CATHETER TIP FOR A RAPIDLY INSERTED CENTRAL CATHETER AND METHOD THEREFOR

Abstract

The rapid-insertion central catheter may include a catheter tube, a catheter hub, and one or more extension legs. The catheter tube may include a single-piece catheter tip having a first section, a second section, and a third section coupled to a distal end portion of the catheter tube. The first section of the catheter tip may have a uniform taper in outer diameter from a size equivalent to the outer diameter of the needle shaft of the introducer needle to a size equivalent to the outer diameter of the second section of the catheter tip to dilate tissue around the needle track. The third section of the catheter tip may have a non-uniform taper in outer diameter from a size equivalent to the outer diameter of the second section of the catheter tip to a size equivalent to the outer diameter of the catheter tube to dilate tissue.

Description

[Technical Field]

[0001] The present invention relates to a catheter tip and method for a rapid insertion central catheter. [Background technology]

[0002] Acute central venous catheters ("ACVCs") are typically inserted using the Seldinger technique. According to the Seldinger technique, the needle path into the vessel lumen is dilated with a separate dilator before advancing the ACVC over an access guidewire into the vessel lumen for subsequent placement. It would be advantageous if clinicians could omit dilating the vessel lumen with a separate dilator. However, current ACVCs have relatively blunt catheter tips, making this difficult.

[0003] Disclosed herein is a catheter tip and method for a rapid insertion central catheter ("RICC") that addresses the foregoing. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a RICC including a catheter tube, a single-piece catheter tip connected to a distal end portion of the catheter tube, a catheter hub connected to a proximal portion of the catheter tube, and one or more extension legs, each extension leg connected to the catheter hub by its distal portion. The catheter tube includes a catheter tube portion of a primary lumen of the RICC, the primary lumen having an inner diameter. The catheter tip has a first section, a second section, and a third section. The first section of the catheter tip has a uniform taper in outer diameter from a size equivalent to the outer diameter of the needle shaft of the introducer needle to a size equivalent to the outer diameter of the second section of the catheter tip to dilate tissue around the needle path. The third section of the catheter tip has a non-uniform taper in outer diameter from a size equivalent to the outer diameter of the second section of the catheter tip to a size equivalent to the outer diameter of the catheter tube to dilate tissue.

[0005] In some embodiments, each successive cross-section of the first section of the catheter tip approaches a larger concentric ring proximally along the first section of the catheter tip, and each successive cross-section of the first section of the catheter tip approaches a smaller concentric ring distally along the first section of the catheter tip, with each of the larger and smaller concentric rings being defined by the outer diameter of the first section of the catheter tip and the inner diameter of the catheter tubing portion of the primary lumen of the RICC, thereby providing a uniform taper of the first section of the catheter tip.

[0006] In some embodiments, each successive cross-section of the catheter tip third section approaches a larger eccentric annulus proximally along the catheter tip third section, and each successive cross-section of the catheter tip third section approaches a smaller eccentric annulus distally along the catheter tip third section, with the larger and smaller eccentric annulus being defined by the outer diameter of the catheter tip third section and the inner diameter of the catheter tubing portion of the primary lumen of the RICC, thereby providing a non-uniform taper of the catheter tip third section.

[0007] In some embodiments, the second section of the catheter tip does not have a taper, and the outer diameter of the second section of the catheter tip is constant along the second section of the catheter tip.

[0008] In some embodiments, the uniform taper of the first section of the catheter tip has a constant first taper angle, and the non-uniform taper of the third section of the catheter tip has a varying third taper angle, the first taper angle being greater than the third taper angle at a maximum taper angle of the third taper angle.

[0009] In some embodiments, the second section of the catheter tip has a uniform taper to dilate tissue from a size equal to the outer diameter of the first section of the catheter tip to a size equal to the outer diameter of the third section of the catheter tip.

[0010] In some embodiments, each successive cross-section of the second section of the catheter tip approaches a larger concentric ring proximally along the second section of the catheter tip. Further, each successive cross-section of the second section of the catheter tip approaches a smaller concentric ring distally along the second section of the catheter tip. Each of the larger and smaller concentric rings is defined by the outer diameter of the second section of the catheter tip and the inner diameter of the catheter tubing portion of the primary lumen of the RICC, thereby providing a uniform taper of the second section of the catheter tip.

[0011] In some embodiments, the uniform taper of the first section of the catheter tip has a constant first taper angle. Furthermore, the uniform taper of the second section of the catheter tip has a constant second taper angle. Finally, the non-uniform taper of the third section of the catheter tip has a varying third taper angle. The first taper angle is greater than the third taper angle at its maximum taper angle. And, the third taper angle is greater than the second taper angle at its maximum taper angle.

[0012] In some embodiments, the second section of the catheter tip is about 4.0 to 5.0 times longer than the first section of the catheter tip. In some embodiments, the third section of the catheter tip is about 4.5 to 7.5 times longer than the second section of the catheter tip.

[0013] In some embodiments, the catheter tip is made of a first polymeric material, and the catheter tube is made of a second polymeric material that is softer than the first polymeric material.

[0014] In some embodiments, the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise significantly deforming when the distal portion of the RICC is advanced into the patient's vascular lumen, and further, the first polymeric material is sufficiently flexible to prevent trauma to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

[0015] In some embodiments, the RICC comprises a tri-set of lumens including a primary lumen, a secondary lumen, and a tertiary lumen. The tri-set of lumens is formed from fluidly connected portions of at least three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The secondary and tertiary lumens terminate at a distal end portion of the catheter tube with at least some fill of molten polymeric material of the first polymeric material.

[0016] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the catheter tip, the secondary lumen has a secondary lumen opening on the side of the distal portion of the catheter tube, and finally, the tertiary lumen has a tertiary lumen opening on the side of the distal portion of the catheter tube but proximal to the secondary lumen opening.

[0017] Also disclosed herein is a method for forming a RICC catheter tip. In some embodiments, the method includes a workpiece inserting step, a die heating step, and a mandrel pushing step. The workpiece inserting step includes inserting a mandrel-mounted catheter tube as the workpiece into a cavity of a radio frequency ("RF") welding die. The distal end of the mandrel of the mandrel-mounted catheter tube remains short of the end of the cavity after the mandrel-mounted catheter tube is inserted into the cavity. The die heating step includes heating the RF welding die to melt a first polymer material within the cavity of the RF welding die. During heating of the RF welding die, the molten polymer material of the first polymer material conforms to the cavity around the mandrel, allowing the initial catheter tip to be formed in a single piece and bonded to the distal end portion of the catheter tube. The mandrel pushing step includes pushing the distal end of the mandrel into the end of the cavity of the RF welding die as the molten polymer material seeps out through an exit hole at the end of the cavity. By forcing the distal end of the mandrel into the end of the cavity, excess polymer material is cut from the distal end of the initial catheter tip to form a catheter tip that is bonded to the distal end portion of the catheter tube.

[0018] In some embodiments, the method further includes a catheter tube obtaining step, which includes procuring or extruding a catheter tube of a second polymeric material that is softer than the first polymeric material, the catheter tube including a primary catheter tube lumen, a secondary catheter tube lumen, and a tertiary catheter tube lumen that correspond to the primary, secondary, and tertiary catheter tube portions of the RICC, respectively.

[0019] In some embodiments, the method further includes a polymer plug inserting step that includes inserting a polymer plug of a first polymer material at least partially into each of the secondary and tertiary catheter tube lumens to melt the first polymer material within the cavity of the RF welding die while heating the RF welding die in the die heating step.

[0020] In some embodiments, the method further includes a workpiece removing step and a mandrel removing step. The workpiece removing step includes removing the mandrel-attached tipped catheter tube as the workpiece from the cavity of the RF welding die. The mandrel removing step includes removing the mandrel from the mandrel-attached tipped catheter tube to provide a tipped catheter tube. Remaining polymer plugs in the secondary and tertiary catheter tube lumens, molten polymer material of the first polymer material in the secondary and tertiary catheter tube lumens, or a combination thereof in the secondary and tertiary catheter tube lumens terminate the secondary and tertiary catheter tube lumens as fillers upon cooling of the mandrel-attached tipped catheter tube or the tipped catheter tube.

[0021] In some embodiments, the catheter tip has a first section, a second section, and a third section. The first section of the catheter tip has a uniform taper in outer diameter from a size equivalent to the outer diameter of the needle shaft of the introducer needle to a size equivalent to the outer diameter of the second section of the catheter tip to dilate tissue around the needle track. The third section of the catheter tip has a non-uniform taper in outer diameter from a size equivalent to the outer diameter of the second section of the catheter tip to a size equivalent to the outer diameter of the catheter tube to dilate tissue around the needle track.

[0022] In some embodiments, the second section of the catheter tip does not have a taper, and the outer diameter of the second section of the catheter tip is constant along the second section of the catheter tip.

[0023] In some embodiments, the second section of the catheter tip has a uniform taper to dilate tissue from a size equal to the outer diameter of the first section of the catheter tip to a size equal to the outer diameter of the third section of the catheter tip.

[0024] In some embodiments, the first polymeric material of the catheter tip is sufficiently rigid to prevent the catheter tip from collapsing, buckling, or otherwise significantly deforming when the distal portion of the RICC is advanced into the patient's vascular lumen, and further, the first polymeric material of the catheter tip is sufficiently flexible to prevent trauma to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

[0025] Also disclosed herein are methods for placing a RICC. In some embodiments, the method includes an initial RICC advancement step and an expansion step. The initial RICC advancement step includes advancing a distal portion of the RICC over an access guidewire into a patient's vascular lumen. The distal portion of the RICC includes a single-piece catheter tip of a first polymeric material having a first section, a second section, and a third section coupled to a distal end portion of a catheter tube of a second polymeric material. The first polymeric material of the catheter tip is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise significantly deforming during advancement of the distal portion of the RICC over the access guidewire into the vascular lumen. The expansion step includes expanding tissue around a needle track leading to the vascular lumen during advancement of the distal portion of the RICC into the vascular lumen in the initial RICC advancement step. The first section of the catheter tip has a uniform taper in outer diameter to dilate tissue from a size equivalent to the outer diameter of the needle shaft of the introducer needle used to establish the needle track to a size equivalent to the outer diameter of the second section of the catheter tip, and the third section of the catheter tip has a non-uniform taper in outer diameter to dilate tissue from a size equivalent to the outer diameter of the second section of the catheter tip to a size equivalent to the outer diameter of the catheter tube.

[0026] In some embodiments, the method further includes a guidewire exchange step, a steering guidewire advancement step, a subsequent RICC advancement step, and a steering guidewire withdrawal step. The guidewire exchange step includes exchanging the access guidewire for the steering guidewire. The steering guidewire advancement step includes further advancing a distal portion of the steering guidewire into the vascular lumen to the lower third of the patient's heart's superior vena cava ("SVC"). The subsequent RICC advancement step includes further advancing a distal portion of the RICC over the steering guidewire into the vascular lumen to the lower third of the patient's SVC. The first polymeric material is also sufficiently flexible to prevent trauma to the vascular lumen while further advancing the distal portion of the RICC over the steering guidewire into the vascular lumen. The steering guidewire withdrawal step includes withdrawing the steering guidewire, leaving the catheter tube in the lower third of the SVC.

[0027] In some embodiments, the second section of the catheter tip does not have a taper, and the outer diameter of the second section of the catheter tip is constant along the second section of the catheter tip.

[0028] In some embodiments, the second section of the catheter tip has a uniform taper to dilate tissue from a size equal to the outer diameter of the first section of the catheter tip to a size equal to the outer diameter of the third section of the catheter tip.

[0029] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0030] [Figure 1] 1 illustrates a RICC according to some embodiments. [Figure 2]10 shows a detailed view of a catheter tip coupled to a distal portion of a catheter tube of a RICC, according to some embodiments. [Figure 3] 3 shows a longitudinal cross section of the catheter tip and catheter tube of FIG. 2 according to some embodiments. [Figure 4] 10 shows a detailed view of another catheter tip coupled to a distal portion of a catheter tube, according to some embodiments. [Figure 5] 5 illustrates a longitudinal cross section of the catheter tip and catheter tube of FIG. 4, according to some embodiments. [Figure 6] 1 shows a cross section of a distal portion of a catheter tube, according to some embodiments. [Figure 7] 3 shows a detailed view of the catheter tip of FIG. 2, according to some embodiments. [Figure 8] 3 shows a cross-section of the second section of the catheter tip of FIG. 2 according to some embodiments. [Figure 9] 3 shows a cross-section of a third section of the catheter tip of FIG. 2 according to some embodiments. [Figure 10] 5 illustrates a method for forming the catheter tip of either FIG. 2 or FIG. 4, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0031] 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 certain embodiments disclosed herein may have features that can be easily separated from the specific embodiment and optionally combined or substituted with any of the other several embodiments disclosed herein.

[0032] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and 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 sequentiality or numerical limitations. For example, "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment including such features or steps be limited to those three features or steps. In addition, any of the aforementioned features or steps can further include one or more additional features or steps unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a specific, fixed position, orientation, or the like. Rather, such designations are used to reflect, for example, relative positions, orientation, or the like. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0033] "Proximal" refers to a portion, section, part, element, etc. of a medical device that is intended to be near or relatively near the clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal section" of a medical device includes a portion or section of the medical device that is intended to be near the clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes a length of the medical device that is intended to be near the clinician when the medical device is used on a patient. A "proximal end" of a medical device is the end of the medical device that is intended to be near the clinician when the medical device is used on a patient. The proximal portion, section, or length of a medical device does not necessarily include the proximal end of the medical device. In fact, the proximal portion, section, or length of a medical device may not reach the proximal end of the medical device. However, the proximal portion, section, or length of a medical device can include the proximal end of the medical device. Where the context does not suggest that the proximal portion, proximal section, or proximal length of a medical device includes the proximal end of the medical device, or where deemed convenient in the following description, the terms "proximal portion," "proximal section," or "proximal length" may be modified to indicate that such portion, section, or length includes the end portion, end section, or end length of the medical device, respectively.

[0034] "Distal" refers to a portion, section, part, element, etc. of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. For example, a "distal portion" or "distal section" of a medical device includes a portion or section of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. Similarly, a "distal length" of a medical device includes a length of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. A "distal end" of a medical device is an end of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. A distal portion, section, or length of a medical device does not necessarily include the distal end of the medical device. In fact, a distal portion, section, or length of a medical device may not reach the distal end of the medical device. However, a distal portion, section, or length of a medical device can include the distal end of the medical device. Where the context does not suggest that a distal portion, section, or length of a medical device includes the distal end of the medical device, or where deemed convenient in the following description, the terms "distal portion," "distal section," or "distal length" may be modified to indicate that such portion, section, or length includes an end portion, end section, or end length of the medical device, respectively.

[0035] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0036] Again, ACVCs are typically inserted using the Seldinger technique. According to the Seldinger technique, the needle path into the vessel lumen is dilated with a separate dilator before advancing the ACVC over an access guidewire into the vessel lumen for subsequent placement. It would be advantageous if clinicians could omit dilating the vessel lumen with a separate dilator. However, current ACVCs have relatively blunt catheter tips, making this difficult.

[0037] Disclosed herein is a catheter tip for RICC and a method thereof that solves the above-mentioned problems. RICC FIG. 1 illustrates a RICC 100 according to some embodiments.

[0038] As shown, the RICC 100 may include a catheter tube 102 having a single-piece catheter tip 104 coupled thereto, a catheter hub 106, and one or more extension legs 108. The catheter tip 104 may be coupled to a distal end portion of the catheter tube 102, and the catheter hub 106 may be coupled to a proximal end portion of the catheter tube 102. Each extension leg of the one or more extension legs 108 may be coupled to the catheter hub 106 by its distal end portion. Additionally, one or more extension leg connectors 110 (e.g., Luer connectors) may be coupled to the one or more extension legs 108 for connecting one or more other medical devices, respectively.

[0039] The RICC 100 can be a single-lumen RICC or a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.). For example, the RICC 100 can be a three-lumen RICC including a set of three lumens as presented in FIG. 1. (See also FIG. 6.) The set of three lumens can be a RICC having an inner diameter (e.g., d in FIG. 8). Ai , d Bi , or d Ci , or d in Figure 9 Di , d Ei , or d FiThe RICC 100 may include a primary lumen 112, a secondary lumen 114, and a tertiary lumen 116, each having a fluidly connected lumen (either a primary lumen 112, a secondary lumen 114, or a tertiary lumen 116). Each of the primary lumen 112, secondary lumen 114, and tertiary lumen 116 of the RICC 100 may be formed from at least three fluidly connected lumen portions: a catheter tube lumen of one of three catheter tubing lumens 118, 120, and 122, a catheter hub lumen of one of three catheter hub lumens, and an extension leg lumen of one of three extension leg lumens. For example, the primary lumen 112 of the RICC 100 may be formed from the primary catheter tube lumen 118, the primary catheter hub lumen, and the primary extension leg lumen; however, the primary lumen 112 of the RICC 100 may also include a fluidly connected catheter tip lumen 124 of the catheter tip section 104. Furthermore, the secondary lumen 114 of the RICC 100 may be formed from a secondary catheter tube lumen 120, a secondary catheter hub lumen, and a secondary extension leg lumen. Finally, the tertiary lumen 116 of the RICC 100 may be formed from a tertiary catheter tube lumen 122, a tertiary catheter hub lumen, and a tertiary extension leg lumen. The primary lumen 112 may have a primary lumen opening 126 at the distal end of the catheter tip section 104, which corresponds to the distal end of the RICC 100. The secondary lumen 114 may have a secondary lumen opening 128 on a side of the distal portion of the catheter tube 102. The tertiary lumen 116 may have a tertiary lumen opening 130 on a side of the distal portion of the catheter tube 102, proximal to the secondary lumen opening 128. Like the secondary lumen 114 and the tertiary lumen 116, each additional lumen may have a corresponding lumen opening on a side of the distal portion of the catheter tube 102 more proximal than the previous lumen.

[0040] Catheter tip Figures 2 and 4 show detailed views of a catheter tube 102 coupled with a catheter tip 104, according to some embodiments. Figures 3 and 5 show longitudinal cross sections of the catheter tube 102 with the catheter tip 104 of Figures 2 and 4, respectively, according to some embodiments. Figure 6 shows a cross section of a distal portion of the catheter tube 102, according to some embodiments.

[0041] As shown, the catheter tube 102 can include one or more catheter tube lumens, such as the three catheter tube lumens 118, 120, and 122 described above. Indeed, when the RICC 100 is a three-lumen RICC, the catheter tube 102 can include a catheter tube portion for the primary lumen 112 of the RICC 100, a catheter tube portion for the secondary lumen 114 of the RICC 100, and a catheter tube portion for the tertiary lumen 116 of the RICC 100. As described in the following methods, prior to forming the catheter tip section 104 coupled to the catheter tube 102, each of the three catheter tube lumens 118, 120, and 122 described above can extend completely through the catheter tube 102. However, after forming the catheter tip section 104, only the primary catheter tube lumen 118 typically extends from the proximal end of the catheter tube 102 to the distal end of the catheter tube 102. Indeed, the primary catheter tube lumen 118 typically extends through both the proximal and distal ends of the catheter tube 102 and continues to extend through a catheter tip lumen 124 at the catheter tip 104. In contrast, the secondary catheter tube lumen 120 and the tertiary catheter tube lumen 122 typically terminate at the distal end portion of the catheter tube 102 with at least some fill of the molten polymeric material of the first polymeric material used to form the catheter tip 104.

[0042] The catheter tube 102 can be formed from a second polymeric material, described below, that is softer than the first polymeric material of the catheter tip 104. In other words, the second polymeric material can have a second durometer that is lower than the first durometer of the first polymeric material. Such second polymeric materials can include, but are not limited to, polyvinyl chloride, polyethylene, polyurethane, or silicone, each having a second durometer that is lower than the first durometer of the first polymeric material. For example, if the catheter tip section 104 is formed from polyurethane as described below, the catheter tube 102 can be formed from a different polyurethane (e.g., the same or different diisocyanate or triisocyanate reacted with a different diol or triol, a different diisocyanate or triisocyanate reacted with the same or different diol or triol, the same diisocyanate or triisocyanate reacted with the same diol or triol under different conditions or with different additives, etc.) having a second durometer that is lower than the first durometer of the polyurethane of the catheter tip section 104. In particular, polyurethane can be advantageous for the catheter tube 102 in that it is relatively stiff at room temperature but becomes flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethane can also be advantageous in that it can be less thrombogenic than some other polymers. Whether the second polymeric material is polyurethane or not, the second polymeric material can be configured to be sufficiently rigid in vitro to provide the catheter tube 102 with column strength that prevents the catheter tube 102 from collapsing, buckling, or otherwise significantly deforming when the RICC 100 is advanced into the lumen of a blood vessel in accordance with the method of deploying the RICC 100 described below.

[0043] Figures 2 and 4 show detailed views of the catheter tip section 104 coupled to the catheter tube 102, according to some embodiments. Figures 3 and 5 show longitudinal cross sections of the catheter tip section 104 coupled to the catheter tube 102 of Figures 2 and 4, respectively, according to some embodiments. In particular, the catheter tip sections 104 of Figures 2 and 3 differ from the catheter tips of Figures 4 and 5 in terms of their tapered shapes, as will be described in more detail below. Figure 7 shows a detailed view of the catheter tip section 104 of Figure 2, according to some embodiments. Figures 8 and 9 show cross sections of the second section 134 of the catheter tip section 104 of Figure 2 and the third section 136 of the catheter tip section 104 of Figure 2, respectively, according to some embodiments.

[0044] As shown, the catheter tip section 104 can have a first section 132, a second section 134, and a third section 136. The second section 134 of the catheter tip section 104 can have a length l2 that is longer than the length l1 of the first section 132 of the catheter tip section 104, and the third section 136 of the catheter tip section 104 can have a length l3 that is longer than the length l2 of the second section 134 of the catheter tip section 104. For example, the length l2 of the second section 134 of the catheter tip section 104 can be approximately 4.0 to 5.0 times longer than the length l1 of the first section 132 of the catheter tip section 104, and the length l3 of the third section 136 of the catheter tip section 104 can be approximately 4.5 to 7.5 times longer than the length l2 of the second section 134 of the catheter tip section 104. However, it should be understood that the relative lengths disclosed herein, such as the lengths of the first, second, and third sections 132, 134, and 136 of the catheter tip 104, and the dimensions disclosed herein generally relate to a 6-8 Fr RICC, such as a 7.33 mm (7 Fr) RICC. The relative lengths and dimensions of larger RICCs (e.g., 7-14 Fr) or smaller RICCs (e.g., 4-6 Fr) as measured on the French catheter scale can optionally vary proportionally, whereby the relative lengths and dimensions of the larger and smaller RICCs are also disclosed.

[0045] Beginning with the first section 132 of the catheter tip 104, the first section 132 can have a uniform taper at its outer diameter with a constant first taper angle configured to immediately dilate tissue around a needle track created with an introducer needle when the RICC 100 is advanced into a patient's vascular lumen in accordance with the method of deploying the RICC 100 described below. The first taper angle can be about 15.0-45.0°, including about 15.0-35.0°, such as about 25.0-35.0°, or, for example, about 30.0°, including or excluding any of the range endpoints. The uniform taper of the first section 132 of the catheter tip 104 can dilate tissue around the needle track from a size equivalent to the outer diameter of the needle shaft of the introducer needle to a size equivalent to the smallest outer diameter of the second section 134 of the catheter tip 104. Because the uniform taper of the first section 132 of the catheter tube 102 is not blunt like the catheter tip of a typical ACVC, the first section 132 of the catheter tip 104 can reduce the force required to insert the RICC 100 into the needle tract compared to a typical ACVC.

[0046] Each successive cross-section of the first section 132 of the catheter tip 104 can approximate a larger concentric ring proximally along the first section 132 of the catheter tip 104. Furthermore, each successive cross-section of the first section 132 of the catheter tip 104 can approximate a smaller concentric ring distally along the first section 132 of the catheter tip 104. Each of the larger and smaller concentric rings is defined by the outer diameter of the first section 132 of the catheter tip 104 and the inner diameter of the catheter tubing portion of the primary lumen 112 of the RICC 100, thereby providing a uniform taper of the first section 132 of the catheter tip 104. While this is not shown for the first section 132 of the catheter tip 104, it is similarly shown in FIGS. 7 and 8 for the second section 134 of the catheter tip 104 in embodiments in which the second section 134 has that uniform taper.

[0047] Continuing with the second section 134 of the catheter tip 104, the second section 134 can have a uniform taper at its outer diameter with a constant second taper angle, as shown in Figures 2, 3, and 8. (See Figure 8.) The outer diameter of the second section 134 of the catheter tip 104 is d Ao , d Bo , and d Co (denoted by ). Alternatively, the outer diameter of the second section 134 of the catheter tip 104 can be constant along the second section 134 without a uniform taper, as shown in FIGS. 4 and 5 . When the second section 134 of the catheter tip 104 has a uniform taper, the second taper angle can be about 10.0° or less, for example, about 1.0° or less, including about 5.0° or less, such as about 2.5° or less. Such a uniform taper can be configured to immediately further dilate tissue around the needle track when the RICC 100 is advanced into the patient's vascular lumen in accordance with the method of deploying the RICC 100 described below. The uniform taper of the second section 134 of the catheter tip 104 can dilate tissue around the needle track from a size equivalent to the maximum outer diameter of the first section 132 of the catheter tip 104 to a size equivalent to the minimum outer diameter of the third section 136 of the catheter tip 104. Furthermore, because the uniform taper of the second section 134 of the catheter tube 102 is not blunt like the catheter tip of a typical ACVC, the second section 134 of the catheter tip 104 can further reduce the force required to insert the RICC 100 into the needle tract compared to a typical ACVC.

[0048] 7 and 8, each successive cross-section of the second section 134 of the catheter tip 104 can approximate a larger concentric ring proximally along the second section 134 of the catheter tip 104. Additionally, each successive cross-section of the second section 134 of the catheter tip 104 can approximate a smaller concentric ring distally along the second section 134 of the catheter tip 104. Each of the larger and smaller concentric rings can be spaced apart by a distance greater than the outer diameter (e.g., d Ao , d Bo , or d Co ) and the inner diameter of the catheter tubing portion of the primary lumen 112 of the RICC 100 (e.g., d Ai , d Bi , or d Ci ), which can provide a uniform taper of the second section 134 of the catheter tip 104.

[0049] Regarding the third section 136 of the catheter tip 104, the third section 136 can have a non-uniform taper at its outer diameter, with a varying third taper angle, as shown in Figures 2, 3, and 9. (See Figure 9. The outer diameter of the third section 136 of the catheter tip 104 is d Do , d Eo , and d Fo(Indicated by ). Such a non-uniform taper can be configured to immediately further dilate the tissue around the needle tract when the RICC 100 is advanced into the patient's vascular lumen in accordance with the method of deploying the RICC 100 described below. The non-uniform taper of the third section 136 of the catheter tip 104 can dilate the tissue around the needle tract from a size equivalent to the maximum outer diameter of the second section 134 of the catheter tip 104 to a size equivalent to the outer diameter of the catheter tube 102. Furthermore, because the non-uniform taper of the third section 136 of the catheter tube 102 is not blunt like the catheter tip of a typical ACVC, the third section 136 of the catheter tip 104 can further reduce the force required to insert the RICC 100 into the needle tract compared to a typical ACVC. In fact, the third section 136 of the catheter tip 104 is configured to incorporate the dilation typically performed by a dilator in the Seldinger technique into the catheter tip 104, thereby reducing the force required to insert the RICC 100 into the needle tract and eliminating a separate dilation step.

[0050] 7 and 9, each successive cross-section of the third section 136 of the catheter tip 104 can approach a larger eccentric annulus proximally along the third section 136 of the catheter tip 104. Additionally, each successive cross-section of the third section 136 of the catheter tip 104 can approach a smaller eccentric annulus distally along the third section 136 of the catheter tip 104. Each of the larger and smaller eccentric annulus may be spaced apart from the outer diameter (e.g., d Do , d Eo , or d Fo ), and the inner diameter of the catheter tubing portion of the primary lumen 112 of the RICC 100 (e.g., d Di , d Ei , or d Fi ), which can provide a non-uniform taper of the third section 136 of the catheter tip 104.

[0051] As described above, the uniform taper of the first section 132 of the catheter tip 104 can have a constant first taper angle, the uniform taper of the second section 134 of the catheter tip 104, if present, can have a constant second taper angle, and the non-uniform taper of the third section 136 of the catheter tip 104 can have a varying third taper angle. As shown in Figures 2 and 3 and 4 and 5, the first taper angle can be greater than the third taper angle at the maximum third taper angle. And, the third taper angle can be greater than the second taper angle at the maximum third taper angle, and the third taper angle associated with the non-uniform taper of the third section 136 of the catheter tip 104 can vary from about 0.0° upwards, as described below.

[0052] In particular, the third taper angle of the non-uniform taper of the third section 136 of the catheter tip section 104 can be non-uniform in at least two different ways. For example, consider the case where the abluminal surface of the third section 136 of the catheter tip section 104 is defined such that all points on the abluminal surface lie on a longitudinal surface line that is coplanar with the central axis of the catheter tip lumen 124 of the catheter tip section 104. The third taper angle can be non-uniform in that a lowermost surface line 138, which coincides with the lower edge of a symmetrical longitudinal cross-section of the third section 136 of the catheter tip section 104, as shown in FIG. 3, can have a different taper angle than an uppermost surface line 140, which coincides with the upper edge of a symmetrical longitudinal cross-section of the third section 136 of the catheter tip section 104, as also shown in FIG. 3. Indeed, the lowermost surface line 138 can have the smallest taper angle (e.g., about 0.0°) and the uppermost surface line 140 can have the largest taper angle, which can be about 7.5° or less, e.g., about 15.0° or less, including about 10.0° or less, such as about 5.0° or less. The third taper angle can be even more non-uniform in that the lowermost surface line 138, as shown in FIG. 5, can be straight, and the uppermost surface line 140, as shown in FIG. 5, can be non-linear, such as having a gentle S-shape. The surface line of the abluminal surface of the third section 136 of the catheter tip 104 between the lowermost surface line 138 and the uppermost surface line 140 may be incrementally non-linear, such as incrementally S-shaped, with the entire lowermost surface line 138 having a minimum taper angle (e.g., about 0.0°) and the uppermost surface line 140 having an intermediate portion that achieves a maximum taper angle, which may be about 7.5° or less, e.g., about 5.0° or less, including about 10.0° or less, and may be about 15.0° or less.

[0053] The catheter tip 104 can be formed from a first polymeric material that is harder than the second polymeric material of the catheter tube 102 described above. In other words, the first polymeric material can have a first durometer that is higher than the second durometer of the second polymeric material. The first durometer can be a Shore A durometer of about 70-100, including a Shore A durometer of about 90-100, such as a Shore A durometer of about 80-100, such as a Shore A durometer of about 90-95. Such first polymeric materials can include, but are not limited to, polytetrafluoroethylene, polypropylene, or polyurethane, each having a first durometer that is higher than the second durometer of the second polymeric material. For example, the catheter tip 104 can be formed from polyurethane having a first durometer. As described above with respect to the catheter tube 102, polyurethane can also be advantageous for the catheter tip 104. Whether the first polymeric material is polyurethane or not, the first polymeric material can be configured to be sufficiently flexible at body temperature in vivo to prevent trauma to the patient's vascular lumen when the RICC 100 is advanced into the vascular lumen in accordance with the method of deploying the RICC 100 described below. However, the first polymeric material can be configured to soften less than the second polymeric material in vivo at body temperature, in the presence of moisture, or both. Indeed, the first polymeric material can be configured to remain sufficiently stiff to prevent the catheter tip 104 from collapsing, buckling, or otherwise significantly deforming when the RICC 100 is advanced into the patient's vascular lumen. Additionally or alternatively, the first polymeric material can be configured to remain sufficiently stiff to prevent the catheter tip lumen 124 of the catheter tip 104 from collapsing when suction is applied through the catheter tip 104.

[0054] 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 hardness scales (e.g., Type A or Type D). With this understanding, when the second durometer is lower than the first durometer, the second durometer of the second polymeric material may not be numerically lower than the first durometer of the first polymeric material. In fact, the hardness of the second polymeric material may still be lower than the hardness of the first polymeric material, since each different hardness scale ranging from 0 to 100 is designed to characterize a different material in a group of materials having similar hardness.

[0055] The catheter hub 106 can include one or more catheter hub lumens corresponding in number to one or more catheter tube lumens, such as the three catheter hub lumens described above, which also correspond in number to the three catheter tube lumens 118, 120, and 122 described above. When the RICC 100 is a three-lumen RICC, the catheter hub 106 can include a catheter hub portion of the primary lumen 112 of the RICC 100, a catheter hub portion of the secondary lumen 114 of the RICC 100, and a catheter hub portion of the tertiary lumen 116 of the RICC 100. The one or more catheter hub lumens can extend entirely through the catheter hub 106, from the proximal end of the catheter hub 106 to the distal end of the catheter hub 106.

[0056] The one or more extension legs 108 can each include one or more extension leg lumens corresponding in number to one or more catheter hub lumens, such as the three extension leg lumens described above, which also correspond in number to the three catheter hub lumens described above. When the RICC 100 is a three-lumen RICC, the one or more extension legs 108 can include a primary extension leg that includes the extension leg of the primary lumen 112 of the RICC 100, a secondary extension leg that includes the extension leg of the secondary lumen 114 of the RICC 100, and a tertiary extension leg that includes the extension leg of the tertiary lumen 116 of the RICC 100. Each extension leg lumen of the one or more extension leg lumens can extend entirely through its corresponding extension leg, from the proximal end of the extension leg to the distal end of the extension leg.

[0057] In particular, any component of the RICC 100 selected from the catheter tip section 104, the catheter tube 102, the catheter hub 106, the one or more extension legs 108, and the one or more extension leg connectors 110 may include an antimicrobial agent thereon or therein. In one example, the catheter tube 102 and the catheter tip section 104 coupled thereto may include an antimicrobial agent coating on the abluminal surface of the catheter tip section 104 and the catheter tube 102. In another example, the pre-extrusion material of the catheter tube 102 may include an antimicrobial agent mixed therein such that the antimicrobial agent is incorporated into the catheter tube 102 upon extrusion, and the antimicrobial agent protects both the abluminal surface of the catheter tube 102 and the luminal surface of the catheter tube 102 from microbial contamination. Additionally or alternatively, the polymer plug 150 of the first polymer material can include an antimicrobial agent mixed therein such that when formed as described below, the antimicrobial agent is incorporated into the catheter tip 104, and the antimicrobial agent protects both the abluminal surface of the catheter tip 104 and the luminal surface of the catheter tip 104 from microbial contamination.

[0058] method The method includes at least a method for forming the catheter tip 104 of the RICC 100 and a method for placing such a RICC in a vascular lumen of a patient.

[0059] FIG. 10 illustrates a method for forming the catheter tip 104 of either FIG. 2 or FIG. 4, according to some embodiments. The method for forming the catheter tip 104 of the RICC 100 can include one or more steps selected from a catheter tube obtaining step, a polymer plug inserting step, a catheter tube attaching step, a workpiece inserting step 142, a die heating step 144, a mandrel pushing step 146, a workpiece removing step 148, and a mandrel removing step.

[0060] The catheter tube obtaining step can include either procuring or extruding the catheter tube 102 of a second polymeric material, which, as described above, is softer than the first polymeric material of the catheter tip 104. Again, the catheter tube 102 can include a primary catheter tube lumen 118, a secondary catheter tube lumen 120, and a tertiary catheter tube lumen 122, which correspond to the catheter tube portions of the primary lumen 112, secondary lumen 114, and tertiary lumen 116 of the RICC 100, respectively.

[0061] The polymer plug insertion step can include at least partially inserting a polymer plug 150 of a first polymer material into each of the secondary catheter tube lumen 120 and the tertiary catheter tube lumen 122 to melt the first polymer material within the cavity 156 of the RF welding die 158 while the RF welding die 158 is heated in the die heating step 144 described below.

[0062] The catheter tube mounting step may include mounting the catheter tube 102 on a straight mandrel 152 to form a mandrel-mounted catheter tube 154 for the workpiece, and may optionally be performed with polymer plugs 150 of a first polymer material inserted into the secondary catheter tube lumen 120 and the tertiary catheter tube lumen 122, and the catheter tube mounting step may be performed either before or after the polymer plug insertion step.

[0063] The workpiece insertion step 142 may include inserting the mandrel-mounted catheter tube 154 into a cavity 156 of an RF welding die 158. The distal end of the mandrel 152 of the mandrel-mounted catheter tube 154 may remain short of the end of the cavity 156 after the mandrel-mounted catheter tube 154 is inserted into the cavity 156.

[0064] The die heating step 144 may include heating an RF welding die 158 to melt the first polymer material of the polymer plug 150 extending from each of the secondary and tertiary catheter tube lumens 120, 122 within a cavity 156 of the RF welding die 158. During heating of the RF welding die 158, the molten polymer material of the first polymer material may be allowed to conform to the cavity 156 around the distal portion of the mandrel 152 to form, in a single piece, an initial catheter tip 160 that is joined to the distal end portion of the catheter tube 102.

[0065] The mandrel pushing step 146 may include pushing the distal end of the mandrel 152 into the end of the cavity 156 of the RF welding die 158 as a molten exudate 162 of molten polymer material exudes through exit holes 164 at the end of the cavity 156. By pushing the distal end of the mandrel 152 into the end of the cavity 156, excess polymer material may be cut from the distal end of the initial catheter tip 160 to provide a mandrel-attached tipped catheter tube 166 for the workpiece, the tipped catheter tube including the catheter tip 104 joined to the distal end portion of the catheter tube 102.

[0066] The workpiece removal step 148 may include removing the mandrel-attached tipped catheter tube 166 from the cavity 156 of the RF welding die 158. In particular, the remnants of the polymer plug 150 in the secondary catheter tube lumens 120 and the tertiary catheter tube lumens 122, the molten polymer material of the first polymer material in the secondary catheter tube lumens 120 and the tertiary catheter tube lumens 122, or a combination thereof in the secondary catheter tube lumens 120 and the tertiary catheter tube lumens 122 terminate or close the secondary catheter tube lumens 120 and the tertiary catheter tube lumens 122 as a filler upon cooling the mandrel-attached tipped catheter tube 166 or upon cooling the tipped catheter tube after the mandrel removal step described below.

[0067] The mandrel removal step can include removing the mandrel 152 from the mandrel-attached tipped catheter tube 166 to free the primary lumen of the mandrel-tipped catheter tube from the mandrel 152, thereby providing a tipped catheter tube.

[0068] In particular, by forming the catheter tip 104 of the RICC 100 according to the methods described above, the abluminal surface of the third section 136 of the catheter tip 104 can smoothly transition to the abluminal surface of the catheter tube 102 without edges that may catch on the patient's skin when the RICC 100 is advanced into the lumen of a blood vessel according to the methods for deploying the RICC 100 described below.

[0069] Although not shown, a method for placing a RICC 100 having a catheter tip 104 may include one or more steps selected from a needle path establishment step, an access guidewire advancement step, an introduction needle withdrawal step, an initial RICC advancement step including a dilation step or operation performed simultaneously therewith, a guidewire exchange step including an access guidewire withdrawal step and an initial operation guidewire advancement step, a subsequent operation guidewire advancement step, a subsequent RICC advancement step, and an operation guidewire withdrawal step.

[0070] The needle pathway establishing step can include establishing a needle pathway from the area of ​​the patient's skin to the lumen of the blood vessel with an introducer needle. The access guidewire advancing step can include advancing a distal portion of the access guidewire through the introducer needle and into the vessel lumen until access to the vessel lumen is secured using the access guidewire.

[0071] The introducer needle withdrawal step can include withdrawing the introducer needle from the vessel lumen, leaving the access guidewire in place in the vessel lumen. The initial RICC advancement step may include advancing a distal portion of the RICC 100 over the access guidewire into the vessel lumen until access to the vessel lumen is secured using the catheter tube 102. Due to tight control of the manufacturing tolerance between the outer diameter of the access guidewire and the inner diameter of the catheter tip 104, neither the skin nor tissue surrounding the needle tract becomes trapped between the outer diameter of the access guidewire and the inner diameter of the catheter tip. As described above, the distal portion of the RICC 100 may include a catheter tip 104 of a first polymeric material having a first section 132, a second section 134, and a third section 136 coupled to a distal end portion of a catheter tube 102 of a second polymeric material. The first polymeric material of the catheter tip 104 may be configured to remain sufficiently rigid to prevent the catheter tip 104 from collapsing, buckling, or otherwise significantly deforming during advancement of the distal portion of the RICC 100 over the access guidewire into the vessel lumen according to the initial RICC advancement step.

[0072] The dilation step or operation can include dilating tissue around the needle track leading to the vessel lumen while advancing the distal portion of the RICC 100 over the access guidewire into the vessel lumen following the initial RICC advancement step. Thus, the dilation step or operation is part of the initial RICC advancement step, rather than a separate step or operation from the initial RICC advancement step, as required by the Seldinger technique. As described above, the first section 132 of the catheter tip 104 can have a uniform taper in its outer diameter configured to immediately dilate tissue from a size equivalent to the outer diameter of the needle shaft of the introducer needle to a size equivalent to the outer diameter of the second section 134 of the catheter tip 104. The third section 136 of the catheter tip 104 has a non-uniform taper in its outer diameter configured to immediately dilate tissue from a size equivalent to the outer diameter of the second section 134 of the catheter tip 104 to a size equivalent to the outer diameter of the catheter tube 102.

[0073] The exchange step can include exchanging the access guidewire for a steering guidewire, which can then include an access guidewire withdrawal step and an initial steering guidewire advancement step. The access guidewire withdrawal step can include withdrawing the access guidewire from the vessel lumen, leaving the catheter tube 102 in place in the vessel lumen. The initial steering guidewire advancement step can include advancing a distal portion of the steering guidewire into the vessel lumen.

[0074] A subsequent steering guidewire advancement step can include further advancing the distal portion of the steering guidewire into the vessel lumen to the lower third of the superior vena cava ("SVC") of the patient's heart.

[0075] A subsequent RICC advancement step can include further advancing the distal portion of the RICC 100 over the steering guidewire into the vessel lumen to the lower one-third of the SVC. Notably, the first polymeric material is also sufficiently flexible to prevent trauma to the vessel lumen during further advancement of the distal portion of the RICC 100 over the steering guidewire into the vessel lumen according to the subsequent RICC advancement step.

[0076] The steering guidewire withdrawal step can include withdrawing the steering guidewire, leaving the catheter tube 102 in place in the lower third of the SVC. 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. Additional improvements or modifications may be apparent to those skilled in the art, and the broader aspects encompass these as well. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A rapid insertion central catheter ("RICC") comprising: a catheter tube including a primary lumen catheter tube portion of the RICC having an inner diameter; a single-piece catheter tip coupled to a distal end portion of the catheter tube, the single-piece catheter tip having a first section, a second section, and a third section; a catheter hub coupled to a proximal portion of the catheter tube; one or more extension legs, each extension leg of the one or more extension legs coupled by a distal portion thereof to the catheter hub; the first section of the catheter tip has a uniform taper in outer diameter from a size equivalent to the outer diameter of the needle shaft of an introducer needle to a size equivalent to the outer diameter of the second section of the catheter tip to dilate tissue around the needle track; A rapid insertion central catheter ("RICC"), wherein the third section of the catheter tip has a non-uniform taper in outer diameter to dilate the tissue from a size equal to the outer diameter of the second section of the catheter tip to a size equal to the outer diameter of the catheter tube.

2. each successive cross-section of the first section of the catheter tip approaches a larger concentric ring proximally along the first section of the catheter tip and approaches a smaller concentric ring distally along the first section of the catheter tip; 2. The RICC of claim 1, wherein each of the larger and smaller concentric rings is defined by the outer diameter of the first section of the catheter tip and the inner diameter of the catheter tube portion of the primary lumen of the RICC, thereby providing the uniform taper of the first section of the catheter tip.

3. each successive cross-section of the third section of the catheter tip approaches a larger eccentric annulus proximally along the third section of the catheter tip and approaches a smaller eccentric annulus distally along the third section of the catheter tip; 3. The RICC of claim 1, wherein each of the larger and smaller eccentric annulus is defined by the outer diameter of the third section of the catheter tip and the inner diameter of the catheter tube portion of the primary lumen of the RICC, thereby providing the non-uniform taper of the third section of the catheter tip.

4. the second section of the catheter tip is not tapered; 4. The RICC of claim 1, wherein the outer diameter of the second section of the catheter tip is constant along the second section of the catheter tip.

5. the uniform taper of the first section of the catheter tip has a constant first taper angle; the non-uniform taper of the third section of the catheter tip has a varying third taper angle; The RICC according to claim 1 , wherein the first taper angle is greater than the third taper angle at a maximum taper angle of the third taper angle.

6. 4. The RICC of claim 1, wherein the second section of the catheter tip has a uniform taper for expanding the tissue from a size equivalent to the outer diameter of the first section of the catheter tip to a size equivalent to the outer diameter of the third section of the catheter tip.

7. each successive cross-section of the second section of the catheter tip approaches a larger concentric ring proximally along the second section of the catheter tip and approaches a smaller concentric ring distally along the second section of the catheter tip; 7. The RICC of claim 6, wherein each of the larger and smaller concentric rings is defined by the outer diameter of the second section of the catheter tip and the inner diameter of the catheter tube portion of the primary lumen of the RICC, thereby providing the uniform taper of the second section of the catheter tip.

8. the uniform taper of the first section of the catheter tip has a constant first taper angle; the uniform taper of the second section of the catheter tip has a second constant taper angle; the non-uniform taper of the third section of the catheter tip has a varying third taper angle; 8. The RICC according to claim 6 or 7, wherein the first taper angle is greater than the third taper angle at a maximum taper angle of the third taper angle, and the third taper angle is greater than the second taper angle at a maximum taper angle of the third taper angle.

9. 9. The RICC of claim 1, wherein the second section of the catheter tip is approximately 4.0 to 5.0 times longer than the first section of the catheter tip.

10. 10. The RICC of any one of claims 1 to 9, wherein the third section of the catheter tip is about 4.5 to 7.5 times longer than the second section of the catheter tip.

11. 11. The RICC of claim 1, wherein the catheter tip is made of a first polymeric material and the catheter tube is made of a second, softer polymeric material.

12. the first polymeric material is sufficiently rigid to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when the distal portion of the RICC is advanced into the patient's vascular lumen; The RICC of claim 11 , wherein the first polymeric material is sufficiently flexible to prevent trauma to the vessel lumen when the distal portion of the RICC is advanced further into the vessel lumen.

13. the RICC includes three sets of lumens, including primary, secondary, and tertiary lumens, formed from fluidly connected portions of at least three catheter tube lumens, three catheter hub lumens, and three extension leg lumens; 13. The RICC of claim 11 or 12, wherein the secondary lumen and the tertiary lumen terminate at the distal end portion of the catheter tube with at least some fill of molten polymeric material of the first polymeric material.

14. 14. The RICC of claim 13, wherein the primary lumen has a primary lumen opening at the distal end of the catheter tip, the secondary lumen has a secondary lumen opening on a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on the side of the distal portion of the catheter tube but proximal to the secondary lumen opening.

15. 1. A method for forming a catheter tip of a rapid insertion central catheter ("RICC"), comprising: Inserting a mandrel-mounted catheter tube into a cavity of a radio frequency ("RF") welding die, wherein a distal end of a mandrel of the mandrel-mounted catheter tube does not reach an end of the cavity after inserting the mandrel-mounted catheter tube into the cavity; heating the RF welding die to melt a first polymeric material within the cavity of the RF welding die, the molten polymeric material of the first polymeric material conforming to the cavity around the mandrel during heating of the RF welding die to enable formation of an initial catheter tip in a single piece that is joined to a distal end portion of the catheter tube; forcing the distal end of the mandrel into the end of the cavity of the RF welding die as the molten polymer material seeps out through an exit hole in the end of the cavity, wherein forcing the distal end of the mandrel into the end of the cavity cuts off excess polymer material from the distal end of the initial catheter tip to form the catheter tip joined to the distal end portion of the catheter tube.

16. 16. The method of claim 15, further comprising procuring or extruding the catheter tube of a second polymeric material that is softer than the first polymeric material, the catheter tube including primary, secondary, and tertiary catheter tube lumens that correspond to primary, secondary, and tertiary catheter tube portions of the RICC, respectively.

17. 17. The method of claim 16, further comprising inserting a polymer plug of the first polymer material at least partially into each lumen of the secondary catheter tube lumen and the tertiary catheter tube lumen to melt the first polymer material within the cavity of the RF welding die while heating the RF welding die.

18. removing the mandrel-attached tip catheter tube from the cavity of the RF welding die; removing the mandrel from the mandrel-attached tipped catheter tube to provide a tipped catheter tube; 18. The method of claim 17, wherein the remainder of the polymer plug in the secondary catheter tube lumen and the tertiary catheter tube lumen, the molten polymer material of the first polymer material in the secondary catheter tube lumen and the tertiary catheter tube lumen, or a combination thereof terminates the secondary catheter tube lumen and the tertiary catheter tube lumen as a filler upon cooling of the mandrel-mounted tipped catheter tube or the tipped catheter tube.

19. the catheter tip has a first section, a second section, and a third section; the first section of the catheter tip has a uniform taper in outer diameter from a size equivalent to the outer diameter of the needle shaft of an introducer needle to a size equivalent to the outer diameter of the second section of the catheter tip to dilate tissue around the needle track; 19. The method of any one of claims 15 to 18, wherein the third section of the catheter tip has a non-uniform taper in its outer diameter to dilate the tissue from a size equivalent to the outer diameter of the second section of the catheter tip to a size equivalent to the outer diameter of the catheter tube.

20. 20. The method of claim 19, wherein the second section of the catheter tip does not have a taper and the outer diameter of the second section of the catheter tip is constant along the second section of the catheter tip.

21. 20. The method of claim 19, wherein the second section of the catheter tip has a uniform taper to dilate the tissue from a size equal to the outer diameter of the first section of the catheter tip to a size equal to the outer diameter of the third section of the catheter tip.

22. the first polymeric material of the catheter tip is sufficiently rigid to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when a distal portion of the RICC is advanced into a patient's vascular lumen; 22. The method of any one of claims 15 to 21, wherein the first polymeric material of the catheter tip is sufficiently flexible to prevent trauma to the vascular lumen when the distal portion of the RICC is advanced further into the vascular lumen.

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