Rapidly insertable central catheters including catheter assemblies and methods thereof

Abstract

A rapid-insertable central catheter (“RICC”) and a method thereof are disclosed, comprising a catheter assembly. The RICC assembly may include a RICC, an inducer, and a coupling system configured to couple the RICC and the inducer together. The catheter tube of the RICC includes a lateral opening within a distal-end portion of the catheter tube, and the lateral opening opens into an induction lumen extending to the distal end of the RICC. The inducer includes an inducer needle extending through the distal end of the RICC when the RICC assembly is at least in its deployment-ready state. The inducer is configured to be operated by one finger of the hand while holding the distal-end portion of the inducer between the thumb and other fingers or fingers of the hand. The coupling system includes a distal coupler slidably attached to the catheter tube proximal to the lateral opening.

Description

Technology Field

[0001] The present disclosure relates to a catheter, and more specifically to a central catheter capable of rapid insertion. Background Technology

[0002] Central venous catheters ("CVCs") are formed from materials with relatively low durometers, which contributes to the fact that while CVCs are flexible, they lack the column strength required for direct insertion. Due to this weak column strength, CVCs are typically introduced into patients and advanced through their blood vessels via the Seldinger technique. The Seldinger technique involves a large number of steps and medical devices (e.g., needles, scalpels, guide wires, introductory sheaths, dilators, CVCs, etc.). While the Seldinger technique is effective, the multiple steps make it time-consuming, and handling numerous medical devices is cumbersome; both of these factors can lead to patient trauma. Furthermore, the risk of touch contamination is relatively high due to the many medical devices that must be replaced during the various steps of the Seldinger technique. Thus, there is a need to reduce the number of steps and medical devices involved in introducing catheters, such as CVCs, into patients and advancing them through their blood vessels. Prior art literature

[65535] U.S. Patent Application Publication US2016 / 0220786

[0003] To solve the aforementioned problems, a rapidly insertable central catheter (“RICC”) and a method comprising a catheter assembly are disclosed herein.

[0004] A RICC assembly for direct insertion into a patient's blood-vessel lumen is disclosed herein. In some embodiments, the RICC assembly comprises a RICC, an inducer, and a coupling system. The RICC comprises a catheter tube, a catheter hub, and one or more extension legs. The catheter tube includes a lateral opening through the side of the catheter tube within its distal end portion. The lateral opening opens into the inducer lumen of the catheter tube extending at least from the lateral opening to the distal end of the RICC. The catheter hub is coupled to the proximal end portion of the catheter tube. Each of the one or more extension legs is coupled to the catheter hub by its distal end portion. The inducer comprises an inducer needle. The inducer needle has a needle shaft extending through the distal end of the RICC when the RICC assembly is in at least the unfolded-ready state of the RICC assembly. The inducer is configured to be operated by one finger of the hand while holding the distal end portion of the inducer between the thumb and other fingers or fingers of the hand. The coupling system is configured to couple the RICC and the inducer together. The coupling system includes a distal coupler slidably attached to a catheter tube proximal to the lateral opening.

[0005] In some embodiments, the catheter tube further comprises a first section and a second section, and a lateral opening is proximal to the first section of the catheter tube. The first section is formed of a first material, and the second section of the catheter tube is formed of a second material. The first material has a first durometer, and the second material has a second durometer lower than the first durometer. Accordingly, the catheter tube is configured to have both column strength and flexibility to advance the catheter tube into the vascular lumen and through the patient's vascular system.

[0006] In some embodiments, the needle shaft extends further through the longitudinal through hole of the distal coupler, through the lateral opening of the catheter tube, and along the introduction lumen of the catheter tube before exiting through the distal end of the RICC when the RICC assembly is at least in the unfolded-ready state.

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

[0008] In some embodiments, the inducer further comprises a syringe. The syringe comprises a body portion, a plunger disposed within the body portion, and a syringe housing around the body portion. The body portion has a syringe tip portion within its distal end portion that is coupled to the needle hub of the inducer needle in at least the unfolded-ready 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 sliding the syringe housing proximally relative to the body portion retracts the plunger from the body portion.

[0009] In some embodiments, the syringe further comprises a push tab extending proximally across the body from a distal end portion of the body to which the push tab is coupled. The push tab is configured to be pushed with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand, which slides the syringe housing proximally relative to the body and retracts the plunger from the body.

[0010] In some embodiments, the inducer further comprises an approach guide wire disposed within the approach guide wire lumen. The approach guide wire lumen is formed by at least the plunger lumen of the plunger and the needle lumen of the inducer needle. The approach guide wire has a length sufficient for the approach guide wire to extend through the distal end of the RICC and into the patient's vascular lumen.

[0011] In some embodiments, the plunger includes a sealing mechanism at the distal end portion of the plunger to seal a distal approach-guide wire lumen to the sealing mechanism. The sealing mechanism is configured to maintain a vacuum for aspirating blood when the plunger is withdrawn from the body portion.

[0012] In some embodiments, the syringe further comprises a slider extending distally from the syringe housing across the body portion. The slider is configured to allow the approach guide wire to be actuated with one finger while holding the distally end portion of the syringe housing between the thumb and other fingers or fingers of the hand. The slider comprises an extension extending through longitudinal slots within the body portion and the plunger, respectively, into an approach-guide wire lumen proximal to the sealing mechanism, and in this approach-guide wire lumen proximal to the sealing mechanism, the extension is coupled to the approach guide wire.

[0013] In some embodiments, the inducer further includes a fluid-pressure indicator extending from a lateral arm of the needle hub. The fluid-pressure indicator is fluidically coupled to the needle lumen of the inducer needle through the lateral arm lumen of the lateral arm for the observation of blood flashbacks caused by accidental arterial perforation.

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

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

[0016] In some embodiments, the RICC further comprises a collapsible catheter-tube sterile barrier across the catheter tube between the catheter hub and the distal coupler, and the catheter-tube sterile barrier is coupled to this distal coupler. The catheter-tube sterile barrier is configured to split when the sterile-barrier pull tab of the catheter-tube sterile barrier is removed from the catheter-hub clip and the catheter-tube sterile barrier is pulled away from the catheter tube by the sterile-barrier pull tab.

[0017] In some embodiments, the catheter-tube sterile barrier has sufficient tensile strength to pull the distal coupler from the catheter tube without being destroyed when the catheter-tube sterile barrier is split into the distal coupler while being pulled away from the catheter tube.

[0018] In some embodiments, the RICC comprises a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen. The set of three lumens is formed by fluidly connected portions of three catheter-tube lumens, three hub lumens, and three extension leg lumens. The introduction lumen of the catheter tube corresponds to 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 lateral opening, and the tertiary lumen has a tertiary-lumen opening on the side of the catheter tube distal to the lateral opening but proximal to the secondary-lumen opening.

[0020] In some embodiments, the RICC further comprises a manipulation guide wire disposed within the primary lumen. The manipulation guide wire has a length sufficient to extend to the lower one-third of the superior vena cava of the heart. The manipulation guide wire is captively disposed within the RICC by a stop portion around the proximal end portion of the manipulation guide wire and a closed end of a fixed-length manipulation-guide wire sterile barrier coupled to a Luer connector. The stop portion provides a distal limit for the advancement of the manipulation guide wire. The closed end of the manipulation-guide wire sterile barrier around the manipulation guide wire provides a proximal limit for the retrieval of the manipulation guide wire.

[0021] A syringe is also disclosed herein. The syringe comprises a body portion, a plunger disposed within the body portion, and a syringe housing surrounding the body portion. The body portion has a syringe tip portion within 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 sliding the syringe housing proximally relative to the body portion retracts the plunger from the body portion. The syringe is configured to be operated by one finger of the hand while holding the distal end portion of the syringe between the thumb and other fingers or fingers of the hand.

[0022] In some embodiments, the syringe further comprises a push tab extending proximally across the body from a distal end portion of the body to which the push tab is coupled. The push tab is configured to be pushed by one finger of the hand while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand, which slides the syringe housing proximally relative to the body and retracts the plunger from the body.

[0023] In some embodiments, the syringe further comprises an access guide wire disposed within an access guide wire lumen. The access guide wire lumen is formed by at least the plunger lumen of the plunger. The access guide wire has a length sufficient for the access guide wire to extend through the tip of the syringe and into the patient's vascular lumen.

[0024] In some embodiments, the plunger includes a sealing mechanism at the distal end portion of the plunger to seal a distal approach-guide wire lumen to the sealing mechanism. The sealing mechanism is configured to maintain a vacuum for aspirating blood when the plunger is withdrawn from the body portion.

[0025] In some embodiments, the syringe further comprises a slider extending distally from the syringe housing across the body portion. The slider is configured to allow the approach guide wire to be actuated with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand. The slider comprises an extension extending through a longitudinal slot within each of the body portion and the plunger into an approach-guide wire lumen proximal to the sealing mechanism, and in this approach-guide wire lumen proximal to the sealing mechanism, the extension is coupled to the approach guide wire.

[0026] Additionally, a method for inserting a RICC into a patient's vascular lumen is disclosed herein. Such a method comprises a RICC assembly-acquisition step, a needle tract-establishment step, a first RICC-advancement step, and a needle-retrieval step. The RICC assembly-acquisition step comprises acquiring a RICC assembly. The RICC assembly comprises a RICC, an inducer comprising a syringe coupled to an inducer needle, and a coupling system comprising a distal coupler that couples the RICC and the inducer together by a distal end portion of at least the RICC assembly in an unfolded-ready state. The needle tract-establishment step comprises establishing a needle tract from a region of the patient's skin to the vascular lumen with the needle shaft of the inducer needle while holding the distal end portion of the syringe housing around the body of the syringe between the thumb and other fingers or fingers of the hand. Meanwhile, at least one finger of the hand can remain easily accessible. The needle shaft extends through the longitudinal through hole of the distal coupler, through a lateral opening within the distal end portion of the RICC catheter tube, along the introduction lumen of the catheter tube, and outside the distal end of the RICC to establish the needle tube. The first RICC-advancement step comprises advancing the distal end portion of the first section of the catheter tube into the vascular lumen over the needle shaft. The needle-retrieval step comprises retrieving the needle shaft from the introduction lumen through the lateral opening of the catheter tube.

[0027] In some embodiments, the method further comprises a blood aspiration step. The blood aspiration step comprises aspirating blood with a syringe prior to the needle retrieval step to ensure that the needle tip is positioned within the patient's vascular lumen. The blood aspiration step comprises pushing a push tab extending over the body portion from the distal end portion with one finger of the hand while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand, which slides the syringe housing proximally relative to the body portion and retrieves the syringe housing-connected plunger from the body portion.

[0028] In some embodiments, the first RICC-advance step comprises advancing the catheter tube into the vascular lumen by pushing the tab of the distal coupler with one finger of the hand while holding the distal end portion of the syringe housing around the body portion of the syringe between the thumb and other fingers or fingers of the hand.

[0029] In some embodiments, the first RICC-advancement step comprises advancing the catheter hub of the RICC from the catheter-hub clip of the proximal coupler of the coupling system and then from one or more extension legs of the RICC within the catheter-hub clip. The RICC is configured to be suspended from the coupling system until at least the needle shaft is retrieved from both the introduction lumen and the longitudinal through hole of the distal coupler.

[0030] In some embodiments, the method further comprises an approach guide wire-advance step. The approach guide wire-advance step comprises advancing an approach guide wire positioned within an approach guide wire lumen formed by at least the plunger lumen of a syringe and the needle lumen of an introductory needle into a vascular lumen beyond the needle tip of the introductory needle. The approach guide wire-advance step is performed prior to the first RICC-advance step. The approach guide wire-advance step comprises advancing a slider coupled to the approach guide wire distally over the body portion with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand.

[0031] In some embodiments, the method further comprises a manipulation guide wire-advancement step. The manipulation guide wire-advancement step comprises advancing the manipulation guide wire into the vascular lumen through a primary lumen having a primary lumen opening within the distal end of the RICC. The introduction lumen of the catheter tube coincides with the distal end portion of the primary lumen, thereby requiring the performance of a needle-retrieval step prior to the manipulation guide wire-advancement step.

[0032] In some embodiments, the method further comprises a second RICC-advancement step. The second RICC-advancement step comprises advancing the distal end portion of the first section of the catheter tube further into the vascular lumen over the manipulation guide wire, which consequently comprises sliding the distal coupler proximally toward the proximal end portion of the catheter tube to expose the catheter tube. The catheter tube is covered by a crushable sterile barrier between the proximal end portion of the catheter tube and the distal coupler, at least in the unfolded-ready state of the RICC assembly.

[0033] In some embodiments, the method further comprises a sterile barrier-removal step. The sterile barrier-removal step comprises splitting the sterile barrier by pulling a sterile barrier pull tab of the sterile barrier opposite to the distal coupler away from the catheter tube, and then removing the sterile barrier and the distal coupler from the RICC by 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 comprises a sterile barrier-removal step. The sterile barrier-removal step comprises removing the distal coupler and the sterile barrier from the RICC by pulling the distal coupler out of the catheter tube to split 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 concept provided herein will become more apparent to those skilled in the art through the accompanying drawings and the following description, which further explain specific embodiments of such concept. Brief explanation of the drawing

[0036] FIG. 1 illustrates an oblique view of a RICC assembly including a RICC, an introductory unit, and a coupling system according to some embodiments. FIG. 2 provides a first detailed view of an RICC assembly according to some embodiments. FIG. 3 provides a second detailed view of an RICC assembly according to some embodiments. FIG. 4 illustrates a longitudinal cross-section of a portion of an introductory device according to some embodiments. FIG. 5 illustrates the distal end portion of a catheter tube of an RICC according to some embodiments. FIG. 6 illustrates a first transverse cross-section of a catheter tube according to some embodiments. FIG. 7 illustrates a second transverse cross-section of a catheter tube according to some embodiments. FIG. 8 illustrates a third or fourth transverse cross-section of a catheter tube according to some embodiments. Specific details for implementing the invention

[0037] The present application claims the benefit of priority to U.S. provisional application No. 63 / 045,649 filed on June 29, 2020, the full text of which is incorporated herein by reference.

[0038] Before specifically disclosing certain embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It will also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may be optionally combined with or substituted with features of any many other embodiments disclosed herein.

[0039] With respect to the terms used herein, it should be understood that the terms are intended for the purpose of describing 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 a sequential or numerical limitation. For example, "first," "second," and "third" features or steps do not necessarily need to appear in such an order, nor is a specific embodiment containing such features or steps necessarily limited to three features or steps. Labels such as "left," "right," "top," "bottom," "front," "rear," etc. are used for convenience and are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. Unless otherwise explicitly stated in the context, the singular forms (“a,” “an,” and “the”) include plural objects.

[0040] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein comprises the portion of the catheter intended to be close to the clinician when the catheter is used on a patient. Likewise, for example, the "proximal length" of a catheter comprises the length of the catheter intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter comprises the end of the catheter intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may comprise the proximal end of the catheter; however, the proximal portion, proximal end portion, or proximal length of a catheter does not necessarily comprise the proximal end of the catheter. That is, unless otherwise indicated in the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of a catheter.

[0041] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. Likewise, for example, the “distal length” of a catheter comprises a length of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. For example, the “distal end” of a catheter comprises a portion of the catheter intended to be positioned near or within the patient when the catheter is used against a patient. The distal portion, distal end portion, or distal length of the catheter may comprise the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter does not need to comprise the distal end of the catheter. That is, unless otherwise indicated in the context, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally understood by those skilled in the art.

[0043] As mentioned above, it is necessary to reduce the number of steps and medical devices involved in introducing a catheter, such as a CVC, into a patient and advancing the catheter through the patient's vascular system.

[0044] A rapidly insertable central catheter (“RICC”), a RICC assembly, and a method for directly inserting such a RICC into a patient’s vascular lumen are disclosed herein. However, it should be understood that the RICC is merely one type of catheter to which the concept provided herein may be implemented or otherwise incorporated. In fact, peripherally inserted central catheters (“PICC”), dialysis catheters, etc., may also implement or incorporate the concept provided herein for the RICC, as well as catheter assemblies and methods thereof.

[0045] RICC Assembly

[0046] FIGS. 1 through 3 illustrate various drawings of an RICC assembly (100) including an RICC (102), an introductory unit (104), and a coupling system (106) according to some embodiments. FIG. 4 illustrates a longitudinal cross-section of a portion of the introductory unit (104) according to some embodiments. FIG. 5 illustrates a distal end portion of a catheter tube (108) of the RICC (102) according to some embodiments. FIGS. 6 through 8 illustrate various transverse cross-sections of the catheter tube (108) according to some embodiments.

[0047] As illustrated, the RICC assembly (100) includes, in some embodiments, a RICC (102), an introductory unit (104), and a coupling system (106) configured to couple the RICC (102) and the introductory unit (104) together. The RICC (102), the introductory unit (104), and the coupling system (106) are subsequently described in the sections described below; however, in terms of the interrelationships of the RICC (102), the introductory unit (104), and the coupling system (106) within the RICC assembly (100), there is some overlap between the sections regarding the RICC (102), the introductory unit (104), and the coupling system (106).

[0048] The RICC (102) includes a catheter tube (108), a catheter hub (110), and one or more extension legs (112).

[0049] The catheter tube (108) comprises two or more sections, each including a catheter tip (114) within the distal end portion of the catheter tube (108), one or more catheter-tube lumens, and a lateral opening (116) through the side of the catheter tube (108) within the distal end portion of the catheter tube (108).

[0050] Two or more sections of the catheter tube (108) may be the main body of the catheter tube (108) and the catheter tip (114), which may be formed from one extruded fragment of one material or one common extruded fragment of two similar materials. Alternatively, the main body of the catheter tube (108) and the catheter tip (114) may be formed from two different extruded fragments of two similar materials and then coupled. However, FIG. 5 illustrates an embodiment of the catheter tube (108) in which the catheter tube (108) is formed from two different extruded fragments of two similar materials and then coupled. In effect, the catheter tube (108) comprises a first section (118) including a catheter tip (114), a second section including a side opening (116), and an optional transition section (122) between them, depending on how the first section (118) and the second section (120) of the catheter tube (108) are coupled internally. For example, the first and second sections (118 and 120) of the catheter tube (108) may be bonded by heat, a solvent, or an adhesive so that the first and second sections (118 and 120) are adjacent to each other, or the second section (120) may be inserted into the first section (118) and bonded thereto by heat, a solvent, or an adhesive, thereby forming the transition section (122). Advantageously, the latter coupling that inserts the second section (120) into the first section (118) facilitates the incorporation of a smooth taper into the transition section (122), and this taper is useful for extending without catching tissue (e.g., skin) during the use of the RICC assembly (100).

[0051] A first section (118) of the catheter tube (108) may be formed of a first material having a first durometer (e.g., a polymer material such as polytetrafluoroethylene, polypropylene, or polyurethane), while a second section (120) of the catheter tube (108) may be formed of a second material having a second durometer lower than the first durometer (e.g., a polymer material such as polyvinyl chloride, polyethylene, polyurethane, or silicone). For example, each section of the first section (118) and the second section (120) of the catheter tube (108) may be made of different polyurethanes having different dumeters. In fact, polyurethane is advantageous in that the polyurethane section of the catheter tube (108) may be relatively rigid at room temperature but becomes more flexible at body temperature, which reduces irritation to the blood vessel walls and phlebitis. Polyurethane is also advantageous in that it causes less blood clot formation than some other polymers.

[0052] A catheter tube (108) having at least a first section (118) of a first polymer material and a second section (120) of a second polymer material has column strength sufficient to prevent buckling of the catheter tube (108) when the catheter tube (108) is inserted into an insertion site, as well as flexibility suitable for advancing the catheter tube (108) through the patient's vascular system. Both the column strength and flexibility of the catheter tube (108) are noteworthy in that they allow the catheter tube (108) to be rapidly inserted into an insertion site and the catheter tube (108) to be advanced through the patient's vascular system without using the Seldinger technique.

[0053] It should be understood that the first durometer and the second durometer may be different scales (e.g., Type A or Type D), and accordingly, the second durometer of the second polymer material may not be numerically smaller than the first durometer of the first polymer material. That is, because different scales (each ranging from 0 to 100) are designed to characterize different materials within a group of materials having similar durometer values ​​(hardness), the durometer value of the second polymer material may still be lower than the durometer value of the first polymer material.

[0054] Notwithstanding the foregoing, if a) the column strength of the catheter tube (108) is sufficient to prevent buckling of the catheter tube (108) when inserted into the insertion site and b) the flexibility of the catheter tube (108) is suitable for advancing the catheter tube (108) through the patient's vascular system, the first section (118) and the second section (120) of the catheter tube (108) may be formed of the same polymer material having substantially the same durometer or different polymer materials.

[0055] Although one or more catheter-tube lumens may extend throughout the entire catheter tube (108); in multi-lumen RICCs (e.g., double-lumen RICC, triple-lumen RICC, quadruple-lumen RICC, pentruple-lumen RICC, six-lumen RICC, etc.), generally only one catheter-tube lumen extends from the proximal end of the catheter tube (108) to the distal end of the catheter tube (108). In fact, the catheter tip (114) generally contains one lumen through its interior. Optionally, the lumen through the catheter tip (114) may be referred to as the "tip lumen," particularly with reference to the first section (118) of the catheter tube (108) when formed separately from and coupled to the remainder of the catheter tube (108).

[0056] Again, the lateral opening (116) is located through the side of the catheter tube (108) within the distal end portion of the catheter tube (108); however, the lateral opening (116) is located proximal to the first section (118) of the catheter tube (108). The lateral opening (116) opens into the introduction lumen (124) of one or more catheter-tube lumens. The introduction lumen (124) extends from the lateral opening (116) within at least the second section (120) of the catheter tube (108), through the first section (118) of the catheter tube (108) distal thereto, and 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) generally corresponds to the distal end portion of the aforementioned catheter-tube lumen extending 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 lateral opening (116).

[0057] A catheter hub (110) is coupled to a proximal end portion of a catheter tube (108). The catheter hub (110) comprises one or more catheter-tube lumens and a corresponding number of one or more catheter-hub lumens. One or more catheter-hub lumens extend through the entire catheter hub (110) from the proximal end of the catheter hub (110) to the distal end of the catheter hub (110).

[0058] Each extension leg of one or more extension legs (112) is coupled to a catheter hub (110) by its distal end portion. Each of the one or more extension legs (112) contains one or more extension-leg lumens, and the number of one or more extension-leg lumens corresponds to one or more catheter-tube lumens. Each extension-leg lumen of one or more extension-leg lumens extends through the entire extension leg from the proximal end of the extension leg to the distal end of the extension leg.

[0059] Each of the one or more extension legs (112) generally includes a Luer connector coupled to the extension leg, and through this Luer connector, the extension leg and the extension-leg lumen can be connected to another medical device.

[0060] Although the RICC (102) may be a single-lumen type or a multi-lumen type RICC (e.g., a double-lumen type RICC, a triple-lumen type RICC, a quadruple-lumen type RICC, a pentruple-lumen type RICC, a six-lumen type RICC, etc.), the RICC (102) illustrated in FIGS. 1 to 3 and FIGS. 6 to 8 is a triple-lumen type comprising a set of three lumens. Such a set of three lumens comprises a primary lumen (126) (e.g., distal lumen), a secondary lumen (128) (e.g., central lumen), and a tertiary lumen (130) (e.g., proximal lumen) formed by fluidly connected portions of, for example, three catheter-tube lumens, three hub lumens, and three extension-leg lumens. Whether the RICC (102) is single-lumen or multi-lumen type, the RICC (102) includes at least a primary lumen (126). The primary lumen (126) includes, at least, the catheter tube lumen portion of the primary lumen (126) as well as the fluidly connected hub- and extended leg-lumen portion of the primary lumen (126), and generally extending from the proximal end of the catheter tube (108) to the distal end of the catheter tube (108). According to the catheter tube lumen, the introduction lumen (124) of the catheter tube (108) corresponds to the distal end portion of the primary lumen (126), particularly the distal end portion of the primary lumen (126) distal to the lateral opening (116). Additionally, 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) within the side of the catheter tube (108) that is proximal to the primary-lumen opening (132) and distal to the subsequent tertiary-lumen opening (136), so that the secondary lumen (128) is located between the primary-lumen opening (132) and the tertiary-lumen opening (136).The tertiary lumen (130) has a tertiary lumen opening (136) within the side of the catheter tube (108) proximal to the secondary lumen opening (134). The side opening (116) of the catheter tube (108) may be positioned 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, so that each lumen opening of the primary lumen opening (132), the secondary lumen opening (134), and the tertiary lumen opening (136) are positioned distally to the side opening (116).

[0061] The RICC (102) may additionally include a manipulation guide wire (138). The manipulation guide wire (138) may include a non-traumatic tip (e.g., a coiled or partially coiled tip) and a length sufficient to advance the manipulation guide wire (138) to the lower one-third of the superior vena cava ("SVC") of the heart. The manipulation guide wire (138) may be captured and positioned within the RICC (102) at least in the unfolded-ready state of the RICC assembly (100). For example, the manipulation guide wire (138) may be placed within the primary lumen (126) of the RICC (102), the proximal end portion or the central portion of the manipulation guide wire (138) may be placed within the extended leg-lumen portion of the primary lumen (126), the central portion or the distal end portion of the manipulation guide wire (138) may be placed within the hub-lumen portion of the primary lumen (126), and the distal end portion of the manipulation guide wire (138) may be placed within the catheter tube-lumen portion of the primary lumen (126), which is formed by the aforementioned catheter tube lumen 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 introduction lumen (124) occupied by the introduction needle (146) in the unfolded-ready state of the RICC assembly (100), as described below. Due to the presence of the introduction needle (146) in the introduction lumen (124), the distal end of the operation guide wire (138) reaches immediately in front of the side opening (116) in the unfolded-ready state of the RICC assembly (100).

[0062] The operation guide wire (138) includes a stop portion (140) (e.g., hub, ball, slug, etc.) around the proximal end portion of the operation guide wire (138) to form a stop portion of the operation guide wire (138) (e.g., hub end, ball end, slug end, etc.). The stop portion of the operation guide wire (138) is larger than the proximal end opening of the primary lumen (126) or its extended leg-lumen portion, thereby providing a distal limit for the operation guide wire (138) to proceed into the RICC (102).

[0063] Additionally, the manipulation guide wire (138) may be placed within a fixed-length sterile barrier (142) (e.g., a longitudinal bag) comprising a closed or sealed proximal end and an otherwise open distal end, and this open distal end is removablely coupled (e.g., removablely fixed) to the proximal end of the Luer connection of the extension leg so that both the sterile barrier (142) and the manipulation guide wire (138) can be manually removed when necessary.

[0064] The combination of a fixed length of the sterile barrier (142), a closed or sealed proximal end of the sterile barrier (142), and a distal end of the sterile barrier (142) coupled to a Luer connection provides a restricted tube in which the manipulation guide wire (138) can move proximally within, thereby providing a proximal limit for retrieving the manipulation guide wire (138) from the RICC (102). The proximal limit maintains the non-traumatic tip of the manipulation guide wire (138) within the primary lumen (126), and in an embodiment of the non-traumatic tip having at least a coiled or partially coiled tip, the non-traumatic tip is maintained in a straightened or uncoiled state. This is advantageous because it can be particularly difficult to reinsert such a guide wire into the lumen of a medical device such as a catheter. Optionally, the stop end of the manipulation guide wire (138) is coupled (e.g., fixed) to the proximal end of the sterile barrier (142) to maintain the stop end of the manipulation guide wire (138) within the proximal end of the sterile barrier (142), thereby reducing the discrepancy between the length of the proximal end portion of the manipulation guide wire (136) extending beyond the proximal end of the RICC (102) (e.g., the proximal end of the Luer connection) and the length of the unfolded sterile barrier (142). Reducing the discrepancy between the aforementioned lengths lowers the likelihood of losing the stop end of the manipulation guide wire (138) within the central portion of the sterile barrier (142), which would require time and effort to realign, and it would be more desirable to focus this time and effort on the patient.

[0065] In addition to providing a proximal limit for retrieving the manipulation guide wire (138) from the RICC (102), the sterile barrier (142) is configured to maintain the sterility of the manipulation guide wire (138) before use of the RICC assembly (100) (e.g., 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-touch advancing means for advancing the manipulation guide wire (138) into the patient's vascular lumen when establishing the needle tube. Likewise, the sterile barrier (142) is configured to provide a non-touch retrieval means for retrieving the manipulation guide wire (138) from the patient's vascular lumen, for example, after the catheter tube (108) has advanced over the manipulation guide wire (138).

[0066] The RICC (102) may additionally include a stiffening stylet, such as a stiffening stylet (144), in either one or both lumens of the secondary lumen (128) and the tertiary lumen (130) of the triple-lumen embodiment of the RICC (102) for stiffening the RICC (102). FIG. 1 illustrates one such stiffening stylet (144). This stiffening stylet provides additional column strength to prevent buckling of the catheter tube (108) when the catheter tube (108) is inserted into the insertion site and advanced through the patient's vascular system.

[0067] The introductor (104) comprises an introductor needle (146), a syringe (148) operably connected to the introductor needle (146), and an access guide wire (150) disposed within the introductor (104). The introductor (104) may further comprise a fluid-pressure indicator (152) operably connected to the introductor needle (146). As described above, the introductor (104) is composed of at least two different operating mechanisms (e.g., an operating mechanism for retrieving the plunger (166) and an operating mechanism for advancing or retrieving the access guide wire (150)) operated by using one finger of the hand while holding the distal end portion of the introductor (104) between the thumb and other fingers or fingers of the same hand.

[0068] The introductory needle (146) comprises a needle hub (154) and a needle shaft (156) extending from the needle hub (154), and the needle shaft (156) terminates in a needle tip (158) (e.g., a beveled tip) within the distal end portion of the needle shaft (156). The needle hub (154) includes a rib (155) configured to be inserted into the slot (189) of the distal coupler (186) and to prevent the syringe (148) from rolling sideways from side to side in at least the unfolded-ready state of the RICC assembly (100). Additionally, the needle hub (154) is translucent and preferably colorless so that blood flashback from a vein puncture using the needle tip (158) can be observed. When the RICC assembly (100) is at least in the unfolded-ready state as shown in FIG. 1, the needle tip (158) for vein puncture is extended slightly from the distal end of the RICC (102). In fact, when the RICC assembly (100) is at least in the unfolded-ready state, a distal end portion of the needle shaft (156) (e.g., about 7 cm) is extended through the longitudinal through hole of the distal coupler (186) of the coupling system (106) described below, through the lateral opening (116) of the catheter tube (108), along the introduction lumen (124) of the catheter tube (108), and through the distal end of the RICC (102). However, in some embodiments, a distal end portion of the needle shaft (156) of 2 to 3 cm or more may be extended from the distal end of the RICC (102) for vein puncture. In this embodiment, the first section (118) of the catheter tube (108) is shorter in length than the longer needle shaft (156).

[0069] The fluid-pressure indicator (152), when present, extends from the side arm (160) of the needle hub (154). The fluid-pressure indicator (152) includes a closed end and an open end fluidically coupled to the needle lumen of the introductory needle (146) through the side arm lumen of the side arm (160). The fluid-pressure indicator (152) is configured as an internal accidental arterial indicator, and blood (e.g., arterial blood) under sufficient pressure can enter the fluid-pressure indicator (152) and compress the column of air within the fluid-pressure indicator (152). However, blood flashback from a venous perforation within the fluid-pressure indicator (152) can also be observed. That is, blood flashback from a venous perforation is generally observed in the needle hub (154), the side arm (160) of the needle hub (154), or the syringe (148).

[0070] The syringe (148) comprises a syringe housing (162) around a body portion (164), a plunger (166) disposed within the body portion (164), and a syringe tip portion (168) within a distal-end portion of the body portion (164), wherein the syringe tip portion is coupled to a needle hub (154) of an introductory needle (146) when the RICC assembly (100) is at least in an unfolded-ready state. The syringe (148) also comprises a syringe portion of an approach-guide wire lumen (174).

[0071] As illustrated, the syringe housing (162) extends from a proximal end portion to a distal end within the distal end portion of the syringe housing (162) which may be coextensive with the distal end portion of the body portion (164). The syringe housing (162) may include a gripping portion (170) (e.g., a pattern of bumps, through holes, etc.) in the distal end portion, configured to help grip the syringe housing (162) and, accordingly, the introductor (104) between the thumb and other fingers or fingers of the same hand described above by the distal end portion. The distal displacement of the gripping portion (170) around the distal end portion of the syringe housing (162) enables holding and handling the RICC assembly (100) in a position that provides better control of the distal end portion of the RICC assembly (100), and in this good control, small accidental yaw- or pitch-type movement is kept relatively small in the distal end portion of the RICC assembly (100) compared to the same type of movement when the RICC assembly (100) is held in a more proximal position.

[0072] The syringe housing (162) and the plunger (166) are configured to operate together as a single unit, for example, to operate the syringe (148) (to retrieve the plunger (166) for blood aspiration). The syringe housing (162) and the plunger (166) or its end piece (180) may be molded together as a single piece, so that the proximal end portion of the syringe housing (162) becomes integral with the proximal end portion of the plunger (166). Alternatively, the syringe housing (162) and the plunger (166) or its end piece (180) may be molded separately and then coupled together as a coupled piece so that the proximal end portion of the syringe housing (162) becomes integral with the proximal end portion of the plunger (166) or its end piece (180). For example, the inner wall within the proximal end of the syringe housing (162) may be joined or welded to the plunger flange or the end piece (180) at the distal end of the plunger (166). Whether the syringe housing (162) and the plunger (166) are integral or coupled to each other, the proximal sliding of the syringe housing (162) relative to the body portion (164) retrieves the plunger (166) from the body portion (164) and thereby operates the syringe (148) as a single unit.

[0073] The syringe (148) may additionally include a push tab (172), which extends proximally over the body (164) from a distal end portion of the body (164) to which the push tab (172) is coupled (e.g., from an integrated connection portion of the body (164) around the syringe tip (168). The push tab (172) is configured to be used when operating the syringe (148) as described above. In effect, the push tab (172) is configured to be pushed with one finger while holding the distal end portion of the syringe housing (162) between the thumb and other fingers of the same hand described above, which slides the syringe housing (162) proximally against the body (164) and retrieves the plunger (166) from the body (164).

[0074] The syringe (148) also includes the syringe portion of the approach-guide wire lumen (174) formed by the fluidically connected portion of the plunger lumen of the plunger (166), the syringe-tip lumen of the syringe tip portion (168), and any space within the body portion (164) formed by partially pulling the plunger (166) out of the body portion (164) during a state of operation among a large number of operating states of the RICC assembly (100), for example (e.g., during the blood-aspiration step of the method described below). Another portion of the approach-guide wire lumen (174) is the introductory-needle portion of the approach-guide wire lumen (174), i.e., the needle lumen of the introductory needle (146), when the introductory needle (146) is operably connected to the syringe (148), particularly as in most states of the RICC assembly (100).

[0075] The plunger (166) includes a sealing mechanism (176) at the distal end portion of the plunger (166) to seal the distal approach-guide wire lumen (174) to the sealing mechanism (176). The sealing mechanism (176) is configured to seal the approach-guide wire lumen (174) to maintain a vacuum for aspirating blood when the plunger (166) is withdrawn from the body portion (164). The sealing mechanism (176) is also configured to seal the approach-guide wire lumen (174) to prevent blood from being released (e.g., flashback) through the longitudinal slots of the body portion (164) and the plunger (166) described below during venous perforation or while the approach guide wire (150) is withdrawn from the patient's vascular lumen, thereby minimizing or preventing the possibility of contamination of the work site or any clinician working at the work site.

[0076] As illustrated in FIG. 4, the sealing mechanism (176) may be a cartridge disposed within a cavity in the distal-end portion of the main body (178) of the plunger (166) and held within the cavity by the end portion (180) of the plunger (166). The cartridge is aligned coaxially with the approach-guide wire lumen (174) or its plunger-lumen portion so that the unwrapped, bare-wire portion of the approach guide wire (150) passes through the proximal- and distal-end through-holes of the cartridge having an inner diameter corresponding to the outer diameter of the approach guide wire (150). Optionally, the sealing mechanism (176) includes one or more gaskets, such as an 'O'-ring, in the cartridge or alternatively for the cartridge. Instead of a cartridge, for example, one or more 'O'-rings may be axially compressed within the cavity by the end portion (180) of the plunger (166), which can then radially compress the 'O'-rings around the approach guide wire (150), thereby sealing the approach-guide wire lumen (174).

[0077] Regardless of the state of the RICC assembly (100), the approach guide wire (150) is captured and positioned within the introductor (104) so ​​that at least a portion of the approach guide wire (150) is always within a portion of the approach-guide wire lumen (174) (e.g., plunger-lumen portion, needle-lumen portion, etc.). For example, when the approach guide wire (150) is retrieved to its proximal limit (e.g., formed by the proximal end of the longitudinal slot described below), the distal end portion of the approach guide wire (150) is positioned within at least the distal end portion of the plunger lumen. Meanwhile, the proximal end portion of the approach guide wire (150) is positioned within the proximal end portion of the plunger lumen. When the RICC assembly (100) is at least in its unfolded-ready state, with the distal end of the approach guide wire (150) reaching just before the needle tip (158), the central portion of the approach guide wire (150) is positioned between the distal end portion of the plunger lumen and the proximal end portion of the needle lumen. And in some of the operating states of the RICC assembly (100) (e.g., during the approach guide wire-advancement step of the method described below), when the approach guide wire (150) is advanced to its distal limit (e.g., formed by the distal end of the longitudinal slot described below), the proximal end portion of the approach guide wire (150) is positioned at least within the distal end portion of the plunger lumen. Meanwhile, as a result of that length, the distal end portion of the approach guide wire (150) extends through or beyond the distal end of the RICC (102), which is sufficient for the approach guide wire (150) to extend into the patient's vascular lumen when establishing access to the patient's vascular lumen after the needle tube-establishment step described below.

[0078] The syringe (148) also includes a slider (182) (e.g., a tap-type slider) extending distally from the syringe housing (162) over the body portion (164). The slider (182) is configured to operate the approach guide wire (150) with one finger of the aforementioned same hand (e.g., with a scroll wheel-type motion of the finger similar to that used in a computer mouse) while holding the distally end portion of the syringe housing (162) between the thumb and other fingers or fingers of the same hand. The slider (182) includes an extension (184) extending into an approach-guide wire lumen (174) proximal to the sealing mechanism (176) through a longitudinal slot (not shown) within each of the body portion (164) and the plunger (166), and the extension (184) in the approach-guide wire lumen proximal to the sealing mechanism is coupled to the approach guide wire (150). The proximal and distal ends of the longitudinal slot provide a stop for the extension (184) and, accordingly, a restricted tube in which the extension (184) can move proximally within, thereby providing a proximal and distal limit for retrieving or advancing the access guide wire (150) into or from the introductory device (104), respectively.

[0079] The coupling system (106) includes a distal coupler (186) and a proximal coupler (188) configured to couple the RICC (102) and the introductory device (104) together by corresponding proximal and distal portions in the deployment-ready state of at least the RICC assembly (100), while allowing the introductory device (104) to slide relative to the RICC (102) (or vice versa).

[0080] The distal coupler (186) includes a catheter-tube clip configured to attach the distal coupler (186) to the proximal catheter tube (108) in a lateral opening (116) in a sliding and removable manner. The distal coupler (186) also includes a longitudinal through hole, a slot (189), and a push tab (190) within the distal end portion of the distal coupler (186). When the RICC assembly (100) is at least in its deployment-ready state, the needle shaft (156) of the introductor needle (146) extends through the longitudinal through hole of the distal coupler (186), through the lateral opening (116) of the catheter tube (108), along the introduction lumen (124) of the catheter tube (108), and through the distal end of the RICC (102). Although the distal coupler (186) is slidably attached to the catheter tube (108), the needle shaft (156) extending through the distal coupler (186) and the catheter tube (108) according to the foregoing description causes the distal coupler (186) to wedge between the needle shaft (156) and the catheter tube (108), and accordingly, the distal coupler (186) is maintained in a position on the catheter tube (108) proximal to the lateral opening (116) at least in the unfolded-ready state of the RICC assembly (100). In fact, the distal coupler (186) can only slide on the catheter tube (108) when the needle shaft (156) is removed from the distal coupler (186). The slot (189) is configured to accommodate the insertion of the rib (155) of the needle hub (154) and to prevent the syringe (148) from rolling from side to side in at least the unfolded-ready state of the RICC assembly (100).The pushing tab (190) is configured to allow a clinician to advance the RICC (102) from the needle shaft (156) with one hand using one finger of the hand (e.g., with a flick-type motion of the finger) while holding the distal end portion of the introductor (104) between the thumb and other fingers of the same hand, and provides a no-touch mechanism for advancing the RICC (102), particularly the distal end portion of the catheter tube (108), on the needle shaft (156) and into the patient's vascular lumen.

[0081] The proximal coupler (188) is an extension of the syringe housing (162) around the syringe (148), and the proximal coupler (188) is integral with the syringe housing (162) (e.g., molded together with the syringe housing (162)) or is coupled to the syringe housing (162) (e.g., molded separately from the syringe housing (162) and joined or welded thereto). The proximal coupler (188) includes a catheter-hub clip configured to be slidably and removablely attached 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 unfolded-ready state of the RICC assembly (100), thereby preventing the RICC (102) from sagging. The catheter-hub clip is also configured to suspend the RICC (102) by one or more extension legs (112) in some of the operating states of the RICC assembly (100) (e.g., during the introduction-removal step of the method described below), thereby further preventing the RICC (102) from sagging.

[0082] The RICC (102) may further include a sterile barrier (192) (e.g., a crushable or foldable bag, casing, etc.) configured to maintain the sterility of the catheter tube (108) between the catheter hub (110) and the distal coupler (186) before inserting the catheter tube (108) into the patient's vascular lumen. (See FIG. 2.) At least in the unfolded-ready state of the RICC assembly (100), the sterile barrier (192) is positioned over the catheter tube (108) between the catheter hub (110) and the distal coupler (186) around the proximal-end portion of the catheter tube (108), and the sterile barrier (192) is coupled to this distal coupler (186). The sterile barrier (192) is configured such that the sterile-barrier pull tab (194) of the sterile barrier (192) splits when removed from the catheter-hub clip (to which it is tucked) and pulled away from the catheter tube (108), thereby providing a no-touch mechanism for removing the sterile barrier (192) from the catheter tube (108). The sterile barrier (192) has sufficient tensile strength to pull the distal coupler (186) away from the catheter tube (108) without being destroyed when the sterile barrier (192) splits away from the catheter tube (108).

[0083] As described above, FIG. 1 illustrates a RICC assembly (100) in at least an unfolded-ready state. Although some of the operating states of the RICC assembly (100) have also been described previously, additional operating states of the RICC assembly (100) can be distinguished from the steps of the method for inserting the RICC (102) described below.

[0084] method

[0085] A method of RICC assembly (100) includes a method of inserting the RICC (102) into the patient's vascular lumen. In some embodiments, this method includes a RICC assembly-acquisition step, a needle tube-establishment step, a first RICC-advancement step, and a needle-retrieval step.

[0086] The RICC assembly-acquisition step includes acquiring a RICC assembly (100). As previously described, the RICC assembly (100) comprises a RICC (102), an introductory unit (104) comprising a syringe (148) coupled to an introductory unit needle (146), and a coupling system (106) comprising a distal coupler (186) that couples the RICC (102) and the introductory unit (104) together by a distal end portion at least in the unfolded-ready state of the RICC assembly (100).

[0087] The method may further include a needle tip-assist step ensuring that the needle tip (158) extends from the distal end of the RICC (102) prior to the needle tube-establishment step. As previously described, the needle shaft (156) extends through the longitudinal through hole of the distal coupler (186), through the lateral opening (116) within the distal end portion of the catheter tube (108), along the introduction lumen (124) of the catheter tube (108), and outside the distal end of the RICC (102).

[0088] The needle tube-establishment step involves establishing the needle tube from a region of the patient's skin to the vascular lumen with the introductor needle (146) while holding the distal end portion of the syringe housing (162) around the body portion (164) of the syringe (148) between the thumb and other fingers or fingers of the hand. Meanwhile, at least one finger of the same hand can continue to be easily used. As previously described, the needle shaft (156) extends through the longitudinal through hole of the distal coupler (186), through the lateral opening (116) within the distal end portion of the catheter tube (108) of the RICC (102), along the introductory lumen (124) of the catheter tube (108), and outside the distal end of the RICC (102) to establish the needle tube.

[0089] The needle tube-establishment step may further include ensuring blood flashback into the needle hub (154) of the introductory 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) upon establishment of the needle tube.

[0090] The method may additionally include a blood-aspiration step. The blood-aspiration step includes aspirating blood with a syringe (148) to ensure that the needle tip (158) is positioned within the patient's vascular lumen prior to the needle-retrieval step. The blood-aspiration step includes pushing a pushing tab (172) extending over the body (164) from the distal end portion of the syringe housing (162) with one finger of the hand while holding the distal end portion of the syringe housing (162) between the thumb and other fingers or fingers of the same hand, which slides the syringe housing (162) proximally relative to the body (164) and retrieves the syringe housing-connected plunger (166) from the body (164).

[0091] The method may additionally include an approach guide wire-advancement step. The approach guide wire-advancement step comprises advancing the approach guide wire (150), which is positioned within the approach guide wire lumen (174), into the vascular lumen beyond the needle tip (158) of the introductory needle (146), and this can be achieved by advancing the slider (182), which is coupled to the approach guide wire (150), distally over the body portion (164) with one finger of the hand while holding the distal end portion of the syringe housing (162) between the thumb and other fingers or fingers of the same hand. As previously described, the approach guide wire (150) is positioned within the approach-guide wire lumen (174) formed by at least the plunger lumen of the plunger (166) and the needle lumen of the introductory needle (146), which helps the first-stick to be successful by making the approach guide wire (150) immediately available before the vascular lumen is missed due to a small accidental movement. The approach guide wire-advancement step must be performed before the first RICC-advancement step so that the distal end portion of the catheter tube (108) can also be advanced over the approach guide wire (150).

[0092] The first RICC-advancement step comprises advancing the distal end portion of the first section (118) of the catheter tube (108) into the vascular lumen over the needle shaft (156), the approach guide wire (150), or both. As previously described, the catheter tube (108) comprises a first section (118) formed of a first material having a first durometer and a second section (120) formed of a second material having a second durometer lower than the first durometer. The first section (118) of the catheter tube (108) is configured with a column strength to advance the catheter tube (108) into the vascular lumen over the approach guide wire (150) or the approach guide wire (138) after the manipulation guide wire-advancement step described below. For example, the first RICC-advance step may include advancing the catheter tube (108) into the vascular lumen by the push tab (190) of the distal coupler (186) with one finger of the hand (e.g., with a flicking motion of the finger) while holding the introductor (104) between the thumb and other fingers or fingers of the same hand by the distal end portion of the syringe housing (162). The distal coupler (186) includes a push tab (190) configured to advance the catheter tube (108) into the vascular lumen with one finger.

[0093] The first RICC-advancement step further comprises advancing the catheter hub (110) of the RICC (102) from the catheter-hub clip of the proximal coupler (188) of the coupling system (106) and then from one or more extension legs (112) of the RICC (102) within the catheter-hub clip. The RICC (102) is configured to be suspended from the coupling system (106) until at least the needle shaft (156) is retrieved from both the introduction lumen (124) and the longitudinal through hole of the distal coupler (186), as in the introduction-removal step described below.

[0094] The method may further include an approach guide wire retrieval step, such as by proximally advancing a slider (182) coupled to the approach guide wire (150) over the torso (164) with one finger of the hand while holding the distal end portion of the syringe housing (162) between the thumb and other fingers or fingers of the same hand, to retrieve the approach guide wire (150) from the patient's vascular lumen. The approach guide wire retrieval step may be performed after the first RICC-advancement step, for example, after the distal end portion of the catheter tube (108) is properly positioned within the vascular lumen over the needle shaft (156) and the approach guide wire (150).

[0095] The needle-retrieval step includes retrieving the needle shaft (156) from the introduction lumen (124) through the side opening (116) of the catheter tube (108). Similar to the approach guide wire-retrieval step, the needle-retrieval step may be performed after the first RICC-advancement step, for example, after the distal end portion of the catheter tube (108) is properly positioned within the vascular lumen over the needle shaft (156) and the approach guide wire (150).

[0096] The method may further include an introductory removal step after the needle retrieval step, in which the introductory (104) is completely removed from the RICC assembly (100). The introductory removal step includes retrieving the needle shaft (156) from the longitudinal through hole of the distal coupler (186) while sliding the catheter-hub clip proximally along one or more extension legs (112). When retrieving the needle shaft (156) from the longitudinal through hole of the distal coupler (186), each of the one or more extension legs (112) may be removed through an opening in the catheter-hub clip, such opening being corresponding to or slightly wider than the diameter of the extension leg.

[0097] The method may further include a manipulation guide wire-advance step. The manipulation guide wire-advance step comprises advancing the manipulation guide wire (138) into the vascular lumen, for example, through a primary lumen (126) having a primary lumen opening (132) within the distal end of the RICC (102). As previously described, the introduction lumen (124) of the catheter tube (108) corresponds to the distal end portion of the primary lumen (126), particularly the distal end portion of the primary lumen (126) distal to the lateral opening (116). Accordingly, in order to ensure that the primary lumen (126) or its introduction lumen (124) does not have both the needle shaft (156) and the approach guide wire (150), a needle-retrieval step must be performed before the manipulation guide wire-advance step.

[0098] The method may further include a second RICC-advancement step. The second RICC-advancement step comprises advancing the distal end portion of the first section (118) of the catheter tube (108) further into the vascular lumen (e.g., into the SVC) over the manipulation guide wire (138). The manipulation guide wire (138) provides column strength to the second section (120) of the catheter tube (108) for the second RICC-advancement step. In conjunction with this, the second catheter-advancement step comprises 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 previously described, the catheter tube (108) can be covered by a crushable sterile barrier (192) between the proximal end portion of the catheter tube (108) and the distal coupler (186) at least in the unfolded-ready state of the RICC assembly (100).

[0099] The method may further include a sterile barrier-removal step. The sterile barrier-removal step includes splitting the sterile barrier (192) by pulling the sterile barrier pull tab (194) of the sterile barrier (192) opposite the distal coupler (186) away from the catheter tube (108), and then removing the sterile barrier (192) and the distal coupler (186) from the RICC (102) by pulling the distal coupler (186) away from the catheter tube (108) by the sterile barrier (192) to which the distal coupler (186) is slidably attached. Alternatively, the sterile barrier-removal step comprises removing the distal coupler (186) and the sterile barrier (192) from the RICC (102) by pulling the distal coupler (186) out of the catheter tube (108) to split the sterile barrier (192), and then pulling the distal coupler (186) proximally toward the proximal end portion of the catheter tube (108) to completely remove the sterile barrier (192).

[0100] The method may further include a manipulation guide wire-retrieval step of retrieving the manipulation guide wire (138) from the patient's vascular lumen and retrieving the manipulation guide wire (138) from the RICC (102).

[0101] While certain specific embodiments have been disclosed herein and some specific embodiments have been disclosed in some detail, such specific embodiments are not intended to limit the scope of the concept provided herein. Further adaptations and / or modifications may be made by those skilled in the art, and, in a broader sense, such adaptations and / or modifications are also included. Accordingly, adaptations and / or modifications may be made from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

Claim 1 A rapid-insertable central catheter ("RICC") assembly for direct insertion into a patient's vascular lumen, comprising, as a RICC, a catheter tube including a lateral opening through the side of the catheter tube within a distal-end portion, wherein the lateral opening is opened into the introduction lumen of the catheter tube extending at least from the lateral opening to the distal end of the RICC; and a catheter hub coupled to a proximal-end portion of the catheter tube; RICC comprising one or more extension legs, each of which is coupled to a catheter hub by its distal end portion; an inducer comprising an inducer needle having a needle shaft extending through the distal end of the RICC when the RICC assembly is in an unfolded-ready state of at least the RICC assembly, and further comprising a syringe, wherein the syringe comprises: a body portion having a syringe tip portion coupled to the needle hub of the inducer needle in its distal end portion at least in the unfolded-ready state of the RICC assembly; a plunger disposed within the body portion; and a syringe housing around the body portion having a distal end portion and a proximal end portion, wherein the proximal end portion of the syringe housing is integral with or coupled to the proximal end portion of the plunger so that proximal sliding of the syringe housing relative to the body portion retracts the plunger from the body portion; A coupling system configured to couple the RICC and the inducer together, comprising a distal coupler slidably attached to the catheter tube proximal to the lateral opening and the needle shaft extending further through a longitudinal through hole of the distal coupler, wherein the needle shaft is detachable from the distal coupler; comprising a RICC assembly. Claim 2 The RICC assembly of claim 1, wherein the catheter tube comprises: a first section formed of a first material having a first durometer, the lateral opening being proximal to the first section of the catheter tube; and a second section formed of a second material having a second durometer lower than the first durometer, wherein the catheter tube is configured to have both column strength and flexibility for advancing the catheter tube into the vascular lumen and through the patient's vascular system. Claim 3 RICC assembly according to claim 1 or 2, wherein the needle shaft extends further along the introduction lumen of the catheter tube, through the longitudinal through hole of the distal coupler, through the lateral opening of the catheter tube, and before exiting through the distal end of the RICC when the RICC assembly is at least in an unfolded-ready state. Claim 4 A RICC assembly according to claim 1 or 2, wherein the distal coupler comprises a push tab, and the push tab is configured to allow a clinician to advance the RICC from the needle shaft with one hand using one finger of the hand while holding the distal-end portion of the introductory device between the thumb and other fingers or fingers of the hand. Claim 5 A rapid-insertable central catheter ("RICC") assembly for direct insertion into a patient's vascular lumen, comprising, as a RICC, a catheter tube including a lateral opening through the side of the catheter tube within a distal-end portion, wherein the lateral opening is opened into the introduction lumen of the catheter tube extending at least from the lateral opening to the distal end of the RICC; and a catheter hub coupled to a proximal-end portion of the catheter tube; RICC comprising one or more extension legs, each of which is coupled to a catheter hub by its distal end portion; an inducer further comprising an inducer needle and a syringe having a needle shaft extending through the distal end of the RICC when the RICC assembly is in an unfolded-ready state of at least the RICC assembly, wherein the inducer is configured to be operated by one finger of the hand while holding the distal end portion of the inducer between the thumb and other fingers or fingers of the hand, and the syringe comprises: a body portion having a syringe tip portion within its distal end portion that is coupled to the needle hub of the inducer needle at least in the unfolded-ready state of the RICC assembly; and a plunger disposed within the body portion. An introductory device comprising a syringe housing around a body portion having a distal end portion and a proximal end portion, wherein the proximal end portion of the syringe housing is integral with or coupled thereto to the proximal end portion of the plunger such that proximal sliding of the syringe housing relative to the body portion retrieves the plunger from the body portion;A RICC assembly comprising a coupling system configured to couple the RICC and the inducer together, the coupling system comprising a distal coupler slidably attached to the catheter tube proximal to the lateral opening, wherein the distal coupler comprises a push tab, and the push tab is configured to allow a clinician to advance the RICC from the needle shaft with one hand using one finger of the hand while holding the distal-end portion of the inducer between the thumb and other fingers or fingers of the hand. Claim 6 In claim 5, the syringe further comprises a push tab extending proximally over the body portion from a distal end portion of the body portion to which the push tab is coupled, and the push tab is configured to be pushed with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand in order to slide the syringe housing proximally relative to the body portion and retrieve the plunger from the body portion. Claim 7 In claim 5, the introductor further comprises an approach guide wire disposed within an approach-guide wire lumen formed by at least the plunger lumen of the plunger and the needle lumen of the introductor needle, wherein the approach guide wire has a length sufficient for the approach guide wire to extend through the distal end of the RICC and into the vascular lumen of the patient, RICC assembly. Claim 8 RICC assembly according to claim 7, wherein the plunger comprises a sealing mechanism within the distal end portion of the plunger for sealing the approach-guide wire lumen distal to the sealing mechanism, and the sealing mechanism is configured to maintain a vacuum for aspirating blood when the plunger is withdrawn from the body portion. Claim 9 In claim 8, the syringe further comprises a slider extending distally over the body portion from the syringe housing, configured to operate the approach guide wire with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand, and the slider comprises an extension extending into the approach-guide wire lumen proximal to the sealing mechanism through a longitudinal slot within each of the body portion and the plunger, and the extension in the approach-guide wire lumen proximal to the sealing mechanism is coupled to the approach guide wire, RICC assembly. Claim 10 In claim 5, the RICC assembly further comprises a fluid-pressure indicator extending from a side arm of the needle hub, wherein the fluid-pressure indicator is fluidly coupled to the needle lumen of the introducer needle through the side-arm lumen of the side arm to observe blood flashbacks caused by accidental arterial perforation. Claim 11 In claim 5, the coupling system further comprises a proximal coupler coupled to the syringe and slidably attached to the catheter hub at least in the unfolded-ready state of the RICC assembly, and the coupling system is configured to allow the RICC to slide relative to the introductory device, the RICC assembly. Claim 12 In claim 11, the proximal coupler comprises a catheter-hub clip, and the RICC is configured to be suspended from the catheter-hub clip by the catheter hub in the unfolded-ready state of the RICC assembly or by the one or more extension legs when the proximal coupler is advanced upward in the operating state of the RICC assembly. Claim 13 In claim 12, the RICC further comprises a crushable catheter-tube sterile barrier over the catheter tube between the catheter hub and the distal coupler, wherein the catheter-tube sterile barrier is coupled to the distal coupler, and the catheter-tube sterile barrier is configured to split when a sterile-barrier pull tab of the catheter-tube sterile barrier is removed from the catheter-hub clip and the catheter-tube sterile barrier is pulled away from the catheter tube by the sterile-barrier pull tab, RICC assembly. Claim 14 In claim 13, the catheter-tube sterile barrier has a tensile strength sufficient to pull the distal coupler from the catheter tube without being destroyed when the catheter-tube sterile barrier is split into the distal coupler while being pulled away from the catheter tube, in a RICC assembly. Claim 15 The RICC assembly according to claim 1 or 2, wherein the RICC comprises a set of three lumens including a primary lumen, a secondary lumen, and a tertiary lumen, formed by fluidically connected portions of three catheter-tube lumens, three hub lumens, and three extension-leg lumens, and the introduction lumen of the catheter tube corresponds to the distal end portion of the primary lumen. Claim 16 In claim 15, 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 lateral opening, and the tertiary lumen has a tertiary-lumen opening on the side of the catheter tube distal to the lateral opening but proximal to the secondary-lumen opening, RICC assembly. Claim 17 In claim 15, the RICC further comprises a manipulation guide wire disposed within the primary lumen, the manipulation guide wire having a length sufficient for the manipulation guide wire to extend to the lower one-third of the superior vena cava of the heart, and the manipulation guide wire is captured and disposed within the RICC by a stop portion around the proximal end portion of the manipulation guide wire and a closed end of a fixed-length manipulation-guide wire sterile barrier coupled to a Luer connector, the stop portion providing a distal limit for the advancement of the manipulation guide wire and the closed end of the manipulation-guide wire sterile barrier around the manipulation guide wire providing a proximal limit for the retrieval of the manipulation guide wire, RICC assembly. Claim 18 delete Claim 19 delete Claim 20 delete Claim 21 delete Claim 22 delete Claim 23 A method for inserting a rapidly insertable central catheter (“RICC”) into the vascular lumen of a non-human subject, comprising the step of obtaining a RICC assembly, wherein the RICC assembly comprises a coupling system comprising the RICC, a syringe coupled to an introductory needle, and a distal coupler that couples the RICC and the introductory together by means of a distal end portion of at least the RICC assembly in an unfolded-ready state; and the step of establishing a needle tube from a region of the subject's skin to the vascular lumen by means of the needle shaft of the introductory needle while maintaining the distal end portion of the syringe housing around the body portion of the syringe between the thumb and other fingers or fingers of the hand and keeping at least one finger of the hand readily available, wherein, to establish the needle tube, the needle shaft extends along the introductory lumen of the catheter tube through a longitudinal through hole of the distal coupler, through a lateral opening in the distal end portion of the RICC catheter tube, and to the outside of the distal end of the RICC A method comprising: a step of extending; a step of advancing a distal-end portion of a first section of the catheter tube into the vascular lumen above the needle tip; and a step of retrieving the needle shaft from the introduction lumen through a lateral opening of the catheter tube. Claim 24 In claim 23, the method further comprises a step of aspirating blood with the syringe prior to the step of retrieving the needle shaft from the introduction lumen, in order to confirm that the needle tip is positioned within the vascular lumen of the target, wherein the aspirating step comprises pushing a pushing tab extending over the body portion from the distal end portion with one finger of the hand while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand, in order to slide the syringe housing proximally with respect to the body portion and retrieving the syringe housing-connected plunger from the body portion. Claim 25 In claim 23, the step of advancing the distal end portion of the first section of the catheter tube into the vascular lumen comprises advancing the catheter tube into the vascular lumen by means of a pushing tab of the distal coupler with one finger of the hand, while holding the distal end portion of the syringe housing around the body portion of the syringe between the thumb and other fingers or fingers of the hand. Claim 26 In claim 23, the step of advancing the distal end portion of the first section of the catheter tube into the vascular lumen comprises advancing the catheter hub of the RICC from the catheter-hub clip of the proximal coupler of the coupling system, and then from one or more extension legs of the RICC within the catheter-hub clip, wherein the RICC is configured to be suspended from the coupling system until at least the needle shaft is retrieved from both the introduction lumen and the longitudinal through hole of the distal coupler. Claim 27 In claim 24, prior to the step of advancing the distal end portion of the first section of the catheter tube into the vascular lumen over the needle shaft, the method further comprises the step of advancing an approach guide wire disposed within an approach guide wire lumen formed by at least the plunger lumen of the syringe and the needle lumen of the introductor needle into the vascular lumen over the needle tip of the introductor needle, wherein the advancing step comprises advancing a slider coupled to the approach guide wire distally over the body portion with one finger while holding the distal end portion of the syringe housing between the thumb and other fingers or fingers of the hand. Claim 28 A method according to any one of claims 24 to 27, further comprising the step of advancing a manipulation guide wire into the vascular lumen through a primary lumen having a primary lumen opening in the distal end of the RICC, wherein the introduction lumen of the catheter tube coincides with the distal end portion of the primary lumen, and thereby, the step of retrieving the needle shaft from the introduction lumen is performed before advancing the manipulation guide wire into the vascular lumen. Claim 29 A method according to claim 28, further comprising the step of advancing the distal end portion of the first section of the catheter tube further into the vascular lumen over the manipulation guide wire and, consequently, sliding the distal coupler proximally toward the proximal end portion of the catheter tube to expose the catheter tube, wherein the catheter tube is covered by a crushable sterile barrier between the proximal end portion of the catheter tube and the distal coupler, at least in the unfolded-ready state of the RICC assembly. Claim 30 A method according to claim 29, further comprising the step of splitting the sterile barrier by pulling a sterile-barrier pull tab of the sterile barrier opposite to the distal coupler away from the catheter tube, and then removing the sterile barrier and the distal coupler from the RICC by pulling the distal coupler away from the catheter tube by the sterile barrier to which the distal coupler is slidably attached. Claim 31 A method according to claim 29, further comprising the step of removing the distal coupler and the sterile barrier from the RICC by pulling the distal coupler from the catheter tube to split the sterile barrier, and then further pulling the distal coupler proximally toward the proximal end portion of the catheter tube to completely remove the sterile barrier.

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