Two-piece rapid-insertion central catheter, introducer therefor, and method

Abstract

Disclosed herein are two-piece rapid insertable central catheters (RICCs), introducers therefor, and methods thereof. For example, an introducer and a distal catheter component of a RICC can be combined in an introducer assembly configured to be actuated with a single finger of the same hand while the introducer is held between the thumb and another finger or fingers of the hand. A catheter advancement hub of the introducer includes a manifold coupled to a proximal portion of a distal catheter hub component of the distal catheter component. A guide needle of a syringe of the introducer has a needle shaft extending through the manifold and a distal end of the distal catheter component. An introducer housing is positioned over a syringe tip, the manifold, and the proximal portion of the distal catheter component. The introducer housing of the introducer is configured to provide column strength to a catheter tube of the distal catheter component during venipuncture.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 059,798, filed July 31, 2020, which is incorporated by reference in its entirety into the present application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a two-piece rapid insertable central catheter, an introducer therefor, and methods thereof. BACKGROUND

[0004] Existing catheters are manufactured as whole ready-to-use catheters. Such catheters can have a length ranging from 30 cm to 40 cm measured from the proximal end to the distal end of any such catheter. Rapid insertable central catheters (“RICCs”) currently under development are introduced over an introducer needle. Introducing a RICC over a 30-40 cm introducer needle can be cumbersome for the clinician. In addition, it can be difficult to identify in a timely manner whether blood reflux has occurred, and to access the intravascular lumen established during any given RICC introduction with a 30-40 cm introducer needle. As such, RICCs typically include a distal guide hole designed for introducing the RICC over a shorter introducer needle. However, it would be beneficial to eliminate the guide hole as these guide holes actually become artifacts after the RICC is introduced.

[0005] Disclosed herein are two-piece RICCs, introducers therefor, and methods thereof that address the above-mentioned problems. SUMMARY

[0006] Disclosed herein is a RICC system, in some embodiments, comprising a distal catheter component of a RICC and an introducer configured to be combined in an introducer assembly having a ready-to-deploy state. The introducer assembly is configured to be actuated with a single finger of a hand when the introducer is held between the thumb and one or more fingers of the hand. The distal catheter component comprises a distal catheter hub component of a two-piece catheter hub and a catheter tube coupled to the distal catheter hub component by a proximal portion of the catheter tube. The catheter tube comprises one or more catheter tube lumens. The introducer comprises a catheter advancement hub, an introducer needle, a syringe, and an introducer housing. The catheter advancement hub comprises a manifold and a side arm coupled to a proximal portion of the distal catheter hub component in the ready-to-deploy state of the introducer assembly. The introducer needle has a needle shaft that extends through the manifold and a distal end of the distal catheter component in the ready-to-deploy state of the introducer assembly. The syringe comprises a barrel having a distal portion terminating in a syringe tip. The syringe is fluidly coupled to the introducer needle. The introducer housing is positioned over the syringe tip, the manifold, and the proximal portion of the distal catheter component in the ready-to-deploy state of the introducer assembly. The introducer housing is configured to provide column strength to the catheter tube during intravenous puncture using the introducer needle. The introducer housing is further configured to longitudinally split apart, allowing the distal catheter component to be removed from the introducer housing after intravenous puncture.

[0007] In some embodiments, the introducer housing comprises a lock in a distal portion of the introducer housing. The lock comprises a hook in a slidable component of the introducer housing and a latch in a fixed component of the introducer housing. The hook and the latch are configured to lock the slidable component and the fixed component together in the ready-to-deploy state of the introducer assembly.

[0008] In some embodiments, the fixed component of the introducer housing comprises a channel. The channel comprises a latch in a proximal portion of the channel and a ramp in a distal portion of the channel. The combination of the hook and the ramp are configured to push the slidable component of the introducer housing away from the fixed component when a distal face of the hook engages a proximal face of the ramp while the slidable component is being distally advanced relative to the fixed component.

[0009] In some embodiments, the introducer housing comprises a sliding hinge in a proximal portion of the introducer housing. The sliding hinge comprises a captive tab of the slidable component of the introducer housing and a track of the fixed component of the introducer housing. The captive tab is captively but slidably disposed in the track, allowing the slidable component to be distally advanced relative to the fixed component without the slidable component being separated from the fixed component in the proximal portion of the introducer housing.

[0010] In some embodiments, a proximal portion of the capture tab that is inside an outer surface of the introducer housing is rounded. The rounded capture tab facilitates the separation of the slidable component of the introducer housing from the fixed component of the introducer housing in the distal portion of the introducer housing.

[0011] In some embodiments, the proximal portion of the introducer housing includes a longitudinal cutout. The cutout is configured to provide a path for the side arms of the catheter advancement hub while advancing the catheter advancement hub distally within the introducer housing.

[0012] In some embodiments, the manifold includes one or more manifold lumens in a number equal to one or more catheter tube lumens. The one or more manifold lumens are fluidly connected to the one or more catheter tube lumens in an immediate deployment state of the introducer assembly.

[0013] In some embodiments, the side arms of the catheter advancement hub include side arm lumens fluidly coupled to the one or more manifold lumens. The combination of the side arm lumens and the one or more manifold lumens are used to simultaneously prime each of the one or more catheter tube lumens prior to insertion of the catheter tube into a blood vessel lumen of a patient.

[0014] In some embodiments, the catheter advancement hub further includes a catheter advancement push tab extending from the side arms. The catheter advancement push tab is configured to be used to advance the catheter advancement hub distally with a single finger of the hand while the syringe is held around the distal portion of the barrel between the thumb and another finger or fingers of the hand.

[0015] In some embodiments, the RICC system further includes a proximal catheter component of the RICC. The proximal catheter component includes a proximal catheter hub component of a two-piece catheter hub and one or more extension legs. The one or more extension legs each include one or more extension leg lumens. Each of the one or more extension leg lumens is coupled to the proximal catheter hub component through a distal portion of the extension leg. The RICC has a connected state in which the proximal catheter hub component is connected to the distal catheter hub component. In the connected state of the RICC, the one or more extension leg lumens are each fluidly coupled to the one or more catheter tube lumens through the two-piece catheter hub.

[0016] In some embodiments, the RICC includes a set of three lumens in the connected state of the RICC. The set of three lumens includes a first lumen, a second lumen, and a third lumen.

[0017] In some embodiments, the first lumen has a first lumen aperture located in a distal end of the two-piece catheter, the second lumen has a second lumen aperture located in a side of the catheter tube proximal of the first lumen aperture, and the third lumen has a third lumen aperture located in a side of the catheter tube proximal of the second lumen aperture.

[0018] In some embodiments, the catheter tube further comprises a first section formed of a first material having a first stiffness and a second section formed of a second material having a second stiffness that is less than the first stiffness. The catheter tube is thus configured with column strength for inserting the catheter tube into a patient and compliance for advancing the catheter tube through the vasculature of the patient.

[0019] In some embodiments, the introducer further comprises a syringe housing that surrounds a barrel of the syringe, the syringe housing having a distal portion and a proximal portion. The proximal portion of the syringe housing is integral with or coupled to a proximal portion of a plunger disposed in the barrel. Whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, proximally sliding the syringe housing relative to the barrel withdraws the plunger from the barrel.

[0020] In some embodiments, the syringe further comprises a plunger withdrawal tab that extends proximally on the barrel from a distal portion of the barrel to which the plunger withdrawal tab is coupled. The plunger withdrawal tab is configured to be depressed with a single finger of the hand while the syringe is held between the thumb and another finger or fingers of the hand around the distal portion of the barrel to proximally slide the syringe housing relative to the barrel and withdraw the plunger from the barrel.

[0021] In some embodiments, the introducer further comprises an access guidewire disposed in an access guidewire lumen formed at least by the plunger lumen of the plunger and the needle lumen of the introducer needle. The access guidewire has a length sufficient for the access guidewire to extend through the distal catheter component distal end.

[0022] In some embodiments, the introducer further comprises a slider that extends distally on the barrel from the syringe housing. The slider is configured to actuate the access guidewire with a single finger of the hand while the syringe is held between the thumb and another finger or fingers of the hand around the distal portion of the barrel. The slider includes an extension that extends through a longitudinal slot in each of the barrel and the plunger into the access guidewire lumen where the extension is coupled to the access guidewire.

[0023] Also disclosed is an introducer configured to couple to a distal catheter component of a RICC in an introducer assembly. The introducer includes a catheter advancement hub, a guide needle, a syringe, and an introducer housing. The catheter advancement hub includes a manifold and a side arm configured to couple to the distal catheter component in the introducer assembly. The guide needle has a needle shaft that extends through the manifold and a distal end of the distal catheter component in an immediately deployed state of the introducer assembly. The syringe is fluidly coupled to the guide needle. The syringe includes a barrel having a distal portion that terminates in a syringe tip. The syringe is configured to be held between a thumb and one or more fingers of a hand around the distal portion of the barrel while reserving a single finger for actuating the introducer. In the immediately deployed state of the introducer assembly, the introducer housing is positioned over the syringe tip, the manifold, and a proximal portion of the distal catheter component. The introducer housing is configured to provide column strength to a catheter tube of the distal catheter component during intravenous puncture using the guide needle. The introducer housing is further configured to longitudinally split apart, allowing the distal catheter component to be removed from the introducer housing after intravenous puncture.

[0024] In some embodiments, the introducer housing includes a lock in a distal portion of the introducer housing. The lock includes a hook in a slidable component of the introducer housing and a latch in a fixed component of the introducer housing. The hook and the latch are configured to lock the slidable component and the fixed component together.

[0025] In some embodiments, the fixed component of the introducer housing includes a channel. The channel includes a latch in a proximal portion of the channel and a ramp in a distal portion of the channel. The combination of the hook and the ramp are configured to push the slidable component of the introducer housing away from the fixed component when a distal face of the hook engages a proximal face of the ramp while the slidable component is being advanced distally relative to the fixed component.

[0026] In some embodiments, the introducer housing includes a sliding hinge in a proximal portion of the introducer housing. The sliding hinge includes a capture tab of a slidable component of the introducer housing and a track of a fixed component of the introducer housing. The capture tab is captively but slidably disposed in the track, allowing the slidable component to be advanced distally relative to the fixed component without the slidable component separating from the fixed component in the proximal portion of the introducer housing.

[0027] In some embodiments, a proximal portion of the capture tab inside an outer surface of the introducer housing is rounded. The capture tab being rounded facilitates the slidable component of the introducer housing separating from the fixed component of the introducer housing in the distal portion of the introducer housing.

[0028] In some embodiments, the proximal portion of the introducer housing includes a longitudinal cutout. The cutout is configured to provide a path for the side arms of the catheter advancement bushing while advancing the catheter advancement bushing distally within the introducer housing.

[0029] In some embodiments, the side arms of the catheter advancement bushing include side arm lumens fluidly coupled to the one or more manifold lumens. The combination of the side arm lumens and the one or more manifold lumens are used to simultaneously prime each of the one or more lumens of the distal catheter component of the RICC in the ready-to-deploy state of the introducer assembly.

[0030] In some embodiments, the catheter advancement bushing further includes a catheter advancement tab extending from the side arms. The catheter advancement tab is configured to be advanced distally with a single finger of the hand while the syringe is held around the distal portion of the barrel between the thumb and another finger or fingers of the hand.

[0031] In some embodiments, the introducer further includes a syringe housing around the barrel of the syringe, the syringe housing having a distal portion and a proximal portion. The proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger disposed in the barrel. Whether the proximal portion of the syringe housing is integral with or coupled to the proximal portion of the plunger, proximally sliding the syringe housing relative to the barrel withdraws the plunger from the barrel.

[0032] In some embodiments, the syringe further includes a plunger withdrawal tab extending proximally on the barrel from a distal portion of the barrel to which the plunger withdrawal tab is coupled. The plunger withdrawal tab is configured to be depressed with a single finger of the hand while the syringe is held around the distal portion of the barrel between the thumb and another finger or fingers of the hand to proximally slide the syringe housing relative to the barrel and withdraw the plunger from the barrel.

[0033] In some embodiments, the introducer further includes an access guidewire disposed in an access guidewire lumen formed at least by the plunger lumen of the plunger and the needle lumen of the introducer needle. The access guidewire has a length sufficient for the access guidewire to extend through the distal end of the distal catheter component in the ready-to-deploy state of the introducer assembly.

[0034] In some embodiments, the introducer further includes a slider extending distally on the barrel from the syringe housing. The slider is configured to actuate the access guidewire with a single finger of the hand while the syringe is held around the distal portion of the barrel between the thumb and another finger or fingers of the hand. The slider includes an extension that extends through a longitudinal slot in each of the barrel and the plunger into the access guidewire lumen where the extension is coupled to the access guidewire.

[0035] A method for creating a RICC system is also disclosed. In some embodiments, the method includes an RICC system acquisition step, a needle tract establishment step, a first RICC advancement step, a guide housing cleavage step, and a guide removal step. The RICC system acquisition step includes acquiring the RICC system. The RICC system includes a proximal catheter component of the RICC and a guide assembly. The guide assembly includes a guide and a distal catheter component of the RICC, the distal catheter component being partially disposed within the guide housing of the guide. The needle tract establishment step includes establishing a needle tract from a patient's skin area to the intravascular lumen using a guide needle of the guide. The guide needle has a needle shaft that extends through the distal end of the distal catheter component in an immediately deployed state of the guide assembly. The needle tract establishment step is performed while keeping at least one finger of one hand readily available for actuating the guide assembly, with the distal portion of the guide's syringe held between the thumb and one or more other fingers of that hand. The first RICC advancement step includes advancing the distal portion of the first segment of the distal catheter assembly into the vascular lumen on a needle shaft. The guide housing splitting step includes splitting the guide housing along its length. The guide removal step includes removing the distal catheter assembly from the guide housing, leaving the distal portion of the first segment of the catheter body in the appropriate position within the vascular lumen.

[0036] In some embodiments, the method further includes a blood aspiration step. The blood aspiration step includes aspirating blood using a syringe prior to the guide needle removal step to confirm that the tip of the guide needle is positioned within the blood vessel lumen. The blood aspiration step includes pushing a plunger retraction tab with a single finger of the hand while the distal portion of the syringe is held between the thumb and one or more fingers of the hand by the syringe housing over the syringe barrel. The plunger retraction tab extends from the distal portion of the syringe over the syringe barrel such that pushing the plunger retraction tab while holding the distal portion of the syringe by the syringe housing causes the syringe housing to slide proximally relative to the syringe barrel and retract the plunger connected to the syringe housing from the syringe barrel.

[0037] In some implementations, the first RICC advance step includes pushing a catheter advance pusher with a single finger of one hand while holding the distal portion of the syringe between the thumb and one or more other fingers of that hand. The catheter advance pusher is a portion of the catheter advance bushing that is attached to the proximal portion of the distal catheter component in the pre-deployed state of the guide assembly.

[0038] In some implementations, the catheter advance pusher advances the side arm of the catheter advance bushing along the path provided by the longitudinal cut in the guide housing.

[0039] In some embodiments, the method further includes a priming step. The priming step includes, prior to the first RICC advancing step, priming the distal catheter component with a common syringe through the catheter to advance the side arms of the hub. The side arms have side arm lumens that are fluidly coupled to one or more manifold lumens for simultaneously priming each of the corresponding one or more lumens of the distal catheter component.

[0040] In some embodiments, the introducer housing splitting step includes unlocking a lock located in a distal portion of the introducer housing by sliding a slidable component of the introducer housing distally relative to a fixed component of the introducer housing. The unlocking of the lock includes separating a hook of the slidable component and a latch of the fixed component as the slidable component is slid relative to the fixed component.

[0041] In some embodiments, the fixed component of the introducer housing includes a channel that includes a latch located in a proximal portion of the channel and a ramp located in a distal portion of the channel. The sliding of the slidable component relative to the fixed component causes a distal face of the hook to engage a proximal face of the ramp and split the introducer housing along a length of the introducer housing.

[0042] In some embodiments, the method further includes an access guidewire advancing step. The access guidewire advancing step includes advancing an access guidewire disposed in an access guidewire lumen into the vascular lumen beyond a distal end of the distal catheter component. The access guidewire lumen is formed at least by the plunger lumen of the syringe and the needle lumen of the introducer needle. Additionally, the slide is coupled to the access guidewire such that advancing the slide distally with a single finger while holding the distal portion of the syringe housing between the thumb and another finger or fingers of the hand advances the access guidewire into the vascular lumen. The access guidewire advancing step is performed prior to the first RICC advancing step.

[0043] In some embodiments, the method further includes a catheter hub clamping step. The catheter hub clamping step includes clamping together a proximal catheter hub component of the proximal catheter component and a proximal catheter hub component of the distal catheter component. The catheter hub clamping step connects one or more extension leg lumens coupled to one or more extension legs of the proximal catheter hub component to one or more catheter tube lumens of the catheter tube, respectively, thereby forming the RICC.

[0044] In some embodiments, the method further includes a steering guidewire advancing step. The steering guidewire advancing step includes advancing a steering guidewire through a first lumen of the RICC into the vascular lumen to a target location in the vasculature of the patient, the first lumen having a first lumen aperture located in a distal end of the distal catheter component.

[0045] In some embodiments, the method further includes a second RICC advancing step and a steering guidewire removing step. The second RICC advancing step includes advancing the remaining portion of the distal portion of the first section of the catheter tube into the blood vessel lumen using the steering guidewire as a guide until the proximal portion of the second section of the catheter tube. The second RICC advancing step stops relative to the advancing when the distal end of the distal catheter component reaches the target location. The steering guidewire removing step includes withdrawing the steering guidewire and leaving the catheter tube in place in the patient.

[0046] These and other features of the concepts provided herein will become more apparent from the following description in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF DRAWINGS

[0047] Figure 1 A first perspective view of a guide assembly including a guide and a two-piece RICC of a distal catheter component is shown in accordance with some embodiments.

[0048] Figure 2 A second perspective view of a guide assembly is shown in accordance with some embodiments.

[0049] Figure 3 A top view of a guide assembly is shown in accordance with some embodiments.

[0050] Figure 4 A bottom view of a guide assembly is shown in accordance with some embodiments.

[0051] Figure 5 A side view of a guide assembly in a working state with an access guidewire being advanced through a distal end of a distal catheter component of a RICC is shown in accordance with some embodiments.

[0052] Figure 6 A side view of a guide assembly in another working state with a detached guide housing and a distal catheter component of a RICC advanced from an immediately deployed state of the guide assembly is shown in accordance with some embodiments.

[0053] Figure 7 A perspective view of a guide assembly in the same working state as Figure 6

[0054] Figure 8 A sliding articulation in a proximal portion of a guide housing is shown in accordance with some embodiments.

[0055] Figure 9 A lock located in a distal portion of a guide housing is shown in accordance with some embodiments. ​

[0056] Figure 10 A syringe of an introducer is shown in accordance with some embodiments.

[0057] Figure 11 A longitudinal section of a portion of a syringe is shown in accordance with some embodiments.

[0058] Figure 12 A catheter pusher hub of a distal catheter hub component coupled to a distal catheter component in an immediately deployed state of an introducer assembly is shown in accordance with some embodiments.

[0059] Figure 13 A two-piece RICC in an unconnected state is shown in accordance with some embodiments.

[0060] Figure 14 A two-piece RICC in a connected state is shown in accordance with some embodiments.

[0061] Figure 15 A proximal catheter hub component and a distal catheter hub component of a two-piece catheter hub of a RICC in an unconnected state are shown in accordance with some embodiments.

[0062] Figure 16 A proximal catheter hub component and a distal catheter hub component of a RICC in a connected state are shown in accordance with some embodiments.

[0063] Figure 17 A distal portion of a catheter tube of a RICC of Figure 13 and Figure 14 is shown in accordance with some embodiments.

[0064] Figure 18 A first transverse section of a catheter tube of Figure 17 is shown in accordance with some embodiments.

[0065] Figure 19 A second transverse section of a catheter tube of Figure 17 is shown in accordance with some embodiments.

[0066] Figure 20 A third transverse section of a catheter tube of Figure 17 is shown in accordance with some embodiments.

[0067] Figure 21 A fourth or fifth transverse section of a catheter tube of Figure 17 is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0068] Before certain specific embodiments are disclosed in more detail, it is to be understood that the specific embodiments disclosed herein are not limiting of the scope of the concepts provided herein. It is also to be understood that the specific embodiments disclosed herein can have features that are readily separated from the specific embodiments into which they are otherwise disclosed and that can be optionally combined with features of any of the other specific embodiments disclosed herein or otherwise disclosed in connection with the concepts provided herein.

[0069] With respect to the terms used, it is also to be understood that these terms are used herein to describe some particular embodiments and are not limiting to the scope of the concepts provided herein. Sequence numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps and do not provide a consecutive or numerical limitation. For example, the “first,” “second,” and “third” features or steps need not appear in that order and particular embodiments including such features or steps are not necessarily limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used, and these labels are not intended to be limiting, except where otherwise expressly indicated. Rather, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0070] With respect to “proximal,” “proximal portion,” or “proximal end portion” of, for example, a catheter disclosed herein includes the portion of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. Likewise, “proximal length” of, for example, a catheter includes the length of the catheter that is intended to be proximate to a clinician when the catheter is used on a patient. For example, “proximal end” of a catheter includes the end of the catheter that is intended to be proximate to a 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 otherwise indicates, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0071] “Distal,” “distal portion,” or “distal end portion” of, for example, a catheter disclosed herein includes the portion of the catheter intended to be proximate to or within a patient when the catheter is used on the patient. Likewise, “distal length” of, for example, a catheter includes the length of the catheter intended to be proximate to or within a patient when the catheter is used on the patient. For example, “distal end” of a catheter includes the end of the catheter intended to be proximate to or within a patient when the catheter is used on 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 indicates otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or length of the catheter.

[0072] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art.

[0073] As noted above, RICCs typically include distal guide holes designed for introducing the RICC onto a shorter guide needle. However, it would be beneficial to eliminate the guide holes as these guide holes effectively become artifacts after the RICC is introduced.

[0074] Disclosed herein are two-piece RICCs, introducers thereof, and methods thereof that address the above-noted problems. For context, a description of the RICC is first presented. The description of the RICC is followed by a description of the introducer, sometimes in the context of the introducer assembly, given the interrelatedness of the introducer and the RICC. Following the description of the RICC and the introducer, methods are presented that use at least RICC systems comprising the above-noted RICCs and introducers.

[0075] Quickly insertable central catheter

[0076] Figure 13 and Figure 14 A two-piece RICC 100 in an unconnected state and a connected state is shown in accordance with some embodiments.

[0077] As shown, the two-piece RICC 100 includes two components, including a proximal catheter component 102 and a distal catheter component 104. It should be understood that the RICC 100 can include different components or additional components than those in the illustrated embodiment. Indeed, the “two pieces” of the two-piece RICC 100 generally refer to at least two components that are obtained by laterally dividing such RICC at some point along its length, in this case at the two-piece catheter hub 108 described below.

[0078] The proximal conduit component 102 includes a proximal conduit hub component 106 of a two-piece conduit hub 108 and one or more extension legs 110. The distal conduit component 104 includes a distal conduit hub component 112 of the two-piece conduit hub 108 and a conduit tube 114. The description of the two-piece conduit hub 108 is presented first, followed by the description of the conduit tube 114, the one or more extension legs 110, and other aspects of the RICC 100.

[0079] Figure 15 and Figure 16 The proximal conduit hub component 106 and the distal conduit hub component 112 of the two-piece conduit hub 108 of the RICC 100 in the unconnected state and the connected state are shown in accordance with some embodiments.

[0080] The proximal conduit hub component 106 of the two-piece conduit hub 108 includes one or more rigid tubes 116 (e.g., metal tubes) respectively arranged in one or more proximal conduit hub lumens 118, effectively extending the one or more proximal conduit hub lumens 118 in the connector. The proximal conduit hub component 106 can be molded over the one or more rigid tubes 116 during manufacturing, such that the one or more rigid tubes 116 extend from a distal end of the proximal conduit hub component 106. Alternatively, the one or more rigid tubes 116 are inserted into the one or more proximal conduit hub lumens 118 during manufacturing, such that the one or more rigid tubes 116 extend from a distal end of the proximal conduit hub component 106.

[0081] The distal catheter hub component 112 of the two-piece catheter hub 108 includes one or more distal catheter hub lumens 120 that include one or more mechanical grommets 122 disposed therein, respectively. The one or more mechanical grommets 122 are configured to be positioned between the proximal lumen surface of the one or more rigid tubes 116 and the lumen surface of the one or more distal catheter hub lumens 120 in the connected state of the RICC 100. The one or more mechanical grommets 122 include, but are not limited to, “O”-rings or cylinders. The one or more mechanical grommets 122 can be formed of a compressible polymeric material, such as silicone. The use of a compressible polymeric material, such as silicone, is advantageous because when the one or more rigid tubes 116 are inserted into the one or more distal catheter hub lumens 120, axial compression of the one or more mechanical grommets 122 by the compression ring 124 forces the one or more mechanical grommets 122 to radially expand in the limited space between the proximal lumen surface of the one or more rigid tubes 116 and the lumen surface of the one or more distal catheter hub lumens 120, thereby creating one or more fluid-tight lumen seals between the proximal catheter hub component 106 and the distal catheter hub component 112 of the two-piece catheter hub 108 and respectively continuing the one or more proximal catheter hub lumens 118 into the one or more distal catheter hub lumens 120.

[0082] In the alternative described above, the distal catheter hub component 112 can alternatively include the one or more rigid tubes 116 disposed in the one or more distal catheter hub lumens 120, respectively. Likewise, the proximal catheter hub component 106 can alternatively include the one or more mechanical grommets 122 disposed in the one or more proximal catheter hub lumens 118, respectively. It should be understood that the above description of the one or more rigid tubes 116, the one or more mechanical grommets 122, etc. for the illustrated embodiment of the proximal catheter hub component 106 and the distal catheter hub component 112 applies when the one or more rigid tubes 116 are part of the distal catheter hub component 112 and when the one or more mechanical grommets 122 are part of the proximal catheter hub component 106.

[0083] Continuing with the illustrated embodiment of the proximal catheter hub component 106 and the distal catheter hub component 112, the proximal catheter hub component 106 and the distal catheter hub component 112 include complementary connectors of a connection system that are configured to securely and, in some embodiments, irreversibly connect the proximal catheter hub component 106 and the distal catheter hub component 112 in the connected state of the RICC 100. In this context, “irreversibly” connecting the proximal catheter hub component 106 and the distal catheter hub component 112 should be understood to mean that the proximal catheter hub component 106 and the distal catheter hub component 112 cannot be separated without a tool or damaging the proximal catheter hub component 106 or the distal catheter hub component 112.

[0084] For the connection system, the distal catheter hub component 112 can include an integral clip molded with the distal catheter hub component 112 itself, the integral clip having a tabbed arm 126 extending proximally from the distal catheter hub component 112. The proximal catheter hub component 106 can include a complementary receiver, such as a surface recess 128, configured to receive the tabbed arm 126 and a tab 130 of the tabbed arm 126 therein in the connected state of the RICC 100. As Figure 15 As best shown in the middle, the tabbed arm 126 can extend from a major side of the distal catheter hub component 112, and the surface recess 128 can be in a major surface of the proximal catheter hub component 106. However, the tabbed arm 126 can instead extend from a minor side of the distal catheter hub component 112, and the surface recess 128 can be in a minor surface of the proximal catheter hub component 106. Due to having greater design space across the width of the two-piece catheter hub 108, the complementary receiver can instead be a longitudinal cavity inboard of a minor surface of the proximal catheter hub component 106, the tabbed arm 126 extending from a minor side of the distal catheter hub component 112 configured to be inserted into the longitudinal cavity, similar to the case of a common plastic belt buckle on a backpack or the like.

[0085] In the above-described alternative, the proximal catheter hub component 106 can instead include the integral clip having the tabbed arm 126. In effect, the integral clip effectively protects the one or more rigid tubes 116 from accidental damage so long as the one or more rigid tubes 116 are also disposed in the one or more proximal catheter hub inner lumens 118 of the proximal catheter hub component 106. Likewise, the distal catheter hub component 112 can instead include the complementary receiver including the surface recess 128 configured to dispose the tabbed arm 126. It is understood that the above description of the tabbed arm 126, the complementary receiver, etc. for the illustrated embodiment of the proximal catheter hub component 106 and the distal catheter hub component 112 applies when the tabbed arm 126 is part of the proximal catheter hub component 106 and when the complementary receiver is part of the distal catheter hub component 112.

[0086] Figure 17 A distal portion of the catheter tube 114 of the RICC 100 is shown in accordance with some embodiments. Figures 18 to 21 Various transverse cross-sections of the catheter tube 114 are shown in accordance with some embodiments.

[0087] The catheter tube 114 is coupled to the distal catheter hub component 112 by a proximal portion of the catheter tube 114. As such, the one or more distal catheter hub inner lumens 120 continue as one or more catheter tube inner lumens, respectively. (See Figure 21The first lumen 142, the second lumen 146, and the third lumen 150 of the RICC 100 in FIG. 1.

[0088] The catheter tube 114 can include a hard portion and a soft portion, where "hard" and "soft" are used in a relative sense, as the hard portion of the catheter tube 114 is harder than the soft portion of the catheter tube 114. The hard portion of the catheter tube 114 includes the first section 132 located in the distal portion of the catheter tube 114, while the soft portion of the catheter tube 114 includes the second section 134 extending from the proximal portion of the catheter tube 114 to the distal portion of the catheter tube 114 but located proximal to the first section 132. While the taper joint 136 of the catheter tube 114 includes a proximal portion of the hard portion of the catheter tube 114 disposed in the joint 136, the soft portion of the catheter tube 114 is generally considered to include the joint 136 in view of its structure. In sum, the above-described arrangement of the first section 132 of the catheter tube 114, the second section 134 of the catheter tube 114, and the joint 136 provides the catheter tube 114 with column strength sufficient to prevent buckling of the catheter tube 114 when inserted into an insertion site established by a percutaneous puncture and compliance sufficient to advance the catheter tube 114 over a guide wire through a patient's vasculature to a target location, such as the superior vena cava ("SVC").

[0089] The first section 132 of the catheter tube 114 is located in 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 a needle tip 140 of the introducer needle 164 to an outer diameter of a remainder of the first section 132 when the introducer needle 164 is disposed in the catheter tube 114 of the distal catheter component 104. (See Figures 1 to 4 .) The short taper of the distal tip 138 is configured for immediate expansion of tissue surrounding a percutaneous puncture established with the introducer needle 164 up 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 portion disposed in and fixedly coupled (e.g., solvent bonded, adhered, welded, etc.) to a receiver of the joint 136 described below.

[0090] The first section 132 of the catheter tube 114 is formed of a first polymeric material having a first durometer. The first polymeric material can be polytetrafluoroethylene, polypropylene, or polyurethane, although the first polymeric material is not limited to the above-mentioned polymers. Polyurethane is advantageous because the first section 132 of the catheter tube 114 can be relatively rigid at room temperature but becomes more flexible at body temperature in vivo, which reduces irritation to vessel walls and phlebitis.

[0091] The second section 134 of the catheter tube 114 extends from the proximal portion of the catheter tube 114 to the distal portion of the catheter tube 114, but is proximal of the first section 132 of the catheter tube 114. The second section 134 includes a distal end coupled to the joint 136 and a proximal portion disposed in the distal catheter hub component 112 and fixedly coupled (e.g., solvent-bonded, welded, adhered, etc.) thereto.

[0092] The second section 134 of the catheter tube 114 is formed of a second polymeric material having a second hardness that is less than the first hardness. The second polymeric material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but the second polymeric material is not limited to the above-mentioned polymers. Polyurethane is advantageous in addition to what is set forth above for the polyurethane in the first section 132 of the catheter tube 114 in that it forms fewer thrombi than some other polymers.

[0093] The joint 136 of the catheter tube 114 couples the first section 132 and the second section 134 of the catheter tube 114 together. The joint 136 includes a receptacle in the distal portion that includes a proximal portion of the first section 132 of the catheter tube 114 disposed therein and fixedly coupled (e.g., solvent-bonded, welded, adhered, etc.) thereto. (See Figure 17 and Figures 1 to 4 from which the receptacle can be seen.) The joint 136 also includes a planar proximal end fixedly coupled (e.g., molded with the second section 134, solvent-bonded, welded, adhered, etc.) to a planar distal end of the second section 134 of the catheter tube 114 that, when coupled, effectively terminates the lumen of the second section 134 of the catheter tube 114 rather than the first inner lumen 142 of the RICC 100 passing through the joint 136. The joint 136 also includes a taper from the distal end to the proximal end over its length that is configured for immediate expansion of the tissue surrounding a percutaneous puncture up to the outer diameter of the second section 134 of the catheter tube 114. The proximal lumen surface of the joint 136 smoothly transitions from the proximal lumen surface of the proximal portion of the first section 132 without edges that catch the skin when inserted into the insertion site of a patient. In addition to the edges being minimized to negligible, the edges can include solvent interdiffusion of the polymeric material of the first polymeric material and the polymeric material of the joint 136 that smoothes the transition from the first section 132 of the catheter tube 114 to the joint 136.

[0094] The joint 136 of the catheter tube 114 is formed of a second polymeric material or a third polymeric material having a third hardness that is closer to the second hardness than the first hardness. Again, the second polymeric material can be polyvinyl chloride, polyethylene, polyurethane, or silicone, but the second polymeric material is not limited to the above-mentioned polymers.

[0095] Likewise, the first section 132 of the catheter tube 114 is formed of a first polymeric material having a first durometer, the second section 134 of the catheter tube 114 is formed of a second polymeric material having a second durometer that is less than the first durometer, and the joint 136 of the catheter tube 114 is formed of the second polymeric material or a third polymeric material having a third durometer that is closer to the second durometer than the first durometer. Since each of the second and third durometers is less than the first durometer, the soft portion of the catheter tube 114 including the second portion of the catheter tube 114 and the joint 136 is softer 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 greater than each of the second and third durometers. Since the first durometer is greater than each of 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 joint 136.

[0096] It should be appreciated that the first durometer of the first polymeric material, the second durometer of the second polymeric material, and the third durometer of the third polymeric material can lie on different scales (e.g., Type A or Type D), such that the second or third durometer can not be numerically less than the first durometer. In other words, the first durometer can not be numerically greater than the second or third durometer in view of the different scales. That is, the durometer of the second or third polymeric material can still be less than the durometer of the first polymeric material, or the durometer of the first polymeric material can still be greater than the durometer of the second or third polymeric material, because the different scales, each of which ranges from 0 to 100, are designed to characterize different materials in a group of materials having similar durometers.

[0097] Although as described above, the first section 132 of the catheter tube 114, the second section 134 of the catheter tube 114, and the joint 136 can be formed of the same polymeric material or different polymeric materials having substantially equal durometers, as long as the column strength of the catheter tube 114 is sufficient to prevent the catheter tube 114 from buckling when inserted into an insertion site established by a percutaneous puncture, and the compliance of the catheter tube 114 is sufficient to advance the catheter tube 114 through a patient's vasculature to a target location.

[0098] Each of the one or more extension legs 110 is coupled to the proximal catheter hub component 106 by a distal portion of the extension leg. The one or more extension legs 110 each include one or more extension leg lumens. As such, the one or more proximal catheter hub lumens 118 each continue as the one or more extension leg lumens.

[0099] Each of the one or more extension legs 110 generally includes a luer connector coupled to the extension leg through which the extension leg and its extension leg lumen can be connected to another medical device.

[0100] Regardless of whether the RICC 100 is a single lumen with one lumen or a multi-lumen with a set of multiple lumens, the RICC 100 includes at least a first 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 component 104 are fluidly connected to one or more extension leg lumens in the proximal catheter component 102, respectively, through the two-piece catheter hub 108. The first lumen 142 generally extends from a proximal end of the RICC 100 to a distal end of the RICC 100, e.g., from an opening of the respective luer connector to a first lumen aperture 144 (e.g., a distal lumen aperture) in the distal end of the RICC 100. When the RICC 100 has more than two lumens, the RICC 100 also includes at least a second lumen 146 (e.g., an intermediate lumen). The second lumen 146 generally extends from a proximal end of the RICC 100 to a distal portion of the RICC 100, e.g., from an opening of the respective luer connector to a second lumen aperture 148 (e.g., an intermediate lumen aperture) in the distal portion of the catheter tube 114 proximally of the first lumen aperture 144. When the RICC 100 has more than three lumens, the RICC 100 also includes at least a third lumen 150 (e.g., a proximal lumen). The third lumen 150 generally extends from a proximal end of the RICC 100 to a distal portion of the RICC 100, e.g., from an opening of the respective luer connector to a third lumen aperture 152 (e.g., a proximal lumen aperture) in the distal portion of the catheter tube 114 proximally of the second lumen aperture 148. While each of the second lumen 146 and the third lumen 150 can extend slightly farther distally than the second lumen aperture 148 and the third lumen aperture 152, respectively, as described above, different manufacturing methods are contemplated. However, as described above, the planar proximal end of the junction 136 is fixedly coupled (e.g., molded with, solvent bonded to, welded to, adhered to, etc.) to the planar distal end of the second segment 134 of the catheter tube 114, which effectively terminates the lumens such as the second lumen 146 and the third lumen 150 and prevents passage through the junction 136 when coupled.

[0101] Introducer and introducer assembly

[0102] Figures 1 to 4 Various views of an introducer assembly 154 including an introducer 156 and a distal catheter component 104 of a two-piece RICC 100 are shown in accordance with some embodiments.

[0103] As shown, the introducer 156 is configured to couple with the distal catheter component 104 of the two-piece RICC 100 to form an introducer assembly 154. In practice, Figure 12 An introducer 156 coupled with the distal catheter component 104 in an immediate-to-deployment state (e.g., ready for venipuncture) of the introducer assembly 154 is shown. The introducer assembly 154 is configured to be actuated in at least three ways with a single finger (e.g., index finger) of the same hand while the introducer assembly 154 is held between the thumb and another one or more fingers (e.g., middle finger and ring finger) of the same hand. Accordingly, multiple working states of the introducer assembly 154 are also possible, some of which are identified or discernible from the description set forth below, including working states for methods of using the RICC system provided herein.

[0104] The introducer 156 includes a catheter advancement hub 158, an introducer housing 160, and a syringe 162, including a guide needle 164. The catheter advancement hub 158, the introducer housing 160, and the syringe 162 are described in turn below, followed by some other features of the introducer 156; however, there is some cross-over between the descriptions of the catheter advancement hub 158, the introducer housing 160, the syringe 162, and the other features of the introducer 156 in view of the interrelatedness of the aforementioned features in the introducer 156. Likewise, some descriptions of the introducer 156 are also presented in the context of the introducer assembly in view of the interrelatedness of the introducer 156 and the RICC.

[0105] Figure 12 A catheter advancement hub 158 coupled to the distal catheter hub component 112 of the distal catheter component 104 in an immediate-to-deployment state of the introducer assembly 154 is shown in accordance with some embodiments.

[0106] As shown, the catheter advancement hub 158 is configured to couple to the distal catheter component 104 in the introducer assembly 154. In practice, Figure 12 A catheter advancement hub 158 coupled to the distal catheter hub component 112 of the distal catheter component 104 in an immediate-to-deployment state of the introducer assembly 154 is shown.

[0107] The catheter advancement hub 158 includes a manifold 166, a side arm 168, and a catheter advancement tab 170 extending proximally from the side arm 168. As Figure 12 As best shown in FIG. 16, the catheter advancement hub 158 includes an integrated proximal connector (e.g., female luer connector) configured to fluidly couple the syringe 162 to the catheter advancement hub 158 through the syringe tip. This fluid coupling between the catheter advancement hub 158 and the syringe 162 is useful for observing blood reflux (if present) in the hub 204 of the syringe 162 when establishing a needle path to an intravascular lumen of a patient.

[0108] The manifold 166 includes one or more manifold lumens 172 equal in number to the one or more distal catheter hub lumens 120 that continue into the one or more catheter tube lumens in the distal catheter component 104, as described above. In the immediately deployed state of the introducer assembly 154, the one or more manifold lumens 172 are fluidly connected to the one or more catheter tube lumens via the one or more distal catheter hub lumens 120 such that the one or more catheter tube lumens can be simultaneously filled with fluid (e.g., saline, heparinized saline, etc.) prior to insertion of the distal catheter component 104 or catheter tube 114 thereof into a patient's vascular lumen.

[0109] As Figure 6 As best shown in FIG. 6, the side arm 168 of the catheter advancement hub 158 includes an integrated side arm connector (e.g., female luer connector) and a side arm lumen 174 fluidly coupled to the one or more manifold lumens 172. The combination of the side arm lumen 174 and the one or more manifold lumens 172 are thus configured for simultaneous filling of each of the one or more catheter tube lumens prior to insertion of the distal catheter component 104 or catheter tube 114 thereof into a patient's vascular lumen. In the immediately deployed state of the introducer assembly 154, the needle shaft of the introducer needle 164 extends through the manifold 166 or at least one of the manifold lumens and the distal end of the distal catheter component 104. As such, the simultaneous filling of each of the one or more catheter tube lumens occurs in the at least one manifold lumen about the introducer needle 164 when performing the simultaneous filling.

[0110] The catheter advancement tab 170 is configured to be pushed by a single finger (e.g., index finger) of the same hand that holds the syringe 162 about its distal portion between the thumb and another one or more fingers (e.g., middle finger and ring finger) of the hand to distally advance the catheter advancement hub 158 and thus the distal catheter component 104 via the distal catheter hub component 112 coupled thereto. Likewise, the catheter advancement tab 170 extends proximally from the side arm 168 of the catheter advancement hub 158. Indeed, in the immediately deployed state of the introducer assembly 154, the catheter advancement tab 170 extends proximally over a portion of the plunger withdrawal tab 212 set forth below that in turn extends proximally over the distal portion of the syringe 162. The above-described arrangement of the plunger withdrawal tab 212 and the catheter advancement tab 170 enables the catheter advancement tab 170 and the plunger withdrawal tab 212 to be immediately accessible for actuation of the introducer assembly 154 with the single finger while the syringe 162 is held about its distal portion between the thumb and another one or more fingers of the same hand.

[0111] Figure 7and Figures 1 to 4 Different views of the introducer assembly 154 in a working state are shown, with the introducer housing 160 split along its length, in accordance with some embodiments.

[0112] As shown, the introducer housing 160 includes two components, including a slidable component 176 and a fixed component 178 configured to split along the length of the introducer housing 160. In practice, the slidable component 176 and the fixed component 178 are configured to split along the length of the introducer housing 160 in the immediate deployment state of the introducer assembly 154. Figure 6 In the immediate deployment state of the introducer assembly 154 shown, the introducer housing 160 is closed over the syringe tip, the manifold 166, and the proximal portion of the distal catheter component 104 to which the fixed component 178 is coupled, while the introducer housing 160 is split along the length of the introducer housing 160 at the slidable component 176. Figure 7 and Figure 9 In the working state of the introducer assembly 154 shown, the introducer housing 160 is split. The introducer housing 160 is configured to provide column strength to the catheter tube 114 of the distal catheter component 104 for venipuncture with the introducer needle 164 (e.g., the needle path establishment step set forth below) while the introducer assembly 154 is in the immediate deployment state. Additionally, in the immediate deployment state of the introducer assembly 154, at least a proximal portion of the catheter tube 114 is disposed in the introducer housing 160, thereby providing a no-touch mechanism for not touching and contaminating the catheter tube 114 during venipuncture.

[0113] Figure 8 A lock 180 located in the distal portion of the introducer housing 160 is shown, in accordance with some embodiments.

[0114] As shown, the lock 180 includes a hook 182 located in the slidable component 176 of the introducer housing 160 and a latch 184 located in the fixed component 178 of the introducer housing 160. Each of the hook 182 and the latch 184 can be integral (e.g., molded) with its respective component of the introducer housing; that is, the hook 182 can be integral with the slidable component 176 and the latch 184 can be integral with the fixed component 178. The hook 182 and the latch 184 are configured to lock the slidable component 176 and the fixed component 178 together in the immediate deployment state of the introducer assembly 154.

[0115] The fixed component 178 of the introducer housing 160 also includes a channel 186 that can be molded into the fixed component 178. The channel 186, in turn, includes a latch 184 in a proximal portion of the channel 186 and a ramp 188 in a distal portion of the channel 186. Like the latch 184, the ramp 188 can be integral (e.g., molded) with the fixed component 178. The combination of the ramp 188 and the hook 182 of the slidable component 176 of the introducer housing 160 is configured to advance the slidable component 176 distally relative to the fixed component 178 while simultaneously pushing the slidable component 176 away from the fixed component 178. In effect, advancing the slidable component 176 distally relative to the fixed component 178 while the distal face of the hook 182 engages the proximal face of the ramp 188 lifts the hook 182 out of the channel 186 and pushes the slidable component 176 away from the fixed component 178, thereby longitudinally splitting the introducer housing 160.

[0116] Figure 8 A sliding articulation 190 in a proximal portion of the introducer housing 160 is shown in accordance with some embodiments.

[0117] As shown, the sliding articulation 190 includes a capture tab 192 of the slidable component 176 of the introducer housing 160 and a track 194 in the fixed component 178 of the introducer housing 160. Like the hook 182, the capture tab 192 can be integral (e.g., molded) with the slidable component 176. Like the channel 186, the track 194 can be molded into the fixed component 178. The capture tab 192 is capturedly but slidably disposed in the track 194, allowing the slidable component 176 to be advanced distally relative to the fixed component 178 without the slidable component 176 separating from the fixed component 178 in the proximal portion of the introducer housing 160. That is, advancing the slidable component 176 distally relative to the fixed component 178 causes the slidable component 176 to separate from the fixed component 178 in the distal portion of the introducer housing 160, as described above. In effect, a proximal portion of the capture tab 192 that is inboard of an outer surface of the introducer housing 160 is undercut or radiused, which facilitates the slidable component 176 to smoothly separate from the fixed component 178 in the distal portion of the introducer housing 160 while the slidable component 176 is being advanced distally relative to the fixed component 178.

[0118] As Figure 10 As further shown in FIG. 6, the proximal portion of the introducer housing 160 includes an introducer housing tab 196 and a longitudinal cutout 198 that narrows as the introducer housing 160 tapers from the proximal portion to the distal portion of the introducer housing 160.

[0119] The introducer housing tab 196 is configured to provide a point on the introducer housing 160 against which the side arms 168 of the catheter advancement hub 158 can be pushed as the catheter advancement hub 158 is advanced distally within the introducer housing 160. In effect, the above-described arrangement of the introducer housing tab 196 and the side arms 168 of the catheter advancement hub 158 is such that the slidable component 176 of the introducer housing 160 can be advanced distally relative to the fixed component 178 of the introducer housing 160 by pushing the catheter advancement tab 170, as described above.

[0120] The longitudinal cutout 198 is configured to provide a narrow path for the side arms 168 of the catheter advancement hub 158 to follow as the catheter advancement hub 158 is advanced distally, which in turn is configured to separate the slidable component 176 from the fixed component 178 based on the side arms as the side arms 168 of the catheter advancement hub 158 are advanced distally through the narrow path. For example, as the slidable component 176 is advanced distally relative to the fixed component 178 by the catheter advancement hub 158, when the hooks 182 of the slidable component 176 are lifted out of the channels 186 by the ramps 188 of the fixed component 178, the introducer housing tab 196 pivots over the side arms 168, allowing the side arms 168 to enter the narrow path provided by the longitudinal cutout 198. Because the longitudinal cutout 198 narrows from the proximal portion to the distal portion of the introducer housing 160, the side arms 168 of the catheter advancement hub 158 continue to lift and separate the slidable component 176 from the fixed component 178 until the side arms 168 exit the longitudinal cutout 198. Once the introducer housing 160 has sufficiently split apart and advanced the distal catheter component 104 of the RICC 100 distally from its initial position in the immediately deployed state of the introducer assembly 154, the distal catheter hub component 112 can be used to manually separate the distal catheter hub component 112 from the manifold 166 of the catheter advancement hub 158 and remove the distal catheter component 104 from the introducer housing 160.

[0121] In particular, the introducer housing 160 is configured such that the slidable component 176 and the fixed component 178 are held locked together by the lock 180 of the introducer housing until after the venipuncture when the catheter advancement hub 158 is advanced, as described above.

[0122] Figure 12 A syringe 162 of the introducer 156 is shown in accordance with some embodiments.

[0123] The syringe 162 includes a plunger 200 disposed in a barrel 202 having a distal portion terminating in a syringe tip to which the introducer needle 164 is fluidly coupled and fixedly attached. As Figure 12As best shown, the syringe tip includes a syringe tip connector (e.g., a male luer connector) configured to fluidly couple to the catheter advancement hub 158 via a proximal coupler of the syringe tip connector at least in the immediate deployment state of the introducer assembly 154. Optionally, the syringe tip can include a hub 204 and a side arm 206 coupled to a fluid pressure indicator 228 set forth below. In addition, the syringe 162 includes a syringe housing 208 that surrounds the barrel 202. As set forth below, the syringe housing 208 is configured to hold the syringe 162 around a distal portion of the barrel 202 between a thumb and another finger or fingers (e.g., middle finger or ring finger) of the same hand while reserving a single finger (e.g., index finger) of the hand for actuating the introducer assembly 154. Holding and manipulating the introducer assembly 154 in accordance with the foregoing provides for better control of the introducer assembly 154 and its distal catheter component 104, particularly during venipuncture.

[0124] The syringe housing 208 extends around the distal portion of the barrel 202 of the syringe 162 from a distal end located in a distal portion of the syringe housing 208 to a proximal end located in a proximal portion of the syringe housing 208 that generally coextends with a proximal portion of the barrel 202. The syringe housing 208 can include a gripping portion 210 (e.g., a pattern of protrusions, through holes, etc.) located in the distal portion thereof that is configured to facilitate gripping of the syringe 162, and thus the introducer 156 or introducer assembly 154, around the portion of the barrel 202 between the thumb and the other finger or fingers of the same hand as set forth above. The distal arrangement of the gripping portion 210 around the distal portion of the barrel 202 facilitates holding and manipulating the introducer assembly 154 in a position that provides for better control of a distal portion of the introducer assembly 154 (e.g., the first section 132 of the catheter tube 114 of the distal catheter component 104). In practice, by holding and manipulating the introducer assembly 154 in the foregoing position, small inadvertent deflection or pitch type movements in the first section 132 of the catheter tube 114 remain relatively small compared to the same type of movements when the introducer assembly 154 is held in a more proximal position.

[0125] The syringe housing 208 and the plunger 200 are configured to work together as a single unit to the extent that the syringe 162 is actuated (e.g., to withdraw the plunger 200 for the blood draw steps set forth below). The syringe housing 208 and the plunger 200, or end piece 220 thereof, can be molded together as a unitary 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 the plunger 200, or end piece 220 thereof, can be molded separately and then coupled together in a coupling piece such that the proximal portion of the syringe housing 208 is coupled to the proximal portion of the plunger 200, or end piece 220 thereof. For example, an inner wall in the proximal end of the syringe housing 208 can be bonded or welded to the plunger flange of the distal end of the plunger 200, or end piece 220 thereof. Whether the syringe housing 208 and the plunger 200 are integral 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.

[0126] The syringe 162 can also include a plunger withdrawal tab 212 that extends proximally from the distal portion of the barrel 202 (e.g., the syringe tip) to which it is coupled, e.g., by a ring-type coupling. (See Figure 11 .) The plunger withdrawal tab 212 is configured for use when actuating the syringe 162 as described above. In practice, the plunger withdrawal tab 212 is configured to be pushed with a single finger (e.g., the index finger) of the same hand while the syringe housing 208 is held between the thumb and another finger or fingers (e.g., the middle and ring fingers) of the same hand around the distal portion of the barrel 202, which slides the syringe housing 208 proximally relative to the barrel 202 and withdraws the plunger 200 from the barrel 202.

[0127] Figure 11 A longitudinal cross-section of a portion of the syringe 162 is shown in accordance with some embodiments.

[0128] As shown, the syringe 162 also includes a syringe portion of the access guidewire lumen 214 that is formed by the plunger lumen of the plunger 200, the syringe tip lumen of the syringe tip, and a fluid connection portion of any space within the barrel 202 that is formed by partially pulling the plunger 200 out of the barrel 202, e.g., in the working state of the introducer assembly 154 (e.g., during the blood draw steps of the method set forth above). Another portion of the access guidewire lumen 214 is the introducer needle portion of the access guidewire lumen 214, i.e., the needle lumen of the introducer needle 164.

[0129] The plunger 200 includes a sealing mechanism 216 located in the distal portion of the plunger 200 for sealing the guidewire lumen 214 distal to the sealing mechanism 216. The sealing mechanism 216 is configured to seal the guidewire lumen 214 to maintain a vacuum for blood aspiration when the plunger 200 is withdrawn from the syringe 202. The sealing mechanism 216 is also configured to seal the guidewire lumen 214 to prevent blood from leaking (e.g., backflow) through the longitudinal slots of the syringe 202 and plunger 200 during venipuncture or while withdrawing the guidewire 222 (described below) from the patient's vascular lumen, thereby minimizing or preventing the possibility of contamination of the surgical area or any clinician within the surgical area.

[0130] like Figure 5 As shown, the sealing mechanism 216 may be a cartridge, which is disposed in a cavity in the distal portion of the body 218 of the plunger 200 and held in the cavity by the end member 220 of the plunger 200. The cartridge is coaxially aligned with the guidewire inlet cavity 214 or a portion of its plunger cavity such that the unwound bare portion of the guidewire 222 passes through the proximal and distal through-holes of the cartridge, which have an inner diameter corresponding to the outer diameter of the bare portion of the guidewire 222. Optionally, the sealing mechanism 216 includes one or more washers, such as O-rings, located within the cartridge or as an alternative to the cartridge. Instead of a cartridge, for example, one or more O-rings may be axially compressed within the cavity by the end member 220 of the plunger 200, which in turn radially compresses the O-rings around the guidewire 222, thereby sealing the guidewire inlet cavity 214.

[0131] Figure 10 A side view of the guide assembly 154 in another operational state according to some embodiments is shown, wherein the inlet guidewire 222 is advanced through the distal end of the distal catheter component 104.

[0132] The entry guide wire 222 is capturedly disposed in the introducer 156 such that at least a portion of the entry guide wire 222 is always located in a portion of the entry guide wire 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 entry guide wire 222 is withdrawn to its proximal limit (e.g., defined by the proximal end of the longitudinal slot set forth below), a proximal portion of the entry guide wire 222 is disposed in at least a proximal portion of the plunger lumen. At the same time, a distal portion of the entry guide wire 222 is disposed in a distal portion of the needle lumen. When the introducer assembly 154 is in at least its immediate deployment state, a proximal portion of the entry guide wire 222 is disposed in an intermediate portion of the plunger lumen, and a distal portion of the entry guide wire 222 remains disposed in a distal portion of the needle lumen; however, the distal end of the entry guide wire 222 is advanced in the needle lumen such that the distal end of the entry guide wire 222 just misses the needle tip 140. And when the entry guide wire 222 is advanced to its distal limit (e.g., defined by the distal end of the longitudinal slot set forth below) in some of the working states of the introducer assembly 154 (e.g., during the entry guide wire advancement step of the method set forth below), a proximal portion of the entry guide wire 222 is disposed in a distal portion of the plunger lumen. At the same time, due to its length, the distal end of the entry guide wire 222 extends through or beyond the distal catheter component 104, which is sufficient to extend the entry guide wire 222 into the patient's vascular lumen when access to the patient's vascular lumen is established after the needle path establishment step set forth below.

[0133] The syringe 162 also includes a slider 224 (e.g., a protruding slider) extending distally on the syringe housing 208 from underneath the syringe housing 208 on the needle barrel 202. The slider 224 is configured to be actuated with a single finger (e.g., an index finger) of the same hand that is holding the distal portion of the syringe housing 208 between the thumb and another finger or fingers (e.g., the middle finger and the ring finger) of the same hand (e.g., a roller-like motion with the finger similar to that used on a computer mouse). The slider 224 includes an extension 226 that extends through a longitudinal slot (not shown) in each of the needle barrel 202 and the plunger 200 into the entry guide wire lumen 214 proximal of the seal mechanism 216, where the extension 226 is coupled to the entry guide wire 222. The proximal and distal ends of the longitudinal slot provide stops for the extension 226 and thus provide a limited track in which the extension 226 can move proximally or distally, thereby providing proximal and distal limits for withdrawing or advancing the entry guide wire 222 from or into the introducer 156, respectively.

[0134] ​ The syringe 162 of the introducer 156 is shown including a fluid pressure indicator 228, in accordance with some embodiments.

[0135] As shown, a fluid pressure indicator 228, when present, extends from the side arm 206 of the hub 204. The fluid pressure indicator 228 includes a closed end and an open end fluidly coupled to the needle lumen of the introducer needle 164 through the side arm lumen of the side arm. The fluid pressure indicator 228 is configured as an in-line accidental arterial indicator, wherein blood at sufficient pressure (e.g., arterial blood) can enter the fluid pressure indicator 228 and compress an air column within the fluid pressure indicator 228. However, blood reflux from venipuncture can also be observed in the fluid pressure indicator 228 in some cases. That said, blood reflux from venipuncture is typically observed in the hub 204, the side arm of the hub 204, or the syringe 162.

[0136] Method

[0137] The methods of the RICC system provided herein include at least a method of using the RICC system. Such a method of using the RICC system can include a RICC system obtaining step, a needle tract establishing step, a first RICC advancing step, an introducer housing splitting step, and an introducer removing step.

[0138] The RICC system obtaining step includes obtaining a RICC system. As described above, the RICC system includes the proximal catheter component 102 of the RICC 100 and the introducer assembly 154. The introducer assembly 154, in turn, includes the distal catheter component 104 of the RICC 100 disposed partially in the introducer housing 160 of the introducer 156.

[0139] The method can also include a needle tip assurance step prior to the needle tract establishing step. Again, the introducer needle 164 has a needle shaft extending through the distal end of the distal catheter component 104 in the immediately deployed state of the introducer assembly 154. The needle tip assurance step includes assuring that the needle tip 140 extends from the distal end of the distal catheter component 104 prior to the needle tract establishing step.

[0140] The method can also include a priming step prior to the needle tract establishing step. The priming step includes priming the distal catheter component 104 with a common syringe through the catheter side arm 168 prior to the first RICC advancing 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 corresponding one or more lumens of the distal catheter component 104.

[0141] The needle path establishing step includes establishing a needle path from the skin area to the intravascular lumen of the patient with the guide needle 164 of the introducer. The needle path establishing step is performed while the distal portion of the syringe 162 of the introducer 156 is held between the thumb and another finger or fingers (e.g., the ring and middle fingers) of one hand. At the same time, at least a single finger (e.g., the index finger) of the same hand is held available to actuate the introducer assembly 154.

[0142] The needle path establishing step can also include ensuring blood backflow into the hub 204, the side arm of the hub 204, or the fluid pressure indicator 228 extending from the side arm of the hub 204 while the needle path is established.

[0143] The method also includes a blood aspiration step. The blood aspiration step includes aspirating blood with the syringe 162 prior to the introducer removal step to confirm that the needle tip 140 of the guide needle 164 is disposed in the intravascular lumen. The blood aspiration step includes pushing the plunger withdrawal tab 212 with a single finger of the same hand while the distal portion of the syringe 162 is held between the thumb and another finger or fingers of one hand by the syringe housing 208 on the barrel 202 of the syringe 162. The plunger withdrawal tab 212 extends from the distal portion of the syringe 162 on the barrel 202 such that pushing the plunger withdrawal tab while the distal portion of the syringe 162 is held by the syringe housing 208 causes the syringe housing 208 to slide proximally relative to the barrel 202 and causes the plunger 200 connected to the syringe housing to withdraw from the barrel 202.

[0144] The method can also include an access guidewire advancing step. The access guidewire advancing step includes advancing the access guidewire 222 disposed in the access guidewire lumen 214 into the intravascular lumen beyond the distal end of the distal catheter component 104. As described above, the access guidewire lumen 214 is formed by at least the plunger lumen of the syringe 162 and the needle lumen of the guide needle 164, and the distal end of the access guidewire 222 just misses the needle tip 140 in the needle lumen, which facilitates the first successful puncture by making the access guidewire 222 immediately available before the intravascular lumen can be lost due to small inadvertent movements. Additionally, the slide 224 is coupled to the access guidewire 222 such that advancing the slide 224 distally with a single finger of the same hand while the distal portion of the syringe housing 208 is held between the thumb and another finger or fingers of one hand advances the access guidewire 222 into the intravascular lumen. The access guidewire advancing step is performed prior to the first RICC advancing step.

[0145] The first RICC advancement step includes advancing a distal portion of the first section 132 of the catheter tube 114 of the distal catheter component 104 over the needle shaft into the endovascular lumen. As noted above, the catheter tube 114 includes the first section 132 formed of a first material having a first stiffness and the second section 134 formed of a second material having a second stiffness that is less than the first stiffness. The first section 132 of the catheter tube 114 is configured with a certain column strength for advancing the catheter tube 114 over the access or steering guidewire 222 into the endovascular lumen after the steering guidewire advancement step set forth below.

[0146] The first RICC advancement step includes advancing a distal portion of the first section 132 of the catheter tube 114 of the distal catheter component 104 over the needle shaft into the endovascular lumen. As noted above, the catheter tube 114 includes the first section 132 formed of a first material having a first stiffness and the second section 134 formed of a second material having a second stiffness that is less than the first stiffness. The first section 132 of the catheter tube 114 is configured with a certain column strength for advancing the catheter tube 114 over the access or steering guidewire 222 into the endovascular lumen after the steering guidewire advancement step set forth below.

[0147] The introducer housing splitting step includes unlocking the lock 180 located in the distal portion of the introducer housing 160 and then splitting the introducer housing 160 along its length. Unlocking the lock 180 includes disengaging the hook 182 of the slidable component 176 of the introducer housing 160 from the latch 184 of the fixed component 178 of the introducer housing 160 by sliding the slidable component 176 distally relative to the fixed component 178. While the lock 180 can be manually unlocked by sliding the slidable component 176 relative to the fixed component 178, the introducer assembly 154 is configured such that the catheter advancement pusher 170 of the catheter advancement hub 158 pushes against the introducer housing tab 196 which causes the slidable component 176 to slide relative to the fixed component 178. Unlocking the lock 180 according to the latter while holding the introducer assembly 154 around the distal portion of the syringe 162 minimizes issues related to over-handling of the introducer assembly 154 such as fumbling and dropping the introducer assembly 154 or contaminating any exposed portion of the catheter tube 114 of the distal catheter component 104 in the introducer assembly 154.

[0148] To split the introducer housing 160, the fixed component 178 of the introducer housing 160 includes a channel 186 that includes a latch 184 in a proximal portion of the channel 186 and a ramp 188 in a distal portion of the channel 186, as described above. Sliding the slidable component 176 distally relative to the fixed component 178 causes the distal face of the hook 182 to engage the proximal face of the ramp 188 and, as the hook 182 is lifted out of the channel 186, the introducer housing 160 splits along its length. While the introducer housing 160 can be manually split by sliding the slidable component 176 relative to the fixed component 178, the introducer assembly 154 is configured such that pushing the catheter advancement pusher 170 of the catheter advancement hub 158 causes the side arms 168 of the catheter advancement hub 158 to advance along a path provided by a longitudinal cut 198 of the introducer housing 160. Because the longitudinal cut 198 narrows from a proximal portion to a distal portion of the introducer housing 160, the side arms 168 of the catheter advancement hub 158 continue to lift and separate the slidable component 176 from the fixed component 178 until the side arms 168 exit the longitudinal cut 198.

[0149] The introducer removal step includes removing the distal catheter component 104 from the introducer housing 160, withdrawing the introducer 156 from the distal catheter component 104, and leaving the distal portion of the first section 132 of the catheter tube 114 in place in the endovascular lumen. Withdrawing the introducer 156 from the distal catheter component 104 includes withdrawing both the needle shaft and the access guidewire 222 from the distal catheter component 104.

[0150] The method also includes a catheter hub clamping step. The catheter hub clamping step includes clamping the proximal catheter hub component 106 of the proximal catheter component 102 and the proximal catheter hub component 106 of the distal catheter component 104 together. The catheter hub clamping step connects one or more extension leg lumens coupled to the one or more extension legs 110 of the proximal catheter hub component 106 to one or more catheter tube lumens of the catheter tube 114, respectively, thereby forming the RICC 100 and its lumen through the two-piece catheter hub 108.

[0151] The method can also include a steering guidewire advancement step. The steering guidewire advancement step includes advancing a steering guidewire through a first lumen 142 of the RICC 100 into the endovascular lumen to a target location (e.g., the SVC) in the vasculature of the patient, the first lumen having a first lumen aperture 144 in a distal end of the RICC 100.

[0152] The method can also include a second RICC advancement step and a steering guidewire removal step. The second RICC advancement step includes further advancing the remaining portion of the distal portion of the first section 132 of the catheter tube 114 into the blood vessel lumen using the steering guidewire as a guide until the proximal portion of the second section 134 of the catheter tube 114. For the second RICC advancement step, the steering guidewire provides column strength to the second section 134 of the catheter tube 114. The second RICC advancement step stops relative to advancement when the distal end of the distal catheter component 104 reaches the target location (e.g., the SVC). The steering guidewire removal step includes withdrawing the steering guidewire and leaving the catheter tube 114 in place within the patient.

[0153] While certain specific embodiments have been disclosed herein, and while the specific embodiments have been disclosed in some detail to provide a thorough understanding thereof, it will be apparent that alternatives and modifications will occur to those of ordinary skill in the art. These alternatives and modifications are intended to be encompassed within the scope of the concepts provided herein. Accordingly, changes can be made in the particular embodiments disclosed, which are encompassed within the scope of the concepts provided herein.

Claims

1. A system for rapid insertion of a central catheter, characterized in that, include: A distal catheter component that allows for rapid insertion of a central catheter, the distal catheter component comprising: The distal catheter bushing component of a two-piece catheter bushing; and A catheter body including one or more catheter body lumens, the catheter body being coupled to the distal catheter liner assembly via a proximal portion of the catheter body; and a guide configured to be combined with the distal catheter assembly in a guide assembly having an immediately deployable state, the guide assembly being configured to be actuated using a single finger of one hand while holding the guide between the thumb and one or more other fingers of the hand, the guide comprising: A catheter advance bushing, comprising a manifold and a side arm, is coupled to the proximal portion of the distal catheter bushing assembly in the immediate deployment state of the guide assembly. A guide needle having a needle shaft that extends through the manifold and the distal end of the distal catheter component in the immediate deployment state of the guide assembly; A syringe comprising a syringe barrel having a distal portion terminating at a syringe tip, the syringe being fluidly connected to the guide needle; and The guide housing, in the immediately deployed state of the guide assembly, is positioned above the syringe tip, the manifold, and the proximal portion of the distal catheter component, and is configured as follows: During intravenous puncture of a patient using the guide, column strength is provided to the catheter body; and The longitudinal split allows the distal catheter component to be removed from the guide housing after venous puncture.

2. The rapidly insertable central catheter system according to claim 1, characterized in that, The guide housing includes a lock in the distal portion of the guide housing, the lock comprising a hook of a slidable part of the guide housing and a latch of a fixed part of the guide housing, the hook and the latch being configured to lock the slidable part and the fixed part together in an immediately deployed state of the guide assembly.

3. The rapidly insertable central catheter system according to claim 2, characterized in that, The fixing member of the guide housing includes a channel, the channel including a latch in a proximal portion of the channel and a ramp in a distal portion of the channel, the hook and the ramp being configured to push the slidable member of the guide housing away from the fixing member while the slidable member is advanced distally relative to the fixing member, and when the distal side of the hook engages the proximal side of the ramp.

4. The rapidly insertable central catheter system according to claim 2, characterized in that, The guide housing includes a sliding hinge in the proximal portion of the guide housing, the sliding hinge including a capturing tab of the slidable component of the guide housing and a track of the fixed component of the guide housing, the capturing tab being captured and slidably arranged in the track, allowing the slidable component to be advanced distally relative to the fixed component, while keeping the slidable component from separating from the fixed component in the proximal portion of the guide housing.

5. The rapidly insertable central catheter system according to claim 4, characterized in that, The proximal portion of the capturing tab on the inner side of the outer surface of the guide housing is rounded so as to allow the sliding component of the guide housing to split from the fixed component of the guide housing in the distal portion of the guide housing.

6. The rapidly insertable central catheter system according to claim 4, characterized in that, The proximal portion of the guide housing includes a longitudinal cut configured to provide a path for the side arm of the catheter advance bushing while simultaneously advancing the catheter advance bushing distally within the guide housing.

7. The rapidly insertable central catheter system according to claim 1, characterized in that, The manifold includes one or more manifold lumens equal in number to the lumen of the one or more catheter bodies, wherein the one or more manifold lumens are fluidly connected to the lumen of the one or more catheter bodies in the immediate deployment state of the guide assembly.

8. The rapidly insertable central catheter system according to claim 7, characterized in that, The side arm of the catheter advancement bushing includes a side arm lumen fluidly connected to the lumen of the one or more manifolds, so as to simultaneously fill each lumen of the one or more catheter body lumens before inserting the catheter body into the patient's vascular lumen.

9. The rapidly insertable central catheter system according to claim 1, characterized in that, The catheter advance liner also includes a catheter advance pusher extending from the side arm, the catheter advance pusher being configured to advance the catheter advance liner distally using a single finger of one hand, while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe.

10. The rapidly insertable central catheter system according to claim 1, characterized in that, It also includes the proximal catheter component for rapid insertion of the central catheter, the proximal catheter component comprising: The proximal catheter liner component of the two-piece catheter liner; and One or more extension legs, each including one or more extension leg lumens, each of the one or more extension legs being coupled to the proximal catheter bushing assembly via a distal portion of the extension leg, wherein the quick-insertion central catheter is in a connected state, in which the proximal catheter bushing assembly is connected to the distal catheter bushing assembly such that the one or more extension leg lumens are fluidly coupled to the one or more catheter body lumens across the two-piece catheter bushing.

11. The rapidly insertable central catheter system according to claim 10, characterized in that, The quick-insertion central catheter, in its connected state, comprises a group of three lumens, the group of three lumens including a first lumen, a second lumen, and a third lumen.

12. The rapidly insertable central catheter system according to claim 11, characterized in that, The first lumen has a first lumen hole in the distal end of the two-piece catheter, the second lumen has a second lumen hole in the catheter body on the side proximal to the first lumen hole, and the third lumen has a third lumen hole in the catheter body on the side proximal to the second lumen hole.

13. The rapidly insertable central catheter system according to claim 1, characterized in that, The catheter body also includes: The first segment is formed of a first material having a first hardness; and The second section, formed of a second material having a second hardness less than the first hardness, thereby configuring the catheter body with column strength for inserting the catheter body into the patient and compliance for advancing the catheter body through the patient's vascular system.

14. The rapidly insertable central catheter system according to claim 1, characterized in that, The guide also includes a syringe housing surrounding the syringe barrel, the syringe housing having a distal portion and a proximal portion, the proximal portion of the syringe housing being integrally formed with or connected to a proximal portion of a plunger disposed in the syringe barrel, such that the syringe housing slides proximally relative to the syringe barrel to retract the plunger from the syringe barrel.

15. The rapidly insertable central catheter system according to claim 14, characterized in that, The syringe also includes a plunger retraction pusher that extends proximally from a distal portion of the syringe barrel to which the plunger retraction pusher is coupled, the plunger retraction pusher being configured to be pushed using a single finger of one hand while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe barrel to slide the syringe housing proximally relative to the syringe barrel and retract the plunger from the syringe barrel.

16. The rapidly insertable central catheter system according to claim 14, characterized in that, The guide also includes an entry guidewire disposed in an entry guidewire lumen, the entry guidewire lumen being formed at least by a plunger lumen of the plunger and a needle lumen of the guide needle, the entry guidewire having a length sufficient to allow the entry guidewire to extend through the distal end of the distal catheter component.

17. The rapidly insertable central catheter system according to claim 16, characterized in that, The guide also includes a slider extending distally from the syringe housing over the syringe barrel, the slider being configured to actuate the inlet guidewire with a single finger of one hand while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe barrel, the slider including an extension extending through a longitudinal slot in each of the syringe barrel and the plunger into the inlet guidewire lumen, in which the extension is coupled to the inlet guidewire.

18. A guide for rapid insertion of a central catheter, characterized in that, include: A catheter advance bushing, comprising a manifold and a side arm, is configured to be coupled in the guide assembly to the distal catheter component of the rapidly insertable central catheter. A guide needle having a needle shaft configured to extend through the manifold and the distal end of the distal catheter component in an immediately deployed state of the guide assembly; A syringe, fluidly connected to the guide needle, the syringe including a syringe barrel having a distal portion terminating at the tip of the syringe, the syringe configured to be held around the distal portion of the syringe barrel between the thumb of one hand and one or more other fingers, while reserving a single finger for actuating the guide needle; and The guide housing, in the immediately deployed state of the guide assembly, is positioned above the syringe tip, the manifold, and the proximal portion of the distal catheter component, and is configured as follows: During intravenous puncture of the patient using the guide, column strength is provided to the catheter body of the distal catheter component; and The longitudinal split allows the distal catheter component to be removed from the guide housing after venous puncture.

19. The guide according to claim 18, characterized in that, The guide housing includes a lock in the distal portion of the guide housing, the lock including a hook of a slidable part of the guide housing and a latch of a fixed part of the guide housing, the hook and the latch being configured to lock the slidable part and the fixed part together.

20. The guide according to claim 19, characterized in that, The fixing member of the guide housing includes a channel, the channel including a latch in a proximal portion of the channel and a ramp in a distal portion of the channel, the hook and the ramp being configured to push the slidable member of the guide housing away from the fixing member while the slidable member is advanced distally relative to the fixing member, and when the distal side of the hook engages the proximal side of the ramp.

21. The guide according to claim 19, characterized in that, The guide housing includes a sliding hinge in a proximal portion of the guide housing, the sliding hinge including a capture tab of the slidable component of the guide housing and a track of the fixed component of the guide housing, the capture tab being captured and slidably arranged in the track, allowing the slidable component to be advanced distally relative to the fixed component, while the slidable component is not separated from the fixed component in the proximal portion of the guide housing.

22. The guide according to claim 21, characterized in that, The proximal portion of the capturing tab on the inner side of the outer surface of the guide housing is rounded so as to allow the sliding component of the guide housing to split from the fixed component of the guide housing in the distal portion of the guide housing.

23. The guide according to claim 21, characterized in that, The proximal portion of the guide housing includes a longitudinal cut configured to provide a path for the side arm of the catheter advance bushing while simultaneously advancing the catheter advance bushing distally within the guide housing.

24. The guide according to claim 18, characterized in that, The side arm of the catheter advance bushing includes a side arm lumen fluidly connected to one or more manifold lumens so that, in the immediate deployment state of the guide assembly, each of one or more lumens of the distal catheter component capable of rapid insertion into the central catheter is simultaneously filled.

25. The guide according to claim 18, characterized in that, The catheter advance liner also includes a catheter advance pusher extending from the side arm, the catheter advance pusher being configured to advance the catheter advance liner distally using a single finger of one hand, while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe.

26. The guide according to claim 18, characterized in that, The guide also includes a syringe housing surrounding the syringe barrel, the syringe housing having a distal portion and a proximal portion, the proximal portion of the syringe housing being integrally formed with or connected to a proximal portion of a plunger disposed in the syringe barrel, such that the syringe housing slides proximally relative to the syringe barrel to retract the plunger from the syringe barrel.

27. The guide according to claim 26, characterized in that, The syringe also includes a plunger retraction pusher that extends proximally from a distal portion of the syringe barrel to which the plunger retraction pusher is coupled, the plunger retraction pusher being configured to be pushed using a single finger of one hand while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe barrel to slide the syringe housing proximally relative to the syringe barrel and retract the plunger from the syringe barrel.

28. The guide according to claim 26, characterized in that, The guide also includes an entry guidewire disposed in an entry guidewire lumen, the entry guidewire lumen being formed at least by a plunger lumen of the plunger and a needle lumen of the guide needle, the entry guidewire having a length sufficient to extend through the distal end of the distal catheter component in the immediate deployment state of the guide assembly.

29. The guide according to claim 28, characterized in that, The guide also includes a slider extending distally from the syringe housing over the syringe barrel, the slider being configured to actuate the inlet guidewire with a single finger of one hand while holding the syringe between the thumb and one or more other fingers of the hand around the distal portion of the syringe barrel, the slider including an extension extending through a longitudinal slot in each of the syringe barrel and the plunger into the inlet guidewire lumen, in which the extension is coupled to the inlet guidewire.

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