple errors. For example, a selected insertion site on the patient is percutaneously punctured with a needle, thereby establishing a puncture pathway from the area of ​​skin to the vascular lumen, followed by insertion of an access guidewire through the needle into the vascular lumen. After removal of the needle, the CVC is inserted into the vascular lumen over the access guidewire. At this point, the access guidewire can be replaced with a steering guidewire, after which the catheter tube of the CVC is advanced through the patient's vasculature over the steering guidewire. However, the CVC may include a stylet that is assembled during manufacture. This stylet fills the extra annular space between the inner diameter of the catheter tube and the outer diameter of the access guidewire that would otherwise cause the tip of the catheter tube to catch on the patient's skin as the CVC is inserted. Additionally, the stylet stiffens and provides additional buckling strength to the catheter tube to prevent buckling as the CVC is inserted over the access guidewire into the vascular lumen. The stylet must be removed after the CVC is inserted over the access guidewire into the vascular lumen, but the stylet is often forgotten, which can lead to an ineffective procedure or even injury to the patient. In view of the foregoing, there is a need for an automated stylet removal means and method for removing a stylet from a CVC or other catheter.

[0002] Disclosed herein are guidewires, stylet assemblies, catheter assemblies, and methods thereof that address at least the foregoing. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is a guidewire including a proximal portion, a distal portion, and a guidewire tip within the distal portion of the guidewire. The proximal portion has a first outer diameter. The distal portion includes an expanded section having a second outer diameter greater than the first outer diameter. The expanded section of the guidewire is configured to abut a stylet tip of the stylet when at least the proximal portion of the guidewire is disposed within the stylet in a corresponding orientation and withdrawn proximally therefrom by the proximal portion of the guidewire.

[0004] In some embodiments, the guidewire includes a step that defines an expanded section having a second outer diameter from a remainder of the guidewire having a first outer diameter. In some embodiments, the guidewire includes a taper from the expansion section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

[0005] In some embodiments, the guidewire tip is an atraumatic J-shaped guidewire tip. Also disclosed herein, in some embodiments, is a guidewire including a proximal portion, a distal portion, and a guidewire tip within the distal portion of the guidewire. The proximal and distal portions of the guidewire have a first outer diameter. The guidewire tip within the distal portion of the guidewire terminates in a ball-shaped end cap. The ball-shaped end cap has a third diameter greater than the first outer diameter, the ball-shaped end cap adapted to abut against a stylet tip of the stylet when at least a proximal portion of the guidewire is disposed within the stylet in a corresponding orientation and withdrawn proximally therefrom by the proximal portion of the guidewire.

[0006] Also disclosed herein, in some embodiments, is a stylet assembly including a guidewire disposed within a stylet. The guidewire includes a proximal portion, a distal portion, and a guidewire tip within the distal portion of the guidewire. The proximal portion has a first outer diameter. The distal portion includes an expanded section having a second outer diameter greater than the first outer diameter. The stylet includes a stylet tip and a stylet lumen passing through the stylet. The stylet lumen has a stylet inner diameter corresponding to the first outer diameter of the guidewire. At least a proximal portion of the guidewire is disposed within the stylet lumen of the stylet in a corresponding orientation. The expanded section of the guidewire is configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter with the guidewire.

[0007] In some embodiments, the guidewire includes a step that defines an expanded section having a second outer diameter from a remainder of the guidewire having a first outer diameter. In some embodiments, the guidewire includes a taper from the expanded section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

[0008] In some embodiments, the guidewire tip is an atraumatic J-shaped guidewire tip. Also disclosed herein, in some embodiments, is a catheter assembly including a guidewire disposed within a stylet and a stylet disposed within a catheter. The guidewire includes a proximal portion, a distal portion, and a guidewire tip within the distal portion of the guidewire. The proximal portion has a first outer diameter. The distal portion includes an expansion section having a second outer diameter greater than the first outer diameter. The stylet includes a stylet tip and a stylet lumen through the stylet. The stylet lumen has a stylet inner diameter corresponding to the first outer diameter of the guidewire. The catheter includes a catheter tube including a catheter tip and a catheter lumen through the catheter. A primary lumen, at least within the catheter tube, has a catheter inner diameter corresponding to the stylet outer diameter. At least a proximal portion of the guidewire is disposed within the stylet lumen of the stylet in a corresponding orientation, and the stylet is disposed within the primary lumen of the catheter in a corresponding orientation. The expanded section of the guidewire is configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter along with the guidewire.

[0009] In some embodiments, the guidewire includes a step that defines an expanded section having a second outer diameter from a remainder of the guidewire having a first outer diameter. In some embodiments, the guidewire includes a taper from the expansion section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

[0010] In some embodiments, the guidewire tip is an atraumatic J-shaped guidewire tip. In some embodiments, the catheter is a tri-lumen catheter including a three-pronged catheter hub coupled to a proximal portion of the catheter tube and three extension legs extending from the catheter hub, each of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg.

[0011] In some embodiments, the primary lumen extends from an opening at the proximal end of the first Luer connector to an opening at the catheter tip, the secondary lumen extends from an opening at the proximal end of the second Luer connector to a secondary lumen opening in the distal portion of the catheter tube, and the tertiary lumen extends from an opening at the proximal end of the third Luer connector to a tertiary lumen opening in the distal portion of the catheter tube proximal to the secondary lumen opening.

[0012] Also disclosed herein is a method for inserting a catheter into a vascular lumen of a patient. The method, in some embodiments, includes the steps of establishing a puncture path, inserting a guidewire, removing a needle, advancing a catheter, and automatically removing a stylet. The establishing a puncture path includes establishing a puncture path from an area of ​​skin to a vascular lumen with a needle. The inserting a guidewire includes inserting a guidewire into a needle lumen of the needle and advancing the guidewire into the vascular lumen. The removing a needle includes removing the needle from the puncture path leaving the guidewire in place in the vascular lumen. The advancing a catheter includes advancing a catheter including a stylet disposed within a primary lumen of the catheter over the guidewire with at least a proximal portion of the guidewire disposed within a stylet lumen of the stylet until a sufficient portion of the catheter tube of the catheter is disposed within the vascular lumen. The automatic stylet removal includes removing both the guidewire and the stylet from the catheter. The guidewire includes a proximal portion having a first outer diameter and a distal portion including an expanded section having a second outer diameter greater than the first outer diameter. The expanded section of the guidewire is configured to abut against the stylet tip of the stylet when the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter with the guidewire.

[0013] In some embodiments, the guidewire includes a step that defines an expanded section having a second outer diameter from a remainder of the guidewire having a first outer diameter. In some embodiments, the guidewire includes a taper from the expansion section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

[0014] In some embodiments, the guidewire tip is an atraumatic J-shaped guidewire tip. In some embodiments, the primary lumen of the catheter has a catheter inner diameter that corresponds to the stylet outer diameter, at least within the catheter tube of the catheter, such that the annular space that would otherwise exist between them prevents the catheter tip of the catheter tube from catching on the patient's skin during advancement of the catheter into the patient's vascular lumen.

[0015] These and other features of the concepts presented herein will become more apparent to those of ordinary skill in the art upon review of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0016] [Figure 1] 1 illustrates a catheter assembly including a catheter, a stylet, and a guidewire for automatically removing the stylet from the catheter, according to some embodiments. [Diagram 2] 13A-13C show detailed views of a distal portion of the guidewire, including the dilated section prior to abutting the stylet tip of the stylet, as the guidewire is withdrawn proximally from the catheter, according to some embodiments. [Diagram 3] 13A-13C show detailed views of an expanded section of the guidewire while abutting the stylet tip of the stylet as the guidewire is withdrawn proximally from the catheter, in accordance with some embodiments. [Figure 4] FIG. 13 shows a detailed view of an expanded section of the guidewire while abutting the stylet tip of the stylet, just before the stylet is automatically removed from the catheter by the guidewire as the guidewire is withdrawn proximally from the catheter, in accordance with some embodiments. [Diagram 5] 13A-13C show detailed views of an expanded section of the guidewire while the stylet continues to be automatically withdrawn from the catheter by the guidewire as the guidewire is withdrawn proximally from the catheter, according to some embodiments. [Figure 6] FIG. 13 shows a detailed view of a distal portion of a guidewire, including a spherical end cap in place of an expanded section of the guidewire, before the spherical end cap abuts the stylet tip of the stylet, as the guidewire is withdrawn proximally from the catheter, in accordance with some embodiments. [Figure 7] 13 shows another detailed view of a distal portion of the guidewire including the bulbous end cap prior to abutting the stylet tip of the stylet as the guidewire is withdrawn proximally from the catheter, according to some embodiments. [Figure 8] FIG. 13 shows a detailed view of the bulbous end cap of the guidewire while abutting the stylet tip of the stylet, just before the stylet is automatically removed from the catheter by the guidewire as the guidewire is withdrawn proximally from the catheter, in accordance with some embodiments. [Figure 9] FIG. 13 shows a detailed view of the bulbous end cap of the guidewire while abutting the stylet tip of the stylet as the guidewire is automatically removed from the catheter by the guidewire as the guidewire is withdrawn proximally from the catheter, in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0018] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, unless otherwise defined, any of the aforementioned features or steps can further include one or more features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0019] With respect to "proximal," for example, a "proximal portion" or "proximal section" of a catheter includes the portion or section of the catheter that is intended to be near the clinician when the catheter is used with a patient. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used with a patient. For example, the "proximal end" of a needle includes the end of the catheter that is intended to be near the clinician when the catheter is used with a patient. Although a proximal portion, section, or length of a catheter can include the proximal end of the catheter, a proximal portion, section, or length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, section, or length of a catheter is not a terminal portion or length of a catheter.

[0020] With respect to "distal," for example, a "distal portion" or "distal section" of a catheter includes a portion or section of a catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, section, or length of a catheter can include the distal end of the catheter, a distal portion, section, or length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, section, or length of a catheter is not a terminal portion or length of a catheter.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As discussed above, the insertion of a CVC into a patient is a multi-step process that is prone to multiple errors. For example, after percutaneously puncturing a selected insertion site on a patient with a needle, thereby establishing a puncture pathway from the area of ​​skin to the vascular lumen, an access guidewire is inserted through the needle into the vascular lumen. After removing the needle, the CVC is inserted over the access guidewire into the vascular lumen. At this point, the access guidewire can be replaced with a steering guidewire, after which the catheter tube of the CVC is advanced over the steering guidewire through the patient's vasculature. However, the CVC may include a stylet that is assembled during manufacture. This stylet fills the extra annular space between the inner diameter of the catheter tube and the outer diameter of the access guidewire. The extra annular space would otherwise cause the tip of the catheter tube to snag on the patient's skin as the CVC is inserted. Additionally, the stylet stiffens and provides additional buckling strength to the catheter tube to prevent buckling as the CVC is inserted over the access guidewire into the vascular lumen. The stylet must be removed after the CVC is inserted over the access guidewire into the vascular lumen, but the stylet is often forgotten, which can lead to an ineffective procedure or even injury to the patient. In view of the foregoing, there is a need for an automated stylet removal means and method for removing a stylet from a CVC or other catheter.

[0022] Disclosed herein are guidewires, stylet assemblies, catheter assemblies, and methods thereof that address at least the foregoing. For example, the stylet assembly can include a guidewire disposed within a stylet. The guidewire can include a proximal portion having a first outer diameter, a distal portion including an expanded section having a second outer diameter greater than the first outer diameter, and a guidewire tip within the distal portion of the guidewire. The stylet can include a stylet tip and a stylet lumen through the stylet having a stylet inner diameter corresponding to the first outer diameter of the guidewire. At least a proximal portion of the guidewire can be disposed within the stylet lumen of the stylet in a corresponding orientation. The expanded section of the guidewire can be configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter with the guidewire.

[0023] FIG 1 illustrates a catheter assembly 100 including a catheter 102, a stylet 104, and a guidewire 106 for automatically removing the stylet 104 from the catheter 102, according to some embodiments. FIGS 2-5 and 6-9 illustrate various detailed views of a distal portion of the catheter assembly 100, according to some embodiments. In particular, FIGS 2-5 illustrate a catheter assembly 100 having a guidewire 106 with an extended guidewire section 112, while FIGS 6-9 illustrate a guidewire 106 having two different features or automatic stylet detachment means for automatically removing the stylet 104 from the catheter assembly 100, by illustrating a catheter assembly 100 having a guidewire 106 with a bulbous end cap 115 at the guidewire tip 110.

[0024] As shown, the catheter assembly 100 includes a guidewire 106 that is positioned within a stylet 104 (e.g., a stylet lumen of the stylet 104) to form a stylet assembly 108, which is positioned within the catheter 102 (e.g., a primary lumen 132 of the catheter 102) in a corresponding orientation (i.e., the guidewire 106, stylet 104, and a distal portion or distal end of the catheter 102 are pointed in a distal direction, and the guidewire 106, stylet 104, and a proximal portion of the proximal end of the catheter 102 are pointed in a proximal direction).

[0025] Guidewire 106 (eg, an access guidewire) includes a proximal portion, a distal portion, and a guidewire tip 110 within the distal portion of guidewire 106 . 2-5, the proximal portion of guidewire 106 has an outer diameter that is nominally a first outer diameter as used herein. (See diameter d1 in FIG. 2, with the understanding that both the proximal and distal portions of guidewire 106 have the first outer diameter proximal to expansion section 112 in the embodiment shown in FIGS. 2-5.) The first outer diameter of guidewire 106 can be constant along the length of the proximal portion of guidewire 106.

[0026] With further reference to the guidewire 106 of FIGS. 2-5, the distal portion of the guidewire 106 includes an expansion section 112 having an outer diameter that is nominally a second outer diameter as used herein. (See diameter d2 in FIG. 2.) The second outer diameter of the guidewire 106, specifically the second outer diameter of the expansion section 112 of the guidewire 106, is greater than the first outer diameter of the guidewire 106 (i.e., d2>d1), regardless of whether the first outer diameter is at the proximal portion of the guidewire 106 or at the distal portion of the guidewire 106 proximal to the expansion section 112 of the guidewire 106. (See FIG. 2, where d1 corresponds to the first outer diameter of the distal portion of the guidewire 106 proximal to the expansion section 112 of the guidewire 106.) The second outer diameter of the guidewire 106 may be constant along the length of the expansion section 112 of the guidewire 106. However, the second outer diameter may have a taper 114, described below. Notwithstanding the above, the expanded section 112 of the guidewire 106, e.g., the proximal portion or proximal end of the expanded section 112 of the guidewire 106, is configured to abut against the stylet tip 116 of the stylet 104 when the guidewire 106 is withdrawn proximally from the catheter 102 in order to automatically withdraw the stylet 104 from the catheter 102 together with the guidewire 106 as the stylet assembly 108.

[0027] With further reference to the guidewire 106 of FIGS. 2-5, the expanded section 112 of the guidewire 106 can have a taper 114 that tapers from a second outer diameter of the expanded section 112 to a first outer diameter of a remainder of the guidewire 106 proximal to the expanded section 112, such as a distal portion of the guidewire 106 proximal to the expanded section 112 or a proximal portion of the guidewire 106 as best shown in FIG. 2. The taper 114 can be relatively short (e.g., 5% or less of the length of the expanded section 112 of the guidewire 106, such as 3% or less, 2% or less, or 1% or less of the length of the expanded section 112 of the guidewire 106) as shown in FIG. 2, or relatively long (e.g., 25% or more of the length of the expanded section 112 of the guidewire 106). Such a taper can be established, for example, using windings of one or more round wires as described below where the one or more round wires are individually tapered or ground to form the taper 114. Alternatively, guidewire 106 can include a step that defines dilated section 112 having a second outer diameter from the remainder of guidewire 106 having a first outer diameter.

[0028] With reference to the guidewire 106 of Figures 6-9, both the proximal and distal portions of the guidewire 106 can have a first outer diameter as described above, which can be constant along the length of the guidewire 106, except for the outer diameter associated with the spherical end cap 115. That said, the proximal and distal portions of the guidewire 106 may have different outer diameters if the proximal and distal portions of the guidewire 106 are differently constructed, as described below, with respect to different options for one or more core wires and any windings thereabout. However, it should be understood that any different outer diameters of the proximal and distal portions of the guidewire 106 of Figures 6-9 that may result from their different constructions do not affect the spherical end cap 115 as an automatic stylet detachment means for automatically detaching the stylet 104 from the catheter assembly 100 of Figures 6-9.

[0029] The guidewire tip 110 may be an atraumatic J-shaped guidewire tip, as best shown in Figures 2-5 and 6. Such a J-shaped guidewire tip may terminate in a hemispherical end cap, as shown in Figures 2-5. However, such a J-shaped guidewire tip may alternatively terminate in a spherical end cap 115. In such an embodiment, the spherical end cap 115 of the guidewire tip 110 may have a diameter that is nominally a third diameter, as used herein, that corresponds at least to the second outer diameter of the expanded section 112 described above, and thus is greater than the first outer diameter of the guidewire 106. The spherical end cap 115 obviates the need for the expanded section 112 of the guidewire 106 shown in Figures 2-5, such that both the proximal and distal portions of the guidewire 106 may have the first outer diameter. Also, similar to the expansion section 112 of the guidewire 106 of Figures 2-5, the spherical end cap 115 of the guidewire tip 110 shown in Figures 6-9 can be similarly configured to abut against the stylet tip 116 of the stylet 104 when the guidewire 106 is withdrawn proximally from the catheter 102 in order to automatically withdraw the stylet 104 from the catheter 102 together with the guidewire 106 as the stylet assembly 108.

[0030] The guidewire 106 may comprise one or more bare cores around which one or more windings of round wire are wound, one or more windings of polished round wire that are then flattened, one or more windings of tape in place of one or more round wire, or any combination thereof. In one example, the guidewire 106 may include at least a bare wire portion and a round wound portion, the round wound portion of the guidewire 106 being distal to the bare wire portion of the guidewire 106, and the round wound portion of the guidewire 106 corresponding to the expanded section 112 of the guidewire 106. In another example, the guidewire 106 may include at least a polished or flat wound portion and a round wound portion, the round wound portion of the guidewire 106 being distal to the polished or flat wound portion of the guidewire 106, and the round wound portion of the guidewire 106 corresponding to the expanded section 112 of the guidewire 106. When any of the exemplary guidewires described above are assembled into a sealed needle assembly for both establishing a percutaneous puncture and inserting the guidewire 106 into a blood vessel lumen via a puncture path established by the needle assembly, the bare, polished, or flat-wrapped portions of the guidewire 106, which have fewer gaps than the rolled portions, can advantageously facilitate sealing of the sealed needle assembly in establishing a leak-tight seal around the guidewire 106. Each of the one or more cores can be selected from round or cylindrical cores, prismatic cores, such as elongated triangular, square, pentagonal, hexagonal, heptagonal, or octagonal cores, and subcombinations thereof. Whether the guidewire 106 is rolled, polished, or flat-wrapped, the edges of any prismatic cores present in the guidewire 106 can advantageously bite into one or more round wires or tapes, thereby minimizing slippage of the windings on the one or more cores. In particular, the stiffness of guidewire 106 or a portion thereof can be tailored by one or more core wires, with greater penetration of one or more core wires or portions thereof creating a stiffer guidewire or portion of guidewire 106.

[0031] As shown, the stylet 104 includes a stylet tip 116 and a stylet lumen extending therethrough. The stylet lumen has a stylet inner diameter that corresponds to or is larger than the first outer diameter of the guidewire 106 .

[0032] The stylet 104 also includes a stylet outer diameter (see, e.g., diameter d3 in FIG. 2 ) that corresponds to an inner catheter diameter of the primary lumen 132 of the catheter 102, described below, specifically within at least the catheter tube 118 of the catheter 102. The stylet outer diameter causes the stylet 104 to occupy an annular space that would otherwise exist between the first outer diameter of the guidewire 106 and the inner catheter diameter of the primary lumen 132 of the catheter 102. Such annular space could otherwise cause the catheter tip 130 of the catheter tube 118 to catch on the patient's skin when the catheter 102 is advanced over the guidewire 106 into the patient's vascular lumen.

[0033] As shown, the catheter 102 includes a catheter tube 118, a catheter hub 120, one or more extension legs 122, and one or more extension leg connectors 124. Such a catheter may be a rapid insertion central catheter (RICC), although the catheter 102 is not limited thereto.

[0034] The catheter tube 118 includes a first section 126 at a distal portion of the catheter tube 118 and a second section 128 proximal to the first section 126 . The first section 126 of the catheter tube 118 terminates distally at a catheter tip 130. Furthermore, the first section 126 of the catheter tube 118 tapers from a flat proximal end of the first section 126, the proximal end of which is fixedly attached to the distal end of the second section 128 of the catheter tube 118, to the distal end of the first section 126, or its catheter tip 130. In effect, the first section 126 of the catheter tube 118 includes a taper from an outer catheter diameter at the proximal end of the first section 126, which corresponds to the outer catheter diameter of the second section 128 of the catheter tube 118, to an outer catheter diameter at the distal end of the first section 126, or its catheter tip 130. The taper of the first section 126 of the catheter tube 118 is configured to immediately dilate the tissue around the puncture path established by the introducer needle to the outer catheter diameter of the second section 128 of the catheter tube 118.

[0035] The second section 128 of the catheter tube 118 includes a constant outer catheter diameter along its length from the flattened distal end of the second section 128 to the proximal end of the second section 128. The constant diameter of the second section 128 of the catheter tube 118 is configured for smooth insertion into the aforementioned puncture path and target vasculature after expansion by the first section 126 of the catheter tube 118.

[0036] The first section 126 and the second section 128 of the catheter tube 118 are fixedly joined to each other at their ends. In fact, the flat surface proximal end of the first section 126 of the catheter tube 118 is joined to the flat surface distal end of the second section 128 of the catheter tube 118 by solvent bonding, adhesive bonding, or heat welding. Furthermore, the abluminal surface of the catheter tube 118 smoothly transitions from the abluminal surface of the first section 126 of the catheter tube 118 to the abluminal surface of the second section 128 of the catheter tube 118 with minimal to negligible edges that do not catch on the skin when the catheter tube 118 is inserted into the puncture path. And, when solvent bonded, minimal to negligible edges can include solvent interdiffusion of the polymeric materials from which the first section 126 and the second section 128 of the catheter tube 118 are formed, which smooths the transition from the first section 126 of the catheter tube 118 to the second section 128 of the catheter tube 118.

[0037] The first section 126 of the catheter tube 118 can be formed from a first polymeric material having a first durometer (e.g., polytetrafluoroethylene, polypropylene, or polyurethane), and the second section 128 of the catheter tube 118 can be formed from a second polymeric material having a second durometer lower than the first durometer (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone). For example, the first section 126 of the catheter tube 118 can be formed from a first polyurethane having a first durometer, and the second section 128 of the catheter tube 118 can be formed from a second, different polyurethane having a second durometer lower than the first durometer (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, the same diisocyanates or triisocyanates reacted with the same diols or triols under different conditions or with different additives, etc.). Indeed, polyurethanes are advantageous for the catheter tube 118 in that they are relatively stiff at room temperature, but may become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous in that they may be less thrombogenic than some other polymers. Notwithstanding the above, however, the first section 126 and the second section 128 of the catheter tube 118 may be formed from the same polymeric material selected from among the polymeric materials previously mentioned.

[0038] It should be understood that the first durometer of the first polymeric material and the second durometer of the second polymeric material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer of the second polymeric material may not be numerically lower than the first durometer of the first polymeric material when the second durometer is lower than the first durometer. In fact, the hardness of the second polymeric material may still be lower than the hardness of the first polymeric material because each of the different scales ranging from 0 to 100 are designed to characterize different materials in a group of materials having similar hardness.

[0039] Returning to the catheter tip 130 of the first section 126 of the catheter tube 118, the catheter tip 130 may include a reinforcement band as a reinforcement within the catheter tip 130. Such a reinforcement band has sufficient stiffness over its length to support aspiration through the catheter tube 118 without collapsing the catheter tip 130. Additionally or alternatively, the reinforcement band has sufficient stiffness over its length to prevent buckling of the catheter tip 130 when the catheter tube 118 is rapidly inserted over the guidewire 106 into the lumen of the target vasculature. The reinforcement band may be formed of a metal or a thermoplastic polymer that is inserted into a bore of the first section 126 of the catheter tube 118 corresponding to the reinforcement band. Alternatively, the first section 126 of the catheter tube 118 may be molded or extruded over the metallic or polymeric reinforcement band. When the reinforcement band is formed of a metal, the metal may be selected from at least stainless steel, titanium, and nitinol. When the reinforcement band is formed from a thermoplastic polymer, the thermoplastic polymer may be selected from at least thermoplastic polyurethanes, carbonate-based thermoplastic polyurethanes, polyamides, and polyamide-block-polyether copolymers. Advantageously, the thermoplastic polymer of the reinforcement band may be selected to remain relatively rigid at body temperature in vivo, as opposed to those described above for the first and second sections 126, 128 of the catheter tube 118. Additionally, the thermoplastic polymer of the reinforcement band may be formulated to include a radiopaque agent, such as bismuth trioxide or barium sulfate, to enhance the radiopacity of the catheter tip 130.

[0040] The catheter tube 118 includes one or more catheter tube lumens extending therethrough. Typically, however, in a single lumen catheter or in a multi-lumen catheter (e.g., a two-lumen catheter, a three-lumen catheter, a four-lumen catheter, a five-lumen catheter, a six-lumen catheter, etc.), there is only one catheter tube lumen extending from the proximal end of the catheter tube 118 to the distal end of the catheter tube 118. In fact, the first section 126 of the catheter tube 118 typically includes one lumen therethrough, namely, the primary lumen 132. In particular, the secondary lumen 134 and the tertiary lumen 136 each terminate at the distal end of the second section 128 of the catheter tube 118.

[0041] According to the first section 126 of the catheter tube 118, the second section 128 of the catheter tube 118, and the catheter tip 130 described above, the catheter tube 118, optionally in combination with the access guidewire 106 disposed therein, has sufficient buckling strength to prevent the catheter tube 118 from buckling when it is rapidly inserted into the puncture path into the vascular lumen of the patient. The buckling strength of the catheter tube 118 is also sufficient to prevent the catheter tube 118 from buckling when it is advanced through the vascular system of the patient without pre-dilating the tissue around the puncture path or any blood vessels of the vascular system with a separate dilator. In fact, the buckling strength of the catheter tube 118 is noteworthy in that it allows the catheter 102 or its catheter tube 118 to be rapidly inserted into the puncture path into the vascular lumen and the catheter tube 118 to be advanced through the vascular system of the patient without using the Seldinger technique.

[0042] The catheter hub 120 includes a pair of suture wings 121 that includes a number of suture wing through-holes for suturing the catheter hub 120 to a patient. Each wing of the pair of suture wings 121 can include one, two, three, or four suture wing through-holes for suturing the catheter hub 120 to a patient.

[0043] The catheter hub 120 also includes one or more catheter hub lumens that correspond in number to the one or more catheter tube lumens that extend entirely through the catheter hub 120 from the proximal end of the catheter hub 120 to the distal end of the catheter hub 120. When the catheter hub 120 is coupled to the proximal portion of the catheter tube 118, as shown in FIG. 1, the one or more catheter tube lumens each continue through one or more catheter hub lumens.

[0044] Each of the one or more extension legs 122 is coupled by its distal portion to the catheter hub 120 and thus extends from the catheter hub 120. The one or more extension legs 122 each include one or more extension leg lumens, the number of which corresponds to the number of the one or more catheter hub lumens. Each of the one or more extension leg lumens extends entirely through the extension leg from the proximal end of the extension leg to the distal end of the extension leg. When the one or more extension legs 122 are coupled to the catheter hub 120, as shown in FIG. 1, the one or more catheter hub lumens each continue through the one or more extension leg lumens.

[0045] Each extension leg connector of the one or more extension leg connectors 124 is on a proximal portion of one of the one or more extension legs 122. For example, each extension leg connector of the one or more extension leg connectors 124 can be a Luer connector on a proximal portion of one of the one or more extension legs 122. Through such an extension leg connector, a corresponding extension leg and its extension leg lumen can be connected to another medical device and its lumen.

[0046] The catheter 102 may be a single lumen catheter or a multi-lumen catheter, such as a two-lumen catheter, a three-lumen catheter, a four-lumen catheter, a five-lumen catheter, a six-lumen catheter, etc. When the catheter 102 is configured as a three-lumen catheter as shown in FIG. 1, the catheter 102 includes a set of three lumens. The set of three lumens includes a primary lumen 132, a secondary lumen 134, and a tertiary lumen 136 formed from the fluidly connected portions of the three catheter tube lumens of the catheter tube 118, the three catheter hub lumens of the three-way hub for the catheter hub 120, and the three extension leg lumens of the three extension legs 122. The primary lumen 132 extends from an opening at the proximal end of a corresponding luer connector to a primary lumen opening 138 at the distal end of the first section 126 of the catheter tube 118 or its catheter tip 130, which corresponds to the distal end of the catheter 102. The secondary lumens 134 extend from an opening at the proximal end of their respective Luer connectors to a secondary lumen opening 140 in the side of the distal portion of the catheter tube 118. The tertiary lumens 136 extend from an opening at the proximal end of their respective Luer connectors to a tertiary lumen opening 142 in the side of the distal portion of the catheter tube 118 proximal to the secondary lumen opening 140.

[0047] method The method includes inserting the catheter 102 into a vascular lumen of a patient. Such method includes one or more steps selected from the steps of establishing a puncture path, inserting a guidewire, removing the needle, advancing the catheter, and removing the automatic stylet.

[0048] The puncture pathway establishing step includes establishing a puncture pathway from the area of ​​skin to the lumen of the blood vessel with the needle. The guidewire insertion step involves inserting a guidewire 106 into the needle lumen of the needle and advancing the guidewire 106 into the blood vessel lumen.

[0049] The needle removal step involves removing the needle from the puncture tract, leaving the guidewire 106 in place within the vessel lumen. The catheter advancement step involves advancing the catheter 102, including the stylet 104 disposed within the primary lumen 132 of the catheter 102, over the guidewire 106, with at least a proximal portion of the guidewire 106 disposed within the stylet lumen of the stylet 104, until a sufficient portion of the catheter tube 118 of the catheter 102 is disposed within the vascular lumen. Again, the primary lumen 132 of the catheter 102 has a catheter inner diameter that corresponds to the stylet outer diameter within at least the catheter tube 118 of the catheter 102, such that the annular space that would otherwise exist therebetween prevents the catheter tip 130 of the catheter tube 118 from catching on the patient's skin during advancement of the catheter 102 into the vascular lumen of the patient.

[0050] The automatic stylet removal step includes removing both the guidewire 106 and the stylet 104 from the catheter 102. As described above with respect to Figures 2-5, the guidewire 106 includes a proximal portion having a first outer diameter and a distal portion including an expanded section 112 having a second outer diameter greater than the first outer diameter. Alternatively, both the proximal and distal portions of the guidewire 106 have a first outer diameter as described with respect to Figures 6-9. Thus, either the expanded section 112 or the bulbous end cap 115 of the guidewire 106 abuts the stylet tip 116 of the stylet 104 as the guidewire 106 is withdrawn proximally from the catheter 102 to automatically withdraw the stylet 104 from the catheter 102 along with the guidewire 106.

[0051] With respect to the automatic stylet removal step according to Figures 2-5, the automatic stylet removal step begins with proximal withdrawal of the guidewire 106 from the catheter 102, as shown in Figure 2. As the guidewire 106 continues to be withdrawn from the catheter 102, the expanded section 112 of the guidewire 106 abuts against the stylet tip 116 of the stylet 104, as shown in Figure 3. As the guidewire 106 continues to be withdrawn from the catheter 102, the expanded section 112 of the guidewire 106 continues to abut against the stylet tip 116 of the stylet 104 during withdrawal of the guidewire 106 from the catheter 102, as shown in Figure 4, thereby automatically removing the stylet 104 along with the guidewire 106. In FIG. 5, the expanded section 112 of the guidewire 106 remains in contact with the stylet tip 116 of the stylet 104, but the expanded section 112 of the guidewire 106 and the stylet tip 116 of the stylet 104 remain within the primary lumen 132 of the catheter 102 until they are completely removed in accordance with the automatic stylet removal step.

[0052] With respect to the automatic stylet removal step according to Figures 6-9, the automatic stylet removal step begins with proximal withdrawal of the guidewire 106 from the catheter 102, as shown in Figures 6 and 7. As the guidewire 106 continues to be withdrawn from the catheter 102, the bulbous end cap 115 of the guidewire 106 abuts against the stylet tip 116 of the stylet 104, as shown in Figure 8. As the guidewire 106 continues to be withdrawn from the catheter 102, the bulbous end cap 115 of the guidewire 106 continues to abut against the stylet tip 116 of the stylet 104 during withdrawal of the guidewire 106 from the catheter 102, as shown in Figure 9, thereby automatically removing the stylet 104 along with the guidewire 106. The bulbous end cap 115 of the guidewire 106 remains in contact with the stylet tip 116 of the stylet 104 within the primary lumen 132 of the catheter 102 until it is completely removed in accordance with the automatic stylet removal step.

[0053] Although some specific embodiments are disclosed herein and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations or modifications may become apparent to those skilled in the art, and the broader aspects of the invention encompass these adaptations or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A guidewire comprising: a proximal portion having a first outer diameter; a distal portion including an expansion section, the expansion section having a second outer diameter greater than the first outer diameter; a guidewire tip within the distal portion of the guidewire; wherein the expanded section of the guidewire is configured to abut a stylet tip of the stylet when at least the proximal portion of the guidewire is disposed within a stylet in a corresponding orientation and when the proximal portion of the guidewire withdraws the guidewire proximally.

2. The guidewire of claim 1 , wherein the guidewire includes a step defining the expanded section having the second outer diameter from a remainder of the guidewire having the first outer diameter.

3. The guidewire of claim 1 , wherein the guidewire includes a taper from the dilated section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

4. The guidewire of claim 1 , wherein the guidewire tip is an atraumatic J-shaped guidewire tip.

5. A guidewire comprising: A proximal portion; a distal portion, wherein the proximal and distal portions of the guidewire have a first outer diameter; a guidewire tip within the distal portion of the guidewire; the guidewire tip terminating in a ballized end cap having a third diameter greater than the first outer diameter such that the ballized end cap abuts a stylet tip of the stylet when at least the proximal portion of the guidewire is disposed within a stylet in a corresponding orientation such that the proximal portion of the guidewire proximally withdraws the guidewire.

6. A stylet assembly comprising: A guidewire comprising: a proximal portion having a first outer diameter; a distal portion including an expansion section, the expansion section having a second outer diameter greater than the first outer diameter; a guidewire tip within the distal portion of the guidewire; A guidewire comprising: A stylet, A stylet tip portion, a stylet lumen having a stylet inner diameter corresponding to the first outer diameter of the guidewire; A stylet containing wherein at least the proximal portion of the guidewire is disposed within the stylet lumen of the stylet in a corresponding orientation, and the expanded section of the guidewire is configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter with the guidewire.

7. The stylet assembly of claim 6 , wherein the guidewire includes a step defining the expanded section having the second outer diameter from a remainder of the guidewire having the first outer diameter.

8. The stylet assembly of claim 6 , wherein the guidewire includes a taper from the dilated section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

9. The stylet assembly of claim 6 , wherein the guidewire tip is an atraumatic J-shaped guidewire tip.

10. 1. A catheter assembly comprising: A guidewire comprising: a proximal portion having a first outer diameter; a distal portion including an expansion section, the expansion section having a second outer diameter greater than the first outer diameter; a guidewire tip within the distal portion of the guidewire; A stylet, A stylet tip portion, a stylet lumen having a stylet inner diameter corresponding to the first outer diameter of the guidewire; A catheter comprising: a catheter tube including a catheter tip; a primary lumen having a catheter inner diameter corresponding at least to an outer diameter of a stylet in the catheter tube; A catheter comprising: the stylet is disposed within the primary lumen of the catheter in a corresponding orientation, at least the proximal portion of the guidewire is disposed within the stylet lumen of the stylet in a corresponding orientation, and the expanded section of the guidewire is configured to abut the stylet tip as the guidewire is withdrawn proximally from the catheter to automatically withdraw the stylet from the catheter.

11. The catheter assembly of claim 10 , wherein the guidewire includes a step defining the expanded section having the second outer diameter from a remainder of the guidewire having the first outer diameter.

12. The catheter assembly of claim 10 , wherein the guidewire includes a taper from the expansion section having the second outer diameter to a remainder of the guidewire having the first outer diameter.

13. 13. A catheter assembly according to any one of claims 10 to 12, wherein the guidewire tip is an atraumatic J-shaped guidewire tip.

14. 14. The catheter assembly of claim 10, wherein the catheter is a tri-lumen catheter including a three-pronged catheter hub coupled to a proximal portion of the catheter tube and three extension legs extending from the catheter hub, each of the three extension legs including a Luer connector coupled to a proximal portion of the extension leg.

15. 15. The catheter assembly of claim 14, wherein the primary lumen extends from an opening at a proximal end of a first Luer connector to an opening at the catheter tip, the secondary lumen extends from an opening at a proximal end of a second Luer connector to a secondary lumen opening in a distal portion of the catheter tube, and the tertiary lumen extends from an opening at a proximal end of a third Luer connector to a tertiary lumen opening in the distal portion of the catheter tube proximal to the secondary lumen opening.

Images