Rapid insertion central catheter, catheter insertion assembly, and method

Abstract

Rapidly insertable central catheters (RICCs), RICC insertion assemblies and methods are disclosed. For example, the RICC insertion assembly may include a RICC, an introducer, and an access guidewire. The introducer needle may include a needle shaft having a longitudinal gap extending from a proximal portion of the needle shaft through the needle tip. The introducer sheath may include a splittable sheath hub coupled to a splittable sheath body. The introducer sheath may be positioned over the introducer needle with the sheath body sealing the needle shaft so that a vacuum may be drawn through the introducer needle. The access guidewire may extend along the entire primary lumen of the RICC, through a valved splittable port in the sheath hub, along a needle channel in the needle shaft covered by the sheath body, to a location within the introducer proximal to the needle tip.

Description

[[TECHNICAL FIELD]]

[0001] The present invention relates to rapid insertion central catheters, catheter insertion assemblies, and methods. [[BACKGROUND ART]]

[0002] Central venous catheters (CVCs) are generally introduced into a patient and advanced through the patient's vasculature by the Seldinger technique. The Seldinger technique utilizes several steps and medical instruments (e.g., needle, scalpel, guide wire, introducer sheath, dilator, CVC, etc.). Although the Seldinger technique is effective, many steps are time-consuming, handling multiple medical instruments is inconvenient, and both of these factors can lead to patient trauma. Additionally, due to the large number of medical instruments that need to be exchanged during the many steps of the Seldinger technique, the probability of contact contamination is relatively high. Therefore, there is a need to reduce the number of steps and medical instruments involved in introducing a catheter such as a CVC into a patient and advancing the catheter through the patient's vasculature.

[0003] Disclosed herein are rapidly insertable central catheters (RICCs), RICC insertion assemblies, and methods that solve the above-mentioned problems. [[SUMMARY OF THE INVENTION]]

[0004] In this specification, in some embodiments, RICC insertion assemblies are disclosed that include an RICC, an introducer, and an access guide wire positioned in both the RICC and the introducer. The introducer includes an introducer needle and a splittable introducer sheath. The introducer needle includes a needle shaft. The needle shaft includes a longitudinal gap extending from the proximal portion of the needle shaft through the needle tip. The introducer sheath includes a splittable sheath body and a splittable sheath hub coupled to the proximal portion of the sheath body. The introducer sheath is positioned to cover the needle shaft, with the sheath body sealing the needle shaft, so that a vacuum can be drawn through the introducer needle. The sheath hub includes a splittable port having a valve on the side of the sheath hub. The access guidewire extends along the entire primary lumen of the RICC, through the port valve, and along the needle channel of the needle shaft, which is covered by the sheath body, to a position within the introducer proximal to the needle tip.

[0005] In some embodiments, the RICC includes a catheter tube. The catheter tube includes a first section of the distal portion of the catheter tube, a second section of the distal portion of the catheter tube located proximal to the first section, and a tapered joint between the first and second sections of the catheter tube. The first section of the catheter tube is formed from a first polymer material having a first durometer. The second section of the catheter tube is formed from a second polymer material having a second durometer smaller than the first durometer. The joint has a length between the length of the exposed portion of the first section of the catheter tube and the length of the exposed portion of the second section.

[0006] In some embodiments, the catheter tube has sufficient column strength to prevent buckling when inserted into a needle pathway established by percutaneous puncture with an introducer. Furthermore, the column strength of the catheter tube is also sufficient to prevent buckling when advancing the catheter tube through the patient's vascular system without pre-dilating any surrounding tissues or vessels in the vascular system using a separate dilator.

[0007] In some embodiments, the access guide wire includes an unwound portion and a wound portion. The unwound portion of the access guide wire extends through the valve of the port. In some embodiments, the valve includes a tearable or split partition wall compressed within the port. An access guide wire extends through the partition wall within the RICC insertion assembly.

[0008] In some embodiments, the partition wall is positioned to cover the notch in the needle shaft. The longitudinal gap of the needle shaft extends distally from the notch. In some embodiments, the sheath body is configured to split relative to the access guide wire when the sheath body is pulled away from the access guide wire after the sheath hub has been split.

[0009] In some embodiments, the sheath hub includes a non-tapered female sheath-hub connector in the proximal portion of the sheath hub. In some embodiments, a needle hub coupled to the proximal portion of a needle shaft includes a non-tapered male needle-hub connector at the distal portion of the needle hub. The male needle-hub connector is configured to form a fluid-seal connection with a female sheath-hub connector.

[0010] In some embodiments, the male needle-hub connector includes an O-ring positioned in a circumferential groove around the male needle-hub connector, configured to form a fluid-seal connection.

[0011] In some embodiments, the RICC insertion assembly further includes a syringe. The syringe includes a tapered male syringe tip extending from the distal portion of the syringe. The syringe tip is configured to be inserted into a tapered female needle-hub connector at the proximal portion of the needle hub.

[0012] Furthermore, in some embodiments, introducers for RICCs are disclosed herein, including an introducer needle and a cleavable introducer sheath. The introducer needle includes a needle shaft, a needle hub coupled to the proximal portion of the needle shaft, and a needle tip at the distal portion of the needle shaft. The needle shaft includes a longitudinal gap. The longitudinal gap extends from the proximal portion of the needle shaft distal to the needle hub through the needle tip. The introducer sheath is configured to cover the needle shaft, at least in the introducedr's ready-to-operate state. The introducer sheath includes a cleavable sheath body and a cleavable sheath hub coupled to the proximal portion of the sheath body. The sheath body is configured to seal the needle shaft so that a vacuum can be drawn through the introducer needle, at least in the introducedr's ready-to-operate state. The sheath hub includes a cleavable port with a valve on its side.

[0013] In some embodiments, the valve includes a tearable or split partition wall compressed within the port. The partition wall is configured to allow an access guide wire to pass through. In some embodiments, the partition wall is positioned to cover the notch in the needle shaft, at least when the introducer is ready for operation. The longitudinal gap of the needle shaft extends distally from the notch.

[0014] In some embodiments, the sheath hub further includes a pair of tabs extending radially from the sheath hub. The tabs are configured to split the sheath hub by pulling the tabs apart.

[0015] In some embodiments, the sheath hub includes a pair of longitudinal hub faults. The hub faults include a primary fault and a secondary fault. The primary fault runs along a portion of the primary side of the introducer sheath containing the port. The secondary fault runs along a portion of the secondary side of the introducer sheath opposite the primary side. The sheath hub is configured to split along both the primary and secondary hub faults and propagate along the sheath body on both the primary and secondary sides of the introducer sheath.

[0016] In some embodiments, the sheath hub includes a non-tapered female sheath-hub connector in the proximal portion of the sheath hub. In some embodiments, the needle hub includes a non-tapered male needle-hub connector at the distal portion of the needle hub. The male needle-hub connector is configured to form a fluid-seal connection with a female sheath-hub connector, at least in the introducer's ready-to-operate state.

[0017] In some embodiments, the male needle-hub connector includes an O-ring positioned in a circumferential groove around the male needle-hub connector, configured to form a fluid-seal connection.

[0018] In some embodiments, the distal portion of the sheath body includes a taper that narrows from the outer diameter of most of the sheath body to the outer diameter of the needle shaft. The taper provides a smooth transition from the needle tip to the sheath body when the introducer is ready for operation.

[0019] In some embodiments, the taper has a taper angle smaller than either the tip bevel angle of the needle tip bevel or the primary bevel angle of the primary bevel.

[0020] In some embodiments, the introducer further includes a syringe. The syringe includes a tapered male syringe tip extending from the distal portion of the syringe. The syringe tip is configured to be inserted into a tapered female needle-hub connector at the proximal portion of the needle hub.

[0021] Furthermore, in some embodiments, a RICC is disclosed herein, comprising a catheter tube, a catheter hub, and one or more extension legs. The catheter tube comprises a first section distal to the catheter tube, a second section distal to the catheter tube proximal to the first section, and a tapered joint between the first and second sections of the catheter tube. The first section of the catheter tube is formed from a first polymer material having a first durometer. The second section of the catheter tube is formed from a second polymer material having a second durometer smaller than the first durometer. The joint has a length between the length of the exposed portion of the first section of the catheter tube and the length of the exposed portion of the second section. The catheter hub is coupled to the proximal portion of the catheter tube. Each of the one or more extension legs is coupled to the catheter hub by its distal portion.

[0022] In some embodiments, the proximal portion of the first section of the catheter tube is positioned within a hole in the distal portion of the joint and is bonded to that hole. In some embodiments, the distal end of the second section of the catheter tube is coplanar with the proximal end of the joint and is bonded to that proximal end.

[0023] In some embodiments, the catheter tube has sufficient column strength to prevent buckling when inserted into a needle pathway established by percutaneous puncture. Furthermore, the column strength of the catheter tube is also sufficient to prevent buckling when advancing the catheter tube through the patient's vascular system without pre-dilating any surrounding tissues or vessels in the vascular system using a separate dilator.

[0024] In some embodiments, the RICC includes a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen. The three lumens are formed from fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens.

[0025] In some embodiments, the primary lumen has a primary lumen opening at the distal end of the catheter tube. The secondary lumen has a secondary lumen opening on the side of the distal portion of the catheter tube. The tertiary lumen has a tertiary lumen opening on the side of the distal portion of the catheter tube, proximal to the secondary lumen opening.

[0026] Also disclosed herein is a method for inserting a RICC into the vascular lumen of a patient. The method comprises an assembly obtaining step, a needle tract establishing step, an access guidewire advancing step, an introducer needle withdrawing step, an introducer sheath splitting step, and a RICC advancing step. The assembly obtaining step comprises obtaining a RICC insertion assembly. The RICC insertion assembly comprises the RICC, an introducer, and an access guidewire in a substantially ready-to-operate state of the RICC insertion assembly. The introducer comprises an introducer needle disposed within a splittable introducer sheath fluidly connected to a syringe. The needle tract establishing step comprises establishing a needle tract from a skin region to the vascular lumen using the introducer. The access guidewire advancing step comprises advancing the distal end of the access guidewire from its initial position within the introducer proximal to the needle tip of the introducer needle into the vascular lumen. The introducer needle withdrawing step comprises withdrawing the introducer needle from the introducer while leaving both the introducer sheath and the access guidewire in the vascular lumen. The introducer needle comprises a longitudinal gap extending from a proximal portion of the needle shaft through the needle tip, enabling the introducer needle withdrawing step while the access guidewire remains in the vascular lumen. The introducer sheath splitting step comprises splitting the introducer sheath away from the access guidewire and removing the split portion of the introducer sheath from the vascular lumen. The RICC advancing step comprises inserting the RICC into the vascular lumen by advancing the catheter tube of the RICC over the access guidewire into the vascular lumen.

[0027] In some embodiments, the step of establishing a needle tract comprises confirming that the needle tract extends into the vascular lumen by checking for blood backflow along the longitudinal gap of the introducer needle into the needle hub of the introducer needle, into the tip of the syringe, into the barrel of the syringe, or a combination thereof.

[0028] In some embodiments, the step of establishing a needle tract comprises applying a slight vacuum with a syringe during establishment of the needle tract such that blood backflows into the introducer needle when the needle tract is established.

[0029] In some embodiments, the method further comprises an ultrasound confirmation step. The ultrasound confirmation step comprises confirming via ultrasonic imaging that the access guidewire is located within the vascular lumen.

[0030] In some embodiments, the method further comprises a blood aspiration step. The blood aspiration step comprises aspirating blood with a syringe coupled to the introducer needle to confirm that the needle tract extends into the vascular lumen before the step of withdrawing the introducer needle.

[0031] In some embodiments, the sheath body seals the longitudinal gap of the needle shaft for aspirating blood with the syringe. In some embodiments, the step of advancing the access guidewire secures vascular access for the step of advancing a RICC.

[0032] In some embodiments, the method further comprises a step of advancing an introducer sheath. The step of advancing the introducer sheath comprises advancing the introducer sheath over the introducer needle into the vascular lumen before the step of advancing the access guidewire. The step of advancing the introducer sheath secures vascular access for the step of advancing a RICC.

[0033] In some embodiments, the introducer sheath splitting step includes splitting the sheath hub, which includes a port on the side of the sheath hub, by pulling apart a pair of tabs extending radially from the sheath hub, and propagating one or more tears resulting from the splitting of the sheath hub along the sheath body of the introducer sheath.

[0034] In some embodiments, propagating one or more tears involves continuing to pull the tabs apart after the sheath hub has been split. In some embodiments, propagating one or more tears involves pulling the sheath body away from the access guide wire so that the sheath body splits relative to the access guide wire.

[0035] In some embodiments, the method further includes an access guidewire withdrawal step, which involves withdrawing the access guidewire while leaving the catheter tube in the lumen of the blood vessel.

[0036] In some embodiments, the method further includes a guidewire advancement step, an additional RICC advancement step, and a guidewire withdrawal step. The guidewire advancement step includes advancing the guidewire into the vascular lumen via the primary lumen of the RICC. The additional RICC advancement step includes further advancing the distal portion of the catheter tube into the vascular lumen on the guidewire to the lower third of the superior vena cava (SVC) of the patient's heart. The guidewire withdrawal step includes withdrawing the guidewire while leaving the catheter tube in the lower third of the SVC.

[0037] These and other features of the concepts provided herein will become more apparent to those skilled in the art in consideration of the accompanying drawings illustrating in more detail specific embodiments of such concepts and the following description. [Brief explanation of the drawing]

[0038] [Figure 1] Several embodiments of RICC are shown. [Figure 2] The distal portion of the RICC catheter tube is shown in several embodiments. [Figure 3] A first cross-section of the distal portion of a catheter tube according to several embodiments is shown. [Figure 4] A second cross-section of the distal portion of the catheter tube according to several embodiments is shown. [Figure 5] The longitudinal cross-section of the distal portion of a catheter tube according to several embodiments is shown. [Figure 6] A first figure shows an introducer having a syringe for inserting an RICC into a patient, according to several embodiments. [Figure 7] A second figure shows an introducer having a syringe according to several embodiments. [Figure 8] A third figure shows an introducer with a syringe according to several embodiments. [Figure 9] A first figure shows an introducer without a syringe, according to several embodiments. [Figure 10] A second figure shows an introducer without a syringe, according to several embodiments. [Figure 11] The distal portion of the introducer according to several embodiments is shown. [Figure 12] For illustrative purposes only, an introducer without a sheath hub is shown. [Figure 13] The introducer needle of the introducer is shown in several embodiments. [Figure 14] The following shows a slittable introducer sheath of an introducer according to several embodiments. [Figure 15] Several embodiments of RICC insertion assemblies are shown. [Figure 16]The first figure shows the distal portion of an RICC insertion assembly according to several embodiments. [Figure 17] A second figure shows the distal portion of an RICC insertion assembly according to several embodiments. [Figure 18] The distal portion of another RICC insertion assembly according to several embodiments is shown. [Modes for carrying out the invention]

[0039] Before disclosing in more detail some specific embodiments, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that can be easily separated from a particular embodiment and can be optionally combined with or replaced by any of several other embodiments disclosed herein.

[0040] With regard to the terminology used herein, it should be understood that the terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd) are generally used to distinguish or identify different features or stages within a group of features or stages and do not provide continuity or numerical limitations. For example, the features or stages "1st," "2nd," and "3rd" do not have to appear in that order, and a particular embodiment containing such features or stages does not have to be limited to those three features or stages. In addition, any of the aforementioned features or steps may further include one or more features or steps unless otherwise indicated. Notations such as "left," "right," "top," "bottom," "front," and "back," and similar phrases, are used for convenience and are not intended to mean, for example, a specific, fixed position, direction, or orientation. Rather, such notations are used to reflect, for example, a relative position, direction, or orientation. The singular forms "a," "an," and "the" include references to the plural unless the context explicitly indicates that it is singular.

[0041] For example, with respect to the “proximal,” “proximal portion,” or “proximal end” of a catheter, it includes the portion of the catheter intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the “proximal length” of a catheter includes the length of the catheter intended to be located near the clinician when the catheter is used on a patient. For example, the “proximal end” of a catheter includes the end of the catheter intended to be located near the clinician when the catheter is used on a patient. The proximal portion, proximal end, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal portion, proximal end, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0042] For example, with respect to the “distal,” “distal portion,” or “distal end” of a catheter, it includes the portion of the catheter intended to be near the patient or located within the patient’s body when the catheter is used in a patient. Similarly, for example, the “distal length” of a catheter includes the length of the catheter intended to be near the patient or located within the patient’s body when the catheter is used in a patient. For example, the “distal end” of a catheter includes the end of the catheter intended to be near the patient or located within the patient’s body when the catheter is used in a patient. The distal portion, distal end, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, distal end, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0043] Unless otherwise defined, all technical or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art.

[0044] As mentioned above, while the Seldinger procedure is effective, its many steps are time-consuming, and handling numerous medical instruments is inconvenient; both of these factors can lead to patient trauma. In addition, the Seldinger procedure has a relatively high risk of contact contamination due to the many medical instruments that need to be replaced during its numerous steps. Therefore, it is necessary to reduce the number of steps and medical instruments involved in introducing a catheter, such as a CVC, into the patient and advancing it through its vascular structure.

[0045] This specification discloses RICCs, RICC insertion assemblies, and methods that solve the above-mentioned problems. RICC Figure 1 shows the RICC100 in several embodiments. Figure 2 shows the distal portion of the catheter tube 102 of the RICC100 in several embodiments. Figures 3 to 5 show different cross-sections of the distal portion of the catheter tube 102 in several embodiments.

[0046] As shown in the figure, the RICC100 includes a catheter tube 102, a catheter hub 104, and one or more extension legs 106. The catheter tube 102 includes a first section 108 in the distal portion of the catheter tube 102, a second section 110 in the distal portion of the catheter tube 102 located proximal to the first section 108, and a tapered joint 112 between the first section 108 and the second section 110 of the catheter tube 102.

[0047] The first section 108 of the catheter tube 102 includes a distal tip 114 having a relatively short taper from the outer diameter of the distal end of the first section 108 to the outer diameter of the rest of the first section 108. The taper of the distal tip 114 is configured to immediately expand the tissue around the needle path established by the introducer 132 or 184 to the outer diameter of the rest of the first section 108 of the catheter tube 102. Also, as best shown in Figure 5, the first section 108 of the catheter tube 102 includes a proximal portion, which is located within the hole of the distal portion of the joint 112 and is fixedly bonded to the hole by solvent bonding, adhesive bonding, or heat welding, etc.

[0048] The second section 110 of the catheter tube 102 has a constant outer diameter along its length from the distal end to the proximal end. The constant diameter of the second section 110 of the catheter tube 102 is configured for smooth insertion into the needle pathway and target vascular system after any expansion by the first section 108 and joint 112 of the catheter tube 102. The distal end of the second section 110 of the catheter has a flat surface, which is coplanar with the proximal end of the flat surface of the joint 112 and is fixedly joined to the proximal end of the flat surface by solvent bonding, adhesive bonding, or heat welding, etc.

[0049] The joint 112 includes a taper along its length from the distal end to the proximal end. The taper of the joint 112 is configured to immediately expand the tissue around the needle path from the outer diameter of most of the first section 108 of the catheter tube 102 to the outer diameter of the second section 110 of the catheter tube 102. The non-luminal surface of the joint 112 transitions smoothly from the non-luminal surface of the first section 108 of the catheter tube 102 to the non-luminal surface of the second section 110 of the catheter tube 102 without creating an edge that would catch on the skin when the catheter tube 102 is inserted into the needle path. In addition to having minimal or negligible edges, the edges may include solvent interdiffusion polymer material among the polymer material forming the catheter tube 102, thereby smoothing the transition from the first section 108 to the joint 112 and from the joint 112 to the second section 110 of the catheter tube 102. In particular, the joint 112 has a length approximately equivalent to the length of the exposed portion 116 of the first section 108 of the catheter tube 102, or a length between the length of the exposed portion of the first section 108 and the length of the exposed portion of the second section 110 of the catheter tube 102. Thus, the length of the exposed portion 116 of the first section 108 of the catheter tube 102 is shorter than the length of the joint 112, and at most approximately equivalent to the length of the joint 112.

[0050] The first section 108 of the catheter tube 102 is formed from a first polymer material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer. The second section 110 of the catheter tube 102 is formed from a second polymer material (e.g., polyvinyl chloride, polyethylene, another polyurethane, or silicone) having a second durometer smaller than the first durometer. For example, the first section 108 of the catheter tube 102 can be formed from a first polyurethane having a first durometer, and the second section 110 of the catheter tube 102 can be formed from a second different polyurethane having a second durometer smaller than the first durometer (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, etc.). In fact, polyurethane is advantageous for the catheter tube 102 because, although relatively rigid at room temperature, it can become more flexible at body temperature in vivo, thereby reducing irritation to the blood vessel wall and phlebitis. Polyurethane is also advantageous because it can be less thrombogenic than some other polymers. The joint 112 is formed from a second or third polymer material (e.g., yet another polyurethane) having a third durometer that is smaller than the first durometer and larger than, approximately equal to, or smaller than the second durometer.

[0051] It should be understood that the first durometer of the first polymer material, the second durometer of the second polymer material, and the third durometer of the third polymer material may be on different scales (e.g., Type A or Type D). With this understanding, the second durometer of the second polymer material or the third durometer of the third polymer material may not be numerically smaller than the first durometer of the first polymer material if the second or third durometer is smaller than the first durometer. In fact, the hardness of the second or third polymer material may still be lower than that of the first polymer material. This is because the different scales, each ranging from 0 to 100, are designed to characterize separate materials within a group of materials having similar hardness.

[0052] With respect to the first section 108 of the catheter tube 102, the second section 110 of the catheter tube 102, and the joint 112 between the first section 108 and the second section 110 of the catheter tube 102, the catheter tube 102 has sufficient column strength to prevent buckling of the catheter tube 102 when inserted into a needle pathway established by percutaneous puncture using an introducer 132 or 184, as described later. Furthermore, the column strength of the catheter tube 102 is also sufficient to prevent buckling of the catheter tube when advancing the catheter tube 102 through the patient's vascular system without pre-dilating any blood vessels in the surrounding tissue or vascular system using a separate dilator.

[0053] The catheter tube 102 contains one or more catheter tube lumens extending through it. However, in typical multi-lumen RICCs (e.g., two-lumen RICC, three-lumen RICC, four-lumen RICC, five-lumen RICC, six-lumen RICC, etc.), there is usually only one catheter tube lumen extending from the proximal end to the distal end of the catheter tube 102. (See Figures 3-5.) In fact, the first section 108 of the catheter tube 102 usually contains one lumen, as shown in Figure 5.

[0054] The catheter hub 104 is connected to the proximal portion of the catheter tube 102. The catheter hub 104 contains one or more catheter hub lumens, each corresponding to one or more catheter tube lumens. One or more catheter hub lumens extend throughout the entire catheter hub 104 from the proximal end to the distal end.

[0055] Each of the one or more extension legs 106 is connected to the catheter hub 104 by its distal portion. Each of the one or more extension legs 106 contains one or more extension leg lumens, and the number of extension leg lumens corresponds to the number of catheter hub lumens. Each of the one or more extension leg lumens extends through the entire extension leg from the proximal end to the distal end.

[0056] Each of the one or more extension legs 106 includes a Luer connector 118 coupled to the extension leg, through which the extension leg and its lumen can be connected to another medical device and its lumen.

[0057] As illustrated, RICC100 is a triple-lumen RICC including three sets of lumens. However, RICC100 is not limited to the three sets of lumens described above. The three sets of lumens include a primary lumen 120, a secondary lumen 122, and a tertiary lumen 124, formed from the fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. The primary lumen 120 has a primary lumen opening 126 at the distal end of the first section 108 of the catheter tube 102, and the primary lumen opening 126 corresponds to the distal end of the catheter tube 102 and the distal end of RICC100. The secondary lumen 122 has a secondary lumen opening 128 on the side of the distal portion of the catheter tube 102. The tertiary lumen 124 has a tertiary lumen opening 130 on the side of the distal portion of the catheter tube 102, proximal to the secondary lumen opening 128.

[0058] Introducer Figures 6 to 10 show different diagrams of an introducer 132, which includes an introducer needle 134 and a splinterable introducer sheath 136, with and without a syringe 138, according to several embodiments. Figure 11 shows the distal portion of the introducer 132 according to several embodiments.

[0059] As shown in the figures, the introducer 132 includes an introducer needle 134 and an introducer sheath 136. In at least the operationally ready state of the introducer 132 configured to insert the RICC 100 into a patient, the introducer needle 134 is positioned within the introducer sheath 136. In other words, the introducer sheath 136 is positioned to cover the introducer needle 134, at least in the operationally ready state of the introducer 132 shown in Figures 6 to 10 and Figures 15 to 17.

[0060] Figure 13 shows the introducer needle 134 of the introducer 132 in several embodiments. The introducer needle 134 includes a needle shaft 140 and a needle hub 142 coupled to the proximal portion of the needle shaft 140.

[0061] The needle shaft 140 includes a needle tip 144 at the distal end of the needle shaft 140, a longitudinal gap 146, and a notch 148 at the proximal end of the needle shaft 140 distal to the needle hub 142.

[0062] The needle tip 144 includes a bevel 150 having a tip bevel 152 and a primary bevel 154 proximal to the tip bevel 152. The tip bevel angle of the tip bevel 152 (see ∠A in Figure 11) is greater than the primary bevel angle of the primary bevel 154 (see ∠B in Figure 11) so that the bevel 150 provides a smooth transition across the needle tip 144. Thus, such a needle tip is configured to establish a needle path from a region of skin to the lumen of a patient's blood vessel, according to the needle path establishment step of the method described later.

[0063] The longitudinal gap 146 extends distally from the notch 148 in the needle shaft 140 through the needle tip 144, thereby forming a needle channel along most of the length of the introducer needle 134, in contrast to the needle lumen that passes through the introducer needle 134. (In particular, the introducer needle 134 contains a needle lumen, but the needle lumen extends proximal from the notch 148 in the needle shaft 140 through the proximal end of the needle hub 142). The longitudinal gap 146 has a width dimensional to the outer diameter of the access guide wire 208, which will be described later, so that the access guide wire 208 can pass through the wider notch 148 in the needle shaft 140 through the needle tip 144 when the introducer needle withdrawal step of the method described later is performed.

[0064] The needle hub 142 may include a tapered or non-tapered male needle-hub connector 156 at its distal portion and a tapered female needle-hub connector 158 at its proximal portion. The male needle-hub connector 156 is configured to form a fluid-seal connection with a female sheath-hub connector 182, described later, at least when the introducer 132 is ready for operation. If the male needle-hub connector 156 is not tapered, it includes an O-ring 160 positioned in a circumferential groove around the male needle-hub connector 156, configured to form a fluid-seal connection. Such an O-ring is not required if the male needle-hub connector 156 is not tapered. The female needle-hub connector 158 is configured to form a fluid-seal connection with the syringe tip 204 of the syringe 138, described later.

[0065] Figure 14 shows the introducer sheath 136 of the introducer 132 according to several embodiments. The introducer sheath 136 includes a splittable sheath body 162 and a splittable sheath hub 164 coupled to the proximal portion of the sheath body 162. The introducer sheath 136 is configured such that the entire introducer sheath 136 covers the needle shaft 140 and needle hub 142 of the introducer needle 134, at least when the introducer 132 is ready for operation.

[0066] The sheath body 162 includes an opening 166 in its proximal portion and a sheath tip 168 in its distal portion (see Figure 12 for the opening 166). Despite the opening 166 being covered by the sheath hub 164 coupled to the proximal portion of the sheath body 162, the sheath body 162 is configured to seal the needle shaft 140 so that a vacuum can be drawn through the introducer needle 134, at least in the operational ready state of the introducer 132 shown in Figures 6-10 and 15-17.

[0067] The opening 166 has a width approximately equal to the width of the notch 148 in the needle shaft 140, and this width is wider than the width of the longitudinal gap 146 in the needle shaft 140, which is dimensioned according to the diameter of the access guide wire 208. Thus, the opening 166 is configured to allow the access guide wire 208 to pass through the opening 166 and enter the notch 148 in the needle shaft 140, at least when the introducer 132 is ready for operation.

[0068] The sheath tip 168 includes a taper 170 that widens from the outer diameter of the needle shaft 140 to the outer diameter of most of the sheath body 162. In other words, the taper 170 narrows from the outer diameter of most of the sheath body 162 to the outer diameter of the needle shaft 140. The taper 170 has a smaller taper angle (see ∠C in Figure 11) than the primary bevel angle (see ∠B in Figure 11) of the primary bevel 154 of the needle tip 144, and this taper angle is smaller than the tip bevel angle (see ∠A in Figure 11) of the tip bevel 152 of the needle tip 144. The sheath tip 168 including such a taper is configured to provide a smooth transition from the needle tip 144 to the sheath body 162 when the introducer 132 is ready for operation.

[0069] The sheath body 162 may also include one or more longitudinal body faults 172 (e.g., grooves, lines of weakening material, etc.), such as a pair of body faults 172 extending along opposing sides of the sheath body 162, if the sheath body 162 is not formed from a material configured to split or to propagate one or more cracks. For example, the sheath body 162 may be formed from a polymer material such as polytetrafluoroethylene, which facilitates a smooth and consistent split of the sheath body 162 without body faults 172 along the sides of the sheath body 162. In fact, when the sheath body 162 is pulled away from the access guide wire 208 after the sheath hub 164 has split, such a sheath body may be configured to split relative to the access guide wire 208, as described later. The one or more body faults 172, if present, include at least a primary body fault extending along at least a portion of the primary side of the introducer sheath 136 containing the port 174. In fact, the primary main fault may extend along the entire sheath body 162, as shown in Figure 12. If a pair of main faults 172 are present, the secondary main fault extends along at least a portion of the secondary side of the introducer sheath 136 opposite the primary side. Although not shown, the secondary main fault may extend along the entire sheath body 162.

[0070] The sheath hub 164 includes a splittable port 174 having a valve located on the primary side of the introducer sheath 136, and a pair of tabs 176 extending from the sheath hub 164 proximal to the port 174.

[0071] Port 174 is positioned to overlap the opening 166 in the proximal portion of the sheath body 162. Port 174 has a length approximately equal to the length of the opening 166, but its width is wider than the width of the opening 166, and houses a valve 178, such as a tearable septum compressed within port 174, a partially fractured septum, or a completely fractured septum, located above the opening 166 of the sheath body 162. As best shown in Figures 16 and 17, the valve 178 is configured to allow an access guidewire 208 to pass through the valve 178, through port 174, and into the opening 166 of the sheath body 162, in particular, to enable the blood aspiration step of the method described later by maintaining fluid-sealed access to the patient's vascular lumen using an introducer 132. Furthermore, in order to split the introducer sheath 136 and separate it from the access guide wire 208 according to the introducer sheath splitting step of the method described later, such a valve is configured to split together with the rest of the sheath hub 164.

[0072] Tabs 176 extend radially from opposing sides of sheath hubs 164 perpendicular to the primary and secondary sides of introducer sheath 136, and when present on the primary side of introducer sheath 136, tabs 176 are positioned at least perpendicular to the primary fault. Such tabs are configured to split the sheath hubs 164 when the tabs 176 are pulled apart from each other according to the introducer sheath splitting step of the method described later. Notwithstanding the foregoing, the tabs 176 do not need to be 180° apart from each other as shown. In fact, tabs 176 may extend radially from sides of sheath hubs 164 that are less than 180° apart (including less than 135° apart, such as less than 90° apart, such as approximately 67.5° apart), with the ports 174 facing the apex of the interior angle formed between the tabs 176. Such tabs are configured to split the sheath hub 164 when the tabs 176 are pressed against each other, such as by pinching the tabs 176 together with one hand.

[0073] The sheath hub 164 may also include a pair of longitudinal hub faults 180 (e.g., grooves, lines of weakening material, etc.) extending along opposing sides of the sheath hub 164. The hub faults 180, if present, include a primary hub fault and a secondary hub fault. The primary hub fault extends along at least a portion of the primary side of the introducer sheath 136 (i.e., the side of the introducer sheath 136 containing the port 174). In fact, the primary hub fault may extend along the entire sheath hub 164, as shown in Figure 9. Similarly, the secondary hub fault extends along at least a portion of the secondary side of the introducer sheath 136 opposite the primary side. The secondary hub fault may extend along the entire sheath hub 164, as shown in Figure 10. The sheath hub 164 is configured to split along both the primary and secondary hub faults 180 when the tab 176 is pulled apart (or pinched together) in order to propagate one or more tears resulting from splitting the sheath hub 164 along the sheath body 162 on the primary and secondary sides of the introducer sheath 136.

[0074] The sheath hub 164 may also include a tapered or non-tapered female sheath-hub connector 182 in the proximal portion of the sheath hub 164. The female sheath-hub connector 182 is configured to form a fluid-seal connection with the male needle-hub connector 156 described above, at least when the introducer 132 is ready for operation. In particular, non-tapered connectors are less likely to stick together than tapered connectors (e.g., Luer tapered connectors), which is advantageous for the introducer needle withdrawal step of the method described later, as the introducer needle withdrawal step involves withdrawing the introducer needle 134 from the introducer 132, leaving the introducer sheath 136 in the lumen of the patient's blood vessel.

[0075] Figure 18 shows the distal portion of another introducer 184 according to several embodiments. Similar to introducer 132, introducer 184 includes introducer needle 186 and splittable introducer sheath 188.

[0076] The introducer needle 186 of introducer 184 is similar to the introducer needle 134 of introducer 132 described above, except that 1) the needle shaft 190 of introducer needle 186 is of a larger gauge (e.g., 18 gauge) than the needle shaft 140 of introducer needle 134, in order to accommodate the catheter tube 102 of RICC100 (e.g., 16 gauge) when it is inserted. Therefore, the description of the introducer needle 134 of introducer 132 described above generally applies to the introducer needle 186 of introducer 184, except for the aforementioned main difference.

[0077] The introducer sheath 188 of introducer 184 is similar to the introducer sheath 136 of introducer 132 described above, with two main differences: 1) the sheath body 192 of introducer sheath 188 is typically larger in gauge than the sheath body 162 of introducer sheath 136 to accommodate the needle shaft 190 of introducer needle 186 when it is inserted; and 2) the sheath hub 194 of introducer sheath 188 includes side arms 196 and a splittable port 198 having a valve within the side arms 196 of the sheath hub 194. Similar to the sheath body 192, the port 198 of the sheath hub 194 is typically larger than the port 174 of the sheath hub 164 to accommodate the catheter tube 102 of RICC 100 when it is inserted. In particular, if primary and secondary hub faults are present, these hub faults extend along at least a portion of the primary and secondary sides of the introducer sheath 188, respectively, with the primary side of the introducer sheath 188 including port 198. Therefore, the above-described description of the introducer sheath 136 of introducer 132 generally applies to the introducer sheath 188 of introducer 184, with the exception of the two main differences mentioned above.

[0078] In either introducer 132 or 184, introducer 132 or 184 may further include a syringe 138. Syringe 138 includes a barrel 200, a plunger 202 positioned within the barrel 200, and a tapered male syringe tip 204 extending from the distal portion of syringe 138. Syringe tip 204 is configured to be inserted into the female needle-hub connector 158 described above, at least in the ready-to-operate state of introducer 132. Similarly, syringe tip 204 is configured to be inserted into the female needle-hub connector of introducer 184 shown in Figure 18. In fact, such syringes are useful for aspirating at least blood according to the blood aspiration step of the method described later.

[0079] RICC Insertion Assembly Figures 15 to 17 show different diagrams of the RICC insertion assembly 206 according to several embodiments.

[0080] As shown in the figure, the RICC insertion assembly 206 includes a RICC 100, an introducer 132, and an access guide wire 208 which is positioned in both the RICC 100 and the introducer 132 when the RICC insertion assembly 206 is ready for operation.

[0081] The RICC100 and introducer 132 have been described above. In particular, when the RICC insertion assembly 206 is ready for operation, the introducer 132 is also ready for operation, and its description has also been given above.

[0082] The access guidewire 208 extends along the entire primary lumen 120 of the RICC 100, through the valve 178 (e.g., a partition) of the port 174 of the sheath hub 164 of the introducer sheath 136, along the needle channel covered by the sheath body of the needle shaft 140 of the introducer needle 134, to a position in the introducer 132 proximal to the needle tip 144. In particular, the access guidewire 208 includes not only a wound portion of less than approximately 7 cm, but also a straight or unwound portion, where the wound portion of the access guidewire 208 is located in the distal portion of the access guidewire 208, including the distal end of the access guidewire 208. If the wound portion of the access guidewire 208 extends through the valve 178, leakage will occur at the valve 178, so the straight or unwound portion of the access guidewire 208 proximal to the wound portion extends through the valve 178. The position of the access guidewire 208 proximal to the needle tip 144 is advantageous for immediately advancing the distal end of the access guidewire 208 into the vascular lumen through the remainder of the introducer 132, following the establishment of the needle pathway into the vascular lumen, in accordance with the access guidewire advancement step of the method described later. In particular, the access guidewire 208 also includes a stopper 210 (e.g., a guidewire hub) around the proximal end of the access guidewire 208, which is configured to prevent loss of the RICC insertion assembly 206 or the access guidewire 208 in the patient, which could cause guidewire embolism, by preventing the access guidewire 208 from advancing too far during the access guidewire advancement step.

[0083] As described above with respect to the introducer 132, the RICC insertion assembly 206 may further include a syringe 138, as shown in the figure. Again, such a syringe is useful for aspirating at least blood according to the blood aspiration step of the method described later.

[0084] Figure 18 shows the distal portion of another RICC insertion assembly 212 according to several embodiments. Similar to the RICC insertion assembly 206, the RICC insertion assembly 212 includes, at least in the operational-ready state of the RICC insertion assembly 212, the RICC 100, the introducer 184, and the access guidewire 208. However, unlike the RICC insertion assembly 206, the catheter tube 102 of the RICC 100 is located within the introducer 184, at least in the operational-ready state of the RICC insertion assembly 212. In fact, the catheter tube 102 passes through the port 198 of the sheath hub 194 of the introducer sheath 188, along the side arm 196 of the sheath hub 194, along the needle channel of the needle shaft 190 of the introducer needle 186, to a position within the introducer 184 proximal to the needle tip 214 of the needle shaft 190. In addition, the RICC insertion assembly 212 may include a hollow stylet 216 positioned within the primary lumen 120 of the RICC 100, at least in the operational-ready state of the RICC insertion assembly 212, with the distal end of the stylet 216 extending to the same position as the distal end of the catheter tube 102 within the introducer 184, or to another position more proximal. In particular, the stylet 216 may be positioned within a Tuohy-Borst Luer connector (not shown), which is configured to connect to an extension leg of the primary lumen 120 of the RICC 100, including the extension leg lumen portion, thereby fluid-sealing the primary lumen 120 with the stylet 216 inside. A Tuohy-Borst Luer connector for sealing the stylet 216 within the primary lumen 120 of the RICC100, and a sealing means for sealing the access guidewire 208 within the stylet lumen of the stylet 216 (described later), are combined with a port 198 of a sheath hub 194 for sealing the catheter tube 102 of the RICC100 within the introducer sheath 188, thereby enabling the blood aspiration step of the method described later by providing fluid-sealed access to the patient's vascular lumen using the introducer 184.

[0085] The RICC100, introducer 184, and access guide wire 208 have been described above. In particular, when the RICC insertion assembly 212 is ready for operation, the introducer 184 is also ready for operation, and its description has also been given above.

[0086] The stylet 216 includes a tubular stylet body 218 having a stylet lumen, and sealing means for sealing the stylet 216, which is selected from a sealable stylet hub (not shown) around the proximal portion of the stylet body 218 and one or more internal O-rings.

[0087] The stylet body 218 is configured to occupy extra lumen space between the access guidewire 208 positioned within the stylet 216 and the lumen wall of the primary lumen 120 of the RICC 100, at least in the operational-ready state of the RICC insertion assembly 212. The stylet 216 is also configured to provide structural support for advancing the access guidewire 208 within the RICC insertion assembly 212 according to the access guidewire advancement step of the method described later. In fact, the stylet 216 reduces non-lumen movement of the access guidewire 208 during the access guidewire advancement step (i.e., movement that is not along or in conjunction with the lumen), which, in the absence of the stylet 216, could damage the primary lumen 120 of the RICC 100. Therefore, the distal end of the access guidewire 208 must extend to the same position as the distal end of the stylet 216 or to another position more proximal, at least when the RICC insertion assembly 212 is ready for operation, in order to prevent unintended non-luminal movement. Here again, the position of the access guidewire 208 proximal to the needle tip 214 is advantageous for immediately advancing the distal end of the access guidewire 208 into the vascular lumen through the remainder of the introducer 184, following the access guidewire advancement step that follows the establishment of the needle path into the vascular lumen.

[0088] If the sealing means for sealing the stylet 216 is a stylet hub, the stylet hub may include a Luer connector configured to connect to a Tuohy-Borst connector or another Tuohy-Borst Luer connector (i.e., another Tuohy-Borst Luer connector in addition to the Tuohy-Borst connector mentioned above for connecting to the extension leg of RICC 100). The access guide wire 208 is placed in either the Tuohy-Borst connector or the other Tuohy-Borst Luer connector, allowing the stylet lumen to be fluid-sealed with the access guide wire 208 inside. (In particular, since the stylet hub is also configured to prevent any over-advancement of the stylet 216, if the sealing means for sealing the stylet 216 is one or more internal O-rings, the stylet 216 may optionally include a stylet hub configured as a Luer connector). If the sealing means for sealing the stylet 216 is one or more internal O-rings, one or more internal O-rings may be positioned within the stylet lumen, either in the proximal portion of the stylet 216, in the distal portion of the stylet 216, or, in the case of any two or more internal O-rings, dispersed between the proximal and distal portions of the stylet 216. The one or more internal O-rings are configured to form a seal around the access guidewire 208 when the access guidewire 208 is positioned within the stylet 216. A Tuohy-Borst Luer connector for sealing the stylet 216 within the primary lumen 120 of the RICC100, and a sealing means for sealing the access guidewire 208 within the stylet lumen of the stylet 216, are combined with a port 198 of a sheath hub 194 for sealing the catheter tube 102 of the RICC100 within the introducer sheath 188, thereby enabling the blood aspiration step of the method described later by providing fluid-sealed access to the patient's vascular lumen using the introducer 184.

[0089] As described above with respect to the introducer 132, the RICC insertion assembly 212 may further include a syringe 138, as shown in the figure. Again, such a syringe is useful for aspirating at least blood according to the blood aspiration step of the method described later.

[0090] RICC insertion kit Although not shown, the RICC insertion kit includes the RICC 100, an introducer 132 or 184, an access guide wire 208, instructions for using the RICC insertion kit, and packaging. If the RICC insertion kit includes the introducer 184, the RICC insertion kit further includes a stylet 216. The aforementioned components of the RICC insertion assembly 206 or 212 are optionally assembled within the RICC insertion kit so that the RICC insertion assembly 206 or 212 is substantially ready for operation and placed in its packaging. Instructions for using the RICC insertion kit are placed inside the packaging or printed on the packaging.

[0091] method A method for inserting an RICC insertion assembly 206 or its components includes a method for inserting an RICC 100 into the lumen of a patient's blood vessel. This method includes one or more steps selected from the following: an assembly acquisition step, a needle path establishment step, an introducer sheath advancement step, an access guidewire advancement step, an ultrasound confirmation step, a blood aspiration step, an introducer needle withdrawal step, an introducer sheath splitting step, an RICC advancement step, an access guidewire withdrawal step, a maneuver guidewire advancement step, an additional RICC advancement step, and a maneuver guidewire withdrawal step.

[0092] The assembly acquisition step includes acquiring the RICC insertion assembly 206. Optionally, the RICC 100, introducer 132, and access guide wire 208 are acquired directly in a substantially operational-ready state of the RICC insertion assembly 206. If the RICC 100, introducer 132, and access guide wire 208 are not acquired directly in a substantially operational-ready state of the RICC insertion assembly 206, the assembly acquisition step may include assembling the aforementioned components in order to acquire the RICC insertion assembly 206 in at least a substantially operational-ready state of the RICC insertion assembly 206.

[0093] The needle pathway establishment step includes establishing a needle pathway from a skin area to the lumen of a blood vessel using the introducer 132. The needle pathway establishment step may include drawing a slight vacuum in the syringe 138 while establishing the needle pathway so that blood flows back into at least the introducer needle 134 when the needle pathway is established. With such vacuum drawing, the needle pathway establishment step can confirm that the needle pathway extends into the lumen of a blood vessel by ensuring that blood flows back into the longitudinal gap 146 of the introducer needle 134 if the sheath body 162 is formed of a transparent polymer material, into the needle hub 142 of the introducer needle 134 if the needle hub 142 is formed of a transparent polymer material, into the syringe tip 204, into the barrel 200 of the syringe 138, or a combination thereof.

[0094] The introducer sheath advancement step includes advancing the introducer sheath 136 onto the introducer needle 134 into the vascular lumen to secure vascular access for the RICC advancement step. When the introducer sheath advancement step is performed to secure vascular access for the RICC advancement step, the introducer sheath advancement step is performed before the access guidewire advancement step. However, alternatively, the access guidewire advancement step may be performed to secure vascular access for the RICC advancement step. When the access guidewire advancement step is performed to secure vascular access for the RICC advancement step, the introducer sheath advancement step is not required.

[0095] The access guidewire advancement step includes advancing the distal end of the access guidewire 208 from its initial position in the introducer 132 proximal to the needle tip 144 of the introducer needle 134 into the vascular lumen to secure or maintain vascular access for the RICC advancement step. The remainder of the access guidewire 208 extends proximal along the needle channel covered by the sheath body of the needle shaft 140 of the introducer needle 134, through the valve 178 of the port 174 on the side of the sheath hub 164 of the introducer sheath 136, along the entire primary lumen 120 of the RICC 100, and exits from the proximal end of the RICC 100. Again, the access guidewire 208 includes a stopper 210 (e.g., a guidewire hub) around the proximal end of the access guidewire 208, configured to prevent the access guidewire 208 from advancing too far during the access guidewire advancement step.

[0096] The ultrasound confirmation step includes confirming by ultrasound imaging that the access guidewire 208 is within the vascular lumen after the access guidewire advancement step. The blood aspiration step includes aspirating blood with a syringe 138 coupled to the introducer needle 134 to confirm that the needle path extends into the vascular lumen before performing the introducer needle withdrawal step. As described above, the width of the longitudinal gap 146 within the needle shaft 140 of the introducer needle 134 is dimensioned according to the outer diameter of the access guidewire 208. The needle shaft 140 has an inner diameter dimensioned according to the width of the longitudinal gap 146 within the needle shaft 140 such that the inner diameter of the needle shaft 140 is larger than the outer diameter of the access guidewire 208. This conveniently allows the blood aspiration step to be performed after the access guidewire advance step while the access guidewire 208 is securing or maintaining vascular access for the RICC advance step.

[0097] The introducer needle withdrawal step includes withdrawing the introducer needle 134 from the introducer 132 while leaving both the introducer sheath 136 and the access guidewire 208 in the vascular lumen. Again, the introducer needle 134 includes a longitudinal gap 146 extending from the proximal portion of the needle shaft 140 through the needle tip 144, thereby enabling the introducer needle withdrawal step while the access guidewire 208 remains in the vascular lumen.

[0098] The introducer sheath splitting step includes splitting the sheath hub 164, which includes the port 174 on the side of the sheath hub 164, by pulling apart the tabs 176 extending from the sheath hub 164. The introducer sheath splitting step also includes propagating one or more tears resulting from splitting the sheath hub 164 along the sheath body 162 of the introducer sheath 136. The step of propagating one or more tears may include continuing to pull apart the tabs 176 after splitting the sheath hub 164, or pulling the sheath body 162 away from the access guidewire 208 so that the sheath body 162 splits relative to the access guidewire 208. In this way, the introducer sheath 136 is split and detached from the access guidewire 208, and the split portion of the introducer sheath 136 is removed from the vascular lumen. To maintain vascular access using the access guidewire 208 for the RICC advancement step, it is advantageous to hold the access guidewire 208 in your hand or press it against the patient while the introducer sheath splitting step is performed.

[0099] The RICC advancement step includes inserting the RICC100 into the vascular lumen by advancing the distal portion of the catheter tube 102 of the RICC100 into the vascular lumen on the access guidewire 208.

[0100] The access guidewire withdrawal step includes withdrawing the access guidewire 208 while leaving the catheter tube 102 in the vascular lumen. The access guidewire withdrawal step also includes removing the access guidewire 208 from the primary lumen 120 of the RICC 100 so that the maneuvering guidewire advance step can be performed.

[0101] The guidewire advancement step includes advancing the guidewire into the vascular lumen through the primary lumen 120 of the RICC100. According to the guidewire advancement step, the distal portion of the guidewire can be advanced to the lower one-third of the SVC of the patient's heart.

[0102] An additional RICC advancement step includes further advancing the distal portion of the catheter tube 102 within the vascular lumen, on the maneuvering guidewire, to the lower third of the patient's SVC.

[0103] The guidewire withdrawal step includes withdrawing the guidewire while leaving the catheter tube 102 in the lower third of the SVC. Furthermore, the RICC insertion assembly 212 or its components includes a method for inserting the RICC 100 into the lumen of a patient's blood vessel. Similarly, this method includes one or more steps selected from the following: assembly acquisition step, needle path establishment step, introducer sheath advancement step, access guidewire advancement step, ultrasound confirmation step, blood aspiration step, introducer needle withdrawal step, introducer sheath splitting step, RICC advancement step, access guidewire withdrawal step, maneuvering guidewire advancement step, additional RICC advancement step, and maneuvering guidewire withdrawal step. However, this method or the aforementioned steps thereof may be modified as necessary according to the features of the RICC insertion assembly 212. For example, the RICC advancement step may be performed before the introducer sheath splitting step, because the catheter tube 102 of the RICC 100 is positioned within the introducer sheath 188 throughout the method until the introducer sheath splitting step is performed. In addition, additional steps in this method to the aforementioned steps may be performed as necessary according to the features of the RICC insertion assembly 212. For example, this method may include a stylet withdrawal step. However, the access guidewire removal step may also be modified to include withdrawing the stylet 216 together with the access guidewire 208 during the access guidewire removal step.

[0104] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concept provided herein. Additional improvements or modifications may be obvious to those skilled in the art, and in broader embodiments, these improvements or modifications are also encompassed. Thus, one may deviate from a particular embodiment disclosed herein without departing from the scope of the concept provided herein. [Note 1] A rapidly insertable central catheter (RICC), It is a catheter tube, A first section formed from a first polymer material having a first durometer, the first section being located in the distal portion of the catheter tube, A second section formed from a second polymer material having a second durometer smaller than the first durometer, the second section being located in the distal portion of the catheter tube, which is proximal to the first section of the catheter tube, A catheter tube comprising: a tapered joint between the first section and the second section of the catheter tube, the tapered joint having a length between the length of the exposed portion of the first section and the length of the exposed portion of the second section of the catheter tube; A catheter hub connected to the proximal portion of the catheter tube, An RICC comprising one or more extension legs, each of which is coupled to the catheter hub by its distal portion. [Note 2] The RICC as described in Appendix 1, wherein the proximal portion of the first section of the catheter tube is positioned within the hole of the distal portion of the joint and is bonded to the hole. [Note 3] The RICC as described in Appendix 1, wherein the distal end of the second section of the catheter tube is coplanar with the proximal end of the joint and is bonded to the proximal end. [Note 4] The RICC as described in Appendix 1, wherein the catheter tube is inserted into a needle pathway established by percutaneous puncture and has sufficient column strength to prevent buckling of the catheter tube when the catheter tube is advanced through the patient's vascular system without pre-dilating any blood vessels in the surrounding tissue or vascular system of the needle pathway using a separate dilator. [Note 5] The RICC described in any one of the appendices 1 to 4 comprises a set of three lumens, including a primary lumen, a secondary lumen, and a tertiary lumen, formed from the fluid-connected portions of three catheter tube lumens, three catheter hub lumens, and three extension leg lumens. [Note 6] The RICC as described in Appendix 5, wherein the primary lumen has a primary lumen opening at the distal end of the catheter tube, the secondary lumen has a secondary lumen opening on the side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary lumen opening on the side of the distal portion of the catheter tube located proximal to the secondary lumen opening.

Claims

1. A rapidly insertable central catheter (RICC) insertion assembly, RICC and, He is an introducer, It is an introducer needle, An introducer needle, including a needle shaft with a longitudinal gap extending distally from a notch located in its proximal portion through the needle tip, A splittable introducer sheath positioned to cover the needle shaft, A splittable sheath body for sealing the longitudinal gap of the needle shaft so that a vacuum can be drawn through the introducer needle, the sheath body includes a sheath opening positioned to overlap the notch of the needle shaft, A splittable sheath hub is attached to the proximal portion of the sheath body, An introducer, including a split introducer sheath, which includes A RICC insertion assembly comprising: an access guide wire positioned in both the RICC and the introducer, the access guide wire extending along the entire primary lumen of the RICC, through the valve of the port, through the sheath opening, along the needle channel of the needle shaft covered by the sheath body, to a position in the introducer proximal to the needle tip.

2. The RICC is a catheter tube, A first section formed from a first polymer material having a first durometer, the first section being located in the distal portion of the catheter tube, A second section formed from a second polymer material having a second durometer smaller than the first durometer, the second section being located proximal to the first section of the catheter tube and in the distal portion of the catheter tube, The RICC insertion assembly according to claim 1, comprising a catheter tube including a tapered joint between the first section and the second section of the catheter tube, the tapered joint having a length between the length of the exposed portion of the first section and the length of the exposed portion of the second section of the catheter tube.

3. The RICC insertion assembly according to claim 2, wherein the catheter tube has sufficient column strength to prevent buckling of the catheter tube when it is inserted into a needle pathway established by percutaneous puncture by the introducer and advanced through the patient's vascular system using a separate dilator without pre-dilating any blood vessels in the surrounding tissue or vascular system of the needle pathway.

4. The RICC insertion assembly according to claim 1, wherein the access guide wire includes an unwound portion and a wound portion, the unwound portion of the access guide wire extending through the valve of the port.

5. The RICC insertion assembly according to claim 1, wherein the valve includes a tearable or split partition compressed within the port, and the access guide wire extends through the partition.

6. The RICC insertion assembly according to claim 5, wherein the partition wall is positioned to cover the notch of the needle shaft.

7. The RICC insertion assembly according to claim 1, wherein the sheath body is configured to split relative to the access guide wire when the sheath body is pulled away from the access guide wire after the sheath hub has been split.

8. The RICC insertion assembly according to claim 1, wherein the sheath hub includes a non-tapered female sheath-hub connector in the proximal portion of the sheath hub.

9. The RICC insertion assembly according to claim 8, wherein the needle hub coupled to the proximal portion of the needle shaft includes a non-tapered male needle-hub connector configured to form a fluid-seal connection with the female sheath-hub connector at the distal portion of the needle hub.

10. The RICC insertion assembly according to claim 9, wherein the male needle-hub connector includes an O-ring disposed in a circumferential groove around the male needle-hub connector, configured to form the fluid-seal connection.

11. The RICC insertion assembly according to claim 9 or 10, further comprising a syringe including a tapered male syringe tip extending from the distal portion of the syringe, wherein the syringe tip is configured to be inserted into a tapered female needle-hub connector at the proximal portion of the needle hub.

12. An introducer for a rapidly insertable central catheter (RICC), It is an introducer needle, A needle shaft including a notch and longitudinal gap located in its proximal portion, A needle hub coupled to the proximal portion of the needle shaft, An introducer needle including a needle tip portion of the distal portion of the needle shaft, wherein the longitudinal gap extends from the notch located in the proximal portion of the needle shaft distal to the needle hub through the needle tip portion, At least when the introducer is ready for operation, a split introducer sheath is configured to cover the needle shaft, A split sheath body configured to seal the longitudinal gap of the needle shaft so that a vacuum can be drawn through the introducer needle, at least in the ready-to-operate state of the introducer, includes a sheath opening positioned to overlap the notch of the needle shaft, A splittable sheath hub is attached to the proximal portion of the sheath body, An introducer comprising: an introducer sheath including a splittable port having a valve located on the side of the sheath hub, configured to allow an access guide wire to enter the needle through the port and through the sheath opening.

13. The introducer according to claim 12, wherein the valve includes a tearable or split partition compressed within the port, the partition being configured to allow an access guide wire to pass through.

14. The introducer according to claim 13, wherein the partition wall is positioned to cover the notch of the needle shaft, at least when the introducer is ready for operation.

15. The introducer according to claim 12, wherein the sheath hub further includes a pair of tabs extending radially from the sheath hub, the tabs being configured to split the sheath hub by pulling them apart.

16. The introducer according to claim 12, wherein the sheath hub includes a pair of longitudinal hub faults, the hub faults comprising a primary hub fault along a portion of the primary side of the introducer sheath including the port, and a secondary hub fault along a portion of the secondary side of the introducer sheath opposite to the primary side, and the sheath hub is configured to split along both the primary and secondary hub faults and propagate along the sheath body on the primary and secondary sides of the introducer sheath.

17. The introducer according to claim 12, wherein the sheath hub includes a non-tapered female sheath hub connector in the proximal portion of the sheath hub.

18. The introducer according to claim 17, wherein the needle hub includes a non-tapered male needle-hub connector configured to form a fluid-seal connection with the female sheath-hub connector at least in the ready-to-operate state of the introducer, at the distal portion of the needle hub.

19. The introducer according to claim 18, wherein the male needle-hub connector includes an O-ring disposed in a circumferential groove around the male needle-hub connector, configured to form the fluid-seal connection.

20. The introducer according to claim 12, wherein the distal portion of the sheath body includes a taper that narrows from the outer diameter of most of the sheath body to the outer diameter of the needle shaft, and the taper provides a smooth transition from the needle tip to the sheath body when the introducer is ready for operation.

21. The introducer according to claim 20, wherein the taper has a taper angle smaller than either the tip bevel angle of the needle tip bevel or the primary bevel angle of the primary bevel.

22. The introducer according to any one of claims 12 to 21, further comprising a syringe including a tapered male syringe tip extending from the distal portion of the syringe, wherein the syringe tip is configured to be inserted into a tapered female needle-hub connector at the proximal portion of the needle hub.

Images