CATHETER ASSEMBLY FOR DIRECT INSERTION INTO A VASCULAR LUMEN OF A PATIENT - Patent application

Abstract

A rapid insertion central venous catheter (RICC) (102) and method thereof are disclosed, including a catheter assembly (100). The RICC assembly (100) can include the RICC (102), an introducer (104), and a coupling system (106) configured to couple the RICC and the introducer. The catheter tube (108) of the RICC includes a side opening (116) at a distal end portion of the catheter tube (108), the side opening opening into an introducer lumen (124) that extends to the distal end of the RICC. The introducer (104) has an introducer needle (146) that extends through the distal end of the RICC (102) when the RICC assembly (100) is in at least its ready-to-deploy state. The introducer is configured to be actuated with one finger while its distal end portion is held between the thumb and one or more fingers. The coupling system (106) includes a distal coupler slidably mounted on the catheter tube proximal to the side opening (116).

Description

[Technical Field]

[0001] The present invention relates to a rapid insertion central venous catheter including a catheter assembly and method thereof. [Background technology]

[0002] Central venous catheters (CVCs) are typically constructed from materials with relatively low durometer hardness, making them compliant but lacking the column strength for direct insertion. Due to this lack of column buckling strength, CVCs are typically introduced into a patient's body and advanced through the vasculature using the Seldinger technique. The Seldinger technique involves many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the many steps are time-consuming, and the handling of numerous medical devices is cumbersome, all of which can potentially cause trauma to the patient. Additionally, the large number of medical devices that need to be replaced during the multiple steps of the Seldinger technique increases the likelihood of contact contamination. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient's body and advancing it through the vasculature.

[0003] Disclosed herein are rapidly insertable central catheters ("RICCs") including catheter assemblies and methods that address the above. Summary of the Invention

[0004] Disclosed herein is a RICC assembly for direct insertion into a patient's vascular lumen. In some embodiments, the RICC assembly includes a RICC, an introducer, and a coupling system. The RICC includes a catheter tube, a catheter hub, and one or more extension legs. The catheter tube includes a side opening through a side of the catheter tube at a distal end portion thereof. The side opening opens into an introducer lumen of the catheter tube, which extends at least from the side opening to the distal end of the RICC. The catheter hub is coupled to a proximal end portion of the catheter tube. Each extension leg of the one or more extension legs is coupled to the catheter hub at its distal end portion. The introducer includes an introducer needle. The introducer needle has a needle shaft that extends through the distal end of the RICC when the RICC assembly is in at least its ready-to-deploy state. The introducer is configured to be manipulated with one finger while its distal end portion is held with a thumb and one or more other fingers. The coupling system is configured to couple the RICC and the introducer, and includes a distal coupler slidably mounted on the catheter tube proximal to the side opening.

[0005] In some embodiments, the catheter tube further includes a first section and a second section, and the side opening is proximal to the first section of the catheter tube. The first section of the catheter tube is formed from a first material, and the second section is formed from a second material. The first material has a first durometer hardness, and the second material has a second durometer hardness that is less than the first durometer hardness. This provides the catheter tube with both column buckling strength and compliance for entering a blood vessel lumen and passing through a patient's vascular system.

[0006] In some embodiments, the needle shaft further extends through the longitudinal through-hole of the distal coupler, through a side opening in the catheter tube, along the introducer lumen of the catheter tube, and out the distal end of the RICC when the RICC assembly is in at least its ready-to-deploy state.

[0007] In some embodiments, the distal coupler includes a push tab configured to allow a clinician to one-handedly advance the RICC from the needle shaft using one finger while holding the distal end portion of the introducer between the thumb and one or more fingers.

[0008] In some embodiments, the introducer further includes a syringe. The syringe includes a barrel, a plunger disposed within the barrel, and a syringe housing surrounding the barrel. The barrel has a syringe tip at its distal end portion that is coupled to the needle hub of the introducer needle, at least in the ready-to-deploy state of the RICC assembly. The syringe housing has a distal end portion and a proximal end portion. The proximal end portion of the syringe housing is integral with or coupled to the proximal end portion of the plunger so that the plunger is withdrawn from the barrel by sliding the syringe housing proximally relative to the barrel.

[0009] In some embodiments, the syringe further comprises a push tab extending proximally on the barrel from the distal end portion of the coupled barrel, the push tab being configured to be pressed with one finger while holding the distal end portion of the syringe housing with a thumb and one or more other fingers, thereby sliding the syringe housing proximally relative to the barrel and withdrawing the plunger from the barrel.

[0010] In some embodiments, the introducer further includes an access guidewire disposed within the access guidewire lumen. The access guidewire lumen is formed from at least a plunger lumen of the plunger and a needle lumen of the introducer needle. The access guidewire has a length sufficient to extend from the distal end of the RICC to the patient's vascular lumen.

[0011] In some embodiments, the plunger includes a sealing mechanism at its distal end portion that seals the access guidewire lumen distally thereto, the sealing mechanism being configured to maintain a vacuum to aspirate blood as the plunger is withdrawn from the barrel.

[0012] In some embodiments, the syringe further includes a slider extending distally from the syringe housing over the barrel. The slider is configured to allow actuation of the access guidewire with one finger while holding the distal end portion of the syringe housing between the thumb and one or more fingers. The slider includes an extension that extends through longitudinal slots in the barrel and plunger and into the access guidewire lumen proximal to the sealing mechanism, the extension being coupled to the access guidewire.

[0013] In some embodiments, the introducer further includes a fluid pressure indicator extending from the side arm of the needle hub, the fluid pressure indicator being fluidly coupled to the needle lumen of the introducer needle via the side arm lumen of the side arm for monitoring blood flashback due to accidental arterial puncture.

[0014] In some embodiments, the coupling system further includes a proximal coupler coupled to the syringe and slidably attached to the catheter hub at least in a ready-to-deploy state of the RICC assembly, the coupling system being configured to allow the RICC to slide relative to the introducer.

[0015] In some embodiments, the proximal coupler includes a catheter hub clip, and the RICC is configured to be suspended from the catheter hub clip by the catheter hub at least in a ready-to-deploy state of the RICC assembly, and the RICC is configured to be suspended from the catheter hub clip by the one or more extension legs when the proximal coupler is advanced over the one or more extension legs in an actuated state of the RICC assembly.

[0016] In some embodiments, the RICC further includes a collapsible catheter tube sterility barrier that covers the catheter tube between the catheter hub and the distal coupler, the catheter tube sterility barrier being coupled to the distal coupler, the catheter-tube sterility barrier being configured to separate when a sterile barrier pull tab of the catheter-tube sterility barrier is removed from the catheter-hub clip and the catheter-tube sterility barrier is pulled away from the catheter tube by the sterile barrier pull tab.

[0017] In some embodiments, the catheter tube sterility barrier has sufficient tensile strength when torn to the distal coupler while being pulled away from the catheter tube to pull the distal coupler away from the catheter tube without breaking.

[0018] In some embodiments, the RICC includes a three-lumen set having a primary lumen, a secondary lumen, and a tertiary lumen. The three-lumen set is formed from fluidly connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens. The catheter tube's introducer lumen is coincident with the distal end portion of the primary lumen.

[0019] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the RICC, the secondary lumen has a secondary lumen opening on the side of the catheter tube distal to the side opening, and the tertiary lumen has a tertiary lumen opening on the side of the catheter tube distal to the side opening but proximal to the secondary lumen opening.

[0020] In some embodiments, the RICC further includes a navigation guidewire disposed within the primary lumen. The navigation guidewire has a length sufficient to extend the navigation guidewire to the lower third of the superior vena cava of the heart. The navigation guidewire is anchored within the RICC by a stop around the proximal end portion of the navigation guidewire and a closed end of a fixed-length navigation guidewire sterile barrier connected to a Luer connector. The stop provides a distal limit for advancing the navigation guidewire. The closed end of the navigation guidewire sterile barrier around the navigation guidewire provides a proximal limit for withdrawing the navigation guidewire.

[0021] Also disclosed herein is a syringe. The syringe includes a barrel, a plunger disposed within the barrel, and a syringe housing surrounding the barrel. The barrel has a syringe tip at its distal end portion. The syringe housing has a distal end portion and a proximal end portion. The proximal end portion of the syringe housing is integral with or coupled to the proximal end portion of the plunger so that the plunger is withdrawn from the barrel by sliding the syringe housing proximally relative to the barrel. The syringe is configured to be actuated with one finger while the distal end portion of the syringe is held between the thumb and one or more fingers.

[0022] In some embodiments, the syringe further comprises a push tab extending proximally on the barrel from the distal end portion of the coupled barrel, the push tab being configured to be pressed with one finger while holding the distal end portion of the syringe housing between a thumb and a finger(s), thereby sliding the syringe housing proximally relative to the barrel and withdrawing the plunger from the barrel.

[0023] In some embodiments, the syringe further includes an access guidewire disposed within the access guidewire lumen, the access guidewire lumen being formed from at least the plunger lumen of the plunger, the access guidewire having a length sufficient to allow the access guidewire to extend through the syringe tip and into the patient's vascular lumen.

[0024] In some embodiments, the plunger includes a sealing mechanism at its distal end portion that seals the access guidewire lumen distally thereto, the sealing mechanism being configured to maintain a vacuum to aspirate blood as the plunger is withdrawn from the barrel.

[0025] In some embodiments, the syringe further includes a slider extending distally from the syringe housing over the barrel. The slider is configured to allow actuation of the access guidewire with one finger while holding the distal end portion of the syringe housing between the thumb and one or more fingers. The slider includes an extension that extends through longitudinal slots in the barrel and plunger and into the access guidewire lumen proximal to the sealing mechanism, the extension being coupled to the access guidewire.

[0026] Also disclosed herein is a method for inserting a RICC into a patient's vascular lumen. The method includes a RICC assembly acquisition step, a needle path establishment step, a first RICC advancement step, and a needle withdrawal step. The RICC assembly acquisition step includes acquiring a RICC assembly. The RICC assembly includes a RICC, an introducer including a syringe coupled to an introducer needle, and a coupling system having a distal coupler that couples the RICC and the introducer at a distal end portion thereof when the RICC assembly is in a ready-to-deploy state. The needle path establishment step includes establishing a needle path from an area of ​​the patient's skin to the vascular lumen using the needle shaft of the introducer needle while holding a distal end portion of a syringe housing around a barrel of the syringe between a thumb and one or more fingers, while at least one finger is readily available. The needle shaft extends through the longitudinal through-hole of the distal coupler, through a side opening of the distal end portion of the catheter tube of the RICC, along the introducer lumen of the catheter tube, and exits the distal end of the RICC to establish a needle path. The first RICC advancement step includes advancing the distal end portion of the first section of the catheter tube over the needle shaft into the blood vessel lumen. The needle withdrawal step includes withdrawing the needle shaft from the introducer lumen through the side opening of the catheter tube.

[0027] In some embodiments, the method further includes a blood drawing step, which includes drawing blood with the syringe to confirm that the needle tip is positioned in the lumen of the patient's blood vessel before the needle withdrawal step. The blood drawing step includes holding the distal end portion of the syringe housing between a thumb and one or more fingers, pressing a push tab extending from the distal end portion of the barrel onto the barrel with one finger, sliding the syringe housing proximally relative to the barrel, and withdrawing the plunger connected to the syringe housing from the barrel.

[0028] In some embodiments, the first RICC advancement step includes advancing the catheter tube into the vascular lumen by using a push tab on the distal coupler with one finger while holding the distal end portion of the syringe housing around the barrel of the syringe between the thumb and one or more fingers.

[0029] In some embodiments, the first RICC advancement step includes advancing a catheter hub of the RICC through a catheter hub clip of a proximal coupler of the coupling system, followed by advancing one or more extension legs of the RICC within the catheter hub clip, wherein the RICC is configured to suspend from the coupling system at least until the needle shaft is withdrawn from both the introducer lumen and the longitudinal through-hole of the distal coupler.

[0030] 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 formed from at least the plunger lumen of the syringe and the needle lumen of the introducer needle past the tip of the introducer needle and into the lumen of the blood vessel. The access guidewire advancing step occurs before the first RICC advancing step. The access guidewire advancing step includes advancing a slider coupled to the access guidewire distally over the barrel with one finger while holding a distal end portion of the syringe housing between a thumb and one or more fingers.

[0031] In some embodiments, the method further includes a steering guidewire advancement step, which includes advancing a steering guidewire into the vessel lumen via a primary lumen having a primary lumen opening at the distal end of the RICC. Because the introducer lumen of the catheter tube is aligned with the distal end portion of the primary lumen, a needle withdrawal step must be performed before the steering guidewire advancement step.

[0032] In some embodiments, the method further includes a second RICC advancement step, which includes further advancing a distal end portion of the first section of the catheter tube over the steering guidewire into the blood vessel lumen and concomitantly sliding the distal coupler proximally toward the proximal end portion of the catheter tube to expose the catheter tube, which is covered by a foldable sterile barrier between the proximal end portion of the catheter tube and the distal coupler, at least in the ready-to-deploy state of the RICC assembly.

[0033] In some embodiments, the method further includes a sterile barrier removal step that includes removing the sterile barrier and distal coupler from the RICC by pulling a sterile barrier pull tab on the sterile barrier opposite the distal coupler away from the catheter tube to separate the sterile barrier, and then pulling the distal coupler away from the catheter tube by the sterile barrier to which the distal coupler is slidably attached.

[0034] In some embodiments, the method further includes a sterile barrier removal step that includes removing the distal coupler and sterile barrier from the RICC by pulling the distal coupler away from the catheter tube to separate the sterile barrier and then pulling the distal coupler further proximally toward the proximal end portion of the catheter tube to completely remove the sterile barrier.

[0035] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0036] [Figure 1] 1 illustrates a perspective view of a RICC assembly including a RICC, an introducer, and a coupling system, according to some embodiments. [Figure 2]FIG. 1 illustrates a first detailed view of a RICC assembly according to some embodiments. [Figure 3] FIG. 10 illustrates a second detailed view of a RICC assembly according to some embodiments. [Figure 4] 1 shows a longitudinal cross section of a portion of an introducer according to some embodiments. [Figure 5] 1 illustrates a distal end portion of a catheter tube of a RICC according to some embodiments. [Figure 6] 1 illustrates a first cross section of a catheter tube according to some embodiments. [Figure 7] 1 shows a second cross section of a catheter tube according to some embodiments. [Figure 8] 10 illustrates a third cross section of a catheter tube according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0037] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0038] Regarding the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are for convenience and do not imply, for example, a specific fixed location, direction, or orientation. Instead, such designations are used, for example, to reflect relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0039] For example, references to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0040] For example, references to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is in use with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As discussed above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient's body and advancing the catheter within the patient's vasculature.

[0042] Disclosed herein are rapid insertion central venous catheters ("RICCs"), RICC assemblies, and methods for inserting such RICCs directly into a patient's vascular lumen. However, it should be understood that RICCs are but one type of catheter in which the concepts provided herein may be embodied or otherwise incorporated. Indeed, peripherally inserted central catheters ("PICCs"), dialysis catheters, and the like, may also embody or otherwise incorporate the concepts provided herein for RICCs, as well as catheter assemblies and methods thereof. RICC Assembly Figures 1-3 show various views of a RICC assembly 100 including a RICC 102, an introducer 104, and a coupling system 106, according to some embodiments. Figure 4 shows a longitudinal cross-section of a portion of the introducer 104, according to some embodiments. Figure 5 shows a distal end portion of a catheter tube 108 of the RICC 102, according to some embodiments. Figures 6-8 show various cross-sections of the catheter tube 108, according to some embodiments.

[0043] As shown, the RICC assembly 100, in some embodiments, includes a RICC 102, an introducer 104, and a coupling system 106 configured to couple the RICC 102 and the introducer 104. The RICC 102, the introducer 104, and the coupling system 106 are described in order in the following sections, although there is overlap between the sections relating to the RICC 102, the introducer 104, and the coupling system 106 given the inter-relatedness of the RICC assembly 100.

[0044] The RICC 102 includes a catheter tube 108 , a catheter hub 110 , and one or more extension legs 112 . The catheter tube 108 has two or more sections including a catheter tip 114 at the distal end portion of the catheter tube 108, one or more catheter tube lumens, and a side opening 116 through the side of the catheter tube 108 at the distal end portion of the catheter tube 108.

[0045] The two or more portions of the catheter tube 108, which may be the main body of the catheter tube 108 and the catheter tip 114, may be formed as a single extruded piece of a single material or a single coextruded piece of two similar materials. Alternatively, the main body of the catheter tube 108 and the catheter tip 114 may be formed as two different extruded pieces of two similar materials and then joined together. However, FIG. 5 shows an embodiment of the catheter tube 108 in which the catheter tube 108 is formed as two different extruded pieces of two different materials and then joined together. In effect, the catheter tube 108 includes a first portion 118 that includes the catheter tip 114, a second portion that includes the side opening 116, and an optional transition portion 122 between these portions, depending on how the first portion 118 and the second portion 120 of the catheter tube 108 are joined together. For example, the first and second portions 118, 120 of the catheter tube 108 may be joined by heat, solvent, or adhesive so that the portions abut one another, or the second portion 120 may be inserted into the first portion 118 and joined to the first portion 118 by heat, solvent, or adhesive, thereby forming the transition portion 122. Advantageously, the latter bonding, in which the second portion 120 is inserted into the first portion 118, facilitates the incorporation of a smooth taper into the transition portion 122, which is useful for expanding without snagging tissue (e.g., skin) during the method of using the RICC assembly 100.

[0046] The first portion 118 of the catheter tube 108 can be formed from a first material (e.g., a polymeric material such as polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer, and the second portion 120 of the catheter tube 108 can be formed from a second material (e.g., a polymeric material such as polyvinyl chloride, polyethylene, polyurethane, or silicone) having a second durometer that is less than the first durometer. For example, the first portion 118 and the second portion 120 of the catheter tube 108 can be formed from different polyurethanes having different durometers. In fact, polyurethane is advantageous in that the polyurethane portion of the catheter tube 108 is relatively stiff at room temperature but can become more flexible in vivo at body temperature, which reduces irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous in that it is less thrombogenic than some other polymers.

[0047] The catheter tube 108, having at least a first portion 118 of a first polymeric material and a second portion 120 of a second polymeric material, has sufficient column buckling strength to prevent buckling of the catheter tube 108 when the catheter tube 108 is inserted into an insertion site and suitable compliance for advancing the catheter tube 108 through a patient's vasculature. Both the column buckling strength and compliance of the catheter tube 108 are notable in that they allow the catheter tube 108 to be rapidly inserted into an insertion site and advanced through a patient's vasculature without the need for the Seldinger technique.

[0048] The first durometer hardness and the second durometer hardness may be on different scales (e.g., Type A or Type D), and thus the second durometer hardness of the second polymeric material may not necessarily be numerically less than the first durometer hardness of the first polymeric material, although the hardness of the second polymeric material may still be less than the hardness of the first polymeric material, as each different scale ranging from 0 to 100 is intended to characterize a different material within a group of materials having similar hardnesses.

[0049] Notwithstanding the above, the first section 118 and the second section 120 of the catheter tube 108 may be formed from the same or different polymeric materials having substantially equal durometer hardness, provided that a) the column buckling strength of the catheter tube 108 is sufficient to prevent buckling of the catheter tube 108 when inserted into an insertion site, and b) the compliance of the catheter tube 108 is suitable for advancing the catheter tube 108 through a patient's vasculature.

[0050] One or more catheter tube lumens can extend through the entire catheter tube 108. However, in a multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), typically only one catheter tube lumen extends from the proximal end of the catheter tube 108 to the distal end of the catheter tube 108. Indeed, the catheter tip 114 typically includes a single lumen therethrough. Optionally, the single lumen through the catheter tip 114, particularly with respect to the first portion 118 of the catheter tube 108, can be referred to as a "tip lumen" when formed separately from and coupled to the remainder of the catheter tube 108.

[0051] Again, the side opening 116 penetrates the side of the catheter tube 108 at its distal end portion, but the side opening 116 is proximal to the first portion 118 of the catheter tube 108. The side opening 116 opens into an introduction lumen 124 of one or more catheter tube lumens. The introduction lumen 124 extends from at least the side opening 116 in the second portion 120 of the catheter tube 108, through the distal first portion 118 of the catheter tube 108, to the distal end of the RICC 102 (e.g., the distal end of the catheter tube 108 or the distal end of the catheter tip 114). The introduction lumen 124 typically coincides with the distal end portion of one of the catheter tube lumens mentioned above, which extends from the proximal end of the catheter tube 108 to the distal end of the catheter tube 108, particularly the distal end portion of the aforementioned catheter tube lumen distal to the side opening 116.

[0052] A catheter hub 110 is coupled to the proximal end portion of the catheter tube 108. The catheter hub 110 includes one or more catheter hub lumens corresponding in number to the one or more catheter tube lumens. The one or more catheter hub lumens extend entirely through the catheter hub 110 from the proximal end to the distal end of the catheter hub 110.

[0053] Each of the one or more extension legs 112 is coupled at its distal end portion to the catheter hub 110. Each of the one or more extension legs 112 includes one or more extension leg lumens, the number of which corresponds to the number of the one or more catheter tube lumens. Each of the one or more extension leg lumens extends entirely through the extension leg, from the proximal end to the distal end of the extension leg.

[0054] Each extension leg of the one or more extension legs 112 typically includes a luer connector coupled thereto, through which the extension leg and its extension leg lumen can be connected to another medical device.

[0055] The RICC 102 may be a single-lumen or multi-lumen RICC (e.g., a two-lumen RICC, a three-lumen RICC, a four-lumen RICC, a five-lumen RICC, a six-lumen RICC, etc.), and the RICC 102 shown in Figures 1-3 and 6-8 is a three-lumen RICC including a set of three lumens. Such a set of three lumens is formed from fluidly connected portions of three catheter tube lumens, three hub lumens and three extension leg lumens; A primary lumen 126 (e.g., a distal lumen), a secondary lumen 128 (e.g., an intermediate lumen), and Bisan The RICC 102 includes a primary lumen 126 (e.g., a proximal lumen) and a secondary lumen 130 (e.g., a proximal lumen). Whether the RICC 102 is single-lumen or multi-lumen, the RICC 102 includes at least a primary lumen 126. The primary lumen 126 typically includes at least one catheter tube lumen, as described above, extending from the proximal end of the catheter tube 108 to the distal end of the catheter tube 108, as well as a fluidly connected hub lumen portion and an extension leg lumen portion of the primary lumen 126. According to the catheter tube lumens described above, the introducer lumen 124 of the catheter tube 108 coincides with the distal end portion of the primary lumen 126, particularly the distal end portion of the primary lumen 126 distal to the side opening 116. In addition, the primary lumen 126 has a primary lumen opening 132 at the distal end of the RICC 102 (e.g., the distal end of the catheter tube 108 or the distal end of the catheter tip 114). The secondary lumen 128 has a secondary lumen opening 134 on a side of the catheter tube 108 proximal to the primary lumen opening 132 and distal to the next tertiary lumen opening 136, such that the secondary lumen 128 is between the primary lumen opening 132 and the tertiary lumen opening 136. The tertiary lumen 130 has a tertiary lumen opening 136 on a side of the catheter tube 108 proximal to the secondary lumen opening 134. The side opening 116 of the catheter tube 108 is between the primary lumen opening 132 and the secondary lumen opening 134, between the secondary lumen opening 134 and the tertiary lumen opening 136, or proximal to the tertiary lumen opening 136 as shown in FIG. 5, with the primary lumen opening 132, secondary lumen opening 134, and tertiary lumen opening 136 distal to the side opening 116.

[0056] The RICC assembly 100 may further include a steering guidewire 138. The steering guidewire 138 has an atraumatic tip (e.g., a coiled or partially coiled tip) (not shown) and a length sufficient to advance the steering guidewire 138 to the lower third of the heart's superior vena cava ("SVC") The steering guidewire 138 may be tethered within the RICC 102, at least in the ready-to-deploy state of the RICC assembly 100. For example, the steering guidewire 138 may be disposed within the primary lumen 126 of the RICC 102, with a proximal or intermediate portion of the steering guidewire 138 disposed within the extension leg lumen portion of the primary lumen 126, an intermediate or distal portion of the steering guidewire 138 disposed within the hub lumen portion of the primary lumen 126, and a distal end portion of the steering guidewire 138 disposed within the catheter tube lumen portion of the primary lumen 126, the catheter tube lumen portion typically being formed from the single catheter tube lumen described above extending from the proximal end of the catheter tube 108 to the distal end of the catheter tube 108. However, the distal end portion of the aforementioned catheter tube lumen distal to the side opening 116 coincides with the introducer lumen 124 and is occupied by the introducer needle 146, at least in the ready-to-deploy state of the RICC assembly 100, as described below. Due to the presence of the introducer needle 146 within the introducer lumen 124, the distal end of the steering guidewire 138 is immediately proximal to the side opening 116, at least in the ready-to-deploy state of the RICC assembly 100.

[0057] The manipulation guidewire 138 includes a stop 140 (e.g., a hub, ball, slug, etc.) about its proximal end portion, which stop forms a stop end (e.g., a hub end, a ball end, a slug end, etc.) of the manipulation guidewire 138. The stop end of the manipulation guidewire 138 is larger than the proximal end opening of the primary lumen 126 or the extension leg lumen portion thereof, thereby providing a distal limit for advancing the manipulation guidewire 138 into the RICC 102. Additionally, the manipulation guidewire 138 can be disposed within a sterile barrier 142 (e.g., an elongated pouch) having a fixed length, the sterile barrier 142 including a closed or sealed proximal end and an otherwise open distal end removably coupled (e.g., removably glued) to the proximal end of the luer connector of the extension leg for manual removal of both the sterile barrier 142 and the manipulation guidewire 138 when needed. The combination of the fixed length of the sterile barrier 142, the closed or sealed proximal end of the sterile barrier 142, and the distal end of the sterile barrier 142 coupled to a Luer connector provides a limited path through which the manipulation guidewire 138 can travel proximally, thereby providing a proximal limit for withdrawing the manipulation guidewire 138 from the RICC 102. The proximal limit keeps the atraumatic tip of the manipulation guidewire 138 within the primary lumen 126, and at least in atraumatic tip embodiments having a coiled or partially coiled tip, the atraumatic tip remains in a straight or uncoiled state. This is advantageous because reinserting such a guidewire into a lumen of a medical device such as a catheter can be particularly difficult. Optionally, the stop end of the manipulation guidewire 138 is coupled (e.g., glued) to the proximal end of the sterile barrier 142 to maintain the stop end of the manipulation guidewire 138 within the proximal end of the sterile barrier 142, thereby reducing the mismatch between the length of the proximal end portion of the manipulation guidewire 138 that extends beyond the proximal end of the RICC 102 (e.g., the proximal end of the Luer connector) and the unpleated length of the sterile barrier 142. Reducing this length mismatch reduces the likelihood of losing the stop end of the manipulation guidewire 138 in the middle portion of the sterile barrier 142, requiring time and effort for realignment that would be better focused on the patient.

[0058] In addition to providing a proximal limit for withdrawal of the operating guidewire 138 from the RICC 102, the sterility barrier 142 is configured to maintain the sterility of the operating guidewire 138 both prior to use of the RICC assembly 100 (e.g., during shipping and handling, storage, etc.) and during use of the RICC assembly 100. During use of the RICC assembly 100, the sterility barrier 142 is configured to provide a non-contact advancement means for advancing the operating guidewire 138 into the patient's vascular lumen, which advancement means is provided upon establishing a needle pathway therein. Similarly, the sterility barrier 142 is configured to provide a non-contact withdrawal means for withdrawing the operating guidewire 138 from the patient's vascular lumen, for example, after the catheter tube 108 has been advanced over the operating guidewire 138.

[0059] The RICC 102 may further include a reinforcing stylet, such as a reinforcing stylet 144, within either or both of the secondary lumen 128 and the tertiary lumen 130 in a three-lumen embodiment of the RICC 102 to reinforce the RICC 102. Figure 1 illustrates one such reinforcing stylet 144. This reinforcing stylet provides additional column buckling strength to prevent buckling of the catheter tube 108 as it is inserted into an insertion site and advanced through the patient's vasculature.

[0060] The introducer 104 includes an introducer needle 146, a syringe 148 operably connected to the introducer needle 146, and an access guidewire 150 disposed within the introducer 104. The introducer 104 may further include a fluid pressure indicator 152 operably connected to the introducer needle 146. As described below, the introducer 104 is configured with at least two different actuation mechanisms (e.g., an actuation mechanism for retracting the plunger 166 and an actuation mechanism for advancing or retracting the access guidewire 150) that are activated by a single finger while a distal end portion of the introducer 104 is held between the thumb and one or more fingers.

[0061] The introducer needle 146 includes a needle hub 154 and a needle shaft 156 extending from the needle hub 154, the needle shaft 156 terminating in a needle tip 158 (e.g., a beveled tip) within a distal end portion of the needle shaft 156. The needle hub 154 includes a rib 155 configured to be inserted into a slot 189 in the distal coupler 186 to prevent the syringe 148 from rolling from side to side, at least in the ready-to-deploy state of the RICC assembly 100. Additionally, the needle hub 154 is translucent, preferably colorless, to allow observation of blood flashback from the venipuncture site by the needle tip 158 (e.g., the beveled tip). When the RICC assembly 100 is in at least the ready-to-deploy state as shown in FIG. 1 , substantially a portion of the needle tip 158 extends from the distal end of the RICC 102 for venipuncture. In practice, a distal portion (e.g., approximately 7 cm) of the needle shaft 156 extends through a longitudinal through-hole in the distal coupler 186 of the coupling system 106 (described below), through the side opening 116 of the catheter tube 108, along the introducer lumen 124 of the catheter tube 108, and through the distal end of the RICC 102 when the RICC assembly 100 is in at least a ready-to-deploy state. However, in some embodiments, 2-3 cm or more of the distal portion of the needle shaft 156 can extend from the distal end of the RICC 102 for venipuncture. In such embodiments, the length of the first portion 118 of the catheter tube 108 is short in contrast to the long needle shaft 156.

[0062] When present, the fluid pressure indicator 152 extends from a side arm 160 of the needle hub 154. The fluid pressure indicator 152 includes a closed end and an open end that are fluidly coupled to the needle lumen of the introducer needle 146 by the side arm lumen of the side arm 160. The fluid pressure indicator 152 is configured as a self-contained, accidental arterial indicator, whereby blood under sufficient pressure (e.g., arterial blood) can enter the fluid pressure indicator 152 and compress an air column within the fluid pressure indicator 152. However, it is also possible to observe blood flashback from a venipuncture at the fluid pressure indicator 152. Nevertheless, blood flashback from a venipuncture is typically observed at the needle hub 154, the side arm 160 of the needle hub 154, or the syringe 148.

[0063] Syringe 148 includes a syringe housing 162 around a barrel 164, a plunger 166 disposed within barrel 164, and a syringe tip 168 within a distal end portion of barrel 164 that is coupled to needle hub 154 of introducer needle 146 when RICC assembly 100 is in at least a ready-to-deploy state. Syringe 148 also includes a syringe portion of access guidewire lumen 174.

[0064] The syringe housing 162 extends from the proximal end portion to the distal end at the distal end portion of the syringe housing 162, which may be coextensive with the distal end portion of the barrel 164, as shown. The syringe housing 162 may include a gripping portion 170 (e.g., a pattern of bumps, through-holes, etc.) at its distal end portion that is configured to allow the syringe housing 162, and thus the introducer 104, to be easily grasped by its distal end portion with the thumb and finger(s) described above. The distal placement of the gripping portion 170 about the distal end portion of the syringe housing 162 allows the RICC assembly 100 to be held and handled in a position that provides greater control of the distal end portion of the RICC assembly 100, in that small inadvertent yaw or pitch-type movements remain relatively small at the distal end portion of the RICC assembly 100, compared to the same types of movements when the RICC assembly 100 is held in a more proximal position.

[0065] The syringe housing 162 and plunger 166 are configured to operate together as a single unit so long as the syringe 148 is actuated (e.g., the plunger 166 is withdrawn to aspirate blood). The syringe housing 162 and plunger 166, or its end piece 180, can be molded together as a single piece, such that the proximal end portion of the syringe housing 162 is integral with the proximal end portion of the plunger 166. Alternatively, the syringe housing 162 and plunger 166, or its end piece 180, may be molded separately and then joined together, such that the proximal end portion of the syringe housing 162 is joined to the proximal end portion of the plunger 166 or the end piece 180 of the plunger 166. For example, the inner wall of the proximal end of the syringe housing 162 may be bonded or welded to the plunger flange at the distal end of the plunger 166 or the end piece 180 of the plunger 166. Regardless of whether the syringe housing 162 and plunger 166 are integral with or coupled to one another, sliding the syringe housing 162 proximally relative to the barrel 164 withdraws the plunger 166 from the barrel 164, thereby operating the syringe 148 as a single unit.

[0066] The syringe 148 may further include a push tab 172 extending proximally on the barrel 164 from the distal end portion of the barrel 164 (e.g., from an integral connector of the barrel 164 around the syringe tip 168), where the push tab 172 is coupled to the distal end portion of the barrel 164. The push tab 172 is configured for use in actuating the syringe 148, as described above. In practice, the push tab 172 is configured to be pressed with one finger while holding the distal end portion of the syringe housing 162 with a thumb and one or more other fingers, causing the syringe housing 162 to slide proximally relative to the barrel 164 and withdraw the plunger 166 from the barrel 164.

[0067] Syringe 148 also includes a syringe portion of access guidewire lumen 174 formed from the fluidly connected portion of the plunger lumen of plunger 166, a syringe tip lumen of syringe tip 168, and any space within barrel 164 formed by partially withdrawing plunger 166 from barrel 164, such as in one of several operating states of RICC assembly 100 (e.g., during the blood aspiration step of the methods described below). Another portion of access guidewire lumen 174 is the introducer needle portion of access guidewire lumen 174, i.e., the needle lumen of introducer needle 146, particularly when introducer needle 146 is operably connected to syringe 148, as in most states of RICC assembly 100.

[0068] Plunger 166 includes a sealing mechanism 176 at a distal end portion thereof that seals access guidewire lumen 174 distally thereof. Sealing mechanism 176 is configured to seal access guidewire lumen 174 to maintain a vacuum for aspirating blood as plunger 166 is withdrawn from barrel 164. Sealing mechanism 176 is also configured to seal access guidewire lumen 174 to prevent blood from being expelled (e.g., flashing back) through the longitudinal slots in barrel 164 and plunger 166, described below, during venipuncture or withdrawal of access guidewire 150 from the patient's vascular lumen, thereby minimizing or preventing the possibility of contamination of the surgical field or by a clinician working within the surgical field.

[0069] As shown in FIG. 4 , sealing mechanism 176 can be a cartridge disposed within a cavity in the distal end portion of body 178 of plunger 166 and retained therein by end piece 180 of plunger 166. The cartridge is coaxially aligned with access guidewire lumen 174 or its plunger lumen portion such that the unwrapped bare wire portion of access guidewire 150 passes through proximal and distal through-holes of the cartridge, which have inner diameters corresponding to the outer diameter of access guidewire 150. Optionally, sealing mechanism 176 includes one or more gaskets, such as “O” rings, within or as an alternative to a cartridge. Instead of a cartridge, for example, one or more “O” rings can be axially compressed within the cavity by end piece 180 of plunger 166, which in turn radially compresses the “O” rings around access guidewire 150, thereby sealing access guidewire lumen 174.

[0070] The access guidewire 150 is anchored within the introducer 104 such that at least a portion of the access guidewire 150 is always within a portion of the access guidewire lumen 174 (e.g., the plunger lumen portion, the needle lumen portion, etc.), regardless of the state of the RICC assembly 100. For example, when the access guidewire 150 is withdrawn to its proximal limit (e.g., defined by the proximal end of a longitudinal slot, described below), the distal end portion of the access guidewire 150 is disposed within at least the distal end portion of the plunger lumen. Meanwhile, the proximal end portion of the access guidewire 150 is disposed within the proximal end portion of the plunger lumen. When the RICC assembly 100 is in at least its ready-to-deploy state and the distal end of the access guidewire 150 is just short of the needle tip 158, an intermediate portion of the access guidewire 150 is disposed between the distal end portion of the plunger lumen and the proximal end portion of the needle lumen. When the access guidewire 150 is advanced to its distal limit (e.g., defined by the distal end of a longitudinal slot, described below) in some of a number of operating states of the RICC assembly 100 (e.g., during the access guidewire advancement step of the method described below), a proximal end portion of the access guidewire 150 is disposed within at least a distal end portion of the plunger lumen. Meanwhile, such a length of the access guidewire 150 causes the distal end portion of the access guidewire 150 to extend through or beyond the distal end of the RICC 102, which is effective for extending the access guidewire 150 into the patient's vascular lumen when establishing access to the patient's vascular lumen after the needle path establishment step described below.

[0071] Syringe 148 also includes a slider 182 (e.g., a tabbed slider) extending distally from syringe housing 162 across barrel 164. Slider 182 is configured to allow the distal end portion of syringe housing 162 to be held between the thumb and finger(s) while actuating access guidewire 150 with one finger of the same hand (e.g., with a scroll-wheel-style finger motion as used with a computer mouse). Slider 182 includes an extension 184 that extends through longitudinal slots (not shown) in barrel 164 and plunger 166 and into access guidewire lumen 174 proximal to sealing mechanism 176, and extension 184 is coupled to access guidewire 150. The proximal and distal ends of the longitudinal slot provide stops for the extension 184 and therefore a limited area (tract) within which the extension 184 can move proximally, thereby providing a proximal limit for withdrawing the access guidewire 150 from the introducer 104 and a distal limit for advancing the access guidewire 150 into the introducer 104.

[0072] The coupling system 106 includes a distal coupler 186 and a proximal coupler 188 configured to couple the RICC 102 and the introducer 104 to each other at their corresponding proximal and distal end portions, at least when the RICC assembly 100 is in a ready-to-deploy state, while allowing the introducer 104 to slide relative to the RICC 102 (or vice versa).

[0073] The distal coupler 186 includes a catheter tube clip configured to slidably and removably attach the distal coupler 186 to the catheter tube 108 proximal to the side opening 116. The distal coupler 186 also includes a longitudinal through-hole, a slot 189, and a push tab 190 at a distal end portion of the distal coupler 186. The needle shaft 156 of the introducer needle 146 extends through the longitudinal through-hole of the distal coupler 186, through the side opening 116 of the catheter tube 108, along the introducer lumen 124 of the catheter tube 108, and through the distal end of the RICC 102 when the RICC assembly 100 is in at least its ready-to-deploy state. While the distal coupler 186 is slidably attached to the catheter tube 108, the needle shaft 156 extends through the distal coupler 186 and the catheter tube 108 as described above, thereby wedging the distal coupler 186 between the needle shaft 156 and the catheter tube 108 so that the distal coupler 186 remains in its position on the catheter tube 108 proximal to the side opening 116, at least in the ready-to-deploy state of the RICC assembly 100. In fact, the distal coupler 186 can slide onto the catheter tube 108 only when the needle shaft 156 is detached from the distal coupler 186. The slot 189 is configured to receive the rib 155 of the needle hub 154 and to prevent the syringe 148 from rolling from side to side, at least in the ready-to-deploy state of the RICC assembly 100. The push tab 190 is configured to allow a clinician to one-handedly advance the RICC 102 off the needle shaft 156 using one finger (e.g., with a flicking motion of the finger) while holding the distal end portion of the introducer 104 between the thumb and one or more fingers, thereby providing a contactless mechanism for advancing the RICC 102, and specifically the distal end portion of the catheter tube 108, over the needle shaft 156 and into the patient's vascular lumen.

[0074] The proximal coupler 188 is an extension of the syringe housing 162 around the syringe 148 and is either integral with the syringe housing 162 (e.g., molded together with the syringe housing 162) or coupled to the syringe housing 162 (e.g., molded separately from the syringe housing 162 and bonded or welded to the syringe housing 162). The proximal coupler 188 includes a catheter hub clip configured to slidably and removably attach to the catheter hub 110 or one or more extension legs 112. The catheter hub clip is configured to suspend the RICC 102 by the catheter hub 110, at least in the ready-to-deploy state of the RICC assembly 100, thereby preventing the RICC 102 from sagging. The catheter-hub clip is also configured to float the RICC 102 by one or more extension legs 112 during some of any number of operating states of the RICC assembly 100 (e.g., during the introducer removal step of the method described below), thereby further preventing the RICC 102 from sagging.

[0075] The RICC 102 may further include a sterile barrier 192 (e.g., a collapsible or pleatable bag, casing, etc.) configured to maintain the sterility of the catheter tube 108 between the catheter hub 110 and the distal coupler 186 prior to insertion of the catheter tube 108 into a patient's vascular lumen. (See FIG. 2.) At least in the ready-to-deploy state of the RICC assembly 100, the sterile barrier 192 resides on the catheter tube 108, around a proximal end portion of the catheter tube 108, between the catheter hub 110 and the distal coupler 186, to which the sterile barrier 192 is coupled. The sterile barrier 192 is configured to separate when a sterile barrier pull tab 194 of the sterile barrier 192 is removed from the catheter hub clip to which it is clipped and pulled away from the catheter tube 108, thereby providing a contactless mechanism for removing the sterile barrier 192 from the catheter tube 108. The sterility barrier 192 has sufficient tensile strength when torn to the distal coupler 186 while being pulled away from the catheter tube 108 to pull the distal coupler 186 away from the catheter tube 108 without breaking.

[0076] 1 illustrates RICC assembly 100 in at least a ready-to-deploy state. While several of a number of operational states of RICC assembly 100 are also described above, additional operational states of RICC assembly 100 can be identified from the method steps for inserting RICC 102 described below. method The method of RICC assembly 100 includes a method for inserting RICC 102 into a vascular lumen of a patient. Such a method includes a RICC assembly acquisition step, a needle path establishment step, a first RICC advancement step, and a needle withdrawal step.

[0077] The RICC assembly obtaining step includes obtaining a RICC assembly 100. As described above, the RICC assembly 100 includes the RICC 102, the introducer 104 including the syringe 148 coupled to the introducer needle 146, and the coupling system 106 including the distal coupler 186 that couples the RICC 102 and the introducer 104 at their distal end portions, at least in a ready-to-deploy state of the RICC assembly 100.

[0078] The method may further include, prior to the needle path establishment step, a needle tip confirmation step of confirming that the needle tip 158 extends from the distal end of the RICC 102. As described above, the needle shaft 156 extends from the distal end of the RICC 102 through the longitudinal through-hole of the distal coupler 186, through the side opening 116 of the distal end portion of the catheter tube 108, and along the introducer lumen 124 of the catheter tube 108.

[0079] The needle pathway establishment step involves using the introducer needle 146 to establish a needle pathway from an area of ​​the patient's skin to a lumen of a blood vessel while holding the distal end portion of the syringe housing 162 around the barrel 164 of the syringe 148 between the thumb and one or more fingers, while at least one finger of the same hand is ready for use. As described above, the needle shaft 156 extends from the distal end of the RICC 102 through the longitudinal through-hole in the distal coupler 186, through the side opening 116 in the distal end portion of the catheter tube 108 of the RICC 102, and along the introducer lumen 124 of the catheter tube 108 to establish the needle pathway.

[0080] The needle path establishment step may further include a step of verifying that blood flashes back into the needle hub 154 of the introducer needle 146, the side arm 160 of the needle hub 154, or the fluid pressure indicator 152 extending from the side arm 160 of the needle hub 154 when the needle path is established.

[0081] The method may further include a blood drawing step, which involves drawing blood into the syringe 148 to confirm that the needle tip 158 is positioned in the lumen of the patient's blood vessel before the needle withdrawal step. The blood drawing step includes holding the distal end portion of the syringe housing 162 between a thumb and one or more fingers, pressing a push tab 172 extending from the distal end portion of the barrel 164 with one finger, and sliding the syringe housing 162 proximally relative to the barrel 164 to withdraw the syringe housing connection plunger 166 from the barrel 164.

[0082] The method may further include an access guidewire advancing step. The access guidewire advancing step includes advancing the access guidewire 150, disposed within the access guidewire lumen 174, past the needle tip 158 of the introducer needle 146 and into the lumen of the blood vessel. This may be accomplished by advancing the slider 182 coupled to the access guidewire 150 distally over the barrel 164 with one finger while holding the distal end portion of the syringe housing 162 between the thumb and one or more fingers. As described above, the access guidewire 150 is disposed within the access guidewire lumen 174, formed by at least the plunger lumen of the plunger 166 and the needle lumen of the introducer needle 146, thereby facilitating a successful initial puncture by making the access guidewire 150 readily available before a small, inadvertent movement could cause the blood-vessel path to be lost. The access guidewire advancement step must occur before the first RICC advancement step so that the distal end portion of the catheter tube 108 can also be advanced over the access guidewire 150 .

[0083] The first RICC advancement step includes advancing a distal end portion of the first section 118 of the catheter tube 108 into the vessel lumen over the needle shaft 156, the access guidewire 150, or both. As described above, the catheter tube 108 includes the first section 118 formed of a first material having a first durometer and the second section 120 formed of a second material having a second durometer less than the first durometer. The first section 118 of the catheter tube 108 is configured to have a column buckling strength to advance the catheter tube 108 into the vessel lumen over the access guidewire 150 or the steering guidewire 138 after the steering guidewire advancement step described below. For example, the first RICC advancement step may include holding the introducer 104 between a thumb and finger(s) at the distal end portion of the syringe housing 162 while advancing the catheter tube 108 into the vessel lumen with a single finger of the same hand (e.g., with a flicking motion of the finger) via a push tab 190 on the distal coupler 186. The distal coupler 186 includes a push tab 190 configured to advance the catheter tube 108 into the vessel lumen with the single finger.

[0084] The first RICC advancement step further includes advancing the catheter hub 110 of the RICC 102 from the catheter hub clip of the proximal coupler 188 of the coupling system 106, followed by advancing one or more extension legs 112 of the RICC 102 within the catheter hub clip. The RICC 102 is configured to suspend from the coupling system 106 at least until the needle shaft 156 is withdrawn from both the introducer lumen 124 and the longitudinal throughbore of the distal coupler 186, such as after an introducer removal step described below.

[0085] The method may further include an access guidewire retraction step of withdrawing the access guidewire 150 from the patient's vascular lumen, such as by advancing a slider 182 coupled to the access guidewire 150 proximally over the barrel 164 with one finger while holding the distal end portion of the syringe housing 162 between the thumb and one or more fingers. The access guidewire retraction step may be performed after the first RICC advancement step, such as after the distal end portion of the catheter tube 108 is suitably positioned within the vascular lumen over both the needle shaft 156 and the access guidewire 150.

[0086] The needle withdrawal step involves withdrawing the needle shaft 156 from the introducer lumen 124 via the side opening 116 of the catheter tube 108. Similar to the access guidewire retraction step, the needle withdrawal step may occur after the first RICC advancement step, such as after the distal end portion of the catheter tube 108 is suitably positioned within the blood vessel lumen over both the needle shaft 156 and the access guidewire 150.

[0087] The method may further include, after the needle withdrawal step, an introducer removal step of completely removing the introducer 104 from the RICC assembly 100. The introducer removal step includes withdrawing the needle shaft 156 from the longitudinal through-hole of the distal coupler 186 while sliding the catheter-hub clip proximally along the one or more extension legs 112. Upon withdrawing the needle shaft 156 from the longitudinal through-hole of the distal coupler 186, each extension leg of the one or more extension legs 112 may be removed from an opening in the catheter hub clip that is equal to or slightly wider than the diameter of the extension leg.

[0088] The method can further include a steering guidewire advancement step, which includes, for example, advancing a steering guidewire 138 into the lumen of the blood vessel via a primary lumen 126 having a primary lumen opening 132 at the distal end of the RICC 102. As noted above, the introducer lumen 124 of the catheter tube 108 coincides with the distal end portion of the primary lumen 126, particularly the distal end portion of the primary lumen 126 distal to the side opening 116. Therefore, a needle withdrawal step must be performed before the steering guidewire advancement step to ensure that the primary lumen 126, or both the needle shaft 156 and the access guidewire 150, are clear of the primary lumen 126 or its introducer lumen 124.

[0089] The method may further include a second RICC advancement step. The second RICC advancement step includes further advancing the distal end portion of the first section 118 of the catheter tube 108 over the steering guidewire 138 into the blood vessel lumen (e.g., into the SVC). The steering guidewire 138 provides column buckling strength to the second section 120 of the catheter tube 108 for the second RICC advancement step. Concomitantly, the second RICC advancement step includes sliding the distal coupler 186 proximally toward the proximal end portion of the catheter tube 108 (e.g., toward the catheter hub 110) to expose the catheter tube 108. As described above, the catheter tube 108 may be covered with a foldable sterile barrier 192 between the proximal end portion of the catheter tube 108 and the distal coupler 186, at least in the ready-to-deploy state of the RICC assembly 100.

[0090] The method can further include a sterility barrier removal step, which includes removing the sterility barrier 192 and distal coupler 186 from the RICC 102 by pulling the sterility barrier pull tab 194 of the sterility barrier 192 opposite the distal coupler 186 away from the catheter tube 108 to separate the sterility barrier 186, and then pulling the distal coupler 186 from the catheter tube 192 by the sterility barrier 192 to which the distal coupler 186 is slidably attached. Alternatively, the sterility barrier removal step includes removing the distal coupler 186 and the sterility barrier 192 from the RICC 102 by pulling the distal coupler 186 away from the catheter tube 108 to separate the sterility barrier 192, and then pulling the distal coupler 186 further proximally toward the proximal end portion of the catheter tube 108 to completely remove the sterility barrier 192.

[0091] The method may further include the step of withdrawing the steering guidewire 138 from the patient's vascular lumen and withdrawing the steering guidewire 138 from the RICC 102.

[0092] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter assembly for direct insertion into a vascular lumen of a patient, comprising: A catheter comprising: a catheter tube including a side opening through a side of the catheter tube at a distal end portion of the catheter tube, the side opening opening into an introducer lumen of the catheter tube extending at least from the side opening to the distal end of the catheter; a catheter hub coupled to a proximal end portion of the catheter tube; a catheter having one or more extension legs, each extension leg of the one or more extension legs being coupled at a distal end portion thereof to a catheter hub; An introducer configured to be actuated with one finger while a distal end portion of the introducer is held between a thumb and one or more other fingers, the introducer comprising: an introducer needle having a needle shaft that extends through the distal end of the catheter when the catheter assembly is in at least its ready-to-deploy state; a syringe operably connected to an introducer needle for aspirating blood, a barrel having a syringe tip at its distal end portion that is coupled to the needle hub of the introducer needle in at least the ready-to-deploy state of the catheter assembly; a plunger disposed within the barrel; an introducer comprising a syringe having a syringe housing surrounding a barrel, the syringe housing having a distal end portion and a proximal end portion, the proximal end portion of the syringe housing being integral with or coupled to the proximal end portion of the plunger such that the plunger can be withdrawn from the barrel by sliding the syringe housing proximally relative to the barrel; a coupling system configured to couple a catheter and an introducer, the coupling system including a distal coupler slidably attached to the catheter tube proximal to a side opening, the distal coupler having a slot configured to receive a rib on the needle hub to prevent the syringe from rolling from side to side.

2. The catheter tube a first portion formed from a first material having a first durometer, the side opening being located proximal to the first portion; and a second portion formed from a second material having a second durometer less than the first durometer, whereby the catheter tube is configured to have both column buckling strength and compliance for advancement into a patient's vascular lumen and through the patient's vasculature.

3. 3. The catheter assembly of claim 1, wherein the needle shaft extends through a longitudinal through-hole in the distal coupler, through a side opening in the catheter tube, along an introducer lumen in the catheter tube, and out the distal end of the catheter when the catheter assembly is in at least the ready-to-deploy state.

4. 4. The catheter assembly of claim 1, wherein the distal coupler has a push tab configured to allow a clinician to advance the catheter from the needle shaft with one hand using one finger while holding the distal end portion of the introducer between the thumb and one or more other fingers.

5. 2. The catheter assembly of claim 1, wherein the syringe further has a push tab extending proximally on the barrel from the distal end portion of the barrel, the push tab being coupled to the distal end portion of the barrel, and the push tab being configured to be pressed with one finger while holding the distal end portion of the syringe housing between a thumb and one or more other fingers to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

6. 2. The catheter assembly of claim 1, wherein the introducer further comprises an access guidewire disposed within an access guidewire lumen formed from at least a plunger lumen of the plunger and a needle lumen of the introducer needle, the access guidewire having a length sufficient to extend through the distal end of the catheter and into a vascular lumen of a patient.

7. 7. The catheter assembly of claim 6, wherein the plunger includes a sealing mechanism at its distal end portion that seals the distal access guidewire lumen and is configured to maintain a vacuum for aspirating blood when the plunger is withdrawn from the barrel.

8. 8. The catheter assembly of claim 6 or 7, wherein the syringe further comprises a slider extending distally from the syringe housing over the barrel, configured to actuate the access guidewire with one finger while holding the distal end portion of the syringe housing between a thumb and one or more other fingers, the slider having an extension extending through the longitudinal slots of the barrel and plunger and into the access guidewire lumen proximal to the sealing mechanism, the extension being coupled to the access guidewire.

9. 9. A catheter assembly according to claim 1, wherein the introducer further comprises a fluid pressure indicator extending from a side arm of the needle hub, the fluid pressure indicator being fluidly coupled to the needle lumen of the introducer needle via a side arm lumen of the side arm for monitoring blood flashback due to accidental arterial puncture.

10. 10. The catheter assembly of claim 1, further comprising a proximal coupler coupled to a syringe and slidably attached to a catheter hub at least in the ready-to-deploy state of the catheter assembly, the coupling system configured to allow the catheter to slide relative to the introducer.

11. 11. The catheter assembly of claim 10, wherein the proximal coupler includes a catheter hub clip, and the catheter is configured to float from the catheter hub clip by the catheter hub in at least the ready-to-deploy state of the catheter assembly, or by one or more extension legs when the proximal coupler is advanced over the one or more extension legs in the operating state of the catheter assembly.

12. 12. The catheter assembly of claim 11, wherein the catheter further comprises a collapsible catheter tube sterility barrier covering the catheter tube between the catheter hub and the distal coupler, the catheter tube sterility barrier being coupled to the distal coupler and configured to separate when the sterility barrier pull tab is removed from the catheter hub clip and the catheter tube sterility barrier is pulled away from the catheter tube by the sterility barrier pull tab.

13. 13. The catheter assembly of claim 12, wherein the catheter tube sterility barrier, when torn to the distal coupler while being pulled away from the catheter tube, has sufficient tensile strength to pull the distal coupler away from the catheter tube without breaking.

14. 14. The catheter assembly of claim 1, wherein the catheter comprises a set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen formed from fluidly connected portions of three catheter tube lumens, three hub lumens, and three extension leg lumens, and wherein an introduction lumen of the catheter tube is coincident with a distal end portion of the primary lumen.

15. 15. The catheter assembly of claim 14, wherein a primary lumen has a primary lumen opening at a distal end of the catheter, a secondary lumen has a secondary lumen opening in a side of the catheter tube distal to the side opening, and a tertiary lumen has a tertiary lumen opening in a side of the catheter tube distal to the side opening but proximal to the secondary lumen opening.

16. 16. The catheter assembly of claim 1, wherein the catheter further comprises an operating guidewire disposed within the primary lumen having a length sufficient to extend the operating guidewire to the lower third of the superior vena cava of the heart, the operating guidewire being anchored within the catheter by a stop around a proximal end portion of the operating guidewire and a closed end of a fixed length operating guidewire sterile barrier coupled to a luer connector, the stop providing a distal limit for advancing the operating guidewire and the closed end of the operating guidewire sterile barrier around the operating guidewire providing a proximal limit for retracting the operating guidewire.

17. 1. A catheter assembly for direct insertion into a vascular lumen of a patient, comprising: a catheter having a catheter tube with a side opening through a side of the catheter tube at a distal end portion thereof, the side opening opening into an introducer lumen of the catheter tube extending at least from the side opening to the distal end of the catheter; an introducer, an introducer needle having a needle hub and a needle shaft extending from the needle hub through the distal end of the catheter; A syringe, a barrel having a syringe tip at a distal end portion thereof coupled to a needle hub of the introducer needle; an introducer comprising a syringe having a syringe housing surrounding a barrel, the syringe housing having a distal end portion and a proximal end portion, the proximal end portion of the syringe housing being integral with or coupled to the proximal end portion of the plunger such that the plunger can be withdrawn from the barrel by sliding the syringe housing proximally relative to the barrel; a coupling system configured to couple a catheter and an introducer, the coupling system including: a distal coupler slidably attached to the catheter tube proximal to a side opening; and a needle shaft extending from the needle hub and further extending through a longitudinal through-hole in the distal coupler, the needle shaft being detachable from the distal coupler.

18. 18. The catheter assembly of claim 17, wherein the syringe further has a push tab extending proximally on the barrel from the distal end portion of the barrel, the push tab being coupled to the distal end portion of the barrel and configured to be pressed with one finger while holding the distal end portion of the syringe housing between a thumb and one or more other fingers to slide the syringe housing proximally relative to the barrel and withdraw the plunger from the barrel.

19. 18. The catheter assembly of claim 17, wherein the introducer further comprises an access guidewire disposed within an access guidewire lumen formed from at least a plunger lumen of the plunger and a needle lumen of the introducer needle, the access guidewire having a length sufficient to extend through the distal end of the catheter and into a vascular lumen of a patient.

20. 20. The catheter assembly of claim 19, wherein the plunger includes a sealing mechanism at its distal end portion that seals the distal access guidewire lumen and is configured to maintain a vacuum for aspirating blood when the plunger is withdrawn from the barrel.

21. 20. The catheter assembly of claim 19, wherein the syringe further comprises a slider extending distally from the syringe housing over the barrel, configured to actuate the access guidewire with one finger while holding the distal end portion of the syringe housing between a thumb and one or more other fingers, the slider having an extension extending through the longitudinal slots of the barrel and plunger and into the access guidewire lumen proximal to the sealing mechanism, the extension being coupled to the access guidewire.

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