Introducer and rapid insertion central venous catheter assembly

Abstract

The introducer assembly (220, 206) may include an introducer (132) and an access guidewire (208) disposed therein. The introducer needle (134) of the introducer (132) may include a needle shaft (140) having a needle slot (146) extending from a proximal portion of the needle shaft (140) to a distal tip (144). The introducer sheath (136) of the introducer (132) may include a sheath body (162) that covers the needle shaft (140) sealing the needle slot (146) therebelow, except for a sheath body opening (166) at a proximal portion of the sheath body (162). The access guidewire (208) includes a distal end portion disposed within the introducer (132) having a larger outer diameter than the proximal end portion of the needle slot (146) such that the proximal end portion of the needle slot (146) captures the distal end portion of the access guidewire (208) to prevent proximal withdrawal of the access guidewire (208) from the needle shaft (140). The method can include inserting the rapid insertion central venous catheter (100) into a vascular lumen of a patient using the introducer assembly (220, 206).

Description

[Background technology]

[0001] Central venous catheters (CVCs) are commonly introduced into a patient's body and advanced through the vasculature by the Seldinger technique. The Seldinger technique involves many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, the many steps are time consuming and the handling of numerous medical devices is cumbersome, all of which may cause trauma to the patient. In addition, the large number of medical devices that need to be replaced during the many steps of the Seldinger technique presents a relatively high potential for contamination through contact. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient's body and advancing the catheter through the vasculature.

[0002] Disclosed herein are introducer and rapidly insertable central catheter (RICC) assemblies and methods that address the above. Summary of the Invention

[0003] Disclosed herein, in some embodiments, is an introducer assembly including an introducer and an access guidewire disposed within the introducer. The introducer includes an introducer needle and a splittable introducer sheath covering the introducer needle. The introducer needle includes a needle shaft having a longitudinal needle slot extending from a proximal portion of the needle shaft to a distal needle tip. The introducer sheath includes a sheath body covering the needle shaft sealing the needle slot therebelow except for a sheath body opening at a proximal portion of the sheath body. The access guidewire includes a distal end portion disposed within the introducer. The distal end portion of the access guidewire has an outer diameter larger than at least a proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire to prevent proximal withdrawal of the access guidewire from the needle shaft.

[0004] In some embodiments, the proximal portion of the access guidewire has an outer diameter that corresponds to the outer diameter of the distal portion of the access guidewire, and further, an intermediate portion of the access guidewire between the proximal portion of the access guidewire and the distal portion of the access guidewire has an outer diameter that is smaller than the outer diameter of the proximal portion of the access guidewire and the distal portion of the access guidewire.

[0005] In some embodiments, the proximal portion of the distal end portion of the access guidewire includes a rigid tubular fitting thereon, thereby preventing the proximal portion of the distal end portion of the access guidewire from bending. By preventing the proximal portion of the distal end portion of the access guidewire from bending, the distal end portion of the access guidewire is oriented to engage the proximal end portion of the needle slot over the remainder of the needle slot.

[0006] In some embodiments, the proximal end portion of the needle slot has the same width as the remainder of the needle slot. In some embodiments, the proximal end portion of the needle slot is narrower than the remainder of the needle slot.

[0007] In some embodiments, the sheath body opening extends over the proximal end portion of the needle slot without extending substantially over the remainder of the needle slot such that the sheath body interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

[0008] In some embodiments, the introducer sheath further comprises a splittable sheath hub about the proximal portion of the sheath body. In some embodiments, the sheath hub extends over the remaining portion of the needle slot exposed by the sheath body opening such that the sheath hub prevents proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal end portion of the access guidewire.

[0009] In some embodiments, the sheath hub includes a port over the remaining portion of the needle slot exposed by the sheath body opening, the port configured to direct the access guidewire exclusively into the proximal end portion of the needle slot, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

[0010] In some embodiments, the introducer needle further includes a needle hub about a proximal end portion of the needle shaft. In some embodiments, the introducer assembly further includes a syringe including a tapered male syringe tip extending from a distal portion of the syringe configured to be inserted into a tapered female needle hub connector in a proximal portion of the needle hub.

[0011] Also disclosed herein in some embodiments is a RICC insertion assembly including a RICC, an introducer, and an access guidewire disposed in both the RICC and the introducer. The introducer includes an introducer needle and a splittable introducer sheath covering the introducer needle. The introducer needle includes a needle shaft having a longitudinal needle slot extending from a proximal portion of the needle shaft to a distal needle tip. The introducer sheath includes a sheath body covering the needle shaft sealing the needle slot thereunder except for a sheath body opening at a proximal portion of the sheath body. The access guidewire includes a proximal portion disposed within the RICC and a distal end portion disposed within the introducer. The distal end portion of the access guidewire has an outer diameter larger than at least a proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire to prevent proximal withdrawal of the access guidewire from the needle shaft.

[0012] In some embodiments, the proximal portion of the access guidewire has an outer diameter that corresponds to the outer diameter of the distal portion of the access guidewire, and further, an intermediate portion of the access guidewire between the proximal portion of the access guidewire and the distal portion of the access guidewire has an outer diameter that is smaller than the outer diameter of the proximal portion of the access guidewire and the distal portion of the access guidewire.

[0013] In some embodiments, the proximal portion of the distal end portion of the access guidewire includes a rigid tubular fitting thereon, thereby preventing the proximal portion of the distal end portion of the access guidewire from bending. By preventing the proximal portion of the distal end portion of the access guidewire from bending, the distal end portion of the access guidewire is oriented to engage the proximal end portion of the needle slot over the remainder of the needle slot.

[0014] In some embodiments, the proximal end portion of the needle slot has the same width as the remainder of the needle slot. In some embodiments, the proximal end portion of the needle slot is narrower than the remainder of the needle slot.

[0015] In some embodiments, the sheath body opening extends over the proximal end portion of the needle slot without extending substantially over the remainder of the needle slot such that the sheath body interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

[0016] In some embodiments, the introducer sheath further comprises a splittable sheath hub about the proximal portion of the sheath body. In some embodiments, the sheath hub extends over the remaining portion of the needle slot exposed by the sheath body opening such that the sheath hub interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

[0017] In some embodiments, the sheath hub includes a port over the remaining portion of the needle slot exposed by the sheath body opening, the port configured to direct the access guidewire exclusively into the proximal end portion of the needle slot, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

[0018] In some embodiments, the introducer needle further includes a needle hub about a proximal end portion of the needle shaft. In some embodiments, the RICC insertion assembly further includes a syringe including a tapered male syringe tip extending from a distal portion of the syringe configured to be inserted into a tapered female needle hub connector in a proximal portion of the needle hub.

[0019] Also disclosed herein is a method for inserting a RICC into a vascular lumen of a patient. The method, in some embodiments, includes the steps of obtaining an insertion assembly, establishing a puncture path, advancing an access guidewire, withdrawing an introducer needle, splitting an introducer sheath, and advancing a RICC. The obtaining an insertion assembly includes obtaining a RICC insertion assembly including a RICC, an introducer, and an access guidewire disposed in both the RICC and the introducer, with the RICC insertion assembly in a substantially ready-to-operate state. The introducer includes an introducer needle and a splittable introducer sheath covering the introducer needle. The introducer needle includes a needle shaft having a longitudinal needle slot extending from a proximal portion of the needle shaft to a distal needle tip. The introducer sheath includes a sheath body covering the needle shaft sealing the needle slot therebelow, except for a sheath body opening at a proximal portion of the sheath body. The access guidewire includes a proximal portion disposed within the RICC and a distal portion disposed within the introducer.

[0020] The distal end portion of the access guidewire has a larger outer diameter than at least the proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire to prevent proximal withdrawal of the access guidewire from the needle shaft. The establishing a puncture path step includes establishing a puncture path from the area of ​​skin to the vessel lumen with the introducer. The advancing the access guidewire step includes advancing the distal end of the access guidewire from its initial position within the introducer proximal to the needle tip into the vessel lumen. The withdrawing the introducer needle step includes withdrawing the introducer needle from the introducer sheath while leaving both the introducer sheath and the access guidewire within the vessel lumen. The needle slot allows for removal of the introducer needle from the introducer sheath while the access guidewire remains within the vessel lumen. The introducer sheath splitting step includes splitting the introducer sheath off the access guidewire and removing the split portion of the introducer sheath from the vessel lumen, and the RICC advancing step includes inserting the RICC into the vessel lumen by advancing a catheter tube of the RICC over the access guidewire into the vessel lumen.

[0021] In some embodiments, the method further includes a blood aspirating step, which includes aspirating blood with a syringe coupled to the introducer needle to confirm that the puncture path extends into the blood vessel lumen before withdrawing the introducer needle from the introducer sheath in the introducer needle withdrawing step.

[0022] In some embodiments, the method further comprises the step of withdrawing the access guidewire, the step of withdrawing the access guidewire comprising withdrawing the access guidewire while leaving the catheter tube within the blood vessel lumen.

[0023] In some embodiments, the method further includes a steering guidewire advancement step, an additional RICC advancement step, and a steering guidewire withdrawal step. The steering guidewire advancement step includes advancing a steering guidewire into the vessel lumen via the primary lumen of the RICC. Another RICC advancement step includes advancing a distal portion of the catheter tube over the steering guidewire into the vessel lumen further into the lower third of the superior vena cava (SVC) of the patient's heart. The steering guidewire withdrawal step includes withdrawing the steering guidewire while leaving the catheter tube in the lower third of the SVC.

[0024] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0025] [Figure 1] 1 illustrates a RICC according to some embodiments. [Diagram 2] 1 illustrates a distal portion of a catheter tube of a RICC according to some embodiments. [Diagram 3] 1 illustrates a first cross-section of a distal portion of a catheter tube according to some embodiments. [Figure 4] 1 shows a second cross-section of a distal portion of a catheter tube according to some embodiments. [Diagram 5] 1 shows a longitudinal cross-section of a distal portion of a catheter tube according to some embodiments. [Figure 6] 1 shows a first view of an introducer assembly including a syringe for inserting a RICC into a patient, according to some embodiments. [Figure 7] FIG. 13 shows a second view of an introducer assembly including a syringe, according to some embodiments. [Figure 8]13 shows a third view of an introducer assembly including a syringe, according to some embodiments. [Figure 9] 1 shows a first view of an introducer including an introducer needle and a splittable introducer sheath, according to some embodiments. [Figure 10] 1 shows a first view of an introducer according to some embodiments. [Figure 11] 1 illustrates a distal portion of an introducer according to some embodiments. [Figure 12] For ease of illustration, the introducer is shown without the sheath hub of the introducer sheath. [Figure 13] 1 illustrates an introducer including a needle shaft and a needle hub, according to some embodiments. [Figure 14] 1 illustrates an introducer sheath including a sheath body and a sheath hub, according to some embodiments. [Figure 15] 1 shows a longitudinal cross-sectional view of a distal portion of an introducer assembly according to some embodiments. [Figure 16] 1 shows a detailed view of a distal portion of an introducer assembly, according to some embodiments, with the introducer sheath removed from the introducer needle for ease of illustration. [Figure 17] 13 shows a detailed view of a distal portion of an introducer assembly according to some other embodiments, with the introducer sheath removed from the introducer needle for ease of illustration. [Figure 18] 13 shows a detailed view of a distal portion of an introducer assembly according to yet some other embodiments, with the introducer sheath removed from the introducer needle for ease of illustration. [Figure 19] 19 shows a longitudinal cross-section of the distal portion of the introducer assembly of FIG. 18, with the introducer sheath removed from the introducer needle for ease of illustration. [Figure 20]22 shows a detailed view of a distal portion of the introducer assembly of FIG. 21 having an introducer sheath. [Figure 21] 19 shows a longitudinal view of a distal portion of the introducer assembly of FIG. 18 with a rigid tubular fitting over the access guidewire, according to some embodiments. [Figure 22] 19 shows a longitudinal cross-sectional view of the distal portion of the introducer assembly of FIG. 18, with the sheath hub of the introducer sheath partially blocking the needle slot of the needle shaft, according to some embodiments. [Figure 23] 1 illustrates a RICC insertion assembly according to some embodiments. [Figure 24] 1 shows a first view of a distal portion of a RICC insertion assembly, according to some embodiments. [Diagram 25] 13 shows a second view of a distal portion of the RICC insertion assembly, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] 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.

[0027] 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, any of the aforementioned features or steps may further include one or more features or steps, unless otherwise indicated. Labels such as "left," "right," "upper," "lower," "front," "rear," etc. are used for convenience and do not imply a particular fixed position, orientation, or direction, for example. Instead, such designations are used to reflect a relative position, orientation, or direction, for example. The singular forms "one," "one," and "said" include plural references unless the context clearly dictates otherwise.

[0028] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes the portion 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, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise indicated by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0029] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter includes a portion of the 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 the 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, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0030] 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, although the Seldinger technique is effective, the many steps are time consuming and the handling of numerous medical devices is cumbersome, all of which can be traumatic for the patient. In addition, the large number of medical devices that need to be replaced during the multiple steps of the Seldinger technique creates a relatively high potential for contamination through contact. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient's body and advancing the catheter through its vasculature.

[0031] Disclosed herein are introducer and rapid insertion central venous catheter assemblies and methods that address the above. For example, the introducer assembly can include an introducer and an access guidewire disposed within the introducer. An introducer needle of the introducer can include a needle shaft having a needle slot extending from a proximal portion of the needle shaft to a distal needle tip. An introducer sheath of the introducer can include a sheath body that covers the needle shaft sealing the needle slot therebelow except for a sheath body opening at a proximal portion of the sheath body. The access guidewire can include a distal end portion disposed within the introducer. The distal end portion of the access guidewire can have a larger outer diameter than the proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire to prevent proximal withdrawal of the access guidewire from the needle shaft. These and other features of the assemblies and methods provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such assemblies and methods.

[0032] RIC Figure 1 shows a RICC 100, according to some embodiments. Figure 2 shows a distal portion of a catheter tube 102 of the RICC 100, according to some embodiments. Figures 3-5 show different cross sections of the distal portion of the catheter tube 102, according to some embodiments.

[0033] As shown, the RICC 100 includes a catheter tube 102, a catheter hub 104, and one or more extension legs 106. The catheter tube 102 includes a first section 108 at a distal portion of the catheter tube 102, a second section 110 at a distal portion of the catheter tube 102 proximal to the first section 108, and a tapered junction 112 between the first section 108 and the second section 110 of the catheter tube 102.

[0034] The first section 108 of the catheter tube 102 includes a distal tip 114 having a relatively short taper from an outer diameter at the distal end of the first section 108 to an outer diameter of the remainder of the first section 108. The taper of the distal tip 114 is configured to immediately dilate tissue around the puncture path established by the introducer 132 to the outer diameter of the remainder of the first section 108 of the catheter tube 102. As best shown in FIGURE 5, the first section 108 of the catheter tube 102 also includes a proximal portion that is disposed within the bore of the distal portion of the joint 112 and is fixedly bonded thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0035] The second section 110 of the catheter tube 102 includes a constant outer diameter over its length from the distal end of the second section 110 to the proximal end of the second section 110. The constant diameter of the second section 110 of the catheter tube 102 is configured for smooth insertion into the puncture tract and target vasculature after any expansion by the first section 108 of the catheter tube 102 and the junction 112. The distal end of the catheter second section 110 has a flattened surface that is flush with the flattened proximal end of the junction 112 and is fixedly bonded thereto, such as by solvent bonding, adhesive bonding, or heat welding.

[0036] The junction 112 includes a taper over the length from the distal end of the junction 112 to the proximal end of the junction 112. The taper of the junction 112 is configured to immediately expand the tissue around the puncture path from the outer diameter of the majority of the first section 108 of the catheter tube 102 to the outer diameter of the second section 110 of the catheter tube 102. The abluminal surface of the junction 112 smoothly transitions from the abluminal surface of the first section 108 of the catheter tube 102 to the abluminal surface of the second section 110 of the catheter tube 102 without creating an edge that may catch on the skin as the catheter tube 102 is inserted into the puncture path. In addition to having minimal or negligible edges, the edges may include solvent interdiffusion polymeric material of the polymeric material forming the catheter tube 102, which provides a smooth transition from the first section 108 of the catheter tube 102 to the junction 112 and from the junction 112 to the second section 110 of the catheter tube 102. In particular, the junction 112 has a length that is approximately equal to the length of the exposed portion 116 of the first section 108 of the catheter tube 102, or a length between the lengths of the exposed portions of the first section 108 and the second section 110 of the catheter tube 102. Thus, the length of the exposed portion 116 of the first section 108 of the catheter tube 102 is less than the length of the junction 112 and at most approximately equal to the length of the junction 112.

[0037] The first section 108 of the catheter tube 102 is formed from a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer. The second section 110 of the catheter tube 102 is formed from a second polymeric material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer less than the first durometer. For example, the first section 108 of the catheter tube 102 can be formed from a first polyurethane having a first durometer, and the second section 110 of the catheter tube 102 can be formed from a second, different polyurethane (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, etc.) having a second durometer less than the first durometer. Indeed, polyurethane is advantageous for the catheter tube 102 in that it is relatively rigid at room temperature but can become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethane is also advantageous in that it can be less thrombogenic than some other polymers. The joint 112 is formed from a second polymeric material or a third polymeric material (e.g., yet another polyurethane) having a third durometer hardness less than the first durometer hardness and greater than, approximately equal to, or less than the second durometer hardness.

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

[0039] According to the above-described first section 108 of the catheter tube 102, the second section 110 of the catheter tube 102, and the junction 112 between the first section 108 and the second section 110 of the catheter tube 102, the catheter tube 102 has sufficient column strength to prevent buckling of the catheter tube 102 when inserted into a puncture path established by percutaneous puncture using the introducer 132 according to the puncture path establishment step described below. The column strength of the catheter tube 102 is also sufficient to prevent buckling of the catheter tube 102 when the catheter tube 102 is advanced through the patient's vasculature without pre-dilating any of the tissue or blood vessels of the vasculature around the puncture path using a separate dilator.

[0040] The catheter tube 102 includes one or more catheter tube lumens extending therethrough. However, typically in 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.), there is only one catheter tube lumen extending from the proximal end of the catheter tube 102 to the distal end of the catheter tube 102 (see Figures 3-5). Indeed, the first section 108 of the catheter tube 102 typically has one lumen running therethrough, as shown in Figure 5.

[0041] A catheter hub 104 is coupled to a proximal portion of the catheter tube 102. The catheter hub 104 includes one or more catheter hub lumens that correspond in number to the one or more catheter tube lumens. The one or more catheter hub lumens extend entirely through the catheter hub 104 from a proximal end of the catheter hub 104 to a distal end of the catheter hub 104.

[0042] Each of the one or more extension legs 106 is coupled by its distal portion to the catheter hub 104. Each of the one or more extension legs 106 includes 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 a proximal end of the extension leg to a distal end of the extension leg.

[0043] Each extension leg of the one or more extension legs 106 includes a luer connector 118 coupled thereto through which the extension leg and its extension leg lumen can be connected to another medical device and its lumen.

[0044] As shown, the RICC 100 is a three-lumen RICC including three sets of lumens. However, the RICC 100 is not limited to the three sets of lumens. The three sets of lumens include a primary lumen 120, a secondary lumen 122, and a tertiary lumen 124 formed from fluidly connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 120 has a primary lumen opening 126 at the distal end of the first section 108 of the catheter tube 102, which corresponds to the distal end of the catheter tube 102 and the distal end of the RICC 100. The secondary lumen 122 has a secondary lumen aperture 128 at the side of the distal portion of the catheter tube 102. The tertiary lumen 124 has a tertiary lumen aperture 130 on the side of the distal portion of the catheter tube 102 proximal to the secondary lumen aperture 128 .

[0045] Introducer 6-10 show different views of an introducer 132 including an introducer needle 134 and a splittable introducer sheath 136, with and without a syringe 138, according to some embodiments. Figure 11 shows a distal portion of the introducer 132, according to some embodiments.

[0046] As shown, the introducer 132 includes an introducer needle 134 and an introducer sheath 136. At least in a ready-to-operate state of the introducer 132 configured to establish a puncture path according to a puncture path establishing step described below, the introducer needle 134 is disposed within the introducer sheath 136. In other words, the introducer sheath 136 is disposed so as to cover the introducer needle 134 at least in the ready-to-operate state of the introducer 132 shown in Figures 6 to 10 and Figures 23 to 25.

[0047] FIG. 13 shows an introducer needle 134 of an introducer 132, according to some embodiments. The introducer needle 134 includes a needle shaft 140 and a needle hub 142 coupled to a proximal portion of the needle shaft 140 , and in particular to a proximal end portion of the needle shaft 140 .

[0048] The needle shaft 140 includes a needle tip 144 at a distal portion of the needle shaft 140 and a longitudinal needle slot 146 . The needle tip 144 includes a bevel 150 having a primary bevel 152 and a secondary or tip bevel 154 distal to the primary bevel 152. The tip bevel angle of the tip bevel 154 (see ∠A in FIG. 11 ) is greater than the primary bevel angle of the primary bevel 152 (see ∠B in FIG. 11 ) such that the bevel 150 provides a smooth transition across the needle tip 144. Such a needle tip is thus configured to establish a puncture path from an area of ​​the skin into the patient's vascular lumen in accordance with the puncture path establishment steps of the method described below.

[0049] The needle slot 146 extends distally from a proximal portion of the needle shaft 140 to the needle tip 144, thereby forming a needle channel, as opposed to a needle lumen, along most of the length of the introducer needle 134. (Notably, the introducer 132 includes an introducer lumen; however, the introducer 132 lumen arises from an introducer sheath 136 that covers the needle shaft 140 and seals off the needle slot 146 below to form the introducer 132 lumen from the needle channel.) The needle slot 146 has a width sized according to the outer diameter of the access guidewire 208, which may vary as described below to prevent proximal withdrawal of the access guidewire from the needle shaft 140 during an introducer needle withdrawal step of the method described below. Indeed, various configurations of the needle slot 146 and access guidewire 208 that prevent proximal withdrawal of the access guidewire 208 from the needle shaft 140 are described below with respect to the introducer assembly 220.

[0050] The needle hub 142 may include a non-tapered, but optionally chamfered, male needle hub connector 156 at a distal portion of the needle hub 142, and a tapered female needle hub connector 158 at a proximal portion of the needle hub 142. The male needle hub connector 156 is configured to form a fluid-tight connection with a female sheath hub connector 182, described below, at least in a ready-to-operate state of the introducer 132. Indeed, the male needle hub connector 156 may include an "O" ring 160 disposed in a circumferential groove around the male needle hub connector 156, configured to form a fluid-tight connection. The female needle hub connector 158 is configured to form a fluid-tight connection with a syringe tip 204 of the syringe 138, described below.

[0051] FIG. 14 shows an introducer sheath 136 of the introducer 132, according to some embodiments. The introducer sheath 136 includes a splittable sheath body 162 and a splittable sheath hub 164 that surrounds and is coupled to a proximal portion of the sheath body 162. The introducer sheath 136 is configured such that the entirety of the introducer sheath 136 is disposed over the introducer needle 134, at least in the ready-to-operate state of the introducer 132. Indeed, the entirety of the sheath body 162 is disposed over the needle shaft 140, and the sheath hub 164 is coupled to the proximal portion of the sheath body 162, such that the male needle hub connector 156 of the needle hub 142 forms a fluid-tight connection with the female sheath-hub connector 182 of the sheath hub 164 in the ready-to-operate state of the introducer 132.

[0052] The sheath body 162 includes a sheath body opening 166 at a proximal portion of the sheath body 162 and a sheath tip 168 at a distal portion of the sheath body 162. (See FIG. 12 for the sheath body opening 166.) Despite the sheath body opening 166 being covered by a sheath hub 164 coupled to the proximal portion of the sheath body 162, the sheath body 162 is configured to seal the needle shaft 140 thereunder such that a vacuum can be drawn through the introducer 132, at least in the ready-to-operate state of the introducer 132 shown in FIGS. 6-10 and 23-25.

[0053] The sheath body opening 166 has a width that generally corresponds to the width of the needle slot 146 in the needle shaft 140, which width may vary according to the outer diameter of the access guidewire 208 to prevent proximal withdrawal of the access guidewire from the needle shaft, as described above. Thus, the sheath body opening 166 is configured to allow the access guidewire 208 to pass therethrough and into the needle slot 146 of the needle shaft 140.

[0054] The sheath tip 168 includes a taper 170 that expands from the outer diameter of the needle shaft 140 to the outer diameter of the majority of the sheath body 162. In other words, the taper 170 reduces from the outer diameter of the majority of the sheath body 162 to the outer diameter of the needle shaft 140. The taper 170 has a taper angle (see ∠C in FIG. 11 ) that is less than the primary bevel angle (see ∠B in FIG. 11 ) of the primary bevel 152 of the needle tip 144, which in turn is less than the tip bevel angle (see ∠A in FIG. 11 ) of the tip bevel 154 of the needle tip 144. The sheath tip 168, including such a taper, is configured to provide a smooth transition from the needle tip 144 to the sheath body 162 when the introducer 132 is in a ready-to-operate state.

[0055] The sheath body 162 may also include one or more longitudinal body faults 172 (e.g., grooves, lines of weakened material, etc.), such as a pair of body faults 172 extending along both sides of the sheath body 162, if the sheath body 162 is not formed from a material configured to split or propagate a tear. For example, the sheath body 162 may be formed from a polymeric material, such as polytetrafluoroethylene, to facilitate smooth and consistent splitting of the sheath body 162 without the body faults 172 along the sides of the sheath body 162. The one or more body faults 172, if present, include at least a primary body fault extending along at least a portion of the primary side of the introducer sheath 136, including the port 174. In fact, the primary body fault may extend along the entirety of the sheath body 162, as shown in FIG. 12. If a pair of body faults 172 is present, a secondary body fault extends along at least a portion of the secondary side of the introducer sheath 136 opposite the primary side. Although not shown, the secondary body section may extend along the entirety of the sheath body 162 .

[0056] The sheath hub 164 includes a valved, splittable port 174 upstream of the introducer sheath 136 and a pair of tabs 176 extending from the sheath hub 164 proximal to the port 174 .

[0057] The port 174 is positioned to overlie the opening 166 in the proximal portion of the sheath body 162. The port 174 has a length that corresponds approximately to the length of the sheath body opening 166, but a width of the port 174 that is greater than the width of the sheath body opening 166 and accommodates a valve 178, such as a partially or fully split septum compressed within the port 174, overlying the sheath body opening 166 of the sheath body 162. As best shown in FIGS. 15, 24, and 25, the valve 178 is configured to allow the access guidewire 208 to pass through the valve 178, through the port 174, and into the sheath body opening 166 of the sheath body 162, while maintaining fluid-tight access to the patient's vascular lumen with the introducer 132, among other things, to enable the blood aspiration step of the method described below. Such a valve is also configured to split along with the remaining portion of the sheath hub 164 when the introducer sheath 136 is split away from the access guidewire 208 in accordance with the introducer sheath splitting step of the method described below.

[0058] The tabs 176 extend radially from both sides of the sheath hub 164 perpendicular to the primary and secondary sides of the introducer sheath 136, and if present on the primary side of the introducer sheath 136, the tabs 176 would be positioned perpendicular to at least the primary body plane. Such tabs are configured to split the sheath hub 164 when the tabs 176 are pulled away from each other in accordance with the introducer sheath splitting step of the method described below. Notwithstanding the above, the tabs 176 need not be 180° apart as illustrated. In fact, the tabs 176 may extend radially from sides of the sheath hub 164 that are less than 180° apart (including less than 135° apart, such as less than 90° apart, e.g., about 67.5° apart), with the ports 174 facing the apex of the included angle formed between the tabs 176. Such tabs are configured to split the sheath hub 164 when the tabs 176 are pressed towards each other, such as by pinching the tabs 176 together in one hand.

[0059] The sheath hub 164 may also include a pair of longitudinal hub faults 180 (e.g., grooves, lines of weakened material, etc.) that extend along opposing sides of the sheath hub 164. The hub faults 180, when present, include a primary hub fault and a secondary hub fault. The primary hub fault extends along at least a portion of the primary side of the introducer sheath 136 (i.e., the side of the introducer sheath 136 that includes the port 174). In fact, the primary hub fault may extend along the entirety of the sheath hub 164, as shown in FIG. 9. Similarly, the secondary hub fault extends along at least a portion of the secondary side of the introducer sheath 136 opposite the primary side. The secondary hub fault may extend along the entirety of the sheath hub 164, as shown in FIG. 10. The sheath hub 164 is configured to split along both the primary and secondary hub fractures 180 when the tabs 176 are pulled apart (or pinched together) to propagate a tear resulting from splitting the sheath hub 164 along the sheath body 162 on the primary and secondary sides of the introducer sheath 136.

[0060] The sheath hub 164 may also include a non-tapered female sheath-hub connector 182 at a proximal portion of the sheath hub 164. The female sheath-hub connector 182 is configured to form a fluid-tight connection with the male needle hub connector 156 described above, at least in the ready-to-operate state of the introducer 132. Such non-tapered connectors are less likely to stick than tapered connectors (e.g., luer tapered connectors), which is advantageous for the introducer needle withdrawal step of the methods described below, since this step involves withdrawing the introducer needle 134 from the introducer 132, leaving the introducer sheath 136 within the patient's vascular lumen.

[0061] Figures 15 and 20-22 show different views of a distal portion of an introducer assembly 220, according to some embodiments. Figures 16-19 show different views of a distal portion of an introducer assembly 220, according to the same or different embodiments, with the introducer sheath 136 removed from the introducer needle 134 for ease of illustration.

[0062] As shown, the introducer 132 may be coupled with an access guidewire 208, a syringe 138, or both the access guidewire 208 and the syringe 138 to form an introducer assembly 220. In particular, in view of other techniques, such as advancing the introducer sheath 136 into the patient's vascular lumen to secure vascular access, the access guidewire advancement step of the method described below is not required to secure vascular access. As such, the access guidewire 208 does not need to be included in the introducer assembly 220 in the ready-to-operate state or other state of the introducer assembly 220. In addition, in view of other techniques, such as ensuring that blood flows back into the introducer 132, the blood aspiration step of the method described below is not required to ensure that the puncture path extends into the patient's vascular lumen. As such, the syringe 138 does not need to be included in the introducer assembly 220 in the ready-to-operate state or other state of the introducer assembly 220. It should also be appreciated that the introducer assembly 220 can be used separately from the RICC 100 to introduce a CVC into a patient. Indeed, the puncture pathway establishment steps of the methods described below can be performed using the introducer assembly 220, and after securing vascular access using the access guidewire 208 or introducer sheath 136, the tissue around the puncture pathway can be dilated using a dilator for subsequent CVC introduction.

[0063] The access guidewire 208 includes a proximal portion including a proximal end, which may include a stop 210, described below, to prevent over-advancement of the access guidewire 208. The access guidewire 208 also includes a distal portion including a distal end portion, which may include the distal end of the access guidewire 208. As shown in FIG. 15 and described in detail below, the proximal portion of the access guidewire 208 is disposed within the RICC 100 in the ready-to-operate state of the RICC insertion assembly 206. The distal portion of the access guidewire 208 is disposed within the introducer 132 in both the ready-to-operate state of the introducer assembly 220 and the ready-to-operate state of the RICC insertion assembly 206 when the access guidewire 208 is present within the aforementioned assemblies.

[0064] The access guidewire 208 may also have an outer diameter (e.g., D as shown in FIGS. 16-18 ) that may vary over at least a distal portion of the access guidewire 208. 1 Or D 2 16-18 ) sized according to the outer diameter of the access guidewire 208 to prevent proximal withdrawal of the access guidewire 208 from the needle shaft 140 while still allowing the access guidewire 208 to pass through the needle shaft 140 during the introducer needle withdrawal step of the method described below. 1 Or W 2 Indeed, various configurations of the access guidewire 208 and needle slot 146 that prevent proximal withdrawal of the access guidewire 208 from the needle shaft 140 are described immediately below.

[0065] The outer diameter of the distal end portion of the access guidewire 208 (e.g., D 1 ) is the width of at least the proximal end portion of the needle slot 146 (e.g., W 2) so that as the access guidewire 208 is withdrawn proximally, at least the proximal end portion of the needle slot 146 captures the distal end portion of the access guidewire 208, thereby preventing the access guidewire 208 from being withdrawn proximally from the needle shaft 140 and, therefore, the introducer needle 134. (See FIGS. 16-19.) The needle slot 146, including its proximal end portion, then reduces the outer diameter of the distal end portion of the access guidewire 208 (e.g., D 1 ) smaller than a certain width (e.g., W 2 ). In other words, the proximal end portion of needle slot 146 can have the same width as the remainder of needle slot 146, which is less than the outer diameter of the distal end portion of access guidewire 208. (See FIG. 16.) With such a configuration, distal advancement of access guidewire 208 is limited to stop 210 of access guidewire 208, and proximal withdrawal of access guidewire 208 is prevented by both the distal end portion of access guidewire 208 and the proximal end portion of needle slot 146.

[0066] The outer diameter of the distal end portion of the access guidewire 208 (e.g., D 1 ) is greater than the width of at least the proximal end portion of the needle slot 146 (e.g., W 2 Following the above, the proximal end portion of the needle slot 146 may alternatively be narrower than the remainder of the needle slot 146. In other words, the remainder of the needle slot 146 may have a greater width (e.g., W as shown in FIGS. 17 and 18 ) than the proximal end portion of the needle slot 146. 1), which facilitates loading of the access guidewire 208, and particularly its distal end portion, into the needle shaft 140 when assembling the introducer assembly 220. (See FIGS. 17-19.) The sheath body opening 166 of the introducer sheath 136, the port 174 including its valve 178, or the surrounding sheath hub 164 (e.g., housing) can be configured to direct (e.g., by interference) the distal end portion of the access guidewire 208 into the proximal end portion of the needle slot 146 as the access guidewire 208 is withdrawn proximally, thereby preventing proximal withdrawal of the access guidewire 208 from the needle shaft 140. Indeed, as shown in Fig. 20, the sheath body opening 166 extends over the proximal end portion of the needle slot 146 without extending substantially over the remainder of the needle slot 146 such that the sheath body 162 would interfere with the distal end portion of the access guidewire 208, thereby preventing proximal withdrawal of the access guidewire 208 from the needle shaft 140. Also, as shown in Fig. 22, the port 174 is over the remainder of the needle slot 146 exposed by the sheath body opening 166, and the port 174 prevents proximal withdrawal of the access guidewire 208 from the needle shaft 140 by directing the access guidewire 208 exclusively into the proximal end portion of the needle slot 146. Alternatively or additionally, the sheath hub 164 extends over the remaining portion of the needle slot 146 exposed by the sheath body opening 166 such that the sheath hub 164 interferes with the distal end portion of the access guidewire 208, thereby preventing proximal withdrawal of the access guidewire 208 from the needle shaft 140. As discussed above, distal advancement of the access guidewire 208 is limited by this configuration to the stop 210 of the access guidewire 208, and proximal withdrawal of the access guidewire 208 is prevented by both the distal end portion of the access guidewire 208 and the proximal end portion of the needle slot 146.

[0067] The outer diameter of the proximal portion of the access guidewire 208 (e.g., D 2 ) is the outer diameter of the distal end portion of the access guidewire 208 (e.g., D 1 ), thereby allowing the proximal portion of the access guidewire 208 to be easily advanced into the constant width needle slot 146 described above, or into the narrower proximal end portion of the needle slot 146, and subsequently into the blood vessel lumen in the access guidewire advancement step of the method described below. (See FIGS. 15-17.) However, the outer diameter of the proximal portion of the access guidewire 208 (e.g., D 1 ) may alternatively be the outer diameter of the distal end portion of the access guidewire 208 (e.g., D 1 18-22). When so configured, the outer diameter of the intermediate portion of the access guidewire 208 between the proximal portion of the access guidewire 208 and the distal end portion of the access guidewire 208 (e.g., D 1) is smaller than the outer diameter of the proximal portion of the access guidewire 208 and the distal end portion of the access guidewire 208. In certain embodiments, such as the embodiment of FIGS. 18 and 19 , the proximal portion of the access guidewire 208, i.e., the portion of the access guidewire 208 proximal to the intermediate portion, slides over the narrower proximal end portion of the needle slot 146 and into the remainder of the needle slot 146 (optionally facilitated by a taper from the proximal portion of the access guidewire 208 to the intermediate portion of the access guidewire 208) during the access guidewire advancement step of the method described below. However, as the access guidewire 208 is withdrawn proximally, the intermediate portion of the access guidewire 208 slides into and captures the narrower proximal end portion of the needle slot 146, thereby preventing proximal withdrawal of the access guidewire 208 from the needle shaft 140. As described above, with this configuration, distal advancement of the access guidewire 208 is limited to the stop 210 of the access guidewire 208, and proximal withdrawal of the access guidewire 208 is prevented by both the distal end portion of the access guidewire 208 and the proximal end portion of the needle slot 146.

[0068] Notwithstanding the above, the proximal portion of the distal end portion of the access guidewire 208 may include a rigid tubular fitting 222 thereon, thereby preventing the proximal portion of the distal end portion of the access guidewire 208 from bending. (See FIG. 21.) By preventing the proximal portion of the distal end portion of the access guidewire 208 from bending, the distal end portion of the access guidewire 208 may be oriented to engage the proximal end portion of the needle slot 146 rather than the remainder of the needle slot 146.

[0069] The access guidewire 208 can include a guidewire tip at a distal end portion of the access guidewire 208, the guidewire tip assuming a "J" shape configured to prevent puncturing the posterior wall of a blood vessel. Such guidewire tip assumes a straight state in a ready-to-operate state of the RICC insertion assembly 206 and a curved state when the guidewire tip is advanced beyond the needle tip 144 (e.g., advanced into a blood vessel lumen) in one or more operational states of the RICC insertion assembly 206 in which the access guidewire 208 is deployed.

[0070] The access guidewire 208 may further include a bare wire portion and a wrapped wire portion distal to the bare wire portion, proximal to the bare wire portion, or both. Although not shown, the bare wire portion, if present, extends distally through the valve 178 of the port 174 of the sheath hub 164 such that, at least in the ready-to-operate state of the RICC insertion assembly 206, the valve 178 forms a fluid-tight seal around the bare wire portion of the access guidewire 208. Notably, the aforementioned bare wire portion may instead be a flatwound or groundwound portion of the access guidewire 208, where the flatwound portion includes a wrap of tape instead of a round wire, and the groundwound portion includes a wrap of round wire that has been ground to flatten the wrap.

[0071] Syringe 138 includes a barrel 200, a plunger 202 disposed within barrel 200, and a tapered male syringe tip 204 extending from a distal portion of syringe 138. Syringe tip 204 is configured to be inserted into female needle hub connector 158 described above. Such a syringe is useful for at least aspirating blood in accordance with the blood aspirating steps of the method described below.

[0072] RICC Insertion Assembly 23-25 ​​show different views of the RICC insertion assembly 206, according to some embodiments.

[0073] As shown, the RICC insertion assembly 206 includes the RICC 100, the introducer 132, and an access guidewire 208 that is disposed within both the RICC 100 and the introducer 132 at least in the ready-to-operate state of the RICC insertion assembly 206. Specifically, in the ready-to-operate state of the RICC insertion assembly 206, a proximal portion of the access guidewire 208 is disposed within the RICC 100 and a distal end portion of the access guidewire 208 is disposed within the introducer 132.

[0074] The RICC 100 and the introducer 132 have been described above. In particular, at least in the ready-to-operate state of the RICC insertion assembly 206, the introducer 132 is also in its ready-to-operate state, and has also been described above.

[0075] The access guidewire 208 extends along the entirety of the primary lumen 120 of the RICC 100, through a valve 178 (e.g., a septum) of the port 174 of the sheath hub 164 of the introducer sheath 136, and along the introducer lumen of the introducer 132 to a location within the introducer 132 proximal to the needle tip 144. The location of the access guidewire 208 proximal to the needle tip 144 is convenient for immediate advancement of the distal end of the access guidewire 208 through the remainder of the introducer 132 and into the vascular lumen in accordance with the access guidewire advancement step of the method described below. In particular, the access guidewire 208 includes a stop 210 (e.g., a guidewire hub) around the proximal end of the access guidewire 208 that is configured to prevent the access guidewire 208 from advancing too far during the access guidewire advancement step, thereby preventing loss of the access guidewire 208 within the RICC insertion assembly 206 or within the patient, which could cause guidewire embolism.

[0076] As described above for the introducer 132, the RICC insertion assembly 206 may further include a syringe 138 as shown. Again, such a syringe is useful for at least aspirating blood in accordance with the blood aspirating steps of the method described below.

[0077] RICC Insertion Kit Although not shown, the RICC insertion kit includes the RICC 100, the introducer 132, the access guidewire 208, RICC insertion kit instructions, and packaging. The aforementioned components of the RICC insertion assembly 206 are optionally assembled within the RICC insertion kit to render the RICC insertion assembly 206 substantially ready for operation and placed within the packaging. The RICC insertion kit instructions are placed within or printed on the packaging.

[0078] method The method includes at least a method for inserting the RICC 100 into a blood vessel lumen of a patient, the method including one or more steps selected from obtaining an insertion assembly, establishing a puncture path, advancing an access guidewire, aspirating blood, withdrawing an introducer needle, splitting an introducer sheath, advancing a RICC, withdrawing an access guidewire, advancing a steering guidewire, advancing an additional RICC, and withdrawing a steering guidewire.

[0079] The insertion assembly obtaining step includes obtaining a RICC insertion assembly 206 including the RICC 100, the introducer 132, and an access guidewire 208 disposed in both the RICC 100 and the introducer 132. Optionally, the RICC insertion assembly 206 is obtained in a substantially ready-to-operate state of the RICC insertion assembly 206. If the RICC insertion assembly 206 is not obtained in substantially its ready-to-operate state, the RICC insertion assembly 206 may be adjusted as necessary to bring the RICC insertion assembly 206 into its ready-to-operate state prior to performing the puncture path establishing step.

[0080] The puncture path establishing step includes establishing a puncture path from the area of ​​skin to the lumen of the blood vessel with the introducer 132. The puncture path establishing step may include drawing a slight vacuum with the syringe 138 while establishing the puncture path such that blood flows back into at least the introducer needle 134 when the puncture path is established. By drawing such a vacuum, the puncture path establishing step may include verifying that blood flows back along the needle slot 146 of the introducer needle 134 if the sheath body 162 is made of a transparent polymeric material, into the needle hub 142 of the introducer needle 134 if the needle hub 142 is made of a transparent polymeric material, into the syringe tip 204, into the barrel 200 of the syringe 138, or a combination thereof, thereby verifying that the puncture path extends into the lumen of the blood vessel.

[0081] The access guidewire advancement step includes advancing the distal end of the access guidewire 208 from its initial position within the introducer 132 proximal to the needle tip 144 into the vascular lumen to secure vascular access for the RICC advancement step. Again, the access guidewire 208 includes a stop 210 (e.g., a guidewire hub) about the proximal end of the access guidewire 208 configured to prevent over-advancement of the access guidewire 208 during the access guidewire advancement step.

[0082] The blood aspiration step involves aspirating blood using a syringe 138 coupled to the introducer needle 134 to ensure that the puncture path extends into the vascular lumen prior to withdrawing the introducer needle 134 from the introducer sheath 136 in the introducer needle withdrawal step. In particular, the needle shaft 140 has an inner diameter sized according to the outer diameter of the distal end portion of the access guidewire 208 to allow for blood reflux and aspiration. This advantageously allows the blood aspiration step to be performed after the access guidewire advancement step while the access guidewire 208 secures or maintains vascular access for the RICC advancement step.

[0083] The introducer needle withdrawal step involves withdrawing the introducer needle 134 from the introducer sheath 136, while leaving both the introducer sheath 136 and the access guidewire 208 within the vessel lumen. Again, the introducer needle 134 includes a needle slot 146 extending from a proximal portion of the needle shaft 140 to the needle tip 144, thereby allowing the introducer needle 134 to be removed from the introducer sheath 136 while the access guidewire 208 remains within the vessel lumen.

[0084] The introducer sheath splitting step includes splitting the introducer sheath 136 off the access guidewire 208 and removing the split portion of the introducer sheath 136 from the intravascular lumen. Such splitting includes splitting the sheath hub 164 and its ports 174 by pulling apart the tabs 176 extending from the sheath hub 164. The introducer sheath splitting step also includes propagating a tear resulting from splitting the sheath hub 164 along the sheath body 162 of the introducer sheath 136. In this manner, the introducer sheath 136 is split off the access guidewire 208 and the split portion of the introducer sheath 136 is removed from the intravascular lumen.

[0085] The RICC advancement step involves inserting the RICC 100 into the vessel lumen by advancing a distal portion of the catheter tube 102 of the RICC 100 over the access guidewire 208 into the vessel lumen.

[0086] The access guidewire withdrawal step involves withdrawing the access guidewire 208 while leaving the catheter tube 102 within the vessel lumen and removing the access guidewire 208 from the primary lumen 120 of the RICC 100 so that a steering guidewire advancement step can be performed.

[0087] The steering guidewire advancement step includes advancing a steering guidewire into the vessel lumen via the primary lumen 120 of the RICC 100. According to the steering guidewire advancement step, a distal portion of the steering guidewire may be advanced to the lower third of the SVC of the patient's heart.

[0088] An additional RICC advancement step involves advancing the distal portion of the catheter tube 102 further into the vessel lumen over the longitudinal guidewire until it reaches the lower third of the patient's SVC.

[0089] The steering guidewire withdrawal step involves 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. 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. 1. An introducer assembly comprising: an introducer, an introducer needle including a needle shaft having a needle slot extending longitudinally from a proximal portion of the needle shaft to a distal tip; a splittable introducer sheath including a sheath body, the sheath body covering the needle shaft sealing the needle slot beneath the sheath body except for a sheath body opening at a proximal portion of the sheath body; an introducer comprising: an access guidewire including a distal end portion disposed within the introducer; wherein the distal end portion of the access guidewire has an outer diameter greater than at least the proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire and prevents proximal withdrawal of the access guidewire from the needle shaft.

2. 2. The introducer assembly of claim 1, wherein a proximal portion of the access guidewire has an outer diameter corresponding to the outer diameter of the distal end portion of the access guidewire, and an intermediate portion of the access guidewire between the proximal portion of the access guidewire and the distal end portion of the access guidewire has an outer diameter smaller than the outer diameters of the proximal portion of the access guidewire and the distal end portion of the access guidewire.

3. 2. The introducer assembly of claim 1, wherein a proximal portion of the distal end portion of the access guidewire includes a rigid tubular fitting thereon, the rigid tubular fitting preventing the proximal portion of the distal end portion of the access guidewire from bending, thereby orienting the distal end portion of the access guidewire to engage the proximal end portion of the needle slot over the remainder of the needle slot.

4. The introducer assembly of claim 1 , wherein the proximal end portion of the needle slot has the same width as the remainder of the needle slot.

5. The introducer assembly of claim 1 , wherein the proximal end portion of the needle slot is narrower than the remainder of the needle slot.

6. 6. The introducer assembly of claim 3, wherein the sheath body opening extends over the proximal end portion of the needle slot without extending substantially over the remaining portion of the needle slot, such that the sheath body interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

7. The introducer assembly of claim 6 , wherein the introducer sheath further comprises a splittable sheath hub about the proximal portion of the sheath body.

8. 8. The introducer assembly of claim 7, wherein the sheath hub extends over the remaining portion of the needle slot exposed by the sheath body opening such that the sheath hub interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

9. 8. The introducer assembly of claim 7, wherein the sheath hub includes a port overlying the remaining portion of the needle slot exposed by the sheath body opening, the port configured to direct the access guidewire exclusively into the proximal end portion of the needle slot, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

10. The introducer assembly of claim 1 , further comprising a needle hub around a proximal end portion of the needle shaft.

11. 11. The introducer assembly of claim 10, further comprising a syringe including a tapered male syringe tip extending from a distal portion of the syringe, the syringe tip configured to be inserted into a tapered female needle hub connector at a proximal portion of the needle hub.

12. 1. A rapid insertion central venous catheter (RICC) insertion assembly comprising: RICC and an introducer, an introducer needle including a needle shaft having a needle slot extending longitudinally from a proximal portion of the needle shaft to a distal tip; a splittable introducer sheath including a sheath body, the sheath body covering the needle shaft sealing the needle slot beneath the sheath body except for a sheath body opening at a proximal portion of the sheath body; an introducer comprising: an access guidewire including a proximal end portion disposed within the RICC and a distal end portion disposed within the introducer; wherein the distal end portion of the access guidewire has an outer diameter greater than at least a proximal end portion of the needle slot such that the proximal end portion of the needle slot captures the distal end portion of the access guidewire and prevents proximal withdrawal of the access guidewire from the needle shaft.

13. 13. The RICC insertion assembly of claim 12, wherein a proximal portion of the access guidewire has an outer diameter corresponding to an outer diameter of the distal end portion of the access guidewire, and an intermediate portion of the access guidewire between the proximal portion of the access guidewire and the distal end portion of the access guidewire has an outer diameter smaller than the outer diameters of the proximal portion of the access guidewire and the distal end portion of the access guidewire.

14. 13. The RICC insertion assembly of claim 12, wherein a proximal portion of the distal end portion of the access guidewire includes a rigid tubular fitting thereon that prevents the proximal portion of the distal end portion of the access guidewire from bending, thereby orienting the distal end portion of the access guidewire to engage the proximal end portion of the needle slot over the remainder of the needle slot.

15. The RICC insertion assembly of claim 12 , wherein the proximal end portion of the needle slot has the same width as the remainder of the needle slot.

16. The RICC insertion assembly of claim 12 , wherein the proximal end portion of the needle slot is narrower than the remainder of the needle slot.

17. 17. The RICC insertion assembly of claim 14, wherein the sheath body opening extends over the proximal end portion of the needle slot without extending substantially over the remainder of the needle slot such that the sheath body interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

18. 17. The RICC insertion assembly of any one of claims 14 to 16, further comprising a splittable sheath hub about the proximal portion of the sheath body.

19. 20. The RICC insertion assembly of claim 18, wherein the sheath hub extends over the remainder of the needle slot exposed by the sheath body opening such that the sheath hub interferes with the distal end portion of the access guidewire, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

20. 20. The RICC insertion assembly of claim 18, wherein the sheath hub includes a port extending over the remaining portion of the needle slot exposed by the sheath body opening, the port configured to direct the access guidewire exclusively into the proximal end portion of the needle slot, thereby preventing proximal withdrawal of the access guidewire from the needle shaft.

21. 17. The RICC insertion assembly of any one of claims 12 to 16, further comprising a needle hub around a proximal end portion of the needle shaft.

22. 22. The RICC insertion assembly of claim 21, further comprising a syringe including a tapered male syringe tip extending from a distal portion thereof, the syringe tip configured to be inserted into a tapered female needle hub connector at a proximal portion of the needle hub.

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