Quick insertable central catheter comprising a catheter assembly and method thereof

Abstract

A rapidly insertable central catheter ("RICC") including a catheter assembly and methods thereof are disclosed. The RICC assembly can include a RICC, an introducer, and a coupling system. The coupling system is configured to couple the RICC and the introducer together. The catheter tube of the RICC includes a side hole in a distal end portion of the catheter tube that opens into a guide lumen that extends to a distal end of the RICC. The introducer includes a guide needle that extends through the distal end of the RICC when the RICC assembly is at least in an immediate deployment state. The introducer is configured to be actuated by a single finger of one hand while the distal end portion of the introducer is held between the thumb and another finger or fingers of the same hand. The coupling system includes a distal coupler that is slidably attached to a proximal end of the side hole of the catheter tube.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 045,649, filed June 29, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to a rapidly insertable central catheter including a catheter assembly and a method thereof. Background Technology

[0004] Central venous catheters (“CVCs”) are formed from materials with low rigidity, which contributes to their compliance but lacks the column strength required for direct insertion. Due to this lack of column strength, CVCs are typically introduced into the patient via the Seldinger technique and advanced through their vascular system. The Seldinger technique utilizes multiple steps and medical devices (e.g., needles, scalpels, guidewires, guide sheaths, dilators, CVCs, etc.). While effective, the multiple steps are time-consuming, handling multiple medical devices is challenging, and both can lead to patient trauma. Furthermore, the potential for contamination is relatively high due to the need to exchange multiple medical devices during the multiple steps of the Seldinger technique. Therefore, there is a need to reduce the number of steps and medical devices involved in introducing catheters such as CVCs into the patient and advancing them through their vascular system.

[0005] This article discloses a rapidly insertable central catheter (“RICC”) that includes catheter assemblies and methods for addressing the aforementioned problems. Summary of the Invention

[0006] This document discloses a central catheter (“RICC”) assembly for direct insertion into the lumen of a patient’s blood vessel. In some embodiments, the RICC assembly includes an RICC, a guide, and a coupling system. The RICC includes a catheter fitting, a catheter liner, and one or more extension legs. The catheter fitting includes a side hole passing through a side portion of its distal portion. The side hole opens into a guide lumen of the catheter fitting, which extends at least from the side hole to the distal end of the RICC. The catheter liner is coupled to the proximal portion of the catheter fitting. Each of the one or more extension legs is coupled to the catheter liner through its distal portion. The guide includes a guide needle. The guide needle has a needle shaft that extends through the distal end of the RICC when the RICC assembly is at least in a ready-to-deploy state. The guide is configured to be actuated by a single finger of a hand while holding the distal portion of the guide between the thumb and one or more other fingers of the hand. The coupling system is configured to couple the RICC and the guide together. The connection system includes a distal connector that is slidably attached to the proximal end of a conduit fitting in the side hole.

[0007] In some embodiments, the catheter fitting further includes a first segment and a second segment, wherein a side hole is located proximal to the first segment of the catheter fitting. The first segment is formed of a first material, and the second segment of the catheter fitting is formed of a second material. The first material has a first hardness, and the second material has a second hardness less than the first hardness. Thus, the catheter fitting is configured to simultaneously possess column strength and compliance for advancing the catheter fitting into the vascular lumen and through the patient's vascular system.

[0008] In some implementations, when the RICC assembly is at least in its immediately deployed state, the needle shaft extends further through the longitudinal through-hole of the distal connector, through the side hole of the conduit fitting, and through the guide lumen of the conduit fitting before exiting the distal end of the RICC.

[0009] In some implementations, the distal connector includes a push tab configured to allow a clinician to advance the RICC away from the needle shaft with a single finger of one hand, while holding the distal portion of the guide between the thumb of that hand and one or more other fingers.

[0010] In some embodiments, the guide 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 portion, the syringe tip being coupled to a needle bushing of the guide needle, at least in the immediately deployed state of the RICC assembly. The syringe housing has a distal portion and a proximal portion. The proximal portion of the syringe housing is integrally formed with or coupled to the proximal portion of the plunger, such that sliding the syringe housing proximally relative to the barrel retracts the plunger from the barrel.

[0011] In some embodiments, the syringe further includes a pusher that extends proximally from a distal portion of the barrel to which it is coupled. The pusher is configured to be pushed with a single finger when the distal portion of the syringe housing is held between the thumb and one or more other fingers of the hand, causing the syringe housing to slide proximally relative to the barrel and retracting the plunger from the barrel.

[0012] In some embodiments, the guide device further includes an access guidewire disposed within an access guidewire lumen. The access guidewire lumen is formed at least by a plunger lumen of a plunger and a needle lumen of a guide needle. The access guidewire has a length sufficient to extend through the distal end of the RICC and into the patient's vascular lumen.

[0013] In some embodiments, the plunger includes a sealing mechanism in the distal portion of the plunger for sealing the guidewire lumen distal to the sealing mechanism. The sealing mechanism is configured to maintain a vacuum for blood aspiration when the plunger is withdrawn from the barrel.

[0014] In some embodiments, the syringe further includes a slider extending distally from the syringe housing on the barrel. The slider is configured to actuate the guidewire with a single finger when the distal portion of the syringe housing is held between the thumb and one or more other fingers. The slider includes an extension extending through a longitudinal groove in each of the barrel and the plunger into an entry guidewire lumen proximal to the sealing mechanism, in which the extension engages with the entry guidewire.

[0015] In some embodiments, the guide further includes a fluid pressure indicator extending from the side arm of the needle bushing. The fluid pressure indicator is fluidly connected via the lumen of the side arm to the lumen of the guide needle for observing blood backflow caused by accidental arterial puncture.

[0016] In some embodiments, the coupling system further includes a proximal connector that is coupled to the syringe and slidably attached to the catheter liner, at least in the immediate deployment state of the RICC assembly. The coupling system is configured to allow the RICC to slide relative to the guide.

[0017] In some implementations, the proximal connector includes a catheter bushing clamp, and the RICC is configured to be suspended from the catheter bushing clamp at least in the immediate deployment state of the RICC assembly. The RICC is also configured to be suspended from one or more extension legs in the operational state of the RICC assembly as the proximal connector is advanced over it.

[0018] In some embodiments, the RICC further includes a collapsible catheter fitting sterile barrier on the catheter fitting between the catheter liner and the distal connector, the catheter fitting sterile barrier being coupled to the distal connector. The catheter fitting sterile barrier is configured to separate when the sterile barrier pull tab of the catheter fitting sterile barrier is removed from the catheter liner clamp and the catheter fitting sterile barrier is pulled away from the catheter fitting by the sterile barrier pull tab.

[0019] In some implementations, the sterile barrier of the catheter fitting has sufficient tensile strength to pull the distal connector away from the catheter fitting without breaking as it is pulled away from the catheter fitting and as the sterile barrier separates downward toward the distal connector.

[0020] In some implementations, the RICC includes a group of three lumens: a main lumen, a secondary lumen, and a third lumen. The group of three lumens is formed by fluid connections of three catheter fitting lumens, three bushing lumens, and three extension leg lumens. The guide lumen of the catheter fitting coincides with the distal portion of the main lumen.

[0021] In some embodiments, the main lumen has a main lumen orifice in the distal end of the RICC, the secondary lumen has a secondary lumen orifice on the side of the catheter fitting away from the side orifice, and the third lumen has a third lumen orifice on the side of the catheter fitting away from the side orifice but close to the secondary lumen orifice.

[0022] In some embodiments, the RICC further includes a manipulator guidewire disposed within the main lumen. The manipulator guidewire has a length sufficient to extend to the lower third of the superior vena cava of the heart. The manipulator guidewire is captively disposed within the RICC by a stop around the proximal portion of the manipulator guidewire and a closed end of a fixed-length manipulator guidewire sterile barrier coupled to a Luer connector. The stop provides distal restriction on advance of the manipulator guidewire. The closed end of the manipulator guidewire sterile barrier surrounding the manipulator guidewire provides proximal restriction on withdrawal of the manipulator guidewire.

[0023] This document also discloses 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. The syringe housing has a distal portion and a proximal portion. The proximal portion of the syringe housing is integrally formed with or coupled to the proximal portion of the plunger, such that sliding the syringe housing proximally relative to the barrel retracts the plunger from the barrel. The syringe is configured to be actuated by a single finger of a hand, while holding the distal portion of the syringe between the thumb of that hand and one or more other fingers.

[0024] In some embodiments, the syringe further includes a pusher that extends proximally from a distal portion of the barrel to which it is coupled. The pusher is configured to be pushed proximally with a single finger of the hand when the distal portion of the syringe housing is held between the thumb and one or more other fingers, causing the syringe housing to slide proximally relative to the barrel and retracting the plunger from the barrel.

[0025] In some embodiments, the syringe further includes an access guidewire disposed within the lumen of the access guidewire. The lumen of the access guidewire is formed at least by the plunger lumen of a plunger. The access guidewire has a length sufficient to extend through the syringe tip and into the lumen of the patient's blood vessel.

[0026] In some embodiments, the plunger includes a sealing mechanism in the distal portion of the plunger for sealing the guidewire lumen distal to the sealing mechanism. The sealing mechanism is configured to maintain a vacuum for blood aspiration when the plunger is withdrawn from the barrel.

[0027] In some embodiments, the syringe further includes a slider extending distally from the syringe housing on the barrel. The slider is configured to actuate the guidewire with a single finger when the distal portion of the syringe housing is held between the thumb and one or more other fingers. The slider includes an extension extending through a longitudinal groove in each of the barrel and the plunger into an entry guidewire lumen proximal to the sealing mechanism, in which the extension engages with the entry guidewire.

[0028] This article also discloses a method for inserting a RICC into a patient's vascular lumen. The method includes an 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 the RICC assembly. The RICC assembly includes the RICC; a guide including a syringe coupled to a guide needle; and a coupling system including a distal connector, which connects the RICC assembly to the distal portions of the RICC and the guide needle at least in an immediately deployed state. The needle path establishment step includes establishing a needle path from the patient's skin area to the vascular lumen using the needle axis of the guide needle while the distal portion of the syringe housing surrounding the syringe barrel is held between the thumb and one or more other fingers of the hand. At least one finger of the hand is readily available. The needle axis extends through a longitudinal through-hole of the distal connector, through a side hole in the distal portion of the RICC catheter fitting, extends along the guide lumen of the catheter fitting, and extends beyond the distal end of the RICC for needle path establishment. The first RICC advancement step involves advancing the distal portion of the first segment of the catheter fitting into the vascular lumen along the needle shaft. The needle withdrawal step involves withdrawing the needle shaft from the guide lumen through the side port of the catheter fitting.

[0029] In some embodiments, the method further includes a blood aspiration step. The blood aspiration step includes aspirating blood with a syringe prior to the needle withdrawal step to confirm that the needle tip is positioned within the lumen of the patient's blood vessel. The blood aspiration step includes pushing a pusher extending from the distal portion of the syringe housing with a single finger of the hand while holding the distal portion of the syringe housing between the thumb and one or more other fingers, causing the syringe housing to slide proximally relative to the barrel and withdrawing the plunger connected to the syringe housing from the barrel.

[0030] In some implementations, the first RICC advancement step includes advancing the catheter fitting into the vascular lumen with a single finger of the hand through the pusher tab of the distal connector while the distal portion of the syringe housing surrounding the syringe barrel is held between the thumb of the hand and one or more other fingers.

[0031] In some implementations, the first RICC advancement step includes advancing the catheter bushing of the RICC from the catheter bushing clamp of the proximal connector of the coupling system, followed by advancing one or more extension legs of the RICC within the catheter bushing clamp. The RICC is configured to hang on the coupling system until the needle shaft is withdrawn from at least the longitudinal through-hole of the guide lumen and the distal connector.

[0032] In some embodiments, the method further includes an entry guidewire advancement step. The entry guidewire advancement step includes advancing the entry guidewire, disposed within the lumen of the entry guidewire, into the vascular lumen beyond the needle tip of the guide needle, the lumen of the entry guidewire being formed at least by the plunger lumen of the syringe and the needle lumen of the guide needle. The entry guidewire advancement step is performed prior to the first RICC advancement step. The entry guidewire advancement step includes advancing a slider coupled to the entry guidewire distally on the barrel with a single finger while the distal portion of the syringe housing is held between the thumb and one or more other fingers.

[0033] In some embodiments, the method further includes a manipulating guidewire advancement step. The manipulating guidewire advancement step involves advancing the manipulating guidewire into the vascular lumen through a main lumen having a main lumen port at the distal end of the RICC. The guiding lumen of the catheter fitting coincides with the distal portion of the main lumen, thereby allowing a needle withdrawal step prior to the manipulating guidewire advancement step.

[0034] In some embodiments, the method further includes a second RICC advancement step. The second RICC advancement step includes further advancing the distal portion of the first segment of the catheter fitting into the vascular lumen on a manipulating guidewire, accompanied by sliding the distal connector proximally toward the proximal portion of the catheter fitting to expose the catheter fitting. At least in the immediate deployment state of the RICC assembly, the catheter fitting is covered by a foldable sterile barrier between the proximal portion of the catheter fitting and the distal connector.

[0035] In some embodiments, the method further includes a sterile barrier removal step. The sterile barrier removal step includes separating the sterile barrier by pulling a sterile barrier pull tab of the sterile barrier opposite the distal connector from the catheter fitting, and then pulling the distal connector from the catheter fitting by means of the sterile barrier that is slidably attached to the distal connector, to remove the sterile barrier and the distal connector from the RICC.

[0036] In some embodiments, the method further includes a sterile barrier removal step. The sterile barrier removal step includes separating the sterile barrier by pulling the distal connector away from the catheter fitting, and then completely removing the sterile barrier by pulling the distal connector proximally toward the proximal portion of the catheter fitting, thereby removing the distal connector and the sterile barrier from the RICC.

[0037] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings, which describe specific embodiments of these concepts in more detail, and the following description. Attached Figure Description

[0038] Figure 1 An oblique view of an RICC assembly, including an RICC, a guide, and a coupling system, is shown according to some implementation schemes.

[0039] Figure 2 A first detailed view of the RICC components according to some implementation schemes is shown.

[0040] Figure 3 A second detailed view of the RICC components according to some implementation schemes is shown.

[0041] Figure 4 A longitudinal section of a portion of a guide according to some embodiments is shown.

[0042] Figure 5 The distal portion of a RICC conduit fitting according to some embodiments is shown.

[0043] Figure 6 A first cross-section of a conduit fitting according to some embodiments is shown.

[0044] Figure 7 A second cross-section of a conduit fitting according to some embodiments is shown.

[0045] Figure 8 A third or fourth cross-section of a conduit fitting according to some embodiments is shown. Detailed Implementation

[0046] 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 a specific embodiment disclosed herein may have multiple features that can be readily separated from that specific embodiment and optionally combined or substituted with features of any of the many other embodiments disclosed herein.

[0047] Regarding the terminology used herein, it should be understood that these terms are intended to describe certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and there are no sequential or numerical restrictions. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in order, and the specific embodiment including these features or steps is not limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms “an,” “a,” and “the” include the plural forms.

[0048] For example, the terms "proximal," "proximal portion," or "proximal portion" as used with respect to the catheter disclosed herein include the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Similarly, for example, the term "proximal length" of the catheter includes the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the term "proximal end" of the catheter includes the tip of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of the catheter may include the proximal end of the catheter. However, the proximal portion, proximal portion, or proximal length of the catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

[0049] For example, the terms "distal," "distal portion," or "distal part" as used with respect to the catheter disclosed herein include the portion of the catheter intended to be close to or within the patient when the catheter is used in the patient. Similarly, for example, the term "distal length" of the catheter includes the length of the catheter intended to be close to or within the patient when the catheter is used in the patient. For example, the term "distal end" of the catheter includes the tip of the catheter intended to be close to or within the patient when the catheter is used in the patient. The distal portion, distal part, or distal length of the catheter may include the distal end of the catheter. However, the distal portion, distal part, or distal length of the catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0050] 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.

[0051] As mentioned above, there is a need to reduce the number of steps and medical devices involved in inserting a catheter, such as a CVC, into a patient and advancing the catheter through their vascular system.

[0052] This article discloses rapidly insertable central catheters (“RICCs”), RICC assemblies, and methods for directly inserting such RICCs into the lumen of a patient's blood vessels. However, it should be understood that RICCs are merely one type of catheter, in which the concepts presented herein may be embodied or incorporated. In practice, peripherally inserted central venous catheters (“PICCs”), dialysis catheters, and the like may also embody or otherwise incorporate the concepts, catheter assemblies, and methods for RICCs presented herein.

[0053] RICC components

[0054] Figures 1 to 3 Various views of the RICC component 100, including RICC 102, guide 104, and coupling system 106, are shown according to some embodiments. Figure 4A longitudinal section of a portion of a guide 104 according to some embodiments is shown. Figure 5 The distal portion of the conduit fitting 108 of the RICC 102 according to some embodiments is shown. Figures 6 to 8 Various cross sections of the conduit fitting 108 according to some embodiments are shown.

[0055] As shown in the figure, in some embodiments, the RICC assembly 100 includes an RICC 102, a guide 104, and a coupling system 106 configured to connect the RICC 102 and the guide 104 together. The RICC 102, guide 104, and coupling system 106 are described sequentially in the following sections. However, given the interrelationships of the RICC 102, guide 104, and coupling system 106 in the RICC assembly 100, there are some intersections between the sections of the RICC 102, guide 104, and coupling system 106.

[0056] RICC 102 includes a catheter fitting 108, a catheter bushing 110, and one or more extension legs 112.

[0057] The catheter fitting 108 includes two or more segments, including a catheter tip 114 in the distal portion of the catheter fitting 108; one or more catheter fitting lumens; and a side hole 116 passing through one side of the catheter fitting 108 in the distal portion of the catheter fitting 108.

[0058] Two or more sections of the conduit fitting 108 may be the body of the conduit fitting 108 and the conduit tip 114, which may be formed as a single extrusion of a single material or a single co-extrusion of two similar materials. Alternatively, the body of the conduit fitting 108 and the conduit tip 114 may be formed as two different extrusions of two similar materials and subsequently joined together. However, Figure 5An embodiment of the conduit fitting 108 is shown, wherein the conduit fitting 108 is formed as two different extrusions of two different materials and subsequently joined together. Specifically, the conduit fitting 108 includes a first segment 118 comprising a conduit tip 114; a second segment comprising a side hole 116; and an optional transition segment 122 between them, depending on the joining method of the first segment 118 and the second segment 120 of the conduit fitting 108. For example, the first segment 118 and the second segment 120 of the conduit fitting 108 can be bonded together by heat, solvent, or adhesive, such that the first segment 118 and the second segment 120 are adjacent to each other, or the second segment 120 can be inserted into the first segment 118 and bonded thereto by heat, solvent, or adhesive, thereby forming the transition segment 122. Advantageously, the latter connection, in which the second segment 120 is inserted into the first segment 118, facilitates the incorporation of a smooth cone into the transition segment 122, which is used to expand without capturing tissue (e.g., skin) during the use of the RICC component 100.

[0059] The first segment 118 of the catheter fitting 108 may be formed of a first material (e.g., a polymeric material, such as polytetrafluoroethylene, polypropylene, or polyurethane) having a first hardness, while the second segment 120 of the catheter 108 may be formed of a second material (e.g., a polymeric material, such as polyvinyl chloride, polyethylene, polyurethane, or silicone) having a second hardness less than the first hardness. For example, each segment of the first segment 118 and the second segment 120 of the catheter fitting 108 may be made of different polyurethanes with different hardnesses. In practice, polyurethane is advantageous because the polyurethane segment of the catheter 108 can be relatively rigid at room temperature but becomes more flexible at body temperature, which reduces phlebitis and irritation to the vessel wall. Polyurethane is also advantageous because it has a lower thrombogenicity compared to some other polymers.

[0060] The catheter fitting 108, having at least a first segment 118 of a first polymeric material and a second segment 120 of a second polymeric material, possesses column strength and compliance. The column strength is sufficient to prevent buckling of the catheter fitting 108 when inserted into the insertion site, and the compliance is suitable for advancement of the catheter fitting 108 through the patient's vascular system. Both the column strength and compliance of the catheter fitting 108 are significant because they enable rapid insertion of the catheter fitting 108 into the insertion site and through the patient's vascular system without the use of the Sedinger technique for advancement.

[0061] It should be understood that the first hardness and the second hardness can be on different scales (e.g., type A or type D), so the second hardness of the second polymer material may not be numerically less than the first hardness of the first polymer material. That is, the hardness of the second polymer material can still be less than the hardness of the first polymer material because different scales (each ranging from 0 to 100) are designed to characterize different materials in a group of materials with the same hardness.

[0062] Nevertheless, the first segment 118 and the second segment 120 of the catheter fitting 108 may be formed of the same polymeric material or different polymeric materials of substantially equal hardness, provided that a) the column strength of the catheter fitting 108 is sufficient to prevent the catheter fitting 108 from buckling when inserted into the insertion site, and b) the compliance of the catheter fitting 108 is suitable for advancement of the catheter fitting 108 through the patient's vascular system.

[0063] One or more catheter fitting lumens may extend through the entire catheter fitting 108. However, in multi-lumen RICCs (e.g., double-lumen RICCs, triple-lumen RICCs, quadruple-lumen RICCs, quintuple-lumen RICCs, hexaple-lumen RICCs, etc.), typically only one catheter fitting lumen extends from the proximal end to the distal end of the catheter fitting 108. In practice, the catheter tip 114 typically includes a single lumen passing through it. Alternatively, the single lumen passing through the catheter tip 114 may be referred to as the “tip lumen,” specifically referring to the first segment 118 of the catheter fitting 108 when it is formed separately from and coupled to the remainder of the catheter fitting 108.

[0064] Furthermore, a side hole 116 passes through the side of the catheter fitting 108 in the distal portion of the catheter fitting 108. However, the side hole 116 is close to the first segment 118 of the catheter fitting 108. The side hole 116 opens into a guide lumen 124 of one or more catheter fitting lumens. The guide lumen 124 extends at least from the side hole 116 in the second segment 120 of the catheter fitting 108 through the first segment 118 of the catheter fitting 108 remote therefrom, and extends to the distal end of the RICC 102 (e.g., the distal end of the catheter fitting 108 or the distal end of the catheter tip 114). The guide lumen 124 coincides with the distal portion of one of the catheter fitting lumens described above, which typically extends from the proximal end of the catheter fitting 108 to the distal end of the catheter fitting 108, specifically, the distal portion of the aforementioned catheter fitting lumen distal to the side hole 116.

[0065] The catheter bushing 110 is coupled to the proximal portion of the catheter fitting 108. The catheter bushing 110 includes one or more catheter bushing lumens, which correspond in number to one or more catheter fitting lumens. The one or more catheter bushing lumens extend from the proximal end of the catheter bushing 110 through the entire catheter bushing 110 to the distal end of the catheter bushing 110.

[0066] Each of the one or more extension legs 112 is coupled to the catheter bushing 110 via its distal portion. Each of the one or more extension legs 112 includes one or more extension leg lumens, which sequentially correspond in number to the lumens of one or more catheter fittings. Each of the one or more extension leg lumens extends from the proximal end of the extension leg through the entire extension leg to the distal end of the extension leg.

[0067] Each of the one or more extension legs 112 typically includes a Luer connector coupled to the extension leg, through which the extension leg and its interior can be connected to another medical device.

[0068] RICC 102 can be a single-lumen RICC or a multi-lumen RICC (e.g., double-lumen RICC, triple-lumen RICC, quadruple-lumen RICC, pentalumen RICC, hexalumen RICC, etc.). Figures 1 to 3 and Figures 6 to 8 The RICC 102 shown is a three-lumen RICC comprising a group of three lumens. This group of three lumens includes, for example, a main lumen 126 (e.g., a distal lumen) formed by fluid connection portions of three fitting lumens, three bushing lumens, and three extension leg lumens; a secondary lumen 128 (e.g., an intermediate lumen); and a third lumen 130 (e.g., a proximal lumen). Whether the RICC 102 is single-lumen or multi-lumen, it includes at least a main lumen 126. The main lumen 126 includes at least one fitting lumen as described above, which typically extends from the proximal to the distal end of the fitting 108 as a fitting lumen portion of the main lumen 126; and fluid connection bushing lumen portions and extension leg lumen portions of the main lumen 126. According to the aforementioned catheter fitting lumen, the guiding lumen 124 of the catheter fitting 108 coincides with the distal portion of the main lumen 126, specifically with the distal portion of the main lumen 126 distal to the side port 116. Furthermore, the main lumen 126 has a main lumen orifice 132 at the distal end of the RICC 102 (e.g., the distal end of the catheter fitting 108 or the distal end of the catheter tip 114). A secondary lumen 128 has a secondary lumen orifice 134 on the side of the catheter fitting 108 adjacent to the main lumen orifice 132 and distal to the subsequent third lumen orifice 136, such that the secondary lumen 128 lies between the main lumen orifice 132 and the third lumen orifice 136. A third lumen 130 has a third lumen orifice 136 on the side of the catheter fitting 108 near the secondary lumen orifice 134. The side hole 116 of the catheter fitting 108 may be between the main lumen hole 132 and the secondary lumen hole 134, between the secondary lumen hole 134 and the third lumen hole 136, or as follows: Figure 5 As shown, at the proximal end of the third inner cavity 136, each of the main inner cavity 132, the secondary inner cavity 134 and the third inner cavity 136 is at the distal end of the side cavity 116.

[0069] RICC 102 may further include a manipulator guidewire 138. The manipulator guidewire 138 may include a non-invasive tip (e.g., a coiled or partially coiled tip) (not shown) and a length sufficient to advance the manipulator guidewire 138 to the lower third of the superior vena cava (“SVC”) of the heart. The manipulator guidewire 138 may be constrainedly positioned in RICC 102 at least in an immediately deployable state of RICC assembly 100. For example, the manipulating guidewire 138 may be disposed in the main lumen 126 of the RICC 102, with the proximal or intermediate portion of the manipulating guidewire 138 disposed in the extension leg lumen portion of the main lumen 126, the intermediate or distal portion of the manipulating guidewire 138 disposed in the bushing lumen portion of the main lumen 126, and the distal portion of the manipulating guidewire 138 disposed in the catheter fitting lumen portion of the main lumen 126, the catheter fitting lumen portion being formed by the aforementioned catheter fitting lumen, which typically extends from the proximal end to the distal end of the catheter fitting 108. However, the distal portion of the aforementioned catheter fitting lumen distal to the side port 116 coincides with the guide lumen 124, which, as described below, is occupied by the guide needle 146 at least in the immediate deployment state of the RICC assembly 100. Since the guide pin 146 is present in the guide cavity 124, at least in the immediate deployment state of the RICC assembly 100, the distal end of the manipulating guide wire 138 just does not extend beyond the side hole 116.

[0070] The manipulating guidewire 138 includes a stop 140 (e.g., a bushing, ball, block, etc.) surrounding the proximal portion of the manipulating guidewire 138, the stop 140 forming a blocking end (e.g., bushing end, ball end, block end, etc.) of the manipulating guidewire 138. The blocking end of the manipulating guidewire 138 is larger than the proximal opening of the main lumen 126 or the lumen portion of its extension leg, thereby providing distal restriction for advancing the manipulating guidewire 138 into the RICC 102. Furthermore, the manipulating guidewire 138 may be disposed within a fixed-length sterile barrier 142 (e.g., a longitudinal pouch), the sterile barrier including a closed or sealed proximal end and an additionally open distal end, the distal end being removably coupled (e.g., removably adhered) to the proximal end of a Luer connector of the extension leg for manual removal of both the sterile barrier 142 and the manipulating guidewire 138 if necessary. The fixed length of the sterile barrier 142, the combination of the closed or sealed proximal end of the sterile barrier 142 and the distal end of the sterile barrier 142 coupled to the Luer connector, provides a limited tract within which the manipulating guidewire 138 can be moved proximally, thereby providing proximal restriction for withdrawal of the manipulating guidewire 138 from the RICC 102. The proximal restriction retains the abductive tip of the manipulating guidewire 138 within the main lumen 126, wherein, at least in embodiments with a coiled or partially coiled tip, the abductive tip is held in a straight or uncoiled state. This is advantageous because it can be particularly difficult to reinsert such a guidewire into the lumen of a medical device such as a catheter. Optionally, the blocking end of the manipulating guidewire 138 is coupled (e.g., by adhesion) to the proximal end of the sterile barrier 142 to retain the blocking end of the manipulating guidewire 138 within the proximal end of the sterile barrier 142, thereby reducing the mismatch between the length of the proximal portion of the manipulating guidewire 138 extending beyond the proximal end of the RICC 102 (e.g., the proximal end of the Luer connector) and the pleated length of the sterile barrier 142. Reducing the aforementioned mismatch reduces the likelihood of losing the blocking end of the manipulating guidewire 138 in the middle portion of the sterile barrier 142, which could require time and effort to re-match; it would be better to spend that time and effort on the patient.

[0071] In addition to providing proximal restriction for withdrawing the manipulator guidewire 138 from the RICC 102, the sterile barrier 142 is configured to maintain the sterility of the manipulator guidewire 138 prior to (e.g., during transport and handling, storage, etc.) and during use of the RICC assembly 100. During use of the RICC assembly 100, the sterile barrier 142 is configured to provide a non-contact advance method for advancing the manipulator guidewire 138 into the patient's intravascular lumen as a needle tract is established. Similarly, the sterile barrier 142 is configured to provide a non-contact withdrawal method for withdrawing the manipulator guidewire 138 from the patient's intravascular lumen, for example, after the catheter fitting 108 has been advanced over the manipulator guidewire 138.

[0072] RICC 102 may further include a reinforcing core, such as a reinforcing core 144 in any one or both lumens of the secondary lumen 128 and the third lumen 130 in a three-lumen embodiment of RICC 102, for reinforcing RICC 102. Figure 1 A reinforced core 144 is shown. Such a reinforced core provides additional column strength to prevent the catheter fitting 108 from buckling as it is inserted into the insertion site and advanced through the patient’s vascular system.

[0073] Guide device 104 includes a guide needle 146 operatively connected to a syringe 148; and an entry guidewire 150 disposed within guide device 104. Guide device 104 may further include a fluid pressure indicator 152 operatively connected to guide needle 146. As described below, guide device 104 is configured with at least two distinct actuation mechanisms (e.g., an actuation mechanism for withdrawing plunger 166 and an actuation mechanism for advancing or withdrawing entry guidewire 150), which are actuated by using a single finger of the hand while holding the distal portion of guide device 104 between the thumb and one or more other fingers of the same hand.

[0074] The guide needle 146 includes a needle bushing 154 and a needle shaft 156 extending from the needle bushing 154, the needle shaft 156 terminating at a needle tip 158 (e.g., a beveled tip) in the distal portion of the needle shaft 156. The needle bushing 154 includes ribs 155 configured to insert into a slot 189 of the distal connector 186 and prevent the syringe 148 from rolling from one side to the other, at least in the immediate deployment state of the RICC assembly 100. Furthermore, the needle bushing 154 is translucent and preferably colorless for observing blood return resulting from venous puncture performed by the needle tip 158 (e.g., a beveled tip, etc.). When the RICC assembly 100 is at least in the position as described above... Figure 1 In the immediately deployed state, the needle tip 158 extends slightly beyond the distal end of the RICC 102 for intravenous puncture. In practice, when the RICC assembly 100 is at least in the immediately deployed state, the distal portion of the needle shaft 156 (e.g., approximately 7 cm) extends through the longitudinal through-hole of the distal connector 186 of the connection system 106 presented below, through the side hole 116 of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and through the distal end of the RICC 102. However, in some embodiments, 2-3 cm or more of the distal portion of the needle shaft 156 may extend from the distal end of the RICC 102 for intravenous puncture. In such embodiments, the first segment 118 of the catheter fitting 108 is shorter, while the needle shaft 156 is longer.

[0075] When present, a fluid pressure indicator 152 extends from the side arm 160 of the needle sheath 154. The fluid pressure indicator 152 includes a closed end and an open end, the open end being fluidly connected to the needle lumen of the guide needle 146 via the side arm lumen of the side arm 160. The fluid pressure indicator 152 is configured as a built-in accidental artery indicator, wherein blood at sufficient pressure (e.g., arterial blood) can enter the fluid pressure indicator 152 and compress the air column within it. However, blood backflow from venipuncture can also be observed in the fluid pressure indicator 152. That is, blood backflow caused by venipuncture is typically observed in the needle sheath 154, the side arm 160 of the needle sheath 154, or the syringe 148.

[0076] Syringe 148 includes a syringe housing 162 surrounding a barrel 164, a plunger 166 disposed within the barrel 164, and a syringe tip 168 in a distal portion of the barrel 164, the syringe tip 168 being coupled to a needle bushing 154 of the guide needle 146 when the RICC assembly 100 is at least in an immediately deployed state. Syringe 148 also includes a syringe portion that enters the guidewire lumen 174.

[0077] Syringe housing 162 extends from its proximal portion to a distal end of the distal portion of syringe housing 162 that may coexist with the distal portion of barrel 164, as shown. Syringe housing 162 may include a gripping portion 170 (e.g., raised pattern, through-hole, etc.) in its distal portion, the gripping portion 170 being configured to facilitate gripping of syringe housing 162, thereby facilitating gripping of syringe housing 162 between the thumb and one or more other fingers of the same hand via the distal portion of guide 104, as described above. Positioning of the gripping portion 170 around the distal end of the distal portion of syringe housing 162 promotes holding and handling of RICC assembly 100 in a position providing better control over the distal portion of RICC assembly 100, in which small, unintentional deflection or tilting movements in the distal portion of RICC assembly 100 are kept relatively small compared to the same type of movement when RICC assembly 100 is held in a closer position.

[0078] The syringe housing 162 and plunger 166 are configured to operate together as a single unit within the scope of actuating the syringe 148 (e.g., by withdrawing the plunger 166 to aspirate blood). The syringe housing 162 and plunger 166, or their end pieces 180, may be molded together as a single piece, such that the proximal portion of the syringe housing 162 is integrally formed with the proximal end of the plunger 166. Alternatively, the syringe housing 162 and plunger 166, or their end pieces 180, may be molded separately and subsequently coupled together with a coupling, such that the proximal portion of the syringe housing 162 is coupled to the proximal portion of the plunger 166, or their end pieces 180. For example, the inner wall of the proximal end of the syringe housing 162 may be bonded or welded to the plunger flange or their end piece 180 at the distal end of the plunger 166. Whether the syringe housing 162 and the plunger 166 are integral or connected to each other, sliding the syringe housing 162 proximally relative to the barrel 164 retracts the plunger 166 from the barrel 164, thereby actuating the syringe 148 as a single unit.

[0079] The syringe 148 may further include a pusher 172 that extends proximally on the barrel 164 from a distal portion thereto (e.g., from an integrated connector of the barrel 164 surrounding the syringe tip 168). The pusher 172 is configured for use when actuating the syringe 148 as described above. Specifically, the pusher 172 is configured to be pushed with a single finger while holding the distal portion of the syringe housing 162 between the thumb and one or more other fingers of the same hand, as described above, causing the syringe housing 162 to slide proximally relative to the barrel 164 and retracting the plunger 166 from the barrel 164.

[0080] The syringe 148 also includes a syringe portion that enters the guidewire lumen 174, which is formed by a fluid connection between the plunger lumen of the plunger 166, the syringe tip lumen of the syringe tip 168, and any space within the barrel 164 formed by partially pulling the plunger 166 out of the barrel 164, for example, in various operating states of the RICC assembly 100 (e.g., during the blood aspiration step of the method described below). Another portion entering the guidewire lumen 174 is the guide needle portion entering the guidewire lumen 174, namely the needle lumen of the guide needle 146, specifically when the guide needle 146 is operatively connected to the syringe 148, as in most states of the RICC assembly 100.

[0081] The plunger 166 includes a sealing mechanism 176 in its distal portion for sealing the guidewire lumen 174 distal to the sealing mechanism 176. The sealing mechanism 176 is configured to seal the guidewire lumen 174 to maintain a vacuum for blood aspiration when the plunger 166 is withdrawn from the barrel 164. The sealing mechanism 176 is also configured to seal the guidewire lumen 174 to prevent blood from flowing out (e.g., flashback) through the longitudinal grooves of the barrel 164 and the plunger 166 as described below during venipuncture or when the guidewire 150 is withdrawn from the patient's vascular lumen, thereby minimizing or preventing the possibility of contamination of the surgical area or any clinician manipulation within the surgical area.

[0082] like Figure 4 As shown, the sealing mechanism 176 may be a box disposed in a cavity in the distal end of the body 178 of the plunger 166 and held in the cavity by the end piece 180 of the plunger 166. The box is coaxially aligned with the guidewire inlet cavity 174 or a portion of its plunger cavity such that the unfolded bare wire portion of the guidewire 150 passes through proximal and distal through-holes of the box having an inner diameter corresponding to the outer diameter of the guidewire 150. Optionally, the sealing mechanism 176 includes one or more gaskets, such as O-rings within the box or as a substitute for the box. For example, instead of the box, one or more O-rings may be axially compressed within the cavity by the end piece 180 of the plunger 166, thereby compressing the O-rings radially around the guidewire 150 to seal the guidewire inlet cavity 174.

[0083] The guidewire 150 is confined within the guide 104 such that at least a portion of the guidewire 150 is always within a portion of the 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 guidewire 150 is retracted to its proximal confinement (e.g., defined by the proximal end of the longitudinal groove described below), the distal portion of the guidewire 150 is at least disposed within the distal portion of the plunger lumen. Simultaneously, the proximal portion of the guidewire 150 is disposed within the proximal portion of the plunger lumen. When the RICC assembly 100 is at least in its immediately deployed state, and the distal end of the guidewire 150 is just before the needle tip 158, the intermediate portion of the guidewire 150 is disposed between the distal portion of the plunger lumen and the proximal portion of the needle lumen. In some of the various operating states of the RICC assembly 100 (e.g., during the guidewire advancement step described below), when the guidewire 150 is advanced to its distal limit (e.g., defined by the distal end of the longitudinal groove described below), the proximal portion of the guidewire 150 is positioned at least in the distal portion of the plunger lumen. Simultaneously, as a result of its length, the distal portion of the guidewire 150 extends through or beyond the distal end of the RICC 102, sufficient to extend the guidewire 150 into the patient's vascular lumen upon establishment of the needle path as described below.

[0084] The syringe 148 also includes a slider 182 (e.g., a protruding slider) extending distally from the syringe housing 162 on the barrel 164. The slider 182 is configured to actuate the entry guidewire 150 with a single finger of the same hand (e.g., with a scroll wheel-like motion similar to that used on a computer mouse), while holding the distal portion of the syringe housing 162 between the thumb and one or more other fingers of the same hand. The slider 182 includes an extension 184 extending through longitudinal slots (not shown) in each of the barrel 164 and the plunger 166 into the entry guidewire lumen 174 proximal to the sealing mechanism 176, wherein the extension 184 is coupled to the entry guidewire 150. The proximal and distal ends of the longitudinal groove provide stops for the extension 184 and thus provide a limiting channel within which the extension 184 can move proximally, thereby providing proximal and distal restrictions for retracting or advancing the guidewire 150 from or into the guidewire 104, respectively.

[0085] The coupling system 106 includes a distal coupling 186 and a proximal coupling 188, configured to allow the guide 104 to slide relative to the RICC 102 while the RICC assembly 100 is at least in an immediately deployed state, coupling the RICC 102 and the guide 104 together through their respective proximal and distal portions (or vice versa).

[0086] The distal connector 186 includes a catheter fitting clamp configured to slidably and removably attach the distal connector 186 to a catheter fitting 108 adjacent to a side bore 116. The distal connector 186 also includes a longitudinal through-hole, a slot 189, and a pusher 190 in the distal portion of the distal connector 186. When the RICC assembly 100 is at least in its immediate deployment state, the needle shaft 156 of the guide pin 146 extends through the longitudinal through-hole of the distal connector 186, through the side bore 116 of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and through the distal end of the RICC 102. When the distal connector 186 is slidably attached to the catheter fitting 108, according to the foregoing, the needle shaft 156 extends through the distal connector 186 and the catheter fitting 108, wedging the distal connector 186 between the needle shaft 156 and the catheter fitting 108, such that, at least in the immediate deployment state of the RICC assembly 100, the distal connector 186 is held in its position on the catheter fitting 108 at the proximal end of the side hole 116. In fact, the distal connector 186 can only slide on the catheter fitting 108 when the needle shaft 156 is removed. The groove 189 is configured to receive the rib 155 of the needle bushing 154 inserted therein and, at least in the immediate deployment state of the RICC assembly 100, prevents the syringe 148 from rolling from one side to the other. The pusher 190 is configured to allow a clinician to advance the RICC 102 away from the needle shaft 156 with a single finger of their hand (e.g., by a flicking motion of the finger) while keeping the distal portion of the guide 104 between one thumb and one or more other fingers of the same hand, thereby providing a non-contact mechanism for advancing the RICC 102 (specifically the distal portion of the catheter fitting 108) on the needle shaft 156 and into the patient's vascular lumen.

[0087] The proximal connector 188 is an extension of the syringe housing 162 surrounding the syringe 148. The proximal connector 188 is integral with the syringe housing 162 (e.g., molded together with the syringe housing 162) or coupled to the syringe housing 162 (e.g., separately molded from and bonded or welded to it). The proximal connector 188 includes a catheter bushing clip configured to be slidably and removably attached to the catheter bushing 110 or one or more extension legs 112. The catheter bushing clip is configured to suspend the RICC 102 via the catheter bushing 110, at least in the immediate deployment state of the RICC assembly 100, thereby preventing the RICC 102 from sagging. The catheter bushing clip is also configured to suspend the RICC 102 via one or more extension legs 112 in some of the various operating states of the RICC assembly 100 (e.g., during the guide removal step of the method described below), thereby further preventing the RICC 102 from sagging.

[0088] RICC 102 may further include a sterile barrier 192 (e.g., a foldable or pleated bag, cannula, etc.) configured to maintain the sterility of the catheter fitting 108 between the catheter liner 110 and the distal connector 186 prior to insertion of the catheter fitting 108 into the patient's vascular lumen 275. (See also...) Figure 2 At least in the immediate deployment state of the RICC assembly 100, the sterile barrier 192 is coupled to the distal connector 186 between the catheter bushing 110 and the distal connector 186 surrounding the proximal portion of the catheter fitting 108. The sterile barrier 192 is configured to separate when the sterile barrier pull tab 194 of the sterile barrier 192 is removed from the catheter bushing clamp, in which the sterile barrier is rolled up and pulled away from the catheter fitting 108, thereby providing a non-contact mechanism for removing the sterile barrier 192 from the catheter fitting 108. The sterile barrier 192 has sufficient tensile strength to pull the distal connector 186 away from the catheter fitting 108 without breaking as it is pulled away from the catheter fitting 108 and as the sterile barrier 192 separates downward toward the distal connector 186.

[0089] As mentioned above, Figure 1 The RICC component 100 is shown in at least an immediately deployable state. While some of the various operational states of the RICC component 100 have been described above, additional operational states of the RICC component 100 can be identified from the steps of the method for inserting the RICC 102 described below.

[0090] method

[0091] The method for RICC assembly 100 includes a method for inserting RICC 102 into the lumen of a patient's blood vessel. In some embodiments, such a method includes an RICC assembly acquisition step, a needle tract establishment step, a first RICC advancement step, and a needle withdrawal step.

[0092] The RICC component acquisition step includes acquiring the RICC component 100. As described above, the ICC component 100 includes an RICC 102; a guide 104, which includes a syringe 148 coupled to a guide needle 146; and a coupling system 106, which includes a distal connector 186, which couples the RICC 102 and the distal portion of the guide 104 together, at least in the immediate deployment state of the RICC component 100.

[0093] The method may further include a needle tip securing step, which secures the needle tip 158 extending from the distal end of the RICC 102 prior to the needle channel establishment step. As described above, the needle shaft 156 extends through the longitudinal through-hole of the distal connector 186, through the side hole 116 in the distal end of the catheter fitting 108, along the guide lumen 124 of the catheter fitting 108, and extends beyond the distal end of the RICC 102.

[0094] The needle path creation step involves using a guide needle 146 to create a needle path from the patient's skin area to the blood vessel lumen, while holding the distal portion of the syringe housing 162 around the barrel 164 of the syringe 148 between the thumb and one or more other fingers of the hand. At least one finger of the same hand is readily available. As described above, the needle shaft 156 extends through the longitudinal through-hole of the distal connector 186, through the side hole 116 in the distal portion of the catheter fitting 108 of the RICC 102, extends along the guide lumen 124 of the catheter fitting 108, and extends beyond the distal end of the RICC 102 for needle path creation.

[0095] The needle path establishment step may further include ensuring blood flashback during needle path establishment of the guide needle 146, the needle bushing 154, the side arm 160 of the needle bushing 154, or a fluid pressure indicator 152 extending from the side arm 160 of the needle bushing 154.

[0096] The method may further include a blood aspiration step. The blood aspiration step includes aspirating blood with syringe 148 prior to the needle withdrawal step to confirm that the needle tip 158 is positioned within the lumen of the patient's blood vessel. The blood aspiration step includes pushing a pusher 172 extending from the distal portion of the barrel 164 with a single finger of the hand while holding the distal portion of the syringe housing 162 between the thumb and one or more other fingers, causing the syringe housing 162 to slide proximally relative to the barrel 164 and withdrawing the plunger 166 connected to the syringe housing 162 from the barrel 164.

[0097] The method may further include an entry guidewire advancement step. This step involves advancing the entry guidewire 150, disposed within the entry guidewire lumen 174, into the vessel lumen beyond the needle tip 158 of the guide needle 146. This can be achieved by advancing a slider 182 connected to the entry guidewire 150 distally on the barrel 164 using a single finger of the hand, while holding the distal portion of the syringe housing 162 between the thumb and one or more other fingers of the same hand. As described above, the entry guidewire 150 is disposed within the entry guidewire lumen 174, formed at least by the plunger lumen of the plunger 166 and the needle lumen of the guide needle 146. This facilitates initial insertion success by making the entry guidewire 150 immediately available before the vessel might be lost due to small, unintentional movements. The entry guidewire advancement step should be performed prior to the first RICC advancement step so that the distal portion of the catheter fitting 108 can also be advanced over the entry guidewire 150.

[0098] The first RICC advancement step includes advancing the distal portion of a first segment 118 of catheter fitting 108 over a needle shaft 156, an entry guidewire 150, or both, into the vascular lumen. As described above, catheter 108 includes a first segment 118 formed of a first material having a first hardness and a second segment 120 formed of a second material having a second hardness less than the first hardness. The first segment 118 of catheter fitting 108 is configured to have column strength for advancing catheter fitting 108 into the vascular lumen over entry guidewire 150 or manipulation guidewire 138 after the manipulation guidewire advancement step described below. For example, the first RICC advancement step may include advancing catheter fitting 108 into the vascular lumen using a single finger of the hand (e.g., by a flicking motion of the finger) through a pusher 190 of distal connector 186 while holding guide 104 between the thumb and one or more other fingers of the same hand via the distal portion of syringe housing 162. The distal connector 186 includes a pusher 190 configured to advance the catheter fitting 108 into the vascular lumen using a single finger.

[0099] The first RICC advancement step further includes advancing the catheter bushing 110 of the RICC 102 from the catheter bushing clamp of the proximal connector 188 of the coupling system 106, followed by advancing one or more extension legs 112 of the RICC 102 within the catheter bushing clamp. The RICC 102 is configured to hang on the coupling system 106 until the needle shaft 156 is withdrawn from at least the longitudinal through-holes of the guide lumen 124 and the distal connector 186, for example, after the guide removal step described below.

[0100] The method may further include an entry guidewire withdrawal step, which, for example, involves advancing a slider 182 attached to the entry guidewire 150 proximally on the barrel 164 using a single finger of the hand, while holding the distal portion of the syringe housing 162 between the thumb and one or more other fingers of the same hand, to withdraw the entry guidewire 150 from the patient's intravascular lumen. The entry guidewire withdrawal step may be performed after the first RICC advancement step, for example, after the distal portion of the catheter fitting 108 has been properly positioned on the needle shaft 156 and the intravascular lumen of the entry guidewire 150.

[0101] The needle withdrawal step involves withdrawing the needle shaft 156 from the guide lumen 124 through the side hole 116 of the catheter fitting 108. Similar to the guidewire withdrawal step, the needle withdrawal step can be performed after the first RICC advancement step, for example, after the distal portion of the catheter fitting 108 has been properly positioned on the needle shaft 156 and into the vascular lumen of the guidewire 150.

[0102] The method may further include a guide removal step, which completely removes the guide 104 from the RICC assembly 100 after the needle withdrawal step. The guide removal step includes withdrawing the needle shaft 156 from the longitudinal through-hole of the distal connector 186 while sliding the catheter bushing clamp proximally along one or more extension legs 112. During the withdrawal of the needle shaft 156 from the longitudinal through-hole of the distal connector 186, each of the one or more extension legs 112 can be removed through an opening in the catheter bushing clamp, the opening being approximately equal to or slightly wider than the diameter of the extension leg.

[0103] The method may further include a guidewire advancement step. This step includes, for example, advancing the guidewire 138 into the vascular lumen through a main lumen 126 having a main lumen port 132 at the distal end of the RICC 102. As described above, the guiding lumen 124 of the catheter fitting 108 coincides with the distal portion of the main lumen 126, specifically with the distal portion of the main lumen 126 distal to the side port 116. Therefore, a needle withdrawal step must be performed before the guidewire advancement step to ensure that neither the main lumen 126 nor its guiding lumen 124 is within the needle shaft 156 or the guidewire 150.

[0104] The method may further include a second RICC advancement step. The second RICC advancement step includes further advancing the distal portion of the first segment 118 of the catheter fitting 108 into the vascular lumen (e.g., into the SVC) on a manipulating guidewire 138. The manipulating guidewire 138 provides column strength for the second segment 120 of the catheter fitting 108 for the second RICC advancement step. Accompanyingly, the second catheter advancement step includes sliding the distal connector 186 proximally toward the proximal portion of the catheter fitting 108 (e.g., toward the catheter liner 110) to expose the catheter fitting 108. As described above, at least in the immediate deployment state of the RICC assembly 100, the catheter fitting 108 may be covered by a foldable sterile barrier 192 between the proximal portion of the catheter fitting 108 and the distal connector 186.

[0105] The method may further include a sterile barrier removal step. The sterile barrier removal step includes separating the sterile barrier 192 by pulling the sterile barrier pull tab 194 of the sterile barrier 192, which is opposite to the distal connector 186, from the catheter fitting 108, and then pulling the distal connector 186 from the catheter fitting 108 via the sterile barrier 192, which is slidably attached to the distal connector 186, to remove the sterile barrier 192 and the distal connector 186 from the RICC 102. Alternatively, the sterile barrier removal step includes separating the sterile barrier 192 by pulling the distal connector 186 from the catheter fitting 108, and then further proximally pulling the distal connector 186 toward the proximal portion of the catheter fitting 108 to completely remove the sterile barrier 192, thereby removing the distal connector 186 and the sterile barrier 192 from the RICC 102.

[0106] The method may further include a manipulator withdrawal step, namely withdrawing the manipulator 138 from the patient's intravascular lumen and withdrawing the manipulator 138 from the RICC 102.

[0107] While specific embodiments have been disclosed herein, and while they have been disclosed in considerable detail, these embodiments are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A rapidly insertable central catheter assembly for direct insertion into a blood vessel lumen of a patient, characterized by, Comprising: a rapid-insertable central catheter comprising: a catheter tube including a side hole through a side of the catheter tube in a distal end portion of the catheter tube, the side hole opening into a guide lumen of the catheter tube extending at least from the side hole to a distal end of the rapid-insertable central catheter; a catheter hub coupled to a proximal end portion of the catheter tube; and one or more extension legs, each of the one or more extension legs coupled to the catheter hub by a distal end portion thereof; a introducer comprising an introducer needle having a needle shaft extending through the distal end of the rapid-insertable central catheter when the rapid-insertable central catheter assembly is at least in an immediate deployment state of the rapid-insertable central catheter assembly, the introducer configured to be actuated by a single finger of one hand while the distal end portion of the introducer is held between the thumb and another finger or fingers of the one hand, wherein the introducer further comprises: a syringe comprising: a barrel having a syringe tip at a distal end portion thereof, the syringe tip coupled to a needle hub of the introducer needle at least in the immediate deployment state of the rapid-insertable central catheter assembly; a plunger disposed in the barrel; and a syringe housing surrounding the barrel and having a distal end portion and a proximal end portion, the proximal end portion of the syringe housing being integral with or coupled to a proximal end portion of the plunger such that proximal sliding of the syringe housing relative to the barrel withdraws the plunger from the barrel; and a coupling system configured for coupling the rapid-insertable central catheter and the introducer together, the coupling system comprising a distal coupler slidably attached to the catheter tube proximally of the side hole, wherein the coupling system further comprises a proximal coupler coupled to the syringe and slidably attached to the catheter hub at least in the immediate deployment state of the rapid-insertable central catheter assembly, the coupling system configured to allow sliding of the rapid-insertable central catheter relative to the introducer.

2. The quick insertable central catheter assembly of claim 1, wherein, the catheter tube further comprising: a first section formed of a first material having a first stiffness, the side hole being proximal of the first section of the catheter tube; and a second section formed of a second material having a second stiffness, the second stiffness being less than the first stiffness, the catheter tube thereby configured with both column strength and compliance for pushing the catheter tube into the blood vessel lumen and through the vasculature of the patient.

3. The quick insertable central catheter assembly of claim 1, wherein, the needle shaft further extending through a longitudinal through-hole of the distal coupler, through the side hole of the catheter tube, and along the guide lumen of the catheter tube before exiting through the distal end of the rapid-insertable central catheter when the rapid-insertable central catheter assembly is at least in its immediate deployment state.

4. The quick insertable central catheter assembly of claim 1, wherein, The distal coupler includes a push tab configured to allow a clinician to use a single finger of the hand to single-handedly advance the rapidly-insertable central catheter off the needle shaft while maintaining a distal end portion of the introducer between the thumb and another finger or fingers of the hand.

5. The quick insertable central catheter assembly of claim 1, wherein, The injector further includes a push tab extending proximally on the barrel from a distal end portion of the barrel to which the push tab is coupled, the push tab configured for actuation using the single finger while maintaining a distal end portion of the injector housing between the thumb and another finger or fingers of the hand to slide the injector housing proximally relative to the barrel and withdraw the plunger from the barrel.

6. The quick insertable central catheter assembly of claim 1, wherein, The introducer further includes an access guidewire disposed in an access guidewire lumen formed by at least a plunger inner lumen of the plunger and a needle inner lumen of the introducer needle, the access guidewire having a length sufficient for the access guidewire to extend through a distal end of the rapidly-insertable central catheter and into a vessel lumen of the patient.

7. The quick insertable central catheter assembly of claim 6, wherein, The plunger includes a sealing mechanism in a distal end portion of the plunger for sealing the access guidewire lumen distally of the sealing mechanism, the sealing mechanism configured to maintain a vacuum for drawing blood as the plunger is withdrawn from the barrel.

8. The quick insertable central catheter assembly of claim 7, wherein, The injector further includes a slide extending distally on the barrel from the injector housing, the slide configured for actuation of the access guidewire using the single finger while maintaining a distal end portion of the injector housing between the thumb and another finger or fingers of the hand, the slide including an extension that extends through a longitudinal slot in each of the barrel and the plunger into the access guidewire lumen proximally of the sealing mechanism, where the extension is coupled to the access guidewire.

9. The quick insertable central catheter assembly of claim 1, wherein, The introducer further includes a fluid pressure indicator extending from a side arm of the needle hub, the fluid pressure indicator fluidly coupled to the needle inner lumen of the introducer needle by way of a side arm inner lumen of the side arm for observation of blood backflow due to accidental arterial puncture.

10. The quick insertable central catheter assembly of claim 1, wherein, The proximal coupler includes a catheter hub clamp through which the rapidly-insertable central catheter is configured to be suspended by the catheter hub clamp at least in an immediate deployment state of the rapidly-insertable central catheter assembly, or in an operational state of the rapidly-insertable central catheter assembly when the proximal coupler is advanced on the one or more extension legs.

11. The quick insertable central catheter assembly of claim 10, wherein, The rapidly-insertable central catheter further includes a collapsible catheter tube sterile barrier on the catheter tube between the catheter hub and the distal coupler, the catheter tube sterile barrier coupled to the distal coupler, the catheter tube sterile barrier configured to separate when a sterile barrier pull tab of the catheter tube sterile barrier is removed from the catheter hub clamp and the catheter tube sterile barrier is pulled away from the catheter tube by the sterile barrier pull tab.

12. The quick insertable central catheter assembly of claim 11, wherein, The catheter tube aseptic barrier has sufficient tensile strength to pull the distal coupler away from the catheter tube without breaking when the catheter tube aseptic barrier is pulled away from the catheter tube while being pulled downwardly apart from the distal coupler.

13. The quick insertable central catheter assembly of claim 1, wherein, The rapid insertable central catheter includes a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen, formed from fluid connections of three catheter tube lumens, three hub lumens, and three extension leg lumens, the guide lumen of the catheter tube coinciding with a distal portion of the primary lumen.

14. The quick insertable central catheter assembly of claim 13, wherein, The primary lumen has a primary lumen aperture in a distal end of the rapid insertable central catheter, the secondary lumen has a secondary lumen aperture in a side of the catheter tube distal of the side aperture, and the tertiary lumen has a tertiary lumen aperture in a side of the catheter tube distal of the side aperture but proximal of the secondary lumen aperture.

15. The quick insertable central catheter assembly of claim 13, wherein, The rapid insertable central catheter further includes a steering guidewire disposed in the primary lumen, the steering guidewire having a length sufficient to extend the steering guidewire to a lower 1 / 3 of a superior vena cava of a heart, the steering guidewire being restrained in the rapid insertable central catheter by a stop around a proximal portion of the steering guidewire and a closed end of a fixed length steering guidewire aseptic barrier coupled to a luer connector, the stop providing a distal limit to advancing the steering guidewire and the closed end of the steering guidewire aseptic barrier around the steering guidewire providing a proximal limit to retracting the steering guidewire.

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