Rapid insertion central venous catheter system and introducer for rapid insertion central venous catheter

Abstract

Two-piece rapid insertion central venous catheters ("RICCs"), introducers, and methods are disclosed. For example, an introducer and a distal catheter piece of a RICC can be coupled to form an introducer assembly configured to be actuated with one finger of one hand while the introducer is held between the thumb and one or more fingers of the same hand. The introducer's catheter advancement hub includes a manifold coupled to a proximal portion of the distal catheter hub piece of the distal catheter piece. The introducer's syringe introducer needle has a needle shaft extending through the manifold and the distal end of the distal catheter piece. The introducer housing is located over the syringe tip, the manifold, and the proximal portion of the distal catheter piece. The introducer of the introducer housing is configured to provide column strength to the catheter tube of the distal catheter piece during venipuncture.

Description

[Technical Field]

[0001] The present invention , fast Rapid insertion central venous catheter System and Rapid insertion central venous catheter introducer Sa Regarding. [Background technology]

[0002] Existing catheters are manufactured as whole, ready-to-use catheters. Such catheters can range in length from 30 to 40 cm, measured from the proximal to distal end of any such catheter. Rapidly insertable central catheters (RICCs) currently under development are introduced over an introducer needle. Introducing a RICC over a 30- to 40-cm introducer needle can be cumbersome for clinicians. Additionally, during a given RICC introduction with a 30- to 40-cm introducer needle, it can be difficult to timely recognize whether flashback has occurred and access the established vascular lumen. Therefore, RICCs generally include a distal introduction opening designed for introducing the RICC over a shorter introducer needle. However, these introduction openings effectively become artifacts after RICC introduction, so eliminating the introduction opening would be beneficial. Summary of the Invention [Problem to be solved by the invention]

[0003] Disclosed herein are a two-piece RICC, an introducer for a two-piece RICC, and methods thereof that address the above. [Means for solving the problem]

[0004] Disclosed herein, in some embodiments, is a RICC system including an introducer and a distal catheter piece of the RICC configured to couple into an introducer assembly having a ready-to-deploy state. The introducer assembly is configured to be actuated by one finger of one hand when the introducer is held between the thumb and one or more fingers of the other hand. The distal catheter piece includes a distal catheter hub piece of a two-piece catheter hub and a catheter tube, the catheter tube being coupled to the distal catheter hub piece by a proximal portion of the catheter tube. The catheter tube comprises one or more catheter tube lumens. The introducer includes a catheter advancement hub, an introducer needle, a syringe, and an introducer housing. The catheter advancement hub includes a manifold and a side arm and is coupled to the proximal portion of the distal catheter hub piece in the ready-to-deploy state of the introducer assembly. The introducer needle has a needle shaft that extends through both the manifold and the distal end of the distal catheter piece when the introducer assembly is in a ready-to-deploy state. The syringe includes a barrel having a distal portion that terminates in a syringe tip. The syringe is fluidly coupled (hereinafter referred to as "fluidly coupled") to the introducer needle. The introducer housing is located over the syringe tip, the manifold, and the proximal portion of the distal catheter piece when the introducer assembly is in a ready-to-deploy state. The introducer housing is configured to provide column strength to the catheter tube during venipuncture with the introducer needle. The introducer housing is also configured to split longitudinally to allow the distal catheter piece to be removed from the introducer housing after venipuncture.

[0005] In some embodiments, the introducer housing includes a lock at a distal portion of the introducer housing, the lock including a hook on the slidable piece of the introducer housing and a latch on the stationary piece of the introducer housing, the hook and latch configured to lock the slidable piece and the stationary piece together in a ready-to-deploy state of the introducer assembly.

[0006] In some embodiments, the stationary piece of the introducer housing comprises a groove comprising a latch at a proximal portion of the groove and a ramp at a distal portion of the groove, the combination of the hook and the ramp being configured to displace the slidable piece of the introducer housing from the stationary piece when the distal surface of the hook engages the proximal surface of the ramp while advancing the slidable piece distally relative to the stationary piece.

[0007] In some embodiments, the introducer housing includes a sliding hinge at a proximal portion of the introducer housing, the sliding hinge including a capture tab on the slidable piece of the introducer housing and a track on the stationary piece of the introducer housing, the capture tab being captured but slidably disposed within the track to allow the slidable piece to advance distally relative to the stationary piece at the proximal portion of the introducer housing without separating the slidable piece from the stationary piece.

[0008] In some embodiments, the proximal portion of the capture tab, located inside the outer surface of the introducer housing, is rounded to facilitate splitting the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing.

[0009] In some embodiments, the proximal portion of the introducer housing includes a longitudinal notch configured to provide a passageway for a side arm of the catheter advancement hub when the catheter advancement hub is advanced distally within the introducer housing.

[0010] In some embodiments, the manifold comprises one or more manifold lumens equal in number to the one or more catheter tube lumens, which are fluidly connected (hereinafter referred to as "fluidly connected") to the one or more catheter tube lumens in the ready-to-deploy state of the introducer assembly.

[0011] In some embodiments, the side arm of the catheter advancement hub comprises a side arm lumen fluidly coupled to one or more manifold lumens, the combination of the side arm lumen and the one or more manifold lumens being for simultaneously priming each of the one or more catheter tube lumens prior to insertion of the catheter tube into a vascular lumen of a patient.

[0012] In some embodiments, the catheter advancement hub further comprises a catheter advancement push tab extending from the side arm configured to advance the catheter advancement hub distally with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel.

[0013] In some embodiments, the RICC system further includes a proximal catheter piece of the RICC. The proximal catheter piece includes a proximal catheter hub piece of the two-piece catheter hub and one or more extension legs. Each of the one or more extension legs includes one or more extension leg lumens. Each extension leg of the one or more extension legs is coupled to the proximal catheter hub piece by a distal portion of the extension leg. The RICC has a connected state in which the proximal catheter hub piece is connected to the distal catheter hub piece. In the connected state of the RICC, the one or more extension leg lumens are fluidly coupled to one or more catheter tube lumens, respectively, through the two-piece catheter hub.

[0014] In some embodiments, the RICC comprises a set of three lumens in the connected state of the RICC, the set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen. In some embodiments, the primary lumen has a primary lumen opening at the distal end of the two-piece catheter, the secondary lumen has a secondary lumen opening on a side of the catheter tubing proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on a side of the catheter tubing proximal to the secondary lumen opening.

[0015] In some embodiments, the catheter tube further comprises a first portion formed from a first material having a first durometer and a second portion formed from a second material having a second durometer that is lower than the first durometer, thereby providing the catheter tube with a combination of column strength for insertion into a patient and compliance for advancement of the catheter tube through the patient's vasculature.

[0016] In some embodiments, the introducer further comprises a syringe housing having a distal portion and a proximal portion disposed around the barrel of the syringe. The proximal portion of the syringe housing is integral with or coupled to a proximal portion of a plunger disposed within the barrel. Regardless of whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, sliding the syringe housing proximally relative to the barrel withdraws the plunger from the barrel.

[0017] In some embodiments, the syringe further comprises a plunger withdrawal push-tab coupled to the distal portion of the barrel and extending proximally over the barrel from the distal portion of the barrel, the plunger withdrawal push-tab configured to be pressed with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

[0018] In some embodiments, the introducer further comprises an access guidewire disposed within an access guidewire lumen formed from at least the plunger lumen of the plunger and the needle lumen of the introducer needle, the access guidewire having a length sufficient to allow the access guidewire to extend through the distal end of the distal catheter piece.

[0019] In some embodiments, the introducer further includes a slider extending distally from the syringe housing over the barrel, the slider configured to actuate the access guidewire with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel, and the slider includes an extension that extends through a longitudinal slot in each of the barrel and plunger and into the access guidewire lumen, where the extension is coupled to the access guidewire.

[0020] Also disclosed is an introducer configured to couple to a distal catheter piece of a RICC to form an introducer assembly. The introducer includes a catheter advancement hub, an introducer needle, a syringe, and an introducer housing. The catheter advancement hub includes a manifold and a side arm and is configured to couple to the distal catheter piece in the introducer assembly. The introducer needle has a needle shaft that extends through both the manifold and the distal end of the distal catheter piece when the introducer assembly is in a ready-to-deploy state. The syringe is fluidly coupled to the introducer needle. The syringe includes a barrel having a distal portion that terminates in a syringe tip. The syringe is configured to be held around the distal portion of the barrel between the thumb and one or more fingers of one hand, while retaining one finger to actuate the introducer. The introducer housing is located over the syringe tip, the manifold, and the proximal portion of the distal catheter piece when the introducer assembly is in a ready-to-deploy state. The introducer housing is configured to provide column strength to the catheter tube of the distal catheter piece during venipuncture with the introducer needle and is also configured to split longitudinally to allow removal of the distal catheter piece from the introducer housing after venipuncture.

[0021] In some embodiments, the introducer housing includes a lock at a distal portion of the introducer housing, the lock including a hook on the slidable piece of the introducer housing and a latch on the stationary piece of the introducer housing, the hook and latch configured to lock the slidable piece and the stationary piece together.

[0022] In some embodiments, the stationary piece of the introducer housing comprises a groove comprising a latch at a proximal portion of the groove and a ramp at a distal portion of the groove, the combination of the hook and the ramp being configured to displace the slidable piece of the introducer housing from the stationary piece when the distal surface of the hook engages the proximal surface of the ramp while advancing the slidable piece distally relative to the stationary piece.

[0023] In some embodiments, the introducer housing includes a sliding hinge at a proximal portion of the introducer housing, the sliding hinge including a capture tab on the slidable piece of the introducer housing and a track on the stationary piece of the introducer housing, the capture tab being captured but slidably disposed within the track to allow the slidable piece to advance distally relative to the stationary piece at the proximal portion of the introducer housing without separating the slidable piece from the stationary piece.

[0024] In some embodiments, the proximal portion of the capture tab, located inside the outer surface of the introducer housing, is rounded to facilitate splitting the slidable piece of the introducer housing from the stationary piece of the introducer housing at the distal portion of the introducer housing.

[0025] In some embodiments, the proximal portion of the introducer housing includes a longitudinal notch configured to provide a passageway for a side arm of the catheter advancement hub when the catheter advancement hub is advanced distally within the introducer housing.

[0026] In some embodiments, the side arm of the catheter advancement hub comprises a side arm lumen fluidly coupled to one or more manifold lumens, the combination of the side arm lumen and the one or more manifold lumens for simultaneously priming each of the one or more lumens of the distal catheter piece of the RICC in the ready-to-deploy state of the introducer assembly.

[0027] In some embodiments, the catheter advancement hub further comprises a catheter advancement push tab extending from the side arm configured to advance the catheter advancement hub distally with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel.

[0028] In some embodiments, the introducer further comprises a syringe housing having a distal portion and a proximal portion disposed around the barrel of the syringe. The proximal portion of the syringe housing is integral with or coupled to a proximal portion of a plunger disposed within the barrel. Regardless of whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, sliding the syringe housing proximally relative to the barrel withdraws the plunger from the barrel.

[0029] In some embodiments, the syringe further comprises a plunger withdrawal push-tab coupled to the distal portion of the barrel and extending proximally over the barrel from the distal portion of the barrel, the plunger withdrawal push-tab configured to be pressed with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

[0030] In some embodiments, the introducer further comprises an access guidewire disposed within an access guidewire lumen formed from at least the plunger lumen of the plunger and the needle lumen of the introducer needle, the access guidewire having a length sufficient to allow the access guidewire to extend through the distal end of the distal catheter piece when the introducer assembly is in a ready-to-deploy state.

[0031] In some embodiments, the introducer further includes a slider extending distally from the syringe housing over the barrel, the slider configured to actuate the access guidewire with one finger of one hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel, and the slider includes an extension that extends through a longitudinal slot in each of the barrel and plunger and into the access guidewire lumen, where the extension is coupled to the access guidewire.

[0032] A method for a RICC system is also disclosed. In some embodiments, the method includes the steps of obtaining a RICC system, establishing a needle path, advancing a first RICC, splitting an introducer housing, and removing the introducer. The obtaining the RICC system step includes obtaining a RICC system. The RICC system includes a proximal catheter piece of the RICC and an introducer assembly. The introducer assembly includes an introducer and a distal catheter piece of the RICC partially disposed within an introducer housing of the introducer. The establishing the needle path step includes establishing a needle path from the patient's skin area to the blood vessel lumen with an introducer needle of the introducer. The introducer needle has a needle shaft extending through the distal end of the distal catheter piece when the introducer assembly is in a ready-to-deploy state. The needle path establishment step is performed by holding a distal portion of the introducer syringe between the thumb and one or more fingers of one hand while keeping at least one finger of the other hand ready for use to actuate the introducer assembly. The first RICC advancement step includes advancing a distal portion of a first portion of the catheter tubing of the distal catheter piece over the needle shaft into the vessel lumen. The introducer housing splitting step includes splitting the introducer housing along the length of the introducer housing. The introducer removal step includes removing the distal catheter piece from the introducer housing, leaving the distal portion of the first portion of the catheter tubing in place within the vessel lumen.

[0033] In some embodiments, the method further includes a blood aspirating step. The blood aspirating step includes aspirating blood with a syringe to confirm that the needle tip of the introducer needle is positioned within the blood vessel lumen before the introducer removing step. The blood aspirating step includes holding a distal portion of the syringe between the thumb and one or more fingers of one hand by a syringe housing positioned above the syringe barrel, while pressing a plunger retraction push tab with one finger of the same hand. The plunger retraction push tab extends from the distal portion of the syringe above the barrel so that pressing the plunger retraction tab while holding the distal portion of the syringe by the syringe housing slides the syringe housing proximally relative to the barrel and retracts the syringe housing-connected plunger from the barrel.

[0034] In some embodiments, the first RICC advancement step includes holding the distal portion of the syringe between the thumb and one or more fingers of one hand while pressing a catheter advancement push tab with one finger of the same hand. The catheter advancement push tab is part of a catheter advancement hub that is coupled to a proximal portion of the distal catheter piece in the ready-to-deploy state of the introducer assembly.

[0035] In some embodiments, pressing the catheter advancement push tab advances the side arms of the catheter advancement hub along a path provided by a longitudinal notch in the introducer housing.

[0036] In some embodiments, the method further includes a priming step, prior to the first RICC advancement step, of priming the distal catheter piece with a common syringe through a side arm of the catheter advancement hub, the side arm having a side arm lumen fluidly coupled to one or more manifold lumens for simultaneously priming each lumen of one or more respective lumens of the distal catheter piece.

[0037] In some embodiments, the introducer housing splitting step includes releasing a lock on the distal portion of the introducer housing by sliding a slidable piece of the introducer housing distally relative to a stationary piece of the introducer housing, where the releasing of the lock includes separating a hook of the slidable piece and a latch of the stationary piece by sliding the slidable piece relative to the stationary piece.

[0038] In some embodiments, the stationary piece of the introducer housing comprises a groove comprising a latch at a proximal portion of the groove and a ramp at a distal portion of the groove, and sliding of the slidable piece relative to the stationary piece causes the distal surface of the hook to engage the proximal surface of the ramp and causes the introducer housing to split along the length of the introducer housing.

[0039] In some embodiments, the method further includes an access guidewire advancing step. The access guidewire advancing step includes advancing an access guidewire disposed within the access guidewire lumen past the distal end of the distal catheter piece and into the blood vessel lumen. The access guidewire lumen is formed from at least the plunger lumen of the syringe and the needle lumen of the introducer needle. Additionally, a slider is coupled to the access guidewire such that the access guidewire is advanced into the blood vessel lumen by advancing the slider distally with one finger while holding a distal portion of the syringe housing between the thumb and one or more fingers of one hand. The access guidewire advancing step is performed before the first RICC advancing step.

[0040] In some embodiments, the method further includes a catheter hub clipping step, which includes clipping together a proximal catheter hub piece of the proximal catheter piece and a proximal catheter hub piece of the distal catheter piece, and connecting one or more extension leg lumens of one or more extension legs coupled to the proximal catheter hub piece to one or more catheter tube lumens of the catheter tube, respectively, thereby forming a RICC.

[0041] In some embodiments, the method further includes advancing an operating guidewire through a primary lumen of a RICC having a primary lumen opening at a distal end of a distal catheter piece, and into a blood vessel lumen to a target location within the patient's vasculature.

[0042] In some embodiments, the method further includes a second RICC advancement step and a steering guidewire removal step. The second RICC advancement step includes using the steering guidewire as a guide to further advance the remainder of the distal portion of the first portion of the catheter tube into the blood vessel lumen until it reaches the proximal portion of the second portion of the catheter tube. The second RICC advancement step is stopped in its advancement when the distal end of the distal catheter piece reaches the target location. The steering guidewire removal step includes withdrawing the steering guidewire, leaving the catheter tube in place within the patient.

[0043] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0044] [Figure 1]FIG. 1 is a first perspective view of an introducer assembly including an introducer and a distal catheter piece of a two-piece RICC, according to some embodiments. [Figure 2] FIG. 10 is a second perspective view of an introducer assembly according to some embodiments. [Figure 3] 1 is a top view of an introducer assembly according to some embodiments. [Figure 4] 1 is a bottom view of an introducer assembly according to some embodiments. FIG. [Figure 5] FIG. 10 is a side view of an introducer assembly in an operational state with an access guidewire advanced through the distal end of the distal catheter piece of the RICC, according to some embodiments. [Figure 6] FIG. 10 is a side view of the introducer assembly in another operational state where the split introducer housing and distal catheter piece of the RICC have advanced from the ready-to-deploy state of the introducer assembly, according to some embodiments. [Figure 7] 7 is a perspective view of the introducer assembly in the same operational state as FIG. 6, according to some embodiments. [Figure 8] 10A-10D illustrate a sliding hinge at a proximal portion of the introducer housing, according to some embodiments. [Figure 9] 10A-10D illustrate a lock at a distal portion of the introducer housing, according to some embodiments. [Figure 10] 10A-10D illustrate an introducer syringe, according to some embodiments. [Figure 11] 1 is a longitudinal cross-sectional view of a portion of a syringe, according to some embodiments. [Figure 12] 1A-1C illustrate a catheter advancement hub coupled to a distal catheter hub piece of a distal catheter piece in a ready-to-deploy state of an introducer assembly, according to some embodiments. [Figure 13] 1 illustrates a two-piece RICC in an unconnected state, according to some embodiments. [Figure 14]1 illustrates a two-piece RICC in a connected state, according to some embodiments. [Figure 15] 1A-1C illustrate the proximal and distal catheter hub pieces of a two-piece catheter hub in an unconnected state of the RICC, according to some embodiments. [Figure 16] 1A-1C illustrate the proximal and distal catheter hub pieces in a connected state in a RICC, according to some embodiments. [Figure 17] 15A and 15B illustrate a distal portion of the catheter tube of the RICC of FIGS. 13 and 14, according to some embodiments. [Figure 18] FIG. 18 illustrates a first cross-section of the catheter tube of FIG. 17, according to some embodiments. [Figure 19] FIG. 18 illustrates a second cross-section of the catheter tube of FIG. 17, according to some embodiments. [Figure 20] FIG. 18 illustrates a third cross-section of the catheter tube of FIG. 17, according to some embodiments. [Figure 21] 18A-18C show fourth and fifth cross sections of the catheter tube of FIG. 17, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0045] Before disclosing some specific embodiments 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 may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0046] Regarding the terms used herein, it should also be understood that these 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 serial or numerical limitations. For example, "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. Designations such as "left," "right," "top," "bottom," "front," and "back" are for convenience and do not imply, for example, a specific fixed location, direction, or orientation. Instead, such designations are used, for example, to reflect relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0047] For example, references to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0048] For example, references to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is in use with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0049] 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 mentioned above, RICCs typically include a distal introduction opening designed to allow the RICC to be introduced over a shorter introducer needle. However, the introduction opening effectively becomes an artifact after introduction of the RICC, so it would be beneficial to eliminate the introduction opening.

[0050] Disclosed herein are two-piece RICCs, introducers for two-piece RICCs, and methods thereof that address the above. For context, a description of the RICC is presented first. The description of the RICC is followed by a description of the introducer, which is sometimes presented in the context of an introducer assembly, taking into account the interrelationship between the introducer and the RICC. Following the description of the RICC and introducer, methods for using a RICC system that includes at least the aforementioned RICC and introducer are presented.

[0051] Rapid insertion central venous catheter 13 and 14 show the two-piece RICC 100 in an unconnected and connected state, according to some embodiments.

[0052] As shown, the two-piece RICC 100 comprises two pieces, including a proximal catheter piece 102 and a distal catheter piece 104. It should be understood that the RICC 100 may comprise different or additional pieces than those in the illustrated embodiment. Indeed, the "two-piece" in two-piece RICC 100 generally refers to at least two pieces resulting from splitting such a RICC transversely at some point along its length, in this case at a two-piece catheter hub 108, described below.

[0053] The proximal catheter piece 102 comprises a proximal catheter hub piece 106 of a two-piece catheter hub 108 and one or more extension legs 110. The distal catheter piece 104 comprises a distal catheter hub piece 112 of the two-piece catheter hub 108 and a catheter tube 114. A description of the two-piece catheter hub 108 will be presented first, followed by a description of the catheter tube 114, the one or more extension legs 110, and other aspects of the RICC 100.

[0054] 15 and 16 show the proximal catheter hub piece 106 and the distal catheter hub piece 112 of the two-piece catheter hub 108 in the unconnected and connected states of the RICC 100, according to some embodiments.

[0055] The proximal catheter hub piece 106 of the two-piece catheter hub 108 includes one or more rigid tubes 116 (e.g., metal tubes) disposed in one or more proximal catheter hub lumens 118, respectively, thereby effectively extending the one or more proximal catheter hub lumens 118 within the connector. The proximal catheter hub piece 106 may be molded onto the one or more rigid tubes 116 during manufacture, such that the one or more rigid tubes 116 extend from the distal end of the proximal catheter hub piece 106. Alternatively, the one or more rigid tubes 116 are inserted into the one or more proximal catheter hub lumens 118 during manufacture, such that the one or more rigid tubes 116 extend from the distal end of the proximal catheter hub piece 106.

[0056] The distal catheter hub piece 112 of the two-piece catheter hub 108 includes one or more distal catheter hub lumens 120 each having one or more mechanical gaskets 122 disposed therein. The one or more mechanical gaskets 122 are configured to be positioned between the abluminal surface of the one or more rigid tubes 116 and the luminal surface of the one or more distal catheter hub lumens 120 in the connected state of the RICC 100. The one or more mechanical gaskets 122 include, but are not limited to, an "O" ring or a cylinder. The one or more mechanical gaskets 122 may be formed from a compressible polymeric material, such as silicone. The use of a compressible polymeric material such as silicone is advantageous in that axial compression of the one or more mechanical gaskets 122 by the compression rings 124 when the one or more rigid tubes 116 are inserted into the one or more distal catheter hub lumens 120 causes the one or more mechanical gaskets 122 to expand radially in the confined space between the abluminal surface of the one or more rigid tubes 116 and the luminal surface of the one or more distal catheter hub lumens 120, thereby forming one or more fluid-tight luminal seals between the proximal catheter hub piece 106 and the distal catheter hub piece 112 of the two-piece catheter hub 108 and connecting the one or more proximal catheter hub lumens 118 to the one or more distal catheter hub lumens 120, respectively.

[0057] Alternatively, the distal catheter hub piece 112 can instead comprise one or more rigid tubes 116 disposed in one or more distal catheter hub lumens 120, respectively. Similarly, the proximal catheter hub piece 106 can instead comprise one or more mechanical gaskets 122 disposed in one or more proximal catheter hub lumens 118, respectively. It should be understood that the above descriptions of the one or more rigid tubes 116, one or more mechanical gaskets 122, etc., for the illustrated embodiments of the proximal catheter hub piece 106 and the distal catheter hub piece 112 also apply to the one or more rigid tubes 116 when part of the distal catheter hub piece 112, the one or more mechanical gaskets 122 when part of the proximal catheter hub piece 106, etc.

[0058] Continuing with the illustrated embodiment of the proximal catheter hub piece 106 and the distal catheter hub piece 112, the proximal catheter hub piece 106 and the distal catheter hub piece 112 comprise complementary connectors of a connection system configured to securely, and in some embodiments, irreversibly, connect the proximal catheter hub piece 106 and the distal catheter hub piece 112 in the connected state of the RICC 100. In this regard, it should be understood that "irreversibly" connecting the proximal catheter hub piece 106 and the distal catheter hub piece 112 means that the proximal catheter hub piece 106 and the distal catheter hub piece 112 cannot be disconnected without tools or without damaging the proximal catheter hub piece 106 or the distal catheter hub piece 112.

[0059] With respect to the connection system, the distal catheter hub piece 112 can include an integral clip molded therewith, the integral clip having a tabbed arm 126 extending proximally from the distal catheter hub piece 112. The proximal catheter hub piece 106 can include a complementary receiving portion, such as a surface recess 128, configured to seat both the tabbed arm 126 and a tab 130 of the tabbed arm 126 therein when the RICC 100 is in the connected state. As best shown in FIG. 15 , the tabbed arm 126 can extend from a long side of the distal catheter hub piece 112, and the surface recess 128 can be on a major surface of the proximal catheter hub piece 106. However, the tabbed arm 126 can instead extend from a short side of the distal catheter hub piece 112, and the surface recess 128 can be on a minor surface of the proximal catheter hub piece 106. Because there is more design space across the width of the two-piece catheter hub 108, the complementary receiving portion can instead be a longitudinal cavity located on the inside of a minor surface of the proximal catheter hub piece 106, and the tabbed arms 126 extending from the short sides of the distal catheter hub piece 112 are configured to be inserted into this longitudinal cavity, similar to that of a common plastic buckle on a backpack or the like.

[0060] Alternatively, the proximal catheter hub piece 106 can instead comprise an integral clip having tabbed arms 126. Indeed, if one or more rigid tubes 116 are also disposed within one or more proximal catheter hub lumens 118 of the proximal catheter hub piece 106, the integral clip effectively protects the one or more rigid tubes 116 from inadvertent breakage. Similarly, the distal catheter hub piece 112 can instead comprise a complementary receiver including a surface recess 128 configured to seat the tabbed arms 126. It should be understood that the above descriptions of the tabbed arms 126, complementary receivers, etc., for the illustrated embodiments of the proximal catheter hub piece 106 and the distal catheter hub piece 112 apply to the tabbed arms 126 when part of the proximal catheter hub piece 106, the complementary receivers when part of the distal catheter hub piece 112, etc.

[0061] Figure 17 shows a distal portion of the catheter tube 114 of the RICC 100 according to some embodiments. Figures 18-21 show various cross sections of the catheter tube 114 according to some embodiments.

[0062] The catheter tube 114 is coupled to the distal catheter hub piece 112 by a proximal portion of the catheter tube 114. Thus, the one or more distal catheter hub lumens 120 are continuous with one or more catheter tube lumens (see the primary, secondary, and tertiary lumens 142, 146, 150 of the RICC 100 in FIG. 21 for the one or more catheter tube lumens).

[0063] The catheter tube 114 can comprise a rigid portion and a flexible portion, where "rigid" and "flexible" are used in a relative sense, with the rigid portion of the catheter tube 114 being stiffer than the flexible portion of the catheter tube 114. The rigid portion of the catheter tube 114 includes a first portion 132 at the distal portion of the catheter tube 114, while the flexible portion of the catheter tube 114 includes a second portion 134 extending from a proximal portion of the catheter tube 114 to a distal portion of the catheter tube 114 but proximal to the first portion 132. Although the tapered junction 136 of the catheter tube 114 includes a proximal portion of the rigid portion of the catheter tube 114 disposed therein, the flexible portion of the catheter tube 114 is generally considered to include the junction 136 in view of its structure. The overall above-described configuration of the first portion 132 of the catheter tube 114, the second portion 134 of the catheter tube 114, and the junction 136 provides the catheter tube 114 with both sufficient column strength to prevent buckling of the catheter tube 114 when inserted into an insertion site established by percutaneous puncture, and sufficient compliance to allow the catheter tube 114 to be advanced over a steering guidewire through the patient's vasculature to a target location (e.g., the superior vena cava (“SVC”)).

[0064] The first section 132 of the catheter tube 114 is located at the distal portion of the catheter tube 114. The first section 132 includes a distal tip 138 having a relatively short taper configured to continue from the needle tip 140 of the introducer needle 164 to the outer diameter of the remainder of the first section 132 when the introducer needle 164 is disposed within the catheter tube 114 of the distal catheter piece 104 (see FIGS. 1-4). The short taper of the distal tip 138 is configured to immediately expand tissue around the percutaneous puncture established by the introducer needle 164 to the outer diameter of the remainder of the first section 132 of the catheter tube 114. The first section 132 also includes a proximal section that is disposed in a receiving portion of a joint 136, described below, and is fixedly coupled (e.g., solvent bonded, adhered, welded, etc.) thereto.

[0065] The first section 132 of the catheter tube 114 is formed from a first polymeric material having a first durometer. The first polymeric material may be, but is not limited to, polytetrafluoroethylene, polypropylene, or polyurethane. Polyurethane is advantageous in that the first section 132 of the catheter tube 114 is relatively stiff at room temperature but can become more flexible in vivo at body temperature, thereby reducing irritation to blood vessel walls and phlebitis.

[0066] The second portion 134 of the catheter tube 114 extends from the proximal portion of the catheter tube 114 to a distal portion thereof but proximal to the first portion 132 of the catheter tube 114. The second portion 134 has a distal end joined to a joint 136 and a proximal portion disposed within the distal catheter hub piece 112 and fixedly joined thereto (e.g., solvent bonded, adhered, welded, etc.).

[0067] The second portion 134 of the catheter tube 114 is formed from a second polymeric material having a second durometer that is lower than the first durometer. The second polymeric material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but the second polymeric material is not limited to the aforementioned polymers. In addition to what was discussed above about polyurethane in the first portion 132 of the catheter tube 114, polyurethane is advantageous in that it may be less thrombogenic than other polymers.

[0068] A junction 136 of the catheter tube 114 joins the first and second sections 132, 134 of the catheter tube 114 together. The junction 136 comprises a receiver at a distal portion that includes a proximal section of the first section 132 of the catheter tube 114 disposed within the receiver and fixedly joined (e.g., solvent bonded, adhered, welded, etc.) thereto (see FIGS. 17 and 19 for the receiver of the junction 136, where the receiver can be seen). The junction 136 also comprises a flat-faced proximal end that is fixedly joined (e.g., molded, solvent bonded, welded, adhered, etc. with the second section 134) to the flat-faced distal end of the second section 134 of the catheter tube 114. When joined, this flat-faced proximal end effectively terminates passage of lumens of the second section 134 of the catheter tube 114 other than that corresponding to the primary lumen 142 of the RICC 100 from the junction 136. The junction 136 also comprises a taper along its length from the distal end to the proximal end configured to immediately expand the tissue around the percutaneous puncture of the catheter tube 114 to the outer diameter of the second section 134. The abluminal surface of the junction 136 transitions smoothly from the abluminal surface of the proximal portion of the first section 132 without any edges that may catch on the skin when inserted into a patient's insertion site. In addition to having minimal or negligible edges, the edges may comprise a solvent-interdiffused polymer material of the first polymer material and the polymer material of the junction 136, thereby providing a smooth transition from the first section 132 of the catheter tube 114 to the junction 136.

[0069] The junction 136 of the catheter tube 114 is formed from a second polymeric material or a third polymeric material having a third durometer that is closer to the second durometer than the first durometer. Again, the second polymeric material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but is not limited to the foregoing polymers.

[0070] To reiterate, the first portion 132 of the catheter tube 114 is formed from a first polymeric material having a first durometer, the second portion 134 of the catheter tube 114 is formed from a second polymeric material having a second durometer that is lower than the first durometer, and the junction 136 of the catheter tube 114 is formed from the second polymeric material or a third polymeric material having a third durometer that is closer to the second durometer than the first durometer. Because the second and third durometers are each lower than the first durometer, the soft portion of the catheter tube 114, including the second portion of the catheter tube 114 and the junction 136, is more flexible than the hard portion of the catheter tube 114, including the first portion of the catheter tube 114. In other words, the first durometer is higher than the second and third durometers. Because the first durometer is higher than the second and third durometers, the hard portion of the catheter tube 114, including the first portion of the catheter tube 114, is harder than the soft portion of the catheter tube 114, including the second portion of the catheter tube 114 and the junction 136.

[0071] It should be understood that because 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), the second or third durometer hardness may not be numerically lower than the first durometer hardness. In other words, the first durometer hardness material may not be numerically higher than the second or third durometer hardness when considering the different scales. However, because the different scales, each ranging from 0 to 100, are intended to characterize different materials within a group of materials having similar hardnesses, the hardness of the second or third polymeric material may still be lower than the hardness of the first polymeric material, or the hardness of the first polymeric material may still be higher than the hardness of the second or third polymeric material.

[0072] Notwithstanding the foregoing, the first portion 132 of the catheter tube 114, the second portion 114 of the catheter tube 114, and the joint 136 may be formed of the same polymeric material or different polymeric materials having approximately equal durometer hardness, provided that the column strength of the catheter tube 114 is sufficient to prevent buckling of the catheter tube 114 when inserted into an insertion site established by percutaneous puncture, and the compliance of the catheter tube 114 is sufficient to advance the catheter tube 114 through the patient's vasculature to a target location.

[0073] Each of the one or more extension legs 110 is coupled by a distal portion of the extension leg to the proximal catheter hub piece 106. The one or more extension legs 110 each include one or more extension leg lumens. Thus, the one or more proximal catheter hub lumens 118 are continuous with the one or more extension leg lumens, respectively.

[0074] Each extension leg of the one or more extension legs 110 typically includes a luer connector coupled thereto, through which the extension leg and its extension leg lumen can be connected to another medical device.

[0075] Whether the RICC 100 is single-lumen or multi-lumen, the RICC 100 comprises at least a primary lumen 142 (e.g., a distal lumen) in a connected state of the RICC 100, in which one or more catheter tube lumens in the distal catheter piece 104 are fluidly connected to one or more extension leg lumens in the proximal catheter piece 102 through the two-piece catheter hub 108. The primary lumen 142 typically extends from the proximal end of the RICC 100 to the distal end of the RICC 100, e.g., from the opening of a corresponding Luer connector to a primary lumen opening 144 (e.g., a distal lumen opening) at the distal end of the RICC 100. When the RICC 100 has two or more lumens, the RICC 100 further comprises at least a secondary lumen 146 (e.g., a middle lumen). The secondary lumen 146 typically extends from the proximal end of the RICC 100 to a distal portion of the RICC 100, e.g., from the opening of a corresponding Luer connector to a secondary lumen opening 148 (e.g., a mid-lumen opening) in a distal portion of the catheter tube 114 proximal to the primary lumen opening 144. If the RICC 100 has three or more lumens, the RICC 100 further comprises at least a tertiary lumen 150 (e.g., a proximal opening). The tertiary lumen 150 typically extends from the proximal end of the RICC 100 to a distal portion of the RICC 100, e.g., from the opening of a corresponding Luer connector to a tertiary lumen opening 152 (e.g., a proximal lumen opening) in a distal portion of the catheter tube 114 proximal to the secondary lumen opening 148. Notwithstanding the foregoing, the secondary lumen 146 and the tertiary lumen 150 may extend slightly distally beyond the secondary lumen opening 148 and the tertiary lumen opening 152, respectively, given various manufacturing methods. However, as noted above, the flat-faced proximal end of junction 136 is fixedly joined (e.g., molded, solvent bonded, welded, adhered, etc.) to the flat-faced distal end of second section 134 of catheter tubing 114, effectively terminating lumens such as secondary and tertiary lumens 150 from passing through junction 136 when joined.

[0076] Introducers and introducer assemblies 1-4 show various views of an introducer assembly 154 including an introducer 156 and the distal catheter piece 104 of a two-piece RICC 100, according to some embodiments.

[0077] As shown, the introducer 156 is configured to couple to the distal catheter piece 104 of the two-piece RICC 100 to form the introducer assembly 154. Indeed, FIGS. 1-4 illustrate the introducer 156 coupled to the distal catheter piece 104 in a ready-to-deploy state (e.g., a state ready for venipuncture) of the introducer assembly 154. The introducer assembly 154 is configured to be actuated in at least three ways with one finger (e.g., the index finger) of one hand when the introducer assembly 154 is held between the thumb and one or more fingers (e.g., the middle and ring fingers) of the same hand. Thus, multiple operational states of the introducer assembly 154 are possible, some of which are identified or discernible in the description below, including at least a description of how to use the RICC system provided herein.

[0078] The introducer 156 comprises a catheter advancement hub 158, an introducer housing 160, and a syringe 162 with an introducer needle 164. A description of the catheter advancement hub 158, the introducer housing 160, and the syringe 162 is presented below in order, followed by some other features of the introducer 156, although there is some overlap between the descriptions of the catheter advancement hub 158, the introducer housing 160, the syringe 162, and other features of the introducer 156 in light of the interrelationship of the aforementioned features in the introducer 156. Again, in light of the interrelationship of the introducer 156 with the RICC, some of the description of the introducer 156 is also presented in the context of an introducer assembly.

[0079] FIG. 12 shows a catheter advancement hub 158 coupled to the distal catheter hub piece 112 of the distal catheter piece 104 in a ready-to-deploy state of the introducer assembly 154, according to some embodiments.

[0080] As shown, the catheter advancement hub 158 is configured to couple to the distal catheter piece 104 in the introducer assembly 154. Indeed, Figure 12 shows the catheter advancement hub 158 coupled to the proximal portion of the distal catheter hub piece 112 in the ready-to-deploy state of the introducer assembly 154.

[0081] The catheter advancement hub 158 includes a manifold 166, a side arm 168, and a catheter advancement push tab 170 extending proximally from the side arm 168. As best seen in FIG. 12 , the catheter advancement hub 158 includes an integral proximal connector (e.g., a female Luer connector) configured to fluidly couple the syringe 162 to the catheter advancement hub 158 through the syringe tip. Such a fluid coupling between the catheter advancement hub 158 and the syringe 162 is useful for observing blood reflux, if any, at the hub 204 of the syringe 162 during establishment of a needle pathway into the patient's vascular lumen.

[0082] The manifold 166 includes one or more manifold lumens 172, a number equal to the one or more distal catheter hub lumens 120, which are respectively continuous with one or more catheter tube lumens in the distal catheter piece 104, as described above. In the ready-to-deploy state of the introducer assembly 154, the one or more manifold lumens 172 are fluidly connected to one or more catheter tube lumens through one or more distal catheter hub lumens 120 so that one or more catheter tube lumens can be simultaneously primed with a fluid (e.g., saline, heparinized saline, etc.) before inserting the distal catheter piece 104 or its catheter tube 114 into the patient's vascular lumen.

[0083] As best seen in FIG. 12 , the side arm 168 of the catheter advancement hub 158 includes an integral side arm connector (e.g., a female Luer connector) and a side arm lumen 174 fluidly coupled to one or more manifold lumens 172. The combination of the side arm lumen 174 and the one or more manifold lumens 172 is thus configured to allow simultaneous priming of each of the one or more catheter tube lumens prior to insertion of the distal catheter piece 104 or catheter tubing 114 into a patient's vascular lumen. The needle shaft of the introducer needle 164 extends through the manifold 166 or at least one manifold lumen thereof and the distal end of the distal catheter piece 104 in the ready-to-deploy state of the introducer assembly 154. Thus, simultaneous priming of each of the one or more catheter tube lumens occurs around the introducer needle 164 with at least one manifold lumen when simultaneous priming is performed.

[0084] The catheter advancement push tab 170 is configured to distally advance the catheter advancement hub 158, and thus the distal catheter piece 104 coupled to the catheter advancement hub 158 via the distal catheter hub piece 112, by depressing the catheter advancement push tab 170 with one finger (e.g., the index finger) of one hand while holding the syringe 162 around its distal portion between the thumb and one or more fingers (e.g., the middle and ring fingers) of the same hand. Again, the catheter advancement push tab 170 extends proximally from the side arm 168 of the catheter advancement hub 158. Indeed, in the ready-to-deploy state of the introducer assembly 154, the catheter advancement push tab 170 extends proximally over a portion of the plunger retraction push tab 212, described below, which in turn extends proximally over a distal portion of the syringe 162. The above-described configuration of the plunger withdrawal push tab 212 and the catheter advancement push tab 170 allows ready access to the push tabs 170, 212 for actuating the introducer assembly 154 with one finger while holding the syringe 162 about its distal portion between the finger and one or more fingers of the same hand.

[0085] 6 and 7 show different views of the introducer assembly 154 in an operational state where the introducer housing 160 is split along its length, according to some embodiments.

[0086] As shown, the introducer housing 160 comprises two pieces, including a slidable piece 176 and a stationary piece 178, configured to split open along the length of the introducer housing 160. Indeed, in the ready-to-deploy state of the introducer assembly 154 illustrated in Figures 1-4, the introducer housing 160 is closed over the syringe tip, manifold 166, and proximal portion of the distal catheter piece 104 to which the stationary piece 178 is coupled, whereas in the actuated state of the introducer assembly 154 illustrated in Figures 6 and 7, the introducer housing 160 is split open. The introducer housing 160 is configured to provide column strength to the catheter tube 114 of the distal catheter piece 104 for venipuncture by the introducer needle 164 (e.g., the needle path establishment step described below) when the introducer assembly 154 is in the ready-to-deploy state. Additionally, at least the proximal portion of the catheter tube 114 rests within the introducer housing 160 when the introducer assembly 154 is ready to be deployed, thereby providing a no-touch mechanism for avoiding touching and contaminating the catheter tube 114 during venipuncture.

[0087] FIG. 9 shows a lock 180 on the distal portion of the introducer housing 160, according to some embodiments. As shown, lock 180 includes a hook 182 on slidable piece 176 of introducer housing 160 and a latch 184 on stationary piece 178 of introducer housing 160. Hook 182 and latch 184 may each be integral (e.g., molded) with their respective pieces of the introducer housing. That is, hook 182 may be integral with slidable piece 176 and latch 184 may be integral with stationary piece 178. Hook 182 and latch 184 are configured to lock slidable piece 176 and stationary piece 178 together in the ready-to-deploy state of introducer assembly 154.

[0088] Stationary piece 178 of introducer housing 160 also includes a groove 186 that may be molded into stationary piece 178. Groove 186, in turn, includes a latch 184 at a proximal portion of groove 186 and a ramp 188 at a distal portion of groove 186. Like latch 184, ramp 188 may be integral with (e.g., molded into) stationary piece 178. The combination of ramp 188 of introducer housing 160 and hook 182 of slidable piece 176 is configured to advance slidable piece 176 distally relative to stationary piece 178 and push slidable piece 176 away from stationary piece 178. Indeed, as the slidable piece 176 is advanced distally relative to the stationary piece 178, the distal surface of the hook 182 engages the proximal surface of the ramp 188, which lifts the hook 182 out of the groove 186 and pushes the slidable piece 176 away from the stationary piece 178, thereby splitting the introducer housing 160 longitudinally open.

[0089] FIG. 8 shows a sliding hinge 190 in the proximal portion of the introducer housing 160, according to some embodiments. As shown, the sliding hinge 190 includes a capture tab 192 on the slidable piece 176 of the introducer housing 160 and a track 194 on the stationary piece 178 of the introducer housing 160. Like the hook 182, the capture tab 192 can be integral with (e.g., molded into) the slidable piece 176. Like the groove 186, the track 194 can be molded into the stationary piece 178. The capture tab 192 is captured but slidably disposed within the track 194, allowing the slidable piece 176 to be advanced distally relative to the stationary piece 178 at a proximal portion of the introducer housing 160 without separating the slidable piece 176 from the stationary piece 178. However, advancing the slidable piece 176 distally relative to the stationary piece 178 separates the slidable piece 176 from the stationary piece 178 at a distal portion of the introducer housing 160, as described above. In fact, the proximal portion of the capture tab 192 located inside the outer surface of the introducer housing 160 is truncated or rounded, which makes it easier to smoothly separate the slidable piece 176 from the stationary piece 178 at the distal portion of the introducer housing 160 while advancing the slidable piece 176 distally relative to the stationary piece 178.

[0090] As further shown in FIG. 8, the proximal portion of the introducer housing 160 includes an introducer housing tab 196 and a longitudinal notch 198 that narrows as the introducer housing 160 tapers from the proximal portion toward the distal portion of the introducer housing 160.

[0091] The introducer housing tab 196 is configured to provide a location on the introducer housing 160 against which the side arm 168 of the catheter advancement hub 158 can press when the catheter advancement hub 158 is advanced distally within the introducer housing 160. In fact, the above-described configuration of the introducer housing tab 196 and the side arm 168 of the catheter advancement hub 158 enables the slidable piece 176 of the introducer housing 160 to be advanced distally relative to the stationary piece 178 of the introducer housing 160 by pressing on the catheter advancement push tab 170 as described above.

[0092] The longitudinal notch 198 is configured to provide a narrowing path for the side arm 168 of the catheter advancement hub 158 to follow as the catheter advancement hub 158 is advanced distally, which narrowing path is then configured to separate the slidable piece 176 from the stationary piece 178 relative to the side arm as the side arm 168 of the catheter advancement hub 158 is advanced distally through the narrowing path. For example, when the catheter advancement hub 158 advances the slidable piece 176 distally relative to the stationary piece 178 and the hook 182 of the slidable piece 176 is lifted from the groove 186 by the ramp 188 of the stationary piece 178, the introducer housing tab 196 pivots on the side arm 168, allowing the side arm 168 to enter the narrowing path provided by the longitudinal notch 198. Because the longitudinal notch 198 narrows from the proximal to the distal portion of the introducer housing 160, the side arms 168 of the catheter advancement hub 158 continue to lift the slidable piece 176 away from the stationary piece 178 until the side arms 168 exit the longitudinal notch 198. Once the introducer housing 160 is sufficiently split open and the distal catheter piece 104 of the RICC 100 has been advanced distally from its initial position in the ready-to-deploy state of the introducer assembly 154, the distal catheter hub piece 112 can be used to manually disconnect the distal catheter hub piece 112 from the manifold 166 of the catheter advancement hub 158 and remove the distal catheter piece 104 from the introducer housing 160.

[0093] In particular, introducer housing 160 is configured to maintain slidable piece 176 and stationary piece 178 locked together by their locks 180 after venipuncture until catheter advancement hub 158 is advanced as described above.

[0094] FIG. 10 illustrates a syringe 162 of the introducer 156 according to some embodiments. Syringe 162 includes a plunger 200 disposed within a barrel 202 having a distal portion terminating in a syringe tip, to which an introducer needle 164 is fluidly coupled and fixedly attached. As best seen in FIG. 12 , the syringe tip includes a syringe tip connector (e.g., a male Luer connector) that is configured to be fluidly coupled to a catheter advancement hub 158 through its proximal coupler, at least in the ready-to-deploy state of introducer assembly 154. Optionally, syringe tip can include a side arm 206 coupled to hub 204 and a fluid pressure indicator 228, described below. Additionally, syringe 162 includes a syringe housing 208 disposed about barrel 202. As described below, the syringe housing 208 is configured so that one finger (e.g., the index finger) of one hand can be secured to actuate the introducer assembly 154, while the syringe 162 can be held around the distal portion of the barrel 202 between the thumb and one or more fingers (e.g., the middle or ring finger) of the same hand. Holding and handling the introducer assembly 154 in the foregoing manner provides greater control of the introducer assembly 154 and its distal catheter piece 104, particularly during venipuncture.

[0095] The syringe housing 208 extends from a distal end at a distal portion of the syringe housing 208 around the distal portion of the barrel 202 of the syringe 162 to a proximal end at a proximal portion of the syringe housing 208 that is generally coextensive with the proximal portion of the barrel 202. The syringe housing 208 can include a gripping portion 210 (e.g., a pattern of ridges, perforations, etc.) at its distal portion that is configured to facilitate grasping the syringe 162, and thus the introducer 156 or introducer assembly 154 around the distal portion of the barrel 202, between the thumb and one or more fingers of the same hand, as described above. The distal location of the gripping portion 210 about the distal portion of the barrel 202 facilitates holding and handling the introducer assembly 154 in a position that provides better control of the distal portion of the introducer assembly 154, e.g., the first portion 132 of the catheter tube 114 of the distal catheter piece 104. Indeed, by holding and handling the introducer assembly 154 in the aforementioned position, small inadvertent yaw- or pitch-type movements therein remain relatively small in the first portion 132 of the catheter tube 114, as compared to the same types of movements when the introducer assembly 154 is held in a more proximal position.

[0096] The syringe housing 208 and plunger 200 are configured to operate together as a single unit so long as the syringe 162 is actuated (e.g., when the plunger 200 is withdrawn for the blood aspiration step described below). The syringe housing 208 and plunger 200 or its end piece 220 may be molded together into a single piece, such that the proximal portion of the syringe housing 208 is integral with the proximal portion of the plunger 200. Alternatively, the syringe housing 208 and plunger 200 or its end piece 220 may be molded separately and then joined together into a combined piece, such that the proximal portion of the syringe housing 208 is joined to the proximal portion of the plunger 200 or its end piece 220. For example, the inner wall of the proximal end of the syringe housing 208 may be glued or welded to a plunger flange at the distal end of the plunger 200 or its end piece 220. Whether the syringe housing 208 and plunger 200 are integral with or coupled to one another, sliding the syringe housing 208 proximally relative to the barrel 202 withdraws the plunger 200 from the barrel 202, thereby actuating the syringe 162 as a single unit.

[0097] The syringe 162 may further include a plunger pull-out push tab 212 extending proximally onto the barrel 202 from a distal portion of the barrel 202 (e.g., the syringe tip), the plunger pull-out push tab 212 being coupled to the distal portion of the barrel 202, for example, by a ring-type connector (see FIG. 12 ). The plunger pull-out push tab 212 is configured to be used when actuating the syringe 162 as described above. In practice, the plunger pull-out push tab 212 is configured to be pressed with one finger (e.g., the index finger) of one hand while holding the syringe housing 208 around the distal portion of the barrel 202 between the thumb and one or more fingers (e.g., the middle finger and ring finger) of the same hand, thereby sliding the syringe housing 208 proximally relative to the barrel 202 and withdrawing the plunger 200 from the barrel 202.

[0098] FIG. 11 shows a longitudinal cross-sectional view of a portion of a syringe 162 according to some embodiments. As shown, syringe 162 also includes a syringe portion of access guidewire lumen 214 formed from the fluidly connected portions of the plunger lumen of plunger 200, the syringe tip lumen of the syringe tip, and any space within barrel 202 formed by partially withdrawing plunger 200 from barrel 202, such as during an operating state of introducer assembly 154 (e.g., during the blood aspiration step of the method described below). Another portion of access guidewire lumen 214 is the introducer needle portion of access guidewire lumen 214, i.e., the needle lumen of introducer needle 164.

[0099] Plunger 200 includes a sealing mechanism 216 at a distal portion of plunger 200 for sealing access guidewire lumen 214 distal to sealing mechanism 216. Sealing mechanism 216 is configured to seal access guidewire lumen 214 to maintain a vacuum for aspirating blood as plunger 200 is withdrawn from barrel 202. Sealing mechanism 216 is also configured to seal access guidewire lumen 214 to prevent blood from flowing (e.g., backflowing) through longitudinal slots in barrel 202 and plunger 200, described below, during venipuncture or while withdrawing access guidewire 222, described below, from the patient's vascular lumen, thereby minimizing or preventing the possibility of contaminating the surgical field or any clinician within the surgical field.

[0100] As shown in FIG. 11 , the sealing mechanism 216 can be a cartridge disposed within a cavity in the distal portion of the body 218 of the plunger 200 and retained therein by the end piece 220 of the plunger 200. The cartridge is coaxially aligned with the access guidewire lumen 214 or its plunger lumen portion such that the unwrapped bare wire portion of the access guidewire 222 passes through proximal and distal through-holes in the cartridge, which have inner diameters corresponding to the outer diameter of the bare wire portion of the access guidewire 222. Optionally, the sealing mechanism 216 comprises one or more gaskets, such as “O” rings, within the cartridge or in place of a cartridge. Instead of a cartridge, for example, one or more “O” rings can be axially compressed within the cavity by the end piece 220 of the plunger 200, which in turn radially compresses the “O” rings around the access guidewire 222, thereby sealing the access guidewire lumen 214.

[0101] FIG. 5 shows a side view of the introducer assembly 154 in another operating state with an access guidewire 222 advanced through the distal end of the distal catheter piece 104, according to some embodiments.

[0102] The access guidewire 222 is positioned to be captured within the introducer 156 so that at least a portion of the access guidewire 222 is always located in a portion of the access guidewire lumen 214 (e.g., a plunger lumen portion, a needle lumen portion, etc.) regardless of the state of the introducer assembly 154. For example, when the access guidewire 222 is withdrawn to its proximal limit (e.g., defined by the proximal end of a longitudinal slot described below), the proximal portion of the access guidewire 222 is located in at least the proximal portion of the plunger lumen, while the distal portion of the access guidewire 222 is located in the distal portion of the needle lumen. When introducer assembly 154 is in at least its ready-to-deploy state, a proximal portion of access guidewire 222 is disposed in a middle portion of the plunger lumen, and a distal portion of access guidewire 222 remains disposed in a distal portion of the needle lumen, but the distal end of access guidewire 222 has been advanced within the needle lumen such that the distal end of access guidewire 222 is located just short of needle tip 140. Also, in some of the operational states of introducer assembly 154 (e.g., during the access guidewire advancement step of the methods described below), when access guidewire 222 is advanced to its distal limit (e.g., defined by the distal end of a longitudinal slot, described below), the proximal portion of access guidewire 222 is disposed in the distal portion of the plunger lumen. Meanwhile, the distal end of the access guidewire 222 extends through or beyond the distal end of the distal catheter piece 104 as a result of its length, which is sufficient to extend the access guidewire 222 into the patient's vascular lumen when establishing access to the patient's vascular lumen after the needle path establishment step described below.

[0103] Syringe 162 also includes a slider 224 (e.g., a tabbed slider) that extends distally from below syringe housing 208 onto barrel 202. Slider 224 is configured to allow actuation of access guidewire 222 with one finger (e.g., the index finger) of one hand (e.g., with a scroll-wheel-type motion of the finger as used on a computer mouse) while holding a distal portion of syringe housing 208 between the thumb and one or more fingers (e.g., the middle and ring fingers) of the same hand. Slider 224 includes an extension 226 that extends through longitudinal slots (not shown) in each of barrel 202 and plunger 200 and into access guidewire lumen 214 proximal to sealing mechanism 216, where extension 226 is coupled to access guidewire 222. The proximal and distal ends of the longitudinal slot provide stops for the extension 226 and therefore a limited path within which the extension 226 can move proximally or distally, thereby providing proximal and distal limits for retracting or advancing the access guidewire 222 into or out of the introducer 156, respectively.

[0104] FIG. 10 shows the syringe 162 of the introducer 156 with a fluid pressure indicator 228, according to some embodiments. As shown, fluid pressure indicator 228, if present, extends from side arm 206 of hub 204. Fluid pressure indicator 228 has a closed end and an open end that is fluidly coupled to the needle lumen of introducer needle 164 through a side arm lumen of the side arm. Fluid pressure indicator 228 is configured as a built-in accidental arterial indicator, where blood under sufficient pressure (e.g., arterial blood) can enter fluid pressure indicator 228 and compress the air column within fluid pressure indicator 228. However, in some cases, backflow of blood from a venipuncture can also be observed at fluid pressure indicator 228. However, backflow of blood from a venipuncture is typically observed at hub 204, a side arm of hub 204, or syringe 162.

[0105] method Methods for the RICC system provided herein include at least a method of using the RICC system, which can include the steps of obtaining the RICC system, establishing a needle path, first advancing the RICC, disrupting the introducer housing, and removing the introducer.

[0106] The RICC system obtaining step includes obtaining a RICC system. As described above, the RICC system includes the proximal catheter piece 102 of the RICC 100 and the introducer assembly 154. The introducer assembly 154, in turn, includes the distal catheter piece 104 of the RICC 100 partially disposed within the introducer housing 160 of the introducer 156.

[0107] The method may further include a needle tip assurance step prior to the needle path establishment step. Again, the introducer needle 164 has a needle shaft that extends through the distal end of the distal catheter piece 104 in the ready-to-deploy state of the introducer assembly 154. The needle tip assurance step includes ensuring that the needle tip 140 extends from the distal end of the distal catheter piece 104 prior to the needle path establishment step.

[0108] The method may further include a priming step prior to the needle path establishment step, which includes priming the distal catheter piece 104 with a common syringe via a side arm 168 of the catheter advancement hub 158 prior to the first RICC advancement step. As described above, the side arm 168 has a side arm lumen 174 fluidly coupled to one or more manifold lumens 172 for simultaneously priming each of the one or more lumens of the distal catheter piece 104.

[0109] The needle path establishment step involves establishing a needle path from the patient's skin area to the vascular lumen with the introducer needle 164 of the introducer. The needle path establishment step is performed while holding the distal portion of the syringe 162 of the introducer 156 between the thumb and one or more fingers (e.g., the ring finger and middle finger) of one hand, while at least one finger (e.g., the index finger) of the same hand is kept ready for use to actuate the introducer assembly 154.

[0110] The needle path establishment step may further include ensuring that blood flows back into the hub 204, a side arm of the hub 204, or a fluid pressure indicator 228 extending from the side arm of the hub 204 once the needle path is established.

[0111] The method further includes a blood aspirating step. The blood aspirating step involves aspirating blood with the syringe 162 to confirm that the needle tip 140 of the introducer needle 164 is positioned within the blood vessel lumen before the introducer removal step. The blood aspirating step includes holding the distal portion of the syringe 162 between the thumb and one or more fingers of one hand by the syringe housing 208 located on the barrel 202 of the syringe 162, while pressing the plunger retraction push tab 212 with one finger of the same hand. The plunger retraction push tab 212 extends from the distal portion of the syringe 162 above the barrel 202 so that the syringe housing 208 slides proximally relative to the barrel 202 and the syringe housing connecting plunger 200 is retracted from the barrel 202 by pressing the plunger retraction tab while holding the distal portion of the syringe 162 by the syringe housing 208.

[0112] The method may further include an access guidewire advancing step, which includes advancing an access guidewire 222 disposed within the access guidewire lumen 214 and into the blood vessel lumen beyond the distal end of the distal catheter piece 104. As described above, the access guidewire lumen 214 is formed from at least the plunger lumen of the syringe 162 and the needle lumen of the introducer needle 164, with the distal end of the access guidewire 222 located within the needle lumen just short of the needle tip 140, which facilitates a successful initial puncture by making the access guidewire 222 immediately available before the blood-lumen vessel can be lost due to a minor inadvertent movement. Additionally, slider 224 is coupled to access guidewire 222 such that access guidewire 222 can be advanced into the vascular lumen by advancing slider 224 distally with one finger of one hand while holding a distal portion of syringe housing 208 between the thumb and one or more fingers of the same hand. The access guidewire advancement step is performed before the first RICC advancement step.

[0113] The first RICC advancement step involves advancing a distal portion of the first portion 132 of the catheter tube 114 of the distal catheter piece 104 over the needle shaft into the vessel lumen. As described above, the catheter tube 114 comprises the first portion 132 formed from a first material having a first durometer and the second portion 134 formed from a second material having a second durometer that is lower than the first durometer. The first portion 132 of the catheter tube 114 is configured with column strength that enables the catheter tube 114 to be advanced over the access guidewire 222 or steering guidewire into the vessel lumen after the steering guidewire advancement step described below.

[0114] The first RICC advancement step involves holding the distal portion of the syringe 162 between the thumb and one or more fingers of one hand while depressing the catheter advancement push tab 170 with one finger of the same hand to advance the distal portion of the first section 132 of the catheter tubing 114 over the needle shaft and into the vessel lumen. Again, the catheter advancement push tab 170 is part of the catheter advancement hub 158 that is coupled to the proximal portion of the distal catheter piece 104 in the ready-to-deploy state of the introducer assembly 154.

[0115] The introducer housing splitting step involves releasing a lock 180 on a distal portion of the introducer housing 160 and then splitting the introducer housing 160 along its length. Releasing the lock 180 involves sliding the slidable piece 176 distally relative to the stationary piece 178, thereby separating the hook 182 on the slidable piece 176 of the introducer housing 160 and the latch 184 on the stationary piece 178 of the introducer housing 160. While the lock 180 can be manually released by sliding the slidable piece 176 relative to the stationary piece 178, the introducer assembly 154 is configured so that the slidable piece 176 is slid relative to the stationary piece 178 by pressing the catheter advancement push tab 170 of the catheter advancement hub 158 against the introducer housing tab 196. By holding the introducer assembly 154 around the distal portion of the syringe 162 while releasing the lock 180 in accordance with the latter, problems associated with excessive handling of the introducer assembly 154, such as dropping the introducer assembly 154 by fumbling, or contamination of any exposed portion of the catheter tube 114 of the distal catheter piece 104 at the introducer assembly 154 are minimized.

[0116] With respect to splitting the introducer housing 160, the stationary piece 178 of the introducer housing 160 includes a groove 186 with a latch 184 in a proximal portion of the groove 186 and a ramp 188 in a distal portion of the groove 186, as described above. When the slidable piece 176 is slid distally relative to the stationary piece 178, the distal surface of the hook 182 engages the proximal surface of the ramp 188, splitting the introducer housing 160 along its length as the hook 182 is lifted out of the groove 186. While the introducer housing 160 can be manually split by sliding the slidable piece 176 relative to the stationary piece 178, the introducer assembly 154 is configured such that the side arm 168 of the catheter advancement hub 158 is advanced along a path provided by a longitudinal notch 198 in the introducer housing 160 by depressing the catheter advancement push tab 170 of the catheter advancement hub 158. Because the longitudinal notch 198 narrows from the proximal portion to the distal portion of the introducer housing 160, the side arm 168 of the catheter advancement hub 158 continues to lift and separate the slidable piece 176 from the stationary piece 178 until the side arm 168 exits the longitudinal notch 198.

[0117] The introducer removal step involves detaching the distal catheter piece 104 from the introducer housing 160 and withdrawing the introducer 156 from the distal catheter piece 104, leaving the distal portion of the first section 132 of the catheter tube 114 in place within the blood vessel lumen. Withdrawing the introducer 156 from the distal catheter piece 104 involves withdrawing both the needle shaft and the access guidewire 222 from the distal catheter piece 104.

[0118] The method further includes a catheter hub clipping step, which includes clipping together the proximal catheter hub piece 106 of the proximal catheter piece 102 and the proximal catheter hub piece 106 of the distal catheter piece 104. The catheter hub clipping step connects one or more extension leg lumens of one or more extension legs 110 coupled to the proximal catheter hub piece 106 to one or more catheter tube lumens of the catheter tube 114, respectively, thereby forming the RICC 100 and its lumens through the two-piece catheter hub 108.

[0119] The method may further include advancing a steering guidewire through a primary lumen 142 of the RICC 100, which has a primary lumen opening 144 at its distal end, and into a blood vessel lumen to a target location (e.g., the SVC) within the patient's vasculature.

[0120] The method may further include a second RICC advancement step and a steering guidewire removal step. The second RICC advancement step involves further advancing the remainder of the distal portion of the first portion 132 of the catheter tube 114 into the vessel lumen, using the steering guidewire as a guide, to the proximal portion of the second portion 134 of the catheter tube 114. The steering guidewire provides the second portion 134 of the catheter tube 114 with column strength for the second RICC advancement step. The second RICC advancement step is stopped in its advancement when the distal end of the distal catheter piece 104 reaches the target location (e.g., the SVC). The steering guidewire removal step involves withdrawing the steering guidewire, leaving the catheter tube 114 in place within the patient.

[0121] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A rapid insertion central catheter ("RICC") system, comprising: A distal catheter piece of an RICC, the distal catheter piece comprising: a distal catheter hub piece of a two-piece catheter hub; a distal catheter piece including a catheter tube having one or more catheter tube lumens, the catheter tube being coupled to the distal catheter hub piece by a proximal portion of the catheter tube; an introducer configured to couple with the distal catheter piece to form an introducer assembly having a ready-to-place state, the introducer assembly configured to be actuated by one finger of one hand when the introducer is held between the thumb and one or more fingers of the other hand, the introducer comprising: a catheter advancement hub comprising a manifold and a side arm, the catheter advancement hub being coupled to a proximal portion of the distal catheter hub piece in a ready-to-deploy state of the introducer assembly; an introducer needle having a needle shaft extending through the manifold and the distal end of the distal catheter piece in a ready-to-deploy state of the introducer assembly; a syringe having a barrel having a distal portion terminating in a syringe tip, the syringe being fluidly coupled to the introducer needle; an introducer housing positioned over the syringe tip, the manifold, and a proximal portion of the distal catheter piece in a ready-to-deploy state of the introducer assembly, the introducer housing comprising: providing column strength to the catheter tube during venipuncture of a patient with the introducer needle; an introducer housing configured to split longitudinally to allow removal of the distal catheter piece from the introducer housing after the venipuncture.

2. 2. The RICC system of claim 1, wherein the introducer housing comprises a lock at a distal portion of the introducer housing, the lock including a hook on a slidable piece of the introducer housing and a latch on a stationary piece of the introducer housing, the hook and latch configured to lock the slidable piece and the stationary piece together in a ready-to-deploy state of the introducer assembly.

3. 3. The RICC system of claim 2, wherein the stationary piece of the introducer housing comprises a groove comprising the latch at a proximal portion of the groove and a ramp at a distal portion of the groove, the combination of the hook and the ramp being configured to advance the slidable piece distally relative to the stationary piece and push the slidable piece of the introducer housing away from the stationary piece when a distal surface of the hook engages a proximal surface of the ramp.

4. 4. The RICC system of claim 2 or 3, wherein the introducer housing comprises a sliding hinge at a proximal portion of the introducer housing, the sliding hinge including a capture tab on the slidable piece of the introducer housing and a track on the stationary piece of the introducer housing, the capture tab being captured but slidably disposed within the track to allow the slidable piece to advance distally relative to the stationary piece at the proximal portion of the introducer housing without separating the slidable piece from the stationary piece.

5. 5. The RICC system of claim 4, wherein a proximal portion of the capture tab located inside the outer surface of the introducer housing is rounded to facilitate splitting the slidable piece of the introducer housing from the stationary piece of the introducer housing at a distal portion of the introducer housing.

6. 6. The RICC system of claim 4, wherein the proximal portion of the introducer housing comprises a longitudinal notch configured to provide a pathway for the side arm of the catheter advancement hub when the catheter advancement hub is advanced distally within the introducer housing.

7. 7. The RICC system according to claim 1, wherein the manifold comprises one or more manifold lumens equal in number to the one or more catheter tube lumens, the one or more manifold lumens being fluidly connected to the one or more catheter tube lumens when the introducer assembly is in a ready-to-deploy state.

8. 8. The RICC system of claim 7, wherein the side arm of the catheter advancement hub comprises a side arm lumen fluidly coupled to the one or more manifold lumens for simultaneously priming each lumen of the one or more catheter tube lumens prior to inserting the catheter tube into the patient's vascular lumen.

9. 9. The RICC system of claim 1, wherein the catheter advancement hub further comprises a catheter advancement push-tab extending from the side arm, the catheter advancement push-tab configured to advance the catheter advancement hub distally with one finger of the same hand while holding the syringe between the thumb and one or more fingers of the same hand around a distal portion of the barrel.

10. The method further comprises a proximal catheter piece of the RICC, the proximal catheter piece comprising: a proximal catheter hub piece of the two-piece catheter hub; and one or more extension legs each including one or more extension leg lumens, each extension leg of the one or more extension legs being coupled to the proximal catheter hub piece by a distal portion of the extension leg, the RICC having a connection in which the proximal catheter hub piece is connected to the distal catheter hub piece such that the one or more extension leg lumens are fluidly coupled to the one or more catheter tube lumens, respectively, through the two-piece catheter hub.

11. The RICC system of claim 10 , wherein the RICC comprises a set of three lumens in the connected state of the RICC, the set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen.

12. 12. The RICC system of claim 11, wherein the primary lumen has a primary lumen opening at a distal end of the catheter tube, the secondary lumen has a secondary lumen opening on a side of the catheter tube proximal to the primary lumen opening, and the tertiary lumen has a tertiary lumen opening on a side of the catheter tube proximal to the secondary lumen opening.

13. The catheter tube a first portion formed from a first material having a first durometer; 13. The RICC system of claim 1, further comprising a second portion formed from a second material having a second durometer that is lower than the first durometer, whereby the catheter tube comprises a combination of column strength for insertion of the catheter tube into the patient and compliance for advancement of the catheter tube through the patient's vasculature.

14. The RICC system of any one of claims 1 to 13, wherein the introducer further comprises a syringe housing having a distal portion and a proximal portion around the barrel of the syringe, the proximal portion of the syringe housing being integral with or coupled to a proximal portion of a plunger disposed within the barrel, such that sliding the syringe housing proximally relative to the barrel causes the plunger to be withdrawn from the barrel.

15. 15. The RICC system of claim 14, wherein the syringe further comprises a plunger withdrawal push-tab extending proximally over the barrel from a distal portion of the barrel, the plunger withdrawal push-tab coupled to the distal portion of the barrel, the plunger withdrawal push-tab configured to be pressed with one finger of the hand while holding the syringe between a thumb and one or more fingers of the hand around the distal portion of the barrel to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

16. 16. The RICC system of claim 14 or 15, wherein the introducer further comprises an access guidewire disposed within an access guidewire lumen formed from at least a plunger lumen of the plunger and a needle lumen of the introducer needle, the access guidewire having a length sufficient to allow the access guidewire to extend through the distal end of the distal catheter piece.

17. 17. The RICC system of claim 16, wherein the introducer further comprises a slider extending distally from the syringe housing over the barrel, the slider configured to actuate the access guidewire with one finger of the hand while holding the syringe between the thumb and one or more fingers of the hand around a distal portion of the barrel, the slider comprising an extension that extends through longitudinal slots in each of the barrel and the plunger and into the access guidewire lumen, wherein the extension is coupled to the access guidewire within the access guidewire lumen.

18. 1. An introducer for a rapid insertion central venous catheter ("RICC"), said introducer comprising: a catheter advancement hub comprising a manifold and a side arm, the catheter advancement hub configured to couple to a distal catheter piece of the RICC in an introducer assembly; an introducer needle having a needle shaft configured to extend through the manifold and the distal end of the distal catheter piece in a ready-to-deploy state of the introducer assembly; a syringe fluidly coupled to the introducer needle, the syringe comprising a barrel having a distal portion terminating in a syringe tip, the syringe configured to be held between the thumb and one or more fingers of one hand around the distal portion of the barrel while reserving one finger to actuate the introducer; an introducer housing positioned over the syringe tip, the manifold, and a proximal portion of the distal catheter piece in a ready-to-deploy state of the introducer assembly, the introducer housing comprising: providing column strength to a catheter tube of the distal catheter piece during venipuncture of a patient with the introducer needle; an introducer housing configured to split longitudinally to allow removal of the distal catheter piece from the introducer housing after the venipuncture.

19. 20. The introducer of claim 18, wherein the introducer housing includes a lock at a distal portion of the introducer housing, the lock including a hook on a slidable piece of the introducer housing and a latch on a stationary piece of the introducer housing, the hook and latch configured to lock the slidable piece and the stationary piece together.

20. 20. The introducer of claim 19, wherein the stationary piece of the introducer housing comprises a groove comprising the latch at a proximal portion of the groove and a ramp at a distal portion of the groove, the combination of the hook and the ramp being configured to advance the slidable piece distally relative to the stationary piece and push the slidable piece of the introducer housing away from the stationary piece when the distal surface of the hook engages the proximal surface of the ramp.

21. 21. The introducer of claim 19 or 20, wherein the introducer housing comprises a sliding hinge at a proximal portion of the introducer housing, the sliding hinge including a capture tab on the slidable piece of the introducer housing and a track on the stationary piece of the introducer housing, the capture tab being captured but slidably disposed within the track to allow the slidable piece to advance distally relative to the stationary piece at the proximal portion of the introducer housing without separating the slidable piece from the stationary piece.

22. 22. The introducer of claim 21, wherein a proximal portion of the capture tab located inside the outer surface of the introducer housing is rounded to facilitate splitting the slidable piece of the introducer housing from the stationary piece of the introducer housing at a distal portion of the introducer housing.

23. 23. The introducer of claim 21 or 22, wherein a proximal portion of the introducer housing comprises a longitudinal notch configured to provide a pathway for the side arm of the catheter advancement hub when the catheter advancement hub is advanced distally within the introducer housing.

24. 24. The introducer of any one of claims 18 to 23, wherein the side arm of the catheter advancement hub comprises a side arm lumen fluidly coupled to one or more manifold lumens for simultaneously priming each lumen of one or more catheter lumens of the distal catheter piece of the RICC when the introducer assembly is ready to be deployed.

25. 25. The introducer of any one of claims 18-24, wherein the catheter advancement hub further comprises a catheter advancement push-tab extending from the side arm, the catheter advancement push-tab configured to advance the catheter advancement hub distally with one finger of the same hand while holding the syringe between the thumb and one or more fingers of the same hand around the distal portion of the barrel.

26. The introducer of any one of claims 18 to 25, further comprising a syringe housing having a distal portion and a proximal portion disposed around the barrel of the syringe, the proximal portion of the syringe housing being integral with or connected to a proximal portion of a plunger disposed within the barrel, such that sliding the syringe housing in a proximal direction relative to the barrel causes the plunger to be withdrawn from the barrel.

27. 27. The introducer of claim 26, wherein the syringe further comprises a plunger withdrawal push-tab extending proximally over the barrel from a distal portion of the barrel, the plunger withdrawal push-tab coupled to the distal portion of the barrel, the plunger withdrawal push-tab configured to be pressed with one finger of the hand while holding the syringe between a thumb and one or more fingers of the hand around the distal portion of the barrel to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

28. 28. The introducer of claim 26 or 27, further comprising an access guidewire disposed within an access guidewire lumen formed from at least a plunger lumen of the plunger and a needle lumen of the introducer needle, the access guidewire having a length sufficient to extend through the distal end of the distal catheter piece when the introducer assembly is in a ready-to-deploy state.

29. 29. The introducer of claim 28, further comprising a slider extending distally from the syringe housing over the barrel, the slider configured to actuate the access guidewire with one finger of the hand while holding the syringe between the thumb and one or more fingers of the hand around the distal portion of the barrel, the slider comprising an extension extending through longitudinal slots in each of the barrel and the plunger and into the access guidewire lumen, wherein the extension is coupled to the access guidewire within the access guidewire lumen.

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